Farm Service Agency
Food and Nutrition Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
National Park Service
Surface Mining Reclamation and Enforcement Office
Drug Enforcement Administration
Employee Benefits Security Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Transit Administration
Foreign Assets Control Office
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.
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Federal Emergency Management Agency, U.S. Department of Homeland Security.
Final rule.
In accordance with the Privacy Act of 1974, the U.S. Department of Homeland Security is issuing a final rule to amend its regulations to exempt portions of a newly established system of records titled, “U.S. Department of Homeland Security/Federal Emergency Management Agency-015 Fraud Investigations System of Records” from specific provisions of the Privacy Act. This system of records includes records on individuals being investigated for or involved in an investigation relating to the misuse of federal disaster funds and/or benefits. Specifically, the Department exempts portions of the “-DHS/FEMA-015 Fraud Investigations System of Records” from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.
This final rule is effective November 19, 2024.
For general questions, please contact: Russell Bard, (202-646-3606), Privacy Officer, Federal Emergency Management Agency, and 500 C Street SW, Washington, DC 20478. For privacy questions, please contact: Deborah T. Fleischaker,
The U.S. Department of Homeland Security (DHS) Federal Emergency Management Agency (FEMA) published a Notice of Proposed Rulemaking (NPRM) in the
DHS/FEMA received a total of one public comment. The one comment was received on the NPRM.
DHS/FEMA received one public comment in support of the NPRM. The individual noted that they were “in agreeance with this proposed regulation. However, the individual also cited concerns about the parameters or stipulations from which a fraud investigation can be launched. The publication process for the Fraud Investigations SORN, as required by the Privacy Act, promotes the accountability, responsibility, legislative oversight, and open government requested by the commenter. In addition to the publication of the Fraud Investigations SORN in the
DHS received no comments on the SORN. After consideration of the one public comment, the Department will implement the rulemaking as proposed.
Freedom of information; Privacy.
For the reasons stated in the preamble, DHS/FEMA amends Chapter I of Title 6, Code of Federal Regulations, as follows:
6 U.S.C. 101
Subpart A also issued under 5 U.S.C. 552.
Subpart B also issued under 5 U.S.C. secs. 552a and 552 note.
90. The DHS/FEMA-015 Fraud Investigations System of Records consists of electronic and paper records that DHS and its components will use. The DHS/FEMA-015 Fraud Investigations System of Records is a repository of information held by DHS in connection with its several and varied missions and functions, including, but not limited to, the enforcement of civil and criminal laws; investigations, inquiries, and proceedings there under; national security and intelligence activities; and protection of the President of the U.S. or other individuals pursuant to Section 3056 and 3056A of Title 18. The DHS/FEMA-015 Fraud Investigations System of Records contains information that is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other federal, state, local, tribal, foreign, or international government agencies. The Secretary of Homeland Security, pursuant to 5 U.S.C. 522a (k)(2), has exempted this system from the following provisions of the Privacy Act, subject to limitations set forth in 5 U.S.C. secs. 552a(c)(3); (d); (e)(1); (e)(4)(G); (e)(4)(H); (e)(4)(I); and (f). When a record received from another system has been exempted in that source system under 5 U.S.C. 552a(j)(2), DHS will claim the same exemptions for those records that are claimed for the original primary systems of records from which they originated and claims any additional exemptions set forth here.
Exemptions from these particular subsections are justified on a case-by-case basis to be determined at the time a request is made for the following reasons:
(a) From subsection (c)(3) (Accounting for Disclosures) because the release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of the investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would, therefore, present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, tamper with witnesses or evidence, and avoid detection or apprehension, which would undermine the entire investigative process.
(b) From subsection (d) (Access and Amendment to Records) because access to the records contained in this system of records could apprise the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of the investigation and reveal investigative interest on the part of DHS or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, tamper with witnesses or evidence, and avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and impose an unreasonable administrative burden by requiring investigations to be continually reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to homeland security.
(c) From subsection (e)(1) (Relevancy and Necessity of Information) because in the course of investigations into potential violations of federal law, the accuracy of information obtained or introduced occasionally may be unclear, or the information may not be strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of unlawful activity.
(d) From subsections (e)(4)(G), (e)(4)(H), and (e)(4)(I) (Agency Requirements) and (f) (Agency Rules), because portions of this system are exempt from the individual access provisions of subsection (d) for the reasons noted above, and DHS is therefore not required to establish requirements, rules, or procedures with respect to such access. Providing notice to individuals concerning the existence of records about them in the system of records or otherwise setting up procedures pursuant to which individuals may access and view records pertaining to themselves in the system would undermine investigative efforts and reveal the identities of witnesses, potential witnesses, and confidential informants.
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain MD Helicopters, LLC (MDHI), Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters. This AD was prompted by a report of a seized and damaged roller bearing in the pilot interconnecting cyclic torque tube (torque tube) assembly. This AD requires repetitively inspecting the torque tube assembly and roller bearings, and depending on the results, replacing parts, or accomplishing additional inspections. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective December 24, 2024.
Eduardo Orozco-Duran, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone: (562) 627-5264; email:
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to MDHI Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters with a torque tube part number 369H7133-7 installed. The NPRM published in the
The FAA received no comments on the NPRM or on the determination of the costs.
The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes and clarifying two paragraph cross-references in the Required Actions section of this AD, paragraphs (g)(2)(iii)(A) and (g)(2)(iv), by replacing the text “paragraph (g)(2)(iii) of this AD” with “the introductory text of paragraph (g)(2)(iii) of this AD,” this AD is adopted as proposed in the NPRM.
The FAA estimates that this AD affects 353 helicopters of U.S. registry. Labor costs are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.
Visually inspecting the torque tube and roller bearings will take 1 work-hour for an estimated cost of $85 per helicopter and $30,005 for the U.S. fleet,
If required, replacing a torque tube will take 6 work-hours and parts will cost $4,773 for an estimated cost of $5,283 per torque tube replacement. Replacing a roller bearing will take 6 work-hours and parts will cost $210 for an estimated cost of $720 per roller bearing replacement.
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.
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.
This AD will not have federalism implications under Executive Order 13132. This AD will 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.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective December 24, 2024.
None.
This AD applies to MD Helicopters, LLC, Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters, certificated in any category, with a pilot interconnecting cyclic torque tube (torque tube) part number 369H7133-7 installed.
Joint Aircraft System Component (JASC) Code: 6700, Rotorcraft Flight Control.
This AD was prompted by a report of a seized and damaged roller bearing in the torque tube assembly. The FAA is issuing this AD to prevent failure of the torque tube assembly. The unsafe condition, if not addressed, could result in reduced controllability and subsequent loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 100 hours time-in-service (TIS) or within one year after the effective date of this AD, whichever occurs first, and thereafter at intervals not to exceed 100 hours TIS, accomplish the actions required by paragraphs (g)(1)(i) and (ii) of this AD.
(i) Using a flashlight and mirror, visually inspect the torque tube for corrosion and cracks. If there is any corrosion or a crack, before further flight, remove the torque tube from service and install an airworthy torque tube.
(ii) Visually inspect each roller bearing (number 5) as depicted in Figure 1 to paragraph (g)(1) of this AD for corrosion and degradation. If a roller bearing has any corrosion or degradation, before further flight, remove the roller bearing from service and install an airworthy roller bearing.
(2) Before the helicopter accumulates 3,000 total hours TIS or within 100 hours TIS after the effective date of this AD, whichever occurs later, and thereafter at intervals not to exceed 100 hours TIS, perform a freedom-of-movement inspection on the torque tube assembly by accomplishing the actions required by paragraphs (g)(2)(i) through (v) of this AD.
(i) Disconnect the one-way lock (number 6) of the torque tube by removing the cotter pin (number 7), nut (number 8), bolt (number 9), washers (number 10), and slotted bushing (number 11) from the torque tube assembly as depicted in Figure 1 to paragraph (g)(1) of this AD.
(ii) Loosen the longitudinal cyclic friction knob (number 12 or 13) of the torque tube assembly as depicted in Figure 1 to paragraph (g)(1) of this AD.
(iii) While moving the cyclic control forward and aft to allow the torque tube assembly to rotate through its full range of motion, inspect the torque tube assembly for binding and ratcheting.
(A) If there is any binding or ratcheting as a result of the action required by the introductory text of paragraph (g)(2)(iii) of
(B) If any roller bearing (number 5) as depicted in Figure 1 to paragraph (g)(1) of this AD has any damage, before further flight, remove the roller bearing from service and install an airworthy roller bearing.
(iv) If there is not any binding or ratcheting as a result of the action required by the introductory text of paragraph (g)(2)(iii) of this AD or after accomplishing the action required by paragraph (g)(2)(iii)(B) of this AD, as applicable, tighten the cyclic friction knob (number 12 or 13) as depicted in Figure 1 to paragraph (g)(1) of this AD.
(v) Connect the one-way lock (number 6) as depicted in Figure 1 to paragraph (g)(1) of this AD by accomplishing the actions required by paragraphs (g)(2)(v)(A) and (B).
(A) Install the slotted bushing (number 11), washers (number 10), bolt (number 9), nut (number 8), and new (zero total hours TIS) cotter pin (number 7) as depicted in Figure 1 to paragraph (g)(1) of this AD.
(B) Ensure the edge of the slotted bushing (number 11) protrudes 0.010 to 0.080 inch (0.25 to 2.03 mm) above the surface of the cyclic torque tube after the nut is tightened.
(1) The Manager, West Certification 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 West Certification Branch, send it to the attention of the person identified in paragraph (i) of this AD. Information may be emailed to:
(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.
For more information about this AD, contact Eduardo Orozco-Duran, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone: (562) 627-5264; email:
None.
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects final rule typographic errors published in the
The effective date of the final rule published on July 30, 2024 (89 FR 61012; corrected September 30, 2024 (89FR79429)) remains October 31,2024 0901 UTC. This correction is effective November 19, 2024.
A copy of this final rule, and all background material may be viewed online at
Rebecca Shelby, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5857.
The FAA published a final rule in the
Accordingly, pursuant to the authority delegated to me, the preamble for the final rule amending of Class D airspace at Dallas, TX, published in the
The FAA published an NPRM for Docket No. FAA-2024-2370 in the
Bureau of Industry and Security, Department of Commerce.
Interim final rule; extension of comment period.
On October 23, 2024, the Bureau of Industry and Security (BIS) published in the
The comment period for the interim final rule published October 23, 2024, at 89 FR 84770, is extended. Comments must be received by BIS no later than December 23, 2024.
Comments on this rule may be submitted to the Federal rulemaking portal at:
All filers using the portal should use the name of the person or entity submitting the comments as the name of their files, in accordance with the instructions below. Anyone submitting business confidential information should clearly identify the business confidential portion 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. 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 at:
For technical questions, contact Joseph A. Cristofaro, Director, Sensors, Aerospace and Marine Division, Office of National Security Controls, Bureau of Industry and Security, U.S. Department of Commerce, at 202-482-2440 or by email:
On October 23, 2024, BIS published in the
In response to requests from the regulated community, the Department of Commerce is extending the comment period for this rule (RIN 0694-AJ87) by 30 days.
Securities and Exchange Commission.
Final rule; technical amendments.
The Securities and Exchange Commission (“Commission”) is adopting technical amendments to various rules under the Investment Advisers Act of 1940 (“Advisers Act”) to reflect a Federal court's vacatur of new rules and rule amendments that the Commission adopted on August 23, 2023. The Commission adopted new rules designed to protect investors who directly or indirectly invest in private funds, corresponding amendments to the Advisers Act books and records rule to facilitate compliance with the new rules and assist examination staff, and additional amendments to the Advisers Act compliance rule to better enable staff to conduct examinations (together, the “Private Fund Adviser Rules”). The court's vacatur of the Private Fund Adviser Rules was effective as of June 5, 2024, and had the legal effect of: vacating the new rules and the reservation of a rule number in the Code of Federal Regulations (“CFR”); as well as vacating the amendments to the existing books and records and compliance rules such that those vacated amendments are no longer in effect. These technical amendments revise the CFR to reflect the court's vacatur of the Private Fund Adviser Rules.
Effective November 19, 2024; however, the Federal court issued its vacatur of the rule amendments June 5, 2024.
John Cavanagh, Senior Counsel; Robert Holowka, Branch Chief; Jennifer Porter, Assistant Director, Investment Adviser Regulation Office, Division of Investment Management at (202) 551-6787 or
The Commission is adopting technical amendments to the following rules: 17 CFR 275.206(4)-9, 17 CFR 275.206(4)-10, 17 CFR 275.211(h)(1)-1, 17 CFR 275.211(h)(1)-2, 17 CFR 275.211(h)(2)-1, 17 CFR 275.211(h)(2)-2, 17 CFR 275.211(h)(2)-3, 17 CFR 275.204-2, and 17 CFR 275.206(4)-7 under the Advisers Act.
On August 23, 2023, the Commission adopted the Private Fund Adviser Rules, which, through its constituent parts, would have protected investors who directly or indirectly invest in private funds and better enabled staff to conduct examinations. The Private Fund Adviser Rules became effective on November 13, 2023.
The Administrative Procedure Act (“APA”) generally requires an agency to publish notice of a rulemaking in the
The technical amendments do not impose any new substantive regulatory requirements on any person and merely reflect the vacatur of the Private Fund Adviser Rules. For these reasons, for good cause, the Commission finds that notice and public comment are unnecessary.
For similar reasons, although the APA generally requires publication of a rule at least 30 days before its effective date, the Commission finds there is good cause for the amendments to take effect on [INSERT DATE OF PUBLICATION IN THE
Pursuant to the Congressional Review Act, the Office of Information and Regulatory Affairs has designated these amendments as not a “major rule,” as defined by 5 U.S.C. 804(2).
Administrative practice and procedure, Reporting and recordkeeping requirements, Securities.
For the reasons set forth in the preamble, title 17, chapter II of the Code of Federal Regulations is amended as follows:
15 U.S.C. 80b-2(a)(11)(G), 80b-2(a)(11)(H), 80b-2(a)(17), 80b-3, 80b-4, 80b-4a, 80b-6(4), 80b-6a, 80b-11, 1681w(a)(1), 6801-6809, and 6825, unless otherwise noted.
Section 275.204-2 is also issued under 15 U.S.C. 80b-6.
(b)
Drug Enforcement Administration, Department of Justice; Substance Abuse and Mental Health Services Administration, Department of Health and Human Services.
Temporary rule.
The Drug Enforcement Administration (DEA) in concert with the Department of Health and Human Services (HHS) is issuing a third extension of telemedicine flexibilities for the prescribing of controlled medications, through December 31, 2025.
This rule is effective January 1, 2025, through December 31, 2025.
Heather E. Achbach, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882.
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), a prescribing practitioner—subject to certain exceptions—may prescribe controlled medications to a patient only after conducting an in-person evaluation of that patient. In response to the COVID-19 Public Health Emergency (COVID-19 PHE), as declared by the Secretary (the Secretary) of the Department of Health and Human Services (HHS) on January 31, 2020, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247), the Drug Enforcement Administration (DEA) granted temporary exceptions to the Ryan Haight Act and DEA's implementing regulations under 21 U.S.C. 802(54)(D).
In order to prevent lapses in care, these exceptions allowed for the prescribing of controlled medications via telemedicine encounters even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient. These telemedicine flexibilities authorized practitioners to prescribe schedule II-V controlled medications via audio-video telemedicine encounters, including schedule III-V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters, provided that such prescriptions otherwise comply with the requirements outlined in DEA guidance documents, DEA regulations, and applicable Federal and State law. DEA granted those temporary exceptions to the Ryan Haight Act and DEA's implementing regulations via two letters published in March 2020:
• A March 25, 2020 “Dear Registrant” letter signed by William T. McDermott, DEA's then-Assistant Administrator, Diversion Control Division (the McDermott Letter);
• A March 31, 2020 “Dear Registrant” letter signed by Thomas W. Prevoznik, DEA's then-Deputy Assistant
On March 1, 2023, DEA, in concert with HHS, promulgated two notices of proposed rulemaking (NPRMs) in the
On May 10, 2023 DEA, jointly with HHS (with the Substance Abuse and Mental Health Services Administration (SAMHSA) acting on behalf of HHS), issued the first temporary extension (First Temporary Rule), which extended the full set of telemedicine flexibilities regarding the prescribing of controlled medications, as had been in place under the COVID-19 PHE, through November 11, 2023.
On August 7, 2023, DEA announced that it would host Telemedicine Listening Sessions on September 12 and 13, 2023, in order to receive additional input concerning the practice of telemedicine with regards to prescribing controlled medications and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. On October 10, 2023, DEA, jointly with HHS, issued a second temporary extension (Second Temporary Rule) extending the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE, through December 31, 2024.
On June 13 and 27, 2024, DEA held virtual Tribal Consultations with numerous Tribal governments and organizations in order to elicit further comment from interested Tribal parties regarding the prescribing of controlled medications via telemedicine and its impact on Tribal persons. Additionally, in June 2024, DEA transmitted a new draft telemedicine NPRM to the Office of Management and Budget (OMB) for review under Executive Order (E.O.) 12866. Since then, DEA has also attended several meetings with interested parties coordinated by OMB pursuant to E.O. 12866, which have provided interested parties with the opportunity to provide further views to OMB.
With the deadline of December 31, 2024, granted by the Second Temporary Rule quickly approaching, DEA, jointly with HHS, is now issuing a third temporary extension (Third Temporary Rule) to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions. This additional time will allow DEA (and also HHS, for rules that must be issued jointly) to promulgate proposed and final regulations that are consistent with public health and safety, and that also effectively mitigate the risk of possible diversion. Furthermore, this Third Temporary Rule will allow adequate time for providers to come into compliance with any new standards or safeguards eventually adopted in a final set of regulations. DEA remains committed to carefully evaluating the comments received in response to the prior NPRMs, as well as the information and perspectives presented at the Telemedicine Listening Sessions, the Tribal Consultations, and the E.O. 12866 meetings.
The Ryan Haight Act amended the Controlled Substances Act (CSA) to generally require that the dispensing of controlled medications by means of the internet be predicated on a valid prescription involving at least one in-person medical evaluation.
One of these categories authorizes the Attorney General and the Secretary to jointly promulgate rules that would allow practitioners to prescribe medications for patients via telemedicine without having had an in-person evaluation when such telemedicine practice is in accordance with applicable Federal and State laws, uses an approved telecommunications system, and is “conducted under . . . circumstances that the[y have] . . . determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.”
Pursuant to this authority, DEA, jointly with HHS, is hereby promulgating this Third Temporary Rule specifying certain circumstances under which practitioners may
As noted previously, DEA and, for rules that must be issued jointly, HHS anticipate implementing a final set of regulations that are consistent with the public health and safety and that also effectively mitigate the risk of possible diversion. However, given the impending expiration of the flexibilities provided in the Second Temporary Rule and the additional consideration of the input received during the Telemedicine Listening Sessions, the Tribal Consultations, and the E.O. 12866 meetings, DEA, jointly with HHS, has elected to again extend those flexibilities to maintain access to care during a limited window of time as the agencies consider the appropriate pathway forward.
As explained further below, because this is an extension of limited duration of flexibilities that existed during the COVID-19 PHE, DEA and HHS have determined that this Third Temporary Rule is consistent “with effective controls against diversion and otherwise consistent with the public health and safety” as required under 21 U.S.C. 802(54)(G). Thus, DEA, jointly with HHS, is promulgating this temporary rule pursuant to 21 U.S.C. 802(54)(G).
HHS has advised DEA that no additional rulemaking by HHS is necessary as it pertains to the promulgation of these provisions pursuant to 21 U.S.C. 802(54)(G).
The purpose of this rulemaking is to further extend, for a limited period of time, the telemedicine flexibilities that existed during the COVID-19 PHE in order to:
• Prevent a reduction in access to care for patients who do not yet have an existing telemedicine relationship with their practitioners pending promulgation of a final rule or rules addressing telemedicine more generally;
• For relationships established both during the COVID-19 PHE and those established during the prior extensions, prevent backlogs with respect to in-person medical evaluations in the months shortly before and after the expiration of the telemedicine flexibilities and ensure the availability of telemedicine for practitioners and patients who have come to rely on it;
• Address the urgent public health need for continued access to buprenorphine as medication for opioid use disorder in the context of the continuing opioid public health crisis;
• Allow patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine;
• Enable DEA to continue considering the presentations made at the Telemedicine Listening Sessions, the Tribal Consultations, and the E.O. 12866 meetings;
• Enable DEA, with HHS for rules that must be issued jointly, to conduct a thorough evaluation of regulatory alternatives in order to promulgate regulations that most effectively expand access to telemedicine encounters in a manner that is consistent with the public health and safety, while also effectively mitigating against the risk of possible diversion; and
• Avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices by limiting the third extension of flexibilities to a short, time-limited period.
This Third Temporary Rule amends portions of 21 CFR 1307.41 and 42 CFR 12.1 through December 31, 2025.
Paragraph (a) is amended to state that the authorization granted in the amended paragraph (c) expires at the end of December 31, 2025, instead of December 31, 2024.
Current paragraph (b) is deleted.
Current paragraph (c) is redesignated as paragraph (b) and is amended to reflect that current paragraph (d) has been deleted and to extend the COVID-19 telemedicine prescribing flexibilities through December 31, 2025, provided all the conditions listed in current paragraph (e) are met.
Current paragraph (d) is deleted.
Current paragraph (e) is redesignated as paragraph (c) and is amended to reflect that current paragraphs (b) and (d) have been deleted.
DEA and HHS are using the revise and republish instruction to reflect these changes as parts of newly redesignated paragraph (c) are not changing.
DEA and HHS are issuing this rule without prior notice and an opportunity to comment pursuant to the Administrative Procedure Act's (APA's) “good cause” exception. In certain circumstances, agencies may forgo notice-and-comment rulemaking when a rulemaking is published in the
As discussed earlier, DEA, jointly with HHS, is publishing this third temporary extension of certain exceptions to existing DEA regulations, granted in March 2020 as a result of the COVID-19 PHE, in order to prevent reduced access to care for patients that do not yet have an existing telemedicine relationship with their practitioners pending promulgation of a final rule or rules addressing telemedicine more generally. It would be impracticable for DEA and HHS to publish a notice of proposed rulemaking; await, review, and respond to new comments; and issue a rule in the time remaining before the second extension expires on December 31, 2024. Further, the reduction in access to care that patients would experience if the existing telemedicine flexibilities ended on December 31, 2024 would be contrary to the public interest, as it could lead to potential patient harm—due to an inability to access appropriate care—in some instances.
As noted above, in March 2023, DEA received 38,369 comments on two proposed rules regarding the flexibilities that would be extended by this rule. DEA considered those comments in publishing the First Temporary Rule and Second Temporary Rule.
For these reasons, each of which individually constitutes good cause, DEA, jointly with HHS, finds that notice and public comment on this rule are impracticable, unnecessary, and contrary to the public interest.
This Third Temporary Rule was developed in accordance with the principles of E.O. 12866, as amended by E.O. 14094 and E.O. 13563. E.O. 12866 directs 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 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review established in E.O. 12866.
The economic, interagency, budgetary, legal, and policy implications of this temporary rule have been examined, and DEA has determined that it is a significant regulatory action under E.O. 12866, but not a Section 3(f)(1) significant regulatory action. Accordingly, this rule has been submitted to OMB for review.
DEA, jointly with HHS, is publishing this Third Temporary Rule to further extend certain exceptions DEA granted to its existing regulations in March 2020 as a result of the COVID-19 PHE in order to avoid a lapse of care for patients. The additional extension of the COVID-19 flexibilities until December 31, 2025, is necessary to thoroughly consider the presentations made at the Telemedicine Listening Sessions, the Tribal Consultations, the E.O. 12866 meetings, as well as the comments made to the proposed rules set forth in the March 2023 NPRMs.
Without this Third Temporary Rule, the COVID-19 PHE telemedicine flexibilities are scheduled to expire on December 31, 2024. This rule extends the expiration of those flexibilities through December 31, 2025. Because this rule does not create or remove any regulatory requirements, DEA and HHS estimate that there is no cost associated with this Third Temporary Rule. However, DEA and HHS believe this extension creates a benefit in the form of cost savings to prescribers and patients and reduced transfer payments to the Federal Government, similar to those described in the General Telemedicine NPRM. However, DEA is unable to quantify the cost savings and reduction in transfer payments.
The Third Temporary Rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This Third Temporary Rule does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This Third Temporary Rule does not have substantial direct effects on the Tribes, on the relationship between the national government and the Tribes, or the distribution of power and responsibilities between the Federal Government and Indian Tribes. However, DEA has determined that there is a reasonable basis that the March 2023 NPRMs may have Tribal implications, consistent with the definition in E.O. 13175. As such, DEA engaged in virtual consultations with numerous Tribal governments and organizations on June 13 and 27, 2024. DEA plans to incorporate the concerns raised during those virtual consultations when a final set of regulations is promulgated.
The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this Third Temporary Rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. This Third Temporary Rule, as discussed above, merely extends for a limited time the status quo with respect to the current flexibilities allowed during the COVID-19 PHE, in order to avoid lapses in coverage for patients.
Without this Third Temporary Rule, the COVID-19 PHE telemedicine flexibilities would expire on December 31, 2024. While this Third Temporary Rule does not create or remove any regulatory requirements, this Third Temporary Rule extends the expiration of those flexibilities through December 31, 2025. DEA and HHS believe this extension creates a benefit in the form of cost savings to prescribers and patients and reduced transfer payments to the Federal Government.
In accordance with the RFA, DEA will be evaluating the impact on small entities at the time the final rule or rules are issued as part of these rulemakings.
The estimated annual impact of this rule is minimal. Thus, DEA has determined in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This temporary rule is not a major rule as defined by Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act or CRA).
This temporary rule will not impose a new collection or modify an existing collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Also, this temporary rule does not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or other organizations. 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.
Administrative practice and procedure, Drug traffic control, Prescription drugs.
Administrative practice and procedure, Drug traffic control, Prescription drugs.
For the reasons set out above, the Drug Enforcement Administration amends 21 CFR part 1307 as follows:
21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.
(a) This section is in effect until the end of the day December 31, 2025. The authorization granted in paragraph (b) of this section expires at the end of December 31, 2025.
(b) During the period May 12, 2023, through December 31, 2025, a DEA-registered practitioner is authorized to prescribe schedule II-V controlled substances via telemedicine, as defined in 21 CFR 1300.04(i), to a patient without having conducted an in-person medical evaluation of the patient if all of the conditions listed in paragraph (c) of this section are met.
(c) A practitioner is only authorized to issue prescriptions for controlled substances pursuant to paragraph (b) of this section if all of the following conditions are met:
(1) The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
(2) The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3);
(3) The practitioner is:
(i) Authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled substance specified on the prescription; or
(ii) Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d); and
(4) The prescription is consistent with all other requirements of 21 CFR part 1306.
For the reasons set out above, the Department of Health and Human Services amends 42 CFR part 12 as follows:
21 U.S.C. 802(54)(G).
(a) This section is in effect until the end of the day December 31, 2025. The authorization granted in paragraph (b) of this section expires at the end of December 31, 2025.
(b) During the period May 12, 2023, through December 31, 2025, a Drug Enforcement Administration (DEA)-registered practitioner is authorized to prescribe schedule II-V controlled substances via telemedicine, as defined in 21 CFR 1300.04(i), to a patient without having conducted an in-person medical evaluation of the patient if all of the conditions listed in paragraph (c) of this section are met.
(c) A practitioner is only authorized to issue prescriptions for controlled substances pursuant to paragraph (b) of this section if all of the following conditions are met:
(1) The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
(2) The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3);
(3) The practitioner is:
(i) Authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled substance specified on the prescription; or
(ii) Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d); and
(4) The prescription is consistent with all other requirements of 21 CFR part 1306.
This document of the Drug Enforcement Administration and the Department of Health and Human Services was signed on November 14, 2024, by DEA Administrator Anne Milgram and the HHS Assistant Secretary for Mental Health and Substance Use. Those documents with the original signatures and dates are maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule; approving, in part.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving, in part, an amendment to the Montana regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). During the 2019 legislative session, Montana updated its Montana Strip and Underground Mine Reclamation Act codified in the Montana Code Annotated. Accordingly, Montana submitted this amendment to OSMRE on its own initiative. The amendment requires a permit applicant's compliance information to be updated and approved if a bankruptcy or reorganization results in
The effective date is December 19, 2024.
Jeffrey Fleischman, Field Office Director, Office of Surface Mining Reclamation and Enforcement, 100 East B Street, Casper, Wyoming 82602, Telephone: (307) 261-6550, Email:
Section 503(a) of SMCRA permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior approved the Montana program on October 24, 1980. You can find background information on the Montana program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Montana program in the October 24, 1980,
By letter dated February 16, 2023 (Administrative Record No. MT-040-01), Montana sent OSMRE an amendment to its program under SMCRA (30 U.S.C. 1201
Second, Montana proposed to add language at Mont. Code Ann. sec. 82-4-222(1)(g)(iii) that would require DEQ to develop rules for permit owners to provide bonding or other financial assurance necessary to meet their financial obligations for employee pensions and reclamation obligations. Furthermore, operators would be prohibited from passing associated costs from financial assurance for employee pension programs onto purchasers who are dependent on the operator to generate electricity for customers. Lastly, Montana proposed a typographical correction at Mont. Code Ann. sec. 82-4-222(1)(q).
SB 201 states that the purpose of the statute is to ensure private pensions plans remain in good standing and that employees who have earned benefits under those plans receive them. It also states that it is imperative that private employers not backtrack on pension plans or shift the burden to the State of Montana, and that if a private pension plan fails to provide earned benefits, the State of Montana may be burdened with additional financial responsibilities and demands.
We announced receipt of the proposed amendment in the May 23, 2023,
The following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving, in part, the amendment as described below.
We are not approving Montana's proposed revision of Mont. Code Ann. sec. 82-4-222(1)(g)(i). Montana proposed a substantive revision to Mont. Code Ann. sec. 82-4-222(1)(g)(i) that does not have a direct counterpart in the Federal regulations. As proposed, Mont. Code Ann. sec. 82-4-222(1)(g)(i) would require an applicant for a permit to update its compliance history and ownership and control information in the Applicant Violator System and with the Montana DEQ if bankruptcy or reorganization results in changes in a permittee's officers, partners, directors, “or any individual owning of record or beneficially, alone or with associates, 10% or more of any class of stock of the applicant.”. The proposed language would also require that DEQ approve these changes.
Montana's proposed amendment conflicts with Federal regulations because all changes to ownership information resulting from bankruptcy would trigger permit approval provisions and give DEQ approval authority over changes in a permittee's applicant and operator information. Under Federal regulations, while a regulatory authority has approval authority over transfer, assignment, or sale of permit rights (TAS), it does not have approval authority over changes in applicant and operator information. See 30 CFR 774.17. OSMRE clarified this distinction in its December 3, 2007, rule, which states that “a change of a permittee's owners or controllers does not constitute a transfer, assignment, or sale.” (72 FR 68000, 68008-09). While there could be situations related to bankruptcy that would trigger a TAS, such as the conveying of permit rights to a new person or a reorganization resulting in a new type of business entity, not all changes from bankruptcy, including a change in individual owners or operators, would trigger a TAS. Under the proposed regulation, all changes resulting from bankruptcy trigger a TAS, even when those changes do not effectuate a transfer, assignment, or sale of permit rights, and that conflicts with the Federal regulations.
With this issue in mind, OSMRE is denying the proposed amendment to Mont. Code Ann. sec. 82-4-222(1)(g)(i). We note that this permittee information is still required to be updated anytime there is a change of ownership or control, regardless of the reason for the change. And while the regulatory authority must require changes to ownership and control information to be updated in the Applicant Violator System, it cannot provide for all ownership and control information changes resulting from bankruptcy to trigger the need for a permit approval.
We note that the proposed amendment to Mont. Code Ann. sec. 82-4-222(1)(g)(i) has only been interpreted in terms of whether the
While we understand and commend Montana's effort to limit the financial burden on the State should a bankruptcy occur, this section of the statute, as currently written, is less effective than the Federal regulations and must be denied. We encourage Montana and DEQ to resubmit the amendment with changes addressing this issue to OSMRE through the informal amendment process. Through the informal amendment process, OSMRE and the State can collaborate on proposed changes to Montana's coal regulations that may achieve the State's goal of lessening the State's financial burden while also meeting SMCRA requirements.
We are not approving Montana's proposed revision of Mont. Code Ann. sec. 82-4-222(1)(g)(iii). Montana proposed a substantive revision to Mont. Code Ann. sec. 82-4-222(1)(g)(iii) that does not have a direct counterpart in the Federal regulations. As proposed, Mont. Code Ann. sec. 82-4-222(1)(g)(iii) would require the DEQ to develop rules for permit owners to provide bonding or other financial assurance necessary to meet its financial obligations for employee pensions and reclamation obligations. Operators are prohibited from passing associated costs from financial assurance for pension programs onto purchasers who are dependent on the operator to generate electricity for customers. Following our review, OSMRE has noted the following issues with this proposed section:
First, while normally outside the purview of SMCRA, requiring pension bonds could impact Montana's ability to fully collect on a performance bond as required by 30 U.S.C. 1259(a). In a situation where both a pension and a reclamation bond would be forfeited at the same time, there is the potential that fulfilling a pension bond could interfere with Montana's ability to fully collect the mining operation's performance bond. This is especially true if an operation is self-bonded or if both the performance and pension bond come from the same surety company. Therefore, Montana's inclusion of pension bonds in this framework would make its program less effective in accomplishing SMCRA's requirements than the Federal program.
Second, while we have not made an official determination as to whether a prohibition on passing costs associated with bonds, reclamation, or otherwise onto purchasers who depend on the mine to generate electricity conflicts with SMCRA or our regulations, we believe the proposed prohibition on passing costs associated with pension bonds onto these purchasers conflicts with SMCRA because pension bonds in this framework conflict with 30 U.S.C. 1259(b) (see above). Because this proposed prohibition is applicable to pension bonds only, it cannot be approved in part.
With these issues in mind, we are denying the proposed changes to Mont. Code Ann. sec. 82-3-222(1)(g)(iii). Please note that the proposed amendment to Mont. Code Ann. sec. 82-4-222(1)(g)(iii) has only been interpreted in terms of whether the section conflicts with SMCRA and its regulations. There has been no official determination as to whether Mont. Code Ann. sec. 82-4-222(1)(g)(iii) conflicts with other Federal laws, like the Employee Retirement Income Security Act (ERISA) at 29 U.S.C. 1001-1461.
While we understand and commend Montana's effort to limit the financial risk to pension programs and the financial burden on the State should a bankruptcy occur, this section of the statute, as currently written, is less effective than the Federal regulations and must be denied. The financial assets would be at the discretion of the bankruptcy court, and the pension bonds could take precedence over the reclamation bonds, leaving inadequate funding for DEQ to collect on the reclamation bond and reclaim the permit. We encourage Montana and DEQ to resubmit the amendment, with changes addressing the efficacy issue, to OSMRE through the informal amendment process. Through the informal amendment process, OSMRE and the State can collaborate on proposed changes to Montana's coal regulations that may achieve the State's goals for employee pension protection against bankruptcy and lessening of the State's financial burden while also meeting SMCRA requirements.
We are approving Montana's proposed revision of Mont. Code Ann. sec. 82-4-222(1)(q). Montana proposed a minor revision to Mont. Code Ann. sec. 82-4-222(1)(q). The specific minor revision to Mont. Code Ann. sec. 82-4-222(1)(q) is a correction of a typographical error, removing the word “and” from the end of the section. Montana does not propose any substantive changes to the text of this previously approved section. Because the proposed revision is minor and results in no substantive changes to the Montana program, we are approving the revision and find that it is no less effective than the corresponding Federal regulations at 30 CFR part 780.
We asked for public comments on the proposed rule and received none.
On February 23, 2023, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Montana program (Administrative Record No. MT-040-06). We received one comment from the Bureau of Land Management saying it has reviewed the document and has no comments to offer (Administrative Record No. MT-040-07).
Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On February 21, 2023, we requested comments on the Montana amendment (Administrative Record No.MT-040-04 and MT-040-05). We did not receive comments from the SHPO or ACHP.
Based on the above findings, we are approving, in part, Montana's proposed amendment (MT-040-FOR) that it sent to OSMRE on February 26, 2023
This rule would not effect a taking of private property or otherwise have taking implications that would result in public property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.
Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), the approval of State program amendments is exempted from OMB review under Executive Order 12866, as amended by Executive Order 14094. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.
The Department of the Interior has reviewed this rule as required by Section 3 of Executive Order 12988. The Department determined that this
This rule has potential Federalism implications, as defined under Section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. Montana, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the state level. This rule approves in part an amendment to the Montana program submitted and drafted by the State and, thus, is consistent with the direction to provide maximum administrative discretion to States.
The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal government and Tribes. The basis for this determination is that our decision on the Montana program does not include Indian lands as defined by SMCRA or other Tribal lands and it does not affect the regulation of activities on Indian lands or other Tribal Lands. Indian lands under SMCRA are regulated independently under the applicable approved Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.
Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not a significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.
Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C).
This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in
This rule does not impose an unfunded mandate on State, local, or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
State regulatory program approval, State-Federal cooperative agreement, required program amendments.
For the reasons set out in the preamble, 30 CFR part 926 is amended as set forth below:
30 U.S.C. 1201
Office of Foreign Assets Control, Treasury.
Publication of a web general license.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing a general license (GL) issued pursuant to the Iranian Transactions and Sanctions Regulations and Global Terrorism Sanctions Regulations: GL N. This GL was previously made available on OFAC's website.
GL N was issued on June 17, 2021. See
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Compliance, 202-622-2490 or
This document and additional information concerning OFAC are available on OFAC's website:
On June 17, 2021, OFAC issued GL N to authorize certain transactions otherwise prohibited by the Iranian Transactions and Sanctions Regulations, 31 CFR part 560, the Global Terrorism Sanctions Regulations, 31 CFR part 594, or Executive Order 13224 of September 23, 2001 (“Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism,” 66 FR 49079), as amended. GL N was made available on OFAC's website (
(a)
(1)
(2)
(3)
(b)
(c)
(d) Any exportation or reexportation of goods or technology pursuant to paragraph (a) of this general license is subject to the following conditions:
(1) Any goods or technology exported or reexported must:
(i) Be designated as EAR99 under the Export Administration Regulations, 15CFR parts 730 through 774 (EAR); or
(ii) In the case of goods or technology that are not subject to the EAR, not be listed on any multilateral export control regime; and
(2) All exports or reexports made pursuant to this general license must be concluded prior to the expiration date of this general license.
(e) This general license does not authorize:
(1) The exportation or reexportation of goods or technology to CBI, NIOC, or any entity in which NIOC owns, directly or indirectly, a 50 percent or greater interest;
(2) The exportation or reexportation of any goods, technology, or services to military, intelligence, or law enforcement purchasers or importers;
(3) The exportation or reexportation of any goods, technology, or services used to facilitate the development or production of a chemical or biological weapon or weapon of mass destruction;
(4) The unblocking of any property blocked pursuant to any part of 31 CFR chapter V; or
(5) Any transactions or activities otherwise prohibited by the ITSR, the GTSR, or E.O. 13224, as amended, or prohibited by any other part of 31 CFR chapter V, or involving any person blocked pursuant to the GTSR or E.O. 13224, as amended, except as identified in paragraph (b) of this general license.
Dated: June 17, 2021.
Office of Foreign Assets Control, Treasury.
Publication of a determination.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing a sector determination pursuant to a January 10, 2020 Executive Order. The determination was previously issued on OFAC's website.
The determination was issued on October 11, 2024. See
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Compliance, 202-622-2490 or
This document and additional information concerning OFAC are available on OFAC's website:
On January 10, 2020, the President, invoking the authority of,
On October 11, 2024, the Secretary of the Treasury, in consultation with the Department of State, determined that section 1(a)(i) of E.O. 13902 shall apply to the petroleum and petrochemical sectors of the Iranian economy. This determination took effect on October 11, 2024.
The determination was made available on OFAC's website (
Section 1(a)(i) of Executive Order (E.O.) 13902 of January 10, 2020 (“Imposing Sanctions With Respect to Additional Sectors of Iran”) imposes economic sanctions on any person determined by the Secretary of the Treasury, in consultation with the Secretary of State, to operate in such sectors of the Iranian economy as may be determined by
To further address the unusual and extraordinary threat to the national security, foreign policy, and economy of the United States described in E.O. 12957 of March 15, 1995 (“Prohibiting Certain Transactions With Respect to the Development of Iranian Petroleum Resources”) and E.O. 13902, and in consultation with the Department of State, I hereby determine that section 1(a)(i) of E.O. 13902 shall apply to the petroleum and petrochemical sectors of the Iranian economy. Any person determined to operate in these sectors shall be subject to sanctions pursuant to section 1(a)(i).
This determination shall take effect on October 11, 2024.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing approval of a state implementation plan (SIP) revision submitted by the State of California to meet Clean Air Act (CAA or “Act”) requirements for the 1997 fine particulate matter (PM
This rule is effective on December 19, 2024.
The EPA has established dockets for this action under Docket ID No. EPA-R09-OAR-2024-0250 and EPA-R09-OAR-2024-0301. All documents in the dockets are listed on the
Ashley Graham, Geographic Strategies and Modeling Section (AIR-2-2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105; phone: (415) 972-3877; email:
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On July 8, 2024, the EPA proposed two actions related to the CAA requirements for the 1997 annual PM
In the first action, under CAA section 110(k)(3), the EPA proposed to approve through parallel processing the “Amendments to the 15 µg/m
In the second action, based in part on our proposal to approve the 15 µg/m
For details regarding the EPA's reasons for proposing to approve the 15 µg/m
On August 22, 2024, California submitted the final version of the 15 µg/m
The public comment period for the proposed rulemakings opened on July 8, 2024, the date of publication of both proposals in the
The EPA received nine comment submissions in response to the proposal to grant the one-year extension of the attainment date for the 1997 annual PM
CCAC also expressed concern that PM
Moreover, 2023 annual mean concentrations were lower than annual mean concentrations in 2021 and 2022, indicating an improvement in air quality conditions in 2023 relative to previous years.
The EPA notes that while this final action extends the attainment date for the San Joaquin Valley for the 1997 annual PM
As CCAC accurately explains, the EPA reclassified the San Joaquin Valley as Serious nonattainment for the 1997 annual PM
Crucially, following a finding of failure to attain for a Serious PM
[T]he State in which such area is located shall, after notice and opportunity for public comment, submit within 12 months after the applicable attainment date, plan revisions which provide for attainment of the [PM
With respect to the new applicable attainment date for an area governed by CAA section 189(d), the EPA explained in the PM
[T]he final rule includes the overarching requirement for a Serious area that failed to attain by the previous attainment date to establish a new date for attaining the standard as expeditiously as practicable. However, neither CAA section 189(d) nor other sections in subpart 4 explicitly establish or provide the authority to establish a new attainment date for the area. Therefore, once an area is beyond the attainment dates that Congress specified in subpart 4 for the
Thus, subpart 4 controls the requirements for an attainment plan under CAA section 189(d); however, after a Serious PM
Contrary to the commenter's assertion, section 172 explicitly provides for the extension that the EPA is finalizing as part of this action. The commenter cites CAA section 172(a)(2)(D), which states, “[t]his paragraph shall not apply with respect to nonattainment areas for which attainment dates are specifically provided under other provisions of this part.” But as explained above, the attainment date for an attainment plan required under CAA section 189(d) is not specifically provided under the provisions in subpart 4, which is why the EPA relied on section 172 in setting the December 31, 2023 attainment date for the San Joaquin Valley.
Because CAA section 172 controls for purposes of setting an attainment date for a plan required under CAA section 189(d), it is logical and reasonable that the generally applicable provisions in section 172 would control an extension of that attainment date in the absence of any specific authority in subpart 4 for such extensions.
In contrast, the authority for the requirements in 40 CFR 51.1004(a)(3) governing nonattainment areas subject to CAA section 189(d) for failure to attain by the applicable Serious area attainment date comes from CAA section 172(a)(2)(C), not section 188. As explained in Response 2.A, CAA section 172 controls for purposes of setting an attainment date for a plan required under CAA section 189(d) because the provisions of subpart 4, including section 188(c), do not specifically provide authority for establishing attainment dates for 189(d) attainment plans. Because a state required to adopt and submit a 189(d) plan is subject to the attainment date requirements of CAA section 172(a)(2),
Santa Rosa Rancheria's comment letter notes an attachment that appeared to be inadvertently omitted from the comment submission. The EPA followed up with Santa Rosa Rancheria regarding the data referenced in its letter, and in response, Santa Rosa Rancheria provided data files to the EPA that include PM
Regarding the correlation between farming and animal husbandry and elevated levels of PM
As described in detail in our proposals, the EPA reviewed environmental and demographic data for the San Joaquin Valley using the EPA's EJ screening and mapping tool (“EJSCREEN”)
For the reasons discussed in our proposed rules and herein, the EPA is finalizing our approval of the 15 µg/m
Additionally, in response to a request from the State of California on May 23, 2024, the EPA is granting a one-year extension to the applicable attainment date for the 1997 annual PM
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 Act. Accordingly, this final action merely approves a state plan as meeting federal requirements and grants a state request for an attainment date extension consistent with federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• 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);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• 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
• 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);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• 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.
In addition, the SIP 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, the rule 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).
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 minority populations and low-income populations 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
The State did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. Consistent with the EPA's discretion under the CAA, the EPA performed an EJ analysis, as is described above in the section titled, “Environmental Justice Considerations.” The analysis was done for the purpose of providing additional context and information about this rulemaking to the public, not as a basis of the action. Due to the nature of the action being taken here, this action is expected to have a neutral impact on the air quality of the affected area. In addition, there is no information in the record upon which this decision is based inconsistent with the stated goal of E.O. 12898 of achieving EJ for communities with EJ concerns.
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). 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 January 21, 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).)
Environmental protection, Air pollution control, Ammonia, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(620)-(622) [Reserved]
(623) The following plan revisions were submitted electronically on August 22, 2024, by the Governor's designee as an attachment to a letter of the same date.
(i) [Reserved]
(ii)
(
(
(B) [Reserved]
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving the Regional Haze State Implementation Plan (SIP) revision submitted by the Wisconsin Department of Natural Resources (Wisconsin or WDNR) on July 30, 2021, along with subsequent information discussed herein, as satisfying applicable requirements under the Clean Air Act (CAA) and EPA's Regional Haze Rule (RHR) for the program's second implementation period. Wisconsin's SIP submission and the subsequent information addresses the requirement that states must periodically revise their long-term strategies for making reasonable progress towards the national goal of preventing any future, and remedying any existing, anthropogenic impairment of visibility, including regional haze, in mandatory Class I Federal areas. The SIP submission also addresses other applicable requirements for the second implementation period of the regional haze program. EPA is taking this action pursuant to sections 110 and 169A of the CAA.
This final rule is effective on December 19, 2024.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2021-0545. All documents in the docket are listed on the
Charles Hatten, Air and Radiation Division (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6031,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On August 9, 2024, (89 FR 65492), EPA proposed to partially approve and partially disapprove the Wisconsin regional haze SIP revision. In the same notice of proposed rulemaking (NPRM), EPA also proposed to approve the Wisconsin regional haze SIP in full if WDNR provided evidence that boiler B26 at the Ahlstrom-Munksjö-Rhinelander Mill had permanently ceased operations. A detailed analysis of Wisconsin's plan and EPA's evaluation are contained in the NPRM and will not be restated here.
As noted in the NPRM, WDNR indicated that the Ahlstrom-Munksjö-Rhinelander Mill ceased operation of its coal-fired cyclone Boiler B26 in 2022 and decided to retire it. In its place, the facility installed a new natural gas-fired Boiler B40 under title I construction permit 22-MMC-035, which WDNR issued on May 24, 2022.
Following the publication of the NPRM, on September 17, 2024, WDNR issued the renewal for the Ahlstrom-Munksjö-Rhinelander Mill's operation permit. The operation permit 74400810A-P30 is the renewal of the facility's title V operation permit 744008100-P22.
As noted in the NPRM, “if the Ahlstrom-Munksjö-Rhinelander Mill were to resume the operation of Boiler B26 or replace it with a comparable coal-fired boiler after the title V operation permit 74400810A-P30 is renewed, either boiler would be considered a new source and the emissions would be limited by WDNR's construction permitting process requiring a PSD [Prevention of Significant Deterioration] review and BACT [Best Available Control Technology].” 89 FR 65492, 65506 (August 9, 2024). By issuing the title V operation permit renewal 74400810A-P30, WDNR revoked the facility's permission to operate Boiler B26, specifically, under permit condition ZZZ.11, and a revision to the operation permit renewal on its own would not allow Boiler B26 to recommence operation. In order for the facility to regain the ability to legally operate Boiler B26, WDNR would require the Ahlstrom-Munksjö-Rhinelander Mill to acquire a new construction permit under Wisconsin's SIP-approved construction permitting program. The permit application would trigger New Source Review and PSD requirements under Wisconsin Administrative Code NR 405, including BACT, and analyses of air quality and air quality impacts. EPA finds that Wisconsin has met the terms described in EPA's proposal in order to received full approval. In place of coal-fired Boiler B26, Ahlstrom-Munksjö-Rhinelander constructed new Boiler B40 in 2022 such that it would burn natural gas only, using low oxides of nitrogen (NO
Based on the provisions in operation permit renewal 74400810A-P30, in addition to the information provided in WDNR's analysis, preliminary determination, and in the previous permitting actions described above, EPA finds that Wisconsin has produced sufficient evidence that coal-fired cyclone Boiler B26 at the Ahlstrom-Munksjö-Rhinelander Mill has permanently ceased operation and is being decommissioned. Thus, EPA is fully approving Wisconsin's regional haze plan as satisfying the regional haze requirements for the second implementation period.
The retirement of Boiler B26 at the Ahlstrom-Munksjö-Rhinelander Mill provides federally enforceable and permanent emission reductions from one of Wisconsin's largest sources. WDNR initially determined that continued operation of Boiler B26, with the new limits for SO
The permanent cessation of operation of both Boiler B26 and Boiler B11 at the Ahlstrom-Munksjö-Kaukauna Mill demonstrate additional emission reductions during the second implementation period than were projected in WDNR's initial SIP submittal. Tables 1 and 12 in appendix 3 of Wisconsin's submittal compared 2016 actual emissions with 2028 projected emissions as if the emissions from both boilers continued at the same levels from 2016 to 2028. With the cessation of operation of coal-fired boilers B26 and B11, there are additional emission reductions from Boiler B26 at the Ahlstrom-Munksjö-Rhinelander Mill (1,145 tpy NO
EPA provided a 30-day review and comment period in the NPRM. The comment period ended September 9, 2024. We received a total of four comments, only two of which were substantive. Both substantive comments received were from agencies with authority as Federal Land Managers (FLMs) over Federal Class I Areas: the United States Forest Service (USFS) and the United States National Park Service (NPS). The other two comments received were from individuals and raised issues that are not relevant to this action. Neither of the two comments from individuals addressed the specific regulation or provision in question or recommended a different action on the SIP submission from what EPA proposed. All comments received are included in the rulemaking docket. Comments from USFS and NPS are summarized and addressed below.
During Wisconsin's public comment period, USFS and NPS recommended that WDNR select additional facilities with a Q/d between 4 and 10 to be screened in for a four-factor analysis. The facilities USFS and NPS identified include: Wisconsin Rapids Paper Mill, Catalyst Paper-Biron Mill, Graymont Superior, Ahlstrom-Munksjö-Mosinee Mill, and Calumet Superior Refinery. While WDNR characterized these facilities as being “well controlled,” USFS and NPS asserted that they are not “effectively controlled.” USFS and NPS suggest that a four-factor analysis at these facilities would likely identify cost-effective controls. NPS noted that EPA's July 8, 2021, “Clarifications Regarding Regional Haze State Implementation Plans for the Second Implementation Period” (“2021 Clarifications Memo”)
WDNR reasonably explained its criteria and the technical basis for its process to select units with a Q/d greater than 10 for a potential four-factor analysis as well as its reasoning for not selecting facilities identified by the FLMs with a Q/d between 4 and 10. Additionally, WDNR's approach resulted in a reasonable outcome, identifying the units with the greatest potential to impair visibility at Class I areas, as discussed below.
WDNR first considered the Class I areas affected during the second implementation period. Although NPS contends that WDNR used a more lenient visibility impact threshold than other states in EPA's Region 5, Wisconsin's approach was consistent with the 2 percent light extinction threshold LADCO identified with its 2028 source apportionment modeling as accounting for 92 percent or more of the total light extinction applied to all six LADCO states as well as seven other states on the most impaired days. Using the 2 percent threshold, WDNR determined that Wisconsin emissions in the second implementation period impact visibility impairment at Isle Royale National Park, Seney Wilderness Area, and Boundary Waters Canoe Wilderness Area. Additionally, WDNR included Voyageurs National Park as a carryover from the first implementation period even though LADCO's 2028 projections estimated Wisconsin's contribution to total light extinction there as 1 percent. As to Wisconsin's impact on other Class I areas, WDNR explained that LADCO's 2028 source apportionment modeling identified Wisconsin as contributing to the total light extinction at 42 other Class I areas, however, at levels less than the 2 percent threshold. As such, WDNR noted that Wisconsin did not receive any requests to engage in interstate consultation for the second implementation period.
After considering the Class I areas affected during the second implementation period, WDNR chose a Q/d threshold of 10 based on identifying a significant gap between the largest four units with a Q/d ranging from 11 to 22 and the remaining 41 units, all with a Q/d of 6.1 or less.
Although these units mentioned in the paragraph above were below Wisconsin's Q/d threshold of 10, WDNR addressed them in its July 30, 2021, SIP submittal because they were flagged by the FLMs. WDNR characterized them as “well controlled,” providing information on their control measures and emissions limits within the applicable title V operating permits. Notwithstanding this information, USFS and NPS contend that those units are not “effectively controlled,” a term described in EPA's “Guidance on Regional Haze State Implementation Plans for the Second Implementation Period” (“2019 Guidance”)
EPA agrees that Wisconsin examined a reasonable set of sources by choosing criteria that would focus on the largest sources having the greatest potential to impair visibility at Class I areas. Additionally, WDNR's threshold, based on unit Q/d rather than facility-wide Q/d, is appropriate in Wisconsin's case since any new control measures would be initiated on a unit-by-unit basis, rather than a facility-wide basis. In sum, EPA is determining that the WDNR's decision to only select units with a Q/d greater than 10 was reasonable in this case. While NPS raised concerns that WDNR cited the uniform rate of progress and emissions from out-of-state sources in describing its source selection process, EPA's determination is based on the reasoning provided above, which was further elaborated upon in the NPRM. Thus, Wisconsin's regional haze plan has satisfied the regional haze requirements of 40 CFR 51.308(f)(2)(i) regarding the sources it selected to evaluate and determine the potential emission reduction measures necessary to make reasonable progress during the second implementation period.
For the Alliant Energy-Columbia Power Plant, both B21 and B22 each had a Q/d of 6, which was below WDNR's source selection threshold. WDNR identified the existing control measures in place and noted that the planned shutdown in 2025 was not relied upon by LADCO's modeling in assessing visibility impacts. As explained above, EPA finds WDNR's approach to source selection based on a Q/d of 10 is reasonable, so making the planned shutdown of B21 and B22 federally enforceable would not be considered necessary for reasonable progress in the second implementation period.
WDNR also did not rely on the publicly announced shutdown of Alliant Energy-Edgewater's Boiler B25 for reasonable progress. With a Q/d of 11, WDNR selected Boiler B25 at Alliant Energy-Edgewater for further analysis since it exceeded WDNR's Q/d threshold of 10. As noted in the NPRM, WDNR explained its decision to forgo a full four-factor analysis on the basis that the existing controls for Boiler B25 are effective and not necessary for reasonable progress. “With the combination of recently installed SO
For We Energies-Oak Creek Power Plant, the planned retirements are discussed in response to the comment below.
WDNR did not rely on the planned shutdowns at We Energies—Oak Creek Power Plant and Wisconsin Public Service Corporation—Weston Power Plant or the conversion to natural gas for B09 at Ahlstrom-Munksjö—Kaukauna Mill as a reason to exclude these units from four-factor analyses. However, recent and upcoming shutdowns of these units provide additional support for WNDR's decision making and further emissions reductions, as well as insight into the potential reduction in visibility impairment that was not accounted for in LADCO's 2028 modeled projections. For We Energies—Oak Creek Power Plant, WDNR listed six boilers under Table 1 of appendix 3 of their submittal and indicated that four would be retired by 2025: B25, B26, B27, and B28. For Wisconsin Public Service Corporation Weston—Power Plant, WDNR listed 12 units under Table A2-1 of appendix 2 of their submittal and indicated the following 8 units are projected to have zero emissions in 2028: B02, B12, B13, F24, F26, P36, P43, and P56. For Ahlstrom-Munksjö—Kaukauna Mill Boiler B09, WDNR's four-factor analysis noted that the unit switched to natural gas in 2016, and the federally enforceable title V operation permit 44503118A-P30 referenced in the NPRM reflects the permit modification that has been in effect since 2016, stating, “The permittee shall only burn natural gas in Boiler B09.”
After considering the FLMs' comments, EPA finds that nothing in the comments warrants a change to EPA's proposed action. Therefore, EPA is finalizing its approval of the Wisconsin SIP submission for the second planning period.
In consideration of the documentation from WDNR that coal-fired Boiler B26 at the Ahlstrom-Munksjö—Rhinelander Mill has permanently ceased operation and is being decommissioned, EPA is approving the Regional Haze SIP revision submitted by WDNR on July 30, 2021, as satisfying the regional haze requirements for the second implementation period contained in 40 CFR 51.308(f).
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:
• 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);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• 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
• 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);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• 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.
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).
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 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.”
Wisconsin 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. 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 E.O. 12898/14096 of achieving EJ for communities with EJ concerns.
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).
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 January 21, 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).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.
For the reasons stated in the preamble, title 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; quota transfer.
NMFS is transferring 59.5 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the General category for the remainder of the 2024 fishing year. With this transfer, the adjusted General category December time period subquota is 76 mt and the Reserve category quota is 2 mt. This action is intended to provide further harvest opportunities for General category fishermen, based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic Tunas General category (commercial) permitted vessels and Atlantic Highly Migratory Species (HMS) Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT.
The quota transfer is effective December 1, 2024, through December 31, 2024.
Anna Quintrell (
Atlantic BFT fisheries are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP) and its amendments, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801
As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 mt (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area). The baseline quotas for the General and Reserve categories are 710.7 mt and 38.2 mt, respectively. The General category baseline quota is suballocated to different time periods. Relevant to this action, the baseline subquota for the December time period is 37.0 mt. To date, NMFS has published one action that adjusted the December time period quota (89 FR 3361, January 18, 2024) and three actions that adjusted the Reserve category quota (89 FR 58074, July 17, 2024; 89 FR 77029, September 20, 2024; 89 FR 81032, October 7, 2024). The current adjusted December time period quota is 16.5 mt and the Reserve category quota is 61.5 mt.
Under § 635.27(a)(8), NMFS has the authority to transfer quota among fishing categories or subcategories after considering the determination criteria provided under § 635.27(a)(7). This section focuses on the calculations involved in transferring quota from the Reserve category to the General category; the consideration of the determination criteria can be found below after this section.
As stated above, the adjusted December time period subquota and adjusted Reserve quota are 16.5 mt and 61.5 mt, respectively. At this time, after considering the relevant determination criteria (see below), NMFS is transferring 59.5 mt from the Reserve category to the General category December time period. This transfer will result in an adjusted December time period subquota of 76 mt (16.5 mt + 59.5 mt = 76 mt) and an adjusted Reserve category quota of 2 mt (61.5 mt-59.5 mt = 2 mt). The General category quota is available for use by Atlantic Tunas General category (commercial) permitted vessels and HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT. These quotas will be in effect when the fishery automatically opens on December 1, 2024.
NMFS has considered all of the relevant determination criteria and their applicability to this inseason quota transfer (§ 635.27(a)(7)). These criteria include, but are not limited to, the following:
Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(7)(i)), biological samples collected from BFT landed by General category fishermen and provided by BFT dealers continue to provide NMFS with valuable parts and data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT in the General category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.
NMFS also considered the catches of the General category quota to date (including during the summer/fall and winter fisheries in the last several years) and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(7)(ii)), as well as daily landing trends and the availability of BFT on fishing grounds (§ 635.27(a)(7)(ix)). The General category is currently closed and the December time period has not yet opened. However, without a quota transfer at this time, based on recent catch rates in comparison to the current available quota (16.5 mt), NMFS would likely need to close the General category fishery shortly after the December time period begins. Once the fishery is closed, participants would have to stop BFT fishing activities while commercial-sized BFT remain available in the areas where General category permitted vessels operate. A quota transfer at this time provides limited additional opportunities to harvest the U.S. BFT quota while avoiding exceeding it.
Regarding the projected ability of the vessels fishing under the General category to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(7)(iii)), NMFS considered General category landings over the last several years and landings to date this year. Landings are highly variable and depend on access to commercial-sized
NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(7)(iv)) and the ability to account for all 2024 landings and dead discards (§ 635.27(a)(7)(xi)). Preliminary landings across all categories are below the available U.S. quota and are similar to landing estimates calculated at this time in recent past years. Additionally, in the last several years, the total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS recently took such an action to carry over the allowable 134.1 mt of underharvest from 2023 to 2024 (89 FR 77029, September 20, 2024).
NMFS anticipates having sufficient quota to account for landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations.
NMFS also considered the effects of the adjustment on BFT rebuilding and overfishing, and the effects of the transfer on accomplishing the objectives of the FMP (§ 635.27(a)(7)(v) and (vi)). This quota transfer would be consistent with established quotas and subquotas, which are implemented consistent with ICCAT recommendations (established in Recommendation 22-10), ATCA, and the objectives of the 2006 Consolidated HMS FMP and amendments. In establishing these quotas and subquotas and associated management measures, ICCAT and NMFS considered the best scientific information available, objectives for stock management and status, such as rebuilding and avoiding overfishing, and effects on the stock. This quota transfer is in line with the established management measures and stock status determinations. It is also important that NMFS limit landings to the quota both to adhere to the FMP quota allocations and to ensure that landings are as consistent as possible with the pattern of fishing mortality (
NMFS will continue to monitor the BFT fishery closely. Per § 635.5(b)(2)(i)(A), dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustments, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required per § 635.5(a)(4) to report their own catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)) and regulations at 50 CFR part 635 and this action is exempt from review under Executive Order 12866.
The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and opportunity to provide comment on this action, as notice and comment would be impracticable and contrary to the public interest. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason adjustments and quota transfers to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing prior notice and opportunity for public comment on this quota transfer to the General category for the remainder of 2024 is impracticable and contrary to the public interest as the General category fishery is currently underway. Based on General category catch rates, a delay in this action would likely result in closure of the General category fishery when the baseline quota is met, with attendant administrative costs and costs to the fishery. NMFS could not have proposed this action earlier, as it needed to consider updated landings data in deciding whether to transfer a portion of the Reserve category quota to the General category quota. A delay in implementing this quota transfer would preclude the fishery from harvesting BFT that are currently available on the fishing grounds and that might otherwise become unavailable during a delay. This action does not raise conservation and management concerns and would support effective management of the BFT fishery. Transferring quota from the Reserve category to the General category December time period does not affect the overall ICCAT-allocated U.S. BFT quota, and available data show the adjustment would have a minimal risk of exceeding the overall quota. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment criteria.
For all of the above reasons, the AA finds that pursuant to 5 U.S.C. 553(d), there is good cause to waive the 30-day delay in effective date.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; adjustment to specifications.
Under the Magnuson-Stevens Fishery Conservation and Management Act (MSA), this final rule: adjusts the 2024 fishing year allocations to sectors and the common pool specified in Framework Adjustment 66 to the Northeast Multispecies Fishery Management Plan (Framework 66); makes minor adjustments to common pool limits based on final 2023 fishing year catch information; and distributes sector annual catch entitlements carried over from fishing year 2023 into fishing year 2024 as required by regulation. The revisions are necessary to account for changes to 2024 sub-annual catch limits based on final 2024 sector rosters and to respond to a 2023 overage of Gulf of Maine (GOM) cod in the common pool. These adjustments are routine and formulaic, aiming to ensure that final allocations are determined using the most reliable scientific information available.
Effective November 18, 2024, through April 30, 2025.
Anjali Bhardwaj, Fishery Management Specialist, (978) 281-9293.
Framework 66 was approved on May 2, 2024 (89 FR 35755), setting specifications for 8 of the 20 Northeast multispecies stocks including redfish, northern windowpane flounder, and southern windowpane flounder for fishing years 2024-2026; and Georges Bank (GB) cod, GB haddock, Gulf of Maine (GOM) haddock, GB yellowtail flounder, and white hake for fishing years 2024-2025. The framework also adjusted commercial management measures for Atlantic halibut and modified sea scallop accountability measure implementation for GB yellowtail flounder. These changes were made to prevent overfishing, ensure rebuilding, and help achieve optimal yield in the commercial and recreational groundfish fisheries. Framework 66 included preliminary allocations for sectors and the common pool based on the fishing year 2024 catch limits and preliminary sector rosters. A sector receives an allocation of each stock, or annual catch entitlement (ACE or allocation), based on the sum of its members' catch histories' and Potential Sector Contributions (PSC) as described at 50 CFR 648.87(b)(1)(i). State-operated permit banks in New Hampshire and Maine also receive an allocation that can be transferred to qualifying sector vessels. The sum of all sector and State-operated permit bank allocations is known as the sector sub-annual catch limit (sub-ACL). The remaining groundfish allocations after sectors and State-operated permit banks receive their allocations are subsequently allocated to the common pool (
The MSA at section 305(d) gives the Secretary of Commerce (Secretary) the authority and “responsibility to carry out any fishery management plan or amendment approved or prepared by him, in accordance with the provisions of this Act” (16 U.S.C. 1855(d)). The Secretary may promulgate such regulations as may be necessary to discharge such responsibility or to carry out any other provision of the MSA. The Secretary delegates this authority to NMFS. Using this authority, this rule adjusts the 2024 fishing year sector and common pool sub-ACLs and sector ACEs based on final sector rosters as of May 1, 2024. Permits enrolled in a sector and the vessels associated with those permits have until April 30, the last day before the beginning of a new fishing year, to withdraw from a sector and fish in the common pool. As a result, the actual sector enrollment for the new fishing year is unknown when the final specifications are published. Each year, NMFS subsequently publishes an adjustment rule modifying sector and common pool allocations based on final sector enrollment, ACE carryover each sector is allowed to bring in from the previous fishing year, and any ACL or sub-ACL overages that the fishery must mitigate under the accountability measures of the FMP through payback. The process of validating fishery catch from the previous fishing year is completed following the end of the fishing year (April 30), and it may take several months to complete and reconcile commercial data, receive of State fishery catch data and complete recreational fishing estimates. In the case of this adjustment rule, the 2023 fishing year information was finalized in early October 2024 and is the basis of the carryover and payback adjustments in the rule. The proposed and final rules for Framework 66 both explained that sector enrollments may change and that there would be a need to adjust the sub-ACLs and sector ACEs in accordance with the final rosters and the resulting sector PSCs. Table 1 shows the changes to the sub-ACLs between Framework 66 and this adjustment rule in metric tons (mt), and table 2 shows changes to the sub-ACLs between Framework 66 and this adjustment rule in pounds (lb). This action adjusts sub-ACLs and ACEs for the common pool and sectors, distributes unused sector quota carried over from fishing year 2023 to fishing year 2024, and revises the GOM cod common pool sub-ACL in response to an overage that occurred in fishing year 2023.
Sector regulations at 50 CFR 648.87(b) require NMFS to adjust ACE carryover to ensure that the total unused ACE combined with the overall sub-ACL does not exceed the acceptable biological catch (ABC) for the fishing year in which the carryover may be harvested. NMFS completed 2023 fishing year data reconciliation with sectors and determined final 2023 fishing year sector catch and the amount of allocation that sectors may carry over from the 2023 to the 2024 fishing year. A sector may carry over up to 10 percent of unused ACE for each stock, except in instances where the amount of unused ACE was reduced so as not to exceed the ABC. Accordingly, carryover for all stocks is capped by the ABC and reduced to a value below the full 10-percent of the original quota allocation from the fishing year 2023, consistent with carryover accounting requirements at 50 CFR 648.87. Complete details on carryover reduction percentages can be found at:
Table 3 includes the final amount of ACE that sectors may carry over from the 2023 to the 2024 fishing year. Table
If the common pool sub-ACL for any stock is exceeded, 50 CFR 648.82(n)(2)(iii) requires reducing the common pool sub-ACL by the amount of the overage in the next fishing year. The fishing year 2023 common pool sub-ACL for GOM cod was exceeded by 0.3 mt. Therefore, this action reduces the fishing year 2024 GOM cod common pool sub-ACL by 0.3 mt resulting in a sub-ACL of 9.5 mt. The revised trimester total allowable catch (TAC) based on the overage deduction is provided in table 6. No other changes were made other than slight adjustments to sub-ACLs to account for final sector rosters.
The NMFS Assistant Administrator has determined that this final rule is consistent with the Northeast Multispecies Fishery Management Plan, other provisions of the MSA, and other applicable law.
This action is exempt from the procedures of Executive Order 12866 because this action contains no implementing regulations.
Pursuant to 5 U.S.C. 553(b)(3)(B), NMFS finds good cause to waive prior public notice and opportunity for public comment on the catch limit and allocation adjustments because allowing time for notice and comment is impracticable, unnecessary, and contrary to the public interest. This adjustment process regularly occurs each year in accordance with directions to carry over unused catch that is added to, and deduct overages from, catch limits. These processes, described more specifically below, were subject to public notice and comment and set forth in regulations as noted throughout this action. The proposed and final rules for Framework 66 explained the need and likelihood for adjustments of sector and common pool allocations, because final sector rosters were not available before either the proposed or final rules were published (89 FR 20412; 89 FR 35755). As described in the Framework 66 final rule, NMFS calculates a sector's allocation for each stock by summing its members' PSC for the stock and then multiplying that total percentage by the commercial sub-ACL for that stock (89 FR 35755). No comments were received on the potential for carryover adjustments or the process for determining them, which provide an accurate accounting of a sector's or the common pool's allocation. These adjustments are routine and in accordance with specified carryover and sector (50 CFR 648.87(b)(1)) and common pool (50 CFR 648.82(n)(2)(iii)) accountability requirements based on final sector and common pool enrollment.
