[Federal Register Volume 90, Number 100 (Tuesday, May 27, 2025)]
[Proposed Rules]
[Pages 22214-22222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09421]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 90, No. 100 / Tuesday, May 27, 2025 /
Proposed Rules
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0465; FRL-8155.1-01-OCSPP]
RIN 2070-AL28
Methylene Chloride; Regulation Under the Toxic Substances Control
Act (TSCA); Compliance Date Extensions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: 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.
DATES: Comments must be received on or before June 26, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0465, using the Federal eRulemaking Portal
at https://www.regulations.gov. 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 https://www.epa.gov/dockets/.
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-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (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 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);
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
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 FCC v. Fox Television Stations, Inc., 556
U.S. 502, 515 (2009); see also FDA v. Wages & White Lion Invs., L.L.C.,
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.
C. What action is the agency taking?
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
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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.
D. Why is the agency taking this action?
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 somewhat infrequently (Refs. 2, 3).
For example, one police department submitted a post-rulemaking inquiry
to EPA to discuss their use of methylene chloride in the detection of
controlled substances. Several universities contacted EPA to ask about
how the rule applies to their activities, such as solvent extractions
performed by students in an organic chemistry laboratory (Refs. 4, 5,
6, 7, 8). Several of the university laboratories that contacted EPA
indicated that their use of methylene chloride occurred exclusively
under a fume hood. They questioned whether initial monitoring would
still be required, and whether initial monitoring would have to be done
for each fume hood in use on the campus (Refs. 3, 5, 6, 7, 8).
Environmental monitoring laboratories also contacted EPA shortly
after the final rule was published. They provided additional
information on the various EPA test methods and voluntary consensus
standards used in compliance testing that require the use of methylene
chloride, including methods that are part of EPA's SW-846 Hazardous
Waste Test Methods Compendium (available online at https://www.epa.gov/hw-sw846), such as Method 0010, used in the determination of
destruction and removal efficiency of semivolatile principal organic
hazardous compounds (POHCs) from incineration systems or the
determination of particulate emission rates from stationary sources
(Refs. 9, 10, 11). In the view of these laboratories, EPA should not be
imposing the burden of the TSCA WCPP on laboratories that are using
methylene chloride pursuant to EPA methods mandated for use by other
regulatory programs. Rather, these laboratories believe that EPA should
first revise its mandatory analytical methods that require the use of
methylene chloride to allow for the use of other solvents, or other
techniques that would reduce methylene chloride use by environmental
monitoring laboratories. These laboratories also have concerns about
their ability to meet the TSCA rule's requirements to perform initial
monitoring of potentially exposed person's exposures by the compliance
deadline.
While EPA received several comments along these lines during the
public comment period on the proposed rule, EPA was not aware of the
breadth of laboratories needing to comply with the WCPP as a result of
mandatory EPA 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 PPE based on the exposure monitoring.
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.
Quantified costs are expected to be the same as estimated in the final
rule but will not be incurred until the proposed compliance date
extension expires. The extension would also postpone when decreases in
potential exposures to methylene chloride in laboratory settings and
delay when potential benefits begin to accrue. On balance, this
proposed further extension of 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. The May 2023 Notice of Proposed Rulemaking
1. Summary of the notice of proposed rulemaking. In May 2023, EPA
proposed a rule under TSCA section 6(a) to address unreasonable risk of
injury to
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human health presented by methylene chloride under 52 of its 53 total
conditions of use (Ref. 10). In the 2023 notice of proposed rulemaking
(Ref. 10), EPA noted that methylene chloride was a widely used solvent
in a variety of commercial and consumer applications and has a number
of known health effects that may result from exposure. As described in
more detail in EPA's proposed rule and as described in the TSCA section
6(b) 2020 Risk Evaluation for Methylene Chloride, EPA identified non-
cancer adverse effects from both acute and chronic inhalation and
dermal exposures to methylene chloride, and cancer from chronic
inhalation and dermal exposures to methylene chloride (Refs. 10, 13).
To address the unreasonable risks, the 2023 proposed rule (Ref. 10)
sought to prohibit the manufacture, processing, and distribution in
commerce of methylene chloride for consumer use; require a workplace
chemical protection program (WCPP) for those industrial and commercial
uses not proposed to be prohibited, which included a requirement to
meet inhalation exposure concentration limits for both an 8-hour time-
weighted average and 15-minute time-weighted average exposures, and to
conduct exposure monitoring for certain continued conditions of use of
methylene chloride; prohibit most industrial and commercial uses of
methylene chloride; require recordkeeping and downstream notification
requirements for several conditions of use of methylene chloride; and
provide certain time-limited exemptions from requirements for uses of
methylene chloride that would otherwise significantly disrupt national
security or critical infrastructure.
