I. Background

Pursuant to the Critical Infrastructure Information Act of 2002  1 (CII Act), the Department of Homeland Security (DHS) established uniform procedures for the receipt, care, and storage of critical infrastructure information voluntarily provided to the Federal government by the public. (69 FR 8074, Feb. 20, 2004; 71 FR 52262, Sep. 1, 2006). Today, these procedures are known as the Protected Critical Infrastructure Information (PCII) regulations outlined in Title 6, part 29 of the Code of Federal Regulations (6 CFR part 29). In 2007, DHS transitioned the responsibility to carry out the functions and responsibilities of the PCII Program from the DHS Preparedness Directorate to the National Protection and Programs Directorate (NPPD). 2 In 2018, Congress passed the Cybersecurity and Infrastructure Security Agency Act of 2018 which redesignated NPPD as the Cybersecurity and Infrastructure Security Agency (CISA) and established it as a new agency within DHS. 3 This technical amendment is intended to account for the organizational changes related to responsibility for the PCII Program within DHS and improve the regulation's accuracy through non-substantive, technical, and editorial updates. See the Description of Technical Amendments section below for a more detailed discussion of the updates included in this action.

Technical amendments are made through this final rule to apply throughout the entirety of 6 CFR part 29. A majority of the changes made throughout 6 CFR part 29 are intended to reflect that CISA is the agency responsible for operating the PCII Program within DHS and providing the public with accurate information regarding how CISA currently operates the program. Specifically, the part is amended to accurately identify the names of offices and titles of personnel responsible for operating the PCII Program within CISA and to update legal citations and cross-references. This rule also creates several new definitions and amends existing definitions to clarify terms, titles, and acronyms used throughout the part that are specific to CISA's operation of the PCII Program. For example, some new definitions include “CISA”, “Director”, “Executive Assistant Director”, and “PCII Program Manager” and do not create substantive changes to the regulations. Other definitions such as “Critical Infrastructure”, “Information Sharing and Analysis Organization”, and “Voluntary or Voluntarily” are amended through this rule to align the definitions with the exact statutory text of the CII Act or to update outdated legal citations.

This final rule also makes changes throughout the entirety of 6 CFR part 29 to correct typographical and grammatical errors and to clarify the regulation through stylistic wording and organizational changes. Some of these changes in the wording of the regulation are to align the regulatory text with the statutory text of the CII Act by incorporating the exact statutory language instead of cross-references to the CII Act or to add words from the statutory language of the CII Act which were initially erroneously omitted from 6 CFR part 29. Other wording and organizational changes are editorial in nature and intended to improve the clarity of the regulatory text. An example of such changes in wording includes the deletion of “tribal” used throughout the PCII regulations in the interest of brevity and ease of reading. Deleting “tribal” does not change the scope or substance of the rule because the definition of “Local government” in Section 29.2 expressly includes “Indian tribe or authorized tribal organization, or in Alaska, a Native village or Alaska Regional Native Corporation.” Overall, none of the technical amendments made through this final rule should be construed as modifying or creating any new substantive requirements.

Some of the most significant changes to the regulation include changes to:

The section title has been replaced with “FOIA Exemptions and Restrictions on Regulatory Use of PCII” to more accurately describe the content provided in this section which relates to FOIA exemptions for PCII and other restrictions on the use of PCII.

In section 29.5(a)(3)(iii)(A) & (B), the “and” inserted between subparagraphs (A) & (B) has been replaced with “or” to correct a technical drafting error. As currently written, the “and” between both subparagraphs suggests that submitters must provide identical electronic and non-electronic express statements to CISA in order to receive PCII protection for electronically submitted information. However, the statute only requires, and PCII Program only needs, one express statement to accompany written information or records seeking PCII protection regardless of the method used to submit the information to CISA ( e.g., documentary, oral, or electronic submission formats). This change aligns the regulatory text with the legal requirements for PCII protection of information under the CII Act and eliminates the technical drafting error suggesting that submitters must follow a duplicative and more burdensome process for electronic submissions to receive PCII protection.

Throughout this section, the term “calendar” has been added throughout the section to areas describing deadlines where it was erroneously omitted. This change is made to improve consistency and clarity throughout the section and to reflect the PCII Program's longstanding practice of using calendar days for all deadlines related to this section.

In section 29.6(e)(2)(ii), the paragraph was reorganized and revised to improve clarity on the chronological steps that CISA follows to return to the submitter information that is not eligible for PCII protection. The changes to this paragraph are editorial in nature to reflect a chronological sequence. They do not change any of the steps that CISA will follow to return information to submitters.

Amendatory instructions are the standard terms that the Office of the Federal Register uses to give specific instructions on how to change the CFR. Due to the extensive number of technical and conforming amendments made through this final rule, CISA is utilizing the Office of the Federal Register's new amendatory instruction “revise and republish” to codify the revisions set out in this regulatory action. 4 Use of the combined instruction allows CISA to republish 6 CFR part 29 in its entirety instead of using piecemeal amendments to revise the full unit of the CFR. Because piecemeal amendments are not used in this rule to signal where changes have been made, CISA intends to publish an unofficial, informal document showing what changes CISA made through this final rule to assist industry and other stakeholders in reviewing the changes that this final rule makes to the regulatory text. CISA will make the unofficial, informal document showing edits available on its website at https://www.cisa.gov/pcii-program.

DHS has determined that this rulemaking is exempt from notice-and-comment rulemaking requirements under 5 U.S.C. 553(b)(A) and 5 U.S.C. 553(b)(B). Many of the amendments made through this action pertain solely to the organizational change in responsibility for the PCII Program within DHS and constitute “rules of agency organization, procedure, or practice” not subject to the Administrative Procedure Act's (APA) notice and comment requirements under 5 U.S.C. 553(b)(A). All of the amendments made through this action are technical or editorial non-substantive corrections, which are intended to provide the public with more accurate and current regulatory information about the PCII Program. These changes are necessary to correct errors and grammatical language, update definitions and titles, provide current legal citations, and make other non-substantive amendments that improve the clarity of the CFR. None of the amendments included in this action will have a substantive impact on the public and nor will they alter the regulatory requirements in the affected part. Accordingly, CISA finds for good cause that this final rule is exempt from public notice-and-comment rulemaking procedures under 5 U.S.C. 553(b)(B) because such procedures are unnecessary.

For the same reasons that this rule is exempt from notice-and-comment rulemaking requirements, and because affected parties will not need time to adjust to the amendments to the regulation made through this action, CISA finds that good cause exists to make this final rule effective upon publication in the Federal Register under 5 U.S.C. 553(d)(3).

This final rule constitutes final agency action under the APA and is issued under the authority of 5 U.S.C. 552(a), 5 U.S.C. 553, and 6 U.S.C. 673.

Because CISA has determined that this rule is exempt from notice and comment rulemaking requirements, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply to this action. This technical amendment also does not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866.

There is no new or amended collection of information required by this document; therefore, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable.

In the temporary rule, FR Doc. 2022-27236, beginning on page 76816 in the issue of Thursday, December 15, 2022, make the following corrections:

1. On page 76816, in the first column, the DOL docket is corrected to read “[DOL Docket No. ETA 2022-0008]”.

2. On page 76829, in the third column, in footnote 93, the citation to “(h)(6)(xii)(A)( 1 )( b )” is corrected to read “(h)(6)(xiii)(A)( 1 )( ii )”.

3. On page 76830, in the second column, in footnote 94, the citation to “(h)(6)(xii)(A)( 1 )( c )” is corrected to read “(h)(6)(xiii)(A)( 1 )( iii )”.

4. On page 76831, in the second column, in footnote 100, the citation to “(h)(6)(xii)(A)( 2 )” is corrected to read “(h)(6)(xiii)(A)( 2 )”.

5. On page 76840, in the third column, in footnote 142, the citation to “ Notification of Temporary Travel Restrictions Applicable to Land Ports of Entry and Ferries Service Between the United States and Mexico, 87 FR 24048 (Apr. 22, 2022)” is corrected to read “ Notification of Temporary Travel Restrictions Applicable to Land Ports of Entry and Ferries Service Between the United States and Canada, 87 FR 24048 (Apr. 22, 2022)”.

Accordingly, 8 CFR part 214 is corrected by making the following correcting amendments:

The Home Mortgage Disclosure Act (HMDA) requires certain banks, savings associations, credit unions, and for-profit nondepository institutions to collect, report, and disclose data about originations and purchases of mortgage loans, as well as mortgage loan applications that do not result in originations (for example, applications that are denied or withdrawn). 1 The Bureau's Regulation C, 12 CFR part 1003, implements HMDA, 12 U.S.C. 2801 through 2810.

In October 2015, the Bureau issued a final rule (2015 HMDA Rule) that, among other things, established institutional and transactional loan-volume coverage thresholds in Regulation C that determine whether financial institutions are required to report certain HMDA data on closed-end mortgage loans or open-end lines of credit. 2 These thresholds apply uniformly to covered depository and nondepository institutions; they took effect for depository institutions on January 1, 2017, and for nondepository institutions on January 1, 2018. The loan-volume thresholds in the 2015 HMDA Rule required an institution that originated at least 25 closed-end mortgage loans or at least 100 open-end lines of credit in each of the two preceding calendar years to report HMDA data, provided that the institution meets all other criteria for institutional coverage.

In April 2020, the Bureau issued a final rule (2020 HMDA Rule) to amend Regulation C to increase the thresholds for reporting data about both closed-end mortgage loans and open-end lines of credit. 3 In particular, the 2020 HMDA Rule set the closed-end mortgage loan reporting threshold at 100 in each of the two preceding calendar years, effective July 1, 2020, and the open-end line of credit reporting threshold at 200 in each of the two preceding calendar years, effective January 1, 2022.

On July 30, 2020, five nonprofit organizations and the City of Toledo, Ohio, initiated a lawsuit challenging the 2020 HMDA Rule. 4 On September 23, 2022, the United States District Court for the District of Columbia concluded that the 2020 HMDA Rule's increased reporting threshold for closed-end mortgage loans was arbitrary and capricious. The Court issued an order vacating and remanding the loan-volume reporting threshold for closed-end mortgage loans under the 2020 HMDA Rule. Accordingly, the threshold for reporting data about closed-end mortgage loans is 25 in each of the two preceding calendar years, which is the threshold set by the 2015 HMDA Rule. This technical amendment reflects the vacatur in the Code of Federal Regulations by replacing the closed-end reporting threshold numbers in §§ 1003.2(g)(1)(v)(A) and (2)(ii)(A), and 1003.3(c)(11), and comments 2(g)-5 and 3(c)(11)-2 with those in effect on June 30, 2020; and replacing in their entirety, comments 2(g)-1 and 3(c)(11)-1 with the versions in effect on June 30, 2020.

To conform with current Federal Register requirements for structuring statutory authority citations within the CFR, the Commission is making technical changes to Commission rules to provide enhanced clarity regarding citations of statutory authority for part 200 of 17 CFR (“part 200”) and its subparts. 1 Specifically, the Commission is moving the citations of statutory authority contained in subparts of 17 CFR part 200 to appear directly under 17 CFR part 200. Currently, the citations of statutory authority for part 200 are provided at the subpart level. The technical amendments move these citations of statutory authority from the subpart level to the part level. In connection with these changes, the Commission is amending the citations to statutory authority for the subparts of part 200 to: (1) remove duplication in the citations of statutory authority resulting from this change; and (2) update citation formats to match current Federal Register standards.

The Commission finds, in accordance with the Administrative Procedure Act (“APA”), that these amendments relate solely to agency organization, procedure, or practice. 2 Accordingly, the APA's provisions regarding notice of rulemaking and opportunity for public comment are not applicable. These changes are therefore effective on December 21, 2022. In accordance with the APA, we find that there is good cause to establish an effective date less than 30 days after publication of these amendments. 3 These amendments do not substantially affect the rights or obligations of non-agency parties and pertain to clarifying the authority of internal Commission operations. For the same reasons, the provisions of the Small Business Regulatory Enforcement Fairness Act are not applicable. 4 Additionally, the provisions of the Regulatory Flexibility Act, 5 which apply only when notice and comment are required by the APA or other law, are not applicable. 6 These amendments do not contain any collection of information requirements as defined by the Paperwork Reduction Act of 1995. 7 Further, because these amendments impose no new burdens on private parties, the Commission does not believe that the amendments will have any impact on competition for purposes of section 23(a)(2) of the Exchange Act. 8

We are adopting these technical amendments under the authority set forth in section 19(a) of the Securities Act of 1933 [15 U.S.C. 77s], section 319 of the Trust Indenture Act of 1939 [15 U.S.C. 77sss], section 23(a) of the Securities Exchange Act of 1934 [15 U.S.C. 78w(a)], section 38(a) of the Investment Company Act of 1940 [15 U.S.C. 80a-37(a)], and section 211(a) of the Investment Advisers Act of 1940 [15 U.S.C. 80b-11(a)].

For reasons set forth in the preamble, title 17, chapter II of the Code of Federal Regulations is amended as follows:

Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a “food additive” as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. Under this definition, a substance that is GRAS under the conditions of its intended use is not a “food additive” and is therefore not subject to mandatory premarket review by FDA under section 409 of the FD&C Act (21 U.S.C. 348). In this document, we refer to a person who is responsible for a conclusion that a substance may be used in human food or animal food on the basis of the GRAS provision of the FD&C Act, without premarket review by FDA under section 409 of the FD&C Act, as the “proponent” of that substance.

We have established regulations implementing the GRAS provision of section 201(s) of the FD&C Act in part 170 (21 CFR part 170) for human food and in part 570 (21 CFR part 570) for animal food. Those regulations include a voluntary procedure (“GRAS notification procedure”) through which a proponent may notify us of a conclusion that a substance is GRAS under the conditions of its intended use in human food (part 170, subpart E) or animal food (part 570, subpart E).

In some cases, the process whereby the proponent evaluates whether the available data and information support a conclusion that a substance is GRAS under the conditions of its intended use includes considering the opinion of a “GRAS panel” of qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food. Depending on the outcome of the GRAS panel's analysis, the proponent could either reach a conclusion regarding the safety of the substance under the conditions of its intended use or be advised of one or more issues (such as gaps in the data and information or alternative interpretations of the available data and information) that warrant investigation before a conclusion can be drawn about whether the substance is safe under the conditions of its intended use. When the outcome of the GRAS panel's analysis supports the proponent's conclusion that a substance is safe under the conditions of its intended use, in essence the proponent then relies on the members of the GRAS panel to act as a proxy for the larger scientific community knowledgeable about the safety of substances directly or indirectly added to food and, in so doing, relies on the outcome of the GRAS panel's analysis to support the proponent's conclusion that the safety of the intended use is “generally recognized” by qualified experts. Whether a GRAS panel is a sufficient proxy for the larger scientific community depends on a number of factors, such as the subject matter expertise of the members of the GRAS panel and whether the members of the GRAS panel would be considered representative of experts qualified by scientific training and experience to evaluate the safety of the substance under the conditions of its intended use.

A GRAS panel is one mechanism that proponents have used to demonstrate that the safety of a substance under the conditions of its intended use is generally recognized by qualified experts. However, the use of a GRAS panel is not the only mechanism for doing so, and the use of a GRAS panel does not necessarily mean that the GRAS criteria have been met (81 FR 54960 at 54974 through 54975, August 17, 2016).

We are announcing the availability of a guidance for industry entitled “Best Practices for Convening a GRAS Panel.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. 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.