The process for determining carryover for sectors is described at 50 CFR 648.87(b)(1)(i)(C). With the exception of GB yellowtail flounder, a sector may carryover an amount of ACE equal to 10 percent of its original ACE for each stock that is unused at the end of one fishing year into the following fishing year, provided that the total unused sector ACE plus the overall ACL for the following fishing year does not exceed the ABC for the fishing year in which the carryover may be harvested. The process for determining the reduction to the overall sub-ACL in the common pool, due to an overage, is described at 50 CFR 648.82(n)(2)(iii). Following Trimester 3, uncaught portions of any trimester TAC for the common pool may not be carried over into the following fishing year. If the entire sub-ACL for a particular stock that is allocated to the common pool is exceeded, an amount equal to the overage shall be deducted from the sub-ACL for that stock that is allocated to common pool vessels for the following fishing year.
Thus, this action is expected by fishing industry participants and the public, as the public was made aware of how the sector pools and allocations would be adjusted during the notice and comment period for the Framework 66 rule. It provides sector and common pool vessels with catch limit information that reflects their actual final allocations, which will help ensure fishing industry participants operate with accurate information for planning and recordkeeping as the fishing year progresses and total catch increases. Additional catch available from carryover also is expected to provide more operational flexibility and financial benefit to the fishery participants.
Because advanced notice and the opportunity for public comment are not required for this action under the Administrative Procedure Act, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601,
16 U.S.C. 1801
U.S. Small Business Administration.
Proposed rule.
The U.S. Small Business Administration (SBA or Agency) proposes to amend its regulations for the Surety Bond Guarantee Program to reduce the burden on participating surety companies for submission and retention of documents. SBA is also correcting conflicting provisions, as well as revising the obsolete preferred surety admissions requirements and the Quarterly Contract Completion Report.
SBA must receive comments to this proposed rule on or before January 21, 2025.
Identify your comments by Docket No. SBA-2023-0009 or RIN 3245-AI06 and submit them by one of the following methods: (1) Federal eRulemaking Portal:
SBA will post all comments to this proposed rule on
Kevin Valdes, Management Analyst, Office of Surety Guarantees, U.S. Small Business Administration, 409 3rd Street SW, 8th Floor, Washington, DC 20416, (202) 816-0137 or
SBA is amending several regulations applicable to its Surety Bond Guarantee (SBG) program. SBA guarantees bid, payment, and performance bonds for small and emerging contractors who cannot obtain surety bonds through regular commercial channels. SBA's guarantee, authorized pursuant to part B of title IV of the Small Business Investment Act of 1958, 15 U.S.C. 694a
As part of its ongoing responsibility to ensure that the rules it issues align with surety industry practices and do not have an adverse economic impact on those affected by those rules, SBA held a series of listening sessions with Surety professionals for input about their experiences using the SBG program. Findings of the listening sessions and additional impact studies resulted in the decision to change and clarify several current procedures and regulations to improve customer experience and better enable modernization efforts within the SBG program.
Current SBA regulation 13 CFR 115.11 requires prospective Surety Partners to submit applications by mail. SBA proposes adding the option to email Surety Partner application packages. This change will modernize regulation to align with current business practices.
The SBG program requires signed certification by Surety Partners participating in SBA's Prior Approval program each time a bond application is submitted to the program. Each signed form certifies small business program eligibility, the need for program assistance, and the accuracy of applicant information. The certification process involves completion of the SBA Form 990 fields (normally electronically) along with download, signature, and re-upload of the form to SBA's Capital Access Financial System (CAFS). In SBA's Preferred Surety Bond (PSB) program, SBA Form 990 is not required due to delegated authority and a written Surety Partner participation agreement that blanketly certifies the same items as in SBA Form 990. SBA proposes removing the signature requirement in 115.30(b) for each application and replace with a master certification.
All Prior Approval participants surveyed agreed that having a Surety Partner participation agreement for the Prior Approval program would greatly benefit program participants by removing SBA's requirement to individually certify every application submission. SBA proposes changes to 13 CFR 115.30(d) to require a new Prior Approval Agreement between SBA and the Prior Approval Surety Partner which will contain a master certification for all the applications to follow. This removes the need for each application to be individually certified. SBA estimates the new agreements would reduce application time burden on program participants by 557 hours, or $15,818 according to fiscal year 2023 program activity.
Currently, SBA requires two fees to support surety bonds on awarded contracts: a fee charged to the Surety company under § 115.32(a), and a fee charged to the small business contractor under § 115.32(b). SBA's SBG program requires that the payment of SBA contractor fees be submitted by small business applicants at the time of application approval. For the Prior Approval program, § 115.32(b) requires that the contractor must submit receipt of the payment to SBA before an application is given final approval, and § 115.32(d) requires that for bond increases the Principal must submit the
While payments are verified via payment receipt, the receipt of the payments by SBA are not always successful due to a variety of issues that can occur during the processing of the payment. When contractor fee payments are unsuccessful, SBA must seek remittance of the delinquent payments due to SBA from the small businesses through surety professional participants in both PSB and Prior Approval programs. If still unsuccessful, a small business becomes ineligible for further SBA guarantees and SBA writes off the delinquent debt. Over the last five fiscal years, SBA wrote off over $100,000 in uncollected contractor fees. Relatedly, SBA surety fee payments are due to SBA within 60 days of a guarantee's approval. Surety companies remit these payments directly to SBA. While delinquency is periodically an issue, SBA has not written off any surety fees over the last five fiscal years.
All surety professional participants surveyed stated SBA's contractor fee collection process is incongruent with surety industry practice for premium (industry fee) collection. Instead of small businesses directly paying surety bond companies for each individual premium due, surety bond companies typically bill premiums (fees) due to surety bond agencies (intermediaries) representing applicant businesses via monthly billing statements. Collection is directly from these agencies, net their commission. The agencies independently manage premium collection from applicant businesses and are responsible for payment to surety bond companies. The industry almost always issues bonds before receiving premium.
Prior Approval survey participants all stated SBA's current contractor fee collection requirements delay the bonding process since payment cannot be made prior to an initial intent-to-approve from SBA and the surety bond cannot be issued until payment is made by the small business. Two participants noted a small business can sometimes take days to pay SBA's fee, which further delays the bonding process.
SBA proposes streamlining fee collection by changing regulations to allow SBA merger of contractor fee collection procedures into the same process as SBA surety fee collection. The regulatory changes would allow SBA to procedurally adjust contractor fee collection to be with Surety Partners in the same format as current surety fee collection. Likewise, any guarantee fee refund owed by SBA will be remitted to the Surety that collected the fee from the Principal. The new process will be the same for the Prior Approval and PSB Sureties.
SBA estimates the change would reduce application time burden on program participants and small businesses by approximately 568 hours per year, or roughly $14,495 in annual savings, on average. To estimate time burden, the SBA relies on a combination of FY2023 program data and interviews with program participants and small businesses. The change would shift small business contractor fee remittance to SBA from small businesses to Surety Partners, enable the industry to align their SBA contractor fee collection procedures with industry fee collection practices, and reduce the amount of uncollectible fees with small businesses.
The proposed change is estimated to save each impacted small business an average of 5 minutes per response, or a total of 284 total burden hours for all small businesses. To quantify the value of time saved, the SBA relies on the most recently available Bureau of Labor Statistics (BLS) wage data and assumes that the representative impacted small business occupation would be “miscellaneous construction and related workers.” The median wage from 2023 for this occupation was $22.64. In FY2023, there were approximately 3,406 small businesses in the program which brings the estimated total burden hours saved for small businesses per year to roughly 284. The total annual savings that the SBA estimates for small businesses as a result of the proposed changes comes to $6,430 ($23*284), on average.
To quantify the value of time saved for program participants, the SBA relies on BLS wage data and assumes that the representative impacted occupation would be “insurance sales agents”. The median wage from 2023 for this occupation was $28.40. Using the same program data from FY2023, the estimated total burden hours saved for program participants per year comes to 284. The total annual savings that the SBA estimates for program participants as a result of the proposed changes comes to $8,066 ($28*284), on average.
Currently, 13 CFR 115.22 requires Surety Partners to submit a quarterly certification report detailing all contracts for guaranteed bonds that were completed during the most recent quarter. The report was implemented in 2017 with the intention of ensuring that fees due for increases on successfully completed contracts are accurately calculated and paid timely. At that time, industry commented on the proposed rule that the report creates an administrative burden on Surety Partners. During SBA's recent survey, participants stated the industry typically considers contracts up to $250,000 complete upon the estimated completion date on file without verification. In fiscal year 2023, over 43% of guaranteed bonds for awarded contracts were within this range. Surety Partners for the program have stated reporting details, such as the contract completion date, can require additional work when contracts are within this range.
SBA proposes modifying the regulation to allow SBA to set the timeframe. The change will create greater program office agility in adapting completion reporting to the practices of the industry. It will also allow the program office to adjust internal guarantee closeout monitoring procedures to secure collection of deferred fees due at the time of contract completion.
Currently, 13 CFR 115.33(b)(1) allows Sureties participating in SBA's Prior Approval program to submit applications up to 15 days after bond execution under an SBA-approved bonding line. However, 13 CFR 115.19(f)(1)(i) requires bonds be approved by SBA prior to execution. The two regulations conflict and must be reconciled to allow SBA acceptance of executed bonds under an SBA bonding line. SBA is also clarifying when a bonding line expires in 13 CFR 115.33(b)(1). Currently, regulations state “not to exceed 1 year.” However, SBA bonding lines cannot extend past the originated fiscal year per allocated funding restrictions of the program. SBA proposes modifying current regulatory language by removing the conflicting requirement in 13 CFR 115.19(f)(1)(i) and clarify its effective period in 13 CFR 115.33(b)(1).
SBA's Preferred Surety Bond (PSB) program is for sureties that seek delegated authority to approve SBA guaranteed surety bonds. Sureties can be selected to participate in the PSB program if they meet criteria established
SBA proposes revising its admissions policies for PSB sureties. The admissions criteria for PSB sureties found in 13 CFR 115.60 that SBA proposes for revision include the minimum underwriting limit assigned by the U.S. Treasury of $6,500,000.00, the limit on the proportion of government-backed bonds to their overall premium income, and the requirement that the surety obtain SBA's approval before issuing a bond greater than $2 million during the initial 9 months the surety is first in the PSB program.
SBA identified that 61, or 24%, of all currently T-listed surety companies have limits below SBA's required threshold to participate in the PSB program. Some companies in the surety industry utilize affiliate entities to manage different portfolio segments, including the portfolio segment SBA assists, termed “small specialty.” Given the typical bond size need of small and emerging businesses, some surety bond companies utilize affiliates with low T-listing limits to support small specialty before moving them to surety affiliates with higher T-listing amounts.
The T-listing is based on a surety's ability to pay losses via reserve funds and is not an indicator of surety performance. By excluding some of these affiliates via the T-listing limit, the program also potentially reduces access to the program for some small businesses. Removing the regulatory limit will allow greater agility for SBA to adjust the requirement based on inflation and industry practices. This allows the PSB program to support more small surety bond companies. The PSB agreement outlines delegated authority for PSB participation and can be given in amounts that reflect the participating surety's T-listing limit.
SBA also proposes removing: (1) the limit on government-backed bonds as a proportion of their premium income, and (2) the requirement that a PSB surety get approval before issuing a bond greater than $2 million during the initial 9 months of program participation. SBA could not identify a current benefit to the implementation of these requirements. PSB surety participation as a percent of premium income unduly restricts small business access to the SBG program. Restricting program participation for a surety bond company on this basis potentially forces a participating surety to deny small business access to strictly due to reaching their premium share limit.
The 9-month delegated authority restriction for new Surety participants does not contain enough time to obtain a program performance assessment of the new participant. SBA could not identify rationale for the restriction. Additionally, the conclusion of a review of program performance for new PSB surety partners between fiscal year 2018 and 2024 did not support the initial 9-month program performance period as an indicator of program performance thereafter. The language will be replaced with SBA maintaining the right to restrict participation to evaluate the Surety's program performance. This language is in line with 13 CFR 115.18, pertaining to improper practices within the program. These proposals are anticipated to increase the pool of PSB sureties, which will expand the SBA surety agency base and increase bond opportunities for small businesses.
Current SBA regulations 13 CFR 115.11, 13 CFR 115.60(a)(4), and 13 CFR 115.65(b) require all Surety partners to oversee its underwriting function with surety staff and for PSB sureties to underwrite using employees of the surety and in “the same manner and with the same staff” for SBA bonds as they do for their non-SBA bonds. During listening sessions, meetings, and other engagements with the surety bond industry, SBA found it is common practice in the industry to delegate bond writing authority to staff of an affiliated surety and vetted surety bond agencies. Agents in these agencies are vetted for their knowledge and performance in the industry in relation to their portfolio with the surety bond company delegating such authority. Agencies with this authority are referred to as “Managing General Agencies” (MGAs) and “Managing General Underwriters” (MGUs). With this authority, these entities act on behalf of the surety by performing the underwriting of a bond application and issuing the surety bond. Oftentimes, MGAs and MGUs handle large books of business that are too cumbersome or time-consuming for surety bond companies to manage.
Sureties have stated to SBA that surety bonds to small businesses who have trouble being approved for a bond fit this category of business. The Prior Approval program does not have staff restrictions on underwriting by participating surety bond companies. A comparative review of program performance for fiscal years 2014-2021 by known MGAs and MGUs in the Prior Approval program shows that performance by these entities has been on par with the rest of the program during the same period. SBA will refer to MGAs and MGUs delegated by SBA-partnered surety bond companies as partner-affiliated entities. SBA proposes to allow PSB sureties to use affiliate staff for underwriting and allow the use of partner-affiliated entities. This change will allow surety partners to write more bonds with fewer resources and align SBA regulation with industry practice. Overall, SBA expects this to increase the number of surety partners and bond opportunities for small businesses.
SBA's Quick Bond agreement (Quick Bond) is for small contract amounts. The program aligns with the surety bond industry practice of providing reduced and expedient underwriting for surety bonds with limited scope and size in private industry programs collectively referred to as fast-track programs. SBA's Quick Bond option removes bonding barriers for start-ups and other emerging small businesses by reducing qualification to small business and contract eligibility for SBA assistance. Currently, 13 CFR 115.30(d)(2) outlines Quick Bond limitations. In surety bond industry listening sessions, meetings, and day-to-day program application review, SBA has found many industries (
Additionally, SBA historically lags behind industry adjustments to similar programs outside SBA in regard to limits on contract size, liquidated damages, and job duration. During engagements, surety industry professionals have advised SBA that the industry supports more expansive small business needs within fast-track programs outside SBA and that not all emerging small business contractors are able to regularly maintain financial statements. When reviewing program performance, SBA found some industries may experience elevated risk of failure due to external impacts. In these events, applications from small businesses in the impacted industry would benefit from regular application underwriting even when qualifying for SBA's Quick Bond application type. Due to Quick Bond limitations being part of regulation, SBA cannot readily adapt to economic changes and emerging program risks. SBA proposes removing the regulatory limitations for Quick Bond application types. This will enable SBA to better align the program
SBA proposes making several technical corrections to clarify and correct current regulations. 13 CFR 115.11 states the T-listing limit is for bonds in connection with Federal procurement contracts. However, U.S. Treasury clarified to SBA that the requirement is in connection with all bonds issued by the surety bond company should the company be Treasury listed. SBA proposes removing reference to Federal procurement contracts to align with U.S. Treasury.
13 CFR 115.12(f) explains procedures for SBA-approved transfers and sales of files and accounts by a surety. SBA proposes adding language that clarifies sale of an entire SBA-partnered business operation without prior-written approval by SBA voids SBA's guarantee and claims reimbursement agreements to that division unless the sale is to an existing SBA partner.
13 CFR 115.18(c) references SBA form 912. SBA's form 994 was previously modified to capture the same information as SBA form 912 and the program stopped actively collecting SBA form 912. SBG program currently relies solely on SBA form 994 for the information previously collected on SBA form 912. SBA proposes replacing reference to SBA form 912 with reference to individual certification by applicant owners.
13 CFR 115.30(b) and (c) refer to SBA staff as SBA officers. This will be changed to SBA staff to be consistent with references to employees throughout the rest of the regulations.
13 CFR 115.31(d) includes an example calculation for determining a reduced guarantee percent on a contract over the statutory limit of the program. For consistency with other examples as guidance, this example will be removed from the regulations.
13 CFR 115.35(a)(1)(iv) states a surety must notify SBA when it receives any adverse information concerning a Principal's financial condition or possible inability to complete the project or pay laborers or suppliers. In practice, SBA verifies this information when submitted to SBA. Additionally, these conditions for notification are collectively defined by SBA in § 115.10 as “imminent breach” when the conditions, unless remedied by the Surety, make a default under the bond appear to be inevitable. SBA proposes clarifying this requirement by stating the surety must notify SBA when it verifies any adverse information concerning imminent breach by the Principal.
Remove the requirement that physical applications be submitted and allow Surety Partners to email application packages. Remove the requirement that a Surety's salaried staff must oversee its underwriting function. Remove language stating that T-listing limit for bonds is in connection with Federal procurement contracts.
Add clarifying language that the sale of an entire business operation partnered with SBA occurs without prior written approval of SBA, it will void SBA's guarantee and claims reimbursement agreements to that division unless the sale is to an existing SBA partner.
Remove reference to SBA Form 912 Statement of Personal History as it is no longer in use.
Add language to 13 CFR 115.19(f)(1)(i) to clarify that timeliness for a bonding line is determined by § 133(d).
Change time frame for contract completion reporting from quarterly to requiring the Surety to submit to SBA notification of successfully completed contracts within the time frame set by SBA.
Remove the signature requirement in § 115.30(b) for each application and replace with a master certification. Change § 115.30 (d) to require a new Prior Approval Agreement between SBA and the Prior Approval Surety Partner which will contain a master certification for all the applications that follow.
Revise § 115.30(b) and (c) by removing references to “authorized SBA officer” and replace with the SBA's Director, Office of Surety Guarantees (D/SG) or their designee.
Revise Quick Bond Agreement requirements in paragraph (d)(2) by removing the restriction that a Quick Bond Agreement can only be used for contract amounts under $500,000 at the time of application and remove the regulatory exclusions in paragraph (d)(ii).
Remove from paragraph (d) the example calculation for when a contract amount increases above the statutory limit.
Revise paragraph (b) to delete the requirement that the SBA's charge to Principal be remitted with the application, and replace that with a requirement that the Prior Approval Surety is responsible to collect the guarantee fee from the Principal and remit to SBA within 60 calendar days of the approval of the
Revise paragraph (d)(1) by changing the cross reference in paragraph (d)(1) for the payment of the increased Principal's guarantee fee from in accordance with (d)(2) to (b). Revise (d)(2) by deleting the provision requiring payment for an increase in the Principal's fee from resulting from an increase in the contract amount. Revise paragraph (d)(3) by detecting that refunds fees from bond increases will go from SBA to the Principal and replace it with the refund will be returned to the Surety who collected the payment.
Revise the duration of a Bonding Line from 1 year to the fiscal year of approval.
Revise when a Surety must notify SBA about adverse information. Change the reporting threshold from when the Surety has adverse information concerning a Principal's financial condition to when the Surety has verified imminent breach by the Principal.
Remove underwriting limitation of $6,500,000 in paragraph (a)(1) and replace with a minimum threshold set by SBA for the applicant Surety or an SBA-partnered affiliate. Delete paragraph (a)(3). Revise paragraph (a)(4) by adding employees of a Surety's affiliates and SBA approved affiliated entities as those who are allowed to do underwriting on behalf of the Surety. Revise paragraph (b) by removing the 9-month trial period before a Surety can be admitted into the PSB program and replace with a time frame set by SBA.
Revise by eliminating the restriction that the approval, execution, and administration of SBA Bonds by a PSB Surety must be handled by the same staff as the Surety's outside activity and
Revise § 115.66 which relates to fee collection by PSB Sureties to mirror the requirements for Prior Approval Sureties in § 115.32. Revisions include deleting existing text and adding subsections (a), (b), and (c). Subsection (a) describes the Surety's Premium. Subsection (b) describes the SBA charge to the Principal. Subsection (c) describes the SBA charge to the Surety. None of these are new charges or fees.
SBA invites public comments on any part of the proposed rule.
When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis,” which shall “describe the impact of the proposed rule on small entities.” (5 U.S.C. 603(a)). Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities.
This is expected to be a time saving rule making so it is not anticipated to have a significant economic impact. As of fiscal year end 2023, the Program had 9,265 surety bond guarantees to 32 active surety companies (which may or may not be small businesses) that would be impacted by this rulemaking. Accordingly, the Administrator of the SBA hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities. SBA invites comments from members of the public who believe this rule will have a significant economic impact on a substantial number of small entities.
Executive Order 12866, Regulatory Planning and Review, as amended by Executive Order 14094, Modernizing Regulatory Review, requires agencies to provide a Regulatory Impact Analysis assessing costs and benefits and addressing available alternatives for any “significant regulatory action.” The Office of Management and Budget has determined that this rule does not constitute a “significant regulatory action” as defined in Executive Order 12866.
Executive Order 13563, Improving Regulation and Regulatory Review, reaffirms the principles of Executive Order 12866 and requires agencies to adopt regulations through a process that involves public participation and, to the extent feasible, base regulations on the open exchange of information and perspectives from affected stakeholders and the public as a whole. SBA has developed this rule in a manner consistent with these requirements. In addition, Executive Order 13563 requires agencies to assess the benefits and costs of any regulations and address available alternatives to direct regulation.
As described above, this proposed rule could affect small entities that participate as sureties in SBA's Surety Bond Guarantee program and small entities seeking assistance through the program. SBA's proposed rule will reduce time in two significant ways.
First, All Prior Approval participants surveyed agreed that having a Surety Partner participation agreement for the Prior Approval program would greatly benefit program participants by removing SBA's requirement to individually certify every application submission. SBA proposes changes to 13 CFR 115.30(d) to require a new Prior Approval Agreement between SBA and the Prior Approval Surety Partner which will contain a master certification for all the applications to follow. This removes the need for each application to be individually certified. SBA estimates the new agreements would reduce application time burden on program participants by 557 hours, or $15,818 according to fiscal year 2023 program activity.
The proposed change is estimated to save each impacted program participant an average of 3 minutes per response, or a total of 557 total burden hours for all small businesses. To quantify the value of time saved, the SBA relies on BLS wage data and assumes that the representative impacted occupation would be “insurance sales agents”. The median wage from 2023 for this occupation was $28.40. Using the program data from FY2023, the estimated total burden hours saved for program participants per year is approximately 557. The total annual savings that the SBA estimates for program participants as a result of the proposed changes comes to $15,818 ($28*557), on average.
Second, SBA proposes shifting how small business contractor remit fees to SBA from the small businesses itself to being remitted by the Surety Partners. This enables the industry to align their SBA contractor fee collection procedures with industry fee collection practices and reduce the amount of uncollectible fees with small businesses. As explained on page 6 of this text, SBA estimates the change would reduce application time burden on program participants and small businesses by 568 hours, or $14,495 according to fiscal year 2023 program activity.
This action meets applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. This rule does not have retroactive or preemptive effect.
For purposes of Executive Order 13132, SBA has determined this rulemaking 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, SBA has determined that this proposed rule has no federalism implications warranting preparation of a federalism assessment.
For the purpose of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA will update the affected information collections and go through the typical Paperwork Reduction Act process.
Administrative practice and procedure, Bonding, Surety bonds, Surety, Small businesses.
For the reasons set forth in the preamble, SBA proposes to amend 13 CFR part 115 as follows:
5 U.S.C. app 3; 15 U.S.C. 636i, 687b, 687c, 694a, and 694b note.
Sureties interested in participating as Prior Approval Sureties or PSB Sureties should apply by email or in writing to the D/SG at 409 3rd Street SW, Washington, DC 20416. OSG will determine the eligibility of the applicant considering its standards and procedures for underwriting, administration, claims and recovery. Each applicant must be a corporation listed by the U.S. Treasury as eligible to issue bonds. At a minimum, each applicant must have salaried staff that is employed directly (not an agent or other individual or entity under contract with the applicant) to perform all claims and recovery functions other than specialized services the costs of which may be reimbursable under 13 CFR 115.16(e)(1). Final settlement authority for claims and recovery must be vested only in the applicant's salaried claims staff. The applicant must continue to comply with SBA's standards and procedures for underwriting, administration, claims, recovery, and staffing requirements while participating in SBA's Surety Bond Guarantee Program.
(f)
(c)
(f) * * *
(1) Either:
(i) The bond was Executed prior to the date of SBA's guarantee, or in the case of a bonding line commitment under § 115.33 the bonding line was not established in accordance with § 115.33(d); or
(ii) The bond was Executed (or approved, if the Surety is legally bound by such approval) after the work under the Contract had begun, unless SBA approves a “Surety Bond Guarantee Agreement Addendum” (SBA Form 991) after receiving all of the following from the Surety:
(A) Satisfactory evidence, including a certified copy of the Contract (or a sworn affidavit from the Principal), showing that the bond requirement was contained in the original Contract, or other documentation satisfactory to SBA, showing why a bond was not previously obtained and is now being required;
(B) Certification by the Principal that all taxes and labor costs are current, and listing all suppliers and subcontractors, indicating that they are all paid to date, and attaching a waiver of lien from each; or an explanation satisfactory to SBA why such documentation cannot be produced; and
(C) Certification by the Obligee that all payments due under the Contract to date have been made and that the job has been satisfactorily completed to date.
(g)
The Surety must submit to SBA notification of successfully completed contracts and claims files within the timeframe set by SBA, and in the manner as prescribed by SBA.
(b) SBA's approval or decline of a guarantee application is made in writing by the D/SG or their designee. SBA may provide telephone notice before the Prior Approval Surety receives SBA's guarantee approval form if the guarantee has already received approval by SBA staff with delegated authority. In the event of a conflict between the telephone notice and the written form, the written form controls.
(c) A Prior Approval Surety may request reconsideration of a decline from the D/SG or their designee who made the decision. If the decision on reconsideration is negative, the Surety may appeal to an individual designated by the D/SG. If the decision is again adverse, the Surety may appeal to the D/SG, who will make the final decision.
(d) Prior Approval Agreement. To apply for a bond guarantee, a Prior Approval Surety must have an active Prior Approval Agreement, submit a Surety Bond Guarantee Agreement (SBA Form 990), and select one of the following application types:
(2)
(b)
(d)
(2)
(3)
(b) * * *
(1) The term of the bonding line, not to exceed the fiscal year of approval subject to renewal in writing;
(a) * * *
(1) * * *
(iv) The Surety has verified any adverse information concerning imminent breach by the Principal.
(a)
(1) An underwriting limitation on the U.S. Treasury Department list of acceptable sureties of at least the minimum threshold set by SBA for the applicant Surety or an SBA-partnered affiliate;
(2) An agreement that the Surety will neither charge a bond premium in excess of that authorized by the appropriate State insurance department, nor impose any non-premium fee unless such fee is permitted by applicable State law and approved by SBA.
(3) The vesting of underwriting authority for SBA guaranteed bonds only in employees of the Surety, its affiliates, or partner-affiliated entities approved by SBA;
(4) The rating or ranking designations assigned to the Surety by recognized authority.
(b)
(b)
(a)
(b)
(c)
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Leonardo S.p.a. Model A109C, A109E, A109S, and AW109SP helicopters. This proposed AD was prompted by a report of a quality escape on a batch of main rotor blades (MRBs). This proposed AD would require repetitively tap inspecting certain MRBs, replacing those MRBs, and prohibit installing those MRBs, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this NPRM by January 3, 2025.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For EASA material identified in this proposed AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
• You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. It is also available at
Frank Huynh, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (404) 983-5288; email:
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
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
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 Frank Huynh, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (404) 983-5288; email:
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2023-0159, dated August 10, 2023 (EASA AD 2023-0159) (also referred to as the MCAI), to correct an unsafe condition on all Leonardo S.p.a. Model A109C, A109E, A109S, and AW109SP helicopters. The MCAI states that a report was received of a quality escape on a batch of MRBs, where the tip cap had been replaced by following a procedure and using tools not in accordance with Leonardo Technical Publications. The FAA is proposing this AD to prevent premature debonding of an MRB tip cap, which could lead to the loss of the MRB tip cap in flight, possibly resulting in loss of control of, and damage to, the helicopter, and injury to occupants.
You may examine the MCAI in the AD docket at
EASA AD 2023-0159 requires repetitively tap inspecting certain part-numbered and serial-numbered MRBs for deficiency (debonding) of the tip cap, and depending on the results, replacing the MRB. For affected MRBs that are not replaced as a result of a tap inspection, EASA AD 2023-0159 requires replacing those MRBs within a longer compliance time. EASA AD 2023-0159 also prohibits installing those MRBs on any helicopter.
This material is reasonably available because the interested parties have
The FAA also reviewed Leonardo Helicopters Alert Service Bulletin (ASB) No. 109-159, ASB No. 109EP-181, ASB No. 109S-116, and ASB No. 109SP-158, each dated August 2, 2023. This material specifies procedures for tap inspecting the MRB tip cap for debonding, determining if any debonding exceeds allowable limits, and replacing an MRB.
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.
This proposed AD would require accomplishing the actions specified in EASA AD 2023-0159, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD.
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 2023-0159 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2023-0159 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 2023-0159 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 2023-0159. Material referenced in EASA AD 2023-0159 for compliance will be available at
The FAA estimates that this AD, if adopted as proposed, would affect 19 helicopters of U.S. registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.
Tap inspecting the MRBs (up to four affected MRBs per helicopter) would take up to 1 work-hour for an estimated cost of up to $85 per helicopter and $1,615 for the U.S. fleet, per inspection cycle. Replacing an MRB would take 4 work-hours and parts would cost $111,218 for an estimated cost of $111,558 per MRB.
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.
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.
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.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by January 3, 2025.
None.
This AD applies to Leonardo S.p.a. Model A109C, A109E, A109S, and AW109SP helicopters, certificated in any category.
Joint Aircraft System Component (JASC) Code 6210, Main Rotor Blades.
This AD was prompted by a report of a quality escape on a batch of main rotor blades (MRBs). The FAA is issuing this AD to detect and address non-conforming MRB tip caps. The unsafe condition, if not addressed, could result in premature debonding of an MRB tip cap, loss of the MRB tip cap in flight, and subsequent loss of control of, and damage to, the helicopter, and injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency AD 2023-0159, dated August 10, 2023 (EASA AD 2023-0159).
(1) Where EASA AD 2023-0159 requires compliance in terms of flight hours, this AD requires using hours time-in-service.
(2) Where EASA AD 2023-0159 refers to its effective date, this AD requires using the effective date of this AD.
(3) Where the note in the material referenced in paragraph (1) of EASA AD 2023-0159 specifies that the hammer tapping inspection must be performed only by appropriate qualified personnel in accordance with the national aviation regulation; for this AD, the tap test must be accomplished by persons authorized under 14 CFR 43.3. These inspections must be performed by at least a Level I inspector certified in the FAA-acceptable standards for nondestructive inspection personnel.
(4) Where paragraph (2) of EASA AD 2023-0159 states “any deficiency;” this AD requires replacing that text with “any debonding.”
(5) Where paragraph (2) of EASA AD 2023-0159 states “replace that affected part with a serviceable part in accordance with the instructions of Part II of the ASB;” this AD requires replacing that text with “replace that affected part, as defined in EASA AD 2023-0159, with a serviceable part, as defined in EASA AD 2023-0159.”
(6) Where paragraph (3) of EASA AD 2023-0159 states “replace each affected part with a serviceable part in accordance with the instructions of Part II of the ASB;” this AD requires replacing that text with “replace each affected part, as defined in EASA AD 2023-0159, with a serviceable part, as defined in EASA AD 2023-0159.”
(7) This AD does not adopt the “Remarks” section of EASA AD 2023-0159.
Although the material referenced in EASA AD 2023-0159 specifies to submit certain information to the manufacturer, this AD does not require that action.
Special flight permits are prohibited.
(1) 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 (l)(1) of this AD and email to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
(1) For more information about this AD, contact Frank Huynh, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (404) 983-5288; email:
(2) For advisory circular material identified in this AD that is not incorporated by reference, go to
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2023-0159, dated August 10, 2023.
(ii) [Reserved]
(3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
(4) You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(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
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Colored Federal Airways Green 8 (G-8), Green 10 (G-10), Green 12 (G-12), and Red 99 (R-99). Revocation of Colored Federal Airway Blue 27 (B-27) and Alaskan Very High Frequency Omnidirectional Range (VOR) Federal Airway V-619 in Alaska. This proposed action is due to the decommissioning of the Chinook, Fort Davis, Hotham, Oscarville, and Kachemak Nondirectional Radio Beacons (NDB) in Alaska.
Comments must be received on or before January 3, 2025.
Send comments identified by FAA Docket No. FAA-2024-2533 and Airspace Docket No. 22-AAL-26 using any of the following methods:
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*
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FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the airway structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
Colored Federal Airways are published in paragraph 6009 and Alaskan VOR Federal Airways are published in paragraph 6010(b) of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.
In support of NextGen, this proposal is part of an ongoing, large, and comprehensive airway modernization project in the state of Alaska. Part of this project is to transition the Alaskan en route navigation structure away from dependency on NDBs and move to develop and improve the RNAV route structure. The FAA is planning to decommission the Chinook, Fort Davis, Hotham, Oscarville, and Kachemak NDBs in Alaska. As a result, portions of G-8, G-10, G-12, and R-99 will become unusable. Additionally, B-27 and V-619 will become unusable.
The FAA is proposing an amendment to 14 CFR part 71 to by amending Colored Federal Airways G-8, G-10, G-12, and R-99. Additionally, the FAA is proposing to revoke B-27 and V-619 in their entirety in Alaska. These proposed actions are due to the decommissioning of the Chinook, Fort Davis, Hotham, Oscarville, and Kachemak Nondirectional Radio Beacons (NDB) in Alaska.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, ” Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Shemya, AK, NDB, 20 AGL; Mount Moffett, AK, NDB, 20 AGL; Dutch Harbor, AK, NDB, 20 AGL; INT Dutch Harbor, AK, NDB 041° and Elfee, AK, NDB 253° bearings, 20 AGL; Elfee, AK, NDB.
From Cape Newenham, AK, NDB; 20 AGL St. Paul Island, AK, NDB; 20 AGL Elfee AK, NDB; 20 AGL INT Elfee NDB 041° and Port Heiden, AK, NDB 248° bearings; 20 AGL Port Heiden NDB; 67 miles 12 AGL, 77 miles 85 MSL, 67 miles 12 AGL, Woody Island, AK, NDB.
Port Heiden, AK, NDB, 20 AGL; Borland, AK, NDB; 20 AGL; to Elfee, AK, NDB.
From St. Paul Island, AK, NDB, 20 AGL; Dutch Harbor, AK, NDB.
Bureau of Industry and Security, Department of Commerce.
Proposed rule; extension of comment period.
On October 23, 2024, the Bureau of Industry and Security (BIS) published in the
The comment period for the proposed rule published October 23, 2024, at 89 FR 84784, is extended. Comments must be received by BIS no later than December 23, 2024.
Comments on this rule may be submitted to the Federal rulemaking portal at:
All filers using the portal should use the name of the person or entity submitting the comments as the name of
For technical questions, contact Joseph A. Cristofaro, Director, Sensors, Aerospace and Marine Division, Office of National Security Controls, Bureau of Industry and Security, U.S. Department of Commerce, at 202-482-2440 or by email:
On October 23, 2024, BIS published in the
Department of State.
Proposed rule; extension of comment period.
The Department of State is extending the comment period for a proposed rule published on October 23, 2024. The original comment period required submission of comments on or before November 22, 2024. In response to requests from the public, the Department extends the comment period through December 23, 2024.
The comment period for the proposed rule published October 23, 2024, at 89 FR 84482, is extended. Comments should be received on or before December 23, 2024.
Interested parties may submit comments by one of the following methods:
•
•
Mr. Robert Rasmussen, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-2217; email
On October 23, 2024, the Department of State published a proposed rule (89 FR 60980) proposing revisions to the International Traffic in Arms Regulations (ITAR, 22 CFR parts 120 through 130). Specifically, the publication proposed to amend the ITAR to revise U.S. Munitions List (USML) Categories IV and XV and related sections of the ITAR to clarify and standardize the regulatory text, add items that warrant designation on the USML, and remove those items that no longer warrant designation on the USML. The publication further proposed to add three new license exemptions to the ITAR and requested public comment by November 22, 2024. In response to requests received from the public to extend the comment period, the Department of State is extending the comment period for the proposed rule for an additional 30 days, through December 23, 2024.
Coast Guard, DHS.
Advance notice of proposed rulemaking.
The Coast Guard seeks comments regarding the possible establishment of shipping safety fairways (“fairways”) in the Gulf of Maine identified in the Approaches to Maine, New Hampshire, and Massachusetts Port Access Route Study.
Comments and related material must be received by the Coast Guard on or before January 21, 2025.
You may submit comments identified by docket number USCG-2024-0248 using the Federal Decision-Making Portal at
For information about this document call or email Mr. Brian Mottel, Coast Guard; telephone 202-372-1526, email
The Coast Guard views public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
The purpose of this advance notice of proposed rulemaking (ANPRM) is to seek public input on the potential establishment of shipping safety fairways (“fairways”) in the Gulf of Maine. The fairway locations would be added to title 33 of the Code of Federal Regulations (CFR) part 166. The Approaches to Maine, New Hampshire, and Massachusetts Port Access Route Study (MNMPARS)
Establishing the recommended fairways would prohibit artificial islands or fixed structures within designated areas and would reduce the risk of vessel collisions, allisions, and groundings. Fairways would also reduce the potential for increased transit time and associated economic impacts that could result from redirecting vessel traffic, should offshore structures be integrated into the Marine Transportation System on the outer continental shelf (OCS).
The MNMPARS and follow-on analysis confirmed the need to codify traditional routes into fairways in the study area. As such, the Coast Guard believes it is prudent to proceed with an ANPRM, followed by a notice of proposed rulemaking (NPRM) and final rule. This strategy enables robust engagement with interested persons who may not have contributed to the MNMPARS, supports further evolution of regulatory alternatives, enhances the Coast Guard's understanding of regional spatial planning needs, and reduces the need for a supplemental NPRM before a final rule.
The legal basis for the potential establishment of fairways is Title 46 of the United States Code (U.S.C.), section 70003; Department of Homeland Security (DHS) Delegation No. 00170.1(II)(70), Revision No. 01.4.
The First Coast Guard District conducted the MNMPARS from March 31, 2022, to April 6, 2023. The study concluded that vessels transiting in the vicinity of offshore renewable energy lease areas may be affected, especially near or within traditional vessel traffic routes. Existing traffic separation schemes (TSSs) are established for vessels entering and exiting the ports of Portland, ME and Boston, MA; however, the TSSs do not extend far enough into the OCS to account for planned offshore renewable energy development within the study area.
Currently, no commercial leases have been awarded in the MNMPARS study area; however, on March 15, 2024, the Bureau of Ocean Energy Management
In addition, BOEM has finalized and issued a 15,000-acre research lease to the State of Maine with an effective date of Sep 1, 2024. The project would construct up to 12 floating wind turbines adjacent to the Eastern Approach TSS, which is approximately 20 nautical miles off the coast of Portland, ME. BOEM, USCG, and the state of Maine have worked together to deconflict the research lease with the recommended fairways and existing navigation safety systems. In order to provide a dependable and safe corridor for mariners in the area, the Coast Guard is considering an alternative fairway design for the Portland Eastern Approach Fairway that is different in design than the fairway recommended by the MNMPARS. This alternative fairway design is intended to meet vessel traffic needs, while also considering other uses of the waterway.
In summary, the Coast Guard is seeking input on the potential to establish four fairways, as recommended by the MNMPARS (Massachusetts Bay Fairway, Coastal Zone Fairway, Portland Southern Approach Fairway, and Gulf of Maine Fairway), and one fairway (Portland Eastern Approach Fairway) that is a different design than the fairway recommended by the MNMPARS.
In this ANPRM, the Coast Guard seeks information and your input to assist us in establishing, through a potential future rulemaking, fairways in the Gulf of Maine. The Coast Guard seeks public comments, positive or negative, on the impacts that the potential fairways may have on navigational safety and on other activities in these offshore areas to aid us in developing an NPRM and the supporting analyses.
Where possible and pertinent, please provide sources, citations, and references to back up or justify your responses. Also, for all pertinent responses, please provide a detailed explanation of how you arrived at this conclusion, and your underlying assessment that supports your conclusion. Finally, for all numerical responses, please provide us with sufficient information to recreate your calculations.
The following questions were designed to scope this process:
The Coast Guard encourages all respondents to review and reference the MNMPARS, specifically the Executive Summary, Purpose, and Background sections, as well as the illustrations, when responding to the following questions. These resources can be found in the docket.
1. Do the recommended fairways provide safe and efficient routes for vessels transiting to and from international ports and the United States? Why or why not? If not, what would you recommend instead?
2. Are the recommended fairways described in this ANPRM necessary for ensuring a safe and orderly passage for vessels transiting among U.S. domestic ports of call? Why or why not? Please explain your answer, including your specific comments on how the fairways described in this ANPRM would affect maritime traffic patterns, navigational safety, and access to ports.
3. Are there any positive or negative impacts of not establishing the recommended fairways noted in this ANPRM? If so, please describe them.
4. If these recommended fairways are established, how would commercial fishing vessels be positively or negatively impacted?
5. If these recommended fairways are established, what other persons, entities, or organizations would be positively or negatively impacted? In other words, which groups of people, businesses, or industries (maritime and non-maritime) would be positively or negatively impacted by these potential fairways?
6. What other offshore uses may be positively or negatively affected by the recommended fairways? Please include specific locations, potential impact, and associated costs or benefits. Please also describe the safety significance of the recommended fairways on the activity.
7. Do the recommended fairways unduly limit offshore development? If so, is there information on costs, or cost model or structure that should be considered for analysis?
8. From an environmental perspective, would the recommended fairways (on traditional routes) negatively impact living marine resources? If so, which marine resources would be impacted and how? What measures should the Coast Guard take to avoid, minimize, or mitigate any such impacts?
9. Beyond the environmental impacts mentioned in question 8, are there any other positive or negative environmental impacts from the recommended fairways? If so, please provide detail as to how and what would be impacted. To the degree possible, please provide the data, impact assessments, and other pertinent background information necessary to understand and reproduce your results.
10. Are there additional measures that should be considered to improve safety or to relieve the area should an economic burden be imposed by the recommended fairways? What are the expected costs and/or associated benefits of the suggested additional measures?
11. Are there other variables that should be considered in developing this system of recommended fairways? If so, please indicate particular issues and the specific areas to which they pertain.
12. Have there been any offshore developments built or installed in the past 10 years that have impacted traffic patterns, navigational safety, or maritime commerce? If so, were the net impacts positive or negative? Please provide a detailed explanation of how you arrived at this conclusion.
13. Please offer any other comments or suggestions that may improve this initiative.
The Coast Guard is proposing a Portland Eastern Approach Fairway that is slightly different in design than the fairway recommended by the MNMPARS. The fairway contemplated in this ANPRM is designed to meet the needs of vessel traffic entering and departing the Port of Portland via the Eastern Approach TSS, while also considering the state of Maine's lease adjacent to the TSS to develop a 15,000-acre research array of up to 12 floating offshore wind turbines.
1. Are there any positive or negative impacts from the recommended Portland Eastern Approach Fairway? Please explain your answer, including specific comments on how this recommended fairway would affect maritime traffic patterns, navigational
2. Does the recommended Portland Eastern Approach Fairway provide a safe and efficient route for vessels transiting to and from the Eastern Approach TSS? Why or why not? If not, what would you recommend instead?
3. Would the recommended Portland Eastern Approach Fairway have any positive or negative environmental impacts?
4. Would the recommended Portland Eastern Approach Fairway have any positive or negative tribal impacts?
The Coast Guard is proposing a Gulf of Maine Fairway to meet the needs of vessel traffic primarily proceeding between Boston, Massachusetts, and the Bay of Fundy. The Coast Guard may consider design alternatives to the recommended Gulf of Maine Fairway to ensure safe transit for vessels, while providing ocean space for wind energy leasing.
1. Are there any positive or negative economic impacts from the recommended Gulf of Maine Fairway?
2. Is the recommended Gulf of Maine Fairway necessary to provide safe and efficient routes for vessels transiting to and from domestic and international ports? Why or why not? If not, what would you recommend instead?
3. What are the positive or negative vessel transit impacts to altering the recommended fairway's design, location, and characteristics, such as narrower width and change in cardinal direction? Please explain your answer, including specific comments on how any changes to this recommended fairway would affect maritime traffic patterns, navigational safety, marine or other environmental resources, and access to ports.
4. What other offshore uses may be positively or negatively impacted by alteration to this recommended fairway design, location, and characteristics, such as narrower width and change in cardinal direction? Please include specific locations, potential impact, and associated costs or benefits. Please also describe the safety significance of alterations to this recommended fairway on other offshore use activity.
5. If this fairway is established as recommended, what persons, entities, or organizations would be positively or negatively impacted? In other words, which groups of people, businesses, or industries (maritime and non-maritime) would be positively or negatively impacted by this recommended fairway?
6. Would the recommended Gulf of Maine Fairway have any positive or negative environmental impacts?
7. Would the recommended Gulf of Maine Fairway have any positive or negative tribal impacts?
Environmental Protection Agency (EPA).
Advance notice of proposed rulemaking (ANPRM).
In granting a petition filed under the Toxic Substances Control Act (TSCA) by Earthjustice on behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the Puyallup Tribe of Indians, the Environmental Protection Agency (EPA or Agency) committed to pursuing an action to solicit and collect information from the public on the potential risks associated with N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8, DTXSID 9025114) and its transformation product, 6PPD-quinone (CASRN 2754428-18-5, DTXSID 301034849). With this document, EPA is soliciting that information, along with information about potential alternatives and regulatory options to help inform the Agency's consideration of potential future regulatory actions under TSCA.
Comments must be received on or before January 21, 2025.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0403, through
You may be potentially affected by this action if you manufacture (including import), process (including recycling), distribute in commerce, dispose of, or use 6PPD and/or 6PPD-quinone. The following list of North American Industry 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:
• 325130 Synthetic Dye and Pigment Manufacturing;
• 325199 All Other Basic Organic Chemical Manufacturing ;
• 325212 Synthetic Rubber Manufacturing;
• 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing;
• 326211 Tire Manufacturing (Except Retreading);
• 326291 Rubber Product Manufacturing for Mechanical Use;
• 336999 All Other Transportation Equipment Manufacturing; and
• 424690 Other Chemical and Allied Products Merchant Wholesalers.
If you have any questions regarding the applicability of this action to you, please consult the technical information contact listed under
This action is being taken under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601
TSCA section 21 allows any person to petition EPA to initiate a rulemaking proceeding for the issuance, amendment, or repeal of a rule under
Under TSCA section 6(a), if EPA determines that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance presents an unreasonable risk to human health or the environment, it must “apply one or more of the [TSCA section 6(a)] requirements . . . to the extent necessary so that the chemical substance . . . no longer presents such risk,” which may range from prohibiting or otherwise restricting the manufacturing, processing, or distribution in commerce of the chemical substance (or a particular use), to commercial use requirements or disposal restrictions, to labeling and recordkeeping.
EPA is seeking public comment on all of the information included in and referenced by this ANPRM. EPA also seeks any additional information relevant to 6PPD, 6PPD-quinone, and potential 6PPD substitutes that could help inform potential future rulemakings. Topics in this ANPRM include but are not limited to: Information on the chemicals' environmental effects on aquatic and terrestrial ecosystems, potential human health effects, environmental fate and transport, exposure pathways, persistence and bioaccumulation, additional uses of 6PPD, and releases from consumer products (
When submitting information, the Agency is interested in receiving quantitative information, data and/or case examples, including peer-reviewed studies, statistical analyses, and industry, scientific, or technical reports describing datasets or syntheses of environmental or human health impacts of 6PPD, 6PPD-quinone, or potential alternatives for 6PPD.
This action does not propose or impose any requirements, and instead seeks comments and suggestions that will help inform the Agency's consideration of potential future actions for 6PPD and/or 6PPD-quinone. As such, there are no incremental costs or benefits associated with this ANPRM. Should the Agency pursue a rulemaking in the future, EPA will conduct the appropriate assessments of the potential costs and benefits associated with the proposed action.
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On August 1, 2023, Earthjustice, on behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the Puyallup Tribe of Indians, filed a TSCA section 21 petition requesting that EPA establish regulations prohibiting the manufacturing, processing, use, and distribution of 6PPD (CASRN 793-24-8, DTXSID 9025114) in and for tires under EPA's TSCA section 6(a) authority, 15 U.S.C. 2605(a). The petitioners requested that such regulation take effect as soon as practicable to eliminate the unreasonable risk 6PPD in tires presents to the environment (Ref. 1).
In the petition, concerns were raised that the chemical 6PPD, which has been used in tires since the 1960s to prevent tire degradation (Ref. 2), poses unreasonable risk to the environment due to the acute toxicity of its transformation product, 6PPD-quinone (CASRN 2754428-18-5, DTXSID 301034849), to coho salmon
On November 2, 2023, EPA granted the petition, stating that the petition, along with information reasonably available to EPA, set forth facts establishing that it was appropriate to initiate a TSCA section 6(a) proceeding to address risks to the environment from 6PPD and its transformation product, 6PPD-quinone (Ref. 3 [3]). Specifically, EPA committed to: (a) Issuing an ANPRM for 6PPD and 6PPD-quinone under TSCA section 6(a) by fall 2024; and (b) Finalizing a TSCA section 8(d) rulemaking by the end of 2024 that would require persons who manufacture (including import) 6PPD to submit lists or copies of unpublished health and safety studies to EPA. With this action, the Agency has promptly commenced an appropriate proceeding. The expected information resulting from this action will inform the Agency's consideration of future potential action though, as noted in the petition response, EPA cannot commit to a specific timeframe or outcome (Ref. 3).
6PPD is the organic compound N-(1,3-dimethylbutyl)-N′-phenyl-p-phenylenediamine (CASRN 793-24-8, DTXSID 9025114), which is added to tires and other rubber products to prevent degradation. As a solid, 6PPD is dark brown with violet flakes and is generally sold as pellets, pastilles, or in liquid form (Refs. 4 and 5). 6PPD can diffuse easily to the surface of a rubber product and quickly react with ozone (O
6PPD has been used globally since the 1960s as an antidegradant and antiozonant to prevent automobile tire degradation caused by exposure to ozone, oxygen, and temperature fluctuations (Refs. 2 and 7). By continuously migrating to the surface of the tire to fill microcracks and react with oxygen and ambient ozone in the environment, 6PPD protects the tire's rubber polymers from becoming brittle and cracked over time (Ref. 4). In doing so, 6PPD increases tire longevity, safety, and performance due to its ability to protect tires from premature degradation (Ref. 4).
Products that use recycled tire crumbs or pieces such as rubber-modified asphalt, playgrounds (rubber mulch), artificial turf, and sneakers may also contain 6PPD (Refs. 8 and 9).
6PPD is also used as an additive in other rubber goods (
Although more information is needed on the environmental fate and transport of 6PPD, one source of 6PPD in the environment occurs through the release of tire wear particles (TWP) from tires containing 6PPD (Refs. 12, 13, 14, and 15). Though limited data suggest 6PPD has a short half-life (hours to several days) in aqueous solutions (Ref. 16), TWP are continuously being emitted into the environment, especially as cars brake, accelerate, or turn (Refs. 17, 18, and 19). It is believed that TWP reach soils and aquatic media close to roadways, with a small fraction emitted into the atmosphere or sorbed to sediments (Refs. 4 and 19). During rainfall events, TWP can be mobilized from roads and road dust into nearby waterbodies (Ref. 20). For example, one study in Denmark investigating the annual TWP generated in a local road network and released into the aquatic environment found that 8-40 percent of the TWP from the roads reached surface waters after storm events depending on the stormwater treatment system (Ref. 21).
Once TWP containing 6PPD enter the environment, it is hypothesized that the environmental transformation of 6PPD primarily occurs through hydrolysis (water breaking down chemical bonds) or by reaction with oxygen and ozone and photodegradation from exposure to sunlight and air (Ref. 4). The more frequent detection of 6PPD in extractions from TWP but not road runoff suggests that these reactions occur on the surface of the tire or road and/or that 6PPD rapidly transforms once released from the tire (Ref. 4). However, fully understanding these processes since 6PPD is such a reactive compound remains an information gap.
Abiotic degradation of 6PPD occurs in water and the atmosphere. In water, 6PPD is highly reactive and can be affected by the water's pH, temperature, available sunlight, and other constituents in water such as metals (Ref. 4). Reported half-lives in water have ranged between 3.4 hours to less than a day, with warmer waters containing more heavy metals leading to a shorter half-life of 6PPD (Refs. 4 and 16). In the atmosphere, 6PPD can degrade quickly via indirect photodegradation, with a half-life in air between 1-2 hours, further limiting the gas phase dispersal of the unreacted chemical (Ref. 22). Direct entry into the environment in the gas phase is likely limited given the low vapor pressure of 6PPD (Ref. 22).
As for 6PPD's degradation in sediments, very little is known. Initial indications suggest that 6PPD is likely to adsorb to organic matter such as soil, sediments, and suspended particulate matter once released into the environment. This suggests that it may persist in aquatic and terrestrial sediments unless it undergoes photodegradation and hydrolysis through resuspension (Ref. 4). There are no available data on how 6PPD adheres to and binds to soil under different environmental conditions, but leaching of 6PPD through soil to groundwater is anticipated to be unlikely (Ref. 4). EPA's Estimation Program Interface (EPI) Suite estimates 6PPD's half-life to be 75 days in soil with photodegradation likely being the main process in which it is lost in surface soils (Refs. 4 and 23).
Both in tires and in TWP, 6PPD reacts at the rubber's surface with ambient ozone (O
One of 6PPD's transformation products is 6PPD-quinone, or 2-anilino-5-(4-methylpentan-2-ylamino) cyclohexa-2,5-diene-1,4-dione (CASRN 2754428-18-5, DTXSID 301034849). Due to 6PPD's highly reactive nature, it is thought that 6PPD is continually reacting with ozone at the surface of tires to form 6PPD-quinone (Refs. 6 and 27). As 6PPD-quinone forms on the surface of the tire, it adds to the protective film that 6PPD naturally creates, providing further protection from cracking of the tire rubber (Refs. 6, 27, and 28). However, this also means that 6PPD-quinone and 6PPD are likely present in most TWP that are common in the environment (Refs. 12, 29, and 30).
There are currently little data available to describe the environmental fate and transport of 6PPD-quinone, but data from several monitoring studies suggest that it persists longer in the environment than 6PPD (Ref. 31). One study found that 6PPD-quinone had a half-life of 33 hours in dechlorinated tap water compared to 5 hours for 6PPD (Ref. 16). The longer persistence of 6PPD-quinone in water indicates more potential exposure time to induce toxic effects in aquatic life (Ref. 16). Another study found that leachate from TWP remained toxic after exposure to extreme heat (80 °C) for 72 hours, suggesting that 6PPD-quinone is stable under extreme heat conditions (Ref. 32). It is also likely that the polar carbonyl groups (added oxygen atoms from oxidation) may make 6PPD-quinone more mobile in the environment than 6PPD (Ref. 33).
The number of studies on 6PPD and/or 6PPD-quinone's impacts on aquatic ecosystems has increased since 6PPD-quinone from TWPs was identified in 2020 as the likely causative agent for urban runoff mortality syndrome (URMS) (Ref. 32). URMS has been occurring in the Pacific Northwest at
For the hazard effects of 6PPD on aquatic species, there are acute toxicity data for nine freshwater species as of December 2023. The following acute toxicity data includes both the author-reported mortality values (LC
For the hazard effects of 6PPD-quinone on aquatic species, coho salmon (
These LC
Studies have also identified that certain fish species appear to be significantly more sensitive to 6PPD-quinone exposure than other species. For example, studies show that coho, steelhead, and chinook salmon are sensitive to 6PPD-quinone exposure; however, sockeye and chum salmon lacked a similar response and were not significantly affected by 6PPD-quinone (Refs. 12 and 49). The modes of action driving the large variation in the toxicity of 6PPD-quinone across species remains unknown, but one study suggests that a tissue-specific disruption of mitochondrial respiration is involved. Increased ventilation and gasping of sensitive species (coho salmon, brook trout, rainbow trout) was observed after exposure, suggesting that 6PPD-quinone exposure (5-80 μg/L) impacts cellular respiration and the oxygen consumption rate (Ref. 50). Another study found that the large increases in hematocrit commonly associated with coho salmon mortality after being exposed to roadway runoff could be due to a disruption in the blood-brain barrier since plasma leakage from the cerebrovasculature was observed (Ref. 51). This early research indicates that neurologic, metabolic, and mitochondrial disruption may be involved (Refs. 50, 51, and 52), but more research and tests are needed to confirm the specific modes of action for 6PPD-quinone and why it is acutely toxic to certain species. The mode of action driving 6PPD's toxicity may be different from 6PPD-quinone's, as 6PPD is toxic to many tested aquatic organisms but never reaches the high toxicity exerted by 6PPD-quinone to selected species.
Further, although EPA's published acute screening values for 6PPD and 6PPD-quinone in freshwater provided critical concentrations for protecting aquatic life from the two chemicals, the reports suggest that additional research will be important to fully characterize the toxicity of 6PPD-quinone and other key transformation products and degradants of 6PPD to aquatic life (Refs. 36 and 43). For example, the reports indicated that additional research that includes analytical confirmation of 6PPD-quinone is needed, as some of the available studies lacked analytical measurements of 6PPD-quinone at the end of the tests, which is important given the uncertainty of 6PPD-quinone's fate in lab water. In addition, the screening value reports noted that most of the available aquatic species' tests on
For these reasons, additional acute and chronic toxicity studies that include full analytical measurements at appropriate intervals across the study duration that are conducted using standard toxicity test guidelines would be useful. Additionally, the completion of tests on a broader range of aquatic taxa would provide a broader understanding of how these chemicals are impacting fish and other aquatic species (Refs. 36 and 43).
There are very limited data publicly available on how 6PPD and/or 6PPD-quinone may impact terrestrial ecosystems. As of December 2023, there was one available terrestrial study on the hazard effects of 6PPD on chicken embryos (
In the one terrestrial study focused on the hazard effects of 6PPD, 3-day old chicken embryos were exposed to 80 different rubber tire chemicals in either acetone or water (Ref. 53). Exposure to 6PPD resulted in deaths and malformations (EC50 of 1.5 umol 11 days post-exposure), but the authors reported an incomplete, irregular or flat dose-response curve for early death and malformations (Ref. 53). Given the incomplete dose-response characterization, more information on avian species and other terrestrial organisms will be important to further characterize the potential hazard effects of 6PPD.
Of the five other studies on the hazard effects of 6PPD-quinone on terrestrial organisms, four studies investigated the chronic effects of 6PPD-quinone exposure on nematodes (an invertebrate). One study on nematodes found that prolonged exposure to 6PPD-quinone at 1-10 μg/L shortened lifespan by up to 27.4 percent due to insulin signaling pathway dysfunction, decreased the amount of fertilized eggs due to DNA and signaling pathway damage, and decreased pharyngeal pumping and locomotion behavior (Ref. 54). Another study by the same authors found that after exposing nematodes to environmentally relevant concentrations of 6PPD-quinone (0.1-100 μg/L) for 4.5 days (from the larval to adult stage), several forms of abnormal locomotion behavior and neurodegeneration was observed, with exposure to 100 μg/L causing 5 percent lethality (Ref. 55). A similar study on nematodes found that 6PPD-quinone exposure negatively affected their digestive systems and lipid metabolism, with evidence of lipid accumulation and fatty acid deposition (Ref. 56) and that plastic nanoparticles in the environment enhanced the neurotoxicity and accumulation of 6PPD-quinone in nematodes (Ref. 57). In springtails, a soil organism, one study found that 6PPD-quinone exposure impaired the survival of the organisms, with a LC
There are limited data on the exposure pathways of 6PPD and 6PPD-quinone, however several recent studies in Asia have predicted potential exposure through dust inhalation and ingestion. For example, one study in Hangzhou, China measured 6PPD and 6PPD-quinone levels in indoor dust and estimated the daily intake of 6PPD and 6PPD-quinone for children based on expected ingestion and inhalation rates for indoor dust (Ref. 59). The study found 6PPD and 6PPD-quinone to be the predominant phenylene diamine (PPD) and PPD-q in indoor dust and that children, especially infants, were potentially ingesting 6PPD and 6PPD-quinone through indoor dust based on the measured concentrations and daily intake estimations (Ref. 59). A similar study measured 6PPD-quinone levels in outdoor dust near roads, homes, and kindergartens in Guiyu, an e-waste-exposed area, and in Haojiang, a reference area, from 2019-2021 (Ref. 60). The study found that 6PPD-quinone levels were significantly higher in home and kindergarten classroom dust within the e-waste-exposed area compared to the reference area, indicating that dust may be an exposure pathway for humans and that e-waste may be another potential source of 6PPD-quinone in the environment (Ref. 60). Using the measured concentrations of 6PPD-quinone in dust, the study also estimated that higher daily intakes of 6PPD-quinone from kindergarten classroom dust could be associated with lower body mass indexes and higher incidences of influenza and diarrhea in kindergarten children, although these data are potentially confounded by other environmental stressors and chemicals that may be found within e-waste-exposed areas (Ref. 60). Another study in Hong Kong that measured the environmental occurrence of 6PPD and 6PPD-quinone in road dust to estimate potential pathways of human exposure found that exposure levels for contaminated road dust were higher for 6PPD-quinone than for 6PPD (Ref. 61).
Although these studies were primarily done in Asia and under unique exposure scenarios (
A limited number of biomonitoring studies in Asia identified 6PPD-quinone in human samples, some of which also monitored for 6PPD. However, it is important to note that many of these studies had a small sample size. In one study, after 6PPD-quinone levels were recorded in the cerebrospinal fluid (CSF) of 13 patients with Parkinson's disease (PD) and 11 control participants, researchers found that 6PPD-quinone levels were twice as high in PD patients compared to controls and confirmed through immunostaining assays that 6PPD-quinone at environmentally relevant concentrations exacerbated the formation of Lewy neurites and impaired mitochondrial activity (Ref. 62). Four other studies detecting PPDs and PPD-qs in human urine and blood found that the median concentrations of 6PPD and 6PPD-quinone were significantly higher than other PPD and PPD-qs measured in the study, especially in pregnant women and people with liver disease which may
Although there are limited data available on the potential human health effects of 6PPD and/or 6PPD-quinone, the health effects of 6PPD are better characterized than 6PPD-quinone in the scientific literature (Refs. 4, 25, and 66). 6PPD is a known skin-sensitizer that can lead to contact dermatitis in sensitized individuals and is listed as a category 1B reproductive toxicant by the European Chemicals Agency (Ref. 67).
Preliminary toxicity studies in rodents may also inform human health effects. For example, one study found that 6PPD and 6PPD-quinone bioaccumulate in the liver, with higher doses of both chemicals potentially causing an inflammatory response, altered hepatic metabolism, and hepatotoxicity in mice (Ref. 62) while another study identified that repeated exposure over 4 weeks to 6PPD-quinone (4 mg/kg) caused multiple organ injury in male BALB mice (Ref. 68). These early mammalian toxicity studies indicate that repeated exposure to 6PPD and 6PPD-quinone may affect organ function, metabolism, bioaccumulation, and inflammation in humans, but more studies are needed on 6PPD and 6PPD-quinone's impacts on human health.
As for bioaccumulation potential, one study found that when lettuce plants were exposed to TWP-derived 6PPD and 6PPD-quinone (among other TWP compounds) in hydroponic solutions over 14 days in a lab, the chemicals were taken up and metabolized by the lettuce with concentrations of 6PPD and 6PPD-quinone found in the plant's roots, leaves, and nutrient solution (Ref. 69). Other limited studies that reported bioaccumulative potential of 6PPD-quinone in aquatic species predicted that although there is potential for uptake, the data suggests that 6PPD-quinone does not significantly accumulate in fish tissues and instead metabolizes rapidly
Overall, more research on the effects, characteristics, relevant exposure pathways, and dose-response data are needed to identify the potential human health impacts from exposure to 6PPD and 6PPD-quinone. This is of particular importance for pregnant women and children, communities and workers near roadways, people with existing medical conditions, populations that participate in subsistence activities (
In their petition, the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the Puyallup Tribe of Indians present many potential impacts of 6PPD's transformation product, 6PPD-quinone, on their resources. They explain that their health, wellbeing, and culture are intimately connected to the health of their waters and ecosystems. The petition states that many Tribes share an important connection with their waterbodies, rendering them culturally significant and protected resources. The petitioners, along with additional Tribes that EPA engaged with related to this action, all emphasized that thriving shellfish and abundant salmonids are essential for their subsistence, cultural, and economic lifeways and has been one of their most important resources since time immemorial (Refs.1, 72, and 73).
The petition further explains that “exposure to 6PPD-q[uinone] can kill a coho salmon within hours, and the chemical is responsible for `urban runoff mortality syndrome,' which kills up to 100% of coho returning to spawn in urban streams” (Refs. 1 and 32). Petitioners state that the decline of coho salmon has negatively impacted their access to commercial fishing income, food security, health, and wellbeing and has affected their ability to pass on traditional ceremonial and ecological knowledge to future generations. Decreased fish populations and diminished water quality have also meant a loss of cultural identity and have led to increased reliance on expensive, less-healthy food sources, especially in rural, low-income communities (Refs. 1, 72, and 73).
Petitioners also assert that Tribal Treaty Rights, such as the Treaty of Point No Point, “guarantees the Tribe[s] access to salmon . . . and that any action that reduces the number of salmon available for harvest by Tribal members is a violation of its rights under this treaty.”
The Tribes also conclude that, “salmon and steelhead populations, central to the ecosystems, Tribal cultures, and economies of the West Coast, have already declined dramatically, due in part to exposure to 6PPD-q[uinone], and they cannot recover without its removal from the environment . . . We therefore call on EPA to exercise its authority under TSCA to protect the environment from the unreasonable risk presented by the use of 6PPD in tires” (Ref. 1).
Studies have shown that one source of 6PPD and 6PPD-quinone contamination in the environment is from TWP that are constantly entering the environment as tires roll across the road's surface (Ref. 30). These chemicals can also enter the environment from tire rubber if tires are disposed of in or near waterways. Tires and tire pieces are sometimes used as parts of dams, embankments, and erosion-control infrastructure, but little is known about whether 6PPD and 6PPD-quinone leach from these structures into the environment (Ref. 74). E-waste recycling and rubber-modified asphalt have been identified as other potential sources (Refs. 60 and 75). For example, a recent study found that rubber-modified asphalt containing 6PPD was acting as a sorbent for tire-derived 6PPD-quinone that released 6PPD-quinone into the environment after simulated rainfall events, with 0.0015-0.0049 μg/L of 6PPD-quinone recorded in the rainfall runoff (Refs. 76 and 77).
Additionally, although 6PPD has been identified in other non-tire rubber products (described in Unit II.B.3.) (Refs. 78, 79, and 80), more research is needed to determine the full suite of products that may contain 6PPD and the extent to which these products may be contributing to environmental contamination and exposure.
Monitoring studies have measured both 6PPD and 6PPD-quinone in air (Refs. 61 and 81), water (Ref. 61), outdoor and indoor dust (Refs. 82 and 59), sediments, and soil (Ref. 61), indicating that 6PPD and 6PPD-quinone contamination is widespread across multiple media (Ref. 83). Overall, 6PPD and 6PPD-quinone have been measured in environmental media around the world and a limited number of studies have shown both chemicals in human biomonitoring samples (Refs. 62, 63, 64, and 65).
TSCA section 6 requires EPA to take action to address unreasonable risks of injury to human health or the environment from a chemical substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk. If EPA determines that a chemical substance presents unreasonable risk to health or the environment, it must promulgate requirements under TSCA section 6(a) that can include one or more of the following actions, alone or in combination, to the extent necessary such that the chemical no longer presents the unreasonable risk:
• Prohibit or otherwise restrict the manufacturing (including import), processing, or distribution in commerce of the substance, or limit the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce (TSCA section 6(a)(1)).
• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance for a particular use or above a specific concentration for a particular use (TSCA section 6(a)(2)).
• Limit the amount of the substance which may be manufactured, processed, or distributed in commerce for a particular use or above a specific concentration for a particular use (TSCA section 6(a)(2)).
• Require clear and adequate minimum warning and instructions with respect to the substance, distribution in commerce, or disposal, or any combination of those activities, to be marked on or accompanying the substance (TSCA section 6(a)(3)).
• Require manufacturers and processors of the substance to make and retain certain records or conduct certain monitoring or testing (TSCA section 6(a)(4)).
• Prohibit or otherwise regulate any manner or method of commercial use of the substance (TSCA section 6(a)(5)).
• Prohibit or otherwise regulate any manner or method of disposal of the substance, or any article containing such substance, by its manufacturer or processor or by any person who uses or disposes of it for commercial purposes (TSCA section 6(a)(6)), and
• Direct manufacturers or processors of the substance to give notice of the unreasonable risk determination to distributors, certain other persons, and the public, and to replace or repurchase the substance (TSCA section 6(a)(7)).
Per TSCA section 6(c)(2)(B), in selecting among prohibitions and other restrictions, EPA must factor in, to the extent practicable, the effects of the substance on human health and the environment, any benefits of uses of the substance, and the reasonably ascertainable economic consequences of the rule.