2. Summary of the comments received on the notice of proposed
rulemaking. After publication of the 2023 proposed rule for methylene
chloride (Ref. 10), EPA opened a public comment from May 3, 2023, to
July 3, 2023. During this time, EPA received almost 40,000 public
comments, the vast majority of which were submitted by individuals
participating in mass mailer campaigns requesting that EPA protect
workers and consumers expeditiously and to strengthen the proposed
requirements (Refs. 14, 15, 16, 17). Other commenters requested
expansion of the WCPP to include additional conditions of use or to
allow all industrial and commercial conditions of use under the WCPP,
additional time for compliance with the WCPP (ranging from 6 months to
5 years), additional exemptions under TSCA section 6(g), and a de
minimis regulatory threshold (Refs. 18, 19, 20, 21, 22, 23, 24, 25, 26,
27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44,
45, 46). EPA also received specific information from various industry
sectors requesting changes to the proposed rule, including information
from laboratories that use methylene chloride. For a full discussion of
comments related to WCPP compliance timeframes, refer to Final Rule
Unit III.D.1., and Response to Comments section 5.1.7 (Refs. 1, 47).
Comments were received by laboratory-affiliated organizations such
as the American Council of Independent Laboratories (ACIL), Pace
Analytical, and the Environmental Monitoring Coalition (EMC) (Refs. 48,
49, 50). While ACIL's comment expressed broad support of the 2023
proposed rule, their comment conveyed the concerns of its members
regarding use of methylene chloride in environmental testing and
compliance required by EPA's analytical methods (Ref. 48). Similarly,
EMC stated that the proposed rule could affect environmental compliance
monitoring, remediation of hazardous waste sites, and emergency
responses thereby impacting public health and the environment (Ref.
50). ACIL suggested that for laboratories conducting environmental and
food safety testing using methylene chloride, potentially exposed
persons should be protected through prescriptive controls such as
ventilation and dermal PPE instead of the WCPP (Ref. 48). Both ACIL's
and EMC's comments, which were supported by Pace Analytical, requested
that EPA revise its analytical methods under other statutes prior to
finalizing the TSCA regulation and to grant the private sector and
Voluntary Consensus Standard Bodies the opportunity to develop new
approaches that reduce the amount of the solvent within a shorter
timeframe than EPA's process to develop new analytical methods (Refs.
48, 49, 50). ACIL highlighted challenges and costs associated with
meeting the exposure monitoring compliance date, training requirements,
validation of new methods, modification of equipment, and
reaccreditation of the laboratories by third parties (Ref. 48). This
issue is discussed further in Unit II.C.2.
Other commenters provided remarks on various aspects of the
laboratory condition of use and its coverage under the 2023 proposed
rule's WCPP. An independent commenter expressed concern that the
approach of laboratories under the WCPP was unreasonable because the
scale of use is not analogous to industry (Ref. 51). The commenter also
highlighted that colleges and universities may contain numerous amounts
of laboratories which would place an unacceptable burden on them to
comply with the proposed rule's WCPP. The American Chemical Society
(ACS) iterated a similar concern for small scale use of methylene
chloride in laboratories and exposure monitoring under the proposed
WCPP (Ref. 52). Their comment cited concerns for the WCPP compliance
costs and costs of retaining safety professional services (Ref. 52).
Additionally, ACS stated that tracking personnel for the WCPP's
recordkeeping in an academic environment is impractical because the
turnover rate among universities for students/faculty is high and
requested that EPA adopt a different approach (Ref. 52).
B. The May 2024 Final Rule
On May 8, 2024, EPA published the final regulation for methylene
chloride under TSCA section 6(a) (Ref. 1). Many of the provisions in
the 2023 proposed rule were finalized as proposed. EPA considered
information received through public comments, making a number of
revisions to: include additional uses under the WCPP, broaden the scope
of some WCPP uses to include those in the private sector in addition to
the Federal agencies, provide a delayed prohibition for two conditions
of use, include a de minimis regulatory threshold, extend the
compliance dates for the WCPP and prohibition, and revise specific
provisions of the WCPP. For a complete description of these changes,
see Unit III. of the 2024 final regulation (Ref. 1). This Unit
additionally provides a summary of comments which compelled EPA to
extend the compliance timeframes for the WCPP.
EPA originally proposed that the WCPP compliance activities begin
with initial monitoring to be completed at six months. However, after
considering information received from commenters, EPA finalized the
WCPP compliance activities to begin at 12 months for general industry
users and at 30 months for Federal agencies and their contractors from
the date of publication of the final rule, by which time regulated
entities would be required to complete their initial monitoring. This
revision to the compliance timeframe resulted from public commenters,
such as those described in the previous paragraphs, who stated that the
proposed compliance timeframes for the WCPP were inadequate to
implement for several reasons including: challenges associated with the
implementation of recordkeeping for the hierarchy of controls; that the
proposed rule did not account for the increased demand of professional
safety services; and because
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development of an exposure assessment strategy would require additional
time (Refs. 33, 34, 36, 53, 54). During the public comment period,
commenters submitted concerns that the Good Laboratory Practice
standards were atypical within the industrial hygiene community to use
for air monitoring samples (Refs. 25, 34, 36, 44). Based on these
comments, in addition to revising the compliance timeframes after
consideration of public comments, the Agency revised its approach to
expand the analysis of monitoring results and associated recordkeeping
requirements to any accredited lab including GLP, AIHA (Laboratory
Accreditation Program), and analogous industry-recognized programs.
