[Federal Register Volume 90, Number 217 (Thursday, November 13, 2025)]
[Rules and Regulations]
[Pages 50894-50900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19881]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0465; FRL-8155.1-02-OCSPP]
RIN 2070-AL28
Methylene Chloride; Regulation Under the Toxic Substances Control
Act (TSCA); Compliance Date Extension
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: 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.
DATES: This final rule is effective on December 15, 2025.
ADDRESSES: 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 https://www.regulations.gov. 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 information, such as
copyrighted material, will be available only in hard copy form.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: 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: [email protected].
For general information contact: 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
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).
[[Page 50895]]
B. What is the Agency's authority for taking this action?
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.g., 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. See, e.g., FDA v. Wages & White Lion Invs., L.L.C., 145
S. Ct. 898, 917 (2025); Encino Motorcars v. Navarro, 579 U.S. 211, 221
(2016); FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009);
Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 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).
C. What action is the Agency taking?
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.
D. Why is the Agency taking this action?
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 through research and
development and through academic grants for Research 1 universities
under the Carnegie Classification of Institutions of Higher Education.
E. What are the incremental economic impacts?
EPA evaluated the potential incremental economic impacts and
determined that these changes would have minimal impacts on the
estimated costs and benefits of the existing action and would primarily
result in a delay in when those costs and benefits begin accruing,
thereby resulting in cost savings related to the time value of money.
Quantified costs are expected to be the same as estimated in the 2024
final rule but will not be incurred until the final compliance date
extension expires. The extension would also delay when potential
benefits begin to accrue. On balance, this final action which further
extends the compliance dates is appropriate to prevent the disruptive
consequences of requiring laboratories to begin implementing the WCPP
by May 5, 2025, without a further compliance extension.
II. Background
A. Regulation of Methylene Chloride Under the Toxic Substances Control
Act (TSCA)
In May 2023, EPA proposed a rule under TSCA section 6(a) to address
unreasonable risk posed by methylene chloride under its conditions of
use (Refs. 3, 4, 5). The proposed rule included the requirement that
industrial and commercial laboratories implement a WCPP. EPA received
comments from laboratory-affiliated stakeholders that expressed
concerns of the potential impacts for environmental testing and
compliance activities required by EPA's analytical methods. The
commenters requested that EPA adopt a risk management approach for
laboratories that was similar to the perchloroethylene rule (89 FR
103560) (FRL-8329-01-OCSPP), or prior to promulgating the requirements
of the WCPP, EPA should first remove the regulatory requirements under
other EPA program's that require the use of analytical methods that use
methylene chloride (Refs. 6, 7, 8). EPA considered these comments and,
in the final rule promulgated in May 2024, extended the WCPP compliance
dates by an additional six months. For more details, see the 2025
proposed rule (Unit II), the 2024 final rule (Unit III.D.1), and
Response to Comments for the 2024 final rule (Section 5.1.7) (Refs. 1,
2, 6).
[[Page 50896]]
B. The 2025 Notice of Proposed Rulemaking To Extend Certain Compliance
Dates
In May 2025, EPA proposed to extend the applicable compliance dates
for non-Federal owners or operators that use methylene chloride as a
laboratory chemical to align with the timeframes for Federal
laboratories and Federal contractors. Under the 2025 proposed rule,
laboratories would have until November 9, 2026, to conduct initial
monitoring, until February 8, 2027, to establish regulated areas and
ensure compliance with the ECEL and EPA STEL, and until May 10, 2027,
to develop and implement an exposure control plan. As explained in
Units II.C and III.B of the proposed rule, EPA based the compliance
date revision on multiple factors including challenges of WCPP
compliance identified by laboratories and methylene chloride's utility
in support of: academia as a laboratory solvent; public health in
environmental compliance testing; and in various city and state law
enforcement crime laboratories. EPA provided a 30-day public comment
period that concluded on June 26, 2025.
C. Summary of Public Comments
EPA received 28 comments from various universities, trade
organizations, state government entities, an environmental laboratory,
and several individuals, some of whom previously commented on the 2023
proposed rule. The vast majority of commenters supported the 2025
proposed rule to extend the WCPP compliance timeframes for non-Federal
laboratories. One commenter disagreed with EPA's approach in the
proposed rule approach and ``recommend[ed] the [EPA] immediately fully
regulate methylene chloride and not extend the time for compliance for
safety considerations.'' Some commenters additionally requested an
exemption for the laboratory condition of use from the requirements of
the WCPP, while others requested that EPA take alternative risk
management approaches, develop alternative analytical methods prior to
restrictions, or include additional COUs under the compliance
extension. Several commenters submitted information related to
compliance and impacts of the 2024 final rule on laboratories. For
EPA's response to these comments, see the 2025 Response to Public
Comments document that accompanies this final rule (Ref. 9).