In addition, TSCA section 6(g) allows EPA to grant an exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that: the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available; compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety.
At this time, an effective alternative to 6PPD's use in tires has not been identified, but multiple researchers, states, and tire manufacturers are studying potential replacements. For example, in October 2023, California's Department of Toxic Substances Control (DTSC) listed tires containing 6PPD as a Priority Product under the Safer Consumer Products Regulations (SCPR, Cal. Code Regs. Tit. 22, § 69511.7). Manufacturers of tires which contain 6PPD and are entered into the stream of commerce in California have submitted Preliminary Alternatives Analysis Reports to California DTSC, including a submission from the United States Tire Manufacturers Association's (USTMA) consortium of over 30 tire manufacturers (Refs. 2 and 84). Many of the identified potential alternatives in phase I of USTMA's alternatives analysis were other PPDs or non-PPD alternatives, including: 7PPD (CASRN 3081-01-4; DTXSID 5027516), IPPD (CASRN 101-72-4; DTXSID 1025485), 77PD (CASRN 3081-14-9; DTXSID 2024618), CCPD (CASRN 4175-38-6; DTXSID 8063335), and NA (an unnamed, specialized graphene nano-platelet). According to the report, early data suggests that these potential alternatives would have reduced impacts on salmonids and overall hazard relative to 6PPD based on screening level performance data and acceptable physical and chemical properties indicative of exposure potential (Ref. 2). California has granted a Notice of Compliance for the Preliminary (Stage 1) Alternatives Analysis report, and manufacturers will proceed with a Stage 2 Alternatives Analysis to confirm their list of possible alternatives, assess the potential impacts of these options, and initiate a more detailed review of the chemicals' potential hazards and exposure-related properties (Ref. 85).
Similarly, Washington State's Department of Ecology recently published a 6PPD Alternatives Assessment Hazard Criteria and an Alternatives Assessment (AA) Guide for them and other businesses to use when conducting an AA for 6PPD in tires (Ref. 86). The State of Washington also included 6PPD as a proposed priority chemical under their Safer Products of Washington law which will result in a list of products containing 6PPD in 2025 (Ref. 87).
Efforts are also underway to analyze other potential alternatives. For example, researchers are investigating gallates (antioxidant food preservative), lignins (plant-based polymer), Durazone-37 (another existing rubber antiozonant), Graphene, and N,N′-dicyclohexyl-1,4-phenylene diamine (CCPD) as potential replacements for 6PPD in tires (Ref. 88). USTMA and the U.S. Geological Survey are testing the toxicity of potential 6PPD alternatives and refining methods for evaluating potential alternatives, including the ones identified in USTMA's alternatives analysis report in California (Ref. 89). The U.S. Department of Agriculture's Western Regional Research Center and Flexsys are collaborating to explore a bio-based alternative to 6PPD (Ref. 90). EPA is funding multiple research efforts to test and identify potential alternatives, including EPA-funded Small Business Innovation Research (SBIR) grants (Ref. 91). Efforts are also underway to identify other potential solutions to reducing the risks posed by 6PPD and 6PPD-quinone, including reformulating tires using natural rubbers without 6PPD or modifying 6PPD molecules to avoid transformation into 6PPD-quinone (Ref. 88).
EPA is seeking public comment on all information included or referenced in this ANPRM and is also seeking any other information relevant to 6PPD and/or 6PPD-quinone. The Agency is particularly interested in receiving quantitative information, data and/or case examples (
EPA is interested in all information regarding 6PPD and/or 6PPD-quinone's effects on aquatic ecosystems (such as aquatic toxicity data). Adherence to standard guidelines or laboratory practices (
1. To ensure that EPA has robust, reasonably available data and information that is consistent with the best available science, EPA requests monitoring data reporting 6PPD and/or 6PPD-quinone concentrations and detection frequency in groundwater, surface waters, wastewater, saltwater, or estuaries across the United States. Specifically, EPA is requesting information and data on the volumes, locations, sources, dates/timeframes, and types of 6PPD and/or 6PPD-quinone contamination in impacted surface waters and sediments (
2. EPA is interested in information and data concerning the acute exposure hazard effects of 6PPD and/or 6PPD-quinone on a broader range of aquatic species than are discussed in Unit II.D.1 of this ANPRM, as well as chronic effects on all aquatic taxa. Even for species and effects that have been investigated previously, repeated high-quality tests with analytical measurements following testing guidelines are desired. Such hazard information includes, but it is not limited to, mortality (lethal concentrations), growth, developmental, behavioral, reproductive, hormonal, immunological, neurological, cardiovascular, respiratory, and renal effects from the cellular level to the organismal and population levels that might inform lethal and sub-lethal physiological, histological, and accumulative effects as well as any other hazard information that may be relevant to 6PPD and/or 6PPD-quinone. EPA seeks hazard effects information for any aquatic species, including but not limited to:
• Fish species (
• Aquatic studies done using new approach methodologies such as fish cell line assays or in vitro methods;
• Species of Tribal or cultural significance such as lamprey and mussels;
• Aquatic plants (including vascular and non-vascular (algae) species);
• Aquatic invertebrates (including benthic species);
• Aquatic and aquatic-dependent vertebrates other than fish (
• Bacteria/microbiome; and
• Any other potentially sensitive species.
3. EPA is requesting information and data concerning known concentrations of 6PPD and/or 6PPD-quinone found in aquatic animal and plant tissue that may indicate the bioaccumulation of 6PPD and/or 6PPD-quinone in these species, particularly in species which are culturally significant to Tribes or subsistence fisher populations. This information may have important implications for potential exposure through the consumption of affected plant and animal species.
EPA is interested in all information regarding 6PPD and/or 6PPD-quinone's effects on terrestrial ecosystems (such as terrestrial toxicity data). Data collected by any means is requested. Adherence to standard guidelines or laboratory practices (
1. To ensure that EPA has robust, reasonably available data and information that is consistent with the best available science, EPA requests monitoring information and data reporting for 6PPD and/or 6PPD-quinone concentrations and detection frequency in air, soil, and other terrestrial media. Specifically, EPA is requesting information and data on the volumes, locations, sources, dates/timeframes/pollutographs, and types of 6PPD and/or 6PPD-quinone contamination (
2. EPA is also interested in information and data concerning the hazard effects of 6PPD and/or 6PPD-quinone on a broader range of terrestrial species than are discussed in Unit II.D.2 of this ANPRM. Such hazard information includes, but it is not limited to, data on mortality (lethal concentrations), growth, development, genetics, behavior, and reproduction as well as data on the cellular, hormonal, immunological, neurological, accumulative, histological, and physiological effects of 6PPD and/or 6PPD-quinone and any other hazard information. EPA seeks hazard effects information for any terrestrial species, including:
• Terrestrial vertebrates (
• Soil fauna (
• Land invertebrates (
• Terrestrial plants (including nonvascular plants such as moss and lichen) with an emphasis on roadside plants;
• Fungi;
• Bacteria/microbiome; and
• Potentially sensitive species.
3. EPA is requesting information and data concerning known concentrations of 6PPD and/or 6PPD-quinone found in terrestrial animal and plant tissue that may indicate the bioaccumulation of 6PPD and/or 6PPD-quinone in these species, particularly in species which are culturally significant to Tribes or subsistence fisher populations. This information may have important implications for potential exposure through the consumption of affected species.
4. EPA is requesting information and data on any used methods of detection of 6PPD and/or 6PPD-quinone in biota, sediments, and soils.
1. As discussed in Unit II.E. of this ANPRM, there are limited data on the
• Pregnant women and children;
• Workers, including roadway workers, auto repair workers, racetrack maintenance crews, tire manufacturers or recyclers, and others who may be more frequently exposed to tires, TWP, vehicle dust, and road dust that may contain 6PPD and/or 6PPD-quinone; and
• Other potentially exposed or susceptible subpopulations (PESS), which may include:
—Communities that engage in subsistence fishing and/or gathering activities (
—Near-roadway communities that may be more frequently exposed to tires, TWP, vehicle dust, and road dust that may contain 6PPD and/or 6PPD-quinone;
—Communities living near goods-movement facilities, such as seaports, inland ports, land ports of entry, intermodal facilities and warehouse distribution centers;
—Populations with existing disabilities or medical conditions whose inhalation or ingestion of 6PPD and/or 6PPD-quinone may exacerbate existing medical concerns; and
—Populations that are otherwise vulnerable or experiencing multiple environmental stressors; and
• Studies showing the composition and purity of test substances should be reported, if available.
2. As discussed in Unit II.E. of this ANPRM, there is also limited data on relevant human exposure pathways (the ways a person can be exposed to 6PPD and/or 6PPD-quinone), including inhalation, ingestion, or direct contact with the chemicals in media such as air, water, soil, and dust. To ensure that EPA has robust, reasonably available data and information that is consistent with the best available science, EPA requests information and data on human exposure pathways of 6PPD and/or 6PPD-quinone on the general population, and especially for the following:
• Pregnant women and children;
• Disproportionately affected workers, including roadway workers, auto repair workers, and others who may be more frequently exposed to tires, TWP, vehicle dust, and road dust that may contain 6PPD and/or 6PPD-quinone; and
• Other potentially exposed or susceptible subpopulations (PESS), which may include:
—Communities that engage in subsistence fishing and/or gathering activities (
—Near-roadway communities that may be more frequently exposed to tires, TWP, vehicle dust, and road dust that may contain 6PPD and/or 6PPD-quinone;
—Populations with existing disabilities or medical conditions whose inhalation or ingestion of 6PPD and/or 6PPD-quinone may exacerbate existing medical concerns; and
—Populations that are otherwise vulnerable or experiencing multiple environmental stressors.
3. EPA is requesting information on the cultural, political, economic, and environmental justice impacts of 6PPD and 6PPD-quinone contamination on Tribes.
4. EPA is requesting information and data on the detection of 6PPD and/or 6PPD-quinone contamination in drinking water. Specifically, EPA is requesting information on the volumes, locations, sources, and types of 6PPD and/or 6PPD-quinone contamination in drinking water, including the concentration and analytical method used to detect the chemicals (including quantification and detection limits) when available.
1. To help inform EPA's understanding of how 6PPD from tires and/or TWP enters the environment, EPA is requesting information on the use of 6PPD in tires, including quantity and concentration. For example, this information includes but is not limited to the following:
• How many and what types of businesses are engaged in importing, manufacturing, processing, distributing in commerce, using, and disposing of 6PPD?
• What percent by weight of 6PPD meets the minimum criteria for the chemical's function within tires? Since the concentration of 6PPD in tires is not necessarily equivalent to the concentration that is released by tires, due to varying tire structures and designs, the amount and production of 6PPD's transformation products such as 6PPD-quinone and other degradants may be among the considerations for this response.
• What concentration of 6PPD is currently used during the tire manufacturing process? How does this vary across tire manufacturing companies and processes, as well as across different types of tire use (
• What is the rate of release of 6PPD and 6PPD-quinone from tires on electric vehicles vs. gas-powered vehicles?
• What is the concentration of 6PPD in the finished tire and where in the tire is 6PPD present (
• How does the concentration of 6PPD in the tire change over time during normal wear and tear—after one year of use, versus after 5 years, etc over the normal lifespan of a tire? Does the 6PPD concentration decrease steadily, or are there seasonal or other variations?
• Whether, and if so how, 6PPD content in tires has changed over the last several decades. Specifically, has 6PPD content changed on a per-pound basis? Or has it changed on a per-tire basis given that tire size and formulation can vary for light versus heavy duty vehicles?
• Has the trend toward increased specialization in light duty vehicle tires altered 6PPD use/content in tires? In particular, has the use of high-performance summer tires, winter tires, and tires with off-road capability increased over time?
• What are the water discharges from tire manufacturing facilities, including wastewater from processing and stormwater originating from these sites? Are monitoring data from near such sites available?
• What are the water discharges from other aquatic and terrestrial sites that use or reuse tires, including but not limited to artificial reefs, playgrounds that use crumb rubber or artificial turf, and/or tire dumps? Are monitoring data from near such sites available?
2. EPA is requesting data and information concerning the contribution of tire disposal, tire recycling, and tire reuse on environmental releases of, and
3. For EPA to better understand the fate and transport of 6PPD and 6PPD-quinone, EPA is requesting data and information on 6PPD as it moves from tires into the environment, reacts with ozone, and evolves into multiple transformation products, such as 6PPD-quinone. EPA is requesting information and data regarding the fate and transport of 6PPD and/or 6PPD-quinone in and for use in tires, as well as the fate and transport of TWP containing 6PPD and/or 6PPD-quinone. For example, EPA is requesting information on, but not limited to, the following:
• What factors influence the transformation of 6PPD to 6PPD-quinone and other transformation products (
• What are the degradation and transformation products of 6PPD, how do they move through the environment (
• How do 6PPD and 6PPD-quinone react with water quality sampling equipment (
4. To gain a better understanding of 6PPD's uses, EPA is requesting information and data regarding other products that contain 6PPD and the potential for 6PPD and/or 6PPD-quinone contamination from these other sources, some of which are mentioned in Unit II.G. (sneakers, plumbing seals, elastics, etc).
5. EPA is requesting information and data on successful water, air, soil, or sediment remediation and mitigation technologies that help reduce 6PPD and/or 6PPD-quinone exposure, such as green infrastructure, bioinfiltration basins, or technologies that capture TWP before they enter the environment, including methods that reduce 6PPD and/or 6PPD-quinone bound to airborne particulate matter. EPA is interested in information on remediation technologies once 6PPD and/or 6PPD-quinone has entered the environment and the scalability and feasibility of implementing those remediation approaches for reducing 6PPD and/or 6PPD-quinone in the environment.
6. EPA is requesting information and data regarding the cost and efficacy of technologies for remediating water sources that have been contaminated with 6PPD and/or 6PPD-quinone. EPA is particularly interested in examples or case studies of remediation efforts that have addressed 6PPD and/or 6PPD-quinone contamination, and cost and efficacy comparisons with other remediation efforts.
1. There are multiple efforts underway investigating potential alternatives to 6PPD in tires, many of which are summarized in Unit IV of this ANPRM. EPA is requesting information and data on potential alternatives and their associated transformation or degradation products, including those not identified in this ANPRM, that may replace 6PPD as an antiozonant in tires. In addition to identifying potential alternatives, EPA is requesting information and data on the following:
• What concentration of the potential alternative would be used during the tire manufacturing process and what concentration would be present in the finished tire? How would this vary across different types of tire use (
• What are the degradation and transformation products of the potential alternative, how do they move through the environment (
• What are the risks posed by potential alternatives to 6PPD on human health and the environment, including but not limited to hazard and toxicity effects of the parent and/or its transformation and degradation products on humans, aquatic and terrestrial species and ecosystems, and on air quality, greenhouse gas emissions, and potential disposal;
• What are relevant considerations to include when evaluating an alternative that might replace 6PPD in tires (
• Are there any potential non-chemical alternatives to 6PPD, such as, but not limited to, bio-based alternatives, self-healing polymers, or making physical changes to the tire or 6PPD molecule that could result in less release into the environment of 6PPD or TWP; and
• Any other exposure information, properties, or considerations of the potential alternatives.
2. More generally, EPA is requesting information and data on the potential challenges and timelines of transitioning to using an alternative to 6PPD as a tire antiozonant, such as:
• What is a timeframe for finding an alternative that presents no/less hazards than 6PPD?
• Once an alternative is identified, how long would it take for the alternative to be screened for feasibility in terms of its use in tires (
• What safety testing and approval processes need to occur on the alternative to ensure it passes federal highway safety regulations? What are the relevant timeframes for completing those processes?
• Once there is a feasible alternative that has passed initial safety screenings and is scalable, how might an extended phaseout be implemented to replace tires currently in use that contain 6PPD with the new tires?
• How much time would be necessary for tire and rubber manufacturers to phase out and/or replace 6PPD as an antiozonant from their production cycle once a safe and feasible alternative was ready to be implemented?
• What is a reasonable timeframe to phase out existing stocks of 6PPD that have already been produced for use in tires? Can existing stocks of 6PPD that have not been added to tires yet be safely disposed of (include associated methodologies)?
• What is a reasonable timeframe to phase out existing stocks of 6PPD-containing tires?
• How can 6PPD-containing tires be disposed of or repurposed (include associated methodologies) and what are the potential impacts of such actions?
• What is a reasonable timeframe to phase out the need for further introduction into commerce of 6PPD-containing tires?
• What transition periods (
• If a ban on the use of 6PPD in tires were in place, how long would it take to replace all tires currently in use given the expected lifespan of current tires (7-10 years)? EPA is requesting information
3. EPA is requesting information and data on the economic considerations and tradeoffs of removing 6PPD from tires and switching to an alternative formulation, process, or chemical.
4. EPA is requesting information and data based on actual releases to the environment of potential alternatives and their associated transformation products and degradants; including degree of contamination, and the cost and efficacy of the technologies available to remediate such contamination. Specifically, EPA is requesting, to the extent possible, information on the volumes, concentrations, locations, sources, and types of contamination from potential alternatives in water, soil, and air.
As explained in this ANPRM, EPA is gathering information on a potential rulemaking. EPA requests comment on:
1. If the Agency moves forward with a proposed rule after the ANPRM is published, what potential actions could EPA take under TSCA section 6(a)? Potential options include:
• Regulate the manufacturing, processing, or distribution in commerce of the chemical, including a complete ban of any such activity or limiting the amounts of the chemical manufactured, distributed, and/or included in tires;
• Regulate the manufacturing, processing, or distribution in commerce of the chemical for particular uses, including banning any such activity for a particular use; limiting the concentration of the chemical that may be used; or limiting the amounts of the chemical for particular uses;
• Require warning statements and/or instructions for use with respect to the chemical's use in tires and non-tire materials (
• Require manufacturers/processors to make and retain such records of the manufacturing process and/or monitor or conduct tests to ensure compliance with a TSCA section 6 rule;
• Prohibiting or regulating any manner or method of commercial use of the chemical;
• Prohibit or regulate the disposal of the chemical; and
• Require manufacturers/processors to provide warnings to distributors or users and to replace or repurchase the chemical.
2. TSCA provides EPA authority to select a combination of TSCA section 6(a) actions and limit the geographic application of a rule under TSCA section 6(a). EPA is requesting comment on whether, and if so, where EPA should consider limits to the geographical scope of any potential action under TSCA section 6(a)?
3. TSCA section 9 provides that the EPA Administrator shall consult and coordinate with the heads of other appropriate federal executive departments or agencies to achieve maximum enforcement of TSCA, while imposing the least burden of duplicative requirements. The Administrator is also directed to coordinate actions taken under TSCA with actions taken under other federal laws administered by the EPA, such as the Resource Conservation and Recovery Act, the Clean Air Act and the Clean Water Act. Are there other statutory authorities administered by EPA that could be used to eliminate or reduce to a sufficient extent any risk identified?
4. As discussed in Unit II.H., TSCA section 6(g) allows EPA to grant an exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that: the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available; compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. What should EPA consider regarding a potential TSCA section 6(g) exemption for 6PPD use in tires? If so, what conditions may be necessary to protect health and the environment while achieving the purposes of an exemption?
The following is a list of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Additional information about these statutes and executive orders can be found at
This action is not a significant regulatory action as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to a requirement for Executive Order 12866 review.
Because this action does not impose or propose any requirements, the various other review requirements in statutes and Executive Orders that apply when an agency imposes or proposes requirements do not apply to this ANPRM. Should EPA subsequently determine to pursue a rulemaking, EPA will address the requirements in the statutes and executive orders as applicable to that rulemaking.
Chemicals, Environmental protection, Exports, Hazardous substances, Imports, Reporting and recordkeeping requirements.
U.S. Agency for International Development.
Notice of public information collection.
The U.S. Agency for International Development (USAID) seeks Office of Management and Budget (OMB) approval to continue the information collection described below. In accordance with the Paperwork Reduction Act of 1995, USAID requests public comment on this collection from all interested individuals and organizations.
Submit comments on or before December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Ms. Nicole Thompson, at (202) 286-4696 or via email at
This proposed information collection was published in the
All comments must be in writing and submitted through the method(s) specified in the Addresses section above. All submissions must include the information collection title. Please include your name, title, organization, postal address telephone number, and email address in the text of the message. Please note that comments submitted in response to this Notice are public record. We recommend that you do not submit detailed personal information, Confidential Business Information, or any information that is otherwise protected from disclosure by statute.
Farm Service Agency, USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act requirement, the Farm Service Agency (FSA) is requesting comments from all interested individuals and organizations on an extension of a currently approved information collection to continue WHIP and the QLA Program. FSA provides payments to eligible producers who suffered eligible crop, tree, bush, and vine losses resulting from a qualifying disaster event. FSA also administers the QLA Program to provide financial assistance to eligible producers who experienced a crop quality loss due to a qualifying disaster event in calendar years 2018 or 2019. The application periods for WHIP and the QLA Program have ended; however, the collection is continuing for additional information that may be needed to verify compliance with program eligibility requirements.
We will consider comments that we receive by January 21, 2025.
We invite you to submit comments on this notice. You may submit comments by this method:
You may also send comments to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. Copies of the information collection may be requested by contacting Kathy Sayers.
For specific questions related to collection activity, contact Kathy Sayers; (202) 720-6870; email:
FSA is announcing plans to extend the information collection approval of a currently approved information collection that supports WHIP and the QLA Program. FSA provides payments to eligible producers who suffered eligible crop, tree, bush, and vine losses resulting from a qualifying disaster event that occurred in the 2017 calendar year under WHIP, which was authorized
FSA also administers the QLA Program to provide financial assistance to eligible producers who experienced a crop quality loss due to a qualifying disaster event in calendar years 2018 or 2019, which was authorized by the Additional Supplemental Appropriations for Disaster Relief Act, 2019 (Pub. L. 116-20), as amended by the Further Consolidated Appropriations Act, 2020 (Pub. L. 116-94).
For the following estimated total annual burden on respondents, the formula used to calculate the total burden hour is the estimated average time per response multiplied by the estimated total annual responses.
We are requesting comments on all aspects of this information collection to help us to:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the FSA, including whether the information will have practical utility;
(2) Evaluate the accuracy of the FSA's estimate of burden including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; or
(4) 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.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for Office of Management and Budget approval.
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a new information collection for the contract of the study titled Guidance for SNAP Certification and Quality Control Interviews. The purpose of this collection is to help FNS develop new guidance for SNAP eligibility and Quality Control interviews based on principles of human-centered design and cultural competency.
Written comments must be received on or before January 21, 2025.
Comments may be mailed to Eric Williams, Food and Nutrition Service, U.S. Department of Agriculture, 1320 Braddock Place, 5th Floor, Alexandria, VA 22314. Comments may also be submitted via email to
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Eric Williams at (703) 305-2640.
Comments are invited 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, including the validity of the methodology and assumptions that were 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 information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
This project will produce new guides for SNAP eligibility and QC interviews that SNAP agencies will have the option to use or adapt. The guides will incorporate principles of human-centered design (HCD) and cultural competency (that is, the ability to serve clients from diverse cultures and communities effectively). Infusing the interview processes with the principles of HCD and cultural competency will help expand equitable access to SNAP.
To draft the updated interview guides, the study team examined literature on HCD and cultural competency and reviewed existing guidance on SNAP interviews. The study team also assembled expert panels of SNAP participants and State SNAP agency staff to get their perspectives.
The study team will conduct semi-structured interviews with staff from state SNAP agencies in four States during virtual site visits. During these interviews, the team will collect qualitative data on State SNAP agency interview processes, the training SNAP staff receive on conducting them, and information about any written guidance State agencies give staff on conducting interviews. The team will also ask State agency staff for feedback on the draft guides. After revising the guides based on this feedback, the study team will test them with the community; for each guide, they will conduct cognitive interviews with 40 individuals with low incomes. The cognitive interviews will use a mix of in-person and telephone formats.
Across the four States selected, the study will seek to complete semi-structured interviews with four State SNAP management officials who helped develop interview guides, four State SNAP policy officials, four State SNAP training officials, 16 State QC reviewers, and 32 SNAP eligibility workers. The study team will send the interview guides to respondents at least a week before the interviews so that they can review them in advance. State SNAP management officials, SNAP policy officials, and SNAP training officials will review both the eligibility and QC interview guides before their semi-structured interviews. Eligibility workers will review the eligibility interview guide and QC reviewers will review the QC interview guide. The study team will seek assistance from the SNAP agency directors in the four participating States to schedule interviews and identify community partners.
To locate people with low incomes to participate in cognitive testing, the study team will contact up to eight CBO managers and request referrals. The study team expects to contact as many as 160 individuals with low incomes and ask them to participate. The study team will schedule cognitive tests with up to 120 of them, with the expectation that 40 will not agree to participate. Among the 120 individuals scheduled to participate in a cognitive test, the study team expects to complete a cognitive test with 80, with the expectation that the other 40 will ultimately be considered nonrespondents. Of the 80 respondents, 40 will complete a cognitive test of the eligibility interview guide and 40 will complete a cognitive test of the QC interview guide.
Before the start of data collection, the study team will pre-test the semi-structured interview guide with one State SNAP management official who helped develop interview guides, one State SNAP policy official, one State SNAP training official, two State QC reviewers, and four eligibility workers in one non-study State. The study team will pre-test the eligibility interview guide with up to nine individuals with low incomes. Up to nine individuals with low incomes will complete a cognitive test of the QC interview guide.
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the North Carolina Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a virtual, public meeting via Zoom at 1:00 p.m. ET on Wednesday, February 26, 2025. The purpose of this meeting is to discuss the Committee's report on the topic,
Wednesday, February 26, 2025, from 1:00 p.m.-2:30 p.m. Eastern Time.
The meeting will be held via Zoom Webinar.
Ana Victoria Fortes, Designated Federal Officer, at
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Ana Victoria Fortes at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file sharing website,
U.S. Commission on Civil Rights.
Notice of public meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Utah Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom at 3:00 p.m. MT on Wednesday, November 20, 2024. The purpose of the meeting is to debrief the testimony received on the topic,
Wednesday, November 20, 2024, from 3:00 p.m.-4:30 p.m. Mountain Time.
The meeting will be held via Zoom Webinar.
David Barreras, Designated Federal Officer, at
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available by selecting “CC” in the meeting platform. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received within 30 days following the meeting. Written comments may be emailed to David Barreras at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file sharing website,
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the North Carolina Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a virtual, public meeting via Zoom at 1:00 p.m. ET on Wednesday, January 22, 2025. The purpose of this meeting is to discuss the Committee's report on the topic,
Wednesday, January 22, 2025, from 1:00 p.m.-2:30 p.m. Eastern Time.
The meeting will be held via Zoom Webinar.
Ana Victoria Fortes, Designated Federal Officer, at
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Ana Victoria Fortes at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file sharing website,
U.S. Commission on Civil Rights.
Notice of public meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the North Carolina Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a virtual, public meeting via Zoom at 1:00 p.m. ET on Wednesday, February 5, 2025. The purpose of this meeting is to discuss the Committee's report on the topic,
Wednesday, February 5, 2025, from 1:00 p.m.-2:30 p.m. Eastern Time.
The meeting will be held via Zoom Webinar.
Ana Victoria Fortes, Designated Federal Officer, at
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Ana Victoria Fortes at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file sharing website,
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Ohio Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom. The purpose of this meeting is to discuss post-report activities.
Wednesday, December 4, 2024, from 1:30 p.m. to 2:30 p.m. Eastern Time.
This meeting will be held via Zoom.
Melissa Wojnaroski, Designated Federal Officer, at
This Committee meeting is available to the public through the registration link above. Any interested members of the public may attend this meeting. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Sarah Villanueva at
Records generated from these meetings may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after each meeting. Records of the meetings will be available via the file sharing website,
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice; correction.
The U.S. Department of Commerce (Commerce) published notice in the
Ashley Cossart (China) and Zachary Shaykin (Vietnam), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0462 and (202) 482-2638, respectively.
On November 4, 2024, Commerce published in the
In the
“Thermoformed molded fiber products are classified under subheadings 4823.70.0020 and 4823.70.0040, Harmonized Tariff Schedule of the United States (HTSUS).”
For a full description of the scope of these investigations, revised to reflect the correction specified above,
This notice is issued and published in accordance with sections 702 and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.203(c).
The merchandise subject to these investigations consists of thermoformed molded fiber products regardless of shape, form, function, fiber source, or finish. Thermoformed molded fiber products are formed with cellulose fibers, thermoformed using one or more heated molds, and dried/cured in the mold.
Thermoformed molded fiber products include, but are not limited to, plates, bowls, clamshells, trays, lids, food or foodservice contact packaging, and consumer or other product packaging.
Thermoformed molded fiber products are relatively dense, with a typical fiber density above 0.5 grams per cubic centimeter, and are generally characterized by relatively smooth surfaces. They may be derived from any virgin or recycled cellulose fiber source (including, but not limited to, those sourced from wood, woody crops, agricultural crops/byproducts/residue, and agricultural/industrial/other waste). They may have any weight, shape, dimensionality, design, or size, and may be bleached, unbleached, dyed, colored, or printed. They may include ingredients, additives, or chemistries to enhance functionality including, but not limited to, anti-microbial, antifungal, anti-bacterial, heat/flame resistant, hydrophobic, oleophobic, absorbent, or adsorbent. Thermoformed molded fiber products may also be subject to other processing or treatments, including, but not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting. Thermoformed molded fiber products subject to these investigations may also have additional design features, including, but not limited to, tab closures, venting, channeling, or stiffening.
Thermoformed molded fiber products remain covered by the scope of these investigations whether the subject product is encased by exterior packaging or whether the subject product forms the outer packaging for non-subject products. They also remain covered by the scope of these investigations whether imported alone, or in any combination of subject and non-subject merchandise (
Excluded from the scope of these investigations are thermoformed molded fiber products imported as packaging material that enclose and/or surround non-subject merchandise prepackaged for final sale upon importation into the United States (
Thermoformed molded fiber products include thermoformed molded fiber products matching the above description that have been finished, packaged, or otherwise processed in a third country by performing finishing, packaging, or processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the thermoformed molded fiber products. Examples of finishing, packaging, or other processing in a third country that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the thermoformed molded fiber products include, but are not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting.
Thermoformed molded fiber products are classified under subheadings 4823.70.0020 and 4823.70.0040, Harmonized Tariff Schedule of the United States (HTSUS). Imports may also be classified under subheadings 4823.61.0020, 4823.61.0040, 4823.69.0020, 4823.69.0040, 4823.90.1000, HTSUS. References to the HTSUS classification are provided for convenience and customs purposes, and the written description of the merchandise under investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable November 12, 2024.
Kelsie Hohenberger (Cambodia) and Rachel Jennings (Sri Lanka), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2517 and (202) 482-1110, respectively.
On October 21, 2024, the U.S. Department of Commerce (Commerce) received antidumping duty (AD) petitions concerning imports of paper file folders from Cambodia and Sri Lanka filed in proper form on behalf of the Coalition of Domestic Folder Manufacturers (the petitioner),
Between October 25 and 28, 2024, Commerce requested supplemental information pertaining to certain aspects of the Petitions in supplemental questionnaires.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of paper file folders from Cambodia and Sri Lanka are being, or are likely to be, sold in the United States at less than fair value (LTFV) within the meaning of section 731 of the Act, and that imports of such products are materially injuring, or threatening material injury to, the paper file folders industry in the United States. Consistent with section 732(b)(1) of the Act, the Petitions were accompanied by information reasonably available to the petitioner supporting its allegations.
Commerce finds that the petitioner filed the Petitions on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(F) of the Act.
Because the Petitions were filed on October 21, 2024, pursuant to 19 CFR 351.204(b)(1), the period of investigation (POI) for the Cambodia and Sri Lanka LTFV investigations is October 1, 2023, through September 30, 2024.
The products covered by these investigations are paper file folders from Cambodia and Sri Lanka. For a full description of the scope of these investigations,
As discussed in the
Commerce requests that any factual information that parties consider relevant to the scope of these investigations be submitted during that period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent LTFV and CVD investigations.
All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies.
Commerce is providing interested parties an opportunity to comment on the appropriate physical characteristics of paper file folders to be reported in response to Commerce's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant cost of production (COP) accurately, as well as to develop appropriate product comparison criteria.
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) general product characteristics; and (2) product comparison criteria. We note that it is not always appropriate to use all product characteristics as product comparison criteria. We base product comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe paper file folders, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, Commerce attempts to list the most important physical characteristics first and the least important characteristics last.
In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all product characteristics comments must be filed by 5:00 p.m. ET on December 2, 2024, which is 20 calendar days from the signature date of this notice. Any rebuttal comments must be filed by 5:00 p.m. ET on December 12, 2024, which is 10 calendar days from the initial comment deadline. All comments and submissions to Commerce must be filed electronically using ACCESS, as explained above, on the record of each of the LTFV investigations.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigations.
In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petitions with reference to the domestic like product as defined in the “Scope of the Investigations,” in the appendix to this notice. To establish industry support, the petitioner provided the 2023 total shipment values of the domestic like product for U.S. producers that support the Petitions and compared this to the estimated total shipment values of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petitions, the General Issues Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petitions.
The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at LTFV. In addition, the petitioner alleges that subject imports from Cambodia exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by the significant and increasing volume of subject imports; reduced market share; underselling and price depression and/or suppression; lost sales and revenues; and declines in the domestic industry's production, U.S. shipments, net sales, and financial performance.
The following is a description of the allegations of sales at LTFV upon which Commerce based its decision to initiate LTFV investigations of imports of paper file folders from Cambodia and Sri Lanka. The sources of data for the deductions and adjustments relating to U.S. price and normal value (NV) are discussed in greater detail in the Country-Specific AD Initiation Checklists.
For Cambodia, the petitioner based export price (EP) on pricing information for paper file folders produced in Cambodia and sold or offered for sale in the U.S. market during the POI.
For Cambodia and Sri Lanka, the petitioner stated that it was unable to obtain home market or third-country prices for paper file folders in the respective countries to use as a basis for NV.
As noted above, for Cambodia and Sri Lanka, the petitioner stated it was unable to obtain home market or third-country prices for paper file folders to use as a basis for NV. Therefore, for both countries, the petitioner calculated NV based on CV.
Pursuant to section 773(e) of the Act, the petitioner calculated CV as the sum of the cost of manufacturing, selling, general and administrative (SG&A) expenses, financial expenses, and profit.
Based on the data provided by the petitioner, there is reason to believe that imports of paper file folders from Cambodia and Sri Lanka are being, or are likely to be, sold in the United States at LTFV. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margins for paper file folders for each of the countries covered by this initiation are as follows: (1) Cambodia—127.58 to 288.36 percent; and (2) Sri Lanka—23.57 to 91.28 percent.
Based upon the examination of the Petitions and supplemental responses, we find that they meet the requirements of section 732 of the Act. Therefore, we are initiating LTFV investigations to determine whether imports of paper file folders from Cambodia and Sri Lanka are being, or are likely to be, sold in the United States at LTFV. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determinations no later than 140 days after the date of these initiations.
In the Petitions, the petitioner identified four companies in Cambodia and five companies in Sri Lanka as producers and/or exporters of paper file folders.
On November 7, 2024, Commerce released CBP data on imports of paper file folders from Cambodia and Sri Lanka under administrative protective order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment on CBP data and/or respondent selection must do so within three business days of the publication date of the notice of initiation of these investigations.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at
In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petitions have been provided to the governments of Cambodia and Sri Lanka via ACCESS. To the extent
Commerce will notify the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petitions were filed, whether there is a reasonable indication that imports of paper file folders from Cambodia and/or Sri Lanka are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Section 773(e) of the Act addresses the concept of particular market situation (PMS) for purposes of CV, stating that “if a particular market situation exists such that the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost of production in the ordinary course of trade, the administering authority may use another calculation methodology under this subtitle or any other calculation methodology.” When an interested party submits a PMS allegation pursuant to section 773(e) of the Act (
Neither section 773(e) of the Act, nor 19 CFR 351.301(c)(2)(v), sets a deadline for the submission of cost-based PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a cost-based PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of a respondent's initial section D questionnaire response.
We note that a PMS allegation filed pursuant to sections 773(a)(1)(B)(ii)(III) or 773(a)(1)(C)(iii) of the Act (
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce.
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in these investigations should ensure that they meet the requirements of 19 CFR 351.103(d) (
This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).
The products within the scope of these investigations are file folders consisting primarily of paper, paperboard, pressboard, or other cellulose material, whether coated or uncoated, that has been folded (or creased in preparation to be folded), glued, taped, bound, or otherwise assembled to be suitable for holding documents. The scope includes all such folders, regardless of color, whether or not expanding, whether or not laminated, and with or without tabs, fasteners, closures, hooks, rods, hangers, pockets, gussets, or internal dividers. The term “primarily” as used in the first sentence of this scope means 50 percent or more of the total product weight, exclusive of the weight of fasteners, closures, hooks, rods, hangers, removable tabs, and similar accessories, and exclusive of the weight of the packaging.
Subject folders have the following dimensions in their folded and closed position: lengths and widths of at least 8 inches and no greater than 17 inches, regardless of depth.
The scope covers all varieties of folders, including but not limited to manila folders, hanging folders, fastener folders, classification folders, expanding folders, pockets, jackets, and wallets.
Excluded from the scope are:
• mailing envelopes with a flap bearing one or more adhesive strips that can be used permanently to seal the entire length of a side such that, when sealed, the folder is closed on all four sides;
• binders, with two or more rings to hold documents in place, made of paperboard or pressboard encased entirely in plastic;
• binders consisting of a front cover, back cover, and spine, with or without a flap; to be excluded, a mechanism with two or more metal rings must be included on or adjacent to the interior spine;
• non-expanding folders with a depth exceeding 2.5 inches and that are closed or closeable on the top, bottom, and all four sides (
• expanding folders that have: (1) 13 or more pockets; (2) a flap covering the top; (3) a latching mechanism made of plastic and/or metal to close the flap; and (4) an affixed plastic or metal carry handle;
• folders that have an outer surface (other than the gusset, handles, and/or closing mechanisms, if any) that is covered entirely with fabric, leather, and/or faux leather;
• fashion folders, which are defined as folders with all of the following characteristics: (1) plastic lamination covering the entire exterior of the folder; (2) printing, foil stamping, embossing (
• portfolios, which are folders having: (1) a width of at least 16 inches when open flat; (2) no tabs or dividers; and (3) one or more pockets that are suitable for holding letter size documents and that cover at least 15 percent of the surface area of the relevant interior side or sides; and
• report covers, which are folders having: (1) no tabs, dividers, or pockets; and (2) one or more fasteners or clips, each of which is permanently affixed to the center fold, to hold papers securely in place.
Imports of the subject merchandise are provided for under Harmonized Tariff Schedule of the United States (HTSUS) category 4820.30.0040. Subject imports may also enter under other HTSUS classifications. While the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of these investigations is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
In response to requests from Bull Moose Tube Company, Maruichi American Corporation, Wheatland Tube Company, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO, CLC (collectively, the domestic interested parties), the U.S. Department of Commerce (Commerce) is initiating a country-wide circumvention inquiry to determine whether circular welded carbon quality steel pipe (CWP) from the People's Republic of China (China), which is completed in the Sultanate of Oman (Oman) from hot-rolled steel (HRS) produced in China, is circumventing the antidumping duty (AD) and countervailing duty (CVD) orders on CWP from China.
Applicable November 19, 2024.
Krisha Hill, AD/CVD Operations, Office IV Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4037.
On July 9, 2024, pursuant to section 781(b) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.226(i), the domestic interested parties filed circumvention inquiry requests alleging that CWP completed in Oman using HRS manufactured in China is circumventing the AD and CVD
On August 12, 2024, we extended the deadline to initiate this circumvention inquiry by 30 days, in accordance with 19 CFR 351.226(d)(1).
On August 28, 2024, we issued a request for information questionnaire to the domestic interested parties.
On October 7, 2024, Al Jazeera filed opposition comments in response to the Domestic Interested Parties' Request.
The merchandise covered by the scope of the
This circumvention inquiry covers CWP from China, completed in Oman using Chinese-produced HRS, and subsequently exported from Oman to the United States.
Section 351.226(d) of Commerce's regulations states that if Commerce determines that a request for a circumvention inquiry satisfies the requirements of 19 CFR 351.226(c), then Commerce “will accept the request and initiate a circumvention inquiry.” Section 351.226(c)(1) of Commerce's regulations, in turn, requires that each circumvention inquiry request alleges “that the elements necessary for a circumvention determination under section 781 of the Act exist” and be “accompanied by information reasonably available to the interested party supporting these allegations.” The domestic interested parties alleged circumvention pursuant to section 781(b) of the Act, which pertains to merchandise completed or assembled in other foreign countries.
Section 781(b)(1) of the Act provides that Commerce may find circumvention of an AD or CVD order when merchandise of the same class or kind subject to the order is completed or assembled in a foreign country other than the country to which the order applies. In conducting a circumvention inquiry, under section 781(b)(1) of the Act, Commerce relies on the following criteria: (A) merchandise imported into the United States is of the same class or kind as any merchandise produced in a foreign country that is the subject of an AD or CVD order or finding; (B) before importation into the United States, such imported merchandise is completed or assembled in another foreign country from merchandise which is subject to the order or merchandise which is produced in the foreign country that is subject to the order; (C) the process of assembly or completion in the foreign country referred to in section (B) is minor or insignificant; (D) the value of the merchandise produced in the foreign country to which the AD or CVD order applies is a significant portion of the total value of the merchandise exported to the United States; and (E) the administering authority determines that action is appropriate to prevent evasion of such order or finding.
In determining whether the process of assembly or completion in a third country is minor or insignificant under section 781(b)(1)(C) of the Act, section 781(b)(2) of the Act directs Commerce to consider: (A) the level of investment in the foreign country; (B) the level of research and development in the foreign country; (C) the nature of the production process in the foreign country; (D) the extent of production facilities in the foreign country; and (E) whether or not the value of processing performed in the foreign country represents a small proportion of the value of the merchandise imported into the United States. However, no single factor, by itself, controls Commerce's determination of whether the process of assembly or completion in a third country is minor or insignificant.
In addition, section 781(b)(3) of the Act sets forth additional factors to consider in determining whether to include merchandise assembled or completed in a third country within the scope of an AD or CVD order. Specifically, Commerce shall take into account such factors as: (A) the pattern of trade, including sourcing patterns; (B) whether the manufacturer or exporter of the merchandise is affiliated with the person who, in the third country, uses the merchandise to complete or assemble the merchandise which is subsequently imported into the United States; and (C) whether imports of the merchandise into the third country have increased after the initiation of the investigation that resulted in the issuance of such order or finding.
Based on our analysis of the domestic interested parties' circumvention request, Commerce determines that the domestic interested parties have satisfied the criteria under 19 CFR 351.226(c) to warrant the initiations of circumvention inquiries of these
Consistent with the approach in the prior circumvention inquiries that we initiated on a country-wide basis, Commerce intends to issue questionnaires to solicit information from producers and exporters in Oman concerning their shipments of CWP, made from Chinese-origin HRS, to the United States. A company's failure to respond completely to Commerce's requests for information may result in the application of partial or total facts available, pursuant to section 776(a) of the Act, which may include adverse inferences, pursuant to section 776(b) of the Act.
Pursuant to 19 CFR 351.226(l)(1), Commerce will notify U.S. Customs and Border Protection (CBP) of the initiation and direct CBP to continue the suspension of liquidation of entries of products subject to the circumvention inquiry that were already subject to the suspension of liquidation under the
In accordance with 19 CFR 351.226(d) and section 781(b) of the Act, Commerce determines that the domestic interested parties' requests for this circumvention inquiry satisfies the requirements of 19 CFR 351.226(c). Accordingly, Commerce is notifying all interested parties of the initiation of this circumvention inquiry to determine whether certain imports of CWP from China, completed in and exported from Oman using HRS inputs manufactured in China, are circumventing the
This notice is published in accordance with section 781(b) of the Act and 19 CFR 351.226(d)(1)(ii).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that oil country tubular goods (OCTG) from Ukraine were sold at prices below normal value during the period of review (POR) July 1, 2022, through June 30, 2023.
Applicable November 19, 2024.
Toni Page, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1398.
On August 8, 2024, Commerce published the
A summary of the events that occurred since Commerce published the
The products covered by the
All issues raised in Interpipe's case brief and Vallourec's letter in lieu of a rebuttal brief are addressed in the Issues and Decision Memorandum. A list of these issues is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
We have calculated the following estimated weighted-average dumping margin for Interpipe for the POR, July 1, 2022, through June 30, 2023:
Normally, Commerce will disclose the calculations performed in connection with the final results of a review to interested parties within five days of the date of publication of the notice of final results in the
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with these final results of review.
Consistent with Commerce's assessment practice, for entries of subject merchandise during the POR produced by Interpipe for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Interpipe will be equal to the weighted-average dumping margin established in these final results; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review or in a prior segment of the proceeding, but the producer was covered, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be the all-others rate of 7.47 percent established in the less-than-fair-value investigation.
These cash deposit requirements, when imposed, shall remain in effect until further notice.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to an APO of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these final results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice; correction.
The U.S. Department of Commerce (Commerce) published notice in the
Rebecca Trainor or Dennis McClure at (202) 482-4007 or (202) 482-5973, respectively (China), and Thomas Martin at (202) 482-3936 (Vietnam), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On November 4, 2024, Commerce published in the
In the
“Thermoformed molded fiber products are classified under subheadings 4823.70.0020 and 4823.70.0040, Harmonized Tariff Schedule of the United States (HTSUS).”
For a full description of the scope of these investigations, revised to reflect the correction specified above,
This notice is issued and published in accordance with sections 732 and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.203(c).
The merchandise subject to these investigations consists of thermoformed molded fiber products regardless of shape, form, function, fiber source, or finish. Thermoformed molded fiber products are formed with cellulose fibers, thermoformed using one or more heated molds, and dried/cured in the mold.
Thermoformed molded fiber products include, but are not limited to, plates, bowls, clamshells, trays, lids, food or foodservice contact packaging, and consumer or other product packaging.
Thermoformed molded fiber products are relatively dense, with a typical fiber density above 0.5 grams per cubic centimeter, and are generally characterized by relatively smooth surfaces. They may be derived from any virgin or recycled cellulose fiber source (including, but not limited to, those sourced from wood, woody crops, agricultural crops/byproducts/residue, and agricultural/industrial/other waste). They may have any weight, shape, dimensionality, design, or size, and may be bleached, unbleached, dyed, colored, or printed. They may include ingredients, additives, or chemistries to enhance functionality including, but not limited to, anti-microbial, antifungal, anti-bacterial, heat/flame resistant, hydrophobic, oleophobic, absorbent, or adsorbent. Thermoformed molded fiber products may also be subject to other processing or treatments, including, but not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting. Thermoformed molded fiber products subject to these investigations may also have additional design features, including, but not limited to, tab closures, venting, channeling, or stiffening.
Thermoformed molded fiber products remain covered by the scope of these investigations whether the subject product is encased by exterior packaging or whether the subject product forms the outer packaging for non-subject products. They also remain covered by the scope of these investigations whether imported alone, or in any combination of subject and non-subject merchandise (
Excluded from the scope of these investigations are thermoformed molded fiber products imported as packaging material that enclose and/or surround non-subject merchandise prepackaged for final sale upon importation into the United States (
Thermoformed molded fiber products include thermoformed molded fiber products matching the above description that have been finished, packaged, or otherwise processed in a third country by performing finishing, packaging, or processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the thermoformed molded fiber products. Examples of finishing, packaging, or other processing in a third country that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the thermoformed molded fiber products include, but are not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting.
Thermoformed molded fiber products are classified under subheadings 4823.70.0020 and 4823.70.0040, Harmonized Tariff Schedule of the United States (HTSUS). Imports may also be classified under subheadings 4823.61.0020, 4823.61.0040, 4823.69.0020, 4823.69.0040, 4823.90.1000, HTSUS. References to the HTSUS classification are provided for convenience and customs purposes, and the written description of the merchandise under investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable November 12, 2024.
Shane Subler, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6241.
On October 21, 2024, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) petition concerning imports of paper file folders from Cambodia filed in proper form on behalf of the Coalition of Domestic Folder Manufacturers (the petitioner),
Between October 25 and 28, 2024, Commerce requested supplemental
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of Cambodia (GOC) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of paper file folders from Cambodia, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing paper file folders in the United States. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating a CVD investigation, the Petition was accompanied by information reasonably available to the petitioner supporting its allegations.
Commerce finds that the petitioner filed the Petition on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(F) of the Act.
Because the Petition was filed on October 21, 2024, the period of investigation for the CVD investigation is January 1, 2023, through December 31, 2023.
The products covered by this investigation are paper file folders from Cambodia. For a full description of the scope of this investigation,
As discussed in the
Commerce requests that any factual information that parties consider relevant to the scope of the investigation be submitted during that time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent AD and CVD investigations.
All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies.
Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified the GOC of the receipt of the Petition and provided an opportunity for consultations with respect to the Petition.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like,
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation.
In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the appendix to this notice. To establish industry support, the petitioner provided the 2023 total shipment values of the domestic like product for U.S. producers that support the Petitions and compared this to the estimated total shipment values of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, the General Issues Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.
Because Cambodia is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from Cambodia materially injure, or threaten material injury to, a U.S. industry.
The petitioner alleges that imports of the subject merchandise are benefiting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioner alleges that subject imports from Cambodia individually exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by the significant and increasing volume of subject imports; reduced market share; underselling and price depression and/or suppression; lost sales and revenues; and declines in the domestic industry's production, U.S. shipments, net sales, and financial performance.
Based upon the examination of the Petition and supplemental responses, we find that they meet the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of paper file folders benefit from countervailable subsidies conferred by the GOC. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 12 of the 12 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program,
In the Petition, the petitioner identified four companies in Cambodia as producers and/or exporters of paper file folders.
On November 7, 2024, Commerce released CBP data on imports of paper file folders from Cambodia under administrative protective order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment on CBP data and/or respondent selection must do so within three business days of the publication date of the notice of initiation of this investigation.
Interested parties must submit applications for disclosure under administrative protective order (APO) in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at
In accordance with section 702(b)(4)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOC via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).
Commerce will notify the ITC of its initiation, as required by section 702(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of paper file folders from Cambodia are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors of production under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce.
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in this investigation should ensure that they meet the requirements of 19 CFR 351.103(d) (
This notice is issued and published pursuant to sections 702 and 777(i) of the Act, and 19 CFR 351.203(c).
The products within the scope of this investigation are file folders consisting primarily of paper, paperboard, pressboard, or other cellulose material, whether coated or
Subject folders have the following dimensions in their folded and closed position: lengths and widths of at least 8 inches and no greater than 17 inches, regardless of depth.
The scope covers all varieties of folders, including but not limited to manila folders, hanging folders, fastener folders, classification folders, expanding folders, pockets, jackets, and wallets.
Excluded from the scope are:
• mailing envelopes with a flap bearing one or more adhesive strips that can be used permanently to seal the entire length of a side such that, when sealed, the folder is closed on all four sides;
• binders, with two or more rings to hold documents in place, made of paperboard or pressboard encased entirely in plastic;
• binders consisting of a front cover, back cover, and spine, with or without a flap; to be excluded, a mechanism with two or more metal rings must be included on or adjacent to the interior spine;
• non-expanding folders with a depth exceeding 2.5 inches and that are closed or closeable on the top, bottom, and all four sides (
• expanding folders that have: (1) 13 or more pockets; (2) a flap covering the top; (3) a latching mechanism made of plastic and/or metal to close the flap; and (4) an affixed plastic or metal carry handle;
• folders that have an outer surface (other than the gusset, handles, and/or closing mechanisms, if any) that is covered entirely with fabric, leather, and/or faux leather;
• fashion folders, which are defined as folders with all of the following characteristics: (1) plastic lamination covering the entire exterior of the folder; (2) printing, foil stamping, embossing (
• portfolios, which are folders having: (1) a width of at least 16 inches when open flat; (2) no tabs or dividers; and (3) one or more pockets that are suitable for holding letter size documents and that cover at least 15 percent of the surface area of the relevant interior side or sides; and
• report covers, which are folders having: (1) no tabs, dividers, or pockets; and (2) one or more fasteners or clips, each of which is permanently affixed to the center fold, to hold papers securely in place.
Imports of the subject merchandise are provided for under Harmonized Tariff Schedule of the United States (HTSUS) category 4820.30.0040. Subject imports may also enter under other HTSUS classifications. While the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that PT Ecos Jaya Indonesia and PT Grantec Jaya Indonesia (collectively, Ecos/Grantec) and one non-individually examined company made sales of subject merchandise in the United States at prices below normal value (NV) during the period of review (POR), May 1, 2022, through April 30, 2023. Additionally, Commerce determines that PT. Zinus Global Indonesia (Zinus Indonesia) did not make sales of mattresses from Indonesia at prices below NV during the POR. Moreover, we are rescinding this review with respect to one company that withdrew its request for review and 29 companies that had no reviewable entries during the POR.
Applicable November 19, 2024.
Brian Smith or Noah Wetzel, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1766 or (202) 482-7466, respectively.
On June 3, 2024, Commerce published the
The merchandise covered by this
We addressed all issues raised in the case and rebuttal briefs filed in this administrative review in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is included in appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on an analysis of the comments received, we made one change to the margin calculation in the
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if all parties who requested a review withdraw their requests within 90 days of the date that the notice of initiation of the requested review was published in the
Because PTC timely withdrew its request for review of itself and no other parties requested a review of PTC, Commerce is rescinding this administrative review with respect to PTC.
Pursuant to 19 CFR 351.213(d)(3), when there are no reviewable entries of subject merchandise during the POR subject to the antidumping duty order for which liquidation is suspended, Commerce may also rescind an administrative review, in whole or only with respect to a particular exporter or producer.
The statute and Commerce's regulations do not address the establishment of a weighted-average dumping margin to be determined for companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when determining the weighted-average dumping margin for companies which were not selected for individual examination in an administrative review.
Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
We determine that the following weighted-average dumping margins exist for the POR:
The final
We intend to disclose the calculations performed for these final results of review to interested parties within five days of the date of publication of this notice in the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
Pursuant to 19 CFR 351.212(b)(1), where the respondent Ecos/Grantec reported the entered value for their U.S. sales, we calculated importer-specific
Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by Ecos/Grantec or Zinus Indonesia for which the reviewed companies did not know that the merchandise they sold to the intermediary (
For the company that was not selected for individual review, we assigned an assessment rate calculated as noted in the “Rate for Non-Examined Respondent” section, above.
For the companies for which this review is rescinded with these final results (
The following cash deposit requirements will be effective for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rates for the reviewed companies will be equal to the weighted-average dumping margin established in the final results of this review; (2) for producers or exporters not covered in this review but covered in a prior completed segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published in the most recently completed segment; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation, but the producer is, then the cash deposit rate will be the rate established in the most recently completed segment for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 2.22 percent, the all-others rate established in the LTFV investigation in this proceeding.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.
We are issuing and publishing these final results of administrative review in accordance with sections 751(a) and 777(i) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that producers and/or exporters of stainless steel flanges (flanges) from India made sales of subject merchandise in the United States at prices below normal value (NV) during the period of review (POR) October 1, 2022, through September 30, 2023. In addition, we are rescinding this review for three companies. We invite interested parties to comment on these preliminary results.
Applicable November 19, 2024.
Benito Ballesteros or Eric Chen, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4725 or (202) 482-2860, respectively.
On October 9, 2018, Commerce published in the
For details regarding the events that occurred subsequent to the initiation of this review,
The merchandise covered by the
Pursuant to 19 CFR 351.213(d)(3), Commerce will rescind an administrative review when there are no entries of subject merchandise during the POR for which liquidation is suspended.
On December 21, 2023, we notified parties of our intent to rescind this administrative review, in part, with respect to: (1) Hilton Metal Forging Limited (Hilton); (2) Jay Jagdamba Profile Private Limited (Jay Profile); and (3) Shree Jay Jagdamba Flanges Private Limited (Shree Jay), because there were no suspended entries of subject merchandise produced or exported by these companies during the POR, and we invited interested parties to comment.
The Act and Commerce's regulations do not address the rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a less-than-fair value (LTFV) investigation for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
Commerce is conducting this review in accordance with sections 751(a)(1) and (2) of the Act. We calculated constructed export price in accordance with section 772 of the Act. We calculated NV in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results,
We preliminarily determine the following estimated weighted-average dumping margins exist for the period October 1, 2022, through September 30, 2023:
Commerce intends to disclose its calculations and analysis performed to interested parties for these preliminary results within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Interested parties may submit case briefs no later than 30 days after the date of publication of this notice.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings, we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide, at the beginning of their briefs, a public executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain: (1) party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing.
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).
Upon completion of this administrative review, Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
Pursuant to 19 CFR 351.212(b)(1), because the individually-examined respondents reported the entered value for their U.S. sales, we will calculate importer-specific
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by each respondent where the company did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the LTFV investigation (
For the companies listed in appendix II which were not selected for individual review, we will assign an assessment rate based on the review-specific average rate, calculated as noted in the “Preliminary Results of Review” section, above. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties, where applicable.
For the companies for which we are rescinding the review, we will instruct CBP to assess antidumping duties on all appropriate entries at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue these rescission instructions to CBP no earlier than 35 days after the date of publication of this notice in the
Commerce intends to issue assessment instructions to CBP regarding Chandan, BFN/Viraj, and the companies listed in appendix II no earlier than 35 days after the date of
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies under review will be equal to the weighted-average dumping margin established in the final results of this review, except if the rate is
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from the University of Texas at Austin (UT) for authorization to take marine mammals incidental to a marine geophysical survey in coastal waters off Texas in the northwest (NW) Gulf of Mexico (GOM). Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met, as described in the Request for Public Comments section at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.
Comments and information must be received no later than December 19, 2024.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service and should be submitted via email to
Rachel Wachtendonk, Office of Protected Resources, NMFS, (301) 427-8401.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the monitoring and reporting of the takings. The definitions of all applicable MMPA statutory terms used above are included in the relevant sections below and can be found in section 3 of the MMPA (16 U.S.C. 1362) and NMFS regulations at 50 CFR 216.103.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
On July 25, 2024, NMFS received a request from UT for an IHA to take marine mammals incidental to a marine geophysical survey in coastal waters off Texas in the NW GOM. The application was deemed adequate and complete on September 24, 2024. UT's request is for take of bottlenose dolphins, Atlantic spotted dolphins, and rough-toothed dolphins by Level B harassment only. Neither UT nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
Researchers from UT propose to conduct a low-energy marine seismic survey using airguns as the acoustic source from the research vessel (R/V) Brooks McCall (McCall) or similar vessel operated by TDI-Brooks International. The proposed survey would occur within Texas State waters in the NW GOM from approximately January to April 2025. The proposed survey would occur within the Exclusive Economic Zone (EEZ) of the United States and in Texas State waters, in water depths less than 30 meters (m). To complete this high resolution 3D (HR3D) seismic survey, the McCall would tow a 2-airgun array with a total discharge volume of ~210 cubic inches (in
The purpose of the proposed survey is to study the geologic section beneath the GOM for secure, long-term, large-scale carbon dioxide storage and enhanced hydrocarbon recovery.
The proposed survey is anticipated to take place from January to April 2025. The survey is expected to last 23 days, including approximately 20 days of seismic operations and 3 days of transit and equipment deployment.
The proposed survey would occur within approximately lat. 27.1-29.6° N, long. 93.6-97.4° W, the EEZ of the United States and in Texas State waters, in water depths less than 30 m. The primary study area is around the 10 m isobaths, and if no suitable sites are within Texas State waters, the alternate study area is on the outer continental shelf within the 30 m isobaths. The region where the survey is proposed to occur is depicted in figure 1; the tracklines could occur anywhere within the polygon shown in figure 1. The McCall would likely mobilize and demobilize from the nearest available port.
The procedures to be used for the proposed survey would be similar to those used during previous seismic surveys by UT and would use conventional seismic methodology. The survey would involve one source vessel, the McCall, or similar vessel operated by TDI-Brooks. During the low-energy HR3D seismic survey, the McCall would tow two Generator-Injector (GI) airguns with a total discharge volume of 210 in
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs;
Table 1 lists all species or stocks for which take is expected and proposed to be authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or proposed to be authorized here, PBR and annual serious injury and mortality (M/SI) from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed
As indicated above, all three species (with four managed stocks) in table 1 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. All species that could potentially occur in the proposed survey areas are included in table 2 of the IHA application. While the additional 11 species listed in table 2 of UT's application have been infrequently sighted in the survey area, the temporal and/or spatial occurrence of these species is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Species or stocks that only occur in deep waters (>200 m) within the GOM are unlikely to be observed during this survey where the maximum water depth is 30 m, and thus, the following species or stocks will not be considered further: offshore stock of bottlenose dolphins, pantropical spotted dolphin, spinner dolphin, striped dolphin, Clymene dolphin, Fraser's dolphin, Risso's dolphin, melon-headed whale, pygmy killer whale, false killer whale, killer whale, and short-finned pilot whale.
Bottlenose dolphins are cosmopolitan, occurring in tropical, subtropical, and temperate waters around the world (Wells and Scott 2018). The bottlenose dolphin is the most widespread and common delphinid in coastal waters of the GOM (Würsig
There are 31 bay, sound, and estuary (BSE) stocks in the northern GOM, which are small, resident populations of bottlenose dolphins that live inshore or, occasionally, close to shore or in passes, and are genetically discrete. There are two of the BSE stocks that occur near the survey area, the West Bay stock and the Galveston Bay/East Bay/Trinity Bay stock. These areas in and near West Bay and Galveston Bay, along with numerous other ones along the coast of Texas, have been identified as year-round Biologically Important Areas (BIAs) for resident bottlenose dolphins (LeBrecque
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities (
This section provides a discussion of the ways in which components of the specified activity may impact marine mammals and their habitat. The Estimated Take of Marine Mammals section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take of Marine Mammals section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
This section contains a brief technical background on sound, the characteristics of certain sound types, and on metrics used in this proposal inasmuch as the information is relevant to the specified activity and to a discussion of the potential effects of the specified activity on marine mammals found later in this document.
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in hertz (Hz) or cycles per second. Wavelength is the distance between two peaks or corresponding points of a sound wave (length of 1 cycle). Higher frequency sounds have shorter wavelengths than lower frequency sounds, and typically attenuate (decrease) more rapidly, except in certain cases in shallower water. Amplitude is the height of the sound pressure wave or the “loudness” of a sound and is typically described using the relative unit of the dB. A sound pressure level (SPL) in dB is described as the ratio between a measured pressure and a reference pressure (for underwater sound, this is 1 micropascal (μPa)) and is a logarithmic unit that accounts for large variations in amplitude; therefore, a relatively small change in dB corresponds to large changes in sound pressure. The source level (SL) represents the SPL referenced at a distance of 1 m from the source (referenced to 1 μPa) while the received level is the SPL at the listener's position (referenced to 1 μPa).
Root mean square (RMS) is the quadratic mean sound pressure over the duration of an impulse. Root mean square is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Root mean square accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.
Sound exposure level (SEL; represented as dB re 1 μPa
When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in a manner similar to ripples on the surface of a pond and may be either directed in a beam or beams or may radiate in all directions
Even in the absence of sound from the specified activity, the underwater environment is typically loud due to ambient sound. Ambient sound is defined as environmental background sound levels lacking a single source or point (Richardson
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and human activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of this dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson
Sounds are often considered to fall into one of two general types: Pulsed and non-pulsed. The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (
Pulsed sound sources (
Non-pulsed sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or non-continuous (ANSI, 1995; NIOSH, 1998). Some of these non-pulsed sounds can be transient signals of short duration but without the essential properties of pulses (
Airgun arrays produce pulsed signals with energy in a frequency range from about 10-2,000 Hz, with most energy radiated at frequencies below 200 Hz. The amplitude of the acoustic wave emitted from the source is equal in all directions (
Here, we discuss the effects of active acoustic sources on marine mammals.
Richardson
We describe the more severe effects of certain non-auditory physical or physiological effects only briefly as we do not expect that use of airgun arrays are reasonably likely to result in such effects (see below for further discussion). Potential effects from impulsive sound sources can range in severity from effects such as behavioral disturbance or tactile perception to physical discomfort, slight injury of the internal organs and the auditory system, or mortality (Yelverton
Depending on the degree (elevation of threshold in dB), duration (
Many studies have examined noise-induced hearing loss in marine mammals (see Finneran (2015) and Southall
The amount and onset of TTS depends on the exposure frequency. Sounds at low frequencies, well below the region of best sensitivity for a species or hearing group, are less hazardous than those at higher frequencies, near the region of best sensitivity (Finneran and Schlundt, 2013). At low frequencies, onset-TTS exposure levels are higher compared to those in the region of best sensitivity (
Relationships between TTS and PTS thresholds have not been studied in marine mammals, and there is no PTS data for cetaceans. However, such relationships are assumed to be similar to those in humans and other terrestrial mammals. PTS typically occurs at exposure levels at least several dB above that inducing mild TTS (
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal. If a marine mammal briefly reacts to underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant (
Changes in dive behavior can vary widely, and may consist of increased or decreased dive times and surface intervals as well as changes in the rates of ascent and descent during a dive (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Visual tracking, passive acoustic monitoring (PAM), and movement recording tags were used to quantify sperm whale behavior prior to, during, and following exposure to airgun arrays at received levels in the range 140-160 dB at distances of 7-13 km, following a phase-in of sound intensity and full array exposures at 1-13 km (Madsen
Changes in respiration naturally vary with different behaviors and alterations to breathing rate as a function of acoustic exposure can be expected to co-occur with other behavioral reactions, such as a flight response or an alteration in diving. However, respiration rates in and of themselves may be representative of annoyance or an acute stress response. Various studies have shown that respiration rates may either be unaffected or could increase, depending on the species and signal characteristics, again highlighting the importance in understanding species differences in the tolerance of underwater noise when determining the potential for impacts resulting from anthropogenic sound exposure (
Marine mammals vocalize for different purposes and across multiple modes, such as whistling, echolocation click production, calling, and singing. Changes in vocalization behavior in response to anthropogenic noise can occur for any of these modes and may result from a need to compete with an increase in background noise or may reflect increased vigilance or a startle response. For example, in the presence of potentially masking signals, humpback whales and killer whales have been observed to increase the length of their songs or amplitude of calls (Miller
Cerchio
Castellote
Seismic pulses at average received levels of 131 dB re 1 μPa
Avoidance is the displacement of an individual from an area or migration path as a result of the presence of sound or other stressors, and is one of the most obvious manifestations of disturbance in marine mammals (Richardson
Forney
Forney
A flight response is a dramatic change in normal movement to a directed and rapid movement away from the perceived location of a sound source. The flight response differs from other avoidance responses in the intensity of the response (
Behavioral disturbance can also impact marine mammals in more subtle ways. Increased vigilance may result in costs related to diversion of focus and attention (
Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Disruption of such functions resulting from reactions to stressors, such as sound exposure, are more likely to be significant if they last more than 1 diel cycle or recur on subsequent days (Southall
Stone (2015) reported data from at-sea observations during 1,196 seismic surveys from 1994 to 2010. When arrays of large airguns (considered to be 500 in
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance (
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and distress is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficiently to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments and for both laboratory and free-ranging animals (
Under certain circumstances, significant masking could disrupt behavioral patterns, which in turn could affect fitness for survival and reproduction. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.
The frequency range of the potentially masking sound is important in predicting any potential behavioral impacts. For example, low-frequency signals may have less effect on high-frequency echolocation sounds produced by odontocetes but are more likely to affect detection of mysticete communication calls and other potentially important natural sounds such as those produced by surf and some prey species. The masking of communication signals by anthropogenic noise may be considered as a reduction in the communication space of animals (
Masking affects both senders and receivers of acoustic signals and can potentially have long-term chronic effects on marine mammals at the population level as well as at the individual level. Low-frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, with most of the increase from distant commercial shipping (Hildebrand, 2009). All anthropogenic sound sources, but especially chronic and lower-frequency signals (
Masking effects of pulsed sounds (even from large arrays of airguns) on marine mammal calls and other natural sounds are expected to be limited, although there are few specific data on this. Because of the intermittent nature and low duty cycle of seismic pulses, animals can emit and receive sounds in the relatively quiet intervals between pulses. However, in exceptional situations, reverberation occurs for much or all of the interval between pulses (
Some baleen and toothed whales are known to continue calling in the presence of seismic pulses, and their calls usually can be heard between the pulses (
Vessel noise from the McCall could affect marine mammals in the proposed survey areas. Houghton
Vessel noise, through masking, can reduce the effective communication distance of a marine mammal if the frequency of the sound source is close to that used by the animal, and if the sound is present for a significant fraction of time (
Baleen whales are thought to be more sensitive to sound at these low frequencies than are toothed whales (
In summary, project vessel sounds would not be at levels expected to cause anything more than possible localized and temporary behavioral changes in marine mammals, and would not be expected to result in significant negative effects on individuals or at the population level. In addition, in all oceans of the world, large vessel traffic is currently so prevalent that it is commonly considered a usual source of ambient sound (NSF-USGS, 2011).