The 2024 methylene chloride final rule's WCPP, with revisions
prompted by public commenters, includes and finalizes exposure limits;
initial, periodic, and additional exposure monitoring requirements;
regulated areas; PPE and respirator requirements; an exposure control
plan; recordkeeping; and notification requirements (Ref. 1).
C. Impacts of the 2024 Final Rule on Laboratories
As discussed in Unit II.A. and B., EPA's final regulation of
methylene chloride addresses unreasonable risk of injury to human
health presented by all known, intended and reasonably foreseen uses of
methylene chloride. Since the publication of the final rule, EPA has
received many inquiries requesting clarification with respect to that
final rule, but a majority of those inquiries came from laboratories,
and some inquirers provided new information or additional context to
the challenges specific to laboratories with implementation of the
WCPP. That information is summarized in more detail in this Unit.
1. The utility of methylene chloride as a laboratory solvent. EPA
recognizes that methylene chloride has numerous uses in
pharmaceuticals, research and development, academia, and environmental
monitoring and compliance laboratories. It is a common laboratory
solvent due to its polarity, low boiling point, and inability to act as
a proton donor in a reaction, making it suitable for various
applications like liquid chromatography, extractions, synthesis, and
purification. Its volume of use is often low and may vary from
laboratory to laboratory. In environmental testing and compliance
laboratories, methylene chloride is an analyte that is required to be
monitored. For these types of laboratories, environmental testing is
conducted in situations where contaminant level requirements exist
under certain environmental statutes. Methylene chloride is also used
in sample preparation before an analysis of persistent organic
pollutants (Ref. 55).
2. Use of methylene chloride in analyses of environmental
monitoring samples. Although a few commenters on the 2023 proposal
(Ref. 10) noted that laboratories performing sample analysis for
environmental monitoring and environmental compliance purposes would be
affected by the rule (Refs. 48, 49, 50), after the final rule was
issued in May 2024 (Ref. 1), EPA began receiving more information on
the number of laboratories involved in environmental monitoring and
environmental compliance testing, the variety of EPA-approved and
mandatory methods that require the use of methylene chloride as a
solvent, and the equipment and procedures used by these laboratories
that ensure that worker exposures are low. According to the ACIL, their
members perform more than 3 million tests annually using methylene
chloride, many of which are performed pursuant to regulatory
requirements of other statutes and use more than 50 EPA-approved
methods or voluntary consensus standards that mandate the use of
methylene chloride as a solvent (Refs. 48, 56). In addition to the
previously-mentioned Method 0010 (Ref. 9), used to test the efficiency
of incineration systems or determine particulate emission rates, other
hazardous waste test methods (known as SW-846 methods) that require the
use of methylene chloride include Method 3511, Organic Compounds in
Water by Microextraction, and Method 3535A, Solid-Phase Extraction,
which is used to isolate target organic analytes from aqueous samples
(Ref. 9). EPA's National Primary Drinking Water Regulations at 40 CFR
part 141 require methods that use methylene chloride, including Method
506, used to detect phthalate and adipate esters in drinking water, and
Method 525.2, used to detect organic compounds in drinking water (Ref.
57). EPA's National Pollutant Discharge Elimination System regulations
under the Clean Water Act also require, at 40 CFR part 136, methods
that use methylene chloride, including Method 608 for organochlorine
pesticides and polychlorinated biphenyls, Method 612 for chlorinated
hydrocarbons, and Method 613 for 2,3,7,8-tetrachlorodibenzo-p-dioxin
(Refs. 9, 58, 59, 60). The Clean Air Act also requires under its
regulations methods that use methylene chloride, including, under 40
CFR part 60, Method 23A, the Determination of Polychlorinated Dibenzo-
p-Dioxins, Polychlorinated Dibenzofurans, Polychlorinated Biphenyls,
and Polycyclic Aromatic Hydrocarbons from Stationary Sources (Ref. 61).
Many analytical methods that must be used for environmental testing
involve the use of methylene chloride. Unlike other affected entities,
environmental testing laboratories are currently unable to select an
alternative analytical method that does not require the use of
methylene chloride due to requirements to use certain analytical
methods. As such, these laboratories are not afforded the same ability
or flexibility to eliminate the use of methylene chloride or substitute
alternative solvent chemicals as other industries are able to do under
the same rule. Many of these analytical methods do not list alternative
chemicals that may be used in place of methylene chloride in the
analytical method, and the process to revise or develop new analytical
methods using different chemicals is a multi-year process that would
exceed the WCPP compliance dates (Ref. 48). EPA now recognizes that the
specification for the use of methylene chloride in analytical methods
limits the ability of laboratories to exercise certain exposure control
methods under the WCPP's Exposure Control Plan, including elimination
and substitution, prior to implementing PPE and/or respirators.