In the Federal Register of November 16, 2017 (82 FR 53433), we made available a draft guidance for industry entitled “Best Practices for Convening a GRAS Panel” (“draft guidance”), which was intended for any proponent who convenes a GRAS panel and provided our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of a GRAS panel report, including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information ( e.g., by not providing the GRAS panel with information such as trade secret information). We gave interested parties until May 15, 2018, to submit comments for us to consider before beginning work on the final version of the guidance.

We received 13 comments on the draft guidance. Most comments supported the draft guidance and offered ideas on how to improve the guidance. One comment discussed FDA's analysis of the proposed collection of information, and another comment involved issues not related to the draft guidance. We have modified the final guidance where appropriate. Changes to the guidance include:

• Emphasizing that, in many cases, a GRAS panel is not necessary, in response to comments suggesting the GRAS notification process may become too burdensome;

• Providing additional background information regarding the value of a GRAS panel in providing evidence to support the “general acceptance” aspect of the criteria for eligibility for GRAS status through scientific procedures;

• Clarifying the GRAS panel policy discussions around evaluating and managing conflicts of interest and appearance issues, as well as honoraria;

• Removing one reference, as it has been withdrawn since publication of the draft guidance; and

• Removing a mistaken reference to a section V.J.

The guidance announced in this notice finalizes the draft guidance dated November 2017.

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in this guidance have been approved under OMB control number 0910-0911.

This guidance also refers to previously approved FDA collections of information. The collections of information in 21 CFR parts 170 and 570 have been approved under OMB control number 0910-0342.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA websites listed in the previous sentence to find the most current version of the guidance.

Preamble acronyms and abbreviations. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

Background information. On February 4, 2022, the EPA proposed the Reconsideration of the 2020 National Emission Standards for Hazardous Air Pollutants (NESHAP): Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review (87 FR 6466). In this action, we are finalizing decisions on the two issues for which we granted reconsideration. We summarize specific comment topics received on our proposed action and our responses central to our rationale for the decisions in this action. A summary of all public comments on the proposal and the EPA's responses to those comments is available in Summary of Public Comments and Responses for the Reconsideration of the 2020 National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review, Docket ID No. EPA-HQ-OAR-2018-0746.

Organization of this document. The information in this preamble is organized as follows:

The source of authority for this action is provided by sections 112 and 307(d)(7)(B) of the Clean Air Act (CAA) (42 U.S.C. 7412 and 7607(d)(7)(B)).

Regulated entities. Categories and entities potentially regulated by this action are shown in Table 1 of this preamble.

Table 1 of this preamble is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by the final action for the source category listed. To determine whether your facility is affected, you should examine the applicability criteria in the appropriate NESHAP. If you have any questions regarding the applicability of any aspect of this NESHAP, please contact the appropriate person listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

In addition to being available in the docket, an electronic copy of this final action will also be available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this final action at: https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission. Following publication in the Federal Register , the EPA will post the Federal Register version and key technical documents at this same website.

Copies of all oral and written comments received on the proposed rulemaking (Reconsideration of the 2020 National Emission Standards for Hazardous Air Pollutants (NESHAP): Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review (87 FR 6466; February 4, 2022) are available at the EPA Docket Center Public Reading Room. Comments are also available electronically through https://www.regulations.gov/ by searching Docket ID No. EPA-HQ-OAR-2018-0746. Additional information is available on the RTR website at https://www.epa.gov/stationary-sources-air-pollution/risk-and-technology-review-national-emissions-standards-hazardous. This information includes an overview of the RTR program and links to project websites for the RTR Source categories.

Under Clean Air Act (CAA) section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by February 21, 2023. Under CAA section 307(b)(2), the requirements established by this final action may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.

Section 307(d)(7)(B) of the CAA further provides that only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. This section also provides a mechanism for the EPA to reconsider the rule if the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within the period for public comment or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule. Any person seeking to make such a demonstration should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, WJC South Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, with a copy to both the person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

The EPA promulgated the Miscellaneous Organic Chemical Manufacturing NESHAP (MON) on November 10, 2003 (68 FR 63852), and further amended the MON on July 1, 2005 (70 FR 38562), and July 14, 2006 (71 FR 40316). The standards are codified at 40 CFR part 63, subpart FFFF. The MON regulates HAP emissions from miscellaneous organic chemical manufacturing process units (MCPUs) located at major sources. An MCPU includes equipment necessary to operate a miscellaneous organic chemical manufacturing process, as defined in 40 CFR 63.2550(i), and must meet the following criteria: (1) it manufactures any material or family of materials described in 40 CFR 63.2435(b)(1); (2) it processes, uses, or generates any of the organic HAP described in 40 CFR 63.2435(b)(2); and, (3) except for certain process vents that are part of a chemical manufacturing process unit, as identified in 40 CFR 63.100(j)(4), the MCPU is not an affected source or part of an affected source under another subpart of 40 CFR part 63. An MCPU also includes any assigned storage tanks and transfer racks; equipment in open systems that is used to convey or store water having the same concentration and flow characteristics as wastewater; and components such as pumps, compressors, agitators, pressure relief devices (PRDs), sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems that are used to manufacture any material or family of materials described in 40 CFR 63.2435(b)(1). Sources of HAP emissions regulated by the MON include the following: process vents, storage tanks, transfer racks, equipment leaks, wastewater streams, and heat exchange systems.

The EPA conducted an RTR for the MON, pursuant to CAA sections 112(d)(6) and (f)(2), publishing proposed amendments on December 17, 2019 (84 FR 69182). As of November 6, 2018, the Source category covered by this MACT standard included 201 facilities, herein referred to as “MON facilities.” This facility population count was developed using methods described in section II.C of the RTR proposal preamble (84 FR 69182, 69186-87). A complete list of known MON facilities is available in Appendix 1 of the document, Residual Risk Assessment for the Miscellaneous Organic Chemical Manufacturing Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this rulemaking (see Docket Item No. EPA-HQ-OAR-2018-0746-0011). After soliciting and considering public comments, the EPA took final action in 2020 (85 FR 49084; August 12, 2020). The 2020 MON final rule included revisions to the NESHAP pursuant to the technology review for equipment leaks and heat exchange systems, and revisions pursuant to the risk review to specifically address ethylene oxide emissions from storage tanks, process vents, and equipment leaks. In addition, the 2020 MON final rule corrected and clarified regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing general exemptions for periods of SSM, adding work practice standards for periods of SSM where appropriate, and clarifying regulatory provisions for certain vent control bypasses. The final action also added monitoring and operational requirements for flares that control ethylene oxide emissions and flares used to control emissions from processes that produce olefins and polyolefins, added provisions for electronic reporting of performance test results and other reports, and included other technical corrections to improve consistency and clarity.

In the 2020 MON final rule's risk assessment, 1 the Agency calculated cancer risks associated with emissions of ethylene oxide using the EPA's IRIS value for that pollutant, 2 3 and the risk review included a determination that the risks for this source category under the current Maximum Achievable Control Technology (MACT) provisions were unacceptable due to ethylene oxide emissions. When risks are unacceptable, the EPA must determine the emissions standards necessary to reduce risk to an acceptable level. As such, the EPA promulgated final amendments to the MON pursuant to CAA section 112(f)(2) that require control of ethylene oxide emissions for process vents, storage tanks, and equipment in ethylene oxide service. The 2020 MON final rule reduced risks to an acceptable level that also provides an ample margin of safety to protect public health.

The EPA received comments from TCEQ during the public comment period that included their draft cancer dose-response assessment for ethylene oxide. The final rule preamble stated that “the EPA remains open to new and updated scientific information” and new dose-response values, such as the dose-response value then being developed by the TCEQ (85 FR at 49098). However, by the close of the public comment period for the proposed rulemaking, on March 19, 2020, the TCEQ dose-response value had not yet been finalized and could not be considered in the final action.

Following promulgation of the 2020 MON final rule, the EPA received five separate petitions for reconsideration from four unique petitioners. The EPA received two petitions from the American Chemistry Council (ACC) (one petition dated October 2020, one dated December 2020), one from the TCEQ (dated October 2020), one from Squire Patton Boggs (US) LLP (submitted on behalf of Huntsman Petrochemical, LLC) (dated October 2020), and one from Earthjustice (submitted on behalf of RISE St. James, Louisiana Bucket Brigade, Louisiana Environmental Action Network, Texas Environmental Justice Advocacy Services (t.e.j.a.s.), Air Alliance Houston, Ohio Valley Environmental Coalition, Blue Ridge Environmental Defense League, Inc., Environmental Justice Health Alliance for Chemical Policy Reform, Sierra Club, Environmental Integrity Project, and Union of Concerned Scientists) (dated October 2020). Copies of the petitions are available in the docket for this rulemaking (see Docket ID Nos. EPA-HQ-OAR-2018-0746-0259, EPA-HQ-OAR-2018-0746-0260, EPA-HQ-OAR-2018-0746-0261, EPA-HQ-OAR-2018-0746-0262, and EPA-HQ-OAR-2018-0746-0263).

Three petitioners (ACC, TCEQ, and Huntsman Petrochemical, LLC) requested that EPA reconsider the rule to reassess the risk assessment for the 2020 MON final rule using the TCEQ's alternative risk value for ethylene oxide instead of the EPA's IRIS value for ethylene oxide. These three petitioners further argued that the EPA's IRIS value for ethylene oxide is flawed, citing their disagreement with the EPA Office of Research and Development's model selection and inclusion of breast cancer data in the IRIS assessment. In their petitions, ACC and Earthjustice also raised other issues unrelated to the use of the IRIS value or the TCEQ value for assessing risk from ethylene oxide emissions.

On June 22, 2021, the EPA sent letters to all of the petitioners informing them that: (1) the EPA was granting reconsideration requests on two specific issues (described in the next paragraph), (2) the EPA intended to issue a Federal Register document initiating a document and comment rulemaking on the issues for which the Agency granted reconsideration, and (3) the EPA was continuing to review the other issues in the petitions for reconsideration and may choose to initiate reconsideration of additional issues in the future. Copies of the letters to petitioners are available in the docket for this rulemaking (see Docket ID Nos. EPA-HQ-OAR-2018-0746-0249, EPA-HQ-OAR-2018-0746-0250, EPA-HQ-OAR-2018-0746-0251, and EPA-HQ-OAR-2018-0746-0252).

On February 4, 2022 (87 FR 6466), pursuant to CAA section 307(d)(7)(B), the EPA proposed to take comment on the issues for which reconsideration was granted in the June 22, 2021 letters. In the proposal, the EPA solicited public comment on the following aspects of the 2020 MON final rule: (1) the use of the EPA's IRIS value for ethylene oxide in assessing cancer risk for the Source category, and (2) the use of the TCEQ risk value for ethylene oxide as an alternative risk value to the EPA's IRIS value for purposes of evaluating risk under CAA section 112(f)(2). Reconsideration was granted on these two topics on the following bases: the TCEQ risk value for ethylene oxide was finalized after the comment period for the proposed MON rulemaking closed, and the 2020 MON final rule preamble stated that the EPA remains open to new and updated scientific information, such as the TCEQ value; and because the risk posed by ethylene oxide is of central relevance to the EPA's determination that the risks from sources in the Miscellaneous Organic Chemical Manufacturing Source category remaining after imposition of the then-current CAA section 112(d)(2) MACT standards were unacceptable and that more stringent standards are required.

Note that, for this reconsideration action, the EPA sought comment only on the two issues subject to mandatory reconsideration described in the proposal preamble for this reconsideration (87 FR 6466; February 4, 2022). Because the criteria for mandatory reconsideration under CAA section 307(d)(7)(B) have been satisfied, the Agency is publishing this final reconsideration action in the Federal Register .

In this section of the preamble, the EPA sets forth its final decisions on the two issues for which reconsideration was granted and on which the EPA solicited comment in the proposed document of reconsideration. We also present the Agency's rationale for the decisions.

After careful consideration of the comments and information submitted through the public comment process for this rulemaking, the Agency has decided that use of the EPA IRIS value for ethylene oxide for the risk assessment performed for the 2020 MON final rule was appropriate. As described in the reconsideration proposal (87 FR 6466, 6471; February 4, 2022), EPA has an established approach supported by the Science Advisory Board for selecting dose-response values for the CAA section 112(f)(2) risk reviews. 4 5 Application of this approach generally results in an EPA IRIS value being given preference over values from other organizations or agencies. Neither the petitioners nor commenters identified a basis for the EPA to deviate from this documented approach for selecting dose-response values for use in the risk assessment for the 2020 MON final rule. Further, the EPA IRIS assessment of ethylene oxide is scientifically sound, as evidenced by the toxicological assessment itself, 6 as well as the supporting technical documentation. As described in section III.A.2 below and in greater detail in sections 4.1.1 and 4.1.2 of the response to comment document for this rulemaking, the IRIS assessment underwent an extensive peer and public review process that adhered to the guidelines in EPA's Peer Review Handbook   7 for peer review of highly influential scientific assessments. The IRIS assessment and supporting documentation provide evidence of full consideration of the array of scientific questions and comments presented to the EPA and addressed by the EPA prior to issuing the final assessment in December 2016. In addition, since the issuance of the final assessment, there is no new scientific information that would alter EPA's derivation of the IRIS value or other aspects of the EPA IRIS assessment for ethylene oxide. The IRIS assessment continues to provide sound scientific conclusions that are consistent with the latest scientific knowledge. For these reasons, which are addressed in section III.A.2 below, and in greater detail in the response to comment document for this rulemaking, the EPA IRIS value for ethylene oxide is the most appropriate risk value to use in assessing cancer risk for the MON Source category.

The Agency received a range of comments on the proposed rule. While many commenters agreed with the use of EPA's IRIS value for ethylene oxide, several commenters disagreed with EPA's choice to rely on the Agency's IRIS assessment, as opposed to TCEQ's assessment, as the source of the value used to calculate cancer risk from ethylene oxide exposure.

Many of the comments submitted regarding the EPA IRIS assessment of ethylene oxide have been addressed previously by the EPA as part of the extensive peer review and public review process of the draft IRIS assessment of ethylene oxide. For those comments challenging the IRIS assessment, documented in detail in the response to comment document for this rulemaking, we cite to our previous responses. For example, we again received comments claiming that potential background levels of ethylene oxide (ethylene oxide present in ambient air or produced through metabolism in a person's body ( i.e., endogenously)) contribute to cancer risk but were not accounted for in the calculation of the cancer risk value. We have addressed these comments previously in the 2020 MON final rule  8 and in the IRIS Assessment for ethylene oxide, 9 in addition to the EPA's December 13, 2021, response  10 to the Request for Correction (RFC)  11 of the IRIS value that was submitted to the EPA by petitioner ACC under the Information Quality Act, Public Law 106-554 (IQA). We cite these responses in the response to comment document for this rulemaking, where we explain:

It is important to recognize that the IRIS [unit] risk estimate for EtO represents the increased cancer risk due to exposure to ethylene oxide emissions—above any potential existing risks from endogenous or ambient background levels of EtO exposure. The occupational exposures in the NIOSH study represent workplace EtO levels these workers experienced—and are in addition to any endogenous or broad population background exposures to which the workers may also have been exposed.

In this section, we describe specific comment topics central to our rationale for EPA's decision to continue to use the EPA IRIS value; detailed comment summaries and responses are presented in the response to comment document for this rulemaking.

EPA received a number of comments in support of and against the use of the EPA IRIS value for ethylene oxide. As described in the reconsideration proposal (87 FR 6466, 6471; February 4, 2022), EPA has a documented approach for selecting dose-response values for the CAA section 112(f)(2) risk reviews. For these risk reviews, the EPA performs health risk assessments for the hazardous air pollutants (HAP) that are emitted from the source category after imposition of MACT standards under CAA section 112(d)(2). Consistent with the purpose of the IRIS database and the advice from the EPA SAB, and as described in the risk assessment documentation for the 2020 MON final rule, 12 the IRIS database is the preferred source of chronic dose-response data.