Vessel collisions with marine mammals, or vessel strikes, can result in death or serious injury of the animal. Wounds resulting from vessel strike may include massive trauma, hemorrhaging, broken bones, or propeller lacerations (Knowlton and Kraus, 2001). An animal at the surface may be struck directly by a vessel, a surfacing animal may hit the bottom of a vessel, or an animal just below the surface may be cut by a vessel's propeller. Superficial strikes may not kill or result in the death of the animal. These interactions are typically associated with large whales (
Pace and Silber (2005) also found that the probability of death or serious injury increased rapidly with increasing vessel speed. Specifically, the predicted probability of serious injury or death increased from 45 to 75 percent as vessel speed increased from 10 to 14 knots (kn; 26 kilometers per hour (kph)), and exceeded 90 percent at 17 kn (31 kph). Higher speeds during collisions result in greater force of impact, but higher speeds also appear to increase the chance of severe injuries or death through increased likelihood of collision by pulling whales toward the vessel (Clyne, 1999; Knowlton
The McCall will travel at a speed of 4-5 kn (7-9 kph) while towing seismic survey gear. At this speed, both the possibility of striking a marine mammal and the possibility of a strike resulting in serious injury or mortality are discountable. At average transit speed, the probability of serious injury or mortality resulting from a strike is less than 50 percent. However, the likelihood of a strike actually happening is again discountable. Vessel strikes, as analyzed in the studies cited above, generally involve commercial shipping, which is much more common in both space and time than is geophysical survey activity. Jensen and Silber (2004) summarized vessel strikes of large whales worldwide from 1975 to 2003 and found that most collisions occurred in the open ocean and involved large vessels (
It is possible for vessel strikes to occur while traveling at slow speeds. For example, a hydrographic survey vessel traveling at low speed (5.5 kn (10 kph)) while conducting mapping surveys off the central California coast struck and killed a blue whale in 2009. The State of California determined that the whale had suddenly and unexpectedly surfaced beneath the hull, with the result that the propeller severed the whale's vertebrae, and that this was an unavoidable event. This strike represents the only such incident in approximately 540,000 hours of similar coastal mapping activity (
Although the likelihood of the vessel striking a marine mammal is low, we propose a robust vessel strike avoidance protocol (see Proposed Mitigation), which we believe eliminates any foreseeable risk of vessel strike during transit. We anticipate that vessel
Marine mammals strand for a variety of reasons, such as infectious agents, biotoxicosis, starvation, fishery interaction, vessel strike, unusual oceanographic or weather events, sound exposure, or combinations of these stressors sustained concurrently or in series. However, the cause or causes of most strandings are unknown (Geraci
There is no conclusive evidence that exposure to airgun noise results in behaviorally-mediated forms of injury. Behaviorally-mediated injury (
It is important to distinguish between energy (loudness, measured in dB) and frequency (pitch, measured in Hz). In considering the potential impacts of mid-frequency components of airgun noise (1-10 kHz, where beaked whales can be expected to hear) on marine mammal hearing, one needs to account for the energy associated with these higher frequencies and determine what energy is truly “significant.” Although there is mid-frequency energy associated with airgun noise (as expected from a broadband source), airgun sound is predominantly below 1 kHz (Breitzke
Aside from frequency content, there are other significant differences between MFA sonar signals and the sounds produced by airguns that minimize the risk of severe behavioral reactions that could lead to strandings or deaths at sea,
The available scientific literature also provides a useful contrast between airgun noise and MFA sonar regarding the likely risk of behaviorally-mediated injury. There is strong evidence for the association of beaked whale stranding events with MFA sonar use, and particularly detailed accounting of several events is available (
A review of possible stranding associations with seismic surveys (Castellote and Llorens, 2016) states that, “[s]peculation concerning possible links between seismic survey noise and cetacean strandings is available for a dozen events but without convincing causal evidence.” The authors' search of available information found 10 events worth further investigation via a ranking system representing a rough metric of the relative level of confidence offered by the data for inferences about the possible role of the seismic survey in a given stranding event. Only three of these events involved beaked whales. Whereas D'Amico
However, one of these stranding events, involving two Cuvier's beaked whales, was contemporaneous with and reasonably associated spatially with a 2002 seismic survey in the Gulf of California conducted by Lamont-Doherty Earth Observatory (L-DEO), as was the case for the 2007 Gulf of Cadiz seismic survey discussed by Castellote and Llorens (also involving two Cuvier's beaked whales). Neither event was considered a “true atypical mass stranding” (according to Frantzis (1998)) as used in the analysis of Castellote and Llorens (2016). While we agree with the authors that this lack of evidence should not be considered conclusive, it is clear that there is very little evidence that seismic surveys should be considered as posing a significant risk of acute harm to beaked whales or other high frequency cetaceans. We have considered the potential for the proposed surveys to result in marine mammal stranding and, based on the best available information, do not expect a stranding to occur.
Skalski
SPLs of sufficient strength have been known to cause injury to fish and fish mortality and, in some studies, fish auditory systems have been damaged by airgun noise (McCauley
A comprehensive review (Carroll
Available data suggest that cephalopods are capable of sensing the particle motion of sounds and detect low frequencies up to 1-1.5 kHz, depending on the species, and so are likely to detect airgun noise (Kaifu
A review article concluded that, while laboratory results provide scientific evidence for high-intensity and low-frequency sound-induced physical trauma and other negative effects on some fish and invertebrates, the sound exposure scenarios in some cases are not realistic to those encountered by marine organisms during routine seismic operations (Carroll
In summary, impacts of the specified activity on marine mammal prey species will likely generally be limited to behavioral responses, the majority of prey species will be capable of moving out of the area during the survey, a rapid return to normal recruitment, distribution, and behavior for prey species is anticipated, and, overall, impacts to prey species will be minor and temporary. Prey species exposed to sound might move away from the sound source, experience TTS, experience masking of biologically relevant sounds, or show no obvious direct effects. Mortality from decompression injuries is possible in close proximity to a sound, but only limited data on mortality in response to airgun noise exposure are available (Hawkins
Soundscapes are also defined by, and acoustic habitat influenced by, the total contribution of anthropogenic sound. This may include incidental emissions from sources such as vessel traffic, or may be intentionally introduced to the marine environment for data acquisition purposes (as in the use of airgun arrays). Anthropogenic noise varies widely in its frequency content, duration, and loudness and these characteristics greatly influence the potential habitat-mediated effects to marine mammals (please see also the previous discussion on masking under
Problems arising from a failure to detect cues are more likely to occur when noise stimuli are chronic and overlap with biologically relevant cues used for communication, orientation, and predator/prey detection (Francis and Barber, 2013). Although the signals emitted by seismic airgun arrays are generally low frequency, they would also likely be of short duration and transient in any given area due to the nature of these surveys. As described previously, exploratory surveys such as these cover a large area but would be transient rather than focused in a given location over time and therefore would not be considered chronic in any given location.
Based on the information discussed herein, we conclude that impacts of the specified activity are not likely to have more than short-term adverse effects on any prey habitat or populations of prey species. Further, any impacts to marine mammal habitat are not expected to result in significant or long-term consequences for individual marine mammals, or to contribute to adverse impacts on their populations.
This section provides an estimate of the number of incidental takes proposed for authorization through the IHA, which will inform NMFS' consideration of “small numbers,” the negligible impact determinations, and impacts on subsistence uses.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of 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).
Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to sound from low energy seismic airguns. Based on the nature of the activity,
For acoustic impacts, generally speaking, we estimate take by considering: (1) acoustic thresholds above which NMFS believes the best available science indicates marine mammals will likely be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available (
NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur auditory injury of some degree (equated to Level A harassment).
UT's proposed survey includes the use of impulsive seismic sources (
These thresholds are provided in the tables below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS' 2018 Updated Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.
When the Technical Guidance was initially published (NMFS, 2016), in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a user spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which may result in some degree of overestimation of Level A harassment take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools and will qualitatively address the output where appropriate.
The proposed survey would entail the use up to two 105 in
The proposed low-energy survey would acquire data with up to two 105-in
L-DEO's methodology is described in greater detail in UT's IHA application. The estimated distances to the Level B harassment isopleth for the proposed airgun configuration are shown in table 4.
Table 5 presents the modeled Level A harassment isopleths for the high-frequency cetacean hearing group based on L-DEO modeling incorporated in the companion user spreadsheet, for the low-energy surveys with the shortest shot interval (
Predicted distances to Level A harassment isopleths, which vary based on marine mammal hearing groups, were calculated based on modeling performed by L-DEO using the Nucleus software program and the NMFS user spreadsheet, described below. The acoustic thresholds for impulsive sounds contained in the NMFS Technical Guidance were presented as dual metric acoustic thresholds using both SEL
The SEL
Auditory injury is unlikely to occur for high-frequency cetaceans, given the very small modeled zones of injury for those species (all estimated zones are less than 10 m for high-frequency cetaceans), in the context of distributed source dynamics.
In consideration of the received sound levels in the near-field as described above, we expect the potential for Level A harassment of high-frequency cetaceans to be de minimis, even before the likely moderating effects of aversion and/or other compensatory behaviors (
The Level A and Level B harassment estimates are based on a consideration of the number of marine mammals that could be within the area around the operating airgun array where received levels of sound ≥160 dB re 1 µPa rms are predicted to occur. The estimated numbers are based on the densities (numbers per unit area) of marine mammals expected to occur in the area in the absence of seismic surveys. To the extent that marine mammals tend to move away from seismic sources before the sound level reaches the criterion level and tend not to approach an operating airgun array, these estimates likely overestimate the numbers actually exposed to the specified level of sound.
In this section we provide information about the occurrence of marine mammals, including density or other relevant information which will inform the take calculations.
For the proposed survey area in the NW GOM, UT determined that the best source of density data for marine mammal species that might be encountered in the project area was habitat-based density modeling conducted by Garrison
Rough-toothed dolphins were not modeled by Garrison
Here we describe how the information provided above is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and proposed for authorization. In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in Level B harassment, radial distances from the airgun array to the predicted isopleth corresponding to the Level B harassment threshold was calculated, as described above. Those radial distances were then used to calculate the area(s) around the airgun array predicted to be ensonified to sound levels that exceed the harassment thresholds. The area expected to be ensonified on 1 day was determined by multiplying the number of line km possible in 1 day by two times the 160-dB radius plus adding endcaps to the start and beginning of the line. The daily ensonified area was then multiplied by the number of survey days (20 days). The highest mean monthly density for each species was then multiplied by the total ensonified area to calculate the estimated takes of each species.
No takes by Level A harassment are expected or proposed for authorization. Estimated takes for the proposed survey are shown in table 7.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting the activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation (probability implemented as planned); and,
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, and impact on operations.
Visual monitoring requires the use of trained observers (herein referred to as visual protected species observers (PSOs)) to scan the ocean surface visually for the presence of marine mammals. PSOs shall establish and monitor a pre-start clearance zone and, to the extent practicable, a Level B harassment zone (Table 4). These zones shall be based upon the radial distance from the edges of the acoustic source (rather than being based on the center of the array or around the vessel itself). During pre-start clearance (
During survey operations (
PSOs shall establish and monitor a pre-start clearance zone and to the extent practicable, a Level B harassment zone. These zones shall be based upon the radial distance from the edges of the acoustic source (rather than being based on the center of the array or around the vessel itself). Any observations of marine mammals by crew members shall be relayed to the PSO team. During good conditions (
Visual PSOs may be on watch for a maximum of 4 consecutive hours followed by a break of at least 1 hour between watches and may conduct a maximum of 12 hours of observation per 24-hour period.
Ramp-up (sometimes referred to as “soft start”) means the gradual and systematic increase of emitted sound levels from an airgun array. The intent of pre-start clearance observation (30 minutes) is to ensure no marine mammals are observed within the pre-start clearance zone prior to the beginning of ramp-up. The intent of the ramp-up is to warn marine mammals of pending seismic survey operations and to allow sufficient time for those animals to leave the immediate vicinity prior to the sound source reaching full intensity. A ramp-up procedure, involving a stepwise increase in the number of airguns firing and total array volume until all operational airguns are activated and the full volume is achieved, is required at all times as part of the activation of the airgun array. All operators must adhere to the following pre-start clearance and ramp-up requirements:
• The operator must notify a designated PSO of the planned start of ramp-up as agreed upon with the lead PSO; the notification time should not be less than 60 minutes prior to the planned ramp-up in order to allow PSOs time to monitor the pre-start clearance zone for 30 minutes prior to the initiation of ramp-up (pre-start clearance).
• Ramp-ups shall be scheduled so as to minimize the time spent with the source activated prior to reaching the designated run-in.
• One of the PSOs conducting pre-start clearance observations must be notified again immediately prior to initiating ramp-up procedures and the operator must receive confirmation from the PSO to proceed.
• Ramp-up may not be initiated if any marine mammal is within the pre-start clearance zone. If a marine mammal is observed within the pre-start clearance zone during the 30 minutes pre-clearance period, ramp-up may not begin until the animal(s) has been observed exiting the zone or until an additional time period has elapsed with no further sightings (15 minutes for small delphinids and 30 minutes for all other species).
• Ramp-up must begin by activating one GI airgun for no less than 5 minutes and then activating the second airgun. The operator must provide information to the PSO documenting that appropriate procedures were followed.
• PSOs must monitor the pre-start clearance zone during ramp-up, and ramp-up must cease and the source must be shut down upon detection of a marine mammal within the pre-start clearance zone. Once ramp-up has begun, observations of marine mammals for which take authorization is granted within the pre-start clearance zone does not require shutdown.
• If the acoustic source is shut down for brief periods (
• Testing of the acoustic source involving all elements requires ramp-up. Testing limited to individual source elements or strings does not require ramp-up but does require a 30-minute pre-start clearance period.
The shutdown of an airgun array requires the immediate de-activation of all individual airgun elements of the array. Any PSO on duty will have the authority to call for shutdown of the airgun array. The operator must also establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the airgun array to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. The shutdown requirement will be waived for small dolphins. As defined here, the small dolphin group is intended to encompass those members of the Family Delphinidae most likely to voluntarily approach the source vessel for purposes of interacting with the vessel and/or airgun array (
We include this small dolphin exception because shutdown requirements for these species under all circumstances represent practicability concerns without likely commensurate benefits for the animals in question. Small dolphins are generally the most commonly observed marine mammals in the specific geographic region and would typically be the only marine mammals likely to intentionally approach the vessel. As described above, auditory injury is extremely unlikely to occur for high-frequency cetaceans (
A large body of anecdotal evidence indicates that small dolphins commonly approach vessels and/or towed arrays during active sound production for purposes of bow riding with no apparent effect observed (
Vessel personnel should use an appropriate reference guide that includes identifying information on all marine mammals that may be encountered. Vessel operators must comply with the below measures except under extraordinary circumstances when the safety of the vessel or crew is in doubt or the safety of life at sea is in question. These requirements do not apply in any case where compliance would create an imminent and serious threat to a person or vessel or to the extent that a vessel is restricted in its ability to maneuver and, because of the restriction, cannot comply.
Vessel operators and crews must maintain a vigilant watch for all marine mammals and slow down, stop their vessel, or alter course, as appropriate and regardless of vessel size, to avoid striking any marine mammal. A single marine mammal at the surface may indicate the presence of submerged animals in the vicinity of the vessel; therefore, precautionary measures should always be exercised. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel (separation distances stated below). Visual observers monitoring the vessel strike avoidance zone may be third-party observers (
Vessel speeds must be reduced to 10 kn (18.5 kph) or less when mother/calf pairs, pods, or large assemblages of cetaceans are observed near a vessel. The vessel must maintain a minimum separation distance of 500 m from baleen whales. If a baleen whale is sighted within the relevant separation distance, the vessel must steer a course away at 10 knots or less until the 500-m separation distance is established. If a whale is observed but cannot be confirmed as a species other than a baleen whale, the vessel operator must assume that it is a baleen whale and take appropriate action. All vessels must maintain a minimum separation distance of 100 m from sperm whales. All vessels must, to the maximum extent practicable, attempt to maintain a minimum separation distance of 50 m from all other marine mammals, with an understanding that at times this may not be possible (
When marine mammals are sighted while a vessel is underway, the vessel shall take action as necessary to avoid violating the relevant separation distance (
Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present while conducting the activities. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
As described above, PSO observations would take place during daytime airgun operations. During seismic survey operations, two visual PSOs would be on duty at all times during daytime hours. The operator will work with the selected third-party observer provider to ensure PSOs have all equipment (including backup equipment) needed to adequately perform necessary tasks, including accurate determination of distance and bearing to observed marine mammals. SIO must use dedicated, trained, and NMFS-approved PSOs. At least one visual PSO aboard the vessel must have a minimum of 90 days at-sea experience working in those roles, respectively, with no more than 18 months elapsed since the conclusion of the at-sea experience. One visual PSO with such experience shall be designated as the lead for the entire protected species observation team. The lead PSO shall serve as primary point of contact for the vessel operator and ensure all PSO requirements per the IHA are met. To the maximum extent practicable, the experienced PSOs should be scheduled to be on duty with those PSOs with appropriate training but who have not yet gained relevant experience. The PSOs must have no tasks other than to conduct observational effort, record observational data, and communicate with and instruct relevant vessel crew with regard to the presence of marine mammals and mitigation requirements. PSO resumes shall be provided to NMFS for approval. Monitoring shall be conducted in accordance with the following requirements:
• PSOs shall be independent, dedicated, trained visual PSOs and must be employed by a third-party observer provider.
• PSOs shall have no tasks other than to conduct observational effort, collect data, and communicate with and instruct relevant vessel crew with regard to the presence of protected species and mitigation requirements (including brief alerts regarding maritime hazards).
• PSOs shall have successfully completed an approved PSO training course appropriate for their designated task.
• NMFS must review and approve PSO resumes accompanied by a relevant training course information packet that includes the name and qualifications (
• PSOs must successfully complete relevant training, including completion of all required coursework and passing (80 percent or greater) a written and/or oral examination developed for the training program.
• PSOs must have successfully attained a bachelor's degree from an accredited college or university with a major in one of the natural sciences, a minimum of 30 semester hours or equivalent in the biological sciences, and at least one undergraduate course in math or statistics.
• The educational requirements may be waived if the PSO has acquired the relevant skills through alternate experience. Requests for such a waiver shall be submitted to NMFS and must include written justification. Requests shall be granted or denied (with justification) by NMFS within 1 week of receipt of submitted information. Alternate experience that may be considered includes, but is not limited to (1) secondary education and/or experience comparable to PSO duties; (2) previous work experience conducting academic, commercial, or government-sponsored protected species surveys; or (3) previous work experience as a PSO; the PSO should demonstrate good standing and consistently good performance of PSO duties.
• For data collection purposes, PSOs shall use standardized electronic data collection forms. PSOs shall record detailed information about any implementation of mitigation requirements, including the distance of animals to the airgun array and description of specific actions that ensued, the behavior of the animal(s), any observed changes in behavior before and after implementation of mitigation, and if shutdown was implemented, the length of time before any subsequent ramp-up of the airgun array. If required mitigation was not implemented, PSOs should record a description of the circumstances. At a minimum, the following information must be recorded:
○ Vessel name, vessel size and type, maximum speed capability of vessel;
○ Dates (MM/DD/YYYY) of departures and returns to port with port name;
○ PSO names and affiliations, PSO ID (initials or other identifier);
○ Date (MM/DD/YYYY) and participants of PSO briefings;
○ Visual monitoring equipment used (description);
○ PSO location on vessel and height (meters) of observation location above water surface;
○ Watch status (description);
○ Dates (MM/DD/YYYY) and times (Greenwich Mean Time/UTC) of survey on/off effort and times (GMC/UTC) corresponding with PSO on/off effort;
○ Vessel location (decimal degrees) when survey effort began and ended and vessel location at beginning and end of visual PSO duty shifts;
○ Vessel location (decimal degrees) at 30-second intervals if obtainable from data collection software, otherwise at practical regular interval;
○ Vessel heading (compass heading) and speed (knots) at beginning and end of visual PSO duty shifts and upon any change;
○ Water depth (meters) (if obtainable from data collection software);
○ Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions changed significantly), including BSS and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon;
○ Factors that may have contributed to impaired observations during each PSO shift change or as needed as environmental conditions changed (description) (
○ Vessel/Survey activity information (and changes thereof) (description), such as airgun power output while in operation, number and volume of airguns operating in the array, tow depth of the array, and any other notes of significance (
• Upon visual observation of any marine mammals, the following information must be recorded:
○ Sighting ID (numeric);
○ Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);
○ Location of PSO/observer (description);
○ Vessel activity at the time of the sighting (
○ PSO who sighted the animal/ID;
○ Time/date of sighting (GMT/UTC, MM/DD/YYYY);
○ Initial detection method (description);
○ Sighting cue (description);
○ Vessel location at time of sighting (decimal degrees);
○ Water depth (meters);
○ Direction of vessel's travel (compass direction);
○ Speed (knots) of the vessel from which the observation was made;
○ Direction of animal's travel relative to the vessel (description, compass heading);
○ Bearing to sighting (degrees);
○ Identification of the animal (
○ Species reliability (an indicator of confidence in identification) (1 = unsure/possible, 2 = probable, 3 = definite/sure, 9 = unknown/not recorded);
○ Estimated distance to the animal (meters) and method of estimating distance;
○ Estimated number of animals (high/low/best) (numeric);
○ Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition,
○ Description (as many distinguishing features as possible of each individual seen, including length, shape, color, pattern, scars or markings, shape and size of dorsal fin, shape of head, and blow characteristics);
○ Detailed behavior observations (
○ Animal's closest point of approach (meters) and/or closest distance from any element of the airgun array;
○ Description of any actions implemented in response to the sighting (
○ Photos (Yes/No);
○ Photo Frame Numbers (List of numbers); and
○ Conditions at time of sighting (Visibility; BSS).
UT shall submit a draft comprehensive report on all activities and monitoring results within 90 days of the completion of the survey or expiration of the IHA, whichever comes sooner. The report must describe all activities conducted and sightings of marine mammals, must provide full documentation of methods, results, and interpretation pertaining to all monitoring, and must summarize the dates and locations of survey operations and all marine mammal sightings (dates, times, locations, activities, associated survey activities). The draft report shall also include geo-referenced time-stamped vessel tracklines for all time periods during which airgun arrays were operating. Tracklines should
• Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
• Species identification (if known) or description of the animal(s) involved;
• Condition of the animal(s) (including carcass condition if the animal is dead);
• Observed behaviors of the animal(s), if alive;
• If available, photographs or video footage of the animal(s); and
• General circumstances under which the animal was discovered.
• Time, date, and location (latitude/longitude) of the incident;
• Vessel's speed during and leading up to the incident;
• Vessel's course/heading and what operations were being conducted (if applicable);
• Status of all sound sources in use;
• Description of avoidance measures/requirements that were in place at the time of the strike and what additional measure were taken, if any, to avoid strike;
• Environmental conditions (
• Species identification (if known) or description of the animal(s) involved;
• Estimated size and length of the animal that was struck;
• Description of the behavior of the marine mammal immediately preceding and following the strike;
• If available, description of the presence and behavior of any other marine mammals present immediately preceding the strike;
• Estimated fate of the animal (
• To the extent practicable, photographs or video footage of the animal(s).
NMFS has defined negligible impact 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 (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analysis applies to Atlantic spotted dolphins, bottlenose dolphins, and rough-toothed dolphins, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity.
NMFS does not anticipate that serious injury or mortality would occur as a result of UT's planned survey, even in the absence of mitigation, and no serious injury or mortality is proposed to be authorized. As discussed in the Potential Effects of Specified Activities on Marine Mammals and Their Habitat section above, non-auditory physical effects and vessel strike are not expected to occur. NMFS expects that all potential take would be in the form of Level B behavioral harassment in the form of temporary avoidance of the area or decreased foraging (if such activity was occurring), responses that are considered to be of low severity, and with no lasting biological consequences (
In addition, the maximum expected Level B harassment zone around the survey vessel is 1,750 m. Therefore, the ensonified area surrounding the vessel is relatively small compared to the overall distribution of animals in the area and their use of the habitat. Feeding behavior is not likely to be significantly impacted as prey species are mobile and are broadly distributed throughout the survey area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the short duration (20 survey days) and temporary nature of the disturbance and the availability of similar habitat and resources in the surrounding area, the impacts to marine mammals and marine mammal prey species are not expected to cause significant or long-term fitness consequences for individual marine mammals or their populations.
Additionally, the acoustic “footprint” of the proposed survey would be very small relative to the ranges of all marine mammals that would potentially be affected. Sound levels would increase in the marine environment in a relatively small area surrounding the vessel compared to the range of the marine mammals within the proposed survey area. The seismic array would be active 24 hours per day throughout the duration of the proposed survey. However, the very brief overall duration of the proposed survey (20 survey days) would further limit potential impacts that may occur as a result of the proposed activity.
There are no rookeries, mating, or calving grounds known to be biologically important to marine mammals within the planned survey area and there are no feeding areas known to be biologically important to marine mammals within the survey area. There is no designated critical habitat for any ESA-listed marine mammals within the project area.
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or authorized;
• No auditory injury (Level A harassment) is anticipated or proposed to be authorized;
• The proposed activity is temporary and of relatively short duration (23 days total with 20 days of planned survey activity);
• The anticipated impacts of the proposed activity on marine mammals would be temporary behavioral changes due to avoidance of the ensonified area, which is relatively small (see tables 4 and 5);
• The availability of alternative areas of similar habitat value for marine mammals to temporarily vacate the survey area during the proposed survey to avoid exposure to sounds from the activity is readily abundant;
• The potential adverse effects on fish or invertebrate species that serve as prey species for marine mammals from the proposed survey would be temporary and spatially limited and impacts to marine mammal foraging would be minimal; and
• The proposed mitigation measures are expected to reduce the number and severity of takes, to the extent practicable, by visually detecting marine mammals within the established zones and implementing corresponding mitigation measures (
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The number of takes NMFS proposes to authorize is below one-third of the modeled abundance for all relevant populations (specifically, take of individuals is less than 7 percent of the most appropriate abundance estimate for each stock, see table 6). This is conservative because this approach assumes all takes are of different individual animals, which is likely not the case. Some individuals may be encountered multiple times in a day, but PSOs would count them as separate individuals if they cannot be identified.
Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals would be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to UT for conducting marine geophysical surveys in coastal waters off Texas in the NW GOM from approximately January to April 2025, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed IHA can be found at:
We request comment on our analyses, the proposed authorization, and any other aspect of this notice of proposed IHA for the proposed marine geophysical survey. We also request comment on the potential renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform decisions on the request for this IHA or a subsequent renewal IHA.
On a case-by-case basis, NMFS may issue a one-time, 1-year renewal IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical or nearly identical activities as described in the Description of Proposed Activity section of this notice is planned or (2) the activities as described in the Description of Proposed Activity section of this notice would not be completed by the time the IHA expires and a renewal would allow for completion of the activities beyond
• A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA).
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; solicitation of nominations.
NMFS solicits nominations for the Atlantic Highly Migratory Species (HMS) Advisory Panel (AP). NMFS consults with and considers the comments and views of the HMS AP when preparing and implementing Fishery Management Plans (FMPs) or FMP amendments for Atlantic tunas, swordfish, sharks, and billfish. Nominations are being sought to fill approximately one-third (12) of the seats on the HMS AP, each with a 3-year appointment. NMFS will consider individuals with definable interests in recreational and commercial fishing and related industries, including those from the environmental community, academia, and non-governmental organizations, for membership on the HMS AP.
Submit nominations on or before December 19, 2024.
You may submit nominations and requests for the Advisory Panel Statement of Organization, Practices, and Procedures by email to
Anna Quintrell at 301-427-7861 or via email at
HMS fisheries (tunas, swordfish, sharks, and billfish) are managed under the 2006 Consolidated HMS FMP and its amendments pursuant to the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801
The Magnuson-Stevens Act requires NMFS to establish an AP for each HMS FMP (16 U.S.C. 1854(g)(1)(A)-(B)). Since the inception of the AP in 1998, NMFS has consulted with and considered the comments and views of AP members when preparing and implementing HMS FMPs or FMP amendments. In this notice, NMFS solicits nominations for the HMS AP. Nominations are being sought to fill approximately one-third (12) of the seats on the HMS AP for 3-year appointments. NMFS will consider individuals with definable interests in recreational and commercial fishing and related industries, including those from the environmental community, academia, and non-governmental organizations for membership on the HMS AP as described below.
Nomination packages should include:
1. The name and contact information, including mailing address, email address, and phone number of the nominee;
2. A description of the nominee's interest in HMS or HMS fisheries, or in particular species of tunas, swordfish, sharks, or billfish;
3. A statement of the nominee's background and/or qualifications;
4. A list of outreach resources that the nominee has at their disposal to communicate qualifications for HMS AP membership; and
5. A written commitment that the nominee shall actively participate in good faith in the meetings and tasks of the HMS AP.
Advisory Panel members will be required to comply with applicable rules of conduct, including all ethics requirements. Qualification for membership includes experience in one or more of the following:
1. HMS recreational fisheries;
2. HMS commercial fisheries;
3. Fishery-related industries (
4. The scientific community working with HMS; and/or
5. Representation of a private, non-governmental, regional, national, or international organization that represents marine fisheries, or environmental, governmental, or academic interests regarding HMS.
Members are appointed for 3-year terms. Approximately one-third of the members' terms expire on December 31 of each year. NMFS is seeking nominations for terms beginning January 2025 and expiring December 2027.
Members can serve a maximum of three consecutive terms (a total of 9 consecutive years). Afterwards, a member must then sit off the HMS AP for a single year before becoming eligible to apply for a new term.
NMFS will accept nominations for the HMS AP that allow for representation from commercial and recreational fishing interests, academic/scientific interests, and the environmental/non-governmental organization community, for individuals who are knowledgeable about HMS and/or HMS fisheries. Current representation on the HMS AP, as shown in table 1, consists of 12 members representing commercial interests, 12 members representing recreational interests, 4 members representing environmental interests, 4 academic representatives, and the ICCAT Advisory Committee Chair.
In filling vacancies, NMFS will seek to maintain the current representation from each of the sectors. NMFS also considers species expertise and representation from the fishing regions (Northeast, Mid-Atlantic, Southeast, Gulf of Mexico, and Caribbean) to ensure the diversity and balance of the HMS AP. table 1 includes the current representation on the HMS AP by sector, region, and species with terms that are expiring identified in the “Member Status” column. It is not meant to indicate that NMFS will only consider persons who have expertise in the species or fishing regions that are listed. Rather, NMFS will aim toward having as diverse and balanced an AP as possible. The intent is to have a group that, as a whole, reflects an appropriate and equitable balance and mix of interests given the responsibilities of the HMS AP.
Five additional members on the HMS AP include one member representing each of the following Fishery Management Councils: New England Fishery Management Council, the Mid-Atlantic Fishery Management Council, the South Atlantic Fishery Management Council, the Gulf of Mexico Fishery Management Council, and the Caribbean Fishery Management Council. The HMS AP also includes 22 ex-officio participants: 20 representatives of the coastal states and 2 representatives of the interstate commissions (the Atlantic States Marine Fisheries Commission and the Gulf States Marine Fisheries Commission).
NMFS will provide the necessary administrative support, including technical assistance, for the HMS AP. However, NMFS will not compensate participants with monetary support of any kind. Depending on availability of funds, members may be reimbursed for travel costs related to the HMS AP meetings.
NMFS will hold meetings of the HMS AP as frequently as necessary and, at a minimum, twice each year. In recent years, NMFS held meetings once in the spring, and once in the fall. The meetings may be held in conjunction with public hearings.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Marine Planning Committee (MPC) will hold an online public meeting.
The online meeting will be held Thursday, December 5, 2024, from 1 p.m. to 4 p.m., Pacific standard time or
This meeting will be held online. Specific meeting information, including a proposed agenda and directions on how to attend the meeting and system requirements, will be provided in the meeting announcement on the Pacific Council's website (see
Kerry Griffin, Staff Officer, Pacific Council; telephone: (503) 820-2409.
The purpose of this online meeting is for the MPC to consider two draft Programmatic Environmental Impact Statements (PEIS) anticipated for release in November. The Bureau of Ocean Energy Management (BOEM) is developing a draft PEIS to analyze the potential impacts of, and mitigation measures for, floating offshore wind (OSW) energy development in the five leased areas off Humboldt and Morro Bays, CA. In addition, the National Oceanic and Atmospheric Administration (NOAA) is developing a draft PEIS to identify areas in Federal waters off Southern California that would be suitable for future aquaculture development, and to analyze potential impacts to the human environment that may occur should aquaculture projects be proposed in Aquaculture Opportunity Areas. The MPC may consider other OSW or aquaculture issues as appropriate.
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.
Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
Consumer Product Safety Commission.
Notice.
The Commission publishes in the
Any interested person may ask the Commission not to accept this agreement or otherwise comment on its contents by filing a written request with the Office of the Secretary by December 4, 2024.
Persons wishing to comment on this Settlement Agreement should send written comments to Comment 25-C0001, Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (240) 863-8938 (mobile), (301) 504-7479 (office); email:
Serena Anand, Trial Attorney, Division of Enforcement and Litigation, Office of Compliance and Field Operations, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814;
The text of the Settlement Agreement and Order appear below.
1. In accordance with the Consumer Product Safety Act, 15 U.S.C. 2051—2089 (“CPSA”), and 16 CFR 1118.20, Bestar, Inc. (“Bestar”), and the United States Consumer Product Safety Commission (“Commission” or “CPSC”), through its staff, hereby enter into this Settlement Agreement (“Agreement”). The Agreement and the incorporated attached Order resolve staff's charges set forth below.
2. The Commission is an independent federal regulatory agency, established pursuant to, and responsible for, the enforcement of the CPSA, 15 U.S.C. 2051-2089. By executing the Agreement, staff is acting on behalf of the Commission, pursuant to 16 CFR § 1118.20(b). The Commission issues the Order under the provisions of the CPSA.
3. Bestar is a corporation, organized and existing under the laws of the province of Québec, Canada, with its principal place of business in Lac-Mégantic, Québec, Canada. Bestar also maintains a manufacturing facility in Jamestown, NY and distribution center in Erie, PA.
4. Between June 2014 and March 2022, Bestar manufactured and distributed in the United States approximately 129,000 wall beds (the “Subject Products”).
5. The Subject Products are “consumer products” that were “manufactur[ed]”and “distribut[ed] in commerce,” as those terms are defined or used in Sections 3(a)(5), (7), and (10) of the CPSA, 15 U.S.C. 2052(a)(5), (7), and (10). Bestar is a “manufacturer” and “distributor” of the Subject Products, as such terms are defined in Sections 3(a)(8) and (11) of the CPSA, 15 U.S.C. 2052(a)(8) and (11).
6. The Subject Products contain a defect which could create a substantial product hazard or create an unreasonable risk of serious injury because the wall beds can detach from the wall and fall onto those nearby, posing a serious impact and crush hazard.
7. Beginning in September 2014 and continuing through 2022, Bestar received numerous reports that the Subject Products had detached from the wall. By 2016, Bestar had received notice of two incidents in which consumers were injured by a falling Subject Product. Bestar engaged with CPSC and Health Canada in response to these two incidents, but did not inform regulators of the additional five incidents it had become aware of by that time.
8. In 2018, a Subject Product detached and fell on top of a consumer, causing injuries which required immediate hospitalization and eventually led to her death later that year, constituting grievous bodily injury, as defined in 16 CFR 1115.12(d).
9. During the relevant timeframe, Bestar continued to accumulate incident information, and by the time Bestar filed its Section 15(b) Full Report with the Commission under 15 U.S.C. 2064(b), Bestar was aware of at least 35 incidents, including 1 fatality and 15 injuries, some of which were serious.
10. Despite possessing information that reasonably supported the conclusion that the Subject Products contained a defect that could create a substantial product hazard or created an unreasonable risk of serious injury or death, Bestar did not immediately report to the Commission.
11. The Commission and Bestar jointly announced a recall of the Subject Products on April 7, 2022.
12. Despite having information reasonably supporting the conclusion that the Subject Products contained a defect which could create a substantial product hazard or created an unreasonable risk of serious injury or death, Bestar did not notify the Commission immediately of such defect or risk, as required by Sections 15(b)(3) and (4) of the CPSA, 15 U.S.C. 2064(b)(3) and (4), in violation of Section 19(a)(4) of the CPSA, 15 U.S.C. 2068(a)(4).
13. Because the information in Bestar's possession about the Subject Products constituted actual and presumed knowledge, Bestar knowingly violated Section 19(a)(4) of the CPSA, 15 U.S.C. 2068(a)(4), as the term “knowingly” is defined in Section 20(d) of the CPSA, 15 U.S.C. 2069(d).
14. Pursuant to Section 20 of the CPSA, 15 U.S.C. 2069, Bestar is subject to civil penalties for its knowing violation of Section 19(a)(4) of the CPSA, 15 U.S.C. 2068(a)(4).
15. This Agreement does not constitute an admission by Bestar to the allegations set forth in paragraphs 4 through 14, including allegations that Bestar violated any statute or regulation, or knowingly violated the CPSA or CPSIA.
16. At all times, Bestar acted in good faith.
17. Bestar has received no substantiated claims that the Subject Products have fallen or injured consumers when the beds were properly assembled and anchored to the wall.
18. Bestar asserts that the Subject Products do not contain any defect, let alone a defect that could create a substantial product hazard or an unreasonable risk of serious injury or death.
19. Bestar asserts that it timely submitted a report after the 2018 incident in accordance with Section 15(b) of the CPSA, and its implementing regulations, following a reasonable investigation which indicated that despite robust instructions and warnings, the Subject Products may pose a risk of injury if improperly installed.
20. Under the CPSA, the Commission has jurisdiction over the matter involving the Subject Products and Bestar.
21. The parties enter into the Agreement for settlement purposes only. The Agreement does not constitute an admission by Bestar or a determination by the Commission that Bestar violated the CPSA.
22. In settlement of staff's allegations, and to avoid the cost, distraction, delay, uncertainty, and inconvenience of protracted litigation or other proceedings, Bestar shall pay a civil penalty in the amount of sixteen million, twenty-five thousand dollars ($16,025,000) (“Total Civil Penalty Amount”). In reliance on the accuracy, truthfulness, and completeness of Bestar's representations and the documentation referenced below in paragraph 23, the Commission agrees to suspend all but four million dollars ($4,000,000) of the Total Civil Penalty Amount (“$4,000,000 Payment”), on the terms and conditions set forth in this Agreement. The $4,000,000 Payment shall be paid in six total installments. The first installment, one million dollars ($1,000,000), shall be paid within thirty (30) calendar days after Bestar receives service of the Commission's Final Order accepting the Agreement. The remaining three million dollars ($3,000,000) shall be paid in installments annually on the following schedule: five hundred thousand dollars ($500,000) one (1) year from the date of final acceptance; five hundred thousand dollars ($500,000) two (2) years from the date of final acceptance; five hundred thousand dollars ($500,000) three (3) years from the date of final acceptance; five hundred thousand dollars ($500,000) four (4) years from the date of final acceptance; one million dollars ($1,000,000) five (5) years from the date of final acceptance. All payments to be made under the Agreement shall constitute debts owing to the United States and shall be made by electronic wire transfer to the United States via
23. The Commission's agreement to suspend part of the Total Civil Penalty Amount is expressly premised upon Bestar's representations that the following financial documents, communications, and representations provided by Bestar do not contain any untrue statement of a material fact or omit any material fact necessary in order to make the statement therein, true, accurate, and not misleading:
(i) the sworn Affidavit of Luc Mongeau (attached as Exhibit A to the Agreement) signed on October 17, 2024; and
(ii) the Audited Financial Statements, documentation on the industry outlook and Bestar's decline in sales, and the Credit Forbearance Letter of Bestar, submitted to Commission counsel Serena Anand on June 19, 2024 and September 26, 2024 (collectively, “Bestar's Representations”).
24. If Bestar failed to disclose any material asset, materially misstated the value of any asset, or made any other material misstatement or omission in Bestar's Representations, or if Bestar fails to make a payment ordered pursuant to this agreement within the agreed upon time frame, the suspension of the Total Civil Penalty Amount shall be lifted, and the entire $16,025,000 Total Civil Penalty Amount shall become immediately due and payable.
25. The Commission or the United States may seek enforcement for any breach of, or any failure to comply with, any provision of this Agreement and Order in United States District Court, to seek relief including, but not limited to,
26. All unpaid amounts, if any, due and owing under the Agreement, shall constitute a debt due and immediately owing by Bestar to the United States, and interest shall accrue and be paid by Bestar at the federal legal rate of interest set forth at 28 U.S.C. 1961(a) and (b) from the date of Default, until all amounts due have been paid in full (hereinafter “Default Payment Amount” and “Default Interest Balance”). Bestar shall consent to a Consent Judgment in the amount of the Default Payment Amount and Default Interest Balance, and the United States, at its sole option, may collect the entire Default Payment Amount and Default Interest Balance, or exercise any other rights granted by law or in equity, including, but not limited to, referring such matters for private collection, and Bestar agrees not to contest, and hereby waives and discharges any defenses to, any collection action undertaken by the United States, or its agents or contractors, pursuant to this paragraph. Bestar shall pay the United States all reasonable costs of collection and enforcement under this paragraph, respectively, including reasonable attorney's fees and expenses.
27. After staff receives this Agreement executed on behalf of Bestar, staff shall promptly submit the Agreement to the Commission for provisional acceptance. Promptly following provisional acceptance of the Agreement by the Commission, the Agreement shall be placed on the public record and published in the
28. This Agreement is conditioned upon, and subject to, the Commission's final acceptance, as set forth above, and it is subject to the provisions of 16 CFR 1118.20(h). Upon the later of: (i) Commission's final acceptance of this Agreement and service of the accepted Agreement upon Bestar, and (ii) the date of issuance of the Final Order, this Agreement shall be in full force and effect, and shall be binding upon the parties.
29. Effective upon the later of: (1) the Commission's final acceptance of the Agreement and service of the accepted Agreement upon Bestar and (2) the date of issuance of the Final Order, for good and valuable consideration, Bestar hereby expressly and irrevocably waives and agrees not to assert any past, present, or future rights to the following, in connection with the matter described in this Agreement:
(i) an administrative or judicial hearing;
(ii) judicial review or other challenge or contest of the Commission's actions;
(iii) a determination by the Commission of whether Bestar failed to comply with the CPSA and the underlying regulations;
(iv) a statement of findings of fact and conclusions of law; and
(v) any claims under the Equal Access to Justice Act.
30. Bestar shall maintain a compliance program designed to ensure compliance with the CPSA with respect to any consumer product imported, manufactured, distributed or sold by Bestar, which shall contain the following elements:
(i) written standards, policies and procedures concerning products sold by Bestar in the United States, including those designed to ensure that information that may relate to or impact CPSA compliance is conveyed effectively to personnel responsible for CPSA compliance, whether or not an injury has been reported;
(ii) procedures and systems for tracking and reviewing claims, including warranty claims and reports for safety concerns, and for implementing corrective and preventive actions when compliance deficiencies or violations are identified;
(iii) procedures requiring that information required to be disclosed by Bestar to the Commission is recorded, processed, and reported in accordance with applicable law;
(iv) procedures requiring that all reporting made to the Commission is timely, truthful, complete, accurate, and in accordance with applicable law;
(v) procedures requiring that immediate disclosure is made to Bestar's management of any significant deficiencies or material weaknesses in the design or operation of such internal controls that are reasonably likely to affect adversely, in any material respect, Bestar's ability to record, process and report to the Commission in accordance with applicable law;
(vi) mechanisms to effectively communicate to all applicable Bestar employees, through training programs or other means, compliance-related company policies and procedures to prevent violations of the CPSA;
(vii) a mechanism for confidential employee reporting of compliance-related questions or concerns to either a compliance officer or to another senior manager with authority to act as necessary;
(viii) Bestar's senior management responsibility for CPSA compliance including the implementation of steps to ensure that incident and injury data is reviewed and analyzed for purposes of CPSA Section 15(b) reporting;
(ix) for at least three (3) years, an annual internal audit of the effectiveness of policies, procedures, systems, and training related to CPSA compliance that evaluates opportunities for improvement, deficiencies or weaknesses, and the Firm's overall culture of compliance; and
(x) retention of all CPSA compliance-related records for at least five (5) years, and availability of such records to CPSC staff upon request.
31. Bestar shall submit a report under CPSA Section 16(b), sworn to under penalty of perjury:
(i) describing in detail its compliance program and internal controls and the actions Bestar has taken to comply with each subparagraph of paragraph 30;
(ii) affirming that during the reporting period Bestar has reviewed its compliance program and internal controls, including the actions referenced in subparagraph (i) of this paragraph, for effectiveness, and that it complies with each subparagraph of paragraph 30, or describing in detail any non-compliance with any such subparagraph; and
(iii) identifying the results of the annual internal audit referenced in paragraph 30(ix) and any changes or modifications made during the reporting period to the Bestar's compliance program or internal controls to ensure compliance with the terms of the CPSA and, in particular, the requirements of CPSA Section 15 related to timely reporting.
Such reports shall be submitted annually to the Director, Office of Compliance and Field Operations, Division of Enforcement and Litigation, for a period of three (3) years beginning 12 months after the Commission's Final Order of acceptance of the Agreement. The first report shall be submitted 30 days after the close of the first 12-month reporting period, and successive reports shall be due annually on the same date thereafter. Without limitation, Bestar acknowledges and agrees that failure to make such timely and accurate reports as required by this Agreement and Order may constitute a violation of Section 19(a)(3) of the CPSA.
32. Notwithstanding and in addition to the above, Bestar shall promptly provide written documentation of any
33. The parties acknowledge and agree that the Commission may publicize the terms of the Agreement and the Order.
34. Bestar represents that the Agreement:
(i) is entered into freely and voluntarily, without any degree of duress or compulsion whatsoever;
(ii) has been duly authorized; and
(iii) constitutes the valid and binding obligation of Bestar, enforceable against Bestar in accordance with its terms.
35. The signatories represent that they are duly authorized to execute this Agreement.
36. The Agreement is governed by the laws of the United States.
37. The Agreement and the Order shall apply to, and be binding upon, Bestar and each of successors, transferees, and assigns; and a violation of the Agreement or Order may subject Bestar, and each of successors, transferees, and assigns, to appropriate legal action.
38. The Agreement, any attachments, and the Order constitute the complete agreement between the parties on the subject matter contained therein.
39. The Agreement may be used in interpreting the Order. Understandings, agreements, representations, or interpretations apart from those contained in the Agreement and the Order may not be used to vary or contradict their terms. For purposes of construction, the Agreement shall be deemed to have been drafted by both of the parties and shall not, therefore, be construed against any party, for that reason, in any subsequent dispute.
40. The Agreement may not be waived, amended, modified, or otherwise altered, except as in accordance with the provisions of 16 CFR 1118.20(h). The Agreement may be executed in counterparts.
41. If any provision of the Agreement or the Order is held to be illegal, invalid, or unenforceable under present or future laws effective during the terms of the Agreement and the Order, such provision shall be fully severable. The balance of the Agreement and the Order shall remain in full force and effect, unless the Commission and Bestar agree in writing that severing the provision materially affects the purpose of the Agreement and the Order.
Upon consideration of the Settlement Agreement entered into between Bestar, Inc. (“Bestar”) and the U.S. Consumer Product Safety Commission (“Commission” or “CPSC”), and the Commission having jurisdiction over the subject matter and over Bestar it appearing that the Settlement Agreement is in the public interest, the Settlement Agreement is incorporated by reference and it is:
Provisionally accepted and provisional Order issued on the 12th day of November, 2024.
By Order of the Commission:
I, the undersigned, swear and affirm that I am employed by Bestar, Inc. (“Bestar”), that I hold the position indicated below, and, by reason of my position, I am authorized and qualified to make the following statements. All capitalized terms not defined in this affidavit shall have the meanings given to them in the Settlement Agreement between Bestar and the U.S. Consumer Product Safety Commission (“CPSC”) dated the same date, of which this affidavit is a part:
1. I have reviewed Bestar's financial statements and other documents identified in paragraph 23 of the Settlement Agreement, and they are complete, accurate and current, and fairly represent the financial conditions of Bestar as of the dates, and for the periods, indicated therein.
2. To my knowledge and belief, Bestar has provided all available documents and information responsive to the CPSC's requests.
3. To my knowledge and belief, the information provided by Bestar to the CPSC does not, as of the date of the Settlement Agreement, and did not, at the time provided to the CPSC, contain any untrue statement of a material fact or omit any material fact necessary in order to make the statement therein, in light of the circumstances under which they were made, not misleading.
4. Bestar has insufficient cash or other liquid assets to satisfy a civil penalty payment in excess of $4,000,000. Bestar is wholly owned by shareholders who will not infuse additional capital into the company, and who are under no obligation to do so.
5. As of December 31, 2023, Bestar breached certain loan covenants based on its financial ratios and was in Default under the terms of its Credit Agreement. Bestar has provided copies of the Tolerance Letter entered into between Bestar and its lenders to CPSC staff. As a result of this breach, Bestar has been unable to obtain additional funding from its existing lenders and was operating under a “Tolerance Period” while in Default. Since then, Bestar has been cooperating with its lenders to continue operations while it works toward a long-term solution for its dire financial condition.
6. Bestar has attempted to obtain funding from unaffiliated third-parties but has been unable to secure such funding. To my knowledge, Bestar has provided copies of these documents and communications to CPSC staff.
7. Any civil penalty payment by Bestar in excess of $4,000,000, would cause Bestar significant financial hardship and compel Bestar to cease operations as an ongoing business.
I declare under penalty of perjury that the foregoing is true and correct to my knowledge and belief. I understand that any intentional false statement in this declaration may be a criminal offense under 18 U.S.C. 1001.
Office of the Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD).
Notice of Federal advisory committee meeting.
The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place.
DACOWITS will hold an open to the public meeting—Tuesday, December 10, 2024, from 8 a.m. to 12:15 p.m. (EST). Wednesday, December 11, 2024, from 8 a.m. to 11:30 a.m. (EST).
The meeting will take place at the Association of the United States Army Conference Center, located at 2425 Wilson Boulevard, Arlington, Virginia 22201. The meeting will also be streamed virtually. To participate in the meeting, see the Meeting Accessibility section for instructions.
Colonel Seana Jardin, Designated Federal Officer (DFO), (703) 697-2122 (voice),
This meeting is being held under the provisions of chapter 10 of title 5, United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41, Code of Federal Regulations (CFR) sections 102-3.140 and 102-3.150.
Wednesday, December 11, 2024, from 8 a.m. to 11:30 a.m.—Welcome; Introductions; Announcements; Awards Ceremony; Briefing from the Defense Health Agency and the Military Services on Eating Disorders; and Briefing from the Defense Health Agency and the Military Services on Perimenopause, Menopause, and Hormonal Imbalance.
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by January 21, 2025.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to: DoD Office of Force Resiliency, Office of Command Climate and Well-Being Integration (OFR-OCCWI), 4000 Defense Pentagon, Suite 5A668, Washington, DC 20301-4000, Dr. Andra L. Tharp, 202-819-3023.
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by January 21, 2025.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Defense Human Resources Activity, 4800 Mark Center Drive, Suite 08F05, Alexandria, VA 22350, CDR Giuliana Vellucci, (571) 256-0775.
Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), Department of Defense (DoD).
30-Day information collection notice.
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.
Consideration will be given to all comments received by December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Reginald Lucas, (571) 372-7574,
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), Department of Defense (DoD).
30-Day information collection notice.
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.
Consideration will be given to all comments received by December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Reginald Lucas, (571) 372-7574,
Office of the Under Secretary of Defense for Intelligence and Security (OUSD(I&S)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by January 21, 2025.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to DCSA, 27130 Telegraph Rd., Quantico, VA 22134, ATTN: Jarvis Waters, 571-305-6366.
Office of the Under Secretary for Policy (OUSD(P)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by January 21, 2025.
You may submit comments, identified by docket number and title, by any of the following methods:
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 Special Coordinator for Afghanistan (OSCA), 2000 Defense Pentagon, Washington, DC 20301-2000, CAPT Louis Carl, 703-614-0797.
Office of the DoD Chief Information Officer, Department of Defense (DoD).
30-Day information collection notice.
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.
Consideration will be given to all comments received by December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Reginald Lucas, (571) 372-7574,
The DIB CS Program implements statutory authorities to established programs and activities to protect sensitive DoD information, including when such information resides on or transits information systems operated by
The DIB CS Program is focused on sharing cyber threat information and cybersecurity best practices with DIB CS participants. DoD needs to collect POC information to implement, manage, and administer the Program, and to share cyber threat information with participants. The Government will collect business POC information from all DIB CS participants to facilitate emails, teleconferences, meetings, and other Program activities.
The DIB CS Program uses a web portal (
Applicants are then required to complete the POC fields that are provided (
If companies want to update their POC information, they can access the portal using their DoD-approved medium assurance certificates. Only designated company representatives and the DIB CS Program system administrators may view or update company POC information.
Headquarters Marine Corps (HQMC), Department of the Navy (DON), Department of Defense (DoD).
30-Day information collection notice.
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.
Consideration will be given to all comments received by December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Reginald Lucas, (571) 372-7574,
Respondents are contractors/vendors/offerors (hereinafter called “contractors”) who would like to conduct business (such as sell goods or services or perform construction activities) with an MCCS or other Marine Corps NAFIs. They are responding to opportunities to qualify for and receive a contract award by documenting business eligibility requirements; providing quotes, proposals, and contract modifications; and documenting areas of responsibility. The information collected from contractors will vary depending on the nature of the solicitation and its associated contract
Take notice that on November 1, 2024, pursuant to Rule 206 of the Rules of Practice and Procedure of the Federal Energy Regulatory Commission, 18 CFR 385.206 (2024), Husky Marketing and Supply Company filed a complaint challenging the lawfulness of the Base Tariff Rates and Incentive Tariff Rates charged by Buckeye Pipe Line, L.P. for transportation of refined petroleum products from Lima, Ohio, to Columbus, Ohio.
The Complainant certifies that copies of the complaint were served on the contacts listed for Respondents in the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
In addition to publishing the full text of this document in the
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
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
On July 5, 2024, EcoEléctrica, L.P. (EcoEléctrica), filed an application in Docket No. CP24-490-000 requesting authorization under section 3(a) of the Natural Gas Act to increase the sendout capacity in its LNG Supply Pipeline Capacity Project (Project) to the existing off-site Truck Loading Facility (TLF) from 250 gpm to 500 gpm in Peñuelas, Puerto Rico.
On July 19, 2024, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing Federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a Federal authorization within 90 days of the date of issuance of the Commission staff's environmental document for the Project.
This notice identifies Commission staff's intention to prepare an environmental assessment (EA) for the Project and the planned schedule for the completion of the environmental review.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
EcoEléctrica proposes to increase the sendout capacity in its LNG Supply Pipeline to the existing off-site TLF from
On October 22, 2024, the Commission issued a
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
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
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.552b:
Federal Energy Regulatory Commission.
November 21, 2024, 10:00 a.m.
Room 2C, 888 First Street NE, Washington, DC 20426.
Open to the public.
Agenda.
* Note—Items listed on the agenda may be deleted without further notice.
Debbie-Anne A. Reese, Secretary, Telephone (202) 502-8400.
For a recorded message listing items Stricken from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed online at the Commission's website at
A free webcast of this event is available through the Commission's website. Anyone with Internet access who desires to view this event can do so by navigating to www.ferc.gov's Calendar of Events and locating this event in the Calendar. The Federal Energy Regulatory Commission provides technical support for the free webcasts. Please call (202) 502-8680 or email
Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters but will not be telecast.
Take notice that on November 4, 2024, ANR Pipeline Company (ANR), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, filed in the above referenced docket, a prior notice request pursuant to sections 157.205 and 157.208(b) of the Commission's regulations under the Natural Gas Act (NGA), and ANR's blanket certificate issued in Docket No. CP82-480-000, for authorization to construct and operate one 1,900 horsepower natural gas-fired reciprocating compressor unit and appurtenant facilities at ANR's existing Joliet Compressor Station located in Will County, Illinois. The project will allow ANR to increase the delivery capability of its existing Youngs Road interconnect with Northern Border Pipeline Company by 75,000 Dekatherms per day. The estimated cost for the project is $38 million, all as more fully set forth in the request which is on file with the Commission and open to public inspection.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at
Any questions concerning this request should be directed to David A. Alonzo, Manager of Project Authorizations, ANR Pipeline Company, 700 Louisiana Street Suite 1300, Houston, Texas 77002-2700, at (832) 320-5477, or
There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to
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
Pursuant to section 157.205 of the Commission's regulations under the NGA,
Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before January 13, 2025. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP25-14-000 in your submission.
(1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP25-14-000.
The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail at: David A. Alonzo, Manager of Project Authorizations, ANR Pipeline Company, 700 Louisiana Street Suite 1300, Houston, Texas 77002-2700, or by email (with a link to the document) at
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. 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. For more information and to register, go to
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
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.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
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
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
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.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
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
Environmental Protection Agency (EPA).
Notice.
EPA is issuing a notice of receipt of requests by registrants, submitted as part of their 2024 Pesticide Registration Maintenance Fee responses, to voluntarily cancel certain pesticide registrations. EPA intends to grant these requests to cancel at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests to cancel, or unless the registrants withdraw its requests to cancel. If these requests to cancel are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled only if such sale, distribution, or use is consistent with the terms as described in the final order. Additionally, EPA is issuing a notice of intent to cancel other pesticide product registrations as a result of registrants' non-payment of 2024 Pesticide Registration Maintenance Fees.
Comments must be received on or before December 19, 2024.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2024-0094, through the
Submit written withdrawal request by mail to: Registration Division (7505M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. ATTN: Brenda Minnema.
Brenda Minnema, Registration Division (7505M), Office of Pesticide Programs, Environmental Protection Agency, 1200
This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 6(f) (7 U.S.C. 136d(f)), this document announces receipt by the Agency of requests from registrants to cancel the pesticide products listed in table 1 of unit II. that are registered under FIFRA section 3 (7 U.S.C. 136a) or section 24(c) (7 U.S.C. 136v(c)). Unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the
Additionally, pursuant to FIFRA section 4(i)(1)(M) (7 U.S.C. 136a-1(i)(1)(M)), EPA is issuing a notice of intent to cancel the pesticide product registrations listed in table 3 of unit II, as a result of registrants' non-payment of 2024 Pesticide Registration Maintenance Fees.
This notice announces receipt by the Agency of requests from registrants to cancel 64 pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or section 24(c) (7 U.S.C. 136v(c)). These registrations are listed in sequence by registration number (or company number and 24(c) number) in table 1 of this unit.
Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the
Additionally, pursuant to FIFRA section 4(i)(1)(M) (7 U.S.C. 136a-1(i)(1)(M)), this notice announces the Agency's intent to cancel 424 other pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or section 24(c) (7 U.S.C. 136v(c)) as a result of registrants' failure to pay maintenance fees for those registered products by the statutory deadline. These registrations are listed in sequence by registration number (or company number and 24(c) number) in table 3 of this unit.
Unless the Agency receives prompt payment of maintenance fees due for the registrations listed in table 3, the Agency will issue an order in the
Table 2 of this unit includes the names and addresses of record for all registrants of the products in table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.
FIFRA section 6(f)(1) (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be cancelled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Additionally, FIFRA section 4(i)(1) (7 U.S.C. 136a-1(i)(1)) requires that all pesticide registrants pay an annual registration maintenance fee, due by January 15 of each year, to keep their registrations in effect. This requirement applies to all registrations granted under FIFRA section 3 (7 U.S.C. 136a) as well as those granted under FIFRA section 24(c) (7 U.S.C. 136v(c)) to meet special local needs. Registrations for which the fee is not paid are subject to cancellation by order and without a hearing pursuant to FIFRA section 4(i)(1)(M) (7 U.S.C. 136a-1(i)(1)(M)). Accordingly, no comment period is being provided for the products listed in table 3 of unit XXII.
EPA recognizes that this notice of intent to cancel pursuant to FIFRA section 4(i)(1)(M) for failure to pay 2024 FIFRA maintenance fees is being issued at roughly the same time as the notice of cancellation for failure to pay 2023 FIFRA maintenance fees. This timing largely results from unusual circumstances in fiscal year 2023, where FIFRA section 4(i) maintenance fees were collected in two billing cycles, as opposed to the normal single billing cycle. For additional explanation of the circumstances resulting in that procedural change, please refer to the document published in the
Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Upon cancellation of the products identified in table 1 of unit II, the registrants listed in table 2 of unit II will be permitted to sell and distribute existing stocks of these products for one year after the date that the cancellation notice is published in the
Under EPA's existing stocks policy, if a registrant fails to pay the appropriate maintenance fee and the product subject to that fee is later cancelled, the registrant will generally not be allowed to sell or distribute existing stocks of the cancelled product more than 1 year after the date the maintenance fee was due. Here, the registrants of products listed in table 3 were required to submit maintenance fees by January 16, 2024. Accordingly, the registrants listed in table 4 of unit II will be permitted to sell and distribute existing stocks of products listed in table 3 until January 16, 2025. Thereafter, the registrants are prohibited from selling or distributing products listed in table 3, except for export in accordance with FIFRA section 17 (7 U.S.C. 136o), or proper disposal. Persons other than registrants listed in table 4 may sell, distribute, or use existing stocks of products listed in Table 3 until existing stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the cancelled products.
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and
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
Comments received are subject to public disclosure. In general, comments received will be made available without 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.
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 December 4, 2024.
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Board of Governors of the Federal Reserve System.
The notificants listed below have applied under the Change in Bank Control Act (“Act”) (12 U.S.C. 1817(j)) and of the Board's Regulation LL (12 CFR 238.31) to acquire shares of a savings and loan holding company. The factors that are considered in acting on the notices are set forth in paragraph 6 of the Act (12 U.S.C. 1817(j)(6)).
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
Comments received are subject to public disclosure. In general, comments received will be made available without 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.
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 December 4, 2024.
90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291. Comments can also be sent electronically to
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Board of Governors of the Federal Reserve System.
The companies listed in this notice have given notice under section 10 of the Home Owners' Loan Act (12 U.S.C. 1467a) (HOLA) and Regulation LL (12 CFR part 238) to engage de novo, or to acquire or control voting securities or
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
Comments received are subject to public disclosure. In general, comments received will be made available without 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.
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 December 19, 2024.
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Board of Governors of the Federal Reserve System.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
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
Comments received are subject to public disclosure. In general, comments received will be made available without 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.
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 December 19, 2024.
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Board of Governors of the Federal Reserve System.
Office of Acquisition Policy, General Services Administration (GSA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, GSA invites the public to comment on a request to review and approve an extension of a previously approved information collection requirement regarding GSA clauses and Forms that assist with contract administration and quality assurance (
Submit comments on or before: December 19, 2024.
Written comments and recommendations for this information collection should be sent within 30 days of publication of this notice to
Ms. Vernita Misidor, Procurement Analyst, General Services Acquisition Policy Division, at 202-357-9681 or via email to
Under certain contracts the Government must rely on contractor inspection in lieu of Government
A 60-day notice was published in the
Comment: “I have not find any type of business on the ride I am not self-employed all the income than I'd bring claimed against me is not mine I did not earn that or file that.”
Office of Government-wide Policy, General Services Administration (GSA).
Notice.
GSA is providing notice of the second, third, and fourth public meetings of the Open Government Federal Advisory Committee (hereinafter “the Committee” or “the OG FAC”). All meetings are open to the public.
The GSA OG FAC will hold 3 virtual (webcast) meetings, which are open to the public, on the following days and times:
• Wednesday, December 11, 2024, from 1 p.m. to 4 p.m., eastern standard time (EST).
• Wednesday, January 8, 2025, from 1 p.m. to 4 p.m., EST.
• Friday, February 7, 2025, from 1 p.m. to 4 p.m., EST.
The December 11, 2024, January 8, 2025, and February 7, 2025 meetings will be available via webcast. Registrants will receive the webcast information when they register for each respective meeting.
Arthur Brunson, OG FAC Designated Federal Officer, Office of Government-wide Policy, 202-501-1126, or email:
The Administrator of GSA established the OG FAC as a discretionary advisory committee under agency authority in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. ch. 10.
The OG FAC serves as an advisory body to GSA on open government initiatives including GSA's creation, implementation and monitoring of U.S. Open Government National Action Plans (NAPs) and commitment themes. The initial focus for the OG FAC will be to provide advice to GSA on the development of NAP 6, Open Government Policy, and Public Engagement. The OG FAC advises GSA's Administrator on emerging open government issues, challenges and opportunities to support GSA's U.S. Open Government Secretariat.
The purpose of these meetings is to continue the work of the advisory committee by further developing committee norms for the operation of the committee, a framework for recommendations for the U.S. National Action Plan 6 (NAP 6), and a framework for recommendations on emerging open government issues. These meetings may include presentations, deliberations, and voting by members on five subject areas:
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The public is invited to attend and provide oral comments in these meetings. All three meetings are virtual-only and will be recorded.
Public Meeting (2) December 11, 2024, 1 p.m. to 4 p.m., EST.
Public Meeting (3) January 8, 2025, 1 p.m. to 4 p.m., EST.
Public Meeting (4) February 7, 2025, 1 p.m. to 4 p.m., EST.
Agenda
Registration is requested for all 3 virtual meetings. An email address is requested so that we can provide you with information to access the meeting.
Meeting agendas and materials will be posted in advance of each meeting on our website at:
Written public comments will be provided to OG FAC members in advance of the meetings if received by the following dates and times:
• Wednesday, December 4, 2024, no later than 5 p.m. EST, for the Wednesday, December 11, 2024 meeting.
• Tuesday, December 31, 2024, no later than 5 p.m. EST, for the Wednesday, January 8, 2025 meeting.
• Friday, January 31, 2025, no later than 5 p.m. EST, for the Friday, February 7, 2025 meeting.
Written comments may be sent to
If you wish to offer oral public comments during the public comments period of any of these meetings, you are requested to register in advance. We request that you register by the following dates and times:
• Tuesday, December 10, 2024, no later than 5 p.m. EST for the Wednesday, December 11, 2024 meeting.
• Tuesday, January 7, 2025, no later than 5 p.m. EST for the Wednesday, January 8, 2025 meeting.
• Thursday, February 6, 2025, no later than 5 p.m. EST for the Friday, February 7, 2025 meeting.
Oral public comments will be limited to three (3) minutes per individual and may be made virtually.
For information on services for individuals with disabilities, or to request accommodation of a disability, please contact the Designated Federal Officer at least 10 business days prior to the meeting to give GSA as much time as possible to process the request. Closed captioning and live ASL interpreter services are available.
Office of Child Care, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Administration for Children and Families (ACF) Office of Child Care (OCC) is requesting a 3-year extension of the form ACF-118A: Child Care and Development Fund for Tribes (Office of Management and Budget (OMB) #0970-0198, expiration April 30,2025) for Federal Fiscal Year (FFY) 2026-2028. There are changes proposed to the form to improve formatting, streamline questions, and reduce burden.
Comments due December 19, 2024. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
OCC made the following changes based on feedback from Tribes, including several listening sessions conducted over the past year:
• Reduced the burden overall by streamlining and removing questions;
• Revised questions based on the two 2024 CCDF final rules;
• Clarified requirements based on CCDBG Act and regulations;
• Improved skip patterns to reduce burden; and
• Edited the document for plain language.
Office of Family Assistance, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Administration for Children and Families (ACF) is proposing to collect data for new Temporary Assistance for Needy Families (TANF) work outcomes measures required by the Fiscal Responsibility Act (FRA) of 2023. Information collections include the Work Outcomes of TANF Exiters Report, Secondary School Diploma or its Recognized Equivalent Rate, and the Supplemental Work Outcomes Report.
Comments due December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The data and information from these reports will be used for program analysis and oversight, including the calculation of the indicators of performance required by the FRA: Employment Rate-2nd Quarter After Exit, Employment Retention Rate-4th Quarter After Exit, Median Earnings-2nd Quarter After Exit, and Secondary School Diploma or its Recognized Equivalent Attainment Rate.
For the Work Outcomes of TANF Exiters Report, states will be required to submit Social Security Numbers of all work-eligible individuals who exit TANF in each quarter on a quarterly basis.
For the Secondary School Diploma Attainment Rate, states will be asked to submit their calculated rate following the definitions and formula set by ACF. The report must include documentation of methodology and data sources.
The Supplemental Work Outcomes Report will be submitted annually by interested states. The report will include documentation of data sources and methodology to assess validity and support ongoing learning and identification of best practices.
Office on Trafficking in Persons, Administration for Children and Families, Department of Health and Human Services.
Establishment of Federal advisory committee.
The National Advisory Committee on the Trafficking of Children and Youth in the United States (Committee) was established on November 7, 2024, to build on the work of the previous National Advisory Committee on the Sex Trafficking of Children and Youth in the United States, authorized pursuant to section 121 of the Preventing Sex Trafficking and Strengthening Families Act. The Committee advises on practical and general policies concerning improvements in the Nation's response to the human trafficking of children and youth in the United States, including the cooperation of Federal, State, local, and Tribal governments; child welfare agencies; social service providers; physical health and mental health providers; victim service providers; Federal, State, and local police; juvenile detention centers; State or local courts with responsibility for conducting or supervising proceedings related to child welfare or social services for children and their families; runaway and homeless youth programs; schools; technology, gaming and entertainment industry; and businesses and organizations that provide services to youth. While addressing the response to the trafficking of children and youth, the Committee shall consider recommendations related to the intersection of sex trafficking and labor trafficking among children and youth in the United States. Note that this
The Committee's charter was filed on November 7, 2024.
To learn more about the Committee, access the Committee's website:
Katherine Chon (Designated Federal Officer) at (202) 205-5778 or
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AGILI-C and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
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• 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”).
Submit written/paper submissions as follows:
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• 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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device AGILI-C. AGILI-C is indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7 cm
FDA has determined that the applicable regulatory review period for AGILI-C is 1,988 days. Of this time, 1,807 days occurred during the testing phase of the regulatory review period, while 181 days occurred during the approval phase. These periods of time were derived from the following dates:
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This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 189 days or 1,085 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Frequently asked Questions—Developing Potential Cellular and Gene Therapy Products.” The draft guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology.
Submit either electronic or written comments on the draft guidance by February 18, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
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• 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”).
Submit written/paper submissions as follows:
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• 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.”
• 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
Myrna Hanna, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft document entitled “Frequently asked Questions—Developing Potential Cellular and Gene Therapy Products.” The draft guidance document provides industry with answers to FAQs and commonly faced issues that arise during the development of CGT products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; CMC; pharmacology/toxicology; clinical; and clinical pharmacology.
The guidance was created as part of FDA's response to the PDUFA VII commitment to increase efficiency and to support development of CGT products by providing a repository of common questions posed to the Office of Therapeutic Products by sponsors and other key stakeholders. The Agency compiled FAQs received from a variety of sources, including FDA interactions with sponsors in development programs.