According to a commenter, laboratories analyzing environmental
samples for monitoring and compliance purposes explained that their use
of methylene chloride typically occurs in areas with high-level
ventilation and in a fume hood (Ref. 48). This practice is intended to
protect workers from exposure to methylene chloride and prevents
contamination of laboratory surfaces and the air by methylene chloride
that could compromise the analysis of the samples (Ref. 48). The
American Council of Independent Laboratories noted that, in order to
ensure that such contamination is not occurring, their laboratories
routinely test blank samples for contamination (Ref. 48). They further
noted that laboratory accreditation organizations ensure that
accredited laboratories are monitoring processes for potential
contamination on a regular basis (Ref. 48). Thus, ACIL concludes that,
if exposure to high levels of methylene chloride was occurring, their
routine testing for sample contamination would likely flag such
problems (Ref. 48). After EPA promulgated the May 2024 final rule, ACIL
referred to statements
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presented in the Response to Comments document and in a public webinar
that the Agency's data and rationale supported the use of fume hoods as
an exposure control to protect laboratory personnel (Refs. 47, 56, 62).
As EPA stated in the Response to Public Comments and the public
webinar, the Agency maintains high confidence in laboratories' ability
to achieve the protective measures needed to address the unreasonable
risk and to meet the requirements of the WCPP and ECEL (Refs. 47, 62).
During the proposed rule's public comment period, one of the main
concerns voiced by environmental monitoring laboratories was the cost
and difficulty of performing initial monitoring, and, potentially,
periodic monitoring (Refs. 48, 49, 50). Due to compliance costs as a
result of the final regulation, ACIL stated that smaller laboratories
serving rural communities may cease environmental analyses that require
the use of methylene chloride-based methods (Ref. 56). According to
other laboratories, most have not had to perform exposure monitoring
under the OSHA Methylene Chloride Standard, 29 CFR 1910.1052, because
they are complying with the OSHA Laboratory Standard at 29 CFR
1910.1450, and monitoring is not required unless there is reason to
believe that exposure levels routinely exceed the applicable OSHA
action level, which for methylene chloride is 12.5 ppm (Refs. 52, 63,
64, 65). In their view, compliance with the containment requirements of
the Laboratory Standard at 29 CFR 1910.1450, such as proper use of fume
hoods or glove boxes, precludes ambient methylene chloride levels that
exceed the TSCA action level, as well as the OSHA action level (Refs.
52, 63, 64, 65). These commenters did not provide monitoring data in
support of their views, and while EPA agrees that proper use of fume
hoods or glove boxes would likely be sufficient to address unreasonable
risks from methylene chloride, without monitoring information to
demonstrate as such, any laboratory could not be considered to be in
compliance with the WCPP.
Some organizations indicated a desire to undertake an arduous and
potentially costly process to revise existing analytical method
requirements rather than monitoring to demonstrate compliance with the
ECEL, which, as noted above, could likely be met with use of laboratory
hoods. Two organizations expressed that the better approach would be
for EPA to work with the FDA, States, and standards-setting
organizations to revise mandatory analytical methods to not require the
use of methylene chloride, although they recognized that this would
take a significant amount of time, and is outside the scope of a 6(a)
TSCA rulemaking. One mentioned the phase-out of chlorofluorocarbons
(CFCs) as an example, and stated that EPA took 20 years to conduct the
needed research and to make the needed regulatory changes to remove the
requirement to employ CFCs as solvents in its required oil and grease
methods. They further noted that the use of methylene chloride is
specified in many more methods than CFCs were. EPA understands the
appeal of this approach, which would result in the elimination of
methylene chloride hazards in many laboratories. However, EPA has
determined that methylene chloride can be safely used in laboratories
operating under the WCPP, so there is no need to terminate use of an
effective solvent.
3. Use of methylene chloride in other laboratories. After EPA
promulgated the final rule in 2024, representatives of academic
laboratories also began contacting the Agency about the rule's impacts.
EPA heard from individual universities, such as the University of
California and Purdue University, as well as from the College Safety
Health Environmental Management Association (CSHEMA) and the American
Chemical Society, speaking on behalf of academic teaching and research
laboratories. These stakeholders explained additional challenges that
academic laboratories face in complying with the final rule.
Universities often have multiple campuses, with a variety of
laboratories on each, and methylene chloride is typically used only
infrequently in most of these laboratories. In their view, it would be
cost prohibitive to perform initial monitoring, and periodic monitoring
if necessary, in each laboratory that they control, particularly where
it is unlikely that anyone may be routinely exposed to methylene
chloride (Ref. 48). In addition, because EPA's final rule extends
protections beyond workers to all potentially exposed persons in the
area, students will be covered by the rule and will potentially have to
be provided with training, medically qualified to don a respirator,
fit-tested for respirator use, and issued PPE and respirators, and
records would have to be kept accordingly.