Based on EPA's careful review, the Agency has determined that neither the petitioners requesting that EPA reconsider the 2020 MON final rule nor commenters on the proposed reconsideration identified a basis for EPA to change our approach generally, nor our approach to the risk assessment specifically in the 2020 MON final rule. Where commenters identified specific topics, such as new analyses or information related to the cancer risk value for ethylene oxide, we address those comments either in the preamble to this final action or in sections 3 and 4 of the response to comment document for this action.

Some commenters oppose the use of the ethylene oxide IRIS value, for the most part reiterating previously provided comments ( e.g., on model selection) and citing information that the Agency has already considered, including in the development of the IRIS assessment or the 2020 MON final rule. Where new comments or information have been provided, we address those in this preamble or in the response to comment document for this rulemaking.

Many commenters supporting the use of the EPA IRIS value reiterated that the IRIS value must be applied because it reflects the latest scientific knowledge and is the result of an extensive review process. The EPA agrees that the EPA IRIS assessment is scientifically sound and robust and represents the best estimate of the increased cancer risk posed by inhalation exposure to ethylene oxide for use in a risk assessment. This is evidenced by the toxicological assessment itself  13 and its supporting technical documentation, as well as the extensive peer and public review process that was an integral part of the development of the final assessment.

Many of the comments received on the peer and public review of the EPA IRIS ethylene oxide assessment have been addressed previously by the EPA. Specifically, as stated in the response to comments received on the 2020 MON final rule, 14 the EPA followed its standard review process in the ethylene oxide IRIS assessment, which included multiple rounds of review and comment by experts and the public. This included internal agency review, interagency review, public external peer review, and public review. The ethylene oxide IRIS assessment underwent two peer and public review processes over a 10-year period. After the second peer and public review, the Agency followed its normal process to finalize the assessment by considering the peer and public review comments received, making final revisions to the assessment in response to those comments, and then issuing the final ethylene oxide IRIS assessment.

Given this process, the EPA stated that it disagreed with comments suggesting that scientific information and comments were not fully addressed during the IRIS assessment development and review process. In responding to these comments, the EPA further noted the Agency's adherence to the guidelines in the EPA's Peer Review Handbook   15 for highly influential scientific assessments. The IRIS assessment itself and supporting documentation provide evidence of full consideration of the array of scientific questions and comments presented to the EPA. Responses to new comments received regarding statistical support for the IRIS dose-response model are included in the response to comments document.

As described in the EPA's Peer Review Handbook, 16 there are a range of types of peer review. For the ethylene oxide IRIS assessment, the Agency requested review by the EPA SAB. The EPA's SAB is a statutorily established committee with a broad mandate to provide advice and recommendations to the Agency on scientific and technical matters. The SAB considers requests for advice and peer review from across the Agency as part of an annual process, initiated by a request from the Deputy Administrator to the EPA's senior leadership to identify requests for review by the EPA. Highly influential scientific assessments, such as IRIS assessments, or other scientific work products associated with highly visible or controversial environmental issues are most suited to review by the SAB. Much of the SAB's peer review work is done using ad hoc panels formed to review specific EPA draft technical products. All SAB panels provide advice through the chartered SAB, which is composed of approximately 50 nationally renowned scientists, engineers and economists who are screened for conflicts of interest. The chartered SAB further reviews reports prepared by project-specific panels, accepts further public comment, and reports final conclusions directly to the EPA Administrator.

In addition, to address concerns raised about opportunities for review of the draft IRIS assessment, it is important to note that the assessment review and revision process took place over a 10-year period, from 2006 to 2016. Stakeholders, including the American Chemistry Council, had an awareness of the Agency's IRIS assessment early in the process, as evidenced by their review of the 2006 and 2013 draft IRIS assessments and the extensive comments that the ACC and other stakeholders provided on those drafts.

After completion of an initial draft of the assessment, the EPA undertook an extensive, transparent review process. We agree with commenters who stated that the ethylene oxide assessment underwent extensive internal EPA review, as well as external review by other federal agencies. Drafts of the assessment were available for public comment at three different times and were twice submitted for external peer review by the SAB, which is an additional round of external review than is typically received by IRIS assessments. It is correct that at least four drafts of the IRIS ethylene oxide cancer evaluation were reviewed by a wide range of “EPA scientists, interagency reviewers from other federal agencies and the Executive Office of the President, the public, and independent scientists external to the EPA.”  17

Not only did the SAB reviews involve large panels of experts with diverse expertise; they also provided opportunity for public comment and SAB consideration of that comment. EPA's IRIS assessment methods and conclusions directly relied on detailed recommendations presented by the SAB ( e.g., SAB, 2015, page 9 presents specific recommendations on preferred dose-response models). The EPA has determined that the IRIS assessment is scientifically sound and robust and represents the best inhalation cancer risk value for ethylene oxide.

Regarding comments questioning EPA's use of the best available and most recent scientific knowledge, EPA has carefully considered the range of information submitted to EPA on the IRIS assessment since its issuance in 2016. This includes, for example, the EPA's response to the ACC's Request for Correction of the use of the IRIS value for ethylene oxide. 18 The Agency's response documents further evidence of consideration of scientific information submitted to the EPA on the assessment of ethylene oxide since the IRIS assessment was issued in 2016. While there have been several new publications since issuance of the final ethylene oxide IRIS assessment in December 2016, those publications most pertinent to developing an inhalation cancer risk value for ethylene oxide have focused on re-analyses of published studies previously considered in the 2016 IRIS assessment and, therefore, yield no new scientific information. EPA is not aware of new epidemiological, toxicological, or basic scientific studies that suggest the current cancer risk value is no longer appropriate or that could fundamentally alter the basis for the current ethylene oxide IRIS assessment. Specifically, there is no new scientific information that would alter aspects of the EPA IRIS assessment or call into question the scientific judgements reflected in that assessment. The IRIS value for ethylene oxide continues to reflect the latest scientific knowledge.

After careful consideration of the final TCEQ assessment  19 and comments and information submitted through the public comment process for this rulemaking, the Agency finds that the TCEQ risk value is unsuitable for use as an alternative to the IRIS value for ethylene oxide in assessing cancer risk under CAA section 112(f).

The EPA disagrees with several foundational aspects of the final TCEQ assessment. First, EPA disagrees with TCEQ's decision to exclude breast cancer in women as an endpoint for ethylene oxide dose response assessment. EPA finds that TCEQ's decision to exclude breast cancer in women in their derivation of the ethylene oxide risk value is not scientifically sound; this decision reduces the accuracy of, and confidence in, the TCEQ risk value as an appropriate metric of increased cancer risk from inhalation exposure to ethylene oxide. Second, with regard to TCEQ's dose-response modeling, the EPA finds that: (1) the dose-response model selected by TCEQ is unsupported by the underlying epidemiological data, and (2) TCEQ's analyses to justify their model choice were erroneous and relied on flawed assumptions. For the reasons listed here and described in detail in section III.B.2 below, as well as in the response to comment document for this rulemaking, the TCEQ risk value for ethylene oxide is not appropriate to use in assessing cancer risk for the MON Source category.

While many commenters were opposed to EPA's use of the TCEQ risk value for ethylene oxide, several commenters were in favor of the use of the TCEQ value. In this section, we describe specific comment topics key to explaining the rationale for EPA's decision to reject the use of the TCEQ risk value for assessing cancer risk for the source category; detailed comment summaries and responses are presented in the response to comment document for this rulemaking.

While many commenters agree with the inclusion of breast cancer as an endpoint in the dose-response assessment of ethylene oxide, as was done in the EPA IRIS assessment, several commenters, including TCEQ and ACC, support exclusion of breast cancer as an endpoint, as was done in the final TCEQ assessment of ethylene oxide.

EPA disagrees with TCEQ and other commenters who support exclusion of breast cancer in women as an endpoint when assessing the cancer risk from exposure to ethylene oxide. In the IRIS assessment of ethylene oxide, the EPA determined that the available epidemiological evidence for a causal relationship between ethylene oxide exposure and breast cancer in women was strong, and there were sufficient data to include breast cancer in the derivation of the IRIS value for ethylene oxide. The SAB supported this determination. Comments on the evidence for breast cancer as an endpoint following ethylene oxide exposure were also addressed during the review process for the IRIS ethylene oxide assessment. For example, in response to a public comment on the IRIS 2013 draft claiming that the evidence for breast cancer is too weak to rely on in setting the URE, the EPA responded: “Although the epidemiological database for breast cancer is more limited ( i.e., few studies with sufficient numbers of female breast cancer cases) than that for lymphohematopoietic cancers, the EPA determined that the available evidence is sufficient to consider breast cancer a potential hazard from ethylene oxide exposure . . . The 2007 SAB panel did not object to the derivation of unit risk estimates based on the available breast cancer evidence.”  20 The IRIS cancer risk value is representative of potential health risks to the general population because it reflects the combined cancer risk of developing lymphoid cancers in all people, and breast cancer in women.

EPA examined what TCEQ describes as new scientific information and found it to primarily consist of publications providing further reviews covering the same epidemiological data on breast cancer that had already been comprehensively reviewed in the EPA's ethylene oxide IRIS assessment. EPA's examination of these review articles finds that the authors of these journal article reviews have mostly dismissed the strongest data on ethylene oxide and breast cancer, and EPA finds these decisions to be unwarranted. Comments against the inclusion of breast cancer cite two meta-analyses addressing ethylene oxide breast cancer studies that were published after the completion of the 2016 IRIS assessment (Marsh et al. (2019). Both reviews included five breast cancer studies, all of which were examined in the IRIS assessment (Coggon, 2004; Mikoczy, 2011; Norman, 1995; Steenland, 2003; and Steenland, 2004). The conclusions of these meta-analyses are flawed for two major reasons: (1) the authors did not consider findings of increased cancer incidence or mortality in highly exposed study subgroups, and (2) the authors excluded published findings using internal comparison groups within the worker populations, which goes against best practice in epidemiology. 21 Consequently, the meta-analyses inappropriately omitted all positive findings from the Steenland et al. (2003 and 2004) and Mikoczy et al. (2011) studies for breast cancer mortality and incidence and treated these studies as providing negative evidence of an effect of ethylene oxide on breast cancer. These flawed re-analyses of data (data that had been previously reviewed in the IRIS assessment and found to provide positive evidence) led the authors to conclude that the weight of evidence does not support breast cancer as an endpoint.

EPA also examined a new study by Jain (2020) using NHANES data to investigate associations between exposure to ethylene oxide in tobacco smoke and self-reported diagnosis of cancers. The author concluded that levels of ethylene oxide in the general population in the U.S. were not found to be associated with cancers, including breast cancer. There are three major issues that call into question the interpretation of the results from this study. First, it appears that Jain misleadingly interpreted a biomarker of exposure as “[ethylene oxide] levels in the blood”. Importantly, since NHANES did not measure ethylene oxide levels in the blood, this suggests a misunderstanding of the NHANES data consistent with Jain's overinterpretation of the results. Second, Jain failed to note the large number of unaccounted-for variables that may contribute to one's lifetime breast cancer risk, such as lifestyle, a history of breast cancer in relatives, co-exposures, and cumulative exposure to ethylene oxide and other chemicals. NHANES provides cross-sectional data representing a snapshot in time of exposure and health outcome and is not designed to establish temporal causality between chemical exposure and cancer outcomes. For this reason, NHANES data cannot be used to reliably rule out causation between chemical exposure and breast cancer. Third, biomarker measurements that offer a snapshot in time of one's exposure to chemicals are not necessarily representative of continuous, lifetime exposure leading to the development of breast cancer. Taken together, the Jain study results do not support the author's conclusion.

EPA disagrees with commenters that dismiss the breast cancer findings in the National Institute for Occupational Safety and Health (NIOSH) studies of sterilizer workers. Available epidemiologic data provide strong evidence of an elevated breast cancer risk in female workers exposed to ethylene oxide. Results from the NIOSH studies of sterilizer workers (Steenland et al., 2003, and Steenland et al., 2004) demonstrate excess breast cancer risk, substantiated through several different epidemiological analysis approaches. Other smaller studies also indicate an elevated breast cancer risk. No substantial studies challenge this conclusion. The breast cancer findings from the studies of Steenland et al. (2003, 2004) are broadly regarded as the largest and most detailed studies of this endpoint. These studies presented cancer findings for the NIOSH cohort of workers at U.S. sterilization facilities with Steenland et al. (2004) examining cancer mortality rates for breast and other cancers and Steenland et al. (2003) specifically studying incidence (occurrence of disease) of breast cancer. Particularly for breast cancer in women (who are not adequately represented in some industrial cohorts), the NIOSH study is generally regarded as preeminent. These cancer mortality and incidence studies include multiple statistical comparisons that provide evidence of the effect of ethylene oxide exposure increasing breast cancer rates. EPA reaffirms that it is sound and reasonable to include breast cancer as a major endpoint in the IRIS ethylene oxide assessment. Detailed comment summaries and responses on this subject are provided in the response to comment document for this rulemaking.

For these reasons, the EPA finds TCEQ's decision to exclude breast cancer as an endpoint in the derivation of their ethylene oxide risk value to be without adequate scientific basis.

EPA received a range of comments regarding the dose-response model selection for the final TCEQ assessment and for the EPA IRIS assessment. A number of the comments submitted on the reconsideration proposal were on aspects of the dose-response model that EPA had previously addressed either in the peer review of the EPA IRIS ethylene oxide assessment  22 or in the response to comment document for the 2020 MON final rule. 23 New comments regarding TCEQ's assessment focused primarily on support for, and opposition to, the model itself and TCEQ's analyses to support the model selected.

After examining the final TCEQ assessment, as well as analyses and arguments submitted as part of the public comment process for the MON reconsideration proposed rulemaking, the EPA disagrees with TCEQ's model selection, including TCEQ's claim that the biological evidence supports a model with a single, gradual slope through the full range of both general population and occupational exposures. For their model selection, TCEQ chose a model that is inconsistent with the underlying epidemiological data, particularly for ethylene oxide levels in the range of general population exposure (where the general population would include children and other potentially vulnerable groups), which is of most relevance for the CAA section 112 risk assessments.

The epidemiological data indicate that cancer risk rises more rapidly with increasing exposure in the lower exposure range and more gradually in the higher exposure range. TCEQ selected a model that is unable to fit the shape of the data throughout the exposure range. The slope of TCEQ's model is more representative of higher, occupational exposures. By using a single slope (a line) to project risks, TCEQ's model predicts risks at lower exposure ranges that are inconsistent with the underlying epidemiological dose-response data. EPA rejects TCEQ's model because it is inconsistent with the underlying epidemiological dose-response data and mischaracterizes risk at the lower exposure range ( i.e., the range representing potential general population exposures).

