# Phasedown of Hydrofluorocarbons: Review and Renewal of Eligibility for Application-Specific Allowances > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2025-16357 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** August 26, 2025 - **Citation:** 90 FR 41676 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 84 [EPA-HQ-OAR-2024-0196; FRL-10782-02-OAR] RIN 2060-AV98 Phasedown of Hydrofluorocarbons: Review and Renewal of Eligibility for Application-Specific Allowances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The U.S. Environmental Protection Agency (EPA) is finalizing, pursuant to the statutory framework established in the American Innovation and Manufacturing Act of 2020 (AIM Act), the eligibility of six applications to continue to receive priority access to allowances to produce or import hydrofluorocarbons. In this final rule, EPA establishes the framework for how EPA interprets the statutory criteria for assessing whether to renew the eligibility of applications to receive application-specific allowances and sets out determinations to renew or not renew each of the six applications that currently receive application-specific allowances. EPA is also finalizing revisions to the Technology Transitions regulations relevant to the specific applications under review, a procedural process for submitting a petition to designate a new application as eligible for priority access to allowances, the methodology used to allocate allowances to application-specific allowance holders for calendar years 2026 and beyond, and limited revisions to existing regulations. In addition, EPA is authorizing an entity to produce regulated substances for export. Lastly, EPA is finalizing certain regulatory confidentiality determinations for newly reported information. DATES: This rule is effective on September 25, 2025. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2024-0196. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard-copy form. Publicly available docket materials are available electronically through https://www.regulations.gov or in hard copy at the EPA Docket Center, Room 3334, WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742. FOR FURTHER INFORMATION CONTACT: Michelle Graff, U.S. Environmental Protection Agency, Stratospheric Protection Division, telephone number: (202) 564-5387; or email address: graff.michelle@epa.gov. You may also visit EPA's website at https://www.epa.gov/climate-hfcs-reduction for further information. SUPPLEMENTARY INFORMATION: Throughout this document, whenever “we,” “us,” “the Agency,” or “our” is used, we mean EPA. Acronyms and abbreviations that are used in this rulemaking that may be helpful include: 2-BTP—2-bromo-3,3,3-trifluoropropene AAGR—Average Annual Growth Rate ACE—Automated Commercial Environment AD/CVD—Anti-dumping and Countervailing Duties AES—Automated Export System AIM Act—American Innovation and Manufacturing Act of 2020 AHRI—Air-Conditioning, Heating, and Refrigeration Institute APU—Auxiliary Power Unit ASHRAE—American Society for Heating, Refrigerating, and Air-Conditioning Engineers ASA—Application-specific Allowance CAA—Clean Air Act CBI—Confidential Business Information CBP—U.S. Customs and Border Protection CFR—Code of Federal Regulations CGMP—Current Good Manufacturing Practice CO 2 —Carbon Dioxide COVID—Coronavirus Disease CRA—Congressional Review Act CVD—Chemical Vapor Deposition DOC—U.S. Department of Commerce DOD—U.S. Department of Defense EEI—Electronic Export Information EV—Exchange Value EVe—Exchange Value Equivalent EPA—U.S. Environmental Protection Agency FDA—U.S. Food and Drug Administration FIFRA—Federal Insecticide, Fungicide, and Rodenticide Act FR—Federal Register GDP—Gross Domestic Product GHG—Greenhouse Gas GWP—Global Warming Potential HCFC—Hydrochlorofluorocarbon HFA—Hydrofluoroalkane HFC—Hydrofluorocarbon HFO—Hydrofluoroolefin HHS—U.S. Department of Health and Human Services HVM—High Volume Manufacturing ICR—Information Collection Request IPCC—Intergovernmental Panel on Climate Change ITN—Internal Transaction Number Kg—Kilogram MCMEU—Mission-Critical Military End Uses MCTOC—Medical and Chemicals Technical Options Committee MDI—Metered Dose Inhaler MT—Metric Ton MTEVe—Metric Tons of Exchange Value Equivalent NAICS—North American Industry Classification System OMB—U.S. Office of Management and Budget PFAS—Per- and Polyfluoroalkyl Substances PFC—Perfluorocarbon PII—Personally Identifiable Information PRA—Paperwork Reduction Act PU—Polyurethane RACA—Request for Additional Consumption Allowance RFA—Regulatory Flexibility Act RIA—Regulatory Impact Analysis RSV—Respiratory Syncytial Virus SCPPU—Structural Composite Preformed Polyurethane SNAP—Significant New Alternatives Policy TCE—Trichloroethylene TEAP—Technology and Economic Assessment Panel TSCA—Toxic Substances Control Act TSD—Technical Support Document UMRA—Unfunded Mandates Reform Act Table of Contents I. Executive Summary A. Purpose of Regulatory Action B. Summary of Final Actions II. General Information A. Does this action apply to me? B. What is EPA's authority for taking this action? III. Background IV. How is EPA assessing whether to extend eligibility for application-specific allowances? A. How is EPA interpreting the “no safe or technically achievable substitute will be available” criterion? B. How is EPA interpreting the insufficient supply of regulated substances criterion? C. What is EPA's framework for renewing applications? V. Review of the Six Applications Listed in the AIM Act A. Propellants in Metered Dose Inhalers 1. Availability of Safe and Technically Achievable Substitutes 2. Supply 3. Final Determination on Application-Specific Allowance Eligibility B. Defense Sprays 1. Availability of Safe and Technically Achievable Substitutes 2. Supply 3. Final Determination on Application-Specific Allowance Eligibility 4. Restriction Under 40 CFR Part 84, Subpart B C. Structural Composite Preformed Polyurethane Foam for Marine Use and Trailer Use 1. Availability of Safe and Technically Achievable Substitutes 2. Supply 3. Final Determination on Application-Specific Allowance Eligibility D. Etching of Semiconductor Material or Wafers and the Cleaning of Chemical Vapor Deposition Chambers Within the Semiconductor Manufacturing Sector 1. Availability of Safe and Technically Achievable Substitutes 2. Supply 3. Final Determination on Application-Specific Allowance Eligibility E. Mission-Critical Military End Uses F. Onboard Aerospace Fire Suppression VI. What are the requirements associated with a petition to be listed as an application that will receive application-specific allowances? VII. Revisions to Existing Regulations A. Expected Total HFC Purchases B. Unique Circumstances 1. Healthcare System Needs 2. Economic Disruptions 3. Stockpiling C. Inventory D. Methodology for Small Purchasers of HFCs, Entities That Do Not Purchase HFCs Every Year, and Entities With Irregular HFC Usage E. Department of Defense Conferrals F. Limited Set-Aside for Unique Circumstances Related to Metered Dose Inhalers G. Return of Unneeded Allowances H. Enabling Auctions of Illegally Imported HFCs I. Quarterly Exporter Reporting of Internal Transaction Numbers J. Date of Purchase for Requests for Additional Consumption Allowances (RACAs) VIII. Authorization To Produce for Export A. To what entities is EPA finalizing provisions to allocate production for export allowances? B. How many production for export allowances will EPA issue to Iofina on an annual basis, and for how many years will EPA issue these allowances? C. Will Iofina need to expend consumption allowances for materials produced with production for export allowances and subsequently exported? D. How will this process affect the issuance of other types of allowances? E. What are the final recordkeeping and reporting requirements for production for export allowances? 1. Annual Certifications 2. Quarterly Export and Inventory Reporting 3. Recordkeeping IX. How will EPA handle confidentiality for newly reported information? A. Data Elements Associated With a Petition To Be Listed as an Application That Will Receive Application-specific Allowances B. Data Elements Related to Proposed Revisions to Existing Regulations C. Data Elements Reported to EPA Related to Production for Export X. What are the costs and benefits of this action? XI. Judicial Review XII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 14192: Unleashing Prosperity Through Deregulation C. Paperwork Reduction Act (PRA) D. Regulatory Flexibility Act (RFA) E. Unfunded Mandates Reform Act (UMRA) F. Executive Order 13132: Federalism G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use J. National Technology Transfer and Advancement Act K. Congressional Review Act (CRA) I. Executive Summary A. Purpose of Regulatory Action The U.S. Environmental Protection Agency (EPA) is undertaking this action to implement certain provisions of the American Innovation and Manufacturing Act of 2020, codified at 42 U.S.C. 7675 (AIM Act or the Act). The Act directs EPA to implement the phasedown of hydrofluorocarbons (HFCs) by issuing a limited quantity of production and consumption allowances, which entities must expend to produce or import HFCs. Subsection (e)(4)(B) of the Act authorizes EPA to allocate allowances exclusively for the use of HFCs in specific applications for which there is (1) no safe or technically achievable substitute during the applicable period and (2) an insufficient supply of the HFCs used in the application that can be secured from chemical manufacturers to accommodate the application. The Act listed six applications to receive these allowances for a five-year period beginning on December 27, 2020: propellants in metered dose inhalers (MDIs), defense sprays, structural composite preformed polyurethane (SCPPU) foam for marine use and trailer use (hereafter referred to as SCPPU foam for marine and trailer uses), the etching of semiconductor material or wafers and the cleaning of chemical vapor deposition (CVD) chambers within the semiconductor manufacturing sector, mission-critical military end uses (MCMEU), and onboard aerospace fire suppression. 1 EPA has created a category for these allowances, which EPA refers to as application-specific allowances (ASAs). ASAs provide priority access for eligible applications and are allocated ahead of general pool allowances based on a methodology intended to determine eligible entities' needs for regulated substances (see section VII. of this preamble and the Allocation Framework Rule for more information). 2 After the total ASA quantity is determined, the remaining allowances are distributed to general pool allowance recipients using the methodology codified in regulation. 1 EPA codified that application-specific allowances are available to entities using regulated substances in the statutorily listed applications for calendar years 2022, 2023, 2024, and 2025 in “ Phasedown of Hydrofluorocarbons: Establishing the Allowance Allocation and Trading Program Under the American Innovation and Manufacturing Act” (hereafter referred to as the “Allocation Framework Rule”) (86 FR 55116, October 5, 2021). 40 CFR 84.13(a). Accordingly, EPA made the final allocation under the preexisting regulations when it allocated calendar year 2025 allowances on October 1, 2024. See “Phasedown of Hydrofluorocarbons: Notice of 2025 Allowance Allocations for Production and Consumption of Regulated Substances Under the American Innovation and Manufacturing Act of 2020, and Notice of Final Actions Establishing Administrative Consequences” (89 FR 84583, October 23, 2024). 2 EPA first codified the allocation methodology for general pool and ASA holders in the Allocation Framework Rule. The methodology for general pool allowance holders was subsequently updated in “ Phasedown of Hydrofluorocarbons: Allowance Allocation Methodology for 2024 and Later Years” (hereafter referred to as the “2024 Allocation Rule”; 88 FR 46836, July 20, 2023); the ASA methodology was not updated in the 2024 Allocation Rule. Subsection (e)(4)(B)(v) of the AIM Act directs EPA to review applications receiving priority access to allowances not less frequently than once every five years and establishes statutory criteria under which EPA is to review the applications. If an application is deemed to meet the statutory criteria, EPA is to renew the eligibility of the application to receive priority access to allowances for a period of not more than five years. As explained in the proposed rule, 89 FR 75898 (September 16, 2024), EPA is undertaking this review in this rulemaking, and therefore this final rule establishes how the Agency is interpreting the statutory criteria for reviewing applications receiving ASAs. EPA is also making decisions to renew or not renew each of the six applications that currently receive ASAs. Separately, subsection (i) of the Act authorizes EPA, by rulemaking, to restrict the use of HFCs in sectors or subsectors where the regulated substances are used. Based on this provision, EPA promulgated a final rule entitled “ Phasedown of Hydrofluorocarbons: Restrictions on the Use of Certain Hydrofluorocarbons Under the American Innovation and Manufacturing Act of 2020” (hereafter referred to as the “2023 Technology Transitions Rule”; 88 FR 73098, October 24, 2023), which established restrictions for three sectors and numerous subsectors. The rule exempted applications currently eligible to receive ASAs for the year or years in which that application receives an ASA. As such, if an application is no longer eligible to receive ASAs, it would become subject to the restrictions established in the 2023 Technology Transitions Rule. Therefore, as part of this rulemaking, EPA considered whether there are any appropriate changes to make specific to applications under review in this rule, and if so, whether to finalize those modifications to the Technology Transitions regulations, codified at 40 CFR part 84, subpart B. 3 3 Through a separate rulemaking, EPA announced reconsideration of the Technology Transitions requirements for certain refrigeration applications, including in supermarket systems and at semiconductor fabrication plants. See https://www.epa.gov/newsreleases/trump-epa-takes-action-lower-costs-american-families-grocery-store-reconsidering. The Act also allows members of the public to petition EPA to designate an application as eligible for priority access to allowances. EPA is finalizing a procedure for submitting a petition under this provision and defining minimum required elements of such a petition. In addition, EPA is making narrow revisions in this final rule to the methodology used to allocate allowances to ASA holders for calendar years 2026 and beyond as well as other limited revisions to the existing 40 CFR part 84, subpart A regulations. EPA is also authorizing an entity to produce regulated substances for export for application-specific uses pursuant to subsection (e)(5) of the Act, which authorizes EPA to permit the production in excess of allowances held by an entity so long as the excess production is solely for export purposes and meets additional requirements in the Act. Lastly, EPA is finalizing certain regulatory confidentiality determinations for newly reported information. B. Summary of Final Actions Application-specific allowance eligibility review: EPA is finalizing its interpretation of the criteria under subsection (e)(4)(B) of the AIM Act and applying that interpretation to evaluate the six categories of ASA holders listed in subsection (e)(4)(B)(v) of the Act. EPA is renewing the following applications for the full five-year period from 2026-2030: propellants in MDIs, SCPPU foams for marine and trailer uses, the etching of semiconductor material or wafers and the cleaning of CVD chambers within the semiconductor manufacturing sector, MCMEU, and onboard aerospace fire suppression. EPA is also finalizing the option set out in the proposed rule of not renewing the eligibility of defense sprays for ASAs beginning with calendar year 2026 allowances, 4 and is excluding defense sprays from Technology Transitions restrictions that would otherwise apply under the current regulation. 