Law enforcement agencies and laboratories also shared information
with EPA after promulgation of the final rule. The Texas Department of
Public Safety, New York City Police Department, the Johnson County (KS)
Sheriff's Office, and the Wyoming State Crime Laboratory described the
use of methylene chloride in small quantities for testing purposes,
such as testing for controlled substances, like cocaine and heroin
(Refs. 66, 67, 68, 69). These labs requested clarity on how the
rulemaking would apply to their use, including if EPA was aware of
alternatives to methylene chloride for testing of controlled substances
and asking if methylene chloride use could continue with an exposure
control plan in place.
III. Provisions of This Proposed Rule
A. Establishing Compliance Dates
TSCA section 6(d) includes a number of provisions relating to
establishment of effective or compliance dates applicable to TSCA
section 6 rules. TSCA section 6(d)(1)(A) directs EPA to specify a date
on which the TSCA section 6(a) rule is to take effect that is ``as soon
as practicable,'' while TSCA section 6(d)(1)(B) requires EPA to specify
mandatory compliance dates for each requirement of a rule promulgated
under TSCA section 6(a), which must be as soon as practicable but no
later than five years after promulgation, with few exceptions.
EPA's 2023 NPRM would have required entities subject to the WCPP to
conduct initial exposure monitoring no later than six months after the
final rule was published, establish regulated areas and provide
personal protective equipment (PPE) within the next three months, and
develop and implement an exposure control plan three months after that,
or within one year of the publication of the final rule. Many industry
commenters thought that the compliance dates for WCPP implementation
were too ambitious, while environmental advocacy organizations thought
that industry should be required to comply sooner with worker
protection measures once monitoring data showing exceedances of the
ECEL or STEL was obtained. Industry commenters cited concerns about the
availability of industrial hygiene personnel and monitoring methods, as
well as the time it would take to implement engineering and
administrative controls in the workplace.
In balancing questions over the practicability of WCPP compliance
dates with the interest in protecting workers from unreasonable risks,
EPA determined that the proposed timeframe was not practicable for all
who would need to comply with it. Therefore, the final rule provided an
additional six months of time for all owners and operators to implement
the WCPP. Federal agencies and their contractors have approximately 18
additional months to comply with the WCPP,
[[Page 22219]]
based on EPA's concern about the ability of certain departments and
agencies of the Federal Government to achieve compliance with the
private-sector timeframes and given the importance of methylene
chloride to mission-critical Department of Defense and National
Aeronautics and Space Administration operations and overall military
readiness. For more information on this issue, see Unit III.D.1 of the
2024 final rule.
B. Proposed Compliance Date Extension for the Industrial and Commercial
Use of Methylene Chloride as a Laboratory Chemical
As a result of the information from laboratories and organizations
representing laboratories subsequent to the publication of the 2024
final rule, EPA is proposing to extend the compliance dates applicable
to non-federal owners and operators that use methylene chloride as a
laboratory chemical, aligning with timeframes for Federal laboratories
and Federal contractors. Under this proposal, such 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. EPA has based this proposal on
number of challenges to WCPP compliance identified by 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 the availability and cost of industrial hygiene personnel to
conduct initial monitoring. In EPA's view, the newly proposed
compliance dates are practicable and represent a reasonable transition
period under TSCA section 6(d). Moreover, using compliance dates
already established for Federal agencies and their contractors avoids
the confusion that EPA may have created by having multiple compliance
dates for various WCPP provisions.
EPA requests comments and specific information addressing:
The ability of the various laboratories to comply with the
requirements of the WCPP by the newly proposed compliance dates.
Alternative compliance timeframes for laboratories that
represent dates that are as soon as practicable and provide for a
reasonable transition period.
Information related to laboratory use of methylene
chloride, addressing risks associated with that use, that may not have
been previously available to EPA during risk management and should now
be considered.
The costs of compliance with the WCPP for laboratories,
such as the cost of: obtaining the services of an industrial hygienist,
identifying relevant tasks associated with methylene chloride exposure,
collecting and analyzing exposure samples, including the cost of
equipment necessary to collect exposure samples, training,
recordkeeping, implementing engineering and administrative controls and
PPE, and modifying existing chemical hygiene plans developed under 29
CFR 1910.1450 to meet the requirements of 40 CFR 751.109(e)(2).
The cost differential of compliance between EPA
requirements (40 CFR 751.109) and the current OSHA laboratory standard
(29 CFR 1910.1450).
The number of potentially exposed persons who operate in
various laboratories under the workplace chemical protection program
requirements and the costs and benefits.