The guidance covers relevant, current, and timely topics related to the development of CGT products, which may be updated to include additional FAQs as appropriate. Sponsors are encouraged to visit the Cellular and Gene Therapy Guidances web page on the FDA website for a full list of finalized as well as draft guidances relevant to the development of CGT products.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Frequently asked Questions—Developing Potential Cellular and Gene Therapy Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Action of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 312 pertaining to investigational new drug applications, clinical trials and clinical trial design, meetings with FDA, and Form FDA 1571, have been approved under OMB control number 0910-0014. The collections of information in section 402(j)(5)(B) of the Public Health Service Act (42 U.S.C. 282(j)(5)(B)), which requires certification that all applicable requirements of section 402(j) have been met on Form FDA 3674, and the collections of information in 21 CFR part 601 pertaining to the submission of biologics license applications and Form FDA 356h have been approved under OMB control number 0910-0338.
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that HYDROCORTONE (hydrocortisone sodium phosphate) injection, equivalent to (EQ) 50 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, if all other legal and regulatory requirements are met.
Beth Holck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 240-402-7133,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, is the subject of NDA 012052, held by Merck & Co., Inc., and initially approved on June 8, 1960. HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, is synthetic glucocorticoid for use as an anti-inflammatory or immunosuppressant agent.
The indications for glucocorticoid drugs, including HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL (Merck Sharpe & Dohme (now Merck & Co., Inc.); NDA 012052) were reviewed for efficacy under the Drug Efficacy Study Implementation program. Under this program, which was implemented in response to the 1962 amendments to the FD&C Act requiring demonstration of effectiveness (Kefauver-Harris Amendments of 1962 (Pub. L. 87-781)), the National Academy of Sciences-National Research Council (NAS-NRC) studied about 4,000 drug formulations to assess the efficacy of the drug products. Upon consideration of the findings and recommendations of the NAS-NRC, FDA set forth in the
FDA published a subsequent notice in the
HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, is currently listed in the “Discontinued Drug Product List” section of the Orange Book. In a letter dated April 4, 2003, Merck & Co., Inc., notified FDA that HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, was discontinued effective September 20, 2002. In the same letter, Merck & Co., Inc., also requested withdrawal of NDA 012052 for HYDROCORTONE (hydrocortisone sodium phosphate), and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. In the
Hyman, Phelps & McNamara, P.C., submitted an initial citizen petition dated September 21, 2020 (Docket No. FDA-2020-P-1991) as well as a second citizen petition dated August 25, 2021 (Docket No. FDA-2021-P-0940), under 21 CFR 10.30, requesting that the Agency determine whether HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petitions and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, may be approved by the Agency if they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ivette Maria Portela Martinez from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Portela Martinez was convicted of two felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Ms. Portela Martinez was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 14, 2024 (30 days after receipt of the notice), Ms. Portela Martinez has not responded. Ms. Portela Martinez's failure to respond and request a hearing constitutes a waiver of Ms. Portela Martinez's right to a hearing concerning this matter.
This order is applicable November 19, 2024.
Any application by Ms. Portela Martinez for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) may be submitted at any time as follows:
•
• If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
•
• For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit an application with confidential information that you do not wish to be made publicly available, submit your application 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 your application. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Jaime Espinosa, Division of Field Enforcement, Office of Field Regulatory Operations, Office of Inspections and Investigations, Food and Drug Administration, 240-402-8743, or
Section 306(a)(2)(A) of the FD&C Act requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product. On November 30, 2023, Ms. Portela Martinez was convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. District Court for the Southern District of Florida-Miami Division when the court entered judgment against her, after a jury trial, for one count of conspiracy to commit wire fraud in violation of 18 U.S.C. 1349 and one count of wire fraud in violation of 18 U.S.C. 1343.
The underlying facts supporting the conviction are as follows: as contained in the witness testimony reflected in the transcripts from her trial, Ms. Portela Martinez worked for AMB Research Center, Inc. (AMB), a medical clinic located in Miami, Florida. AMB conducted clinical trials of new drugs for pharmaceutical companies and other sponsors. At AMB, Ms. Portela Martinez served as recruiter, site manager, data entry specialist, and pharmacist. In March 2016, AMB entered into a Clinical Trial Agreement with a Contract Research Organization (CRO) that managed and oversaw a clinical trial designed to evaluate the safety and efficacy of an investigational drug intended to treat persons with Clostridium difficile-associated diarrhea (CDAD clinical trial) on behalf of a sponsor (a pharmaceutical company). Ms. Portela Martinez, along with her co-conspirators, entered into a conspiracy to cause the sponsor and/or the CRO to make payments on the contracts for the CDAD clinical trial, by making false and fraudulent representations regarding, among other things, subject eligibility for and participation in the CDAD clinical trial, and falsifying and fabricating documents, data, and other items relating to the CDAD clinical trial including subject informed consent forms, case histories, and data. Ms. Portela Martinez participated with two other co-conspirators with falsifying and fabricating study documents. Ms. Portela Martinez and her co-conspirators falsified the study data of subjects who did not participate in the CDAD clinical trial in full compliance with the protocol. Ms. Portela Martinez participated in falsifying the consent forms and falsifying subjects' signatures to make it appear as though the patients had consented to participate in the clinical trial when they had not.
For purposes of obtaining money from the sponsor and/or CRO, Ms. Portela Martinez, along with her co-conspirators, created false and fraudulent study records, and submitted fraudulent stool and blood samples. For example, electronic case record files (eCRFs) falsely represented that the subjects completed the informed consent form (ICF) process with the Principal Investigator which required her to review the ICF with each subject and personally obtain the subject's written informed consent. In fact, the Principal Investigator never completed the ICF process with subjects, and some subjects had never been to AMB or did not participate in the trial. Ms. Portela Martinez knew that false information and data was submitted in the case report forms and eCRFs including false information and data representing that subjects had satisfied eligibility criteria
Furthermore, Ms. Portela Martinez was one of only two individuals who inputted CDAD clinical trial data in the Almac Clinical Technology Integrated Response Technology database (Almac database). The information in the Almac database was the foundation for all subsequent subject CDAD clinical trial data. Ms. Portela Martinez repeatedly entered false and fabricated subject screening and randomization information in the Almac database.
Ms. Portela Martinez received $19,620 in proceeds for the CDAD clinical trial. AMB received over $277,000 for the CDAD clinical trial.
FDA sent Ms. Portela Martinez, by certified mail, on August 12, 2024, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) of the FD&C Act, that Ms. Portela Martinez was convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product. The proposal informed Ms. Portela Martinez of the proposed debarment and offered her an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Portela Martinez received the proposal and notice of opportunity for a hearing on August 15, 2024. Ms. Portela Martinez failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and waived any contentions concerning her debarment (21 CFR part 12).
Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(a)(2)(A) of the FD&C Act, under authority delegated to the Division of Field Enforcement Director, finds that Ms. Ivette Maria Portela Martinez has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product.
As a result of the foregoing finding, Ms. Portela Martinez is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kevin Sheng Hsiang Fang for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Fang was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Fang was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 1, 2024 (30 days after receipt of the notice), Mr. Fang has not responded. Mr. Fang's failure to respond and request a hearing constitutes a waiver of Mr. Fang's right to a hearing concerning this matter.
This order is applicable November 19, 2024.
Any application by Mr. Fang for termination of debarment under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be submitted at any time as follows:
•
• If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the
•
• For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit an application with confidential information that you do not wish to be made publicly available, submit your application 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 your application. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Jaime Espinosa, Division of Field Enforcement, Office of Field Regulatory Operations, Office of Inspections and Investigations, Food and Drug Administration, 240-402-8743, or
Section 306(b)(1)(C) of the FD&C Act permits FDA to debar an individual from importing an article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any food.
On February 26, 2024, Mr. Fang was convicted as defined in section 306(l)(1)(A) of the FD&C Act, in the U. S. District Court for the Central District of California, when the court entered judgment against him, after his plea of guilty, to the offense of importing merchandise contrary to law in violation of 18 U.S.C. 545 and 18 U.S.C. 2(b). The underlying facts supporting the conviction are as follows: As contained in the information from his case, Mr. Fang worked as a manager at a company called Heng Xing Foods, Inc., which was a business entity that imported shipments of Chinese roasted eel as a food wholesaler. Mr. Fang also imported shipments of Chinese roasted eel as a food wholesaler and did business as Young Chang Trading Co., Ltd. in or about October 16, 2017, in Los Angeles County. Mr. Fang knowingly and fraudulently imported and brought, and willfully caused to be imported and brought, Chinese roasted eel adulterated with Gentian Violet and Leucogentian Violent, both being new unsafe animal drugs, into the United States and contrary to law.
As a result of this conviction, FDA sent Mr. Fang, by certified mail, on May 29, 2024, a notice proposing to debar him for a 5-year period from importing articles of food or offering such articles for import into the United States. The proposal was based on a finding under section 306(b)(1)(C) of the FD&C Act that Mr. Fang's felony conviction under Federal law for importing merchandise contrary to law in violation of 18 U.S.C. 545 and 18 U.S.C. 2(b), was for conduct relating to the importation into the United States of an article of food because the offense involved Mr. Fang and his company importing roasted eel adulterated with Gentian Violet and Leucogentian Violent, both being new unsafe animal drugs. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Fang's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Fang of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Fang received the proposal and notice of opportunity for a hearing on June 1, 2024. Mr. Fang failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).
Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(b)(1)(C) of the FD&C Act, under authority delegated to the Division of Field Enforcement Director, finds that Mr. Kevin Sheng Hsiang Fang has been convicted of a felony under Federal law for conduct relating to the importation into the United States of an article of food and that he is subject to a 5-year period of debarment. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Fang is debarred for a period of 5 years from importing articles of food or offering such articles for import into the United States, effective (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and regulatory requirements are met.
Awo Archampong-Gray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-796-0110,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, are the subject of NDA 216951, held by GlaxoSmithKline Intellectual Property (No. 2) Limited England, and initially approved on February 1, 2023. JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 4 months. JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, are currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Qilu Pharmaceutical (Hainan) Co., Ltd., submitted a citizen petition dated July 24, 2024 (Docket No. FDA-2024-P-3482), under 21 CFR 10.30, requesting that the Agency determine whether JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, or 8 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 26 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of December 19, 2024.
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137,
The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing.
Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of December 19, 2024. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Comments on this ICR should be received no later than December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request a copy of the clearance requests submitted to OMB for review, email Joella Roland, the HRSA Information Collection Clearance Officer, at
A 60-day notice was published in the
Office of the Secretary, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the Information Collection Request (ICR) must be received on or before January 21, 2025.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 0990-0278-60D and project title for reference, to Sherrette A. Funn, email:
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
OMB No. 0990-0278.
In accordance with 41 CFR 102-3.65(a), notice is hereby given that the charter for the National Toxicology Program Board of Scientific Counselors was renewed for an additional two-year period on November 14, 2024.
It is determined that the National Toxicology Program Board of Scientific Counselors, is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group.
Inquiries may be directed to Claire Harris, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or
Coast Guard, DHS.
Notice of availability.
The Coast Guard announces the availability of Maritime Security (MARSEC) Directive 105-5, which outlines cyber risk management requirements for ship-to-shore cranes manufactured by People's Republic of China (PRC) companies. These requirements are in addition to those previously promulgated via MARSEC Directive 105-4. The Directive contains security-sensitive information and, therefore, cannot be made available to the general public. Owners or operators of ship-to-shore (STS) cranes manufactured by PRC companies should immediately contact their local Coast Guard Captain of the Port (COTP) or District Commander for a copy of MARSEC Directive 105-5.
MARSEC Directive 105-5 has been available since November 13, 2024.
For information about this document call or email Brandon Link, Commander, U.S. Coast Guard, Office of Port and Facility Compliance; telephone 202-372-1107, email
MARSEC Directive 105-5 outlines requirements in addition to those previously promulgated via MARSEC Directive 105-4 on cyber risk management actions for owners or operators of STS cranes manufactured by PRC companies. MARSEC Directive 105-4 was issued on February 21, 2024 and was announced in a notice of availability published on February 23, 2024. 89 FR 13726 (February 23, 2024). Owners or operators of STS cranes manufactured by PRC companies should immediately contact their local COTP or cognizant District Commander for a copy of MARSEC Directive 105-5.
The Maritime Transportation Security Act's implementing regulations in 33 CFR parts 101-105 are designed to protect the maritime elements of the national transportation system. Under 33 CFR 101.405, the Coast Guard may set forth additional security measures to respond to a threat assessment or to a specific threat against those maritime elements. In addition, per 33 CFR 6.14-1, the Commandant “may prescribe such conditions and restrictions relating to the safety of waterfront facilities and vessels in port as the Commandant finds to be necessary under existing circumstances.”
STS cranes manufactured by PRC companies make up the largest share of the global ship-to-shore crane market and account for nearly 80% of the STS cranes at U.S. ports. By design, these cranes may be controlled, serviced, and programmed from remote locations, and those features potentially leave STS cranes manufactured by PRC companies vulnerable to exploitation, threatening the maritime elements of the national transportation system.
As such, additional measures are necessary to prevent a Transportation Security Incident in the national transportation system due to the prevalence of STS cranes manufactured by PRC companies in the U.S., threat intelligence related to the PRC's interest in disrupting U.S. critical infrastructure, and the built-in vulnerabilities for remote access and control of these STS cranes.
Owners and operators of STS cranes manufactured by PRC companies must contact their local COTP or cognizant District Commander to acquire a copy of MARSEC Directive 105-5. COTPs or cognizant District Commanders may provide this MARSEC Directive to appropriate owners and operators via email, mail or fax in accordance with Sensitive Security Information (SSI) handling procedures.
Pursuant to 33 CFR 101.405, we consulted with the Department of State, Department of Defense, Department of Transportation/Maritime Administration, Department of Homeland Security, Transportation Security Administration, Cybersecurity and Infrastructure Security Agency, and National Maritime Intelligence-Integration Office.
All MARSEC Directives issued pursuant to 33 CFR 101.405 are marked as SSI in accordance with 49 CFR part 1520. COTPs and District Commanders will require individuals requesting a MARSEC Directive to prove that they meet the standards for a “covered person” under 49 CFR 1520.7, have a “need to know” the information, as defined in 49 CFR 1520.11, and that they will safeguard the SSI in MARSEC Directive 105-5 as required in 49 CFR 1520.9.
This notice is issued under authority of 33 CFR 6.14-1 and 101.405(a)(2) and 5 U.S.C. 552(a).
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the U.S. Indian Vocational School, Bernalillo County, NM.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, two individuals were collected at the U.S. Indian Vocational School, Bernalillo County, NM. The human remains are hair clippings collected from one individual who was recorded as being 14 years old and one individual who was recorded as being 13 years old and identified as “San Felipe.” Reuben Perry took the hair clippings at the U.S. Indian Vocational School between 1930 and 1933. Perry sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Pueblo of San Felipe, New Mexico.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Sherman Institute, Riverside County, CA.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, three individuals were collected at the Sherman Institute, Riverside County, CA. The human remains are hair clippings collected from two individuals who were recorded as being 19 years old and one individual who was recorded as being 16 years old and identified as “Karok.” Samuel H. Gilliam took the hair clippings at the Sherman Institute between 1930 and 1933. Gilliam sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of three individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Karuk Tribe.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the University of New Mexico, Bernalillo County, NM.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, seven individuals were collected at the University of New
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of seven individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Pueblo of Santa Clara, New Mexico.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the University of New Mexico, Bernalillo County, NM.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, three individuals were collected at the University of New Mexico, Bernalillo County, NM. The human remains are hair clippings collected from one individual who was recorded as being 16 years old, one individual who was recorded as being 14 years old, and one individual who was recorded as being 13 years old and identified as “Santo Domingo.” Dr. Clyde Kay Maben Kluckhohn took the hair clippings at the University of New Mexico between 1930 and 1933. Kluckhohn sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of three individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Santo Domingo Pueblo.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Department of the Interior, Office of Indian Affairs, Field Services, Yukon-Koyukuk Census Area, AK.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, 20 individuals were collected at the Department of the Interior, Office of Indian Affairs, Field Services, Yukon-Koyukuk Census Area, AK. The human remains are hair clippings collected from one individual who was recorded as being 65 years old, one individual who was recorded as being 53 years old, one individual who was recorded as being 51 years old, one individual who was recorded as being 47 years old, one individual who was recorded as being 39 years old, one individual who was recorded as being 38 years old, one individual who was recorded as being 35 years old, one individual who was recorded as being 33 years old, one individual who was recorded as being 31 years old, one individual who was recorded as being 28 years old, one individual who was recorded as being 26 years old, one individual who was recorded as being 25 years old, one individual who was recorded as being 23 years old, one individual who was recorded as being 22 years old, two individuals who were recorded as being 21 years old, one individual who was recorded as being 20 years old, one individual who was recorded as being 15 years old, one individual who was recorded as being 14 years old, and one individual who was recorded as being 13 years old. All individuals are identified as “Tana.” Mrs. Jessie Mazie took the hair clippings at the Department of the Interior, Office of Indian Affairs, Field Services between 1930 and 1933. Mazie sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of 20 individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Native Village of Tanana.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Sherman Institute, Riverside County, CA and Chemawa (Salem) Indian School, Marion County, OR.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The
Based on the information available, human remains representing, at minimum, one individual was collected at the Sherman Institute, Riverside County, CA. The human remains are hair clippings collected from one individual who was recorded as being 17 years old and identified as “Nisqually.” Samuel H. Gilliam took the hair clippings at the Sherman Institute between 1930 and 1933. Gilliam sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the information available, human remains representing, at minimum, one individual was collected at the Chemawa (Salem) Indian School, Marion County, OR. The human remains are hair clippings collected from one individual who was recorded as being 18 years old and identified as “Nisqually.” James T. Ryan took the hair clippings at the Chemawa (Salem) Indian School between 1930 and 1933. Ryan sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Nisqually Indian Tribe.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Laboratory of Anthropology, Santa Fe County, NM and University of New Mexico, Bernalillo County, NM.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, four individuals were collected at the Laboratory of Anthropology, Santa Fe County, NM. The human remains are hair clippings collected from one individual who was recorded as being 42 years old, one individual who was recorded as being 16 years old, and two individuals who were recorded as being 13 years old and identified as “San Juan.” An unknown collector took the hair clippings at the Laboratory of Anthropology between 1930 and 1933. They sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the information available, human remains representing, at minimum, six individuals were collected at the University of New Mexico, Bernalillo County, NM. The human remains are hair clippings collected from one individual who was recorded as being 17 years old, two individuals who were recorded as being 16 years old, one individual who was recorded as being 15 years old, and two individuals who were recorded as being 12 years old and identified as “San Juan.” Dr. Clyde Kay Maben Kluckhohn took the hair clippings at the University of New Mexico between 1930 and 1933. Kluckhohn sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of 10 individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Ohkay Owingeh, New Mexico.
Written requests for repatriation of the human remains in this notice must be
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the U.S. Indian Vocational School, Bernalillo County, NM.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, one individual was collected at the U.S. Indian Vocational School, Bernalillo County, NM. The human remains are hair clippings collected from one individual who was recorded as being 15 years old and identified as “Sandia.” Reuben Perry took the hair clippings at the U.S. Indian Vocational School between 1930 and 1933. Perry sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Pueblo of Sandia, New Mexico.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in ADDRESSES. Requests for repatriation may be submitted by:
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Chemawa (Salem) Indian School, Marion County, OR.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including
Based on the information available, human remains representing, at minimum, one individual was collected at the Chemawa (Salem) Indian School, Marion County, OR. The human remains are hair clippings collected from one individual who was recorded as being 15 years old and identified as “Quileute.” James T. Ryan took the hair clippings at the Chemawa (Salem) Indian School between 1930 and 1933. Ryan sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Quileute Tribe of the Quileute Reservation.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Standing Rock School, Sioux County, ND.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, one individual was collected at the Standing Rock School, Sioux County, ND. The human remains are hair clippings collected from one individual who was recorded as being 24 years old and identified as “Ottawa.” E.D. Mossman took the hair clippings at the Standing Rock School between 1930 and 1933. Mossman sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Ottawa Tribe of Oklahoma.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the U.S. Indian Vocational School, Bernalillo County, NM, and the University of New Mexico, Bernalillo County, NM.
Repatriation of the human remains in this notice may occur on or after December 19, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at minimum, one individual was collected at the U.S. Indian Vocational School, Bernalillo County, NM. The human remains are hair clippings collected from one individual who was recorded as being 16 years old and identified as “Taos.” Reuben Perry took the hair clippings at the U.S. Indian Vocational School between 1930 and 1933. Perry sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the information available, human remains representing, at minimum, three individuals were collected at the University of New Mexico, Bernalillo County, NM. The human remains are hair clippings collected from one individual who was recorded as being 19 years old, one individual who was recorded as being 18 years old, and one individual who was recorded as being 14 years old and identified as “Taos.” Dr. Clyde Kay Maben Kluckhohn took the hair clippings at the University of New Mexico between 1930 and 1933. Kluckhohn sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the available information and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of four individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Pueblo of Taos, New Mexico.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Sonoma State University has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after December 19, 2024.
Doshia Dodd, Sonoma State University, 1801 East Cotati Avenue, Rohnert Park, CA 94928, telephone (530) 514-8472, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Sonoma State University, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
The lot of 51 associated funerary objects under Accession number 81-06 removed from CA-YOL-136, CA-YOL-137, CA-YOL-138, CA-YOL-139, and CA-YOL-140 in Yolo County, California. The associated funerary objects are flaked tools and debitage and fauna! bones. The Accession Number 81-06 collection is the result of cultural resource study of 7,600 acres in Napa and Yolo Counties done by the Anthropological Studies Center at
The lot of 208 associated funerary objects under Accession Number 82-04 were removed from CA-YOL-138 and CA-YOL-140 in Yolo County, California is flaked stone tools and debitage, groundstone, quartz crystal, fauna) bone and historic-period items. The collection, Accession Number 82-04, has been housed at Sonoma State University since 1983.
The lot of 5,095 associated funerary objects are under Accession Number 83-08 were removed from CA-YOL-138, CA-YOL-139 and CA-YOL-140 in Yolo County, California. A previously published Notice of Inventory Completion (75 FR 68377, November 5, 2010) concerning CA-YOL-139 covered two individuals and 555 associated funerary objects. The remaining associated funerary objects are obsidian tools, obsidian flakes, chert flakes, basalt flakes, basalt tool, fauna) bone fragments, abalone shell fragment, ash/soil samples, groundstone, quartz chunk, abalone pendants and olivella beads. The entire accession remains at Sonoma State University.
Based on the information available, human remains representing, at least, three individuals removed from Accession Number 84-19 site CA-YOL-139 have been reasonably identified. A minimum 14 ancestors and 54 associated funerary objects were previously published in a Notice of Inventory Completion (75 FR 68377, November 5, 2010). The remaining 9,314 associated funerary objects are flaked stone tools and debitage, Groundstone, historic material, Unmodified fauna! bone, shell beads and ornaments, baked clay, bone tools, steatite pipe, dietary shell. This Inventory updates the minimum number of individuals. The Accession number 84-19 collection was the result of a field school led by Sonoma State University and Santa Rosa Junior College from Fall 1984 to Summer 1985. The collection, Accession Number 82-04, has been housed at Sonoma State University since 1985.
Based on records concerning the associated funerary objects and the institution in which they are housed, there is no evidence of the associated funerary objects being treated with hazardous substances.
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.
The Sonoma State University has determined that:
• The human remains described in this notice represent the physical remains of three individuals of Native American ancestry.
• The 14,668 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the human remains and associated funerary objects described in this notice and the Yocha Dehe Wintun Nation, California.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after December 19, 2024. If competing requests for repatriation are received, the Sonoma State University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Sonoma State University is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined not to review an initial determination (“ID”) (Order No. 9) of the presiding administrative law judge (“ALJ”) granting a joint motion to terminate the enforcement proceeding based on settlement. The enforcement proceeding is hereby terminated.
Edward S. Jou, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3316. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
The Commission instituted the underlying investigation on October 19, 2022, based on an amended complaint filed by Vego Garden, Inc. of Houston, Texas (“Vego
On March 21, 2024, the Commission issued a final determination finding a violation of section 337 based on trade secret misappropriation and false advertising. 89 FR 21270-71 (Mar. 27, 2024). The Commission determined to issue a limited exclusion order (“LEO”) directed to respondents Huizhou Green Giant Technology Co., Ltd. (“Green Giant”) of Guangdong, China and Utopban Limited (“Utopban”) of Hong Kong, and a cease and desist order (“CDO”) directed to Utopban.
The Commission instituted an enforcement proceeding in this investigation on June 26, 2024, based upon a complaint filed by Vego Innovations, Inc. f/k/a Vego Garden (“Vego”). 89 FR 53443-44 (June 26, 2024). The complaint alleges that Green Giant and Utopban have continued to import, sell, offer for sale, market, advertise, distribute, transfer, and/or solicit agents or distributors for products in violation of the LEO and CDO.
On October 3, 2024, Vego, Green Giant, and Utopban filed a joint motion for termination of the enforcement proceeding based on a settlement agreement. On October 11, 2024, OUII filed a response in support of the motion. On October 17, 2024, the ALJ issued the subject ID granting the joint motion for termination, attaching confidential and public versions of the settlement agreement. The ALJ found that the motion complied with the requirements of Commission Rule 210.21(b)(1) (19 CFR 210.21(b)(1)). ID at 1-3. The ALJ also found that termination “would not adversely affect the public interest.”
The Commission has determined not to review the subject ID. The enforcement proceeding is hereby terminated.
The Commission vote for this determination took place on November 13, 2024.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping investigation Nos. 731-TA-1675-1678 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of dioctyl terephthalate (DOTP) from Malaysia, Poland, Taiwan, and Turkey, provided for in subheadings 2917.39.70 or 3812.20.10 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (“Commerce”) to be sold at less-than-fair-value.
November 5, 2024.
Jesse Sanchez ((202) 205-2402), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter 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 (
DOTP that is otherwise subject to this investigation is not excluded when commingled with DOTP from sources not subject to this investigation. Commingled refers to the mixing of subject and non-subject DOTP. Only the subject component of such commingled products is covered by the scope of this investigation.
DOTP has the general chemical formulation of C
For further information concerning the conduct of this phase of the investigations, hearing procedures, and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference, if deemed necessary, to be held at 9:30 a.m. on Friday, March 21, 2025. Parties shall file and serve written testimony and presentation slides in connection with their presentation at the hearing by no later than noon on March 24, 2025. Oral testimony and written materials to be submitted at the public hearing are governed by sections 201.6(b)(2), 201.13(f), and 207.24 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony
Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to review in part a final initial determination (“FID”) issued by the presiding administrative law judge (“ALJ”). The Commission requests written submissions from the parties on the issues under review and submissions from the parties, interested government agencies, and other interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below.
The Commission has determined to extend the target date for this investigation to January 15, 2025.
Paul Lall, Office of the General Counsel, U.S.
On June 9, 2023, the Commission instituted this investigation based on a complaint filed on behalf of Shoals Technologies Group, LLC (“Shoals Technologies”) of Portland, Tennessee. 88 FR 37905-06 (June 9, 2023). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United States, the sale for importation, or sale within the United States after importation of certain photovoltaic connectors and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 10,553,739 (“the '739 patent”) and 10,992,254 (“the '254 patent”). The Commission's notice of investigation (“NOI”) named the following eight respondents: (1) Hikam America, Inc. of Chula Vista, California; (2) Hikam Electrónica de México, S.A. de C.V. of Mexicali, Mexico; (3) Hikam Tecnologia de Sinaloa of Guasave, Mexico; (4) Hewtech Philippines Corp. of Laguna, Philippines; (5) Hewtech Philippines Electronics Corp. of Pampanga, Philippines; (6) Hewtech (Shenzhen) Electronics Co., Ltd. of Shenzhen, China (collectively the “Hikam Respondents”); (7) Voltage, LLC (“Voltage”) of Chapel Hill, North Carolina; and (8) Ningbo Voltage Smart Production Co. (“Ningbo Voltage”) of Ningbo, China (collectively “Respondents”).
On August 15, 2023, the Commission amended the complaint and NOI to add allegations of infringement against Voltage related to certain claims of U.S. Patent No. 11,689,153 (“the '153 patent”).
The presiding ALJ held a
On March 11, 2024, the Commission terminated the following claims from the investigation based on Shoals' withdrawal of the complaint as to those claims: claims 2, 3, 6, 8, 9, 11, 12, and 15-18 of the '739 patent, claims 2-4, 8-12, 14, and 15 of the '254 patent, and claims 2, 3, 6, and 15-17 of the '153 patent.
On March 25, 2024, the Commission terminated the '254 patent from this investigation based on Shoals' withdrawal of the complaint as to that patent.
On April 19, 2024, the Commission determined not to review the ALJ's grant of summary determination that Shoals has not satisfied the technical prong of the domestic industry requirement for the '739 Patent and, thus, found no violation as to the '739 patent. Order No. 20 (March 6, 2024),
On April 26, 2024, the Commission terminated this investigation with respect to asserted claim 8 of the '153 patent based on Shoals' withdrawal of the complaint as to that claim.
The ALJ held an evidentiary hearing on March 18-22, 2024. As of the hearing, Shoals asserted claims 1, 11-14, 18, 21, 23, and 24 of the '153 patent against the accused Voltage Trunk Bus, and Voltage sought adjudication of the Voltage Alternative Design [“AD”] Trunk Bus with respect to and claims 21 and 24 of the '153 patent. Shoals also asserted that its domestic industry product practices claims 1 and 21 of the '153 patent for purposes of the domestic industry requirement.
On August 30, 2024, the presiding ALJ issued the FID, finding that there has been a violation of section 337 in the importation into the United States, the sale for importation, and/or the sale in the United States after importation of certain photovoltaic connectors and components thereof with respect to certain claims of the '153 patent. Specifically, the FID finds as to the '153 patent that: (1) the Voltage Trunk Bus and Voltage AD Trunk Bus have been imported into the United States, sold for importation, and/or sold within the United States after importation; (2) the Voltage Trunk Bus satisfies claims 1, 11-14, and 18; (3) the Voltage Trunk Bus does not satisfy claims 21, 23, and 24; (4) the Voltage AD Trunk Bus does not satisfy claims 1, 11-14, 18, 21, 23, and 24; (5) Shoals has satisfied the technical prong of the domestic industry requirement; (6) Shoals has satisfied the economic prong of the domestic industry requirement; and (7) Voltage has not shown that claims 1, 11-14, 18, 21, 23, and 24 are invalid.
On September 13, 2024, the presiding ALJ issued a Recommended Determination on Remedy and Bonding (“RD”). The RD recommends that the Commission issue a limited exclusion order in the event it finds a violation of section 337 and impose a bond of 100 percent during the period of Presidential Review.
On October 15 and 16, 2024, Shoals and Voltage, respectively, filed a statement on the public interest pursuant to Commission Rule 210.50(a)(4), 19 CFR 210.50(a)(4). On October 2 and October 15, 2024, American Wire Group of Miami, Fla. and Strata Clean Energy of Durham, N.C. respectively filed statements on the public interest in response to the Commission's
On September 16, 2024, Shoals filed a petition for review of the FID. In its petition, Shoals Technologies argued that the ALJ should not have considered respondents' redesign product, the Voltage AD Trunk Bus, as being within the scope of the investigation.
On the same day, Respondents also filed a petition for review of several of the FID's findings, including: (1) the FID's construction of the term “aperture, recited in the asserted claims of the '153 patent” as defined by the “Modified Cable Test”; (2) the FID's finding that the asserted claims of the '153 patent are not invalid for lack of written
Also on the same day, OUII filed a petition for review of the FID, seeking review of several of the FID's findings, including: (1) the FID's construction of the three “aperture” terms recited in the asserted claims of the `153 patent; (2) the FID's finding that Shoals' asserted domestic industry products satisfy the technical prong of the domestic industry requirement; and (3) the ALJ's determination to exclude the testimony of Respondents' invalidity expert.
On September 24, 2024, Shoals, Voltage and OUII each filed responses to the respective petitions for review. On October 4, 2024, Voltage filed a notice of supplemental authority and on October 7, 2024, Shoals filed a response.
Having reviewed the record of the investigation, including the FID, the parties' petitions for review and related submissions, the Commission has determined to review the FID's: (1) construction of the “aperture” terms recited in the asserted claims of the '153 Patent; (2) finding that the accused products infringe the asserted claims of the '153 patent; (3) finding that the asserted claims of the '153 patent are not invalid under 35 U.S.C. 112 for lack of written description and/or indefiniteness; and (4) finding that Shoals' domestic industry products satisfy the domestic industry requirement of section 337, including the FID's findings concerning the technical prong and the economic prong.
In connection with the final disposition of this investigation, the statute authorizes issuance of,
(1) Please identify whether and where in the record Shoals presented arguments with supporting evidence that the accused products infringe any asserted claim of the '153 patent under OUII's proposed construction of the “aperture” terms.
(2) Please identify whether and where in the record Shoals presented arguments with supporting evidence that its domestic industry products satisfy the technical prong of the domestic industry requirement of section 337 under OUII's proposed construction of the “aperture” terms.
The parties are invited to brief only the discrete issues requested above. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.
The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist orders would have on: (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination.
In its initial submission, Complainant is also requested to identify the remedy sought and Complainant and OUII are requested to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to state the dates that the Asserted Patents expire, to provide the HTSUS subheadings under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. The initial written submissions must be filed no later than close of business on November 27, 2024. Reply submissions must be filed no later than the close of business on December 5, 2024. No further submissions on these issues will be permitted unless otherwise ordered by the Commission. Opening submissions are limited to 50 pages. Reply submissions are limited to 25 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1365”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed with the Commission and served on any parties to the investigation within two business days of any confidential filing. All
The Commission has determined to extend the target date for this investigation to January 15, 2025.
The Commission's vote on this determination took place on November 13, 2024.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until January 21, 2025.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, contact: John Basile, EIPB, either by mail at Bureau of Alcohol, Tobacco, Firearms, and Explosives; 99 New York Ave. NE; Washington, DC 20226, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
7.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until January 21, 2025.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, contact: John Basile, EIPB, either by mail at Bureau of Alcohol, Tobacco, Firearms, and Explosives; 99 New York Ave NE; Washington, DC 20226, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6. An estimate of the total annual burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 44,083 hours, which is equal to 264,498 (total respondents) * 1 (# of response per respondent) * 10 minutes (0.16666667 hours).
7.
In accordance with section 512(a)(1) of the Employee Retirement Income Security Act of 1974 (ERISA) and the provisions of the Federal Advisory Committee Act and its implementing regulations issued by the General Services Administration (GSA), the charter for the Advisory Council on Employee Welfare and Pension Benefit Plans is renewed.
The Advisory Council on Employee Welfare and Pension Benefit Plans shall advise the Secretary of Labor on technical aspects of the provisions of ERISA and shall provide reports and/or recommendations each year on its findings to the Secretary of Labor. The Council shall be composed of fifteen members appointed by the Secretary. Not more than eight members of the Council shall be of the same political party. Three of the members shall be representatives of employee organizations (at least one of whom shall be a representative of any organization members of which are participants in a multiemployer plan); three of the members shall be representatives of employers (at least one of whom shall be a representative of employers maintaining or contributing to multiemployer plans); three members shall be representatives appointed from the general public (one of whom shall be a person representing those receiving benefits from a pension plan); and there shall be one representative each from the fields of insurance, corporate trust, actuarial counseling, investment counseling, investment management, and accounting.
The Advisory Council will report to the Secretary of Labor. It will function solely as an advisory body and in compliance with the provisions of the Federal Advisory Committee Act, and its charter will be filed under the Act. For further information, contact Pinar Shapiro, Executive Secretary, Advisory Council on Employee Welfare and Pension Benefit Plans, U.S. Department of Labor, 200 Constitution Avenue NW, Suite N-5623, Washington, DC 20210, telephone (202) 693-8448 or via email to
10 a.m., Thursday, November 21, 2024.
Board Room, 7th Floor, Room 7B, 1775 Duke Street (All visitors must use Diagonal Road Entrance), Alexandria, VA 22314-3428.
Open.
1. Board Briefing, Share Insurance Fund Quarterly Report.
2. Central Liquidity Facility's 2025-2026 Budget.
Melane Conyers-Ausbrooks, Secretary of the Board, Telephone: 703-518-6304.
National Science Foundation.
Notice.
The National Science Foundation (NSF) is announcing plans to request clearance for this collection. In accordance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting OMB clearance of this collection for no longer than three years.
Written comments should be received by January 21, 2025, to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Written comments regarding the information collection and requests for copies of the proposed information collection request should be addressed to Suzanne Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Room W6700, Alexandria, VA 22314, or by email to
Suzanne Plimpton on (703) 292-7556 or send email to
Comments are invited on (a) whether the proposed
Nuclear Regulatory Commission.
Notice; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued exemptions in response to a December 7, 2023, request from Constellation Energy Generation, LLC (Constellation), regarding the submittal of subsequent license renewal applications for Calvert Cliffs Nuclear Power Plant, Units 1 and 2. Pursuant to these exemptions, if the licensee submits the subsequent license renewal applications at least 3 years prior to the expiration of the existing operating licenses, and if the NRC staff finds them acceptable for docketing, the existing operating licenses will be in timely renewal under NRC regulations until the NRC has made final determinations on whether to approve the subsequent license renewal applications.
The exemptions were issued on November 12, 2024.
Please refer to Docket ID NRC-2024-0179 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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•
•
Brian Harris, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2277; email:
The text of the exemptions is attached.
For the Nuclear Regulatory Commission.
Constellation Energy Generation, LLC (Constellation, the licensee), is the holder of Renewed Facility Operating License Nos. DPR-53 and DPR-69 which authorize operation of the Calvert Cliffs Nuclear Power Plant (Calvert), Units 1 and 2. These units are pressurized-water reactors located in Calvert County, Maryland. The operating licenses provide, among other things, that the facility is subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC, Commission) now or hereafter in effect. The current operating licenses for Calvert, Units 1 and 2, expire on July 31, 2034, and August 13, 2036, respectively.
By letter dated December 7, 2023 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23341A188), Constellation requested exemptions from 10 CFR 2.109(b), which provides that if a nuclear power plant licensee files a sufficient license renewal application “at least 5 years before the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined.” Specifically,
In its December 7, 2023, letter, the licensee stated that three special circumstances apply to its exemption requests. The three special circumstances that Constellation included in its requests are:
(1) Application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule;
(2) Compliance would result in undue hardship or other costs that are significantly in excess of those contemplated when the regulation was adopted, or that are significantly in excess of those incurred by others similarly situated; and
(3) There is present any other material circumstance not considered when the regulation was adopted for which it would be in the public interest to grant an exemption.
Under 10 CFR 54.17(a), the NRC requires that the filing of an application for a renewed license be in accordance with, among other regulations, 10 CFR 2.109(b). As provided in 10 CFR 54.15, exemptions from the requirements of 10 CFR part 54 may be granted by the Commission in accordance with 10 CFR 50.12. Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50 when (1) the exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) special circumstances are present, as defined in 10 CFR 50.12(a)(2).
These exemptions would allow Constellation to receive timely renewal protection under 10 CFR 2.109(b) if it submits sufficient SLRAs for Calvert at least 3 years prior to the expiration of its existing licenses. This means that if the licensee submits an SLRA by July 31, 2031, for Calvert, Unit 1, and by August 13, 2033, for Calvert, Unit 2, and the staff finds them acceptable for docketing, the existing licenses for Calvert will not be deemed to have expired until the NRC has made final determinations on whether to approve the SLRAs. The staff has determined that granting these exemptions are authorized by law.
Section 103(c) of the Atomic Energy Act of 1954, as amended, permits the Commission to issue operating licenses, including renewed licenses. 10 CFR 2.109 implements section 9(b) of the Administrative Procedure Act (APA), 5 U.S.C. 558(c), which states:
When the licensee has made timely and sufficient application for a renewal or a new license in accordance with agency rules, a license with reference to an activity of a continuing nature does not expire until the application has been finally determined by the agency.
The 5-year time period specified in 10 CFR 2.109(b) is not required by the Atomic Energy Act of 1954, as amended, or the APA. It is the result of a discretionary agency rulemaking under sections 161 and 181 of the Atomic Energy Act of 1954, as amended (56 FR 64943; December 13, 1991) that was designed to provide the NRC with a reasonable amount of time to review a license renewal application and decide whether to approve it. Prior to 1992, the rules provided that licensees would have received timely renewal protection when they submitted their license renewal applications 30 days before the expiration of the current license (56 FR 64962; December 13, 1991). In 1990, the NRC proposed modifying 10 CFR 2.109 to provide that applications must be submitted 3 years before expiration of the current license to be afforded timely renewal protection (55 FR 29058; July 17, 1990). There is nothing in the preamble supporting the proposed rule or final rule revising 10 CFR 2.109(b) that suggests that applying the timely renewal doctrine to license renewal applications submitted 30 days before the expiration of the license was not authorized by law. Instead, it appears the Commission proposed to revise 10 CFR 2.109(b) from 30 days to 3 years before the expiration of the license so that the final determination on a license renewal application would typically be made before the current operating license expired. In the proposed rule, the Commission explained that it did not believe 30 days would provide “a reasonable time to review an application for a renewed operating license” and estimated that the technical review of a license renewal application would take approximately 2 years (55 FR 29051; July 17, 1990). In the final rule, the Commission stated that the technical review of the application would take approximately 2 years due to the review of “many complex technical issues” and that “[a]ny necessary hearing could likely add an additional year or more” (56 FR 64962; December 13, 1991). Ultimately, the Commission concluded in the final rule that timely renewal protection would be provided for license renewal applications filed 5 years before the operating license expired to promote consistency with the requirement that licensees submit decommissioning plans and related financial assurance information on or about 5 years prior to the expiration of their current operating license. Thus, in promulgating 10 CFR 2.109(b), the Commission considered that the time period needed to reach a final determination may be less than 5 years in some cases, but the rule also provides timely renewal protection for timely-filed applications to account for situations where the resolution of complex technical issues may take more time.
The exemptions constitute a change to the schedule by which the licensee must submit its SLRAs and are administrative in nature; they do not involve any change to the current operating licenses. Under 10 CFR 54.17(a), an application for a renewed license must be filed in accordance with subpart A of 10 CFR part 2, which includes 10 CFR 2.109(b). However, the NRC may grant exemptions from the requirements of 10 CFR part 54 pursuant to 10 CFR 54.15. For the reasons stated above, the NRC has determined that granting these exemptions will not result in a violation of the Atomic Energy Act of 1954, as amended, the APA, or the NRC's regulations. Therefore, the exemptions are authorized by law.
The requested exemptions to allow a 3-year time period, rather than the 5 years specified in 10 CFR 2.109(b), for Constellation to submit sufficient SLRAs and receive timely renewal protection are scheduling changes. The actions do not change the manner in which Calvert operates and maintains public health and safety because the exemptions from 10 CFR 2.109(b) do not result in a change to the facility or the current operating licenses. The NRC expects that a period of 3 years provides sufficient time for the NRC to perform a full and adequate safety and environmental review, and for the completion of the hearing process. Pending final action on the SLRAs, the NRC will continue to conduct all regulatory activities associated with licensing, inspection, and oversight, and will take whatever action may be necessary to ensure adequate protection of the public health and safety. The existence of these exemptions does not
The requested exemptions are scheduling changes that do not alter the design, function, or operation of any structures or plant equipment that are necessary to maintain safe and secure status of any site security matters. Therefore, the NRC finds that the actions are consistent with the common defense and security.
The Commission will not consider granting a specific exemption from the requirements in 10 CFR part 50 unless special circumstances are present. For the following reasons, the NRC finds that the special circumstances of 10 CFR 50.12(a)(2)(ii) are present for Calvert, Units 1 and 2. That is, application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule.
The purpose of 10 CFR 2.109(b), as it is applied to nuclear power reactors licensed by the NRC, is to implement the “timely renewal” provision of section 9(b) of the APA, 5 U.S.C. 558(c). The underlying purpose of this “timely renewal” provision in the APA is to protect a licensee who is engaged in an ongoing licensed activity and who has complied with agency rules in applying for a renewed or new license from facing license expiration as the result of delays in the administrative process.
On December 13, 1991, the NRC published the final license renewal rule, 10 CFR part 54, with associated changes to 10 CFR parts 2, 50, and 140, in the
Accordingly, application of the 5-year period in 10 CFR 2.109(b) is not necessary to achieve the underlying purpose of the timely renewal provision in the regulation if Constellation files sufficient SLRAs at least 3 years prior to expiration of the Calvert licenses. The NRC's current schedule for review of SLRAs is to complete its review and make a decision on issuing the renewed license within 18 months of acceptance if there is no hearing. If a hearing is held, the NRC's model schedule anticipates completion of the NRC's review, the hearing process, and issuance of a decision on the license renewal application within 30 months of receipt.
However, it is recognized that the estimate of 30 months for completion of a contested hearing is subject to variation in any given proceeding. A period of 3 years (36 months), nevertheless, is expected to provide sufficient time for performance of a full and adequate safety and environmental review, and completion of the hearing process. Meeting this schedule is based on a sufficient application being submitted and on the review being completed in accordance with the NRC's established license renewal review schedule.
Based on the above, the NRC finds that the special circumstance of 10 CFR 50.12(a)(2)(ii) is present in the particular circumstances of Calvert, Units 1 and 2. Because the NRC staff finds that special circumstances exist under 10 CFR 50.12(a)(2)(ii), the NRC staff did not consider whether special circumstances also exist under 10 CFR 50.12(a)(2)(iii) or 10 CFR 50.12(a)(2)(vi), as presented by the licensee in its exemption requests.
The NRC has determined that the issuance of the requested exemptions meets the provisions of categorical exclusion specified in 10 CFR 51.22(c)(25). Under 10 CFR 51.22(c)(25), the granting of an exemption from the requirements of any regulation of Title 10, Chapter 1 of the
To qualify for a categorical exclusion under 10 CFR 51.22(c)(25)(i), the exemption must involve a no significant hazards consideration. The criteria for making a no significant hazards consideration determination are found in 10 CFR 50.92(c). The NRC has determined that the granting of the exemption requests involves no significant hazards consideration because allowing the submittal of the SLRAs at least 3 years before the expiration of the existing licenses while maintaining the protection of the timely renewal provision in 10 CFR 2.109(b) does not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. Therefore, the requirements of 10 CFR 51.22(c)(25)(i) are met.
The exemptions constitute a change to the schedule by which Constellation must submit its SLRAs and still place the licenses in timely renewal, which is administrative in nature, and does not involve any change in the types or significant increase in the amounts of effluents that may be released offsite and does not contribute to any significant increase in occupational or public radiation exposure. Therefore, the requirements of 10 CFR 51.22(c)(25)(ii) and (iii) are met.
The exempted regulation is not associated with construction, and the exemptions do not propose any changes to the site, alter the site, or change the operation of the site. Therefore, the requirements of 10 CFR 51.22(c)(25)(iv) are met because there is no significant construction impact.
The exemptions constitute changes to the schedule by which Constellation must submit its SLRAs and still place
To qualify for a categorical exclusion under 10 CFR 51.22(c)(25)(vi)(G), the exemption must involve scheduling requirements. The exemptions involve scheduling requirements because they would allow Constellation to submit SLRAs for Calvert, Units 1 and 2, at least 3 years prior to the expiration of the existing licenses, rather than the 5 years specified in 10 CFR 2.109(b), and still place the licenses in timely renewal under 10 CFR 2.109(b). Therefore, the requirements of 10 CFR 51.22(c)(25)(vi) are met.
Based on the above, the NRC concludes that the proposed exemptions meet the eligibility criteria for a categorical exclusion set forth in 10 CFR 51.22(c)(25). Therefore, pursuant to 10 CFR 51.22(b), no environmental assessment or environmental impact statement need be prepared in connection with the approval of these exemption requests.
Accordingly, the NRC has determined that, pursuant to 10 CFR 54.15 and 10 CFR 50.12, the requested exemptions are authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security. Also, special circumstances, as defined in 10 CFR 50.12(a)(2)(ii), are present. Therefore, the NRC hereby grants the licensee a one-time exemption for each Unit such that if the licensee submits SLRAs for Calvert, Units 1 and 2, at least 3 years prior to the expiration of each of the existing operating licenses, and if the NRC staff finds them acceptable for docketing, the existing operating licenses will be in timely renewal under NRC regulations until the NRC has made final determinations on whether to approve the SLRAs.
These exemptions are effective upon issuance.
Dated: November 12, 2024.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued an exemption in response to a December 7, 2023, request from Constellation Energy Generation, LLC (Constellation), regarding the submittal of a subsequent license renewal application for James A. FitzPatrick Nuclear Power Plant. Pursuant to this exemption, if the licensee submits a subsequent license renewal application at least 3 years prior to the expiration of the existing operating license, and if the NRC staff finds it acceptable for docketing, the existing operating license will be in timely renewal under NRC regulations until the NRC has made a final determination on whether to approve the subsequent license renewal application.
The exemption was issued on November 12, 2024.
Please refer to Docket ID NRC-2024-0178 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Brian Harris, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2277; email:
The text of the exemption is attached.
For the Nuclear Regulatory Commission.
Constellation Energy Generation, LLC (Constellation, the licensee), is the holder of Renewed Facility Operating License No. DPR-59 which authorizes operation of the James A. FitzPatrick Nuclear Power Plant (FitzPatrick). This unit is a boiling-water reactor located in Oswego County, New York. The operating license provides, among other things, that the facility is subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC, Commission) now or hereafter in effect. The current operating license for FitzPatrick expires on October 17, 2034.
By letter dated December 7, 2023 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23341A189), Constellation requested an exemption from 10 CFR 2.109(b), which provides that if a nuclear power plant licensee files a sufficient license renewal application “at least 5 years before the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined.” Specifically, Constellation requested timely renewal protection under 10 CFR 2.109(b) if it
In its December 7, 2023, letter, the licensee stated that three special circumstances apply to its exemption request. The three special circumstances that Constellation included in its request are:
(1) Application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule;
(2) Compliance would result in undue hardship or other costs that are significantly in excess of those contemplated when the regulation was adopted, or that are significantly in excess of those incurred by others similarly situated; and
(3) There is present any other material circumstance not considered when the regulation was adopted for which it would be in the public interest to grant an exemption.
Under 10 CFR 54.17(a), the NRC requires that the filing of an application for a renewed license be in accordance with, among other regulations, 10 CFR 2.109(b). As provided in 10 CFR 54.15, exemptions from the requirements of 10 CFR part 54 may be granted by the Commission in accordance with 10 CFR 50.12. Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50 when (1) the exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) special circumstances are present, as defined in 10 CFR 50.12(a)(2).
This exemption would allow Constellation to receive timely renewal protection under 10 CFR 2.109(b) if it submits a sufficient SLRA for FitzPatrick at least 3 years prior to the expiration of its existing license. This means that if the licensee submits an SLRA by October 17, 2031, and the staff finds it acceptable for docketing, the existing license for FitzPatrick will not be deemed to have expired until the NRC has made a final determination on whether to approve the SLRA. The staff has determined that granting this exemption is authorized by law.
Section 103(c) of the Atomic Energy Act of 1954, as amended, permits the Commission to issue operating licenses, including renewed licenses. 10 CFR 2.109 implements section 9(b) of the Administrative Procedure Act (APA), 5 U.S.C. 558(c), which states:
When the licensee has made timely and sufficient application for a renewal or a new license in accordance with agency rules, a license with reference to an activity of a continuing nature does not expire until the application has been finally determined by the agency.
The 5-year time period specified in 10 CFR 2.109(b) is not required by the Atomic Energy Act of 1954, as amended, or the APA. It is the result of a discretionary agency rulemaking under sections 161 and 181 of the Atomic Energy Act of 1954, as amended (56 FR 64943; December 13, 1991) that was designed to provide the NRC with a reasonable amount of time to review a license renewal application and decide whether to approve it. Prior to 1992, the rules provided that licensees would have received timely renewal protection when they submitted their license renewal applications 30 days before the expiration of the current license (56 FR 64962; December 13, 1991). In 1990, the NRC proposed modifying 10 CFR 2.109 to provide that applications must be submitted 3 years before expiration of the current license to be afforded timely renewal protection (55 FR 29058; July 17, 1990). There is nothing in the preamble supporting the proposed rule or final rule revising 10 CFR 2.109(b) that suggests that applying the timely renewal doctrine to license renewal applications submitted 30 days before the expiration of the license was not authorized by law. Instead, it appears the Commission proposed to revise 10 CFR 2.109(b) from 30 days to 3 years before the expiration of the license so that the final determination on a license renewal application would typically be made before the current operating license expired. In the proposed rule, the Commission explained that it did not believe 30 days would provide “a reasonable time to review an application for a renewed operating license” and estimated that the technical review of a license renewal application would take approximately 2 years (55 FR 29051; July 17, 1990). In the final rule, the Commission stated that the technical review of the application would take approximately 2 years due to the review of “many complex technical issues” and that “[a]ny necessary hearing could likely add an additional year or more” (56 FR 64962; December 13, 1991). Ultimately, the Commission concluded in the final rule that timely renewal protection would be provided for license renewal applications filed 5 years before the operating license expired to promote consistency with the requirement that licensees submit decommissioning plans and related financial assurance information on or about 5 years prior to the expiration of their current operating license. Thus, in promulgating 10 CFR 2.109(b), the Commission considered that the time period needed to reach a final determination may be less than 5 years in some cases, but the rule also provides timely renewal protection for timely-filed applications to account for situations where the resolution of complex technical issues may take more time.
The exemption constitutes a change to the schedule by which the licensee must submit its SLRA and is administrative in nature; it does not involve any change to the current operating license. Under 10 CFR 54.17(a), an application for a renewed license must be filed in accordance with subpart A of 10 CFR part 2, which includes 10 CFR 2.109(b). However, the NRC may grant exemptions from the requirements of 10 CFR part 54 pursuant to 10 CFR 54.15. For the reasons stated above, the NRC has determined that granting this exemption will not result in a violation of the Atomic Energy Act of 1954, as amended, the APA, or the NRC's regulations. Therefore, the exemption is authorized by law.
The requested exemption to allow a 3-year time period, rather than the 5 years specified in 10 CFR 2.109(b), for Constellation to submit a sufficient SLRA and receive timely renewal protection is a scheduling change. The action does not change the manner in which FitzPatrick operates and maintains public health and safety because the exemption from 10 CFR 2.109(b) does not result in a change to the facility or the current operating license. The NRC expects that a period of 3 years provides sufficient time for the NRC to perform a full and adequate safety and environmental review, and for the completion of the hearing process. Pending final action on the SLRA, the NRC will continue to conduct all regulatory activities associated with licensing, inspection, and oversight, and will take whatever action may be necessary to ensure adequate protection of the public health and safety. The existence of this exemption does not affect NRC's authority, applicable to all licenses, to modify, suspend, or revoke a license for cause, such as a serious safety concern. Based on the above, the NRC finds that the exemption does not
The requested exemption is a scheduling change that does not alter the design, function, or operation of any structures or plant equipment that are necessary to maintain safe and secure status of any site security matters. Therefore, the NRC finds that the action is consistent with the common defense and security.
The Commission will not consider granting a specific exemption from the requirements in 10 CFR part 50 unless special circumstances are present. For the following reasons, the NRC finds that the special circumstances of 10 CFR 50.12(a)(2)(ii) are present for FitzPatrick. That is, application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule.
The purpose of 10 CFR 2.109(b), as it is applied to nuclear power reactors licensed by the NRC, is to implement the “timely renewal” provision of section 9(b) of the APA, 5 U.S.C. 558(c). The underlying purpose of this “timely renewal” provision in the APA is to protect a licensee who is engaged in an ongoing licensed activity and who has complied with agency rules in applying for a renewed or new license from facing license expiration as the result of delays in the administrative process.
On December 13, 1991, the NRC published the final license renewal rule, 10 CFR part 54, with associated changes to 10 CFR parts 2, 50, and 140, in the
Accordingly, application of the 5-year period in 10 CFR 2.109(b) is not necessary to achieve the underlying purpose of the timely renewal provision in the regulation if Constellation files a sufficient SLRA at least 3 years prior to expiration of the FitzPatrick license. The NRC's current schedule for review of SLRAs is to complete its review and make a decision on issuing the renewed license within 18 months of acceptance if there is no hearing. If a hearing is held, the NRC's model schedule anticipates completion of the NRC's review, the hearing process, and issuance of a decision on the license renewal application within 30 months of receipt.
However, it is recognized that the estimate of 30 months for completion of a contested hearing is subject to variation in any given proceeding. A period of 3 years (36 months), nevertheless, is expected to provide sufficient time for performance of a full and adequate safety and environmental review, and completion of the hearing process. Meeting this schedule is based on a sufficient application being submitted and on the review being completed in accordance with the NRC's established license renewal review schedule.
Based on the above, the NRC finds that the special circumstance of 10 CFR 50.12(a)(2)(ii) is present in the particular circumstance of FitzPatrick. Because the NRC staff finds that special circumstances exist under 10 CFR 50.12(a)(2)(ii), the NRC staff did not consider whether special circumstances also exist under 10 CFR 50.12(a)(2)(iii) or 10 CFR 50.12(a)(2)(vi), as presented by the licensee in its exemption request.
The NRC has determined that the issuance of the requested exemption meets the provisions of categorical exclusion specified in 10 CFR 51.22(c)(25). Under 10 CFR 51.22(c)(25), the granting of an exemption from the requirements of any regulation of Title 10, Chapter 1 of the
To qualify for a categorical exclusion under 10 CFR 51.22(c)(25)(i), the exemption must involve a no significant hazards consideration. The criteria for making a no significant hazards consideration determination are found in 10 CFR 50.92(c). The NRC has determined that the granting of the exemption request involves no significant hazards consideration because allowing the submittal of the SLRA at least 3 years before the expiration of the existing license while maintaining the protection of the timely renewal provision in 10 CFR 2.109(b) does not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. Therefore, the requirements of 10 CFR 51.22(c)(25)(i) are met.
The exemption constitutes a change to the schedule by which Constellation must submit its SLRA and still place the license in timely renewal, which is administrative in nature, and does not involve any change in the types or significant increase in the amounts of effluents that may be released offsite and does not contribute to any significant increase in occupational or public radiation exposure. Therefore, the requirements of 10 CFR 51.22(c)(25)(ii) and (iii) are met.
The exempted regulation is not associated with construction, and the exemption does not propose any changes to the site, alter the site, or change the operation of the site. Therefore, the requirements of 10 CFR 51.22(c)(25)(iv) are met because there is no significant construction impact.
The exemption constitutes a change to the schedule by which Constellation must submit its SLRA and still place the license in timely renewal, which is administrative in nature, and does not impact the probability or consequences of accidents. Thus, there is no significant increase in the potential for, or consequences of, a radiological
To qualify for a categorical exclusion under 10 CFR 51.22(c)(25)(vi)(G), the exemption must involve scheduling requirements. The exemption involves scheduling requirements because it would allow Constellation to submit an SLRA for FitzPatrick at least 3 years prior to the expiration of the existing license, rather than the 5 years specified in 10 CFR 2.109(b), and still place the license in timely renewal under 10 CFR 2.109(b). Therefore, the requirements of 10 CFR 51.22(c)(25)(vi) are met.
Based on the above, the NRC concludes that the proposed exemption meets the eligibility criteria for a categorical exclusion set forth in 10 CFR 51.22(c)(25). Therefore, pursuant to 10 CFR 51.22(b), no environmental assessment or environmental impact statement need be prepared in connection with the approval of this exemption request.
Accordingly, the NRC has determined that, pursuant to 10 CFR 54.15 and 10 CFR 50.12, the requested exemption is authorized by law, will not present an undue risk to the public health and safety, and is consistent with the common defense and security. Also, special circumstances, as defined in 10 CFR 50.12(a)(2)(ii), are present. Therefore, the NRC hereby grants the licensee a one-time exemption such that if the licensee submits an SLRA for FitzPatrick at least 3 years prior to the expiration of the existing operating license, and if the NRC staff finds it acceptable for docketing, the existing operating license will be in timely renewal under NRC regulations until the NRC has made a final determination on whether to approve the SLRA.
This exemption is effective upon issuance.
Dated: November 12, 2024.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft report; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft report entitled, NUREG-1307, Revision 20, “Report on Waste Burial Charges: Changes in Decommissioning Waste Disposal Costs at Low-Level Waste Burial Facilities.” This report, which is revised periodically, explains the formula acceptable to the NRC for determining the minimum decommissioning fund requirements for nuclear power reactor licensees, as required by NRC regulations. Specifically, this report provides the adjustment factor and updates the values for the labor, energy, and waste burial escalation factors of the minimum formula.
Submit comments by December 19, 2024. 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 before this date.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Emil Tabakov, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6814; email:
Please refer to Docket ID NRC-2024-0188 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:
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The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for
Pursuant to section 50.75 of title 10 of the
Revision 20 of NUREG-1307, “Report on Waste Burial Charges: Changes in Decommissioning Waste Disposal Costs at Low-Level Waste Burial Facilities,” modifies the previous revision to this report issued in February 2023 (ADAMS Accession No. ML23044A207) and incorporates updates to the labor, energy, and waste burial escalation factors of the NRC minimum decommissioning fund formula. Due to moderately lower low-level waste (LLW) burial charges at two of the nation's four LLW disposal facilities to which a majority of licensees are anticipated to dispose some portion of their LLW, and slightly to moderately higher charges at the remaining two facilities to which a small number of licensees are anticipated to dispose of their LLW, the minimum decommissioning fund formula amounts calculated by licensees, based on revised LLW burial factors presented in this report, will likely reflect minimum decommissioning fund requirements that are lower, on average, when compared to those previously reported by licensees in 2023.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). Section II also establishes comment deadline(s) pertaining to each such request.
The Commission invites comments on whether the Postal Service's request(s) identified in section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in section II.
Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review.
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This Notice will be published in the
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens.
The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date.
Under section 7(b) of the Railroad Retirement Act (RRA) (45 U.S.C. 231f), and section 5(c) of the Railroad Unemployment Insurance Act (RUIA) (45 U.S.C. 355) any person aggrieved by a decision made by an office of the RRB on his or her application for an annuity or benefit under those Acts has the right to appeal to the RRB. This right is prescribed in 20 CFR part 260 and 20 CFR part 320. The notification letter, which is provided at the time of filing the original application, informs the applicant of such right. When an applicant protests a decision, the concerned RRB office reviews the entire file and any additional evidence submitted and sends the applicant a letter explaining the basis of the determination. The applicant is then notified that to protest further, they can appeal to the RRB's Bureau of Hearings and Appeals. The appeal process is prescribed in 20 CFR 260.5 and 260.9 and 20 CFR 320.12 and 320.38.
To file a request for an appeal the applicant must complete Form HA-1,
Under section 3(f)(3) of the Railroad Retirement Act (RRA) (45 U.S.C. 231b), the total monthly benefits payable to a railroad employee and his/her family are guaranteed to be no less than the amount which would be payable if the employee's railroad service had been covered by the Social Security Act. This is referred to as the Social Security Overall Minimum Guarantee, which is prescribed in 20 CFR part 229. To administer this provision, the Railroad Retirement Board (RRB) requires information about a retired employee's spouse and child(ren) who would not be eligible for benefits under the RRA but would be eligible for benefits under the Social Security Act if the employee's
• In Section 1, updated the year in example date format.
• In Section 2, changed first sentence to “Check the information entered by the Railroad Retirement Board (RRB) for accuracy.”
• In Receipt For Your Statement section (page 11), updated the office hours.
The RRB proposes no changes to Form G-320.
Under section 2 of the Railroad Retirement Act (RRA) (45 U.S.C. 231a), a railroad employee's retirement annuity or an annuity paid to the spouse of a railroad employee is subject to work deductions in the Tier II component of the annuity and any employee supplemental annuity for any month in which the annuitant works for a Last Pre-Retirement Non-Railroad Employer (LPE). The LPE is defined as the last person, company, or institution, other than a railroad employer, that employed an employee or spouse annuitant. In addition, the employee, spouse, or divorced spouse Tier I annuity benefit is subject to work deductions under section 2(f)(1) of the RRA for earnings from any non-railroad employer that are over the annual exempt amount. The regulations pertaining to non-payment of annuities by reason of work and LPE are contained in 20 CFR 230.1 and 230.2.
The RRB utilizes Form RL-231-F, Request to Non-Railroad Employer for Information About Annuitant's Work and Earnings, to obtain the information needed to determine if a work deduction should be applied because an annuitant worked in non-railroad employment after the annuity beginning date. One response is requested of each respondent. Completion is voluntary.
Under provisions of the Railroad Retirement Act (RRA), there are two types of benefit payments that are based on the status of a child being in full-time elementary or secondary school attendance at age 18-19: (1) A survivor child's annuity benefit under section 2(d)(1)(iii) (45 U.S.C. 231a) and (2) an increase in the employee retirement annuity under the Special Guaranty computation as prescribed in section 3(f)(2) (45 U.S.C. 231b) and 20 CFR 229.
The survivor student annuity is usually paid by direct deposit to a financial institution either into the student's checking or savings account or into a joint bank account with a parent. The requirements for eligibility as a student are prescribed in 20 CFR 216.74 and include students in independent study and home schooling.
To help determine if a child is entitled to student benefits, the RRB requires evidence of full-time school attendance. This evidence is acquired through the RRB's student monitoring program, which utilizes the following forms. Form G-315, Student Questionnaire, obtains certification of a student's full-time school attendance as well as information on the student's marital status, social security benefits, and employment, which are needed to determine entitlement or continued entitlement to benefits under the RRA. Form G-315A, Statement of School Official, is used to obtain, from a school, verification of a student's full-time attendance when the student fails to return a monitoring Form G-315. Form G-315A.1, School Official's Notice of Cessation of Full-Time School Attendance, is used by a school to notify the RRB that a student has ceased full-time school attendance.
In order to carry out the financial interchange provisions of section 7(c)(2) of the Railroad Retirement Act (RRA) (45 U.S.C. 231f), the RRB obtains annually from railroad employer's the gross earnings for their employees on a one-percent basis,
The gross earnings information is essential in determining the tax amounts involved in the financial interchange with the Social Security Administration and Centers for Medicare & Medicaid Services. Besides being necessary for current financial interchange calculations, the gross earnings file tabulations are also an integral part of the data needed to estimate future tax income and corresponding financial interchange amounts. These estimates are made for internal use and to satisfy requests from other government agencies and interested groups. In addition, cash flow projections of the social security equivalent benefit account, railroad retirement account and cost estimates made for proposed amendments to laws administered by the RRB are dependent on input developed from the information collection.
The RRB utilizes Form BA-11 to obtain gross earnings information from railroad employers. Employers have the option of preparing and submitting BA-11 reports online via the RRB's Employer Reporting System or on paper (or in like format) on magnetic tape cartridges, by File Transfer Protocol (FTP), or secure Email. The online BA-11 includes the option to file a “negative report” (no employees, or no employees with the digits “30”). Completion is mandatory. One response is requested of each respondent.
Section 6 of the Railroad Retirement Act (45 U.S.C. 231e) provides for a lump-sum payment to an employee or the employee's survivors equal to the Tier II taxes paid by the employee on a separation allowance or severance payment for which the employee did not receive credits toward retirement. The lump-sum is not payable until retirement benefits begin to accrue or the employee dies. Also, section 4 (a-1) (iii) (45 U.S.C. 231c) of the Railroad Unemployment Insurance Act provides that a railroad employee who is paid a separation allowance is disqualified for unemployment and sickness benefits for the period of time the employee would have to work to earn the amount of the allowance. The reporting requirements are specified in 20 CFR 209.14.
In order to calculate and provide payments, the Railroad Retirement Board (RRB) must collect and maintain records of separation allowances and severance payments which were subject to Tier II taxation from railroad employers. The RRB uses Form BA-9, Report of Separation Allowance or Severance Pay, to obtain information from railroad employers concerning the separation allowances and severance payments made to railroad employees and/or the survivors of railroad employees. Employers currently have the option of submitting their reports on paper Form BA-9, (or in like format) on a CD-ROM, or by File Transfer Protocol (FTP), or Secure Email. Completion is mandatory. One response is requested of each respondent. The
Under section 2(e)(3) of the Railroad Retirement Act (RRA) (45 U.S.C. 231a), an annuity is not payable for any month in which a beneficiary works for a railroad. In addition, an annuity is reduced for any month in which the beneficiary works for an employer other than a railroad employer and earns more than a prescribed amount. Under the 1988 amendments to the RRA, the Tier II portion of the regular annuity and any supplemental annuity must be reduced by one dollar for each two dollars of Last Pre-Retirement Non-Railroad Employment (LPE) earnings for each month of such service. However, the reduction cannot exceed 50 percent of the Tier II and supplemental annuity amount for the month to which such deductions apply. The LPE generally refers to an annuitant's last employment with a non-railroad person, company, or institution prior to retirement, which was performed at the same time as railroad employment or after the annuitant stopped railroad employment. The collection obtains earnings information needed by the RRB to determine if possible reductions in annuities are in order due to LPE.
The RRB utilizes Form G-19L,
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934,
The principal purpose of the proposed rule change is to revise the Operational Risk Management Framework. These revisions do not require any changes to the ICC Clearing Rules (the “Rules”).
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change, security-based swap submission, or advance notice and discussed any comments it received on the proposed rule change, security-based swap submission, or advance notice. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
ICC proposes to revise its ORMF. The ORMF details ICC's dynamic and independent program of risk assessment and oversight that aims to reduce operational incidents, encourage process, and control improvement, bring transparency to operational performance standard monitoring, and fulfill regulatory obligations. ICC believes such proposed revisions will facilitate the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions for which it is responsible. ICC proposes to make such changes effective following Commission approval of the proposed rule change. The proposed revisions are described in detail as follows.
The primary purpose of the proposed revisions is to incorporate procedures designed to comply with Commission Rule 17Ad-25(i)
ICC further proposes to revise and replace the former `Vendor Assessment' processes in Section II.B. with updated Section II.C. `External Service Provider Assessments' processes. Accordingly, the proposed revisions include renaming “critical vendors” as “external SPCS” and, together with new Section II.B., clarifying that ICC's assessment of external SPCS is in addition to, and will take into consideration, ICE, Inc.'s third party risk management program. ICC proposes to remove the bullet point list of items that may be included in the risk assessments and replace it with language to mirror the regulatory requirement of new Commission Rule 17ad-25(i).
