The FRTIB administers the Thrift Savings Plan (TSP), which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP provisions of FERSA are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79. The TSP is a tax-deferred retirement savings plan for Federal civilian employees and members of the uniformed services. The TSP is similar to cash or deferred arrangements established for private-sector employees under section 401(k) of the Internal Revenue Code (26 U.S.C. 401(k)).

The Internal Revenue Code requires TSP participants to receive a portion of their TSP account (“required minimum distribution”) beginning when they reach a specific age and are separated from service. Currently, a participant's entire TSP account—both traditional and Roth—is subject to the required minimum distribution rules of the Internal Revenue Code. If a separated participant does not withdraw from his or her account an amount sufficient to satisfy his or her required minimum distribution for the year, FRTIB regulations provide that the TSP record keeper will automatically distribute the necessary amount pro rata from the participant's traditional balance and the participant's Roth balance.

Section 325 of the SECURE 2.0 Act of 2022, which was included in Division T of the Consolidation Appropriation Act, 2023 (Pub. L. 117-328), amended the Internal Revenue Code to eliminate the requirement to take mandatory Roth distributions. To conform FRTIB regulations to this statutory amendment, this rule will delete the provision of FRTIB regulations that says the TSP record keeper will distribute required minimum distributions pro rata from traditional balances and Roth balances.

A direct final rule is a final rule that does not go through proposed rulemaking first. We use direct final rulemaking when we expect that the rule will generate no significant adverse comments. We are issuing a direct final rule because we expect this regulatory change to be entirely non-controversial. This rule does not involve any statutory interpretation or create any new regulatory law. We believe this rule does no more than conform FRTIB regulations to the Internal Revenue Code as amended by the SECURE Act of 2022. However, to be certain that we are correct, we set the comment period to end before the effective date. If we receive a significant adverse comment, we will withdraw the direct final rule before it becomes effective.

For purposes of this rulemaking, a significant adverse comment is one that explains (1) why the rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the rule will be ineffective or unacceptable without a change. In determining whether a significant adverse comment necessitates withdrawal of this direct final rule, the FRTIB will consider whether the comment raises an issue serious enough to warrant a substantive response had it been submitted in a standard notice-and-comment process. A comment that objects to the underlying statutory amendments to which FRTIB regulations must conform will be considered out of scope. A comment recommending an addition to the rule will not be considered significant and adverse unless the comment explains how this direct final rule would be ineffective or unacceptable without the addition.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect only participants and beneficiaries of the Thrift Savings Plan, which is a Federal defined contribution retirement savings plan created under the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514, and which is administered by the FRTIB.

I certify that these regulations do not require additional reporting under the criteria of the Paperwork Reduction Act.

Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, 1501-1571, the effects of this regulation on State, local, and Tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by State, local, and Tribal governments, in the aggregate, or by the private sector. Therefore, a statement under section 1532 is not required.

Pursuant to 5 U.S.C. 810(a)(1)(A), the FRTIB submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States before publication of this rule in the Federal Register . This rule is not a major rule as defined at 5 U.S.C. 804(2).

For the reasons stated in the preamble, the FRTIB amends 5 CFR chapter VI as follows:

Section 1207(c) of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234; May 22, 2008) directed the Secretary of Agriculture (Secretary) to provide economic adjustment assistance to domestic users of upland cotton under the Economic Adjustment Assistance to Users of Upland Cotton program. Under the program, domestic users of upland cotton may qualify for financial assistance that can be used to acquire, construct, install, modernize, develop, convert, or expand land, plant, buildings, equipment, facilities, or machinery used in the manufacture of final cotton products. Payments for such assistance are issued by the Commodity Credit Corporation (CCC). Recipients must use these funds within a certain timeframe and must maintain and provide, to program administrators, records related to their use of upland cotton and allowable capital expenditures under the program.

Section 1203(b) of the Agriculture Improvement Act of 2018 (Pub. L. 115-334; December 20, 2018) renamed the program “Economic Adjustment Assistance for Textile Mills” (EAATM). In a memorandum dated July 1, 2019, the Secretary redelegated authority to administer EAATM from the Farm Service Agency to AMS. A final rule published in the Federal Register on October 15, 2020 (85 FR 65500), amended 7 CFR part 2 to reflect the redelegation. The amended 7 CFR 2.79(a)(23) authorizes the AMS Administrator to administer the EAATM program (7 U.S.C. 9037(c)). A final rule published in the Federal Register on October 1, 2021 (86 FR 54339), removed the EAATM regulations from 7 CFR part 1427 and added them in a new 7 CFR part 870—Economic Adjustment Assistance for Textile Mills, in §§ 870.1 to 870.9.

For participation in the EAATM program, domestic users must enter into an Upland Cotton Domestic User Agreement (Form CCC-1045-DOM) (Agreement) and submit upland cotton consumption documentation to AMS's Warehouse and Commodity Management Division (WCMD) to receive financial assistance.

AMS is now codifying the requirements specified in the Agreement as regulations. This final rule amends 7 CFR part 870 by reorganizing and revising existing sections and adding several new sections, supplying definitions of certain program terms, and clarifying current program practices to provide a better understanding of CCC requirements for program participants.

Under this final rule, references in 7 CFR part 870 to the Upland Cotton Domestic User Program are revised to reflect the current name of the program, Economic Adjustment Assistance for Textile Mills. The final rule adds a new § 870.2—Definitions, to provide the meaning of several terms used in program administration that have been subject to differing interpretations in the past. For example, the term domestic user is defined as a person regularly engaged in the business of opening bales of eligible upland cotton for the purpose of spinning such cotton into yarn, papermaking, or production of non-woven cotton products. This definition clarifies and enhances the use of other terms already defined in the current regulations. Eligible domestic users is defined as domestic users who have entered into an Agreement with CCC to participate in the program. Eligible upland cotton is defined to mean baled lint; loose samples used for classification purposes that have been re-baled; semi-processed motes that are suitable for spinning, paper making, or production of non-woven fabric; or re-ginned motes. Eligible upland cotton cannot be cotton for which previous EAATM payments have been made, unprocessed derivatives of the lint cleaning process, or textile mill wastes. Similarly, the term final cotton product is defined to mean a domestically manufactured final product that contains upland cotton to clarify those manufacturing purposes for which program assistance funds are eligible. Each of these definitions is intended to clarify eligibility for program participation.

The term capital expenditures is defined to mean a business's expenses related to the purchase or improvement of depreciable fixed assets, such as physical property, facilities, and equipment used in the manufacture of final products containing upland cotton. The terms equipment and facility or plant is defined to identify those fixed assets for which capital expenditures are recognized under the program. Equipment is defined to mean any machine used directly in the production of final cotton products in order to improve product quality, handling, and/or production efficiency, and facility or plant would mean the structures that house such equipment. Readily put into service is defined to mean facilities, equipment, and/or plants put into service within 24 months of purchase. The definition of operating expenses includes examples of funds expended that are not eligible for EAATM benefits, such as rent, salaries, supplies, utilities, insurance, taxes, and maintenance. Each of these definitions are necessary to clarify which expenses program participants can include in claims for assistance under the program.

Terms including linters, pills, and raw motes are defined to clarify types of processing byproducts that are not considered eligible upland cotton for program purposes. Terms including agreement effective date, date of consumption, fiscal year, and marketing year would be defined to clarify various timeframes related to application and reporting deadlines for program participation.

Terms used in the existing Agreement that are related to reporting and recordkeeping requirements also are defined in the regulations. The Upland Cotton Domestic User Agreement (Form CCC-1045 DOM) means the agreement between CCC and an EAATM program participant, which outlines general program provisions and responsibilities of the program participant. This agreement is required of all program participants. The Monthly Consumption Report refers to Form CCC-1045-UP-2—Monthly Consumption/Application for Payment Report, or other form as prescribed by CCC, that contains documentation of the baled cotton inventory consumed, the eligible domestic user's calculation of program payments for the month, and a signed certification regarding the documents submitted. Participants are required to maintain a supplemental ledger, which is defined as a line-item ledger of proposed capital expenditures for audit purposes. Statement of eligible claim certification is the document that identifies which domestic user in the manufacturing chain is eligible to claim financial assistance under the EAATM program for the use of specific semi-processed motes or re-ginned mote bales.

Terms used in filling out records and reports are also defined in § 870.2. Upland cotton means the widely cultivated American cotton plant ( Gossypium hirsutum ) that has short-to-medium staple fibers. Final cotton product is defined to mean domestically manufactured products containing upland cotton. Net weight means the gross weight of baled upland cotton consumed, less the weight of the bagging and ties.

Finally, § 870.2 includes definitions for other terms necessary for administration of the program as explained earlier, such as Agricultural Marketing Service, Commodity Credit Corporation, Director of AMS's Warehouse and Commodity Management Division, and the Economic Adjustment Assistance for Textile Mills program.

Currently, §§ 870.3 to 870.9 contain the definitions of upland cotton and domestic users eligible for program participation and provide instructions for filing applications for participation and payments under the program. Under this final rule, those sections are reorganized and revised to incorporate program provisions that are currently only provided in the Agreement, and other sections are added to ensure that all of the program's parameters are codified.

Under the final rule, § 870.3—Upland Cotton Domestic User Agreement, specifies how domestic users of upland cotton can enter into Agreements with CCC to participate in the EAATM program. Applicants are required to agree to use EAATM Program funds only in compliance with the program and to identify all manufacturing facilities under their operational control and for inclusion in the Agreement.

Section 870.5—Eligible upland cotton, describes upland cotton eligible for payment under EAATM and specifies that only eligible cotton consumed by the user in the United States on or after the effective date of the Agreement is eligible for payment claims. Further, EAATM Program funds cannot be used for expenses incurred by a domestic user prior to signature by both parties to the Agreement.

Section 870.7—Monthly Consumption Report, requires program participants to submit cotton consumption reports and supporting documentation to AMS during each month of the Agreement term, including those months in which no eligible upland cotton was consumed. Required reports would constitute participants' claims for payments under the program and include their calculations for such payments. Under the final rule, delinquent Monthly Consumption Reports are ineligible for payment for the applicable month. Section 870.7 further provides that AMS will not process reports/claims that contain errors or omissions. Finally, § 870.7 requires that, in the event of a transfer of eligible upland cotton bales, both program participants involved report to AMS any transfers of eligible upland cotton bales between them and that such transactions must be accompanied by a statement of eligible claim certification. Submission of the Monthly Consumption Report allows for validation of active participants, enumeration of domestic consumption, and provides a baseline for verifying that duplicate claims are not submitted for program payments.

Section 870.9—Payment, specifies that the current rate for payment under the EAATM program is 3 cents per pound of eligible cotton consumed, and that cotton is considered consumed on the date the eligible cotton user removes the bale's bagging and ties immediately prior to manufacturing it into final cotton products—without further processing. Section 870.9 further provides that payments are based on the bale's net weight and are made available upon the eligible cotton user's submission of the required reports and documentation.

Section 870.11—Capital expenditures, specifies that eligible domestic cotton users can only use payments under the EAATM program to acquire or modernize land, buildings, or equipment in the United States which are directly attributable to the purpose of manufacturing upland cotton into final cotton products in the United States. Other uses, such as for operating expenses or other purchases are not allowed. Under § 870.11, participants using EAATM program funds for disallowed purposes are required to repay the money to CCC with interest and are ineligible for program participation for one year after the year of violation. Section § 870.11 further specifies that program participants must submit requests for pre-approval of capital expenditures under the program that exceed an amount specified in the Agreement and for any expenditures greater than $10 million on a single, allowable, fixed asset. The regulation outlines the elements required to be submitted in a pre-approval request. The threshold value is specified in the latest Upland Cotton Domestic User Agreement, rather than in the regulations to allow the Agency to consider and respond to economic pressures.

Under the final rule, participants are required to make capital expenditures equal to or greater than amounts received as EAATM program payments within 18 months of the end of the marketing year for which payments are made, unless participants apply for and are granted a Funding Utilization Extension, but in no case more than an additional 36 months.

Fixed assets acquired and/or modernized with EAATM Program funds must be in operation within 24 months after the date of delivery. If unforeseen difficulties prevent utilization within the 24-month period, written approval must be obtained from WCMD for an extension of time. The timeframes and increased communication about expenditures between the Agency and participants are expected to increase auditability and transparency. Finally, § 870.11 provides that program participants cannot transfer—directly or indirectly—EAATM Program funds to another entity. Participants are required to complete an asset transfer certification in the event of a sale or transfer of assets to another program participant. Except for extenuating circumstances approved by AMS, fixed assets, purchased using EAATM Program funds, cannot be sold until they have been in operation for at least 36 months and cannot be purchased with EAATM Program funds again by another eligible domestic user.

Section 870.13—Records and inspection, requires program participants to maintain all records and reports relating to their EAATM Agreement for a period of three years following termination of the Agreement. Detailed record requirements are intended to provide better guidance to the participants and expedite audits. These requirements include identifying elements of the monthly consumption listing, supporting documentation of purchased and consumed cotton, supporting documentation of used but ineligible cotton, inventory records, capital expenditures, and the supplemental ledger. Section 870.13 requires program participants to provide copies of records supporting payment claims to AMS upon demand, and to make all records related to their Agreements accessible to AMS, USDA, and/or any other governmental unit needing access for audit or inspection purposes. The reporting and recordkeeping requirements are needed for oversight to safeguard program integrity.

Section 870.15—Compliance, enforcement, and appeals, provides that AMS will notify appropriate investigating agencies—and that CCC may terminate an Agreement and demand full repayment plus interest—if a program participant is suspected of violating the Agreement, making any fraudulent representation, or misrepresenting any fact affecting a determination under the Agreement. Under the final rule, the participant could be barred from further government program participation as necessary to protect government interests. Further, CCC retains the authority to terminate an Agreement at any time. Section 870.15 also provides a process for appealing program administration decisions.

The Economic Adjustment Assistance for Textile Mills Program is exempt from the requirements of the Paperwork Reduction Act (Agricultural Act of 2014 (Pub. L. 113-79, Title I, Subtitle F, Administration Generally, Section 1601(c)(2)). Accordingly, the information collection requirements of this final rule have not been reviewed by the Office of Management and Budget.

This final rule was reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions have Tribal implications. AMS has determined that this final rule is unlikely to have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

Executive Order 12866—Regulatory Planning and Review, and Executive Order 13563—Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget (OMB) designated this rule as not significant under Executive Order 12866. Therefore, OMB has not reviewed this rule.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of the action on small entities, and, accordingly, has prepared this Regulatory Flexibility Analysis (RFA).

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be unduly or disproportionately burdened. AMS certifies that this rule will not have a significant economic impact or burden on small Textile Mill entities. In making this determination, AMS considered the current and possible participant base of the Economic Adjustment Assistance for Textile Mills (EAATM) Program and the nature of this action. The EAATM Program is authorized by the Farm Bill, first in 2008 (Food, Conservation, and Energy Act (Pub. L. 110-246)), reauthorized in 2014 (Agricultural Act of 2014 (Pub. L. 113-79)) and 2018 (Pub. L. 115-334), and funded through Commodity Credit Corporation (CCC), with administrative oversight delegated to AMS.

AMS used the Small Business Administration's (SBA) definition of small business in reference to Textile Mills, found at 13 CFR 121.201. The affected industry falls under the North American Industry Classification System (NAICS) as Subsector 313, with most current participants classified as code 313110—Textile Mills, Fiber, Yarn, and Thread Mills. This classification includes firms that process raw cotton into cotton products. SBA determines firm size for this industry by number of employees, but on a per firm basis, with small firms defined as having fewer than 1,500 employees. Current participants of the EAATM Program are required to be registered with the System for Awards Management; however, none of the current participants appear to have the small business registration denoted on their entity profile. EAATM participants do not disclose the number of employees in the agreements or applications submitted to CCC but based on familiarity with the industry and information from SBA's Dynamic Small Business Search Database, AMS estimates that 25 out of the 34 current participants can be considered small entities.

This action codifies existing requirements in the EAATM Domestic User Agreement and does not impose any new requirements. In analyzing the current economic impact on small entities, AMS could only deduce positive impact. The EAATM program has fewer than 40 participants, and AMS does not anticipate any surge in participation due to the action. Small Textile Mill participants in the EAATM Program will not be unduly or disproportionately burdened. Textile Mills of all sizes may benefit proportionately from the program, as it provides a payment per pound of cotton consumed to encourage domestic consumption of cotton.

The definition of an eligible participant in reference to the EAATM Program is someone regularly engaged in opening bales of eligible upland cotton for the purposes of spinning cotton into yarn, paper making, or production of non-woven cotton products in the United States, who has entered into an agreement with the CCC to participate in the upland cotton user program. Participants may be public or private nonprofit entities. All entities that adhere to the eligible participant definition and submit a monthly application indicating consumed bales of upland cotton, regardless of size, can voluntarily participate and benefit from the EAATM Program. Program provisions are administered without regard for business size. The paperwork required to participate asks for information that is part of normal business records. The information collection burden for eligible participants is minimal as they must only compete the user application form with the Textile Mill's monthly consumption. The voluntary nature of the program allows any eligible participant to stop participating if they find program participation causes an undue or disproportionate burden.

USDA is committed to complying with the E-Government Act (44 U.S.C. 3601 et seq. ) by promoting the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

This final rule was reviewed under Executive Order 12988—Civil Justice Reform. This rule will not preempt State or local laws, regulations, or policies unless they represent an irreconcilable conflict with this rule. The final rule is not intended to have retroactive effect. Before any judicial actions may be brought regarding the provisions of this rule, administrative appeal provisions of 7 CFR parts 11 and 780 must be exhausted.

The EAATM program is authorized under Title I of the Agricultural Act of 2014. As such, regulations for EAATM may be made without regard to the notice and comment provisions of the Administrative Procedures Act at 5 U.S.C. 553. (See 7 U.S.C. 9091(C)(2)(a)) Nevertheless, AMS is interested in public feedback and invites comments on this final rule from interested persons that may inform future rulemaking. Comments are due January 2, 2024.

Further, AMS finds there is good cause for making this rule effective immediately. Implementing the provisions of this final rule without a 30-day delay provides program continuity and enumerates participation requirements necessary for the industry to ensure access to program benefits.