4 Entities without ASAs can continue to purchase and use HFCs in accordance with the overall requirements established in 40 CFR part 84. Application-specific allowance eligibility petitions: EPA is finalizing the process and information requirements for submitting petitions under subsection (e)(4)(B) of the AIM Act which seek the designation of an application as eligible for priority allowance access consistent with EPA's proposal. Application-specific allowance methodology: EPA is making targeted revisions to the existing ASA methodology as proposed: to require companies to provide a total request for allowances for the calendar year, to expand permissible scenarios that could qualify as unique circumstances, to use a different allocation methodology for certain very small users of HFCs and entities with irregular HFC usage history, to account for inventory in allocation decisions, and to establish a set-aside of allowances for situations that meet the criteria for unique circumstances related to medical conditions treated by MDIs. EPA is also finalizing new requirements for conferrals of MCMEU allowances in line with the proposed rule. Other regulatory revisions: EPA is finalizing amendments to existing regulations as proposed to: clarify the ability of the federal government to pursue, if appropriate, auctioning illegally imported HFCs that are seized by enforcement officials, require exporting companies to report “Internal Transaction Numbers” (ITNs) quarterly, and simplify the reporting on “date of purchase” for a Request for Additional Consumption Allowances (RACA). Authorization of production for export: As proposed, EPA is authorizing an entity to produce regulated substances for export for application-specific uses abroad. Handling of confidentiality for newly reported information: EPA is finalizing certain regulatory confidentiality determinations for newly reported information. II. General Information A. Does this action apply to me? You may be potentially affected by this action if you use HFCs in one of the six applications eligible for an allocation under section (e)(4)(B)(iv) of the AIM Act. You may also potentially be affected if you produce, import, export, purify, destroy, reclaim, package, or otherwise distribute HFCs for end users in one of these six applications or are a current HFC allowance holder. Potentially affected categories, North American Industry Classification System (NAICS) codes, and examples of potentially affected entities are included in table 1. Table 1—NAICS Classification of Potentially Affected Entities NAICS Code NAICS industry description 325120 Industrial Gas Manufacturing. 325199 All Other Basic Organic Chemical Manufacturing. 325211 Plastics Material and Resin Manufacturing. 325412 Pharmaceutical Preparation Manufacturing. 325414 Biological Product (except Diagnostic) Manufacturing. 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing. 326220 Rubber and Plastics Hoses and Belting Manufacturing. 326150 Urethane and Other Foam Product. 326299 All Other Rubber Product Manufacturing. 333415 Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing. 333511 Industrial Mold Manufacturing. 334413 Semiconductor and Related Device Manufacturing. 334419 Other Electronic Component Manufacturing. 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing. 336212 Truck Trailer Manufacturing. 336214 Travel Trailer and Camper Manufacturing. 336411 Aircraft Manufacturing. 336611 Ship Building and Repairing. 336612 Boat Building. 336992 Military Armored Vehicle, Tank, and Tank Component Manufacturing. SIC 373102 Military Ships, Building, and Repairing.. 339112 Surgical and Medical Instrument Manufacturing. 423720 Plumbing and Heating Equipment and Supplies (Hydronics) Merchant Wholesalers. 423730 Warm Air Heating and Air-Conditioning Equipment and Supplies Merchant Wholesalers. 423740 Refrigeration Equipment and Supplies Merchant Wholesalers. 423830 Industrial Machinery and Equipment Merchant Wholesalers. 423840 Industrial Supplies Merchant Wholesalers. 423860 Transportation Equipment and Supplies (except Motor Vehicle) Merchant Wholesalers. 424690 Other Chemical and Allied Products Merchant Wholesalers. 488510 Freight Transportation Arrangement. 541380 Testing Laboratories. 541714 Research and Technology in Biotechnology (except Nanobiotechnology). 562111 Solid Waste Collection. 562211 Hazardous Waste Treatment and Disposal. 562920 Materials Recovery Facilities. 922160 Fire Protection. This table is not intended to be exhaustive, but rather provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this section could also be affected. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What is EPA's authority for taking this action? On December 27, 2020, the AIM Act was enacted as section 103 in Division S, Innovation for the Environment, of the Consolidated Appropriations Act, 2021 (codified at 42 U.S.C. 7675). In subsection (k)(1)(A), the AIM Act provides EPA with the authority to promulgate necessary regulations to carry out EPA's functions under the Act, including its obligations to ensure that the Act's requirements are satisfied (42 U.S.C. 7675(k)(1)(A)). Subsection (k)(1)(C) of the Act also provides that Clean Air Act (CAA) sections 113, 114, 304, and 307 apply to the AIM Act and any regulations EPA promulgates under the AIM Act as though the AIM Act were part of title VI of the CAA. Accordingly, this rulemaking is subject to CAA section 307(d) (42 U.S.C. 7607(d)(1)(I)), which applies to “promulgation or revision of regulations under subchapter VI of this chapter (relating to stratosphere and ozone protection).” The AIM Act authorizes EPA to address HFCs in three main ways: phasing down HFC production and consumption through an allowance allocation program, promulgating certain regulations for purposes of maximizing reclaiming and minimizing releases of HFCs from equipment and ensuring the safety of technicians and consumers, and facilitating the transition to next-generation technologies by restricting use of these HFCs in the sector or subsectors in which they are used. This rulemaking relates to the first area and also addresses restrictions in the third area solely for impacted subsectors. The Act required EPA, for the five-year period beginning on December 27, 2020, to allocate the full quantity of allowances necessary, based on projected, current, and historical trends, for the production or consumption of regulated substances for the exclusive use in six applications: propellants in MDIs, defense sprays, SCPPU foam for marine and trailer uses, the etching of semiconductor material or wafers and the cleaning of CVD chambers within the semiconductor manufacturing sector, MCMEU, and onboard aerospace fire suppression (42 U.S.C. 7675(e)(4)(B)(iv)(I)). EPA has defined these allowances as ASAs. Subsection (e)(4)(B)(v) of the AIM Act requires EPA to review applications receiving allocations pursuant to subsection (e)(4)(B)(iv) at least every five years. If pursuant to this review EPA determines that the requirements of two statutory criteria are met, EPA shall authorize production or consumption, as applicable, of regulated substances for exclusive use in the application for renewable periods of not more than five years. Specifically, EPA must determine whether: (1) no safe or technically achievable substitute will be available during the applicable period for the application; and (2) the supply of the regulated substance that manufacturers or users of the regulated substance for that application are capable of securing from chemical manufacturers is insufficient to accommodate the application. Separately, an entity may file a petition for an application to receive ASAs. The AIM Act outlines timeframes and deadlines for EPA to act on such a petition and describes how the Agency should assess such a petition (42 U.S.C. 7675(e)(4)(B)(ii)). Specifically, not later than 180 days after receiving a petition, EPA must propose and seek public comment on whether to provide ASAs for the application. Not later than 270 days after EPA receives a petition, the Agency must take final action on the petition. Any application determined to be eligible for ASAs would also be subject to the periodic eligibility review established in subsection (e)(4)(B)(v). Subsection (i) of the AIM Act, “Technology Transitions,” provides that “the Administrator may by rule restrict, fully, partially, or on a graduated schedule, the use of a regulated substance in the sector or subsector in which the regulated substance is used” (42 U.S.C. 7675(i)(1)). However, rules promulgated under subsection (i) “shall not apply to . . . an essential use under clause (i) or (iv) of subsection (e)(4)(B), including any use for which the production or consumption of the regulated substance is extended under clause (v)(II) of that subsection” (42 U.S.C. 7675(i)(7)(B)(i)). Therefore, per subsection (i)(7)(B)(i), the Technology Transitions regulations are not currently applicable to any application receiving an ASA (40 CFR 84.56(a)(2)). In this final rule, EPA is clarifying how the 40 CFR part 84, subpart B restrictions will apply to an application no longer receiving an ASA, based on EPA's consideration of the factors listed in subsection (i)(4) of the AIM Act. III. Background HFCs are anthropogenic 5 fluorinated chemicals that have no known natural sources. HFCs are used in a variety of applications such as refrigeration and air conditioning, foam blowing agents, solvents, aerosols, and fire suppression. HFCs have 100-year global warming potentials (GWPs) 6 (a measure of the relative climatic impact of a greenhouse gas (GHG)) that can be hundreds to thousands of times that of carbon dioxide (CO 2 ). There are hundreds of possible HFC compounds. The 18 HFCs listed as regulated substances by the AIM Act are some of the most commonly used HFCs (neat and in blends). These 18 HFCs are all saturated, meaning they have only single bonds between their atoms, and therefore have longer atmospheric lifetimes than fluorinated compounds that are unsaturated. More detailed information on HFCs, their uses, and their impacts is available in the Allocation Framework Rule. 5 While the overwhelming majority of HFC production is intentional, EPA is aware that HFC-23 can be a byproduct associated with the production of other chemicals, including but not limited to hydrochlorofluorocarbon (HCFC)-22 and other fluorinated gases. 6 EPA notes that the exchange values (EVs) listed in the AIM Act for each regulated HFC are numerically identical to the 100-year GWPs of each substance, as given in the Errata to Table 2.14 of the Intergovernmental Panel on Climate Change's (IPCC) Fourth Assessment Report (AR4). See IPCC, 2007: Summary for Policymakers. In: Climate Change 2007: The Physical Science Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change [Solomon, S., D. Qin, M. Manning, Z. Chen, M. Marquis, K.B. Averyt, M. Tignor and H.L. Miller (eds.)]. Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA. Available at https://www.ipcc.ch/report/ar4/wg1. IV. How is EPA assessing whether to extend eligibility for application-specific allowances? As noted in section II.B. of this preamble, the AIM Act directs EPA to undertake a review of applications receiving allowances pursuant to subsection (e)(4)(B)(iv) at least every five years. The statute provides that access to ASAs shall be authorized for a renewed period if two statutory criteria are met. Specifically: (1) “no safe or technically achievable substitute will be available during the applicable period for that application; and” (2) “the supply of the regulated substance that manufacturers or users of the regulated substance for that application are capable of securing from chemical manufacturers . . . including any quantities of a regulated substance available from production or import, is insufficient to accommodate the application” (42 U.S.C. 7675(e)(4)(B)(i), (e)(4)(B)(v)). In this section, we outline how EPA interprets these criteria, what information the Agency considers in assessing these criteria, and establish a framework for evaluating if an application is eligible for renewal and for what time period. EPA notes that under the statute, these criteria also apply to new applications that may be listed; however, aside from the discussion of the petition process in section VI., this final rule only considers the renewal of existing applications. EPA's interpretations of the criteria discussed in this section would apply to future actions to add new applications. The AIM Act includes additional evaluation considerations for new applications in subsection (e)(4)(B)(i), but the Agency is not addressing their interpretation in this final rule. A. How is EPA interpreting the “no safe or technically achievable substitute will be available” criterion? In order for an application to continue to be eligible to receive ASAs, EPA must determine “no safe or technically achievable substitute will be available” for the application during the time period under review (42 U.S.C. 7675(e)(4)(B)(i)(I)). EPA proposed to interpret this criterion to mean that if there is an available substitute that is both safe and technically achievable, an application would not meet this criterion for renewal. In other words, if EPA determines