III. Rationale
Based on public comments, EPA is finalizing the rule to extend the
WCPP compliance timeframes by an additional 18 months for non-Federal
laboratories as proposed. Units III.A and III.B set forth the
information that EPA considered and EPA's rationale for the final rule.
A. Compliance Date Extension
For any TSCA section 6(a) rule, EPA must specify mandatory
compliance dates that are ``as soon as practicable'' within the 5-year
window after promulgating the rule, while allowing for ``a reasonable
transition period.'' 15 U.S.C. 2605(d)(1)(B) and (E). EPA proposed to
extend the WCPP compliance dates for non-Federally owned or operated
industrial or commercial laboratories by an additional 18 months based
on the challenges laboratories are facing to comply with the WCPP
requirements, including their inability to choose a different, less
toxic solvent when performing analyses, especially environmental
monitoring sample analyses that must be performed in accordance with
specified methods, and the availability and cost of industrial hygiene
personnel to conduct initial monitoring. EPA proposed that this
extension resulted in compliance dates that represent a reasonable
transition period under TSCA section 6(d) (Ref. 1).
In Unit III.B of the 2025 proposed rule, EPA requested information
including the viability of the proposed compliance dates, alternative
timeframes for consideration, and compliance costs (Ref. 1). During the
public comment period, EPA received additional information on
regulatory impacts, realized and estimated costs, allocation of funding
under research grants, the number of potentially exposed persons,
professional safety services, exposure controls, the number of
facilities, the number of laboratories, the frequency of tasks, the
volumes of methylene chloride used, compliance with the Occupational
Safety and Health Administration's laboratory standard (29 CFR
1910.1450) and adherence to voluntary consensus standards, use of
similar exposure groups, and air monitoring measurements. Given the
additional information from commenters, EPA determined that
implementing a WCPP in a laboratory presents unique compliance
challenges, particularly with respect to when implementing a WCPP is
practicable and what amounts to a reasonable transition period for this
use. EPA also recognizes that extrapolating the WCPP's requirements
over numerous facilities, laboratories, and personnel, especially
taking infrequent or low-volume use (laboratory scale) into account,
can increase the magnitude of those challenges for some laboratories
such as those owned or operated by large academic institutions.
For example, according to a comment submitted by a large
university, without adequate time to implement the WCPP's requirements,
some laboratories may be unable to meet the compliance timeframes. The
university suggested that an extension of the compliance timeframes
would allow them to complete initial monitoring for additional research
groups (Ref. 10). EPA agrees that additional compliance time is
necessary to avoid disruption of important laboratory functions, as
well as allowing non-Federal laboratories sufficient time to come into
compliance and fully protect potentially exposed persons from exposure.
Similarly, a comment provided by a state Department of Environmental
Quality also expressed support for a compliance timeframe extension and
noted that their environmental laboratory, which has ceased certain
environmental analyses that use of methylene chloride, would cease use
of methylene chloride again once the revised compliance date was
reached due to costs (Ref. 11). Based on comments like these, the
Agency determined that extending the WCPP's compliance dates will
result in compliance dates that represent a reasonable transition
period, allowing for the continuity of vital laboratory functions that
protect human health and the environment such as environmental
monitoring analyses that serve communities across the United States and
help facilitate clean soil, water, and air.
B. Data Supporting Alternative Risk Management Approaches for
Laboratories
Laboratory-affiliated commenters also submitted information and
data that could potentially support alternative risk management
approaches for laboratories regulated under TSCA. While the focus of
this final rulemaking is to extend compliance dates of the WCPP for
non-Federal laboratories using methylene chloride, EPA will consider
all submitted information from commenters in future TSCA rulemakings,
as appropriate.
IV. Provisions of This Final Rule
EPA is finalizing this rule as proposed. EPA is aligning the
compliance dates for non-Federal laboratories using methylene chloride
with those for Federal agencies and their contractors in the 2024 final
rule (Ref. 2). This extension of compliance
[[Page 50897]]
dates addresses the issues with the practicability of the originally
promulgated compliance dates identified by non-Federal laboratories,
including their inability to choose a different, less toxic solvent
when performing analyses, especially environmental monitoring sample
analyses that must be performed in accordance with specified methods,
and cost of industrial hygiene personnel to conduct initial monitoring
within an adequate amount of time. The Agency believes that these final
compliance dates represent a reasonable transition period under TSCA
section 6(d). Moreover, aligning with the compliance dates that were
already established for Federal agencies and their contractors as part
of the 2024 final rule will minimize confusion by consolidating
multiple compliance dates. Specifically, non-Federal laboratories under
this final rule will have until November 9, 2026, to conduct initial
monitoring, until February 8, 2027, to establish regulated areas and
ensure compliance with the ECEL and EPA STEL, and until May 10, 2027,
to develop and implement an exposure control plan.