It is important to note that, as part of the ethylene oxide IRIS assessment, EPA considered and evaluated 12 dose-response models for lymphoid cancer mortality and 9 dose-response models for breast cancer incidence. The dose-response model selected by TCEQ (a Cox proportional hazards model) is one of the models that was considered by the EPA as part of the IRIS assessment. EPA found that the linear curve selected by TCEQ was highly influenced by the uppermost 5% of the exposure range and did not fit the full range of epidemiological data points, leading to an underestimation of risk for points below the highest exposure levels. After considering all models, EPA found that the two-piece spline model best captured the initial increase in risk at lower doses followed by an attenuation at higher doses. Spline models are generally useful for exposure-response data in which risk increases with exposure at low doses but attenuates at higher exposures, as observed in the ethylene oxide lymphoid cancer data. The plateauing exposure-response relationship has been observed for other occupational carcinogens and may be explained by the depletion of susceptible subpopulations at high exposures, mismeasurement of high exposures, or a healthy worker survivor effect (Stayner et al., 2003). The EPA subsequently rejected the model selected by TCEQ, as well as other similar models, and selected a two-piece linear spline model. In its response to the SAB's recommendations, 24 the EPA noted: “The EPA has followed the SAB's recommendations for model selection. Model selection for both the breast cancer incidence (see section 4.1.2.3) and lymphoid cancer (see section 4.1.1.2) data prioritizes functional forms that allow more local fits in the low exposure range ( e.g., spline models), relies less on AIC, 25 and includes consideration of biological plausibility . . .” As such, in the ethylene oxide IRIS assessment, the EPA selected a model that best represented potential general population exposures, making it align well with the purpose of the risk assessment in the 2020 MON final rule, which sought to assess general risk exposure to the public. Importantly, EPA found TCEQ's chosen model to be a poor fit of the data in the low exposure range ( i.e., the range representing potential general population exposures). 26

Unlike model selection for the TCEQ assessment of ethylene oxide, for the ethylene oxide IRIS assessment, EPA selected the model that best represented potential general population exposures, as well as higher, occupational exposures. EPA's statistical model selection was based on model fit with the observed results in the NIOSH study and was consistent with peer review advice received from the SAB. In the terminology of cancer risk assessment and EPA's Carcinogen Guidelines, the EPA two-piece linear spline model predicts a linear association between environmentally relevant ethylene oxide exposures and cancer risk. 27 SAB (2015) peer review comments noted consistency in model fit and categorical results. 28

In addition to disagreeing with the dose-response model selected by TCEQ, EPA also disagrees with TCEQ's analytical approach to justifying its model selection. TCEQ supported their model choice using flawed calculations and inappropriate assumptions. TCEQ takes an approach that they claim allows for statistical testing of model predictions. EPA has examined TCEQ's inferences and calculations and has identified problems with: (1) TCEQ's assumption that national lymphoid cancer mortality rates equal rates of cancer mortality for members of the NIOSH cohort in the absence of ethylene oxide exposures; (2) TCEQ's calculation of projected cancer rates; and (3) the statistical confidence intervals TCEQ developed for the “predicted” numbers of cancers. These are summarized below and described in greater detail in the response to comment document for this rulemaking.

TCEQ made errors in their calculation of projected cancer rates and in the “reality check” calculations they used to justify their model choice. TCEQ's “reality check” calculations are not statistically appropriate and do not support TCEQ's claims. Further, TCEQ relied on flawed assumptions. For example, in making a claim that TCEQ's model more accurately predicts cancers attributable to ethylene oxide exposure, TCEQ incorrectly assumes that, in the absence of ethylene oxide exposure, cancer incidence rates in the worker cohort (the basis of the URE calculation in EPA's IRIS assessment) would be the same as national cancer mortality rates for the general population. This is, at best, a rough approximation and is subject to considerable error. Importantly, the development of Cox model “internal” risk estimates instead of a national mortality rate-based analysis by Steenland et al. (2004) reflects that comparisons to national mortality rates are not appropriate for this worker cohort. Use of an “internal” statistical analysis rather than an external (national mortality rate-based) analysis is broadly accepted as best practice in occupational epidemiology and was endorsed by the EPA SAB for the EtO IRIS assessment. The EPA disagrees with TCEQ's approach and these assumptions, as described in detail in the response to comment document for this rulemaking.

For the reasons stated above, the EPA finds that the dose-response model selected by TCEQ is unsupported by the data, and the analyses fail to justify the selection of the model. The TCEQ assessment, petitions, and the comments submitted as part of this rulemaking process do not provide a scientifically supportable basis for relying on the TCEQ risk value to assess the residual risk for sources in the 2020 MON final rule. No new studies or other information have been identified by TCEQ, the petitioners requesting reconsideration, or the commenters that would call into question the conclusions in the IRIS ethylene oxide assessment. The EPA reaffirms its use of the EPA IRIS value for ethylene oxide for the risk assessment performed for the 2020 MON final rule.

We estimate that, as of November 6, 2018, there were 201 MON facilities, nine of which reported ethylene oxide emissions to the 2014 National Emissions Inventory. However, as the EPA is not finalizing any changes to the regulatory text or regulatory requirements in this action, we do not anticipate that any sources will be affected by this reconsideration. A complete list of known MON facilities is available in Appendix 1 of the document, Residual Risk Assessment for the Miscellaneous Organic Chemical Manufacturing Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this rulemaking (see Docket Item No. EPA-HQ-OAR-2018-0746-0011).

The EPA does not project any air quality impacts associated with this action because this action does not finalize any changes to the standards or other requirements on affected sources.

The EPA does not project any incremental costs associated with this action because it does not finalize any changes to the standards or other requirements on affected sources.

The EPA does not project any economic impacts because there are no incremental costs associated with this action.

The EPA does not project any incremental benefits associated with this action because it does not finalize any changes to the standards or other requirements on affected sources.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action acts to reaffirm decisions made in a previously promulgated regulatory action and does not have any impact on human health or the environment.

This action is not subject to Executive Order 13045 because it is not economically significant, as defined in Executive Order 12866, and because this action does not present any changes to the rule that would affect environmental health or safety risks, including those that would present a disproportionate risk to children.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the Agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities if the rule has no net burden on the small entities subject to the rule. As we are not finalizing any changes to the regulatory text or regulatory requirements, we do not anticipate any economic impacts resulting from this action. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action finalizes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. None of the MON facilities that have been identified as being affected by this action are owned or operated by tribal governments or located within tribal lands within a 10 mile radius. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because this action does not present any changes to the rule that would affect environmental health or safety risks, including those that would present a disproportionate risk to children.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action acts to clarify the language in the preamble of a previously promulgated regulatory action and does not have any impact on human health or the environment.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The safe transport of lithium batteries by air has been an ongoing concern due to the unique challenges they pose to safety in the air transportation environment. Unlike most other hazardous materials, lithium batteries have a dual hazard of chemical and electrical. This combination of hazards, when involved in a fire, has the potential to create a scenario that exceeds the fire suppression capability of an aircraft and lead to a catastrophic failure of the aircraft.

The Pipeline and Hazardous Materials Safety Administration (PHMSA) issued an interim final rule (IFR)  1 to amend the hazardous materials regulations (HMR; 49 CFR parts 171-180) to (1) prohibit the transport of lithium ion cells and batteries as cargo on passenger aircraft; (2) require all lithium ion cells and batteries to be shipped at not more than a 30 percent state of charge (SOC) on cargo-only aircraft; and (3) limit the use of alternative provisions for smaller lithium cells or batteries to one package per consignment. The IFR amendments predominately affected air carriers (both passenger and cargo-only) and shippers that offer lithium ion cells and batteries for transport as cargo by aircraft. The IFR amendments neither restricted passengers or crew members from bringing electronic devices containing lithium cells or batteries aboard aircraft nor restricted the air transport of lithium ion cells or batteries when packed with or contained in equipment. The IFR also fulfilled the section 333 mandates in the Federal Aviation Administration (FAA) Reauthorization Act of 2018 and amended the HMR to allow shipments of not more than two replacement lithium cells or batteries specifically used for medical devices as cargo on passenger aircraft—with the approval of the Associate Administrator—to accommodate persons in areas potentially not serviced daily by cargo aircraft. Furthermore, these lithium batteries may be excepted from the SOC requirements when they meet certain provisions.

As discussed in further detail in this final rule (see IV. Section-by-Section Review), PHMSA amends certain sections of the HMR in response to public comments received to the IFR. Overall, the comments to the IFR were supportive of PHMSA's action; however, PHMSA did receive a few comments seeking further clarification or revisions to the IFR which PHMSA also addresses in this final rule. Specifically, PHMSA revises the HMR to better ensure that it reflects the original intent of the IFR, particularly in the alignment with the lithium battery transportation requirements with the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transportation of Dangerous Goods by Air (Technical Instructions). In addition, PHMSA clarifies the implementation of the exception, with approval of the Associate Administrator, for air transportation of lithium batteries intended for use in medical devices. Finally, PHMSA responds to comments related to the marking requirement for smaller lithium ion cells or batteries transported by modes other than aircraft and addresses a safety risk associated with lithium batteries transported in overpacks.

A final regulatory impact analysis (RIA) is included in the docket for this rulemaking and supports the amendments made in this rulemaking. PHMSA examined the benefits and costs of PHMSA action in this rulemaking using the final rule as a baseline as shown in Table 1 below.

PHMSA estimates the present value of costs at about $1.6 million over 10 years and about $0.2 million annualized (at a 7 percent discount rate).

PHMSA expects adoption of these amendments will improve the safety of shipments of lithium batteries, which are expected to increase as the use of lithium batteries in the transportation sector and other economic sectors increases in the years ahead. The final rule also provides regulatory consistency and harmonization with international standards, which reduces delays and interruptions in the global transportation of lithium batteries.

PHMSA issued an IFR to amend the HMR) to (1) prohibit the transport of lithium ion cells and batteries as cargo on passenger aircraft; (2) require all lithium ion cells and batteries to be shipped at not more than a 30 percent state of charge (SOC) on cargo-only aircraft; and (3) limit the use of alternative provisions for smaller lithium cells or batteries to one package per consignment. The IFR amendments predominately affected air carriers (both passenger and cargo-only) and shippers that offer lithium ion cells and batteries for transport as cargo by aircraft. The IFR amendments did not affect requirements for passenger and crew personal items containing lithium cells or batteries aboard aircraft, nor restricted the air transport of lithium ion cells or batteries when packed with or contained in equipment. The IFR fulfilled the section 333 requirement in the FAA Reauthorization Act of 2018 to allow shipments of not more than two replacement lithium cells or batteries specifically used for medical devices as cargo on passenger aircraft—with the approval of the Associate Administrator—to accommodate persons in areas potentially not serviced daily by cargo aircraft. Furthermore, these lithium batteries may be excepted from the SOC requirements when they meet certain provisions. See “Section II. Comment Discussion; Exception for Medical Devices” for further discussion.

The IFR was necessary to address an immediate safety hazard and meet a statutory requirement to harmonize the HMR with emergency amendments to the 2015-2016 edition of the ICAO Technical Instructions. The serious public safety hazards associated with lithium battery transportation and the statutory deadline in the FAA Reauthorization Act of 2018 necessitated the immediate adoption of these standards in accordance with the APA. 5 U.S.C. 553(b)(3)(B) and 553(d)(3). The potential for a catastrophic loss of an aircraft, especially a passenger aircraft carrying lithium battery cargo, the need for harmonization of the HMR with emergency amendments to the ICAO Technical Instructions, and the statutory deadline in the FAA Reauthorization Act of 2018  2 provided compelling justification to adopt these changes into the HMR immediately without prior notice and comment.

The IFR, including the APA good cause determination, was supported by the findings of lithium battery research conducted by the FAA's William J. Hughes Technical Center (FAA Technical Center), the National Transportation Safety Board (NTSB), and several other well-respected academic sources on lithium batteries and their hazards with respect to amendments that were adopted. The FAA Technical Center's research found that lithium batteries subject to certain conditions could result in adverse events, such as smoke and fire, that could impair the safe operation of the aircraft. Specifically, they found that in a lithium battery fire, flammable gases could collect, ignite, and ultimately exceed the capabilities of an aircraft's fire suppression system. See “Section III. Need for the Rule” of the IFR for further explanation of the testing and research that supports this finding. The ICAO also recognized these dangers and adopted additional measures into the international air transport standards, which went into effect on April 1, 2016. The potential for a catastrophic loss of an aircraft, especially a passenger aircraft carrying lithium battery cargo, the need for harmonization of the HMR with emergency amendments to the ICAO Technical Instructions, and the statutory deadline in the FAA Reauthorization Act of 2018 provided compelling justification to adopt these changes into the HMR immediately without prior notice and comment.

In this final rule, PHMSA responds to public comments received to the IFR and revises the HMR based on those comments. Specifically, PHMSA revises the HMR to better align the lithium battery transportation requirements with the ICAO Technical Instructions. In addition, PHMSA clarifies the implementation of the exception, with approval of the Associate Administrator, for lithium batteries intended for use in medical devices. PHMSA also responds to comments related to the marking requirement for smaller lithium ion cells or batteries transported by modes other than aircraft.

In response to the March 6, 2019, IFR, PHMSA received comments from the following organizations and individuals, which are listed in order of docket submission:

Below, PHMSA addresses comments to the IFR, including a brief synopsis and response. Additional comments are discussed in “Section III. Section-by-Section Review.” Those comments not addressed herein were considered beyond the scope of the rulemaking.

The IFR intended to align the HMR with international air transport standards for the transportation of lithium cells and batteries, as mandated in the FAA Reauthorization Act of 2018, specifically to (1) prohibit the transport of lithium ion cells and batteries as cargo on passenger aircraft; (2) require all lithium ion cells and batteries to be shipped at not more than a 30 percent SOC on cargo-only aircraft; and (3) limit the use of alternative provisions for smaller lithium cells or batteries to one package per consignment.

Commenters were generally supportive of this rulemaking. Out of 23 comments received (one duplicate), 15 commenters expressed general support, three (3) expressed opposition based on certain provisions, and the remainder sought amendment of certain provisions to improve clarity or avoid unintended consequences. Specifically, commenters supported the rulemaking's alignment with international standards and acknowledged the potential risk that lithium ion cells and batteries pose in passenger and cargo aircraft transportation.

The IFR prohibited the transportation of lithium ion cells and batteries as cargo on passenger aircraft. Prior to publication of the IFR, only lithium metal cells and batteries were prohibited from transportation as cargo on passenger aircraft. For smaller lithium metal cells and batteries, the HMR required that these packages display a statement of prohibition or the cargo aircraft only (CAO) label, regardless of the mode of transportation. Because the IFR expanded the passenger aircraft transportation prohibition to include lithium ion cells and batteries, PHMSA also expanded the smaller lithium metal cell and battery marking or labeling requirement to include smaller lithium ion cells or batteries. PHMSA expected that the expansion of the hazard communication requirement would help to ensure that smaller lithium ion cells and batteries would not be accidentally transported as cargo on passenger aircraft. PHMSA notes that internationally— i.e., under the 2015-2016 ICAO Technical Instructions, and later editions—lithium ion battery packages are required to be labeled with the CAO label. See ICAO Technical Instructions Packing Instruction 965.

PHMSA received several comments that opposed this requirement, particularly when the package of smaller lithium ion cells and batteries is transported by a mode other than aircraft ( e.g., highway, rail, and/or vessel), citing additional transport burden and costs. While PHMSA acknowledges the additional burden, if there is no indication on the package that the package is forbidden for transport aboard passenger aircraft, there is a higher likelihood that these packages will be placed on a passenger aircraft. Although packages shipped by highway, rail, and/or vessel may be part of a closed transportation system, a package of smaller lithium ion cells or batteries that is only marked with the lithium battery mark—without an indication that it is forbidden for passenger aircraft—could still find its way into the air transportation stream. For example, recent FAA data shows that there have been approximately 306 reported incidents where lithium cells and batteries forbidden aboard passenger aircraft have been transported aboard passenger aircraft. As discussed in the IFR, based on past incidents and the inherent potential danger of lithium ion battery thermal runaway events, there is a safety reason to reduce the likelihood that lithium ion batteries are placed on passenger aircraft as cargo. Therefore, PHMSA and FAA expect that the marking, which serves as a clear visual indication that the package is forbidden for transport on passenger aircraft, will help prevent air operator workers from inadvertently loading lithium ion battery packages as cargo on passenger aircraft. Because of this safety concern, PHMSA opted to maintain the requirement that packages of smaller lithium ion cells and batteries must be marked with an indication that the package is forbidden for transport aboard passenger aircraft or labeled with the CAO label. However, to communicate fully the burdens associated with this requirement, PHMSA quantified the costs attributable to the IFR in Appendix 11 of the final RIA.