EPA also welcomes comments, including data supporting alternative
approaches to ensuring that potentially exposed persons are protected
when they are working in, or otherwise present in, laboratories where
methylene chloride is being used. For example, several commenters on
the 2023 proposal took note of the approach taken in EPA's proposed
TSCA section 6 rule on perchloroethylene (Ref. 48), which addressed
laboratory exposures to perchloroethylene by requiring fume hoods or
other enclosures and dermal protection. EPA understands that much of
the methylene chloride use in laboratories is done under a fume hood or
in glove boxes or other enclosures that limit air concentrations in the
vicinity of the use. However, data in the methylene chloride risk
evaluation indicates the potential for air concentrations in
laboratories to exceed the ECEL. EPA is interested in any information
that describes exposure reductions that fume hoods or other enclosures
currently in use in laboratories provide that may reduce risks such
that they are no longer unreasonable.
IV. 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; Final Rule. RIN 2070-AK70. Federal Register
(89 FR 39254) (FRL-8155-01-OCSPP). May 8, 2024. https://www.govinfo.gov/content/pkg/FR-2024-05-08/pdf/2024-09606.pdf.
2. EPA. American Chemical Society Meeting Memo. January 7, 2025.
3. EPA. American Council of Independent Laboratories Meeting
Memo. January 8, 2025.
4. EPA. Temple University Correspondence Memo. July 16, 2024.
5. EPA. University of Minnesota Meeting Memo. December 3, 2024.
6. EPA. Vanderbilt University Correspondence Memo. May 31, 2024.
7. EPA. Colorado School of Mines Correspondence Memo. June 25,
2024.
8. EPA. University of Connecticut Correspondence Memo. June 10,
2024.
9. EPA. SW-846 Hazardous Waste Test Methods Compendium. Accessed
March 25, 2025. https://www.epa.gov/hw-sw846/sw-846-compendium.
10. EPA. Methylene Chloride; Regulation under the Toxic
Substances Control Act (TSCA); Proposed Rule. Federal Register (88
FR 28284) (FRL-8155-02-OCSPP). May 3, 2023. https://www.govinfo.gov/content/pkg/FR-2023-05-03/pdf/2023-09184.pdf.
11. EPA. Vermont Department of Health Laboratory Correspondence
Memo. July 11, 2024.
12. EPA. Philadelphia Water Department Correspondence Memo. June
11, 2024.
13. EPA. Risk Evaluation for Methylene Chloride (MC). EPA
Document #740-R1-8010.
14. Public Interest Research Group. Mass Comment Campaign. EPA-
HQ-OPPT-2020-0465-0168. February 5, 2023.
15. Clean Water Action. Mass Comment Campaign. EPA-HQ-OPPT-2020-
0465-0169. February 5. 2023.
16. Toxic Free Future. Mass Comment Campaign. EPA-HQ-OPPT-2020-
0465-0170. February 5, 2023.
17. Safer Chemicals Healthy Families. Mass Comment Campaign.
EPA-HQ-OPPT-2020-0465-0171. February 5, 2023.
18. Michael Kennedy. American Petroleum Institute (API) Comment
EPA-HQ-OPPT-2020-0465-0198. June 29, 2023. National Federation of
Independent Business.
19. David S. Addington. National Federation of Independent
Business Comment EPA-HQ-OPPT-2020-0465-0186. June 16, 2023.
20. Melanie Barrett. Millipore Sigma Comment EPA-HQ-OPPT-2020-
0465-0212. June 30, 2023. Aerospace Industries Association.
21. Remy Nathan. Aerospace Industries Association (AIA) Comment
EPA-HQ-OPPT-2020-0465-0168. June 30, 2023.
22. William E. Allmond, IV. The Adhesives and Sealants Council,
Inc. Comment EPA-HQ-OPPT-2020-0465-0229. June 30, 2023.
23. Richard E. Engler. TSCA New Chemicals Coalition. Comment
EPA-HQ-OPPT-2020-0465-0230. July 6, 2023.
24. Major L. Clark, III. Small Business Administration. Comment
EPA-HQ-OPPT-2020-0465-0235. July 3, 2023.
[[Page 22220]]
25. 3M Company. Comment EPA-HQ-OPPT-2020-0465-0222. July 7,
2023.
26. Richard Szembrot. Eastman Kodak Company. Comment EPA-HQ-
OPPT-2020-0465-0236. July 6, 2023.
27. Jennifer C. Gibson. National Association of Chemical
Distributors. Comment EPA-HQ-OPPT-2020-0465-0238. July 6, 2023.
28. Martin J. Durbin. U.S. Chamber of Commerce. Comment EPA-HQ-
OPPT-2020-0465-0279. July 7, 2023.
29. Danielle Jones. Chemours Company Comment EPA-HQ-OPPT-2020-
0465-0242. July 3, 2023.
30. Jim LaBrake. Nalas Engineering Services. Comment EPA-HQ-
OPPT-2020-0465-0286. July 7, 2023.
31. Genevieve Strand. Society of Chemical Manufacturers &
Affiliates (SOCMA) Comment EPA-HQ-OPPT-2020-0465-0250. July 3, 2023.
