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

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 751</CFR> <DEPDOC>[EPA-HQ-OPPT-2020-0465; FRL-8155.1-01-OCSPP]</DEPDOC> <RIN>RIN 2070-AL28</RIN> <SUBJECT>Methylene Chloride; Regulation Under the Toxic Substances Control Act (TSCA); Compliance Date Extensions</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or Agency) is proposing to extend the compliance date applicable to certain entities subject to the regulation of methylene chloride recently promulgated under the Toxic Substances Control Act (TSCA). Specifically, EPA is proposing to extend by 18 months the Workplace Chemical Protection Program (WCPP) and the associated recordkeeping compliance dates for laboratories that are not owned or operated by agencies or Federal contractors acting on behalf of the Federal government. Under this proposal, all laboratories, whether federal or not, would have the same compliance dates, which would be aligned with current compliance dates for Federal agencies and Federal contractors. EPA is proposing to extend the compliance dates for associated laboratory activities detailed in this proposal to avoid disruption of important functions such as the use of environmental monitoring methods needed for cleanup sites and wastewater treatment, as well as activities associated with university laboratories. The use of environmental monitoring methods, a common function of non-federal laboratories, is important to EPA's mission to ensure that the air is safe to breathe, water is safe for drinking or recreating, and disposal activities protect the environment. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before June 26, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0465, using the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/dockets/.</E> <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-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (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 rule if you use methylene chloride in a 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. For the purposes of this proposed rulemaking, EPA emphasizes that 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 Federal contractor acting on behalf of the Federal government for research, government, and academic institutions. Under the following list of North American Industrial Classification System (NAICS) codes, potentially affected entities may include: • Testing Laboratories (NAICS code 541380); • Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology (NAICS code 541715); • Hazardous Waste Treatment and Disposal (NAICS code 562211); • Solid Waste Combustors and Incinerators (NAICS code 562213); <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 through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment for one or more condition(s) of use. With the obligation to promulgate these rules, the Agency also has the inherent authority to amend them if circumstances change, including based on the receipt of new information and in relation to compliance deadlines established under TSCA section 6(d). It is well settled that EPA has inherent authority to reconsider, revise, or repeal past decisions to the extent permitted by law so long as the Agency provides a reasoned explanation. See <E T="03">FCC</E> v. <E T="03">Fox Television Stations, Inc.,</E> 556 U.S. 502, 515 (2009); see also <E T="03">FDA</E> v. <E T="03">Wages & White Lion Invs., L.L.C.,</E> 145 S. Ct. 898, slip op. at 20 (2025). Here, as explained further in Unit I.D., based on information submitted by regulated entities, the Agency proposes that revised compliance dates are necessary to address recently-received information that the original compliance dates for laboratories not owned or operated by Federal agencies, or Federal contractors acting on behalf of the Federal government, are not practicable and do not provide adequate transition time because they disrupt environmental monitoring and associated laboratory-based activities discussed further in Unit II.C.3. <HD SOURCE="HD2">C. What action is the agency taking?</HD> EPA is proposing to amend the regulations at 40 CFR 751.109 to extend the WCPP compliance dates for the industrial or commercial use of methylene chloride as a laboratory chemical, established in the May 2024 final rule (Ref. 1), for an additional 18 months to match the compliance dates for Federal agencies and their contractors. Specifically, for laboratories not owned or operated by Federal agencies, or Federal contractors acting on behalf of the Federal government, this proposal would extend the compliance date for initial monitoring from May 5, 2025 to November 9, 2026, the compliance date for establishing regulated areas and ensuring compliance with the Existing Chemical Exposure Limit (ECEL) from August 1, 2025 to February 8, 2027, and the compliance date for ensuring the methods of compliance as well as developing and implementing an exposure control plan from October 30, 2025, to May 10, 2027. The May 2024 final rule for methylene chloride (Ref. 1) prohibits the manufacture (including import), processing, use, and distribution of methylene chloride and methylene chloride-containing products for all consumer use and most industrial and commercial uses, with specified exclusions; requires owners and operators of workplaces engaged in the manufacture, processing, and use of methylene chloride for permitted uses to comply with a Workplace Chemical Protection Program (WCPP) to reduce exposures; and requires persons manufacturing, processing, or distributing in commerce methylene chloride and products containing methylene chloride to notify their customers of these prohibitions and restrictions. The compliance dates for the prohibitions began as early as February 3, 2025, while the first compliance date for the WCPP provisions is May 5, 2025, for initial exposure monitoring (Ref. 1). EPA is interested in receiving new specific information that was not accessible during the proposed or final rulemaking on the barriers to WCPP compliance for different kinds of laboratories, and in any information that shows the exposure reductions that fume hoods or other enclosures currently in use in laboratories provide to address risks such that they are no longer unreasonable. EPA seeks comment on these compliance difficulties and on legitimate reliance interests, if any, on the original deadlines, that the Agency should consider in the course of this limited rulemaking. EPA notes that it has not, and is not, reopening the entirety of the methylene chloride final rule by issuing this proposal. Accordingly, EPA requests that commenters limit their submissions to the laboratory compliance deadline issues raised in this proposed rule. <HD SOURCE="HD2">D. Why is the agency taking this action?</HD> EPA is issuing this proposal to address the unanticipated hardships that were inadvertently created for laboratories by the May 2024 final rule on methylene chloride (Ref. 1) due to the widespread, often mandatory, use of methylene chloride as a laboratory chemical that was not fully understood by EPA before the rule was published. Although EPA responded to comments and revised provisions of the final rule in consideration of commenter's concerns on laboratory use of methylene chloride, shortly after the final rule was published in May 2024, many representatives of various laboratories using methylene chloride began contacting EPA with questions about the applicability of the rule, difficulties in complying with the requirements of the WCPP, and other concerns (Ref. 1). Many of these laboratories, especially those associated with local governments or universities, use methylene chloride in small quantities and ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 63k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━