PHMSA also received suggestions for potential exceptions from the forbidden for passenger air mark or CAO label requirement for packages of smaller lithium cells and batteries. For example, COSTHA, PRBA, Alaska Air Carriers Association, RILA and other commenters recommended that PHMSA provide an exception from this mark or label requirement for packages of smaller lithium ion cells and batteries transported only by highway on dedicated trucks ( i.e., a private fleet) that are not transferred between motor carriers. PHMSA acknowledges that there may be some circumstances where the potential for packages to be placed on passenger aircraft is minimized considerably, however, no exceptions are adopted. As mentioned previously, it is vital to ensure that lithium ion cells and batteries are not placed on a passenger aircraft as cargo in the interest of safe transportation. Additionally, as there are no exceptions from this marking or labeling requirement for smaller lithium metal cells and batteries, the addition of an exception for only lithium ion cells and batteries will create an inconsistency in the application of the HMR and may result in uncertainties when complying with the HMR lithium battery requirements. The availability of the special permit program allows a person to present its case via application for an exemption from the mark or label requirement in accordance with 49 CFR part 107, subpart B. This process of issuing a special permit on a case-by-case basis allows PHMSA to maintain oversight by way of specific, tailored operational and safety controls that will prevent lithium ion batteries from being transported on passenger aircraft. For example, PHMSA has issued two special permits  4 that exempt the § 173.185(c)(1)(iii) marking or labeling requirements, subject to certain operational or safety controls. The special permits were granted to Amazon.com, Inc. and Inmar Supply Chain Solutions, LLC. The operational and safety controls included modal restrictions to highway and rail. The special permits also authorized the transportation of lithium batteries to designated locations only and required markings on overpacks such as “OVERPACK,” special permit number, the words “Packages must remain within this overpack during transport,” and the words “LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD AIRCRAFT AND VESSEL.” These special permit operational and safety controls demonstrated equivalent levels of safety while providing relief from certain HMR requirements while also requiring package marking to ensure lithium battery packagings are not unintentionally placed as cargo on passenger aircraft.

Commenters also noted that PHMSA did not revise the sections of the HMR associated with authorization and use of international standards and regulations ( i.e., §§ 171.12 (North American shipments), 171.24 (additional requirements for use of the ICAO Technical instructions), and 171.25 (additional requirements for use of the International Maritime Dangerous Goods (IMDG) Code)) to mirror the changes made in § 173.185. Specifically, commenters noted that §§ 171.12 and 171.24 did not include the restriction of lithium ion cells and batteries from transportation on passenger aircraft and §§ 171.12, 171.24, and 171.25 did not include the additional marking or labeling requirement for smaller lithium ion cells and batteries, as currently specified for smaller lithium metal cells and batteries. Additionally, COSTHA, Infotrac, MDBTC, PRBA, and Ms. Sandra Harding commented that the smaller lithium ion cell and battery requirement did not align with the IMDG Code or Transport Canada's Transportation of Dangerous Goods (TDG) Regulations and requested clarification on how the mark or label requirement for smaller lithium ion cells and batteries applies to international shipments. While PHMSA acknowledges that the marking requirement differs, as previously mentioned, PHMSA expects that the requirement will increase the safe transportation of lithium batteries. Furthermore, Part 5;2.4.1.3 of the ICAO Technical Instructions allows for markings required by other international or national transport regulations in addition to marks required by the ICAO Technical Instructions, provided they are not confused with or conflict with any ICAO prescribed markings.

The absence of the conforming regulatory language for the passenger aircraft restriction and smaller lithium ion cell and battery mark or label requirement was an unintentional omission and PHMSA thanks commenters for bringing it to PHMSA's attention. Therefore, PHMSA adds language to §§ 171.12 and 171.24 to specify that lithium ion cells and batteries are forbidden from transportation as cargo on passenger aircraft. Additionally, PHMSA adds language to §§ 171.12, 171.24, and 171.25 to indicate that smaller lithium ion cells and batteries must be marked with an indication that the package is forbidden for transport aboard passenger aircraft or be labeled with a CAO label. See “Section IV. Section-by-Section Review; Section 171.12,” “Section IV. Section-by-Section Review; Section 171.24,” and “Section IV. Section-by-Section Review; Section 171.25” for a further discussion on these changes.

Commenters also suggested that PHMSA provide an additional text marking option for smaller lithium cells and batteries without specifically indicating the battery chemistry ( i.e., “LITHIUM BATTERIES—FORBIDDEN FOR PASSENGER AIRCRAFT”) as lithium battery chemistry ( i.e., ion vs. metal) no longer differentiates whether the package may be offered for transportation as cargo on passenger aircraft. PHMSA agrees that this additional option provides greater flexibility, without a reduction in safety. Specifically, this also allows shippers to use preprinted packaging and avoids the need for separate markings if both smaller lithium ion and metal cells and batteries are shipped in the same package. Therefore, PHMSA adds the additional marking option of a general lithium battery indication to § 173.185(c)(3)(iii) as well as §§ 171.24(d)(1)(ii) and 171.25(b)(3).

Lastly, RILA requested clarification that when the § 173.185(c)(1)(iv) marking is applied to a shipment ( i.e., a package) of intermediate-sized lithium cells or batteries, the mark or label in § 173.185(c)(1)(iii) is not also required to be displayed. PHMSA did not intend for the mark or label required by § 173.185(c)(1)(iii) to also apply to packages of lithium batteries marked as specified in § 173.185(c)(1)(iv). Section 173.185(c)(1)(iv) authorizes that when transported only by highway or rail the lithium content limitation in § 173.185(c)(1)(ii) may be increased to 5 g for a lithium metal cell or 25 g for a lithium metal battery and the watt-hour (Wh) rating limitation in § 173.185(c)(1)(i) may be increased to 60 Wh for a lithium ion cell or 300 Wh for a lithium ion battery. This allowance is authorized contingent on the outer package being marked: “LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD AIRCRAFT AND VESSEL.” Because this outer package marking provides an indication that the lithium batteries may not be transported by aircraft or vessel, the marking in § 173.185(c)(1)(iii), which indicates that the package is forbidden for passenger aircraft, would be redundant and the CAO label option would be confusing because the authorize increase in lithium content is not allowed for aircraft transportation (both passenger and cargo). To ensure that there is no confusion, PHMSA adds an indication in § 173.185(c)(1)(iv) to specify that a shipment of lithium cells and batteries marked with the forbidden for transport aboard aircraft and vessel statement does not need to display the marking required in § 173.185(c)(1)(iii).

PHMSA received five comments that PHMSA delay the compliance date  5 for the marking or labeling requirement in § 173.185(c)(1)(iii) for modes other than aircraft, including requests to issue a Statement of Enforcement Discretion. One of these comments was submitted as a direct letter to the Department of Transportation (DOT) by PRBA, MDBTC, Dangerous Goods Advisory Council (DGAC), Power Tool Institute, National Electrical Manufacturers Association, Outdoor Power Equipment Institute, and International Vessel Operators Dangerous Goods Association. 6 PHMSA issued a response to this request on April 4, 2019, in which PHMSA specified that a transition period was not provided and a Statement of Enforcement Discretion would not be issued. 7 PHMSA explained that this marking or labeling requirement is essential to ensure smaller lithium ion cells and batteries are not inadvertently transported as cargo by passenger aircraft consistent with the prohibition of the carriage of lithium metal batteries as cargo on passenger aircraft and thus, no transition period is provided ( i.e., no delay in compliance date).

PHMSA also received an anonymous comment that PHMSA provide a transition period for the entire rulemaking. The commenter stated that a transition period would assist with rerouting of shipments where a cargo aircraft option does not exist and allow for proper notification of potential delays to customers. While PHMSA acknowledges that the immediate compliance of the IFR may have placed some burden on scheduling and potential delays, immediate compliance ensured continued safety for air transportation as the risks posed by lithium batteries on an aircraft were promptly minimized.

As previously mentioned, § 173.185(c)(1)(iii) provides a variety of methods to identify that a package is forbidden for transportation by passenger aircraft, which includes use of the CAO label. PRBA, COSTHA, RILA and some anonymous commenters noted that the use of the CAO label should not be authorized when the package is not properly prepared for cargo aircraft ( i.e., lithium ion batteries shipped above a 30 percent SOC and not contained in or packed with equipment), as the CAO label is an indication that the package is permitted on cargo aircraft. PHMSA disagrees with the commenters' understanding. The intent of the CAO label is only to provide an indication that the package is forbidden for passenger aircraft. It does not indicate that the package is authorized or has been properly prepared for transport on cargo aircraft. Instead, the CAO label represents that the hazard of the contents of the package are too great of a risk for transportation in passenger aircraft. This is articulated by the message on the CAO label, which states “FORBIDDEN IN PASSENGER AIRCRAFT.” Therefore, PHMSA maintains that this label can still be used as an appropriate indication that the package of smaller lithium ion cells or batteries is forbidden for transportation aboard passenger aircraft, even if, for example, the batteries do not meet the SOC requirement for transport of lithium ion batteries aboard cargo aircraft.

In addition to instructing DOT to harmonize lithium battery regulations with the ICAO Technical Instructions, the FAA Reauthorization Act of 2018 instructed DOT to issue limited exceptions to the restrictions on transportation of lithium ion and metal cells and batteries specifically used for a medical device. 8 PHMSA added paragraph (g) to § 173.185 to provide limited exceptions for the air transportation of medical device batteries, with the approval of the Associate Administrator. PRBA, MDBTC, and AACA all submitted comments related to the regulatory text in paragraph (g).

PRBA asserts that PHMSA's regulatory text is inconsistent with the intent of the medical device batteries mandate. Specifically, PRBA does not consider the approval requirement outlined in the IFR to be an exception to the HMR's requirements. MDBTC also asserts that the approval requirement does not constitute an exception, claiming that the legislative intent was “to allow shipments of medical device batteries aboard passenger aircraft in urgent situations and for PHMSA to define the parameters where this exception can be used.” AACA expresses support for MDBTC's comments, and further states that the legislative intent of the FAA Reauthorization Act of 2018 “must include small and large quantities of lithium ion and lithium metal batteries . . . in urgent situations.” PRBA, MDBTC, and AACA allege that PHMSA's approval process for medical device batteries under § 173.185(g) would fail to accommodate urgent situations where medical device batteries need to be shipped expeditiously, such as for patients that require urgent medical care. MDBTC and AACA also note that the timeline for the approval process—90 to 120 days—is unrealistic to meet real-world situations when batteries are urgently needed.

PHMSA does not agree with the commenters' description of the legislative intent, and notes that there is no legislative history available to support the commenters' assertions. The regulatory text under § 173.185(g) establishes a process to authorize the transport of medical device batteries consistent with the Act's limited exceptions mandate under Section 333(b)(2), and PHMSA remains confident that the approval process can accommodate urgent shipping needs.

Section 333(b)(1) of the FAA Reauthorization Act of 2018 sets forth that DOT shall consider and either grant or deny, not later than 45 days after receipt, an application submitted in compliance with part 107 of title 49, Code of Federal Regulations, for special permits or approvals for air transportation of lithium ion cells or batteries specifically used by medical devices. Section 333(b)(2) directs DOT to “issue limited exceptions” to the HMR “to allow the shipment on a passenger aircraft of not more than two (2) replacement batteries specifically used for a medical device” if certain conditions are met.

The statutory language does not specify how PHMSA should limit these exceptions, and there is no legislative history available. In the absence of direction from Congress, PHMSA responded to these mandates by authorizing, contingent on the approval of the Associate Administrator, a limited exception of up to two (2) lithium batteries used for medical devices to be transported on passenger aircraft and, as applicable, at an SOC higher than 30 percent, when the intended destination of the batteries is not serviced daily by cargo aircraft. The approval process is subject to an expedited processing period of no longer than 45 days. Under this approval process up to two replacement lithium cells or batteries specifically used for a medical device may be transported as cargo on a passenger aircraft, when approved by the Associate Administrator and provided the conditions set forth in the Section 333(b)(2) of the FAA Reauthorization Act of 2018 are met. PHMSA also adopted the definition of medical device as used in Section 333(b)(3) of the FAA Reauthorization Act of 2018.

Further, as discussed in the IFR preamble, 9 even though Section 333(b)(1) of the FAA Reauthorization Act of 2018 references lithium ion batteries and not lithium metal batteries, PHMSA understands the language to also apply to lithium metal batteries because Section 333(b)(2) applies to both lithium ion and lithium metal batteries for medical devices. Therefore, all approvals requested pursuant to § 173.185 are subject to the expedited processing period of no longer than 45 days.

PHMSA's regulatory text complies with the FAA Reauthorization Act of 2018 by: (1) adopting the Act's definition of medical device, (2) setting up an expedited approval process to allow the transport of medical devices on an urgent basis, and (3) implementing packaging requirements mandated in the Act to ensure the safe transportation of each medical device battery that is transported at a SOC greater than 30 percent. Limiting the exception via an approval requirement allows PHMSA to maintain oversight of these lithium battery shipments and address the risks they pose in air transportation, with the aim of ensuring the aircraft's cargo and the aircraft's passengers arrive safely at their destination. To date, PHMSA has received only two approval applications neither of which sought exception from the SOC requirements. These requests were denied due to not making the case for how the requested transport would mitigate risks posed by a lithium battery heat, smoke, or fire event on a passenger aircraft. Based on this experience with approval applications, PHMSA maintains its position that approval oversight is needed.

Additionally, AACA and MDBTC assert that PHMSA's approval process needs to be clarified, including whether each shipment of medical device batteries would require approval. PHMSA understands this viewpoint and provides clarity as follows. When an applicant applies for any PHMSA approval—including this type of medical device batteries approval—they may choose to request an approval for a one-time shipment or for recurring shipments, on either a periodic or as needed basis. See 49 CFR 107.705(b)(2). Specific to recurring shipments, PHMSA expects that issuing this type of approval will accommodate emergency circumstances because a person who wishes to offer or transport lithium batteries for medical devices will have prior approval before the emergency need occurs.

MDBTC also commented that the expedited approval process should be codified in part 107. PHMSA agrees that the unique procedures for lithium cells and batteries for medical devices in § 173.185(g) should be included in part 107. PHMSA revises §§ 107.709(b) and (f) to reflect the expedited application process found in the FAA Reauthorization Act of 2018. See “Section IV. Section-by-Section Review; Section 107.709” for further detail on the specific revisions to these paragraphs.

Additionally, PHMSA requested comment on certain criteria for this provision, including potential impacts these criteria may have on stakeholders. The following details the criteria, along with a discussion of the comments PHMSA received.

• Definition of “not more than two replacement lithium cells or batteries. PHMSA requested comment on whether the limitation that “not more than two replacement lithium cells or batteries” applies to the number of cells or batteries per package. MDBTC agreed the intent of Section 333(b)(2) of the 2018 FAA Reauthorization Act provision is two cells or batteries per package (and not per shipment or consignment). As this provision minimizes the number of batteries in each package, which reduces the potential for a thermal runaway event in transportation and thus increases safety, PHMSA maintains § 173.185(g) as written such that not more than two (2) lithium cells or batteries are allowed per package.