Under the Horse Protection Act (HPA, or the Act, 15 U.S.C. 1821 et seq. ), the Secretary of Agriculture is authorized to promulgate regulations to prohibit the movement, showing, exhibition, or sale of sore horses.

The Secretary has delegated responsibility for administering the Act to the Administrator of the U.S. Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS). Within APHIS, the responsibility for administering the Act has been delegated to the Deputy Administrator for Animal Care. Regulations and standards established under the Act are contained in 9 CFR part 11 (referred to below as the regulations), and 9 CFR part 12 lists the rules of practice governing administrative proceedings. 1

On July 26, 2016, APHIS published in the Federal Register (81 FR 49112-49137, Docket No. APHIS-2011-0009) a proposal  2 to amend the regulations. Primarily, APHIS proposed to discontinue third-party training and oversight of Designated Qualified Persons, or DQPs, who inspect regulated horses for evidence of soring. Instead, we proposed all inspectors would have to be trained and licensed by APHIS. The rule also proposed several changes to the requirements that pertain to the management of horse shows, exhibitions, sales, and auctions, as well as changes to the list of devices, equipment, substances, and practices that are prohibited to prevent the soring of horses. Finally, we proposed to revise the inspection procedures that inspectors are required to perform.

We solicited public comments on the proposal and received 130,975 submissions, as well as comments provided at 5 listening sessions. After APHIS reviewed the comments, on January 11, 2017, we submitted a final rule to the Office of the Federal Register (OFR) for publication (the 2017 HPA final rule). That rule was filed for public inspection, in advance of publication, on January 19, 2017. However, on January 20, 2017, the Executive Office of the President issued a memorandum instructing Federal agencies to immediately withdraw all regulations awaiting publication at the OFR. 3 In response to the memorandum, the 2017 HPA final rule, which was filed for public inspection (and available on the Federal Register website, www.federalregister.gov ), was withdrawn from publication by USDA on January 23, 2017, the first business day following January 20, 2017.

In August 2019, the Humane Society of the United States (HSUS) and other non-governmental organizations sued USDA. HSUS argued that the 2017 HPA final rule had been duly promulgated and could not be withdrawn without first providing public notice in the Federal Register and an opportunity for public comment. On July 22, 2022, the Court of Appeals for the D.C. Circuit held that “an agency must provide notice and an opportunity for comment when withdrawing a rule that has been filed for public inspection but not yet published in the Federal Register .” Humane Soc'y of the U.S. v. U.S. Dep't of Agric., 41 F.4th 564, 565 (D.C. Cir. 2022). In remanding the case to the lower court, the Court of Appeals clarified that “[o]n remand, the district court may consider all remedial issues, including the question of whether remand to the agency without vacatur is appropriate under the criteria established by Circuit precedent.” Humane Soc'y of the U.S. v. U.S. Dep't of Agric., 54 F.4th 733, 734 (D.C. Cir. 2022).

On May 12, 2023, the District Court issued its decision on remand. Humane Soc'y of the U.S. v. U.S. Dep't of Agric., No. 19-cv-2458 BAH, 2023 WL 3433970 (D.D.C. May 12, 2023). The Court remanded the withdrawal of the 2017 HPA final rule to APHIS without vacatur, but ordered that the withdrawal of the 2017 HPA final rule would be vacated in 120 days if the agency failed to take appropriate remedial action before then. The Court indicated that USDA could attempt to promulgate a new HPA rule or “remedy the deficiency in the withdrawal of [the 2017 HPA final rule] by conducting notice and comment on the withdrawal.” 2023 WL 3433970, at *14. On May 23, 2023, APHIS requested that the Court extend the deadline for action from 120 days to 180 days and the court granted that request on June 1, 2023.

On July 21, 2023, we published a notice of proposed rulemaking for the proposed withdrawal  4 of the 2017 HPA final rule (“notice of proposed rulemaking”) in the Federal Register (88 FR 47068-47071, Docket No. APHIS-2011-0009). In that notice of proposed rulemaking, we cited several bases for the proposal to withdraw the 2017 HPA final rule. First, the National Academy of Sciences (NAS) reviewed methods for detecting soreness in horses and published a report of their findings in 2021, and we determined that the 2017 HPA final rule did not sufficiently address the report's findings. Second, a significant period of time had elapsed since the 2017 HPA final rule was issued, and the underlying data and analyses that supported the rule likely needed to be updated. Third, it was our intent to issue a new proposed rule (“new proposed HPA regulations”) that would incorporate more recent findings and recommendations, including the NAS report, and the new proposed HPA regulations were then under review by the Office of Management and Budget (OMB) pursuant to Executive Order 12866. Finally, withdrawing the 2017 HPA final rule would avoid regulatory whiplash by having the final rule go into effect only to have it subject to change, within a relatively short period of time, by another rulemaking.

We solicited comments concerning our notice of proposed rulemaking for 30 days, ending August 21, 2023.

We received 22,971 unique submissions comprising 114,994 comments by the close of the comment period. They were from non- governmental organizations; national organizations representing veterinarians, equine practitioners, and equestrian interests; a State farm bureau; former and current judges of walking horse shows; former walking horse inspectors; and private citizens.

Below, we discuss the comments that we received, by topic.

We received a number of comments that suggested we implement the 2017 HPA final rule rather than withdraw that rule and proceed with new proposed HPA regulations.

Many commenters stated that the HPA final rule included protections to preclude sore horses from being shown or exhibited that do not exist in the current regulations, and therefore should be implemented. For example, several commenters pointed out that the 2017 HPA final rule had restrictions and prohibitions specific to the Tennessee Walking and Racking Horse (TWH) industry that are not found in the current regulations.

We agree that the 2017 HPA final rule is preferable to the current regulations, but consider the new proposed HPA regulations to be preferable to the 2017 HPA final rule for reasons discussed in the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule and in this document. Additionally, allowing the 2017 HPA final rule to go into effect would have a significant adverse effect on the new proposed HPA regulations that we wish to avoid; we discuss this at greater length later in this document.

A number of commenters stated that it would be easier and quicker for the Agency to allow the 2017 HPA final rule to go into effect than to proceed with new proposed HPA regulations.

Even if allowing the 2017 HPA final rule to go into effect were easier and quicker, we consider the new proposed HPA regulations to be preferrable to the 2017 HPA final rule for reasons discussed in the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule and this document.

A commenter stated that the 2017 HPA final rule should not be withdrawn because it prohibited the use of chemicals and devices associated with soring.

Section 11.2 of the current regulations already prohibits the use of chemicals associated with soring, as well as the devices mentioned by the commenter.

Finally, a commenter stated that the 2017 HPA final rule should not be withdrawn because, in its absence, there would be none of the current protections in place against allowing sore horses to be shown or exhibited.

The commenter appears to mistakenly believe that we proposed withdrawal of the HPA regulations in their entirety, rather than withdrawal of the 2017 HPA final rule that revised the existing HPA regulations. Because the existing HPA regulations are not affected by the withdrawal, the current protections will remain in place, and this is not a reason to refrain from withdrawing the 2017 HPA final rule.

As noted above, one of our stated reasons for proposing to withdraw the 2017 HPA final rule was to avoid regulatory whiplash associated with implementing that rule, only to have it subject to change, within a relatively short period of time, by another rulemaking.

Several commenters disagreed with this position.

One commenter stated that issuing new proposed HPA regulations does not preclude the agency from subsequently implementing the 2017 HPA final rule after the new proposed HPA regulations are published and proceed through the rulemaking process.

While the publication of new proposed HPA regulations  5 on August 21, 2023 (88 FR 56924-56962, Docket No. APHIS-2022-0004) does not necessarily preclude APHIS from implementing the 2017 HPA final rule, as we stated in the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule and further elaborate on in this document, we would prefer not to implement a rule that is based on outdated data. Moreover, implementing the 2017 HPA final rule would substantially adversely impact the new proposed HPA regulations. The new proposed HPA regulations were drafted as a complete revision of the existing HPA regulations, meaning that, the new proposed HPA regulations do not propose to amend the regulations as set forth in the 2017 HPA final rule but instead propose to amend the regulations that were in place before the 2017 HPA final rule. Thus, allowing the 2017 HPA final rule to become the current HPA regulations would fundamentally and unnecessarily shift the regulatory scheme on which the new proposed HPA regulations are predicated. As one commenter opined, APHIS would thus have to withdraw, substantially revise, and repropose the new proposed HPA regulations were the 2017 HPA final rule implemented. We agree that either withdrawal or a new regulatory action, such as a supplemental proposal, would be warranted. Specifically, we would have to revise the amendatory instructions and regulatory text of the new proposed HPA regulations—which do not refer to the 2017 HPA final rule or otherwise take that rule and its changes to the pre-existing regulatory landscape into account—to comport with the structure of the regulations in the 2017 HPA final rule, and allow for public comment on this revised regulatory text. This additional regulatory action would significantly extend the timelines for any possible finalization of the new proposed HPA regulations, and any withdrawal or substantive modification to the new proposed HPA regulations heightens the likelihood of confusion regarding the Agency's intent. This likelihood of confusion is underscored by the comments on the notice of proposed rulemaking regarding the withdrawal itself, many of which interpreted the proposed withdrawal of the 2017 HPA final rule as indicating an intent not to issue new HPA regulations despite the stated intent in the notice of proposed rulemaking to do so.

One commenter stated that regulatory whiplash would not occur because it would take a significant amount of time to finalize the new proposed HPA regulations. Another commenter stated that regulatory whiplash would not occur because the horse industry could easily adjust to regulatory changes.

As noted above, implementing the 2017 final rule would substantially adversely impact the new proposed HPA regulations, and trigger the need for regulatory actions to withdraw or modify it. For this reason, we disagree with the commenters that regulatory whiplash will not occur if the new proposed HPA regulations takes significantly longer than anticipated to finalize. Rather, it is the Agency's position that any such withdrawal or modification to the new proposed HPA regulations is likely to result in confusion regarding the Agency's intent, and thus actual or perceived regulatory whiplash.

We also disagree that the 2017 HPA final rule could quickly be implemented. We note that most of the sections in the 2017 HPA final rule would have had an effective date of January 1, 2018, that is, about 1 year after the date it was placed on public inspection. This was done out of recognition that there were aspects of the rule that were dependent on other aspects, such as the need to implement a process for Agency training of new third-party inspectors before the inspectors could be appointed to shows and exhibitions, and the rule therefore could not be immediately implemented. We also note that the final rule indicated that one of the provisions of the final rule, a prohibition on the use of pads by Tennessee Walking Horses (TWHs) “would be harmful to some horses currently on high pads . . . without a phasing-in period,” and indicated that the January 1, 2018 effective date was chosen in part to ensure this phasing-in period could occur.

Finally, several commenters stated that we could implement the 2017 HPA final rule, and then issue new proposed HPA regulations proposing any additional revisions to the regulations that were necessary.

This was an option before the Agency; however, as noted in the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule, we had reservations about implementing a rule that relied on underlying data and analyses that were at least 7 years old. Indeed, as several commenters noted, the preponderance of data in support of the 2017 HPA final rule was from 2011 or prior, and not necessarily indicative of current industry practices. One of these commenters also noted that the age of the data could present a possible legal vulnerability in the event of litigation by the industry. Accordingly, we preferred to withdraw the 2017 HPA final rule in favor of new proposed HPA regulations that would completely revise the existing HPA regulations and would be based on the most up-to-date data, including that in the NAS report.

Many commenters urged us to finalize the new proposed HPA regulations referenced in the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule as expeditiously as possible, and that the proposed withdrawal of the 2017 HPA final rule should not be finalized until the new proposed HPA regulations are issued. Several commenters stated that the 2016 proposed rule on which the 2017 HPA final rule was based should be reissued until new proposed HPA regulations are issued, while others stated that, if new proposed HPA regulations could not be issued expeditiously, the 2017 HPA final rule should go into effect instead. A number of commenters stated that APHIS was not intent on issuing new HPA regulations, with some citing the length of time they had been under OMB review as purported evidence of this. Finally, many commenters pointed out that APHIS did not provide a timeline for issuance of new HPA regulations.

These comments have all been overtaken by the fact that the new proposed HPA regulations have been published. As we noted above, the new proposed HPA regulations were published in the Federal Register on August 21, 2023.

Several commenters stated that the 2017 HPA final rule should not be withdrawn until the new proposed HPA regulations are finalized.

As noted previously in this document, the District Court afforded APHIS 180 days, or until November 8, 2023, to remedy the deficiency in its previous withdrawal of the 2017 HPA final rule. APHIS has remedied that deficiency by providing notice and opportunity for public comment on the proposed withdrawal and, based on the comments received, making this determination to withdraw the 2017 HPA final rule. Whereas the deadline to undertake this rulemaking process is November 8, 2023, the comment period for the new proposed HPA regulations ended on October 20, 2023. It is not possible to fulfill the legal and procedural requirements associated with issuance of a final regulatory action regarding the new proposed HPA regulations—which include reviewing and responding to all issues raised by commenters, as well as revising supplemental documentation, as warranted, and clearing the final action and documentation through the appropriate offices—in the 19 days between October 20, 2023, and November 8, 2023.

A commenter stated that the withdrawal of the 2017 HPA final rule should only be finalized before the new proposed HPA regulations are finalized if legally or procedurally necessary.

As noted above, it will be legally necessary to publish a final determination on the proposed withdrawal of the 2017 HPA final rule before we can take any subsequent regulatory action regarding the comments on the new proposed HPA regulations.

A number of commenters urged us to finalize and implement a final rule resulting from the new proposed HPA regulations as expeditiously as possible. Several of the commenters stated that, if this were not to occur, the withdrawal of the 2017 HPA final rule would possibly be in violation of the Administrative Procedure Act (APA). Specifically, they stated that the withdrawal could be found unlawful pursuant to 5 U.S.C. 706(2)(A). (This section of the APA provides that a reviewing court shall hold unlawful and set aside agency action that is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.) In their estimation, APHIS provided no evidence that the 2017 HPA final rule was without foundation or otherwise inadequate, and thus the basis for the withdrawal was predicated solely on the issuance, finalization, and implementation of the new proposed HPA regulations.

We note that the commenters urged us to finalize the new proposed HPA regulations irrespective of the comments received on the proposed rule; the APA precludes us from doing so.

Additionally, we disagree with the commenters that the proposed withdrawal did not articulate concerns with the foundation for the 2017 HPA final rule; as noted above, we stated that the underlying data and analyses in support of the final rule were outdated and without the benefit of the recent NAS report's findings or recent inspection data. We further noted that allocating resources towards implementing outdated regulations would hamper APHIS' efforts to modernize the horse protection regulations. We also agree with a commenter who stated that the age of the data could present a possible legal vulnerability in the event of litigation by the industry.

Finally, while it is APHIS' intent to act as promptly as possible regarding the new proposed HPA regulations, we note that there are legal and procedural requirements that we must follow regarding any regulatory action. This includes, but is not limited to, the need for fulsome review of the comments received to fulfill the requirements of the APA; the need to review, and, as necessary, revise supporting documentation in response to comments; and the need to comply with Executive Orders governing the regulatory process. We also note that we have never claimed that a complete revision to the existing HPA regulations could be immediately implemented; as noted above, the 2017 HPA final rule afforded nearly a year between when it was placed on public inspection and when it would have been effective.

As noted above, one of our stated reasons for proposing to withdraw the 2017 HPA final rule was that we had reviewed the 2017 HPA final rule in light of the NAS report, and determined that the rule did not sufficiently address the report's findings.

One commenter disagreed and stated that, having watched discussions regarding the drafting of the report and having reviewed the report, the commenter was certain it was entirely consistent with the provisions of the 2017 HPA final rule. Other commenters stated that the report recommended revising the “scar rule,” which the 2017 HPA final rule did not propose to do, and that new proposed HPA regulations would indeed be needed to incorporate all of the report's recommendations.

We agree with the latter commenters; the former commenter is in error about the report's consistency with the 2017 HPA final rule for the reasons the latter commenters articulated.

A number of commenters cited provisions of the 2017 HPA final rule that, they stated, should be retained in the new proposed HPA regulations if APHIS were to withdraw the 2017 HPA final rule.

Several commenters stated the new proposed HPA regulations should also propose to relieve horse industry organizations, or HIOs, of all regulatory responsibilities for approving and training third-party inspectors.

The new proposed HPA regulations propose to relieve HIOs of such responsibilities.

A commenter stated that the new proposed HPA regulations should also contain clear criteria for being a third-party inspector, as well as a process for denying an application to be an inspector.

The new proposed HPA regulations do contain such criteria and such a process.

A commenter stated that the new proposed HPA regulations should also propose to limit third-party inspectors to veterinarians and other individuals with knowledge of the equine industry who had been screened for possible conflicts of interests.

The new proposed HPA regulations do so.

A commenter stated that the new proposed HPA regulations should also propose to require horse show management to pay for inspectors.

The new proposed HPA regulations do so, provided that management elects to use third-party inspectors. The proposed HPA regulations do propose to allow inspection directly by APHIS representatives, free of charge.

Several commenters stated that the new proposed HPA regulations should also include additional requirements specific to the TWH industry, which, the commenters stated, has a long history of documented instances of soring and violations of the regulations.

The new proposed HPA regulations proposes additional requirements specific to that industry.

A commenter stated that the new proposed HPA regulations should also prohibit any device, method, practice, or substance that could mask evidence of soring.

The new proposed HPA regulations propose such a prohibition.

A commenter stated that the new proposed HPA regulations should contain the reporting requirements specific to the TWH industry that were contained in the 2017 HPA final rule.

They contain such reporting requirements.

Finally, a number of commenters stated that the new proposed HPA regulations should retain all key elements of the 2017 HPA final rule, without further elaborating regarding which elements they considered “key”.

We believe that they do, insomuch as they further the same purposes under the HPA.

Several commenters noted that the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule stated that the new proposed HPA regulations would take into consideration the findings of the NAS report, and asked for assurances that it did in fact do so.

The new proposed HPA regulations do take the NAS report's findings into consideration.