32. Haakan Jonsson. Covestro LLC Comment EPA-HQ-OPPT-2020-0465-
0377. June 29, 2023.
33. Riaz Zaman. American Coatings Association. Comment EPA-HQ-
OPPT-2020-0465-0211. July 6, 2023.
34. Paul DeLeo. American Chemistry Council (ACC) Comment EPA-HQ-
OPPT-2020-0465-0281. July 3, 2023.
35. LeaAnne Forest. American Chemistry Council (ACC). Comment
EPA-HQ-OPPT-2020-0465-0268. July 7, 2023.
36. James Lee. Ohio Manufacturers Association (OMA). Comment
EPA-HQ-OPPT-2020-0465-0185. June 21, 2023.
37. Halogenated Solvents Industry Alliance (HSIA). Comment EPA-
HQ-OPPT-2020-0465-0285. July 7, 2023.
38. Sherolyn Bishop. Savannah River National Laboratory--U.S.
Department of Energy. Comment EPA-HQ-OPPT-2020-0465-0196. June 30,
2023.
39. James Lee. Hach Company. Comment EPA-HQ-OPPT-2020-0465-0180.
May 24, 2023.
40. Carrie McMichael. Solvay Specialty Polymers USA, LLC Comment
EPA-HQ-OPPT-2020-0465-0215. June 30, 2023.
41. EaglePicher. EaglePicher Technologies, LLC Comment EPA-HQ-
OPPT-2020-0465-0214. June 30, 2023.
42. Andy Barsala. GE Aerospace Comment EPA-HQ-OPPT-2020-0465-
0234. July 3, 2023.
43. Wanda Copeland Smith. Halocarbon. Comment EPA-HQ-OPPT-2020-
0465-0252. July 3, 2023.
44. Lee French. DuPont de Nemours, Inc. Comment EPA-HQ-OPPT-
2020-0465-0224. June 30, 2023.
45. Steven Bennett. Household and Commercial Products
Association (HCPA). Comment EPA-HQ-OPPT-2020-0465-0257. July 6,
2023.
46. Steve Shestag. The Boeing Company. Comment EPA-HQ-OPPT-2020-
0465-0253. July 6, 2023.
47. U.S. Tire Manufacturers Association. Comment EPA-HQ-OPPT-
2020-0465-0239. July 6, 2023.
48. EPA. Methylene Chloride; Regulation Under the Toxic
Substances Control Act (TSCA); Response to Public Comments. RIN
2070-AK70. April 2024.
49. Judith Morgan and David Friedman. American Council of
Independent Laboratories (ACIL). Comment EPA-HQ-OPPT-2020-0465-0258.
June 6, 2023.
50. Judy Morgan. Pace Analytical. Comment EPA-HQ-OPPT-2020-0465-
0274. July 7, 2023.
51. Jerry Parr. Environmental Monitoring Coalition (EMC).
Comment EPA-HQ-OPPT-2020-0465-0255. June 6, 2023.
52. Steven McLean. Comment EPA-HQ-OPPT-2020-0465-0184. June 13,
2023.
53. Caroline Trupp Gil. American Chemical Society (ACS). Comment
EPA-HQ-OPPT-2020-0465-0247. July 6, 2023.
54. EPA. Initial Regulatory Flexibility Analysis for Methylene
Chloride; Regulation of Methylene Chloride under TSCA Sec. 6(a)
Proposed Rule; RIN 2070-AK70. November 22, 2022.
55. Kenji Saito. American College of Occupational and
Environmental Medicine (ACOEM). Comment EPA-HQ-OPPT-2020-0465-0237.
July 3, 2023.
56. Karen Ethier. ThermoFisher. Comment EPA-HQ-OPPT-2020-0465-
0213. July 6, 2023.
57. EPA. American Council of Independent Laboratories Meeting
Memo. April 23, 2025.
58. EPA. EPA Analytical Method 506 and 525.2 Revision 2.0.
Accessed March 25, 2025. https://www.epa.gov/system/files/documents/2024-02/organic-methods-table.pdf.
59. EPA. Method 608: Organochlorine Pesticides and PCBs.
Accessed March 25, 2025. https://www.epa.gov/sites/default/files/2015-09/documents/method_608_1984.pdf.
60. EPA. Method 612: Chlorinated Hydrocarbons. Accessed March
25, 2025. https://www.epa.gov/sites/default/files/2015-10/documents/method_612_1984.pdf.
61. EPA. Method 613: 2, 3, 7, 8-Tetrachloro-dibenzo-p-Dioxin.
Accessed March 25, 2025. https://www.epa.gov/sites/default/files/2015-10/documents/method_613_1984.pdf.
62. EPA. EPA Method 23A. Accessed March 25, 2025. https://www.epa.gov/sites/default/files/2020-04/documents/method_0023a_0.pdf.