• Determination of destination no longer “serviced daily by cargo aircraft”: PHMSA requested comment on what should be considered to determine when a destination is no longer “serviced daily by a cargo aircraft.” MDBTC, supported by the AACA, commented that it was not necessary for PHMSA to specify a specific distance to define when a location is no longer serviced daily by cargo aircraft. Furthermore, MDBTC commented that availability of the exception should be based on the need for urgent patient care when other means of transport are unavailable or inappropriate. AACA also stated that the distance should not be a condition of the exception. PHMSA agrees with MDBTC and AACA that “serviced daily by a cargo aircraft” should not be tied to a specified distance, as this will provide greater flexibility for handling unique transport circumstances. It is necessary for the person who wishes to transport the lithium cell or battery for medical devices to demonstrate that the location is not serviced daily by cargo aircraft in their application, as this is a condition for the exception that is articulated in § 173.185(g). PHMSA is also making a conforming revision to add § 107.705(b)(6) to specify that this information must be provided in the approval application.

• Definition of batteries “required for medically necessary care”: PHMSA stated that batteries “required for medically necessary care” are batteries that are needed for a medical device that is used by the recipient for medical care and requested comment on stakeholder impact. MDBTC commented that the definition of “required for medically necessary care” is appropriate. PHMSA received no further comment on this subject. Therefore, PHMSA maintains that batteries required for medically necessary care in § 173.185(g) means the batteries are needed for a medical device that is used by the recipient for medical care.

MDBTC and PRBA both commented that PHMSA should harmonize the HMR with Special Provision A334 found in the Supplement to ICAO Technical Instructions for all lithium batteries. MDBTC further stated that this provision would expand the allowance to ship lithium batteries for emergency needs to remote areas in circumstances outside of medical device transportation. AACA was supportive of MDBTC's comments and further commented that allowances should be made for small quantities of lithium ion cells and batteries to be shipped to remote locations. Special Provision A334 provides guidance to competent authorities on exceptions for lithium cells or batteries to be transported on passenger aircraft when other forms of transport—including cargo aircraft—are impracticable. This special provision identifies specific quantity limits and performance test criteria that can be used to acquire the approval of the State of Origin, the State of the Operator, and the State of Destination. It is unnecessary to adopt this specific language as PHMSA already provides a general approval mechanism for lithium batteries that do not conform to the provisions of the HMR ( see § 173.185(h)). Finally, as previously mentioned, the FAA Reauthorization Act of 2018 required PHMSA to harmonize the HMR with emergency amendments to the 2015-2016 edition of the ICAO TI. Special Provision A334 was not part of these emergency amendments to the 2015-16 edition but rather part of the Supplement to the ICAO TI that provides non-binding guidance to competent authorities ( e.g., State of Origin) on approval requirements. Therefore, PHMSA is choosing to use the non-binding guidance offered in Special Provision A334 as part of the approval process already in place in § 173.185(h) and not specifically codify the Special provision A334 non-binding guidance into the HMR.

UPS commented that the IFR preamble language ineffectively portrayed the effectiveness of Fire Resistant Containers (FRCs) and Fire Containment Covers (FCCs). Specifically, UPS stated that the FRC tests used preliminary container configurations and containers altered from the specification, and while important steps, the tests were not a final assessment. Furthermore, UPS commented that they have quantifiable data that demonstrates FRC and FCC effectiveness as shipping devices for lithium ion batteries, especially when it is combined with a multi-layered approach to safety measures.

PHMSA appreciates this feedback from UPS and agrees that testing is continuously ongoing, and the current state of results is not intended to be an indication of the final assessment in ensuring the safe transportation of lithium ion batteries by aircraft. PHMSA looks forward to continuing to work with UPS and any other industry partners to better enhance safety through measures such as performance packaging while ensuring continued efficient operations in lithium battery transportation and appreciates any data that can be shared that will help inform decision-making.

PHMSA received several additional comments on various subjects, which are discussed as follows.

Mr. Kevin McAuley requested clarification on whether the provisions of the IFR prohibited lithium batteries from being transported as cargo on passenger and cargo aircraft or whether the prohibition only applied to lithium ion batteries transported above a 30 percent SOC on cargo aircraft. The IFR and this final rule prohibit lithium ion cells and batteries from being offered as cargo on passenger aircraft (emphasis added). Further, regarding carriage on cargo aircraft, consistent with international standards, this rulemaking prohibits lithium ion cells and batteries from being offered as cargo on cargo aircraft above a 30 percent SOC. Finally, when smaller lithium cells and batteries (both ion and metal) are offered as cargo on cargo-only aircraft, they are limited to one package per consignment as provided in § 173.185(c)(4)(iii).

AACA supported an automatic approval system, particularly for Alaska and other states where the population is less than 25 people per square mile, noting that other agencies have provided special exemptions based on that population density. PHMSA is not implementing an automatic approval in response to this comment, which is not mandated under § 333(b) of the FAA Reauthorization Act of 2018. However, while PHMSA has worked to streamline the approval process over the years, such as approval submissions being accepted via an online portal, PHMSA continues to look for new ways to improve this process. PHMSA looks forward to working with AACA and other stakeholders in the future to continue to identify new and improved avenues to expedite the approval process.

AACA also commented on the need for additional allowances for shipments of larger quantities of lithium ion and metal batteries by aircraft, particularly to remote areas. PHMSA understands that there may be additional unique transport circumstances beyond the scope of § 173.185(g). While scenarios outside of § 173.185(g) are not identified, PHMSA can facilitate shipments of lithium batteries through the issuance of an approval under § 173.185(h) or a special permit and urges those persons offering these large shipments to apply.

An anonymous commenter requested that PHMSA add new paragraph § 173.185(a)(4), which would contain the SOC limitation (specifically, the commenter suggested: “For [transport] by air only, lithium ion cells or batteries, [except] when they are contained in equipment, shall not exceed [SOC] 30%.”). PHMSA added Special Provision A100 to the list of special provisions in § 172.102 and assigned it to the entry for “UN3480, Lithium ion batteries” in Column (7) in the § 172.101 Hazardous Materials Table (HMT). This special provision specifies that lithium ion cells and batteries must be offered for transportation at a SOC that does not exceed 30 percent of their rated capacity. Adding the SOC limitation to § 173.185(a) is not necessary and would create confusion because § 173.185(a)(1) details the classification requirements for all lithium cells or batteries, regardless of the United Nations (UN) Identification number, mode of transportation, or if shipped separately or contained in or packed with equipment. Furthermore, placement of the requirement in the HMR as a special provision is consistent with its applicability only to the air mode.

The following is a section-by-section review of the amendments adopted in this final rule:

Section 107.705 details the requirements for an approval application. PHMSA adds paragraph (b)(6) to specify that an applicant applying for an approval for lithium cells and batteries for medical devices, as authorized in § 173.185(g), must include details on the extent to which the destination(s) of the lithium cells and batteries are not serviced daily by cargo aircraft. See “Section II.E IFR Comment Discussion; Exception for Medical Devices” for additional discussion on this revision. In addition, PHMSA revises paragraphs (b)(4) and (5)(ii) editorially to account for the new paragraph.

This section includes the processing requirements for approvals. Paragraph (b) specifies PHMSA's process for reviewing approval applications, including the time frame for requesting additional information. Paragraph (f) specifies that PHMSA will notify the approval applicant in writing of the decision on the application. PHMSA revises paragraphs (b) and (f) to detail the expedited review process for § 173.185(g) shipments of lithium cells and batteries specifically used for medical devices. PHMSA revises paragraph (b) to specify that there will be an expedited review. PHMSA also revises paragraph (f) to specify that for approvals of lithium cells and batteries for medical devices, as outlined in § 173.185(g), the approvals will be either granted or denied no later than 45 days after receipt of a completed application. See “Section II.E IFR Comment Discussion; Exception for Medical Devices” for additional discussion on this revision.

This section details the requirements for the transportation of hazardous materials throughout North America. Specifically, paragraph (a) provides allowances for the shipment of hazardous materials in accordance with the Transport Canada TDG Regulations. Paragraph (a)(6) details additional requirements when lithium metal cells and batteries are transported in accordance with the TDG regulations. COSTHA and PRBA both commented that PHMSA did not revise § 171.12(a)(6) to reflect the newly adopted provisions that lithium ion cells and batteries were forbidden for transportation aboard passenger aircraft. PHMSA agrees with the commenters as this was an unintentional omission. Therefore, PHMSA amends § 171.12(a)(6) to add an indication that lithium ion cells and batteries (UN3480) are prohibited for transport as cargo aboard passenger aircraft.

Additionally, PHMSA revises paragraph (a)(6) to add a reference to § 173.185(c)(1)(vi). As discussed in “Section III. Section-by-Section Review; Section 173.185,” PHMSA revises § 173.185(c)(1)(vi) to add a requirement that when a package is marked or labeled in accordance with §§ 173.185(c)(1)(iii) or (iv) and is placed in an overpack, the selected marking or label must either be clearly visible through the overpack, or the marking or label must also be affixed on the outside of the overpack. This requirement addresses a hazard communication safety gap and ensures that the overpack includes the same hazard information as displayed on the package. Therefore, to ensure this requirement also applies to shipments transported in accordance with the TDG regulations, PHMSA adds a cross reference to § 173.185(c)(1)(vi).

This section provides additional requirements for the use of the ICAO Technical Instructions. COSTHA, MDBTC, and PRBA noted that PHMSA did not revise § 171.24(d)(1)(ii) to reflect the IFR provisions, specifically the prohibition of lithium ion cells and batteries from being transported aboard passenger aircraft and the requirement in § 173.185(c)(1)(iii) to mark the outside of a package containing smaller lithium ion cells and batteries ( i.e., Packaging Instruction 965, Section II) with a mark or label that indicates the package is forbidden for transport aboard passenger aircraft. This was an unintentional omission. PHMSA agrees with the commenters and makes the conforming amendment in § 171.24(d)(1)(ii) to reflect the prohibition and hazard communication requirement.

PHMSA also received comments that PHMSA add an alternative forbidden for passenger aircraft marking in § 173.185(c)(1)(iii) ( i.e., “LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT”). Since PHMSA allows this alternative in § 173.185(c)(1)(iii), for consistency, PHMSA adds this marking alternative in § 171.24(d)(1)(ii) to allow packages containing smaller lithium cells and batteries of both chemistries to be appropriately marked. See “Section II.B IFR Comment Discussion; Marking Requirements for Transport Modes Other than Aircraft” for further discussion.

Lastly, PHMSA revises paragraph (d)(1)(ii) to specify that when a package that is marked or labeled with an indication that the package is forbidden for transport aboard passenger aircraft and is placed in an overpack, the selected mark or label must either be clearly visible through the overpack, or the marking or label must be affixed on the outside of the overpack. As discussed in “Section III. Section-by-Section Review; Section 173.185,” PHMSA revises § 173.185(c)(1)(vi) to add this requirement to address a hazard communication safety gap and ensure that the overpack also communicates that it is forbidden for transport on passenger aircraft. Therefore, to ensure this requirement also applies to shipments transported in accordance with the ICAO Technical Instructions, PHMSA adds the same requirement to § 171.24.

This section provides additional requirements for use of the IMDG Code. COSTHA, MDBTC, PRBA, Infotrac, and Ms. Sandra Harding commented that PHMSA did not revise § 171.25(b)(3) to reflect the IFR provisions in § 173.185(c)(1)(iii) to require a mark or label that indicates a package of smaller lithium ion cells or batteries transported in accordance with Special Provision 188 is forbidden for transportation on passenger aircraft. This was an unintentional omission. PHMSA agrees with the commenters and is making the conforming amendment in § 171.25(b)(3) to reflect the prohibition and hazard communication requirement.

PHMSA also received comments that requested PHMSA add an alternative forbidden for passenger aircraft marking in § 173.185(c)(1)(iii) ( i.e., “LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT”). Since PHMSA allows this alternative in § 173.185(c)(1)(iii), for consistency, PHMSA adds this marking alternative in § 171.25(b)(3) to allow packages containing smaller lithium cells and batteries of both chemistries to be appropriately marked. See “Section II.B IFR Comment Discussion; Marking Requirements for Transport Modes Other than Aircraft” for further discussion.

Lastly, PHMSA revises paragraph (b)(3) to specify that when a package that is marked or labeled with an indication that the package is forbidden for transport aboard passenger aircraft and is placed in an overpack, the selected mark or label must either be clearly visible through the overpack, or the marking or label must be affixed on the outside of the overpack. As discussed in “Section III. Section-by-Section Review; Section 173.185,” PHMSA revises § 173.185(c)(1)(vi) to add this requirement to address a hazard communication safety gap and ensure that the overpack also communicates that it is forbidden for transport on passenger aircraft. Therefore, to ensure this requirement also applies to shipments transported in accordance with the IMDG Code, PHMSA adds the same requirement to § 171.25.

This section outlines the HMT and instructions for its use. PHMSA received no comments to the amendments. The IFR amendments met the requirements of Section 333 of the FAA Reauthorization Act of 2018, harmonize with international standards, and ensure the safe transportation of lithium batteries. Accordingly, no changes are being made to § 172.101.

This section lists special provisions applicable to specific hazardous materials, as listed in Column (7) of the § 172.101 HMT. PHMSA received no comments to the amendments. The IFR amendments met the requirements of Section 333 of the FAA Reauthorization Act of 2018, harmonize with international standards, and ensure the safe transportation of lithium batteries.

PHMSA added a new special provision A100, assigning it to “UN3480, Lithium ion batteries, including lithium ion polymer batteries, 9.” This new special provision, consistent with the ICAO Technical Instructions, requires that when lithium ion cells and batteries are offered for transportation by cargo aircraft, they may not be shipped at a SOC that exceeds 30 percent of their rated capacity. Lithium ion cells and batteries may be offered for transportation at a SOC greater than 30 percent only with the approval of the Associate Administrator. This special provision does not apply to those lithium ion cells and batteries packed with or contained in equipment.

PHMSA received an anonymous comment that requested PHMSA add the SOC limitation (currently specified in special provision A100) in a new paragraph § 173.185(a)(4). It is unclear whether the commenter requested the removal of special provision A100 or the addition of a statement of the SOC limitation in § 173.185(a)(4). As discussed in “Section II.G IFR Comment Discussion; Miscellaneous Comments,” PHMSA disagrees with the commenter that it would provide further clarification to a shipper. Furthermore, special provision A100 aligns with ICAO Technical Instructions and ensures the safe transportation of lithium ion batteries on cargo aircraft (see “Section V.B. State of Charge Requirement” of the IFR for a more detailed discussion of the positive impacts to transportation at a reduced state of charge). As such, PHMSA maintains special provision A100 as written.

This section prescribes the packaging requirements for the transportation of lithium batteries. PHMSA adopted a new definition for “medical device” in the introductory paragraph, as defined in the FAA Reauthorization Act of 2018. As previously detailed, PHMSA adopted the definition of a medical device from section 333(b)(3) of the FAA Reauthorization Act of 2018 to mean “an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent, including any component, part, or accessory thereof, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, of a person.” PHMSA did not receive any comments related to this definition. PHMSA maintains that this definition provides regulatory clarity in the applicability of § 173.185(g), which aids in increased regulatory compliance and thus, safety. In addition, PHMSA maintains the definition as defined in the FAA Reauthorization Act of 2018, and no changes are being made to the “medical device” definition.