there is a safe substitute, but it is not technically achievable, or the only technically achievable substitutes are not safe, the application would meet the first criterion for renewal. EPA included further explanation regarding this proposed interpretation in the notice of proposed rulemaking (89 FR 75898, September 16, 2024). In the proposal, EPA explained its intent to consider a wide range of possibilities in assessing whether there was a safe and technically achievable substitute for an application under subsection (e)(4)(B)(i)(I). Specifically, EPA proposed to consider regulated substances ( i.e., other HFCs), alternative substances ( e.g., hydrofluoroolefins (HFOs), hydrocarbons), and blends of HFCs and/or HFC alternatives that can perform the same function as the current HFC in use; of these substances, EPA proposed to assess only those with a lower GWP than the regulated substance currently in use. EPA proposed to include substitute chemicals that are both a chemical-for-chemical replacement and those that would require a change in manufacturing process or the product. In addition to looking at chemicals that could serve as substitutes, EPA also proposed to include in its analysis any potentially available not-in-kind technologies ( e.g., finger-pump bottles that would not use any chemical propellant in lieu of aerosol cans) for purposes of subsection (e)(4)(B)(i)(I). The Agency proposed to assess this criterion, specifically whether a safe and technically achievable substitute(s) is available, on an application-wide basis. For applications that use multiple HFCs, a safe and technically achievable substitute would need to be able to replace all HFCs used (or multiple substitutes that replace all individual HFCs would need to be available). For applications that have sub-applications ( e.g., defense sprays include those intended for humans and those intended for animals), there would need to be a safe and technically achievable substitute for known sub-applications that have been relying on ASAs to date. EPA proposed that its evaluation of each application is not intended to be a company-specific review; the commercialization 7 of a substitute in one sub-application suggests the substitute is safe or technically achievable for the entire application barring evidence, such as testing data, to the contrary. However, EPA noted at proposal that if there are additional barriers to commercialization, those would be considered when assessing if the identified substitute is available for an entire application and the renewal period, as applicable. In addition, EPA's interpretation of the statutory language is that applications are intended to be viewed as a whole and not renewed by sub-application. 7 EPA is using the term “commercialization” to mean that the substitute is commercially available and actively being used in an application's equipment or sold on the market (domestically or internationally) for use in the application. “Commercialization” is not intended to be equated with “available,” as explained in more detail in the main text. One commenter requested further clarification regarding EPA's interpretation of “technically achievable substitute.” 8 The commenter noted its support of the sources of information that EPA outlined in the proposed rule in determining the availability of substitutes, specifically noting Significant New Alternatives Policy (SNAP) Program listings (pursuant to section 612 of the CAA) and 2023 Technology Transitions Rule evaluations. However, the commenter stated a need for more clarity on how EPA plans to interpret the phrase “technically achievable substitute.” 8 All comments referenced in this preamble can be found in the “Response to Comments” document in the docket for this rulemaking. EPA has responded to the most significant comments in the final rule preamble. All other comments are only addressed in the Response to Comments document. EPA disagrees with the commenter that the proposed action lacked sufficient clarity and notes that the commenter does not specify what was unclear in the proposal. As the commenter acknowledges, EPA listed numerous sources of information the Agency intended to draw from in developing its assessment of the availability of a technically achievable substitute for individual applications. How EPA incorporates information from these sources is necessarily source-specific and will vary depending on the information received from the source. For example, EPA listed manufacturer announcements as an information source. If a company within an application has announced that it is commercializing a product using a substitute chemical, that would be meaningful for EPA's assessment. Conversely, if a company announces it is starting the first stage of testing for use of a substitute chemical, that will also be information EPA will take into account, but the analysis will be different. Similarly, many peer-reviewed technical reports discuss whether substitutes are currently and/or expected to be technically achievable, and how EPA will account for that information will depend on the content of the report. Moreover, the Technical Support Document (TSD), “Review of Applications in the American Innovation and Manufacturing (AIM) Act Subsection (e)(4)(B)(4),” accompanying the proposed rule demonstrated exactly how this variation would play out. EPA took information from cited sources and then developed an assessment of the availability of substitutes for each individual application. EPA received no adverse comment on its more general approach to analyzing substitute availability in the TSD for the applications as a whole. To the extent any commenter raised concerns about this application-specific assessment, EPA has accounted for that in the individual application decisions contained in section V. of this preamble to the final rule. Finally, as the commenter acknowledges, EPA explained in the proposal its intent to consider the listings under the SNAP Program and evaluations carried out for the 2023 Technology Transitions Rule as part of its assessment. This includes listings themselves and the information underlying those decisions. In evaluation of substitutes and related decisions ( e.g., to list as acceptable or unacceptable), the SNAP Program carries out a comparative risk evaluation and considers whether a substitute to an ozone-depleting substance presents human health and environmental risks that are lower than or comparable to such risks from other substitutes that are currently or potentially available for the same uses. The analysis undertaken when evaluating a proposed substitute includes ozone depletion potential, GWP, local air quality, toxicity, flammability, and occupational and consumer health/safety. Information and data relied upon in the SNAP Program are directly relevant to EPA's assessment of substitutes in this rulemaking, and therefore EPA has pulled from and relied upon SNAP Program assessments as appropriate. The 2023 Technology Transitions Rule applied a list of criteria that are similar, but not identical, to the ASA review process ( e.g., the availability of substitutes, considering both safety and technological achievability), and EPA has also considered the information prepared for that rule, which is available in the relevant docket. Another commenter stated that the criteria “no available substitute that is both safe and technically achievable” is ambiguous and restrictive and does not provide an incentive for applications to explore substitutes. EPA acknowledges this comment, but notes that the language cited by the commenter comes directly from the AIM Act. The Agency has no authority to alter the statutory language enacted by Congress. EPA's role, as an executive branch agency, is to implement the language in such a way to give effect to the text provided by the legislature. EPA did not receive any further adverse comments on this part of its proposal, including what can be considered a substitute ( i.e., the various chemicals that will be considered along with not-in-kind substitutes), the proposal to assess the availability of substitutes on an application-wide basis, and the proposal to not determine availability of substitutes on a company-specific basis. EPA is therefore finalizing its interpretation of the “no safe or technically achievable substitute will be available” criterion as proposed, which EPA views as the best reading of the statutory text. In the proposed rule, EPA outlined a range of sources of information it intended to, and did, review in developing the assessment of the availability of safe, technically achievable substitutes for applications under review. EPA's TSD that accompanied the proposed rule also included detailed information of the substitute assessment for each individual application, including citations to all sources of information considered. Sources include, but are not limited to: manufacturer announcements; information provided by stakeholders under reporting requirements of part 84 of the CFR and other communications; relevant federal and state regulations; evaluations carried out under the 2023 Technology Transitions Rule and the SNAP Program; standards from industry, standard-setting bodies ( e.g., American Society for Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE)), and the U.S. Government ( e.g., the U.S. Food and Drug Administration's (FDA) regulations and guidance for MDIs); and peer-reviewed technical reports. EPA did not receive general comment on additional sources to consider, but we note that the Agency may consider additional information as relevant when assessing this criterion in future actions. The TSD accompanying this final rule has detailed information on the sources used in analyzing substitutes for each individual application in this final rulemaking. To the extent any commenter suggested additional sources of information for particular applications, EPA has considered these additional sources and incorporated that information as warranted into the analyses of the individual applications, as outlined in detail in the TSD. B. How is EPA interpreting the insufficient supply of regulated substances criterion? Under the second criterion for renewal of an application's eligibility to receive ASAs, EPA must determine that “the supply of the regulated substance that manufacturers or users of the regulated substance for that application are capable of securing from chemical manufacturers. . . , including any quantities of a regulated substance available from production or import, is insufficient to accommodate the application” (42 U.S.C. 7675(e)(4)(B)(i)(II)). In the proposal, EPA described its intention to look at a number of different factors to assess whether an application met this second criterion, including the available domestic supply of the HFC(s) at issue, demand for said HFC(s), and supply chain constraints particular to a given application ( e.g., federal requirements related to purity specifications). EPA proposed to evaluate only the supply of the HFC(s) currently used in an application's equipment or to manufacture the application's products for use; this excludes any HFC(s) currently used exclusively for research and development. For applications that use multiple HFCs, EPA proposed to individually evaluate each HFC for which ASAs are being expended to assess if supply of that HFC is insufficient. EPA proposed to assess insufficient supply on an application-wide basis. In other words, if the supply of at least one of the HFCs evaluated is insufficient to accommodate the application, EPA proposed to consider the criterion met for the application. EPA discussed in the proposed rule that in assessing supply, the Agency would also consider relevant restrictions, if any, on the type of HFC or supplier of HFCs that would further limit supply to a particular application. For example, FDA regulations govern use of pharmaceutical-grade HFCs by MDI manufacturers. Facilities manufacturing the regulated substances must comply with FDA regulations, and there are a limited number of purifiers. In addition, per the Agency's best interpretation of the statutory language to consider regulated substances “from chemical manufacturers . . . , including any quantities of a regulated substance available from production or import” in 42 U.S.C. 7675(e)(4)(B)(i)(II), EPA proposed to consider only regulated substances that are supplied by chemical manufacturers in its assessment of supply. EPA proposed this assessment covers both virgin and recovered and reprocessed HFCs, and includes both imported material from foreign HFC producers and regulated substances from domestic producers. Relatedly, EPA proposed that “chemical manufacturers” excludes entities that do not produce or import HFCs and therefore that EPA would not consider HFC supply held by and available to entities that do not produce or import HFCs in its assessment of this criterion. This excludes quantities of HFCs held by entities that do not produce or import HFCs with allowances, potentially including reclaimers, distributors, HFC blenders, 9 and HFC repackagers. Further explanation about EPA's interpretation of this statutory language can be found in the proposed rule. 9 For a discussion on the difference between producing HFCs consistent with the AIM Act and blending HFCs to make various refrigerant blends, see “Response to Comments,” pg 193, Docket ID No. EPA-HQ-OAR-2021-0044, associated with the Allocation Framework Rule and the discussion in the 2024 Allocation Rule. EPA did not receive comments related to the Agency's proposed interpretation of the statutory language in subsection (e)(4)(B)(i)(II). EPA is therefore finalizing its interpretation of the supply criterion as proposed, which EPA views as the best reading of the statutory text. EPA also discussed in the proposed rule the sources of data it would consider in its evaluation of whether supply of a regulated substance is insufficient to accommodate an application. These include information regarding the total expected HFC consumption in the United States, global production of individual HFCs used in the applications, manufacturer announcements regarding production of specific HFCs, past and projected market trends for an application that can inform projected demand for the HFC(s) it uses, and allowance usage by an application to date, including conferrals, imports, and open market purchases by ASA holders, as well as expenditures of conferred allowances by suppliers to ASA holders. To the extent available, EPA will consider data from all of these sources collectively in order to gain a more complete picture of projected supply for the relevant individual HFC(s), rather than