63. EPA. Public Webinar on Methylene Chloride; Risk Evaluation
and Risk Management under TSCA Section 6. EPA-HQ-OPPT-2020-0465-
0431. June 4, 2024.
64. Robin Mills Ridgway. Purdue University. Comment EPA-HQ-OPPT-
2020-0465-0243. July 6, 2023.
65. OSHA. Occupational Exposure to Hazardous Chemicals in
Laboratories. Accessed March 31, 2025. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450.
66. OSHA. Methylene Chloride. Accessed March 31, 2025. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1052.
67. EPA. Texas Department of Public Safety Correspondence Memo.
June 12, 2024.
68. EPA. New York Police Department Police Laboratory
Correspondence Memo. June 4, 2024.
69. EPA. Johnson County Sherriff's Office Criminalistic
Laboratory Correspondence Memo. June 4, 2024.
70. EPA. Wyoming State Crime Laboratory Correspondence Memo.
June 4, 2024.
71. EPA. Existing Chemical Exposure Limit (ECEL) for
Occupational Use of Methylene Chloride. December 10, 2020.
72. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical
Methods with Related International Voluntary Consensus Standards. J
Occup Environ Hyg. 12(7):D107-15. 2015.
V. 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 expected to be an Executive Order 14192 deregulatory
action. This proposed rule is expected to provide burden reduction by
providing relief against existing compliance deadlines.
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.
[[Page 22221]]
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. We have 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 as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.
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 an
economically significant regulatory action as defined by Executive
Order 12866.
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)
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272, the Agency has
determined that this proposed rulemaking involves environmental
monitoring or measurement, specifically for occupational inhalation
exposures to methylene chloride. Consistent with the Agency's
Performance Based Measurement System (PBMS), EPA has decided not to
require the use of specific, prescribed analytic methods. Rather, the
Agency will allow the use of any method that meets the prescribed
performance criteria. The PBMS approach is intended to be more flexible
and cost-effective for the regulated community; it is also intended to
encourage innovation in analytical technology and improved data
quality. EPA is not precluding the use of any method, whether it
constitutes a voluntary consensus standard or not, as long as it meets
the performance criteria specified.
For this proposed rulemaking, the key consideration for the PBMS
approach is the ability to accurately detect and measure airborne
concentrations of methylene chloride at the ECEL, the ECEL action
level, and the EPA STEL. Some examples of methods which meet the
criteria are included in appendix A of the ECEL memo (Ref. 71). EPA
recognizes that there may be voluntary consensus standards (Ref. 72).
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, the EPA proposes to
amend 40 CFR part 751 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), (f),
and (g) 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, and
owners or operators when using methylene chloride as a laboratory
chemical;
(ii) After August 1, 2025, for other owners and operators; or
(iii) 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, and
owners or operators when using methylene chloride as a laboratory
chemical;
(ii) After August 1, 2025, for other owners and operators; or
(iii) 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):
(ii) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government,
[[Page 22222]]
and owners or operators when 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 monitoring data consistent with paragraph (d) of this
section.
* * * * *
(d) * * *
(2) Initial monitoring. Each owner or operator covered by this
section must perform an initial exposure monitoring to determine each
potentially exposed person's exposure:
(i) By November 9, 2026, for Federal agencies, Federal contractors
acting for or on behalf of the Federal Government, and owners or
operators when using methylene chloride as a laboratory chemical;
(ii) By May 5, 2025, for other owners and operators; or
(iii) Within 30 days of the owner or operator introducing methylene
chloride into the workplace, whichever is later, unless:
* * * * *
(e) ECEL control procedures and plan. (1) Methods of compliance.
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:
(i) By May 10, 2027, for Federal agencies, Federal contractors
acting for or on behalf of the Federal Government, and owners or
operators using methylene chloride as a laboratory chemical;
(ii) By October 30, 2025, for other owners and operators; or
(iii) Within 7 months of the owner or operator introducing
methylene chloride into the workplace.
(2) Exposure control plan. The owner or operator must develop and
implement an exposure control plan:
(i) By May 10, 2027, for Federal agencies, Federal contractors
acting for or on behalf of the Federal Government, and owners or
operators using methylene chloride as a laboratory chemical;
(ii) By October 30, 2025, for other owners and operators, the owner
or operator must develop and implement an exposure control plan; or
(iii) Within 7 months of the owner or operator introducing
methylene chloride into the workplace.
* * * * *
(f) Respiratory protection--(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, and
owners or operators using methylene chloride as a laboratory chemical;
(ii) After August 1, 2025, for other owners and operators; or
(iii) 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) Dermal protection. 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:
(1) After February 8, 2027, for Federal agencies, Federal
contractors acting for or on behalf of the Federal Government, and
owners or operators using methylene chloride as a laboratory chemical;
(2) After August 1, 2025, for other owners and operators.
* * * * *
[FR Doc. 2025-09421 Filed 5-23-25; 8:45 am]
BILLING CODE 6560-50-P