Section 173.185(a) details classification criteria for lithium cells and batteries, including the requirements for testing lithium batteries and documenting those test requirements. As previously discussed, an anonymous commenter suggested that PHMSA add a new paragraph (a)(4) to detail SOC limitation requirements. PHMSA disagrees that this new paragraph would add clarity, as the SOC limitation only applies to lithium ion cells and batteries transported by cargo aircraft ( i.e., UN3480 assigned to special provision A100) and paragraph (a) applies to the transportation of all lithium cells and batteries, including those packed with and contained in equipment, by all modes. Therefore, no new paragraph is added to specify the lithium ion cell and battery SOC limitation. See “Section III. IFR Comment Discussion; Miscellaneous Amendments” for a further additional discussion on this comment.

Paragraph (c) specifies exceptions for smaller lithium cells and batteries. Paragraph (c)(1)(iii) details requirements for marking of packages with an indication that they are forbidden for transport aboard passenger aircraft or labeling of packages with the CAO label. Prior to the IFR, this paragraph only applied to smaller lithium metal cells and batteries, except when lithium metal cells or batteries are packed with or contained in equipment in quantities not exceeding 5 kg net weight. To align with the provision restricting lithium ion cells and batteries from being transported on passenger aircraft, PHMSA revised § 173.185(c)(1)(iii) to include smaller lithium ion cells and batteries in the requirement. PHMSA received several comments that requested PHMSA revise the hazard communication requirement to apply only to shipments of smaller lithium ion cells and batteries intended for transportation via aircraft, all or in part. Alternatively, commenters requested that PHMSA provide for a delayed compliance date ( i.e., a transition period) for shipments of smaller lithium ion cells and batteries offered by modes other than aircraft as well as exercise enforcement discretion. Although PHMSA acknowledges this requirement is burdensome on persons who offer smaller lithium ion cells and batteries by modes other than aircraft, PHMSA determined that this hazard communication requirement across all modes ensures that smaller lithium ion cells and batteries are not accidently or unintentionally offered for transportation as cargo on passenger aircraft. As previously mentioned in the IFR, the potential for an uncontrolled fire involving a relatively small quantity of lithium batteries to lead to a catastrophic failure of the airframe, the inability of the package or the aircraft fire suppression system to control such a fire presents an unacceptable safety risk. This ultimately increases safe transportation as it reduces the potential for incidents involving lithium ion cells and batteries to occur aboard passenger aircraft. See “Section III.B IFR Comment Discussion; Marking Requirements for Transport Modes Other than Aircraft” and “Section III.C IFR Comment Discussion; Compliance Date” for a more detailed discussion on both issues.

PHMSA also received comments from PRBA, Infotrac, MDBTC, COSTHA, RILA, and an anonymous commenter asking that PHMSA add an alternative text marking in § 173.185(c)(1)(iii). This alternative ( i.e., “LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT”) does not specify lithium battery chemistry. Because both lithium ion and lithium metal cells and batteries are now forbidden from transportation as cargo on passenger aircraft, it is not necessary to distinguish the battery chemistry as part of the marking requirement. This also provides greater flexibility with marking options for packages containing batteries of both chemistries without reducing safety. PHMSA agrees with the commenters and amends § 173.185(c)(1)(iii) to include the alternative marking.

Paragraph (c)(1)(iv) authorizes increased size limits for the paragraph (c) exceptions when the package is offered for highway or rail only and the outer package is marked with “LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD AIRCRAFT AND VESSEL.” As previously discussed, RILA commented about the potential confusion in whether the § 173.185(c)(1)(iii) mark was also required when a package bears this § 173.185(c)(1)(iv) mark. As the paragraph (c)(1)(iv) mark is more conservative than the paragraph (c)(1)(iii) mark or label, PHMSA adds language in § 173.185(c)(1)(iv) to clarify that the § 173.185(c)(1)(iii) mark is not required. See “Section II. Comment Discussion; Marking Requirements for Modes other than Aircraft” for additional discussion on this change.

In final rule HM-215O, 10 PHMSA added a new paragraph (c)(3)(iii) to specify overpack requirements for a package displaying a lithium battery mark. Specifically, when those packages are placed in an overpack and the lithium battery mark is not visible, the mark must be reproduced on the overpack and be marked with the word “OVERPACK” at least 12 mm (0.47 inches) high. In development of this final rule, PHMSA noted that the HM-215O overpack requirement did not include all hazard communication that could potentially be displayed on a package of smaller lithium cells or batteries. Specifically, this requirement does not include requiring the hazard communication in paragraphs (c)(1)(iii) and (iv) ( i.e., the CAO label, the paragraph (c)(1)(iii) mark, and the paragraph (c)(1)(iv) mark) to be visible or reproduced on an overpack. As previously discussed, there is a safety need to require the paragraph (c)(1)(iii) hazard communication on all packages of smaller lithium cells and batteries, even if they are not being offered for transportation by air. This need also applies to the paragraph (c)(1)(iv) mark. The requirement to reproduce the hazard communication on the overpack is consistent with the general overpack requirements in § 173.25 specify that when a package is placed in an overpack, the proper shipping name, identification number, and labels on the package must be displayed on the overpack, unless they are otherwise visible. The overpack requirement ensures that the hazard communication that needs to be displayed on packages is not lost when consolidated or further packed in an overpack. Although not originally included, PHMSA determines that when a package bears the paragraph (c)(1)(iii) and (iv) required mark or label, and the package is placed in an overpack, those marks and labels should be visible or must be reproduced on the outside of the overpack. This is consistent with the requirements to reproduce the required markings and CAO label in § 173.185(c)(4)(ii). To address this safety gap, PHMSA redesignates current paragraph (c)(1)(vi) to paragraph (c)(1)(vii) and adds a new paragraph (c)(1)(vi) to specify the overpack requirements. PHMSA expects that this new requirement will reduce the potential for packages of smaller lithium cells or batteries that have been overpacked to be placed on a passenger aircraft and thereby increasing safety of transportation.

Section 173.185(c)(4)(i) details the quantity limitations for smaller lithium cells and batteries offered by air transportation. PHMSA received comments from COSTHA and an anonymous commenter that § 173.185(c)(4)(i) could be misinterpreted to also require that the limitations in the paragraph apply to lithium batteries packed with or contained in equipment. The commenters suggested PHMSA add “except when packaged with or contained in equipment” to the text of § 173.185(c)(4)(i). PHMSA agrees with the commenters that this provides greater clarity and harmonizes with the ICAO Technical Instructions. Therefore, PHMSA amends § 173.185(c)(4)(i) to reflect that these conditions and limitations do not apply to batteries packed with or contained in equipment.

An anonymous commenter also recommended that PHMSA add a sentence to the end of paragraph (c)(4)(i) to indicate which paragraphs lithium cells and batteries packed with or contained in equipment are subject to. PHMSA disagrees with this suggestion and expects that such addition would cause additional confusion as paragraph (c)(4)(i) does not apply to smaller lithium cells and batteries packed with or contained in equipment.

Section 173.185(c)(4)(ii) details requirements for transportation of smaller lithium cells and batteries in overpacks. The IFR amended § 173.185(c)(4)(ii) to indicate that only one package of smaller lithium cells and batteries may be placed in an overpack, consistent with ICAO Technical Instructions. PRBA, COSTHA, and MDBTC commented that the reference to only paragraph (c)(4) makes § 173.185(c)(4)(ii) inconsistent with the ICAO Technical Instructions, as lithium cells and batteries packed with or contained in equipment are not limited to one package per overpack. The commenters suggested PHMSA amend the section to instead reference paragraph (c)(4)(i) to distinguish that the requirement only applies to smaller lithium cells and batteries. PHMSA agrees, this was an error. Therefore, PHMSA revises the reference to indicate the requirement only applies to those packages prepared in accordance with § 173.185(c)(4)(i). Furthermore, an anonymous commenter suggested PHMSA delete the requirement completely from the paragraph. The commenter did not specify the reason for removing this requirement. As this provision increases the safe transportation of lithium batteries by air and meets the intent of this rulemaking to align the HMR with ICAO Technical Instructions, PHMSA will not remove the requirement in paragraph (c)(4)(i).

PHMSA expanded the overpack marking requirement in § 173.185(c)(4)(ii) to require that when a package displays the paragraph (c)(1)(iii) required mark or label and is placed in an overpack, the mark or label must be reproduced if not visible through the overpack. However, as previously discussed, in § 173.185(c)(1)(vi), PHMSA adds a requirement that when a package displays the paragraph (c)(1)(iii) required mark or label (as well as the paragraph (c)(1)(iv) mark) and is placed in an overpack, the mark or label must be visible or reproduced on overpack. This applies to all modes of transportation and not just air. Additionally, in the HM-215O final rule, PHMSA added § 173.185(c)(3)(iii) to require that for all modes of transportation, when a package displays the lithium battery mark and is placed in an overpack, the mark must be visible or reproduced on the overpack along with the word “OVERPACK.” As both of these requirements apply to all modes of transportation, including air, the second and third sentence of paragraph (c)(4)(ii) are now duplicative. Therefore, PHMSA removes the duplicative requirement in the second and third sentence of paragraph (c)(4)(ii) to eliminate any potential regulatory confusion and increase regulatory compliance.

PHMSA added § 173.185(c)(4)(iii) to specify that a shipper is not permitted to offer more than one package of smaller lithium cells and batteries in any single consignment by aircraft. PHMSA maintains that this requirement aligns the HMR with the ICAO Technical Instructions and increases safety. However, PRBA, COSTHA, MDBTC, and an anonymous commenter noted that the amendments may have unintentionally subjected smaller lithium cells and batteries contained in or packed with equipment to this requirement. PHMSA did not intend the limitation to apply to smaller lithium cells and batteries contained in or packed with equipment, and therefore amends § 173.185(c)(4)(iii) to state that the limitation of one package in any single consignment is only for those packages prepared in accordance with the provisions of paragraph (c)(4)(i).

PHMSA added paragraph (c)(4)(v) to indicate that packages and overpacks of smaller lithium cells and batteries must be offered separately from cargo not subject to the HMR and must not be loaded into a unit load device before being offered to the operator. This paragraph harmonizes with ICAO Technical Instructions and increases safety. PHMSA received comments from PRBA, COSTHA, MDBTC, and an anonymous commenter to revise the reference from “prepared in accordance with paragraph (c)(4)” to “prepared in accordance with paragraph (c)(4)(i)” to ensure that this requirement does not apply to smaller lithium cells and batteries packed with or contained in equipment. PHMSA agrees and did not intend to require that smaller lithium cells and batteries packed with or contained in equipment be subject to this requirement. Therefore, PHMSA revises the reference to read as paragraph (c)(4)(i).

To account for redesignated paragraph (c)(1)(iv) and new paragraph (c)(1)(v), PHMSA redesignated paragraph (c)(4)(iv) to paragraph (c)(4)(vi). This paragraph details quantity limitations for smaller lithium cells and batteries packed with or contained in equipment. MDBTC commented that PHMSA should revise this paragraph to specify “spare sets” instead of “spares” to harmonize more accurately with the ICAO Technical Instructions. PHMSA agrees and this revision was already made in the HM-215O final rule. Therefore, no revisions to this paragraph are needed.

To account for new paragraph (c)(4)(v) and redesignated paragraph (c)(4)(vi), PHMSA redesignated paragraph (c)(4)(v) as paragraph (c)(4)(vii). PHMSA received no comments to this paragraph and there are no revisions to this paragraph.

Following publication of the IFR, PHMSA added paragraph (c)(4)(viii) in the HM-215O final rule to specify that for air transport, smaller lithium cells and batteries may not be placed in the same package as other hazardous materials. Furthermore, packages that contain smaller lithium cells and batteries must not be placed into an overpack with packages that contain materials of Class 1 (explosives) other than Division 1.4S, Division 2.1 (flammable gases), Class 3 (flammable liquids), Division 4.1 (flammable solids) or Division 5.1 (oxidizers). Upon review, PHMSA identified that paragraph (c)(4)(viii) inadvertently referenced packages prepared in accordance with paragraph (c)(4) and not paragraph (c)(4)(i). PHMSA intended that this requirement apply only to packagings of smaller lithium cells and batteries shipped by air, and not those packed with or contained in equipment. Therefore, in § 173.185(c)(4)(viii), PHMSA revises the reference of paragraph (c)(4) to paragraph (c)(4)(i) as a correcting and editorial amendment.

PHMSA added paragraph (c)(5), using text from former paragraph (c)(4)(vi). This paragraph provides minimal exceptions when the number or quantity (mass) limits in the paragraph (c)(4)(i) table, the overpack limit described in paragraph (c)(4)(ii), or the consignment limit in paragraph (c)(4)(iii) is exceeded, but the lithium cells and batteries are still below the size limitations in paragraph (c)(3). PHMSA received an anonymous comment requesting that PHMSA remove the applicability of paragraph (c)(5) to packages that exceed the overpack limit described in paragraph (c)(4)(ii). The commenter did not provide further details to their request for this revision.

If removed, PHMSA would no longer authorize an alternative to limited exceptions when the limitation of one package of lithium cells or batteries per overpack is exceeded. In addition, this would make the regulatory provision inconsistent with the ICAO Technical Instructions, which would decrease consistency and thus, decrease compliance. Therefore, PHMSA does not remove this exception.

Lastly, PHMSA added a new paragraph (g) in the IFR to meet the mandate in the FAA Reauthorization Act of 2018. This new paragraph authorizes, with the approval of the Associate Administrator, an exception for up to two lithium batteries used for medical devices to be transported on passenger aircraft and, as applicable, at a SOC greater than 30 percent, when the intended destination of the batteries is not serviced daily by cargo aircraft. PHMSA received comments from PRBA, MDBTC, and AACA on this new paragraph. As discussed in “Section II.E Comment Discussion; Exception for Medical Devices,” no revisions to this paragraph are made.

This final rule is published under the authority of the Federal Hazardous Materials Transportation Act (HMTA; 49 U.S.C. 5101-5127). Section 5103(b) of the HMTA authorizes the Secretary of Transportation to “prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce.” The Secretary has delegated the authority granted in the HMTA to the PHMSA Administrator at 49 CFR 1.97(b). Lithium cells and batteries are designated as hazardous materials under 49 U.S.C. 5103(a). 11 This final rule revises regulations for the safe transport of lithium cells and batteries by air and the protection of aircraft operators and the flying public.

Executive Order 12866 (“Regulatory Planning and Review”)  12 recommends that agencies assess all costs and benefits of available regulatory alternatives, including the alternative of not regulating. Agencies should consider quantifiable measures and qualitative measure of costs and benefits that are difficult to quantify. Further, Executive Order 12866 recommends that agencies maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach. Similarly DOT Order 2100.6A (“Rulemaking and Guidance Procedures”) requires that regulations issued by PHMSA and other DOT Operating Administrations should consider an assessment of the potential benefits, costs, and other important impacts of the regulatoryaction and should quantify (to the extent practicable) the benefits, costs, and any significant distributional impacts, including any environmental impacts.

Executive Order 12866 and DOT Order 2100.6A require that PHMSA submit “significant regulatory actions” to the Office of Management and Budget (OMB) for review. This rulemaking is not considered a significant regulatory action under section 3(f)(1) under Executive Order 12866 and, therefore, was not formally reviewed by OMB. Furthermore, the final rule is not considered an economically significant regulatory action under Section 3(f)(1). The final rule is not estimated to have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities. Lastly, this rulemaking is also not considered a significant rule under DOT Order 2100.6A.