relying on one data point. While EPA did not receive general comment on additional sources to consider, we note this list is not exhaustive and that the Agency may consider additional information as relevant when assessing this criterion. The TSD accompanying this final rule has detailed information on the sources used in analyzing supply related to each individual application. To the extent any commenter suggested supply data to be considered in an individual application's renewal decision, EPA has considered the data sources and incorporated that information as warranted into the analysis of the individual application, as outlined in detail in the TSD. C. What is EPA's framework for renewing applications? In outlining the requirement that EPA review the applications eligible for ASAs at least every five years, the AIM Act states that if EPA determines “that the requirements described in subclauses (I) and (II) of clause (i) are met” then EPA will renew the application's eligibility to continue to receive ASAs (42 U.S.C. 7675(e)(4)(B)(v)(II)) (emphasis added). Accordingly, EPA explained in the proposed rule that the Agency considered the best interpretation of the statutory language to be that both criterion (I) of clause (i) (that a substitute is not available) and criterion (II) (that supply is insufficient) must be met for an application to be renewed as eligible for ASAs. EPA further proposed that an application will no longer be eligible for ASAs at the time at which EPA has determined it does not fulfill one of these criteria. In practice, this means that if either or both criteria are not met at the beginning of the renewal period, EPA will not renew an application's eligibility to receive ASAs. For example, if, for this review cycle, the Agency determines that supply is not insufficient to accommodate an application as of January 1, 2026 (the beginning of this renewal period), EPA will not renew that application's eligibility for ASAs, regardless of whether a substitute is available. If both statutory criteria are met as of the beginning of the renewal period, EPA proposed it would assess whether an application's fulfillment of a criterion may change over the following five-year period. The outcome of this assessment would be determinative of how long EPA would determine an application eligible to receive ASAs. For example, if, for this renewal cycle, EPA determines that there is no substitute available as of January 1, 2026, but a substitute will be available by January 1, 2028, then EPA would renew the application's eligibility to receive ASAs for only two years ( i.e., calendar years 2026 and 2027). Similarly, if supply is determined to be insufficient to accommodate the application as of January 1, 2026, but the market will change such that supply will not be insufficient to accommodate the application as of January 1, 2028, then EPA would renew the application's eligibility to receive ASAs for only two years ( i.e., calendar years 2026 and 2027). The Agency also proposed that if EPA determines that an application has a safe or technically achievable substitute available that is a regulated substance, EPA would also evaluate the supply of the substitute HFC and assess if supply of the substitute HFC is insufficient to accommodate the application. Further information regarding the Agency's reasoning can be found in the notice of proposed rulemaking for this action. Under this proposed framework, if EPA determines there is an HFC substitute, but there is insufficient supply of that HFC substitute, EPA would continue to list the application as eligible for ASAs. This approach allows an entity transitioning to a lower-GWP HFC to remain eligible to receive allowances until supply of that lower-GWP HFC is no longer insufficient (or a non-HFC substitute is available). EPA also proposed that if an application is renewed for ASAs for less than five years, the application would not be reviewed for eligibility for ASAs again as part of the statutorily mandated schedule ( i.e., once EPA determines that an application is no longer eligible for ASAs, EPA would not re-review that application), given the direction in the statute. In such a situation, an entity may petition the Agency to be evaluated for ASA eligibility, and the Agency would then undertake the relevant petition review process; see section VI. for further discussion of the petition process requirements. One commenter suggested that EPA should review applications more frequently than every five years. The commenter points to the statutory text in the AIM Act in subsection (e)(4)(B)(v) that directs EPA to review applications receiving ASAs “not less frequently than once every 5 years” and to authorize renewals of not more than five years. The commenter states that this text allows EPA to review applications more frequently than every five years. The commenter alleges that EPA's proposal to not do so is inconsistent with EPA's expectation the HFC market will be dynamic given EPA's statement at proposal that the Agency “cannot know the full breadth of technologies that will be developed as replacements for the current HFCs in use,” (89 FR 75898, 75904). EPA notes that the commenter itself acknowledges that the language in the AIM Act is merely permissive of EPA reviewing applications more frequently than every five years and that the commenter does not provide any argument that the best interpretation of the statutory language is that EPA is required to review applications more frequently than every five years. Congress set a clear directive that the Agency review applications receiving ASAs “not less frequently than once every 5 years,” and EPA's approach clearly aligns with this language. The statute provides EPA discretion to determine the appropriate review period, as long as the Agency reviews at least once every five years. To the extent the commenter intended to raise a policy or programmatic rather than a legal argument, EPA disagrees with the commenter's contention that adopting a five-year review period in this final rule is inconsistent with statements EPA made at proposal. The quotation of the proposal language provided by the commenter is from the portion of EPA's proposal that discusses how EPA will analyze the substitute availability criterion, and specifically what types of chemicals and technologies should be considered as potential substitutes. In that passage of the proposed rule, EPA explained why it would be appropriate to consider various types of chemicals as well as not-in-kind technologies in assessing whether an application had an available substitute. This is distinct from the question of whether EPA has sufficient information to prognosticate whether and how an individual application may meet the two statutory criteria for ASA renewal over the next five-year review period adopted in this final rule. As explained in detail in the proposed rule and the TSD accompanying the proposal, EPA examined the availability of substitutes for each individual application and, if not currently available, when a substitute would be expected to become available for the entire application. While EPA expects the market to be dynamic, based on analysis done for this rulemaking and as detailed in the TSD, EPA has explained why a substitute currently unknown is not reasonably expected to be available within the five-year renewal period, thus making an earlier assessment earlier than the five-year period unnecessary. EPA has demonstrated how this assessment plays out for individual applications in the TSD accompanying the proposal and final rule. In determining a final approach, EPA has taken this in balance with the desire to provide certainty to applications for which Congress provided priority access to HFC allowances. One commenter suggested that “because the proposed extension period for some applications overlaps the next phasedown year (2029), it may be appropriate to reevaluate the transition to lower GWP alternatives in these applications and adjust allocations accordingly.” Although the intended meaning of this comment is not entirely clear, EPA interprets this comment to suggest that if an application has a safe and technically achievable substitute available that is a lower-GWP HFC, either at the present time or at some point within the five-year renewal period, EPA should base the application's allocation levels on that lower GWP-HFC. EPA had proposed this as a possibility for applications that may have had a lower-GWP HFC substitute become available ( see, e.g., 89 FR 75898, 75917). However, as described in section V., EPA is not determining this factual situation to be occurring for any application within this renewal period. Therefore, the commenter's suggestion is not relevant for this particular action at this time. If this situation arises within the next renewal period, EPA may consider whether to adjust allocation levels to meet a lower-GWP HFC substitute. EPA did not receive comments on the following aspects of its proposal: that applications must meet both criteria to be renewed as eligible for ASAs, that EPA will review the supply of substitute HFCs if they are determined to be available for an application, that EPA will base the renewal timeline on less than five years if an application will fulfill a criterion within the five-year period, and that if an application is renewed as eligible for ASAs for less than five years, the application will not be reviewed for eligibility for ASAs ahead of the next five-year renewal period. After considering all comments, EPA is finalizing all aspects of this portion of the rule as proposed. V. Review of the Six Applications Listed in the AIM Act EPA reviewed the six applications listed in AIM Act subsection (e)(4)(B)(iv)(I)—propellant in MDIs, defense sprays, SCPPU foam for marine use and trailer use, the etching of semiconductor material or wafers and the cleaning of CVD chambers within the semiconductor manufacturing sector, MCMEU, and onboard aerospace fire suppression—as required under subsection (e)(4)(B)(v)(I). Pursuant to that review, EPA evaluated whether the criteria for renewal described in section IV. of this preamble are met for any part, or the entirety, of the 2026-2030 time period. This section contains EPA's assessment of the criteria for each application and EPA's decision regarding whether to renew each application's eligibility to receive ASAs. EPA provides additional information in the TSD available in the docket for this rulemaking. EPA views the decision made for each individual application to be severable from the decisions made for the other applications, as each application determination is based on facts and assessment specific to that application. In the event that a reviewing court overturns EPA's determination for an individual application, EPA intends that the determinations for the remaining applications should be considered as severable and stand. A. Propellants in Metered Dose Inhalers EPA has been allocating ASAs for regulated substances used for propellants in MDIs in accordance with subsection (e)(4)(B)(iv)(I)(aa) of the AIM Act. In the Allocation Framework Rule, EPA defined a “metered dose inhaler” as “a handheld pressurized inhalation system that delivers small, precisely measured therapeutic doses of medication directly to the airways of a patient. MDIs treat health conditions such as asthma and chronic obstructive pulmonary disease and are approved for such use by the U.S. Food and Drug Administration (FDA),” (40 CFR 84.3). Patients using MDIs to treat pulmonary conditions work closely with their healthcare provider to identify the right treatment for their condition. Pharmaceutical grade HFC-227ea and HFC-134a, more commonly referred to as hydrofluoroalkane (HFA)-227ea and HFA-134a in the pharmaceutical industry, are purified from technical grade HFC-227ea and HFC-134a, respectively, and are both used in MDIs as propellants. 1. Availability of Safe and Technically Achievable Substitutes In the proposed rulemaking, EPA proposed to determine that through calendar year 2030, no safe or technically achievable substitute will be available for propellants in MDIs and that supply of the regulated substances that manufacturers and users are capable of securing from chemical manufacturers is insufficient to accommodate this application. Therefore, EPA proposed to renew the eligibility of entities using regulated substances for propellants in MDIs to receive ASAs for the five-year period of calendar years 2026 through 2030. Many commenters were supportive of EPA's proposed determination that no safe or technically achievable substitute will be available for the MDI application. EPA acknowledges the commenters' support. One commenter was a chemical producer who shared that they are actively developing HFO-1234ze(E) as a low-GWP propellant for use in MDIs and the alternative is currently undergoing clinical trials to prepare for regulatory approvals and marketing authorizations by FDA and other authorities. The commenter also stated that the chemical is an available substitute and described their planned largescale production capabilities of medical-grade HFO-1234ze(E). The commenter also said that based on the SNAP evaluation of HFO-1234ze(E), this chemical should be considered a safe alternative to high-GWP HFCs in MDIs. EPA responds that while the chemical producer stated that “HFO-1234ze is an available substitute,” their comment focused on largescale production of the chemical, which speaks to its available supply as opposed to how EPA is evaluating substitutes for the MDI application. EPA notes that while it has listed HFO-1234ze(E) as an acceptable substitute under the SNAP program for many applications, EPA has not evaluated this substance for applications that concern inhalation, including use as a propellant in MDIs, under the SNAP program. Other than the reference to SNAP's listings for non-MDI applications, the commenter does not discuss how EPA has said it would assess whether a substitute is available. As outlined in the proposed rule in section IV.A., in the Agency's assessment of safe or technically achievable substitutes, EPA takes into account Federal regulations, including from other U.S. Government agencies. For the MDI application, EPA specifically references FDA's requirements for MDIs, and thus considers an alternative to be available for a particular MDI drug product once an MDI containing the alternative propellant has been approved by FDA. Consistent with the proposal, for an assessment of a “safe” alternative for use as a propellant in MDIs, EPA relies on FDA, as FDA takes these considerations into account in their review, as described in more detail in the