A number of commenters noted that the NAS report recommended revisions to the “scar rule,” and requested that the new proposed HPA regulations propose to revise the scar rule consistent with the report's recommendations.

The new proposed HPA regulations do so.

Finally, one commenter interpreted the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule to suggest that the new proposed HPA regulations would allow for inspection directly by an APHIS representative at no cost to show management, rather than inspection by a third-party inspector. The commenter supported this proposed provision and requested that it in fact be included in the new proposed HPA regulations.

The new proposed HPA regulations contain such a provision.

We also received a number of requests for additional provisions that were not included in the 2017 HPA final rule, and that we did not suggest in the proposed withdrawal would be part of the new proposed HPA regulations.

Several commenters suggested that the new proposed HPA regulations should prohibit the use of weighted shoes. Other commenters stated that prohibitions on the use of shoes, pads, wedges, and action devices that were specific to the TWH industry in the 2017 HPA final rule should also be extended to the Spotted Saddle Horse industry in the new proposed HPA regulations. One commenter suggested that the new HPA regulations should require all inspectors to be trained in evidence of pain and anxiety in horses, and should include random and targeted swabbing for use of prohibited chemicals.

We consider these comments to be outside of the scope of the proposed withdrawal.

With that being said, under current operational practice, APHIS does train inspectors in noticing evidence of pain and anxiety in horses, and random and risk-based swabbing for use of prohibited chemicals does occur.

One commenter stated that soring is an inhumane practice, while another, who owned racking horses, said that they did not need to be sored in order to produce an elegant gait.

This comment is outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule. As we noted in the new proposed HPA regulations, Congress has declared that the soring of horses is cruel and inhumane. 15 U.S.C. 1822.

A commenter stated that American Quarter Horse Association horses, Arab horses, American saddlebred horses, and Morgan horses are also sored prior to competitions.

This comment is outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule. We note, however, that in the new proposed HPA regulations, we invited public comment on any observations persons may have regarding soring in breeds other than in the TWH industry.

Several commenters suggested that APHIS should ban all soring of horses, while other commenters stated that this would be outside the scope of the HPA, and either new legislation or a revision to the HPA would be required in order for APHIS to prohibit such practices unilaterally.

The latter commenters are correct; the HPA does not prohibit the practice of soring outright but, rather, requires the disqualification of sore horses from being shown or exhibited, and prohibits them from being shown or exhibited in any horse show or exhibition; and from being sold, auctioned, or offered for sale in any horse sale or auction.

A commenter stated that the Prevent All Soring Tactics Act of 2022 should be issued, while another stated that horse slaughter should be outlawed.

The issuance of legislation is outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule.

A commenter stated that APHIS' Wildlife Services and Animal Care programs should be abolished, while another stated that the latter program should receive additional funding for HPA enforcement.

Both comments are outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule.

A commenter stated that Animal Care should use thermography to detect signs of inflammation in horses.

This is outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule. However, we note that Animal Care uses thermography currently and plans to continue this use.

A commenter stated that Animal Care should collect blood samples to test for use of prohibited medications and medications administered beyond therapeutic levels.

This is outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule.

A commenter stated that all APHIS regulations should be immediately withdrawn and rewritten in plain language, using Webster's dictionary definitions, and maintained on a single government site.

This is outside the scope of the notice of proposed rulemaking regarding the withdrawal of the 2017 HPA final rule.

Finally, a commenter noted that horses are beautiful animals.

We agree.

Therefore, for the reasons set forth in the proposed withdrawal of the 2017 HPA final rule and in this document, we are withdrawing the 2017 HPA final rule.

This proposed withdrawal has been determined to be significant for the purposes of Executive Order 12866, as amended by Executive Order 14094, and, therefore, has been reviewed by the Office of Management and Budget.

We have prepared an economic analysis for this rulemaking. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also examines the potential economic effects of this rulemaking on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below.

APHIS is withdrawing a final rule that was filed for public inspection, in advance of publication, by the Office of the Federal Register on January 19, 2017, amending the Agency's Horse Protection Act regulations (the 2017 HPA final rule). APHIS withdrew the 2017 HPA final rule from publication without undertaking notice and comment procedures on January 23, 2017, in accordance with a memorandum that was issued by the Executive Office of the President on January 20, 2017. However, following a lawsuit, the U.S. Court of Appeals for the District of Columbia Circuit found this withdrawal to be deficient. The U.S. District Court for the District of Columbia has indicated that one way to remedy this deficiency is to undertake notice and comment procedures on the proposed withdrawal. Based on the comments received, APHIS is withdrawing the 2017 HPA final rule.

This withdrawal is an administrative action and is intended to support the withdrawal of the 2017 HPA final rule, and this action will not have a significant impact on the affected entities. In the absence of apparent significant economic impacts, we have not identified alternatives that would minimize any impacts. In addition, APHIS is in the process of developing new HPA regulations that would provide protections to the regulated horses. Also, these new amendments to the Horse Protection regulations propose to incorporate the findings of a 2021 National Academy of Sciences (NAS) report that examined methods used to inspect horses for soreness. This NAS report was published after the 2017 HPA final rule was filed for public inspection.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

This withdrawal has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have determined that this action does not have tribal implications, insofar as it withdraws a final rule that the Agency never implemented or enforced.

This withdrawal contains no reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The PFCSA  1 requires the Commission to promulgate, not later than 30 months after December 27, 2020, a final rule to require flame mitigation devices in portable fuel containers that impede the propagation of flame into the container. 15 U.S.C. 2056d(b)(1), (2). However, the Commission is not required to promulgate a final rule for a class of portable fuel containers within the scope of the PFCSA if the Commission determines at any time that:

• there is a voluntary standard for flame mitigation devices for those containers that impedes the propagation of flame into the container;

• the voluntary standard is or will be in effect not later than 18 months after the date of enactment of the PFCSA ( i.e., June 27, 2022); and

• the voluntary standard is developed by ASTM International or such other standard development organization that the Commission determines to have met the intent of the PFCSA.

15 U.S.C. 2056d(b)(3)(A). Any such Commission determinations regarding applicable voluntary standards must be published in the Federal Register. 15 U.S.C. 2056d(b)(3)(B).

On January 13, 2023, the Commission published favorable determinations under section 2056d(b)(3)(A) of the PFCSA regarding three voluntary standards for portable fuel containers: ASTM F3429/F3429M-20, ASTM F3326-21, and section 18 of ANSI/CAN/UL/ULC 30:2022 (UL 30:2022). 88 FR 2206. Therefore, by operation of the PFCSA, portable fuel containers manufactured after July 12, 2023, must comply with the requirements of either ASTM F3429/F3429M-20, ASTM F3326-21, or section 18 of UL 30:2022, as applicable. In particular, portable fuel containers sold empty (that are not safety cans  2 ) are required to comply with the requirements of ASTM F3326-21. Safety cans are required to meet the requirements of either ASTM F3326-21 or section 18 of UL 30:2022. Portable fuel containers sold pre-filled are required to comply with the requirements of ASTM F3429/F3429M-20. However, in a May 19, 2023, letter, the CPSC Office of Compliance and Field Operations exercised enforcement discretion regarding pre-filled portable fuel containers subject to ASTM F3429/F3429M-20 to prevent a shortage of critical fuels, including fuels used for emergencies. 3

Under section 2056d(b)(5) of the PFCSA, a voluntary standards organization must notify the Commission of any revision to the requirements for flame mitigation devices for the Commission-approved voluntary standards for portable fuel containers. Once a voluntary standards organization notifies the CPSC, the revisions will be incorporated into the consumer product safety rule not later than 180 days after notification (or such later date as the Commission determines appropriate), unless within 90 days of such notice, the Commission determines that the revisions do not meet the requirements of section 2056d(b)(3) of the PFCSA, and so notifies the voluntary standards organization. 15 U.S.C. 2056d(b)(5)(B).

On June 12, 2023, ASTM notified CPSC that it has revised ASTM F3429/F3429M-20 with the publication of ASTM F3429/F3429M-23. On June 23, 2023, the Commission published a notice of availability and request for comment regarding revised ASTM F3429/F3429M-23. Two comments were submitted in support of a favorable Commission determination on the revisions to ASTM F3429/F3429M. 88 FR 41046. On August 22, 2023, as set forth in section B of this preamble, the Commission determined that the revisions meet the requirements of section 2056d(b)(3)(A) of the PFCSA. 4 Accordingly, ASTM F3429/F3429M-23 shall be treated as a consumer product safety rule promulgated under section 9 of the CPSA effective December 9, 2023 (which is 180 days after ASTM's notification). This direct final rule creates a new 16 CFR part 1461 for portable fuel containers to incorporate by reference the revised ASTM F3429/F3429M-23, as well as ASTM F3326-21 and section 18 of UL 30:2022. 5 This direct final rule is codifying the three voluntary standards for portable fuel containers that are mandatory under the PFCSA for the convenience of stakeholders and the public and to provide clarity regarding which versions of the voluntary standards are mandatory for portable fuel containers under the PFCSA.

On January 13, 2023, the Commission published a Federal Register notice in accordance with the PFCSA, determining that pre-filled portable fuel containers must comply with ASTM F3429/F3429M-20 as a consumer product safety rule. 88 FR 2206. On June 12, 2023, ASTM notified the Commission that a revision of that standard, ASTM F3429/F3429M-23, was published in May 2023. ASTM F3429/F3429M-23 includes substantive revisions affecting the flame mitigation performance tests (the endurance test and the flashback test) and non-substantive revisions concerning its scope, a referenced document, a section title, and the appendix of the standard. The substantive revisions affecting the performance test requirements relate to testing containers with large volumes, testing containers with wide mouths, modifying the allowable downward angle of the container during testing, and eliminating redundant testing when the same flame mitigation device is used on differently sized containers.

As discussed below, the Commission concluded that the changes in ASTM F3429/F3429M-23 do not affect the effectiveness of the flame mitigation device in impeding the propagation of a flame or other ignition source into the container. The changes to the standard will improve the safety of testing flame mitigation devices on larger volume containers and facilitate compliance testing of these containers.

Many of the revisions to ASTM F3429/F3429M-20 were requested by laboratories conducting the testing for compliance, to improve safety for test personnel and facilities. Without these changes to the test methods, manufacturers may not be able to find a certification testing laboratory to demonstrate compliance for some of their products, which could limit consumer access to these products. If consumers are unable to buy pre-filled portable fuel containers that are compliant with ASTM F3429/F3429M, they may use hazardous substitute containers.

As explained below, the Commission concluded that the revisions in ASTM F3429/F3429M-23 meet the requirements of section 2056d(b)(3)(A) of the PFCSA is allowing ASTM F3429/F3429M-23 to become the mandatory consumer product safety rule for pre-filled portable fuel containers pursuant to section 2056d(b)(5) of the PFCSA. The background and revisions to ASTM F3429/F3429M are described in more detail in the CPSC staff's briefing memorandum. 6

The first substantive revision in ASTM F3429/F3429M-23 allows the container volume to be reduced for testing purposes if the reduced volume does not impact, change, hinder, or deform the flame mitigation device or how the flame mitigation device is mounted on the container. Laboratories that tested containers with larger volumes to ASTM F3429/F3429M-20 found that a failed test produced a large explosion that presented a risk to test personnel and equipment. Testing laboratories determined that they could not safely mitigate the risks when testing larger volumes without a revision to ASTM F3429/F3429M-20. We note a flame mitigation device impedes the propagation of the flame into the container by quenching an external flame at the mouth of the container before it can ignite the vapors within the container. The shape and size of the container does not impact determination of the flame mitigation device's effectiveness because an effective device stops the flame before it enters the container. The changes proposed affect only the consequences of a failure, not whether the flame mitigation device fails. The Commission therefore concludes that this revision facilitates compliance testing but does not affect the voluntary standard's satisfaction of the requirements of section 2056d(b)(3)(A) of the PFCSA.

The second substantive revision to ASTM F3429/F3429M-23 limits the maximum flow rate of gaseous fuel and air used to fill the container before the tests. This change only alters the rate of filling the container to prepare it to be tested. Laboratories that tested containers with wider mouths to ASTM F3429/F3429M-20 found that the flow of gaseous fuel and air created a large cloud of explosive gas outside the container. Open flames near the cloud of explosive gas presented an explosion risk. Testing laboratories determined that they could not safely mitigate the risks to test personnel when testing containers with wider mouths without modifying ASTM F3429/F3429M-20.

Under the revision, gaseous fuel and air at the appropriate ratio fill the container before the trials, but the flow is stopped before the external flames are introduced. Because the gaseous fuel and air flow is stopped before the external ignition source is introduced, slowing the fill rate does not affect the performance of the flame mitigation device. The Commission concludes that this revision facilitates compliance testing but does not affect the voluntary standard's satisfying the requirements of section 2056d(b)(3)(A) of the PFCSA because the performance of the flame mitigation device when exposed to external ignition sources is evaluated the same as with a faster fill rate.

The third substantive revision to ASTM F3429/F3429M-23 allows the container to be mounted at a downward angle between 45 and 60 degrees when tested, rather than at 45 +/−2 degrees as under the 2020 version of the standard. Testing laboratories proposed this change to allow greater flexibility to position the flame directly onto the mouth of the container as required in the test. Testing laboratories had found it difficult to properly position the flame as required in the performance test without being able to adjust the position of the container significantly. Because an effective flame mitigation device impedes the flame before it reaches inside the container, and an ineffective device allow the ignition of the gaseous fuel and air in the container regardless of the angle, the precise downward angle of the container is not critical to the effectiveness of the flame mitigation device.

The fourth substantive revision to ASTM F3429/F3429M-23 allows a container that uses a flame mitigation device that has met the requirements of the standard when attached in the same manner to a similar container model, to be considered compliant with this standard, without needing to be re-tested. Because a compliant flame mitigation device prevents flame from reaching vapors in the container, changing the shape and size of the container does not affect the effectiveness of the flame mitigation device.

There are three non-substantive revisions in ASTM F3429/F3429M-23. First, ASTM changed the order of the scope subclauses to match the standard structure of other ASTM specifications. The text of the scope was not otherwise changed. Second, ASTM F3326 was removed from the listed reference documents as it was not used elsewhere in ASTM F3429/F3429M-23. A reserved section was renamed from a “permanency” test to a “retention” test. Currently, this is a placeholder for a potential future requirement. Finally, some explanatory information in the non-mandatory appendix for the “retention” test was removed, but no mandatory requirements were added or changed. The Commission concludes these non-substantive changes do not implicate the standard satisfying the requirements of section 2056d(b)(3)(A) of the PFCSA.

This direct final rule creates a new part 1461, “Portable Fuel Container Safety Act Regulation.” Part 1461 incorporates by reference the three voluntary standards the Commission has determined under the PFCSA to be mandatory: ASTM F3429/F3429M-23 (updated from the 2020 version of the standard), ASTM F3326-21, and section 18 of UL 30:2022. The provisions of the direct final rule are described below.

Section 1461.1 of the rule provides, in accordance with the PFCSA, that portable fuel containers must comply with the requirements specified in § 1461.3, which are considered to be consumer product safety rules.

Section 1461.2 of the rule provides the statutory definition of “portable fuel container” found in the PFCSA. Although this definition is provided in the PFCSA, this section restates the definition for the convenience of the regulated community and the public.

Section 1461.3 provides that each portable fuel container manufactured for sale in the United States shall conform to the applicable requirements of this section depending on whether the portable fuel container is sold pre-filled or empty.

Section 1461.3(a)(1) of the rule requires that portable fuel containers sold to consumers pre-filled must comply with the requirements of ASTM F3429/F3429M-23, Standard Specification for Performance of Flame Mitigation Devices Installed in Disposable and Pre-Filled Flammable Liquid Containers. ASTM F3429/F3429M is listed by ASTM as a dual standard in inch-pound (F3429 designation) and metric (F3429M designation) units. Both designations of the standard are substantively identical except for the inch-pound versus metric units used in the standard. The standard requires two performance tests of the container's flame mitigation device. The first is an endurance test, in which the container is subjected to an external and stationary 2.5-inch flame at the mouth of the container for 30 seconds. The second test is a flashback test, in which the container is subjected to an external flash fire near the container mouth. The container passes each test if the contents of the container do not catch fire or otherwise ignite in each of five consecutive trials. The two tests are used to demonstrate that the flame mitigation device impedes the propagation of two different types of ignition sources, a stationary flame and a moving flame.

Section 1461.3(a)(2) of the rule requires portable fuel containers sold empty to the consumer to comply with ASTM F3326-21, Standard Specification for Flame Mitigation Devices on Portable Fuel Containers. ASTM F3326 requires a performance test of the container's flame mitigation devices after the container is exposed to several use-and-abuse tests. Use-and-abuse tests are designed to ensure a flame mitigation device still functions after simulating normal use and reasonably foreseeable abuse of the container over time. The flame mitigation device performance test demonstrates that the container prevents a flame traveling at five meters per second from igniting the contents of the container in each of five consecutive trials. The test also demonstrates that the flame mitigation device impedes the propagation of a rapidly travelling flame front into the container.

Portable fuel containers sold empty to the consumer that are classified as safety cans that meet the requirements of section 18 of UL 30:2022, Standard for Safety Metallic and Nonmetallic Safety Cans for Flammable and Combustible Liquids, are not required to comply with ASTM F3326-21. UL 30:2022 is a voluntary standard that covers various requirements for safety cans, including requirements for flame mitigation devices. Section 18 of UL 30 has two performance test options. The first option is to subject the safety can mouth to an external and stationary 2.5-inch flame for 30 seconds. The safety can passes the test if the interior contents of the safety can do not catch fire or otherwise ignite in each of five consecutive trials. The second performance test option is used for safety cans that have a flame arrestor. In this performance test, a 7.5-inch flame is balanced on one side of the flame arrestor as a fuel-air mixture passes through. The flame arrestor fails if the flame crosses the flame arrestor and ignites the fuel-air mixture.

Section 1461.4 of the rule incorporates by reference the three voluntary standards that are mandatory under the rule.