Furthermore, ICC proposes clarifications to the `Introduction' section of the ORMF to provide uniform abbreviations to existing defined terms. By incorporating these abbreviations, ICC aims to enhance the clarity and readability of the ORMF.
Also, ICC proposes revising the `Operational Risk Lifecycle' chart in Section I. of the ORMF to replace “Respond” with “Monitor,” and to replace “Monitor” with “Mitigate.” The purpose of the revisions to the Operational Risk Lifecycle chart is to ensure that it accurately reflects the description of the operational life cycle narrative contained in Section I. Furthermore, ICC proposes to correct typographical errors in Sections I.A. and I.B., to, in each case, delete an erroneous “The.”
ICC also proposes revisions to Section II., `Operational Risk Focus Areas', to update ICC's reference to certain functions performed by ICE, Inc. ICC proposes to remove the reference to functions being “outsourced” to ICE, Inc. and instead notes that the functions performed by ICE, Inc. are described in the ORMF (
In addition, ICC proposes to amend Section II.A., `Business Continuity Planning and Disaster Recovery,' to better describe the steps in the collaboration process with respect to the business impact analysis (“BIA”) process. Specifically, ICC is proposing to reorder and restate the steps for completing BIA surveys used in creating test plans. Specifically, ICC is clarifying that each critical business unit begins by performing the BIA; then business continuity plans (“BCPs”) are created for those processes identified in the BIA; finally, the BCPs are tested, and the results of such testing are reported. This refresh of the language in Section II.A. better describes the order of ICC's process with respect to recovery from a wide-scale disruption.
ICC proposes revisions to Section II.F. (previously Section II.E.) `Technology Control Functions.' Specifically, ICC proposes changes to the description of the responsibilities of the ICC Technology Department to more accurately reflect the responsibilities of the ICC Technology Department control functions. Such proposed changes clarify that the ICC Technology Department is responsible for end to end design, development, testing, deployment, maintenance and day to day operations of enterprise software systems needed for ICC core functions. In addition, ICC proposes to update the reference to the title of the `ICC Project Delivery Policy' to the document's current title which is the ICC `Credit Technology Delivery Method.' Also, ICC proposes a minor revision to change a reference to the ICC technology director to rather reference the ICC Technology leadership team to more accurately reflect that technology releases are assessed by the entire ICC Technology leadership team and not just the ICC technology director.
Furthermore, ICC proposes to amend
Lastly, ICC proposes to revise the `Revision History' section of the ORMF to reflect the proposed changes described above.
In addition to the foregoing proposed modifications to the ORMF, ICC also proposes to formalize a series of non-material updates to the ORMF which were reviewed and approved by the Board in 2021, 2022 and 2023. Such proposed changes, which are described below, are the output of the annual review of the ORMF conducted by the ICC Compliance Committee
In 2021 the Board approved non-material changes to the ORMF
In 2022 the Board approved non-material changes to the ORMF
In 2023 the Board approved non-material changes to the ORMF
ICC believes that the proposed changes are consistent with the requirements of Section 17A of the Securities Exchange Act of 1934 (“Act”)
Rule 17Ad-22(e)(17)
Rule 17Ad-25(i) requires that a registered clearing agency must establish, implement, maintain, and enforce written policies and procedures reasonably designed to (1) Require senior management to evaluate and document the risks related to an agreement with a service provider for core services, including under changes to circumstances and potential disruptions, and whether the risks can be managed in a manner consistent with the clearing agency's risk management framework; (2) Require senior management to submit to the board of directors for review and approval any agreement that would establish a relationship with a service provider for core services, along with the required risk evaluation; (3) Require senior management to be responsible for establishing the policies and procedures that govern relationships and manage risks related to such agreements with service providers for core services and require the board of directors to be responsible for reviewing and approving
Furthermore, the proposed changes are consistent with the requirements of Rule 17Ad-22(e)(2)(i) and (v)
ICC does not believe the proposed rule change would have any impact, or impose any burden, on competition. The proposed changes to revise the ORMF will apply uniformly across all market participants. Therefore, ICC does not believe the proposed rule change would impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
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:
• Use the Commission's internet comment form (
• Send an email to
Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
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-ICC-2024-011 and should be submitted on or before December 10, 2024.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) proposes to adopt fees for its new offering of market data reports. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
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.
The Exchange proposes to amend its fee schedule to adopt fees for Cboe Timestamping Service reports, effective November 1, 2024. The Exchange recently adopted a new data product known as the Cboe Timestamping Service.
The Cancels Report provides response time details for orders that rest on the book where the Member attempted to cancel that resting order or any other resting order but was unable to do so as the resting order was executed before the system processed the cancel message. The Cancels Report assists the Member in determining by how much time that order missed being canceled instead of executing.
The Missed Liquidity Report provides time details for executions of orders that rest on the book where the Member attempted to execute against that resting order within an Exchange-determined amount of time (not to exceed 1 millisecond) after receipt of the first attempt to execute against the resting order and within an Exchange-determined amount of time (not to exceed 100 microseconds) before receipt of the first attempt to execute against the resting order.
Both the Missed Liquidity Report and Cancels Report include the following data elements for orders
These reports are in response to requests from Members for additional data concerning the timeliness of their incoming orders, cancel messages and executions against resting orders. The Exchange believes these reports will increase transparency by providing Members with an opportunity to learn more about better opportunities to access liquidity and receive better execution rates and improve order cancel success.
The Exchange notes that the data included in the reports are based only on the data of the market participant that opts to subscribe to the reports (“Recipient Member”) and do not include information related to any Member other than the Recipient Member. Additionally, neither report includes real-time market data. Rather, the reports contain historical data from the prior trading day and are available after the end of the trading day, generally on a T+1 basis.
The Exchange now proposes to assess the following monthly fees for Members that wish to purchase the Cancels Report and/or the Missed Liquidity Report. The Exchange proposes a monthly flat fee of $1,000 for the Cancels Report for a subscribing Member. The Exchange also proposes a progressive monthly fee structure for the Missed Liquidity Report based on the
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.
In adopting Regulation NMS, the Commission granted self-regulatory organizations (“SROs”) and broker dealers increased authority and flexibility to offer new and unique market data to consumers of such data. It was believed that this authority would expand the amount of data available to users and consumers of such data and also spur innovation and competition for the provision of market data. The Exchange believes that the proposed reports are the sort of market data product that the Commission envisioned when it adopted Regulation NMS.
The Commission concluded that Regulation NMS—by deregulating the market in proprietary data—would itself further the Act's goals of facilitating efficiency and competition: “[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data. The Commission also believes that efficiency is promoted when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.”
By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history. The Cboe Timestamping Service (
The reports are designed for Members that are interested in gaining insight into latency in connection with their respective (1) orders that failed to execute against an order resting on the Exchange order book and/or (2) cancel messages that failed to cancel resting orders. The Exchange believes that providing this optional data to interested Members for a fee is consistent with facilitating transactions in securities, removing impediments to and perfecting the mechanism of a free and open market and a national market system, and, in general, protecting investors and the public interest because it provides Members with an opportunity to receive additional information and insight into their trading activity on the Exchange.
The Exchange believes the fee proposals for both the Missed Liquidity Report and Cancels Report are reasonable as the Exchange is offering any Member access to subscribe to one or both report(s) in the Member's sole discretion based on their unique business needs. The reports are optional for Members to subscribe to if they believe it to be helpful and are not required for Members to purchase in order to access the Exchange. Additionally, Members may cancel their usage of this report at any time.
The Exchange believes that the fee structure for the Missing Liquidity Report reflects an equitable allocation and will not be unfairly discriminatory as it is a voluntary product designed to ensure that the amount of the charge is tailored to the specific port usage patterns of the Recipient Member. The range of fee options further ensures that Recipient Members are not charged a fee that is inequitably disproportionate to the use that they make of the product. Additionally, Recipient Members aren't required to pay the set threshold for all Ports it has in a given month, instead, Members are able to select which Ports (if any) they would like to subscribe to the Missing Liquidity Report for a given month in order to study its orders in the market to be better informed market participants. Members are under no obligation to subscribe to the Missing Liquidity Report if it does not desire to do so.
The fee structure for the Missing Liquidity Report closely aligns to the fee structure of the previously offered Missed Opportunity—Latency report as part of its NASDAQ Trader Insights offering.
The Exchange believes its proposed fee for the Cancels Report is reasonable as it's a modest, flat fee of $1,000/month. As the Exchange offers mass cancels through Purge Ports in addition to standard cancels through the Ports, and since cancels may occur through a variety of port types as opposed to just the Ports, the Exchange found a modest, flat fee to be more appropriate for the Cancels Report.
The proposed fees are also reasonable as they are lower than the fees assessed for similar reports offered by other exchanges. For example, the MIAX Emerald Liquidity Taker Event Report is substantially similar to the Missed Liquidity Report and Cancels Report
The proposal would also not permit unfair discrimination as both the Cancels Report and Missed Liquidity Report will be available to all Members, who may opt to subscribe to one, both, or neither, and will help to protect a free and open market by continuing to provide additional non-core data (offered on an optional basis for a fee) to the marketplace and by providing investors with greater choices.
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 Exchange believes the reports will contribute to robust competition among national securities exchanges. The Missed Liquidity Report and Late Cancels Report further enhances competition between exchanges by allowing the Exchange to expand its product offerings to include reports similar to reports that are currently offered by other exchanges.
The Exchange also does not believe the proposed fees would cause any unnecessary or inappropriate burden on intermarket competition as other exchanges are free to introduce their own comparable reports with lower prices to better compete with the Exchange's offerings. The Exchange operates in a highly competitive environment, and its ability to price the reports is constrained by competition among exchanges who choose to adopt similar products. The Exchange must consider this in its pricing discipline in order to compete for subscribers of the Exchange's market data via the reports. For example, proposing fees that are excessively higher than fees for potentially similar data products would simply serve to reduce demand for the Exchange's reports, which as discussed, Members are under no obligation to utilize. In this competitive environment, potential purchasers are free to choose which, if any, similar product to purchase to satisfy their need for market information. As a result, the Exchange believes this proposed rule change permits fair competition among national securities exchanges.
The Exchange does not believe the proposed rule change would cause any unnecessary or inappropriate burden on intramarket competition. Particularly, the proposed fees apply uniformly to any purchaser in that the Exchange does not differentiate between the different Members that may purchase the reports. While the Exchange does propose to implement tiered pricing for its Missed Liquidity Report (similar to the pricing used for NASDAQ Trader Insight offering),
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing,
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend The Nasdaq Options Market LLC (“NOM”) Options 9, Section 13, Position Limits, and Section 15, Exercise Limits.
The text of the proposed rule change is available on the Exchange's website at
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.
The Exchange proposes to amend Options 9, Section 13, Position Limits, and Options 9, Section 15, Exercise Limits, to limit the position and exercise limits for options on iShares Bitcoin Trust ETF (“IBIT”) to 25,000 contracts.
Recently, Nasdaq ISE, LLC (“ISE”) received approval to list options on IBIT.
Additionally, the Exchange proposes to amend a grammatical error in Options 3, Section 15(a)(1) to change “exceed” to “exceeded”.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to amend Options 9, Section 13, Position Limits, and Options 9, Section 15, Exercise Limits, to provide that the position and exercise limits for IBIT options shall be 25,000 contracts is consistent with the Act as it will conform NOM's IBIT options position and exercise limits with ISE's IBIT options position and exercise limits in order that IBIT options
Amending “exceed” to “exceeded” in Options 3, Section 15(a)(1) is a non-substantive change.
The proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Amending Options 9, Sections 13 and 15 to provide that the position and exercise limits for IBIT options shall be 25,000 contracts does not impose an undue burden on competition as the position and exercise limits will apply to all trading for IBIT options on the Exchange as well as other exchanges that file a similar proposal.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act normally does not become operative for 30 days after the date of its filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of such 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.
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On November 8, 2023, the Cboe Exchange, Inc. (“Cboe Options”), Cboe C2 Exchange, Inc. (“C2”), Cboe BZX Exchange, Inc. (“BZX”), and Cboe EDGX Exchange, Inc. (“EDGX”) (collectively, “Cboe”)
On April 19, 2024, the Commission instituted proceedings under Rule 608(b)(2)(i) of Regulation NMS,
This order disapproves the Proposed Amendment.
There are eighteen registered national securities exchanges that list and trade standardized listed options (“options”),
Congress directed the Commission to facilitate the establishment of a national market system for securities in accordance with the findings and objectives set forth in Section 11A(a)(1) of the Securities Exchange Act of 1934 (“Act”).
The purpose of OPRA is to collect from each exchange information on the quotes displayed on, and transactions that occur on, each exchange, process and consolidate that information into a single “consolidated tape,” and then distribute the information to subscribers, including the exchanges and market participants, who pay subscription fees to OPRA.
As parties to OPRA, all options exchanges are responsible for “act[ing] jointly with respect to matters to which they share authority . . . in planning, developing, operating, or regulating” OPRA.
As the Commission has previously stated, the transparency provided by the consolidated OPRA data feed is a central feature of the U.S. securities markets that, “in turn, contributes to efficient price discovery, offsets the fragmentation of buying and selling interest on multiple exchanges, and facilitates the best execution of customers' orders by broker-dealers.”
In addition to their responsibility to govern and administer the dissemination of consolidated options data through OPRA, today some exchanges separately sell their own “proprietary market data.”
Exchange proprietary market data might be of interest, for example, to registered options market makers or non-market maker liquidity providers who might want to get exchange data directly and consolidate it themselves rather than wait for the OPRA SIP to consolidate and disseminate the data, which might help liquidity providers better manage their risk and thereby facilitate their ability to provide better-priced displayed quotes to investors.
Options exchanges have not always been able to offer proprietary market data products. When the Commission approved the OPRA Plan in 1981, the Plan as filed by the options exchanges (including Cboe Options as one of the founding members) made OPRA the exclusive means for the dissemination of last sale reports and quotation information for options and did not allow the options exchanges to offer their own proprietary market data separately.
In 2001, the Commission approved an amendment to the OPRA Plan proposed by the Plan participants to allow exchanges to offer proprietary market data to their members under certain conditions,
The provisions in the OPRA Plan that govern the ability of an exchange to offer its own proprietary market data are contained in Section 5.2(c)(ii) and (iii), including the “equivalent access” provision in Section 5.2(c)(iii)(A) (“Equivalent Access Provision”), which states:
(ii) A Member may disseminate information pertaining to quotations and transactions in its market (“Proprietary Information”) through a network separate from the OPRA System only if such dissemination meets the requirements of subparagraph (iii) of this paragraph (c).
(iii) A Member may disseminate its Proprietary Information pursuant to subparagraph (ii) of this paragraph (c) provided that:
(A) such dissemination is limited to other Members and to persons who also have equivalent access to consolidated Options Information disseminated by OPRA for the same classes or series of options that are included in the Proprietary Information. For purposes of this clause (A), “consolidated Options Information” means consolidated Last Sale Reports combined with either consolidated Quotation Information or the BBO furnished by OPRA, and access to consolidated Options Information and access to Proprietary Information are deemed “equivalent” if both kinds of information are equally accessible on the same terminal or work station; and
(B) a Member may not disseminate its Proprietary Information on any more timely basis than the same information is furnished to the OPRA System for inclusion in OPRA's consolidated dissemination of Options Information.
The Cboe exchanges offer a proprietary market data product called the “Cboe One Options Feed.”
Cboe has stated that the Equivalent Access Provision can be satisfied if a subscriber to an exchange's proprietary market data, such as the Cboe One Options Feed, subscribes to a “usage-based” plan from OPRA, which requires users to request information on a quote or trade and pay based on the amount of data consumed, instead of subscribing to the full streaming OPRA feed.
Cboe filed the proposed OPRA Plan amendment without obtaining the unanimous vote of the Plan participants. Cboe sought to amend the Equivalent Access Provision of the OPRA Plan by filing with the Commission the Proposed Amendment, stating that it was filing it pursuant to Rule 608(a)(1) of Regulation NMS.
Under the terms of the OPRA Plan, the plan “may be amended from time to time when authorized by the affirmative vote of all of the [Plan participants], subject to the approval of the [Commission].”
Though the Proposed Amendment did not receive the affirmative vote of all of the members of the OPRA Plan in accordance with Section 10.3 of the OPRA Plan,
Cboe states that under Rule 608(a)(1) of Regulation NMS “there is no requirement to separately satisfy the voting requirements of the OPRA Plan” for plan amendments and the OPRA Plan “nowhere directs that its amendment avenue is the
The OPRA Operating Committee disagrees with Cboe and states that the Commission should disapprove the Proposed Amendment “as improperly filed, violating the explicit terms of the OPRA Plan.”
OPRA further states that “Cboe is attempting to circumvent the requirements of the OPRA Plan through its incorrect interpretation of Rule 608” and states that “[n]ever has an NMS Plan amendment been submitted in the manner Cboe utilized rather than in accordance with the explicit requirements of the relevant NMS Plan.”
A group of affiliated OPRA Plan participants similarly requested that the Commission disapprove the Proposed Amendment.
Cboe's reading of Rule 608(a)(1)—that it alone can move to amend the OPRA Plan without regard to the views of other OPRA members—is nonsensical, contrary to Rule 608 as a whole, and, if accepted by the Commission, would undermine the ability of all national market system plans to govern themselves. Cboe is contending, in effect, that any two SROs disappointed in the outcome in any NMS plan deliberations should be able to file their proposal with the Commission and rehash the same debate in a different forum. This will inject uncertainty in all NMS plan operations, and unnecessarily complicate the plan amendment process.
Cboe cannot use Rule 608(a)(1) to bypass the requirements of the OPRA Plan. The Plan participants have included a clear and specific amendment clause in the OPRA Plan (Article X, Section 10.3) to govern the process of amending the Plan by the Plan participants. This amendment clause provides the specific requirements for amendments of the Plan and is more stringent than the requirements of Rule 608(a)(1). That is, the Plan requires unanimous participant approval for plan amendments, and the Commission approved the OPRA Plan with that unanimous consent amendment requirement.
Rule 608 permits the inclusion in NMS Plans of more stringent requirements for plan amendments that go beyond the “any two or more SROs acting jointly” minimum requirement in Rule 608. Specifically, the Rule states that any NMS Plan or amendment filed with the Commission must be accompanied by certain statements and representations, including “[i]n the case of a proposed amendment, a statement that such amendment has been approved by the sponsors in accordance with the terms of the plan.”
When reviewing amendments to an NMS Plan pursuant to Rule 608(b), the Commission evaluates whether a proposed amendment “is necessary or appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanisms of, a national market system, or otherwise in furtherance of the purposes of the Act.”
The terms of the OPRA Plan are applicable to Cboe as Plan participants, and therefore unanimous agreement was needed for the amendment. Accordingly, the Commission cannot make a finding that the Proposed Amendment is necessary or appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanisms of, a national market system, or otherwise in furtherance of the purposes of the Act.
For the reasons set forth above, the Commission does not find, pursuant to Section 11A of the Act, and Rule 608 thereunder, that the Proposed Amendment is necessary or appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanisms of, a national market system, or otherwise in furtherance of the purposes of the Act.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing a proposal to amend the fee schedule (the “Fee Schedule”) applicable to MIAX Pearl Equities, an equities trading facility of the Exchange.
The text of the proposed rule change is available on the Exchange's website at
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.
The Exchange proposes to amend the Fee Schedule to decrease the rebates for executions of orders in securities priced at or above $1.00 per share that add displayed liquidity (“Added Displayed Volume”) to the Exchange across all Tapes.
Currently, the Exchange offers a standard rebate of ($0.0022)
Pursuant to the NBBO Setter Plus Table in Section 1)c) of the Fee Schedule, the NBBO Program provides six volume tiers enhanced by three market quality levels to provide increasing rebates in this segment. The six volume tiers are achievable by greater volume from the best of four alternative methods. The three market quality levels are achievable by greater NBBO participation in a minimum number of specific securities (described below).
MIAX Pearl Equities first determines the applicable NBBO Program tier based on four different volume calculation methods. The four volume-based methods to determine the Equity Member's tier for purposes of the NBBO Program are calculated in parallel in each month, and each Equity Member receives the highest tier achieved from any of the four methods each month. All four volume calculation methods are based on an Equity Member's respective ADAV,
Under volume calculation Method 1, the Exchange provides tiered rebates based on an Equity Member's ADAV as a percentage of TCV. An Equity Member qualifies for the base rebates in Tier 1 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.00% and less than 0.035% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 2 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.035% and less than 0.05% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 3 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.05% and less than 0.08% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 4 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.08% and less than 0.20% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 5 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.20% and less than 0.40% of TCV. Finally, an Equity Member qualifies for the enhanced rebates in Tier 6 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.40% of TCV.
Under volume calculation Method 2, the Exchange provides tiered rebates based on an Equity Member's NBBO Set Volume as a percentage of TCV. Under volume calculation Method 2, an Equity Member qualifies for the base rebates in Tier 1 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an NBBO Set Volume of at least 0.00% and less than 0.01% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 2 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an NBBO Set Volume of at least 0.01% and less than 0.015% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 3 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an NBBO Set Volume of at least 0.015% and less than 0.02% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 4 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an NBBO
Under volume calculation Method 3, the Exchange provides tiered rebates based on an Equity Member's ADV as a percentage of TCV. An Equity Member qualifies for the base rebates in Tier 1 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADV of at least 0.00% and less than 0.15% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 2 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADV of at least 0.15% and less than 0.18% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 3 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADV of at least 0.18% and less than 0.20% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 4 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADV of at least 0.20% and less than 0.60% of TCV. An Equity Member qualifies for the enhanced rebates in Tier 5 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADV of at least 0.60% and less than 1.00% of TCV. Finally, an Equity Member qualifies for the enhanced rebates in Tier 6 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADV of at least 1.00% of TCV.
Under volume calculation Method 4, the Exchange provides tiered rebates based on an Equity Member's ADAV as a percentage of TCV, excluding executions of orders in securities priced below $1.00 per share across all Tapes from the calculation of both the numerator (ADAV) and denominator (TCV). An Equity Member qualifies for the base rebates in Tier 1 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.00% and less than 0.035% of TCV, exclusive of executions of orders in securities priced below $1.00 per share across all Tapes. An Equity Member qualifies for the enhanced rebates in Tier 2 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.035% and less than 0.05% of TCV, exclusive of executions of orders in securities priced below $1.00 per share across all Tapes. An Equity Member qualifies for the enhanced rebates in Tier 3 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.05% and less than 0.08% of TCV, exclusive of executions of orders in securities priced below $1.00 per share across all Tapes. An Equity Member qualifies for the enhanced rebates in Tier 4 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.08% and less than 0.20% of TCV, exclusive of executions of orders in securities priced below $1.00 per share across all Tapes. An Equity Member qualifies for the enhanced rebates in Tier 5 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.20% and less than 0.40% of TCV, exclusive of executions of orders in securities priced below $1.00 per share across all Tapes. Finally, an Equity Member qualifies for the enhanced rebates in Tier 6 for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes by achieving an ADAV of at least 0.40% of TCV, exclusive of executions of orders in securities priced below $1.00 per share across all Tapes.
After the volume calculation is performed to determine highest tier achieved by the Equity Member, the applicable rebate is calculated based on two different measurements based on the Equity Member's participation at the NBBO on the Exchange in certain securities (referenced below).
The Exchange provides one column of base rebates (referred to in the NBBO Program table as “Level A”) and two columns of enhanced rebates (referred to in the NBBO Program table as “Level B” and “Level C”),
The base rebates (“Level A”) are as follows: ($0.00220) per share in Tier 1; ($0.00290) per share in Tier 2; ($0.00300) per share in Tier 3; ($0.00310) per share in Tier 4; ($0.00335) per share in Tier 5; and ($0.00340) per share in Tier 6. Under Level B, the Exchange provides enhanced rebates for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes if the Equity Member's Percent Time at NBBO is at least 25% and less than 50% in at least 200 MQ Securities per trading day during the month. The Level B rebates are as follows: ($0.00225) per share in Tier 1; ($0.00295) per share in Tier 2; ($0.00305) per share in Tier 3; ($0.00315) per share in Tier 4; ($0.00340) per share in Tier 5; and ($0.00345) per share in Tier 6. Under Level C, the Exchange provides enhanced rebates for executions of
The Exchange offers an NBBO Setter Additive Rebate,
The Exchange proposes to reduce the standard rebate for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes. Currently, the Exchange provides a standard rebate of ($0.0022) per share for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes. The Exchange now proposes to reduce the standard rebate for executions of Added Displayed Volume in securities priced at or above $1.00 per share from ($0.0022) to ($0.0021) per share for all Tapes.
Next, the Exchange proposes to amend the NBBO Setter Plus Table in Section 1)c) of the Fee Schedule to decrease the rebates for all tiers by ($0.0001) per share for all rebate levels of the NBBO Program. With the proposed changes, the Level A rebates will be as follows: ($0.00210) per share in Tier 1; ($0.00280) per share in Tier 2; ($0.00290) per share in Tier 3; ($0.00300) per share in Tier 4; ($0.00325) per share in Tier 5; and ($0.00330) per share in Tier 6. The Level B rebates will be as follows: ($0.00215) per share in Tier 1; ($0.00285) per share in Tier 2; ($0.00295) per share in Tier 3; ($0.00305) per share in Tier 4; ($0.00330) per share in Tier 5; and ($0.00335) per share in Tier 6. The Level C rebates will be as follows: ($0.00220) per share in Tier 1; ($0.00290) per share in Tier 2; ($0.00300) per share in Tier 3; ($0.00310) per share in Tier 4; ($0.00335) per share in Tier 5; and ($0.00340) per share in Tier 6.
The Exchange does not propose to amend any of volume calculation methods used to determine the Equity Member's tier for purposes of the NBBO Program, which will continue to be calculated in parallel in each month, and each Equity Member will continue to receive the highest tier achieved from any of the four methods each month.
The purpose of reducing the standard rebate for executions of Added Displayed Volume is for business and competitive reasons in light of recent volume growth on the Exchange. The Exchange notes that despite the modest reduction proposed herein, the proposed standard rebate for executions of Added Displayed Volume (
The purpose of reducing the enhanced rebates for executions of Added Displayed Volume for all tiers and market quality levels of the NBBO Program is for business and competitive reasons in light of recent volume growth on the Exchange. The Exchange notes that, even with the proposed decrease in the NBBO Program rebates, the base rebates and enhanced rebates of the NBBO Program remain competitive with, or higher than, the rebates provided by other exchanges for executions of orders in securities priced at or above $1.00 per share that add displayed liquidity to those exchanges.
The proposed changes are effective beginning November 1, 2024.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Exchange operates in a highly fragmented and competitive market in which market participants can readily direct their order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. More specifically, the Exchange is only one of sixteen registered equities exchanges, and there are a number of alternative trading systems and other off-exchange venues, to which market participants may direct their order flow. Based on publicly available information, no single registered equities exchange had more than approximately 15-16% of the total market share of executed volume of equities trading for the month of September 2024.
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow or discontinue or reduce use of certain categories of products, in response to new or different pricing structures being introduced into the market. Accordingly, competitive forces constrain the Exchange's transaction fees and rebates, and market participants can readily trade on competing venues if they deem pricing levels at those other venues to be more favorable. The Exchange believes the proposal reflects a reasonable and competitive pricing structure designed to incentivize market participants to direct their order flow to the Exchange, which the Exchange believes would enhance liquidity and market quality in both a broad manner and in a targeted manner with respect to the NBBO Program, in particular, and Added Displayed Volume in securities priced at or above $1.00 per share, in general.
The Exchange believes its proposal to reduce the rebates for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume across all Tapes is reasonable because the Exchange's standard rebate and enhanced rebates will remain competitive with, or higher than, the rebates provided by other exchanges for executions of orders in securities priced at or above $1.00 per share that add displayed liquidity to those exchanges.
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 Exchange does not believe that the proposal will impose any burden on intra-market competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange believes that its proposal to reduce the standard and enhanced rebates provided for in the NBBO Program, for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume will not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because these changes are for business and competitive reasons in light of recent volume growth on the Exchange. The Exchange notes that despite the modest reduction proposed herein of ($0.0001) per share for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume, the Exchange's standard and enhanced rebates remain competitive with, or higher than, the standard and enhanced rebates provided by other exchanges for executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume on those exchanges.
The Exchange believes that, even with the proposed decrease to the standard and enhanced Added Displayed Volume rebates, the Exchange's rebate structure for such orders will continue to incentivize market participants to direct order flow to the Exchange, thereby contributing to a deeper and more liquid market to the benefit of all market participants and enhancing the attractiveness of the Exchange as a trading venue. The Exchange believes that this, in turn, will continue to encourage market participants to direct additional orders in securities priced at or above $1.00 per share to the Exchange. Greater liquidity benefits all Equity Members by providing more trading opportunities and encourages Equity Members to send orders to the Exchange, thereby contributing to robust levels of liquidity, which benefits all market participants.
The Exchange believes the proposed changes will benefit competition, and the Exchange notes that it operates in a highly competitive market. Equity Members have numerous alternative venues they may participate on and direct their order flow to, including sixteen equities exchanges and numerous alternative trading systems and other off-exchange venues. As noted above, no single registered equities exchange currently had more than 15-16% of the total market share of executed volume of equities trading for
Moreover, the Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow in response to new or different pricing structures being introduced to the market. Accordingly, competitive forces constrain the Exchange's transaction fees and rebates generally, including with respect to executions of orders in securities priced at or above $1.00 per share for Added Displayed Volume, and market participants can readily choose to send their orders to other exchanges and off-exchange venues if they deem fee levels at those other venues to be more favorable.
Additionally, the Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Specifically, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and self-regulatory organization (“SRO”) revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing a proposal to amend the MIAX Pearl Options Fee Schedule (“Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
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.
The Exchange proposes to amend Section 1)a) of the Fee Schedule, Exchange Rebates/Fees—Add/Remove Tiered Rebates/Fees, to: (1) amend the Priority Customer
The Exchange currently assesses transaction rebates and fees to all market participants which are based upon the total monthly volume executed by the Member
First, the Exchange proposes to amend the Priority Customer origin in the Exchange Rebates/Fees—Add/Remove Tier Rebates/Fees table at Section 1)a) of the Fee Schedule to decrease the Maker rebates in tiers 1 and 2 for Priority Customer Orders
The Exchange now proposes to amend the Priority Customer origin in the Exchange Rebates/Fees—Add/Remove Tier Rebates/Fees table at Section 1)a) of the Fee Schedule to decrease the Maker rebates in tiers 1 and 2 from ($0.31) to ($0.25) per contract for Priority Customer Orders in Penny Classes that trade against all origins. The Exchange does not propose to amend any of the volume threshold criteria or the Maker rebates or Taker fees in any other tier for Priority Customer Orders.
The purpose of this proposed change is for business and competitive reasons. The Exchange previously amended the Priority Customer origin in the Exchange Rebates/Fees—Add/Remove Tier Rebates/Fees table at Section 1)a) of the Fee Schedule to increase the Maker rebates in tiers 1 and 2 from ($0.25) to ($0.31) per contract for Priority Customer Orders in Penny Classes that trade against all origins in order to encourage Members to submit more Priority Customer Orders, which the Exchange believed may lead to increased liquidity on the Exchange.
Proposal To Remove the Step-Up Maker Rebate for Market Maker Orders in Non-Penny Classes
Next, the Exchange proposes to amend the Market Maker origin in the Exchange Rebates/Fees—Add/Remove Tier Rebates/Fees table at Section 1)a) of the Fee Schedule to remove the “Step-Up Maker Rebate,” which is provided in footnote “(i)” following the table of transaction rebates and fees for the Market Maker origin in Section 1)a) of the Fee Schedule. Currently, pursuant to the Market Maker origin in the Exchange Rebates/Fees—Add/Remove Tier Rebates/Fees table at Section 1)a) of the Fee Schedule, Market Makers qualify for the following Maker rebates when Market Maker orders in Non-Penny Classes trade against all origins: (i) ($0.30) per contract in tier 1 if the Market Maker executes above 0.00% to at least 0.20% of TCV; (ii) ($0.30) per contract in tier 2 if the Market Maker executes above 0.20% to at least 0.50% of TCV, or satisfies one of the two alternative volume criteria of tier 2;
Footnote “(i)” provides that a Market Maker may qualify for a Step-Up Maker Rebate of ($0.86) per contract for Market Maker orders for Non-Penny Classes, instead of the otherwise applicable standard tiered Maker rebate described above for tiers 1 through 6. In order to receive the Step-Up Maker Rebate, a Market Maker must have an increase in the percentage of their added liquidity in Non-Penny Classes, represented as a percentage of TCV, of at least 0.12% as compared to the Market Maker's July 2024
The purpose of this change is for business and competitive reasons. The Exchange initially established the Step-Up Maker Rebate in order to encourage Market Makers to add more liquidity in Non-Penny Classes, thereby promoting price discovery and contributing to a deeper and more liquid market.
The proposed changes are effective beginning November 1, 2024.
The Exchange believes that its proposal to amend the Fee Schedule is consistent with Section 6(b) of the Act
The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange had more than approximately 14-15% of the multiply-listed equity options market share for the month of September 2024.
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can discontinue or reduce use of certain categories of products and services, terminate an existing membership or determine to not become a new member, and/or shift order flow, in response to transaction fee changes.
The Exchange believes its proposal to amend the Priority Customer origin to decrease the Maker rebates in tiers 1 and 2 from ($0.31) to ($0.25) per contract for Priority Customer orders in Penny Classes that trade against all origins is reasonable, equitable and not unfairly discriminatory. The Exchange previously increased the Maker rebates in tiers 1 and 2 from ($0.25) to ($0.31) per contract for Priority Customer orders in Penny Classes that trade against all origins in order to encourage Members to submit more Priority Customer orders.
The Exchange believes its proposal to remove the Step-Up Maker Rebate is reasonable, equitably allocated and not unfairly discriminatory. The Exchange initially established Step-Up Maker Rebate in order to encourage Market Makers to add more liquidity in Non-Penny Classes, thereby promoting price discovery and contributing to a deeper and more liquid market.
The Exchange does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that any of the proposed changes will impose any burden on intra-market competition.
The Exchange believes its proposal to amend the Priority Customer origin to decrease the Maker rebates in tiers 1 and 2 from ($0.31) to ($0.25) per contract for Priority Customer orders in Penny Classes that trade against all origins will not impose any burden on intra-market competition. The Exchange previously increased the Maker rebates in tiers 1 and 2 from ($0.25) to ($0.31) per contract for Priority Customer orders in Penny Classes that trade against all origins in order to encourage Members to submit more Priority Customer orders.
The Exchange believes its proposal to establish the Step-Up Maker Rebate will not impose any burden on intra-market competition. The Exchange initially established Step-Up Maker Rebate in order to encourage Market Makers to add more liquidity in Non-Penny Classes, thereby promoting price discovery and contributing to a deeper and more liquid market, which benefits all market participants and enhances the attractiveness of the Exchange as a trading venue.
The Exchange does not believe that the proposed changes will impose any burden on inter-market competition and the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange had more than approximately 14-15% of the multiply-listed equity options market share for the month of September 2024.
In such an environment, the Exchange must continually adjust its rebates and tiers to remain competitive with other options exchanges. Because competitors are free to modify their own fees and tiers in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. The Exchange believes that the proposed rule changes reflect this competitive environment because they modify the Exchange's tiers and rebates in a manner that encourages market participants to continue to provide liquidity and to send order flow to the Exchange.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe BYX Exchange, Inc. (the “Exchange” or “BYX”) proposes to adopt fees for its new offering of market data reports. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
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.
The Exchange proposes to amend its fee schedule to adopt fees for Cboe Timestamping Service reports, effective November 1, 2024. The Exchange recently adopted a new data product known as the Cboe Timestamping Service.
The Cancels Report provides response time details for orders that rest on the book where the Member attempted to cancel that resting order or any other resting order but was unable to do so as the resting order was executed before the system processed the cancel message. The Cancels Report assists the Member in determining by how much time that order missed being canceled instead of executing.
The Missed Liquidity Report provides time details for executions of orders that rest on the book where the Member attempted to execute against that resting order within an Exchange-determined amount of time (not to exceed 1 millisecond) after receipt of the first attempt to execute against the resting order and within an Exchange-determined amount of time (not to exceed 100 microseconds) before receipt of the first attempt to execute against the resting order.
Both the Missed Liquidity Report and Cancels Report include the following data elements for orders
These reports are in response to requests from Members for additional data concerning the timeliness of their incoming orders, cancel messages and executions against resting orders. The Exchange believes these reports will increase transparency by providing Members with an opportunity to learn more about better opportunities to access liquidity and receive better execution rates and improve order cancel success.
The Exchange notes that the data included in the reports are based only on the data of the market participant that opts to subscribe to the reports (“Recipient Member”) and do not include information related to any Member other than the Recipient Member. Additionally, neither report includes real-time market data. Rather, the reports contain historical data from the prior trading day and are available after the end of the trading day, generally on a T+1 basis.
The Exchange now proposes to assess the following monthly fees for Members that wish to purchase the Cancels Report and/or the Missed Liquidity Report. The Exchange proposes a monthly flat fee of $1,000 for the Cancels Report for a subscribing Member. The Exchange also proposes a progressive monthly fee structure for the Missed Liquidity Report based on the Member's subscribing logical (FIX or BOE) order entry ports (the “Ports”)
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.
In adopting Regulation NMS, the Commission granted self-regulatory organizations (“SROs”) and broker dealers increased authority and flexibility to offer new and unique market data to consumers of such data. It was believed that this authority would expand the amount of data available to users and consumers of such data and also spur innovation and competition for the provision of market data. The Exchange believes that the proposed reports are the sort of market data product that the Commission envisioned when it adopted Regulation NMS.
The Commission concluded that Regulation NMS—by deregulating the market in proprietary data—would itself further the Act's goals of facilitating efficiency and competition: “[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data. The Commission also believes that efficiency is promoted when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.”
By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history. The Cboe Timestamping Service (
The reports are designed for Members that are interested in gaining insight into latency in connection with their respective (1) orders that failed to execute against an order resting on the Exchange order book and/or (2) cancel messages that failed to cancel resting orders. The Exchange believes that providing this optional data to interested Members for a fee is consistent with facilitating transactions in securities, removing impediments to and perfecting the mechanism of a free
The Exchange believes the fee proposals for both the Missed Liquidity Report and Cancels Report are reasonable as the Exchange is offering any Member access to subscribe to one or both report(s) in the Member's sole discretion based on their unique business needs. The reports are optional for Members to subscribe to if they believe it to be helpful and are not required for Members to purchase in order to access the Exchange. Additionally, Members may cancel their usage of this report at any time.
The Exchange believes that the fee structure for the Missing Liquidity Report reflects an equitable allocation and will not be unfairly discriminatory as it is a voluntary product designed to ensure that the amount of the charge is tailored to the specific port usage patterns of the Recipient Member. The range of fee options further ensures that Recipient Members are not charged a fee that is inequitably disproportionate to the use that they make of the product. Additionally, Recipient Members aren't required to pay the set threshold for all Ports it has in a given month, instead, Members are able to select which Ports (if any) they would like to subscribe to the Missing Liquidity Report for a given month in order to study its orders in the market to be better informed market participants. Members are under no obligation to subscribe to the Missing Liquidity Report if it does not desire to do so.
The fee structure for the Missing Liquidity Report closely aligns to the fee structure of the previously offered Missed Opportunity—Latency report as part of its NASDAQ Trader Insights offering.
The Exchange believes its proposed fee for the Cancels Report is reasonable as it's a modest, flat fee of $1,000/month. As the Exchange offers mass cancels through Purge Ports in addition to standard cancels through the Ports, and since cancels may occur through a variety of port types as opposed to just the Ports, the Exchange found a modest, flat fee to be more appropriate for the Cancels Report.
The proposed fees are also reasonable as they are lower than the fees assessed for similar reports offered by other exchanges. For example, the MIAX Emerald Liquidity Taker Event Report is substantially similar to the Missed Liquidity Report and Cancels Report
The proposal would also not permit unfair discrimination as both the Cancels Report and Missed Liquidity Report will be available to all Members, who may opt to subscribe to one, both, or neither, and will help to protect a free and open market by continuing to provide additional non-core data (offered on an optional basis for a fee) to the marketplace and by providing investors with greater choices.
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 Exchange believes the reports will contribute to robust competition among national securities exchanges. The Missed Liquidity Report and Late Cancels Report further enhances competition between exchanges by allowing the Exchange to expand its product offerings to include reports similar to reports that are currently offered by other exchanges.
The Exchange also does not believe the proposed fees would cause any unnecessary or inappropriate burden on intermarket competition as other exchanges are free to introduce their own comparable reports with lower prices to better compete with the Exchange's offerings. The Exchange operates in a highly competitive environment, and its ability to price the reports is constrained by competition among exchanges who choose to adopt similar products. The Exchange must consider this in its pricing discipline in order to compete for subscribers of the Exchange's market data via the reports. For example, proposing fees that are excessively higher than fees for potentially similar data products would simply serve to reduce demand for the Exchange's reports, which as discussed, Members are under no obligation to
The Exchange does not believe the proposed rule change would cause any unnecessary or inappropriate burden on intramarket competition. Particularly, the proposed fees apply uniformly to any purchaser in that the Exchange does not differentiate between the different Members that may purchase the reports. While the Exchange does propose to implement tiered pricing for its Missed Liquidity Report (similar to the pricing used for NASDAQ Trader Insight offering),
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Options 9, Section 13, Position Limits, and Section 15, Exercise Limits.
The text of the proposed rule change is available on the Exchange's website at
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.
The Exchange proposes to amend Options 9, Section 13, Position Limits, and Options 9, Section 15, Exercise Limits, to limit the position and exercise limits for options on iShares Bitcoin Trust ETF (“IBIT”) to 25,000 contracts.
Recently, Nasdaq ISE, LLC (“ISE”) received approval to list options on IBIT.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to amend Options 9, Section 13, Position Limits, and Options 9, Section 15, Exercise Limits, to provide that the position and exercise limits for IBIT options shall be 25,000 contracts is consistent with the Act as it will conform BX's IBIT options position and exercise limits with ISE's IBIT options position and exercise limits in order that IBIT options have the same position and exercise limits on BX and ISE.
The proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Amending Options 9, Sections 13 and 15 to provide that the position and exercise limits for IBIT options shall be 25,000 contracts does not impose an undue burden on competition as the position and exercise limits will apply to all trading for IBIT options on the Exchange as well as other exchanges that file a similar proposal.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act normally does not become operative for 30 days after the date of its filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of such 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.
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Options 9, Section 13, Position Limits, and Options 8, Section 34, FLEX Trading.
The text of the proposed rule change is available on the Exchange's website at
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.
The Exchange proposes to: (1) amend Options 9, Section 13, Position Limits, to limit the position limits for options on iShares Bitcoin Trust ETF (“IBIT”) to 25,000 contracts;
Recently, Nasdaq ISE, LLC (“ISE”) received approval to list options on IBIT.
Today, all options series listed on Phlx may trade as a FLEX Order on Phlx's trading floor.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to amend Options 9, Section 13, Position Limits, to provide that the position and exercise limits for IBIT options shall be 25,000 contracts is consistent with the Act as it will conform Phlx's IBIT options position and exercise limits with ISE's IBIT options position and exercise limits in order that IBIT options have the same position and exercise limits on Phlx and ISE.
The Exchange's proposal to amend Options 8, Section 34 to note that it will
The proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Amending Options 9, Section 13 to provide that the position and exercise limits for IBIT options shall be 25,000 contracts does not impose an undue burden on competition as the position and exercise limits will apply to all trading for IBIT options on the Exchange as well as other exchanges that file a similar proposal.
The Exchange's proposal to note that it will not authorize for trading a FLEX option on IBIT does not impose an undue burden on competition as no Phlx member will be able to transact a FLEX option on IBIT.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act normally does not become operative for 30 days after the date of its filing. However, Rule 19b-4(f)(6)(iii)
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.
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Selective Service System.
Notice.
The following form has been submitted to the Office of Management and Budget (OMB) for clearance in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35):
Copies of the above-identified form can be obtained upon written request to the Selective Service System, Public & Intergovernmental Affairs Directorate, 1501 Wilson Boulevard, Arlington, Virginia 22209.
Written comments and recommendations for the proposed extension of clearance of the form should be sent within 60 days of the publication of this notice to: Daniel A. Lauretano, Sr., General Counsel/Federal Register Liaison, Selective Service System, 1501 Wilson Boulevard, Arlington, Virginia 22209.
A copy of the comments should be sent to the Office of Information and Regulatory Affairs, Attention: Desk Officer, Selective Service System, Office of Management and Budget, New Executive Office Building, Room 3235, Washington, DC 20503.
U.S. Small Business Administration.
Amendment 9.
This is an amendment of the Presidential declaration of a major disaster for the State of South Carolina (FEMA-4829-DR), dated September 29, 2024.
Issued on November 13, 2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of South Carolina, dated September 29, 2024, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to January 7, 2025.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Georgia (FEMA-4821-DR), dated September 24, 2024.
Issued on November 13, 2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of GEORGIA, dated September 24, 2024, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to January 7, 2025.
All other information in the original declaration remains unchanged.
On June 19, 2019, notice was published in the
Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
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
On June 19, 2019, notice was published in the
Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
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,
The Defense Trade Advisory Group (DTAG) will meet in open session. The purpose of the meeting will be to discuss current defense trade issues and topics for further study.
The Defense Trade Advisory Group (DTAG) will meet in open session from 1 p.m. until 5 p.m. on Wednesday, December 4, 2024. This meeting will be held virtually via Zoom or Webex. The virtual forum will open at 12:45 p.m.
Mrs. Whitney Jackson, PM/DDTC, SA-1, 12th Floor, Directorate of Defense Trade Controls, Bureau of Political-Military Affairs, U.S. Department of State, Washington, DC 20522-0112; Telephone (202) 765-6652 or email
The membership of this advisory committee consists of private sector defense trade representatives, appointed by the Assistant Secretary of State for Political-Military Affairs, who advise the Department on policies, regulations, and technical issues affecting defense trade. The DTAG was established as an advisory committee under the authority of 22 U.S.C. 2651a and 2656 and the Federal Advisory Committee Act, 5 U.S.C. 1001
The Directorate of Defense Trade Controls (DDTC) asked the DTAG to present its full analysis and recommendations on nos. 1 and 2 below and provide its initial analysis on nos. 3 and 4: (1) DDTC requests that DTAG analyze and recommend alternative brokering reporting approaches that address all the reporting requirements under section 129.10(b) of the ITAR, so that DDTC receives more accurate and consistent brokering reports to expedite the review process. (2) DDTC requests that DTAG review the format, construct, and organization of DDTC's current FAQs and provide recommendations to improve their effectiveness, including DDTC's communication of updates and modifications. (3) DDTC requests that DTAG present an initial analysis for a multi-phased review of “Production Diplomacy,” focusing on barriers, inefficiencies, and opportunities in co-production, co-development, and sustainment of Defense Articles within laws, regulations, policies, and interagency processes. (4) DDTC requests that DTAG present an initial analysis for a multi-phased review, starting with an assessment of legal and regulatory frameworks and policies impacting USG review and approval for reexports and retransfers. The analysis should consider challenges faced by both U.S. and non-U.S. industries, as well as other relevant factors.
The meeting will be held in Zoom or WebEx. There will be one virtual invitation for each attendee, and only the attendee should use the invitation. In addition, each attendee should access the virtual meeting from a private location. Please let us know if you need any of the following accommodations: live captions, digital/text versions of webinar materials, or other (please specify).
Members of the public may submit questions by email after the formal DTAG virtual presentation. Members of the public may also submit a brief statement (less than three pages) to the committee in writing for inclusion in the public minutes of the meeting. Each member of the public that wishes to attend this virtual session must provide: Name and contact information, including an email address and phone number, and any request for reasonable accommodation to the DTAG Designated Federal Officer (DFO), Paula Harrison, via email at
This announcement might appear in the
Federal Aviation Administration (FAA), Department of Transportation.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew information collection. The collection enables the FAA to monitor the general aviation fleet to anticipate and meet demand for National Airspace System (NAS) facilities and services, assess the impact of regulatory changes on the fleet, and implement measures to assure the safe operation of all aircraft in the NAS. The data are also used by other government agencies, the general aviation industry, trade associations, and private businesses to identify safety problems and to form the basis for research and analysis of general aviation issues.
Written comments should be submitted by December 19, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Robert DeWolf by email at:
The annual GA Survey questionnaire requests the aircraft owner or operator to provide information on flight activity, flight conditions, where the aircraft was flown, and aircraft characteristics. Survey samples are based on statistically selected aircraft registered with the FAA and located in the U.S. or U.S. territories. The sample is stratified by aircraft type, FAA region in which the aircraft is registered, whether the aircraft operates under a Part 135 certificate, and whether the aircraft was manufactured in the past five years. Select aircraft types and/or sub-populations are sampled at 100%.
Responses are collected from owners and operators of the sampled aircraft through two modes: web-form and mailings of the questionnaire. As a result, aggregated statistical activity estimates are published and provided for analytical use in a myriad of applications and/or industries relating to the flight activity and aviation safety.
Issued in Washington, DC, on November 13th, 2024.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of applications for exemption; request for comments.
FMCSA announces receipt of applications from 16 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.
Comments must be received on or before December 19, 2024.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2024-0017 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
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,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2024-0017), 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.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments go to
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
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.
The 16 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.
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.
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).
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.
Bryan Brignac, 28, holds a class R driver's license in Mississippi.
Anthony Byrd, 39, holds a class C driver's license in California.
Margarita Casas, 50, holds a class C driver's license in Texas.
Dorsey Chany, 52, holds a class C driver's license in Texas.
Ali Elmasri, 34, holds a class C driver's license in Texas.
Aldin Erskine, 34, holds a class C driver's license in Texas.
Austin Hughes, 22, holds a class DV driver's license in Alabama.
Milton Hunt, 57, holds a class C driver's license in California.
Irfan Kabir, 38, holds a class A commercial driver's license in Connecticut.
Raymond Lee, 48, holds a class CM driver's license in Texas.
Leon McClish, 36, holds a class CM driver's license in Texas.
Masiel Rodriguez, 34, holds a class D driver's license in Illinois.
Maino Salas, 42, holds a class C driver's license in California.
Jasmine Smith, 35, holds a class R driver's license in Mississippi.
Justin Soliz, 33, holds a class C driver's license in Texas.
Carter Wyant, 22, holds a regular driver's license in Michigan.
In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests public
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to renew exemptions for 23 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates provided below.
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,
To view comments go to
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
On September 26, 2024, FMCSA published a notice announcing its decision to renew exemptions for 23 individuals from the hearing standard in 49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested comments from the public (89 FR 78971). The public comment period ended on October 28, 2024, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(11).
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.
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).
FMCSA received no comments in this proceeding.
Based upon its evaluation of the 23 renewal exemption applications and comments received, FMCSA announces its decision to exempt the following drivers from the hearing requirement in § 391.41 (b)(11).
As of October 3, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following nine individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers (89 FR 78971):
The drivers were included in docket number FMCSA-2012-0332, FMCSA-2014-0104, FMCSA-2014-0387, FMCSA-2017-0060, FMCSA-2017-0061, FMCSA-2020-0026, FMCSA-2020-0027, or FMCSA-2022-0035. Their exemptions were applicable as of October 3, 2024 and will expire on October 3, 2026.
As of October 13, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following eight individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers (89 FR 78971):
The drivers were included in docket number FMCSA-2016-0002, FMCSA-2017-0058, FMCSA-2017-0059, FMCSA-2017-0061, or FMCSA-2018-0135. Their exemptions were applicable as of October 13, 2024 and will expire on October 13, 2026.
As of October 30, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following six individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2020-0027. Their exemptions were applicable as of October 30, 2024 and will expire on October 30, 2026. In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to renew exemptions for 15 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (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.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
The exemptions were applicable on October 21, 2024. The exemptions expire on October 21, 2026.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
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
On September 26, 2024, FMCSA published a notice announcing its decision to renew exemptions for 15 individuals from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in interstate commerce and requested comments from the public (89 FR 78973). The public comment period ended on October 28, 2024, and one comment was received.
FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).
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.
In addition to the regulations, FMCSA has published advisory criteria
FMCSA received one comment in this proceeding. The commenter stated that while they support the renewal process for seizure exemptions, they believe that the Federal Seizure Exemption Program should include stricter and more frequent medical evaluations to ensure safety. FMCSA requires that exemption holders submit annual reports from their treating physicians attesting to the stability of their treatment and that they have remained seizure-free as well as undergo an annual medical examination by a certified medical examiner, as defined by § 390.5, as conditions of hold the exemption. The commenter's statement regarding improvements for clearer signage and roadway conditions to minimize potentials risks of these drivers is outside the scope of this notice.
Based on its evaluation of the 15 renewal exemption applications and comments received, FMCSA announces its decision to exempt the following drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8).
As of October 21, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following 15 individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers (89 FR 78973):
The drivers were included in docket number FMCSA-2012-0294, FMCSA-2013-0443, FMCSA-2013-0445, FMCSA-2014-0212, FMCSA-2014-0213, FMCSA-2015-0321, FMCSA-2018-0051, FMCSA-2018-0052, FMCSA-2018-0054, FMCSA-2019-0033, FMCSA-2020-0046, or FMCSA-2022-0044. Their exemptions were applicable as of October 21, 2024 and will expire on October 21, 2026.
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt 10 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
The exemptions are applicable on November 13, 2024. The exemptions expire on November 13, 2026.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
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
On October 9, 2024, FMCSA published a notice announcing receipt of applications from 10 individuals requesting an exemption from the hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested comments from the public (89 FR 81979). The public comment period ended on November 8, 2024, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(11).
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.
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).
FMCSA received no comments in this proceeding.
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. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on relevant scientific information and literature, and the 2008 Evidence Report, “Executive Summary on Hearing, Vestibular Function and Commercial Motor Driving Safety.” The evidence report reached two conclusions regarding the matter of hearing loss and CMV driver safety: (1) no studies that examined the relationship between hearing loss and
Consequently, FMCSA finds further that in each case exempting these applicants from the hearing standard in § 391.41(b)(11) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).
The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: each driver (1) must report to FMCSA the date, location, and time of any crashes as defined in § 390.5T, within 7 days of the crash; (2) must report to FMCSA any citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 within 7 days of the citations and convictions; (3) must submit to FMCSA annual certified driving records from their SDLA; and (4) is prohibited from operating a motorcoach or bus with passengers in interstate commerce. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the driver must meet all applicable commercial driver's license testing requirements.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 10 exemption applications, FMCSA exempts the following drivers from the hearing standard; in § 391.41(b)(11), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt 11 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (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.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.
The exemptions were applicable on November 13, 2024. The exemptions expire on November 13, 2024.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
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
On October 9, 2024, FMCSA published a notice announcing receipt of applications from 11 individuals requesting an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and requested comments from the public (89 FR 81983). The public comment period
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).
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.
In addition to the regulations, FMCSA has published advisory criteria
FMCSA received no comments in this proceeding.
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 allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on the 2007 recommendations of the Agency's Medical Expert Panel. The Agency conducted an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a seizure history and each certified driving record from their State Driver's Licensing Agency (SDLA). The information obtained from each applicant's driving record provides the Agency with details regarding any moving violations or reported crash data, which demonstrates whether the driver has a safe driving history and is an indicator of future driving performance. If the driving record revealed a crash, FMCSA requested and reviewed the related police reports and other relevant documents, such as the citation and conviction information. A summary of each applicant's seizure history was discussed in the October 9, 2024,
These 11 applicants have been seizure-free over a range of 33 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last 2 years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially.
The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.
Consequently, FMCSA finds further that in each case exempting these applicants from the epilepsy and seizure disorder prohibition in § 391.41(b)(8) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).
The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: each driver must (1) remain seizure-free, maintain a stable treatment, and report to FMCSA within 24 hours if they experience a seizure during the 2-year exemption period; (2) submit to FMCSA annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) undergo an annual medical examination by a certified medical examiner, as defined by § 390.5T; (4) provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of their driver's qualification file if they are self-employed; (5) report to FMCSA the date, location, and time of any crashes as defined in § 390.5T within 7 days of the crash; (6) report to FMCSA any citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 within 7 days of the citations and convictions; and (7) submit to FMCSA annual certified driving records from their SDLA. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the driver must meet all applicable commercial driver's license testing requirements.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 11 exemption applications, FMCSA exempts the following drivers from the epilepsy and seizure disorder prohibition in § 391.41(b)(8), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice; request for comment.
The Federal Railroad Administration (FRA) is seeking comments on whether to grant a waiver of its Buy America requirements to the Alabama State Port Authority (ASPA) for two rubber-tired gantry cranes, which are not produced in the United States, for use in the Rail Expansion, Rehabilitation, and Modernization Project—Montgomery Intermodal Container Transfer Facility (Project). The Project received funds under the Fiscal Year 2022 Consolidated Rail Infrastructure and Safety Improvements (CRISI) program; therefore, FRA's Buy America requirements apply to the Project. The proposed waiver would apply to two rubber-tired gantry cranes based on the domestic nonavailability of the cranes. The proposed waiver would not apply to any construction materials, and therefore, FRA is not waiving any applicable requirements under the Build America, Buy America Act (BABA).
Comments must be received by December 4, 2024.
Please submit all comments electronically to the Federal eRulemaking Portal. Go to
For questions about this notice, please contact Shreyas Bhatnagar, Regional Supervisor, Office of Regional Outreach & Project Delivery—Southcentral Region, Office of Railroad Development, FRA, telephone: (202) 617-0212, email
On March 15, 2022, ASPA received $67,300,000 for the Project as directed by H.R. 2471, div. L, section 417, Joint Explanatory Statement, page 132, under FRA's CRISI program. The Project is a planned intermodal container transfer facility located adjacent to the main CSX rail line between Montgomery and Mobile, Alabama. The Project will consist of an approximately 15,000-foot side-track, two 3,500-foot process tracks, and one 3,500-foot support track located under two rubber-tired gantry cranes, a container storage yard, and associated buildings and features required to support the operation. The Project will provide an alternate shipping option for existing businesses between the Port of Mobile and central Alabama, reduce container storage congestion at the port, and decrease truck traffic on Interstate 65. On June 27, 2023, ASPA requested a waiver of FRA's Buy America requirements for two rubber-tired gantry cranes, which ASPA determined are necessary for the Project. Following its initial request, ASPA further advanced its procurement process. ASPA revised its request on March 6, 2024, which included additional information from ASPA's procurement process.
This notice summarizes FRA's Buy America requirements, ASPA's request for a waiver, and FRA's proposed waiver.
Projects that receive funding under FRA's CRISI Program are subject to FRA's Buy America requirements. FRA's Buy America requirements include both: (i) FRA's statutory requirements for steel, iron, and manufactured goods at 49 U.S.C. 22905(a); and (ii) requirements under BABA and related guidance at 2 CFR 184.6 for construction materials. This means that FRA can fund a project “only if the steel, iron, and manufactured goods used in the project are produced in the United States.” 49 U.S.C. 22905(a). The FRA requirements are more restrictive than what is required under BABA. In addition, FRA-funded projects must also comply with the relevant provisions of BABA, including the requirement that all construction materials used in the project must also be produced in the United States. Pub. L. 117-58, 70914(a); 2 CFR 184.6. FRA is not proposing to waive the applicable BABA requirements for construction materials used in the Project, and therefore this proposed waiver would not apply to any construction materials used in the Project.
FRA strictly enforces compliance with its Buy America requirements to ensure that FRA-funded projects maximize the use of materials produced in the United States. FRA expects recipients to work with suppliers to conduct thorough market research and adequately consider, where appropriate, qualifying alternate items, products, or materials. Compliance with FRA's Buy America requirement supports domestic industry and well-paying jobs.
There are limited circumstances in which FRA can waive its Buy America requirements under section 22905(a) and BABA. FRA will grant a waiver request that is consistent with the statutory criteria for a waiver and where a project sponsor has adequately justified the need for a waiver.
FRA may waive its Buy America requirements if FRA determines that: applying the Buy America requirements would be inconsistent with the public interest; the steel, iron, and goods produced in the United States are not produced in a sufficient and reasonably available amount or are not of a satisfactory quality; rolling stock or power train equipment cannot be bought and delivered in the United States within a reasonable time; or including domestic material will increase the cost of the overall project by more than 25 percent. 49 U.S.C. 22905(a)(2); see also Public Law 117-58, sec. 70914(b) (prescribing similar statutory conditions for waivers); and 2 CFR 184.7 (doing the same).
Specifically, when determining whether the steel, iron and goods produced in the United States are not produced in a sufficient and reasonably available amount or are not of a satisfactory quality pursuant to 49 U.S.C. 22905(a)(2)(B), FRA considers whether the recipient has used appropriate due diligence, such as market research or by soliciting proposals through an open procurement process, to identify domestic products or domestically available alternative products that meet the recipient's specifications. A comparable product that performs a similar function is not necessarily a domestic alternative; the product must also meet the recipient's specific requirements. FRA's statutory requirements do not require recipients to change product specifications in order to utilize domestic products that
If FRA determines a waiver is appropriate, FRA will provide notice and seek comment from the public in accordance with the requirements of both section 22905(a) and BABA, if applicable. In addition, FRA will consult with the National Institute of Standards and Technology's Manufacturing Extension Partnership before granting a waiver, consistent with section 70916 of BABA. Unless otherwise specified, waiver decisions are non-precedential and are only applicable to the entities and products for the specific project identified in the final decision.
ASPA requests a waiver for two (2) rubber-tired gantry cranes, including spreaders. The total value of the non-compliant materials is 7-8 percent of the total project cost.
In its request for a waiver, ASPA described its efforts to identify domestic sources and consider the use of alternative products. ASPA conducted a market research study to determine the availability of rubber-tired gantry cranes from domestic manufacturers and to get ahead of long-lead times in manufacturing. The study found one U.S.-based manufacturer who had made similar products; however, this manufacturer had not made a product that met the technical specifications ASPA developed for the Project. ASPA issued a request for proposals (RFP) in late 2023 based on its technical specifications. ASPA contacted six manufacturers, including the sole U.S.-based manufacturer identified in ASPA's market research. Of the six manufacturers contacted, five acknowledged receipt, and three submitted proposals. However, only non-domestic manufacturers whose products would not be complaint with Buy America requirements submitted proposals; the sole U.S.-based manufacturer declined to submit a proposal, with no reasons given in their email response.
Upon receipt and confirmation of the three responsive bids, ASPA conducted an evaluation of bids using price, performance, compliance with ASPA's technical specifications, references and quality track record of similar equipment delivered and operating in the U.S., schedule, geographic location of parts and service, alternatives offered and substitutions, and warranties. ASPA used a point system to evaluate and rank the proposals. Based on its review, ASPA has selected a preferred manufacturer for the crane, which ASPA indicated will be assembled domestically, but will not be manufactured in the US. FRA was not involved in ASPA's procurement process. FRA's role is limited to reviewing ASPA's request for a waiver, consistent with 49 U.S.C. 22905(a)(2).
Due to the lack of responsive bids from domestic manufacturers and based on its market research, ASPA has concluded that cranes that meet FRA's Buy America requirements are not domestically available. In the absence of a waiver, ASPA asserts that it would not be able to deliver the Project, as planned operations are not possible without two rubber-tired gantry cranes meeting ASPA's technical specifications.
FRA has preliminarily determined that the two rubber-tired gantry cranes, including spreaders, that meet ASPA's technical specifications are not produced in the United States in a sufficient and reasonably available amount or satisfactory quality, consistent with 49 U.S.C. 22905(a)(2)(B). FRA finds ASPA has conducted appropriate due diligence through market research and an open procurement process to identify potential domestic suppliers for the products. ASPA's efforts included a market research study that identified one potential supplier that ultimately did not respond to ASPA's RFP for the Project. Based on its review of the waiver request and ASPA's market research, FRA proposes to waive its Buy America requirements for the products listed in section IV of this notice. FRA is not proposing to waive any requirements under BABA, as the proposed waiver does not apply to construction materials used in the Project.
The proposed waiver would apply only to products listed above for use in the Project, as described in the grant agreement between FRA and ASPA. The proposed waiver would not apply to other FRA recipients or to other grants that might be made to ASPA for other projects. The proposed waiver will expire upon the end of the period of performance and closeout of the grant agreement for the project, estimated to be April 30, 2028.
FRA will consider comments received during the 15-day comment period, consistent with BABA and 2 CFR 184.7, FRA may consider comments received after this period to the extent practicable. Consistent with 49 U.S.C. 22905(a)(4), if FRA determines it is necessary to waive its Buy America requirements, FRA will publish its decision in the
Issued in Washington, DC.
Federal Transit Administration, Department of Transportation.
Notice of public meeting.
The Federal Transit Administration (FTA) announces a public meeting of the Transit Advisory Committee for Safety (TRACS).
The TRACS meeting will be held on December 4, 2024, from 10 a.m. to 4:30 p.m. Eastern Time and December 5, 2024, from 9 a.m. to 2 p.m. eastern time. Requests to attend the meeting in person or virtually must be received no later than November 29, 2024. Requests for disability accommodations must be received no later than November 29, 2024. Requests to verbally address the committee during the meeting must be submitted with a written copy of the remarks to the U.S. Department of Transportation (DOT) no later than November 29, 2024. Requests to submit written materials to be reviewed during the meeting must be received no later than November 29, 2024.
The meeting will be held in person at DOT Headquarters, 1200 New Jersey Avenue SE, Washington, District of Columbia, 20590 and virtually via Zoom for Government. Any committee related requests should be sent by email to
Joseph DeLorenzo, TRACS Designated Federal Officer, Associate Administrator, FTA Office of Transit Safety and Oversight, (202) 366-1783,
This notice is provided in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. ch. 10). TRACS is composed of up to 25 members representing a broad base of perspectives on transit safety necessary to discharge its responsibilities. Please see the TRACS web page for additional information at
The U.S. Secretary of Transportation (Secretary) established TRACS in accordance with FACA to provide information, advice, and recommendations to the Secretary and FTA Administrator on matters relating to the safety of public transportation systems.
TRACS Meeting—Wednesday, December 4, 2024 (Day One, 10 a.m.-4:30 p.m. ET):
TRACS Meeting—Thursday, December 5, 2024 (Day Two, 9 a.m.-2 p.m. ET):
The meeting will be open to the public. Members of the public who wish to participate are asked to register via email by submitting their name and affiliation to the email address listed in the
DOT is committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, such as sign language, interpretation, or other ancillary aids, please contact the email address listed in the
There will be a total of 30 minutes allotted for oral comments from members of the public at the meeting. To accommodate as many speakers as possible, the time for each commenter may be limited. Individuals wishing to reserve speaking time during the meeting must submit a request with the individual's name, address, and organizational affiliation to the email address listed in the
Written and oral comments for consideration by TRACS during the meeting must be submitted no later than the deadline listed in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA or Agency) is finalizing revisions to the regulations for decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)), two of the five persistent, bioaccumulative, and toxic (PBT) chemicals addressed in final rules issued under the Toxic Substances Control Act (TSCA) in January 2021. After receiving additional comments, the Agency has determined that revisions to the decaBDE and PIP (3:1) regulations are necessary to address implementation issues and to further reduce the potential for exposures to decaBDE and PIP (3:1) for humans and the environment to the extent practicable.
This rule is effective on January 21, 2025.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0376, is available online at
You may be affected by this action if you manufacture (including import), process, distribute in commerce, or use decaBDE or decaBDE-containing products or articles. Such uses for decaBDE may include but are not limited to wire and cable insulation for nuclear power generation facilities, plastic shipping pallets, and imported articles such as replacement parts for aerospace and automotive parts. You may also be affected by this action if you manufacture (including import), process, distribute in commerce, or use PIP (3:1) or PIP (3:1)-containing products or articles. Such uses for PIP (3:1) may include flame retardants in plastics, functional fluids in aerospace and industrial machinery, and plastic articles that are components of electronics or electrical articles.