TSD. Since FDA has not yet approved MDIs containing any propellant substitutes to HFC-134a and HFC-227ea, EPA does not consider HFO-1234ze(E) to be available within the applicable renewal period. Further, based on experience with the ozone-depleting substance MDI transition, we expect that companies will seek, and FDA will evaluate, applications for MDIs that use alternative propellants, on an individual MDI product-by-product basis, and thus it is unlikely there will be approvals for all MDIs within the application within the five year timeframe. In other words, EPA does not intend to consider that FDA's approval of a single MDI product containing an alternative propellant to mean that the alternative propellant is therefore available for the entire application. For the reasons outlined here and in the proposed rule, and based on information available in the TSD, EPA is finalizing the determination that no safe or technically achievable substitute will be available for propellants in MDIs. 2. Supply EPA proposed to determine that the supply of the regulated substance that manufacturers and users are capable of securing from chemical manufacturers is insufficient to accommodate propellants in MDIs through calendar year 2030. As part of the manufacturing process for MDIs, technical grade HFC-134a and HFC-227ea are purified into pharmaceutical-grade HFC-134a and HFC-227ea. These pharmaceutical-grade HFC propellants are produced at a limited number of production facilities domestically and abroad. In its analyses of other applications, EPA has noted that HFC-134a is the most widely available HFC. However, this fact does not equate to a sizeable supply for the MDI application because there are a limited number of HFC-134a production and purification facilities that meet FDA's Current Good Manufacturing Practice (CGMP) regulations and MDI manufacturers are not easily able to switch suppliers of pharmaceutical-grade HFCs. Unlike other applications, where EPA has discussed the diverse number of chemical suppliers for HFC-134a globally, in this instance the options are constrained. Producers of pharmaceutical-grade HFC-227ea must also comply with FDA requirements as described in the proposed rule, which limits their ability to switch to other suppliers of HFC-227ea. The two additional years of reported consumption and production data for the United States since the publication of the proposed rulemaking do not change EPA's proposed assessment due to the limitations summarized here and described in more detail in the proposed rule. Commenters were supportive of the determination that supply of the regulated substance that manufacturers and users are capable of securing from chemical manufacturers is insufficient to accommodate the MDI application through calendar year 2030, and there has been no further information EPA has been made aware of that would change the Agency's proposed determination. Therefore, EPA is finalizing as proposed the determinations that the supply of both HFC-134a and HFC-227ea is insufficient to accommodate the propellants in MDIs application. 3. Final Determination on Application-Specific Allowance Eligibility All but one commenter were supportive of EPA's determination to renew the eligibility of entities in this application to continue receiving ASAs for the full five-year period of calendar years 2026 through 2030. One commenter stated their opposition to the federal government's “green inhaler mandate” due to their concerns about lack of medical benefits and cost of generics and that the Agency should commit that it is the policy of the federal government that neither EPA nor FDA should ever ban, phase out, or refuse to approve HFC inhalers based on their GHG emissions. The commenter also stated that any rulemaking should permanently exempt inhalers from the phasedown of HFCs and the administration should seek a change in law so that the permanent exemption need not be reviewed by EPA every five years. EPA responds that the AIM Act in subsection (b)(4)(B)(v) instructs EPA to extend the eligibility of any application that meets the statutory criteria “for renewable periods of not more than 5 years.” In this action, EPA is extending the eligibility of the MDI application for the maximum length of time permitted by the statute. Further, nothing in this rulemaking nor in the AIM Act mandates or requires that MDI manufacturers transition to alternative propellants. In fact, EPA is continuing to provide flexibility for manufacturers of MDIs to use the propellant that they choose. Under the AIM Act, EPA is required to implement an 85 percent phasedown of HFCs on an EV-weighted basis from historic levels by 2036. This is not a complete phaseout as was required under the CAA for ozone-depleting substances, meaning production and import of HFCs is permitted indefinitely at a reduced level. EPA anticipates the continued production and import of HFCs will include applications where alternatives are not available and/or where the transition is more challenging. In other words, there is nothing in this rulemaking, in the AIM Act, or in any current EPA regulation that would prevent MDI manufacturers from continuing to use the current HFCs they are using after 2036. In addition, the AIM Act authorizes EPA under subsection (e)(4)(B)(iv) to provide priority access to allowances for certain applications, including propellants in MDIs. EPA must provide the “full quantity of allowances necessary, based on projected, current, and historical trends, for the production or consumption of a regulated substance for the exclusive use of the regulated substance in an application.” This rulemaking maintains eligibility for MDI manufacturers to receive ASAs for another five years (i.e., through 2030) at which time, the Agency will conduct another review, consistent with the Congressional mandate. Regarding the request for EPA to permanently exempt MDIs from the phasedown of HFCs, that is outside the scope of this rulemaking and likely is not consistent with the AIM Act. However, as stated above, the AIM Act calls for a phasedown and not a phaseout. Given the nature of the phasedown, EPA does not foresee restricting access to all HFCs for MDI manufacturers. EPA can and is finalizing to continue providing priority access to HFCs through eligibility for ASAs for use as a propellant in MDIs. MDIs provide important, life-saving medications, and the flexibilities described in this rule allow for continued production and import of HFCs for use in MDIs. As discussed elsewhere in this rule, EPA is finalizing additional flexibility to allow for continued priority access to HFCs for the manufacture of MDIs at a level that meets their need (see sections VII.B. and VII.F.). One commenter stated that even after FDA grants approvals of MDIs containing alternative propellants, eligibility for receiving ASAs may still be needed as one of the potential alternatives, HFC-152a, is a regulated substance under the AIM Act. The commenter requested that when FDA grants approvals to MDIs containing HFC-152a and HFO-1234ze(E), that the Agency does not encourage the use of one propellant over the other, and that such determinations should be left with FDA. Regarding the first part of the comment regarding eligibility for receiving ASAs for HFC-152a, EPA responds that since FDA has not yet approved any MDIs containing HFC-152a as a propellant, EPA has not yet assessed providing ASAs based on the potential approval of MDIs containing HFC-152a in this application. Regarding the second part of the comment, EPA responds that since FDA has not approved any MDIs containing either alternative propellant, treatment of the two potential alternatives is beyond the scope of this rulemaking. EPA is finalizing as proposed the determination that no safe or technically achievable substitute will be available for propellants in MDIs and that supply of the regulated substance that manufacturers and users are capable of securing from chemical manufacturers is insufficient to accommodate propellants in MDIs through calendar year 2030. Therefore, EPA is finalizing the proposal to renew the eligibility of entities using regulated substances for propellants in MDIs to receive ASAs for the five-year period of calendar years 2026 through 2030. B. Defense Sprays Per subsection (e)(4)(B)(iv)(I)(bb) of the AIM Act, EPA has been allocating ASAs for use of regulated substances in defense sprays. EPA defined a “defense spray” as “an aerosol-based spray used for self-defense, including pepper spray and animal sprays, and containing the irritant capsaicin and related capsaicinoids (derived from oleoresin capsicum), an emulsifier, and an aerosol propellant,” (40 CFR 84.3). Within this application, there are four primary uses: bear sprays, dog sprays, personal defense sprays, and law enforcement sprays (which includes military sprays). The defense sprays chapter in the TSD contains more details on these product categories. HFC-134a is the propellant predominantly used for defense sprays and is the only HFC for which defense spray ASAs have ever been expended. 1. Availability of Safe and Technically Achievable Substitutes EPA proposed that there would not be a safe and technically achievable substitute available for the entire application at the time of rule finalization, but a safe or technically achievable substitute would be available for the entirety of the defense spray application by January 1, 2028. EPA's proposed substitutes determination was based on knowledge at the time of proposal that some entities in the defense sprays application had already successfully commercialized alternative propellants, including non-HFCs, in some of their products. In addition, multiple propellants, including HFC-152a, HFO-1234ze(E), and hydrocarbons, have been listed as acceptable under SNAP and identified as technically and economically feasible alternatives for propellants in aerosols by the Montreal Protocol's Technology and Economic Assessment Panel (TEAP) Medical and Chemicals Technical Options Committee (MCTOC). EPA's Technology Transitions restrictions will also require that all aerosols, including technical aerosols, transition out of HFC-134a by January 1, 2028. EPA's assessment at the time of proposal was that the commercialization of substitutes in some defense spray sub-applications suggests these substitutes are viable application-wide. Comments on the proposed renewal options were all focused on availability of substitutes. Some commenters requested that defense sprays continue to be eligible for ASAs for the full five-year period because there is no safe or technically achievable substitute for specific sub-applications of defense sprays and explained their concerns. One commenter suggested a two-year renewal also based on the availability of substitutes. Another commenter supported a two-year renewal but provided no explanation or additional information that can inform EPA's assessment. Finally, one commenter supported no renewal of ASAs given the availability of alternatives, though did not provide additional information beyond EPA's initial assessment. As discussed in section IV.C., which outlines the application review framework, an application must meet both criteria to be eligible for renewal of ASAs. EPA discusses in the next subsection that EPA is finalizing a determination that the criterion in subsection (e)(4)(B)(i)(II) is not met for this application beginning January 1, 2026. This outcome is determinative, standing alone, for EPA to finalize that defense sprays will not be eligible for ASAs beginning January 1, 2026. As a result, EPA is not making a final determination regarding the availability of substitutes in the context of ASAs. Because EPA is not making a final determination in this rule with respect to the availability of substitutes for this application, the comments filed are not significantly adverse to the outcome in this rule. Therefore, EPA is not responding to comments specific to the substitute criterion of the review of the defense spray application. However, the proposed rulemaking also requested comment on the treatment of defense sprays under the 40 CFR part 84, subpart B Technology Transitions restrictions. Responses to comments regarding availability of substitutes as relevant to the Technology Transitions restrictions are addressed in section V.B.4. of this final rule. 2. Supply As explained, HFC-134a is the propellant predominantly used for defense sprays and is the only HFC for which defense spray ASAs have ever been expended. Therefore, EPA is analyzing the supply of HFC-134a in assessing whether this application meets the second criterion to be renewed as eligible for ASAs. EPA co-proposed two supply determinations: (1) the supply of HFC-134a is not insufficient to accommodate this application; or (2) the supply of HFC-134a will not be insufficient to accommodate this application as of January 1, 2028. In this final rulemaking EPA did not consider the supply of HFC-152a in assessing whether the defense spray application meets the statutory criteria for renewed eligibility for ASAs. EPA noted in the proposal that assessment of HFC-152a supply could be relevant if HFC-152a is an available safe and technologically achievable substitute for the entire defense spray application. EPA did not receive any comments regarding if HFC-152a is an available safe and technically achievable substitute for the entire defense sprays application. Comments from defense spray manufacturers instead highlighted the concerns around the use of flammable propellants in law enforcement and military settings, where defense sprays are often used in conjunction with “Conducted Energy Weapons” ( e.g., Tasers). As described in more detail below in section V.B.3., EPA agrees with commenters regarding the human safety concerns of using stun guns alongside flammable propellants, such that HFC-152a, given its flammability, is not an available safe and technically achievable substitute application-wide. Thus, in this final rulemaking EPA did not consider the supply of HFC-152a as it pertains to the defense sprays application. In the proposal, EPA explained that there is a large available supply of HFC-134a, and demand for HFC-134a from the defense sprays application is very small relative to overall supply. Given its broad use in other applications ( e.g., refrigeration and air conditioning), HFC-134a is the most widely produced HFC globally and is produced in substantial quantities in multiple countries, including the United States. At the time of proposal, domestic production of HFC-134a was nearly 50 percent of total U.S. HFC production, but EPA also noted at the time of proposal that one domestic producer indicated it was transitioning its facility to produce a different chemical; 10 as of the time of this final rulemaking, this retrofit was completed. Significant amounts of HFC-134a were also imported in 2022, such that HFC-134a made up approximately 32 percent of total U.S. HFC consumption in 2022. In addition, suppliers held quantities of HFC-134a in inventory that were approximately 100 percent of calculated consumption of HFC-134a in 2022. EPA had also noted in the proposed rulemaking that it was not aware of any reason this application could not use recovered and reprocessed HFCs, and the supply of reclaimed HFC-134a (the likeliest source of recovered and reprocessed HFCs) was significant and further increased the available supply of HFC-134a. 11 At the time of proposal, EPA had not yet finalized the proposed rulemaking “ Phasedown of Hydrofluorocarbons: Management of Certain Hydrofluorocarbons and Substitutes Under Subsection (h) of the American Innovation and Manufacturing Act of 2020 ” (88 FR 72216, October 19, 2023) (hereafter referred to as the “2024 Emissions Reduction and Reclamation Rule”), which had proposed requirements that reclaimed HFCs be used for certain equipment to support maximizing reclamation. Despite the large supply of HFC-134a, EPA recognized the uncertainty regarding future supply given the stepdown in permissible production and consumption of HFCs taking place in 2024 and that the Agency did not have complete production, consumption, or inventory data available for 2024 when the proposed rulemaking was issued. In addition, at the time of this proposed rulemaking, EPA had not yet finalized another rulemaking related to the use of trichloroethylene (TCE) in the production of HFC-134a; the TCE pathway is the primary production pathway used to produce HFC-134a in the United States. 