The Commission is issuing this rule as a direct final rule. Although the Administrative Procedure Act (APA; 5 U.S.C. 551-559) generally requires agencies to provide notice of a rule and an opportunity for interested parties to comment on it, section 553 of the APA provides an exception when the agency “for good cause finds” that notice and comment are “impracticable, unnecessary, or contrary to the public interest.” Id. 553(b)(B).

The purpose of this direct final rule is to codify in the CFR three voluntary standards (ASTM F3429/F3429M-23, ASTM F3326-21, and section 18 of UL 30:2022) that are mandatory consumer product safety rules by operation of law under the PFCSA. Public comments would not alter whether the three voluntary standards are considered mandatory consumer product safety rules under the PFCSA. The Commission concludes that when it merely codifies voluntary standards that are already mandatory consumer product safety rules by statute under the PFCSA, notice and comment are unnecessary.

In its Recommendation 95-4, the Administrative Conference of the United States (ACUS) endorses direct final rulemaking as an appropriate procedure to expedite rules that are noncontroversial and not expected to generate significant adverse comments. See 60 FR 43108 (Aug. 18, 1995). ACUS recommends that agencies use the direct final rule process when they act under the “unnecessary” prong of the good cause exemption in 5 U.S.C. 553(b)(B). Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule, because CPSC does not expect any significant adverse comments.

Unless CPSC receives a significant adverse comment by November 30, 2023, this rule will become effective on December 9, 2023—the end of the 180-day period specified in the PFCSA. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be “one where the commenter explains why the rule would be inappropriate,” including an assertion challenging “the rule's underlying premise or approach,” or a claim that the rule “would be ineffective or unacceptable without a change.” 60 FR 43108, 43111 (Aug. 18, 1995). As noted, this rule merely codifies in the CFR the three voluntary standards that are mandatory consumer product safety rules under the PFCSA and restates the statutory definition of “portable fuel container”; thus, public comments would not change such statutory requirements or definitions.

If the Commission does receive a significant adverse comment, the Commission will withdraw this direct final rule. Depending on the comment and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment.

Section 1460.3 of the direct final rule incorporates by reference ASTM F3429/F3429M-23, ASTM F3326-21, and section 18 of ANSI/CAN/UL/ULC 30:2022. The Office of the Federal Register (OFR) has regulations regarding incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble to a final rule, ways in which the material the agency incorporates by reference is reasonably available to interested parties, and how interested parties can obtain the material. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b).

In accordance with the OFR regulations, section C of this preamble summarizes the major provisions of ASTM F3429/F3429M-23, ASTM F3326-21, and section 18 of UL 30:2022 that the Commission incorporates by reference into 16 CFR part 1461. The standards are reasonably available to interested parties. Until the direct final rule takes effect, read-only copies of ASTM F3429/F3429M-23 and ASTM F3326-21 are available for viewing, at no cost, on ASTM's website at: www.astm.org/CPSC.htm. Once the rule takes effect, a read-only copy of those two ASTM standards will be available for viewing, at no cost, on the ASTM website at: www.astm.org/READINGLIBRARY/. Interested parties can purchase copies of ASTM F3429/F3429M-23 and ASTM F3326-21 from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959 USA; telephone: (610) 832-9585; www.astm.org.

A read-only copy of UL 30:2022 is available for viewing, free-of-charge at UL's Standards Sale Site at: shopulstandards.com. Click “Browse and Buy Standards,” and search for UL 30 and then click “Digital View,” and sign in, or create a user account. The read-only copy of UL 30:2022 will remain available for viewing, free-of-charge after the direct final rule goes into effect. Interested parties can purchase a copy of UL 30:2022 from UL Standards and Engagement, 151 Eastern Avenue, Bensenville, IL 60106 USA; telephone: (888) 853-3503; shopulstandards.com .

Interested parties can also schedule an appointment to inspect copies of ASTM F3429/F3429M-23, ASTM F3326-21, and UL 30:2022 at CPSC's Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814, telephone: (301) 504-7479; email: cpsc-os@cpsc.gov.

Section 2056d(b)(5)(B) of the PFCSA provides that not later than 180 days after the Commission is notified of a revised voluntary standard (or such later date as the Commission determines appropriate), such revised voluntary standard shall become enforceable as a consumer product safety rule promulgated under 16 U.S.C. 2058, in place of the prior version, unless within 90 days after receiving the notice the Commission determines that the revised voluntary standard does not meet the requirements in section 2056d(b)(3)(A) of the PFCSA. Unless the Commission receives a significant adverse comment by November 30, 2023, the rule therefore will become effective on December 9, 2023. Based on the Commission's January 2023 published determinations under the PFCSA, portable fuel containers that are sold empty to the consumer manufactured after July 12, 2023, must comply with the requirements of either ASTM F3326-21, or section 18 of UL 30:2022, as applicable. This direct final rule's effective date of December 9, 2023, which is the effective date of the ASTM F3429/F3429M-23 revision as a mandatory safety standard, does not alter the previously established effective date of July 12, 2023, for ASTM F3326-21 and section 18 of UL 30:2022 under the PFCSA. Products subject to the requirements of those standards are already required to meet those standards.

Further, portable fuel containers sold pre-filled are also required under the PFCSA to comply with the requirements of ASTM F3429/F3429M-20 after July 12, 2023. However, on May 19, 2023, the Office of Compliance and Field Operations issued a letter exercising enforcement discretion regarding pre-filled portable fuel containers subject to ASTM F3429/F3429M-20 to prevent a shortage of critical fuels used for emergencies.

The Regulatory Flexibility Act (RFA; 5 U.S.C. 601-612) generally requires agencies to review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603, 604. The RFA applies to any rule that is subject to notice and comment procedures under section 553 of the APA. Id. As discussed in section D of this preamble, the Commission has determined that notice and the opportunity to comment are unnecessary for this rule. Therefore, the RFA does not apply. CPSC also notes the limited nature of this document, which merely creates a new part in the Code of Federal Regulations codifying the incorporations by reference to reflect the voluntary standards that are mandatory under the PFCSA and the statutory definition of portable fuel containers.

The Commission's regulations provide a categorical exclusion for the Commission's rules from any requirement to prepare an environmental assessment or an environmental impact statement where they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required.

Section 26(a) of the CPSA provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the federal standard. 15 U.S.C. 2075(a). Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to CPSC for an exemption from this preemption under certain circumstances. The PFCSA deems rules issued under that statute to be a “consumer product safety rule.” Therefore, once a rule issued under the PFCSA takes effect, it will preempt in accordance with section 26(a) of the CPSA.

The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that before a rule can take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission must indicate whether the rule is a “major rule.” The CRA states that the Office of Information and Regulatory Affairs determines whether a rule qualifies as a “major rule.”

Pursuant to the CRA, OIRA has determined that the rule does not qualify as a “major rule,” as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit the required information to each House of Congress and the Comptroller General.

Please note that all comments received in response to this docket are considered part of the public record. DEA will make comments available for public inspection online at https://www.regulations.gov. Such information includes personal or business identifying information (such as name, address, State or Federal identifiers, etc.) voluntarily submitted by the commenter. In general, all information voluntarily submitted by the commenter, unless clearly marked as Confidential Information in the method described below, will be publicly posted. Comments may be submitted anonymously. The Freedom of Information Act applies to all comments received.

Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed confidential PII and business information already redacted. DEA will post only the redacted comment on https://www.regulations.gov for public inspection.

For easy reference, an electronic copy of this document and supplemental information to this interim final rule (IFR) are available at https://www.regulations.gov.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 1 Interested persons, as defined in 21 CFR 1300.01(b), may file requests for a hearing in conformity with the requirements of 21 CFR 1308.44(a) and 1316.47(a), and such requests must:

(1) state with particularity the interest of the person in the proceeding;

(2) state with particularity the objections or issues concerning which the person desires to be heard; and

(3) state briefly the position of the person with regarding to the objections or issues.

Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing in conformity with the requirements of 21 CFR 1308.44©, together with a written statement of position on the matters of fact and law involved in any hearing. 2

All requests for hearings and waivers of participation, together with a written statement of position on the matters of fact and law involved in such hearing, must be sent to DEA using the address information provided above. The decision whether a hearing will be needed to address such matters of fact and law in the rulemaking will be made by the Administrator. If a hearing is needed, DEA will publish a notice of hearing on the proposed rulemaking in the Federal Register . 3 Further, once the Administrator determines a hearing is needed to address such matters of fact and law in rulemaking, she will then designate an Administrative Law Judge (ALJ) to preside over the hearing. The ALJ's functions shall commence upon designation, as provided in 21 CFR 1316.52.

In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing would be to determine whether zuranolone meets the statutory criteria for placement in schedule IV.

Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (section 2(b) of Pub. L. 114-89), DEA is required to commence an expedited scheduling action with respect to certain new drugs approved by the Food and Drug Administration (FDA). As provided in 21 U.S.C. 811(j), this expedited scheduling is required where both of the following conditions apply: (1) The Secretary of the Department of Health and Human Services (HHS) has advised DEA that a New Drug Application (NDA) has been submitted for a drug that has a stimulant, depressant, or hallucinogenic effect on the central nervous system (CNS), and that it appears that such drug has an abuse potential; and (2) the Secretary of HHS recommends that DEA control the drug in schedule II, III, IV, or V pursuant to 21 U.S.C. 811(a) and (b). In these circumstances, DEA is required to issue an interim final rule (IFR) controlling the drug within 90 days.

Subsection 811(j)(2) states that the 90-day timeframe starts the later of (1) the date DEA receives HHS's scientific and medical evaluation/scheduling recommendation, or (2) the date DEA receives notice of the NDA approval by HHS. Subsection 811(j)(3) specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause therefore. Thus, the purpose of subsection 811(j) is to speed the process by which DEA schedules newly approved drugs that are currently either in schedule I or not controlled (but which have sufficient abuse potential to warrant control) so that such drugs may be marketed without undue delay following FDA approval. 4

Subsection 811(j)(3) further provides that the IFR shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, DEA must issue a final rule in accordance with the scheduling criteria of 21 U.S.C. 811(b) through (d), and 812(b).

Zuranolone (chemically known as 1-[2-[(3 R, 5 R, 8 R, 9 R, 10 S, 13 S, 14 S, 17 S )-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1 H -cyclopenta[ a ]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile) is a new molecular entity with CNS activity. Zuranolone is a positive allosteric modulator of gamma-aminobutyric acid type A (GABA A ) receptors and an inhibitory neurosteroid substance that shares structural features and a pharmacological mechanism of action with progesterone, alfaxalone (schedule IV), and brexanolone (allopregnanolone, schedule IV).

On December 5, 2022, Sage Therapeutics, Inc. submitted an NDA for zuranolone to FDA. On August 4, 2023, FDA approved the NDA for zuranolone to be marketed as a prescription drug (ZURZUVAE, capsule) for the treatment of post-partum depression. DEA received notification that FDA approved the NDA on the same date. Pursuant to its FDA-approved prescription drug labeling, ZURZUVAE, 50 mg, is to be administered orally once in the evening with fat-consuming food for 14 days. The dose may be reduced for patients who cannot tolerate 50 mg.

On July 12, 2023, DEA received from HHS a scientific and medical evaluation entitled “Basis for the Recommendation to Control Zuranolone and its Salts in Schedule IV of the Controlled Substances Act” and a scheduling recommendation. Pursuant to 21 U.S.C. 811(b) and (c), this document contained an eight-factor analysis of the abuse potential, legitimate medical use, and dependence liability of zuranolone, along with HHS's recommendation to control zuranolone and its salts under schedule IV of the CSA.

In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS, along with all other relevant data, and completed its own eight-factor review pursuant to 21 U.S.C. 811(c). DEA concluded that zuranolone meets the 21 U.S.C. 812(b)(4) criteria for placement in schedule IV of the CSA.

Pursuant to subsection 811(j), and based on HHS's scheduling recommendation, the approval of the NDA by HHS/FDA, and DEA's determination, DEA is issuing this IFR to schedule zuranolone as a schedule IV controlled substance under the CSA.

Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its scheduling action. Please note that both DEA and HHS analyses are available in their entirety under “Supporting Documents” in the public docket for this IFR at https://www.regulations.gov, under Docket Number “DEA1258.” Full analysis of, and citations to, the information referenced in the summary may also be found in the supporting and related material.

Zuranolone is a new molecular entity that has not been marketed in the United States or any country. Thus, evidence regarding its diversion, illicit manufacturing, or deliberate ingestion is currently lacking. DEA notes that there are no reports of law enforcement encounters of zuranolone in the National Forensic Laboratory Information System (NFLIS)-Drug database. 5 Zuranolone has sedative effects and is likely to have abuse potential, similar to schedule IV sedatives such as alprazolam. Thus, it is reasonable to assume that zuranolone may be diverted from legitimate channels, used contrary to or without medical advice, and capable of creating hazards to the users and to the safety of the community. In human abuse potential studies, zuranolone produced positive subjective responses that are similar to those produced by alprazolam (schedule IV). Zuranolone produces rewarding effects that are comparable to those produced by schedule IV sedatives; therefore, zuranolone is likely to be abused for its sedative effects contrary to medical advice.

Zuranolone is a selective neuroactive steroid that potentiates synaptic (γ subunit-containing) and extra synaptic (δ-subunit containing) GABA A receptor activity. Zuranolone acts on GABA A receptors to enhance the effects of GABA, a major inhibitory neurotransmitter in the CNS. Zuranolone acts directly through the GABA A receptor-channel complex to increase the probability that the channel will enter into naturally occurring open states of relatively long duration and allow the influx of chloride. Zuranolone was found to potentiate GABA-evoked current in cells expressing human GABA A receptor subtypes. HHS noted that these data are consistent with a mechanism of action of zuranolone that is similar to other schedule IV neurosteroids ( e.g., brexanolone) as a positive allosteric modulator of GABA A sites.

In animal studies, zuranolone's effect on the general behavioral profile in male rats showed that it produced behavioral activities, such as decreased activity, ataxia, hypersensitivity to touch and/or sound, and impaired righting reflex at supratherapeutic plasma concentrations. The observations were generally limited to the highest dose test (22.5 mg/kg), although some animals exhibited slight impairments at the lower doses tested (3 and 10 mg/kg).

In a drug discrimination study using male rats trained to discriminate midazolam and saline, intraperitoneally administered zuranolone (0.1, 0.3, 0.5, 1, and 3 mg/kg) produced dose-dependent effects and full substitution to midazolam discriminative stimulus effect at the highest dose tested when considering lever presses over the entire session and not just the first reinforcer (75 percent). However, 3 mg/kg zuranolone produced behavioral impairment, such that only five of ten rodents completed the session. In female rats, intraperitoneally administered zuranolone (0.1, 0.3, 0.5, 1, and 2 mg/kg) also produced dose-dependent effects and full substitution to midazolam discriminative stimulus effect at the highest dose tested when considering lever presses over the entire session and not just the first reinforcer (72.5 percent).

Zuranolone reinforcing properties were assessed by determining whether self-administration behavior was maintained when the drug was substituted for cocaine (schedule II). As stated by HHS in their scientific and medical evaluation, the study found that the selected doses of zuranolone did not maintain robust self-administration in animals with a previous history of cocaine self-administration.

In clinical trials, zuranolone produced significantly greater mean drug liking than placebo. The low (30 mg) and middle (60 mg) doses of zuranolone produced significantly less mean drug liking scores than both alprazolam (schedule IV) doses (1.5 and 3 mg). However, the highest dose of zuranolone produced mean drug liking scores that were similar to both doses of alprazolam (schedule IV).

Zuranolone produced euphoria-related adverse events that are supportive of zuranolone having an abuse potential. However, the abuse-related treatment emergent AE profile of zuranolone was slightly lower than that of alprazolam (a schedule IV benzodiazepine) at a supratherapeutic dose of zuranolone.

Zuranolone produced incidence of euphoria-related adverse events supportive of its abuse potential in animals and humans similar to those of benzodiazepines in schedule IV. These data are consistent with the fact that both drugs share a common mechanism of action involving positive allosteric modulation of the GABA A receptors.

Zuranolone, chemically known as 1-[2-[(3 R, 5 R, 8 R, 9 R, 10 S, 13 S, 14 S, 17 S )-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1 H -cyclopenta[ a ]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile, is a new molecular entity.

Zuranolone is a drug product formulated as 20, 25, and 30 mg colored hard-gelatin capsules. The powder is white to off-white in color. Zuranolone is available as an immediate-release formulation and is absorbed with a time to maximum effect of approximately 6 hours and a half-life of 20 hours.

As discussed in the background section, zuranolone has an accepted medical use in the United States.

There is no information on the history and current pattern of abuse for zuranolone, since it has not been marketed, legally or illegally, in the United States or any other country. There is no evidence of diversion of zuranolone that has been distributed for research, such as for clinical trials. Data from preclinical and clinical studies indicate that the abuse potential of zuranolone is similar to that of schedule IV sedatives, including benzodiazepines. Consistent with the fact that zuranolone is a new molecular entity, the NFLIS-Drug database had no records of encounters by law enforcement.

In summary, pharmacological data on zuranolone show that it produces abuse-related effects and has an abuse potential similar to that of schedule IV CNS depressants.

A search by DEA of the NFLIS-Drug database found no evidence of law enforcement encounters of zuranolone in the United States. Data from preclinical and clinical studies showed that zuranolone has an abuse potential that is similar to that of schedule IV sedatives, including benzodiazepines. Upon availability of zuranolone in the market, it is likely to be abused.

Zuranolone's abuse potential, similar to that of schedule IV sedatives, is an indication of its public health risk. As such, upon availability for marketing, it is likely to pose risk to public health comparable to schedule IV positive allosteric modulators of the GABA A receptor such as brexanolone and benzodiazepines. According to evaluation of public health risks conducted by HHS, the most observed adverse effects were somnolence, dizziness, and sedation. An overdose of zuranolone could result in sedation with or without respiratory depression or other severe adverse effects. Two simulated driving studies demonstrated impairment approximately 9 hours after nighttime administration.

Concomitant use with other CNS depressants such as alcohol may potentiate the impairment of psychomotor performance and cognition. HHS noted that zuranolone is not recommended for chronic administration; it is intended for a 14-day treatment course. This may lessen some public health risks compared to other drugs that are prescribed for longer durations or in larger quantities.