In promulgating this final rule, PHMSA maintains the safety provisions adopted in the IFR, while revising further the lithium battery transport regulations to ensure prohibited lithium battery packages are not transported as cargo on passenger aircraft and ensure better understanding of the requirements to achieve compliance with these provisions. In the absence of this rulemaking, potential benefits may not be gained, including increased air transportation safety and transportation efficiency. These benefits are described qualitatively in the final RIA, which is posted in the rulemaking docket. The costs of this final rule, which are estimated relative to a baseline of IFR regulatory compliance, are qualitatively and quantitatively described in the final RIA. These main costs are attributed to the cost of reproducing the §§ 173.185(c)(i)(iii) or (iv) mark or label on the outside of an overpack, when a package bearing such mark or label is placed in an overpack and the appropriate mark or label is not visible. Based on the analysis described in this final RIA, at the mean, PHMSA estimates the present value costs of the final rule are estimated at $0.2 million annualized (at a 7 percent discount rate).

PHMSA analyzed this rulemaking in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”)  13 and its implementing Presidential Memorandum (“Preemption”). 14 Executive Order 13132 requires agencies to assure meaningful and timely input by state and local officials in development of regulatory policies that may 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.”

This rulemaking may preempt state, local, and Native American Tribe requirements, but does not amend any regulation that has substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government.

The Federal hazmat law contains an express preemption provision at 49 U.S.C. 5125(b) that preempts state, local, and tribal requirements on certain covered subjects, unless the non-federal requirements are “substantively the same” as the federal requirements, including the following:

(1) the designation, description, and classification of hazardous material;

(2) the packing, repacking, handling, labeling, marking, and placarding of hazardous material;

(3) the preparation, execution, and use of shipping documents related to hazardous material and requirements related to the number, contents, and placement of those documents;

(4) the written notification, recording, and reporting of the unintentional release in transportation of hazardous material; and

(5) the design, manufacture, fabrication, inspection, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material in commerce.

This rule addresses subject items (2) and (5) above, which are covered subjects, and therefore, non-federal requirements that fail to meet the “substantively the same” standard are vulnerable to preemption under the Federal hazmat law. Moreover, PHMSA will continue to make preemption determinations applicable to specific non-federal requirements on a case-by-case basis, using the obstacle, dual compliance, and covered subjects tests provided in Federal hazmat law.

Therefore, the consultation and funding requirements of Executive Order 13132 do not apply. Consistent with 49 U.S.C. 5125, this final rule will preempt any State, local, or tribal requirements concerning the subjects identified in 49 U.S.C. 5125(b)(1) unless the non-Federal requirements are “substantively the same” as the Federal requirements. In addition, this final rule does not have sufficient federalism impacts to warrant the preparation of a federalism assessment.

PHMSA analyzed this rulemaking in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”)  15 and DOT Order 5301.1 (“Department of Transportation Policies, Programs, and Procedures Affecting American Indians, Alaska Natives, and Tribes”). Executive Order 13175 and DOT Order 5301.1 require DOT Operating Administrations to assure meaningful and timely input from Native American Tribal government representatives in the development of rules that significantly or uniquely affect tribal communities by imposing “substantial direct compliance costs” or “substantial direct effects” on such communities or the relationship and distribution of power between the federal government and Native American Tribes. Because this rulemaking does not significantly or uniquely affect the communities of Tribal governments and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 and DOT Order 5301.1 do not apply.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires agencies to consider whether a rulemaking would have a “significant economic impact on a substantial number of small entities” to include small business, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. The Regulatory Flexibility Act directs agencies to establish exceptions and differing compliance standards for small businesses, where possible to do so and still meet the objectives of applicable regulatory statutes. Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”)  16 requires agencies to establish procedures and policies to promote compliance with the Regulatory Flexibility Act and to “thoroughly review draft rules to assess and take appropriate account of the potential impact” of the rulemakings on small businesses, governmental jurisdictions, and small organizations. The DOT posts its implementing guidance on a dedicated web page. 17

This rulemaking has been developed in accordance with Executive Order 13272 and with DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act to ensure that potential impacts of rules on small entities are properly considered. This rulemaking addresses safety risks that lithium batteries present in transportation, primarily the risk to passenger aircraft, and facilitates the transportation of hazardous materials in international commerce by providing consistency with international standards. It applies to offerors and carriers of lithium batteries, some of whom are small entities. This includes lithium cell and battery manufacturers, wholesalers, and retailers. As discussed at length in the final RIA posted in the rulemaking docket, the amendments in this final rule impose minimal costs to shippers of lithium cells and batteries when offering a package of lithium cells and batteries in an overpack. However, these costs address a necessary safety gap to ensure the safety of air transportation of lithium cells and batteries. As detailed in the final RIA, PHMSA expects that these amendments will not have a significant economic impact on a substantial number of small entities. For further detail, please review the final regulatory flexibility analysis in the final RIA posted in the rulemaking docket.

Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), no person is required to respond to any information collection unless is has been approved by OMB and displays a valid OMB control number. Pursuant to 44 U.S.C. 3506(c)(2)(B) and 5 CFR 1320.8(d), PHMSA must provide interested members of the public and affected agencies an opportunity to comment on information collection and recordkeeping requests.

PHMSA has analyzed this final rule in accordance with the Paperwork Reduction Act. PHMSA currently has approved information collections under OMB Control Numbers 2137-0034, “Hazardous Materials Shipping Papers and Emergency Response Information” and 2137-0557, “Approvals for Hazardous Materials.” In response to the IFR, PHMSA did not receive any comments related to these information collections. However, for the benefit of the reader of this final rule, the IFR discussion of the estimated paperwork burden follows.

For OMB control number 2137-0034, PHMSA estimated a revision in paperwork and recordkeeping burden as a result of smaller lithium batteries being transported as fully regulated shipments. PHMSA estimated this change in shipment because of the required consignment limitation. When shipped without certain provisions in § 173.185(c), the shipments are subject to shipping papers and Notification to the Pilot in Command (NOPIC) requirements in § 175.33. PHMSA estimated that there will be an additional 28,242 shipments annually that will require a shipping paper. PHMSA also estimated that each shipping paper takes one minute and 30 seconds to complete (28,242 shipments × 90 seconds), resulting in approximately 741 additional burden hours. PHMSA did not estimate any increase in out-of-pocket costs. The NOPIC is estimated to take one (1) minute per shipment (28,242 shipments × 1 minute), which resulted in an increase of approximately 471 burden hours. PHMSA did not estimate any increase in out-of-pocket costs. In total for this information collection, PHMSA estimated an approximate increase of 56,484 annual number of responses (28,242 shipping paper responses + 28,242 NOPIC responses) and approximate increase of 1,212 burden hours (741 shipping paper burden hours + 471 NOPIC burden hours).

For OMB control number 2137-0557, PHMSA estimated that the changes will lead to an additional 468 approval requests. This increase in approval requests resulted from the requirement that lithium ion cells and batteries, when transported by cargo aircraft, may only be shipped at greater than a 30 percent SOC under an approval by the Associate Administrator. As detailed in the IFR, PHMSA estimated that it takes approximately 40 hours to complete the paperwork portion of an approval request, resulting in 18,720 additional burden hours (468 approval requests x 40 hours per request). PHMSA did not estimate any increase in out-of-pocket costs.

A summary of the information collection changes from the rulemaking can be found below:

Annual Increase in Number of Respondents: 0.

Annual Increase in Annual Number of Responses: 56,484.

Annual Increase in Annual Burden Hours: 1,212.

Annual Increase in Annual Burden Costs: $0.

Annual Increase in Number of Respondents: 468.

Annual Increase in Annual Number of Responses: 468.

Annual Increase in Annual Burden Hours: 18,720.

Annual Increase in Annual Burden Costs: $0.

The Unfunded Mandates Reform Act of 1995 (URMA; 2 U.S.C. 1501 et seq. ) requires agencies to assess the effects of federal regulatory actions on state, local, and tribal governments, and the private sector. For any NPRM or final rule that includes a federal mandate that may result in the expenditure by state, local, and tribal governments, or by the private sector of $100 million or more in 1996 dollars in any given year, the agency must prepare, amongst other things, a written statement that qualitatively and quantitatively assesses the costs and benefits of the Federal mandate.

This final rule does not impose unfunded mandates under the UMRA. As explained above, it is not expected to result in costs of $100 million or more in 1996 dollars on either state, local, or tribal governments, in the aggregate, or to the private sector in any one year, and is the least burdensome alternative that achieves the objective of the rulemaking.

The National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ), requires that federal agencies analyze actions to determine whether the action would have a significant impact on the human environment. The Council on Environmental Quality implementing regulations (40 CFR parts 1500-1508) require federal agencies to conduct an environmental review considering (1) the need for the action, (2) alternatives to the action, (3) probable environmental impacts of the action and alternatives, and (4) the agencies and persons consulted during the consideration process. DOT Order 5610.1C (“Procedures for Considering Environmental Impacts”) establishes departmental procedures for evaluation of environmental impacts under NEPA and its implementing regulations.

This final rule is being promulgated in response to comments to the IFR. The final rule maintains IFR provisions including the: (1) prohibition of the transport of lithium ion cells and batteries as cargo on passenger aircraft; (2) requirement for all lithium ion cells and batteries to be shipped at not more than a 30 percent SOC on cargo-only aircraft; and (3) restriction for smaller lithium cell and battery shipments to one package per consignment or overpack. These provisions addressed safety concerns from lithium battery transportation risks and mandates from the FAA Reauthorization Act of 2018, including adding an exception, with approval from the Associate Administrator, for certain medical device lithium batteries.

This final rule provides amendments on certain IFR provisions including marking requirements. In addition, the final rule addresses a safety need by requiring that when a package of smaller lithium cells and batteries that requires a §§ 173.185(c)(1)(iii) or (iv) mark or label is placed in an overpack, the appropriate mark or label must be visible or reproduced on the overpack.

As explained in greater length in this preamble, final RIA, and in the IFR preamble, this rulemaking addresses safety concerns from lithium batteries when transported by air. PHMSA expects that the continuation of the provisions adopted in the IFR and the revisions in this final rule increase the high safety standard currently achieved under the HMR. PHMSA has evaluated each of the amendments on its own merit, as well as the aggregate impact on transportation safety from adoption of those amendments. This EA focuses on the regulatory changes specific to this final rule. The EA for the IFR is available in the rulemaking docket. 18

Background

The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission jointly manage the Atlantic Bluefish Fishery Management Plan (FMP). The FMP requires the specification of annual regulatory limits including: An acceptable biological catch (ABC); commercial and recreational annual catch limits (ACL); commercial and recreational annual catch targets (ACT); a commercial quota; a recreational harvest limit (RHL); and other management measures, for up to 3 years at a time. This action implements adjusted bluefish specifications for the 2023 fishing year, based on the most recent data and Council and Commission recommendations.

Catch limits for the 2023 bluefish fishery were previously projected in a multi-year specifications action (87 FR 5739, February 2, 2022), based on a 2021 assessment update and Amendment 7 to the Bluefish FMP (86 FR 66977, November 24, 2021). Those 2023 specifications would increase the commercial quota 21 percent and the RHL 59 percent from 2022 limits. No changes were necessary to the majority of those projected specifications; however, there was a recreational catch overage of 5.59 million lb (2,536 mt) in 2021 that is required to be paid back pound-for-pound through accountability measures (AM) in 2023, and updated data indicated that the initial projection of recreational discards was too low. To account for this new information, the 2023 RHL has been adjusted from the projected 22.14 million lb (10,044 mt) to 14.11 million lb (6,400 mt), which is an increase of 1.6 percent from 2022, rather than 59 percent. No changes were recommended to recreational management measures because the adjusted RHL is only slightly higher than the 2022 RHL, and there was no compelling reason to change existing measures.

The proposed rule for this action published in the Federal Register on November 15, 2022 (87 FR 68434), and comments were accepted through November 30, 2022. NMFS received five comments from the public, and no changes were made to the final rule because of those comments (see Comments and Responses for additional detail). Additional background information regarding the development of these specifications was provided in the proposed rule and is not repeated here.

This action implements the Council and Commission's recommended 2023 bluefish catch specifications, as outlined in the proposed rule (Table 1). These final specifications increase the coastwide commercial quota by 21 percent, as previously projected, and the RHL by 1.6 percent, rather than 59 percent as originally projected.

The final coastwide commercial quota is allocated among the coastal states from Maine to Florida based on percent shares specified in the FMP, and the phased-in changes to these share allocations specified in Amendment 7 to the FMP (86 FR 66977, November 24, 2021). The 2023 state bluefish quota allocations (Table 2) are unchanged from what was previously projected, as there are no adjustments to the commercial sector. In addition, no states exceeded their allocated quota in 2021 or 2022; therefore, no AMs for the commercial fishery are required for the 2023 fishing year.

As previously mentioned, this action makes no changes to recreational management measures, including the recreational daily bag limit of three fish per person for private anglers and five fish per person for for-hire (charter/party) vessels.

The public comment period for the proposed rule ended on November 15, 2022, and NMFS received five comments from the public. No changes were made to final rule as a result of these comments.

Comment 1: Three comments expressed similar opposition to the current recreational bag limits for bluefish; specifically that private anglers are held to a limit of three fish per person, while party/charter boats are allowed five fish per person.

Response: This action does not change or affect the bluefish recreational management measures, including bag limits. That said, the issue of recreational bag limits was discussed at length following the overfished determination of the stock in 2019, and in the development of specifications for fishing years 2020 and 2021. There is a possibility that these limits will be revisited for the 2024 fishing year following the next assessment, but no changes are considered in this specifications action for 2023.

Comment 2: Another commenter noted that any additional restriction of the recreational bluefish fishery is unnecessary and would cause economic burden.

Response: NMFS understands the concern expressed for the recreational sector; however, this action does not add any restrictions to the bluefish fishery. Even though the RHL is increasing less than previously projected, it is still increasing 1.6 percent from 2022.

Comment 3: The final commenter simply voiced support for the action and encouraged implementation as soon as possible.

Response: NMFS agrees and is implementing this rule in a timely manner.

There are no substantive changes from the proposed rule.

Pursuant to section 304(b)(3) of the Magnuson Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the NMFS Assistant Administrator, Greater Atlantic Region, has determined that these final specifications are necessary for the conservation and management of the Atlantic bluefish fishery, and that they are consistent with the Atlantic Bluefish FMP, the Magnuson-Stevens Act, and other applicable law.

The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date for this rule to ensure that the final specifications are in place as close as practicable to the start of the bluefish fishing year on January 1, 2023. This action establishes the final specifications ( i.e., catch limits) for the 2023 bluefish fishery. A delay in effectiveness well beyond the start of this fishing year would be contrary to the public interest as it could create confusion in the bluefish industry, and compromise the effectiveness of the increased quota allocations both to fishery sectors, and commercially among the states. State agencies also use commercially-allocated quotas to set annual state management measures, so the longer these specifications are delayed, the longer it will take for some states to implement their respective regulations. Additionally, because catch limits are increasing, a further delay into the new fishing year could also cause potential economic harm to the fishery through lost opportunity to fish under the higher limits.

Furthermore, regulated parties do not require any additional time to come into compliance with this rule, and thus, a 30-day delay before the final rule becomes effective does not provide any benefit. Unlike actions that require an adjustment period, bluefish fishery participants will not have to purchase new equipment or otherwise expend time or money to comply with these management measures. Rather, complying with this final rule simply means adhering to the new catch limits set for the 2023 fishing year. Fishery stakeholders have also been involved in the development of this action and are anticipating this rule. For these reasons, NMFS finds that a 30-day delay in effectiveness would be contrary to the public interest, and therefore, waives the requirement consistent with 5 U.S.C. 553(d)(3).

This final rule is not subject to review under Executive Order 12866 because the action contains no implementing regulations.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification, and the initial certification remains unchanged. As a result, a final regulatory flexibility analysis is not required and none was prepared.

This final rule does not duplicate, conflict, or overlap with any existing Federal rules.

This action contains no information collection requirements under the Paperwork Reduction Act of 1995.