The following list of North American Industry Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document might apply to them. Potentially affected entities may include:
• Adhesive Manufacturing (NAICS Code 325520);
• Air and Gas Compressor Manufacturing (NAICS Code 333912);
• Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS Code 333415);
• Aircraft Engine and Engine Parts Manufacturing (NAICS Code 336412);
• Aircraft Manufacturing (NAICS Code 336411);
• All Other Basic Organic Chemical Manufacturing (NAICS Code 325199);
• All Other Miscellaneous General Purpose Machinery Manufacturing (NAICS Code 333998);
• All Other Plastics Product Manufacturing (NAICS Code 326199);
• All Other Transportation Equipment Manufacturing (NAICS Code 336999);
• Analytical Laboratory Instrument Manufacturing (NAICS Code 334516);
• Appliance Repair and Maintenance (NAICS Code 811412);
• Audio and Video Equipment Manufacturing (NAICS Code 334310);
• Automobile and Light Duty Motor Vehicle Manufacturing (NAICS Code 336110);
• Automobile and Other Motor Vehicle Merchant Wholesalers (NAICS Code 423110);
• Boat Building (NAICS Code 336612);
• Broadwoven Fabric Mills (NAICS Code 313210);
• Computer and Computer Peripheral Equipment and Software Merchant Wholesalers (NAICS Code 432430);
• Computer Storage Device Manufacturing (NAICS Code 334112);
• Construction Machinery Manufacturing (NAICS Code 333120);
• Current-Carrying Wiring Device Manufacturing (NAICS Code 335931);
• Custom Compounding of Purchased Resins (NAICS Code 325991);
• Electronic Computer Manufacturing (NAICS Code 334111);
• Farm and Garden Machinery and Equipment Merchant Wholesalers (NAICS Code 423820);
• Farm Machinery and Equipment Manufacturing (NAICS Code 333111);
• Guided Missile and Space Vehicle Manufacturing (NAICS Code 336414);
• Guided Missile and Space Vehicle Propulsion Unit Parts Manufacturing (NAICS Code 336415);
• Heavy Duty Truck Manufacturing (NAICS Code 336120);
• Household Appliances, Electric Housewares, and Consumer Electronics Merchant Wholesalers (NAICS Code 423620);
• Industrial Machinery and Equipment Merchant Wholesalers (NAICS Code 423830);
• Industrial Supplies Merchant Wholesalers (NAICS Code 423840);
• Industrial Truck, Tractor, Trailer and Stacker Machinery Manufacturing (NAICS Code 333924);
• Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (NAICS 334513);
• Lawn and Garden Tractor and Home Lawn and Garden Equipment Manufacturing (NAICS Code 333112);
• Manufacturing and Reproducing Magnetic and Optical Media (NAICS Code 334610);
• Materials Recovery Facilities (NAICS Code 562920);
• Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers (NAICS Code 423450);
• Mining Machinery and Equipment Manufacturing (NAICS Code 333131);
• Miscellaneous Intermediation (NAICS Code 523910);
• Motor and Generator Manufacturing (NAICS Code 335312);
• Motor Vehicle Body Manufacturing (NAICS Code 336211);
• Motor Vehicle Electrical and Electronic Equipment Manufacturing (NAICS Code 336320);
• Motor Vehicle Gasoline Engine and Engine Parts Manufacturing (NAICS Code 336310);
• Motor Vehicle Supplies and New Parts Merchant Wholesalers (NAICS Code 423120);
• Motorcycle, Bicycle and Parts Manufacturing (NAICS Code 336991);
• New Car Dealers (NAICS Code 441110);
• Nuclear Electric Power Generation (NAICS Code 221113);
• Other Aircraft Part and Auxiliary Equipment Manufacturing (NAICS Code 336413);
• Other Basic Inorganic Chemical Manufacturing (NAICS Code 325180);
• Other Chemical and Allied Products Merchant Wholesalers (NAICS Code 424690);
• Other Commercial and Industrial Machinery and Equipment Rental and Leasing (NAICS Code 532490);
• Other Communications and Energy Wire Manufacturing (NAICS Code 335929);
• Other Communications Equipment Manufacturing (NAICS Code 334290);
• Other Electronic Component Manufacturing (NAICS Code 334419);
• Other Electronic Parts and Equipment Merchant Wholesalers (NAICS Code 432690);
• Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing (NAICS Code 336419);
• Other Motor Vehicle Parts Manufacturing (NAICS Code 336390);
• Paint and Coating Manufacturing (NAICS Code 325510);
• Petroleum Lubricating Oil and Grease Manufacturing (324191);
• Petroleum Refineries (NAICS Code 324110);
• Plastics Material and Resin Manufacturing (NAICS Code 325211);
• Plastics Product Manufacturing (NAICS Code 3261);
• Plumbing, Heating, and Air-Conditioning Contractors (NAICS Code 238220);
• Relay and Industrial Control Manufacturing (NAICS Code 335314);
• Semiconductor and Related Device Manufacturing (NAICS Code 334413);
• Semiconductor Machinery Manufacturing (NAICS Code 333242);
• Surface Active Agency Manufacturing (NAICS Code 325613); and
• Surgical Appliance and Supplies Manufacturing (NAICS Code 339113).
To determine whether your entity is regulated by this action, you should carefully examine the provisions found in 40 CFR part 751. If you have any questions regarding the applicability of this action to a particular entity, consult the technical information contacts listed under
TSCA section 6(h), 15 U.S.C. 2601
In response to this directive, in January 2021, EPA promulgated rules to regulate the following five PBT chemical substances: decaBDE (CASRN 1163-19-5); PIP (3:1) (CASRN 68937-41-7); 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3); hexachlorobutadiene (HCBD) (CASRN 87-68-3); and pentachlorothiophenol (PCTP) (CASRN 133-49-3) (Refs. 4, 5, 6, 7, and 8). With the obligation to promulgate these rules, the Agency also has the authority to amend them (
EPA is finalizing revisions to the decaBDE and PIP (3:1) rules issued under TSCA (see 40 CFR part 751, subpart E). Additionally, in response to comments received on the 2023 proposed rule for decaBDE and PIP (3:1) (Ref. 1), EPA is also amending the general provisions at 40 CFR 751.401 to exclude processing and distribution in commerce of an article that contains the chemical substance, and where the chemical substance has not been newly added, for the purpose of repair or maintenance. EPA is not revising the chemical-specific provisions for the other three PBT chemical substances addressed in 40 CFR part 751, subpart E (2,4,6-TTBP, HCBD, and PCTP).
DecaBDE is a flame retardant that has been widely used in textiles, plastics, adhesives, and polyurethane foam. In this action, EPA is finalizing revisions to the 2021 decaBDE final rule to require the use of personal protective equipment (PPE) during certain activities involving decaBDE. EPA is also finalizing: a prohibition on releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products; an extension of the compliance date for the phase-out of processing and distribution in commerce of decaBDE-containing wire and cable insulation for nuclear power generation facilities; an export notification requirement for decaBDE-containing wire and cable for nuclear power generation facilities; and an allowance for unintentional amounts of decaBDE present in products and articles at concentrations less than 0.1% by weight. These final revisions are discussed further in Unit III.F.
PIP (3:1) is a flame retardant, a plasticizer, and an anti-compressibility and anti-wear additive. It is used in lubricants and hydraulic fluids and in the manufacture of other compounds. For PIP (3:1), EPA is finalizing revisions to the 2021 final rule to require the use of PPE for the domestic manufacturing and processing of PIP (3:1) and certain PIP (3:1)-containing products and articles. EPA is also finalizing: phase-outs on processing and distribution for certain uses; new exclusions from the prohibitions on processing and distribution in commerce of PIP (3:1) for use in wire harnesses and electric circuit boards and for the processing and distribution in commerce of such PIP (3:1)-containing harnesses and circuit boards; an exclusion to allow for distribution in commerce of new and replacement parts containing PIP (3:1); and an allowance for unintentional amounts of PIP (3:1) present in products and articles at concentrations less than 0.1% by weight. EPA is not revising the October 2024 compliance date for articles not otherwise covered by an exclusion from prohibition or by an existing or newly finalized extension to a phase-out compliance deadline.
On September 3, 2021, in accordance with Executive Order 13990, “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis,” (86 FR 7037, January 25, 2021), EPA announced its intention to review the five PBT final rules issued on January 6, 2021 (Refs. 9 and 10). Specifically, EPA announced that it planned to determine whether the rules were consistent with the Administration's policy to limit exposure to dangerous chemicals and to identify additional actions that could be taken to address implementation issues and to reduce further exposures to these PBT chemicals to the extent practicable, as directed by TSCA section 6(h). On March 8, 2021, EPA also requested public comment in the
During the development of the 2021 PBT final rules, EPA conducted extensive outreach to stakeholders, including hosting a public webinar to gather use information on the PBTs, holding two comment periods on the Exposure and Use Assessment, and presenting the notice of proposed rulemaking at a Small Business Roundtable hosted by the Small Business Administration (SBA) Office of Advocacy to elicit public comment. Only after the 2021 PBT final rules were published, a wide variety of stakeholders from various sectors, including, for example, the electronics and electrical manufacturing sector and their customers, raised significant concerns about their ability to meet the March 8, 2021 compliance date for the processing and distribution of PIP (3:1) and PIP (3:1)-containing articles (Ref. 12). These stakeholders contended that they needed significantly more time to identify whether and where PIP (3:1) might be present in articles in their supply chains, find and certify alternative chemicals, and produce or import new articles that do not contain PIP (3:1). EPA met with numerous stakeholders, including trade associations, entities who report PIP (3:1) under the Chemical Data Reporting Rule, and other sectors where PIP (3:1) use was identified. Despite EPA's extensive outreach, most stakeholders that contacted EPA after the rule was finalized had not commented on its proposal or otherwise engaged with the Agency on the PIP (3:1) rulemaking and did not appear to have previously surveyed their supply chains to determine whether PIP (3:1) was being used (Refs. 5, 10, 11, and 13). Absent timely input from these stakeholders, in the 2021 PIP (3:1) final rule EPA determined that PIP (3:1) was not widely present in complex articles outside the aerospace and automotive sectors. These stakeholders requested an extension of the compliance dates in order to clear the existing articles through the supply chain, find and certify an alternative chemical, and produce or import new articles that do not contain PIP (3:1).
In response to stakeholder input, in an immediately effective final rule issued in September 2021, EPA extended the compliance deadline for processing and distribution in commerce of PIP (3:1) for use in articles and PIP (3:1)-containing articles, unless subject to an exclusion from or phase-in of prohibition, to March 8, 2022 (Ref. 10). In October 2021, EPA proposed a new extended compliance deadline for processing and distribution in commerce of PIP (3:1) for use in articles and PIP (3:1)-containing articles, unless subject to an exclusion from or phase-in of prohibition, to October 31, 2024, and finalized that extended compliance deadline in March 2022 (Refs. 13 and 14). EPA similarly amended the compliance deadline for recordkeeping requirements for articles in those rulemakings.
Additionally, EPA responded to the comments received on the March 2021 notification that were relevant to the PIP (3:1) compliance deadline extension and related issues when the Agency extended the compliance deadlines in both the September 2021 PIP (3:1) final rule and in an October 2021 PIP (3:1) proposed rule (Refs. 10 and 13). According to the comments received prior to and in response to the March 2021 notification and request for comments, a wide range of key consumer and commercial goods are affected by the prohibitions in the 2021 PIP (3:1) final rule such as cellular telephones, laptop computers, and other electronic devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production (Ref. 15). These comments are addressed in EPA's September 2021 PIP (3:1) final rule and October 2021 PIP (3:1) proposed rule (Refs. 10 and 13). EPA reasoned that these extensions would avoid significant disruption in the supply chains for certain articles necessary to the electronics and electrical manufacturing sector, while EPA determined whether any further compliance date extensions were necessary for certain industry sectors, including the semiconductor and equipment manufacturing sectors.
EPA also announced in the September 2021 PIP (3:1) final rule, October 2021 PIP (3:1) proposed rule, and the March 2022 PIP (3:1) final rule that the Agency intended to consider any additional information received to further reduce exposures and assess how environmental justice could be promoted through further exposure reduction to better protect human health and the environment (Refs. 10, 13, and 14).
In addition, several comments received raised issues pertaining to decaBDE. Commenters recommended further regulation of decaBDE, including narrowing the replacement part exclusion to time-limited critical uses, addressing potential risks from releases to the environment, restricting the disposal of decaBDE and decaBDE-containing products and articles, and addressing potential risks from occupational exposure (EPA-HQ-OPPT-2023-0376-0303, EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-2021-0202). EPA also received a comment requesting the Agency hold a government-to-government consultation with the Yurok Tribal Council (Ref. 16). In November 2022, EPA held a one-on-one Tribal consultation with the Yurok Tribal Council. During this consultation, the Agency received additional information that informed the Agency of considerations to reduce potential exposures to decaBDE, including labeling and a prohibition on the releases to water. EPA received no comments addressing the need for the extending compliance date for decaBDE-containing wire and cable insulation for nuclear power generation facilities.
EPA's estimated incremental impacts for this rulemaking are presented in an Economic Analysis document (Ref. 17), which is available in the docket, described in more detail in Unit IV., and is briefly summarized here. The EPA conducted this analysis for the purpose of providing the public with as full as possible an understanding of the potential impacts of this final action. The EPA believes this can inform the public's understanding, place EPA's
As discussed in the 2021 PBT final rules and Unit II.C., and consistent with TSCA section 6(h)(2), EPA did not perform a risk evaluation for decaBDE or PIP (3:1), nor did EPA develop quantitative risk estimates. TSCA section 6(h)(2) makes clear that Congress did not intend for EPA to conduct a risk evaluation to support TSCA section 6(a) rules issued to satisfy TSCA section 6(h) requirements, but rather intended for EPA to conduct an expedited rulemaking process to “reduce exposures to the extent practicable” pursuant to TSCA section 6(h)(4). EPA also does not interpret TSCA section 6(c)(2) to require a quantification of benefits. Under TSCA section 6(c)(2)(A)(iv), EPA must consider and publish a statement on the reasonably ascertainable economic consequences of the rule, but that provision does not require quantification, particularly if quantification is not possible. While EPA was not able to quantify the benefits of reducing human and environmental exposures to decaBDE or PIP (3:1), the Economic Analysis qualitatively discusses the benefits of reducing exposure under this final rule, as summarized in Unit IV. (Ref. 17).
Total quantified annualized social costs for this final rule are approximately $400 million at a 3 percent discount rate, and $430 million at a 7 percent discount rate. Costs at a 2 percent discount rate are estimated at $390 million (shown in appendix A of the accompanying Economic Analysis for this final rule). Of the final rule costs, those associated with decaBDE alone were estimated at $86 at a 3 percent discount rate and $128 at a 7 percent discount rate. Costs associated with PIP (3:1) alone were estimated at $400 million and $430 million (at 3 and 7 percent discount rates, respectively). PPE requirements were estimated at $373 million and $410 million (at 3 and 7 percent discount rates, respectively) comprising the majority of the total costs. Comparatively, costs for the 2021 PIP (3:1) final rule were estimated at approximately $23.6 million at a 3 percent discount rate and $22.8 million at 7 percent. Costs for this final rule are associated with new requirements and therefore were not included in estimates for the 2021 PIP (3:1) final rule.
This final rule is estimated to impact approximately 24,865 small businesses, all of which pertain to PIP (3:1) and none for decaBDE. Of these, 860 small businesses are expected to incur cost impacts between 1 percent and 3 percent of their annual revenue. No entities are expected to be impacted above 3 percent of their annual revenue.
Since a risk evaluation was not conducted, EPA's understanding of the extent to which reductions in exposure might reduce risks for communities with environmental justice (EJ) concerns is limited. In the Economic Analysis accompanying this rule (Ref. 17), EPA relied on available relevant data sources for PIP (3:1) and decaBDE, including EPA's Chemical Data Reporting (CDR), the U.S. Census Bureau, American Community Survey (2022), and others to assess the economic implications of this final rule. Data, however, are not sufficiently comprehensive to estimate the extent to which the final rule will reduce existing disproportionate impacts on communities with EJ concerns. In addition, only a small subset of the specific facilities (14 facilities reported to 2020 CDR) using decaBDE and PIP (3:1) have been identified, so a proximity analysis examining the characteristics of the communities surrounding the known facilities would not be representative of all exposed communities.
Given the lack of available data, EPA has determined that it is not practicable to assess whether this action is likely to result in new disproportionate impacts or exacerbate any existing disproportionate impacts on communities with EJ concerns. The restrictions placed on decaBDE and PIP (3:1) through this final rule will reduce the potential exposures and risks associated with the manufacture, processing, and use of these chemicals. At a minimum EPA considers that this final rule will not exacerbate any baseline EJ concerns and will increase the level of protection for all affected populations without having any disproportionate and adverse human health or environmental effects on any population, including children. Certain exclusions from prohibition and extensions of compliance dates beyond those adopted in the 2021 PBT final rules, however, may partially delay anticipated reductions in exposure.
Under the 2021
This final rule will not have any significant or unique effects on small governments, or federalism, or Tribal implications.
The decaBDE 2021 final rule prohibited the manufacture (including import) and processing of decaBDE, and products and articles to which decaBDE has been added effective 60 days after publication of the final rule, and distribution in commerce of products and articles to which decaBDE has been added one year after the effective date of the rule. Different compliance dates or exclusions from the date of publication of this prohibition included:
• 18 months for any manufacture, processing and distribution in commerce of decaBDE for use in curtains in the hospitality industry, and the curtains to which decaBDE has been added.
• Two years for any processing and distribution in commerce of decaBDE for use in wire and cable insulation in nuclear power generation facilities, and the decaBDE-containing wire and cable insulation.
• Three years for any manufacture, processing and distribution in commerce of decaBDE for use in parts installed in and distributed as part of new aerospace vehicles, and the parts to which decaBDE has been added for such vehicles. After the end of their service lives for import, processing, and distribution in commerce of aerospace vehicles manufactured before January 7, 2024, that contain decaBDE in any part. After the end of their service lives for manufacture, processing, and distribution in commerce of decaBDE for use in replacement parts for aerospace vehicles, and the replacement parts to which decaBDE has been added for such vehicles.
• After the end of their service lives, or 2036, whichever is earlier, for
• After the end of their service lives for distribution in commerce of plastic shipping pallets manufactured prior to March 8, 2021 that contain decaBDE.
• Exclusion for processing and distribution in commerce for recycling of decaBDE-containing plastic products and articles (
Persons manufacturing, processing, and distributing in commerce decaBDE or decaBDE-containing products and articles were required to maintain, for three years from the date the record is generated, ordinary business records related to compliance with this rule that include the name of the purchaser, and list the products or articles. Excluded from the recordkeeping requirement were persons processing and distributing in commerce for; recycling of plastic that contains decaBDE, those products and articles containing decaBDE from recycled plastic as long as no new decaBDE was added during the recycling process, and plastic shipping pallets manufactured prior to the effective date of the rule. These records must include a statement that the decaBDE, or the decaBDE-containing products and articles, are in compliance with 40 CFR 751.405(a) and be made available to EPA within 30 calendar days upon request.
The 2021 PIP (3:1) final rule prohibited the processing and distribution in commerce of PIP (3:1) and products containing PIP (3:1) except for the following:
• Processing and distribution in commerce for use in hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S. Department of Defense specification requirements;
• Processing and distribution in commerce for use in lubricants and greases;
• Processing and distribution in commerce for use in new and replacement parts for the automotive and aerospace industry, and the distribution in commerce of those parts to which PIP (3:1) has been added;
• Processing and distribution in commerce for use as an intermediate in a closed system to produce cyanoacrylate adhesives;
• Processing and distribution in commerce for use as an adhesive and sealant until January 6, 2025, after which such activity is prohibited;
• Processing and distribution in commerce for use in specialized engine filters for locomotive and marine applications;
• Processing for recycling and distribution in commerce for the recycling of PIP (3:1)-containing plastic provided no new PIP (3:1) is added during the recycling process;
• Processing and distribution in commerce of articles and products made from recycled PIP (3:1)-containing plastic provided no new PIP (3:1) is added during the recycling process or to the articles and products made from the recycled plastic; and
• Processing and distribution in commerce of PIP (3:1) for use in photographic printing articles and PIP (3:1)-containing photographic printing articles until January 1, 2022.
This final rule also prohibited releases to water for from manufacture, processing, distribution in commerce, and commercial uses that are permitted to occur, as outlined in the preceding bullets:
• Persons manufacturing, processing, and distributing in commerce PIP (3:1) and products containing PIP (3:1) are required to notify their customers of these prohibitions on processing and distribution, and the prohibition on releases to water via Safety Data Sheet (SDS) or labeling.
• Persons manufacturing, processing, and distributing in commerce PIP (3:1) are required to maintain, for three years from the date the record was generated, ordinary business records related to compliance with the restrictions, prohibitions, and other requirements set forth in this rule. These records must include a statement that the PIP (3:1), or the PIP (3:1)-containing products or articles, are in compliance with 40 CFR 751.407(a) and be made available to EPA within 30 calendar days upon request.
Based on the PIP (3:1)-specific comments received in response to the March 2021 notification and request for comments, EPA issued an immediately effective final rule in September 2021, which extended the compliance dates applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles, until March 8, 2022, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles (Ref. 10). While most commenters on the March 2021 notification and request for comments requested a longer-term compliance date extension (Ref. 15), EPA determined that a short-term extension was necessary to ensure that the supply chains for these important articles continue uninterrupted in the near term while allowing EPA to conduct notice and comment rulemaking on a longer-term compliance date extension generally.
On March 8, 2022, EPA further extended the compliance deadline established in the September 2021 final rule for the processing and distribution in commerce of PIP (3:1) for use in certain articles and for the processing and distribution in commerce of certain PIP (3:1)-containing articles, from March 8, 2022, to October 31, 2024 (Ref. 14). The compliance date for the recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles was also extended from March 8, 2022, to October 31, 2024. Articles covered by the phased-in prohibition include any article not otherwise covered by an alternative compliance deadline or exclusion described in 40 CFR 751.407(a)(2)(ii) or (b). EPA reasoned that this further extension would avoid significant disruption in the supply chains for certain articles and would provide the public with regulatory certainty, while EPA determined whether any further compliance date extensions were necessary.
On November 24, 2023, EPA proposed updates to the 2021 final decaBDE and PIP (3:1) rules (Ref. 1). For decaBDE, EPA proposed the following: requiring a label on plastic shipping pallets known to contain decaBDE; requiring PPE use for certain activities involving decaBDE; prohibiting the release of decaBDE to water during manufacturing, processing, and distribution in commerce; extending the compliance deadline for processing and distribution of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities; requiring export notification for decaBDE-containing wire and cable for nuclear power generation facilities, and extending the recordkeeping requirements from three to five years
For PIP (3:1), EPA proposed the following: requiring PPE for domestic manufacturing and processing of PIP (3:1) and certain PIP (3:1)-containing products and articles; requiring engineering controls for processing of PIP (3:1) and PIP (3:1)-containing products as an intermediate in a closed system to produce cyanoacrylate adhesives; requiring new compliance deadlines for certain exclusions, modifying existing deadlines, and/or narrowing existing exclusions for processing and distribution of PIP (3:1) for certain excluded uses industries; adding new exclusions for processing and distribution of PIP (3:1) for use in wire harnesses, electric circuit boards, and sealants and adhesives used on circuit boards; providing a new, 5-year compliance deadline for use in Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-approved marine antifouling coating products; and extending the recordkeeping requirements from three to five years and removing the 30-day timeframe to make records available.
The proposed rule provided a 45-day public comment period that closed on January 8, 2024 (Ref. 1). EPA received a total of 33 public comments in response to the proposed rule. Since two of the comments were duplicates, EPA posted a total of 31 public comment submissions to
EPA did not propose to revise and is not revising the other three PBT final rules issued under TSCA section 6(h) for 2,4,6-TTBP, HCBD, or PCTP.
As previously detailed in the 2021 decaBDE and PIP (3:1) final rules, for chemical substances meeting the requirements of TSCA section 6(h)(1)(A) and (B), TSCA section 6(h)(4) required EPA to issue a final TSCA section 6(a) rule to “address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and reduce exposure to the substance to the extent practicable.” EPA made the requisite TSCA section 6(h)(1)(A) and (B) findings for decaBDE and PIP (3:1), triggering the requirement for a TSCA section 6(a) rulemaking under TSCA section 6(h)(4) standard. This final rulemaking does not amend these findings.
In the 2021 PBT final rules, EPA explained that it reads the TSCA section 6(h)(4) standard to apply to the chemical substance generally, thus requiring EPA to “address risks” and “reduce exposures” to the chemical substance without focusing on how or whether the measure taken is specific to an activity that might be characterized as a “condition of use” as that term is defined in TSCA section 3(4). Thus, the 2021 PBT final rules address past, present, and future activity involving the chemical substance. In the 2021 PBT final rules, EPA also explained that because there was no existing risk evaluation or assessment for each chemical substance and one was not contemplated by TSCA section 6(h), EPA's implementation of the standard in TSCA section 6(h)(4) focused on applying the TSCA sections 6(a) and (c) requirements in a manner that reduces exposure to the chemical substance to the extent practicable. This final rulemaking does not amend these interpretations or EPA's approach for implementing TSCA section 6(h)(4).
EPA intends that each provision of this rulemaking be severable. In the event of litigation staying, remanding, or invalidating all or a portion of a particular risk management approach, EPA intends to preserve all other portions of the particular risk management approach and all other risk management approaches in the rule to the fullest extent possible. The Agency considered the risk management options in TSCA section 6(a) and generally each of EPA's particular risk management approaches to reduce exposure to decaBDE and PIP (3:1) to the extent practicable functions independently from EPA's other risk management approaches, which may have different characteristics leading to EPA's risk management decisions. Further, the Agency crafted this rule so that different risk management approaches are reflected in different provisions or elements of the rule that are capable of operating independently. Accordingly, the Agency has organized the rule so that if any provision or element of this rule is determined by judicial review or operation of law to be invalid, that partial invalidation will not render the remainder of this rule invalid.
There are many permutations of this; accordingly, rather than walking through each one, EPA is providing representative examples for illustrative purposes. First, to the extent a court were to find that EPA lacked substantial evidence to support the phase-out of the processing of one type of decaBDE-containing product, or otherwise found flaw with such phase-out, it would have no bearing on other risk management approaches in the rule, including other phase-outs, unless the specific flaw also applies to these other risk management approaches. Second, to the extent that a court were to find that the required interim workplace protections for the processing of certain PIP (3:1)-containing products until a ban on processing goes into effect lacked substantial evidence, or otherwise found fault with such protections, it would have no bearing on EPA's decision to ban the processing of such PIP (3:1)-containing products. The independence of these risk management approaches is reflected in the structure of the rule, which does not intertwine the risk management approaches, but rather separately defines each such approach.
EPA has previously discussed its general interpretation of the term “practicable” in the five 2021 PBT final rules (Refs. 4, 5, 6, 7, and 8), and is not changing the interpretation. Nevertheless, EPA has provided a more fulsome discussion of why its interpretation is consistent with the statute. First, EPA's approach is consistent with the dictionary definitions of the phrase “to the extent practicable” and the term “practicable,” taking into account their plain meaning and the context of this provision in section 6 of TSCA.
The phrase “reduce exposure . . . to the extent practicable” and the term “practicable” within that phrase are not defined in TSCA section 6(h). Nor is the phrase or term defined in any context in which it is used elsewhere in TSCA or the legislative history. Dictionary definitions of “practicable” include technical feasibility as well as characteristics relating to
In sum, the best reading of the TSCA section 6(h)(4) statutory terms and context compels consideration of all reasonably available information on TSCA sections 6(c)(2) and (d) issues, including cost. As a result, while cost does factor into whether a regulatory option is practicable or the time frame for triggering a regulatory option is practicable, EPA also considers, for example, whether alternatives are generally available and what reasonable transition time is needed for identifying and adopting alternatives, the import of the products and articles containing decaBDE or PIP (3:1), and other regulations or voluntary standards that address articles under consideration, based on all available information before the Agency at the time of the decision. In the absence of clear direction from Congress, EPA may take these concerns into consideration in determining what further exposure reductions are practicable.
For purposes of determining whether worker protection measures are practicable under TSCA section 6(h)(4), EPA does not believe it is appropriate to assume as a general matter that an applicable Occupational, Safety and Health Administration (OSHA) requirement or industry practice is consistently or always properly applied. This should not be viewed as an indication that the Agency believes there are no occupational safety protections in place at any location, or that there is widespread noncompliance with applicable OSHA standards. Rather, it reflects the Agency's recognition that its interpretation of the TSCA section 6(h)(4) standard “to reduce exposure . . . to the extent practicable” calls for worker protection measures to reduce the potential for exposure to PBTs generally, considering what is achievable, feasible, workable, and reasonable, in light of the circumstances. This is the case even in the absence of a risk evaluation or risk assessment and even if existing OSHA requirements might apply, such as those under the General Duty Clause of the Occupational Safety and Health Act (29 U.S.C. 654(a)) or OSHA's Respiratory Protection standard (29 CFR 1910.134).
TSCA section 9(d) requires EPA to consult and coordinate TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum applicability of TSCA while avoiding the imposition of duplicative requirements. Pursuant to 29 U.S.C. 651
EPA also considered the hierarchy of controls adopted by OSHA and the National Institute for Occupational Safety and Health (NIOSH) (
EPA received several comments on the Agency's worker protection requirements. One commenter (EPA-HQ-OPPT-2023-0376-0312) argued that EPA must require owner/operators to follow the hierarchy of controls in protecting their workforce. Another commenter (EPA-HQ-OPPT-2023-0376-0297) argued that EPA should not prescribe controls that may not be appropriate for the particular circumstances of an individual workplace. Another commenter (EPA-HQ-OPPT-2023-0376-0313) stated that in proposing measures to address occupational exposures that rely almost exclusively on the use of PPE, EPA's proposal is incompatible with the “hierarchy of controls” for reducing occupational exposures to toxic chemicals. The commenter contended that requiring owners and operators to install engineering and administrative controls to the extent they are practicable would correct this flaw in the proposed amendments. Multiple commenters requested that EPA allow industry to use the hierarchy of controls to determine which controls may be appropriate and most protective for that workplace, rather than prescribing the required PPE for each use (EPA-HQ-OPPT-2023-0376-0312, EPA-HQ-OPPT-2023-0376-0292, EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0302). A commenter also expressed interest in the development of workplace chemical protection programs using existing chemical exposure limits (ECELs) for PBTs, similar to those proposed for other risk management rules under TSCA section 6(a) (EPA-HQ-OPPT-2023-0376-0312). While EPA recognizes the concerns raised by commenters, EPA does not believe it can develop an ECEL for these two chemicals without a risk evaluation, which was neither required nor feasible given the statutory timeline for promulgation of rules under TSCA section 6(h).
While a workplace chemical protection program that sets an ECEL and uses the hierarchy of controls would provide latitude for companies to determine which elements within the hierarchy of controls to implement, developing an ECEL without a risk evaluation is not practicable for these chemicals. EPA has decided not to finalize a requirement to consider the hierarchy of controls in the absence of an ECEL. The workplace requirements for decaBDE and PIP (3:1) were developed based on stakeholder
Although many of the uses where workplace requirements are being finalized include requirements to supply PPE, the last method of control in the hierarchy of controls, EPA disagrees with commenters that the hierarchy of controls was not considered as a part of this rulemaking (EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-2023-0376-0312). For example, the requirement to supply PPE is limited to the regulated area, which must be established where “airborne concentrations or direct dermal contact of a specific chemical substance can reasonably be expected.” 40 CFR 751.403. The establishment of the regulated area provides flexibility to owners/operators to first utilize one or a combination of elimination, substitution, engineering controls or administrative controls to reduce or eliminate the necessity to demarcate a regulated area by eliminating any areas where exposure can “reasonably be expected.” If exposure to the chemical is no longer reasonably expected due to these controls, the owner/operator would not be required to establish a regulated area and the requirement to supply PPE to potentially exposed persons under 40 CFR 751.405(e) and 751.407(f) for decaBDE and PIP (3:1), respectively, would not apply. EPA also requires the owner/operator to keep records of the basis for the regulated area, including monitoring data and documentation of any controls or combination of controls that have reduced exposure to where airborne concentrations of decaBDE or PIP (3:1) can no longer reasonably be expected resulting in a smaller or no regulated area being established.
Unless explicitly stated, the following overview is meant to be a summary of information previously provided by EPA in the 2021 decaBDE and PIP (3:1) final rules regarding TSCA sections 6(c) and 26 considerations. It is not intended to serve as new findings under or interpretations of TSCA section 6(h)(4).
TSCA section 6(c)(2) requires EPA to consider and publish a statement based on reasonably available information with respect to the:
• Health effects of the chemical substance(s) or mixture(s) and the magnitude of human exposure;
• Environmental effects of the chemical substance(s) or mixture(s) and the magnitude of exposure to the environment;
• Benefits of the chemical substance(s) or mixture(s) for various uses; and
• Reasonably ascertainable economic consequences of the rule, including: the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; the costs and benefits of the proposed and final rule and of the one or more primary alternative regulatory actions that EPA considered; and cost effectiveness of the final rule and of the one or more primary alternative regulatory actions that the Agency considered.
In selecting among prohibitions and other restrictions available under TSCA section 6(a), EPA must factor in, to the extent practicable, these considerations. Further, in deciding whether to prohibit or restrict the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, EPA must consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute when the final prohibition or other restriction takes effect.
EPA's summary of the health and environmental effects of and the potential for exposure to the two PBT chemicals subject to this final action can be found in the support documents for the 2021 PBT final rules for each chemical (
The costs and benefits of this final rule and the alternatives EPA considered, as well as the impacts on small businesses, are presented in the Economic Analysis document (Ref. 17). However, the Agency was not able to quantitatively estimate the benefits of this final rule and the alternatives, due to the absence of a risk evaluation, and has instead qualitatively described such benefits.
EPA considered the estimated costs to regulated entities, as well as the cost to administer and enforce the options. EPA considered reasonably available information about the functionality and performance efficacy of the regulatory options and the ability to implement the use of chemical substitutes or other alternatives. A discussion of the costs EPA considered can be found in Unit IV., along with a discussion of the alternatives that the Agency considered. A discussion of the impacts on small businesses can also be found in Unit IV.
With respect to the cost-effectiveness of this final regulatory action, EPA is unable to perform a traditional cost-effectiveness analysis of the options and alternative options for decaBDE and PIP (3:1). The cost-effectiveness of a policy option would properly be calculated by dividing the annualized costs of the option by a final outcome, such as cancer cases avoided, or to intermediate outputs, such as tons of emissions of a pollutant curtailed. Without the supporting analyses from an existing risk evaluation or assessment, the Agency is unable to calculate either a health-based or environment-based denominator. Thus, EPA is unable to perform a quantitative cost-effectiveness analysis of the regulatory action. However, by evaluating the practicability of the policy options, the Agency is confident that it has considered elements related to the cost-effectiveness of the actions, including the cost and the effect on human and environmental exposure to decaBDE and PIP (3:1).
In accordance with TSCA section 26(h) and considering the requirements of TSCA section 6(h), EPA used scientific information, technical procedures, measures, and methodologies that are fit for purpose and consistent with the best available science to inform the 2021 PBT final rules. EPA based its determination that human and environmental exposures to both decaBDE and PIP (3:1) are likely on its 2020 Exposure and Use Assessment (Ref. 19), which underwent a peer review and public comment process, and used best available science and methods sufficient to make that determination. The extent to which the various information, procedures, measures, and methodologies, as applicable, used in the Agency's decision-making have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for this final rule.
In addition, in accordance with TSCA section 26(i), and considering the requirements of TSCA section 6(h), EPA has made scientific decisions based on the weight of the scientific evidence. Additionally, in accordance with TSCA section 26(k), EPA considered reasonably available information, including information on occupational
For the 2019 PBT proposed rule, EPA prepared an Exposure and Use Document, summarizing the information the Agency obtained in its own research or in response to feedback prior to and during the rulemaking process on the types of exposures that might be relevant to a TSCA section 6(a) rulemaking under the TSCA section 6(h)(4) standard. As noted in the 2021 PBT final rules, the Exposure and Use Assessment identified uses of the chemical substances and found that the chemical substances had at least one or more “condition of use” activity where some exposure was likely, but did not attempt to precisely classify all activities for each chemical substance as a “condition of use”.” As EPA explained in the 2021 PBT final rules, the Agency did not perform a systematic review or a weight of the scientific evidence assessment for the hazard characterization of these chemicals. TSCA section 6(h)(2) makes clear that Congress did not intend for EPA to conduct a risk evaluation to support TSCA section 6(a) rules issued to satisfy TSCA section 6(h) requirements, but rather intended for EPA to conduct an expedited rulemaking process to “reduce exposures to the extent practicable” pursuant to TSCA section 6(h)(4). As a result, EPA explained that the hazard characterizations are not definitive or comprehensive. Other hazard information on these chemicals may exist in addition to the description in the 2021 PBT final rules and studies summarized in the Hazard Summary (Ref. 24). The following sections summarize the hazard, exposure, and use information in the 2021 decaBDE and PIP (3:1) final rules.
As EPA explained in the 2021 decaBDE final rule, decaBDE is used as an additive flame retardant in plastic enclosures for televisions, computers, audio and video equipment; textiles and upholstered articles; wire and cables for communication and electronic equipment; and other applications (Ref. 25). DecaBDE is also used as a flame retardant for multiple applications for aerospace and automotive vehicles, including replacement parts for aircraft and cars (Refs. 26 and 27). Exposure information for decaBDE is detailed in EPA's Exposure and Use Assessment and the 2021 decaBDE final rule (Refs. 4 and 19). As EPA explained in that rule, there is potential for exposure to decaBDE under the conditions of use at all stages of its lifecycle (
As described in the 2021 decaBDE final rule, exposure assessments on decaBDE have been conducted by EPA (including industry-supplied information as part of the Voluntary Children's Chemical Evaluation Program), the National Academy of Sciences, and international governments. These assessments describe exposure potential for polybrominated diphenyl ethers (PBDEs), including decaBDE, through a variety of pathways. Adult and child exposures can occur via dust ingestion, dermal contact with dust, and dietary exposures (such as dairy consumption). Household consumer products have been identified as the main source of PBDEs (including decaBDE) in house dust. The next highest exposure pathways included dairy ingestion and inhalation of dust via indoor air. Infant and child exposures can occur via breastmilk ingestion and mouthing of hard plastic toys and fabrics. Occupational exposures for breastfeeding women were highest in women engaged in activities resulting in direct dermal and inhalation contact with decaBDE (Ref. 19).
Finally, as summarized in the 2021 decaBDE final rule, decaBDE is toxic to aquatic invertebrates, fish, and terrestrial invertebrates. Data indicate the potential for developmental, neurological, and immunological effects, general developmental toxicity, and liver effects in mammals. There is some evidence of genotoxicity and carcinogenicity. The 2021 decaBDE final rule and Hazard Summary provides more information on these hazard endpoints (Refs. 4 and 24).
For the 2020 CDR submission period, calendar years 2016-2019, data indicate that three companies manufactured (including imported) decaBDE in the United States (Refs. 17 and 28). The 2020 CDR data indicate a production volume of less than 1 million pounds annually from 2016 through 2019, however, EPA notes that domestic production has ceased, and the identified importers have likely since stopped using decaBDE (Ref. 28).
As explained in the 2021 PBT final rules, PIP (3:1) is used as a plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants, greases, various industrial coatings, adhesives, sealants, and plastic articles. As a chemical that can perform several functions simultaneously, sometimes under extreme conditions, it has several distinctive applications. For example, in lubricating oils, PIP (3:1) is a flame retardant, anti-wear additive, anti-compressibility additive, or some combination of the three. In adhesives and sealants, PIP (3:1) is a plasticizer and flame retardant (Ref. 19). PIP (3:1) is also added to paints, coatings, and plastic components, where it is a plasticizer or flame-retardant additive. In the past, some plastic components to which PIP (3:1) may have been added included those intended for use by children. EPA has received comments that PIP (3:1) acts as a flame-retardant gel in filters surrounding engines in some marine and locomotive applications (EPA-HQ-OPPT-2019-0080-0569).
Exposure information for PIP (3:1) is detailed in EPA's Exposure and Use Assessment and is summarized here (Ref. 19). There is potential for exposure to PIP (3:1) under the conditions of use at all stages of its lifecycle (
For the 2020 CDR submission period, calendar years 2016-2019, data indicate that nine sites manufactured (including imported) PIP (3:1) in the United States and manufacture (including import) held steady at between 1 and 10 million pounds (Refs. 17 and 28).
PIP (3:1) is toxic to aquatic plants, aquatic invertebrates, sediment invertebrates, and fish. Data indicate the potential for reproductive and developmental effects, neurological effects, and effects on systemic organs, specifically the adrenal glands, liver,
In this action, EPA is finalizing revisions to the 2021 decaBDE final rule and the 2021 and 2022 PIP (3:1) final rules. EPA has collected additional information and reconsidered its application of its interpretation of the TSCA section 6(h)(4) direction that the Agency “reduce exposures to the substance to the extent practicable,” focusing particularly on whether additional practicable requirements can reduce occupational exposures, including those associated with exclusions. As described throughout this Unit, EPA has considered the practicability of the final requirements, including how potential requirements and compliance time frames associated with these requirements could impact supply chains, including those prioritized in Executive Order 14017 America's Supply Chains.
As EPA explained in the 2023 proposed rule, EPA did not propose to change its 2021 decision not to use its TSCA section 6(a) authorities to establish a TSCA regulatory program for disposal of decaBDE or PIP (3:1). EPA did not propose such a program and is not finalizing the suggestions made by commenters at this time. EPA remains concerned that developing a new comprehensive regulation for disposal of decaBDE and PIP (3:1) under TSCA section 6(h)(4), in addition to the existing requirements under RCRA (
As also explained in the 2021 PBT final rules, EPA did not propose regulations relating to commercial use of products and articles containing the PBT chemicals, such as televisions and computers, because such regulation would both require testing, which may not be widely available for a chemical, and is expected to be extremely burdensome, necessitating the development of a test method to allow for the identification of products containing PBT chemicals, including decaBDE and PIP (3:1), and the disposal of countless products and articles that would have to be replaced. If EPA prohibited the continued commercial use of these items, widespread economic impacts and disruption in channels of trade could occur while the prohibited items were identified and replaced. EPA also acknowledged, based on additional information provided by industry stakeholders after the 2021 PIP (3:1) final rule, that international supply chains are complex, and that complexity creates challenges for identifying and finding alternatives to PIP (3:1) in international supply chains. Taking this into account, EPA did not reevaluate the practicability of further exposure reductions relating to continued commercial use of products and articles containing decaBDE and PIP (3:1).
Finally, in the 2021 PBT final rules, EPA explained that it did not propose to use its TSCA section 6(a) authorities to restrict recycling activities generally. EPA explained that it recognized the importance and impact of recycling, which contributes to the protection of our environment, and that it would be overly burdensome and not practicable to impose restrictions on the recycling of plastics that may contain decaBDE or PIP (3:1), or on the use of such recycled plastic in plastic articles. EPA also explained that decaBDE and PIP (3:1), if present, are typically present in such articles at low levels and that banning the recycling of plastics containing decaBDE or PIP (3:1) would require decaBDE- and PIP (3:1)-containing plastic to be identified through prohibitively expensive and complicated testing, and separated from other types of plastic before recycling, which is usually done manually (Ref. 30). EPA concluded that it would be difficult to make plastic sorting for this purpose cost-effective, and that it would be overly burdensome and not practicable to prohibit recycling of decaBDE- and PIP (3:1)-containing plastic in the United States. Taking this into account, EPA did not reevaluate the practicability of further exposure reductions relating to a prohibition of, or further regulatory restrictions on, the general recycling of decaBDE- and PIP (3:1)-containing plastic in the United States at this time. As noted in Unit III.C., the one exception relates to the 2021 decaBDE final rule authorization for the continued recycling and distribution in commerce of existing plastic shipping pallets that contain decaBDE for the extent of the pallets' service life because EPA has determined it is practicable to regulate when expensive testing is not necessary to determine the chemical's presence in the article.
EPA proposed to require a label on existing plastic shipping pallets that contain decaBDE. EPA received several comments regarding the proposed labeling requirement for decaBDE-containing plastic shipping pallets (EPA-HQ-OPPT-2023-0376-0304, EPA-HQ-OPPT-2023-0376-0292, EPA-HQ-OPPT-2023-0376-0311, EPA-HQ-OPPT-2023-0376-0313). Specifically, some commenters agreed with the proposed labeling requirement but urged EPA to expand the labeling requirement to all articles containing decaBDE (EPA-HQ-OPPT-2023-0376-0313). Other commenters expressed concern with the labeling requirement and stated the labels should not apply to any recyclers (EPA-HQ-OPPT-2023-0376-0311). Commenters also discussed implementation concerns regarding the label and the need for testing of pallets to determine if decaBDE is present (EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-2023-0376-0304).
In response to a comment received during the March 2021 request for comment, EPA held a government-to-government Tribal consultation in November 2022, in which EPA received comments requesting the Agency require labeling of plastics that contain decaBDE (Refs. 16 and 31), EPA proposed to require a label on existing plastic shipping pallets that contain decaBDE. At the time of the proposal, EPA determined it was practicable to label existing plastic shipping pallets containing decaBDE because all plastic shipping pallets that contain decaBDE are owned by a single company, and it was EPA's understanding that the company tracked, as part of normal business operations, each decaBDE-containing plastic shipping pallet. No
EPA held an additional stakeholder meeting with the company that recycles plastic pallets that contain decaBDE during the public comment period in December 2023 and received additional public comments (Refs. 27 and EPA-HQ-OPPT-2023-0376-0314). Based on this stakeholder meeting and these public comments, EPA determined that its understanding of the company business model was incorrect as described in the proposal. Although an initial bar code is attached to the pallet after it is molded, these labels are quickly damaged once introduced into commerce and are not replaced.
The purpose of EPA's proposed label requirement was to provide notice that PPE is required during the recycling of plastic shipping pallets contain decaBDE. The proposed label would only be seen, if at all, during the initial step of recycling and the disassembly of the pallet. Since exposure to decaBDE in plastic shipping pallets that are in use and moving throughout commerce is not expected (Ref. 19), and public comments indicated that the labels would likely not be present at the time of recycling, EPA has determined that labeling of decaBDE-containing plastic shipping pallets is not practicable and is not finalizing the labeling requirement for plastic shipping pallets that contain decaBDE.
To reduce potential exposures to decaBDE during the recycling of plastic shipping pallets that contain decaBDE, EPA is finalizing a signage requirement in the regulated area, defined at 40 CFR 751.403 as “an area established by the regulated entity to demarcate areas where airborne concentrations of a specific chemical substance can reasonably be expected.” This definition is intended to include those areas where plastic pallets are recycled. This sign will provide notice to workers that PPE is required to be worn during recycling of plastic shipping pallets manufactured before March 8, 2021, which will reduce potential exposures to decaBDE (see Unit III.C.2. for more information on specific PPE requirements). A sign must be posted at every entry point into the regulated area that clearly, prominently, in multiple languages as appropriate, and in an easily readable font size, contains the following text: “Decabromodiphenyl (decaBDE) (CASRN 1163-19-5), a chemical that has been identified as a persistent, bioaccumulative, and toxic (PBT) chemical by the U.S. Environmental Protection Agency, may be present in this regulated area. All persons in this regulated area who recycle plastic shipping pallets that contain decaBDE are required to wear personal protective equipment, including respiratory protection that is at least as protective as a NIOSH-approved N95 respirator with an assigned protection factor (APF) of 10 and dermal protection of gloves that are chemically resistant to decaBDE, per regulations at 40 CFR 751.405(e).” EPA is not requiring testing to determine if decaBDE is present in the plastic shipping pallets.
EPA proposed to require inhalation and dermal PPE during certain ongoing uses listed at 40 CFR 751.405(a)(2) and (b). To ensure exposures to workers are reduced to the extent practicable during domestic manufacturing and processing of decaBDE and decaBDE-containing products and articles, EPA is finalizing at 40 CFR 751.405(e), worker protection requirements to address potential respiratory and dermal exposure to workers during ongoing activities involving decaBDE, specifically certain activities where the prohibitions phase-ins have not passed (
EPA is requiring owner or operators to select and provide respiratory protection that is at least as protective as a NIOSH-approved N95 respirator with an assigned protection factor (APF) of 10 and gloves that are chemically resistant to decaBDE. EPA has determined, based on comments, that it is practicable to require worker protection, including PPE, for the processing of existing plastic shipping pallets because it is already industry practice (Ref. 27). Although it is EPA's understanding that domestic manufacturing and processing of decaBDE for use in new and replacement parts for motor and aerospace vehicles has ceased, EPA is requiring PPE for these uses. This approach ensures that any ongoing activity involving decaBDE, past, present or future, is addressed by this regulatory approach taken, and thus the regulations adopted in this rule reduce the exposures that will result with resumption of past activities or the initiation of similar or other activities in the future. For all other processing for recycling activities of decaBDE-containing plastic from products or articles and decaBDE-containing products or articles made from such recycled plastic, EPA maintains that it would be impracticable to establish a testing program to determine if decaBDE is present. Due to the difficulty in identifying whether and where decaBDE is present in an article, EPA is not requiring worker protections for all other processing for recycling activities.
EPA is not requiring worker protections for all ongoing processing of articles (
For the activities subject to the worker protection requirements and to reduce potential occupational exposure during the recycling process of plastic shipping pallets that contain decaBDE, EPA is finalizing the requirement for, at a minimum, a NIOSH-approved N95 respirator with an APF 10 and gloves that are chemically resistant to decaBDE with activity-specific training where dermal contact with decaBDE is reasonably expected.
Where PPE is required, EPA is finalizing its proposal to require implementation of a PPE program in alignment with certain elements of OSHA's General Requirements for PPE at 29 CFR 1910.132 and Respiratory Protection requirements in 29 CFR 1910.134. EPA is requiring that owners
EPA uses the term “potentially exposed person” in this unit, elsewhere in the preamble, and in the regulatory text to mean any person who may be exposed to a chemical substance or mixture regulated under 40 CFR part 751 subpart E as a result of the use of that chemical or mixture. “Any person” includes workers, occupational non-users, employees, independent contractors, employers, and all other persons in the work area. One important reason to define a potentially exposed person as any person who may be exposed in the workplace is to emphasize the broad scope of exposures. EPA notes that this definition is intended to apply only in the context of risk management (
EPA is requiring that each owner or operator comply with OSHA's respiratory protection training requirements at 29 CFR 1910.134(k) and general PPE training requirements at 29 CFR 1910.132(f) when using respirators and gloves. Owners and operators must provide PPE training to all persons required to use dermal protection or respiratory protection prior to or at the time of initial assignment to a job involving exposure to decaBDE.
EPA is also requiring the implementation of a respiratory protection program in alignment with 29 CFR 1910.134(b), (c)(1), (c)(3) and (4), (d)(1)(iv), (f), and (g) through (l)), which requires each owner or operator to select respiratory protection in accordance with the guidelines for proper respirator use, maintenance, fit-testing, medical evaluation, and training. Owners or operators who are required to administer a respiratory protection program must ensure a respirator is utilized in accordance with 29 CFR 1910.134(d)(1).
EPA is finalizing its proposal to require that owners and operators document respiratory protection used and PPE program implementation and retain those records for five years from the date the record is generated. EPA is also finalizing its requirement that owners and operators must document and keep records of the information on the PPE program, as applicable, and make it available to the Agency upon request. In addition, and in response to comments, owners and operators must also keep records related to the basis for the regulated area as defined in 40 CFR 751.403, as well as provide potentially exposed persons and their designated representative(s) an opportunity to observe records related to the basis of the PPE or another control measure selection, including potential monitoring results that are representative of the potentially exposed person's exposure.
EPA proposed to prohibit the releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products and proposed to require all persons to follow any regulations that may apply and best management practices for preventing the release of decaBDE to water. EPA received a comment in support of the prohibition on certain releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products (EPA-HQ-OPPT-2023-0376-0286).
EPA also received comments requesting EPA expand the provision to regulate wastewater treatment plants, landfills, and land-applied sewage sludge for both decaBDE and PIP (3:1) (EPA-HQ-OPPT-2023-0376-0303, EPA-HQ-OPPT-2023-0376-0313). More discussion of the commenters' request can be found in the RtC Document (Ref. 20). After one commenter expressed concern regarding the lack of specificity around the “best management practices” clause and receiving no additional information during the public comment period on how a prohibition on releases to water could best be achieved through best management practices, EPA is not finalizing the “best management practices” clause (EPA-HQ-OPPT-2023-0376-0297). EPA is finalizing the prohibition on the releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products, and such persons are required to follow applicable regulations that may apply for preventing the release of decaBDE to water. Applicable regulations related to this final prohibition on releases to water may include restrictions on discharges under the Federal Water Pollution Control Act (commonly known as the Clean Water Act), Safe Drinking Water Act (SDWA), or analogous State laws. However, EPA is not amending the 2021 PIP (3:1) final rule restrictions on release to water, which retains the requirement to follow “best management practices.”
The prohibition on the release to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products prevents direct releases of decaBDE to water. Thus, only those facilities that are manufacturing, processing, and/or distributing in commerce decaBDE and decaBDE-containing products, including wastewater treatment plants that engage in those activities, are subject to the prohibition on releases to water. This final rule does not impose restrictions on sources discharging indirectly to publicly owned treatment works (POTWs). EPA is also not imposing specific requirements for wastewater treatment plants, unless those facilities are manufacturing, processing, and/or distributing decaBDE or decaBDE-containing products. EPA determined that it is not practicable to require all wastewater treatment plants to test and potentially treat for decaBDE. However, prohibiting the release from the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products will result in an overall reduction in releases of decaBDE to water generally, including, any potential release to water that could happen from being present at downstream wastewater treatment plants. See the RtC Document for more discussion on regulating PBT disposal (Ref. 20).
After reconsidering the practicability of prohibiting releases to water due to the public comments, and the potential for releases to water, even though there
EPA is not extending this requirement to include a prohibition on the release to water for the processing and distribution in commerce of decaBDE-containing articles, including recycled materials that may contain decaBDE. As described in more detail in the 2021 decaBDE final rule and the supporting response to comment document, it would be extremely burdensome to identify articles containing decaBDE to determine if a facility that recycles articles is subject to this final release to water prohibition (Ref. 36).
EPA proposed to extend the compliance date, limited to processing and distribution in commerce of decaBDE-containing wire and cable insulation and the components containing the wire and cable in nuclear power generation facilities (including test and research reactors), until after the end of the service life of the wire and cable. EPA received several comments in support of the extended compliance date for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities (EPA-HQ-OPPT-2023-0376-0299, EPA-HQ-OPPT-2023-0376-0300). One commenter stated that an alternative is available and disagrees with EPA's proposal to extend the compliance deadline (EPA-HQ-OPPT-2023-0376-0294). However, based on discussions with the Nuclear Regulatory Commission (NRC), EPA disagrees with the commenter that alternative, decaBDE-free, fully qualified wire and cables are available that meet the NRC's requirements in 10 CFR 50.49, “Environmental qualification of electric equipment important to safety for nuclear power plants,” including the Institute of Electrical and Electronics Engineers 383 (“IEEE 383”) standard for instrumentation and power cable insulation. Another commenter stated that the proposed extension for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities is vital, as these cables and components are necessary for the safety systems that prevent release of radioactive materials into the environment (EPA-HQ-OPPT-2023-0376-0299). Additional details can be found in the RtC Document (Ref. 20). EPA is finalizing the proposed compliance date extension for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities.
As mentioned in the proposal, decaBDE has been used in Class 1E cables, which are qualified to meet industry standards and NRC requirements in 10 CFR 50.49, including the Institute of Electrical and Electronics Engineers 383 (“IEEE 383”) standard for instrumentation and power cable insulation. Recognizing this, and in response to stakeholder feedback and engagements with the only known supplier of decaBDE-containing wire and cable, EPA established an extended compliance deadline of January 6, 2023, in the 2021 decaBDE final rule, after which all processing and distribution in commerce of decaBDE for use in wire and cable insulation in nuclear power generation facilities, and decaBDE-containing wire and cable insulation was prohibited (40 CFR 751.405(a)(2)(ii)). EPA interprets the term “nuclear power generation facilities” to include nuclear reactors as defined by the NRC in 10 CFR 50.2, production facilities, test and research reactors, other utilization facilities not specifically designed for or used primarily for the formation of plutonium or U-233, and reactors operated under the oversight of the U.S. Department of Energy (DOE). EPA has added text in 40 CFR 751.405(a)(2)(ii) to include one example of the types of facilities covered by nuclear power generation facilities. In addition, EPA is clarifying that 40 CFR 751.405(a)(2)(ii) and (vi) are not limited to a specific level of power generation and that EPA interprets the provision to include “electrical equipment important to safety” as defined in 10 CFR 50.49(b) and materials required for the safe operation of “Alternate ac source” and “Basic component” as defined in 10 CFR 50.2 that include decaBDE-containing wire and cable.
After the January 6, 2023, extended compliance deadline in the 2021 decaBDE final rule, EPA received multiple requests and letters of concern regarding the availability of decaBDE-containing wire and cable insulation used in the nuclear power sector (Refs. 37 and 38). These inquiries and outreach came shortly after the supplier of this decaBDE-containing wire and cable discontinued processing and distribution in commerce and notified its customers of its inability to continue supplying their wire and cable due to the January 6, 2023, compliance date. Due to the lack of communication and engagement between the primary supplier and their customers, as well as with EPA, the industry reported to EPA that they were at risk of not having qualified wire and cable available, which could negatively affect both scheduled maintenance outages and unplanned equipment failures and, ultimately, could force multiple nuclear power plants to be temporarily taken offline. In response to this, on April 20, 2023, EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) requested that the Office of Enforcement and Compliance Assurance (OECA) issue an enforcement statement
In response to this request, EPA's OECA issued a temporary “Enforcement Statement” on May 2, 2023, which indicates that the Agency does not intend to pursue enforcement for certain violations of the prohibition on processing and distribution in commerce of decaBDE-containing wire and cable insulation for nuclear power generation facilities, including those component and safety systems that contain the decaBDE-containing wire and cable insulation, that went into effect on January 6, 2023, as long as the entities involved are diligently working to qualify their alternative components in accordance with NRC regulations and guidance (Ref. 39).
After considering feedback from the industry and Federal partners, including DOE and NRC, EPA is finalizing its proposal to extend the compliance date, limited to processing and distribution in commerce of decaBDE-containing wire and cable insulation and the components containing the wire and cable in nuclear power generation facilities (
EPA is not allowing resumption of processing and distribution in commerce of raw or compounded decaBDE for use in wire and cable insulation in nuclear power generation facilities. The only known user of raw or compounded decaBDE has been permitted to resume these activities for a limited time under a settlement agreement that provides a mechanism for the continued availability of decaBDE-containing wire and cable insulation, while the nuclear power generation facilities undergoes transition to a decaBDE-free alternative (Ref. 40). The termination conditions of the settlement agreement states that it shall remain in place for five years following the effective date unless terminated earlier, while the company's customers transition to receipt of Class 1E cable that is decaBDE-free.
EPA proposed to amend the current rule to require a TSCA section 12(b) export notice for the export of decaBDE-containing wire and cable for nuclear power generation facilities. EPA received one comment of support and one comment of opposition related to the proposed export notification for decaBDE-containing wire and cable for nuclear power generation facilities (EPA-HQ-OPPT-2023-0376-0286, EPA-HQ-OPPT-2023-0376-0286). The commenter stated that the export notification is precedent-setting and should be a standalone proposal. EPA disagrees with this commenter and is finalizing the export notification requirement for decaBDE-containing wire and cable for nuclear power generation facilities.
As mentioned in the proposal to this final rule, and as discussed in the 2021 decaBDE final rule, decaBDE is listed on Annex A of the Stockholm Convention on Persistent Organic Pollutants (the POPs Convention), which prohibits the production, use, import, and export of decaBDE and decaBDE-containing products and articles for Parties to the listing decision for decaBDE, unless otherwise subject to a specific exemption (Ref. 41). There is no specific exemption under the POPs Convention for decaBDE-containing wire and cable for nuclear power generation facilities, and thus, EPA did not expect import or export for this use to occur. However, since EPA has learned that there is a need for export of decaBDE-containing articles for this purpose (Ref. 40), EPA is finalizing this provision. Although articles are generally exempt under 40 CFR 707.60(b) from the requirement to provide notices of export under TSCA section 12(b), EPA is finalizing its proposal to amend the 2021 decaBDE final rule to require a TSCA section 12(b) export notice for the export of decaBDE-containing wire and cable for nuclear power generation facilities. Such notice requirement was triggered 30 days after publication of the proposed rule, pursuant to TSCA section 12(b) and 40 CFR 707.60(a)(3) and 707.65(a)(1)(i) and (b). The notification to EPA of such intent to export will not provide consent by the importing countries for import of the shipment; the importing countries may choose not to permit import of such shipment. Consistent with 40 CFR 751.7(a), the provisions of subpart D of 40 CFR part 707 still apply to any export notifications required for decaBDE and PIP (3:1) under TSCA section 6(h). EPA is not requiring export notification for any other articles.
EPA proposed to increase the recordkeeping requirement from three to five years and to remove the 30-day time frame to make records available for decaBDE. EPA received support for the proposed extended recordkeeping requirements (EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-2023-0376-0313). One commenter suggested EPA extend the recordkeeping requirements to a much longer period of time, suggesting 20-30 years as an appropriate time frame (EPA-HQ-OPPT-2023-0376-0312). As discussed in the proposed rule and in more detail in the RtC Document, the proposed record retention time frame of five years is consistent with those associated with other TSCA section 6(a) rulemakings, and because it aligns with the statute of limitations for civil penalty enforcement (28 U.S.C. 2462). Also, the proposal to modify the time frame for making records available from a 30-day time frame to upon request is critical to the Agency's ability to promptly identify and correct noncompliance (Refs. 1 and 20).
EPA is finalizing its proposal to increase the recordkeeping requirement from three to five years and is removing the 30-day time frame to make records available for decaBDE and PIP (3:1). In the 2021 decaBDE final rule, EPA required that all persons who manufacture, process, or distribute in commerce decaBDE and products and articles containing decaBDE maintain ordinary business records related to compliance with the prohibitions and restrictions for three years and to make records available within 30 days upon request. Due to the additional requirements being finalized in this rulemaking, specifically those pertaining to worker safety, EPA considers that the five-year time frame
As it relates to recordkeeping for worker protections, EPA is finalizing its proposal to require that owners/operators document respiratory protection used and PPE program implementation and retain those records for five years. One commenter (EPA-HQ-OPPT-2023-0312) stated that this information should be available to workers throughout the period of potential consequences of an exposure. EPA has modified the workplace protection records requirements for both PIP (3:1) and decaBDE to require that the owner or operator provide potentially exposed persons and their designated representatives an opportunity to observe records related to the basis of the PPE or other control measure selection, including potential monitoring results that are representative of the potentially exposed person's exposure.
EPA reviewed the determinations underlying the exclusions from prohibition in the January 2021, PIP (3:1) final rule to consider whether to adopt new restrictions for activities currently excluded, consistent with the statutory directive to reduce exposure to the extent practicable (Refs. 13 and 36). For many of the exclusions, EPA determined that there were no technically feasible alternatives or that the time and cost to identify, research, and replace PIP (3:1) in supply chains were impracticable. During the comment periods following the March 6, 2021, notification, and in comments on the proposed rule for this rulemaking, many stakeholders from the auto, aerospace, semiconductor, heavy machinery, and other sectors provided additional information on time frames that they determined would allow those industries a reasonable period to transition from PIP (3:1) to alternatives (EPA-HQ-OPPT-2021-0202). Where EPA received information that transition from PIP (3:1) to an alternative has already occurred or could occur within a reasonable transition period, EPA has determined the modifications are practicable and is therefore finalizing such modifications. In other instances, where commenters were not able to provide similar information for determining a reasonable period for such transition, EPA did not finalize extending the compliance deadline.
EPA is modifying several exclusions from prohibitions that were finalized in the January 6, 2021, PIP (3:1) final rule (Ref. 5). These final modifications include narrowing the scope of certain exclusions, adding prohibition phase-in dates, and/or in some cases creating new exclusions from a prohibition for certain uses. In conjunction with narrowing the scope of certain exclusions, EPA is also finalizing prohibitions, as proposed, through phase-outs in 40 CFR 751.407(a)(2) on the manufacture (including import), processing, and distribution in commerce of the PIP (3:1)-containing products and articles for the uses that were covered by an exclusion. This restriction will ensure the phase-out of domestic production and imports of PIP (3:1)-containing products and articles. EPA is not generally prohibiting the manufacturing of PIP (3:1), consistent with the 2021 PIP (3:1) rulemaking, due to the number of excluded activities that EPA has found it impracticable to prohibit.
EPA is finalizing as proposed the narrowed exclusion from prohibition in 40 CFR 751.407(b)(1)(ii) for only certain lubricants and greases. Specifically, the final exclusion only covers processing and distribution in commerce of PIP (3:1) for use in lubricants and greases for aerospace use and turbine engines, PIP (3:1)-containing products for use in lubricants and greases for aerospace use and turbine engines, and PIP (3:1)-containing lubricants and greases for use in aerospace and turbine applications. EPA is also finalizing a prohibition phase-in for non-aerospace and non-turbine applications, but based on comments received, EPA is amending the proposed phase-in prohibition time frame from 5 years to 15 years. The processing and distribution in commerce of PIP (3:1) for use in lubricants and greases, PIP (3:1)-containing products for use in lubricants and greases, and PIP (3:1)-containing lubricants and greases, excluding aerospace and turbine uses, likewise will be subject to a 15-year phased-in prohibition.
EPA proposed the 5-year compliance time frame because at least one stakeholder requested a 5-year transition period to move away from PIP (3:1) for their applications (Ref. 42). However, several commenters opposed EPA's proposal. Four commenters requested EPA reconsider the full exclusion in the 2021 final rule. One commenter (EPA-HQ-OPPT-2023-0376-0307) noted the regulatory uncertainty associated with some possible alternatives to PIP (3:1) being on the TSCA 2014 work plan and potentially subject to regulation. Another commenter (EPA-HQ-OPPT-2023-0376-0284) stated the belief that for many applications, it is not possible to estimate how long it will take to develop an alternative that meets required performance specifications and can be stably supplied. Another commenter stated their belief that they do not think an alternative could be found in 30 years. These commenters recommended a 30-year phase-in prohibition, only if it included a means to seek a case-by-case exemption. Another commenter (EPA-HQ-OPPT-2023-0376-0295) argued that that the exclusion was needed in order to maintain access to PIP (3:1)-containing lubricants and greases in case manufacturers reformulate their products so that they no longer contain PIP (3:1) and they discontinue selling these products.
In the 2019 PBT proposed rule, EPA acknowledged, and continues to acknowledge in this final rule, that PIP (3:1) is a crucial anti-wear component for lubricants and greases that are used in electronics and other applications beyond aerospace, and EPA stated its understanding, based on available information, that such applications are not subject to the same extreme performance conditions. Commenters did not provide information to support claims that technically feasible alternatives could not be identified. While EPA did not identify specific alternatives for specific applications, believing that companies are best able to do so, EPA identified potential alternatives in the Economic Analysis for the 2021 PIP (3:1) final rule. For these reasons, EPA is not re-instituting the full exclusion in the 2021 final rule. EPA is also not adopting a mechanism for informal extensions in the final rule. There is no provision under TSCA for the informal extension of compliance dates. Future amendments to the phaseouts in this rule would require
Several commenters proposed alternative prohibition phase-in periods for non-aerospace and non-turbine lubricant and greases. Two commenters (EPA-HQ-OPPT-2023-0376-0287, EPA-HQ-OPPT-2023-0376-0289) recommended EPA finalize the same timelines for lubricants and greases as parts for motor vehicles (15 years for parts for new motor vehicles and 30 years for replacement parts). This is because alternatives for motor vehicles is challenging due to the specific requirements, such as high temperatures, pressures, and durability, as well as safety. EPA notes that the final regulations continue the exclusion for the processing and distribution of PIP (3:1)-containing lubricants and greases for aerospace use and turbine engines, but otherwise requires the phase-out of all other PIP (3:1)-containing lubricants and greases after 15-years unless there is another provision authorizing the processing and distribution of PIP (3:1) for use in articles, for example for replacement parts for motor vehicles (40 CFR 751.407(a)(2)(v) and (vi)). See Unit III.D.1.b. for a further discussion on PIP (3:1) use in motor vehicles and Unit III.D.2. for precedence of phase-in prohibitions.
Two commenters (EPA-HQ-OPPT-2023-0376-0295, EPA-HQ-OPPT-2023-0376-0302) asked the Agency to confirm in the preamble to the final revised rule that the phrase “turbine applications” as used in the proposed regulation refers to the use of PIP (3:1) formulations in gas turbine engines (whether for aviation or in nonaviation aeroderivative gas turbine engines AGTs), and not other kinds of turbines. In the proposal, EPA asked for comment on the scope of the exclusion for turbines. Because EPA understands that PIP (3:1)-containing lubricants and grease may have applications in other categories of turbines, EPA is not further narrowing the scope of the exclusion to only gas turbine engines.
EPA proposed to repeal the 2021 exclusion from prohibition in existing 40 CFR 751.407(b)(1)(iii) for new and replacement parts for motor and aerospace vehicles and to establish phase-in prohibitions related to motor vehicle and aerospace uses. The proposed 15-year phase in prohibition of processing and distribution in commerce of PIP (3:1) and PIP (3:1)-containing products for use in parts for new motor vehicles was based on industry's own description of their experience with transitioning from a different chemical, albeit under different circumstances, and the time frames provided. The aspects of this exclusion that relate to aerospace vehicles and wire harnessing and electric circuit boards are addressed in Unit III.D.1.c. and Unit III.D.1.d., respectively. Multiple industry trade organizations (EPA-HQ-OPPT-2023-0376-0285, EPA-HQ-OPPT-2023-0376-0289, EPA-HQ-OPPT-2023-0376-0308) expressed support for the proposed 15-year phased-in prohibition for new parts and 30-year phase-in for replacement parts for motor vehicles. At least one commenter (EPA-HQ-OPPT-2023-0376-0290) noted that the proposed compliance dates for motor vehicles, now being finalized in this action, appear to be feasible and noted that a shorter compliance period for new motor vehicles would not be feasible, as motor vehicle supply chains are complex, often rely on foreign suppliers, and are likely to take 15 years to phase out the use of PIP (3:1) completely.