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Methylene Chloride; Regulation Under the Toxic Substances
Control Act (TSCA); Compliance Date Extensions; Proposed Rule. RIN
2070-AL28. Federal Register (90 FR 22214, May 27, 2025) (FRL-8155.1-
01-OCSPP). https://www.govinfo.gov/content/pkg/FR-2025-05-27/pdf/2025-09421.pdf.
2. EPA. Methylene Chloride; Regulation under the Toxic Substances
Control Act; Final Rule. RIN 2070-AK70. Federal Register (89 FR
39254, May 8, 2024) (FRL-8155-01-OCSPP). https://www.govinfo.gov/content/pkg/FR-2024-05-08/pdf/2024-09606.pdf.
3. EPA. Methylene Chloride; Regulation Under the Toxic Substances
Control Act (TSCA); Proposed Rule. Federal Register (88 FR 28284,
May 3, 2023) (FRL-8155-02-OCSPP). https://www.govinfo.gov/content/pkg/FR-2023-05-03/pdf/2023-09184.pdf.
4. EPA. Risk Evaluation for Methylene Chloride (MC). EPA Document
#740-R1-8010. June 2020.
5. EPA. Revised Unreasonable Risk Determination for Methylene
Chloride (MC). EPA-HQ-OPPT-2020-0465-0116. October 2022.
6. EPA. Methylene Chloride; Regulation Under the Toxic Substances
Control Act (TSCA); Response to Public Comments. RIN 2070-AK70.
April 2024.
7. Judith Morgan and David Friedman. American Council of Independent
Laboratories (ACIL). Comment EPA-HQ-OPPT-2020-0465-0258. June 6,
2023.
8. Judy Morgan. Pace Analytical. Comment EPA-HQ-OPPT-2020-0465-0274.
July 7, 2023.
9. EPA. Methylene Chloride; Regulation Under the Toxic Substances
Control Act (TSCA); Compliance Date Extensions. Response to Public
Comments. RIN 2070-AL28. October 2025.
10. Katharine Bonneson. University of Minnesota. Comment EPA-HQ-
OPPT-2020-0465-0475. June 26, 2025.
11. Jeff Starling. State of Oklahoma Office of the Secretary of
Energy and Environment and Oklahoma Department of Environmental
Quality (ODEQ). Comment EPA-HQ-OPPT-2020-0465-0476. June 26, 2025.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action under Executive
Order 12866 (58 FR 51735, October 4, 1993) and was therefore not
submitted to the Office of Management and Budget (OMB) for review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
This action is an Executive Order 14192 deregulatory action. This
final rule will provide burden reduction by providing relief against
existing compliance deadlines, thereby resulting in cost savings
related to the time value of money. EPA is providing compliance relief
to non-federal laboratories, including state and local affiliated
laboratories that conduct environmental sampling analyses in support of
clean air, water, and land for the American public, by aligning
compliance timeframes with those separately established for federal
agencies and their contractors in the 2024 final rule for methylene
chloride, thereby streamlining requirements while mitigating confusion
for all laboratories.
C. Paperwork Reduction Act (PRA)
This action does not impose any new information collection
activities or burden subject to OMB review and approval under the PRA,
44 U.S.C. 3501 et seq. However, this action defers the costs associated
with paperwork and recordkeeping burden for an existing information
collection because the delayed compliance date alters the time horizon
of the collection's analysis. Burden is defined in 5 CFR 1320.3(b). OMB
has previously approved the information collection activities contained
in the existing regulations and associated burden under OMB Control No.
