Methylene Chloride; Regulation Under the Toxic Substances Control Act (TSCA); Compliance Date Extension

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 751</CFR> <DEPDOC>[EPA-HQ-OPPT-2020-0465; FRL-8155.1-02-OCSPP]</DEPDOC> <RIN>RIN 2070-AL28</RIN> <SUBJECT>Methylene Chloride; Regulation Under the Toxic Substances Control Act (TSCA); Compliance Date Extension</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or Agency) is finalizing an extension to the compliance dates applicable to certain entities subject to the regulation of methylene chloride promulgated under the Toxic Substances Control Act (TSCA). Specifically, EPA is finalizing an 18-month extension of the Workplace Chemical Protection Program (WCPP) and associated recordkeeping compliance dates for industrial or commercial laboratories that are not owned or operated by Federal agencies or contractors acting on behalf of the Federal government. Under this final rule, all non-Federal laboratories will share the same compliance dates with Federal and Federally contracted laboratories. EPA is finalizing an extension of the compliance dates for associated laboratory activities detailed in this final rule to avoid disruption of important functions of non-Federal laboratories such as the use of environmental monitoring methods needed for cleanup sites and wastewater treatment, as well as activities associated with university laboratories or law enforcement laboratories. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective on December 15, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> EPA has established a docket for this action under Docket ID No. EPA-HQ-OPPT-2020-0465. All documents in the docket are available on the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov.</E> Although listed in the index some information is not publicly available, <E T="03">e.g.,</E> Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other information, such as copyrighted material, will be available only in hard copy form. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For technical information contact:</E> Daniel Whitby, Existing Chemicals Risk Management Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-0598; email address: <E T="03">MethyleneChlorideTSCA@epa.gov.</E> <E T="03">For general information contact:</E> The TSCA Assistance Information Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-1404; email address: <E T="03">TSCA-Hotline@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> You may be potentially affected by this final rule if you use methylene chloride in a non-Federal laboratory setting for the following activities: the industrial or commercial use of methylene chloride in a laboratory process or in specialized laboratory equipment for instrument calibration/maintenance; chemical analysis, chemical synthesis, extracting and purifying other chemicals; dissolving other substances; executing research, development, test and evaluation methods; and similar activities, such as use as a solvent, reagent, analytical standard, or other experimental use. Such laboratory activities may also include methylene chloride use in sample extraction for analysis or preparation for standards for environmental testing, as a mobile phase component in thin-layer chromatography (TLC), as a solvent for column chromatography separation, or the preparation of gas chromatography analyses. Industrial and commercial use of methylene chloride as a laboratory chemical applies to all laboratories, including industrial, commercial, academic and research laboratories, except for those laboratories owned or operated by a Federal agency or a contractor acting on behalf of the Federal government for research, government, and academic institutions. Potentially affected entities may include, but are not limited to: • Testing Laboratories (NAICS code 541380); • Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (NAICS codes 541715 or 541710); • Hazardous Waste Treatment and Disposal (NAICS code 562211); • Solid Waste Combustors and Incinerators (NAICS code 562213); • Colleges, Universities, and Professional Schools (NAICS code 611310); and • Medical and Diagnostic Laboratories (NAICS codes 621511 or 621999). <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines that “the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance . . . presents an unreasonable risk of injury to health or the environment,” EPA shall, by rule, “apply one or more of [the requirements in TSCA section 6(a)(1) through (7)] to such substance . . . to the extent necessary so that the chemical substance . . . no longer presents such risk.” In 2024, EPA promulgated a final risk management rule under TSCA section 6(a) for methylene chloride. In 2025, EPA proposed revisions specific to the non-Federal laboratory requirements of the 2024 rule. Unless provided otherwise by law, agencies may change existing positions ( <E T="03">e.g.,</E> reconsider, revise, or rescind prior rules) provided that they acknowledge the change in position, offer a reasoned explanation for the change, and take any serious reliance interests into account. <E T="03">See, e.g., FDA</E> v. <E T="03">Wages & White Lion Invs., L.L.C.,</E> 145 S. Ct. 898, 917 (2025); <E T="03">Encino Motorcars</E> v. <E T="03">Navarro,</E> 579 U.S. 211, 221 (2016); <E T="03">FCC</E> v. <E T="03">Fox Television Stations, Inc.,</E> 556 U.S. 502, 515 (2009); <E T="03">Motor Vehicle Mfrs. Ass'n</E> v. <E T="03">State Farm Mut. Auto. Ins. Co.,</E> 463 U.S. 29 (1983). For the reasons set out in Units I.D and III.A, EPA is finalizing its proposed rule revising the 2024 risk management rule for methylene chloride to extend the WCPP compliance dates by an additional 18 months for non-Federal laboratories. Based on information submitted by regulated entities, the Agency has determined that revising the compliance dates as proposed is necessary to provide adequate implementation time and to avoid disrupting environmental monitoring and associated laboratory-based activities discussed further in Unit III.A and in Unit II.C.3 of the 2025 proposed rule (Ref. 1). <HD SOURCE="HD2">C. What action is the Agency taking?</HD> EPA is amending 40 CFR 751.109 to extend the WCPP compliance dates for non-Federally owned or operated industrial or commercial laboratories by an additional 18 months. This amendment aligns the compliance dates for non-Federally owned or operated industrial or commercial laboratories with the compliance dates established in the 2024 risk management rule for Federal agencies and their contractors (Ref. 2). Specifically, this final rule extends three compliance dates for non-Federally owned or operated industrial or commercial laboratories. For initial monitoring, the compliance date is extended from May 5, 2025, to November 9, 2026. For establishing regulated areas and ensuring compliance with the Existing Chemical Exposure Limit (ECEL), the compliance date is extended from August 1, 2025, to February 8, 2027. For ensuring the methods of compliance with EPA's exposure limits and for developing and implementing an exposure control plan, the compliance date is extended from October 30, 2025, to May 10, 2027. While the focus of this action is to extend the compliance dates of the WCPP for non-Federal laboratories using methylene chloride, EPA will consider all information received during this rulemaking towards future TSCA section 6(a) rulemakings. <HD SOURCE="HD2">D. Why is the Agency taking this action?</HD> EPA is issuing this final rule to mitigate the unanticipated hardships inadvertently created for non-Federal laboratories by the WCPP compliance dates established as part of the May 2024 final rule on methylene chloride (Ref. 2). These hardships, due to the widespread, often mandatory, use of methylene chloride as a laboratory chemical, were not fully understood by EPA before the 2024 final rule was published. As discussed in greater detail in Unit I.D of the proposed rule, EPA was not aware of the breadth of laboratories needing to comply with the WCPP as a result of mandatory EPA analytical methods that require the use of methylene chloride to perform the analysis, posing unique compliance challenges when combined with other requirements of the WCPP such as conducting exposure monitoring, developing exposure control plans, and assess and acquire necessary personal protective equipment based on the exposure monitoring. EPA recognizes that environmental monitoring services conducted on feeds, fertilizers, pesticides, agricultural samples, soil, water, sludge, solids, and air on behalf of states, private firms, and Federal agencies are vital in ensuring the protection of both human health and the environment. Therefore, EPA is finalizing the compliance date extension as proposed to ensure continuity of public safety services such as environmental monitoring services, the detection of explosives and other controlled substances, and forensic analyses conducted by law enforcement laboratories. The finalized compliance date extension would also mitigate disruptions to important laboratory functions that may indirectly benefit public health and/or safety t ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 42k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━