Zuranolone's psychic and physiological dependence liability was assessed using data from animal physical dependence studies and clinical evaluations of physical dependence, including measures of withdrawal. As described by HHS, data from a physiologic dependence study conducted in rats demonstrated zuranolone did not induce significant withdrawal-related phenotypes at the doses tested; however, zuranolone produced significant toxic effects in dogs, including convulsions and death in the dog toxicity studies. HHS noted the toxic effects in dogs, such as the early mortalities, may be consistent with withdrawal-type effects observed after cessation of chronic dosing of sedative-hypnotic benzodiazepines.

In clinical trials, when zuranolone was administered at therapeutic doses (≤50 mg/day) for a minimum of five days, it produced mild-to-moderate withdrawal-related effects in healthy individuals upon abrupt drug discontinuation, including the following: insomnia, palpitations, decreased appetite, nightmare, nausea, hyperhidrosis, and paranoia. Similar effects were not evident in the patient population. HHS provided caveats for why this may be the case, such as the withdrawal effects may have been obscured by the symptoms of the underlying condition (post-partum depression and major depressive disorder) or inadequate assessment of withdrawal in the various Phase 3 studies. However, based on available data provided by HHS, the withdrawal-related symptoms produced by zuranolone after abrupt drug discontinuation are similar to those that are clinically known for benzodiazepines in schedule IV.

The data taken together suggest that zuranolone maybe produce physical dependence, and the risk of physical dependence and withdrawal syndrome upon drug discontinuation is expected to be more severe for individuals who take a higher than the therapeutic dose of zuranolone for an extended period of time, which may include convulsions based on the dog toxicity studies.

Zuranolone is not an immediate precursor of any controlled substance, as defined by 21 U.S.C. 802(23).

Conclusion: After considering the scientific and medical evaluation and scheduling recommendation provided by HHS, and its own eight-factor analysis, DEA has determined that these facts and all relevant data constitute substantial evidence of potential for abuse of zuranolone. As such, DEA hereby schedules zuranolone as a controlled substance under the CSA.

The CSA lists the findings required to place a drug or other substance in any particular schedule (I, II, III, IV, or V). 6 After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(4), finds that:

(1) Zuranolone has a potential for abuse similar to the drugs or other substances in schedule IV.

Zuranolone, a neuroactive steroid, is a positive allosteric modulator of GABA A receptors and produces sedation in general behavioral studies. In a drug discrimination study in animals, zuranolone produced dose-dependent substitution for midazolam (schedule IV) when considering the full session (partial substitution when considering the first reinforcer), demonstrating it has GABA agonist properties. Zuranolone produced positive subjective responses and euphoria-related adverse events similar to that of alprazolam (schedule IV), and greater than that of placebo in a human abuse potential study.

Furthermore, data from other clinical studies show that zuranolone produced incidence of euphoria-like adverse events in 5 percent of healthy individuals, including euphoric mood, feeling drunk, feeling of relaxation, feeling abnormal, and inappropriate effect compared to no incidence following placebo. Therefore, zuranolone has the potential for abuse similar to alprazolam, midazolam, methohexital, and other substances in schedule IV.

(2) Zuranolone has a currently accepted medical use in treatment in the United States.

FDA approved the NDA for ZURZUVAE (zuranolone) as a treatment for post-partum depression. Thus, zuranolone has a currently accepted medical use in treatment in the United States.

(3) Abuse of zuranolone may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III but similar to other substances in schedule IV.

Zuranolone shares a similar pharmacology profile with brexanolone (schedule IV) and benzodiazepines (schedule IV). Data from a rat physical dependence study demonstrated that discontinuation of chronic administration of zuranolone at the doses tested did not produce physical dependence or withdrawal syndrome. In a dog toxicity study, drug discontinuation after chronic administration at supratherapeutic doses produced convulsions similar to that of benzodiazepines. Further, upon abrupt discontinuation in humans at the therapeutic dose (≤50 mg per day), zuranolone produced mild to moderate withdrawal-like effects in healthy individuals no worse than what is clinically known for schedule IV benzodiazepines. HHS concluded that there would be higher risk of developing physical dependence and withdrawal syndrome and more severe effects after abrupt drug discontinuation in individuals that took more than the therapeutic dose or for an extended duration. Withdrawal symptoms from physical dependence may include convulsions. Zuranolone produced positive subjective responses and euphoria-related adverse events and may produce psychic dependence. Zuranolone may lead to physical or psychological dependence similar to benzodiazepines in schedule IV.

Based on these findings, the Administrator concludes that zuranolone warrants control in schedule IV of the CSA. 7

Zuranolone is subject to the CSA's schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distributing, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) zuranolone must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. These registration requirements, however, are not applicable to patients (end users) who possess zuranolone pursuant to a lawful prescription.

2. Disposal of Stocks. Any person unwilling or unable to obtain a schedule IV registration must surrender all quantities of currently held zuranolone, or may transfer all quantities of currently held zuranolone to a person registered with DEA. Zuranolone is required to be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable Federal, state, local, and tribal laws.

3. Security. Zuranolone is subject to schedule III-V security requirements for DEA registrants and must be handled and stored in accordance with 21 CFR 1301.71-1301.77, pursuant to 21 U.S.C. 823, 821, 871(b). Non-practitioners handling zuranolone must also comply with the employee screening requirements of 21 CFR 1301.90-1301.93. These requirements, however, are not applicable to patients (end users) who possess zuranolone pursuant to a lawful prescription.

4. Labeling and Packaging. All labels and packaging for commercial containers of zuranolone must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

5. Inventory. Every DEA registrant who possesses any quantity of zuranolone must have an initial inventory of all stocks of controlled substances (including zuranolone) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

Any person who registers with DEA to handle zuranolone must take an initial inventory of all stocks of controlled substances (including zuranolone) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).

After the initial inventory, every DEA registrant must take inventory of all controlled substances (including zuranolone) on hand every two years, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. These requirements, however, are not applicable to patients (end users) who possess zuranolone pursuant to a lawful prescription.

6. Records and Reports. DEA registrants must maintain records and submit reports for zuranolone, pursuant to 21 U.S.C. 827, 832(a), and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317.

7. Prescriptions. All prescriptions for zuranolone, or products containing zuranolone, must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.

8. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule IV controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of zuranolone may only be for the legitimate purposes consistent with the drug's labeling, or for research activities authorized by the Federal Food, Drug, and Cosmetic Act (FDCA), as applicable, and the CSA.

9. Importation and Exportation. All importation and exportation of zuranolone must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

10. Liability. Any activity involving zuranolone not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Section 553 of the APA (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, 21 U.S.C. 811(j) provides that in cases where a certain new drug is (1) approved by HHS, under section 505(c) of the FDCA, and (2) HHS recommends control in CSA schedule II-V, DEA shall issue an IFR scheduling the drug within 90 days. As stated in the legal authority section, the 90-day time frame is the later of: (1) the date DEA receives HHS's scientific and medical evaluation/scheduling recommendation, or (2) the date DEA receives notice of the NDA approval by HHS. Additionally, subsection 811(j) specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause.

In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563. E.O. 14094 modernizes the regulatory review process to advance policies that promote the public interest and address national priorities.

This meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does 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 rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This proposed action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As noted in the above discussion regarding the applicability of the APA, DEA is not required to publish a general notice of proposed rulemaking. Consequently, the RFA does not apply to this IFR.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this proposed action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this IFR to both Houses of Congress and to the Comptroller General.

This document of the Drug Enforcement Administration was signed on October 25, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

The Drug Enforcement Administration (DEA) is extremely concerned with the recent increase in the illicit manufacture and distribution of fentanyl and fentanyl analogues. Therefore, on April 14, 2023, DEA published a Notice of Proposed Rulemaking (NPRM) to include halides of 4-anilinopiperidine as list I chemicals. 1 This rulemaking finalizes that NPRM.

This action subjects handlers of halides of 4-anilinopiperidine to the regulatory provisions of the Controlled Substances Act (CSA) and its implementing regulations regarding list I chemicals. This rulemaking does not establish a threshold for domestic and international transactions of halides of 4-anilinopiperidine. As such, all transactions involving halides of 4-anilinopiperidine, regardless of size, shall be regulated and are subject to control under the CSA. In addition, chemical mixtures containing halides of 4-anilinopiperidine are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of halides of 4-anilinopiperidine shall be regulated pursuant to the CSA as list I chemicals.

The CSA gives the Attorney General the authority to specify, by regulation, chemicals as list I chemicals. 2 A “list I chemical” is a chemical that is used in manufacturing a controlled substance in violation of the CSA and is important to the manufacture of the controlled substances. 3 The current list of all listed chemicals is published at 21 CFR 1310.02(a). Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his authority to designate list I chemicals to the Administrator of DEA (Administrator). The DEA regulations set forth the process by which DEA may add a chemical as a listed chemical. As set forth in 21 CFR 1310.02(c), the agency may do so by publishing a final rule in the Federal Register following a published notice of proposed rulemaking with at least 30 days for public comments.

DEA previously found that 4-anilinopiperidine is used in the illicit manufacture of the controlled substance fentanyl (a schedule II substance under the CSA) and fentanyl analogues controlled in schedule I of the CSA, and is important to the manufacture of the controlled substance fentanyl and fentanyl analogues, because it cannot be replaced by other chemicals in its respective synthetic pathways that are used in the illicit manufacture of fentanyl and fentanyl analogues. 4 On this basis, DEA previously specified that 4-anilinopiperidine is a list I chemical. 5

DEA has now found that halides of 4-anilinopiperidine are also used in the illicit manufacture of schedule I controlled substances, such as para -fluorofentanyl, ortho -fluorofentanyl, and para -chlorofentanyl. Accordingly, this action adds halides of 4-anilinopiperidine to the prior listing of 4-anilinopiperidine and thereby subjects handlers of halides of 4-anilinopiperidine to the regulatory provisions of the CSA and its implementing regulations.

This rule does not affect current handlers of 4-anilinopiperidine, including its amides, its carbamates, and its salts, as they are already required to be registered to handle 4-anilinopiperidine. This rule does not establish a threshold for domestic and international transactions of halides of 4-anilinopiperidine. As such, all transactions involving halides of 4-anilinopiperidine, regardless of size, shall be regulated as list I chemicals and are subject to control under the CSA. In addition, chemical mixtures containing halides of 4-anilinopiperidine are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of halides of 4-anilinopiperidine shall be regulated as list I chemicals pursuant to the CSA.

Fentanyl is a synthetic opioid and was first synthesized in Belgium in the late 1950s. Fentanyl was introduced into medical practice and is approved for medical practitioners in the United States to prescribe lawfully for anesthesia and analgesia. Yet, due to its pharmacological effects, fentanyl can be used as a substitute for heroin, oxycodone, and other opioids. Therefore, despite its accepted medical use in treatment in the United States, the DEA controls fentanyl as a schedule II controlled substance due to its high potential for abuse and dependence. 6

The unlawful trafficking and distribution of fentanyl and fentanyl analogues in the United States continues to pose an imminent hazard to public safety. Since 2012, fentanyl has shown a dramatic increase in the illicit drug supply as a single substance, in mixtures with other illicit drugs ( i.e., heroin, cocaine, and methamphetamine), or in forms that mimic pharmaceutical preparations, including prescription opiates and benzodiazepines. 7

In recent years, the United States has experienced a significant increase in overdoses and overdose fatalities from fentanyl and fentanyl analogues. According to the Centers for Disease Control and Prevention (CDC), drug-induced overdose deaths involving synthetic opioids (excluding methadone) in the United States increased from 36,359 in 2019, to 56,516 in 2020, and to 70,589 in 2021 (provisional). 8 Further, CDC reports that opioids, mainly synthetic opioids (which includes fentanyl), are predominately responsible for drug overdose fatalities, as the drug overdose death data (109,247) predicted for the 12 month-ending March 2022, synthetic opioids were involved in about 67.3 percent of all drug-induced overdose deaths. 9

The increase in overdose fatalities involving synthetic opioids coincides with a dramatic increase in law enforcement encounters of fentanyl and fentanyl analogues. According to the National Forensic Laboratory Information System (NFLIS-Drug), 10 reports from forensic laboratories of drug items containing fentanyl and several schedule I fentanyl analogues increased dramatically since 2014, as shown in Table 1.

Fentanyl and its analogues are not naturally occurring substances. As such, the manufacture of these substances requires them to be produced through synthetic organic chemistry. Synthetic organic chemistry is the process in which a new organic molecule is created through a series of chemical reactions, which involve precursor chemicals. Through chemical reactions, the chemical structures of precursor chemicals are modified in a desired fashion. These chemical reaction sequences, also known as synthetic pathways, are designed to create a desired substance. Several synthetic pathways to fentanyl and fentanyl analogues have been identified in clandestine laboratory settings, including the original “Janssen method,” the “Siegfried method,” and the “Gupta method,” which are further explained below.

In response to the illicit manufacture of fentanyl using these methods, DEA controlled N -phenethyl-4-piperidone (NPP);  12 N -(1-benzylpiperidin-4-yl)- N -phenylpropionamide (benzylfentanyl), N -phenylpiperidin-4-amine (4-anilinopiperidine);  13 and 4-piperidone  14 as list I chemicals. DEA also controlled 4-anilino- N -phenethylpiperidine (ANPP)  15 and N -phenyl- N -(piperidin-4-yl)propionamide (norfentanyl)  16 as schedule II immediate precursors to fentanyl under the CSA.

In 2017, the United Nations Commission on Narcotic Drugs (CND) placed NPP and ANPP in Table I of the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (1988 Convention) in response to the international reintroduction of fentanyl on the illicit drug market. 17 As such, member states of the United Nations were required to regulate these precursor chemicals at the national level. In addition, the People's Republic of China regulated NPP and ANPP on February 1, 2018. 18

Following the international control of NPP and ANPP under the 1988 Convention, illicit fentanyl manufacturers moved to unregulated precursor chemicals. These included 4-anilinopiperidine, 1-boc-4-AP, and norfentanyl. In response, the CND placed 4-anilinopiperidine, 1-boc-4-AP, and norfentanyl in Table I of the 1988 Convention. 19

On May 15, 2020, 4-anilinopiperidine became a list I chemical in the United States due to its role in the illicit manufacture of fentanyl. 20 Since that control action, DEA has observed an increase in identifications of certain fentanyl analogues by law enforcement and public health officials. Many of these fentanyl analogues contain a halogen atom on the aniline ring of its respective chemical structure. The presence of the halogen atom suggests that the fentanyl analogue was synthesized from a halogenated precursor chemical. Indeed, halogenated fentanyl precursors have been identified by law enforcement, such as tert -butyl 4-((4-fluorophenyl)amino)piperidine-1-carboxylate ( para -fluoro 1-boc 4-AP). The chemical structure of this precursor defines it as a halide and carbamate of 4-anilinopiperidine. As such, it falls outside of the current definitions of a list I chemical, simply due to the presence of the fluorine (a halogen) atom. Although not previously regulated as a list I chemical, it can be used in the synthesis of fentanyl analogues, such as the schedule I substances para -fluorofentanyl, para -fluoroisobutyryl fentanyl, para -fluorobutyryl fentanyl, and para -fluoro furanyl fentanyl.

In addition, fentanyl analogues with both meta - and ortho -fluoro substitutions have been identified, such as ortho -fluorofuranyl fentanyl and meta -fluorofuranyl fentanyl. The identification of these substances suggests illicit fentanyl analogue manufacturers attempt to utilize unregulated precursor chemicals to evade law enforcement detection and precursor chemical controls. This strategy allows for the synthesis of a variety of fentanyl analogues by simply moving the fluorine atom around the aniline ring while maintaining the same synthetic methodology used to synthesize fentanyl and fentanyl analogues.

Likewise, other halogenated fentanyl analogues, such as those containing a chlorine atom, have been reported by forensic laboratories. According to NFLIS-Drug, para -chlorofentanyl and ortho -chlorofentanyl were reported for the first time in 2020. The identification of these substances suggests that illicit fentanyl analogue manufacturers utilize precursor chemicals containing a chlorine atom as an alternative to a fluorine atom in effort to evade law enforcement detection.

The original published synthetic pathway to fentanyl, known as the Janssen method, involves the two important precursors, benzylfentanyl and norfentanyl. 4-Piperidone, 21 a list I chemical under the CSA, serves as a precursor chemical to benzylfentanyl, a list I chemical under the CSA, 22 which is converted to norfentanyl, the schedule II immediate precursor in this synthetic pathway. Norfentanyl is then subjected to one simple chemical reaction to complete the synthesis of fentanyl. Norfentanyl is controlled in schedule II of the CSA. 23

Like the Janssen method, 4-piperidone serves as an early-stage precursor chemical in the Siegfried method. 4-Piperidone is a precursor to NPP, a known fentanyl precursor and list I chemical under the CSA, 24 in the Siegfried method. NPP is then converted to ANPP, the schedule II immediate precursor in this synthetic pathway. ANPP is then subjected to a simple one-step chemical reaction to complete the synthesis of fentanyl. ANPP is controlled as a schedule II immediate precursor under the CSA. 25

In addition to the Janssen and Siegfried methods, clandestine manufacturers are using other methods to synthesize fentanyl, one of which is known as the Gupta method. 4-Anilinopiperidine, a list I chemical under the CSA, 26 is the key precursor in the Gupta method. 4-Anilinopiperidine serves as an alternative precursor chemical to NPP in the synthesis of ANPP, albeit through a different synthetic process. The resulting ANPP is then used as the immediate precursor chemical in the illicit manufacture of fentanyl.

Recent encounters of precursor chemicals related to 4-anilinopiperidine in chemical structure have occurred. These precursor chemicals contain a halogen atom on the aniline ring of 4-anilinopiperidine. Modifications have included the addition of a fluorine atom, a chlorine atom, or a bromine atom at different positions on the aniline ring of the 4-anilinopiperidine structure. The use of these halogenated 4-anilinopiperidine precursor chemicals in place of 4-anilinopiperidine has resulted in the illicit manufacturing of schedule I fentanyl analogues.