2070-0229 (EPA ICR No. 2735.02). An agency may not conduct or sponsor,
and a person is not required to respond to a collection of information
that requires OMB approval under PRA, unless it has been approved by
OMB and displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations in title 40 of the CFR, after appearing
in the Federal Register, are listed in 40 CFR part 9, and included on
the related collection instrument or form, if applicable.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this action is any significant adverse economic
impact on small entities, and the Agency is certifying that this rule
will not have a significant economic impact on a substantial number of
small entities because the rule relieves regulatory burden. This action
would extend the compliance dates for several provisions of the WCPP
for approximately 18 months for the industrial and commercial use of
methylene chloride as a laboratory chemical. EPA therefore concluded
that this action would relieve regulatory burden for those entities
engaged in the industrial and commercial use of methylene chloride as a
laboratory chemical.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(in 1995 dollars and adjusted annually for inflation) or more as
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The costs involved in this action
are estimated not to exceed $187 million in 2024$ ($100 million in
[[Page 50898]]
1995$, adjusted for inflation using the GDP implicit price deflator) or
more in any one year.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999) because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it does
not have substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes. Thus, Executive Order 13175 does not
apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not a ``covered regulatory action'' under Executive
Order 13045 (62 FR 19885, April 23, 1997) because it is not a
significant regulatory action under section 3(f)(1) of Executive Order
12866 and because the EPA does not believe the environmental health or
safety risks addressed by this action present a disproportionate risk
to children.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under the NTTAA
section 12(d), 15 U.S.C. 272. Although EPA determined that the WCPP
requirements of the May 2024 final rule involve environmental
monitoring or measurement, specifically for occupational inhalation
exposures to methylene chloride and, consistent with the Agency's
Performance Based Measurement System, decided not to require the use of
specific, prescribed analytic methods, this action simply extends the
compliance dates for non-Federal laboratories.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Lee Zeldin,
Administrator.
For the reasons set forth in the preamble, 40 CFR part 751 is
amended as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.109 by revising paragraphs (c), (d)(2), (e)(1)(i),
(e)(2), (f)(1), and (g)(1) to read as follows:
Sec. 751.109 Workplace Chemical Protection Program.
* * * * *
(c) Exposure limits--(1) ECEL. The owner or operator must ensure
that no person is exposed to an airborne concentration of methylene
chloride in excess of 2 parts of methylene chloride per million parts
of air (2 ppm) as an 8-hour TWA:
(i) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government;
(ii) After February 8, 2027, for non-Federal laboratories when
using methylene chloride as a laboratory chemical;
(iii) After August 1, 2025, for other owners and operators; or
(iv) Beginning 4 months after the owner or operator introduces
methylene chloride into the workplace, if methylene chloride use
commences after May 5, 2025, consistent with paragraphs (d) through (f)
of this section.
(2) EPA STEL. The owner or operator must ensure that no person is
exposed to an airborne concentration of methylene chloride in excess of
16 parts of methylene chloride per million parts of air (16 ppm) as
determined over a sampling period of 15 minutes:
(i) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government;
(ii) After February 8, 2027, for non-Federal laboratories when
using methylene chloride as a laboratory chemical;
(iii) After August 1, 2025, for other owners and operators; or
(iv) Beginning 4 months after the owner or operator introduces
methylene chloride into the workplace, if methylene chloride use
commences after May 5, 2025, consistent with paragraphs (d) through (f)
of this section.
(3) Regulated areas. The owner or operator must:
(i) Establish and maintain regulated areas in accordance with 29
CFR 1910.1052(e)(2) and (4) through (7):
(A) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government;
(B) After February 8, 2027, for non-Federal laboratories when using
methylene chloride as a laboratory chemical;
(C) After August 1, 2025, for other owners and operators; or
(D) Within 3 months after the owner or operator's receipt of the
results of any monitoring data consistent with paragraph (d) of this
section.
* * * * *
(d) * * *
(2) Initial monitoring. (i) Unless otherwise specified in
paragraphs (d)(2)(ii) or (iii) of this section, each owner or operator
covered by this section must perform an initial exposure monitoring to
determine each potentially exposed person's exposure:
(A) By November 9, 2026, for Federal agencies, Federal contractors
acting for or on behalf of the Federal Government;
(B) By November 9, 2026, for non-Federal laboratories when using
methylene chloride as a laboratory chemical;
(C) By May 5, 2025, for other owners and operators; or
(D) Within 30 days of the owner or operator introducing methylene
chloride into the workplace, whichever is later.
(ii) An owner or operator has objective data generated within the
last 5 years prior to May 8, 2024, that demonstrates to EPA that
methylene chloride cannot be released in the workplace in airborne
concentrations at or above the ECEL action level (1-ppm 8-hour TWA) or
above the EPA STEL (16 ppm 15-minute TWA) and that the
[[Page 50899]]
data represents the highest methylene chloride exposures likely to
occur under conditions of use described in paragraph (a) of this
section; or
(iii) Where potentially exposed persons are exposed to methylene
chloride for fewer than 30 days per year, and the owner or operator has
measurements by direct-metering devices which give immediate results
and which provide sufficient information regarding exposures to
determine and implement the control measures that are necessary to
reduce exposures to below the ECEL action level and EPA STEL.
* * * * *
(e) * * *
(1) Methods of compliance.