10 See https://www.arkema.com/usa/en/media/news/global/corporate/2022/20221006-two-major-steps-develop-supply-forane-1233zd/. 11 EPA publishes annual data submitted under CAA section 608 showing trends in the reclamation market for ozone-depleting substances and HFC refrigerants. Over 2.5 million pounds of HFC-134a were reclaimed in 2023 and HFC-134a was one of the primary drivers for the 20% year-over-year increase in the reclamation market between the 2022 and 2023. See https://www.epa.gov/section608/summary-refrigerant-reclamation-trends. Regarding demand of HFC-134a, EPA's models project total HFC consumption to be significantly lower than the limit established by the statutory phasedown cap for all years of the phasedown, assuming compliance with the restrictions. 12 This is due in part, as explained in the proposal, to an expected decrease in demand for HFC-134a over time as a result of the 2023 Technology Transitions Rule, which established sector and subsector-level GWP limits and restrictions on the use of certain regulated substances. GWP restrictions under the 2023 Technology Transitions Rule began taking effect on January 1, 2025, with the latest restriction taking effect on January 1, 2028. The majority of sectors or subsectors subject to Technology Transitions restrictions will not be permitted to use neat HFC-134a, as its GWP of 1,430 is greater than the highest relevant GWP limit for those sectors or subsectors ( i.e., 700), so demand for this chemical should relatedly fall over time. Many, perhaps most, of these sectors or subsectors were transitioning away from using HFC-134a before the enactment of the AIM Act ( e.g., light-duty motor vehicle air conditioning and consumer aerosols). However, EPA also noted that some sectors may transition to blends with HFC-134a as a component where the GWP is below the applicable limit, and that HFC-134a will likely continue to be used in other applications not subject to these restrictions ( e.g., air conditioning for heavy-duty vehicles), as well as for servicing existing equipment ( e.g., older light-duty motor vehicle air conditioning). In addition, EPA noted in the proposal that of the six defense spray entities that had received ASAs at some point for calendar years 2022, 2023, and 2024, three did not receive ASAs in at least one of those years and only three requested allowances for 2025. EPA was also aware of at least one entity selling bear sprays that use HFC-134a that has never applied for, and therefore never received, ASAs. 12 See HFC Phasedown Regulatory Impact Analysis (RIA) updated for the 2023 Technology Transitions Rule at https://www.epa.gov/system/files/documents/2024-11/epa-hq-oar-2021-0643-0227_attachment_1.pdf. There were no comments on EPA's proposed assessment for the insufficient supply criterion related to defense sprays. In preparing this final rulemaking, EPA analyzed data that has become newly available since the time of proposal related to supply of regulated substances for this application. In 2024, domestic production of HFC-134a was 34,119.4 metric tons (MT), making up 33 percent of U.S. HFC production on a mass basis; this production amount is nearly equivalent to the HFC produced in the highest quantity in that year. While domestic production of HFC-134a has decreased since 2022, global production of this chemical remains high, 13 and there are multiple entities that import HFC-134a. In 2024, 14 7,791.1 MT of HFC-134a were imported into the United States. Overall, HFC-134a made up approximately 22 percent of total U.S. HFC consumption in 2024 on a mass basis. The defense sprays application has very limited demand for HFC-134a in comparison to U.S. consumption of HFC-134a; allocated ASAs for this application in 2025 are equivalent to 0.5 percent of calculated domestic consumption of HFC-134a in 2024, on a metric tons of exchange value equivalent (MTEVe) basis. In addition, at the end of 2024, suppliers held 24,598.1 MT of HFC-134a in domestic inventory, which is equivalent to 92 percent of calculated consumption of HFC-134a in 2024; however, EPA notes that the entities holding this material in inventory are broader than EPA's interpretation of chemical manufacturers (see section IV.B. for more information), so not all of this HFC-134a may be considered available supply under the statutory review criteria in AIM Act subsection (e)(4)(B)(i)(II). 13 Global production of HFC-134a is estimated to have risen by approximately 20 percent since 2020. See https://ozone.unep.org/system/files/documents/TEAP-May2024-Progress-Report.pdf. 14 All data for 2024 in this preamble is preliminary and includes all data from reports verified as of July 25, 2025. EPA recognizes that the overall market for HFCs is likely to continue changing in light of the AIM Act and other restrictions. However, the market behavior to date suggests that over the first three years of the AIM Act-directed HFC phasedown, there have not been dramatic shifts in the supply of HFC-134a. On January 1, 2024, the second stepdown of the level of permissible production and consumption of HFCs took effect. This stepdown was unique in scale, with a cap of 60% of historic baseline levels and a decrease of 30% compared to 2022 and 2023 permissible production and consumption. Imports and production of HFC-134a remained high, albeit with a decrease in total consumption relative to levels in 2023. While consumption of HFC-134a has decreased relative to 2022 and 2023, this aligns with projected decreases in demand for HFC-134a as products transition to new HFC and non-HFC substitutes. In addition, global production capacity is expected to remain substantial over the coming years, given production will continue in countries on later HFC phasedown schedules, and EPA expects continued domestic and global demand for HFC-134a. EPA notes it is unclear whether there may be impacts on domestic production of HFC-134a from the recently finalized rulemaking, “ Trichloroethylene (TCE); Regulation Under the Toxic Substances Control Act (TSCA)” (89 FR 102568, December 17, 2024). This rulemaking bans, through a phasedown, the use of TCE due to unreasonable risk of injury to human health, including prohibiting TCE from being used as a feedstock to manufacture HFC-134a within eight and a half years from when that rule was finalized ( i.e., by mid-June 2033). The HFC-134a production pathway using TCE is the primary production pathway in the United States, and while there are other pathways to produce HFC-134a, it is EPA's understanding that it is complex to change already existing domestic manufacturing infrastructure built for the TCE production pathways such that transitions may not occur immediately but rather over the course of the eight-and-a-half year TCE phaseout. However, at the end of this ASA five-year renewal period in 2030, production of TCE for use as a feedstock in the manufacture of HFC-134a will still be allowed at 50% of baseline TCE levels. In addition, given entities using TCE to produce HFC-134a can use any 12 consecutive months in the three years preceding the December 2024 publication of the final TCE rule to calculate their TCE feedstock baselines for compliance with the TCE requirements under TSCA, the baseline TCE level could be based on TCE use early in the HFC phasedown when greater levels of HFC-134a production were allowed. Specifically, the AIM Act limit on HFC consumption and production in 2022 and 2023 was 90% of historic HFC baseline levels; in 2030, HFC consumption and production will be limited to 30% of the HFC baseline. The TCE rule under TSCA is not expected to be a limiting factor during the period covered by this rule and will likely allow for substantial U.S. HFC-134a production levels relative to demand, as discussed in more detail below in this section. Further, while the complete phaseout of TCE for the production of HFC-134a may impact production of HFC-134a in the United States, it is unlikely to limit available supply of HFC-134a, as there is still global supply of HFC-134a from foreign producers that could be imported into the United States. The complete prohibition on TCE being used in the domestic production of HFC-134a will occur after the five-year renewal period assessed in this rulemaking. Therefore, when combined with consideration of global supply, the TCE phasedown does not change EPA's determination in this rulemaking that supply of HFC-134a is not insufficient to accommodate the defense spray application. In considering supply of the regulated substance currently used by this application, EPA also notes that the Agency is unaware of any reason why this application cannot use recovered and reprocessed HFCs. For example, EPA is not aware of any specific purity requirements for HFCs used in this application. EPA did not receive any comments suggesting that recovered and reprocessed HFCs cannot be used in this application. One commenter suggested that EPA not rely on the use of reclaimed HFCs for defense sprays because reclaimed HFCs should be utilized in applications where the material is able to be recaptured multiple times, thereby extending the usefulness of the substance. In response, EPA notes that this rulemaking does not require the use of reclaimed HFCs in defense sprays but rather notes that reclaimed HFCs may provide a potential source of supply for this application. Requirements for the use of reclaimed HFCs in equipment, and further information on the related authority to do so under the AIM Act and EPA's relevant analyses, can be found in the recently finalized 2024 Emissions Reduction & Reclamation Rule (89 FR 82682, October 11, 2024). In light of the lack of relevant comments and following on the explanation provided in the proposed rule, EPA is considering the supply of recovered and reprocessed HFCs that can be secured from chemical manufacturers as relevant when assessing whether the supply of HFC-134a is insufficient to accommodate this application. The likeliest source of these reprocessed HFCs for defense sprays would be reclaimed refrigerants, which must meet specific purity requirements. 15 Since there are no federal purity requirements or industry purity standards for HFCs used in aerosols, the purity of reclaimed HFCs is likely the same or higher than the virgin HFCs used in this application. The supply of reclaimed HFC-134a in the United States is substantial and increases the overall supply of HFC-134a available to this application. HFC-134a is the most reclaimed single-component HFC refrigerant since HFC reclamation reporting under CAA section 608 began in 2017 and continues to see growth within the reclamation market due to its prevalence as a refrigerant in various appliances. Annual reported volumes of reclaimed HFC-134a have continued to grow since the beginning of the HFC phasedown under the AIM Act; preliminary HFC reclamation data for reporting year 2024 indicate a quantity of 1,175.6 MT, an increase of approximately 40 percent since 2021. Discussion on reclaim market trends and future growth potential for reclaimed HFCs can be found in EPA's Analysis of the U.S. Hydrofluorocarbon Reclamation Market: Stakeholders, Drivers, and Practices 16 report in the docket for the 2024 Emissions Reduction and Reclamation Rule. EPA expects growth in HFC reclamation, and specifically HFC-134a, to continue due to several factors, such as (1) the increase in refrigeration and air-conditioning appliances using HFC refrigerants reaching their end-of-life—making more HFCs potentially available for recovery and reclamation, (2) provisions established in the 2024 Emissions Reduction and Reclamation Rule intended to maximize reclaim, (3) the overall HFC phasedown's limits on how much virgin HFC can be imported and produced, and (4) increased capacity from EPA-certified reclaimers to reprocess recovered refrigerant. EPA notes that while reclaimed HFC-134a serves as an additional source of available supply, the Agency's assessment that supply of HFC-134a is not insufficient would be the same with or without including the available supply of reclaimed HFC-134a given the significant amounts of HFC-134a available globally and in the United States and other data described in this section. 15 In alignment with the definition in 42 U.S.C. 7675 (b)(9), EPA defined reclaim as “the reprocessing of regulated substances to all of the specifications in appendix A to 40 CFR part 82, subpart F (based on Air-Conditioning, Heating, and Refrigeration Institute (AHRI) Standard 700-2016) that are applicable to that regulated substance and to verify that the regulated substance meets these specifications using the analytical methodology prescribed in section 5 of appendix A to 40 CFR part 82, subpart F” (40 CFR 84.3). Thus, HFC-134a refrigerant that is reclaimed and used by a different user than the original owner of the recovered refrigerant must meet the purity requirements of AHRI 700, Standard for Specifications for Refrigerants. That standard, among other things, requires that reclaimed HFC-134a must be visibly clean (that is, no visible solids or particulate), no more than 1.5 percent by volume of air in the vapor phase, no more than 10 parts per million of water by weight, and no more than 0.5 percent by weight of other volatile impurities. 