EPA is finalizing its replacement of the existing exclusion at 40 CFR 751.407(b)(1)(iii) for use of PIP (3:1) and PIP (3:1)-containing products in new and replacement parts for motor vehicles with: (1) a 15-year phase-in prohibition of processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts for new motor vehicles (
In addition, EPA is amending 40 CFR 751.407(a)(2)(v) to correct an error in the proposed regulatory text. Proposed 40 CFR 751.407(a)(2)(v) read “. . . all persons are prohibited from all processing and distribution in commerce of PIP (3:1) for use in parts for new motor vehicles, including heavy machinery, and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts for new motor vehicles, including heavy machinery, PIP (3:1)-containing parts for such new vehicles,
Stakeholders representing manufacturers of new original equipment and aftermarket components, systems, and materials for use in passenger cars and light trucks indicated that, under the assumption that an alternative to PIP (3:1) could be found in the next three to four years, the industry could transition out of using PIP (3:1) within a seven-to-ten-year time frame (Ref. 43). EPA acknowledges that the time frame contains many contingencies, which could delay the adoption of PIP (3:1) alternatives. Nevertheless, based on the industry's own description of their experience with transitioning from a different chemical, albeit under different circumstances, and the time frames provided, EPA determined a 15-year phase-in prohibition of processing and distribution in commerce of PIP (3:1) and PIP (3:1)-containing products for
EPA is also finalizing new 40 CFR 751.407(a)(2)(vi) to allow processing and distribution in commerce for an additional 15 years (
In addition, EPA is amending the language in the phase-in prohibitions to reference “heavy motorized machinery” instead of “heavy machinery,” as originally proposed. This is being done to further clarify what is included in the phase-in prohibitions in 40 CFR 751.407(a)(2)(v) and (vi). As explained in the March 2022 PIP (3:1) final rule extending the PIP (3:1) compliance date, EPA generally interprets the term “motor vehicle” to mean a transport vehicle that is propelled or drawn by mechanical power, such as cars, trucks, motorcycles, boats, and construction, agricultural, and industrial machinery. The phase-in prohibitions in 40 CFR 751.407(a)(2)(v) and (vi) include offroad motor vehicles, construction vehicles, like excavators and front-loaders, and large, motorized equipment, such as paver, cranes, etc., both for military and non-military applications. These provisions and associated compliance time frames do not include off-road stationary equipment and machinery as discussed by commenters (
Lastly, in response to comments, EPA would like to clarify that this rulemaking does not repeal the “end user” provision in 40 CFR 751.401(b)(1), which allows the distribution in commerce of the chemical substance, or products and articles that contain the chemical substance, that has previously been sold or supplied to an end user (
EPA proposed to repeal the exclusion from prohibition in 40 CFR 751.407(b)(1)(iii) for new and replacement parts for aerospace vehicles and replace it with a phase-in prohibition that would begin 30 years after the publication of the final rule on the processing and distribution in commerce of PIP (3:1) and the manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts installed in and distributed as part of new aerospace vehicles, and the parts to which PIP (3:1) has been added for such vehicles. EPA also proposed a provision that after the end of the aerospace vehicles' service lives, the manufacturing, processing, and distribution in commerce of aerospace vehicles (
As discussed in the January 2021 PIP (3:1) final rule, EPA concluded that a similar reasoning applied to the use of PIP (3:1) in new and replacement parts for motor vehicles readily transfers to a review of the justifications for the use of PIP (3:1) for new and replacement parts in aerospace vehicles. EPA acknowledges the regulatory and safety requirements for the aerospace industry are as stringent or more stringent than those for motor vehicles. In particular, industry stakeholders noted the time required to identify an alternative, and to test and certify its use in parts, to meet safety requirements, as well as a lengthy Federal Aviation Administration approval process. Given these considerations, EPA is finalizing longer time periods for the phase-in prohibitions for the use of PIP (3:1) in new and replacement parts for aerospace vehicles.
One commenter (EPA-HQ-OPPT-2023-0376-0295) recommended that EPA retain the full exclusion from prohibitions in the final rule on PIP (3:1) for new and replacement parts for aerospace vehicles. The commenter noted that the Federal Aviation Administration certification process is often necessary and may be multiyear, unpredictable, and lengthy. The commenter further stated that there may be significant unknowns during the process, such as the availability of candidate formulations, the time needed to identify all affected parts and to certify alternatives for the PIP (3:1) products used to manufacture the parts. The commenter also believes there is uncertainty regarding chemical restrictions the EPA may consider and their impact on investments in alternatives research and development. As discussed in the proposed rule, while EPA acknowledges the uncertainty in determining a feasible time frame for phasing-out the use of PIP (3:1) in aerospace parts, EPA understands that the aerospace industry and motor vehicle industry share similar uses. EPA acknowledges that some uses in the aerospace industry may require more time for an appropriate substitute to be found compared with uses in the motor vehicle industry, given the different performance and regulatory requirements the aerospace industry faces, and has provided a longer phase-out period. Nevertheless, given EPA's mandate to reduce exposures to the extent practicable and the other
EPA is finalizing the new exclusion from the prohibition at 40 CFR 751.407(b)(1)(iii) for the processing and distribution in commerce of PIP (3:1) and PIP (3:1)-containing products for use in wire harnesses and circuit boards, and wire harnesses and circuit boards containing PIP (3:1). This final exclusion is based on industry comments provided in response to the March 2021 notification opening a comment period. Commenters have stated that these components are required to meet certain mandatory regulatory and voluntary industry safety standards (Refs. 44 and 45). According to commenters, alternatives to PIP (3:1) for use as a flame retardant and/or plasticizer in wire harnesses and circuit boards have not been identified (Ref. 11).
Based on information from commenters and engagement with stakeholders, EPA is not aware of a replacement for PIP (3:1) for use in wire harnesses and circuit boards that combines its properties as a plasticizer, a fire retardant, and an anti-wear additive. Hence, EPA agrees with commenters that the replacement for PIP (3:1) in these uses would likely not be a direct substitute but might require multiple chemicals. EPA acknowledges that the process of replacing PIP (3:1) with separate chemicals for each function would likely be time consuming and costly to certify new end-use products and articles (Refs. 45 and 46). EPA is not aware of a technically and economically feasible alternative for PIP (3:1) that would meet the performance requirements and voluntary and regulatory safety standards for these articles. EPA and commenters are not aware of industry efforts to identify or qualify an alternative. For these reasons, EPA is finalizing its proposal that it is impracticable to prohibit the processing and distribution in commerce of PIP (3:1) for use in wire harnesses and circuit boards and PIP (3:1)-containing products for use in wire harnesses and circuit boards, and for wire harnesses and circuit boards containing PIP (3:1).
Several commenters supported the exclusion for wire harnesses and circuit boards. Many commenters also asked EPA to clarify certain aspects of the exclusion. Two commenters (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0297) noted that in the explanations of the reasons why the exclusion for new and replacement parts for motor vehicles and aerospace vehicles is being repealed and replaced with a prohibition EPA states that the proposed prohibition would not apply to PIP (3:1)-containing parts, in particular for wire harnesses and circuit boards, that would be subject to a new exclusion, if adopted as proposed. One of the commenters asked EPA to clarify that this exclusion takes precedence in the situation where other exemptions or phase-out periods are more limited in nature. The commenter recommended that this statement be included in the written text. EPA accepts this comment and is adding the following statement, “except for the activities described in paragraph (b) of this section or where another phase-in prohibitions with longer term deadlines exists as described in this section” to 40 CFR 751.407(a)(2).
One commenter (EPA-HQ-OPPT-2023-0376-0297) requested that EPA clarify the scope of the items included within the exclusion by providing a definition with a non-exclusive list of examples. The commenter suggested that the list of examples be more expansive than “wire harnesses and circuit boards” and include any item that is attached to an electronic circuit board or that is necessary to secure, cover, or insulate an electronic component that gets attached to a circuit board. EPA is not providing a definition of wire harnesses or circuit boards. In the preamble of the proposed rule, EPA explained that the term “wire harnesses” includes a broad class of articles, including but not limited to terminal and fuse covers, cable sleeves, casings, connectors, and tapes, used in a variety of applications, from defense to aerospace and motor vehicle applications, to scientific instrumentation and more. EPA also explained that the Agency understands that PIP (3:1) use in electronic component manufacturing includes the use of PIP (3:1) in circuit boards as well as the use of PIP (3:1)-containing products for the encapsulation of electronics components added to circuit boards and as resins in over molding, dip molding, insert molding applications, or conformal coatings.
In explaining EPA's understanding of the use of PIP (3:1) in circuit boards, EPA distinguishes between those elements that come into direct contact with parts conducting or storing electricity and those that do not. The items the commenter (EPA-HQ-OPPT-2023-0376-0297) referred to as necessary “to secure, cover, or insulate an electronic component that gets attached to a circuit board” do not come into direct contact with parts that conduct or store electricity and therefore do not necessitate the flame-retardant properties of PIP (3:1) in those components. Hence EPA is not expanding the scope of the circuit board exclusion to include these items and these articles may be subject to the October 2024 deadline for processing and the October 2026 deadline for distribution of PIP (3:1)-containing articles unless excluded under 40 CFR 751.407 (b) or where another phase-in prohibitions with longer term deadlines exists under 40 CFR 751.407(a)(2).
EPA is finalizing, at 40 CFR 751.407(a)(2)(vii), a five-year compliance deadline for the prohibition of processing and distribution in commerce of PIP (3:1) for use in a FIFRA-registered marine antifouling coating product for Department of Defense uses only. The January 2021 prohibition on processing and distribution of PIP (3:1) has resulted in the inability of the U.S. Navy to obtain a PIP (3:1)-containing, FIFRA-registered marine antifouling coating product. This compliance date extension will allow the U.S. Navy to continue to procure PIP (3:1)-containing coating while it identifies an alternative PIP (3:1)-free formulation.
PIP (3:1) is used as a plasticizer in the formulation of the marine antifouling coating product and is an inert ingredient under FIFRA. In discussion with the U.S. Navy, it indicated that this antifouling coating falls under the “mission critical” category because hull corrosion on ships can have significant impacts on ship performance. The U.S. Navy also indicated that it would need five years to develop a suitable alternative formulation and undergo U.S. Navy qualification and testing and the FIFRA approval process. Because no technically feasible alternative is currently available for the U.S. Navy's aluminum-hulled ships due to the U.S.
In response to comments, EPA is amending the proposed compliance deadline extension of 10 years at 40 CFR 751.407(a)(2)(ix) for processing and distribution in commerce of PIP (3:1), and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products and articles for use in manufacturing equipment and in the semiconductor industry. EPA received several comments on the proposal regarding articles used in manufacturing equipment and the semiconductor industry. Two commenters supported the 10-year compliance extension for such articles. Several commenters sought to include a particular type of equipment in the articles covered by the proposed extension or to lengthen the compliance time period for a particular type of equipment. For example, one commenter asked EPA to clarify that the semiconductor manufacturing exemption applies to ancillary operations such as the assembly of use-specific and product-specific packages and components and to their installation within other products and finished articles in which finished semiconductor packages are used. Commenters claiming that 10 years was not sufficient cited complex supply chains and performance requirements. Nine commenters noted that these articles have long service lives and need repair parts during their service lives. Taking these comments together, EPA is finalizing an approach to articles used in manufacturing equipment and in the semiconductor industry based on the approach EPA is using for motor vehicles. In this final rule, EPA is adding a compliance deadline extension of 10 years after the publication of the final rule for processing and distribution in commerce of PIP (3:1), manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products, and manufacturing and processing of parts for use in new manufacturing equipment, including in the semiconductor industry, and additional time for the same activities for use in replacement parts for equipment used in those industries. EPA is also expanding the categories of equipment covered by this approach so that the new compliance deadlines will include electronic equipment, heating, ventilation, air-conditioning, and refrigeration equipment, water-heating equipment, and power generating equipment, including outdoor power equipment. EPA is amending the existing compliance deadline to provide an additional 10 years for new parts for these additional categories, except for consumer electronic equipment, which is still subject to the October 31, 2024 deadline. These phase-in prohibitions to do not apply to articles subject to exclusions, in particular wire harnesses and circuit boards.
As mentioned, the categories are (1) manufacturing equipment, including equipment used in the semiconductor manufacturing industry, (2) electronic equipment (3) heating, ventilation, air-conditioning (HVAC), refrigeration, and water-heating equipment, and (4) power generating equipment. Manufacturing equipment generally refers to industrial machinery, such as automated manufacturing equipment, including robotics, and machine tools, that are an integral part of manufacturing or processing a product or article used in the manufacturing sector, including in semiconductor manufacturing and its ancillary support industries. EPA also includes in the manufacturing category non-road mobile machines, large scale fixed installations, and large scale stationary industrial tools. The electronic equipment category includes three subcategories: consumer electronic equipment, such as cell phones, computers and laptops, and game consoles; commercial equipment, including commercial printers and other business-to-business supplied electronics, as well as such as analysis, measurement, test, monitoring, and control instruments; and laboratory and research equipment, such as electron microscopes and laboratory appliances. The heating, ventilation, air-conditioning, refrigeration, and water-heating equipment category includes residential and commercial HVAC equipment as well as commercial refrigeration equipment. The power generating equipment category includes alternative power generation equipment such as batteries and battery charging equipment as well as outdoor power equipment, such as generators, lawnmowers, chain saws, snow throwers, tillers, and other related products. All these categories are subject to the new provisions EPA is finalizing for parts installed in new equipment, with the exception of consumer electronic equipment.
In the preamble to the proposal, EPA explained that the Agency is not further extending the existing October 31, 2024, compliance deadline for most other articles (see Unit III.D.1.vi. in the proposed rule). EPA also noted the Agency expects that in several industries, such as the textile industries, including consumer electronic equipment, the existing compliance time frame for processing and distribution in commerce of PIP (3:1) for use in articles and PIP (3:1)-containing articles ending October 31, 2024, is sufficient (Ref. 46). EPA also asked for comments on these proposed compliance time frames. Based on comments received, EPA continues to believe that the October 31, 2024, compliance deadline is practicable for the textile and consumer product industries, including consumer electronics. For other categories equipment, including commercial and research equipment, EPA continues to be convinced, as several commenters note, that there are difficulties in identifying PIP (3:1) in supply chains. In addition, commenters noted long development cycles for these types of equipment, and argued that additional time is needed to identify, test, certify, and adopt alternative parts, components, and finished products, as well as time to modify the manufacturing processes to accommodate an alternative substance.
For these reasons, EPA believes a time frame shorter than 10 years would not be practicable for the other categories of equipment identified. The 10-year phase-out for manufacturing and processing of PIP (3:1)-containing parts for use in new equipment being finalized applies to manufacturing equipment, commercial and laboratory electronic equipment, HVAC, refrigeration, and water heating equipment, and power generating equipment. It prohibits, after 10 years, all processing, and distribution in commerce of PIP (3:1) for use in parts for new equipment, and the manufacturing, processing and distribution in commerce of PIP (3:1)-containing products for use in parts for new equipment, and the manufacturing and processing of parts to which PIP (3:1) has been added for such equipment.
For replacement parts, EPA is finalizing an approach that accounts for the variability of service lives of the different types of equipment both within each category described previously and between categories. Several commenters (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284)) point out that the equipment produced may be designed to operate for a decade or longer and that replacement parts are critical to keep the equipment running. Commenters also note that redesigned parts for existing finished equipment cannot assure the same or similar performance, safety, and reliability as originally designed parts. For manufacturing equipment, EPA is allowing for the processing and distribution in commerce of PIP (3:1), the manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts, and the manufacturing and processing of replacement parts containing PIP (3:1) for the service lives of such equipment. Based on comments received, manufacturing equipment can survive in operation for decades. For heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, and for power generating equipment, EPA is allowing for the processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1) products for use in replacement parts, and manufacturing and processing of PIP (3:1)-containing replacement parts for 15 years after the manufacturing ban on new PIP (3:1)-containing parts, for a total of 25 years. As discussed previously for new parts, the Agency separated the electronic equipment category into three sub-categories: consumer, commercial, and laboratory. For the laboratory category, EPA is allowing for the processing and distribution of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts, and manufacturing and processing of replacement parts containing PIP (3:1), for the service lives of such equipment. As with manufacturing equipment, based on comments received, laboratory equipment can last for decades. For the commercial category, the Agency is allowing an additional 15 years for the processing and distribution in commerce of PIP (3:1), manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts, and manufacturing and processing of PIP (3:1)-containing replacement parts for use in such equipment, after the manufacturing ban on new PIP (3:1)-containing parts, for a total of 25 years. For both of the commercial and laboratory categories, users often enter into contracts that require manufacturers or dealers to provide ongoing maintenance for extended periods of time. For the processing and distribution in commerce of PIP (3:1) and the manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts for consumer electronic equipment and the manufacturing and processing of PIP (3:1)-containing replacement parts for consumer electronic equipment, EPA is setting a compliance deadline of 7 years. This aligns with right-to-repair laws that have been passed or are pending in many States. While only California, Colorado, Minnesota, and New York have passed right to repair laws, 30 States are considering right to repair laws that address agricultural, digital/electronic, or other equipment categories (
Several commenters (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0295, EPA-HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-0376-0291) asked EPA to clarify exclusion and phase-out precedence. Most commenters requested that EPA make clear that time-limited exemptions did not apply where they were in conflict with an exclusion or time-limited exemption with a longer compliance period, and conversely, that exclusions still applied when they were in conflict with a time-limited exemption.
In the former case, two commenters (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0295) noted that the current compliance deadline for PIP (3:1) for use in articles addressed by 40 CFR 751.407(a)(2)(iii) does not make clear that such deadline does not apply to articles subject to longer alternative compliance deadlines or exclusions, like articles with PIP-containing adhesives/sealants or lubricants/greases. The commenters noted that the proposed text also did not address the issue. To avoid misunderstanding, the commenters suggested that the existing alternative compliance deadline at 40 CFR 751.407(a)(2)(i) and the proposed alternative compliance deadline at 40 CFR 751.407(a)(2)(iv) should also be described as excepted from the phase-in prohibition at 40 CFR 751.407(a)(2)(iii). In response to these comments, EPA is amending 40 CFR 751.407(a)(2) to clarify that other phase-in prohibitions with longer term deadlines in 40 CFR 751.407(a)(2) or exclusions in 40 CFR 751.407(b) may allow the ongoing manufacture, processing, and/or distribution in commerce, where the terms of the longer-term phase-in or exclusion applies. However, the terms of the phase-in prohibition with a longer term for continued processing and distribution in commerce, for example, must expressly apply. For example, the amended regulatory text is clear that pursuant to 40 CFR 751.407(a)(1) any processing and distribution of PIP (3:1) or PIP (3:1)-containing products or articles is prohibited unless another provision in 40 CFR 751.407(a)(2) or (b) authorizes such processing and distribution in commerce. Neither the adhesive and sealant phase-in provision at 40 CFR 751.407(a)(2)(i) nor the lubricant and grease exclusion at40 CFR 751.407(b)(ii), both in the regulatory text adopted in 2021, allows the processing and distribution of PIP (3:1) for use in producing a PIP (3:1)-containing adhesive or lubricant product for use in any type of article. Those provisions allow a PIP (3:1)-containing lubricant, for example, to be processed and distributed in commerce for use, but not for use in an article. However, there are other provisions that do allow the processing and distribution of PIP (3:1) for use in a specific type of article; where EPA intended to allow PIP (3:1) to be processed or distributed in commerce for use in articles, EPA included reference to the article type in the regulatory provision. For example, 40 CFR 751.407(b)(1)(iii) as codified in 2021, and revisions finalized in 40 CFR 751.407(a)(2)(vi), both expressly address
Similarly, one commenter (EPA-HQ-OPPT-2023-0376-0297) asked EPA to make clear that the exclusion related to circuit boards and harnesses takes precedence in situations where other phase-in periods are more limited in nature. For example, if a PIP (3:1)-containing circuit board is used in the production or repair of a piece of manufacturing equipment that is used in semiconductor manufacturing, or is installed or in need of repair in a piece of heavy equipment used in automotive manufacturing, after the extension period has expired for the semiconductor manufacturing equipment or heavy machinery in automotive manufacturing categories, the PIP (3:1)-containing circuit board would still remain subject to the indefinite exclusion. EPA is clarifying that the final rule allows for the ongoing processing and distribution in commerce of PIP (3:1) for use in wire harnesses and circuit boards generally, and that such exclusion is not limited by the phase-outs in 40 CFR 751.407(a)(2). Thus, processing and distribution of PIP (3:1) may continue, for example, when for use in circuit boards, even after the compliance deadline has passed for the processing and distribution in commerce of PIP (3:1)-containing parts for use in motor or aerospace vehicles and other articles. Since this holds as a general rule for 40 CFR 751.407(a)(2) (the phase-in prohibitions), EPA is adding clarifying language to the regulatory text at 40 CFR 751.407(a)(2) to except the activities described in 40 CFR 751.407(b) (the exclusions from prohibitions).
EPA is finalizing, with minor modification to recordkeeping requirements, its proposal to require the use of PPE by workers involved in the manufacturing and processing of PIP (3:1) and certain products and articles containing PIP (3:1). EPA proposed to require inhalation and dermal PPE during domestic manufacturing and processing of PIP (3:1) and certain PIP (3:1)-containing products and articles to address potential respiratory and dermal exposure to occupational workers during certain ongoing domestic manufacturing or processing activities involving PIP (3:1), including those for which EPA is finalizing phase-out periods. Because EPA generally presumes the potential for exposure is low during importation, the Agency did not propose worker protections for import of PIP (3:1) and PIP (3:1)-containing products and articles. The Agency also did not propose worker protection for the processing of certain PIP (3:1)-containing products and articles: PIP (3:1)-containing adhesives and sealants, new and replacement parts to which PIP (3:1) has been added for motor and aerospace vehicles, and the motor and aerospace vehicles that contain new and replacement parts to which PIP (3:1) has been added, PIP (3:1)-containing specialized engine filters for locomotive and marine applications, and the products or articles described in 40 CFR 751.405(b)(1)(vi) and (vii). EPA also proposed excluding processing of PIP (3:1) and PIP (3:1)-containing products for use as an intermediate to produce cyanoacrylate adhesives when contained in a closed system under new 40 CFR 751.407(f)(7)(iii). Finally, EPA also proposed to require that owners/operators implement a PPE program in alignment with certain elements of OSHA's General Requirements for Personal Protective Equipment at 29 CFR 1910.132 and Respiratory Protection requirements in 29 CFR 1910.134. EPA is finalizing these requirements with slight changes to the recordkeeping provision (see Unit III.D.5).
Where PPE is required, EPA is finalizing its proposal to require implementation of a PPE program in alignment with certain elements of OSHA's General Requirements for Personal Protective Equipment at 29 CFR 1910.132 and Respiratory Protection requirements in 29 CFR 1910.134. EPA is requiring that owners/operators maintain PPE in a sanitary, reliable, and undamaged condition and ensure each potentially exposed person who is required to wear PPE to use such PPE. Under this final rule, owners/operators are required to select and provide PPE that properly fits each potentially exposed person who is required to use PPE and to communicate PPE selections (
For the manufacturing and processing of PIP (3:1) and PIP (3:1)-containing products for use in new and replacement parts for motor vehicles, including heavy machinery, and aerospace vehicles, EPA is requiring respiratory protection that must be at least as protective as a NIOSH-approved N95 respirator (APF 10). For processing of PIP (3:1) and PIP (3:1)-containing products for use in the manufacturing of cyanoacrylate adhesives, EPA is finalizing respiratory protection that must be at least as protective as a NIOSH-approved APF 50 respirator, except when the PIP (3:1) or PIP (3:1)-containing product is contained in a closed system. For all other activities covered, EPA is requiring respirators that are at least as protective as a NIOSH-approved APF 10 air-purifying half mask respirator. Based on stakeholder comments (Ref. 36) and OSHA-required Safety Data Sheets, EPA understands these levels of protection are already typically used as industry best practices, although the Agency lacks reasonably available information to determine the scale of adoption. For processing of PIP (3:1) as an intermediate processing aid in the manufacturing of cyanoacrylate adhesives, EPA is requiring engineering controls such that the processing of PIP (3:1) must take place in a closed loop system with general and local exhaust ventilation provided. EPA understands that only one company is currently processing PIP (3:1) for this use, and the proposed engineering controls are the current practice of the company.
EPA is finalizing its proposal that the owner or operator must ensure that all respirators used in the workplace are NIOSH-approved as listed on the NIOSH Certified Equipment List. In choosing appropriate gloves, EPA expects that owners/operators consider the effectiveness of glove type when preventing exposures from PIP (3:1) alone and in likely combination with other chemical substances used in the work area, the degree of dexterity required to perform tasks, and the temperature, as identified in the Hand Protection section of OSHA's Personal
Multiple commenters (EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0307, EPA-HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0290) discussed the import of PIP (3:1)-containing products and articles in their comments. As previously discussed, EPA is finalizing modifications to several exclusions from prohibition finalized in the January 6, 2021, PIP (3:1) final rule. These modifications include narrowing the scope of certain exclusions, adding prohibition phase-in dates, and in some cases creating new exclusions from prohibition for certain uses. In narrowing the scope of certain exclusions, EPA proposed to prohibit the import of the PIP (3:1)-containing articles and PIP (3:1)-containing products for those uses. This is to restrict the ability for these prohibited PIP (3:1)-containing articles and PIP (3:1)-containing products for those uses to be imported where they are no longer allowed to be produced in the United States. EPA is finalizing these phase-in prohibitions on manufacturing, including import, for certain uses under 40 CFR 751.407(a)(2) and has made edits to the regulatory text to make it clear what is prohibited and excluded. EPA modified the general provision title under 40 CFR 751.407(a)(1), to now be titled “General prohibition
In the 2021 PIP (3:1) final rule, EPA required that all persons who manufacture, process, or distribute in commerce PIP (3:1) and products and articles containing PIP (3:1) maintain ordinary business records related to compliance with the prohibitions and restrictions for three years and to make records available within 30 days upon request. EPA is increasing the recordkeeping requirement from three to five years and removing the 30-day time frame to make records available. Due to the additional requirements being finalized in this rulemaking, specifically those pertaining to worker safety, EPA considers the five-year time frame regarding recordkeeping and removal of the 30-day time frame to make records available is more appropriate. Furthermore, this five-year time frame aligns with the statute of limitations for civil penalty enforcement (28 U.S.C. 2462), and it is consistent with the time frame associated with other TSCA section 6(a) rulemakings that include worker protection requirements. EPA is confident that extending each rule's recordkeeping requirement to a consistent five-year requirement will facilitate regulated entities' compliance with minimal impact to regulatory burden. In addition, removal of the 30-day time frame to make records available is critical to the Agency's ability to promptly identify and correct noncompliance. EPA presumes that regulated entities should have the records demonstrating compliance readily available.
In addition, as it relates to recordkeeping for worker protections, EPA is finalizing its proposal to require that owners/operators document respiratory protection used and PPE program implementation and retain those records for five years. One commenter (EPA-HQ-OPPT-2023-0376-0312) requested that EPA modify its worker protection recordkeeping requirements to specify that records be made available to exposed workers and their representatives and to extend the record retention period. This commenter supports EPA's decision to eliminate the 30-day compliance period, thus making records immediately available to the Agency, but emphasized the importance of making records available to workers and their representatives as well. The commenter stated that this would be consistent with similar OSHA regulations. Furthermore, the commenter recommended extending the recordkeeping requirements to a much longer period of time, suggesting 20-30 years as an appropriate time frame. The commenter argued that the health effects due to exposure to toxic chemicals can exhibit long latency periods. This information about latency, the commenter expressed, should be available to workers throughout the period of potential consequences of an exposure.
As discussed in the proposed rule, the final five-year time frame is consistent with those associated with other TSCA section 6(a) rulemakings and removal of the 30-day time frame to make records available is critical to the Agency's ability to promptly identify and correct noncompliance. EPA determined that regulated entities should have the records demonstrating compliance readily available due to previous recordkeeping requirements for PIP (3:1) under TSCA; this measure is intended to make use of ordinary business records and thus not be overly burdensome to industry. In response to the request that EPA require records be made available to workers and to their designated representatives as well, EPA has modified the workplace protection records requirements for PIP (3:1) to require that the owner or operator provide potentially exposed persons and their designated representative an opportunity to observe records related to the basis of the PPE or other control measure selection, including potential monitoring results that are representative of the potentially exposed person's exposure.
EPA is also amending the downstream notification statement that must accompany shipments of PIP (3:1) or PIP (3:1) containing products to conform to the terms of the prohibitions in the final rule. EPA is providing a 3-month transition period to update SDS sheets and an 18-month transition period for updating labels. EPA believes that this transition period should allow time to clear products with old labels through channels of trade. During the 3-month transition period, downstream notification under 40 CFR 751.407(e)(1) and (2) is still required; entities may use the new information provided in new 40 CFR 751.407(e)(3) or existing notification consistent with the restrictions described in this subpart.
EPA received multiple comments on the continued use of articles, including finished goods containing such articles, which may contain PIP (3:1). For example, some commenters stated that certain PBT-containing articles would need to be disposed of or retired from use earlier than needed due to EPA's prohibitions and restrictions which would not allow for repair or general maintenance of an existing component. Such commenters (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0305, EPA-HQ-OPPT-2023-0376-0293, EPA-HQ-OPPT-2023-0376-0310) noted that finished goods move around in distribution channels and usually stay in inventory for weeks to several months, that retailers do not have control over how quickly these goods are sold and do not necessarily operate under a first-in, first-out operation, and that retailers would have difficulty differentiating between PIP (3:1)-containing articles from non-PIP (3:1)-containing articles, and may want to return the entire stock of goods (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0293). Commenters also noted the resulting negative impact of strictly eliminating stocks based on a “distribution in commerce” deadline may cause enormous economic and environmental impact (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0293, EPA-HQ-OPPT-2023-0376-0301, EPA-HQ-OPPT-2023-0376-0305, EPA-HQ-OPPT-2023-0376-0310). For example, one of the commenters noted that premature obsolescence would result in substantial economic losses as affected equipment becomes stranded assets, impacting the environment and the economy. Another commenter noted that companies may carry thousands of spare parts for discontinued goods for up to and beyond 10 years so customers can extend the life of the good (EPA-HQ-OPPT-2023-0376-0293). Two commenters also asked EPA to reiterate that the provision at 40 CFR 751.401(b)(1) permits an article or product that has been purchased or acquired other than for resale to be re-distributed, leased, or re-sold (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284). These two commenters also requested that EPA make clear that the language in 40 CFR 751.401(b)(1) permits the movement within the United States of complex manufacturing equipment and durable goods that might contain PIP (3:1)-containing components when such equipment or durable goods were manufactured prior to the date of any final prohibition in the PIP (3:1) regulation (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284). One commenter requested that EPA make clear that all existing products and articles that were manufactured prior to the various final effective dates in the PBT regulations are exempt (EPA-HQ-OPPT-2023-0376-0297). Another commenter noted that if an article needs to be repaired but was manufactured before the effective date of the final rules, it is simply impossible to check compliance on the article since the article was not managed to comply with the rules (EPA-HQ-OPPT-2023-0376-0284).
EPA is amending the regulatory text covering PIP (3:1) in a number of different ways to address these comments. First, EPA is amending the proposed regulatory text for a number of activities addressed in 40 CFR 751.407(a)(2) and adding an additional regulatory provision in 40 CFR 751.407(b) to make clear that the general prohibition in 40 CFR 751.407(a)(1) and the general phase-in prohibition for articles at 40 CFR 751.407(a)(2)(iii) do not apply to the distribution in commerce of certain PIP (3:1)-containing articles and the finished goods containing such articles, like cars, aerospace vehicles, and complex equipment. It was not EPA's intent to use its TSCA section 6(a) authorities to restrict the continued distribution and sale of such parts for such complex articles, where the manufacture and process of the part complies with the phase-in prohibition in 40 CFR 751.407(a)(2). For example, 40 CFR 751.407(a)(2)(v), as proposed, would have prohibited the distribution in commerce, after 15 years from the publication date, of PIP (3:1)-containing parts for new motor vehicles and the new motor vehicles containing those parts.
EPA has amended that provision to remove the prohibition on distribution in commerce of such parts and vehicles and EPA has added a new provision, 40 CFR 751.407(b)(viii), to exclude the distribution in commerce of such parts and vehicles from the general prohibition in 40 CFR 751.407(a)(1) and general phase-in prohibition in 40 CFR 751.407(a)(2)(iii). However, to be clear, the manufacturing and processing of such parts for such vehicles after 15 years from the date of publication of this rule is prohibited [and distribution in commerce of parts that do not comply with that requirement is not permitted by 40 CFR 751.407(b)(viii). Thus, as long as the parts meet the requirements in 40 CFR 751.407(a)(2)(v) relating to the manufacture and processing of such parts, the parts and the vehicles containing such parts may be distributed in commerce, for any reason, including as new or for use or resale. Similar changes have been made to similar provisions,
EPA is also amending 40 CFR 751.407(a)(2)(iii) to allow for an additional two years for the distribution of PIP (3:1) containing articles subject to the October 31, 2026, compliance deadline in order for those articles to clear channels of trade.
Second, EPA is adding 40 CFR 751.407(b)(1)(viii) to allow processing and distribution in commerce for maintenance and repair of existing PIP (3:1)-containing articles. EPA has stated in the 2021 final rules that is not practicable to use its TSCA section 6(a) authorities to regulate commercial use of products and articles containing the PBT chemicals, such as televisions and computers, because it would be extremely burdensome, necessitating the identification of articles, and the disposal of countless articles that would have to be identified and replaced. For similar reasons, EPA does not believe restricting continued maintenance and repair of existing PIP (3:1)-containing articles is practicable. Commenters raised the need for repair and maintenance for certain PIP (3:1)-containing articles, like equipment and machinery, which could result in the distribution in commerce and processing that would have been prohibited after relevant phase-in prohibition dates. Thus, in response to these comments, EPA is amending the provisions in 40 CFR 751.407 to exclude
Several commenters also supported a “manufactured-by” approach to allow for the sell-through of existing articles and spare parts and further processing and distribution of articles after compliance deadlines. Commenters state that manufacturers can only control the date of manufacture, not the date of distribution in commerce and, further, that manufacturers cannot ensure compliance after the product has left their control (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0305, EPA-HQ-OPPT-2023-0376-0293, EPA-HQ-OPPT-2023-0376-0310). Multiple commenters advocated for a manufactured-by date approach that clarifies that products that contain PIP (3:1) that have been manufactured prior to the prohibition dates may continue to be processed and distributed, and used indefinitely, allowing for continued servicing of equipment that are designed to remain in service for many years with articles containing PIP (3:1) through the lifetime of the equipment and not penalizing dealers with stranded inventory (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-0376-0305).
As discussed in the response to comments to the 2019 PBT proposed rule, EPA does not think, unless otherwise specified, that all products and articles containing PBT chemicals should continue to be processed and distributed without end, as it is practicable eventually to build and service most products that do not contain PBTs, as goods reach the end of their service lives and replacement parts that do not contain PBTs become available. EPA therefore is not adopting a generally applicable “manufactured by” provision. Instead, EPA has finalized specific phase-in prohibitions or exclusions for certain PBT-containing articles and finalized an exclusion solely for the purpose of repair and maintenance of an existing article.
In the 2021 PBT final rules, EPA declined to establish a general exclusion for PBTs produced as a byproduct, present as an unintentional contaminant, or present in what commenters describe as
During the comment period for this rule, several commenters requested that EPA establish a de minimis exemption for decaBDE and PIP (3:1) (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0292, EPA-HQ-OPPT-2023-0376-0297). As noted previously, one commenter proposed that EPA adopt a threshold limit of no less than 0.001% for the presence of PIP (3:1) and 0.1% for the presence of decaBDE in articles. Another commenter stated that a
Commenting on PIP (3:1), one commenter noted that “the lack of a de minimis threshold ensures that manufacturers will need to account for, and remove, trace amounts of PIP (3:1) in their products, which will require expensive lab testing to confirm (assuming PIP (3:1) can be found above the limit of detection)” (EPA-HQ-OPPT-2023-0376-0308). One commenter pointed out the potential for cross contamination since components subject to a prohibition may be manufactured in the same facilities as components containing PIP (3:1) (EPA-HQ-OPPT-2023-0376-0305). At least one commenter requested EPA distinguish between intentionally added PIP (3:1) and unintentional impurities (EPA-HQ-OPPT-2023-0376-0001). A number of commenters also noted that in a complex supply chain it may not always be possible to secure contract specifications or assurances from suppliers regarding the presence of PIP (3:1) and that it would be resource intensive to demonstrate the complete absence of a chemical if there is no threshold to make that determination (EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0308, EPA-HQ-OPPT-2023-0376-0288).
For decaBDE, three commenters argued that a threshold is also needed, and two commenters recommended that EPA set it at 0.1% to align with other major regulatory regimes, such as the Restriction of Hazardous Substances (RoHS) (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0292, EPA-HQ-OPPT-2023-0376-0297). Several commenters on this issue recommended EPA adopt a 0.1% concentration level for PIP (3:1) as well. (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0308). One of the commenters recommended that, as a practical matter, EPA establish in all TSCA section 6(h) regulations for PBTs a de minimis standard of 0.1% by weight of the finished product or article. One commenter (EPA-HQ-OPPT-2023-0376-0310) argued that a 0.1% concentration level is consistent with EPA's export notification requirement for known or suspected carcinogens (EPA-HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-0376-0308), and that, while PIP (3:1) is not covered under Europe's RoHS, a 0.1% concentration level is at least consistent with the level set for most chemicals under RoHS.
EPA agrees with these comments and believes that setting a regulatory
The regulatory threshold level of 0.1% in this final rule applies to products and articles measured by weight, except for any amount present due to an excluded use or phased-out use that has not yet reached its compliance deadline. For complex assemblies of articles, the regulatory threshold level applies to each article individually and not to the complex assembly as a whole. EPA is not adopting the interpretation of article suggested by one commenter, namely that concentrations of a substance present in components of an assembly of articles be measured against the total weight of the assembly (EPA-HQ-OPPT-2023-0376-0306). The commenter stated the belief that EPA's interpretation was aligned with this understanding of how to account for concentrations of a substance in an article (EPA-HQ-OPPT-2023-0376-0306). EPA disagrees, and notes that the definition of an article, provided at 40 CFR 751.403 provides the clarification the comment seeks. The term “article” as defined in 40 CFR 751.403, paragraphs (1) and (2), is a manufactured item “[w]hich is formed to a specific shape or design during manufacture,” and “[w]hich has end use function(s) dependent in whole or in part upon its shape or design during end use.” EPA determined that the individual parts of a complex assembly of parts would meet this definition. EPA is not providing additional interpretive guidance at this time, as the Agency believes the definition of article is sufficiently clear in this regard.
In setting a regulatory threshold level, EPA considered other regulatory thresholds, such as OSHA, which included a 0.1% threshold for determining hazards from certain chemicals to absolve employers from having to evaluate and list chemicals present in mixtures in small quantities that may not result in substantial exposures, and EPA's export notification requirements and reporting requirements under the Toxics Release Inventory Reporting under the Emergency Planning and Community Right-to-know Act, both of which set a threshold of 0.1% for some chemicals. Another example is the European Union's Regulation on the registration, evaluation, authorization and restriction of chemicals (REACH), which states that decaBDE “Shall not be used in the production of, or placed on the market in . . . an article, or any part thereof, in a concentration equal to or greater than 0.1% by weight.” (Ref. 49). Suppliers' familiarity with these levels ought to reduce the administrative burden associated with tracking different thresholds for different uses. EPA also considered the concentration level of 0.001% for PIP (3:1) suggested by a commenter (EPA-HQ-OPPT-0376-0288). This commenter recommended this lower level when PIP (3:1) is measured against the weight of the article as a whole in complex assemblies, rather than each component article that makes up the complex assembly. It is not clear that a regulatory threshold level this low would be practicable for individual components or across industries.
EPA previously reasoned that setting a single regulatory threshold level of 0.1% for all uses is not practicable, given the concentrations of these two chemicals in the supply chain for different types of products, which would make establishing a concentration threshold for each use overly burdensome and impracticable. Given the comments from stakeholders noting that a 0.1% concentration level is consistent with EPA's export notification requirement and is at least consistent with the level set for most chemicals under RoHS, EPA now concludes that stakeholders would be able to comply with a single regulatory threshold level, despite the differing concentrations for different types of products and articles.
Since decaBDE and PIP (3:1) are additive chemicals and are not known to be present as a byproduct, EPA is not establishing a regulatory threshold level where decaBDE or PIP (3:1) is intentionally added. EPA is confident that where decaBDE is intentionally added, it is intended to be present at concentrations at least an order of magnitude higher than 0.1% and EPA has adopted regulatory controls to address such intentional activities. Commenters provided information indicating that an 0.1% concentration is generally below the levels present in the majority of intentional uses of PIP (3:1). However, EPA is aware of the manufacture and processing of certain products or articles containing PIP (3:1) at levels intentionally well below 0.1% (Ref. 50). In such cases, PIP (3:1) levels in such products or articles will be presumed to be intentional and thus the regulatory threshold level of 0.1% adopted in this rule would not apply to those products or articles. Thus, this regulatory threshold of 0.1% allows a practicable approach for managing unintentionally present decaBDE and PIP (3:1).
EPA had previously declined to set a regulatory threshold level in part because EPA asserted that setting a threshold level would require expensive testing. However, EPA is making clear that testing is not required. While that is the case, companies may choose to do so if they believe contaminant or unintentional levels may be present and wish to document that the levels are below the 0.1% regulatory threshold level.
EPA has evaluated the potential costs of the final rule. Industry costs may arise from implementing measures to protect from exposure or switching from the manufacture or use of the chemical to a substitute. These costs include: reformulation of prohibited products using alternative chemicals to manufacture the product, or the price differential of available substitute products that do not contain PIP (3:1), providing workers with the required personal protective equipment (
Total quantified annualized industry costs for the final rule are estimated to be $400 million at a 3 percent discount rate and $430 million at a 7 percent discount rate annualized over 30 years. Costs at a 2 percent discount rates are estimated at $390 million (shown in appendix A of the accompanying Economic Analysis for this final rule). Of the final rule costs, those associated with decaBDE alone were approximately $86 at a 3 percent discount rate and $128 at a 7 percent discount rate. Costs associated with PIP (3:1) were $400 million and $430 million (at 3 and 7 percent discount rates, respectively.) Of this total, worker protection (PPE) costs under the final regulatory option annualized at a 3 percent discount rate is $373 million and $410 million at a 7 percent discount rate with PIP (3:1) accounting for all costs. The reason for the large disparity in the costs between decaBDE and PIP (3:1) results from the difference in the number of firms using each chemical under the final rule's regulated activities. There are only two firms known to be using decaBDE that will be impacted by this final rule. Substantially more firms (up to 26,803) could potentially be impacted by the PIP (3:1) final rule requirements based on the sectors impacted. Prohibition costs for PIP (3:1) annualized at a 3 percent discount rate were estimated at $27 million and $20 million annualized at a 7 percent discount rate. For the economic analyses for the 2021 PBT final rules, EPA estimated that it would need one full-time equivalent (FTE) employee for implementation (
A qualitative discussion of the potential benefits associated with the final action for decaBDE and PIP (3:1) is provided. PIP (3:1) is a neurotoxicant and aquatic toxicant with high persistence and high potential for bioaccumulation. DecaBDE has been found to have an association with liver cancer and benign liver tumors in rats and mice and had hepatic, renal, immune, and reproductive toxicity concerns in animal studies. Research has also indicated that decaBDE is acutely toxic to fish and aquatic invertebrates. As a result of this final rule, prohibition and PPE requirements, EPA anticipates decreased potential for occupational exposures and reduced potential for exposures to the general population, potentially exposed or susceptible subpopulations, and the environment.
With respect to the cost effectiveness of the final regulatory action and the primary alternative regulatory action, EPA is unable to perform a traditional cost-effectiveness analysis of the actions and alternatives for the PBT chemicals. As discussed in the proposed rule, the cost effectiveness of a policy option would properly be calculated by dividing the annualized costs of the option by a final outcome, such as cancer cases avoided, or to intermediate outputs such as tons of emissions of a pollutant curtailed. Without the supporting analyses for a risk determination, EPA is unable to calculate either a health-based or environment-based denominator. Thus, EPA is unable to perform a quantitative cost-effectiveness analysis of the primary and alternative regulatory actions. However, by evaluating the practicability of the final and alternative regulatory actions, EPA is confident that it has considered elements related to the cost effectiveness of the actions, including the cost and the effect on exposure to the PBT chemicals of the primary and alternative regulatory actions.
EPA considered the anticipated effect of this final rule on the national economy and concluded that this rule is highly unlikely to have any measurable effect on the national economy (Ref. 17). EPA analyzed the expected impacts on small business and found that of the 24,865 small businesses potentially impacted by the rule, 860 are expected to incur cost impacts between 1 and 3 percent of their annual revenue. No entities are expected to be impacted above 3 percent of their annual revenue (Ref. 17). Finally, EPA has determined that this final rule is unlikely to have significant impacts on technological innovation, although the rule may create some incentives for chemical manufacturers to develop new chemical alternatives to PIP (3:1).
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult those listed under
Additional information about these statutes and Executive orders can be found at
This action is a “significant regulatory action” as defined under section 3(f)(1)
The information collection activities in this rule have been submitted to OMB for approval under the PRA, 44 U.S.C. 3501
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 EPA regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601,
This action contains a Federal mandate that may result in expenditures of $183 million in 2023 dollars ($100 million in 1995 dollars adjusted for inflation using the GDP implicit price deflator) or more as described in UMRA, 2 U.S.C. 1531-1538, for the private sector in any one year. Total quantified annualized social costs for this final rule are approximately $400 million at a 3 percent discount rate, and $430 million at a 7 percent discount rate. Costs at a 2 percent discount rate are estimated at $390 million. These private sector costs are presented in the Economic Analysis (Ref. 17), a copy of which is available in the docket, and are briefly summarized in Unit I.E. and discussed in Unit IV.
This action is not subject to the requirements of sections 202 and 203 of UMRA because this action imposes no enforceable duty on any State, local or Tribal governments and does not significantly or uniquely affect small governments. This action only impacts only imposes enforceable duties on private sector entities that manufacture (including import), process, distribute in commerce, use, or dispose of decaBDE and PIP (3:1), and government entities are not engaged in these activities.
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because 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. As stated in Unit VI.D., State and local government entities are not engaged in the activities covered by this action. See also the discussion in Unit I.E.6.
This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. As stated in Unit VI.D., Tribal government entities are not engaged in the activities covered by this action. See also the discussion in Unit I.E.6.
Executive Order 13045 (62 FR 19885, April 23, 1997) 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. This action is subject to Executive Order 13045 because it is a significant regulatory action under section 3(f)(1) of Executive Order 12866, and the EPA believes that the environmental health or safety risk addressed by this action may have a disproportionate effect on children. While EPA understands that this action addresses the health and environmental risks presented by the PBT chemicals subject to this action that may have a disproportionate effect on children, EPA did not perform a risk assessment or risk evaluation of these PBT chemicals. However, the final requirements will reduce potential exposure to these PBT chemicals for the general population and for susceptible subpopulations such as workers and children. EPA's evaluation of the exposure potential of these PBT chemicals (Ref. 19) and summary of the health and environmental hazards that may be presented by these chemical substances (Ref. 24) are summarized in Unit II.E., with referenced documents available in the docket. In addition, the regulatory options analyzed are discussed in Unit III.
Furthermore, EPA's
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.
This action does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.
EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on communities with EJ concerns consistent with Executive Order 14096 (88 FR 25251, April 26, 2023) building on and supplementing Executive Order 12898 (59 FR 7629, February 16, 1994). EPA's related evaluation is summarized in Units I.E.4. and VI., and discussed in the Economic Analysis (Ref. 17) that is in the docket.
Since a risk evaluation was not conducted, EPA's understanding of the extent to which reductions in exposure might reduce risks for communities with environmental justice concerns is limited. Data are not sufficiently comprehensive to estimate the extent to which the final rule will reduce existing disproportionate impacts on communities with EJ concerns. Data on the worker composition of affected industries, presented in sections 6.5.1 and 6.5.2 of the Economic Analysis (Ref. 17), provide a general indication of how different demographic groups in the worker population may be affected. Certain exclusions and extensions of compliance dates beyond the onset of the final rule may partially delay addressing these impacts. EPA is confident that the restrictions that will be placed on decaBDE and PIP (3:1) with adoption of this final rule will reduce the potential exposures, and therefore, reduce any potential risks, associated with the manufacture, processing and use of these chemicals. EPA cannot confirm which specific subpopulations are at a disproportionate risk from exposure nor make a quantified estimate of the change in exposure that will result from the rule. In addition, only a small subset of the specific facilities using decaBDE and PIP (3:1) have been identified, so a proximity analysis examining the characteristics of the communities surrounding the known facilities might not be representative of all exposed communities. Some workers will receive PPE with adoption of the rule, while others will no longer be exposed to decaBDE and PIP (3:1). As companies reformulate with chemical alternatives, some workers may be exposed to these alternatives. Local communities will also be less exposed to decaBDE and PIP (3:1), though exposure to chemical alternatives may increase. EPA does not know which chemical alternatives industry will ultimately use. Some alternatives are less toxic than and some are comparably toxic to decaBDE and PIP (3:1).
This action is subject to the CRA, 5 U.S.C. 801
Environmental protection, Chemicals, Export notification, Hazardous substances, Import certification, Reporting and recordkeeping.
Therefore, for the reasons set forth in the preamble, EPA is amending 40 CFR chapter I as follows:
15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
(c)
The revisions and additions read as follows:
(a) * * *
(1)
(ii) Unless otherwise specified in this subpart, the prohibitions and restrictions of this subpart do not apply to products or articles containing decaBDE at concentrations less than 0.1% by weight, if the decaBDE was not intentionally added to the product or article.
(2) * * *
(ii) After January 6, 2023, all persons are prohibited from all processing and distribution in commerce of decaBDE for use in wire and cable insulation in nuclear power generation facilities (including test and research reactors).
(vi) After the end of the wire and cables' service life, all persons are prohibited from all processing and distribution in commerce of decaBDE-containing wire and cable insulation for nuclear power generation facilities (including test and research reactors).
(b)
(c) * * *
(1) * * *
(i) These records must be maintained for a period of five years from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(d)
(2) Each sign must show clearly, prominently, in multiple languages as appropriate, and in an easily readable font size the following text:
Decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5), a chemical that has been identified as a persistent, bioaccumulative, and toxic (PBT) chemical by the U.S. Environmental Protection Agency, may be present in this regulated area. All persons in this regulated area who recycle existing plastic shipping pallets that contain decaBDE are required to wear personal protective equipment, including respiratory protection that is at least as protective as a NIOSH-approved N95 respirator with an assigned protection factor (APF) of 10 and dermal protection of gloves that are chemically resistant to decaBDE, per regulations at 40 CFR 751.405(e).
(2)
(i) The owner or operator must limit access to regulated areas to authorized persons.
(ii) The owner or operator must demarcate regulated areas from the rest of the workplace in a manner that adequately establishes and alerts persons to the boundaries of the regulated area and minimizes the number of authorized persons exposed to decaBDE within the regulated area.
(iii) The owner or operator must ensure that each potentially exposed person is provided with a respirator according to the requirements of paragraph (e) of this section and must ensure that all potentially exposed persons within the regulated area are using the provided respirators whenever exposures to airborne concentrations of decaBDE can reasonably be expected.
(iv) The owner or operator must ensure that while persons are wearing respirators in the regulated area, they do not engage in activities that interfere with respirator seal or performance.
(v) The owner or operator must ensure that, within a regulated area, persons do not engage in non-work activities that may increase exposure to decaBDE.
(3)
(i) For purposes of this paragraph (e)(3), cross-referenced provisions in 29 CFR 1910.134 applying to an “employee” apply equally to potentially exposed persons and cross-referenced provisions applying to an “employer” also apply equally to owners or operators. Other terms in cross-referenced provisions in 29 CFR 1910.134 that are defined in 29 CFR 1910.134(b) have the meaning assigned to them in 29 CFR 1910.134(b).
(ii) Owners and operators must develop and administer a written respiratory protection program consistent with the requirements of 29 CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select respiratory protection that properly fits each affected person and communicate respirator selections to each affected person consistent with the requirements of 29 CFR 1910.134(f).
(iv) Owners and operators must provide, ensure use of, and maintain (in a sanitary, reliable, and undamaged condition) respiratory protection that is of safe design and construction for the applicable condition of use consistent with the requirements of 29 CFR 1910.134(g) through (j).
(v) Prior to or at the time of initial assignment to a job involving potential exposure to decaBDE, owners and operators must provide training to all persons required to use respiratory protection consistent with 29 CFR 1910.134(k).
(vi) Owners and operators must retrain all persons required to use PPE at least annually, or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in PPE to be used render the previous training obsolete.
(vii) The type of respiratory protection that the owners or operator must select and provide to potentially exposed persons must be at least as protective as a NIOSH-approved N95 respirator (APF 10).
(viii) Owners and operators must select and provide respirators as required in paragraph (e)(3) of this section consistent with the requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of workplace and user factors that affect respirator performance and reliability.
(ix) Owners and operators must ensure that respirators are used in compliance with the terms of the respirator's NIOSH certification.
(x) Owners and operators must conduct regular evaluations of the workplace, including consultations with potentially exposed persons using respiratory protection, consistent with the requirements of 29 CFR 1910.134(l), to ensure that the provisions of the written respiratory protection program required under paragraph (e)(3) of this section are being effectively implemented.
(xi) The respiratory protection requirements in this paragraph (e)(3) represent the minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the required respirator may be used.
(4)
(ii) Owners or operators must supply and require the donning of dermal PPE that separates and provides a barrier to prevent direct dermal contact with decaBDE in the specific work area where it is selected for use, selected in accordance with this paragraph (e)(4) and provided in accordance with 29 CFR 1910.132(h), to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact with decaBDE. For the purposes of this paragraph (e)(4), provisions in 29 CFR 1910.132(h) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.
(iii) Dermal PPE that is of safe design and construction for the work to be
(iv) Owners or operators must provide training in accordance with 29 CFR 1910.132(f) to all persons required to use dermal protection prior to or at the time of initial assignment to a job involving exposure to decaBDE. For the purposes of this paragraph (e)(4), provisions in 29 CFR 1910.132(f) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.
(v) Owners and operators must retrain each person required to use dermal protection at least annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use dermal protection, or when changes in the workplace or in dermal protection to be used render the previous training obsolete.
(5)
(A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle decaBDE or handle equipment or materials on which decaBDE may be present;
(B) The basis for the regulated area as defined in § 751.403, including monitoring data and documentation of any controls or combination of controls that have reduced exposure to where airborne concentrations of decaBDE can no longer reasonably be expected resulting in a smaller or no regulated area being established;
(C) The type of PPE selected by the owner or operator for use by each of these persons, the respiratory protection used by each potentially exposed person, and PPE program implementation, including fit-testing and training;
(D) The basis for the PPE selection (
(E) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE.
(ii) These records must be maintained for a period of five years from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(iv) The owner or operator must provide potentially exposed persons and their designate representative an opportunity to observe records related to the basis of the PPE or another control measure selection, including potential monitoring results that are representative of the potentially exposed person's exposure.
(6)
(i) Import of decaBDE and decaBDE-containing products and articles.
(ii) Recycling of decaBDE-containing plastic from products or articles and decaBDE-containing products or articles made from such recycled plastic, where no new decaBDE is added during the recycling or production processes, except for those articles identified in paragraph (a)(2)(v) of this section.
(iii) Processing addressed in paragraph (a)(2)(vi) of this section of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities.
(iv) Processing of new and replacement parts to which decaBDE has been added for motor and aerospace vehicles, and the motor and aerospace vehicles that contain new and replacement parts to which decaBDE has been added.
(f)
(g)
The revisions and additions read as follows:
(a) * * *
(1)
(2)
(iii) After October 31, 2024, all persons are prohibited from all processing and distribution of PIP (3:1) for use in articles and all processing of PIP (3:1)-containing articles. After October 31, 2026, all persons are prohibited from distribution in commerce of PIP (3:1)-containing articles.
(iv) After November 21, 2039, all persons are prohibited from all processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in lubricants and greases and PIP (3:1)-containing lubricants and grease.
(v) After November 21, 2039, all persons are prohibited from all processing and distribution in commerce of PIP (3:1) for use in parts for new motor vehicles, including heavy motorized machinery, and manufacturing, processing, and distribution in commerce of PIP (3:1)-
(vi) After November 19, 2054, all persons are prohibited from all processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts for motor vehicles, including heavy motorized machinery, and manufacturing and processing of PIP (3:1)-containing replacement parts for such vehicles.
(vii) After November 19, 2054, all persons are prohibited from all processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts for new aerospace vehicles, and manufacturing and processing of PIP (3:1)-containing parts for such vehicles.
(viii) After the end of the aerospace vehicles service lives, all persons are prohibited from all processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts for aerospace vehicles and manufacturing and processing of PIP (3:1)-containing replacement parts for such vehicles.
(ix) After November 19, 2029, all persons are prohibited from processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in marine antifouling coating products that are registered under the Federal, Insecticide, Fungicide, Rodenticide Act and that meet U.S. Department of Defense specification requirements.
(x) After November 20, 2034, all persons are prohibited from processing, and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts for new manufacturing equipment, including in the semiconductor industry, for new heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, new power generating equipment, new laboratory equipment, new commercial electronic equipment, and the manufacturing and processing of PIP (3:1)-containing parts for those equipment.
(xi) After the end of the manufacturing and laboratory equipment service lives, all persons are prohibited from processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts and manufacturing and processing of PIP (3:1)-containing replacement parts for manufacturing equipment and laboratory equipment, respectively. After November 19, 2049 all persons are prohibited from processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts and manufacturing and processing of PIP (3:1)-containing replacement parts for heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, for power generating equipment, and for commercial electronic equipment. After November 19, 2031 all persons are prohibited from processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts and manufacturing and processing of PIP (3:1)-containing replacement parts for consumer electronic equipment.
(b) * * *
(1) * * *
(ii) PIP (3:1) for use in lubricants and greases for aerospace use and turbine engines, PIP (3:1)-containing products for use in lubricants and greases for aerospace use and turbine engines, and PIP (3:1)-containing lubricants and greases for aerospace use and turbine engines;
(iii) PIP (3:1) and PIP (3:1)-containing products for use in circuit boards and wire harnesses, including but not limited to terminal and fuse covers, cable sleeves, casings, connectors, and tapes, and PIP (3:1)-containing circuit boards and wire harnesses including but not limited to terminal and fuse covers, cable sleeves, casings, connectors, and tapes.
(vii) Finished products or articles made of plastic recycled or reused from products or articles containing PIP (3:1), where no new PIP (3:1) was added during the production of the products or articles made of recycled plastic.
(viii) Articles that contain PIP (3:1), and where PIP (3:1) has not been newly added, for the purpose of repair or maintenance.
(2) Distribution in commerce of:
(i) PIP (3:1)-containing parts for vehicles meeting the requirements in paragraphs (a)(2)(v) through (viii) of this section, for equipment meeting requirements in paragraphs (a)(2)(x) through (xi) of this section, and the vehicles and equipment that contain such parts.
(ii) [Reserved]
(d) * * *
(1) After March 8, 2021, persons who manufacture, process, or distribute in commerce PIP (3:1) or PIP (3:1)-containing products or articles must maintain ordinary business records, such as invoices and bills-of-lading, related to compliance with the prohibitions, restrictions, and other provisions of this section. These records must be maintained for a period of five years from the date the record is generated.
(3) These records must be made available to EPA upon request.
(e) * * *
(3) Downstream notification must occur by inserting the text in paragraphs (e)(3)(i) and (ii) of this section in the Safety Data Sheet (SDS) by February 19, 2025, or by including on the label of any PIP (3:1) or PIP (3:1)-containing product by May 19, 2026, the label language in paragraph (e)(3)(iii) of this section:
(i)
The Environmental Protection Agency prohibits processing and distribution of this chemical/product for any use other than: (1) In hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S. Department of Defense specification requirements, (2) In lubricants and greases for aerospace and turbine uses and, for all other lubricant and grease uses before November 21, 2039, (3) circuit boards and wire harnesses, including but not limited to terminal and fuse covers, cable sleeves, casings, connectors and tapes, (4) As an intermediate in the manufacture of cyanoacrylate glue, (5) In specialized engine air filters for locomotive and marine applications, (6) In adhesives and sealants before January 6, 2025, after which use in adhesives and sealants is prohibited, (7) In new parts for motor vehicles before November 21, 2039 and replacement parts for motor vehicles before November 19, 2054, (8) In new parts for aerospace vehicles before November 19, 2054 and replacement parts for aerospace vehicles after the end of the aerospace vehicles service lives, (9) In marine antifouling coating products that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act and that meet U.S. Department of Defense specification requirements before November 19, 2029, (10) In new manufacturing equipment, new products or articles in the semiconductor industry, for new heating,
(ii)
The Environmental Protection Agency prohibits processing and distribution of this chemical/product for any use other than: (1) In hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S. Department of Defense specification requirements, (2) In lubricants and greases for aerospace and turbine uses and lubricants and, for all other lubricant and grease uses before November 21, 2039, (3) circuit boards and wire harnesses, including but not limited to terminal and fuse covers, cable sleeves, casings, connectors and tapes, (4) As an intermediate in the manufacture of cyanoacrylate glue, (5) In specialized engine air filters for locomotive and marine applications, (6) In adhesives and sealants before January 6, 2025, after which use in adhesives and sealants is prohibited, (7) In new parts for motor vehicles before November 21, 2039 and replacement parts for motor vehicles before November 19, 2054, (8) In new parts for aerospace vehicles before November 19, 2054 and replacement parts for aerospace vehicles after the end of the aerospace vehicles service lives, (9) In marine antifouling coating products that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act and that meet U.S. Department of Defense specification requirements before November 19, 2029, (10) In new manufacturing equipment, new products or articles in the semiconductor industry, for new heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, new power generating equipment, new laboratory equipment, new commercial electronic equipment, and new consumer electronic equipment before November 20, 2034, (11) replacement parts for manufacturing and laboratory equipment after the end of the equipment's service life, (12) replacement parts for heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, for power generating equipment, and for commercial electronic equipment before November 19, 2049, (13) replacement parts for consumer electronic equipment before November 19, 2031, (14) in other articles before October 31, 2024, after which use in articles other than those with later phase-in prohibition dates or exclusions is prohibited. In addition, all persons are prohibited from releasing PIP (3:1) to water during manufacturing, processing, and distribution in commerce, and must follow all existing regulations and best practices to prevent the release of PIP (3:1) to water during the commercial use of PIP (3:1).
(iii)
The Environmental Protection Agency prohibits processing and distribution of this chemical/product for any use other than: (1) In hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S. Department of Defense specification requirements, (2) In lubricants and greases for aerospace and turbine uses and, for all other lubricant and grease uses before November 21, 2039, (3) circuit boards and wire harnesses, including but not limited to terminal and fuse covers, cable sleeves, casings, connectors and tapes, (4) As an intermediate in the manufacture of cyanoacrylate glue, (5) In specialized engine air filters for locomotive and marine applications, (6) In adhesives and sealants before January 6, 2025, after which use in adhesives and sealants is prohibited, (7) In new parts for motor vehicles before November 21, 2039 and replacement parts for motor vehicles before November 19, 2054, (8) In new parts for aerospace vehicles before November 19, 2054 and replacement parts for aerospace vehicles after the end of the aerospace vehicles service lives, (9) In marine antifouling coating products that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act and that meet U.S. Department of Defense specification requirements before November 19, 2029, (10) In new manufacturing equipment, new products or articles in the semiconductor industry, for new heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, new power generating equipment, new laboratory equipment, new commercial electronic equipment, and new consumer electronic equipment before November 20, 2034, (11) replacement parts for manufacturing and laboratory equipment after the end of the equipment's service life, (12) replacement parts for heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, for power generating equipment, and for commercial electronic equipment before November 19, 2049, (13) replacement parts for consumer electronic equipment before November 19, 2031, (14) in other articles before October 31, 2024, after which use in articles other than those with later phase-in prohibition dates or exclusions is prohibited. In addition, all persons are prohibited from releasing PIP (3:1) to water during manufacturing, processing, and distribution in commerce, and must follow all existing regulations and best practices to prevent the release of PIP (3:1) to water during the commercial use of PIP (3:1).
(4) Any downstream notification that occurs under paragraph (e) of this section between February 19, 2025 and May 19, 2026, must include a safety data sheet with the language in paragraphs (e)(3)(i) and (ii) of this section unless distributing products with labels reflecting the language in paragraph (e)(3)(iii) of this section.
(5) The downstream notification requirements in paragraph (e) of this section do not apply to the activities described in paragraphs (b)(1)(vi) and (vii) of this section.
(f)
(2)
(i) The owner or operator must limit access to regulated areas to authorized persons.
(ii) The owner or operator must demarcate regulated areas from the rest of the workplace in a manner that adequately establishes and alerts persons to the boundaries of the regulated area and minimizes the number of authorized persons exposed to PIP (3:1) within the regulated area.
(iii) The owner or operator must ensure each potentially exposed person is provided with a respirator according to the requirements of paragraph (f) of this section and must ensure that all potentially exposed persons within the regulated area are using the provided respirators whenever exposures to airborne concentrations of PIP (3:1) can reasonably be expected.
(iv) The owner or operator must ensure that while persons are wearing respirators in the regulated area, they do not engage in activities that interfere with respirator seal or performance.
(v) The owner or operator must ensure that, within a regulated area, persons do not engage in non-work activities that may increase exposure to PIP (3:1).
(3)
(i) For purposes of this paragraph (f)(3), cross-referenced provisions in 29 CFR 1910.134 applying to an “employee” apply equally to potentially exposed persons and cross-referenced provisions applying to an “employer” also apply equally to owners or operators. Other terms in cross-referenced provisions in 29 CFR 1910.134 that are defined in 29 CFR 1910.134(b) have the meaning assigned to them in 29 CFR 190.134(b).
(ii) Owners and operators must develop and administer a written respiratory protection program consistent with the requirements of 29 CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select respiratory protection that properly fits each affected person and communicate respirator selections to each affected person consistent with the requirements of 29 CFR 1910.134(f).
(iv) Owners and operators must provide, ensure use of, and maintain (in a sanitary, reliable, and undamaged condition) respiratory protection that is of safe design and construction for the applicable condition of use consistent with the requirements of 29 CFR 1910.134(g) through (j).
(v) Prior to or at the time of initial assignment to a job involving potential exposure to PIP (3:1) owners and operators must provide training to all persons required to use respiratory protection consistent with 29 CFR 1910.134(k).
(vi) Owners and operators must retrain all persons required to use PPE at least annually, or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in PPE to be used render the previous training obsolete.
(vii) The type of respiratory protection that the owner or operator must select and provide to potentially exposed persons must be at least as protective as a NIOSH-approved APF 10 air-purifying half mask respirator except for those uses identified in paragraphs (f)(3)(viii) and (ix) of this section.
(viii) The type of respiratory protection that owners or operators must select and provide to potentially exposed persons must be at least as protective as a NIOSH-approved N95 respirator (APF 10) for the manufacturing and processing of PIP (3:1), and PIP (3:1)-containing products for use in new and replacement parts for motor vehicles, including heavy machinery, and aerospace vehicles.
(ix) The type of respiratory protection that owners or operators must select and provide to potentially exposed persons must be at least as protective as a NIOSH-approved APF 50 purifying respirator for use as an intermediate to produce cyanoacrylate adhesives when PIP (3:1) and PIP (3:1)-containing products are not contained in a closed system (
(x) Owners and operators must select and provide respirators as required in paragraph (f)(3) of this section consistent with the requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of workplace and user factors that affect respirator performance and reliability.
(xi) Owners and operators must ensure that respirators are used in compliance with the terms of the respirator's NIOSH certification.
(xii) Owners and operators must conduct regular evaluations of the workplace, including consultations with potentially exposed persons using respiratory protection, consistent with the requirements of 29 CFR 1910.134(l), to ensure that the provisions of the written respiratory protection program required under paragraph (f)(3) of this section are being effectively implemented.
(xiii) The respiratory protection requirements in this paragraph (f)(3) represent the minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the required respirator may be used.
(4)
(ii) Owners or operators must supply and require the donning of dermal PPE that separates and provides a barrier to prevent direct dermal contact with PIP (3:1) in the specific work area where it is selected for use, selected in accordance with this paragraph (f)(4) and provided in accordance with 29 CFR 1910.132(h), to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact with PIP (3:1) For the purposes of this paragraph (f)(4), provisions in 29 CFR 1910.132(h) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.
(iii) Dermal PPE that is of safe design and construction for the work to be performed must be provided, used, and maintained in a sanitary, reliable, and undamaged condition. Owners and operators must select PPE that properly fits each affected person and communicate PPE selections to each affected person.
(iv) Owners or operators must provide training in accordance with 29 CFR 1910.132(f) to all persons required to use dermal protection prior to or at the time of initial assignment to a job involving exposure to PIP (3:1). For the purposes of this paragraph (f)(4), provisions in 29 CFR 1910.132(f) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.
(v) Owners and operators must retrain each person required to use dermal protection at least annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use dermal protection, or when changes in the workplace or in dermal protection to be used render the previous training obsolete.
(5)
(i) Must take place in a closed loop system, and
(ii) General and local exhaust ventilation must be provided.
(6)
(A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle PIP (3:1) or handle equipment or materials on which PIP (3:1) may be present, and the type of PPE selected to be worn by each of these persons;
(B) The basis for the regulated area as defined in § 751.403, including monitoring data and documentation of any controls or combination of controls that have reduced exposure to where airborne concentrations of PIP (3:1) can no longer reasonably be expected resulting in a smaller or no regulated area being established;
(C) The type of PPE selected by the owner or operator for use by each of these persons, the respiratory protection used by each potentially exposed person and PPE program implementation, including fit-testing and training;
(D) The basis for PPE selection (
(E) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE; and
(F) For owners and operators using PIP (3:1) as an intermediate processing aid in the manufacturing of cyanoacrylate adhesives, compliance with paragraph (f)(5) of this section.
(ii) These records must be maintained for a period of five years from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(iv) The owner or operator must provide potentially exposed persons and their designated representative an opportunity to observe records related to the basis of the PPE or another control measure selection, including potential monitoring results that is representative of the potentially exposed person's exposure.
(7)
(i) Import of PIP (3:1) and PIP (3:1)-containing products and articles.
(ii) Processing of PIP (3:1)-containing adhesives and sealants, specialized engine filters for locomotive and marine applications, and the products or articles described in paragraphs (b)(1)(vi) and (vii) of this section.
(iii) Processing of PIP (3:1)-containing new and replacement parts to which PIP (3:1) has been added for motor and aerospace vehicles and for manufacturing, HVAC, refrigeration and water heating equipment, electric and electronic equipment, and power generating equipment and the motor and aerospace vehicles, manufacturing, HVAC, refrigeration and water heating equipment, electric and electronic equipment, and power generating equipment that contain new and replacement parts to which PIP (3:1) has been added.
(iv) Processing of PIP (3:1) and PIP (3:1)-containing products for use as an intermediate to produce cyanoacrylate adhesives when PIP (3:1) and PIP (3:1)-containing products are contained in a closed system as described in paragraph (f)(6) of this section are not subject to the provisions of paragraphs (f)(3) and (4) of this section.