(i) The owner or operator must institute one or a combination of
elimination, substitution, engineering controls, work practices, or
administrative controls to reduce exposure to or below the ECEL and EPA
STEL except to the extent that the owner or operator can demonstrate
that such controls are not feasible:
(A) By May 10, 2027, for Federal agencies, Federal contractors
acting for or on behalf of the Federal Government;
(B) By May 10, 2027, for non-Federal laboratories using methylene
chloride as a laboratory chemical;
(C) By October 30, 2025, for other owners and operators; or
(D) Within 7 months of the owner or operator introducing methylene
chloride into the workplace.
* * * * *
(2) Exposure control plan.
(i) Exposure control plan deadlines.
(A) By May 10, 2027, for Federal agencies, Federal contractors
acting for or on behalf of the Federal Government;
(B) By May 10, 2027, for non-Federal laboratories using methylene
chloride as a laboratory chemical;
(C) By October 30, 2025, for other owners and operators, the owner
or operator must develop and implement an exposure control plan; or
(D) Within 7 months of the owner or operator introducing methylene
chloride into the workplace.
(ii) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraph (e)(1)(i) of this section, in the following sequence--
elimination, substitution, engineering controls, and work practices and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement the exposure controls selected, including proper
installation, regular inspections, maintenance, training, or other
actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
(E) A description of activities conducted by the owner or operator
to review and update the exposure control plan to ensure effectiveness
of the exposure controls, identify any necessary updates to the
exposure controls, and confirm that all persons are properly
implementing the exposure controls; and
(F) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to methylene chloride, or otherwise result in increased
exposure to methylene chloride, including procedures for implementing
corrective actions to mitigate exposure to methylene chloride.
(iii) Exposure control plan requirements.
(A) The owner or operator must not implement a schedule of
personnel rotation as a means of compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls, instituted under paragraph (e) of this section.
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every 5 years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (c) through (e) of this section.
(iv) Availability of exposure control plan.
(A) Owners or operators must make the exposure control plan and
associated records, including exposure monitoring, respiratory
protection program implementation, and dermal protection program
implementation records, available to potentially exposed persons.
(B) Owners or operators must notify potentially exposed persons of
the availability of the plan and associated records within 30 days of
the date that the exposure control plan is completed and at least
annually thereafter. The notification must be provided in accordance
with the requirements of paragraph (d)(5)(iii) of this section.
(C) Upon request by the potentially exposed person, the owner or
operator must provide the specified records at a reasonable time,
place, and manner. If the owner or operator is unable to provide the
requested records within 15 days, the owner or operator must, within
those 15 days, inform the potentially exposed person requesting the
record(s) of the reason for the delay and the earliest date when the
record can be made available.
* * * * *
(f) * * *
(1) Respirator conditions. The owner or operator must provide
respiratory protection to all potentially exposed persons in the
regulated area as outlined in paragraph (c)(3) of this section, and
according to the provisions outlined in 29 CFR 1910.134(a) through (l)
(except 29 CFR 1910.134(d)(1)(iii)) and as specified in this paragraph
(f) for potentially exposed persons exposed to methylene chloride in
concentrations above the ECEL or the EPA STEL. For the purpose of this
paragraph (f), the maximum use concentration (MUC) as used in 29 CFR
1910.134 must be calculated by multiplying the assigned protection
factor (APF) specified for a respirator by the ECEL or EPA STEL:
(i) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government;
(ii) After February 8, 2027, for non-Federal laboratories using
methylene chloride as a laboratory chemical;
(iii) After August 1, 2025, for other owners and operators; or
(iv) Within 3 months after the owner or operator's receipt of the
results of any exposure monitoring as described in paragraph (d) of
this section.
* * * * *
(g) * * *
(1) The owner or operator must require the donning of gloves that
are chemically resistant to methylene chloride with activity-specific
training where dermal contact with methylene chloride is possible,
after application of the requirements in paragraph (e) of this section,
in accordance with the NIOSH hierarchy of controls:
(i) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government;
(ii) After February 8, 2027, for non-Federal laboratories using
methylene chloride as a laboratory chemical; or
(iii) After August 1, 2025, for other owners and operators.
* * * * *
0
3. Amend Sec. 751.113 by revising paragraph (e) to read as follows:
Sec. 751.113 Recordkeeping requirements.
* * * * *
(e) Availability of exposure control plans. Owners or operators
must
[[Page 50900]]
document the notice to and ability of any potentially exposed persons
to access the exposure control plan and other associated records in
accordance with Sec. 751.109(e)(2)(iv).
* * * * *
[FR Doc. 2025-19881 Filed 11-12-25; 8:45 am]
BILLING CODE 6560-50-P