Halogenated 4-anilinopiperidines  27 are commercially available from both domestic and foreign suppliers. DEA is aware of at least 25 domestic suppliers and 14 foreign suppliers. Modified versions of 4-anilinopiperidine, such as para -fluoro 1-boc-4-AP, are attractive to illicit manufacturers because they are readily available from chemical suppliers and the lack of regulatory control on these substituted precursor chemicals.

para -Fluoro 1-boc-4-AP has been identified in law enforcement encounters in the United States. According to NFLIS-Drug, beginning in 2020, there have been at least nine reports of para -fluoro 1-boc-4-AP from forensic laboratories in the United States. A query of DEA's STARLiMS  28 database provided 16 reports of para -fluoro 1-boc-4-AP from analyses conducted on submitted drug evidence by DEA forensic laboratories. Of these 16 reports, para -fluoro 1-boc-4-AP was the only substance reported in nine exhibits (totaling more than 29 kg), suggesting that these seizures were intended to be used as precursor chemicals in the synthesis of fentanyl analogues. Additionally, para -fluoro 1-boc-4-AP was reported in combination with para -fluorofentanyl in four of the seven exhibits containing a mixture of substances, suggesting that para -fluoro 1-boc-4-AP was a precursor chemical involved in the synthesis of para -fluorofentanyl, a schedule I substance under the CSA.

As of August 2022, in addition to domestic encounters, the International Narcotics Control Board of the United Nations reported two international transactions of para -fluoro 1-boc-4-AP through the Precursors Incident Communication System (PICS)  29 reporting system. These incidents reported to PICS totaled approximately 51 kg and had destinations located in North America.

These recent law enforcement encounters of para -fluoro 1-boc-4-AP coincide with the placement of NPP, ANPP, 4-anilinopiperidine, 1-boc-4-AP ( tert -butyl 4-(phenylamino)piperidine-1-carboxylate), and norfentanyl in Table I of the 1988 Convention, the People's Republic of China regulating NPP and ANPP as of February 1, 2018, and the regulation of benzylfentanyl and proposed control of 4-piperidone as list I chemicals in the United States. The domestic encounters of para -fluoro 1-boc-4-AP at ports of entry indicate a change in precursors used in the illicit manufacture of fentanyl to substituted precursor chemicals used in the illicit manufacture of fentanyl analogues in efforts to evade international controls on NPP, ANPP, 4-anilinopiperidine, 1-boc-4-AP, and norfentanyl and additional controls on benzylfentanyl in the United States.

The CSA, specifically 21 U.S.C. 802(34), and its implementing regulations at 21 CFR 1310.02(c), provide the Attorney General with the authority to specify, by regulation, additional precursor or essential chemicals as listed chemicals if they are used in the manufacture of controlled substances in violation of the CSA. Recent law enforcement encounters indicate halides of 4-anilinopiperidine are being used in the illicit manufacture of schedule I fentanyl analogues. This rule modifies the current listing of 4-anilinopiperidine, including its amides, its carbamates, and its salts to include halides of 4-anilinopiperidine. DEA finds that 4-anilinopiperidine, including its amides, its carbamates, its halides, its salts, and any combination thereof, whenever the existence of such is possible, is used in the illicit manufacture of controlled substances, such as fentanyl and fentanyl analogues, and is important to the manufacture of these substances because it cannot be replaced by other chemicals in their respective synthetic pathways that are used in the illicit manufacture of fentanyl and fentanyl analogues.

As part of this rulemaking, DEA solicited information on any possible legitimate uses of halides of 4-anilinopiperidine unrelated to fentanyl production (including industrial uses) in order to assess the potential economic impact of controlling halides of 4-anilinopiperidine as defined in this rule. DEA has searched information in the public domain for legitimate uses of this chemical, and has not documented a legitimate commercial or industrial use for halides of 4-anilinopiperidine. DEA sought, however, to document any unpublicized use(s) and other proprietary use(s) of halides of 4-anilinopiperidine that are not in the public domain. Therefore, DEA solicited comment on the uses of halides of 4-anilinopiperidine in the legitimate marketplace.

DEA solicited input from all potentially affected parties regarding: (1) The types of legitimate industries using halides of 4-anilinopiperidine; (2) the legitimate uses of halides of 4-anilinopiperidine, if any; (3) the size of the domestic market for halides of 4-anilinopiperidine; (4) the number of manufacturers of halides of 4-anilinopiperidine; (5) the number of distributors of halides of 4-anilinopiperidine; (6) the level of import and export of halides of 4-anilinopiperidine; (7) the potential burden these regulatory controls of halides of 4-anilinopiperidine may have on any legitimate trade; (8) the potential number of individuals/firms that may be adversely affected by these regulatory controls (particularly with respect to the impact on small businesses); and (9) any other information on the manner of manufacturing, distribution, consumption, storage, disposal, and uses of halides of 4-anilinopiperidine by industry and others. DEA invited all interested parties to provide any information on any legitimate uses of halides of 4-anilinopiperidine in industry, commerce, academia, research and development, or other applications. DEA sought both quantitative and qualitative data. DEA did not receive any responses to these specific solicitations, nor did DEA receive any other comments in response to the NPRM.

This rulemaking modifies the current regulations for 4-anilinopiperidine, including its amides, its carbamates, and its salts to include halides of 4-anilinopiperidine. The regulations specify that chemical mixtures containing halides of 4-anilinopiperidine are not exempt from regulatory requirements at any concentration, unless an application for exemption of a chemical mixture is submitted by a manufacturer of halides of 4-anilinopiperidine and the application is reviewed and accepted by DEA under 21 CFR 1310.13 (Exemption by Application Process). The control of chemical mixtures containing any amount of halides of 4-anilinopiperidine is necessary to prevent the extraction, isolation, and use of halides of 4-anilinopiperidine in the illicit manufacture of schedule I fentanyl analogues. This rule modifies the Table of Concentration Limits in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of 4-anilinopiperidine, including its amides, its carbamates, its halides, its salts, and any combination thereof, whenever the existence of such is possible, are subject to the CSA chemical control provisions as list I chemicals.

DEA has implemented an application process to exempt mixtures from the requirements of the CSA and its implementing regulations. 30 Under the application process, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption. Exemption status can be granted if DEA determines that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical cannot be readily recovered. 31

On May 15, 2020, DEA promulgated regulations which listed 4-anilinopiperidine, including its amides, its carbamates, and its salts, as a list I chemical under the CSA. Chemicals that meet the current definition of 4-anilinopiperidine  32 have been, and continue to be, subject to the regulatory provisions of the CSA since May 15, 2020. This rule expands the definitions of 4-anilinopiperidine to include its halides. Halides of 4-anilinopiperidine become subject to the regulatory provisions of the CSA upon the effective date of this rule.

Upon the effective date of this final rule, halides of 4-anilinopiperidine will be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals, just as 4-anilinopiperidine, including its amides, its carbamates, and its salts are currently regulated. Upon the effective date of this final rule, persons potentially handling halides of 4-anilinopiperidine, including regulated chemical mixtures containing halides of 4-anilinopiperidine, will be required to comply with list I chemical regulations, including the following:

1. Registration. Any person who manufactures, distributes, imports, or exports halides of 4-anilinopiperidine, including chemical mixtures containing halides of 4-anilinopiperidine, or proposes to engage in the manufacture, distribution, importation, or exportation of halides of 4-anilinopiperidine, including chemical mixtures containing halides of 4-anilinopiperidine, must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, and 958, if they are not already registered to handle list I chemicals. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309. DEA regulations require separate registrations for manufacturing, distributing, importing, and exporting of list I chemicals. 33 Further, a separate registration is required for each principal place of business at one general physical location where list I chemicals are manufactured, distributed, imported, or exported by a person. 34

DEA notes that under the CSA, “warehousemen” are not required to register and may lawfully possess list I chemicals, if the possession of those chemicals is in the usual course of business or employment. 35 Under DEA implementing regulations, the warehouse in question must receive the list I chemical from a DEA registrant and shall only distribute the list I chemical back to the DEA registrant and registered location from which it was received. A warehouse that distributes list I chemicals to persons other than the registrant and registered location from which they were obtained is conducting distribution activities and is required to register as such. 36

Upon the effective date of this final rule, any person manufacturing, distributing, importing, or exporting halides of 4-anilinopiperidine or a chemical mixture containing halides of 4-anilinopiperidine will become subject to the registration requirement under the CSA for list I chemicals. DEA recognizes, however, that it is not possible for persons who become subject to the registration requirements under this rule to immediately complete and submit an application for registration, and for DEA to immediately issue registrations for those activities. Therefore, to allow any continued legitimate commerce in halides of 4-anilinopiperidine or a chemical mixture containing halides of 4-anilinopiperidine, DEA is updating the listing in 21 CFR 1310.09(p), to include a temporary exemption from the registration requirement for persons desiring to engage in activities with the updated definitions of halides of 4-anilinopiperidine or a chemical mixture containing halides of 4-anilinopiperidine, provided that DEA receives a properly completed application for registration or application for exemption of a chemical mixture under 21 CFR 1310.13 on or before November 30, 2023. The temporary exemption for such persons will remain in effect until DEA takes final action on their application for registration or application for exemption of a chemical mixture.

The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, will become effective on the effective date of this final rule. This is necessary because a delay in regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.

Additionally, the temporary exemption for registration does not suspend applicable Federal criminal laws relating to halides of 4-anilinopiperidine, nor does it supersede State or local laws or regulations. All handlers of halides of 4-anilinopiperidine must comply with applicable State and local requirements in addition to the CSA regulatory controls.

2. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to halides of 4-anilinopiperidine pursuant to 21 U.S.C. 830 and in accordance with 21 CFR part 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04, a record must be kept for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.

Each regulated bulk manufacturer of a listed chemical must submit manufacturing, inventory, and use data on an annual basis. Existing standard industry reports containing the required information are acceptable, provided the information is separate or readily retrievable from the report. 37

The CSA and its implementing regulations require that each regulated person must report to DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of subchapter I of the CSA. In addition, regulated persons must report any proposed regulated transaction with a person whose description or other identifying characteristics DEA has previously furnished to the regulated person, any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person, and any in-transit loss in which the regulated person is the supplier. 38

3. Importation and Exportation. All importation and exportation of halides of 4-anilinopiperidine or a chemical mixture containing halides of 4-anilinopiperidine must be done in compliance with 21 U.S.C. 957, 958, and 971, and in accordance with 21 CFR part 1313.

4. Security. All applicants and registrants must provide effective controls against theft and diversion of list I chemicals in accordance with 21 CFR 1309.71-1309.73.

5. Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for administrative inspections of these controlled premises as provided in 21 CFR part 1316, subpart A. 39

6. Liability. Any activity involving halides of 4-anilinopiperidine not authorized by, or in violation of, the CSA, would be unlawful, and would subject the person to administrative, civil, and/or criminal action.

This final rule, which adds halides of 4-anilinopiperidine to the prior listing of the list I chemical 4-anilinopiperidine, was developed in accordance with the principles of Executive orders (E.O.) 12866, 13563, and 14094. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866.

E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more (adjusted every three years by the Administrator of OIRA  40 for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the E.O., as specifically authorized in a timely manner by the Administrator of OIRA in each case.

A review of the 25 domestic suppliers of halides of 4-anilinopiperidine indicates that these entities are not currently registered with DEA to handle list I chemicals. These 25 suppliers are entities that do not also supply 4-anilinopiperidine, as these entities would already be required to register to handle list I chemicals since 4-anilinopiperidine is currently a list I chemical under the CSA. Therefore, the modified definitions of 4-anilinopiperidine in this final rule would potentially affect 25 entities. DEA anticipates that this rule will impose minimal or no economic impact on affected entities; and thus, will not have a significant economic impact on any of the 25 affected small entities. Therefore, DEA concludes this rule is not a significant regulatory action under E.O. 12866. Upon the effective date of this final rule, halides of 4-anilinopiperidine will be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals, just as 4-anilinopiperidine, including its amides, its carbamates, and its salts, is currently regulated. 4-Anilinopiperidine is a precursor chemical used in, and is important to, the illicit manufacture of the schedule II controlled substance fentanyl and schedule I fentanyl analogues. The distribution of illicitly manufactured fentanyl and fentanyl analogues has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years.

DEA has searched information in the public domain for any legitimate uses of halides of 4-anilinopiperidine, and has not documented a use for halides of 4-anilinopiperidine. DEA requested public comment regarding this estimate; however, no public comment was received during the notice and comment period.

DEA evaluated the costs and benefits of this action.

DEA believes the market for halides of 4-anilinopiperidine for the legitimate manufacturing of pharmaceutical fentanyl is minimal, because halides of 4-anilinopiperidine are not used to synthesize fentanyl or any schedule II fentanyl analogue currently used in medical practice. As stated above, DEA is not aware of any legitimate uses of halides of 4-anilinopiperidine. Any manufacturer, distributor, importer, or exporter of halides of 4-anilinopiperidine will incur costs. The primary costs associated with this rule would be the annual registration fees for list I chemicals ($3,699 for manufacturers and $1,850 for distributors, importers, and exporters). However, DEA believes that the cost will be minimal.

DEA has identified 25 domestic suppliers of halides of 4-anilinopiperidine. None of these 25 suppliers are registered to handle list I chemicals. It is difficult to estimate the quantity of distribution of halides of 4-anilinopiperidine by these suppliers. It is common for chemical distributors to have items in their catalog while not actually having any material level of sales. Suppliers for the legitimate use of halides of 4-anilinopiperidine are expected to choose the least-cost option, and depending on the circumstances, some suppliers might choose to stop selling the minimal quantities, if any, of halides of 4-anilinopiperidine, rather than incur the registration cost. Because DEA believes the quantities of halides of 4-anilinopiperidine supplied for the legitimate manufacturing of pharmaceutical fentanyl are minimal, DEA estimates that the cost of foregone sales is minimal; thus, the cost of this rule is minimal. DEA requested public comment regarding this estimate; however, no public comment was received during the notice and comment period.

This analysis excludes consideration of any economic impact to those businesses that facilitate the manufacturing and distribution of halides of 4-anilinopiperidine for the manufacturing of illicit fentanyl and fentanyl analogues. As a law enforcement organization and as a matter of principle, DEA believes considering the economic utility of facilitating the manufacture of illicit fentanyl would be improper.

Controlling halides of 4-anilinopiperidine is expected to prevent, curtail, and limit the unlawful manufacture and distribution of fentanyl and fentanyl analogues. As a list I chemical, handling of halides of 4-anilinopiperidine requires registration with DEA and various controls and monitoring as required by the CSA. This rule is also expected to assist preventing the possible theft or diversion of halides of 4-anilinopiperidine from any legitimate firms. DEA also believes control is necessary to prevent unscrupulous chemists from synthesizing halides of 4-anilinopiperidine and selling them (as unregulated materials) through the internet and other channels, to individuals who may wish to acquire unregulated intermediary chemicals for the purpose of illicitly manufacturing fentanyl and fentanyl analogues.

In summary, DEA conducted a qualitative analysis of costs and benefits. DEA believes this action will minimize the diversion of halides of 4-anilinopiperidine. DEA believes the market for halides of 4-anilinopiperidine for the legitimate manufacturing of fentanyl or schedule II fentanyl analogues currently used in medical practice is minimal, since halides of 4-anilinopiperidine are not used to synthesize fentanyl or any schedule II fentanyl analogue currently used in medical practice. Therefore, any potential cost as a result of this regulation is minimal.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rule does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of E.O. 13175. This rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. As discussed above, halides of 4-anilinopiperidine or a chemical mixture containing halides of 4-anilinopiperidine shall be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. Halides of 4-anilinopiperidine are precursor chemicals used in, and important to, the illicit manufacture of the schedule I fentanyl analogues. The distribution of illicitly manufactured fentanyl and fentanyl analogues has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years. DEA has not identified any legitimate industrial use for halides of 4-anilinopiperidine. Therefore, DEA believes the vast majority, if not all, of halides of 4-anilinopiperidine is used for the illicit manufacturing of schedule I fentanyl analogues. The primary costs associated with this rule are the annual registration fees ($3,699 for manufacturers and $1,850 for distributors, importers, and exporters). DEA has identified 25 domestic suppliers of halides of 4-anilinopiperidine, all of which are not currently registered with DEA to handle list I chemicals. All non-registered domestic suppliers are affected and are estimated to be small entities (based on Small Business Administration size standard for chemical distributors and Statistics of U.S. Business data). 41 It is impossible to know how much halides of 4-anilinopiperidine is distributed by these suppliers. It is common for chemical distributors to have items in their catalog while not actually having any material level of sales. Therefore, DEA estimates the cost of this rule on any affected small entity is minimal. DEA did not receive public comment regarding this estimate. Based on these factors, DEA projects that this rule will not result in a significant economic impact on a substantial number of small entities.

On the basis of information contained in the Regulatory Flexibility Act section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year . . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.

This document of the Drug Enforcement Administration was signed on October 25, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set out above, DEA amends 21 CFR part 1310 to read as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or otherwise use listed PFAS or any chemicals listed under 40 CFR 372.28. The following list of North American Industry Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this action applies to them. Potentially affected entities may include:

• Facilities included in the following NAICS manufacturing codes (corresponding to Standard Industrial Classification (SIC) codes 20 through 39): 311 *, 312 *, 313 *, 314 *, 315 *, 316, 321, 322, 323 *, 324, 325 *, 326 *, 327 *, 331, 332, 333, 334 *, 335 *, 336, 337 *, 339 *, 111998 *, 113310, 211130 *, 212323 *, 212390 *, 488390 *, 512230 *, 512250 *, 5131 *, 516210 *, 519290 *, 541713 *, 541715 * or 811490 *. * Exceptions and/or limitations exist for these NAICS codes.

• Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 211130 * (corresponds to SIC code 1321, Natural Gas Liquids, and SIC 2819, Industrial Inorganic Chemicals, Not Elsewhere Classified); or 212114, 212115, 212220, 212230, 212290 *; or 2211 *, 221210 *, 221330 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (corresponds to SIC codes 4911, 4931, and 4939, Electric Utilities); or 424690, 424710 (corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants); 425120 (limited to facilities previously classified in SIC code 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 562112 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis (previously classified under SIC code 7389, Business Services, NEC)); or 562211 *, 562212 *, 562213 *, 562219 *, 562920 * (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq. ) (corresponds to SIC code 4953, Refuse Systems). * Exceptions and/or limitations exist for these NAICS codes.

• Federal facilities.

• Facilities that the EPA Administrator has specifically required to report to TRI pursuant to a determination under EPCRA section 313(b)(2).

A more detailed description of the types of facilities covered by the NAICS codes subject to reporting under EPCRA section 313 can be found at: https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility is affected by this action, you should carefully examine the applicability criteria in part 372, subpart B of title 40 of the Code of Federal Regulations. Federal facilities are required to report under Section 6(a)-(b) of Executive Order 14096 (88 FR 25251 April 21, 2023), Revitalizing Our Nation's Commitment to Environmental Justice for All. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

EPA is adding all PFAS included on the Toxics Release Inventory (TRI) pursuant to sections 7321(b) and 7321(c) of the 2020 NDAA to the list of chemicals of special concern (40 CFR 372.28). EPA maintains a list of PFAS added to the TRI list pursuant to the NDAA at: https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa . The addition of PFAS added to TRI pursuant to sections 7321(b) and (c) of the NDAA to the list of chemicals of special concern aligns reporting requirements for these PFAS with other chemicals of special concern. EPA anticipates this will result in additional Form R reports being filed for these PFAS due to the removal of the de minimis exemption and the option to use Form A. It also limits the use of range reporting, which will capture more specific information for PFAS added pursuant to sections 7321(b) and 7321(c) of the NDAA.

In addition, EPA is removing the availability of the de minimis exemption under the Supplier Notification Requirements (40 CFR 372.45) for facilities that manufacture or process any chemicals included on the list of chemicals of special concern.

This action does not make any changes to the article exemption.

This action is issued under EPCRA sections 313, 42 U.S.C. 11023 and 328, 42 U.S.C. 11048. EPCRA is also referred to as Title III of the Superfund Amendments and Reauthorization Act of 1986.

EPA is taking this action to increase the data collected for PFAS. Removing the availability of certain burden-reduction reporting options will result in a more complete picture of the releases and waste management quantities for PFAS. This will increase the number of TRI reports on listed PFAS and the amount of information provided on such reports, resulting in more information on the waste management of these chemicals available to the Agency, as well as to the public. EPA expects this information will be a benefit to the public, including communities with environmental justice concerns and public water utilities, as well as inform future Agency actions, including under the Clean Water Act, the Resource Conservation and Recovery Action, the Comprehensive Environmental Response, Compensation, and Liability Act, and the Toxic Substances Control Act. In addition, this action will increase data collected for all chemicals of special concern by eliminating the de minimis exemption for purposes of the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern. The elimination of this exemption from Supplier Notification Requirements ensures that purchasers of mixtures and trade name products containing such chemicals are informed of their presence in mixtures and products they purchase.

EPA prepared an updated economic analysis for this action entitled, “Economic Analysis for the Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notification Requirements for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting,” which presents an analysis of the costs of the reporting changes for PFAS and other chemicals of special concern based on updated 2022 wage rates and an increase in supplier notification burden estimates (Ref. 1). EPA estimates that this action will result in an additional 623 to 2,015 Form R reports being filed annually. EPA estimates that the costs of this action will be approximately $3,318,492 and $10,733,149 in the first year of reporting and approximately $1,580,214 and $5,111,044 in the subsequent years. In addition, EPA has determined that, of the 486 to 1,333 small businesses affected by this action, none are estimated to incur annualized cost impacts of more than 1% of revenues. Thus, this action is not expected to have a significant adverse economic impact on a substantial number of small entities.

Removing the availability of certain burden-reduction reporting options will result in a more complete picture of the releases and waste management quantities for PFAS. This will increase the number of TRI reports on listed PFAS and the amount of information provided on such reports, resulting in more information on the waste management of these chemicals available to the Agency, as well as to the public.

EPCRA section 313, 42 U.S.C. 11023 (also known as the Toxics Release Inventory (TRI)), requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting activity threshold levels to report their environmental releases and other waste management quantities of such chemicals annually. These facilities must also report pollution prevention and recycling data for such chemicals, pursuant to PPA section 6607, 42 U.S.C. 13106.

TRI provides information about releases of toxic chemicals from covered facilities throughout the United States; however, TRI data do not reveal whether or to what degree the public is exposed to listed chemicals. TRI data can, in conjunction with other information, be used as a starting point in evaluating such exposures and the risks posed by such exposures. The determination of potential risk to human health and/or the environment depends upon many factors, including the toxicity of the chemical, the fate of the chemical in the environment, and the amount and duration of human or other exposure to the chemical.

For more information on TRI, visit the TRI website at https://www.epa.gov/tri. Note that TRI does not cover all chemicals, facilities, or types of pollution (see https://www.epa.gov/toxics-release-inventory-tri-program/what-toxics-release-inventory for information on which chemicals and facilities are regulated under TRI). Additionally, via this website, EPA provides a guidance document entitled “Factors to Consider When Using Toxics Release Inventory Data” available at: https://www.epa.gov/system/files/documents/2022-02/factorstoconsider_approved-by-opa_1.25.22-copy.pdf, which helps explain some of the uses, as well as limitations, of data TRI collects.

PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon chain on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. Definitions of what constitutes “PFAS” differ amongst scientific and regulatory bodies. However, in general, the strong carbon-fluorine bonds of PFAS make them resistant to degradation and thus highly persistent in the environment (Refs. 2 and 3). Some of these chemicals have been used for decades in a wide variety of consumer and industrial products (Refs. 2 and 3). Some PFAS have been detected in wildlife indicating that at least some PFAS have the ability to bioaccumulate (Ref. 3). Because of the widespread use of PFAS in commerce and their tendency to persist in the environment, most people in the United States have been exposed to PFAS (Refs. 2, 4 and 5). Some PFAS can accumulate in humans and remain in the human body for long periods of time ( e.g., months to years) (Refs. 2 and 3), as a result, several PFAS have been detected in human blood serum (Refs. 2, 3, 4, and 5).

On December 20, 2019, the NDAA was signed into law (Pub. L. 116-92, https://www.congress.gov/public-laws/116th-congress ). The NDAA included two provisions that automatically add PFAS to the TRI list. First, section 7321(b) of the NDAA added to the TRI list, effective January 1, 2020, 14 chemicals by name and/or Chemical Abstracts Service Registry Number (CASRN) and additional PFAS that meet specific criteria. On June 22, 2020 (85 FR 37354 (FRL-10008-09)), EPA updated the TRI list in the CFR to reflect the 172 non-CBI PFAS added to TRI by section 7321(b) of the NDAA.

Additional PFAS are added to the TRI list on an annual basis by the NDAA. Specifically, PFAS that meet the criteria in section 7321(c) of the NDAA are deemed added to the TRI list on January 1 of the year after specific criteria are met. Through this provision, the NDAA will continue to add PFAS to the TRI list over time as additional PFAS meet the criteria outlined in 7321(c). The criteria of section 7321(c) require the addition to the TRI list of certain PFAS after any one of the following dates:

• Final Toxicity Value. The date on which the Administrator finalizes a toxicity value for the PFAS or class of PFAS;

• Significant New Use Rule. The date on which the Administrator makes a covered determination for the PFAS or class of PFAS;

• Addition to Existing Significant New Use Rule. The date on which the PFAS or class of PFAS is added to a list of substances covered by a covered determination.

• Addition as an Active Chemical Substance. The date on which the PFAS or class of PFAS to which a covered determination applies is:

• Added to the list published under section 8(b)(1) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq. ) and designated as an active chemical substance under TSCA section 8(b)(5)(A); or

• Designated as an active chemical substance under TSCA section 8(b)(5)(B) on the list published under TSCA section 8(b)(1).

EPA updates the TRI list in the CFR to reflect the PFAS added to TRI by section 7321(c) of the NDAA. The first update rule identifying PFAS that met the 7321(c) criteria during 2020 was published on June 3, 2021 (86 FR 29698 (FRL-10022-25)).

To date, section 7321 of the NDAA has added a total of 189 PFAS to the TRI list at: https://www.epa.gov/tri/PFAS. A complete list of the PFAS added to the TRI list can be found at: https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa. In addition, the NDAA established a manufacture, processing, or otherwise use reporting threshold of 100 pounds for each of the PFAS added to the TRI list by sections 7321(b) and 7321(c) of the NDAA. In the first year of reporting for the initial 172 listed PFAS, EPA only received 89 reports from 38 facilities covering 43 different PFAS. Similar levels of PFAS reporting were observed in the subsequent year: with 176 PFAS on the TRI list in RY2021, only 42 facilities reported submitted a total of 87 reports covering 43 different PFAS.

Upon publication of the proposed rule on December 5, 2022, EPA provided a 60-day comment period (87 FR 74379 (FRL-8714-03-OCSPP)). EPA received 36 comments on the proposed rule. EPA received comments from citizens, industry groups, non-governmental organizations, and state governments. The majority of comments on the proposed rule addressed EPA's burden estimates, with the majority stating EPA underestimated the burden of listing PFAS as chemicals of special concern and removing the supplier notification de minimis exemption would impose. Several commenters requested EPA lower the activity thresholds for PFAS. Many of the commenters stated that EPA has not demonstrated PFAS meet the criteria to be classified as chemicals of special concern. Many of the commenters stated that eliminating the regulatory exemptions for PFAS will create a more complete picture of PFAS in communities and the environment. After considering the public comments, EPA updated the economic analysis to incorporate 2022 wage rates, include a summary of small entity analysis, and increase the supplier notification burden estimates. Further edits to the analysis were not required because EPA has made no substantive changes as compared with what had been proposed. Summaries of the comments and EPA's responses to the comments appear in the Response to Comment document (Ref. 6) which is in the docket for this rulemaking.

EPA is adding all PFAS included on the TRI list pursuant to sections 7321(b) and 7321(c) of the NDAA (see 40 CFR 372.65(d) and (e)) to the list of chemicals of special concern at 40 CFR 372.28. EPA first created the list of chemicals of special concern to increase the utility of TRI data by ensuring that the data collected and shared through TRI are relevant and topical (Ref. 7). EPA lowered the reporting thresholds for chemicals of special concern because even small quantities of releases of these chemicals can be of concern. The first chemicals that were added to the list of chemicals of special concern were those identified as persistent, bioaccumulative and toxic (PBT) chemicals which, except for the dioxin and dioxin-like compounds category, have reporting thresholds of either 10 or 100 pounds depending on their persistent and bioaccumulative properties (Ref. 7). Chemicals of special concern are also excluded from the de minimis exemption, may not be reported on Form A (Alternate Threshold Certification Statement), and have limits on the use of range reporting.

The de minimis exemption allows facilities to not consider small concentrations of TRI chemicals not classified as chemicals of special concern in mixtures or other trade name products when making threshold determinations and release and other waste management calculations. The de minimis exemption does not apply to the manufacture of a TRI chemical except if that chemical is manufactured as an impurity and remains in the product distributed in commerce, or if the chemical is imported below the appropriate de minimis level. The de minimis exemption does not apply to a byproduct manufactured coincidentally as a result of manufacturing, processing, otherwise use, or any waste management activities.

The Form A provides facilities that otherwise meet TRI-reporting thresholds the option of certifying on a simplified reporting form provided that they do not exceed 500 pounds for the total annual reportable amount (described subsequently in this document) for that chemical and that their amounts manufactured, processed, or otherwise used do not exceed 1 million pounds. All chemicals of special concern (except certain instances of reporting lead in stainless steel, brass, or bronze alloys) are excluded from Form A eligibility. Form A does not include any information on releases or other waste management. Nor does it include source reduction information or any other chemical-specific information other than the identity of the chemical.

For certain data elements (Part II, Sections 5, 6.1, and 6.2 of Form R), for chemicals not classified as chemicals of special concern, the reportable quantity may be reported either as an estimate or by using the range codes that have been developed. Currently, TRI reporting provides three reporting ranges: 1-10 pounds, 11-499 pounds, and 500-999 pounds.

The availability of these burden reduction tools is inconsistent with a concern for small quantities of the chemicals and the expanded reporting that was sought for chemicals with lower reporting thresholds. In the preamble to the 1999 final rule (Ref 7), EPA outlined the reasons for promulgating the de minimis exemption ( e.g., that facilities had limited access to information and that low concentrations would not contribute to the activity threshold) and determined that those rationales did not apply to chemicals of special concern. Id. at 58670. Among the reasons provided, EPA explained that even minimal releases of persistent bioaccumulative toxic chemicals may result in significant adverse effects and can reasonably be expected to significantly contribute to exceeding the proposed lower threshold. Id. EPA also determined that facilities reporting on chemicals of special concern could not avail themselves of Form A reporting because the information provided on Form A is “insufficient for conducting analyses” on chemicals of special concern and would be “virtually useless for communities interested in assessing risk from releases and other waste management” of such chemicals ( i.e., the Form A does not include estimated release and other waste management quantities). Id. Lastly, EPA eliminated range reporting for chemicals of special concern because the use of ranges could misrepresent data accuracy for PBT chemicals because the low or the high-end range numbers may not really be that close to the estimated value. Id. For the full discussion, see Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering of Reporting Thresholds for Certain PBT Chemicals; Addition of Certain PBT Chemicals; Community Right-to-Know Toxic Chemical Reporting (Refs. 7 and 8)

EPA has determined that PFAS added to EPCRA section 313 by sections 7321(b) and 7321(c) of the 2020 NDAA should be categorized as chemicals of special concern and added to the list in 40 CFR 372.28. The NDAA set a 100-pound annual reporting threshold for PFAS added by sections 7321(b) and 7321(c), which indicates a concern for small quantities of such PFAS. EPA has therefore determined that the availability of certain burden reduction tools ( i.e., de minimis levels, Form A, and range reporting) is not justified for these chemicals as the availability of these tools is inconsistent with a concern for small quantities.

Further, due to the strength of the carbon-fluorine bonds, many PFAS can be very persistent in the environment (Refs. 2, 3, and 9). Persistence in the environment allows PFAS concentrations to build up over time; thus, even small releases can be of concern. As with PBT chemicals, permitting reporting facilities to continue to rely on the burden reduction tools ( de minimis levels, Form A, and range reporting) would eliminate reporting on potentially significant quantities of the listed PFAS. As explained in more detail in Unit IV., EPA's rationale for eliminating these burden reduction tools for PBT chemicals (Refs. 7 and 8) applies equally well to PFAS.

The de minimis exemption allows facilities to not consider concentrations of TRI listed chemicals in Unit IV., 1% (0.1% for carcinogens) in mixtures or other trade name products they import, process, or otherwise use in making threshold calculations and release and other waste management (including disposal to land and other types of waste management ( i.e., energy recovery, recyling, treatment)) determinations. Since the de minimis level is based on relative concentration rather than a specific amount, the application of this exemption to PFAS listed under sections 7321(b) and 7321(c) could allow significant quantities of such PFAS to be excluded from TRI reporting by facilities. For example, if a facility imports, processes, or otherwise uses 100,000 pounds of a mixture or trade name product that contains 0.5% of a listed PFAS, then 500 pounds (or five times the reporting threshold) would be disregarded. This exclusion is inconsistent with a concern for small quantities of PFAS. Many PFAS are used in products below the established de minimis levels (Refs. 4 and 10), and the continued availability of the exemption for PFAS would permit facilities to discount those uses when determining whether an applicable threshold has been met to trigger reporting.

The Form A provides certain covered facilities the option of submitting a substantially shorter form with a reduced reporting burden (Ref. 11). For example, the Form A does not require facilities to report any information on releases ( e.g., releases through fugitive or non-point air emissions, discharges to streams or water bodies) or waste management quantities. Facilities can qualify to file a Form A if the total annual reportable amount for the listed chemical does not exceed 500 pounds, and the amounts manufactured, processed, or otherwise used do not exceed 1 million pounds. The annual reportable amount is equal to the combined total quantities released at the facility (including disposed of within the facility), treated at the facility (as represented by amounts destroyed or converted by treatment processes), recovered at the facility as a result of recycling operations, combusted for the purpose of energy recovery at the facility, and amounts transferred from the facility to off-site locations for the purpose of recycling, energy recovery, treatment, and/or disposal. This means that facilities that are required to report data on PFAS and also qualify to file a Form A will not be providing specific quantity data on up to 500 pounds of a listed PFAS (five times the reporting threshold). For reporting year 2020, approximately 10% of the reporting forms submitted for the listed PFAS were Forms A ( i.e., reporting for TRI reflects 93 active reporting forms of which 84 were Forms R and 9 were Forms A). This trend continued with reporting year 2021, in which 9 of the total 87 reporting forms for PFAS were Form A.

While the Form A does provide some general information on the quantities of the chemical that the facility manages as waste, this information may be insufficient for conducting analyses on PFAS and may be less meaningful for communities interested in assessing risk from releases of PFAS. The threshold category for amounts managed as waste does not include quantities released to the environment as a result of remedial actions or catastrophic events not associated with production processes (section 8.8 of Form R). Thus, the waste threshold category in Form A does not include all releases. Given that even small quantities of PFAS may result in elevated concentrations in the environment, EPA believes it would be inappropriate to allow a reporting option that would exclude information on some releases. Thus, removing the availability of the use of Form A for PFAS is consistent with a concern for understanding small quantities of PFAS.

For TRI-listed chemicals, other than chemicals of special concern, releases and off-site transfers for further waste management of less than 1,000 pounds can be reported using ranges or as a whole number. The reporting ranges are: 1-10 pounds; 11-499 pounds; and 500-999 pounds. For larger releases and off-site transfers for further waste management of the toxic chemical, the facility must report the whole number. Use of ranges could reduce data accuracy because the low or the high-end range numbers may not be that close to the estimated value, even taking into account inherent data errors ( i.e., errors in measurements and developing estimates). For PFAS, it is important to have accurate data regarding the amount released even when the quantities are relatively small, since concern may be tied to even small quantities of a substance. This issue was apparent for PFAS for reporting years 2020 and 2021 since much of the data reported was for less than 1,000 pounds.