16 See 2024 Emissions Reduction & Reclamation Rule's Analysis of the U.S. Hydrofluorocarbon Reclamation Market: Stakeholders, Drivers, and Practices report at https://www.regulations.gov/document/EPA-HQ-OAR-2022-0606-0169. Restrictions established in the 2023 Technology Transitions Rule began taking effect at the beginning of this year. There has been no further information EPA has been made aware of that would change the Agency's assessment that demand for HFC-134a will continue to fall in part because of these restrictions. Entities do not need to seek or receive ASAs in order to use HFC-134a in defense sprays, barring requirements under other related regulations. Further, entities do not have to expend an allowance to purchase HFC-134a from another entity that has imported or produced the regulated substance. The number of entities requesting allowances for this application has decreased over the years; only three entities requested calendar year 2025 allowances for this application as compared to four for 2024 and five for 2022. As explained earlier in this section, EPA is also aware of at least one entity selling bear spray that uses HFC-134a that has never applied for, and therefore never received, ASAs. This suggests that at least this one entity, as well as the others who have stopped applying for allowances, were able to acquire HFC-134a on the open market without having ASAs. In addition, updated EPA modeling conducted for the 2024 Emissions Reduction & Reclamation Rule continues to support that total projected HFC consumption will be significantly lower than the limit established by the statutory phasedown cap for all years of the phasedown, assuming compliance with the restrictions. 17 If HFC consumption is lower than the amount allowed under the AIM Act in a given year, there should be more allowances than are needed to meet market demand in that year. 18 If demand for HFCs is lower than the cap, general pool consumption and production allowances, which are currently used to produce or import HFCs for entities that do not hold allowances and entities that use HFCs in an application-specific use, would be available to allow for the production or import of HFCs for use by entities that historically have relied upon ASAs. Together, these facts support the conclusion that the supply of HFC-134a is not insufficient to accommodate entities in this application. 17 See HFC Phasedown RIA Addendum at https://www.regulations.gov/document/EPA-HQ-OAR-2022-0606-0175. 18 The actions taken pursuant to subsection (h) and (i) of the AIM Act did not propose to and did not accelerate the HFC phasedown. The RIAs associated with those actions did not analyze an acceleration of the HFC phasedown. Rather, HFCs will continue to be available consistent with the phasedown codified at 40 CFR part 84, subpart A, and this action does not propose to change that phasedown schedule. Even if the requirements finalized pursuant to subsections (h) and (i) in effect reduce the production or consumption of HFCs used in particular sectors or subsectors faster than the scheduled reductions under the AIM Act, that does not make those rules an acceleration under subsection (f). In sum, HFC-134a is currently more widely available than other HFCs, demand for HFC-134a is decreasing, and defense sprays' need for HFC-134a is small compared to the overall demand for HFC-134a across a range of sectors. Further information regarding EPA's assessment of the supply of HFC-134a related to the needs of the defense sprays application can be found in the defense sprays chapter of the TSD. As a result of this review, EPA is finalizing the proposed determination that the criterion in subsection (e)(4)(B)(i)(II) is not met for this application beginning January 1, 2026, i.e., the supply of HFC-134a is not insufficient to accommodate this application for the full five-year period from 2026-2030. 3. Final Determination on Application-Specific Allowance Eligibility EPA co-proposed two renewal options for the defense sprays application—to not renew the eligibility for entities in this application to receive ASAs, such that the application is ineligible for ASAs beginning January 1, 2026, or to renew for two years, such that the application is ineligible to receive ASAs beginning January 1, 2028—and took comment on a full five-year renewal. EPA explained that these renewal options flowed out of how the Agency would land on a range of proposed determinations for the statutory criteria. Specifically, as described earlier in this section, EPA proposed that there would not be a safe and technically achievable substitute available for the entire application at the time of rule finalization, but a safe or technically achievable substitute would be available for the entirety of the defense spray application by January 1, 2028. EPA co-proposed two supply determinations: (1) the supply of HFC-134a is not insufficient to accommodate this application; or (2) the supply of HFC-134a will not be insufficient to accommodate this application as of January 1, 2028. EPA's co-proposals were based on uncertainty at the time of the proposed rulemaking, for which EPA expected to have additional information at the time of this final rulemaking that would inform a final determination. These co-proposals and the related information that supported each co-proposal are discussed in more detail earlier in this section and in the proposal. EPA also took comment on a full five-year renewal based on and tailored only to the application's need to purchase HFC-152a. No defense spray ASAs have been expended for HFC-152a to date, but EPA asked for comment in the proposal on whether HFC-152a could be an available safe and technologically achievable substitute for the entire defense spray application within the renewal period. EPA explained that this proposed option, to renew allowances tailored to the application's need to purchase HFC-152a, could be relevant if HFC-152a was determined by EPA in the final rule to be an available safe and technologically achievable substitute for the entire defense spray application within the renewal period. Comments on the proposed renewal options were all focused on availability of substitutes. EPA responds to these comments in section V.B.1. and section V.B.4. EPA is finalizing a determination that the criterion in subsection (e)(4)(B)(i)(II) is not met for this application beginning January 1, 2026. EPA is not making a final determination regarding the availability of substitutes in the context of ASAs, as described in more detail in section IV.B.3. Because the defense sprays application does not meet both criteria as of January 1, 2026 ( i.e., it fails to meet the insufficient supply criterion), EPA is finalizing that defense sprays are not eligible for ASAs beginning January 1, 2026. 4. Restriction Under 40 CFR Part 84, Subpart B In this final rule, EPA is excluding defense sprays from the provisions of 40 CFR part 84, subpart B. Thus, under this final rule they can continue to be manufactured in the United States and imported into the United States using current propellants indefinitely. The 2023 Technology Transitions Rule restricts the manufacture and import of aerosol products that use HFCs or HFC blends that have a GWP greater than 150. This restriction began January 1, 2025, for all aerosols except for those specifically listed in the rule as technical aerosols, which have manufacture and import restrictions starting January 1, 2028. Sectors and subsectors subject to the GWP limit are also subject to labeling, reporting and recordkeeping requirements. The listed technical aerosols are applications for which EPA received sufficient information through the comment period or through EPA's own analysis indicating that additional time is needed to transition to substitutes due to various technical requirements, such as non-flammability and/or a specific vapor pressure. The list of technical aerosols does not include defense sprays. The 2023 Technology Transitions Rule also exempted applications while they are receiving ASAs (40 CFR 84.56(a)(2)). If an application no longer qualifies for ASAs, the restrictions would then apply. Most of the U.S. aerosol industry subject to the January 1, 2025, compliance date had already transitioned to using propellants that meet the 150 GWP limit as indicated in the information provided by industry and trade associations in the development of the 2023 Technology Transitions Rule, 19 and therefore has available substitutes for use based on EPA's consideration of the factors listed in subsection (i)(4)(B) ( e.g., technological achievability, commercial demands, safety, consumer costs, etc.). By contrast, the aerosol uses that have a January 1, 2028, compliance date ( see 40 CFR 84.54(a)(16)(i)(A)-(O)) currently use HFC-134a (most often as a propellant) and have limitations that require additional time “to reformulate, test, and transition” to ensure availability of substitutes under subsection (i)(4)(B) for these technical uses. EPA determined in the 2023 Technology Transitions Rule that available substitutes for use as aerosol propellants include HFC-152a and HFO-1234ze(E). 19 See Household and Commercial Products Association (HCPA) and National Aerosols Association (NAA) Technology Transitions Petition to EPA dated July 6, 2021. Available in the public docket to the 2023 Technology Transitions Rule at EPA-HQ-OAR-2021-0289-0037. In the proposed rule, EPA requested comment on treating defense sprays consistent with how technical aerosols are treated under 40 CFR part 84, subpart B and the codified restrictions that would therefore apply, such as the GWP limit starting January 1, 2028, a three-year sell-through window for inventory ending January 1, 2031, and labeling, recordkeeping, and reporting requirements. EPA also requested data and information related to the availability of substitutes for use in defense sprays and whether a different timeline would be more appropriate for the transition of defense sprays or for a subset of products in this application. EPA received comments on the use of HFC-134a in defense sprays. First, commenters raised concerns about using a flammable propellant in law enforcement and military applications. These defense sprays could be used by law enforcement or military personnel in combination with a taser, which commenters stated poses a safety risk, as well as a cost to users to retrain personnel to mitigate these risks. The commenters requested an exemption for these uses until a non-flammable alternative propellant is available. EPA received a comment requesting that the Agency provide additional time for compliance with the provisions of 40 CFR part 84, subpart B for bear sprays to transition to new alternatives. The commenter stated that new formulations of bear sprays must gain approval by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as well as every state where those products are sold. EPA also received comments from a defense spray manufacturer and a propellant supplier stating that alternative propellants have been commercialized already and are effective in defense spray applications where flammability is not a concern, e.g., bear repellents. EPA acknowledges these comments regarding the safety, efficacy, and availability of substitute propellants used in defense sprays. The Agency agrees that the circumstances in which law enforcement and military defense sprays may be used warrants proceeding with caution. Almost all currently identified substitutes to HFC-134a as a propellant are either flammable or mildly flammable. While dog sprays use compressed nitrogen gas, which is a non-flammable propellant, technical limitations limit its suitability for use in other types of defense sprays. For example, products using compressed nitrogen gas will steadily reduce in pressure as the contents of the aerosol are used, whereas liquified gas propellants maintain a more constant pressure. Apart from nitrogen gas, we are not aware of available non-flammable substitutes, nor active, in-process development of such substitutes. Of particular concern is that law enforcement or military use of defense sprays in combination with tasers would be applied directly at or on humans, heightening safety risks. We therefore agree with commenters that, at this time, there is no available substitute for the HFCs employed in defense sprays that can safely be used across all uses. Therefore, the Agency is finalizing that defense sprays as defined in 40 CFR 84.3, are excluded from the provisions under 40 CFR part 84, subpart B because there are not available substitutes, per AIM Act section (i)(4)(B), across all defense spray applications. As such, defense sprays are not subject to the restrictions on the manufacture or import at 40 CFR 84.54(a)(16), and subsequent sale and distribution at 40 CFR 84.54(b). The labeling, reporting, and recordkeeping requirements are also not applicable. In other words, defense spray manufacturers will not have to comply with any of the 2023 Technology Transitions Rule aerosol requirements that would otherwise apply to them once they are no longer eligible for ASAs and can purchase HFC-134a to manufacture defense sprays the same way nearly all other entities purchase HFCs, i.e., on the open market. C. Structural Composite Preformed Polyurethane Foam for Marine Use and Trailer Use The third application to which EPA has been allocating ASAs is SCPPU foam for marine and trailer uses, in accordance with subsection (e)(4)(B)(iv)(I)(cc) of the AIM Act. In the Allocation Framework Rule, EPA defined this application as “a foam blown from polyurethane that is reinforced with fibers and with polymer resin during the blowing process, and is preformed into the required shape ( e.g., specific boat or trailer design) to increase structural strength while reducing the weight of such structures,” (40 CFR 84.3). SCPPU foam is different from other types of polyurethane (PU) foams due to its specialized structural properties, and it is preformed into required shapes ( e.g., specific boat or trailer design). At the time of proposal, HFC-134a was the HFC used commercially in the blowing process for SCPPU foam. Transitions have developed such that at the time of this final rulemaking, HFC-152a, in addition to HFC-134a, is a regulated substance used in this application. 1. Availability of Safe and Technically Achievable Substitutes With respect to the statutory criterion regarding availability of substitutes, EPA explained in the proposed rule that commercialization of substitutes is well underway in this application, and the Agency anticipated that the availability of substitutes would evolve significantly between the proposed and final rule. EPA noted that it would consider information collected from regulated entities and other relevant sources through public comment and regulatory reporting to inform a final decision on this criterion. At the time of proposal, EPA was aware, from manufacturer communications and reporting, of two substitutes under development for this application—an HFC-152a/cyclopentane blend and an HFO. Information from the manufacturers of SCPPU foam for marine and trailer uses suggested that the research and development phase for both potential substitutes could be nearing a phase where they would be able to commercialize use of substitutes. According to the information shared with EPA prior to the proposed rule, one substitute seemed close to being available for SCPPU foam for marine use, and the other substitute seemed close to being commercialized for SCPPU foam for trailer use. EPA noted that if commercialization occurred as the companies anticipated and as shared with EPA, the entire application would be able to use a chemical or blend of chemicals different from HFC-134a before January 1, 2026. EPA proposed to determine that the HFO is not an available substitute application-wide for the five-year period of 2026-2030, given additional research and development trials would be needed along with a ramp up to commercialization, before the sub-application could possibly use the HFO as a substitute. With respect to the other substitute under development, EPA noted in its proposal that the Agency was unclear on why the HFC-152a/cyclopentane blend cannot be used across the whole application, and EPA invited comment on reasons why, including supporting data and information. EPA noted that often different companies use different blowing agents to produce the same foam, and that there are two different end uses in this application, but the foam used in both sub-applications is the same ( i.e., it is an SCPPU foam). EPA noted that it was not aware of any other safe and available alternatives other than an HFO and the HFC-152a/cyclopentane blend. As noted earlier in this section, at the time of proposal, EPA explained that transitions were well underway in this application, and the Agency anticipated that the commercial processes used in this application could evolve significantly between the proposed and final rule. To that end, one commenter in the trailer sub-application stated that as of October 2024, the company had nearly completed a full transition to using the HFC-152a/cyclopentane blend and anticipated the transition to be finalized by early 2025 at the latest. On the basis of this statement, as well as regulatory reporting to EPA, the factual framework for the assessment of this application has shifted from the proposal in this final rulemaking. Specifically, EPA is now considering HFC-152a to be commercially used in the SCPPU foam application. Therefore, EPA will be assessing the SCPPU foam application in accordance with the review framework outlined in section IV., and specifically considering this application as one that uses two HFCs, instead of just one. As described at the proposal, beside the HFC-152a/cyclopentane blend that EPA is now considering as an HFC used within this application for purposes of the analysis in this final rule, EPA only identified one other potential substitute to analyze with specificity in considering whether this application met the first statutory criterion for renewal. Specifically, EPA noted testing that had occurred within the application for a potential transition to an HFO. EPA received comments from entities operating within the SCPPU foam application, both in the marine sub-application and trailer sub-application, that all agreed with EPA's proposal that HFOs are not a safe and technically achievable substitute available within the renewal period for this application. The entity operating within the trailer sub-application noted that they had completed nearly 190 trials over close to seven years, which were unsuccessful, regarding transition to an HFO. This is consistent with information EPA had on hand in developing the proposal. With respect to the sub-application for marine uses, multiple commenters raised skepticism about the availability of safe and technically achievable substitutes for the marine uses sub-application. One commenter in the SCPPU foams for marine uses sub-application noted that while it has been working with its key supplier on substitutes for several years, that work has been unsuccessful, and no viable substitute has been identified. The commenter stated that it has not invested heavily into pursuing HFOs as an alternative due to perceived risk of those chemicals being under state-level regulatory scrutiny. Another commenter, the supplier for the marine foams sub-application, provided detailed technical information on the challenges of HFOs as compared to HFC-134a. For example, they note “HFO-containing PU [foam] is much more challenging to formulate and process to reach the same level of processability even with adjustments to processing equipment due to the fact that all the components and chemistries such as polyols, surfactants, catalysts etc. are optimized for HFC blown formulations and processes.” They noted the transition to HFOs will require “more time to optimize and scale for commercial use.” Another commenter, a recreational marine trade associate, stated that while manufacturers are actively pursuing alternatives to HFC-134a, none of those alternatives are currently viable as they have not yet met the stringent technical and safety requirements for marine applications. No stakeholder operating within the application commented that a safe and technically achievable substitute is available in the application nor would be available within the renewal time period. EPA acknowledges the support from the commenters of EPA's proposed determination that there is no HFO alternative that is or will be a safe and technically achievable substitute for this application within the renewal period. To the extent commenters provided data to support this conclusion beyond what was included in the TSD for the proposed action, EPA has incorporated that information into the TSD accompanying this final action. Regarding commenters' allegation that considering transition to HFOs is inadvisable due to regulatory action related to per- and polyfluoroalkyl substances (PFAS), EPA notes that the federal government has not adopted a specific definition of PFAS and has not included HFCs or HFOs in any PFAS-related restrictions. Although EPA does not have a consensus definition of PFAS, the Agency has applied certain criteria or definitions to advance program-specific efforts in specific rules (see section 3.4 of the accompanying TSD). As was detailed in the proposed action and accompanying TSD, HFOs may eventually be considered a safe alternative that is otherwise technically achievable and available. However, for this particular application, as detailed in response to an earlier comment, the Agency is determining that HFOs are not available substitutes at this time. Entities working within the marine sub-application also provided comments regarding a transition from HFC-134a to HFC-152a. However, given that EPA has updated its assessment in this final rule to consider HFC-152a a regulated substance used within the application, as opposed to a potential substitute subject to evaluation, these comments are not significant nor adverse to the action being taken here. However, EPA acknowledges the information provided by the commenter and will incorporate it into future Agency deliberations, as relevant and appropriate. EPA is finalizing a determination that no safe or technically achievable substitute will be available for the SCPPU foams for marine and trailer uses application for the full five-year period from 2026-2030. Further information about EPA's determination regarding available substitutes for this application can be found in the proposed rule and the SCPPU foam chapter of the TSD. 2. Supply As explained, entities manufacturing within the SCPPU foam application have historically used an HFC-134a formulation. Between EPA proposing this rule and its finalization, the application has changed such that the trailer sub-application is now using an HFC-152a formulation. Therefore, EPA is analyzing the supply of both HFCs in assessing whether this application meets the second criterion to be renewed as eligible for ASAs. In the proposed rulemaking, EPA stated its assessment that this application may be able to use recovered and reprocessed HFCs supplied by chemical manufacturers. As a result, EPA did not limit its analysis to only virgin chemicals in assessing what supply of regulated substance may be available to this application at the proposal stage. EPA noted in the proposed rulemaking that it was not aware of any purity requirements or other regulatory restrictions that would prohibit the use of recovered and reprocessed HFCs in this application. However, EPA also noted in the proposed rulemaking that efficacy of blowing agents can be influenced by their composition and purity. Comments on the use of recovered and reprocessed HFCs primarily focused on the challenges of using this material, but one commenter noted it is exploring using reclaimed HFCs. Commenters asserted that impurities can impact the efficacy of blowing agents. Specifically, commenters highlighted how oils can act as defoamers and that impurities can lead to “inconsistent foam formation and cell structure, which will result in products with inconsistent insulation performance, mechanical strength and integrity.” One commenter stated how these inconsistencies might require changing formulation and process conditions with each batch of HFCs. Another commenter asserted their HFC supply must be free of impurities because otherwise the product would “likely be compromised, rendering the product ineffective and unusable,” but did not provide any testing data or purity standards. Reclaimed HFCs, the likeliest source of recovered and reprocessed HFC-134a, are required to be at a very high, but not 100 percent, purity (see footnote 15 in section V.B.). While no commenter suggested that these contaminants cannot be fully removed, EPA recognizes that it may be impractical or infeasible, as EPA is not aware of any purifiers for the SCPPU foams (or other) application that currently purify reclaimed HFC-134a, and commenters did not note any. As described in further detail below, EPA has determined to not incorporate any supply of used HFCs in its assessment of supply for this application at this time, given that inclusion of such used HFCs is not determinative of the supply outcome. However, EPA may take a different approach in future rulemakings and welcomes ongoing stakeholder input regarding the ability to use recovered and reprocessed HFCs for this application. EPA proposed to determine either: (1) the supply of HFC-134a is not insufficient to accommodate this application; or (2) the supply of HFC-134a is not insufficient to accommodate this application as of January 1, 2028. As outlined in further detail in EPA's proposed rule and the accompanying TSD, HFC-134a is the most widely produced of all HFCs. There is substantial domestic and global production of HFC-134a. This application's demand for HFC-134a is very small compared to domestic consumption; allocated ASAs for this application in 2025 are equivalent to 0.2 percent of calculated domestic consumption of HFC-134a in 2024, on an MTEVe basis. In addition, global supply should remain substantial in comparison to this application's demand for HFC-134a. EPA had also noted in the proposed rulemaking that it was not aware of any purity requirements or other regulatory restrictions that would prohibit the use of recovered and reprocessed HFCs. However, EPA also noted in the proposed rulemaking that efficacy of blowing agents can be influenced by their composition and purity. With respect to the supply of HFC-134a, one commenter stated uncertainty about the future availability of HFC-134a to meet the application's needs given the reduction in production and consumption allowances under the AIM Act. In response, EPA notes that the commenter did not provide any specific comments on the data EPA presented nor counter data to support a determination that the supply of HFC-134a will be insufficient to accommodate this application. As noted in section V.B., global production of HFC-134a is expected to continue for the foreseeable future. EPA also notes this application uses a very small amount of HFC-134a (the commenter characterized it as “infinitesimal”) as compared to total domestic consumption. EPA notes this is further evidence that the large supply of HFC-134a is not insufficient to accommodate this application. Further, EPA responds that the commenter's concern does not align with Congress's direction to EPA to review all applications receiving ASAs at least every five years and instruction to consider the supply of regulated substances as part of a determination on whether to renew the eligibility of an application to continue to receive ASAs. In crafting this system, Congress knew that this review would occur against the backdrop of the overall phasedown in production and consumption of HFCs. While EPA acknowledges the commenter's concern that the phasedown creates some uncertainty for an evolving HFC market, the best interpretation of the HFC supply criterion cannot be that it is always met simply because of the HFC phasedown occurring. After considering comments received and reviewing additional data available regarding the supply of HFC-134a, EPA is finalizing a determination that supply of HFC-134a is not insufficient to accommodate the SCPPU foams application as of January 1, 2026. To take a conservative approach, EPA is not including recovered and reprocessed HFC-134a in its assessment of the available supply of HFC-134a to accommodate this application, given the potential concerns raised by commenters about the impacts of even small levels of impurities in the HFCs used as blowing agents. Due to the significant global production of virgin HFC-134a, the exclusion of recovered and reprocessed HFC-1 [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2025-16357. Public record. Not legal advice.