EPA anticipates that the elimination of these burden reduction tools will increase the amount and quality of data collected for PFAS and is consistent with the concern for small quantities of PFAS (Ref. 1).

EPA is also eliminating the use of the de minimis exemption under the Supplier Notification Requirements at 40 CFR 372.45(d)(1) for all substances on the list of chemicals of special concern. EPA extended the de minimis exemption to the supplier notification requirement in its initial TRI reporting rule (53 FR 4500, February 16, 1988 (FRL-3298-2)). The revised text reads as follows:

The de minimis exemption to the Supplier Notification Requirements allows suppliers to not provide notifications for mixtures or trade name products containing the listed toxic chemicals if the chemicals are present at concentrations below 1% of the mixture (0.1% for carcinogens). The de minimis exemption is not a small quantity exemption; it is a small concentration exemption. Therefore, it is possible that significant quantities of chemicals of special concern can be overlooked by reporting facilities if suppliers can use the de minimis exemption. For example, if a mixture or trade name product contains 0.9% of a listed PFAS and 100,000 pounds of the product is purchased, the supplier need not provide notification and the purchaser could be unaware of and not account for 900 pounds of PFAS. The impact of this exemption for the PBT chemicals with 10-pound reporting thresholds is even greater. Using the same 100,000-pound example, if mercury were present at 0.9% then that same 900 pounds would be 90 times the mercury reporting threshold.

It is also possible that quantities of chemicals of special concern would be included in supplier notifications by reporting facilities if suppliers cannot use the de minimis exemption. For example, if a mixture or trade name product contains 0.9% of a listed PFAS and 1,000 pounds of the product is purchased, the supplier would need to provide notification for 9 pounds of PFAS. This would also impact PBT chemicals with 10-pound reporting thresholds. Using the same 1,000-pound example, if mercury was present at 0.9% then that same 9 pounds would be below the mercury reporting threshold. However, such quantities may become reportable, in aggregate, if a reporting entity receives multiple shipments (including from multiple suppliers) of a given product in a year and performs a threshold activity in excess of the TRI reporting threshold. Further, TRI supplier notification regulations do not require a person to consider the total quantity of the chemical being supplied but rather require the person to consider the concentration of the chemical in the product or mixture. Including a consideration of quantity rather than concentration shipped would complicate as well as reduce the ability of supplier notifications to inform downstream recipients of products and mixtures containing a TRI-listed chemical.

EPA considered whether to include a small quantity exemption in lieu of a de minimis exemption for supplier notification. However, EPA is concerned that such an exemption would not provide adequate information to facilities receiving multiple shipments over the course of a year to address TRI reporting requirements that may apply to them, based on the total aggregated quantity received. Without such information on the TRI-listed chemical, the receiving facility may not have sufficient data to inform potential TRI reporting obligations.

Many PFAS are used in products below the established de minimis levels (Refs. 4 and 10) which results in users of those products not knowing they are receiving a product that contains a TRI-reportable PFAS. PFAS reports received for the TRI 2020 and 2021 reporting years were mostly from manufacturers and waste disposal facilities which suggests that the de minimis exemption may have been used by most users and processors see https://www.epa.gov/toxics-release-inventory-tri-program/find-understand-and-use-tri. EPA has concluded that it is important and necessary to eliminate the supplier notification de minimis exemption for PFAS added to the TRI list pursuant to sections 7321(b) and 7321(c) of the NDAA because if that exemption were to remain in place the Agency may fail to collect information on amounts of PFAS that significantly exceed the reporting threshold.

In addition, eliminating the use of the de minimis exemption for supplier notification purposes for all other chemicals of special concern ensures that potentially significant quantities of such chemicals are not overlooked by reporting facilities. The PBT chemicals and chemical categories that are classified as chemicals of special concern, and are thus also impacted by this change, are as follows:

• Aldrin (CASRN: 309-00-2);

• Benzo[g,h,i]perylene (CASRN: 191-24-2);

• Chlordane (CASRN: 57-74-9);

• Dioxin and dioxin-like compounds category (manufacturing; and the processing or otherwise use of dioxin and dioxin-like compounds category if the dioxin and dioxin-like compounds are present as contaminants in a chemical and if they were created during the manufacturing of that chemical) (TRI Category Code: N150);

• Heptachlor (CASRN: 76-44-8);

• Hexabromocyclododecane category (TRI Category Code: N270);

• Hexachlorobenzene (CASRN: 118-74-1);

• Isodrin (CASRN: 465-73-6);

• Lead (this lower threshold does not apply to lead when it is contained in stainless steel, brass or bronze alloy; (CASRN: 7439-92-1);

• Lead compounds category (TRI Category Code: N420);

• Mercury (CASRN: 7439-97-6);

• Mercury compounds category (TRI Category Code: N458);

• Methoxychlor (CASRN: 72-43-5);

• Octachlorostyrene (CASRN: 29082-74-4);

• Pendimethalin (CASRN: 40487-42-1);

• Pentachlorobenzene (CASRN: 608-93-5);

• Polychlorinated biphenyls (CASRN: 1336-36-3);

• Polycyclic aromatic compounds category (PACs) (TRI Category Code: N590);

• Tetrabromobisphenol A (CASRN: 79-94-7);

• Toxaphene (CASRN: 8001-35-2); and

• Trifluralin (CASRN: 1582-09-8).

When EPA established the chemicals of special concern list, it decided to not remove the de minimis exemption eligibility from supplier notification requirements, indicating that the Agency believed that there was sufficient information available on PBT chemicals by suppliers. (Refs. 7 and 8). However, EPA has determined that there are situations where this information is not available. For example, the Agency has found that there is significant variability in the concentration of PACs in fuels, yet the presence and concentration of PACs in fuel oil is often not provided in supplier notifications or SDSs. Additionally, EPA is aware of metal mixtures and products containing low concentrations of lead (not contained in stainless steel, brass or bronze alloys) whose supplier notifications and SDSs do not state there is lead present in the mixture or product. Further, it is unclear whether downstream purchasers would be made aware of PBT chemicals contained in many products without notification of the presence of such chemicals.

In situations where such information is already available, supplier notifications may already be addressed ( e.g., if such information in already included on an SDS) or the burden of a supplier to provide such information is minimal ( i.e., if the information is redundant then the burden to provide such known information should be trivial). However, as noted in Unit IV., the quantity information EPA is requiring for de minimis concentrations below the concentration threshold may not be provided in SDSs. OSHA maintains a 1% concentration threshold for reporting the presence and concentration of most hazardous chemicals on SDSs (29 CFR part 1910, subpart Z). For chronic hazards (with Carcinogenicity, Germ Cell Mutagenicity, and Reproductive Toxicity), OSHA has established a 0.1% concentration threshold for reporting the presence and concentration of chemicals on SDSs (29 CFR part 1910, subpart Z). EPA notes that there may be other reasons for a chemical's exclusion from an SDS ( e.g., a chemical may be in an article that is not covered by SDS requirements but is subject to TRI supplier notification requirements). As described in section 4.3 of the EA (Ref. 1) for this final rule, EPA believes that any potential increase in new supplier reporting is minimal, particularly regarding non-PFAS chemicals of special concern.

In the 1999 proposal to establish a chemical of special concern list, EPA also reasoned that entities subject to TRI supplier notification requirements could retain use of the de minimis exemption for PBTs because “[m]any of the chemicals identified as persistent and bioaccumulative in today's action are not imported, processed, or otherwise used but are manufactured as byproducts” (Ref. 8). However, the Agency has since learned that several PBT chemicals are not manufactured as byproducts, and those chemicals are known to be processed for distribution to customers. For example, in Reporting Year 2021, the Agency received 55 Forms R for tetrabromobisphenol A (TBBPA). None of those forms indicated that TBBPA had been manufactured as a byproduct. However, some forms indicated the TBBPA is processed, including as an article component. Similarly, for Reporting Year 2021, the Agency received 76 Forms R on polychlorinated biphenyls (PCBs); 64 of those forms did not indicate those PCBs had been manufactured as byproducts, though some forms indicated the PCBs had been processed, including as an article component. Because many PBT chemicals are not manufactured as byproducts and may exist in relatively lower concentrations within products or mixtures, the Agency's initial rationale to allow suppliers to exempt concentrations of PBT chemicals below de minimis from supplier notification requirements warrants reconsideration. Therefore, EPA has reassessed this exemption and modified it appropriately to provide TRI facilities that receive products or mixtures containing chemicals of special concern with additional information related to quantities of chemicals of special concern that may contribute to their reporting thresholds. EPA created the de minimis exemption pursuant to the authority provided in EPCRA section 328 (42 U.S.C. 11048) and is adjusting the scope of the exemption under that same authority. EPCRA section 328 provides that EPA has authority to promulgate regulations as may be necessary to carry out this chapter. EPA has concluded that it is important and necessary to eliminate the supplier notification de minimis exemption for all chemicals of special concern because if that exemption were to remain in place the Agency may fail to collect information on amounts of such chemicals that significantly exceed the reporting threshold.

This action reflects EPA's current understanding of chemical activities involving all chemicals of special concern ( i.e., both PBTs and PFAS).

This action revises the regulatory text to add PFAS currently on TRI pursuant to 7321(b) and 7321(c) of the NDAA to the list of chemicals of special concern. Additionally, the regulatory text, as revised by this action, provides that all PFAS added to TRI pursuant to sections 7321(b) and 7321(c), regardless of the date of their addition, are included on the chemicals of special concern list. Thus, as PFAS continue to be added to TRI pursuant to sections 7321(b) and 7321(c), they will also be added to the list of chemicals of special concern as of the date they are added to the TRI. It is likely that some of the substances meeting the criteria in 7321(b) and 7321(c) will be subject to confidential business information claims. For substances subject to such claims, the Agency must follow the process outlined in section 7321(e) of the NDAA.

As with PFAS currently on the TRI list, future PFAS added to the TRI list under 7321(b) and 7321(c) will have a 100-pound reporting threshold, per sections 7321(b)(2)(A) and 7321(c)(2)(B). Congress' use of this low reporting threshold demonstrates a concern for even relatively small quantities of these PFAS. Therefore, EPA has concluded that it is appropriate for all PFAS added to the TRI list under these provisions to be added to the chemicals of special concern list upon listing. If these PFAS were not added to the chemicals of special concern list at the time of their addition to the TRI list, there would be a delay in the reporting requirements while EPA conducts a rulemaking simply to add them to the chemicals of special concern list. This would result in differences in how previously listed PFAS and newly listed PFAS are treated even though they were automatically listed with the same reporting thresholds. The chemicals of special concern designation is a regulatory construct and here, EPA has determined it is appropriate to designate all PFAS added to TRI pursuant to 7321(b) and 7321(c) as chemicals of special concern due to Congress' use of the 100-pound reporting threshold, indicating a concern for even relatively small quantities of PFAS, and PFAS' persistence in the environment and growing evidence showing potential adverse human health effects (Refs. 2, 3, and 9). Further, this regulatory change will provide additional data that will help the Agency to better understand the extent of potential impacts caused by these PFAS. Given that the NDAA set a 100-pound reporting threshold for all PFAS added pursuant to sections 7321(b) and 7321(c), EPA has determined that additional rulemakings to designate these chemicals as chemicals of special concern are unnecessary because the rationale for any future rulemakings would remain the same and would result in a delay of reporting requirements. EPA has finalized regulatory text that adds those PFAS added pursuant to 7321(b) and 7321(c) to the chemicals of special concern list upon their addition to the TRI list.

EPA has decided not to provide a structural definition ( e.g., OECD) of PFAS as part of this action, because doing so is outside the scope of this rulemaking. This rulemaking only concerns chemical substances added to the TRI by sections 7321(b) and 7321(c) of the NDAA, neither of which require EPA to provide a definition of PFAS. Section 7321(b) added by name and/or CASRN specific PFAS to the TRI list and sections 7321(b) and (c) identify EPA activities involving PFAS that would cause a PFAS to be added to the TRI list. The activities described by sections 7321(b) and (c) indicate whether they pertain to a PFAS, and thus a separate determination of whether or not the covered activity involves a PFAS is not necessary. EPA is therefore not providing a definition of PFAS for purposes of this rulemaking, and issues relating to the definition of PFAS are outside the scope of this rulemaking. EPA will consider the need for a PFAS definition for a purpose other than the NDAA section 7321(b) and (c) listings, should the need for such a definition arise. As indicated in the proposal for this rulemaking, EPA acknowledges there is another rulemaking underway to list PFAS additions for NDAA 7321(d), and the Agency expects that rulemaking to clarify the status of those listed PFAS as chemicals of special concern.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not itself physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

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 a “significant regulatory action” as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an economic analysis of the potential impacts associated with this action. This analysis, “Economic Analysis for the Changes to TRI Reporting for PFAS” (Ref. 1) is also available in the docket and summarized in Unit E.1.

The information collection activities in this rule will be submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2724.02 and the OMB Control No. 2070-0225. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here (Ref. 12). The information collection requirements are not enforceable until OMB approves them.

Currently, the facilities subject to the reporting requirements under EPCRA section 313 and PPA section 6607 may use either EPA Toxic Chemicals Release Inventory Form R (EPA Form 1B9350-1), or EPA Toxic Chemicals Release Inventory Form A (EPA Form 1B9350-2). The Form R must be completed if a facility manufactures, processes, or otherwise uses any listed chemical above threshold quantities and meets certain other criteria. For the Form A, EPA established an alternative threshold for facilities with low annual reportable amounts of a listed toxic chemical. A facility that meets the appropriate reporting thresholds, but estimates that the total annual reportable amount of the chemical does not exceed 500 pounds per year, can take advantage of an alternative manufacture, process, or otherwise use threshold of 1 million pounds per year of the chemical, provided that certain conditions are met, and submit the Form A instead of the Form R. In addition, respondents may designate the specific chemical identity of a substance as a trade secret pursuant to EPCRA section 322 (42 U.S.C. 11042) and 40 CFR part 350. OMB has approved the reporting and recordkeeping requirements related to Forms A and R, supplier notification, and petitions under OMB Control number 2070-0212 (EPA ICR No. 2613.04) and those related to trade secret designations under OMB Control 2050-0078 (EPA ICR No. 1428.12). As such, this ICR is intended to amend the existing ICR to include the following additional details:

• Respondents/affected entities: Facilities covered under EPCRA section 313 that manufacture, process or otherwise use listed PFAS (See Unit I.A.).

• Respondent's obligation to respond: Mandatory (EPCRA section 313).

• Frequency of response: Annual.

• Total estimated number of respondents: 623 to 2,015.

• Total estimated burden: 43,843 and 111,768 burden hours in the first year and approximately 22,244 and 71,946 burden hours in the steady state. Burden is defined at 5 CFR 1320.3(b).

• Total estimated cost: Approximately $3,318,492 and $10,733,149 in the first year of reporting and approximately $1,580,214 and $5,111,044 in the steady state (per year) includes $0 annualized capital or operation & maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are primarily classified within the manufacturing and waste management industry sectors. The Agency has determined that of the 623 to 2,015 entities estimated to be impacted by this action, 486 to 1,333 are small businesses; no small governments or small organizations are expected to be affected by this action. The average cost per small firm is $7,413 (at a 3% discount rate) or $7,520 (at a 7% discount rate). All small businesses affected by this action are estimated to incur annualized cost impacts of less than 1%. Even under a worst-case scenario comparing compliance costs to average revenue of firms with between 10 (smallest number required to report) and 14 employees instead of comparing compliance costs to the weighted average revenue of small firms, there are still no costs that exceed the 1% impact threshold. Thus, this action is not expected to have a significant adverse economic impact on a substantial number of small entities. A more detailed analysis of the impacts on small entities is provided in EPA's economic analysis (Ref. 1).

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. EPA did not identify any small governments that would be impacted by this action. EPA's economic analysis indicates that the total cost of this action is estimated to be from $3,318,492 and $10,733,149 in the first year of reporting and from $1,580,214 and $5,111,044 in subsequent reporting years (Ref. 1).

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on 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 (65 FR 67249, November 9, 2000) because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. It does not have substantial direct effects on tribal government because this action relates to toxic chemical reporting under EPCRA section 313, which primarily affects private sector facilities. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to regulatory actions considered significant under section 3(f)(1) of Executive Order 12866 and that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045.

Although this action does not concern an environmental health or safety risk, the data collected as a result of this action will provide information about releases to the environment that could be used to inform the public on potential exposures to toxic chemical releases, pursuant to the right-to-know principles. EPA also believes that the information obtained as a result of this action could be used by government agencies, researchers, and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential exposures and related human health or environmental risks identified as a result of increased knowledge of exposures to PFAS.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.

This action does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.

EPA finds that it is not practicable to perform an environmental justice analysis because it lacks data on the exact locations of every exposure source. EPA was unable to perform an environmental justice analysis because it lacks data on the exact location of every exposure source based on reporting activity. The purpose of this action is to require reporting activity.

However, this regulatory action makes changes to the reporting requirements for PFAS that will result in more information being collected and provided to better evaluate exposures and the risks posed by such exposures. The determination of potential risk to human health and/or the environment depends upon many factors, including the toxicity of the chemical, the fate of the chemical in the environment, and the amount and duration of human or other exposure to the chemical. This action does not directly address human health or environmental risks. However, the action will increase the level of information available to assess environmental protection for all affected populations without having any disproportionate and adverse human health or environmental effects on any population, including any community with environmental justice concerns. Specifically, changes to the reporting requirements for PFAS will provide more information on releases and waste management of PFAS. By requiring reporting of this additional information, EPA will be providing communities across the U.S. (including communities with environmental justice concerns) with access to data which they may use to seek lower exposures and consequently reductions in chemical risks for themselves and their children. This information can also be used by government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential risks to human health and the environment. Therefore, informational benefits, of the action, including behavioral changes such as consumers avoiding specific products, may have positive impact on the human health and environmental impacts on all communities, including communities with environmental justice concerns.

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: