Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA), 103512-103558 [2024-29517]
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103512 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 751
[EPA–HQ–OPPT–2020–0592; FRL–8206–02–
OCSPP]
RIN 2070–AK82
I. Executive Summary
Carbon Tetrachloride (CTC);
Regulation Under the Toxic
Substances Control Act (TSCA)
A. Does this action apply to me?
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA or ‘‘Agency’’) is finalizing
a rule to address the unreasonable risk
of injury to health presented by carbon
tetrachloride (CTC) under its conditions
of use. TSCA requires that EPA address
by rule any unreasonable risk of injury
to health or the environment identified
in a TSCA risk evaluation and apply
requirements to the extent necessary so
that the chemical no longer presents
unreasonable risk. EPA’s final rule will
establish workplace safety requirements
for most conditions of use, including the
condition of use related to the making
of low Global Warming Potential (GWP)
hydrofluoroolefins (HFOs); prohibit the
manufacture (including import),
processing, distribution in commerce,
and industrial/commercial use of CTC
for conditions of use where information
indicates use of CTC has ceased; and
establish recordkeeping and
downstream notification requirements.
The use of CTC in low GWP HFOs is
particularly important in the Agency’s
efforts to support the American
Innovation and Manufacturing Act of
2020 (AIM Act) and the Kigali
Amendment to the Montreal Protocol on
Substances that Deplete the Ozone
Layer, which was ratified on October 26,
2022.
DATES: This final rule is effective on
January 17, 2025.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0592, is
available online at https://
www.regulations.gov. Additional
information about dockets generally,
along with instructions for visiting the
docket in-person, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Emilia
Echeveste Briseño, Existing Chemicals
Risk Management Division (7404M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
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SUMMARY:
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number (202) 566–0543; email address:
CarbonTetrachlorideTSCA@epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
1. General Applicability
This action applies to you if you
manufacture (defined under TSCA to
include import), process, distribute in
commerce, use, or dispose of CTC
(CASRN 56–23–5). TSCA section 3(9)
defines the term ‘‘manufacture’’ to mean
‘‘to import into customs territory of the
United States (as defined in general note
2 of the Harmonized Tariff Schedule of
the United States), produce, or
manufacture’’. Therefore, unless
expressly stated otherwise, importers of
CTC are subject to any provisions
regulating manufacture of CTC. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities include:
• Chemical Manufacturing (NAICS
code 325);
• Nonmetallic Mineral Product
Manufacturing (NAICS code 327);
• Primary Metal Manufacturing
(NAICS code 331);
• Waste Management and
Remediation Services (NAICS code
562);
• Petrochemical Manufacturing
(NAICS code 325110);
• Industrial Gas Manufacturing
(NAICS code 325120);
• Other Basic Inorganic Chemical
Manufacturing (NAICS code 325180);
• Cyclic Crude, Intermediate, and
Gum and Wood Chemical
Manufacturing (NAICS code 325194);
• All Other Basic Organic Chemical
Manufacturing (NAICS code 325199);
• Plastics Material and Resin
Manufacturing (NAICS code 325211);
• Pesticide and Other Agricultural
Chemical Manufacturing (NAICS code
325320);
• All Other Miscellaneous Chemical
Product and Preparation Manufacturing
(NAICS code 325998);
• Cement Manufacturing (NAICS
code 327310);
• Ground or Treated Mineral and
Earth Manufacturing (NAICS code
327992);
• Nonferrous Metal (except
Aluminum) Smelting and Refining
(NAICS code 331410);
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• NAICS code 562211—Hazardous
Waste Treatment and Disposal NAICS
code 562211); and
• Solid Waste Combustors and
Incinerators (NAICS code 562213).
2. Applicability to Importers and
Exporters
This action may also affect certain
entities subject to import certification,
and export notification rules under
TSCA (https://www.epa.gov/tscaimport-export-requirements). Persons
who import any chemical substance in
bulk form, as part of a mixture, or as
part of an article (if required by rule) are
subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements and the corresponding
regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those
persons must certify that the shipment
of the chemical substance complies with
all applicable rules and orders under
TSCA. The EPA policy in support of
import certification appears at 40 CFR
part 707, subpart B.
In addition, any persons who export
or intend to export a chemical substance
that is the subject of this final rule are
subject to the export notification
provisions of TSCA section 12(b) (15
U.S.C. 2611(b)), and must comply with
the export notification requirements in
40 CFR part 707, subpart D.
B. What is the Agency’s authority for
taking this action?
Under TSCA section 6(a) (15 U.S.C.
2605(a)), if the U.S. Environmental
Protection Agency, hereinafter referred
to as EPA or ‘‘the Agency’’, determines
through a TSCA section 6(b) risk
evaluation that a chemical substance
presents an unreasonable risk of injury
to health or the environment, EPA must
by rule apply one or more requirements
listed in TSCA section 6(a) to the extent
necessary so that the chemical
substance or mixture no longer presents
such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA
determined that CTC presents an
unreasonable risk of injury to health,
without consideration of costs or other
nonrisk factors, including an
unreasonable risk to potentially exposed
or susceptible subpopulations (PESS)
identified as relevant to the 2020 Risk
Evaluation for Carbon Tetrachloride by
EPA, under the conditions of use (Refs.
1, 2, 3). A description of the conditions
of use that contribute to EPA’s
determination that CTC presents an
unreasonable risk is in the proposed
rule (88 FR 49190) (FRL–8206–01–
OCSPP) and Unit IV. Accordingly, to
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address the unreasonable risk, EPA is
issuing this final rule under TSCA
section 6(a) to:
(1) Require a Workplace Chemical
Protection Program (WCPP), including
an inhalation exposure concentration
limit, direct dermal contact controls,
and related workplace exposure
controls, for the following occupational
conditions of use of CTC not prohibited,
outlined in Unit IV.B.:
• Domestic manufacture;
• Import;
• Processing as a reactant in the
production of hydrochlorofluorocarbons
(HCFCs), hydrofluorocarbons (HFCs),
HFOs, and perchloroethylene (PCE);
• Incorporation into formulation,
mixture or reaction products in
agricultural products manufacturing,
vinyl chloride manufacturing, and other
basic organic and inorganic chemical
manufacturing;
• Repackaging for use as a laboratory
chemical;
• Recycling;
• Industrial and commercial use as an
industrial processing aid in the
manufacture of agricultural products
and vinyl chloride;
• Industrial and commercial use in
the elimination of nitrogen trichloride
in the production of chlorine and
caustic soda and the recovery of
chlorine in tail gas from the production
of chlorine; and
• Disposal.
(2) Require use of laboratory
ventilation devices, such as fume hoods
or glove boxes, and dermal personal
protective equipment (PPE) for the
industrial and commercial use as a
laboratory chemical, as outlined in Unit
IV.C.;
(3) Prohibit these additional
conditions of use, for which the Agency
understands use of CTC has already
ceased, as outlined in Unit IV.D.:
• Incorporation into formulation,
mixture or reaction products in
petrochemical-derived manufacturing
except in the manufacture of vinyl
chloride (for which EPA is requiring a
WCPP);
• Industrial and commercial use as an
industrial processing aid in the
manufacture of petrochemicals-derived
products except in the manufacture of
vinyl chloride (for which EPA is
requiring a WCPP);
• Industrial and commercial use in
the manufacture of other basic
chemicals (including manufacturing of
chlorinated compounds used in
solvents, adhesives, asphalt, and paints
and coatings), except for use in the
elimination of nitrogen trichloride in
the production of chlorine and caustic
soda and the recovery of chlorine in tail
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gas from the production of chlorine (for
which EPA is requiring a WCPP);
• Industrial and commercial use in
metal recovery;
• Industrial and commercial use as an
additive; and
• Industrial and commercial use in
specialty uses by the U.S. Department of
Defense (DoD).
(4) Require recordkeeping, as outlined
in Unit IV.E.1.
(5) Require manufacturers (including
importers), processors, and distributors
to provide downstream notification of
the requirements, as outlined in Unit
IV.E.2.
EPA notes that not all TSCA
conditions of use of CTC are subject to
this final rule. ‘‘Conditions of use’’ is
defined in TSCA section 3(4) to mean
the circumstances, as determined by
EPA, under which a chemical substance
is intended, known, or reasonably
foreseen to be manufactured, processed,
distributed in commerce, used, or
disposed of. As described in the 2020
Risk Evaluation for Carbon
Tetrachloride (Ref. 1) and the 2022
Revised Unreasonable Risk
Determination for Carbon Tetrachloride
(Ref. 3), two conditions of use of CTC
do not drive the unreasonable risk:
distribution in commerce and
processing as a reactant/intermediate in
reactive ion etching. EPA is not
finalizing any restrictions for the
processing of CTC as a reactant/
intermediate in reactive ion etching.
However, under TSCA section 6(a), EPA
may select from among a suite of risk
management requirements in TSCA
section 6(a), including requirements
related to distribution in commerce, as
part of its regulatory options to address
the unreasonable risk; EPA’s final
regulatory action includes prohibitions
on the distribution in commerce of CTC
for certain downstream conditions of
use to address unreasonable risk from
those downstream conditions of use.
Additionally, as explained in Section
1.4.2.3 of the 2020 Risk Evaluation for
Carbon Tetrachloride and Section
2.2.2.1 of the 2018 Problem Formulation
of the Risk Evaluation for Carbon
Tetrachloride, EPA concluded that the
industrial/commercial/consumer uses of
CTC in adhesives/sealants, paints/
coatings, and cleaning/degreasing
solvent products contain only trace
amounts of CTC, present only de
minimis exposures or otherwise
insignificant risks under TSCA, and did
not warrant inclusion in the risk
evaluation. Therefore, EPA has
excluded from the rule’s requirements
CTC that is solely present
unintentionally in trace quantities with
another chemical substance or mixture,
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whether as a manufacturing residue,
unreacted feedstock, byproduct, or other
contaminant. However, EPA notes that
the Agency has discretion to further
assess trace quantities of CTC under
other regulatory authorities, such as the
Clean Air Act. Finally, manufacture of
CTC as a byproduct was not evaluated
in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1); therefore, in this
final rule, WCPP requirements
applicable to the domestic manufacture
of CTC do not apply where CTC is
manufactured solely as a byproduct.
EPA anticipates that any risks presented
by the presence of CTC as a byproduct
formed during the manufacturing,
processing or use of a parent compound
will be considered in the scope of the
risk evaluation of such parent
compound. For example, EPA will
assess the risks of CTC manufactured as
a byproduct during the manufacture of
1,2-dichloroethane in the TSCA risk
evaluation for 1,2-dichloroethane (Ref.
1).
D. Why is the Agency taking this action?
Under TSCA section 6(a), ‘‘[i]f the
Administrator determines in accordance
with subsection (b)(4)(A) that the
manufacture, processing, distribution in
commerce, use or disposal of a chemical
substance or mixture, or that any
combination of such activities, presents
an unreasonable risk of injury to health
or the environment, the Administrator
shall by rule . . . apply one or more of
the [section 6(a)] requirements to such
substance or mixture to the extent
necessary so that the chemical
substance or mixture no longer presents
such risk.’’ CTC was the subject of a risk
evaluation under TSCA section
6(b)(4)(A) that was issued in November
2020 (Ref. 1). In addition, EPA issued a
revised unreasonable risk determination
in December 2022 (Ref. 3), determining
that CTC, as a whole chemical
substance, presents an unreasonable risk
of injury to health under the conditions
of use. On July 28, 2023, EPA issued a
proposed rulemaking (88 FR 49180)
(FRL–8206–01–OCSPP) under TSCA
section 6(a) to take action to the extent
necessary so that CTC no longer
presents such risk. The Agency received
public comment on the proposal. With
this action, EPA is finalizing with
modifications the July 2023 proposed
rule so that CTC no longer presents an
such risk. The conditions of use that
contribute to the unreasonable risk from
CTC are described in the proposed rule
(88 FR 49190) (FRL–8206–01–OCSPP)
and Unit IV.
CTC’s hazards are well established.
EPA’s 2020 Risk Evaluation for Carbon
Tetrachloride considered the hazards
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associated with exposure to CTC and
determined that CTC presents an
unreasonable risk of injury to health due
to the significant adverse health effects
associated with the exposure of CTC.
While some risks of adverse effects from
CTC exposure are associated with acute
single exposures, other risks are
associated with long-term repeated
exposures. EPA identified cancer and
liver toxicity adverse effects from
chronic inhalation and dermal
exposures as well as liver toxicity from
acute dermal exposures to CTC (Refs. 1,
2, 3). Cancer adverse effects (e.g., liver,
pheochromocytoma, neuroblastoma)
were identified for chronic inhalation
and dermal exposures. Cancer was
selected based on the best available
science and weight of scientific
evidence, and in consideration of the
severity of hazards, magnitude of
exposure, population exposed, and
uncertainties in the November 2020
Risk Evaluation for Carbon
Tetrachloride and the December 2022
Revised Risk Determination for Carbon
Tetrachloride. EPA identified in the
2020 Risk Evaluation for Carbon
Tetrachloride a threshold cancer point
of departure (POD) for liver tumors
(assuming a margin of exposure of 300),
and an inhalation unit risk (IUR) for
adrenal tumors, based on effects
observed in mice following inhalation
exposure. The chronic non-cancer PODs
for inhalation exposures are based on a
study observing increased fatty changes
in rodent livers (fatty changes in the
liver are a precursor for liver fibrosis).
EPA also identified additional risks
associated with other adverse effects
(e.g., immediate and temporary
depression of the central nervous
system, kidney toxicity, reproductive
and developmental toxicity, irritation
and sensitization, and genetic toxicity)
resulting from acute and chronic
exposures. For this action, EPA has
determined that protecting against liver
and adrenal cancer would also address
the risk for acute non-cancer, chronic
non-cancer, and additional cancer risks
from CTC, as identified in the 2020 Risk
Evaluation for Carbon Tetrachloride and
the Revised Unreasonable Risk
Determination for CTC in December
2022 (Ref. 1, 2 and 3).
CTC is primarily used as a feedstock
to make products such as refrigerants,
aerosol propellants, and foam-blowing
agents. Requirements under the
Montreal Protocol and Title VI of the
Clean Air Act (CAA), which were
included in the CAA Amendments of
1990 and are codified at 42 U.S.C.
Chapter 85, Subchapter VI, led to a
phaseout of CTC production in the
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United States for most non-feedstock
domestic uses, such as degreasers and
fire suppressants. In addition, the
Consumer Product Safety Commission
(CPSC) banned the use of CTC in
household (i.e., consumer) products
(excluding unavoidable residues not
exceeding 10 ppm atmospheric
concentration) in 1970 (see 16 CFR
1500.17(a)(2)). The Agency has
considered the benefits of CTC for
various uses as required under TSCA
section 6(c)(2)(A) and (B) and recognizes
that continued use of CTC for some
TSCA conditions of use should be
maintained for several reasons. The use
of CTC may provide benefits that
complement the Agency’s efforts to
address climate-damaging HFCs under
the AIM Act and the Kigali Amendment
to the Montreal Protocol, supporting
human health and environmental
protection under these programs. In
addition, the use of CTC may provide
other benefits due to certain unique
properties of CTC (e.g., it does not react
with the process gasses when used as a
process agent in the manufacture of
agricultural products (Ref. 4)). Finally,
strict workplace controls can be
implemented to address unreasonable
risk across many conditions of use. For
some workplaces, EPA understands that
existing controls may already reduce
exposures enough to meet the inhalation
exposure concentration limit proposed
in this rulemaking or to prevent direct
dermal contact with CTC. For many of
the conditions of use for which EPA is
finalizing workplace controls under a
WCPP, data indicating that certain uses
could meet the exposure limit and
ancillary requirements of an effective
WCPP in addressing unreasonable risk
were submitted during the risk
evaluation, the comment period
following publication of the proposed
rule, or during stakeholder outreach
engagements, and are available in the
corresponding public dockets (EPA–
HQ–OPPT–2016–0733; EPA–HQ–
OPPT–2019–0499; EPA–HQ–OPPT–
2020–0592).
Accordingly, EPA is finalizing
workplace controls to address the
unreasonable risk while allowing
continued use for 100% of the
production volume of CTC
manufactured annually, including the
processing of CTC as a reactant in the
production of HFOs. The rationale for
the final regulatory action, including the
TSCA section 6 requirements
considered in developing the regulatory
action, is described in Units II.D. and III.
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E. What are the estimated incremental
impacts of this action?
EPA has prepared an Economic
Analysis for the potential incremental
impacts associated with this rulemaking
that can be found in the rulemaking
docket (Ref. 5). As described in more
detail in the Economic Analysis and in
Unit V.D., EPA’s estimate of the
incremental costs of this final rule is
$19.7 million per year annualized over
20 years at a 3% discount rate and $19
million per year at a 7% discount rate
(Ref. 5). In response to the updated
Circular A–4 published in November
2023, the incremental costs of this rule
at a 2% discount rate ($19.9 million
annualized over 20 years) are provided
in Appendix C of the Economic
Analysis (Ref. 5).
These costs include compliance with
a WCPP for certain conditions of use,
applicable PPE requirements, and
notification and recordkeeping costs.
EPA was not able to quantify the costs
associated with administrative and
engineering controls because they are
site-specific and depend on the extent to
which controls are already in place,
which is likely to vary across individual
facilities. Thus, for the purpose of
estimating costs and benefits, this
analysis assumes that PPE is used.
Under the WCPP, regulated entities
would be required to consider
respirators and dermal PPE only after
consideration of other more effective
strategies in the hierarchy of controls
adopted by the Occupational Safety and
Health Administration (OSHA) and the
National Institute for Occupational
Safety and Health (NIOSH) to reduce
exposures (Ref. 6). Regulated entities are
required first to consider other measures
in the hierarchy of controls and then to
select PPE based on monitoring results
because the Agency recognizes that
workplaces have unique processes and
equipment in place, and that varying
levels of respiratory Assigned Protection
Factor (APFs) may be needed for
different workplaces.
Industry is expected to incur costs
associated with performing inspections,
documenting efforts to meet the
regulatory requirements associated with
the WCPP, including reducing exposure
and occurrences of exposure,
monitoring, respirators and dermal PPE,
training on the use of respirators and
dermal PPE, and notification and
recordkeeping burdens and costs
associated with the WCPP. Industry is
also expected to incur equipment costs
associated with dermal PPE for
laboratory use. EPA assumes that
industry would not incur equipment
costs associated with the ventilated
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laboratory safety requirement for
laboratory settings because these
requirements are part of baseline
industry practices. All manufacturers
(including importers), processors, and
distributors will bear downstream
notification and recordkeeping costs.
The costs are estimated as
incremental to baseline conditions,
including current use of PPE. The costs
represent a high-end estimate of the
number of entities and workers affected
by the regulation because the high
estimates of workers and entities from
the 2020 Risk Evaluation for Carbon
Tetrachloride were used. To the extent
that EPA’s approach overestimates the
number of entities subject to the
regulation, actual realized costs of this
action will be lower. More details
regarding the provisions of the final rule
are in Unit IV.
In addition to the quantified costs,
there is an unquantified cost to workers
and firms associated with prolonged use
of respirators, which could interfere
with work tasks. The potential for
respirator use to cause discomfort and
productivity losses could lead
companies to offer higher wages as
compensation, but the extent of this
effect is unknown and thus
unquantified. The Economic Analysis
contains additional information about
the unquantified costs in Chapter 3 and
in the Estimated Incremental Costs
section of the Executive Summary (Ref.
5).
Unit IV. details which actions apply
to specific conditions of use. EPA
estimates that 30 firms associated with
72 sites may be manufacturing
(including importing), processing, or
releasing CTC.
EPA estimates that the final rule
would affect at least seven small
entities. EPA compared the highest
annualized per-facility cost of the final
regulatory action with ultimate parent
company annual revenues of the
affected small businesses. EPA found
impacts under 1% of annual revenues
for five of the seven small entities. Two
small entities were estimated to have a
cost-to-revenue impact ratio of between
one and three percent.
In alignment with the goals of
President Biden’s Cancer Moonshot, the
rule will protect people from cancer and
other adverse health effects of CTC (Ref.
7). The actions in this final rule are
expected to achieve health benefits for
the American public. The Economic
Analysis monetizes benefits to
occupational users and non-users of
avoiding cases of adrenal and liver
cancer due to reduced inhalation
exposures that result from
implementation of the WCPP. The
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magnitude of the cancer benefits from
reduced inhalation exposure is
estimated assuming companies provide
respirators to comply. It is also possible
that employees will receive respiratory
benefits from other actions on OSHA’s
hierarchy of controls, such as
engineering controls, since regulated
entities are required first to consider
other measures in the hierarchy of
controls and then to select PPE based on
monitoring results. However, the
Economic Analysis does not estimate
the costs of such controls because
feasible controls and their costs are sitespecific and the amount of additional
exposure reduction that could be
achieved through any given type of
control would depend on the extent to
which such controls are already in
place, which is likely to vary across
individual facilities. This assumption is
made for the purpose of estimating costs
only and is not an assumption about
how facilities would necessarily comply
with WCPP requirements. Other human
health benefits, including noncancer
and additional cancer benefits, while
tangible and significant, cannot be
monetized due to data and methodology
limitations. These include additional
cancer benefits from avoided brain
tumors, noncancer health benefits,
health benefits from avoided dermal
exposure, and benefits to the
environment. The incremental
improvements in health outcomes
achieved by given reductions in
exposure cannot currently be quantified
for non-cancer health effects associated
with CTC exposure, and therefore
cannot be converted into monetized
benefits. Although some benefits cannot
be quantified, they are not necessarily
less important than the quantified
benefits. The primary reason these
benefits were not quantified is the
difficulty in estimating the relationship
between an incremental change in CTC
use and the corresponding change to a
specific health or environmental
outcome.
Adrenal and liver cancer avoidance
benefits are calculated based on
reductions in inhalation exposure using
the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1) for those uses
which are continuing but with a WCPP
in place. Therefore, benefits are only
calculated for the WCPP in the final
rule, which could include respiratory
protection. The estimated monetized
benefit of the final rule ranges from
approximately $0.13 to $0.14 million
per year annualized over 20 years at a
3% discount rate and from $0.06 to
$0.07 million per year at a 7% discount
rate. In response to the updated Circular
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A–4 published in November 2023, the
incremental benefits at a 2% discount
rate ($0.16 to $0.17 million annualized
over 20 years) are provided in Appendix
C of the Economic Analysis (Ref. 5). To
estimate the costs and benefits of the
WCPP, the Economic Analysis
generated a likely distribution of air
monitoring outcomes at CTC facilities.
This distribution was used to project the
number of facilities that would require
each respirator APF. These estimates are
subject to uncertainties, and there could
be facilities with higher or lower air
exposures than estimated in the
Economic Analysis.
Using the high-end estimates for the
number of entities and workers affected
by the final rule, the monetized net
benefit of the final rule, which is
negative, is ¥$19.6 million per year
annualized over 20 years at a 3%
discount rate and is ¥$18.9 million per
year at a 7% discount rate. In response
to the updated Circular A–4 published
in November 2023, the incremental net
benefits at a 2% discount rate (¥$19.7
million annualized over 20 years) are
provided in Appendix C of the
Economic Analysis (Ref. 5). The range
in the monetized net benefits estimate at
each discount rate presented in the
Economic Analysis reflects uncertainty
in cancer risk reductions given the
shorter exposure durations being
considered and the life stage at which
the changes in exposure occur.
Although the estimated monetized net
benefits are negative, there are also nonmonetized benefits due to other avoided
adverse health effects associated with
CTC exposure, including liver,
reproductive, renal, developmental, and
central nervous system (CNS) toxicity
endpoints. These are serious health
endpoints, even though the change in
risk due to CTC exposure was not
quantified in the 2020 Risk Evaluation
for Carbon Tetrachloride.
Section 6.6 of the Economic Analysis,
addressing environmental justice
impacts, provides sociodemographic
data on communities and workers in
industries affected by the rule and
people who live in proximity to
potentially affected facilities. EPA
analyzed the baseline conditions facing
communities near CTC and HFO
manufacturing facilities as well as those
of workers in the same industry and
county as CTC facilities and HFO
manufacturing facilities. The
environmental justice analysis found
that, across the entire population within
1- and 3-miles of CTC facilities, there
are higher percentages of people who
identify as Black and living below the
poverty line and a similar percentage of
people who identify as Hispanic
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compared to the national averages. CTC
facilities are concentrated in Texas and
Louisiana, especially near Houston and
Baton Rouge.
II. Background
A. Overview of Carbon Tetrachloride
As described in more detail in the
proposed rule, EPA identified liver and
adrenal toxicity cancer adverse effects
from chronic inhalation and dermal
exposures, as well as liver toxicity from
acute dermal exposures in the
workplace as the basis for the
unreasonable risk determination for
CTC (Ref. 1, 2, and 3). This final rule is
specifically intended to address the
unreasonable risk of injury to health
EPA identified in the 2020 Risk
Evaluation for Carbon Tetrachloride
(Ref. 1) and the 2022 Revised
Unreasonable Risk Determination for
Carbon Tetrachloride (Ref. 3), as
described in Unit II.C. CTC is a volatile
organic compound that is primarily
used as a feedstock in the production of
HCFCs, HFCs, and HFOs.
According to data submitted for EPA’s
2016 and 2020 Chemical Data Reporting
(CDR) Rule, in Reporting Years (RY)
2015 and 2019, between 100 and 250
million pounds of CTC were
manufactured or imported in the United
States (Refs. 5, 8, 9). CTC’s use as a
feedstock in the production of HCFCs,
HFCs, and HFOs and the description of
finalized requirements to address the
unreasonable risk are described in Unit
IV.B.
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B. Regulatory Actions Pertaining to
Carbon Tetrachloride
Because of its adverse health effects,
CTC is subject to numerous Federal
laws and regulations in the United
States and is also subject to regulation
by some states and other countries. A
summary of EPA regulations pertaining
to CTC, as well as other Federal, State,
and international regulations, is
provided in the docket (Refs. 1, 10).
As described in more detail in Unit
II.C. of EPA’s proposed rule (88 FR
49184, July 28, 2023) (FRL–8206–01–
OCSPP) and the Response to Public
Comments document (Ref. 11), EPA
considered the adequacy of the current
occupational safety and health
standards from the OSHA (29 CFR part
1910) for protection of workers. EPA
notes that the standards for chemical
hazards that OSHA promulgates under
the Occupational Safety and Health
(OSH Act) share a broadly similar
purpose with the worker protectionrelated regulations that EPA
promulgates under TSCA section 6(a).
The control measures OSHA and EPA
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require to satisfy the objectives of their
respective statutes may also, in many
circumstances, overlap or coincide.
However, there are important
differences between EPA’s and OSHA’s
regulatory approaches and jurisdiction,
and EPA considers these differences
when deciding whether and how to
account for OSHA requirements when
evaluating and addressing potential
unreasonable risk to workers so that
compliance requirements are clearly
explained to the regulated community.
TSCA risk evaluations are subject to
statutory science standards, an explicit
requirement to consider risks to
potentially exposed or susceptible
subpopulations, and a prohibition on
considering costs and other non-risk
factors when determining whether a
chemical presents an unreasonable risk
that warrants regulatory actions—all
requirements that do not apply to
development of OSHA regulations. As
such, EPA may find unreasonable risk
for purposes of TSCA notwithstanding
OSHA requirements. In addition, health
standards issued under section 6(b)(5) of
the OSH Act must reduce significant
risk only to the extent that it is
technologically and economically
feasible. OSHA’s legal requirement to
demonstrate that its section 6(b)(5)
standards are technologically and
economically feasible at the time they
are promulgated often precludes OSHA
from imposing exposure control
requirements sufficient to ensure that
the chemical substance no longer
presents a significant risk to workers.
While it is possible in some cases that
the OSHA standards for some chemicals
reviewed under TSCA will eliminate
unreasonable risk, based on EPA’s
experience thus far in conducting
occupational risk assessments under
TSCA, EPA believes that OSHA
chemical standards would in general be
unlikely to address unreasonable risk to
workers within the meaning of TSCA,
since TSCA section 6(b) unreasonable
risk determinations may account for
unreasonable risk to more sensitive
endpoints and working populations
than OSHA’s risk evaluations typically
contemplate and EPA is obligated to
apply TSCA section 6(a) risk
management requirements to the extent
necessary so that the unreasonable risk
is no longer presented. Because the
requirements and application of TSCA
and OSHA regulatory analyses differ, it
is necessary for EPA to conduct risk
evaluations and, where it finds
unreasonable risk to workers, develop
risk management requirements for
chemical substances that OSHA also
regulates, and it is expected that EPA’s
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findings and requirements may
sometimes diverge from OSHA’s.
Additional considerations of OSHA
standards in the 2022 Revised
Unreasonable Risk Determination for
Carbon Tetrachloride are discussed
further in the Federal Register of
December 27, 2022 (87 FR 79303).
EPA intends for this regulation to be
as consistent as possible with OSHA
regulations for toxic and hazardous
substances, with additional
requirements as necessary to address the
unreasonable risk. Consistent with
TSCA section 9(d), EPA consults and
coordinates TSCA activities with OSHA
and other relevant Federal agencies for
the purpose of achieving the maximum
enforcement of TSCA while imposing
the least burdens of duplicative
requirements.
C. Summary of EPA’s Risk Evaluation
Activities on Carbon Tetrachloride
EPA published the scope of the CTC
risk evaluation in July 2017 (82 FR
31592) (FRL–9963–57), and, after
receiving public comments, published
the problem formulation on June 11,
2018 (83 FR 26998) (FRL–9978–40). In
January 2020, EPA published a draft risk
evaluation (85 FR 4658, January 27,
2020) (FRL–10003–92), and, after public
comment and peer review by the
Science Advisory Committee on
Chemicals (SACC), EPA issued the Risk
Evaluation for Carbon Tetrachloride in
November 2020 in accordance with
TSCA section 6(b) (Ref. 1) (85 FR 70147,
November 4, 2020) (FRL–10015–51).
EPA subsequently issued a draft revised
TSCA unreasonable risk determination
for CTC (87 FR 52766, August 29, 2022)
(FRL–9948–01–OCSPP), and, after
public notice and receipt of comments,
published a Revised Unreasonable Risk
Determination for Carbon Tetrachloride
in December 2022 (Ref. 3) (87 FR 79303,
December 27, 2022) (FRL–9948–02–
OCSPP). The 2020 Risk Evaluation for
Carbon Tetrachloride and supplemental
materials are in docket EPA–HQ–OPPT–
2019–0499, and the December 2022
revised unreasonable risk determination
and additional materials supporting the
risk evaluation process in docket EPA–
HQ–OPPT–2016–0733 available at
https://www.regulations.gov.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for
Carbon Tetrachloride, EPA evaluated
risks associated with 15 conditions of
use within the following categories:
manufacture (including import),
processing, distribution in commerce,
industrial and commercial use, and
disposal (Ref. 1). The conditions of use
are described in Unit III.B.1. of the
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proposed rule (88 FR 49190) (FRL–
8206–01–OCSPP) and in Unit IV. of this
final rule. The 2020 Risk Evaluation for
Carbon Tetrachloride identified
significant adverse health effects
associated with short-term and longterm exposure to CTC. A further
discussion of the hazards of CTC is
presented in Unit III.B.3 of the proposed
rule (88 FR 49192) (FRL–8206–01–
OCSPP) and in Unit V. of this final rule.
2. 2022 Revised Unreasonable Risk
Determination
As described in more detail in the
proposed rule, EPA revised the original
unreasonable risk determination based
on the 2020 Risk Evaluation for Carbon
Tetrachloride and issued a final revised
unreasonable risk determination in
December 2022 (Ref. 3). EPA revised the
risk determination for the 2020 Risk
Evaluation for Carbon Tetrachloride
pursuant to TSCA section 6(b) and
consistent with Executive Order 13990
(titled ‘‘Protecting Public Health and the
Environment and Restoring Science to
Tackle the Climate Crisis’’) and other
Administration priorities (Refs. 12, 13,
14). The revisions consisted of making
a single risk determination for the
whole-chemical substance instead of
making the risk determination for each
individual condition of use, which
resulted in the revised risk
determination superseding the prior ‘‘no
unreasonable risk’’ determinations for
specific conditions of use (Ref. 3), the
withdrawal of the associated TSCA
section 6(i)(1) ‘‘no unreasonable risk’’
order, and clarification that the risk
determination does not reflect an
assumption that all workers are always
provided and appropriately wear
personal protective equipment (PPE)
(Ref. 3).
EPA determined that CTC presents an
unreasonable risk of injury to health,
and EPA did not identify risks of injury
to the environment that contribute to
the unreasonable risk determination for
CTC. The CTC conditions of use that
contribute to EPA’s determination that
the chemical substance poses
unreasonable risk to health are listed in
the unreasonable risk determination
(Ref. 3) and also in Unit III.B.1. of the
proposed rule, with descriptions to aid
chemical manufacturers, processors,
and users in determining how their
particular use or activity would be
addressed under the final regulatory
action. The descriptions of the
conditions of use subject to this final
rule are in Unit IV.
The conditions of use that do not
drive the unreasonable risk for CTC
(distribution in commerce and
processing as a reactant/intermediate in
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reactive ion etching) are also listed in
the unreasonable risk determination
(Ref. 3) and in Unit III.B.2. of the
proposed rule. EPA’s final rule includes
prohibitions on the distribution in
commerce of CTC for certain
downstream uses, but does not include
any restrictions for the processing as a
reactant/intermediate in reactive ion
etching.
3. Description of Unreasonable Risk
EPA has determined that CTC
presents an unreasonable risk of injury
to health under the conditions of use,
based on cancer and acute and chronic
toxicity for non-cancer effects. As
described in more detail in the proposed
rule, the TSCA section 6(b) 2020 Risk
Evaluation for Carbon Tetrachloride,
and the July 2022 errata memorandum
correcting risk estimates for acute
dermal exposures, EPA identified
cancer and liver toxicity adverse effects
from chronic inhalation and dermal
exposures as well as liver toxicity from
acute dermal exposures to CTC (Refs. 1,
2, 3). Cancer adverse effects (e.g., liver,
pheochromocytoma, neuroblastoma)
were identified for chronic inhalation
and dermal exposures. For chronic and
acute non-cancer inhalation exposure to
CTC, liver toxicity due to fatty change
in the liver was indicative of cellular
damage and selected as the most
sensitive non-cancer endpoint. EPA
identified additional risks associated
with other adverse effects (e.g.,
immediate and temporary depression of
the central nervous system, kidney
toxicity, reproductive and
developmental toxicity, irritation and
sensitization, and genetic toxicity)
resulting from acute and chronic
exposures (Ref. 1). By establishing
protections from liver and adrenal
cancer, EPA’s final rule will also
prevent the unreasonable risk from
other less sensitive endpoints, including
acute, chronic non-cancer, and
additional cancer risks from CTC (Ref.
15).
EPA considered potentially exposed
or susceptible subpopulations identified
as relevant to the risk evaluation by the
Agency, which are included in the
quantitative and qualitative analyses
described in the 2020 Risk Evaluation
for Carbon Tetrachloride (Ref. 1) and
were considered in the determination of
unreasonable risk for CTC.
4. Conditions of Use Subject to This
Regulatory Action
As noted in Unit I.C., ‘‘Conditions of
use’’ is defined in TSCA section 3(4). To
assist with the implementation and
compliance with the final rule, in Unit
IV., EPA has provided a description of
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the conditions of use subject to the
WCPP and to prescriptive controls, as
well as those conditions of use
prohibited by this final rule. The
descriptions provided were obtained
from EPA sources such as CDR codes,
the 2020 Risk Evaluation for Carbon
Tetrachloride and related documents, as
well as the Organisation for Economic
Co-operation and Development (OECD)
harmonized use codes, and stakeholder
engagements. EPA received public
comments requesting minor
clarifications of the descriptions for
some industrial and commercial uses,
and EPA has clarified those descriptions
in Unit IV. A description of the minor
changes can be found in the response to
comments document (Ref. 11) and in
Unit III.E.
For the purposes of this final rule,
‘‘occupational conditions of use’’ refers
to the TSCA conditions of use described
in Units IV.B.1., IV.C.1., and IV.D.1. of
the final rule. Although EPA identified
both industrial and commercial uses in
the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1) for purposes of
distinguishing exposure scenarios, the
Agency clarified then and clarifies now
that EPA interprets the authority
Congress gave to the Agency to
‘‘regulat[e] any manner or method of
commercial use’’ under TSCA section
6(a)(5) to reach both industrial and
commercial uses.
EPA further notes that this rule does
not apply to any substance excluded
from the definition of ‘‘chemical
substance’’ under TSCA section
3(2)(B)(ii) through (vi). Those exclusions
include, but are not limited to, any
pesticide (as defined by the Federal
Insecticide, Fungicide, and Rodenticide
Act) when manufactured, processed, or
distributed in commerce for use as a
pesticide; and any food, food additive,
drug, cosmetic, or device, as defined in
section 201 of the Federal Food, Drug,
and Cosmetic Act, when manufactured,
processed, or distributed in commerce
for use as a food, food additive, drug,
cosmetic or device.
D. EPA’s Proposed Rule Under TSCA
Section 6(a) for Carbon Tetrachloride
1. Description of TSCA Section 6(a)
Requirements
Under TSCA section 6(a), if the
Administrator determines through a
TSCA section 6(b) risk evaluation that a
chemical substance presents an
unreasonable risk of injury to health or
the environment, without consideration
of costs or other nonrisk factors,
including an unreasonable risk to
potentially exposed or susceptible
subpopulation identified as relevant to
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the Agency’s risk evaluation, under the
conditions of use, EPA must by rule
apply one or more of the TSCA section
6(a) requirements to the extent
necessary so that the chemical
substance or mixture no longer presents
such risk.
The TSCA section 6(a) requirements
can include one or more of the
following actions alone or in
combination:
• Prohibit or otherwise restrict the
manufacturing (including import),
processing, or distribution in commerce
of the substance or mixture, or limit the
amount of such substance or mixture
which may be manufactured, processed,
or distributed in commerce (TSCA
section 6(a)(1)).
• Prohibit or otherwise restrict the
manufacturing, processing, or
distribution in commerce of the
substance or mixture for a particular use
or above a specific concentration for a
particular use (TSCA section 6(a)(2)).
• Limit the amount of the substance
or mixture which may be manufactured,
processed, or distributed in commerce
for a particular use or above a specific
concentration for a particular use
specified (TSCA section 6(a)(2)).
• Require clear and adequate
minimum warnings and instructions
with respect to the substance or
mixture’s use, distribution in commerce,
or disposal, or any combination of those
activities, to be marked on or
accompanying the substance or mixture
(TSCA section 6(a)(3)).
• Require manufacturers and
processors of the substance or mixture
to make and retain certain records, or
conduct certain monitoring or testing
(TSCA section 6(a)(4)).
• Prohibit or otherwise regulate any
manner or method of commercial use of
the substance or mixture (TSCA section
6(a)(5)).
• Prohibit or otherwise regulate any
manner or method of disposal of the
substance or mixture, or any article
containing such substance or mixture,
by its manufacturer or processor or by
any person who uses or disposes of it
for commercial purposes (TSCA section
6(a)(6)).
• Direct manufacturers or processors
of the substance or mixture to give
notice of the unreasonable risk
determination to distributors, certain
other persons, and the public, and to
replace or repurchase the substance or
mixture (TSCA section 6(a)(7)).
This unit summarizes the TSCA
section 6 considerations for issuing
regulations under TSCA section 6(a),
and it is consistent with the
considerations and analyses presented
in the proposed rule to manage the
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unreasonable risk from CTC (88 FR
49180, July 28, 2023 (FRL–8206–01–
OCSPP)).
As required, EPA developed a
proposed regulatory action and an
alternative regulatory action, which are
described in Units IV.A. and IV.B.,
respectively, of the proposed rule (88 FR
49193 through 491205 (FRL–8206–01–
OCSPP)). To identify and select a
regulatory action, EPA considered the
two routes of exposure driving the
unreasonable risk, inhalation and
dermal, and the exposed populations.
For occupational conditions of use, EPA
considered how it could directly
regulate manufacturing (including
import), processing, distribution in
commerce, industrial and commercial
use, or disposal to address the
unreasonable risk.
As required by TSCA section 6(c)(2),
EPA considered several factors, in
addition to the identified unreasonable
risk, when selecting among possible
TSCA section 6(a) regulatory
requirements for the proposed rule.
EPA’s considerations regarding TSCA
section 6(c)(2) and section 6(c)(2)(A) for
CTC are discussed in full in Unit VI. of
the proposed rule (88 FR 49209) (FRL–
8206–01–OCSPP), including the
statement of effects with respect to these
considerations. After review of the
public comments received, EPA has
revised its statement of effects
considerations in Unit V. of this final
rule.
Additionally, as described in more
detail in EPA’s proposed rule in Unit
V.B. (88 FR 49209) (FRL–8206–01–
OCSPP), EPA considered the availability
of alternatives when finalizing a
prohibition or a substantial restriction
(TSCA section 6(c)(2)(C)), and in setting
final compliance dates in accordance
with the requirements in TSCA section
6(d)(1)(B)).
To the extent information was
reasonably available, EPA considered
pollution prevention strategies and the
hierarchy of controls adopted by OSHA
and the NIOSH when developing its
proposed rule, with the goal of
identifying risk management control
methods that would be permanent,
feasible, and effective. EPA also
considered how to address the
unreasonable risk while providing
flexibility to the regulated community
where appropriate, and EPA took into
account the information presented in
the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1), input from
stakeholders, insight received during
consultations, and anticipated
compliance strategies from regulated
entities.
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Taken together, these considerations
led EPA to the proposed regulatory
action and alternative action described
in Unit II.D.3. The proposed rule
presents additional details related to
how the requirements described in Unit
II.D.1. of this document were
incorporated into development of the
proposed rule and primary alternative
action.
2. Consultations and Other Engagement
a. Consultations
EPA conducted consultations and
outreach as part of development of the
July 28, 2023 proposed rule (88 FR
49180) (FRL–8206–01–OCSPP). The
Agency held a federalism consultation
from December 17, 2020, until February
17, 2021, as part of the rulemaking
process and pursuant to Executive
Order 13132 (Ref. 16).
EPA also consulted with Tribal
officials (Ref. 17). The Agency held a
Tribal consultation from December 7,
2020, through March 12, 2021, with
meetings held on January 6 and 12, 2021
(Ref. 17). EPA received no written
comments as part of this consultation.
EPA’s Environmental Justice (EJ)
consultation occurred from February 2,
2021, through April 2, 2021 (Ref. 18).
On February 2 and 18, 2021, EPA held
public meetings as part of this
consultation. These meetings were held
pursuant to Executive Orders 12898 and
14008. EPA received one written
comment following the EJ meeting, in
addition to oral comments provided
during the consultation (Ref. 18).
More information regarding the
consultations is presented in Units
VIII.E., VIII.F. and VIII.J.
b. Other Stakeholder Consultations
In addition to the formal
consultations described in Unit II.D.2.a.,
EPA held a webinar on December 10,
2020, providing an overview of the
TSCA risk management processes and
the risk evaluation findings for CTC
(Ref. 19). EPA also presented on the
TSCA risk management process and the
findings in the 2020 Risk Evaluation for
Carbon Tetrachloride at a Small
Business Administration (SBA)
Roundtable on December 4, 2020 (Ref.
20). Attendees of these meetings were
given an opportunity to voice their
concerns on both the risk evaluation
and risk management.
Furthermore, during development of
the proposed and final rule, EPA
engaged in discussions with
representatives from different
industries, non-governmental
organizations, organized labor, technical
experts, and users of CTC, including a
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webinar providing an overview of the
proposed rule. A list of external
meetings held during the development
of the 2023 proposed and final rule is
available in the docket (Ref. 21);
meeting materials and summaries are
also in the docket.
c. Children’s Environmental Health
The Agency’s 2021 Policy on
Children’s Health (Ref. 22) requires EPA
to protect children from environmental
exposures by consistently and explicitly
considering early life exposures (from
conception, infancy, early childhood
and through adolescence until 21 years
of age) and lifelong health in all human
health decisions through identifying
and integrating children’s health data
and information when conducting risk
assessments. TSCA section 6(b)(4)(A)
also requires EPA to conduct risk
evaluations ‘‘to determine whether a
chemical substance presents an
unreasonable risk of injury to health or
the environment . . . including an
unreasonable risk to a potentially
exposed or susceptible subpopulation
identified as relevant to the risk
evaluation by the Administrator, under
the conditions of use.’’ In addition,
TSCA section 6(a) requires EPA to apply
one or more risk management
requirements under TSCA section 6(a)
so that CTC no longer presents an
unreasonable risk (which includes
unreasonable risk to any relevant
potentially exposed or susceptible
subpopulation). Information on how the
Policy was applied and on the health
and risk assessments supporting this
action is available under Units II.C. II.D.
and V.A., as well as in Unit III.A.3. of
the July 2023 proposed rule (88 FR
49184 through 49188, 49205 through
49208 and 49190) (FRL–8206–01–
OCSPP), the 2020 Risk Evaluation for
Carbon Tetrachloride, and the Economic
Analysis for this rule (Refs. 1, 5).
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3. Proposed Regulatory Action
EPA’s proposed rule under TSCA
section 6(a) to address the unreasonable
risk presented by CTC under its
conditions of use included the
following:
• Requirements for strict workplace
controls, including a CTC WCPP, which
would include requirements to meet an
inhalation exposure concentration limit
and prevent direct dermal contact with
CTC, for 9 occupational conditions of
use;
• Requirements for prescriptive
workplace controls for laboratory use;
and
• Prohibition of certain processing,
industrial, and commercial conditions
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of use and the manufacture, processing,
and distribution for those uses.
The proposed rule included
timeframes for implementation. The
prohibitions EPA proposed would take
effect six months after the date of
publication of the final rule, except for
the prohibition of the industrial and
commercial use of CTC in specialty uses
by the Department of Defense, which
would take effect one year after the date
of publication of the final rule.
Likewise, for the WCPP, EPA proposed
timeframes for phases of compliance,
beginning with monitoring at six
months and full implementation after 12
months, as described in Unit IV.A.1. of
the proposed rule. EPA also proposed a
compliance timeframe of six months for
prescriptive controls for laboratory use.
Under TSCA section 6(c)(2)(A)(iv)(II)
through (III), EPA is mandated to
consider one or more alternative
regulatory actions. The primary
alternative regulatory action was
included in the proposed rule in Unit
IV.B. (88 FR 49204) (FRL–8206–01–
OCSPP). Similar to the proposed
regulatory action, the primary
alternative regulatory action combined
requirements for a WCPP and
prescriptive controls to address the
unreasonable risk from CTC under its
conditions of use.
The primary alternative regulatory
action included prescriptive workplace
controls, specifically respirators and
dermal PPE, for the conditions of use for
which EPA had proposed a WCPP. The
primary alternative action also included
a WCPP for processing, industrial, and
commercial uses of CTC that EPA had
proposed to prohibit. At the time of
proposal, EPA did not have reasonably
available information indicating that
any of the uses proposed for prohibition
were ongoing. EPA requested comment
on whether any of the uses the Agency
proposed to prohibit are ongoing and if
EPA should consider a WCPP for those
conditions of use of CTC. For the
industrial and commercial use of CTC as
a laboratory chemical, the primary
alternative regulatory action considered
by EPA included the implementation of
only the requirements of Direct Dermal
Contact Controls (DDCC) of the WCPP in
combination with the use of fume hoods
in workplace laboratory settings and
advanced engineering controls
specifically for DoD’s use of CTC as a
laboratory chemical in chemical
weapons destruction. The compliance
timeframes for the controls as part of the
primary alternative regulatory action
were the same as the timeframes
proposed.
For a comprehensive overview of the
primary alternative regulatory action
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refer to Unit IV.B. of the proposed rule,
with the rationale for the primary
alternative regulatory action provided in
Unit V.A.4. of the proposed rule (88 FR
49205 through 49208) (FRL–8206–01–
OCSPP).
4. Public Comments Received
EPA requested comment on all
aspects of the proposed rule. During the
public comment period, EPA held a
webinar on August 15, 2023, providing
an overview of the proposed rule and
TSCA section 6; during the webinar,
members of the public had the
opportunity to share their perspectives
(Ref. 23). The comment period closed on
September 11, 2023. EPA received 23
public comments, with a majority
received from industry trade
organizations. The public comments
also include comments from chemical
manufacturers, advocacy organizations,
laboratory users, a union, an academic
institution, members of the regulated
community, and individual residents. A
summary of the comments as well as
EPA’s responses is in the docket for this
rulemaking (Ref. 11). Additionally, Unit
III. contains summaries of public
comments that informed EPA’s
regulatory approach in this final rule.
After the close of the public comment
period for the proposed rule,
stakeholders, including affected
industry and interested groups,
requested meetings with EPA. Topics of
these meetings included exposure
controls, process descriptions,
monitoring data, and specific conditions
of use. EPA received data as part of and
following these stakeholder meetings
and has made the information available
to the public in the rulemaking docket
(EPA–HQ–OPPT–2020–0592) (Ref. 21).
After review of the public comments
received from the proposed rule, EPA
revised certain preliminary
considerations that impacted which
conditions of use were proposed by EPA
to be prohibited or that could continue
under the WCPP or prescriptive controls
(Ref. 11). Similarly, based on public
comments received, EPA modified for
this final rule several proposed
compliance timeframes, with details in
Unit III.
III. Changes From the Proposed Rule
Unit III. summarizes the main changes
from the proposed rule to the final rule,
based on the consideration of the public
comments.
A. Changes to Requirements for Certain
Conditions of Use
As described in Unit III.A.1., when
compared to the proposed rule, EPA’s
final rule no longer prohibits two sub-
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uses, under two separate conditions of
use that were proposed for prohibition,
and now allows them to continue under
the WCPP. In addition, this final rule
broadens the type of prescriptive
controls required for one condition of
use (Unit III.A.2.), as compared to the
proposed rule. The rationale for these
changes is described in this unit. EPA
emphasizes that implementation of the
WCPP or prescriptive controls can fully
address the unreasonable risk from CTC
for these conditions of use, and that
these changes do not significantly
impact the production volume of CTC
expected to remain in commerce when
compared to the proposed regulatory
action. Taken together, EPA estimates
that there are 10 facilities involved in
the changes of the requirements to the
conditions of use described in Units
III.A.1. and 2., nine of which use CTC
for the industrial and commercial use as
a laboratory chemical. In addition, EPA
understands that small quantities of
CTC are used for the sub-uses that will
continue under the WCPP instead of the
proposed prohibition (Ref. 24). The two
sub-uses which will continue under the
WCPP account for approximately 0.4%
to 1% of total production volume, based
on a comparison of 2019 CDR data on
CTC production volume (between 100
million and 250 million lbs.) and
information reported to EPA regarding
the two sub-uses (Ref. 5, Ref. 24).
1. Changes to the Prohibition of Certain
Conditions of Use
EPA’s primary alternative regulatory
action described in the proposed rule
considered regulating several conditions
of use under the WCPP as an alternative
to the proposed prohibition, including
incorporation into formulation,
mixtures, or reaction products in
petrochemicals-derived manufacturing,
and industrial and commercial use as an
industrial processing aid in the
manufacture of petrochemicals-derived
products. In addition, EPA requested
comment on whether the Agency should
require a WCPP or prescriptive controls,
including respirators and dermal PPE,
for any of the conditions of use EPA
proposed to prohibit.
EPA is finalizing a WCPP for
incorporation into formulation,
mixtures, or reaction products in vinyl
chloride manufacturing and the
industrial and commercial use as an
industrial processing aid in the
manufacture of vinyl chloride, as
included in the primary alternative
regulatory action of EPA’s proposal
under the broader categories of
processing: incorporation into
formulation, mixtures, or reaction
products in petrochemical-derived
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manufacturing and industrial and
commercial use as an industrial
processing aid in the manufacture of
petrochemical-derived products. EPA
proposed to prohibit these sub-uses of
CTC due to the lack of information
indicating that these uses are ongoing,
but requested comment on whether CTC
is still used in these and other
conditions of use EPA proposed to
prohibit, and stated that if EPA received
information indicating the continued
use of CTC for these conditions of use,
the Agency would consider regulating
these uses rather than prohibiting them
(88 FR at 49202 through 49203, 49205,
and 49218). EPA received comments
from one entity indicating that the
incorporation of CTC into formulation,
mixtures, or reaction products in vinyl
chloride manufacturing and the
industrial and commercial use of CTC as
an industrial processing aid in the
manufacture of vinyl chloride are
ongoing (Ref. 24). The entity indicated
that switching to an alternative
chemical or process would require
replacement of existing infrastructure
and result in the temporary loss of
revenue. The entity using CTC for these
uses provided manufacturing data used
in the 2020 Risk Evaluation for Carbon
Tetrachloride, indicating that CTC is
used by this entity in industrialized and
standardized settings that can meet the
requirements of the WCPP. Therefore,
EPA understands that the entity is able
to meet the WCPP requirements for
processing: incorporation into
formulation, mixtures, or reaction
products in vinyl chloride
manufacturing and the industrial and
commercial use as an industrial
processing aid in the manufacture of
vinyl chloride as well. Furthermore,
EPA understands as a general matter
that these uses would occur in highly
industrialized settings and controlled
and closed processes, suggesting a
WCPP could be successfully
implemented such that risk of injury to
health presented by CTC is no longer
unreasonable. CTC was used in other
petrochemical-derived manufacturing
(other than vinyl chloride
manufacturing); however, based on the
reasonably available information, such
uses of CTC do not appear to be
ongoing. Therefore, EPA has concluded
that industry has already found feasible
alternatives to CTC for these uses, EPA
is prohibiting processing: incorporation
into formulation, mixtures, or reaction
products in the remainder of
petrochemical-derived manufacturing
and the industrial and commercial use
of CTC as a processing aid in the
manufacture of remaining
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petrochemical-derived products, as
proposed, to address the unreasonable
risk contributed by these conditions of
use.
2. Changes to Restrictions: Prescriptive
Controls for Industrial and Commercial
Use as a Laboratory Chemical
In general, EPA is finalizing the
prescriptive control requirements for the
industrial and commercial use of CTC as
a laboratory chemical as proposed, with
some modifications based on
consideration of public comments. As
described in the proposed rule, to
address the unreasonable risk of injury
to health resulting from dermal
exposures to CTC for the industrial and
commercial use as a laboratory
chemical, EPA proposed to require
dermal PPE in combination with
comprehensive training for tasks related
to the use of CTC in a laboratory setting
for each potentially exposed person in
direct dermal contact with CTC. EPA
also proposed to require the use of fume
hoods to codify the assumption of
existing good laboratory practices that
EPA relied upon as a key basis for its
evaluation of risk from this condition of
use (Ref. 1). EPA requested comment
relative to the ability of owners and
operators to implement laboratory
chemical fume hood and dermal PPE
related requirements within six months
of publication of the final rule. Under
the primary alternative regulatory
action, EPA included DDCC for
laboratory use and solicited comment
on non-prescriptive requirements of
DDCC as compared to the prescriptive
workplace controls of dermal PPE.
EPA received several comments
regarding the industrial and commercial
use as a laboratory chemical. One
commenter stated that the proposed
regulation would result in confusion
and duplication with the OSHA
standard for occupational exposure to
hazardous chemicals in laboratories
under 29 CFR 1910.1450 that is already
in effect (Ref. 25). A couple of
commenters urged EPA to align its
requirements for laboratory use of CTC
more closely with the OSHA’s
laboratory standard to reduce
compliance burden (Refs. 25, 26).
Commenters also requested that EPA
include flexibility for engineering
controls beyond a fume hood for
consistency with the OSHA lab
standard, stating that, while fume hoods
are considered best practice and
commonly used to reduce exposure in
laboratories, experiment designs
utilizing CTC may not be able to be
accommodated within a fume hood
(Refs. 25, 27). Commenters described
other alternative controls that can be
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designed and implemented to reduce
exposure, such as glove boxes,
exhausted enclosures, ducted biosafety
cabinets, and filtration devices.
Based on information provided by
commenters related to exposure
mitigation controls to comply with the
OSHA laboratory standard and best
management practices available to
laboratories, EPA has determined that
requiring laboratory ventilation devices
such as fume hoods or glove boxes,
would better align with the OSHA
laboratory standard and existing good
laboratory practices. As described in
Unit V.A.2. the proposed rule (88 FR
49201, July 28, 2023) (FRL–8206–01–
OCSPP), EPA proposed to require fume
hoods in laboratory settings to codify
assumptions made in the 2020 Risk
Evaluation for CTC, where EPA’s risk
estimates and determination that
inhalation exposures from the industrial
and commercial use of CTC as a
laboratory chemical did not contribute
to the unreasonable risk were predicated
on its findings that expected safety
practices of using CTC in small amounts
under a fume hood reduce the potential
for inhalation exposures (Ref. 1). In
addition to fume hoods, EPA has
determined that other types of
ventilation systems or containment
devices, when used in compliance with
the OSHA laboratory standard at 29 CFR
1910.1450(e)(3), may minimize
inhalation exposures in a laboratory
setting consistent with the qualitative
assumption in the 2020 Risk Evaluation
for CTC that the potential for inhalation
exposure is low due to expected use of
a fume hood. For the industrial and
commercial use as a laboratory
chemical, EPA concurs with the
commenters that indicated EPA’s
requirements should align more closely
with the OSHA laboratory standard
wherever possible to prevent confusion.
The requirement in this final rule that
laboratory ventilation safety devices,
such as fume hoods or glove boxes, are
in use and functioning properly and that
specific measures are taken to ensure
proper and adequate performance of
such equipment to minimize exposures
to persons in the area when CTC is used
in a laboratory setting aligns with
existing requirements from the OSHA
laboratory standard at 29 CFR
1910.1450(e)(3)(iii) while remaining
consistent with the assumptions made
in the 2020 Risk Evaluation.
As detailed in Unit IV.C. of this final
rule, EPA is finalizing the requirements
for dermal PPE in combination with
comprehensive training for tasks related
to the use of CTC in a laboratory setting
as proposed. EPA believes these
requirements align with OSHA’s
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laboratory standard and OSHA’s
General Requirements for Personal
Protective Equipment at 29 CFR
1910.132 to the extent possible while
still addressing the unreasonable risk of
injury to health resulting from dermal
exposures to CTC identified for the
industrial and commercial use as a
laboratory chemical.
B. Changes to WCPP Timeframes
For the conditions of use for which
EPA proposed the WCPP, EPA proposed
several compliance timeframes,
including the following requirements:
that initial exposure monitoring be
conducted within six months of
publication of the final rule in the
Federal Register (or within 30 days of
introduction of CTC into the workplace
if CTC use commences at least six
months after the date of publication);
that each owner or operator ensure that
the exposure to CTC does not exceed the
ECEL as an 8-hour TWA for all
potentially exposed persons within nine
months of publication of the final rule
in the Federal Register; and that owners
and operators implement an exposure
control plan within 12 months of
publication of the final rule in the
Federal Register. EPA requested
comment regarding the ability of owners
or operators to comply with the various
provisions of the WCPP, including
initial exposure monitoring, within the
compliance timelines included in the
proposal, and anticipated timelines
necessary for any procedural
adjustments needed to comply with the
establishment of a respiratory protection
program and development of an
exposure control plan. EPA also
requested comment regarding the
amount of time, if any, it would take the
regulated community to develop a
method to measure at or below the ECEL
over an entire work shift and
information on what levels of detection
are possible over an entire work shift
based on existing monitoring methods,
justification for the timeframe of the
specific steps needed to develop a more
sensitive monitoring method, cost
associated with a more sensitive
monitoring method, and any additional
detailed information related to
establishing a monitoring program to
reliably measure CTC at or below the
ECEL.
Public comments highlighted
challenges with the proposed
timeframes and suggested longer
timeframes for initial exposure
monitoring. For example, one
commenter stated that the proposed 6month timeframe to conduct initial
exposure monitoring may not be
possible because CTC use may be
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infrequent and only occur annually or
even less frequently, such as
maintenance exercises (Ref. 28). Other
commenters expressed concern that
requirements to comply with a new
exposure limit will stress industrial
hygiene consultants and laboratories
that analyze the samples, and urged
EPA to ensure that there is adequate
time for consultant firms and
laboratories to establish sufficient
capacity (Refs. 29, 30, 31). Several
commenters stated that the proposed 6month timeframe for initial monitoring
would be untenable and suggested that
the deadline be extended to 18 months
(Refs. 29, 30, 32). One commenter stated
that owners or operators should be
given sufficient time to implement any
new requirements which could involve
substantial investments (Ref. 27). Two
of the commenters reasoned that,
particularly for CTC, at least 18 months
is necessary to revalidate methods and
determine whether revision to corporate
exposure assessment strategy is
necessary to address the new ECEL,
including to address the specific
implementation and technical feasibility
challenges of measuring the CTC ECEL
for both full shift and task
measurements (Refs. 29, 30). One
commenter indicated that they need to
develop methods to achieve the
detection limit for the proposed ECEL
and ECEL action level, to procure
professional services to implement the
requirements, and most likely require
laboratory analytical support (Ref. 33).
Additionally, one commenter expressed
concern that corporate and facility
industrial hygiene resources as well as
third party laboratories may also be
conducting a reassessment and analysis
for the methylene chloride and PCE
rules recently promulgated under TSCA
section 6(a), thereby requiring
additional time for CTC (Ref. 29).
In consideration of public comments
and the challenges of initiating the
WCPP, even for facilities with industrial
hygiene programs in place, and the
difference in the occupational exposure
limits between the OSHA permissible
exposure limit (PEL) and the EPA ECEL
and the challenges associated with
monitoring to new, lower EPA exposure
thresholds that may spur an increase in
the need for monitoring or other
exposure control assessment
infrastructure, EPA has determined that
a longer compliance deadline of 540
days is as soon as practicable to conduct
initial monitoring for CTC, which likely
would require regulated entities to
contract new services or realign current
industrial hygiene professionals towards
WCPP compliance. Providing 540 days
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for initial monitoring is intended to (1)
prevent professional safety service
sectors from being overwhelmed by new
EPA requirements; (2) provide time to
procure the necessary services while
ensuring the preservation of safety
quality, standards, and practices; and (3)
provide sufficient time for a
comprehensive exposure evaluation,
increasing the likelihood of successful
implementation of the WCPP. Following
initial monitoring, EPA is finalizing the
requirement that each owner or operator
supply a respirator to each person who
enters a regulated area within three
months after the receipt of any exposure
monitoring that indicates exposures
exceeding the ECEL. Therefore, each
owner or operator must ensure that the
exposures to CTC do not exceed the
ECEL as an 8-hour TWA for all
potentially exposed persons, including
by providing respiratory protection, no
later than 630 days after December 18,
2024. Given the full WCPP requirements
(including the exposure control plan)
are required after owners or operators
are required to ensure that no person is
exposed to an airborne concentration
that exceeds the TWA ECEL, EPA
acknowledges that compliance with the
ECEL may include temporary PPE use
(e.g., respiratory protection) until
comprehensive engineering and
administrative controls are fully
implemented. As described in the
proposed rule, EPA believes that three
months after receipt of exposure
monitoring results is as soon as
practicable, while also providing a
reasonable transition period for entities
to evaluate exposure monitoring results,
acquire the correct respiratory
protection, and establish the PPE
program, including training, fit-testing,
and medical evaluation.
EPA also received public comment
regarding the compliance timeframe for
full implementation of the WCPP,
including detailing the evaluation steps
that would be required to assess a
facility and develop, document, and
implement an exposure control plan. To
allow time for orderly transitions and
training to comply with an ECEL (0.03
ppm (8-hr TWA)) that is significantly
lower than the OSHA PEL of 10 ppm (8hr TWA) and the American Conference
of Governmental Industrial Hygienists
(ACGIH) threshold limit value (TLV) of
5 ppm (8-hr TWA) for CTC, two
commenters suggested that EPA adopt a
graduated implementation approach for
ECEL implementation by first requiring
entities that already meet the OSHA PEL
to comply with the ACGIH TLV within
two years from the effective date of the
final rule and then permitting those
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facilities meeting the ACGIH standard
three years to transition to the ECEL
(Refs. 34, 35). Two commenters
expressed concern that the proposed
timeframes would be insufficient for
owners or operators to document their
efforts to implement the hierarchy of
controls as required under the WCPP,
and recommended that the time
required to develop the exposure
control plan be extended to two years
from completion of initial monitoring,
for a total of 24 to 36 months from the
effective date of the final rule, to
provide adequate time for entities to
evaluate and implement appropriate
compliance approaches that provide
flexibility and are the most effective for
protecting workers (Refs. 29, 30).
Based on comments, outreach,
reasonably available information, and
existing OSHA standards, EPA
maintains that the majority of the
exposure reduction and worker safety
infrastructure needed for compliance is
currently in place, but recognizes the
fundamental challenge of building a
new exposure control strategy around
the new, lower EPA exposure limit.
Additionally, based on consideration of
public comment and given that OSHA
has not promulgated a detailed standard
specific to CTC, EPA has determined
that a longer compliance timeframe of
1080 days for development and
implementation of an exposure control
plan is as soon as practicable to ensure
that the regulated community has
adequate time to evaluate monitoring
data, assess and develop an exposure
strategy, procure appropriate control
technology and PPE, and implement the
required chemical safety program for
CTC.
Therefore, EPA is finalizing the
compliance timeframes for the WCPP
provisions as follows: (1) The
requirements for each owner or operator
to conduct initial baseline monitoring
must be met within 540 days after
December 18, 2024, or within 30 days of
introduction of CTC into the workplace,
whichever is later; (2) the requirements
for each owner or operator to ensure
that exposure to CTC does not exceed
the ECEL as an 8-hour TWA for all
potentially exposed persons, including
by providing respiratory protection to
all potentially exposed persons in the
regulated area must be met within 630
days after December 18, 2024, or within
three months after receipt of the results
of any exposure monitoring that
indicates exposures exceeding the
ECEL; and (3) the requirements for
development and implementation of an
exposure control plan must be met
within 1,080 days after December 18,
2024. For greater clarity in this final
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rule, EPA is also finalizing with slight
modification the requirement that
owners and operators institute a training
and information program for potentially
exposed persons and assure their
participation in the training and
information program, and that this
requirement be met within 630 days
after December 18, 2024 (see Unit
IV.B.7.a.).
EPA understands that certain
departments and agencies of the Federal
government, as well as Federal
contractors acting for or on behalf of the
Federal government, need additional
time to comply with these timeframes.
For example, complying with these
timeframes could impact the ability of
the Department of Energy (DOE) to
perform sampling and groundwater
treatment at contaminated plumes and
wastewater treatment facilities. While,
for example, 29 CFR part 1960 sets forth
procedures and guidelines for ensuring
that Federal workers are protected in
comparable ways to their non-Federal
counterparts, EPA believes that
compliance with this final rule will
require increased and different
preparations on the part of Federal
agencies. For example, Federal agencies
must follow procurement requirements,
which will likely result in increased
compliance timelines. In addition, these
requirements will require support in the
Federal budget, which, for some
agencies, is a multi-year process.
Therefore, EPA is providing additional
time for agencies of the Federal
government and their contractors, when
acting for or on behalf of the Federal
government, to comply with the WCPP
provisions as follows: (1) The
requirements for each owner or operator
to conduct initial baseline monitoring
must be met within 915 days after
December 18, 2024, or within 30 days of
introduction of CTC into the workplace,
whichever is later; (2) the requirements
for each owner or operator to ensure
that exposure to CTC does not exceed
the ECEL as an 8-hour TWA for all
potentially exposed persons, including
by providing respiratory protection to
all potentially exposed persons in the
regulated area, must be met within
1,005 days after December 18, 2024, or
within three months after receipt of the
results of any exposure monitoring that
indicates exposures exceeding the
ECEL; (3) the requirements for each
owner or operator to ensure all persons
are separated, distanced, physically
removed, or isolated from direct dermal
contact with CTC, including by
providing dermal PPE, must be met
within 1,005 days after December 18,
2024; (4) the requirements for
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development and implementation of an
exposure control plan must be met
within 1,080 days after December 18,
2024; and (5) the requirement that
owners or operators of workplaces
subject to the WCPP institute a training
and information program for potentially
exposed persons and assure their
participation in the training and
information program within 1,005 days
after the date of publication of the final
rule in the Federal Register (i.e., no later
than September 20, 2027).
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C. Changes to WCPP Requirements
1. Exposure Monitoring Requirements
As part of the WCPP, EPA proposed
to require owners or operators meet
certain documentation requirements for
each monitoring event of CTC,
including compliance with the Good
Laboratory Practice (GLP) Standards in
accordance with 40 CFR part 792.
Numerous commenters expressed
concern regarding the requirement that
the WCPP include compliance with the
GLP Standards (Refs. 28, 29, 30, 31, 35,
36). Commenters stated that it is
atypical, for industrial hygiene
purposes, to use this standard for air
sampling of CTC (Refs. 29, 30, 31).
According to the commenters, it is
common practice within the industrial
hygiene community to have analyses
performed by American Industrial
Hygiene Association (AIHA) accredited
labs (Ref. 29). One commenter added
that collection of occupational
monitoring samples need not be
conducted under the GLP Standards
where planning and collection is
overseen by a Certified Industrial
Hygienist or Environmental Professional
as defined at 40 CFR 312.10 (Refs. 30,
31). Commenters also suggested
applying the policy described in typical
TSCA section 5(e) orders that establish
a New Chemical Exposure Limit (NCEL)
under the TSCA New Chemicals
Program, which states that compliance
with GLP Standards is not required
where exposure monitoring samples are
analyzed by a laboratory accredited by
either: (A) the AIHA Industrial Hygiene
Laboratory Accreditation Program; or
(B) another comparable program
approved in advance in writing by EPA
(Refs. 29, 30, 31). Another commenter
reasoned that GLP Standards were not
intended for air monitoring in a
workplace when compliance with such
standards would mean that real-time
assessments could not be made, as air
samples would need to be processed
and analyzed in a laboratory (Ref. 28).
EPA agrees with the commenter that
the WCPP is incompletely served by
solely relying on the GLP Standards
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initially put forth in the July 29, 2023
proposed rule (88 FR 49180) (FRL–
8206–01–OCSPP). Given the concern
from commenters regarding potential
increases in demand for professional
safety services and sampling
laboratories having a negative impact
due to anticipated industry strain and
sampling limitations (Refs. 29, 30, 31),
EPA has broadened the scope of
laboratory accreditation accordingly.
EPA has considered this laboratory
capacity issue, in addition to other
revisions for finalization in this rule, so
that the additional infrastructure is in
place for the regulated community to
successfully implement the WCPP. For
the final rule, EPA is requiring that
exposure samples be analyzed using an
appropriate analytical method, and
related records retained, by a laboratory
that complies with the GLP Standards in
40 CFR part 792 or that otherwise
maintains a relevant third-party
laboratory accreditation (e.g., under the
AIHA Laboratory Accreditation
Programs, LLC Policy Module 2A/B/E of
Revision 17.3), or other analogous
industry-recognized programs.
Another commenter stated that EPA’s
proposal did not make clear that
‘‘personal breathing zone’’ air samples
to monitor exposures are to be taken
without regard to respirator use. The
commenter noted that OSHA requires
exposure monitoring to be conducted
without regard to respirator use (citing
as an example OSHA’s definition of
‘‘employee exposure’’ at 29 CFR
1910.1052(b)) and asserted that this
important element of OSHA’s
monitoring program was omitted from
EPA’s proposal (Ref. 37). EPA agrees
with the commenter that exposure
monitoring should be conducted
without regard to respiratory protection
to inform engineering control options
and respiratory protection
considerations. Therefore, EPA is
finalizing this rule to explicitly state
that air sampling is required to measure
ambient concentrations for CTC without
taking respiratory protections into
account when being performed. This
will ensure the appropriate degree of
protection to potentially exposed
persons by logging accurate ambient air
concentrations of CTC, thus
empowering owners or operators to
appropriately consider the hierarchy of
controls.
Additionally, as part of the WCPP,
EPA proposed to require owners and
operators to re-monitor within 15
working days after receipt of any
exposure monitoring when results
indicated non-detect, unless an
Environmental Professional as defined
at 40 CFR 312.10 or a Certified
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Industrial Hygienist reviews the
monitoring results and determines remonitoring is not necessary. EPA
received several comments disagreeing
with the proposed requirement to
review non-detect air monitoring
samples. The commenters stated that
facilities use accredited labs to perform
industrial hygiene sampling analysis,
the results are reviewed by industrial
hygiene professionals, and it is an
unnecessary step that adds no value to
reduce risk to workers (Refs. 29, 30, 31).
EPA disagrees with commenters that
expressed the opinion that re-evaluating
a non-detect result adds no value and is
inappropriate. While in some cases a
non-detect result may accurately
indicate that the chemical is not present
and that air concentrations are below
the ECEL action level, in other cases it
may not necessarily imply negligible
occupational exposure to the chemical.
For example, interference from another
chemical during sampling may result in
an incorrect result of non-detect. This
interference may not be recognized at
the time of sampling or analysis.
Owners and/or operators also may not
be using sampling techniques or
analytical procedures that are effective
or appropriate for the particular
chemical of interest. In each of these
cases, non-detect results, along with
supporting documentation about the
sampling and analytical methods used
to get those results, is a meaningful part
of the potentially exposed person’s
exposure record required under the
WCPP. The WCPP in the proposed rule
and in this final rule does not require remonitoring in all cases. Re-monitoring
may be necessary based on a
professional evaluation by an
Environmental Professional as defined
at 40 CFR 312.10 or a Certified
Industrial Hygienist. This flexibility
allows owners or operators options in
terms of revisiting occupational
sampling in the event of a non-detect
result, or evaluation by a qualified
professional.
EPA determined that a non-detect
sampling result when effective sampling
and analysis procedures are used is
valuable to an owner/operator in that it
suggests effective implementation of
exposure controls. Potentially exposed
persons may also use these records in
discussions with owner/operators, in
collective bargaining situations, or in
compliance assistance inquiries to EPA
or other federal agencies. Exposure
monitoring results may also improve
overall workplace health and reducing
owner/operator liability in the effective
detection, treatment, and prevention of
occupational disease or illness. All of
the above scenarios are valuable for
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owner/operators, potentially exposed
persons, and for effective mitigation of
occupational exposures. In
consideration of these factors, EPA has
removed the air monitoring equipment
malfunction from the monitoring
activities that do not require resampling
based on professional evaluation by an
Environmental Professional or Certified
Industrial Hygienist. While professional
discretion may be warranted in
determining whether re-monitoring is
needed following results that indicate
non-detect, EPA has determined this is
not appropriate in the event of air
monitoring equipment malfunction.
This is due to the importance of air
monitoring in ensuring that the
requirements of the WCPP are met, and
the importance of the WCPP in reducing
risks from exposures to CTC in the
workplace. Monitoring results from
malfunctioning air monitoring
equipment are not valid monitoring and
therefore not sufficient to meet the
monitoring requirements under the
WCPP.
EPA may consider developing
additional guidance regarding
occupational monitoring in the future.
Therefore, EPA is finalizing the
requirement to re-monitor within 15
working days after receipt of any
exposure monitoring if results indicated
non-detect unless an Environmental
Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist
reviews the monitoring results and
determines re-monitoring is not
necessary. EPA has updated the
recordkeeping requirements associated
with the WCPP exposures records
required under 40 CFR 751.713(b)(1) to
require documentation of the
determination by the Environmental
Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist to be
maintained as a record. Occupational
monitoring (and associated
recordkeeping) is an area that EPA may
develop guidance as part of final rule
implementation efforts.
2. Designated Representative
EPA proposed to require owners and
operators to provide potentially exposed
persons regular access to the exposure
control plan, exposure monitoring
records, and PPE program
implementation plan (documenting
proper application, wear, and removal
of PPE). EPA requested comment on
how owners and operators could engage
with potentially exposed persons on the
development and implementation of an
exposure control plan and PPE program.
One commenter stated that employees
should be engaged in the development
and implementation of the exposure
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control plan and that the engagement is
best performed during the PPE and
respirator training (Ref. 27). Another
commenter urged EPA to require that
owners and operators consult with
workers and their designated
representatives in developing and
implementing their plans (Ref. 37).
EPA received public comment on the
role of designated representatives in the
WCPP. One commenter, a group of labor
unions, urged EPA to incorporate
requirements similar to OSHA’s access
standard at 29 CFR 1910.1020 (entitled,
‘‘Access to employee exposure and
medical records’’) in EPA’s proposed
recordkeeping requirements for the
WCPP to ensure that exposure
information is promptly and fully
shared with both potentially exposed
persons and their designated
representatives (Ref. 37). The
commenter also suggested that EPA
include a requirement that employers
provide employees or their designated
representatives an opportunity to
observe monitoring events. The
commenter observed that workers and
their designated representatives have a
critical role to play in ensuring effective
control of toxic substances and further
noted that, often, unions are the
organizations with expertise in
understanding occupational exposure
information.
Following review of the comments
received, EPA recognizes the
importance of having the ability for
potentially exposed persons and their
designated representative(s), such as
labor union representatives, to observe
exposure monitoring and have prompt
access to exposure records. EPA
additionally recognizes that, in some
instances, individual workers may be
hesitant to ask owners or operators for
information relating to their chemical
exposure or may be less familiar with
discipline-specific industrial hygiene
practices. EPA determined that it is
appropriate in this final rule to establish
requirements regarding designated
representatives, consistent with existing
OSHA precedent in certain 29 CFR part
1910, subpart Z regulations, to allow
designated representatives the ability to
observe occupational exposure
monitoring and have access to exposure
monitoring records. In EPA’s final rule,
the WCPP includes a requirement that
owners and operators provide
potentially exposed persons or their
designated representatives an
opportunity to observe any exposure
monitoring that is designed to
characterize their exposures and is
conducted under the WCPP. EPA is also
finalizing a requirement that designated
representatives have access to relevant
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exposure records, similar to provisions
in certain OSHA regulations under 29
CFR part 1910, subpart Z, such as 29
CFR 1910.1200 and 29 CFR 1910.1020.
EPA is requiring owners and operators
to notify potentially exposed persons
and their designated representatives of
the availability of the exposure control
plan and associated records of exposure
monitoring and PPE program
implementation within 30 days of the
date that the exposure control plan is
completed and at least annually
thereafter. EPA is also requiring,
consistent with the proposed
requirement for notification of exposure
monitoring results, that the notice of the
availability of the exposure control plan
and associated records be provided in
plain language writing to each
potentially exposed person in a
language that the person understands or
posted in an appropriate and accessible
location outside the regulated area with
an English-language version and a nonEnglish language version representing
the language of the largest group of
workers who do not read English. While
EPA encourages owners or operators to
consult with persons that have potential
for exposure and their designated
representatives on the development and
implementation of the exposure control
plan, EPA has determined that it is not
necessary to include this as a
requirement in the final rule, consistent
with OSHA, because the involvement of
designated representatives in the
observation of occupational monitoring
and the potential to access exposure
records being finalized in this rule
provide a productive forum for
communicating with owner/operators
about the exposure control plan. EPA
believes that the notification of the
exposure control plan and associated
records may help facilitate participation
from potentially exposed persons and
their designated representatives in the
implementation and further
development of that plan.
EPA’s final rule to address the
unreasonable risk of PCE under TSCA
section 6(a) (RIN 2070–AK84)
established the definition of ‘‘designated
representative’’ intended to apply to all
TSCA section 6(a) requirements under
40 CFR part 751 at § 751.5. A recognized
or certified collective bargaining agent
must be treated automatically as a
designated representative without
regard to written authorization.
Additionally, with respect to Federal
Government employees, EPA, like
OSHA at 29 CFR 1960.2(e), will
interpret these designated representative
requirements consistent with the
Federal Service Labor Management
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Relations Statute (5 U.S.C. 7101 et seq.),
or collective bargaining or other labormanagement arrangements that cover
the affected employees.
Should a request be initiated for such
records by the potentially exposed
person or their designated
representative(s), the owner or operator
will be required to provide the specified
records at a reasonable time, place, and
manner, analogous to provisions
outlined in OSHA’s 29 CFR
1910.1020(e)(1)(i). If the owner or
operator is unable to provide the
requested records within 15 working
days, the owner or operator must,
within those 15 days, inform the
potentially exposed person or
designated representative(s) requesting
the record of the reason for the delay
and the earliest date when the record
will be made available. Additionally, in
the event that a designated
representative is observing exposure
monitoring, the owner or operator must
ensure that designated representatives
are provided with PPE appropriate for
the observation of monitoring. Finally,
this rule requires owners or operators to
provide notice to potentially exposed
persons and their designated
representatives of exposure monitoring
results and of the availability of the
exposure control plan and associated
records. For purposes of this
requirement, the owner or operator is
only required to provide notice to those
designated representatives that the
owner or operator is aware of, such as
representatives designated in writing or
a recognized collective bargaining agent
for the owner or operator’s own
employees.
3. Other Changes to the WCPP
EPA proposed various requirements
under the WCPP for owners or operators
to provide PPE, including respiratory
protection and dermal protection, to
potentially exposed persons and to
establish a PPE program. For greater
clarity in this final rule, EPA has revised
the PPE requirements with respect to
the cross-references to the relevant
OSHA regulations. While the language
appears different than the requirements
included in the proposed rule, it
remains EPA’s intention that owners
and operators implement PPE programs
that are consistent with OSHA
requirements. The PPE requirements as
part of the WCPP in this final rule are
described in Unit IV.B.6.
D. CTC Unintentionally Present in Trace
Quantities in Other Chemical
Substances
Several public comments on the
proposed rule urged EPA to establish an
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explicit ‘‘de minimis’’ weight fraction
threshold or add an exemption for
impurities or other contaminants from
the rule’s requirements for small levels
of CTC present in other chemical
substances or mixtures (Refs. 26, 28, 29,
30, 31, 35, 38, 39). Two commenters
raised concerns that absent such
exemption, the proposed prohibition on
industrial and commercial use of CTC as
an industrial processing aid in the
manufacture of petrochemicals-derived
products would inadvertently prohibit
the industrial and commercial use of
PCE as a processing aid in catalyst
regeneration in petrochemical
manufacturing, which EPA is regulating
under a WCPP in a separate TSCA
section 6(a) rulemaking for PCE, because
PCE contains trace amounts of CTC as
an impurity or other contaminant (Refs.
26, 38). Two other commenters who
supported a de minimis exclusion for
impurities noted that prohibiting
impurities in downstream products or
CTC impurities in feedstocks could
severely hamper numerous value chains
and stated that establishing a de
minimis weight fraction threshold of
0.1% by weight for the CTC restrictions
would align with existing requirements
under OSHA’s Hazard Communication
Standard (Refs. 30, 31). One of these
commenters stated that a member
company imports a product containing
a very small amount of CTC as an
impurity, then sells the sealed container
for rubber processing; this commenter
urged EPA to expressly exempt from the
WCPP requirement these zero exposure
and de minimis scenarios (Ref. 31).
Another commenter stated that a
member uses some raw materials that
contain CTC, primarily chlorinated
rubbers and methylene chloride, in the
manufacturing of adhesives and
coatings, and was concerned that this
use would fall under the proposed
prohibitions (Ref. 39). Another
commenter asserted that any formulated
products that contain de minimis
concentrations of CTC (i.e.,
concentrations less than 0.1% by
weight) would not pose a risk and
should not be covered by the rule (Ref.
29). Two other commenters
recommended that EPA include both a
de minimis exemption for materials in
which CTC may appear at de minimis
levels of less than 0.1% by weight, and
an exemption for CTC present in a
formulation, in an intermediate, or in an
end product as an impurity or
byproduct, including when present as
an unintentional byproduct or impurity
in an imported product (Refs. 26, 35).
One commenter suggested that EPA
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implement a de minimis weight fraction
threshold of 0.5% (Ref. 39).
In the final rule, EPA has excluded
from the rule’s requirements CTC that is
solely present unintentionally in trace
quantities with another chemical
substance or mixture. This exclusion is
intended to cover circumstances in
which another chemical substance or
mixture unintentionally contains trace
quantities of CTC that may be present as
a manufacturing residue, unreacted
feedstock, byproduct, or other
contaminant. The Agency determined
that this exclusion was appropriate
because the conditions of use of CTC
that were evaluated in the 2020 Risk
Evaluation for Carbon Tetrachloride and
determined to contribute to the
unreasonable risk presented by CTC did
not include scenarios in which trace
amounts of CTC is unintentionally
present in other chemical substances or
mixtures. To the contrary, Section
1.4.2.3 of the Risk Evaluation stated that
there were conditions of use that EPA
concluded in the 2018 Problem
Formulation of the Risk Evaluation for
Carbon Tetrachloride would present
only de minimis exposures or otherwise
insignificant risks from trace amounts of
CTC and did not warrant inclusion in
the risk evaluation. This conclusion was
related specifically to industrial/
commercial/consumer uses of CTC in
adhesives/sealants, paints/coatings, and
cleaning/degreasing solvent products.
EPA reserves the right to assess and
address potential environmental and
health risks of trace quantities of CTC
under different authorities such as CAA
Title I and VI. The 2020 Risk Evaluation
for Carbon Tetrachloride explained that
while CTC’s use as a process agent in
the manufacturing of other chlorinated
compounds may result in trace levels of
CTC as a manufacturing residue in the
chlorinated substances used to
manufacture downstream products,
those trace amounts are expected to
volatilize during the product
manufacturing process, such that EPA
expected insignificant or unmeasurable
concentrations of CTC in the
chlorinated substances in commercially
available adhesive/sealant, paint/
coating, and cleaning/degreasing
products. The final rule’s exclusion for
CTC unintentionally present in trace
quantities with another chemical
substance or mixture is consistent with
this earlier exclusion from the scope of
the Risk Evaluation for Carbon
Tetrachloride. Any product with CTC
concentrations above trace quantities
that falls within a condition of use
regulated under this rule will be subject
to the relevant rule provisions (e.g.,
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WCPP, prescriptive controls, or
prohibition), as appropriate based on
the condition of use of CTC.
In addition, any potential
occupational risk from the presence of
trace quantities of CTC in PCE is
expected to be eliminated by the
recently promulgated final risk
management rule for PCE under TSCA
section 6(a) (to be codified at 40 CFR
part 751, subpart G). The occupational
and consumer protections from
exposures to PCE under that final rule,
which address the unreasonable risk of
injury to health presented by PCE under
its conditions of use, would also have
the effect of reducing the risk from
exposures to trace amounts of CTC that
may be present in PCE. For example, the
final rule requires a workplace chemical
protection program with both an
Existing Chemical Exposure Limit of
0.14 ppm of PCE as an 8-hr TWA and
direct dermal contact control
requirements for the industrial/
commercial use of PCE as a processing
aid in catalyst regeneration in
petrochemical manufacturing. Any
engineering controls or PPE used to
reduce occupational exposures to PCE
for the use as a processing aid in
catalyst regeneration in petrochemical
manufacturing are expected to reduce
workplace exposures to CTC. The
limitations on inhalation and dermal
exposures to PCE to prevent
unreasonable risk of injury to health
from that chemical substance are also
expected to limit any potential exposure
to trace quantities of CTC that may be
unintentionally present in the PCE,
reducing the risk of injury to health
from the CTC, so that that condition of
use does not contribute to the
unreasonable risk of CTC.
At this time, EPA is not establishing
a specific weight fraction or other
numerical threshold value for the trace
quantities exclusion in the CTC final
rule, consistent with existing exclusions
of trace quantities of remaining
substances from the definitions of
‘‘controlled substance’’ and ‘‘transform’’
under 40 CFR 82.3. Instead, the
exclusion is based on the plain meaning
of the term, ‘‘trace quantities.’’ If the
CTC is intentionally retained in the
chemical substance or mixture of which
it is a part and provides a desired
purpose, then it is not ‘‘present
unintentionally in trace quantities’’ and
would not be excluded from the rule’s
requirements.
E. Other Changes
EPA has revised its proposed
description of industrial and
commercial use of CTC as a laboratory
chemical to provide additional clarity as
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suggested by a commenter (Ref. 33). The
revised description for industrial and
commercial use as a laboratory chemical
appears in Unit IV.C.1. In addition, EPA
has slightly modified the industrial and
commercial use descriptions in 40 CFR
751.705(b)(1)(ii)(B), 751.707(a)(8), and
751.711(c) to clarify that the industrial
and commercial use of CTC in the
recovery of chlorine in tail gas from the
production of chlorine falls under the
WCPP rather than the prohibition on
industrial and commercial use in the
manufacture of other basic chemicals
(including manufacturing of chlorinated
compounds used in solvents, adhesives,
asphalt, and paints and coatings). In the
proposed rule, EPA had intended this
use of CTC to be captured with the
description of ‘‘industrial and
commercial use in the elimination of
nitrogen trichloride in the production of
chlorine and caustic soda,’’ but EPA
agrees with two public commenters that
it would be clearer to specifically list
use of CTC in the recovery of chlorine
in tail gas from the production of
chlorine in the regulatory text (Refs. 29,
30).
EPA has revised its proposed
description of disposal. Based on
coordination across Federal programs,
for the disposal COU, EPA has
determined it is appropriate that owners
and operators of cleanup sites where
potentially exposed persons are
involved in the disposal of CTCcontaining wastewater for the purposes
of cleanup projects of CTCcontaminated water and groundwater,
including industrial pre-treatment and
industrial treatment activities, must
ensure that potentially exposed persons
involved with the activity of removing
the groundwater from the location
where it was found and treating the
removed groundwater on site comply
with the WCPP. At cleanup sites, the
WCPP, including the ECEL, would
apply to any potentially exposed person
involved in the disposal of CTCcontaining groundwater, which most
likely includes a worker who is
involved with the activity of removing
CTC- containing groundwater from the
location where it was found and the onsite treatment of the groundwater,
typically referred to as ex situ
remediation, which is most consistent
with the scope of the 2020 CTC Risk
Evaluation. Ex situ remediation
includes both active and passive
remediation methods that span
traditional (e.g., pump and treat) and
less traditional (e.g., phytoremediation)
approaches, but only if the remediation
method would be considered industrial
wastewater pretreatment, industrial
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wastewater treatment or discharge to a
publicly owned treatment work
(POTW). EPA generally considers
workers in and around those locations
to be potentially exposed persons as that
term is defined in 40 CFR 751.5. For
example, EPA’s requirements would
apply to protect workers conducting
remediation through pump and treat
systems or workers sampling
groundwater in conjunction with
groundwater extraction or treatment
(e.g., remediation or cleanup) activities.
EPA considers only those treatment
activities that are performed at the
cleanup site on CTC-contaminated
wastewater that has been removed from
the subsurface, surface water
impoundments, or aquifers and that are
recognized as industrial treatment,
industrial pretreatment, or discharge to
a POTW to be covered under the
provisions described in Unit IV.B. The
provisions of the WCPP for the disposal
COU, including the ECEL, are not
intended to cover potentially exposed
persons who are sampling groundwater
to monitor the presence of a plume, but
specifically only those sampling at the
site of extraction and treatment
activities. EPA emphasizes that this
standard is only for cleanup sites
involved in the active or passive ex situ
treatment (or disposal) of CTC
contaminated groundwater and
wastewater from cleanup sites and that
no other remedial actions at cleanup
sites will be covered or affected.
Additionally, while EPA considers solid
wastes as part of the waste streams
included in the disposal COU, at
groundwater remediation sites managed
by the Federal government and under
existing waste disposal requirements,
the WCPP requirements under this
rulemaking only apply to water
contaminated with CTC, and any other
type of CTC-impacted waste will be
managed according to relevant existing
requirements under RCRA, other
statutes, and regulatory agreements.
Additionally, it is not necessary to
establish previously proposed Subpart
A definitions for ‘‘authorized person,’’
‘‘owner or operator,’’ ‘‘potentially
exposed person,’’ and ‘‘regulated area’’
in this final rule because EPA already
established definitions for these terms at
40 CFR 751.5 in the TSCA section 6
final rule for methylene chloride (RIN
2070–AK70) (89 FR 39254, May 8, 2024
(FRL–8155–01–OCSPP)) so that these
definitions may be commonly applied to
this and other rules under TSCA section
6 that would be codified under 40 CFR
part 751. Similarly, it is not necessary
to establish previously proposed
Subpart A definitions for ‘‘direct dermal
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contact,’’ ‘‘exposure group,’’ and
‘‘ECEL’’ in this final rule because EPA
already established definitions for these
terms at 40 CFR 751.5 in the TSCA
section 6 final rule for PCE (RIN 2070–
AK84).
EPA proposed to require that the
notification to companies to whom CTC
is shipped under 40 CFR 751.111(c)
identify the uses for which CTC is
allowed to be distributed in commerce.
To provide greater clarity to
downstream users of CTC regarding the
provisions of this rule, EPA is
modifying the notification to identify
the uses prohibited under this
regulation.
EPA also made other minor edits to
the preamble and regulatory text to
provide more clarity to the requirements
of the final rule.
IV. Provisions of the Final Rule
EPA intends that each provision of
this rulemaking be severable. In the
event of litigation staying, remanding, or
invalidating EPA’s risk management
approach for one or more conditions of
use in this rule, EPA intends to preserve
the risk management approaches in the
rule for all other conditions of use to the
fullest extent possible. The Agency
evaluated the risk management options
in TSCA section 6(a)(1) through (7) for
each condition of use and generally
EPA’s regulation of one condition of use
to address its contribution to the
unreasonable risk from CTC functions
independently from EPA’s regulation of
other conditions of use, which may have
different characteristics leading to EPA’s
risk management decisions. Further, the
Agency crafted this rule so that different
risk management approaches are
reflected in different provisions or
elements of the rule that are capable of
operating independently. Accordingly,
the Agency has organized the rule so
that if any provision or element of this
rule is determined by judicial review or
operation of law to be invalid, that
partial invalidation will not render the
remainder of this rule invalid.
There are many permutations of the
above. For example, as discussed in
Unit IV.D., this final rule prohibits both
the industrial and commercial use of
CTC in metal recovery, and the
industrial and commercial use of CTC as
a processing aid in the manufacture of
petrochemical-derived products except
in the manufacture of vinyl chloride (for
which EPA is requiring a WCPP as
described in Unit III.A.). To the extent
that a court were to find that EPA lacked
substantial evidence to support the
prohibition of CTC as a processing aid
in the manufacture of petrochemicalderived products or otherwise found
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legal issues with EPA’s approach to that
condition of use, it would have no
bearing on other similarly situated
conditions of use, such as the industrial
and commercial use in metal recovery,
unless the specific issue also applies to
the particular facts associated with
metal recovery. This is reflected in the
structure of the rule, which describes
the prohibited conditions of use
separately under 40 CFR 751.705.
As another example, for the
processing of CTC as a reactant in the
production of HCFCs, HFCs, HFOs, and
PCE and the industrial and commercial
use of CTC as a laboratory chemical,
EPA took different risk management
approaches—application of the WCPP
for the processing of CTC as a reactant
in the production of HCFCs, HFCs,
HFOs, and PCE and specific prescriptive
controls for use as a laboratory
chemical. To the extent that a court
were to find a legal issue with EPA’s
approach to the WCPP, impacting the
processing of CTC as a reactant in the
production of HCFCs, HFCs, HFOs, and
PCE, it would have no bearing on EPA’s
decision to require specific prescriptive
controls for industrial and commercial
use as a laboratory chemical, and vice
versa. This is reflected in the structure
of the rule, which organizes the WCPP
and prescriptive controls into different
sections of the regulation.
EPA also intends all TSCA section
6(a) risk management requirements in
this rule to be severable from each
regulatory exclusion from those
requirements. For example, to the extent
a court were to find a legal issue with
excluding trace quantities of CTC from
the rule’s requirements pursuant to 40
CFR 751.701(b), or with excluding
manufacture of CTC as a byproduct from
WCPP requirements pursuant to 40 CFR
751.707(a)(1), the underlying risk
management requirements would not be
impacted. Rather, the excluded
activities would become subject to the
underlying TSCA section 6(a) risk
management requirements applicable to
the condition of use. EPA further notes
that the specific examples of
severability described in this unit are
not intended to be exhaustive, but rather
illustrative of a wide variety of scenarios
that reflect EPA’s overarching intent
that each provision of this rulemaking
be severable.
EPA acknowledges that after the
issuance of this rule, a person or entity
may become aware of important
information which indicates a particular
use, that would otherwise be prohibited,
is ongoing, and could meet the criteria
of a WCPP. EPA also notes that there are
multiple avenues to ask EPA to revisit
issues in this TSCA section 6(a)
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rulemaking, both before and after the
mandatory compliance dates are set
consistent with TSCA section 6(d). EPA
has the authority under TSCA section
6(g) to consider whether an exemption
is appropriate and, consistent with
TSCA section 6(g)(1), may propose such
exemptions independently from this
rulemaking. Additionally, any person
could petition EPA to request that EPA
issue or amend a rule under TSCA
section 6.
A. Applicability
This final rule sets prohibitions and
restrictions on the manufacture
(including import), processing,
distribution in commerce, commercial
use, and disposal of CTC to prevent
unreasonable risk of injury to health in
accordance with TSCA section 6(a), 15
U.S.C. 2605(a).
Additionally, pursuant to TSCA
section 12(a)(2), this rule applies to CTC
even if being manufactured, processed,
or distributed in commerce solely for
export from the United States because
EPA has determined that CTC presents
an unreasonable risk to health within
the United States. Several commenters
expressed concern that an unclear
statement in the proposed rule preamble
appeared to indicate that all
manufacture, processing, and
distribution for export would be
prohibited under the proposed rule
(Refs. 29, 30, 32). This was not EPA’s
intent. Rather, EPA intended to indicate
that because EPA determined that CTC
presents an unreasonable risk of injury
to health within the United States,
manufacturing and processing of CTC
for export would not be exempt from
any otherwise-applicable TSCA section
6(a) regulatory requirements. Because
distribution in commerce did not
contribute to EPA’s unreasonable risk
determination for CTC, and because this
final rule permits manufacturing and
processing, including recycling, for
various uses to continue under the
WCPP, EPA intends this final rule to
permit manufacturing and processing in
compliance with the WCPP for export,
as well as distribution in commerce for
export, without regard for the intended
use in the destination country. In other
words, manufacturing, processing, and
distribution for the conditions of use
listed in 40 CFR 751.705(a)(1)(i) and (ii)
are prohibited where such conditions of
use would occur inside the United
States, but in instances where such
conditions of use would occur solely
outside of the United States after export,
the upstream manufacturing,
processing, and distribution for export
would not be prohibited. EPA has
clarified the regulatory text at 40 CFR
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751.707(a) to make clear that any
manufacture and processing for export
must be in accordance with the WCPP.
In addition, any persons who export or
intend to export a chemical substance
that is the subject of this final rule are
subject to the export notification
provisions of TSCA section 12(b) (15
U.S.C. 2611(b)), and must comply with
the export notification requirements in
40 CFR part 707, subpart D.
EPA is revising the description of the
Disposal COU to clarify the
requirements of the WCPP at cleanup
sites which would apply to any
potentially exposed person involved in
the disposal of CTC-containing
groundwater to industrial treatment,
industrial pre-treatment, or POTWs. A
potentially exposed person most likely
includes a worker who is involved with
the activity of removing CTC-containing
groundwater from the location where it
was found and the on-site treatment of
the groundwater, typically referred to as
ex situ remediation, which is most
consistent with the scope of the 2020
CTC Risk Evaluation. Ex situ
remediation includes both active and
passive remediation methods that span
traditional (e.g., pump and treat) and
less traditional (e.g., phytoremediation)
approaches, but only if the remediation
method would be considered industrial
wastewater pretreatment, industrial
wastewater treatment or discharge to a
publicly owned treatment work
(POTW).
As discussed in Unit III.D, the
prohibitions and restrictions described
in this unit do not apply to CTC that is
solely present unintentionally in trace
quantities with another chemical
substance or mixture, whether as a
manufacturing residue, unreacted
feedstock, byproduct, or other
contaminant. Additionally, the
provisions of this final rule only apply
to chemical substances as defined under
TSCA section 3. Notably, TSCA section
3(2) excludes from the definition of
chemical substance ‘‘any food, food
additive, drug, cosmetic, or device (as
such terms are defined in Section 201 of
the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 321]) when
manufactured, processed, or distributed
in commerce for use as a food, food
additive, drug, cosmetic, or device’’ and
‘‘any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.]) when
manufactured, processed, or distributed
in commerce for use as a pesticide.’’
Additional details regarding TSCA
statutory authorities can be found in
section 2 of the response to comments
document (Ref. 11).
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EPA uses the term ‘‘potentially
exposed person’’ in Unit IV. And in the
regulatory text to include workers,
occupational non-users, employees,
independent contractors, employers,
and all other persons in the work area
where CTC is present and who may be
exposed to CTC under the conditions of
use for which a WCPP or specific
prescriptive controls would apply. (EPA
notes that this definition is intended to
apply to occupational workspaces as
part of implementation of the WCPP and
other restrictions, and recognizes that
other individuals or communities may
be exposed to CTC as members of
fenceline communities or members of
the general population.) For certain
conditions of use, EPA requires a
comprehensive WCPP or specific
prescriptive controls to address the
unreasonable risk from CTC to workers
directly handling the chemical or in the
area where the chemical is being used.
Similarly, the 2020 Risk Evaluation for
Carbon Tetrachloride (Ref. 1) did not
distinguish between employers,
contractors, or other legal entities or
businesses that manufacture, process,
distribute in commerce, use, or dispose
of CTC. For this reason, EPA uses the
term ‘‘owner or operator’’ to describe
the entity responsible for implementing
the WCPP or specified prescriptive
controls in any workplace where an
applicable condition of use is identified
in Unit IV. And subject to the WCPP or
prescriptive controls is occurring. The
term includes any person who owns,
leases, operates, controls, or supervises
such a workplace. While owners or
operators remain responsible for
ensuring compliance with the WCPP or
prescriptive controls requirements in
the workplace, they may contract with
others to provide training or implement
a respiratory protection program, for
example. EPA is also clarifying its intent
that for the provisions in this rule, any
requirement for an owner or operator, or
an owner and operator, is a requirement
for any individual that is either an
owner or an operator.
EPA emphasizes that this approach is
essential for addressing the
unreasonable risk presented by CTC,
including to individuals who may not
be covered by OSHA requirements, such
as, volunteers, self-employed persons,
and State, and local government
workers who are not covered by a state
plan. EPA uses the term ‘‘owner or
operator’’ in TSCA programs because
the term is used in other EPA programs
to describe persons with responsibilities
for implementing statutory and
regulatory requirements at particular
locations. See, for example, CAA section
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113, 42 U.S.C. 7412, which defines
‘‘owner or operator’’ as a person who
owns, leases, operates, controls, or
supervises a stationary source. There is
a similar definition in section 306 of the
Clean Water Act (CWA), 33 U.S.C. 1316.
EPA understands that the use of this
term may result in multiple persons’
bearing responsibility for complying
with provisions of this final rule,
including the WCPP. However, this is
also the case for workplaces regulated
by OSHA, including those regulated
under OSHA’s general industry
standards at 29 CFR part 1910. OSHA’s
1999 Multi-Employer Citation Policy
explains which employers should be
cited for a hazard that violates an OSHA
standard (Ref. 40). The Policy describes
four different roles that employers may
fill at a workplace and describes who
should be cited for a violation based on
factors such as whether the employer
created the hazard, had the ability to
prevent or correct the hazard, and knew
or should have known about the hazard.
More than one employer may be cited
for the same hazard. This final rule will
have similar results, in that more than
one owner or operator may be
responsible for compliance.
The OSHA multi-employer citation
policy is an example of a guidance
governing situations where more than
one regulated entity is present. EPA has
received several requests for
clarification of the applicability of the
term ‘‘owner or operator’’ to sites where
more than one entity owns, leases, or
controls a workplace where a CTC
condition of use is ongoing and where
implementation of the WCPP or
prescriptive controls is required. EPA
understands that there are a wide
variety of situations where these
questions could arise, and plans to issue
guidance consistent with TSCA
authorities that explains how EPA will
approach the issue of responsibility for
implementation of, and compliance
with, the WCPP requirements in
practice.
B. Workplace Chemical Protection
Program (WCPP)
1. Applicability
EPA is finalizing the WCPP for all of
the conditions of use for which it was
proposed, as well as for two additional
uses related to vinyl chloride
manufacturing within two conditions of
use for which prohibition was proposed.
EPA is also revising the description of
industrial and commercial use of CTC
related to chlorine production to clarify
that both elimination of nitrogen
trichloride in the production of chlorine
and caustic soda and recovery of
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chlorine in tail gas from the production
of chlorine are subject to the WCPP.
Additionally, EPA is revising the
description of the Disposal COU to
clarify the requirements of the WCPP at
cleanup sites. Specifically, EPA has
determined that at groundwater cleanup
sites, the WCPP would apply to any
potentially exposed person involved in
the disposal of CTC-containing
groundwater to industrial treatment,
industrial pre-treatment, or POTWs. A
potentially exposed person most likely
includes a worker who is involved with
the activity of removing CTC-containing
groundwater from the location where it
was found and the on-site treatment of
the groundwater, typically referred to as
ex situ remediation, which is most
consistent with the scope of the 2020
CTC Risk Evaluation. Ex situ
remediation includes both active and
passive remediation methods that span
traditional (e.g., pump and treat) and
less traditional (e.g., phytoremediation)
approaches, but only if the remediation
method would be considered industrial
wastewater pretreatment, industrial
wastewater treatment or discharge to a
publicly owned treatment work
(POTW). EPA’s descriptions of changes
from the proposed rule in Unit III. The
Agency explained why the WCPP
addresses the unreasonable risk for
certain conditions of use in Unit V. of
the proposed rule (88 FR 49180, July 28,
2023) (FRL 8206–01–OCSPP).
EPA is finalizing the WCPP for the
following conditions of use where
manufacture and processing are not
otherwise prohibited: domestic
manufacturing (except where CTC is
manufactured solely as a byproduct);
import; processing as a reactant in the
production of HCFCs, HFCs, HFOs, and
PCE; processing: incorporation into
formulation, mixture or reaction
product in agricultural products
manufacturing, vinyl chloride
manufacturing, and other basic organic
and inorganic chemical manufacturing;
processing by repackaging for use as a
laboratory chemical; recycling;
industrial and commercial use as a
processing aid in the manufacture of
agricultural products and vinyl
chloride; industrial and commercial use
in the elimination of nitrogen
trichloride in the production of chlorine
and caustic soda and the recovery of
chlorine in tail gas from the production
of chlorine; and disposal. This unit
provides a description of the conditions
of use subject to the WCPP to assist with
compliance.
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a. Manufacturing
i. Domestic Manufacture
This condition of use refers to making
or producing a chemical substance
within the United States (including
manufacturing for export), including the
extraction of a component chemical
substance from a previously existing
chemical substance or a complex
combination of substances. For
purposes of this rule, WCPP
requirements applicable to the
manufacture of CTC do not apply where
CTC is manufactured solely as a
byproduct, because manufacture of CTC
as a byproduct was not evaluated in the
2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1). Under TSCA,
EPA uses the term ‘‘byproduct’’ to refer
to a chemical substance produced
without a separate commercial intent
during the manufacture, processing, use,
or disposal of another chemical
substance(s) or mixture(s) (see, e.g., 40
CFR 710.3(d), 720.3). A byproduct is
distinguishable from a coproduct, which
is a chemical substance produced for a
commercial purpose during the
manufacture, processing, use, or
disposal of another chemical substance
or mixture. CTC could be manufactured
as a byproduct during the
manufacturing of other chlorinated
compounds. EPA anticipates that any
risk presented by the presence of CTC
as a byproduct will be considered in the
scope of the risk evaluation of the
parent chemical in future risk
evaluations, such as the consideration of
CTC as a byproduct in the 1,2dichloroethane risk evaluation, as
explained in Section 1.4.2.3 of the 2020
Risk Evaluation for Carbon
Tetrachloride (Refs. 1, 41).
ii. Import
This condition of use refers to the act
of causing a chemical substance or
mixture to arrive within the customs
territory of the United States. This
condition of use includes loading/
unloading and repackaging associated
with import.
b. Processing
i. Processing as a Reactant in the
Production of
Hydrochlorofluorocarbons,
Hydrofluorocarbons,
Hydrofluoroolefins, and
Perchloroethylene
This condition of use refers to
processing CTC in chemical reactions
for the manufacturing of another
chemical substance or product. Through
processing as a reactant or intermediate,
CTC serves as a feedstock in the
production of another chemical product
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via a chemical reaction in which CTC is
consumed. Currently, CTC is used as a
reactant to manufacture HCFCs, HFCs,
HFOs, and PCE, which are used in the
making of a variety of products
including refrigerants, aerosol
propellants, and foam-blowing agents.
The specifics of the reaction process
(e.g., use and types of catalysts, reaction
temperature) vary depending on the
product being produced; however, a
typical reaction process involves
unloading CTC from containers and
feeding into the reaction vessel(s),
where CTC either completely or
partially reacts with other raw materials
to form the final product. Following the
reaction, the product may be purified to
remove unreacted CTC or other
materials if needed. This condition of
use includes reuse of CTC, including
CTC that is not transformed as feedstock
in other manufacturing processes, as a
reactant.
ii. Processing: Incorporation Into
Formulation, Mixtures, or Reaction
Products for Agricultural Products
Manufacturing; Vinyl Chloride
Manufacturing; Other Basic Organic and
Inorganic Chemical Manufacturing
This condition of use refers to the
process of mixing or blending several
raw materials to obtain a single product
or preparation or formulation. CTC has
historically been incorporated into
formulation or mixtures to manufacture
hydrochloric acid (HCl), vinyl chloride,
ethylene dichloride (EDC), chloroform,
hafnium tetrachloride, thiophosgene,
and methylene chloride. CTC may be
incorporated into various products and
formulations at varying concentrations
for further distribution. For example,
CTC may be unloaded from transport
containers either directly into mixing
equipment or into an intermediate
storage vessel either manually or
through automation via a pumping
system. Mixing of components can
occur in either a batch or continuous
system. The mixture that contains CTC
may be used as a reactant to
manufacture a chlorinated compound
that is subsequently formulated into a
product or a processing aid used to aid
in the manufacture of formulated
products. For the purposes of this
rulemaking, EPA is allowing under the
WCPP the continued incorporation of
CTC into formulation, mixtures, or
reaction products for agricultural
products manufacturing, vinyl chloride
manufacturing, the elimination of
nitrogen trichloride in the production of
chlorine and caustic soda, and the
recovery of chlorine in tail gas from the
production of chlorine.
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iii. Processing: Repackaging for Use as a
Laboratory Chemical
manufacturing of agricultural products
and vinyl chloride.
This condition of use refers to the
physical transfer of a chemical
substance or mixture, as is, from one
container to another container or
containers in preparation for
distribution of the chemical substance
or mixture in commerce. Depending on
the product, formulation products may
be filtered prior to packaging. Final
packaging occurs either through manual
dispensing from transfer lines or
through utilization of an automatic
system. Typically, repackaging sites
receive the chemical in bulk containers
and transfer the chemical from the bulk
container into another smaller container
in preparation for distribution in
commerce.
ii. Industrial and Commercial Use in the
Elimination of Nitrogen Trichloride in
the Production of Chlorine and Caustic
Soda and the Recovery of Chlorine in
Tail Gas From the Production of
Chlorine
This condition of use refers to a
specific use of CTC as a processing aid/
agent in basic inorganic chemical
manufacturing. For purposes of this
rulemaking, EPA is allowing under the
WCPP the continued use of CTC in the
elimination of nitrogen trichloride in
the production of chlorine and caustic
soda and the recovery of chlorine in tail
gas from the production of chlorine.
wastes as part of the waste streams
included in the disposal COU, at
groundwater remediation sites managed
by the Federal government and under
existing waste disposal requirements,
the WCPP requirements under this
rulemaking only apply to water
contaminated with CTC, and any other
type of CTC-impacted waste will be
handled according to relevant existing
requirements under RCRA and other
statutes. The provisions of the WCPP for
the disposal COU, including the ECEL,
are not intended to cover potentially
exposed persons who are sampling
groundwater to monitor the presence of
a plume, but specifically only those
sampling at the site of extraction and
treatment activities.
d. Disposal
This condition of use refers to the
process of disposing waste streams of
CTC that are collected either onsite (e.g.
pumped out of the ground for
treatment), or transported to a thirdparty site for treatment or their final
disposition, such as waste incineration
or landfilling. For this rule, the WCPP
for the disposal of CTC-containing water
and groundwater for purposes of
cleanup projects of CTC-contaminated
water and groundwater, including
industrial pre-treatment and industrial
treatment activities, applies to removing
the groundwater from the location
where it was located and treating the
removed groundwater on site. The
requirements of the WCPP apply to any
potentially exposed person involved in
the disposal of CTC-containing
groundwater to industrial treatment,
industrial pre-treatment, or POTWs. A
potentially exposed person most likely
includes a worker who is involved with
the activity of removing CTC-containing
groundwater from the location where it
was found and the on-site treatment of
the groundwater, typically referred to as
ex situ remediation, which is most
consistent with the scope of the 2020
CTC Risk Evaluation. Ex situ
remediation includes both active and
passive remediation methods that span
traditional (e.g., pump and treat) and
less traditional (e.g., phytoremediation)
approaches, but only if the remediation
method would be considered industrial
wastewater pretreatment, industrial
wastewater treatment or discharge to a
publicly owned treatment work
(POTW). A remediation method would
need to be considered one of these three
types of disposal to fall within the
condition of use under TSCA for
remediation sites managed by the
Federal government and if not, would
not be subject to the requirements of the
rule. Further, while EPA considers solid
2. Overview
The WCPP for CTC encompasses an
inhalation exposure limit and action
level, DDCC, and the associated
implementation requirements described
in this unit, to ensure that the chemical
substance no longer presents
unreasonable risk. Under a WCPP,
owners or operators have the ability to
select controls, within the parameters
outlined in this unit, regarding how
they prevent exceedances of the
identified EPA exposure limit
thresholds or prevent direct dermal
contact. In the case of CTC, meeting the
EPA exposure limit threshold and
implementing the DDCC requirements
for certain occupational conditions of
use would address the unreasonable risk
to potentially exposed persons from
inhalation and dermal exposure.
EPA is finalizing these requirements
to apply beginning on June 11, 2026 for
non-Federal owners or operators, or by
June 21, 2027 for Federal agencies and
Federal contractors acting for or on
behalf of the Federal government, or
within 30 days of introduction of CTC
into the workplace, whichever is later,
at which point entities would be
required to complete initial monitoring
(as described in Unit IV.B.3.b.).
Additionally, EPA requires that each
owner or operator ensure that no person
is exposed to an airborne concentration
of CTC that exceeds the ECEL as an 8hour TWA, including by providing
respirators to potentially exposed
persons in the regulated area, no later
than September 9, 2026 for non-Federal
owners or operators, or no later than
September 20, 2027 for Federal agencies
and Federal contractors acting for or on
behalf of the Federal government, or
beginning four months after
introduction of CTC into the workplace,
whichever is later. EPA also requires
each owner or operator to ensure all
persons are separated, distanced,
iv. Processing: Recycling
This condition of use refers to the
process of treating generated spent
chemical (which would otherwise be
disposed of as waste) that is collected
on-site or transported to third-party sites
for reclamation/recycling. Spent
chemicals can be restored to a condition
that permits reuse via reclamation/
recycling. The recovery process may
involve an initial vapor recovery or
mechanical separation step followed by
distillation, purification, and final
packaging.
c. Industrial and Commercial Use
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i. Industrial and Commercial Use as an
Industrial Processing Aid in the
Manufacture of Agricultural Products
and Vinyl Chloride
A processing aid is a ‘‘chemical that
is added to a reaction mixture to aid in
the manufacture or synthesis of another
chemical substance but is not intended
to remain in or become part of the
product or product mixture.’’
Additionally, processing agents are
intended to improve the processing
characteristics or the operation of
process equipment, but not intended to
affect the function of a substance or
article created. CTC is used as a
processing aid/agent to aid in the
manufacture of formulated products,
including agricultural chemicals and
vinyl chloride. CTC has historically
been used as a processing agent in the
manufacture of chlorosulphonated
polyolefin; stryene butadiene rubber;
endosulfan (insecticide); 1–1 Bis (4chlorophenyl) 2,2,2-trichloroethanol
(dicofol insecticide); and tralomethrin
(insecticide) (Ref. 1). For the purposes of
this rulemaking, EPA is allowing under
the WCPP the continued use of CTC as
an industrial processing aid in the
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physically removed, or isolated from
direct dermal contact with CTC,
including by providing dermal PPE, by
June 16, 2025 for non-Federal owners or
operators, or no later than September
20, 2027 for Federal agencies and
Federal contractors acting for or on
behalf of the Federal government. EPA
also requires implementation of any
needed exposure controls based on
initial monitoring and development of
an exposure control plan, which
requires consideration and documented
application of the hierarchy of controls,
no later than December 3, 2027 (as
described in Unit IV.B.5.).
EPA’s implementation of the
requirement to meet an ECEL as part of
a WCPP aligns with, to the extent
possible, certain elements of the existing
OSHA standards for regulating toxic and
hazardous substances under 29 CFR part
1910, subpart Z. However, EPA is
finalizing as proposed a new, lower
occupational exposure limit, derived
from the TSCA 2020 Risk Evaluation for
Carbon Tetrachloride (Refs. 1, 15). For
CTC, this final rule will eliminate the
unreasonable risk from CTC contributed
to by the conditions of use subject to the
WCPP, enable continued industry use
where appropriate, and provide the
familiarity of a pre-existing framework
for the regulated community.
EPA’s requirements include specific
exposure limits and ancillary
requirements necessary for successful
implementation of an ECEL as part of a
WCPP. Taken together, these WCPP
requirements apply to the extent
necessary so that the unreasonable risk
from CTC under the conditions of use
listed earlier in this unit would no
longer be presented.
Unit IV. includes a summary of the
WCPP, including a description of the
finalized exposure limits including an
ECEL and ECEL action level;
implementation requirements including
monitoring requirements; a description
of potential exposure controls in
accordance with the hierarchy of
controls, including engineering controls,
administrative controls, and PPE as it
relates to respirator selection; and
additional finalized requirements for
recordkeeping and workplace
participation. Additionally, Unit IV.B.4.
describes DDCC requirements for CTC,
including potential exposure controls,
which consider the hierarchy of
controls; PPE as it relates to dermal
protection; and additional requirements
finalized for recordkeeping. Unit IV.
also describes changes to the proposed
compliance timeframes, changes by EPA
to certain provisions of the WCPP based
on public comments, and addition of
new provisions in the WCPP based on
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public comments used to inform this
final rule.
3. Existing Chemical Exposure Limit
(ECEL)
To reduce exposures in the workplace
and address the unreasonable risk of
injury to health resulting from
inhalation exposures to CTC identified
under the occupational conditions of
use in the TSCA 2020 Risk Evaluation
for Carbon Tetrachloride, EPA is
requiring an ECEL and ancillary
requirements for all of the conditions of
use identified in Unit IV.B.1.
a. ECEL and ECEL Action Level (AL)
EPA is finalizing as proposed an ECEL
under TSCA section 6(a) of 0.03 ppm
(0.2 mg/m3) for inhalation exposures to
CTC as an 8-hour TWA based on the
threshold POD for liver cancer
(assuming a margin of exposure of 300)
and the IUR for adrenal cancer. The
ECEL memo includes linear risk
calculations for adrenal gland tumors in
the equation for ‘‘Cancer risk for other
tumor types (e.g., adrenal glands) at the
ECEL,’’ showing that the ECEL is
protective of all tumor types, including
adrenal gland and brain tumors (Ref.
15). EPA has determined that ensuring
exposures remain at or below the 8-hour
TWA ECEL of 0.03 ppm will eliminate
the unreasonable risk of injury to health
for CTC resulting from acute and
chronic inhalation exposures in an
occupational setting (Ref. 15). If ambient
exposures are kept at or below the 8hour TWA ECEL of 0.03 ppm, a
potentially exposed person will be
protected against the effects described
in this unit, including cancer, chronic
non-cancer effects, and effects resulting
from acute inhalation exposures (Ref.
15). In addition to the ECEL memo, to
respond to public comments, EPA also
explained that the ECEL is protective of
short-term acute inhalation exposures
(Refs. 11 and 15). EPA is finalizing
requirements that each owner or
operator ensure that the airborne
concentration of CTC does not exceed
the ECEL for all potentially exposed
persons within 1,005 days after the date
of publication of the final rule (i.e., no
later than September 20, 2027) for
Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, 630 days after the
date of publication of the final rule in
the Federal Register (i.e., no later than
September 9, 2026) for non-Federal
owners and operators, or beginning four
months after introduction of CTC into
the workplace if CTC use commences at
least 540 days after the date of
publication (i.e., the use commences on
or after June 11, 2026).
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EPA is finalizing an ECEL action level
at 0.02 ppm as an 8-hour TWA for CTC.
Below the ECEL action level, certain
compliance activities, such as periodic
monitoring, would be required less
frequently, as described further in this
unit. In this way, EPA’s WCPP for CTC
is consistent with the familiar
framework that is in place in OSHA
standards for regulating toxic and
hazardous substances under 29 CFR
1910 Subpart Z that establish an action
level, although the values differ due to
differing statutory authority. As
explained by OSHA, the action level
provides employers and employees with
greater assurance that their employees
will not be exposed to concentrations
above the PELs (Ref. 42).
In summary, EPA is finalizing as
proposed with slight modification that
owners or operators must ensure the
airborne concentration of CTC within
the personal breathing zone of
potentially exposed persons remains at
or below 0.03 ppm as an 8-hour TWA
ECEL, with an action level finalized as
0.02 ppm as an 8-hour TWA. For
purposes of this rulemaking, the
personal breathing zone is consistent
with how OSHA defines it as a
hemispheric area forward of the
shoulders within a six-to-nine-inch
radius of a worker’s nose and mouth
and requires that exposure monitoring
air samples be collected from within
this space (Ref. 43). EPA is finalizing the
ECEL for most occupational conditions
of use to ensure that no person is
exposed to inhalation of CTC in excess
of these concentrations resulting from
those conditions of use. EPA recognizes
that the regulated community has the
ability to detect the values for the ECEL
because of viable detection limits and
analytical methods of CTC for
monitoring devices that are available in
commerce, currently in use, which are
as low as 4 micrograms per sample
(Refs. 15, 44). For the purposes of this
TSCA section 6(a) rulemaking, EPA will
consider the use of methods for
exposure monitoring (i.e., NIOSH
Method 1003) that produce results that
are accurate, to a confidence level of 95
percent and within 25 percent (plus or
minus) of airborne concentrations of
CTC above 0.03 ppm ECEL, to be in
compliance with this rule. EPA
recognizes that current analytical
methods may not measure CTC to below
the action level of 0.02 ppm,
particularly for short-term tasks;
therefore, owners and operators will be
required to monitor more frequently, as
described further in this unit, until
monitoring methods that measure to or
below the action level become available.
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b. Monitoring Requirements
i. Exposure Sampling
Initial monitoring for CTC is critical
for establishing a baseline of exposure
for potentially exposed persons;
similarly, periodic exposure monitoring
assures continued compliance over time
so that potentially exposed persons are
not exposed to levels that would result
in an unreasonable risk of injury to
health. Exposure monitoring could be
suspended if certain conditions
described in Unit IV. are met. Also, in
some cases, a change in workplace
conditions with the potential to impact
exposure levels would warrant
additional monitoring, which is also
described.
EPA is finalizing with modifications
from proposal its requirement that
owners or operators determine each
potentially exposed person’s exposure
by taking a personal breathing zone air
sample of each potentially exposed
person’s exposure or by taking personal
breathing zone air samples that are
representative of each potentially
exposed person with a similar exposure
profile to chemical substance or mixture
based on substantial similarity of tasks
performed, the manner in which the
tasks are performed, and the materials
and processes with which they work
(hereinafter identified as an ‘‘exposure
group’’). Personal breathing zone air
samples are representative of the 8-hour
TWA of all potentially exposed persons
in an exposure group if the samples are
of the full shift-exposure of at least one
person who represents the highest
potential CTC exposures in that
exposure group. In addition, the initial
monitoring will be required when and
where the operating conditions are best
representative of each potentially
exposed person’s full-shift exposures.
Personal breathing zone air samples
taken during one work shift may be
used to represent potentially exposed
person exposures on other work shifts
where the owner or operator can
document that the tasks performed and
conditions in the workplace are similar
across shifts. Additionally, air sampling
is required to measure ambient
concentrations for CTC without taking
respiratory protections into account as
sampling is being performed. For
purposes of exposure monitoring
requirements, owners and operators are
only required to monitor potentially
exposed persons that are expected to be
present in the workplace.
EPA is also finalizing requirements
that the owner or operator ensure that
their exposure monitoring methods are
accurate to a confidence level of 95%
and are within (plus or minus) 25% of
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airborne concentrations of CTC above
the 8-hour TWA ECEL. To ensure
compliance for monitoring activities,
EPA is finalizing recordkeeping
requirements and will require that
owners or operators document their
choice of monitoring method outlined
in this unit. As described in Unit
III.C.1., EPA is finalizing the
requirement that owners or operators
meet certain documentation
requirements for each monitoring event
of CTC, including compliance with GLP
Standards in accordance with 40 CFR
part 792 or use of a laboratory
accredited by the AIHA (e.g., AIHA
LAP, LLC Policy Module 2A/B/E of
Revision 17.3), or other analogous
industry-recognized program.
Additionally, as described in Unit
III.C.1., EPA is finalizing the
requirement that owners or operators
must re-monitor within 15 working days
after receipt of any exposure monitoring
when results indicate non-detect, unless
an Environmental Professional as
defined at 40 CFR 312.10 or a Certified
Industrial Hygienist reviews the
monitoring results and determines remonitoring is not necessary.
EPA is also finalizing the requirement
that each owner or operator maintain
exposure monitoring records that
include the following information for
each monitoring event:
• Dates, duration, and results of each
sample taken.
• The quantity, location(s) and
manner of use of CTC at the time of each
monitoring event.
• All measurements that may be
necessary to determine the conditions
(e.g., work site temperatures, humidity,
ventilation rates, monitoring equipment
type and calibration dates) that may
affect the monitoring results.
• Name, workplace address, work
shift, job classification, work area, and
type of respiratory protection (if any) of
each monitored person.
• Identification of all potentially
exposed persons that a monitored
person is intended to represent if using
a representative sample.
• Use of appropriate sampling and
analytical methods.
• Compliance with GLP Standards in
accordance with 40 CFR part 792 or use
of a laboratory accredited by AIHA (e.g.,
AIHA LAP, LLC Policy Module 2A/B/E
of Revision 17.3), or another analogous
industry-recognized program.
• Information regarding air
monitoring equipment, including: type,
maintenance, calibrations, performance
tests, limits of detection, and any
malfunctions.
• Notification of exposure monitoring
results to each person whose exposures
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are monitored or who is part of a
monitored exposure group.
ii. Initial Exposure Monitoring
Under the final regulation, each nonFederal owner or operator of a facility
that is engaged in one or more of the
conditions of use listed in Unit IV.B.1.
will be required to perform initial
exposure monitoring within 540 days
after publication of the final rule in the
Federal Register (i.e., no later than June
11, 2026) or within 30 days of
introduction of CTC into the workplace,
whichever is later, to determine the
extent of exposure of potentially
exposed persons to CTC. As discussed
in Unit III.B., EPA is providing
additional time for Federal agencies and
Federal contractors acting for or on
behalf of the Federal government to
comply with the provisions of the
WCPP, so they will be required to
conduct initial monitoring within 915
days after publication (i.e., no later than
June 21, 2027). Initial monitoring will
notify owners and operators of the
magnitude of possible exposures to
potentially exposed persons with
respect to their work conditions and
environments. Based on the magnitude
of possible exposures in the initial
exposure monitoring, the owner or
operator may need to increase or
decrease the frequency of future
periodic monitoring or adopt new
exposure controls (such as engineering
controls, administrative controls, and/or
a respiratory protection program), as
indicated in table 1. In addition, the
initial monitoring will be required when
and where the operating conditions are
best representative of each potentially
exposed person’s work-shift exposures.
If the owner or operator chooses to use
a sample that is representative of
potentially exposed persons’ full shift
exposures (rather than monitor every
individual), such sampling should be
representative (i.e., taken from the
breathing zone of potentially exposed
persons and reflect duration-appropriate
exposure) of the most highly exposed
persons in the workplace. Additionally,
EPA expects that owners and operators
will conduct initial exposure
monitoring representative of all tasks
that a potentially exposed person will
be expected to do. EPA understands that
certain tasks may occur less frequently
or may reflect accidental exposure (for
example, due to malfunction).
EPA also recognizes that some entities
may already have objective exposure
monitoring data. If the owner or
operator has monitoring data conducted
within five years prior to 60 days
following publication of the final rule in
the Federal Register and the monitoring
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satisfies all other requirements in Unit
IV., including the requirement that the
data represents the highest CTC
exposures likely to occur under
reasonably foreseeable conditions of
use, the owner or operator may rely on
such earlier monitoring results for the
initial baseline monitoring sample. Prior
monitoring data cannot be used where
there has been a change in work
conditions or practices that is expected
to result in new or additional exposures.
As described in more detail later in
Unit IV., the owner or operator must
conduct periodic monitoring at least
once every five years since its last
monitoring. This periodic monitoring
must be representative of all the
potentially exposed persons in the
workplace and the tasks that they are
expected to do.
iii. Periodic Exposure Monitoring
EPA is finalizing the following
periodic monitoring for owners or
operators. These finalized requirements
are also outlined in Table 1.
• If samples taken during the initial
exposure monitoring reveal a
concentration below the ECEL action
level (<0.02 ppm 8-hour TWA), the
owner or operator must repeat the
periodic exposure monitoring at least
once every five years.
• If the most recent exposure
monitoring indicates that airborne
exposure is above the ECEL (>0.03 ppm
8-hour TWA), the owner or operator
must repeat the periodic exposure
monitoring within three months of the
most recent exposure monitoring.
• If the most recent exposure
monitoring indicates that airborne
exposure is at or above the ECEL action
level (≥0.02 ppm 8-hour TWA) but at or
below the ECEL (≤0.03 ppm 8-hour
TWA), the owner or operator must
repeat the periodic exposure monitoring
within six months of the most recent
exposure monitoring.
• If the most recent (non-initial)
exposure monitoring indicates that
airborne exposure is below the ECEL
action level, the owners or operators
must repeat such monitoring within six
months of the most recent monitoring
until two consecutive monitoring
measurements, taken at least seven days
apart, are below the ECEL action level
(<0.02 ppm 8-hour TWA), at which time
the owner or operator must repeat the
periodic exposure monitoring at least
once every five years.
• In instances where an owner or
operator does not manufacture, process,
use, or dispose of CTC for a condition
of use for which the WCPP is required
over the entirety of time since the last
required periodic monitoring event,
EPA is requiring that the owner or
operator would be permitted to forgo the
next periodic monitoring event.
However, documentation of cessation of
use of CTC would be required and
periodic monitoring would be required
to resume when the owner or operator
restart any of the conditions of use
listed in Unit IV.B.1.
TABLE 1—PERIODIC MONITORING REQUIREMENTS
Air concentration condition
Periodic monitoring requirement
If initial exposure monitoring is below the ECEL action level (<0.02
ppm 8-hour TWA).
If the most recent exposure monitoring indicates that airborne exposure
is above the ECEL (>0.03 ppm 8-hour TWA).
If the most recent exposure monitoring indicates that airborne exposure
is at or above the ECEL action level but at or below the ECEL (≥0.02
ppm 8-hour TWA, ≤0.03 ppm 8-hour TWA).
If the two most recent (non-initial) exposure monitoring measurements,
taken at least seven days apart within a 6-month period, indicate exposure is below the ECEL action level (<0.02 ppm 8-hour TWA).
If the owner or operator engages in a condition of use for which WCPP
ECEL would be required but does not manufacture, process, use, or
dispose of CTC in that condition of use over the entirety of time
since the last required monitoring event.
Periodic exposure monitoring is required at least once every five years.
Periodic exposure monitoring is required within three months of the
most recent exposure monitoring.
Periodic exposure monitoring is required within six months of the most
recent exposure monitoring.
Periodic exposure monitoring is required within five years of the most
recent exposure monitoring.
The owner or operator may forgo the next periodic monitoring event.
However, documentation of cessation of use of CTC is required and
periodic monitoring would be required when the owner or operator
resumes the condition of use.
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Note: Additional scenarios in which monitoring may be required are discussed in Unit IV.B.3.b.iv.
iv. Additional Exposure Monitoring
EPA is finalizing that each owner or
operator conduct additional exposure
monitoring within a reasonable
timeframe after there has been a change
in the production, process, control
equipment, personnel or work practices
may reasonably be expected to result in
new or additional exposures at or above
the ECEL, or when the owner or
operator has any reason to believe that
new or additional exposures at or above
the ECEL action level have occurred, for
example if an owner or operator
receives information from potentially
exposed person(s) suggesting that such
new or additional exposures may have
occurred. In the event of start-up or
shutdown, or ruptures, malfunctions or
other breakdowns or unexpected
releases that may lead to exposure to
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potentially exposed persons, EPA is
finalizing that each owner or operator
must conduct exposure monitoring of
potentially exposed persons (using
personal breathing zone sampling)
within a reasonable timeframe after the
conclusion of the start-up or shutdown
and/or the cleanup, repair or remedial
action of the malfunction or other
breakdown or unexpected release. EPA
is also requiring that the owner or
operator document that additional
monitoring was completed within a
reasonable timeframe. At this time, EPA
is not finalizing a specific compliance
timeframe for completion of additional
monitoring when there has been a
change in the production, process,
control equipment, personnel or work
practices, or in the event of start-up or
shutdown, or ruptures, malfunctions or
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other breakdowns or unexpected
releases that may lead to exposure to
potentially exposed persons; however,
other TSCA section 6(a) rules are
finalizing a compliance timeframe of 30
days for additional monitoring in these
cases, and such timeframe would be an
indication of what EPA considers likely
to be reasonable in most cases when
these changes are made at facilities that
use CTC or in the event of these
potential releases of CTC. An additional
exposure monitoring event may result in
an increased frequency of periodic
monitoring. For example, if the initial
monitoring results from a workplace are
above the ECEL action level, but below
the ECEL, periodic monitoring is
required every six months. If additional
monitoring is performed because
increased exposures are suspected, and
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the results are above the ECEL,
subsequent periodic monitoring would
have to be performed every three
months. The required additional
exposure monitoring should not delay
implementation of any necessary
cleanup or other remedial action to
reduce the exposures to persons in the
workplace.
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c. Regulated Area
EPA is finalizing its requirement that
the owner or operator demarcate any
area where airborne concentrations of
CTC exceed, or are reasonably expected
to exceed the ECEL. To provide more
clarity regarding how regulated areas
must be demarcated, EPA has
incorporated the language analogous to
OSHA’s regulated area requirements
under the standards for toxic and
hazardous substances (29 CFR part
1910, subpart Z) into this final rule.
Owners and operators must demarcate
regulated areas from the rest of the
workplace in any manner that
adequately establishes and alerts
potentially exposed persons to the
boundaries of the area and minimizes
the number of authorized persons
exposed to CTC within the regulated
area. This can be accomplished using
administrative controls (e.g., highly
visible signifiers) in multiple languages
as appropriate (e.g., when potentially
exposed persons who primarily speak a
language other than English are present,
owners and operators should post
additional highly visible signifiers in
the language of the largest group of
workers who cannot readily
comprehend or read English), placed in
conspicuous areas. The owner or
operator is required to restrict access to
the regulated area from any potentially
exposed person that lacks proper
training or is otherwise unauthorized to
enter.
d. Notification of Monitoring Results
EPA is finalizing the requirement that
the owner or operator must, within 15
working days after the receipt of the
results of any exposure monitoring,
notify each potentially exposed person
whose exposure is represented by that
monitoring and their designated
representatives in writing, either
individually to each potentially exposed
person or by posting the information in
an appropriate and accessible location,
such as public spaces or common areas,
for potentially exposed persons outside
of the regulated area. The notice would
be required to identify the exposure
monitoring results, the ECEL and ECEL
action level and what they mean in
plain language, statement of whether the
monitored airborne concentration of
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CTC exceeds the ECEL and ECEL action
level, and any corresponding respiratory
protection required. If the ECEL is
exceeded, the notice must also include
a description of the actions taken by the
owner or operator to reduce inhalation
exposures to or below the ECEL. The
notice must also include the quantity,
location, manner of CTC use, and
identified releases of CTC that could
result in exposure to CTC at the time of
monitoring. The notice must be posted
in multiple languages if necessary (e.g.,
notice must be in a language that the
potentially exposed person understands,
including a non-English language
version representing the language of the
largest group of workers who cannot
readily comprehend or read English).
4. Direct Dermal Contact Control
(DDCC) Requirements
To reduce exposures in the workplace
and address the unreasonable risk of
injury to health resulting from dermal
exposures to CTC identified under the
occupational conditions of use in the
TSCA 2020 Risk Evaluation for CTC,
EPA is finalizing DDCC requirements for
all of the conditions of use identified in
Unit IV.B.1. EPA is finalizing its
requirements that owners or operators
must separate, distance, physically
remove, or isolate all person(s) from
direct handling of CTC or from skin
contact with surfaces that may be
contaminated with CTC (i.e., equipment
or materials on which CTC may be
present) under routine conditions in the
workplace (hereafter referred to as direct
dermal contact) within 180 days after
the date of publication of the final rule
in the Federal Register (i.e., June 16,
2025) for non-Federal owners or
operators, or within 1,005 days after the
date of publication of the final rule in
the Federal Register (i.e., September 20,
2027) for Federal agencies and Federal
contractors acting for or on behalf of the
Federal government. The 2020 Risk
Evaluation for Carbon Tetrachloride
identified that unreasonable risk to
workers is also driven by the dermal
exposure, specifically from direct skin
contact with CTC; risk exceeding the
benchmark was identified even when
considering use of chemically resistant
gloves in most commercial and
industrial conditions of use. EPA has
determined that preventing direct
dermal contact will eliminate the
unreasonable risk of injury to health
resulting from dermal exposures for
certain occupational conditions of use
of CTC. See the proposed rule for EPA’s
description of how the requirements
related to DDCC would address the
unreasonable risk resulting from dermal
exposures and the rationale for this
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regulatory approach in Units III.B.4. and
V.A. of the proposed rule. and V.A. of
the proposed rule.
5. Exposure Control Plan
EPA is finalizing its requirement that
entities implementing the WCPP adopt
feasible exposure controls, including
one or a combination of elimination,
substitution, engineering controls, and
administrative controls, prior to
requiring the use of PPE (i.e., respirators
or gloves) as a means of controlling
exposures below EPA’s ECEL and/or
prevent directing dermal contact with
CTC for all potentially exposed persons,
in accordance with the hierarchy of
controls (Ref. 6). If an owner or operator
chooses to replace CTC with a
substitute, EPA recommends careful
review of the available hazard and
exposure information on the potential
substitutes to avoid a substitute
chemical that might later be found to
present an unreasonable risk of injury to
health or the environment under its
conditions of use or be subject to
regulation (sometimes referred to as a
‘‘regrettable substitution’’). EPA expects
that, for conditions of use for which
EPA is finalizing a WCPP, compliance at
most workplaces would be part of an
established industrial hygiene program
that aligns with the hierarchy of
controls.
Examples of engineering controls that
may prevent or reduce the potential for
direct dermal contact include
automation, physical barriers between
contaminated and clean work areas,
enclosed transfer liquid lines (with
purging mechanisms in place (e.g.,
nitrogen, aqueous) for operations such
as product changes or cleaning), and
design of tools (e.g., a closed-loop
container system providing contact-free
connection for unloading fresh and
collecting spent solvents, pneumatic
tools, tongs, funnels, glove bags, etc.).
Examples of administrative controls that
may prevent or reduce the potential for
direct dermal contact include adjusting
work practices (i.e., implementing
policies and procedures) such as
providing safe working distances from
areas where direct handling of CTC may
occur.
EPA is finalizing the requirement that
regulated entities use the hierarchy of
controls, instituting one or a
combination of controls to the extent
feasible, and supplement such
protections using PPE, where necessary,
including respirators for potentially
exposed persons at risk of inhalation
exposure above the ECEL and dermal
PPE for persons potentially exposed
through direct dermal contact to CTC. If
efforts of elimination, substitution,
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engineering controls, and administrative
controls are not sufficient to reduce
exposures to or below the ECEL or
prevent direct dermal contact for all
potentially exposed persons in the
workplace, EPA requires that the owner
or operator use feasible controls to
reduce CTC concentrations in the
workplace to the lowest levels
achievable and supplement these
controls with respiratory protection and
dermal PPE as needed to achieve the
ECEL or prevent direct dermal contact.
In such cases, EPA requires that the
owner or operator provide potentially
exposed persons reasonably likely to be
exposed to CTC by inhalation to
concentrations above the ECEL with
respirators affording sufficient
protection against inhalation risk and
appropriate training on the proper use
of such respirators, to ensure that their
exposures do not exceed the ECEL as
described in Unit IV. EPA also requires
that the owner or operator provides
potentially exposed persons reasonably
likely to be exposed to CTC by direct
dermal contact with dermal protection
affording sufficient protection against
dermal risk and appropriate training on
the proper use of dermal protection, as
described in this unit. As part of the
training requirement, the owner or
operator is required to provide
information and comprehensive training
in an understandable manner (i.e., plain
language), considering factors such as
the skills required to perform the work
activity and the existing skill level of
the staff performing the work, and in
multiple languages as appropriate (e.g.,
based on languages spoken by
potentially exposed persons) to
potentially exposed persons. This
training must be provided prior to or at
the time of initial assignment to a job
involving potential exposure to CTC.
Furthermore, EPA also requires that the
owner or operator document their
efforts in using elimination,
substitution, engineering controls, and
administrative controls to reduce
exposure to or below the ECEL in an
exposure control plan.
The Agency understands that certain
engineering controls can reduce
exposures to people inside the
workplace but may lead to increased
ventilation of CTC outside of the
workplace. Increasing CTC releases to
the ambient air could lead to increasing
risks to people in fenceline
communities of adverse health effects
from exposures to CTC in ambient air.
Therefore, as proposed, and considering
the effects of CTC on health and the
magnitude of the exposure of human
beings, as required by TSCA section
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6(c)(2)(A)(i), EPA is prohibiting
increased releases of CTC to outdoor air
associated with the implementation of
the WCPP/ECEL. This requirement is
intended to avoid unintended increases
in exposures to people from CTC
emissions to ambient air. Owners and
operators are required to attest in their
WCPP/ECEL exposure control plan that
engineering controls selected do not
increase emissions of CTC to ambient
air outside of the workplace and
document in their exposure control plan
whether additional equipment was
installed to capture emissions of CTC to
ambient air. Owners and operators may
institute air emissions monitoring or
modeling to assist with meeting this
requirement.
EPA is finalizing its requirement that
the owner or operator include and
document in the exposure control plan
or through any existing documentation
of the facility’s safety and health
program developed as part of meeting
OSHA requirements or other safety and
health standards, the following:
• Identification in the exposure
control plan of available exposure
controls that were considered and
rationale for using or not using available
exposure controls in the following
sequence (i.e., elimination and
substitution, then engineering controls
and administrative controls) to reduce
exposures in the workplace to either at
or below the ECEL or to the lowest level
achievable and to prevent or reduce
direct dermal contact with CTC in the
workplace;
• For each exposure control
considered, exposure controls selected
based on feasibility, effectiveness, and
other relevant considerations;
• A description of actions the owner
or operator must take to implement
exposure controls selected, including
proper installation, regular inspections,
maintenance, training, or other steps
taken;
• A description of regulated areas,
how they are demarcated, and persons
authorized to enter the regulated areas;
• Attestation that exposure controls
selected do not increase emissions of
CTC to ambient air outside of the
workplace and whether additional
equipment was installed to capture or
otherwise prevent increased emissions
of CTC to ambient air;
• 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
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• An explanation of the procedures
for responding to any change that may
reasonably be expected to introduce
additional sources of exposure to CTC,
or otherwise result in increased
exposure to CTC, including procedures
for implementing corrective actions to
mitigate exposure to CTC.
Under this final rule, owners or
operators are prohibited from using
rotating work schedules to comply with
the ECEL 8-hour TWA, in alignment
with certain elements of existing
OSHA’s standards for toxic substances
under 29 CFR part 1910, subpart Z.
Owners or operators must maintain the
effectiveness of any engineering and
administrative controls instituted as
part of the exposure control plan. They
must also review and update the
exposure control plan as necessary, but
at least every five years, to reflect any
significant changes in the status of the
owner or operator’s approach to
compliance with the exposure control
requirements. EPA intends that the
exposure control plan identify the
available exposure controls and, for the
exposure controls not selected,
document the efforts identifying why
these are not feasible, not effective, or
otherwise not implemented. For entities
for which significant amounts of time
are needed to verify suitability of
alternatives or procure funds or
authorization for additional engineering
controls, for example, EPA expects that
as those controls become available the
exposure control plan would be updated
accordingly. EPA requires that the
exposure control plan be revisited under
certain conditions (and at least every
five years) and encourages updates as
more sophisticated controls are
available.
This final rule requires owners or
operators to make the exposure control
plan and associated records, including
ECEL exposure monitoring records,
ECEL compliance records, DDCC
compliance records, and workplace
participation records, available to
potentially exposed persons and their
designated representatives. Owners or
operators must notify potentially
exposed persons and their designated
representatives of the availability of the
exposure control plan and associated
records within 30 days of the date that
the exposure control plan is completed
and at least annually thereafter. The
notice of the availability of the plan and
associated records must be provided in
plain language writing to each
potentially exposed person in a
language that the person understands or
posted in an appropriate and accessible
location outside the regulated area with
an English-language version and a non-
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English version representing the
language of the largest group of workers
who do not read English. This final rule
also requires the owner or operator to
provide the exposure control plan and
associated records at a reasonable time,
place, and manner to a potentially
exposed person or their designated
representative upon request. As
explained in Unit III.C.2., if the owner
or operator is unable to provide the
specified records within 15 days, the
owner or operator must inform the
potentially exposed person or
designated representative requesting the
record within 15 days that reason for the
delay and the earliest date when the
record will be made available.
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6. Personal Protective Equipment (PPE)
Where elimination, substitution,
engineering controls, and administrative
controls are not feasible to reduce the
air concentration to or below the ECEL
and/or prevent direct dermal contact
with CTC for all potentially exposed
persons, EPA is finalizing as proposed
with slight modifications to improve
clarity or for greater consistency with
OSHA’s regulations to require owners
and operators to provide PPE, including
respiratory protection and dermal
protection selected in accordance with
the guidelines described in this unit,
and to implement a PPE program. This
unit includes a description of the PPE
program, including required PPE as it
relates to respiratory protection,
required PPE as it relates to dermal
protection, and other requirements such
as additional training for respirators and
recordkeeping to support
implementation of a PPE program.
a. Respiratory Protection
Where elimination, substitution,
engineering, and administrative controls
are not feasible or sufficiently protective
to reduce the air concentration to or
below the ECEL, or if inhalation
exposure above the ECEL is still
reasonably likely, EPA is finalizing,
with slight modification from the
proposal, minimum respiratory PPE
requirements based on an owner or
operator’s most recent measured air
concentration for one or more
potentially exposed persons and the
level of PPE needed to reduce exposure
to or below the ECEL. In those
circumstances, EPA is finalizing the
requirements for a respiratory protection
PPE program with worksite-specific
procedures and elements for required
respirator use. Owners or operators
must develop and administer a written
respiratory protection program in
accordance with OSHA’s respiratory
protection standard under 29 CFR
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1910.134(c)(1), (c)(3), and (c)(4). EPA is
finalizing requirements that owners and
operators provide training to all persons
required to use respiratory protection
consistent with 29 CFR 1910.134(k)
prior to or at the time of initial
assignment to a job involving potential
exposure to CTC. Owners and operators
must retrain all persons required to use
PPE at least annually, or whenever the
owner or operator has reason to believe
that a previously trained person does
not have the required understanding
and skill to properly use PPE, or when
changes in the workplace or in PPE to
be used render the previous training
obsolete.
EPA is finalizing requirements that
each owner or operator supply a
respirator, selected in accordance with
requirements described in this unit, to
each person who enters a regulated area
within 1,005 days after the date of
publication of the final rule in the
Federal Register (i.e., no later than
September 20, 2027) for Federal
agencies and Federal contractors acting
for or on behalf of the Federal
government, 630 days after the date of
publication of the final rule in the
Federal Register (i.e., no later than
September 9, 2026) for non-Federal
owners and operators, or within three
months after the receipt of any exposure
monitoring that indicates exposures
exceeding the ECEL, and thereafter must
ensure that all persons within the
regulated area are using the provided
respirators whenever CTC exposures
exceed or can reasonably be expected to
exceed the ECEL.
EPA is also finalizing requirements
that owners or operators who are
required to administer a respiratory
protection PPE program must supply a
respirator based on a medical evaluation
consistent with the requirements of 29
CFR 1910.134(e). If a potentially
exposed person cannot use a negativepressure respirator, then the owner or
operator must provide that person with
an alternative respirator. The alternative
respirator must have less breathing
resistance than the negative-pressure
respirator and provide equivalent or
greater protection. If the person is
unable to use an alternative respirator,
then the person must not be permitted
to enter the regulated area. Additionally,
EPA is requiring owners and operators
to select respiratory protection that
properly fits each affected person and
communicate respirator selections to
each affected person in accordance with
the requirements of 29 CFR 1910.134(f).
Consistent with requirements of 29 CFR
1910.134(g) through (j), EPA is requiring
owners and operators to provide, ensure
use of, and maintain (in a sanitary,
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reliable, and undamaged condition)
respiratory protection that is of safe
design and construction. EPA is also
requiring owners and operators to
provide training to all persons required
to use respiratory protection consistent
with the requirements of 29 CFR
1910.134(k).
EPA is finalizing the requirements to
establish minimum respiratory
protection requirements, such that any
respirator affording a higher degree of
protection than the following
requirements may be used. In instances
where respiratory protection is
appropriate, NIOSH Approved®
equipment must be used. NIOSH
Approved is a certification mark of the
U.S. Department of Health and Human
Services (HHS) registered in the United
States and several international
jurisdictions. EPA is finalizing the
following requirements for respiratory
protection, based on the most recent
exposure monitoring concentration
results measured as an 8-hour TWA that
exceed the ECEL (0.03 ppm):
• If the measured exposure
concentration is at or below 0.03 ppm:
no respiratory protection is required.
• If the measured exposure
concentration is above 0.03 ppm and
less than or equal to 0.3 ppm (10 times
ECEL): Any NIOSH Approved airpurifying half mask respirator equipped
with organic vapor cartridges or
canisters; or any NIOSH Approved
Supplied-Air Respirator (SAR) or
Airline Respirator operated in demand
mode equipped with a half mask; or any
NIOSH Approved Self-Contained
Breathing Apparatus (SCBA) in a
demand mode equipped with a half
mask [APF 10].
• If the measured exposure
concentration is above 0.3 ppm and less
than or equal to 0.75 ppm (25 times
ECEL): Any NIOSH Approved Powered
Air-Purifying Respirator (PAPR)
equipped with a loose-fitting facepiece
or hood/helmet equipped with organic
vapor cartridges or canisters; or any
NIOSH Approved SAR or Airline
Respirator in a continuous-flow mode
equipped with a loose-fitting facepiece
or helmet/hood [APF 25].
• If the measured exposure
concentration is above 0.75 ppm and
less than or equal to 1.5 ppm (50 times
ECEL): Any NIOSH Approved airpurifying full facepiece respirator
equipped with organic vapor cartridges
or canisters; any NIOSH Approved
PAPR with a half mask equipped with
organic vapor cartridges or canisters;
any NIOSH Approved SAR or Airline
Respirator in a continuous flow mode
equipped with a half mask; any NIOSH
Approved SAR or Airline Respirator
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operated in a pressure-demand or other
positive-pressure mode with a half
mask; or any NIOSH Approved SCBA in
demand-mode equipped with a full
facepiece or helmet/hood [APF 50].
• If the measured exposure
concentration is above 1.5 ppm and less
than or equal to 30 ppm (1,000 times
ECEL): Any NIOSH Approved PAPR
equipped with a full facepiece equipped
with organic vapor cartridges or
canisters; any NIOSH Approved SAR or
Airline Respirator in a continuous-flow
mode equipped with full facepiece; any
NIOSH Approved SAR or Airline
Respirator in pressure-demand or other
positive-pressure mode equipped with a
full facepiece and an auxiliary selfcontained air supply; or any NIOSH
Approved SAR or Airline Respirator in
a continuous-flow mode equipped with
a helmet or hood and has been tested to
demonstrate performance at a level of a
protection of APF 1,000 or greater. [APF
1,000].
• If the measured exposure
concentration is greater than 30 ppm
(1,000+ times ECEL): Any NIOSH
Approved SCBA equipped with a full
facepiece, hood, or helmet and operated
in a pressure demand or other positive
pressure mode [APF 10,000].
• If the exposure concentration is
unknown: Any NIOSH Approved
combination supplied air respirator
equipped with a full facepiece and
operated in pressure demand or other
positive pressure mode with an
auxiliary self-contained air supply; or
any NIOSH Approved SCBA operated in
pressure demand or other positive
pressure mode and equipped with a full
facepiece or hood/helmet [APF 1000+].
Additionally, EPA is finalizing
requirements that owners or operators
select and provide respirators in
accordance with the requirements of 29
CFR 1910.134(d)(1)(iv) and with
consideration of workplace and user
factors that affect respirator performance
and reliability.
EPA is requiring that the owner or
operator must ensure that all filters,
cartridges, and canisters used in the
workplace are labeled and color coded
per NIOSH requirements and that the
label is not removed and remains
legible. Consistent with 29 CFR
1910.134(d)(3)(iii), EPA is requiring
either the use of NIOSH Approved
respirators with an end-of-life service
indicator for the contaminant, in this
case CTC, or implementation of a
change schedule for canisters and
cartridges that ensures that they are
changed before the end of their service
life. EPA is also requiring owners and
operators to ensure that respirators are
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used in compliance with the terms of
the respirator’s NIOSH approval.
EPA is finalizing requirements that
owners and operators must conduct
regular evaluations of the workplace,
including consultations with potentially
exposed persons using respiratory
protection, consistent with the
requirements of 29 CFR 1910.134(l), to
ensure that the provisions of the written
respiratory protection program
described in this unit are being
effectively implemented.
EPA is finalizing the requirement that
owners and operators document
respiratory protection used and PPE
program implementation. EPA is
finalizing requirements that owners and
operators document in the exposure
control plan or other documentation of
the facility’s safety and health program
information relevant to the respiratory
program, including records on the
name, workplace address, work shift,
job classification, work area, and type of
respirator worn (if any) by each
potentially exposed person,
maintenance, fit-testing, and training as
described in this unit.
b. Dermal Protection
As described in this unit EPA is
finalizing requirements that each owner
or operator supply dermal PPE that
separates and provides a barrier to
prevent direct dermal contact with CTC,
selected in accordance with
requirements described in this unit, to
each person who is reasonably likely to
be dermally exposed in the work area
through direct dermal contact within
1,005 days after the date of publication
of the final rule in the Federal Register
(i.e., no later than September 20, 2027)
for Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, or 180 days after
the date of publication of the final rule
in the Federal Register (i.e., no later
than June 16, 2025) for non-Federal
owners and operators. Where
elimination, substitution, engineering
controls, and administrative controls are
not feasible or sufficient to fully prevent
direct dermal contact with CTC, EPA is
finalizing requirements that appropriate
dermal PPE be provided by owners and
operators to, and be worn by, persons
potentially exposed to direct dermal
contact with CTC. EPA is requiring
owners and operators to provide dermal
PPE that is of safe design and
construction for the work to be
performed. EPA is also requiring owners
and operators ensure each potentially
exposed person who is required to wear
PPE to use and maintain PPE in a
sanitary, reliable, and undamaged
condition. Additionally, EPA is
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requiring owners and operators to select
and provide PPE that properly fits each
potentially exposed person who is
required to use PPE and communicate
PPE selections to each affected person.
In choosing appropriate dermal PPE,
EPA is requiring owners and operators
to select gloves, clothing, and protective
gear (which covers any exposed dermal
area of arms, legs, torso, and face) based
on specifications from the manufacturer
or supplier or individually prepared
third party testing that demonstrate an
impervious barrier to CTC during
expected durations of use and normal
conditions of exposure within the
workplace, accounting for potential
chemical permeation or breakthrough
times. EPA is also requiring that owners
and operators demonstrate that the
selected PPE will be impervious for the
expected duration and conditions of
exposure, such as using the format
specified in ASTM F1194–99(2010)
‘‘Standard Guide for Documenting the
Results of Chemical Permeation Testing
of Materials Used in Protective Clothing
Materials,’’ reporting cumulative
permeation rate as a function of time, or
equivalent manufacturer- or supplierprovided testing. In alignment with the
OSHA Hand Protection PPE Standard
(29 CFR 1910.138), EPA is requiring
owners and operators to select dermal
PPE based on an evaluation of the
performance characteristics of the PPE
relative to the task(s) to be performed,
conditions present, and the duration of
use. EPA is also requiring owners and
operators to consider likely
combinations of chemical substances to
which the clothing may be exposed in
the work area when selecting the
appropriate PPE such that the PPE will
prevent direct dermal contact to CTC.
For example, owners and operators
can select gloves that have been tested
in accordance with the American
Society for Testing and Materials
(ASTM) F739 ‘‘Standard Test Method
for Permeation of Liquids and Gases
through Protective Clothing Materials
under Conditions of Continuous
Contact.’’ EPA is finalizing that PPE be
provided for use for a time period only
to the extent and no longer than the
time period for which testing has
demonstrated that the PPE will be
impervious during expected durations
of use and conditions of exposure. EPA
is finalizing requirements that owners
and operators also consider other factors
when selecting appropriate PPE,
including effectiveness of glove type
when preventing exposures from CTC
alone and in likely combination with
other chemical substances used in the
work area or when used with glove
liners, permeation, degree of dexterity
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required to perform task, and
temperature, as identified in the Hand
Protection section of OSHA’s Personal
Protective Equipment Guidance (Ref.
45).
EPA is finalizing that owners and
operators establish, either through
manufacturer or supplier-provided
documentation or individually prepared
third party testing that the selected PPE
will be impervious for the expected
duration and conditions of exposure,
such as using the format specified in
ASTM F1194–99(2010) ‘‘Standard
Guide for Documenting the Results of
Chemical Permeation Testing of
Materials Used in Protective Clothing
Materials,’’ reporting cumulative
permeation rate as a function of time, or
equivalent manufacturer- or supplierprovided testing. EPA is also requiring
owners and operators to consider likely
combinations of chemical substances to
which the clothing may be exposed in
the work area when selecting the
appropriate PPE such that the PPE will
prevent direct dermal contact to CTC.
Degradation may also be appropriate to
consider in the context of combination
chemical exposures, as some glove types
and materials may demonstrate efficient
permeation barrier results but may not
be fully resistant to degradation from
the chemical exposure. Degradation can
be evaluated using standard test
methods such as select test methods
within ASTM Method D 471 Standard
Test Method for Rubber Property—
Effect of Liquids (e.g., ASTM D412
Standard Test Methods for Vulcanized
Rubber and Thermoplastic ElastomersTension). EPA is finalizing requirements
that PPE must be immediately provided
and replaced if any person is dermally
exposed to CTC longer than the
breakthrough time period for which
testing has demonstrated that the PPE
will be impermeable or if there is a
chemical permeation or breakage of the
PPE.
Additionally, EPA is finalizing
requirements that owners and operators
subject to this rule comply with
provisions of 29 CFR 1910.133(b) for
requirements on selection and use of
eye and face protection.
Additionally, as part of the PPE
program, EPA is also finalizing that
owners and operators must comply with
OSHA’s general PPE training
requirements at 29 CFR 1910.132(f) for
application of a PPE training program,
including providing training on proper
use of dermal PPE (e.g., when and
where PPE is necessary, proper
application, wear, and removal of PPE,
maintenance, useful life and disposal of
PPE). EPA is finalizing that owners and
operators provide PPE training to all
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persons required to use dermal PPE
prior to or at the time of initial
assignment to a job involving potential
exposure to CTC. Owners and operators
have to re-train each affected person at
least once annually or whenever the
owner or operator has reason to believe
that a previously trained person does
not have the required understanding
and skill to properly use PPE, or when
changes in the workplace or in the PPE
to be used render the previous training
obsolete.
EPA is also finalizing requirements
that owners and operators retain records
of dermal PPE used and program
implementation. EPA is requiring that
owners and operators document in the
exposure control plan or other
documentation of the facility’s safety
and health program, information
relevant to any dermal PPE program, as
applicable, including:
• The name, workplace address, work
shift, job classification, and work area of
each person reasonably likely to directly
handle CTC or handle equipment or
materials on which CTC may present
and the type of PPE selected to be worn
by each of these persons;
• The basis for specific PPE selection
(e.g., demonstration based on
permeation testing or manufacturer
specifications that each item of PPE
selected provides an impervious barrier
to prevent exposure during expected
duration and conditions of exposure,
including the likely combinations of
chemical substances to which the PPE
may be exposed in the work area);
• Appropriately sized PPE and
training on proper application, wear,
and removal of PPE, and proper care/
disposal of PPE;
• Occurrence and duration of any
direct dermal contact with CTC that
occurs during any activity or
malfunction at the workplace that
causes direct dermal exposures to occur
and/or glove breakthrough, and
corrective actions to be taken during
and immediately following that activity
or malfunction to prevent direct dermal
contact to CTC; and
• Training described in this unit.
7. Additional Finalized Requirements
a. Workplace Information and Training
EPA is also finalizing its requirements
to implement a training program in
alignment with the OSHA Hazard
Communication Standard (29 CFR
1910.1200) and the OSHA General
Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure
that potentially exposed persons in the
workplace are informed of the hazards
associated with CTC exposure, EPA is
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finalizing as proposed with slight
modification to require that owners or
operators of workplaces subject to the
WCPP institute a training and
information program for potentially
exposed persons and assure their
participation in the training and
information program within 1,005 days
after the date of publication of the final
rule in the Federal Register (i.e., no later
than September 20, 2027) for Federal
agencies and Federal contractors acting
for or on behalf of the Federal
government, or 630 days after the date
of publication of the final rule in the
Federal Register (i.e., no later than
September 9, 2026) for non-Federal
owners and operators. For purposes of
workplace information and training,
owners and operators are only required
to train potentially exposed persons that
are expected to be present in the
workplace or to directly handle CTC or
handle equipment or materials on
which CTC may present.
As part of the training and
information program, the owner or
operator is required to provide
information and comprehensive training
in an understandable manner (i.e., plain
language) and in multiple languages as
appropriate (e.g., based on languages
spoken by potentially exposed persons)
to potentially exposed persons prior to
or at the time of initial assignment to a
job involving potential exposure to CTC.
Owners and operators are required to
provide information and training, as
referenced in the OSHA Hazard
Communication Standard, to all
potentially exposed persons that
includes:
• The requirements of the CTC WCPP
and how to access or obtain a copy of
the requirements of the WCPP,
including but not limited to the
exposure control plan, monitoring
requirements, and PPE program;
• The quantity, location, manner of
use, release, and storage of CTC and the
specific operations in the workplace
that could result in CTC exposure,
particularly noting where each regulated
area is located;
• Principles of safe use and handling
of CTC in the workplace, including
specific measures the owner or operator
has implemented to reduce inhalation
exposure at or below the ECEL or
prevent dermal contact with CTC, such
as work practices and PPE used;
• The methods and observations that
may be used to detect the presence or
release of CTC in the workplace (such
as monitoring conducted by the owner
or operator, continuous monitoring
devices, visual appearance or odor of
CTC when being released, etc.); and
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• The acute and chronic health
hazards of CTC as detailed on relevant
Safety Data Sheets (SDSs).
In addition to providing training at
the time of initial assignment to a job
involving potential exposure to CTC,
owners and operators subject to the CTC
WCPP are required to re-train each
potentially exposed person as necessary,
but at a minimum annually, to ensure
they understand the principles of safe
use and handling of CTC in the
workplace. The owner or operator
would consider factors such as the skills
required to perform the work activity
and the existing skill level of the staff
performing the work. EPA is finalizing
its requirements that owners and update
the training as necessary whenever there
are changes in the workplace, such as
new tasks or modifications of tasks, in
particular, whenever there are changes
in the workplace that increase exposure
to CTC or where potentially exposed
persons’ exposure to CTC can
reasonably be expected to exceed the
action level or increase the potential for
direct dermal contact with CTC. To
support compliance, EPA is finalizing
that each owner or operator of a
workplace subject to the WCPP would
be required to provide to the EPA, upon
request, all available materials related to
workplace information and training.
b. Workplace Participation
EPA encourages owners and operators
to consult with potentially exposed
persons and their designated
representative on the development and
implementation of exposure control
plans and PPE/respirator programs. EPA
is finalizing a requirement that owners
and operators provide potentially
exposed persons and their designated
representatives regular access to the
exposure control plans, exposure
monitoring records, and PPE program
implementation records. To ensure
compliance with workplace
participation, EPA is finalizing a
requirement that the owner or operator
document the notice to and ability of
any potentially exposed person that may
reasonably be affected by CTC exposure
to readily access the exposure control
plans, facility exposure monitoring
records, PPE program implementation
records, or any other information
relevant to CTC exposure in the
workplace.
c. Recordkeeping
For owners and operators to
demonstrate compliance with the WCPP
provisions, EPA is requiring that owners
and operators retain compliance records
for five years (although this requirement
does not supplant any longer
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recordkeeping retention time periods
such as those required under 29 CFR
1910.1020, or other applicable
regulations). EPA is requiring the owner
or operator to retain records of:
• Exposure control plan;
• PPE program implementation and
documentation, including as necessary,
respiratory protection and dermal
protection used and related PPE
training; and
• Information and training provided
to each person prior to or at the time of
initial assignment and any retraining.
In addition, EPA is finalizing
requirements that owners and operators
subject to the WCPP ECEL requirements
maintain records to include:
• Regulated areas and authorized
personnel;
• The exposure monitoring records;
• Notification of exposure monitoring
results; and
• To the extent that the owner or
operator relies on prior exposure
monitoring data, records that
demonstrates that it meets all of the
requirements of this section.
The owners and operators, upon
request by EPA, are required to make all
records that are maintained as described
in Unit IV. available to EPA for
examination and copying in accordance
with EPA requirements. EPA
emphasizes that all records required to
be maintained can be kept in the most
administratively convenient form;
electronic record form or paper form.
8. Compliance Timeframes
EPA is finalizing the requirement that
owners or operators of workplaces
subject to the WCPP implement the
DDCC requirements as outlined in this
unit within 1,005 days after December
18, 2024 for Federal agencies or Federal
contractors acting for or on behalf of the
Federal government, 180 days after
December 18, 2024 for non-Federal
owners and operators, or within 30 days
of introduction of CTC into the
workplace, whichever is later. With
regard to the compliance timeframe for
the WCPP provisions related to the
ECEL, EPA is not finalizing the
timeframes proposed. Rather, as
discussed in Unit III.B., based on
consideration of public comments and
reasonably available information, EPA is
finalizing longer timeframes for
compliance with provisions related to
the ECEL for non-Federal owners or
operators, and is providing Federal
agencies and Federal contractors acting
for or on behalf of the Federal
government additional time to comply
with each of the provisions of the
WCPP. Specifically, EPA is finalizing its
requirement that non-Federal owners
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and operators perform initial exposure
monitoring according to the process
outlined in this unit within 540 days
after date of publication of the final rule
in the Federal Register (i.e., no later
than June 11, 2026) or within 30 days
of introduction of CTC into the
workplace, whichever is later. Federal
agencies and Federal contractors acting
for or on behalf of the Federal
government must conduct initial
exposure monitoring within 915 days
after the date of publication (i.e., no
later than June 21, 2027), or within 30
days of introduction of CTC into the
workplace, whichever is later. EPA is
also finalizing its requirement that each
non-Federal owner or operator ensure
that exposure to CTC does not exceed
the ECEL as an 8-hour TWA for all
potentially exposed persons within 630
days after the date of publication of the
final rule in the Federal Register (i.e.,
no later than September 9, 2026), while
Federal agencies and Federal
contractors acting for or on behalf of the
Federal government must comply with
the ECEL within 1,005 days after the
date of publication (i.e., no later than
September 20, 2027). If applicable, each
owner or operator must provide
respiratory protection sufficient to
reduce inhalation exposures to below
the ECEL to all potentially exposed
persons in the regulated area within
three months after receipt of the results
of any exposure monitoring that
indicates an exceedance of the ECEL.
For non-Federal owners or operators,
this will be within 630 days after the
date of publication of the final rule in
the Federal Register (i.e., no later than
September 9, 2026). For Federal
agencies and Federal contractors acting
for or on behalf of the Federal
government, this will be within 1,005
after the date of publication of the final
rule in the Federal Register (i.e., no later
than September 20, 2027). EPA is also
finalizing the requirement that owners
and operators demarcate a regulated
area within three months after receipt of
any exposure monitoring that indicates
exposures exceeding the ECEL. Owners
and operators shall proceed accordingly
to implement an exposure control plan,
including institution of feasible
exposure controls other than PPE,
within 1,080 days after date of
publication of the final rule in the
Federal Register (i.e., no later than
December 3, 2027).
C. Prescriptive Controls Required for
Laboratory Use
In contrast to the non-prescriptive
requirements of the WCPP, including
the DDCC, where regulated entities
would have the ability to select controls
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in accordance with the hierarchy of
controls to comply with the parameters
outlined in Unit IV.B., EPA has found
it appropriate in certain circumstances
to require specific prescriptive controls
for certain occupational conditions of
use. In general, EPA is finalizing
prescriptive controls, for the industrial
and commercial use of CTC as a
laboratory chemical, as described in
Unit III.A.2. This unit provides a
description of the industrial and
commercial use of CTC as a laboratory
chemical subject to specific prescriptive
controls, the specific prescriptive
control requirements, and the
compliance timeframe for the
requirements.
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1. Applicability
The industrial and commercial use of
CTC as a laboratory chemical refers to
the industrial or commercial use of CTC,
often in small quantities, 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.
After the risk evaluation was
published, DoD did further analysis and
provided additional information
clarifying their current use of CTC as a
laboratory chemical and risk
management measures implemented.
DoD provided information on their use
of CTC as a laboratory chemical in
chemical weapons destruction,
indicating that CTC is used in small
amounts in a confined, laboratory-like
setting with advanced engineering
controls. There is no waste CTC
generated during this process.
EPA recognizes that potentially
exposed persons in a laboratory setting
may include students, researchers,
visiting scholars, or others whose job
classifications may vary, such as
depending on the academic period in
university laboratories. The
requirements described in this unit
apply to all potentially exposed persons
in all laboratory settings, including
academic and research laboratories,
regardless of job classification.
2. Workplace Requirements
To address the unreasonable risk of
injury to health resulting from dermal
exposures to CTC identified for the
industrial and commercial use as a
laboratory chemical, including DoD’s
use of CTC as a laboratory chemical in
chemical weapons destruction, EPA is
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requiring dermal PPE, including
impermeable gloves and protective
clothing, in combination with
comprehensive training for tasks
particularly related to the use of CTC in
a laboratory setting as specified in this
unit for each potentially exposed person
with direct dermal contact to CTC in the
work area through direct handling of the
substance or from contact with surfaces
that may be contaminated with CTC. For
dermal PPE, EPA is requiring that each
owner or operator comply with the
requirements outlined in Units IV.B.6.b.
for selection of dermal PPE and training
for all potentially exposed persons.
EPA’s description for how the
requirements for the industrial and
commercial use as a laboratory chemical
address the unreasonable risk resulting
from dermal exposures under the
conditions of use and the rationale for
this regulatory approach is outlined in
Unit V. of the proposed rule (88 FR
49205, July 28, 2023) (FRL–8206–01–
OCSPP).
In addition, EPA is requiring the use
of laboratory ventilation devices, such
as fume hoods, glove boxes, air handling
units, exhaust fans, biological safety
devices, airflow controls, and other
local exhaust devices, in workplace
laboratory settings for the industrial and
commercial use of CTC as a laboratory
chemical, except for DoD’s use of CTC
as a laboratory chemical in chemical
weapons destruction, to codify existing
good laboratory practices. EPA is
requiring each owner or operator of a
workplace laboratory setting, except for
DoD’s use of CTC as a laboratory
chemical in chemical weapons
destruction, to ensure laboratory
ventilation devices are in use and
functioning properly to minimize
exposures to persons in the area where
CTC is used as a laboratory chemical.
EPA suggests owners or operators refer
to OSHA’s 29 CFR 1910.1450, Appendix
A, for National Research Council
recommendations concerning laboratory
chemical hood ventilation system
characteristics and practices and to
ANSI’s and ASSP’s Z9.5–2022 for
recommendations on additional
laboratory ventilation controls to
minimize exposures to potentially
exposed persons in the work area.
EPA understands that DoD uses CTC
in small amounts in a confined,
laboratory-like setting with advanced
engineering controls (Ref. 46).
Therefore, for DoD’s industrial and
commercial use of CTC as a laboratory
chemical in chemical weapons
destruction, EPA is requiring advanced
engineering controls that essentially
codify existing practices at DoD
facilities. EPA is not requiring a WCPP,
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specifically with monitoring
requirements, for DoD’s industrial and
commercial use of CTC as a laboratory
chemical in chemical weapons
destruction.
3. Recordkeeping
To support and demonstrate
compliance, EPA is requiring that each
owner or operator of a laboratory
workplace subject to the requirements of
this unit retain compliance records for
five years. In alignment with 29 CFR
1910.1450(e)(3)(ii) and (iii) and 29 CFR
1910.132(d)(2), EPA is requiring that
owners and operators must retain
records of:
• Dermal protection used by each
potentially exposed person and PPE
program implementation as outlined in
this unit;
• Criteria that the owner or operator
will use to determine and implement
control measures to reduce potentially
exposed persons’ exposure to CTC
including laboratory ventilation devices
as outlined in this unit;
• Implementation of properly
functioning laboratory ventilation
devices using manufacturer’s
instructions for installation, use, and
maintenance of the systems, including
inspections, tests, development of
maintenance procedures, the
establishment of criteria for acceptable
test results, and documentation of test
and inspection results, except for DoD’s
use of CTC as a laboratory chemical in
chemical weapons destruction; and
• For DoD’s industrial and
commercial use of CTC as a laboratory
chemical in chemical weapons
destruction, implementation of
advanced engineering controls that are
in use and functioning properly and
specific measures taken to ensure
proper and adequate performance.
Owners or operators must maintain
records for five years. EPA expects
owners or operators ensure that records
reflect actions taken within the last five
years to comply with the requirements
of this unit.
4. Compliance Timeframes
With regards to the compliance
timeframe, EPA is requiring that each
owner or operator of a workplace
engaged in the industrial and
commercial of CTC as a laboratory
chemical ensure laboratory ventilation
devices are in use and functioning
properly and that dermal PPE is
provided to all potentially exposed
persons with direct dermal contact with
CTC within 180 days after publication
of the final rule.
Similarly, EPA is requiring that DoD
facilities engaged in the industrial and
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commercial use of CTC as a laboratory
chemical in chemical weapons
destruction ensure that advanced
engineering controls are in use and
functioning properly and dermal PPE is
provided to all potentially exposed
persons with direct dermal contact with
CTC within 365 days after publication
of the final rule.
EPA understands that certain
departments and agencies of the Federal
government, as well as Federal
contractors acting for or on behalf of the
Federal government, need additional
time to comply with these timeframes.
For example, ensuring compliance with
the prescriptive controls could be
challenging due to changing contracting,
procurement decisions and other
processes in Federal facilities. Similarly,
EPA is requiring for that agencies of the
Federal government and their
contractors, when acting for or on behalf
of the Federal government, that are
engaged in the industrial and
commercial use of CTC as a laboratory
chemical ensure laboratory ventilation
devices are in use and functioning
properly, and that dermal PPE and
training on proper use of PPE is
provided to all potentially exposed
persons with direct dermal contact with
CTC within 365 days after publication
of the final rule.
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D. Prohibition of Manufacture,
Processing, Distribution, and Use of
CTC
1. Applicability
EPA is finalizing the prohibitions for
most of the conditions of use for which
prohibition was proposed. Prohibitions
will address the contribution to the
unreasonable risk determined to be
presented by CTC in the 2020 Risk
Evaluation for Carbon Tetrachloride and
2022 Revised Unreasonable Risk
Determination for Carbon Tetrachloride
from industrial and commercial uses of
CTC, and reasonably available
information indicates that industry has
already transitioned away from CTC and
found technically and economically
feasible alternatives to CTC for these
uses. Unit V. of the proposed rule and
the Response to Comments document
present further discussion of EPA’s
rationale for why these conditions of
use are being prohibited (88 FR 49205)
(FRL–8206–01–OCSPP). EPA’s
description of the uses proposed to be
prohibited for which the Agency is
finalizing a WCPP (processing:
incorporation into formulation,
mixtures, or reaction products in vinyl
chloride manufacturing and the
industrial and commercial use as an
industrial processing aid in the
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manufacture of vinyl chloride) are in
Units III.A.1. and IV.B.1. The rule
prohibits manufacture, processing,
distribution in commerce, and use of
CTC for the following industrial and
commercial uses of CTC: industrial and
commercial use as a processing aid in
the manufacture of petrochemicalderived products except in the
manufacture of vinyl chloride (for
which EPA is finalizing a WCPP);
industrial and commercial use in the
manufacture of other basic chemicals
(including chlorinated compounds used
in solvents, adhesives, asphalt, and
paints and coatings), except for use in
the elimination of nitrogen trichloride
in the production of chlorine and
caustic soda and the recovery of
chlorine in tail gas from the production
of chlorine (for which EPA is finalizing
a WCPP); industrial and commercial use
in metal recovery; industrial and
commercial use as an additive; and
industrial and commercial use in
specialty uses by the U.S. Department of
Defense. EPA is also finalizing the
explicit prohibition for processing:
incorporation into formulation, mixture
or reaction products in petrochemicalderived manufacturing except in the
manufacture of vinyl chloride (the
upstream processing condition of use
for the industrial and commercial use of
CTC as a processing aid in the
manufacture of petrochemicals-derived
products except in the manufacture of
vinyl chloride). This unit provides a
description of the uses subject to the
prohibitions to assist with compliance.
a. Processing: Incorporation Into
Formulation, Mixture or Reaction
Products in Petrochemical-Derived
Manufacturing Except in the
Manufacture of Vinyl Chloride
Incorporation into formulation,
mixture, or reaction products refers to
the process of mixing or blending
several raw materials to obtain a single
product or preparation or formulation.
CTC has historically been incorporated
into formulation or mixtures to
manufacture hydrochloric acid (HCl),
vinyl chloride, ethylene dichloride
(EDC), chloroform, hafnium
tetrachloride, thiophosgene, and
methylene chloride. CTC may be
incorporated into various products and
formulations at varying concentrations
for further distribution. For example,
CTC may be unloaded from transport
containers either directly into mixing
equipment or into an intermediate
storage vessel either manually or
through automation via a pumping
system. Mixing of components can
occur in either a batch or continuous
system. The mixture that contains CTC
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may be used as a reactant to
manufacture a chlorinated compound
that is subsequently formulated into a
product or a processing aid used to aid
in the manufacture of petrochemicalsderived products. For the purposes of
this rulemaking, EPA is specifically
prohibiting the incorporation into
formulation, mixture or reaction
products in petrochemical-derived
manufacturing except in the
manufacture of vinyl chloride.
Incorporation into formulation, mixture
or reaction products in agricultural
products manufacturing, vinyl chloride
manufacturing, the elimination of
nitrogen trichloride in the production of
chlorine and caustic soda, and the
recovery of chlorine in tail gas from the
production of chlorine is being
regulated under the WCPP, as described
in Unit IV.B.
b. Industrial and Commercial Use
i. Industrial and Commercial Use as an
Industrial Processing aid in the
Manufacture of Petrochemicals-Derived
Products Except in the Manufacture of
Vinyl Chloride.
A processing aid is a ‘‘chemical that
is added to a reaction mixture to aid in
the manufacture or synthesis of another
chemical substance but is not intended
to remain in or become part of the
product or product mixture.’’
Additionally, processing agents are
intended to improve the processing
characteristics or the operation of
process equipment, but not intended to
affect the function of a substance or
article created. CTC has traditionally
been used as a processing aid/agent to
aid in the manufacture of
petrochemical-derived products (Ref. 1).
The condition of use includes the use of
CTC that has historically been used as
a processing agent in the manufacture of
chlorosulphonated polyolefin; stryene
butadiene rubber; endosulfan
(insecticide); 1–1 Bis (4-chlorophenyl)
2,2,2-trichloroethanol (dicofol
insecticide); and tralomethrin
(insecticide). For the purposes of this
rulemaking, EPA is specifically
prohibiting the industrial and
commercial use of CTC as an industrial
processing aid in the manufacture of
petrochemicals-derived products,
except in the manufacture of vinyl
chloride. The industrial and commercial
use as an industrial processing aid in
the manufacture of agricultural products
and vinyl chloride is being regulated
under the WCPP, as described in Unit
IV.B.
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ii. Industrial and Commercial Use in the
Manufacture of Other Basic Chemicals
(Including Manufacturing of
Chlorinated Compounds Used in
Solvents, Adhesives, Asphalt, and
Paints and Coatings), Except for Use in
the Elimination of Nitrogen Trichloride
in the Production of Chlorine and
Caustic Soda and the Recovery of
Chlorine in Tail Gas From the
Production of Chlorine
CTC has historically been used as a
processing aid/agent in basic organic
and inorganic chemical manufacturing.
CTC could be used as a processing agent
in the manufacturing of chlorinated
compounds that are subsequently used
in the formulation of solvents,
adhesives, asphalt, and paints and
coatings; in the manufacturing of
chlorinated paraffins (e.g., plasticizer in
rubber, paints, adhesives, sealants,
plastics), and chlorinated rubber (e.g.,
additive in paints, adhesives); and in
the manufacturing of inorganic
chlorinated compounds, such as in the
production of chlorine and caustic soda
and the recovery of chlorine in tail gas
from the production of chlorine. For the
purposes of this rulemaking, EPA is
specifically prohibiting the industrial
and commercial use in the manufacture
of other basic chemicals (including
manufacturing of chlorinated
compounds used in solvents, adhesives,
asphalt, and paints and coatings), except
for use in the elimination of nitrogen
trichloride in the production of chlorine
and caustic soda and the recovery of
chlorine in tail gas from the production
of chlorine. The industrial and
commercial use in the elimination of
nitrogen trichloride in the production of
chlorine and caustic soda and the
recovery of chlorine in tail gas from the
production of chlorine is being
regulated under the WCPP, as described
in Unit IV.B.
iii. Industrial and Commercial Use in
Metal Recovery
CTC has historically been used as a
processing aid or agent to aid in metal
recovery.
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iv. Industrial and Commercial Use as an
Additive
Additives are chemicals combined
with a chemical product to enhance the
properties of the product. Additives
typically stay mixed within the finished
product and remain unreacted. The risk
evaluation examined the use of CTC as
an additive for the manufacture of
petrochemical-derived products and
agricultural products. CTC has
historically been used as an additive in
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fuel and in plastic components used in
the automotive industry.
v. Industrial and Commercial Use in
Specialty Uses by the U.S. Department
of Defense (DoD)
During the risk evaluation, DoD
provided monitoring data for CTC uses
in various processes that include worker
activities such as cleaning and sampling
residual metal and ash; destruction of
munitions and storage of resulting
liquid waste; and sampling of energetics
with solvent. The unreasonable risk
determination for CTC further
determined that this condition of use
contributed to the unreasonable risk.
The Agency understands that DoD has
successfully phased out the use of CTC
for this condition of use.
As discussed in Unit II.C.4., the
prohibitions do not apply to any
substance that is excluded from the
definition of ‘‘chemical substance’’
under TSCA section 3(2)(B)(ii) through
(vi).
2. Compliance Timeframes
EPA is finalizing that the prohibitions
apply as of 180 days after the date of
publication of the final rule for the
manufacturing, processing, distribution
in commerce, and use of CTC for the
following: incorporation of CTC into
formulation, mixture or reaction
products in petrochemical-derived
manufacturing except in the
manufacture of vinyl chloride; the
industrial and commercial use of CTC as
a processing aid in the manufacture of
petrochemical-derived products except
in the manufacture of vinyl chloride; the
industrial and commercial use of CTC in
the manufacture of other basic
chemicals (including chlorinated
compounds used in solvents, adhesives,
asphalt, and paints and coatings), except
for use in the elimination of nitrogen
trichloride in the production of chlorine
and caustic soda and the recovery of
chlorine in tail gas from the production
of chlorine; the industrial and
commercial use of CTC in metal
recovery; and the industrial and
commercial use of CTC as an additive.
EPA is also finalizing the prohibitions
for the manufacturing, processing,
distribution in commerce, and use of
CTC for the industrial and commercial
use in specialty uses by the DoD to
apply as of 365 days after the date of
publication of the final rule.
E. Other Requirements
1. Recordkeeping
For conditions of use that are not
otherwise prohibited under this final
rule, EPA is finalizing the requirement
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that manufacturers, processors,
distributors, and commercial users
maintain ordinary business records,
such as invoices and bills-of-lading, that
demonstrate compliance with the
prohibitions, restrictions, and other
provisions of this final regulation; and
to maintain such records for a period of
5 years from the date the record is
generated. This requirement begins on
February 18, 2025. For enforcement
purposes, EPA will have access to such
businesses records plus additional
records required under 40 CFR 751.713.
Recordkeeping requirements would
ensure that owners or operators can
demonstrate compliance with the
regulations if necessary.
2. Downstream Notification
For conditions of use that are not
otherwise prohibited under this final
regulation, EPA is finalizing
requirements that manufacturers
(including importers), processors, and
distributors of CTC provide downstream
notification of the prohibitions through
the SDSs by adding to sections 1(c) and
15 of the SDS the following language:
After June 16, 2025, this chemical
substance (as defined in TSCA section 3(2))
may not be distributed in commerce or
processed in greater than trace quantities for
the following purposes: Incorporation into
formulation, mixture or reaction products in
petrochemical-derived manufacturing except
in the manufacture of vinyl chloride;
Industrial and commercial use as an
industrial processing aid in the manufacture
of petrochemicals-derived products except in
the manufacture of vinyl chloride; Industrial
and commercial use in the manufacture of
other basic chemicals (including
manufacturing of chlorinated compounds
used in solvents, adhesives, asphalt, and
paints and coatings), except for use in the
elimination of nitrogen trichloride in the
production of chlorine and caustic soda and
the recovery of chlorine in tail gas from the
production of chlorine; Industrial and
commercial use in metal recovery; Industrial
and commercial use as an additive; and
beginning December 18, 2025, industrial and
commercial specialty uses by the U.S.
Department of Defense.
To provide adequate time to update
the SDS and ensure that all products in
the supply chain include the revised
SDS, EPA’s final rule requires
manufacturers to revise their SDS
within two months of rule publication
and processors and distributors to revise
their SDS within six months of rule
publication. EPA did not receive public
comments asserting that these
compliance dates for updating the SDS
were impracticable, and is therefore
finalizing the compliance dates as
proposed. The intention of downstream
notification is to spread awareness
throughout the supply chain of the
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restrictions on CTC under TSCA and to
provide information to commercial endusers about prohibited uses of CTC.
V. TSCA Section 6(c)(2) Considerations
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A. Health Effects of Carbon
Tetrachloride and the Magnitude of
Human Exposure to Carbon
Tetrachloride
EPA’s analysis of the health effects of
CTC and the magnitude of human
exposure to CTC are in the 2020 Risk
Evaluation for CTC and the 2022
Revised Unreasonable Risk
Determination for CTC (Refs. 1, 3). A
summary is presented here.
The 2020 Risk Evaluation for CTC
identified potential health effects of
CTC including carcinogenicity, liver
toxicity, neurotoxicity, kidney toxicity,
reproductive and developmental
toxicity, irritation and sensitization, and
genetic toxicity. Acute inhalation
exposures to CTC at relatively high
concentrations induce immediate and
temporary depression of the central
nervous-system, with effects consisting
of escape-impairing symptoms such as
dizziness. For chronic non-cancer
inhalation exposure scenarios to CTC,
liver toxicity is identified as the most
sensitive adverse effect contributing to
the unreasonable risk of CTC exposure
due to fatty changes to the liver
indicative of cellular damage. Under
EPA’s Guidelines for Carcinogen Risk
Assessment (Ref. 47), CTC is classified
as ‘‘Likely to be Carcinogenic in
Humans.’’ CTC has been shown to cause
pheochromocytomas (tumors of the
adrenal glands) in male and female mice
by oral and inhalation exposures, and a
strong association between
neuroblastoma and CTC in a single wellconducted epidemiological study in the
same organ raises concern for potential
carcinogenic effects in human. In
addition, a general correlation has been
observed in animal studies with CTC
between hepatocellular cytotocity and
regenerative hyperplasia and the
induction of liver tumors (Ref. 1).
Populations exposed to CTC include
workers ages 17 and older of either
gender, including pregnant women and
individuals who do not use CTC but
may be indirectly exposed due to their
proximity to the user who is directly
handling CTC (occupational non-users,
or ONUs). EPA estimates that, annually,
there are approximately between 852
and 9,554 workers and between 500 and
4,144 ONUs at between 30 and 71
facilities either manufacturing,
processing, or using CTC for industrial
and commercial conditions of use (Ref.
5).
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In addition to these estimates of
numbers of workers and occupational
non-users directly exposed to CTC, EPA
recognizes there is exposure to the
general population from air and water
pathways for CTC (fenceline
communities are a subset of the general
population who may be living in
proximity to a facility where CTC is
being used in an occupational setting).
EPA separately conducted a screening
approach to assess whether there may
be potential risks to the general
population from these exposure
pathways. This analysis is summarized
in the proposed rule, which includes
information on the SACC peer review.
This unit addresses those areas where
some risk was indicated at the fenceline,
and the conditions of use will be
continuing under this final rule.
EPA’s methodological approach to
assessing potential exposures to
fenceline communities of chemicals
undergoing risk evaluation under TSCA
section 6 was presented to the SACC
peer review panel in March 2022, and
EPA is including SACC
recommendations, as appropriate, in
assessing general population exposures
in upcoming risk evaluations.
EPA’s fenceline analysis for the water
pathway for CTC, based on methods
presented to the SACC, did not find
risks from drinking water, incidental
oral ingestion of ambient water, or
incidental dermal exposure of surface
water (Ref. 48).
Standard cancer benchmarks used by
EPA and other regulatory agencies are
an increased cancer risk above
benchmarks ranging from 1 in 1,000,000
to 1 in 10,000 (i.e., 1 × 10¥6 to 1 ×
10¥4). For example, when setting
standards under section 112(f)(2) of the
CAA, EPA uses a two-step process, with
‘‘an analytical first step to determine an
‘acceptable risk’ that considers all
health information, including risk
estimation uncertainty, and includes a
presumptive limit on maximum
individual risk (MIR) of approximately
1-in-10 thousand’’ (Ref. 49, referencing
the interpretation set forth in the 1989
final National Emission Standards for
Benzene rule (54 FR 38044 Sept. 14,
1989)). In the screening level fenceline
analysis for the ambient air pathway for
CTC, EPA calculated its risk estimates to
certain populations within the general
population living or working near
particular facilities and compared those
risk estimates to a 1 in 1,000,000 (i.e.,
1 × 10¥6) benchmark value for cancer
risk. There are still uncertainties where
the calculated risk exceeds this cancer
risk benchmark value. The benchmark
values are not a bright line, and the
Agency considers a number of factors
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when determining unreasonable risk,
such as the endpoint under
consideration, the reversibility of effect,
and exposure-related considerations
(e.g., duration, magnitude, aggregate or
cumulative impacts, or frequency of
exposure, or size of population exposed,
including PESS).
The screening level fenceline analysis
for CTC calculated risk estimates to
select populations within the general
population living or working near
particular facilities exceeding the 1 ×
10¥6 benchmark value (Ref. 50).
However, EPA has not determined
based on this screening level analysis
whether these risks to the general
population contribute to the
unreasonable risk presented by CTC.
After considering the results,
limitations, and uncertainties of the
screening-level analysis, EPA
determined as a matter of policy that
reopening the TSCA section 6(b) risk
evaluation for CTC for further
evaluation of risk to the general
population, and consequently delaying
the promulgation of this TSCA section
6(a) rule, was not warranted. The
Agency believes it is important to
expeditiously promulgate this final rule
to protect the public from the
unreasonable risk determined in
accordance with TSCA section
6(b)(4)(A), which was driven by
occupational exposures.
The ambient air analysis for the multiyear fenceline analysis identified 19
facilities (in addition to 6 facilities
solely manufacturing CTC as a
byproduct, which were excluded
because, as described earlier, the 2020
Risk Evaluation for Carbon
Tetrachloride did not include the
manufacture of CTC as a byproduct as
a condition of use) with risk estimates
above one in a million, with one facility
with risk estimates above one in ten
thousand, at 100 meters representing
five conditions of use. Under the final
regulatory action described in Unit IV.,
all of the ongoing conditions of use with
an indication of potential risk to
fenceline communities (with the
exception of manufacture of CTC as a
byproduct) would be required to
establish a WCPP. Furthermore, EPA is
prohibiting increased emissions
associated with WCPP requirements,
and in the WCPP exposure control plan
facilities need to evaluate controls to
determine how to reduce releases and
exposures to potentially exposed
persons in the workplace and attest that
engineering controls selected do not
increase emissions of CTC to ambient
air outside of the workplace and
whether additional equipment was
installed to capture emissions of CTC to
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ambient air. EPA anticipates that this
analysis would help facilities to
determine the most effective ways to
reduce releases, including possible
engineering controls or elimination/
substitution of CTC, and therefore may
also reduce the overall risk to fenceline
communities.
EPA recognizes, as was described in
the 2020 Risk Evaluation for Carbon
Tetrachloride, that CTC is highly
persistent in the atmosphere with an
estimated tropospheric half-life
exceeding 330 years. Thus, CTC has
notable global background
concentrations due to its long half-life,
despite having limited air releases in the
US, as noted in both the EPA’s Air
Toxic Screening Assessment modeling
technical support document and in a
recent EPA publication comparing the
national air toxics modeling to regional
monitoring data (Refs. 51, 52). The risk
estimates from the fenceline analysis do
not account for the background
concentrations from historical
emissions, which are persistent in the
atmosphere.
In the instances where manufacturing,
processing, or use of CTC may increase,
EPA expects that potential additional
exposure from emissions to ambient air
to be limited as a result of the
prohibition on the increased ventilation
of CTC to ambient air and existing
National Emission Standards for
Hazardous Air Pollutants (NESHAPs)
that cover CTC for these conditions of
use under the CAA. Applicable
NESHAPs include: 40 CFR part 63,
subparts F, G, H, and I, Organic HAP
from the Synthetic Organic Chemical
Manufacturing Industry and Other
Processes Subject to the Negotiated
Regulation for Equipment Leaks.
The CAA establishes a two-phase
process for the EPA’s development,
review, and potential revision of
NESHAP that impose emission
standards and work practice
requirements on subject categories of
sources of hazardous air pollutants.
First, the EPA sets technology-based or
performance-based standards reflecting
the maximum achievable control
technology (MACT) for major sources
(CAA section 112(d)(2) and (3)) and
generally available control technology
(GACT) for area or non-major sources
(CAA section 112(d)(5)). In the second
phase, eight years after adoption of the
first phase standards, the EPA performs
a residual risk review of major source
MACT standards to ensure that they
provide an ample margin of safety to
protect public health (CAA section
112(f)(2)), and a technology review of all
NESHAP to account for developments
in practices, processes and control
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technologies (CAA section 112(d)(6)).
The CAA only requires the EPA to
conduct the residual risk review one
time for each MACT standard, although
the EPA has discretion to conduct
additional risk reviews where
warranted. The technology review,
instead, is a recurring duty, and the EPA
must perform it no less often than every
eight years.
B. Environmental Effects of Carbon
Tetrachloride and the Magnitude of
Environmental Exposure to Carbon
Tetrachloride
EPA’s analysis of the environmental
effects of CTC and the magnitude of
exposure of the environment to CTC are
in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1). The unreasonable
risk determination for CTC is based
solely on risks to human health; based
on the TSCA 2020 Risk Evaluation for
Carbon Tetrachloride, EPA determined
that exposures to the environment did
not drive the unreasonable risk. A
summary is presented here in Unit V.
Exposures to terrestrial organisms
from the suspended soils and biosolids
pathway was qualitatively evaluated.
Due to its physical-chemical properties,
EPA expects that CTC does not
bioaccumulate in fish or sediments; and
CTC could be mobile in soil and migrate
to water or volatilize to air (Ref. 1).
EPA concluded in the 2020 Risk
Evaluation for Carbon Tetrachloride that
CTC poses a hazard to environmental
aquatic receptors. Amphibians were the
most sensitive taxa for acute and
chronic exposures. Acute exposures of
CTC to fish, freshwater aquatic
invertebrates, and sediment
invertebrates resulted in hazard values
as low as 10.4 mg/L, 11.1 mg/L, and 2
mg/L, respectively. For chronic
exposures, CTC has a hazard value for
amphibians of 0.03 mg/L based on
teratogenesis and lethality in frog
embryos and larvae. Furthermore,
chronic exposures of CTC to fish,
freshwater aquatic invertebrates, and
sediment invertebrates resulted in
hazard values as low as 1.97 mg/L, 1.1
mg/L, and 0.2 mg/L, respectively. In
algal studies, CTC has hazard values
ranging from 0.07 to 23.59 mg/L (Ref. 1).
In addition to the environmental
effects assessed in the 2020 Risk
Evaluation for Carbon Tetrachloride,
EPA recognizes that CTC is an ozonedepleting substance with a 100-year
GWP of 1730 (energy the emissions of
one ton of gas will absorb over 100
years, relative to the emissions of one
ton of carbon dioxide (CO2)) (Ref. 53).
As a result of its ozone-depleting effects,
the Montreal Protocol and Title VI of the
CAA led to a phase-out of CTC
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production in the United States for most
non-feedstock domestic uses. EPA did
not evaluate the effect of CTC or this
rule on ozone depletion. In addition,
while the Agency understands that the
use of CTC is expected to increase to
produce low GWP HFOs, replacing
many of the higher GWP HFCs, there is
uncertainty in the change in volume of
CTC that will be manufactured and used
to produce HFOs. In the final rule, EPA
is requiring owners/operators to ensure
that any engineering controls instituted
under the WCPP do not increase
emissions of CTC to ambient air. EPA
expects that potential additional
exposure from emissions to ambient air
would be limited as a result of the
existing NESHAPs that cover CTC.
However, EPA did not evaluate whether
a possible increase of CTC emissions
with a GWP of 1730 would offset
emissions of the HFCs replaced by the
lower GWP HFOs manufactured with
CTC, or the overall global warming
impact of CTC use.
C. Benefits of Carbon Tetrachloride for
Various Uses
As described in the proposed rule,
CTC is primarily used as a feedstock in
the production of HCFCs, HFCs, and
HFOs. Other conditions of use include
regulated use as a processing agent in
the manufacture of petrochemicalsderived and agricultural products and
other chlorinated compounds such as
chlorinated paraffins, chlorinated
rubber and others that may be used
downstream in the formulation of
solvents for adhesives, asphalt, paints
and coatings. Requirements under the
Montreal Protocol and Title VI of the
CAA led to a phaseout of CTC
production in the United States for most
non-feedstock domestic uses in 1996
and the CPSC banned the use of CTC in
household products (excluding
unavoidable residues not exceeding 10
ppm atmospheric concentration) in
1970.
CTC is a major feedstock for
generation of lower-GWP alternative
fluorocarbon products in the United
States (Ref. 54). EPA anticipates that
many entities currently using HFCs with
higher global warming potential will
transition to alternatives with lower
global warming potential as
requirements under the AIM Act begin
to apply. The manufacturing of CTC is
predicted to increase as a result of the
transition from HFCs to lower-GWP
HFOs that use CTC as a feedstock, such
as HFO–1234yf used in motor vehicle
AC and HFO–1234ze used in some
types of aerosols and foam-blowing
agents.
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D. Reasonably Ascertainable Economic
Consequences of the Final Rule
exposure, including adrenal and liver
cancer.
1. Likely Effect of the Rule on the
National Economy, Small Business,
Technological Innovation, the
Environment, and Public Health
With respect to the anticipated effects
of this rule on the national economy, the
economic impact of a regulation on the
national economy generally only
becomes measurable if the economic
impact of the regulation reaches 0.25
percent to 0.5 percent of Gross Domestic
Product (GDP) (Ref. 55). Given the
current GDP of $23.17 trillion, this is
equivalent to a cost of $58 billion to
$116 billion which is considerably
higher than the estimated cost of this
rule. EPA considered the number of
businesses, facilities, and workers that
would be affected and the costs and
benefits to those businesses and workers
and society at large and did not find that
there would be a measurable effect on
the national economy. In addition, EPA
considered the employment impacts of
this final rule. For businesses subject to
the WCPP, including the ECEL and
DDCC requirements, and prescriptive
workplace control requirements, EPA
estimates the marginal cost of labor will
increase. This may lead to small
negative employment effects. Costs of
prohibition in the final rule are not
quantified, since EPA expects the
prohibited uses are not ongoing.
However, there may be employment
effects proportionate to the extent to
which CTC is still being used in the
prohibited conditions of use.
EPA has determined that the rule will
not have a significant impact on a
substantial number of small entities.
EPA estimates that the rule would affect
at least seven small entities, and that the
cost would only exceed 1 percent of
annual revenues for two of these small
entities. EPA expects that the final rule
will not hinder technological
innovation. Innovative applications of
CTC in recent years have occurred in
the production of HFOs. The regulatory
options with requirements for certain
conditions of use, including processing
as a reactant in the production of
refrigerants (such as HFOs), are not
expected to inhibit innovation since
they permit the continued use of CTC
with appropriate controls. With respect
to those conditions of use where
prohibition is the requirement in the
final action, EPA did not find evidence
of ongoing use of CTC and thus there are
no expected effects on innovation.
The effects of this rule on public
health are estimated to be positive, due
to the avoided incidence of adverse
health effects attributable to CTC
2. Costs and Benefits of the Regulatory
Action and of the 1 or More Primary
Alternative Regulatory Actions
Considered by the Administrator
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The costs and benefits that can be
monetized for this rule are described at
length in in the Economic Analysis (Ref.
5). The total cost of the final rule is
$19.7 million dollars annualized over 20
years at a 3% discount rate and $19
million dollars at a 7% discount rate.
EPA’s Economic Analysis for the rule
quantified the benefits from avoided
cases of adrenal and liver cancers.
Cancer benefits are calculated based on
inhalation exposure estimates from the
Final Risk Evaluation. The estimated
monetized benefit of the final rule
ranges from approximately $0.13 to
$0.14 million per year annualized over
20 years at a 3% discount rate and from
$0.06 to $0.07 million per year at a 7%
discount rate.
There are also unquantified benefits
due to other avoided significant adverse
health effects associated with CTC
exposure, including liver, reproductive,
renal, developmental, and CNS toxicity
end points. EPA believes that the
balance of costs and benefits of this final
rule cannot be fairly described without
considering the additional, nonmonetized benefits of mitigating the
non-cancer adverse effects. The noncancer adverse effects from CTC
exposure can significantly impact an
individual’s quality of life. The
incremental improvements in health
outcomes achieved by given reductions
in exposure cannot currently be
quantified for non-cancer health effects
associated with CTC exposure, and
therefore cannot be converted into
monetized benefits. The qualitative
discussion throughout this rulemaking
and in the Economic Analysis highlights
the importance of these non-cancer
effects, which are not able to be
monetized in the way that EPA is able
to for cancer. These effects include not
only cost of illness but also personal
costs such as emotional and mental
stress that are hard to measure
appropriately. Considering only
monetized benefits significantly
underestimates the impacts of CTC
adverse outcomes and underestimates
the benefits of this final rule.
Net benefits were calculated by
subtracting the costs from the quantified
benefits. The net benefit of the final rule
action is ¥$19.6 million dollars
annualized over 20 years at a 3%
discount rate and ¥$18.9 million
dollars at a 7% discount rate.
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Industry would bear monitoring, PPE,
and notification and recordkeeping
burdens and costs associated with the
ECEL. While companies may comply
with the rule using engineering controls,
when estimating costs and benefits the
Economic Analysis assumes firms will
provide PPE to employees when
monitoring thresholds are exceeded.
EPA estimated monitoring results based
on a log normal distribution estimated
from the median and 95th percentile 8hour time-weighted average exposure
outcomes presented in the 2020 Risk
Evaluation for Carbon Tetrachloride.
PPE, recordkeeping, and monitoring
costs after initial monitoring vary by
industry and by projected initial
monitoring result. Industry is expected
to incur planning, recordkeeping and
PPE costs associated with DDCC
requirements. Industry would incur
costs associated with developing an
exposure control plan, performing
inspections, documenting efforts to
reduce exposure and occurrences of
exposure, respiratory protection and
dermal PPE, and training on the use of
respiratory protection and dermal PPE.
EPA also considered the estimated
costs of alternative regulatory actions to
regulated entities. Estimated costs for
regulatory alternatives can be found in
the Economic Analysis for this final rule
(Ref. 5).
A sensitivity analysis was conducted
based on the low estimates of the
number of affected entities in the 2020
Risk Evaluation for Carbon
Tetrachloride. Based on these estimates,
the total cost of the final rule is $2.1
million dollars annualized over 20 years
at both a 3 and 7% discount rate. The
total benefit of the final rule is estimated
to range from $0.016 million dollars to
$0.018 million dollars annualized over
20 years at a 3% period discount rate,
and ranges from $0.008 million dollars
to $0.009 million dollars annualized
over 20 years at a 7 percent discount
rate. The net benefit of the rule under
this sensitivity analysis is ¥$2.1
million dollars annualized over 20 years
at a 3% discount rate and a 7% discount
rate. At a 2% discount rate, the cost of
the rule assuming the low number of
affected entities is $2.1 million, the
benefit is $0.02 million, and the net
benefit is ¥$2.1 million.
3. Cost Effectiveness of the Regulatory
Action and of 1 or More Primary
Alternative Regulatory Actions
Considered by the Administrator
For the COUs that EPA determined
drive the unreasonable risk of injury to
health from CTC, both the final rule and
the primary alternative action, which is
analyzed in the Economic Analysis,
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reduce unreasonable risk to the extent
necessary such that unreasonable risk is
no longer presented. In achieving this
result, however, the estimated costs of
the final rule and the primary
alternative regulatory action differ as
described in Units I.E. and V.D.2. The
costs of achieving the desired outcome
via the final rule or the primary
alternative regulatory action can be
compared to evaluate cost-effectiveness.
The measure of cost-effectiveness
considered is the annualized cost of
each regulatory option per microrisk
reduction in cancer cases estimated to
occur as a result of each regulatory
option, where a microrisk refers to a one
in one million reduction in the risk of
a cancer case. The cost-effectiveness of
the final rule ranges from $681 to $1,000
dollars per microrisk reduction at a 3%
discount rate, and from $656 to $963
dollars per microrisk reduction at a 7%
discount rate. The cost-effectiveness of
the primary alternative regulatory action
ranges from $611 to $897 dollars per
microrisk reduction at a 3% discount
rate, and from $778 to $1,142 dollars at
a 7% discount rate.
The primary difference between the
final and primary alternative option is
that the alternative requires prescriptive
controls for conditions of use which fall
under the WCPP in the final rule. For
two such conditions of use (Processing
by incorporation into formulation,
mixture, or reaction products in
agricultural products manufacturing,
vinyl chloride manufacturing, and other
basic organic and inorganic chemical
manufacturing; and Industrial and
commercial use as a processing aid in
the manufacture of agricultural products
and vinyl chloride), the Economic
Analysis analyzed a primary alternative
action of prohibition for the vinyl
chloride sub-uses only. In the proposed
rule, EPA proposed prohibition for these
sub-uses of vinyl chloride that at the
time EPA did not have reasonably
available information to indicate the
uses were ongoing but later received
public comments from one entity
indicating that the incorporation of CTC
into formulation, mixtures, or reaction
products in vinyl chloride
manufacturing and the industrial and
commercial use of CTC as an industrial
processing aid in the manufacture of
vinyl chloride were ongoing. While the
final rule requires a WCPP for these subuses, the primary alternative analyzes
the costs and benefits of prohibiting
these sub-uses of vinyl chloride.
Since the regulated universe in both
the final and primary alternative
regulatory actions is identical, the costeffectiveness of the regulatory actions
varies based on the differences in the
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requirements of each action. Section 3.9
of the Economic Analysis provides a
summary of the unquantified costs and
uncertainties in the cost estimates that
may impact the respective costeffectiveness of the final rule and the
primary alternative regulatory action
considered.
VI. TSCA Section 9 Analysis and
Section 26 Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the
Administrator determines, in the
Administrator’s discretion, that an
unreasonable risk may be prevented or
reduced to a sufficient extent by an
action taken under a Federal law not
administered by EPA, the Administrator
must submit a report to the agency
administering that other law that
describes the risk and the activities that
present such risk. TSCA section 9(a)
describes additional procedures and
requirements to be followed by EPA and
the other Federal agency following
submission of any such report. As
discussed in this unit, the Administrator
does not determine that unreasonable
risk from CTC under the conditions of
use may be prevented or reduced to a
sufficient extent by an action taken
under a Federal law not administered by
EPA. EPA’s TSCA section 9(a) analysis
is presented in Unit VII.A. of the
proposed rule (88 FR 49215, July 28,
2023) (FRL–8206–01–OCSPP), and
responses to comments about that
analysis can be found in the Response
Agree. Comments, Section 10.1 (Ref.
11).
TSCA section 9(d) instructs the
Administrator to consult and coordinate
TSCA activities with other Federal
agencies for the purpose of achieving
the maximum enforcement of TSCA
while imposing the least burden of
duplicative requirements. For this
rulemaking, EPA has coordinated with
appropriate Federal executive
departments and agencies, including
OSHA, to, among other things, identify
their respective authorities,
jurisdictions, and existing laws with
regard to risk evaluation and risk
management of CTC.
As discussed in more detail in the
proposed rule, OSHA requires that
employers provide safe and healthful
working conditions by setting and
enforcing standards and by providing
training, outreach, education, and
assistance. OSHA, in 1971, established
a PEL for CTC of 10 ppm of air as an
8-hour TWA with an acceptable ceiling
concentration of 25 ppm and an
acceptable maximum peak above the
acceptable ceiling concentration for an
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eight-hour shift of 200 ppm, maximum
duration of 5 minutes in any 4 hours.
However, the exposure limits
established by OSHA are higher than
the exposure limit that EPA determined
would be sufficient to address the
unreasonable risk identified under
TSCA from occupational inhalation
exposures associated with certain
conditions of use. Gaps exist between
OSHA’s authority to set workplace
standards under the OSH Act and EPA’s
obligations under TSCA section 6 to
eliminate unreasonable risk presented
by chemical substances under the
conditions of use, as further discussed
in Units II.C. and VII.A. of the proposed
rule.
EPA concludes that TSCA is the only
regulatory authority able to prevent or
reduce unreasonable risk of CTC to a
sufficient extent across the range of
conditions of use, exposures, and
populations of concern. An action under
TSCA is able to address occupational
unreasonable risk and would reach
entities that are not subject to OSHA.
Moreover, the timeframe and any
exposure reduction as a result of
updating OSHA regulations for CTC
cannot be estimated, while TSCA
imposes a much more accelerated twoyear statutory timeframe for proposing
and finalizing requirements to address
unreasonable risk. Finally, as discussed
in greater detail in the proposed rule,
the 2016 amendments to TSCA altered
both the manner of identifying
unreasonable risk and EPA’s authority
to address unreasonable risk, such that
risk management is increasingly distinct
from provisions of the OSH Act (88 FR
49180) (FRL–8206–01–OCSPP). For
these reasons, in the Administrator’s
discretion, the Administrator has
analyzed this issue and does not
determine that unreasonable risk
presented by CTC may be prevented or
reduced to a sufficient extent by an
action taken under a Federal law not
administered by EPA.
B. TSCA Section 9(b) Analysis
If EPA determines that actions under
other Federal laws administered in
whole or in part by EPA could eliminate
or sufficiently reduce a risk to health or
the environment, TSCA section 9(b)
instructs EPA to use these other
authorities to protect against that risk
‘‘unless the Administrator determines,
in the Administrator’s discretion, that it
is in the public interest to protect
against such risk’’ under TSCA. In
making such a public interest finding,
TSCA section 9(b)(2) states: ‘‘the
Administrator shall consider, based on
information reasonably available to the
Administrator, all relevant aspects of
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the risk . . . and a comparison of the
estimated costs and efficiencies of the
action to be taken under this title and
an action to be taken under such other
law to protect against such risk.’’
Although several EPA statutes have
been used to limit CTC exposure (Ref.
10), regulations under those EPA
statutes largely regulate releases to the
environment, rather than the
occupational exposures. While these
limits on releases to the environment
may be protective in the context of their
respective statutory authorities,
regulation under TSCA is also
appropriate for occupational exposures
and in some cases can provide upstream
protections that would prevent the need
for release restrictions required by other
EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA),
CAA, CWA). Updating regulations
under other EPA statutes would not be
sufficient to address the unreasonable
risk of injury to the health of workers
and occupational non-users who are
exposed to CTC under its conditions of
use. EPA’s TSCA section 9(b) analysis is
presented in the proposed rule (88 FR
49216) (FRL–8206–01–OCSPP), and
responses to comments on that analysis
can be found in the Response to
Comments, section 10.2 (Ref. 11).
For these reasons, the Administrator
does not determine that unreasonable
risk from CTC under its conditions of
use, as evaluated in the 2020 Risk
Evaluation for Carbon Tetrachloride
(Ref.1), could be eliminated or reduced
to a sufficient extent by actions taken
under other Federal laws administered
in whole or in part by EPA.
C. TSCA Section 14 Requirements
EPA is also providing notice to
manufacturers, processors, and other
interested parties about potential
impacts to CBI. Under TSCA sections
14(a) and 14(b)(4), if EPA promulgates a
rule pursuant to TSCA section 6(a) that
establishes a ban or phase-out of a
chemical substance, the protection from
disclosure of any CBI regarding that
chemical substance and submitted
pursuant to TSCA will be ‘‘presumed to
no longer apply,’’ subject to the
limitations identified in TSCA section
14(b)(4)(B)(i) through (iii). Pursuant to
TSCA section 14(b)(4)(B)(iii), the
presumption against protection from
disclosure will apply only to
information about the specific
conditions of use that this rule
prohibits. Manufacturers or processors
seeking to protect such information may
submit a request for nondisclosure as
provided by TSCA sections 14(b)(4)(C)
and 14(g)(1)(E). Any request for
nondisclosure must be submitted within
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30 days after receipt of notice from EPA
under TSCA section 14(g)(2)(A) stating
EPA will not protect the information
from disclosure. EPA anticipates
providing such notice via the Central
Data Exchange (CDX).
D. TSCA Section 26 Considerations
As explained in the 2023 proposed
rule (88 FR 49216, July 29, 2023) (FRL–
8206–01–OCSPP), EPA fulfilled TSCA
section 26(h) by using scientific
information, technical procedures,
measures, methods, protocols,
methodologies, and models consistent
with the best available science.
Comments received on the proposed
rule about whether EPA adequately
assessed reasonably available
information under TSCA section 26 on
the risk evaluation, and responses to
those comments, can be found in
Section 10.4 of the Response to
Comments document (Ref. 11).
VII. 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. Risk Evaluation for Carbon
Tetrachloride (Methane, Tetrachloro-).
EPA Document #EPA–740–R1–8014.
October 2020. https://
www.regulations.gov/document/EPAHQ-OPPT-2019-0499-0061.
2. EPA. Correction of Dermal Acute Hazard
and Risk Values in the Final Risk
Evaluation for Carbon Tetrachloride. July
2022. (EPA–HQ–OPPT–2019–0499).
https://www.regulations.gov/document/
EPA-HQ-OPPT-2019-0499-0064.
3. EPA. Carbon Tetrachloride; Revision to
Toxic Substances Control Act (TSCA)
Risk Determination. December 2022.
https://www.regulations.gov/document/
EPA-HQ-OPPT-2016-0733-0120.
4. EPA. Memorandum of Communication
between Syngenta and EPA Regarding
Risk Management of Carbon
Tetrachloride. October 2021. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0024.
5. EPA. Carbon Tetrachloride (CTC);
Regulation Under the Toxic Substances
Control Act (TSCA); Economic Analysis.
6. NIOSH. Hierarchy of Controls. https://
www.cdc.gov/niosh/topics/hierarchy/
default.html (accessed April 2024).
7. President Joseph R. Biden. The White
House. The President and First Lady’s
Cancer Moonshot: Ending Cancer As We
Know It. https://www.whitehouse.gov/
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cancermoonshot/ (accessed February 26,
2024).
8. EPA. Access CDR Data: 2016 CDR Data
(updated May 2020). Last Updated on
May 16, 2022. https://www.epa.gov/
chemical-data-reporting/access-cdrdata#2016.
9. EPA. Access CDR Data: 2020 CDR Data.
Last Updated on May 16, 2022. https://
www.epa.gov/chemical-data-reporting/
access-cdr-data.
10. EPA. Regulatory Actions Pertaining to
Carbon Tetrachloride (CTC). June 2023.
https://www.regulations.gov/document/
EPA-HQ-OPPT-2020-0592-0055.
11. EPA. Carbon Tetrachloride (CTC);
Regulation Under the Toxic Substances
Control Act (TSCA); Response to Public
Comments.
12. Executive Order 13985. Advancing Racial
Equity and Support for Underserved
Communities Through the Federal
Government. Federal Register (86 FR
7009, January 25, 2021).
13. Executive Order 13990. Protecting Public
Health and the Environment and
Restoring Science to Tackle the Climate
Crisis. Federal Register (86 FR 7037,
January 25, 2021).
14. Executive Order 14008. Tackling the
Climate Crisis at Home and Abroad.
Federal Register (86 FR 7619, February
1, 2021).
15. EPA. Existing Chemical Exposure Limit
(ECEL) for Occupational Use of Carbon
Tetrachloride. February 2021. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0113.
16. EPA. Federalism Consultation on Risk
Management Rulemakings for HBCD and
Carbon Tetrachloride. December 2021.
https://www.regulations.gov/document/
EPA-HQ-OPPT-2020-0592-0033.
17. EPA. Tribal Consultations on Risk
Management Rulemakings for HBCD and
Carbon Tetrachloride. January 6, 2021
and January 12, 2021. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0041.
18. EPA. Environmental Justice Consultations
Risk Management Rulemakings for
HBCD and Carbon Tetrachloride.
February 2, 2021 and February 18, 2021.
https://www.regulations.gov/document/
EPA-HQ-OPPT-2020-0592-0034.
19. EPA. Public Webinar on Carbon
Tetrachloride: Risk Evaluation and Risk
Management under TSCA Section 6.
December 2020. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0006.
20. EPA. Small Business Administration
Small Business Environmental
Roundtable Risk Evaluation and Risk
Management under TSCA Section 6 for
Carbon Tetrachloride. December 4, 2020.
21. EPA. Updated Stakeholder Meeting List
for Rulemaking for Carbon Tetrachloride
under TSCA Section 6(a). 2024.
22. EPA. EPA’s Policy on Children’s Health.
October 5, 2021. https://www.epa.gov/
children/childrens-health-policy-andplan#A1.
23. EPA. Public Webinar Carbon
Tetrachloride: Risk Evaluation and Risk
Management under TSCA Section 6.
August 15, 2023.
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24. EPA. Meeting with Olin 11.20.23.
December 7, 2023. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0148.
25. Christopher M. Kolodziej. Christopher M.
Kennedy Comment. EPA–HQ–OPPT–
2020–0592–0135. September 11, 2023.
https://www.regulations.gov/document/
EPA-HQ-OPPT-2020-0592-0135.
26. Michael Kennedy. American Petroleum
Institute (API) Comment. EPA–HQ–
OPPT–2020–0592–0129. September 7,
2023. https://www.regulations.gov/
document/EPA-HQ-OPPT-2020-05920129.
27. Mark Ames. AIHA Comment. EPA–HQ–
OPPT–2020–0592–0126. August 29,
2023. https://www.regulations.gov/
document/EPA-HQ-OPPT-2020-05920126.
28. Danielle Jones. The Chemours Company
Comment. EPA–HQ–OPPT–2020–0592–
0134. September 11, 2023. https://
www.regulations.gov/comment/EPA-HQOPPT-2020-0592-0134.
29. W. Caffey Norman. Halogenated Solvents
Industry Alliance, Inc. (HSIA) Comment.
EPA–HQ–OPPT–2020–0592–0133.
September 11, 2023. https://
www.regulations.gov/comment/EPA-HQOPPT-2020-0592-0133.
30. LeaAnne Forest. American Chemistry
Council (ACC) Comment. EPA–HQ–
OPPT–2020–0592–0140. September 11,
2023. https://www.regulations.gov/
comment/EPA-HQ-OPPT-2020-05920140.
31. Paul DeLeo. American Chemistry Council
(ACC) Comment. EPA–HQ–OPPT–2020–
0592–0142. September 11, 2023. https://
www.regulations.gov/comment/EPA-HQOPPT-2020-0592-0142.
32. Martin J. Durbin. US Chamber of
Commerce Comment. EPA–HQ–OPPT–
2020–0592–0137. September 11, 2023.
https://www.regulations.gov/comment/
EPA-HQ-OPPT-2020-0592-0137.
33. Melanie Barrett, Nancy Kahl.
MilliporeSigma Comment. EPA–HQ–
OPPT–2020–0592–0128. September 5,
2023. https://www.regulations.gov/
comment/EPA-HQ-OPPT-2020-05920128.
34. Lawrence E. Culleen. Chemical Users
Coalition (CUC) Comment. EPA–HQ–
OPPT–2020–0592–0130. September 8,
2023. https://www.regulations.gov/
comment/EPA-HQ-OPPT-2020-05920130.
35. Michael Kelly. Honeywell International
Inc. (Honeywell) Comment. EPA–HQ–
OPPT–2020–0592–0144. September 11,
2023. https://www.regulations.gov/
comment/EPA-HQ-OPPT-2020-05920144.
36. Scott Sutton. Olin Comment. EPA–HQ–
OPPT–2020–0592–0127. August 31,
2023. https://www.regulations.gov/
comment/EPA-HQ-OPPT-2020-05920127.
37. American Federation of Labor and
Congress of Industrial Organizations
(AFL–CIO) and United Steelworkers
(USW). AFL–CIO and USW Comment.
EPA–HQ–OPPT–2020–0592–0138.
September 11, 2023. https://
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www.regulations.gov/comment/EPA-HQOPPT-2020-0592-0138.
38. James Cooper. American Fuel &
Petrochemical Manufacturers (AFPM)
Comment. EPA–HQ–OPPT–2020–0592–
0143. September 11, 2023. https://
www.regulations.gov/comment/EPA-HQOPPT-2020-0592-0143.
39. William E. Allmond IV. Adhesive and
Sealant Council (ASC) Comment. EPA–
HQ–OPPT–2020–0592–0139. September
11, 2023. https://www.regulations.gov/
comment/EPA-HQ-OPPT-2020-05920139.
40. OSHA. OSHA 1999 Multi-Employer
Citation Policy. Accessed 10/27/2023.
https://www.osha.gov/enforcement/
directives/cpl-02-00-124.
41. EPA. Final Scope of the Risk Evaluation
for 1,2-Dichloroethane (CASRN 107–06–
2). August 2020. (EPA–HQ–OPPT–2018–
0427–0048). https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0071.
42. OSHA. Final Rule. Occupational
Exposure to Methylene Chloride. Federal
Register (62 FR 1494, January 10, 1997).
https://www.regulations.gov/document/
EPA-HQ-OPPT-2020-0720-0073.
43. OSHA. OSHA Technical Manual (OTM)
Section II: Chapter 1. Personal Sampling
for Air Contaminants. Last updated on
September 14, 2023. https://
www.osha.gov/otm/section-2-healthhazards/chapter-1.
44. NIOSH. Letter to Claudia Menasche from
J. Raymond Wells. EPA’s Carbon
Tetrachloride Risk Management Rule
under TSCA Section 6. June 28, 2024.
45. OSHA. Personal Protective Equipment.
May 4, 2023. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0087.
46. The Program Executive Office, Assembled
Chemical Weapons Alternatives (PEO
ACWA). U.S. Chemical Weapons
Destruction 2018. May 2018. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0020.
47. EPA. Guidelines for Carcinogen Risk
Assessment. March 2005. https://
www.epa.gov/risk/guidelines-carcinogenrisk-assessment.
48. EPA. Carbon Tetrachloride: Fenceline
Technical Support—Water Pathway.
October 2022. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0047.
49. EPA. Final Rule. National Emission
Standards for Hazardous Air Pollutants:
Carbon Black Production and Cyanide
Chemicals Manufacturing Residual Risk
and Technology Reviews, and Carbon
Black Production Area Source
Technology Review. Federal Register (86
FR 66096, November 19, 2021).
50. EPA. Carbon Tetrachloride: Fenceline
Technical Support—Ambient Air
Pathway. October 2022. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0050.
51. EPA. Technical Support Document EPA’s
Air Toxics Screening Assessment 2018
AirToxScreen TSD. Document number
EPA–452/B–22–002. August 2022.
https://www.regulations.gov/document/
EPA-HQ-OPPT-2020-0592-0042.
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52. Weitekamp. C. et al. 2021. An
Examination of National Cancer Risk
Based on Monitored Hazardous Air
Pollutants. Environmental Health
Perspectives. Vol. 129., No. 3. https://
ehp.niehs.nih.gov/doi/full/10.1289/
EHP8044.
53. Myhre, G., D. Shindell, F.-M. Bréon, W.
Collins, J. Fuglestvedt, J. Huang, D. Koch,
J.-F. Lamarque, D. Lee, B. Mendoza, T.
Nakajima, A. Robock, G. Stephens, T.
Takemura and H. Zhang, 2013:
Anthropogenic and Natural Radiative
Forcing. In: Climate Change 2013: The
Physical Science Basis. Contribution of
Working Group I to the Fifth Assessment
Report of the Intergovernmental Panel on
Climate Change [Stocker, T.F., D. Qin,
G.-K. Plattner, M. Tignor, S.K. Allen, J.
Boschung, A. Nauels, Y. Xia, V. Bex and
P.M. Midgley (eds.)]. Cambridge
University Press, Cambridge, United
Kingdom and New York, NY, USA.
https://www.ipcc.ch/site/assets/uploads/
2018/02/WG1AR5_Chapter08_
FINAL.pdf.
54. Halogenated Solvents Industry Alliance,
Inc. (HSIA). Comments submitted to EPA
on the Carbon Tetrachloride Risk
Evaluation and the Risk Management
Process. April 28, 2021. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0003.
55. Office of Management and Budget. March
31, 1995. OMB M–95–09, Memorandum
for the Heads of Executive Departments
and Agencies. Guidance for
Implementing Title II of S. 1. https://
www.whitehouse.gov/wp-content/
uploads/legacy_drupal_files/omb/
memoranda/1995-1998/m95-09.pdf.
56. EPA. Supporting Statement for an
Information Collection Request (ICR)
Under the Paperwork Reduction Act
(PRA); Regulation of Carbon
Tetrachloride under TSCA Section 6(a)
(Final Rule; RIN 2070–AK82). 2024.
57. Kevin Ashley. 2015. Harmonization of
NIOSH Sampling and Analytical
Methods with Related International
Voluntary Consensus Standards. J Occup
Environ Hyg. 12(7): D107–15. https://
www.regulations.gov/document/EPAHQ-OPPT-2020-0592-0032.
VIII. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 14094: Modernizing Regulatory
Review
This action is a ‘‘significant regulatory
action’’ as defined in Executive Order
12866 (58 FR 51735, October 4, 1993),
as amended by Executive Order 14094
(88 FR 21879, April 11, 2023).
Accordingly, EPA submitted this action
to the Office of Management and Budget
(OMB) for Executive Order 12866
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review. Documentation of any changes
made in response to the Executive Order
12866 review is available in the docket.
EPA prepared an analysis of the
potential costs and benefits associated
with this action. This analysis,
Economic Analysis of the Regulation of
Carbon Tetrachloride Under TSCA
Section 6(a) (Ref. 5), is available in the
docket and summarized in Units I.E.
and V.D.
B. Paperwork Reduction Act (PRA)
The information collection activities
in this final rule have been submitted to
OMB for approval under the PRA, 44
U.S.C. 3501 et seq. The Information
Collection Request (ICR) document that
EPA prepared has been assigned EPA
ICR No. 2744.02 and OMB Control No.
2070–0228 (Ref. 56). You can find a
copy of the ICR in the docket for this
rule, and it is briefly summarized here.
The information collection requirements
are not enforceable until OMB approves
them. There are two primary provisions
of the final rule that may increase
burden under the PRA. The first is
downstream notification, which would
be carried out by updates to the relevant
SDS and which will required for
manufacturers, processors, and
distributors in commerce of CTC, who
will provide notice to companies
downstream upon shipment of CTC
about the prohibitions. The information
submitted to downstream companies
through the SDS will provide
knowledge and awareness of the
restrictions to these companies.
The second primary provision of the
final rule that may increase burden
under the PRA is WCPP-related
information generation, recordkeeping,
and notification requirements
(including development of exposure
control plans; exposure level monitoring
and related recordkeeping; development
of documentation for a PPE program and
related recordkeeping; development of
documentation for a respiratory
protection program and related
recordkeeping; development and
notification to potentially exposed
persons (employees and others in the
workplace) about how they can access
the exposure control plans, exposure
monitoring records, PPE program
implementation documentation, and
respirator program documentation;
ordinary business records, such as
invoices and bills-of-lading related to
the continued distribution of CTC in
commerce, as well as records
documenting compliance with the
proposed workplace chemical
protection program requirements and
proposed restrictions on the laboratory
use of CTC.
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Respondents/affected entities:
Persons that manufacture, process, use,
distribute in commerce or dispose of
carbon tetrachloride (see Unit I.A.).
Respondent’s obligation to respond:
Mandatory under TSCA section 6(a) and
40 CFR part 751.
Estimated number of respondents: 72.
Frequency of response: On occasion.
Total estimated burden: 86,186 hours
per year. Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $14,800,653 per
year, including $9,360,626 in
annualized capital or operation and
maintenance costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
number for the EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will
announce that approval in the Federal
Register and publish a technical
amendment to 40 CFR part 9 to display
the OMB control number for the
approved information collection
activities contained in this final rule.
C. 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. The
small entities subject to the
requirements of this action are small
businesses that manufacture/import,
process, or distribute the chemicals
subject to this final rule. The Agency
identified seven small firms in the small
entity analysis that are potentially
subject to the rule. The names and
NAICS codes of these entities can be
found in Section 6.2.2 of the Economic
Analysis (Ref. 5). It is estimated that five
of the seven small companies would
incur a rule cost-to-company revenue
impact ratio of less than one percent,
and two companies would experience
an impact of between one and three
percent. The companies estimated to
experience a greater than one percent
rule cost-to-revenue impact would
potentially be subject to the rule under
the Disposal and the Manufacturing
conditions of use, both of which would
require a WCPP under the final rule. To
avoid understating impacts to small
entities, EPA used the highest perfacility cost presented in the EA
($615,457). Per-facility costs were
estimated by dividing the total costs by
the number of affected facilities for each
use. Details of this analysis are in the
Economic Analysis (Ref. 5), which is in
the docket for this action. Based on the
low number of affected small entities
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and the low impact, EPA does not
expect this action to have a significant
impact on a substantial number of small
entities.
D. 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 action will affect
entities that use CTC. It is not expected
to affect State, local or Tribal
governments because the use of CTC by
government entities is minimal. The
costs involved in this action are
estimated not to exceed $183 million in
2023$ ($100 million in 1995$ adjusted
for inflation using the GDP implicit
price deflator) or more in any one year.
The total quantified annualized social
cost of the final rule is $19,736,400 (at
3% discount rate) and $18,995,752 (at
7% discount rate).
E. Executive Order 13132: Federalism
EPA has concluded that this action
has federalism implications, as specified
in Executive Order 13132 (64 FR 43255,
August 10, 1999), because regulation
under TSCA section 6(a) may preempt
State law. EPA provides the following
preliminary federalism summary impact
statement. The Agency consulted with
State and local officials early in the
process of developing the proposed
action to permit them to have
meaningful and timely input into its
development. This included a
consultation meeting on December 17,
2020. EPA invited the following
national organizations representing
State and local elected officials to this
meeting: National Governors
Association; National Conference of
State Legislatures, Council of State
Governments, National League of Cities,
U.S. Conference of Mayors, National
Association of Counties, International
City/County Management Association,
National Association of Towns and
Townships, County Executives of
America, and Environmental Council of
States. A summary of the meeting with
these organizations, including the views
that they expressed, is available in the
docket (Ref. 16). EPA provided an
opportunity for these organizations to
provide follow-up comments in writing
but did not receive any such comments.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have Tribal
implications as specified in Executive
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Order 13175 (65 FR 67249, November 9,
2000) because it will not have
substantial direct effects on Tribal
governments, on the relationship
between the Federal Government and
the Indian Tribes, or on the distribution
of power and responsibilities between
the Federal Government and Indian
Tribes. CTC is not manufactured,
processed, or distributed in commerce
by Tribes, and therefore, this
rulemaking would not impose
substantial direct compliance costs on
Tribal governments. Thus, Executive
Order 13175 does not apply to this
action.
Notwithstanding the lack of Tribal
implications as specified by Executive
Order 13175, EPA consulted with Tribal
officials during the development of this
action, consistent with the EPA Policy
on Consultation and Coordination with
Indian Tribes, which EPA applies more
broadly than Executive Order 13175.
The Agency held a Tribal consultation
from December 7, 2020, through March
12, 2021, with meetings held on January
6 and 12, 2021. Tribal officials were
given the opportunity to meaningfully
interact with EPA concerning the
current status of risk management.
During the consultation, EPA discussed
risk management under TSCA section
6(a), findings from the 2020 Risk
Evaluation for Carbon Tetrachloride,
types of information to inform risk
management, principles for
transparency during risk management,
and types of information EPA sought
from Tribes (Ref. 17). EPA briefed Tribal
officials on the Agency’s risk
management considerations and Tribal
officials raised no related issues or
concerns to EPA during or in follow-up
to those meetings (Ref. 17). EPA
received no written comments as part of
this consultation.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 (62 FR 19885,
April 23, 1997) directs Federal agencies
to include an evaluation of the health
and safety effects of the planned
regulation on children in Federal health
and safety standards and explain why
the regulation is preferable to
potentially effective and reasonably
feasible alternatives. This action is not
subject to 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 EPA does not believe that
the environmental health or safety risks
addressed by this action will have a
disproportionate risk to children as
reflected by the conclusions of the CTC
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risk evaluation. This action’s health and
risk assessments and impacts on both
children and adults from occupational
use from inhalation and dermal
exposures are described in Units II.C.3,
V.A., and the 2020 Risk Evaluation for
Carbon Tetrachloride (Ref. 1). While the
Agency found risks to children and
adults from occupational use, the
Agency determined that risks to
children were not disproportionate.
EPA’s Policy on Children’s Health
applies to this action. Information on
how the Policy was applied and on the
action’s health and risk assessments are
contained in Unit II.D.2.c., and the 2020
Risk Evaluation for CTC and the
Economic Analysis for this final rule
(Refs. 1, 5).
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001) because it is not likely to have a
significant adverse effect on the supply,
distribution or use of energy and has not
been designated by the Administrator of
the Office of Information and Regulatory
Affairs as a significant energy action.
I. 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 rulemaking
involves environmental monitoring or
measurement, specifically for
occupational inhalation exposures to
CTC. Consistent with the Agency’s
Performance Based Measurement
System (PBMS), EPA will not 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 rulemaking, the key
consideration for the PBMS approach is
the ability to accurately detect and
measure airborne concentrations of CTC
at the ECEL and the ECEL action level.
Some examples of methods which meet
the criteria are included in the appendix
of the ECEL memo (Ref. 15). EPA
recognizes that there may be voluntary
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consensus standards that meet the
proposed criteria (Ref. 57).
J. Executive Orders 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations and 14096:
Revitalizing Our Nation’s Commitment
to Environmental Justice for All
EPA believes that the human health or
environmental conditions that exist
prior to this action result in or have the
potential to result in disproportionate
and adverse human health or
environmental effects on communities
with environmental justice concerns in
accordance with Executive Orders
12898 (59 FR 7629, February 16, 1994)
and 14096 (88 FR 25251, April 26,
2023). As described more fully in the
Economic Analysis for this rulemaking
(Ref. 5), EPA analyzed the baseline
conditions facing communities near
CTC and HFO manufacturing facilities
as well as those of workers in the same
industry and county as CTC facilities
and HFO manufacturing facilities. The
analysis of local demographics found
that, across the entire population within
1- and 3-miles of CTC facilities, there
are higher percentages of people who
identify as Black and living below the
poverty line and a similar percentage of
people who identify as Hispanic
compared to the national averages. CTC
facilities are concentrated in Texas and
Louisiana, especially near Houston and
Baton Rouge. As summarized in Unit
V.A., the screening level fenceline
analysis for CTC calculated risk
estimates to select populations within
the general population living or working
near particular facilities exceeding the 1
× 10¥6 benchmark value (Ref. 49). In
cases where communities with
environmental justice concerns are also
fenceline communities, EPA expects
that the finalized prohibition of
increased emissions associated with
WCPP requirements would prevent an
increase in health and environmental
impacts due to this rule.
The worker analysis was performed at
the county and industry level. In eight
of the 12 counties with CTC facilities
that reported Basic Chemical
Manufacturing, workers who identify as
Black were over-represented compared
to their percentage of the national
demographics for that industry; at the
national level, 11% of workers in the
Basic Chemical Manufacturing industry
identify as Black. In addition, there
were eight counties with CTC facilities
that reported Waste Treatment and
Disposal; workers in that industry in
those counties were more likely to earn
less than the national average for that
industry across several demographic
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groups, as outlined in the Economic
Analysis.
EPA believes that it is not practicable
to assess whether this action is likely to
result in disproportionate and adverse
effects on communities with
environmental justice concerns. EPA
was unable to quantify the
distributional effects of the regulatory
action under consideration and compare
them to baseline conditions for several
reasons. Limitations include a lack of
data regarding exposure reductions that
will occur as a result of the rule and on
the sociodemographic characteristics of
workers in CTC facilities. Another key
limitation that prevents evaluation of
the distributional effects of the rule is a
lack of knowledge of the actions
regulated entities will take in response
to the rule.
EPA additionally identified and
addressed environmental justice
concerns by conducting outreach to
advocates of communities that might be
subject to disproportionate exposure to
CTC. On February 2 and 18, 2021, EPA
held public meetings as part of this
consultation. These meetings were held
pursuant to and in compliance with
Executive Order 12898 and Executive
Order 14008, entitled ‘‘Tackling the
Climate Crisis at Home and Abroad’’ (86
FR 7619, February 1, 2021). EPA
received one written comment following
these public meetings, in addition to
oral comments provided during the
meetings (Ref. 18). Commenters
supported strong regulation of CTC to
protect lower-income communities and
workers. In addition, commenters
recommended EPA conduct analysis of
additional exposure pathways,
including air and water.
The information supporting this
Executive Order review is contained in
Units I.E., II.D., V.D., VI.A. and in the
Economic Analysis (Ref. 5). EPA’s
presentations and fact sheets for the
environmental justice consultations
related to this rulemaking, are available
at https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
materials-june-and-july-2021environmental-justice. These materials
and a summary of the consultation are
also available in the public docket for
this rulemaking.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and the 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).
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List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals,
Export notification, Hazardous
substances, Import certification,
Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the
preamble, 40 CFR chapter I is amended
to read as follows:
PART 751—REGULATION OF CERTAIN
CHEMICAL SUBSTANCES AND
MIXTURES UNDER SECTION 6 OF THE
TOXIC SUBSTANCES CONTROL ACT
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).
■
2. Add subpart H to read as follows:
Subpart H—Carbon Tetrachloride
Sec.
751.701 General.
751.703 Definitions.
751.705 Prohibition of Certain Industrial
and Commercial Uses and
Manufacturing, Processing, and
Distribution in Commerce of Carbon
Tetrachloride for those Uses.
751.707 Workplace Chemical Protection
Program (WCPP).
751.709 Workplace Restrictions for the
Industrial and Commercial Use as a
Laboratory Chemical, Including the Use
of Carbon Tetrachloride as a Laboratory
Chemical by the U.S. Department of
Defense.
751.711 Downstream Notification.
751.713 Recordkeeping Requirements.
§ 751.701
General.
(a) Applicability. This subpart sets
certain restrictions on the manufacture
(including import), processing,
distribution in commerce, use, or
disposal of carbon tetrachloride (CASRN
56–23–5) to prevent unreasonable risk
of injury to health in accordance with
TSCA section 6(a).
(b) Trace quantities exclusion. Unless
otherwise specified in this subpart, the
prohibitions and restrictions of this
subpart do not apply to carbon
tetrachloride that is solely present
unintentionally in trace quantities with
another chemical substance or mixture.
(c) Owner and operator requirements.
Any requirement for an owner or
operator, or an owner and operator, is
a requirement for any individual that is
either an owner or an operator.
§ 751.703
Definitions.
The definitions in subpart A of this
part apply to this Subpart unless
otherwise specified in this section. In
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addition, the following definitions
apply:
ECEL has the same meaning as in
§ 751.5 and for CTC, is an airborne
concentration of carbon tetrachloride of
0.03 parts per million (ppm) calculated
as an eight (8)-hour time-weighted
average (TWA).
ECEL action level means a
concentration of airborne carbon
tetrachloride of 0.02 parts per million
(ppm) calculated as an eight (8)-hour
time-weighted average (TWA).
§ 751.705 Prohibition of Certain Industrial
and Commercial Uses and Manufacturing,
Processing, and Distribution in Commerce
of Carbon Tetrachloride for Those Uses.
(a) Prohibitions. (1) After June 16,
2025, all persons are prohibited from
manufacturing, processing, distributing
in commerce (including making
available) and using carbon
tetrachloride for the following
conditions of use:
(i) Processing condition of use:
Incorporation into formulation, mixture
or reaction products in petrochemicalderived manufacturing except in the
manufacture of vinyl chloride.
(ii) Industrial and commercial
conditions of use:
(A) Industrial and commercial use as
an industrial processing aid in the
manufacture of petrochemicals-derived
products except in the manufacture of
vinyl chloride.
(B) Industrial and commercial use in
the manufacture of other basic
chemicals (including manufacturing of
chlorinated compounds used in
solvents, adhesives, asphalt, and paints
and coatings), except for use in the
elimination of nitrogen trichloride in
the production of chlorine and caustic
soda and the recovery of chlorine in tail
gas from the production of chlorine.
(C) Industrial and commercial use in
metal recovery.
(D) Industrial and commercial use as
an additive.
(2) After December 18, 2025, all
persons are prohibited from
manufacturing, processing, distributing
in commerce (including making
available) and using carbon
tetrachloride for industrial and
commercial specialty uses by the U.S.
Department of Defense except as
provided in § 751.709.
(b) [Reserved].
§ 751.707 Workplace Chemical Protection
Program (WCPP).
(a) Applicability. The provisions of
this section apply to the following
conditions of use of carbon
tetrachloride, including manufacturing
and processing for export, except to the
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extent the conditions of use are
prohibited by § 751.705:
(1) Domestic manufacture, except
where carbon tetrachloride is
manufactured solely as a byproduct.
(2) Import.
(3) Processing as a reactant in the
production of
hydrochlorofluorocarbons,
hydrofluorocarbons, hydrofluoroolefins
and perchloroethylene.
(4) Processing: Incorporation into
formulation, mixture, or reaction
products for agricultural products
manufacturing, vinyl chloride
manufacturing, and other basic organic
and inorganic chemical manufacturing.
(5) Processing: Repackaging for use as
a laboratory chemical.
(6) Processing: Recycling.
(7) Industrial and commercial use as
an industrial processing aid in the
manufacture of agricultural products
and vinyl chloride.
(8) Industrial and commercial use in
the elimination of nitrogen trichloride
in the production of chlorine and
caustic soda and the recovery of
chlorine in tail gas from the production
of chlorine.
(9) Disposal.
(b) Existing chemical exposure limit
(ECEL)—(1) Eight-hour time-weighted
average (TWA) ECEL. Beginning
September 20, 2027 for Federal agencies
or Federal contractors acting for or on
behalf of the Federal government, or by
September 9, 2026 for non-Federal
owners and operators, or beginning four
months after introduction of carbon
tetrachloride into the workplace if
carbon tetrachloride commences after
June 11, 2026, the owner or operator
must ensure that no person is exposed
to an airborne concentration of carbon
tetrachloride in excess of the ECEL,
consistent with the requirements of
paragraph (d)(1)(i) of this section and, if
necessary, paragraph (f) of this section.
(2) Exposure monitoring—(i) General.
(A) Owners or operators must determine
each potentially exposed person’s
exposure, without regard to respiratory
protection, by either:
(1) Taking a personal breathing zone
air sample of each potentially exposed
person’s exposure; or
(2) Taking personal breathing zone air
samples that are representative of the 8hour TWA of each exposure group.
(B) Personal breathing zone air
samples are representative of the 8-hour
TWA of all potentially exposed persons
in an exposure group if the samples are
of at least one person’s full-shift
exposure who represents the highest
potential carbon tetrachloride exposures
in that exposure group. Personal
breathing zone air samples taken during
one work shift may be used to represent
potentially exposed person exposures
on other work shifts where the owner or
operator can document that the tasks
performed and conditions in the
workplace are similar across shifts.
(C) Exposure samples must be
analyzed using an appropriate analytical
method by a laboratory that complies
with the Good Laboratory Practice
Standards in 40 CFR part 792 or a
laboratory accredited by the American
Industrial Hygiene Association (AIHA)
or another industry-recognized program.
(D) Owners or operators must ensure
that methods used to perform exposure
monitoring produce results that are
accurate, to a confidence level of 95
percent, to within plus or minus 25
percent for airborne concentrations of
carbon tetrachloride.
(E) Owners and operators must remonitor within 15 working days after
receipt of any exposure monitoring
when results indicate non-detect, unless
an Environmental Professional as
defined at 40 CFR 312.10 or a Certified
Industrial Hygienist reviews the
exposure monitoring results and
determines re-monitoring is not
necessary.
(ii) Initial monitoring. By June 21,
2027 for Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, or by June 11, 2026
for non-Federal owners and operators,
or within 30 days of introduction of
carbon tetrachloride into the workplace,
whichever is later, each owner or
operator covered by this section must
perform initial monitoring of potentially
exposed persons. Where the owner or
operator has monitoring results from
monitoring conducted within five years
prior to February 18, 2025 and the
monitoring satisfies all other
requirements of this section, the owner
or operator may rely on such earlier
monitoring results to satisfy the
requirements of this paragraph (b)(2)(ii).
(iii) Periodic monitoring. The owner
or operator must establish an exposure
monitoring program for periodic
monitoring of exposure to carbon
tetrachloride in accordance with Table
1.
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TABLE 1 TO § 751.707(b)(3)(iii)—PERIODIC MONITORING REQUIREMENTS
Air concentration condition
Periodic exposure monitoring requirement
If all initial exposure monitoring is below the ECEL action level (<0.02
ppm 8-hour TWA).
If the most recent exposure monitoring indicates that airborne exposure
is above the ECEL (> 0.03 ppm 8-hour TWA).
If the most recent exposure monitoring indicates that airborne exposure
is at or above the ECEL action level but at or below the ECEL (≥0.02
ppm 8-hour TWA, ≤0.03 ppm 8-hour TWA).
If the two most recent (non-initial) exposure monitoring measurements,
taken at least seven days apart within a 6-month period, indicate exposure is below the ECEL action level (<0.02 ppm 8-hour TWA).
If the owner or operator engages in a condition of use for which WCPP
ECEL would be required but does not manufacture, process, use, or
dispose of carbon tetrachloride in that condition of use over the entirety of time since the last required monitoring event.
Periodic exposure monitoring is required at least once every five years.
(iv) Additional exposure monitoring.
(A) The owner or operator must conduct
additional exposure monitoring within a
reasonable timeframe whenever there
has been a change in the production,
process, control equipment, personnel
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Periodic exposure monitoring is required within three months of the
most recent exposure monitoring.
Periodic exposure monitoring is required within six months of the most
recent exposure monitoring.
Periodic exposure monitoring is required within five years of the most
recent exposure monitoring.
The owner or operator may forgo the next periodic exposure monitoring event. However, documentation of cessation of use of carbon
tetrachloride is required; and periodic monitoring would be required
when the owner or operator resumes the condition of use.
or work practices that may reasonably
be expected to result in new or
additional exposures above the ECEL or
when the owner or operator has any
reason to believe that new or additional
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exposures above the ECEL action level
have occurred.
(B) Whenever start-ups or shutdowns,
or ruptures, malfunctions or other
breakdowns or unexpected releases
occur that may lead to exposure to
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potentially exposed persons, the owner
or operator must conduct the additional
exposure monitoring within a
reasonable timeframe after the
conclusion of the start-up or shutdown
and/or the cleanup, repair or remedial
action of the malfunction or other
breakdown or unexpected release. Prior
monitoring data cannot be used to meet
this requirement.
(v) Observation of monitoring. (A)
Owners and operators must provide
potentially exposed persons or their
designated representatives an
opportunity to observe any monitoring
of occupational exposure to CTC that is
conducted under this section and
designed to characterize their exposure.
(B) When monitoring observation
requires entry into a regulated area, the
owner or operator must provide the
observers with the required PPE.
(C) Only persons who are authorized
to have access to facilities classified in
the interest of national security must be
permitted to observe exposure
monitoring conducted in such facilities.
(vi) Notification of monitoring results.
(A) The owner or operator must inform
each person whose exposures are
monitored or who is part of a monitored
exposure group and their designated
representatives of any monitoring
results within 15 working days of
receipt of those monitoring results.
(B) This notification must include the
following:
(1) Exposure monitoring results;
(2) Identification and explanation of
the ECEL and ECEL action level;
(3) Statement of whether the
monitored airborne concentration of
carbon tetrachloride exceeds the ECEL
action level or ECEL;
(4) If the ECEL is exceeded,
descriptions of any exposure controls
implemented by the owner or operator
to reduce exposures to or below the
ECEL, as required by paragraph (d)(1) of
this section;
(5) Explanation of any required
respiratory protection provided in
accordance with paragraphs (b)(3)(iv),
(d)(1)(i), and (f) of this section;
(6) Quantity of carbon tetrachloride in
use at the time of monitoring;
(7) Location of carbon tetrachloride
use at the time of monitoring;
(8) Manner of carbon tetrachloride use
at the time of monitoring; and
(9) Identified releases of carbon
tetrachloride;
(C) Notice must be written in plain
language and either provided to each
potentially exposed person and their
designated representatives individually
in a language that the person
understands, or posted in an
appropriate and accessible location
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outside the regulated area with an
English-language version and a nonEnglish language version representing
the language of the largest group of
workers who do not read English.
(3) Regulated areas—(i)
Establishment. By September 20, 2027
for Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, or by September 9,
2026 for non-Federal owners and
operators, or within three months after
receipt of any exposure monitoring that
indicates exposures exceeding the
ECEL, the owner or operator must
establish and maintain a regulated area
wherever airborne concentrations of
carbon tetrachloride exceeds or can
reasonably be expected to exceed the
ECEL.
(ii) Access. The owner or operator
must limit access to regulated areas to
authorized persons.
(iii) Demarcation. The owner or
operator must demarcate regulated areas
from the rest of the workplace in a
manner that adequately establishes and
alerts persons to the boundaries of the
area and minimizes the number of
authorized persons exposed to carbon
tetrachloride within the regulated area.
(iv) Provisions of respirators. (A) The
owner or operator must ensure that each
person who enters a regulated area is
supplied with a respirator selected in
accordance with paragraph (f) of this
section and must ensure that all persons
within the regulated area are using the
provided respirators whenever carbon
tetrachloride exposures may exceed the
ECEL.
(B) An owner or operator who has
implemented all feasible controls as
required in paragraph (d)(1)(i) of this
section, and who has established a
regulated area as required by paragraph
(b)(3)(i) of this section where carbon
tetrachloride exposure can be reliably
predicted to exceed the ECEL only on
certain days (for example, because of
work or process schedule) must have
persons use respirators in that regulated
area on those days.
(v) Prohibited activities. (A) The
owner or operator must ensure that,
within a regulated area, persons do not
engage in non-work activities which
may increase CTC exposure.
(B) The owner or operator must
ensure that while persons are wearing
respirators in the regulated area, they do
not engage in activities which interfere
with respirator performance.
(c) Direct dermal contact controls
(DDCC). Beginning September 20, 2027
for Federal agencies or Federal
contractors acting for or on behalf of the
Federal government, or by June 16, 2025
for non-Federal owners and operators,
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or within 30 days of introduction of
carbon tetrachloride into the workplace,
whichever is later, owners or operators
must ensure that all persons are
separated, distanced, physically
removed, or isolated to prevent direct
dermal contact with carbon
tetrachloride or from contact with
equipment or materials on which carbon
tetrachloride may exist consistent with
the requirements of paragraph (d)(1)(ii)
of this section and, if necessary,
paragraph (f) of this section.
(d) Exposure control procedures and
plan—(1) Methods of compliance—(i)
ECEL. (A) By December 3, 2027, the
owner or operator must institute one or
a combination of elimination,
substitution, engineering controls, or
administrative controls to reduce
exposure to or below the ECEL except
to the extent that the owner or operator
can demonstrate that such controls are
not feasible, in accordance with the
hierarchy of controls.
(B) If the feasible controls required
under paragraph (d)(1)(i)(A) of this
section that can be instituted do not
reduce exposures for potentially
exposed persons to or below the ECEL,
then the owner or operator must use
such controls to reduce exposure to the
lowest levels achievable by these
controls and must supplement those
controls with the use of respiratory
protection that complies with the
requirements of paragraph (f) of this
section.
(C) Where an owner or operator
cannot demonstrate exposure to carbon
tetrachloride has been reduced to or
below the ECEL through the use of
controls required under paragraphs
(d)(1)(i)(A) and (B) of this section, and
has not demonstrated that it has
appropriately supplemented with
respiratory protection that complies
with the requirements of paragraph (f) of
this section, this will constitute a failure
to comply with the ECEL.
(D) The owner or operator must
ensure that any engineering controls
instituted under paragraph (d)(1)(i)(A)
of this section do not increase emissions
of carbon tetrachloride to ambient air
outside the workplace.
(ii) Direct dermal contact controls
(DDCC). (A) The owner or operator must
institute one or a combination of
elimination, substitution, engineering
controls, or administrative controls to
prevent all persons from direct dermal
contact with carbon tetrachloride except
to the extent that the owner or operator
can demonstrate that such controls are
not feasible.
(B) If the feasible controls required
under paragraph (d)(1)(ii)(A) of this
section that can be instituted do not
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prevent direct dermal contact with
carbon tetrachloride, then the owner or
operator must use such controls to
reduce direct dermal contact to the
extent achievable by these controls and
must supplement those controls by the
use of dermal protection that complies
with the requirements of paragraph (f) of
this section.
(C) Where an owner or operator
cannot demonstrate that direct dermal
contact to carbon tetrachloride is
prevented through the use of controls
required under paragraphs (d)(1)(ii)(A)
and (B) of this section, and has not
demonstrated that it has appropriately
supplemented with dermal protection
that complies with the requirements of
paragraph (f) of this section, this will
constitute a failure to comply with the
DDCC requirements.
(2) Exposure control plan. By
December 3, 2027, each owner and
operator must establish and implement
an exposure control plan.
(i) 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 paragraphs (d)(1)(i)(A)
and (d)(1)(ii)(A) of this section, in the
following sequence: elimination,
substitution, engineering controls 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
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) Attestation that exposure controls
selected do not increase emissions of
carbon tetrachloride to ambient air
outside of the workplace and whether
additional equipment was installed to
capture or otherwise prevent increased
emissions of carbon tetrachloride to
ambient air;
(F) 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;
(G) An explanation of the procedures
for responding to any change that may
reasonably be expected to introduce
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additional sources of exposure to carbon
tetrachloride, or otherwise result in
increased exposure to carbon
tetrachloride, including procedures for
implementing corrective actions to
mitigate exposure to carbon
tetrachloride.
(ii) 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 this paragraph
(d).
(C) The exposure control plan must be
reviewed and updated as necessary, but
at least every five years, to reflect any
significant changes in the status of the
owner or operator’s approach to
compliance with paragraphs (b) through
(d) of this section.
(iii) Availability of exposure control
plan. (A) Owners or operators must
make the exposure control plan and
associated records, including ECEL
exposure monitoring records, ECEL
compliance records, DDCC compliance
records, and workplace participation
records described in § 751.713(b),
available to potentially exposed persons
and their designated representatives.
(B) Owners or operators must notify
potentially exposed persons and their
designated representatives of the
availability of the exposure control plan
and associated records within 30 days of
the date that the exposure control plan
is completed and at least annually
thereafter.
(C) Notice of the availability of the
exposure control plan and associated
records must be provided in plain
language writing to each potentially
exposed person in a language that the
person understands or posted in an
appropriate and accessible location
outside the regulated area with an
English-language version and a nonEnglish language version representing
the language of the largest group of
workers who do not read English.
(D) Upon request by the potentially
exposed person or their designated
representative(s), 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 or
designated representative(s) requesting
the record(s) of the reason for the delay
and the earliest date when the record
will be made available.
(e) Workplace information and
training. (1) By September 20, 2027 for
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Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, or by September 9,
2026 for non-Federal owners and
operators, the owner or operator must
institute a training program and ensure
that persons potentially exposed to
carbon tetrachloride participate in the
program according to the requirements
of this paragraph (e).
(2) The owner or operator must ensure
that each potentially exposed person is
trained prior to or at the time of a
potential exposure to carbon
tetrachloride.
(3) The owner or operator must ensure
that information and training is
presented in a manner that is
understandable to each person required
to be trained and in multiple languages
as appropriate, such as, based on
languages spoken by potentially
exposed persons in the workplace.
(4) The following information and
training must be provided to all persons
potentially exposed to carbon
tetrachloride:
(i) The requirements of this section, as
well as how to access or obtain a copy
of these requirements in the workplace;
(ii) The quantity, location, manner of
use, release, and storage of carbon
tetrachloride and the specific operations
in the workplace that could result in
exposure to carbon tetrachloride,
particularly noting where each regulated
area is located;
(iii) Methods and observations that
may be used to detect the presence or
release of carbon tetrachloride in the
workplace (such as monitoring
conducted by the owner or operator,
continuous monitoring devices, visual
appearance or odor of carbon
tetrachloride when being released);
(iv) The acute and chronic health
hazards of carbon tetrachloride as
detailed on relevant Safety Data Sheets;
and
(v) The principles of safe use and
handling of carbon tetrachloride and
measures potentially exposed persons
can take to protect themselves from
carbon tetrachloride, including specific
procedures the owner or operator has
implemented to protect potentially
exposed persons from exposure to
carbon tetrachloride, such as
appropriate work practices, emergency
procedures, and personal protective
equipment to be used.
(5) The owner or operator must retrain each potentially exposed person as
necessary, but at minimum annually, to
ensure that each such person maintains
the requisite understanding of the
principles of safe use and handling of
carbon tetrachloride in the workplace.
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(6) Whenever there are workplace
changes, such as modifications of tasks
or procedures or the institution of new
tasks or procedures, that increase
exposure, and where such exposure
exceeds or can reasonably be expected
to exceed the ECEL action level or
increase potential for direct dermal
contact with carbon tetrachloride, the
owner or operator must update the
training as necessary to ensure that each
potentially exposed person is re-trained.
(f) Personal protective equipment
(PPE). (1) General. The provisions of
this paragraph (f) apply to any owner or
operator that is required to provide
respiratory protection pursuant to
paragraphs (b)(3)(iv) or (d)(1)(i)(B) of
this section or dermal protection
pursuant to paragraphs (c) or
(d)(1)(ii)(B) of this section or
§ 751.709(b)(3) or (4).
(2) Respiratory protection. (i) By
September 20, 2027 for Federal agencies
and Federal contractors acting for or on
behalf of the Federal government, or by
September 9, 2026 for non-Federal
owners and operators, or within three
months after receipt of any exposure
monitoring that indicates exposures
exceeding the ECEL, if an owner or
operator is required to provide
respiratory protection pursuant to
paragraph (f)(1) of this section, the
owner or operator must ensure that each
potentially exposed person is provided
with a respirator according to the
requirements of this section.
(ii) For purposes of this paragraph
(f)(2), cross-referenced provisions in 29
CFR 1910.134 applying to an
‘‘employee’’ apply equally to potentially
exposed persons and cross-referenced
provisions applying to an ‘‘employer’’
also apply equally to owners or
operators. Other terms in crossreferenced provisions in 29 CFR
1910.134 that are defined in 29 CFR
1910.134(b) have the meaning assigned
to them in that paragraph.
(iii) By September 20, 2027 for
Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, or by September 9,
2026 for non-Federal owners and
operators, or within three months after
receipt of any exposure monitoring that
indicates exposures exceeding the
ECEL, if an owner or operator is
required to provide respiratory
protection pursuant to (f)(1) of this
section, the owner or operator must
develop and administer a written
respiratory protection program
consistent with the requirements of 29
CFR 1910.134(c)(1), (c)(3) and (c)(4).
(iv) Owners and operators must select
respiratory protection required by
paragraph (f)(2)(i) of this section based
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on a medical evaluation consistent with
the requirements of 29 CFR 1910.134(e).
If a potentially exposed person cannot
use a negative-pressure respirator that
would otherwise be required by
paragraph (f)(1) of this section, then the
owner or operator must provide that
person with an alternative respirator.
The alternative respirator must have less
breathing resistance than the negativepressure respirator and provide
equivalent or greater protection. If the
person is unable to use an alternative
respirator, then the person must not be
permitted to enter the regulated area.
(v) Owners and operators must select
respiratory protection that properly fits
each affected person and communicate
respirator selections to each affected
person consistent with the requirements
of 29 CFR 1910.134(f).
(vi) Owners and operators must
provide, ensure use of, and maintain (in
a sanitary, reliable, and undamaged
condition) respiratory protection that is
of safe design and construction for the
applicable condition of use consistent
with the requirements of 29 CFR
1910.134(g) through (j).
(vii) Prior to or at the time of initial
assignment to a job involving potential
exposure to carbon tetrachloride,
owners and operators must provide
training to all persons required to use
respiratory protection consistent with
29 CFR 1910.134(k).
(viii) Owners and operators must
retrain all persons required to use PPE
at least annually, or whenever the
owner or operator has reason to believe
that a previously trained person does
not have the required understanding
and skill to properly use PPE, or when
changes in the workplace or in PPE to
be used render the previous training
obsolete.
(ix) Owners or operators must select
and provide to persons appropriate
respirators as indicated by the most
recent monitoring results as follows:
(A) If the measured exposure
concentration is at or below the 0.03
ppm: no respiratory protection is
required.
(B) If the measured exposure
concentration is above 0.03 ppm and
less than or equal to 0.3 ppm (10 times
ECEL): Any National Institute for
Occupational Safety and Health
(NIOSH)-Approved air-purifying half
mask respirator equipped with organic
vapor cartridges or canisters; or any
NIOSH Approved Supplied-Air
Respirator (SAR) or Airline Respirator
operated in demand mode equipped
with a half mask; or any NIOSH
Approved Self-Contained Breathing
Apparatus (SCBA) in demand mode
equipped with a half mask [APF 10].
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(C) If the measured exposure
concentration is above 0.3 ppm and less
than or equal to 0.75 ppm (25 times
ECEL): Any NIOSH Approved Powered
Air-Purifying Respirator (PAPR)
equipped with a loose-fitting facepiece
or hood/helmet equipped with organic
vapor cartridges or canisters; any
NIOSH Approved continuous flow
supplied air respirator equipped with a
loose-fitting facepiece; or any NIOSH
Approved Supplied-Air Respirator
(SAR) or Airline Respirator in a
continuous-flow mode equipped with a
loose-fitting facepiece or helmet/hood
[APF 25].
(D) If the measured exposure
concentration is above 0.75 ppm and
less than or equal to 1.5 ppm (50 times
ECEL): Any NIOSH Approved airpurifying full facepiece respirator
equipped with organic vapor cartridges
or canisters; any NIOSH Approved
PAPR with a half mask equipped with
organic vapor cartridges or canisters;
any NIOSH Approved SAR or Airline
Respirator in a continuous flow mode
equipped with a half mask; any NIOSH
Approved SAR or Airline Respirator
operated in a pressure-demand or other
positive-pressure mode with a half
mask; or any NIOSH Approved SCBA in
demand-mode equipped with a full
facepiece or helmet/hood [APF 50].
(E) If the measured exposure
concentration is above 1.5 ppm and less
than or equal to 30 ppm (1,000 times
ECEL): Any NIOSH Approved PAPR
equipped with a full facepiece equipped
with organic vapor cartridges or
canisters; any NIOSH Approved SAR or
Airline Respirator in a continuous-flow
mode equipped with full facepiece; any
NIOSH Approved SAR or Airline
Respirator in pressure-demand or other
positive-pressure mode equipped with a
full facepiece and an auxiliary selfcontained air supply; or any NIOSH
Approved SAR or Airline Respirator in
a continuous-flow mode equipped with
a helmet or hood and that has been
tested to demonstrated performance at a
level of a protection of APF 1,000 or
greater [APF 1000].
(F) If the measured exposure
concentration is greater than 30 ppm
(1,000 times ECEL): Any NIOSH
Approved SCBA in a pressure-demand
or other positive-pressure mode
equipped with a full facepiece helmet/
hood [APF 10,000].
(G) If the exposure concentration is
unknown: Any NIOSH Approved
combination supplied air respirator
equipped with a full facepiece and
operated in pressure demand or other
positive pressure mode with an
auxiliary self-contained air supply; or
any NIOSH Approved SCBA operated in
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pressure demand or other positive
pressure mode and equipped with a full
facepiece or helmet/hood [APF 1000+].
(x) Owners and operators must select
and provide respirators as required in
paragraph (f)(2) of this section
consistent with the requirements of 29
CFR 1910.134(d)(1)(iv), and with
consideration of workplace and user
factors that affect respirator performance
and reliability.
(xi) Owners and operators who select
air-purifying respirators must either:
(A) Select respirators that have an
end-of-service-life indicator (ESLI) that
is NIOSH Approved® for carbon
tetrachloride; or
(B) Implement a change schedule for
canisters and cartridges based on
objective information or data that
ensures that canisters and cartridges are
changed before the end of their service
life. The written respiratory protection
program required by paragraph (f)(2)(iii)
of this section must include a
description of the information and data
relied upon, the basis for reliance on the
information and data, and the basis for
the canister and cartridge change
schedule.
(xii) Owners and operators must
ensure that respirators are used in
compliance with the terms of the
respirator’s NIOSH certification.
(xiii) Owners and operators must
conduct regular evaluations of the
workplace, including consultations with
potentially exposed persons using
respiratory protection, consistent with
the requirements of 29 CFR 1910.134(l),
to ensure that the provisions of the
written respiratory protection program
required under paragraph (f)(2)(iii) of
this section are being effectively
implemented.
(xiv) The respiratory protection
requirements in this paragraph (f)(2)
represent the minimum respiratory
protection requirements, such that any
respirator affording a higher degree of
protection than the required respirator
may be used.
(3) Dermal protection. (i) Beginning
September 20, 2027 for Federal agencies
and Federal contractors acting for or on
behalf of the Federal government, or by
June 16, 2025 for non-Federal owners
and operators, if an owner or operator
is required to provide dermal protection
pursuant to paragraph (f)(1), the owner
or operator must ensure that each
potentially exposed person is provided
with dermal PPE according to the
requirements of this section.
(ii) Owners or operators must supply
and require the donning of dermal PPE
that separates and provides a barrier to
prevent direct dermal contact with
carbon tetrachloride in the specific work
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19:26 Dec 17, 2024
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area where it is selected for use, selected
in accordance with this paragraph and
provided in accordance with 29 CFR
1910.132(h), to each person who is
reasonably likely to be dermally
exposed in the work area through direct
dermal contact with carbon
tetrachloride. For the purposes of this
subsection, provisions in 29 CFR
1910.132(h) applying to an ‘‘employee’’
also apply equally to potentially
exposed persons, and provisions
applying to an ‘‘employer’’ also apply
equally to owners or operators.
(iii) Owners or operators must select
and provide dermal PPE in accordance
with 29 CFR 1910.133(b) and
additionally as specified in this
paragraph (f)(3) to each person who is
reasonably likely to be dermally
exposed in the work area through direct
dermal contact with carbon
tetrachloride. For the purposes of this
paragraph (f)(3)(iii), provisions in 29
CFR 1910.133(b) applying to an
‘‘employer’’ also apply equally to
owners or operators.
(iv) Owners or operators must select
and provide to persons appropriate
dermal PPE based on an evaluation of
the performance characteristics of the
PPE relative to the task(s) to be
performed, conditions present, and the
duration of use. Replacement PPE must
be provided immediately if any person
is dermally exposed to CTC longer than
the breakthrough time period for which
testing has demonstrated that the PPE
will be impermeable or if there is a
chemical permeation or breakage of the
PPE. Dermal PPE must include, but is
not limited to, the following items:
(A) Impervious gloves selected based
on specifications from the manufacturer
or supplier or by individually prepared
third-party testing.
(B) Impervious clothing covering the
exposed areas of the body (e.g., long
pants, long sleeved shirt).
(v) Owners or operators must
demonstrate that each item of gloves
and other clothing selected provides an
impervious barrier to prevent direct
dermal contact with carbon
tetrachloride during normal and
expected duration and conditions of
exposure within the work area by
evaluating the specifications from the
manufacturer or supplier or
individually prepared third-party
testing of the dermal PPE, or of the
material used in construction of the
dermal PPE, to establish that the dermal
PPE will be impervious to carbon
tetrachloride alone and in likely
combination with other chemical
substances in the work area.
(vi) Dermal PPE that is of safe design
and construction for the work to be
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performed must be provided, used, and
maintained in a sanitary, reliable, and
undamaged condition. Owners and
operators must select PPE that properly
fits each affected person and
communicate PPE selections to each
affected person.
(vii) Owners or operators must
provide training in accordance with 29
CFR 1910.132(f) to all persons required
to use dermal protection prior to or at
the time of initial assignment to a job
involving exposure to carbon
tetrachloride. For the purposes of this
paragraph (f)(3)(vii), provisions in 29
CFR 1910.132(f) applying to an
‘‘employee’’ also apply equally to
potentially exposed persons, and
provisions applying to an ‘‘employer’’
also apply equally to owners or
operators.
(viii) Owners and operators must
retrain each person required to use
dermal protection at least annually or
whenever the owner or operator has
reason to believe that a previously
trained person does not have the
required understanding and skill to
properly use dermal protection, or when
changes in the workplace or in dermal
protection to be used render the
previous training obsolete.
§ 751.709 Workplace Restrictions for the
Industrial and Commercial Use as a
Laboratory Chemical, Including the Use of
Carbon Tetrachloride as a Laboratory
Chemical by the U.S. Department of
Defense.
(a) Applicability. The provisions of
this section apply to the industrial and
commercial use of carbon tetrachloride
as a laboratory chemical, including the
U.S. Department of Defense’s industrial
and commercial use of carbon
tetrachloride as a laboratory chemical in
chemical weapons destruction.
(b) Laboratory chemical requirements.
(1) After December 18, 2025 for Federal
agencies and Federal contractors acting
for or on behalf of the Federal
government, or after June 16, 2025 for
non-Federal owners and operators,
owners or operators must ensure
laboratory ventilation devices such as
fume hoods or glove boxes are in use
and functioning properly and that
specific measures are taken to ensure
proper and adequate performance of
such equipment to minimize exposures
to potentially exposed persons in the
area when carbon tetrachloride is used
as a laboratory chemical, except for the
U.S. Department of Defense’s use of
carbon tetrachloride as a laboratory
chemical in chemical weapons
destruction.
(2) After December 18, 2025, the U.S.
Department of Defense must ensure that
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advanced engineering controls are in
use and functioning properly and that
specific measures are taken to ensure
proper and adequate performance of
such equipment to minimize exposures
to potentially exposed persons in the
area during the industrial/commercial
use of carbon tetrachloride as a
laboratory chemical in chemical
weapons destruction.
(3) After December 18, 2025 for
Federal agencies and Federal
contractors acting for or on behalf of the
Federal government, or after June 16,
2025 for non-Federal owners and
operators, owners or operators must
ensure that all persons reasonably likely
to be exposed from direct dermal
contact to carbon tetrachloride when
carbon tetrachloride is used as a
laboratory chemical, except for the U.S.
Department of Defense’s industrial and
commercial use of carbon tetrachloride
as a laboratory chemical in chemical
weapons destruction, are provided with
dermal PPE and training on proper use
of PPE in a manner consistent with
§ 751.707(f)(3).
(4) After December 18, 2025, U.S.
Department of Defense must ensure that
all persons reasonably likely to be
exposed from direct dermal contact to
carbon tetrachloride through the
industrial and commercial use of carbon
tetrachloride as a laboratory chemical in
chemical weapons destruction are
provided with dermal PPE and training
on proper use of PPE in a manner
consistent with § 751.707(f)(3), except
that the date listed in paragraph (f)(3)(i)
does not apply.
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§ 751.711
Downstream Notification.
(a) Beginning on February 18, 2025,
each person who manufactures
(including imports) carbon tetrachloride
for any use must, prior to or concurrent
with the shipment, notify companies to
whom carbon tetrachloride is shipped,
in writing, of the restrictions described
in this Subpart in accordance with
paragraph (c) of this section.
(b) Beginning on June 16, 2025, each
person who processes or distributes in
commerce carbon tetrachloride for any
use must, prior to or concurrent with
the shipment, notify companies to
whom carbon tetrachloride is shipped,
in writing, of the restrictions described
in this Subpart in accordance with
paragraph (c) of this section.
(c) The notification required under
paragraphs (a) and (b) of this section
must occur by inserting the following
text in Sections 1(c) and 15 of the Safety
Data Sheet (SDS) provided with the
carbon tetrachloride:
After June 16, 2025, this chemical
substance (as defined in TSCA section 3(2))
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19:26 Dec 17, 2024
Jkt 265001
may not be distributed in commerce or
processed in greater than trace quantities for
the following purposes: Incorporation into
formulation, mixture or reaction products in
petrochemical-derived manufacturing except
in the manufacture of vinyl chloride;
Industrial and commercial use as an
industrial processing aid in the manufacture
of petrochemicals-derived products except in
the manufacture of vinyl chloride; Industrial
and commercial use in the manufacture of
other basic chemicals (including
manufacturing of chlorinated compounds
used in solvents, adhesives, asphalt, and
paints and coatings), except for use in the
elimination of nitrogen trichloride in the
production of chlorine and caustic soda and
the recovery of chlorine in tail gas from the
production of chlorine; Industrial and
commercial use in metal recovery; Industrial
and commercial use as an additive; and
beginning December 18, 2025, industrial and
commercial specialty uses by the U.S.
Department of Defense.
§ 751.713
Recordkeeping Requirements.
(a) General records. After February 18,
2025, all persons who manufacture
(including import), process, distribute
in commerce, or engage in industrial or
commercial use of carbon tetrachloride
must maintain ordinary business
records, such as downstream
notifications, invoices and bills-oflading related to compliance with the
prohibitions, restrictions, and other
provisions of this subpart.
(b) Workplace Chemical Protection
Program compliance—(1) ECEL
exposure monitoring. For each
monitoring event, owners or operators
subject to the ECEL described in
§ 751.707(b) must document and retain
records of the following:
(i) Dates, duration, and results of each
sample taken;
(ii) The quantity, location(s) and
manner of use of carbon tetrachloride in
use at the time of each monitoring
event;
(iii) All measurements that may be
necessary to determine the conditions
that may affect the monitoring results;
(iv) Name, workplace address, work
shift, job classification, work area, and
type of respiratory protection (if any) by
each monitored person;
(v) Identification of all potentially
exposed persons that a monitored
person is intended to represent if using
a representative sample, consistent with
§ 751.707(b)(2)(i)(A) and (B);
(vi) Sampling and analytical methods
used as described in
§ 751.707(b)(2)(i)(D);
(vii) Compliance with the Good
Laboratory Practice Standards in 40 CFR
part 792, or use of laboratory accredited
by the AIHA or another industryrecognized program, as required by
§ 751.707(b)(2)(i)(C); and
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(viii) Information regarding air
monitoring equipment, including: type,
maintenance, calibrations, performance
tests, limits of detection, and any
malfunctions;
(ix) Re-monitoring determinations
conducted by an Environmental
Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist, if
results indicated non-detect; and
(x) Notification of exposure
monitoring results in accordance with
§ 751.707(b)(2)(v).
(2) ECEL compliance. Owners or
operators subject to the ECEL described
in § 751.707(b) must retain records of:
(i) Exposure control plan as described
in § 751.707(d)(2);
(ii) Implementation of the exposure
control plan as described in
§ 751.707(d)(2), including:
(A) Any regular inspections,
evaluations, and updating of the
exposure controls to maintain
effectiveness;
(B) Confirmation that all persons are
implementing the exposure controls;
and
(C) Each occurrence and duration of
any start-up, shutdown, ruptures, or
malfunction of the facility that causes
an exceedance of the ECEL, any
subsequent corrective actions taken by
the owner or operator during the startup, shutdown, ruptures, or malfunctions
to mitigate exposures to CTC, and
documentation indicating that
additional monitoring was completed
within a reasonable timeframe.
(iii) Respiratory protection used by
each potentially exposed person and
PPE program implementation as
described in § 751.707(f)(2) including:
(A) The name, workplace address,
work shift, job classification, work area
of each potentially exposed person, and
the type of respiratory protection
provided to each potentially exposed
person;
(B) The basis for the specific
respiratory protection selection in
accordance with § 751.707(f)(2); and
(C) Fit testing and training in
accordance with § 751.707(f)(2).
(iv) Information and training as
required in § 751.707(e).
(3) DDCC compliance. Owners or
operators subject to DDCC requirements
described in § 751.707(c) must retain
records of:
(i) Exposure control plan as described
in § 751.707(d)(2);
(ii) Dermal protection used by each
potentially exposed person and PPE
program implementation as described in
§ 751.707(f)(3), including:
(A) The name, workplace address,
work shift, job classification, and work
area of each person reasonably likely to
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khammond on DSK9W7S144PROD with RULES8
directly handle carbon tetrachloride or
handle equipment or materials on
which carbon tetrachloride may be
present and the type of PPE selected to
be worn by each of these persons;
(B) The basis for specific PPE
selection (e.g., demonstration based on
permeation testing or manufacturer
specifications that each item of PPE
selected provides an impervious barrier
to prevent exposure during expected
duration and conditions of exposure,
including the likely combinations of
chemical substances to which the PPE
may be exposed in the work area);
(C) Appropriately sized PPE and
training on proper application, wear,
and removal of PPE, and proper care/
disposal of PPE;
(D) Occurrence and duration of any
direct dermal contact with carbon
tetrachloride that occurs during any
activity or malfunction at the workplace
that causes direct dermal exposures to
occur and/or glove breakthrough, and
corrective actions to be taken during
and immediately following that activity
or malfunction to prevent direct dermal
contact to carbon tetrachloride; and
(E) Training in accordance with
§ 751.707(f)(3).
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19:26 Dec 17, 2024
Jkt 265001
(iii) Information and training
provided as required in § 751.707(e).
(4) Workplace participation. Owners
or operators must document the notice
to and ability of any potentially exposed
person that may reasonably be affected
by carbon tetrachloride inhalation
exposure or direct dermal contact and
their designated representatives to
readily access the exposure control
plans, facility exposure monitoring
records, PPE program implementation
records, or any other information
relevant to carbon tetrachloride
exposure in the workplace.
(c) Workplace requirements for
laboratory use compliance. Owners and
operators subject to the laboratory
chemical requirements described in
§ 751.709 must retain records of:
(1) Dermal protection used by each
potentially exposed person and PPE
program implementation, as described
in § 751.713(b)(3)(ii); and
(2) Documentation identifying criteria
that the owner or operator will use to
determine and implement control
measures to reduce potentially exposed
persons’ exposure to carbon
tetrachloride including laboratory
ventilation devices;
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(3) Documentation identifying:
implementation of a properly
functioning laboratory ventilation
devices using manufacturer’s
instructions for installation, use, and
maintenance of the devices including
inspections, tests, development of
maintenance procedures, the
establishment of criteria for acceptable
test results, and documentation of test
and inspection results, except for the
U.S. Department of Defense’s use of
carbon tetrachloride as a laboratory
chemical in chemical weapons
destruction; and
(4) For the U.S. Department of
Defense’s use of carbon tetrachloride as
a laboratory chemical in chemical
weapons destruction, documentation
identifying implementation of advanced
engineering controls that are in use and
functioning properly and specific
measures taken to ensure proper and
adequate performance.
(d) Retention. Owners or operators
must retain the records required under
this section for a period of five years
from the date that such records were
generated.
[FR Doc. 2024–29517 Filed 12–17–24; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Rules and Regulations]
[Pages 103512-103558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29517]
[[Page 103511]]
Vol. 89
Wednesday,
No. 243
December 18, 2024
Part VIII
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 751
Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances
Control Act (TSCA); Final Rule
Federal Register / Vol. 89 , No. 243 / Wednesday, December 18, 2024 /
Rules and Regulations
[[Page 103512]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0592; FRL-8206-02-OCSPP]
RIN 2070-AK82
Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
finalizing a rule to address the unreasonable risk of injury to health
presented by carbon tetrachloride (CTC) under its conditions of use.
TSCA requires that EPA address by rule any unreasonable risk of injury
to health or the environment identified in a TSCA risk evaluation and
apply requirements to the extent necessary so that the chemical no
longer presents unreasonable risk. EPA's final rule will establish
workplace safety requirements for most conditions of use, including the
condition of use related to the making of low Global Warming Potential
(GWP) hydrofluoroolefins (HFOs); prohibit the manufacture (including
import), processing, distribution in commerce, and industrial/
commercial use of CTC for conditions of use where information indicates
use of CTC has ceased; and establish recordkeeping and downstream
notification requirements. The use of CTC in low GWP HFOs is
particularly important in the Agency's efforts to support the American
Innovation and Manufacturing Act of 2020 (AIM Act) and the Kigali
Amendment to the Montreal Protocol on Substances that Deplete the Ozone
Layer, which was ratified on October 26, 2022.
DATES: This final rule is effective on January 17, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0592, is available online
at https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Emilia Echeveste Brise[ntilde]o,
Existing Chemicals Risk Management Division (7404M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number (202)
566-0543; email address: [email protected].
For general information: 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?
1. General Applicability
This action applies to you if you manufacture (defined under TSCA
to include import), process, distribute in commerce, use, or dispose of
CTC (CASRN 56-23-5). TSCA section 3(9) defines the term ``manufacture''
to mean ``to import into customs territory of the United States (as
defined in general note 2 of the Harmonized Tariff Schedule of the
United States), produce, or manufacture''. Therefore, unless expressly
stated otherwise, importers of CTC are subject to any provisions
regulating manufacture of CTC. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
include:
Chemical Manufacturing (NAICS code 325);
Nonmetallic Mineral Product Manufacturing (NAICS code
327);
Primary Metal Manufacturing (NAICS code 331);
Waste Management and Remediation Services (NAICS code
562);
Petrochemical Manufacturing (NAICS code 325110);
Industrial Gas Manufacturing (NAICS code 325120);
Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
Cyclic Crude, Intermediate, and Gum and Wood Chemical
Manufacturing (NAICS code 325194);
All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
Plastics Material and Resin Manufacturing (NAICS code
325211);
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320);
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
Cement Manufacturing (NAICS code 327310);
Ground or Treated Mineral and Earth Manufacturing (NAICS
code 327992);
Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410);
NAICS code 562211--Hazardous Waste Treatment and Disposal
NAICS code 562211); and
Solid Waste Combustors and Incinerators (NAICS code
562213).
2. Applicability to Importers and Exporters
This action may also affect certain entities subject to import
certification, and export notification rules under TSCA (https://www.epa.gov/tsca-import-export-requirements). Persons who import any
chemical substance in bulk form, as part of a mixture, or as part of an
article (if required by rule) are subject to the TSCA section 13 (15
U.S.C. 2612) import certification requirements and the corresponding
regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28.
Those persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this final rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S.
Environmental Protection Agency, hereinafter referred to as EPA or
``the Agency'', determines through a TSCA section 6(b) risk evaluation
that a chemical substance presents an unreasonable risk of injury to
health or the environment, EPA must by rule apply one or more
requirements listed in TSCA section 6(a) to the extent necessary so
that the chemical substance or mixture no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that CTC presents an
unreasonable risk of injury to health, without consideration of costs
or other nonrisk factors, including an unreasonable risk to potentially
exposed or susceptible subpopulations (PESS) identified as relevant to
the 2020 Risk Evaluation for Carbon Tetrachloride by EPA, under the
conditions of use (Refs. 1, 2, 3). A description of the conditions of
use that contribute to EPA's determination that CTC presents an
unreasonable risk is in the proposed rule (88 FR 49190) (FRL-8206-01-
OCSPP) and Unit IV. Accordingly, to
[[Page 103513]]
address the unreasonable risk, EPA is issuing this final rule under
TSCA section 6(a) to:
(1) Require a Workplace Chemical Protection Program (WCPP),
including an inhalation exposure concentration limit, direct dermal
contact controls, and related workplace exposure controls, for the
following occupational conditions of use of CTC not prohibited,
outlined in Unit IV.B.:
Domestic manufacture;
Import;
Processing as a reactant in the production of
hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), HFOs, and
perchloroethylene (PCE);
Incorporation into formulation, mixture or reaction
products in agricultural products manufacturing, vinyl chloride
manufacturing, and other basic organic and inorganic chemical
manufacturing;
Repackaging for use as a laboratory chemical;
Recycling;
Industrial and commercial use as an industrial processing
aid in the manufacture of agricultural products and vinyl chloride;
Industrial and commercial use in the elimination of
nitrogen trichloride in the production of chlorine and caustic soda and
the recovery of chlorine in tail gas from the production of chlorine;
and
Disposal.
(2) Require use of laboratory ventilation devices, such as fume
hoods or glove boxes, and dermal personal protective equipment (PPE)
for the industrial and commercial use as a laboratory chemical, as
outlined in Unit IV.C.;
(3) Prohibit these additional conditions of use, for which the
Agency understands use of CTC has already ceased, as outlined in Unit
IV.D.:
Incorporation into formulation, mixture or reaction
products in petrochemical-derived manufacturing except in the
manufacture of vinyl chloride (for which EPA is requiring a WCPP);
Industrial and commercial use as an industrial processing
aid in the manufacture of petrochemicals-derived products except in the
manufacture of vinyl chloride (for which EPA is requiring a WCPP);
Industrial and commercial use in the manufacture of other
basic chemicals (including manufacturing of chlorinated compounds used
in solvents, adhesives, asphalt, and paints and coatings), except for
use in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine (for which EPA is requiring a WCPP);
Industrial and commercial use in metal recovery;
Industrial and commercial use as an additive; and
Industrial and commercial use in specialty uses by the
U.S. Department of Defense (DoD).
(4) Require recordkeeping, as outlined in Unit IV.E.1.
(5) Require manufacturers (including importers), processors, and
distributors to provide downstream notification of the requirements, as
outlined in Unit IV.E.2.
EPA notes that not all TSCA conditions of use of CTC are subject to
this final rule. ``Conditions of use'' is defined in TSCA section 3(4)
to mean the circumstances, as determined by EPA, under which a chemical
substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
As described in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.
1) and the 2022 Revised Unreasonable Risk Determination for Carbon
Tetrachloride (Ref. 3), two conditions of use of CTC do not drive the
unreasonable risk: distribution in commerce and processing as a
reactant/intermediate in reactive ion etching. EPA is not finalizing
any restrictions for the processing of CTC as a reactant/intermediate
in reactive ion etching. However, under TSCA section 6(a), EPA may
select from among a suite of risk management requirements in TSCA
section 6(a), including requirements related to distribution in
commerce, as part of its regulatory options to address the unreasonable
risk; EPA's final regulatory action includes prohibitions on the
distribution in commerce of CTC for certain downstream conditions of
use to address unreasonable risk from those downstream conditions of
use. Additionally, as explained in Section 1.4.2.3 of the 2020 Risk
Evaluation for Carbon Tetrachloride and Section 2.2.2.1 of the 2018
Problem Formulation of the Risk Evaluation for Carbon Tetrachloride,
EPA concluded that the industrial/commercial/consumer uses of CTC in
adhesives/sealants, paints/coatings, and cleaning/degreasing solvent
products contain only trace amounts of CTC, present only de minimis
exposures or otherwise insignificant risks under TSCA, and did not
warrant inclusion in the risk evaluation. Therefore, EPA has excluded
from the rule's requirements CTC that is solely present unintentionally
in trace quantities with another chemical substance or mixture, whether
as a manufacturing residue, unreacted feedstock, byproduct, or other
contaminant. However, EPA notes that the Agency has discretion to
further assess trace quantities of CTC under other regulatory
authorities, such as the Clean Air Act. Finally, manufacture of CTC as
a byproduct was not evaluated in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1); therefore, in this final rule, WCPP
requirements applicable to the domestic manufacture of CTC do not apply
where CTC is manufactured solely as a byproduct. EPA anticipates that
any risks presented by the presence of CTC as a byproduct formed during
the manufacturing, processing or use of a parent compound will be
considered in the scope of the risk evaluation of such parent compound.
For example, EPA will assess the risks of CTC manufactured as a
byproduct during the manufacture of 1,2-dichloroethane in the TSCA risk
evaluation for 1,2-dichloroethane (Ref. 1).
D. Why is the Agency taking this action?
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' CTC was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in November 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in December 2022 (Ref.
3), determining that CTC, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. On
July 28, 2023, EPA issued a proposed rulemaking (88 FR 49180) (FRL-
8206-01-OCSPP) under TSCA section 6(a) to take action to the extent
necessary so that CTC no longer presents such risk. The Agency received
public comment on the proposal. With this action, EPA is finalizing
with modifications the July 2023 proposed rule so that CTC no longer
presents an such risk. The conditions of use that contribute to the
unreasonable risk from CTC are described in the proposed rule (88 FR
49190) (FRL-8206-01-OCSPP) and Unit IV.
CTC's hazards are well established. EPA's 2020 Risk Evaluation for
Carbon Tetrachloride considered the hazards
[[Page 103514]]
associated with exposure to CTC and determined that CTC presents an
unreasonable risk of injury to health due to the significant adverse
health effects associated with the exposure of CTC. While some risks of
adverse effects from CTC exposure are associated with acute single
exposures, other risks are associated with long-term repeated
exposures. EPA identified cancer and liver toxicity adverse effects
from chronic inhalation and dermal exposures as well as liver toxicity
from acute dermal exposures to CTC (Refs. 1, 2, 3). Cancer adverse
effects (e.g., liver, pheochromocytoma, neuroblastoma) were identified
for chronic inhalation and dermal exposures. Cancer was selected based
on the best available science and weight of scientific evidence, and in
consideration of the severity of hazards, magnitude of exposure,
population exposed, and uncertainties in the November 2020 Risk
Evaluation for Carbon Tetrachloride and the December 2022 Revised Risk
Determination for Carbon Tetrachloride. EPA identified in the 2020 Risk
Evaluation for Carbon Tetrachloride a threshold cancer point of
departure (POD) for liver tumors (assuming a margin of exposure of
300), and an inhalation unit risk (IUR) for adrenal tumors, based on
effects observed in mice following inhalation exposure. The chronic
non-cancer PODs for inhalation exposures are based on a study observing
increased fatty changes in rodent livers (fatty changes in the liver
are a precursor for liver fibrosis). EPA also identified additional
risks associated with other adverse effects (e.g., immediate and
temporary depression of the central nervous system, kidney toxicity,
reproductive and developmental toxicity, irritation and sensitization,
and genetic toxicity) resulting from acute and chronic exposures. For
this action, EPA has determined that protecting against liver and
adrenal cancer would also address the risk for acute non-cancer,
chronic non-cancer, and additional cancer risks from CTC, as identified
in the 2020 Risk Evaluation for Carbon Tetrachloride and the Revised
Unreasonable Risk Determination for CTC in December 2022 (Ref. 1, 2 and
3).
CTC is primarily used as a feedstock to make products such as
refrigerants, aerosol propellants, and foam-blowing agents.
Requirements under the Montreal Protocol and Title VI of the Clean Air
Act (CAA), which were included in the CAA Amendments of 1990 and are
codified at 42 U.S.C. Chapter 85, Subchapter VI, led to a phaseout of
CTC production in the United States for most non-feedstock domestic
uses, such as degreasers and fire suppressants. In addition, the
Consumer Product Safety Commission (CPSC) banned the use of CTC in
household (i.e., consumer) products (excluding unavoidable residues not
exceeding 10 ppm atmospheric concentration) in 1970 (see 16 CFR
1500.17(a)(2)). The Agency has considered the benefits of CTC for
various uses as required under TSCA section 6(c)(2)(A) and (B) and
recognizes that continued use of CTC for some TSCA conditions of use
should be maintained for several reasons. The use of CTC may provide
benefits that complement the Agency's efforts to address climate-
damaging HFCs under the AIM Act and the Kigali Amendment to the
Montreal Protocol, supporting human health and environmental protection
under these programs. In addition, the use of CTC may provide other
benefits due to certain unique properties of CTC (e.g., it does not
react with the process gasses when used as a process agent in the
manufacture of agricultural products (Ref. 4)). Finally, strict
workplace controls can be implemented to address unreasonable risk
across many conditions of use. For some workplaces, EPA understands
that existing controls may already reduce exposures enough to meet the
inhalation exposure concentration limit proposed in this rulemaking or
to prevent direct dermal contact with CTC. For many of the conditions
of use for which EPA is finalizing workplace controls under a WCPP,
data indicating that certain uses could meet the exposure limit and
ancillary requirements of an effective WCPP in addressing unreasonable
risk were submitted during the risk evaluation, the comment period
following publication of the proposed rule, or during stakeholder
outreach engagements, and are available in the corresponding public
dockets (EPA-HQ-OPPT-2016-0733; EPA-HQ-OPPT-2019-0499; EPA-HQ-OPPT-
2020-0592).
Accordingly, EPA is finalizing workplace controls to address the
unreasonable risk while allowing continued use for 100% of the
production volume of CTC manufactured annually, including the
processing of CTC as a reactant in the production of HFOs. The
rationale for the final regulatory action, including the TSCA section 6
requirements considered in developing the regulatory action, is
described in Units II.D. and III.
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis for the potential incremental
impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 5). As described in more detail in the Economic
Analysis and in Unit V.D., EPA's estimate of the incremental costs of
this final rule is $19.7 million per year annualized over 20 years at a
3% discount rate and $19 million per year at a 7% discount rate (Ref.
5). In response to the updated Circular A-4 published in November 2023,
the incremental costs of this rule at a 2% discount rate ($19.9 million
annualized over 20 years) are provided in Appendix C of the Economic
Analysis (Ref. 5).
These costs include compliance with a WCPP for certain conditions
of use, applicable PPE requirements, and notification and recordkeeping
costs. EPA was not able to quantify the costs associated with
administrative and engineering controls because they are site-specific
and depend on the extent to which controls are already in place, which
is likely to vary across individual facilities. Thus, for the purpose
of estimating costs and benefits, this analysis assumes that PPE is
used. Under the WCPP, regulated entities would be required to consider
respirators and dermal PPE only after consideration of other more
effective strategies in the hierarchy of controls adopted by the
Occupational Safety and Health Administration (OSHA) and the National
Institute for Occupational Safety and Health (NIOSH) to reduce
exposures (Ref. 6). Regulated entities are required first to consider
other measures in the hierarchy of controls and then to select PPE
based on monitoring results because the Agency recognizes that
workplaces have unique processes and equipment in place, and that
varying levels of respiratory Assigned Protection Factor (APFs) may be
needed for different workplaces.
Industry is expected to incur costs associated with performing
inspections, documenting efforts to meet the regulatory requirements
associated with the WCPP, including reducing exposure and occurrences
of exposure, monitoring, respirators and dermal PPE, training on the
use of respirators and dermal PPE, and notification and recordkeeping
burdens and costs associated with the WCPP. Industry is also expected
to incur equipment costs associated with dermal PPE for laboratory use.
EPA assumes that industry would not incur equipment costs associated
with the ventilated
[[Page 103515]]
laboratory safety requirement for laboratory settings because these
requirements are part of baseline industry practices. All manufacturers
(including importers), processors, and distributors will bear
downstream notification and recordkeeping costs.
The costs are estimated as incremental to baseline conditions,
including current use of PPE. The costs represent a high-end estimate
of the number of entities and workers affected by the regulation
because the high estimates of workers and entities from the 2020 Risk
Evaluation for Carbon Tetrachloride were used. To the extent that EPA's
approach overestimates the number of entities subject to the
regulation, actual realized costs of this action will be lower. More
details regarding the provisions of the final rule are in Unit IV.
In addition to the quantified costs, there is an unquantified cost
to workers and firms associated with prolonged use of respirators,
which could interfere with work tasks. The potential for respirator use
to cause discomfort and productivity losses could lead companies to
offer higher wages as compensation, but the extent of this effect is
unknown and thus unquantified. The Economic Analysis contains
additional information about the unquantified costs in Chapter 3 and in
the Estimated Incremental Costs section of the Executive Summary (Ref.
5).
Unit IV. details which actions apply to specific conditions of use.
EPA estimates that 30 firms associated with 72 sites may be
manufacturing (including importing), processing, or releasing CTC.
EPA estimates that the final rule would affect at least seven small
entities. EPA compared the highest annualized per-facility cost of the
final regulatory action with ultimate parent company annual revenues of
the affected small businesses. EPA found impacts under 1% of annual
revenues for five of the seven small entities. Two small entities were
estimated to have a cost-to-revenue impact ratio of between one and
three percent.
In alignment with the goals of President Biden's Cancer Moonshot,
the rule will protect people from cancer and other adverse health
effects of CTC (Ref. 7). The actions in this final rule are expected to
achieve health benefits for the American public. The Economic Analysis
monetizes benefits to occupational users and non-users of avoiding
cases of adrenal and liver cancer due to reduced inhalation exposures
that result from implementation of the WCPP. The magnitude of the
cancer benefits from reduced inhalation exposure is estimated assuming
companies provide respirators to comply. It is also possible that
employees will receive respiratory benefits from other actions on
OSHA's hierarchy of controls, such as engineering controls, since
regulated entities are required first to consider other measures in the
hierarchy of controls and then to select PPE based on monitoring
results. However, the Economic Analysis does not estimate the costs of
such controls because feasible controls and their costs are site-
specific and the amount of additional exposure reduction that could be
achieved through any given type of control would depend on the extent
to which such controls are already in place, which is likely to vary
across individual facilities. This assumption is made for the purpose
of estimating costs only and is not an assumption about how facilities
would necessarily comply with WCPP requirements. Other human health
benefits, including noncancer and additional cancer benefits, while
tangible and significant, cannot be monetized due to data and
methodology limitations. These include additional cancer benefits from
avoided brain tumors, noncancer health benefits, health benefits from
avoided dermal exposure, and benefits to the environment. The
incremental improvements in health outcomes achieved by given
reductions in exposure cannot currently be quantified for non-cancer
health effects associated with CTC exposure, and therefore cannot be
converted into monetized benefits. Although some benefits cannot be
quantified, they are not necessarily less important than the quantified
benefits. The primary reason these benefits were not quantified is the
difficulty in estimating the relationship between an incremental change
in CTC use and the corresponding change to a specific health or
environmental outcome.
Adrenal and liver cancer avoidance benefits are calculated based on
reductions in inhalation exposure using the 2020 Risk Evaluation for
Carbon Tetrachloride (Ref. 1) for those uses which are continuing but
with a WCPP in place. Therefore, benefits are only calculated for the
WCPP in the final rule, which could include respiratory protection. The
estimated monetized benefit of the final rule ranges from approximately
$0.13 to $0.14 million per year annualized over 20 years at a 3%
discount rate and from $0.06 to $0.07 million per year at a 7% discount
rate. In response to the updated Circular A-4 published in November
2023, the incremental benefits at a 2% discount rate ($0.16 to $0.17
million annualized over 20 years) are provided in Appendix C of the
Economic Analysis (Ref. 5). To estimate the costs and benefits of the
WCPP, the Economic Analysis generated a likely distribution of air
monitoring outcomes at CTC facilities. This distribution was used to
project the number of facilities that would require each respirator
APF. These estimates are subject to uncertainties, and there could be
facilities with higher or lower air exposures than estimated in the
Economic Analysis.
Using the high-end estimates for the number of entities and workers
affected by the final rule, the monetized net benefit of the final
rule, which is negative, is -$19.6 million per year annualized over 20
years at a 3% discount rate and is -$18.9 million per year at a 7%
discount rate. In response to the updated Circular A-4 published in
November 2023, the incremental net benefits at a 2% discount rate (-
$19.7 million annualized over 20 years) are provided in Appendix C of
the Economic Analysis (Ref. 5). The range in the monetized net benefits
estimate at each discount rate presented in the Economic Analysis
reflects uncertainty in cancer risk reductions given the shorter
exposure durations being considered and the life stage at which the
changes in exposure occur. Although the estimated monetized net
benefits are negative, there are also non-monetized benefits due to
other avoided adverse health effects associated with CTC exposure,
including liver, reproductive, renal, developmental, and central
nervous system (CNS) toxicity endpoints. These are serious health
endpoints, even though the change in risk due to CTC exposure was not
quantified in the 2020 Risk Evaluation for Carbon Tetrachloride.
Section 6.6 of the Economic Analysis, addressing environmental
justice impacts, provides sociodemographic data on communities and
workers in industries affected by the rule and people who live in
proximity to potentially affected facilities. EPA analyzed the baseline
conditions facing communities near CTC and HFO manufacturing facilities
as well as those of workers in the same industry and county as CTC
facilities and HFO manufacturing facilities. The environmental justice
analysis found that, across the entire population within 1- and 3-miles
of CTC facilities, there are higher percentages of people who identify
as Black and living below the poverty line and a similar percentage of
people who identify as Hispanic
[[Page 103516]]
compared to the national averages. CTC facilities are concentrated in
Texas and Louisiana, especially near Houston and Baton Rouge.
II. Background
A. Overview of Carbon Tetrachloride
As described in more detail in the proposed rule, EPA identified
liver and adrenal toxicity cancer adverse effects from chronic
inhalation and dermal exposures, as well as liver toxicity from acute
dermal exposures in the workplace as the basis for the unreasonable
risk determination for CTC (Ref. 1, 2, and 3). This final rule is
specifically intended to address the unreasonable risk of injury to
health EPA identified in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1) and the 2022 Revised Unreasonable Risk
Determination for Carbon Tetrachloride (Ref. 3), as described in Unit
II.C. CTC is a volatile organic compound that is primarily used as a
feedstock in the production of HCFCs, HFCs, and HFOs.
According to data submitted for EPA's 2016 and 2020 Chemical Data
Reporting (CDR) Rule, in Reporting Years (RY) 2015 and 2019, between
100 and 250 million pounds of CTC were manufactured or imported in the
United States (Refs. 5, 8, 9). CTC's use as a feedstock in the
production of HCFCs, HFCs, and HFOs and the description of finalized
requirements to address the unreasonable risk are described in Unit
IV.B.
B. Regulatory Actions Pertaining to Carbon Tetrachloride
Because of its adverse health effects, CTC is subject to numerous
Federal laws and regulations in the United States and is also subject
to regulation by some states and other countries. A summary of EPA
regulations pertaining to CTC, as well as other Federal, State, and
international regulations, is provided in the docket (Refs. 1, 10).
As described in more detail in Unit II.C. of EPA's proposed rule
(88 FR 49184, July 28, 2023) (FRL-8206-01-OCSPP) and the Response to
Public Comments document (Ref. 11), EPA considered the adequacy of the
current occupational safety and health standards from the OSHA (29 CFR
part 1910) for protection of workers. EPA notes that the standards for
chemical hazards that OSHA promulgates under the Occupational Safety
and Health (OSH Act) share a broadly similar purpose with the worker
protection-related regulations that EPA promulgates under TSCA section
6(a). The control measures OSHA and EPA require to satisfy the
objectives of their respective statutes may also, in many
circumstances, overlap or coincide. However, there are important
differences between EPA's and OSHA's regulatory approaches and
jurisdiction, and EPA considers these differences when deciding whether
and how to account for OSHA requirements when evaluating and addressing
potential unreasonable risk to workers so that compliance requirements
are clearly explained to the regulated community. TSCA risk evaluations
are subject to statutory science standards, an explicit requirement to
consider risks to potentially exposed or susceptible subpopulations,
and a prohibition on considering costs and other non-risk factors when
determining whether a chemical presents an unreasonable risk that
warrants regulatory actions--all requirements that do not apply to
development of OSHA regulations. As such, EPA may find unreasonable
risk for purposes of TSCA notwithstanding OSHA requirements. In
addition, health standards issued under section 6(b)(5) of the OSH Act
must reduce significant risk only to the extent that it is
technologically and economically feasible. OSHA's legal requirement to
demonstrate that its section 6(b)(5) standards are technologically and
economically feasible at the time they are promulgated often precludes
OSHA from imposing exposure control requirements sufficient to ensure
that the chemical substance no longer presents a significant risk to
workers. While it is possible in some cases that the OSHA standards for
some chemicals reviewed under TSCA will eliminate unreasonable risk,
based on EPA's experience thus far in conducting occupational risk
assessments under TSCA, EPA believes that OSHA chemical standards would
in general be unlikely to address unreasonable risk to workers within
the meaning of TSCA, since TSCA section 6(b) unreasonable risk
determinations may account for unreasonable risk to more sensitive
endpoints and working populations than OSHA's risk evaluations
typically contemplate and EPA is obligated to apply TSCA section 6(a)
risk management requirements to the extent necessary so that the
unreasonable risk is no longer presented. Because the requirements and
application of TSCA and OSHA regulatory analyses differ, it is
necessary for EPA to conduct risk evaluations and, where it finds
unreasonable risk to workers, develop risk management requirements for
chemical substances that OSHA also regulates, and it is expected that
EPA's findings and requirements may sometimes diverge from OSHA's.
Additional considerations of OSHA standards in the 2022 Revised
Unreasonable Risk Determination for Carbon Tetrachloride are discussed
further in the Federal Register of December 27, 2022 (87 FR 79303).
EPA intends for this regulation to be as consistent as possible
with OSHA regulations for toxic and hazardous substances, with
additional requirements as necessary to address the unreasonable risk.
Consistent with TSCA section 9(d), EPA consults and coordinates TSCA
activities with OSHA and other relevant Federal agencies for the
purpose of achieving the maximum enforcement of TSCA while imposing the
least burdens of duplicative requirements.
C. Summary of EPA's Risk Evaluation Activities on Carbon Tetrachloride
EPA published the scope of the CTC risk evaluation in July 2017 (82
FR 31592) (FRL-9963-57), and, after receiving public comments,
published the problem formulation on June 11, 2018 (83 FR 26998) (FRL-
9978-40). In January 2020, EPA published a draft risk evaluation (85 FR
4658, January 27, 2020) (FRL-10003-92), and, after public comment and
peer review by the Science Advisory Committee on Chemicals (SACC), EPA
issued the Risk Evaluation for Carbon Tetrachloride in November 2020 in
accordance with TSCA section 6(b) (Ref. 1) (85 FR 70147, November 4,
2020) (FRL-10015-51). EPA subsequently issued a draft revised TSCA
unreasonable risk determination for CTC (87 FR 52766, August 29, 2022)
(FRL-9948-01-OCSPP), and, after public notice and receipt of comments,
published a Revised Unreasonable Risk Determination for Carbon
Tetrachloride in December 2022 (Ref. 3) (87 FR 79303, December 27,
2022) (FRL-9948-02-OCSPP). The 2020 Risk Evaluation for Carbon
Tetrachloride and supplemental materials are in docket EPA-HQ-OPPT-
2019-0499, and the December 2022 revised unreasonable risk
determination and additional materials supporting the risk evaluation
process in docket EPA-HQ-OPPT-2016-0733 available at https://www.regulations.gov.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for Carbon Tetrachloride, EPA evaluated
risks associated with 15 conditions of use within the following
categories: manufacture (including import), processing, distribution in
commerce, industrial and commercial use, and disposal (Ref. 1). The
conditions of use are described in Unit III.B.1. of the
[[Page 103517]]
proposed rule (88 FR 49190) (FRL-8206-01-OCSPP) and in Unit IV. of this
final rule. The 2020 Risk Evaluation for Carbon Tetrachloride
identified significant adverse health effects associated with short-
term and long-term exposure to CTC. A further discussion of the hazards
of CTC is presented in Unit III.B.3 of the proposed rule (88 FR 49192)
(FRL-8206-01-OCSPP) and in Unit V. of this final rule.
2. 2022 Revised Unreasonable Risk Determination
As described in more detail in the proposed rule, EPA revised the
original unreasonable risk determination based on the 2020 Risk
Evaluation for Carbon Tetrachloride and issued a final revised
unreasonable risk determination in December 2022 (Ref. 3). EPA revised
the risk determination for the 2020 Risk Evaluation for Carbon
Tetrachloride pursuant to TSCA section 6(b) and consistent with
Executive Order 13990 (titled ``Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis'') and
other Administration priorities (Refs. 12, 13, 14). The revisions
consisted of making a single risk determination for the whole-chemical
substance instead of making the risk determination for each individual
condition of use, which resulted in the revised risk determination
superseding the prior ``no unreasonable risk'' determinations for
specific conditions of use (Ref. 3), the withdrawal of the associated
TSCA section 6(i)(1) ``no unreasonable risk'' order, and clarification
that the risk determination does not reflect an assumption that all
workers are always provided and appropriately wear personal protective
equipment (PPE) (Ref. 3).
EPA determined that CTC presents an unreasonable risk of injury to
health, and EPA did not identify risks of injury to the environment
that contribute to the unreasonable risk determination for CTC. The CTC
conditions of use that contribute to EPA's determination that the
chemical substance poses unreasonable risk to health are listed in the
unreasonable risk determination (Ref. 3) and also in Unit III.B.1. of
the proposed rule, with descriptions to aid chemical manufacturers,
processors, and users in determining how their particular use or
activity would be addressed under the final regulatory action. The
descriptions of the conditions of use subject to this final rule are in
Unit IV.
The conditions of use that do not drive the unreasonable risk for
CTC (distribution in commerce and processing as a reactant/intermediate
in reactive ion etching) are also listed in the unreasonable risk
determination (Ref. 3) and in Unit III.B.2. of the proposed rule. EPA's
final rule includes prohibitions on the distribution in commerce of CTC
for certain downstream uses, but does not include any restrictions for
the processing as a reactant/intermediate in reactive ion etching.
3. Description of Unreasonable Risk
EPA has determined that CTC presents an unreasonable risk of injury
to health under the conditions of use, based on cancer and acute and
chronic toxicity for non-cancer effects. As described in more detail in
the proposed rule, the TSCA section 6(b) 2020 Risk Evaluation for
Carbon Tetrachloride, and the July 2022 errata memorandum correcting
risk estimates for acute dermal exposures, EPA identified cancer and
liver toxicity adverse effects from chronic inhalation and dermal
exposures as well as liver toxicity from acute dermal exposures to CTC
(Refs. 1, 2, 3). Cancer adverse effects (e.g., liver, pheochromocytoma,
neuroblastoma) were identified for chronic inhalation and dermal
exposures. For chronic and acute non-cancer inhalation exposure to CTC,
liver toxicity due to fatty change in the liver was indicative of
cellular damage and selected as the most sensitive non-cancer endpoint.
EPA identified additional risks associated with other adverse effects
(e.g., immediate and temporary depression of the central nervous
system, kidney toxicity, reproductive and developmental toxicity,
irritation and sensitization, and genetic toxicity) resulting from
acute and chronic exposures (Ref. 1). By establishing protections from
liver and adrenal cancer, EPA's final rule will also prevent the
unreasonable risk from other less sensitive endpoints, including acute,
chronic non-cancer, and additional cancer risks from CTC (Ref. 15).
EPA considered potentially exposed or susceptible subpopulations
identified as relevant to the risk evaluation by the Agency, which are
included in the quantitative and qualitative analyses described in the
2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) and were
considered in the determination of unreasonable risk for CTC.
4. Conditions of Use Subject to This Regulatory Action
As noted in Unit I.C., ``Conditions of use'' is defined in TSCA
section 3(4). To assist with the implementation and compliance with the
final rule, in Unit IV., EPA has provided a description of the
conditions of use subject to the WCPP and to prescriptive controls, as
well as those conditions of use prohibited by this final rule. The
descriptions provided were obtained from EPA sources such as CDR codes,
the 2020 Risk Evaluation for Carbon Tetrachloride and related
documents, as well as the Organisation for Economic Co-operation and
Development (OECD) harmonized use codes, and stakeholder engagements.
EPA received public comments requesting minor clarifications of the
descriptions for some industrial and commercial uses, and EPA has
clarified those descriptions in Unit IV. A description of the minor
changes can be found in the response to comments document (Ref. 11) and
in Unit III.E.
For the purposes of this final rule, ``occupational conditions of
use'' refers to the TSCA conditions of use described in Units IV.B.1.,
IV.C.1., and IV.D.1. of the final rule. Although EPA identified both
industrial and commercial uses in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1) for purposes of distinguishing exposure
scenarios, the Agency clarified then and clarifies now that EPA
interprets the authority Congress gave to the Agency to ``regulat[e]
any manner or method of commercial use'' under TSCA section 6(a)(5) to
reach both industrial and commercial uses.
EPA further notes that this rule does not apply to any substance
excluded from the definition of ``chemical substance'' under TSCA
section 3(2)(B)(ii) through (vi). Those exclusions include, but are not
limited to, any pesticide (as defined by the Federal Insecticide,
Fungicide, and Rodenticide Act) when manufactured, processed, or
distributed in commerce for use as a pesticide; and any food, food
additive, drug, cosmetic, or device, as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic or device.
D. EPA's Proposed Rule Under TSCA Section 6(a) for Carbon Tetrachloride
1. Description of TSCA Section 6(a) Requirements
Under TSCA section 6(a), if the Administrator determines through a
TSCA section 6(b) risk evaluation that a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to potentially exposed or susceptible subpopulation
identified as relevant to
[[Page 103518]]
the Agency's risk evaluation, under the conditions of use, EPA must by
rule apply one or more of the TSCA section 6(a) requirements to the
extent necessary so that the chemical substance or mixture no longer
presents such risk.
The TSCA section 6(a) requirements can include one or more of the
following actions alone or in combination:
Prohibit or otherwise restrict the manufacturing
(including import), processing, or distribution in commerce of the
substance or mixture, or limit the amount of such substance or mixture
which may be manufactured, processed, or distributed in commerce (TSCA
section 6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
Require clear and adequate minimum warnings and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records, or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
This unit summarizes the TSCA section 6 considerations for issuing
regulations under TSCA section 6(a), and it is consistent with the
considerations and analyses presented in the proposed rule to manage
the unreasonable risk from CTC (88 FR 49180, July 28, 2023 (FRL-8206-
01-OCSPP)).
As required, EPA developed a proposed regulatory action and an
alternative regulatory action, which are described in Units IV.A. and
IV.B., respectively, of the proposed rule (88 FR 49193 through 491205
(FRL-8206-01-OCSPP)). To identify and select a regulatory action, EPA
considered the two routes of exposure driving the unreasonable risk,
inhalation and dermal, and the exposed populations. For occupational
conditions of use, EPA considered how it could directly regulate
manufacturing (including import), processing, distribution in commerce,
industrial and commercial use, or disposal to address the unreasonable
risk.
As required by TSCA section 6(c)(2), EPA considered several
factors, in addition to the identified unreasonable risk, when
selecting among possible TSCA section 6(a) regulatory requirements for
the proposed rule. EPA's considerations regarding TSCA section 6(c)(2)
and section 6(c)(2)(A) for CTC are discussed in full in Unit VI. of the
proposed rule (88 FR 49209) (FRL-8206-01-OCSPP), including the
statement of effects with respect to these considerations. After review
of the public comments received, EPA has revised its statement of
effects considerations in Unit V. of this final rule.
Additionally, as described in more detail in EPA's proposed rule in
Unit V.B. (88 FR 49209) (FRL-8206-01-OCSPP), EPA considered the
availability of alternatives when finalizing a prohibition or a
substantial restriction (TSCA section 6(c)(2)(C)), and in setting final
compliance dates in accordance with the requirements in TSCA section
6(d)(1)(B)).
To the extent information was reasonably available, EPA considered
pollution prevention strategies and the hierarchy of controls adopted
by OSHA and the NIOSH when developing its proposed rule, with the goal
of identifying risk management control methods that would be permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated
community where appropriate, and EPA took into account the information
presented in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.
1), input from stakeholders, insight received during consultations, and
anticipated compliance strategies from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and alternative action described in Unit II.D.3. The
proposed rule presents additional details related to how the
requirements described in Unit II.D.1. of this document were
incorporated into development of the proposed rule and primary
alternative action.
2. Consultations and Other Engagement
a. Consultations
EPA conducted consultations and outreach as part of development of
the July 28, 2023 proposed rule (88 FR 49180) (FRL-8206-01-OCSPP). The
Agency held a federalism consultation from December 17, 2020, until
February 17, 2021, as part of the rulemaking process and pursuant to
Executive Order 13132 (Ref. 16).
EPA also consulted with Tribal officials (Ref. 17). The Agency held
a Tribal consultation from December 7, 2020, through March 12, 2021,
with meetings held on January 6 and 12, 2021 (Ref. 17). EPA received no
written comments as part of this consultation.
EPA's Environmental Justice (EJ) consultation occurred from
February 2, 2021, through April 2, 2021 (Ref. 18). On February 2 and
18, 2021, EPA held public meetings as part of this consultation. These
meetings were held pursuant to Executive Orders 12898 and 14008. EPA
received one written comment following the EJ meeting, in addition to
oral comments provided during the consultation (Ref. 18).
More information regarding the consultations is presented in Units
VIII.E., VIII.F. and VIII.J.
b. Other Stakeholder Consultations
In addition to the formal consultations described in Unit
II.D.2.a., EPA held a webinar on December 10, 2020, providing an
overview of the TSCA risk management processes and the risk evaluation
findings for CTC (Ref. 19). EPA also presented on the TSCA risk
management process and the findings in the 2020 Risk Evaluation for
Carbon Tetrachloride at a Small Business Administration (SBA)
Roundtable on December 4, 2020 (Ref. 20). Attendees of these meetings
were given an opportunity to voice their concerns on both the risk
evaluation and risk management.
Furthermore, during development of the proposed and final rule, EPA
engaged in discussions with representatives from different industries,
non-governmental organizations, organized labor, technical experts, and
users of CTC, including a
[[Page 103519]]
webinar providing an overview of the proposed rule. A list of external
meetings held during the development of the 2023 proposed and final
rule is available in the docket (Ref. 21); meeting materials and
summaries are also in the docket.
c. Children's Environmental Health
The Agency's 2021 Policy on Children's Health (Ref. 22) requires
EPA to protect children from environmental exposures by consistently
and explicitly considering early life exposures (from conception,
infancy, early childhood and through adolescence until 21 years of age)
and lifelong health in all human health decisions through identifying
and integrating children's health data and information when conducting
risk assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct
risk evaluations ``to determine whether a chemical substance presents
an unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' In addition, TSCA section
6(a) requires EPA to apply one or more risk management requirements
under TSCA section 6(a) so that CTC no longer presents an unreasonable
risk (which includes unreasonable risk to any relevant potentially
exposed or susceptible subpopulation). Information on how the Policy
was applied and on the health and risk assessments supporting this
action is available under Units II.C. II.D. and V.A., as well as in
Unit III.A.3. of the July 2023 proposed rule (88 FR 49184 through
49188, 49205 through 49208 and 49190) (FRL-8206-01-OCSPP), the 2020
Risk Evaluation for Carbon Tetrachloride, and the Economic Analysis for
this rule (Refs. 1, 5).
3. Proposed Regulatory Action
EPA's proposed rule under TSCA section 6(a) to address the
unreasonable risk presented by CTC under its conditions of use included
the following:
Requirements for strict workplace controls, including a
CTC WCPP, which would include requirements to meet an inhalation
exposure concentration limit and prevent direct dermal contact with
CTC, for 9 occupational conditions of use;
Requirements for prescriptive workplace controls for
laboratory use; and
Prohibition of certain processing, industrial, and
commercial conditions of use and the manufacture, processing, and
distribution for those uses.
The proposed rule included timeframes for implementation. The
prohibitions EPA proposed would take effect six months after the date
of publication of the final rule, except for the prohibition of the
industrial and commercial use of CTC in specialty uses by the
Department of Defense, which would take effect one year after the date
of publication of the final rule. Likewise, for the WCPP, EPA proposed
timeframes for phases of compliance, beginning with monitoring at six
months and full implementation after 12 months, as described in Unit
IV.A.1. of the proposed rule. EPA also proposed a compliance timeframe
of six months for prescriptive controls for laboratory use.
Under TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA is
mandated to consider one or more alternative regulatory actions. The
primary alternative regulatory action was included in the proposed rule
in Unit IV.B. (88 FR 49204) (FRL-8206-01-OCSPP). Similar to the
proposed regulatory action, the primary alternative regulatory action
combined requirements for a WCPP and prescriptive controls to address
the unreasonable risk from CTC under its conditions of use.
The primary alternative regulatory action included prescriptive
workplace controls, specifically respirators and dermal PPE, for the
conditions of use for which EPA had proposed a WCPP. The primary
alternative action also included a WCPP for processing, industrial, and
commercial uses of CTC that EPA had proposed to prohibit. At the time
of proposal, EPA did not have reasonably available information
indicating that any of the uses proposed for prohibition were ongoing.
EPA requested comment on whether any of the uses the Agency proposed to
prohibit are ongoing and if EPA should consider a WCPP for those
conditions of use of CTC. For the industrial and commercial use of CTC
as a laboratory chemical, the primary alternative regulatory action
considered by EPA included the implementation of only the requirements
of Direct Dermal Contact Controls (DDCC) of the WCPP in combination
with the use of fume hoods in workplace laboratory settings and
advanced engineering controls specifically for DoD's use of CTC as a
laboratory chemical in chemical weapons destruction. The compliance
timeframes for the controls as part of the primary alternative
regulatory action were the same as the timeframes proposed.
For a comprehensive overview of the primary alternative regulatory
action refer to Unit IV.B. of the proposed rule, with the rationale for
the primary alternative regulatory action provided in Unit V.A.4. of
the proposed rule (88 FR 49205 through 49208) (FRL-8206-01-OCSPP).
4. Public Comments Received
EPA requested comment on all aspects of the proposed rule. During
the public comment period, EPA held a webinar on August 15, 2023,
providing an overview of the proposed rule and TSCA section 6; during
the webinar, members of the public had the opportunity to share their
perspectives (Ref. 23). The comment period closed on September 11,
2023. EPA received 23 public comments, with a majority received from
industry trade organizations. The public comments also include comments
from chemical manufacturers, advocacy organizations, laboratory users,
a union, an academic institution, members of the regulated community,
and individual residents. A summary of the comments as well as EPA's
responses is in the docket for this rulemaking (Ref. 11). Additionally,
Unit III. contains summaries of public comments that informed EPA's
regulatory approach in this final rule.
After the close of the public comment period for the proposed rule,
stakeholders, including affected industry and interested groups,
requested meetings with EPA. Topics of these meetings included exposure
controls, process descriptions, monitoring data, and specific
conditions of use. EPA received data as part of and following these
stakeholder meetings and has made the information available to the
public in the rulemaking docket (EPA-HQ-OPPT-2020-0592) (Ref. 21).
After review of the public comments received from the proposed
rule, EPA revised certain preliminary considerations that impacted
which conditions of use were proposed by EPA to be prohibited or that
could continue under the WCPP or prescriptive controls (Ref. 11).
Similarly, based on public comments received, EPA modified for this
final rule several proposed compliance timeframes, with details in Unit
III.
III. Changes From the Proposed Rule
Unit III. summarizes the main changes from the proposed rule to the
final rule, based on the consideration of the public comments.
A. Changes to Requirements for Certain Conditions of Use
As described in Unit III.A.1., when compared to the proposed rule,
EPA's final rule no longer prohibits two sub-
[[Page 103520]]
uses, under two separate conditions of use that were proposed for
prohibition, and now allows them to continue under the WCPP. In
addition, this final rule broadens the type of prescriptive controls
required for one condition of use (Unit III.A.2.), as compared to the
proposed rule. The rationale for these changes is described in this
unit. EPA emphasizes that implementation of the WCPP or prescriptive
controls can fully address the unreasonable risk from CTC for these
conditions of use, and that these changes do not significantly impact
the production volume of CTC expected to remain in commerce when
compared to the proposed regulatory action. Taken together, EPA
estimates that there are 10 facilities involved in the changes of the
requirements to the conditions of use described in Units III.A.1. and
2., nine of which use CTC for the industrial and commercial use as a
laboratory chemical. In addition, EPA understands that small quantities
of CTC are used for the sub-uses that will continue under the WCPP
instead of the proposed prohibition (Ref. 24). The two sub-uses which
will continue under the WCPP account for approximately 0.4% to 1% of
total production volume, based on a comparison of 2019 CDR data on CTC
production volume (between 100 million and 250 million lbs.) and
information reported to EPA regarding the two sub-uses (Ref. 5, Ref.
24).
1. Changes to the Prohibition of Certain Conditions of Use
EPA's primary alternative regulatory action described in the
proposed rule considered regulating several conditions of use under the
WCPP as an alternative to the proposed prohibition, including
incorporation into formulation, mixtures, or reaction products in
petrochemicals-derived manufacturing, and industrial and commercial use
as an industrial processing aid in the manufacture of petrochemicals-
derived products. In addition, EPA requested comment on whether the
Agency should require a WCPP or prescriptive controls, including
respirators and dermal PPE, for any of the conditions of use EPA
proposed to prohibit.
EPA is finalizing a WCPP for incorporation into formulation,
mixtures, or reaction products in vinyl chloride manufacturing and the
industrial and commercial use as an industrial processing aid in the
manufacture of vinyl chloride, as included in the primary alternative
regulatory action of EPA's proposal under the broader categories of
processing: incorporation into formulation, mixtures, or reaction
products in petrochemical-derived manufacturing and industrial and
commercial use as an industrial processing aid in the manufacture of
petrochemical-derived products. EPA proposed to prohibit these sub-uses
of CTC due to the lack of information indicating that these uses are
ongoing, but requested comment on whether CTC is still used in these
and other conditions of use EPA proposed to prohibit, and stated that
if EPA received information indicating the continued use of CTC for
these conditions of use, the Agency would consider regulating these
uses rather than prohibiting them (88 FR at 49202 through 49203, 49205,
and 49218). EPA received comments from one entity indicating that the
incorporation of CTC into formulation, mixtures, or reaction products
in vinyl chloride manufacturing and the industrial and commercial use
of CTC as an industrial processing aid in the manufacture of vinyl
chloride are ongoing (Ref. 24). The entity indicated that switching to
an alternative chemical or process would require replacement of
existing infrastructure and result in the temporary loss of revenue.
The entity using CTC for these uses provided manufacturing data used in
the 2020 Risk Evaluation for Carbon Tetrachloride, indicating that CTC
is used by this entity in industrialized and standardized settings that
can meet the requirements of the WCPP. Therefore, EPA understands that
the entity is able to meet the WCPP requirements for processing:
incorporation into formulation, mixtures, or reaction products in vinyl
chloride manufacturing and the industrial and commercial use as an
industrial processing aid in the manufacture of vinyl chloride as well.
Furthermore, EPA understands as a general matter that these uses would
occur in highly industrialized settings and controlled and closed
processes, suggesting a WCPP could be successfully implemented such
that risk of injury to health presented by CTC is no longer
unreasonable. CTC was used in other petrochemical-derived manufacturing
(other than vinyl chloride manufacturing); however, based on the
reasonably available information, such uses of CTC do not appear to be
ongoing. Therefore, EPA has concluded that industry has already found
feasible alternatives to CTC for these uses, EPA is prohibiting
processing: incorporation into formulation, mixtures, or reaction
products in the remainder of petrochemical-derived manufacturing and
the industrial and commercial use of CTC as a processing aid in the
manufacture of remaining petrochemical-derived products, as proposed,
to address the unreasonable risk contributed by these conditions of
use.
2. Changes to Restrictions: Prescriptive Controls for Industrial and
Commercial Use as a Laboratory Chemical
In general, EPA is finalizing the prescriptive control requirements
for the industrial and commercial use of CTC as a laboratory chemical
as proposed, with some modifications based on consideration of public
comments. As described in the proposed rule, to address the
unreasonable risk of injury to health resulting from dermal exposures
to CTC for the industrial and commercial use as a laboratory chemical,
EPA proposed to require dermal PPE in combination with comprehensive
training for tasks related to the use of CTC in a laboratory setting
for each potentially exposed person in direct dermal contact with CTC.
EPA also proposed to require the use of fume hoods to codify the
assumption of existing good laboratory practices that EPA relied upon
as a key basis for its evaluation of risk from this condition of use
(Ref. 1). EPA requested comment relative to the ability of owners and
operators to implement laboratory chemical fume hood and dermal PPE
related requirements within six months of publication of the final
rule. Under the primary alternative regulatory action, EPA included
DDCC for laboratory use and solicited comment on non-prescriptive
requirements of DDCC as compared to the prescriptive workplace controls
of dermal PPE.
EPA received several comments regarding the industrial and
commercial use as a laboratory chemical. One commenter stated that the
proposed regulation would result in confusion and duplication with the
OSHA standard for occupational exposure to hazardous chemicals in
laboratories under 29 CFR 1910.1450 that is already in effect (Ref.
25). A couple of commenters urged EPA to align its requirements for
laboratory use of CTC more closely with the OSHA's laboratory standard
to reduce compliance burden (Refs. 25, 26). Commenters also requested
that EPA include flexibility for engineering controls beyond a fume
hood for consistency with the OSHA lab standard, stating that, while
fume hoods are considered best practice and commonly used to reduce
exposure in laboratories, experiment designs utilizing CTC may not be
able to be accommodated within a fume hood (Refs. 25, 27). Commenters
described other alternative controls that can be
[[Page 103521]]
designed and implemented to reduce exposure, such as glove boxes,
exhausted enclosures, ducted biosafety cabinets, and filtration
devices.
Based on information provided by commenters related to exposure
mitigation controls to comply with the OSHA laboratory standard and
best management practices available to laboratories, EPA has determined
that requiring laboratory ventilation devices such as fume hoods or
glove boxes, would better align with the OSHA laboratory standard and
existing good laboratory practices. As described in Unit V.A.2. the
proposed rule (88 FR 49201, July 28, 2023) (FRL-8206-01-OCSPP), EPA
proposed to require fume hoods in laboratory settings to codify
assumptions made in the 2020 Risk Evaluation for CTC, where EPA's risk
estimates and determination that inhalation exposures from the
industrial and commercial use of CTC as a laboratory chemical did not
contribute to the unreasonable risk were predicated on its findings
that expected safety practices of using CTC in small amounts under a
fume hood reduce the potential for inhalation exposures (Ref. 1). In
addition to fume hoods, EPA has determined that other types of
ventilation systems or containment devices, when used in compliance
with the OSHA laboratory standard at 29 CFR 1910.1450(e)(3), may
minimize inhalation exposures in a laboratory setting consistent with
the qualitative assumption in the 2020 Risk Evaluation for CTC that the
potential for inhalation exposure is low due to expected use of a fume
hood. For the industrial and commercial use as a laboratory chemical,
EPA concurs with the commenters that indicated EPA's requirements
should align more closely with the OSHA laboratory standard wherever
possible to prevent confusion. The requirement in this final rule that
laboratory ventilation safety devices, such as fume hoods or glove
boxes, are in use and functioning properly and that specific measures
are taken to ensure proper and adequate performance of such equipment
to minimize exposures to persons in the area when CTC is used in a
laboratory setting aligns with existing requirements from the OSHA
laboratory standard at 29 CFR 1910.1450(e)(3)(iii) while remaining
consistent with the assumptions made in the 2020 Risk Evaluation.
As detailed in Unit IV.C. of this final rule, EPA is finalizing the
requirements for dermal PPE in combination with comprehensive training
for tasks related to the use of CTC in a laboratory setting as
proposed. EPA believes these requirements align with OSHA's laboratory
standard and OSHA's General Requirements for Personal Protective
Equipment at 29 CFR 1910.132 to the extent possible while still
addressing the unreasonable risk of injury to health resulting from
dermal exposures to CTC identified for the industrial and commercial
use as a laboratory chemical.
B. Changes to WCPP Timeframes
For the conditions of use for which EPA proposed the WCPP, EPA
proposed several compliance timeframes, including the following
requirements: that initial exposure monitoring be conducted within six
months of publication of the final rule in the Federal Register (or
within 30 days of introduction of CTC into the workplace if CTC use
commences at least six months after the date of publication); that each
owner or operator ensure that the exposure to CTC does not exceed the
ECEL as an 8-hour TWA for all potentially exposed persons within nine
months of publication of the final rule in the Federal Register; and
that owners and operators implement an exposure control plan within 12
months of publication of the final rule in the Federal Register. EPA
requested comment regarding the ability of owners or operators to
comply with the various provisions of the WCPP, including initial
exposure monitoring, within the compliance timelines included in the
proposal, and anticipated timelines necessary for any procedural
adjustments needed to comply with the establishment of a respiratory
protection program and development of an exposure control plan. EPA
also requested comment regarding the amount of time, if any, it would
take the regulated community to develop a method to measure at or below
the ECEL over an entire work shift and information on what levels of
detection are possible over an entire work shift based on existing
monitoring methods, justification for the timeframe of the specific
steps needed to develop a more sensitive monitoring method, cost
associated with a more sensitive monitoring method, and any additional
detailed information related to establishing a monitoring program to
reliably measure CTC at or below the ECEL.
Public comments highlighted challenges with the proposed timeframes
and suggested longer timeframes for initial exposure monitoring. For
example, one commenter stated that the proposed 6-month timeframe to
conduct initial exposure monitoring may not be possible because CTC use
may be infrequent and only occur annually or even less frequently, such
as maintenance exercises (Ref. 28). Other commenters expressed concern
that requirements to comply with a new exposure limit will stress
industrial hygiene consultants and laboratories that analyze the
samples, and urged EPA to ensure that there is adequate time for
consultant firms and laboratories to establish sufficient capacity
(Refs. 29, 30, 31). Several commenters stated that the proposed 6-month
timeframe for initial monitoring would be untenable and suggested that
the deadline be extended to 18 months (Refs. 29, 30, 32). One commenter
stated that owners or operators should be given sufficient time to
implement any new requirements which could involve substantial
investments (Ref. 27). Two of the commenters reasoned that,
particularly for CTC, at least 18 months is necessary to revalidate
methods and determine whether revision to corporate exposure assessment
strategy is necessary to address the new ECEL, including to address the
specific implementation and technical feasibility challenges of
measuring the CTC ECEL for both full shift and task measurements (Refs.
29, 30). One commenter indicated that they need to develop methods to
achieve the detection limit for the proposed ECEL and ECEL action
level, to procure professional services to implement the requirements,
and most likely require laboratory analytical support (Ref. 33).
Additionally, one commenter expressed concern that corporate and
facility industrial hygiene resources as well as third party
laboratories may also be conducting a reassessment and analysis for the
methylene chloride and PCE rules recently promulgated under TSCA
section 6(a), thereby requiring additional time for CTC (Ref. 29).
In consideration of public comments and the challenges of
initiating the WCPP, even for facilities with industrial hygiene
programs in place, and the difference in the occupational exposure
limits between the OSHA permissible exposure limit (PEL) and the EPA
ECEL and the challenges associated with monitoring to new, lower EPA
exposure thresholds that may spur an increase in the need for
monitoring or other exposure control assessment infrastructure, EPA has
determined that a longer compliance deadline of 540 days is as soon as
practicable to conduct initial monitoring for CTC, which likely would
require regulated entities to contract new services or realign current
industrial hygiene professionals towards WCPP compliance. Providing 540
days
[[Page 103522]]
for initial monitoring is intended to (1) prevent professional safety
service sectors from being overwhelmed by new EPA requirements; (2)
provide time to procure the necessary services while ensuring the
preservation of safety quality, standards, and practices; and (3)
provide sufficient time for a comprehensive exposure evaluation,
increasing the likelihood of successful implementation of the WCPP.
Following initial monitoring, EPA is finalizing the requirement that
each owner or operator supply a respirator to each person who enters a
regulated area within three months after the receipt of any exposure
monitoring that indicates exposures exceeding the ECEL. Therefore, each
owner or operator must ensure that the exposures to CTC do not exceed
the ECEL as an 8-hour TWA for all potentially exposed persons,
including by providing respiratory protection, no later than 630 days
after December 18, 2024. Given the full WCPP requirements (including
the exposure control plan) are required after owners or operators are
required to ensure that no person is exposed to an airborne
concentration that exceeds the TWA ECEL, EPA acknowledges that
compliance with the ECEL may include temporary PPE use (e.g.,
respiratory protection) until comprehensive engineering and
administrative controls are fully implemented. As described in the
proposed rule, EPA believes that three months after receipt of exposure
monitoring results is as soon as practicable, while also providing a
reasonable transition period for entities to evaluate exposure
monitoring results, acquire the correct respiratory protection, and
establish the PPE program, including training, fit-testing, and medical
evaluation.
EPA also received public comment regarding the compliance timeframe
for full implementation of the WCPP, including detailing the evaluation
steps that would be required to assess a facility and develop,
document, and implement an exposure control plan. To allow time for
orderly transitions and training to comply with an ECEL (0.03 ppm (8-hr
TWA)) that is significantly lower than the OSHA PEL of 10 ppm (8-hr
TWA) and the American Conference of Governmental Industrial Hygienists
(ACGIH) threshold limit value (TLV) of 5 ppm (8-hr TWA) for CTC, two
commenters suggested that EPA adopt a graduated implementation approach
for ECEL implementation by first requiring entities that already meet
the OSHA PEL to comply with the ACGIH TLV within two years from the
effective date of the final rule and then permitting those facilities
meeting the ACGIH standard three years to transition to the ECEL (Refs.
34, 35). Two commenters expressed concern that the proposed timeframes
would be insufficient for owners or operators to document their efforts
to implement the hierarchy of controls as required under the WCPP, and
recommended that the time required to develop the exposure control plan
be extended to two years from completion of initial monitoring, for a
total of 24 to 36 months from the effective date of the final rule, to
provide adequate time for entities to evaluate and implement
appropriate compliance approaches that provide flexibility and are the
most effective for protecting workers (Refs. 29, 30).
Based on comments, outreach, reasonably available information, and
existing OSHA standards, EPA maintains that the majority of the
exposure reduction and worker safety infrastructure needed for
compliance is currently in place, but recognizes the fundamental
challenge of building a new exposure control strategy around the new,
lower EPA exposure limit. Additionally, based on consideration of
public comment and given that OSHA has not promulgated a detailed
standard specific to CTC, EPA has determined that a longer compliance
timeframe of 1080 days for development and implementation of an
exposure control plan is as soon as practicable to ensure that the
regulated community has adequate time to evaluate monitoring data,
assess and develop an exposure strategy, procure appropriate control
technology and PPE, and implement the required chemical safety program
for CTC.
Therefore, EPA is finalizing the compliance timeframes for the WCPP
provisions as follows: (1) The requirements for each owner or operator
to conduct initial baseline monitoring must be met within 540 days
after December 18, 2024, or within 30 days of introduction of CTC into
the workplace, whichever is later; (2) the requirements for each owner
or operator to ensure that exposure to CTC does not exceed the ECEL as
an 8-hour TWA for all potentially exposed persons, including by
providing respiratory protection to all potentially exposed persons in
the regulated area must be met within 630 days after December 18, 2024,
or within three months after receipt of the results of any exposure
monitoring that indicates exposures exceeding the ECEL; and (3) the
requirements for development and implementation of an exposure control
plan must be met within 1,080 days after December 18, 2024. For greater
clarity in this final rule, EPA is also finalizing with slight
modification the requirement that owners and operators institute a
training and information program for potentially exposed persons and
assure their participation in the training and information program, and
that this requirement be met within 630 days after December 18, 2024
(see Unit IV.B.7.a.).
EPA understands that certain departments and agencies of the
Federal government, as well as Federal contractors acting for or on
behalf of the Federal government, need additional time to comply with
these timeframes. For example, complying with these timeframes could
impact the ability of the Department of Energy (DOE) to perform
sampling and groundwater treatment at contaminated plumes and
wastewater treatment facilities. While, for example, 29 CFR part 1960
sets forth procedures and guidelines for ensuring that Federal workers
are protected in comparable ways to their non-Federal counterparts, EPA
believes that compliance with this final rule will require increased
and different preparations on the part of Federal agencies. For
example, Federal agencies must follow procurement requirements, which
will likely result in increased compliance timelines. In addition,
these requirements will require support in the Federal budget, which,
for some agencies, is a multi-year process. Therefore, EPA is providing
additional time for agencies of the Federal government and their
contractors, when acting for or on behalf of the Federal government, to
comply with the WCPP provisions as follows: (1) The requirements for
each owner or operator to conduct initial baseline monitoring must be
met within 915 days after December 18, 2024, or within 30 days of
introduction of CTC into the workplace, whichever is later; (2) the
requirements for each owner or operator to ensure that exposure to CTC
does not exceed the ECEL as an 8-hour TWA for all potentially exposed
persons, including by providing respiratory protection to all
potentially exposed persons in the regulated area, must be met within
1,005 days after December 18, 2024, or within three months after
receipt of the results of any exposure monitoring that indicates
exposures exceeding the ECEL; (3) the requirements for each owner or
operator to ensure all persons are separated, distanced, physically
removed, or isolated from direct dermal contact with CTC, including by
providing dermal PPE, must be met within 1,005 days after December 18,
2024; (4) the requirements for
[[Page 103523]]
development and implementation of an exposure control plan must be met
within 1,080 days after December 18, 2024; and (5) the requirement that
owners or operators of workplaces subject to the WCPP institute a
training and information program for potentially exposed persons and
assure their participation in the training and information program
within 1,005 days after the date of publication of the final rule in
the Federal Register (i.e., no later than September 20, 2027).
C. Changes to WCPP Requirements
1. Exposure Monitoring Requirements
As part of the WCPP, EPA proposed to require owners or operators
meet certain documentation requirements for each monitoring event of
CTC, including compliance with the Good Laboratory Practice (GLP)
Standards in accordance with 40 CFR part 792.
Numerous commenters expressed concern regarding the requirement
that the WCPP include compliance with the GLP Standards (Refs. 28, 29,
30, 31, 35, 36). Commenters stated that it is atypical, for industrial
hygiene purposes, to use this standard for air sampling of CTC (Refs.
29, 30, 31). According to the commenters, it is common practice within
the industrial hygiene community to have analyses performed by American
Industrial Hygiene Association (AIHA) accredited labs (Ref. 29). One
commenter added that collection of occupational monitoring samples need
not be conducted under the GLP Standards where planning and collection
is overseen by a Certified Industrial Hygienist or Environmental
Professional as defined at 40 CFR 312.10 (Refs. 30, 31). Commenters
also suggested applying the policy described in typical TSCA section
5(e) orders that establish a New Chemical Exposure Limit (NCEL) under
the TSCA New Chemicals Program, which states that compliance with GLP
Standards is not required where exposure monitoring samples are
analyzed by a laboratory accredited by either: (A) the AIHA Industrial
Hygiene Laboratory Accreditation Program; or (B) another comparable
program approved in advance in writing by EPA (Refs. 29, 30, 31).
Another commenter reasoned that GLP Standards were not intended for air
monitoring in a workplace when compliance with such standards would
mean that real-time assessments could not be made, as air samples would
need to be processed and analyzed in a laboratory (Ref. 28).
EPA agrees with the commenter that the WCPP is incompletely served
by solely relying on the GLP Standards initially put forth in the July
29, 2023 proposed rule (88 FR 49180) (FRL-8206-01-OCSPP). Given the
concern from commenters regarding potential increases in demand for
professional safety services and sampling laboratories having a
negative impact due to anticipated industry strain and sampling
limitations (Refs. 29, 30, 31), EPA has broadened the scope of
laboratory accreditation accordingly. EPA has considered this
laboratory capacity issue, in addition to other revisions for
finalization in this rule, so that the additional infrastructure is in
place for the regulated community to successfully implement the WCPP.
For the final rule, EPA is requiring that exposure samples be analyzed
using an appropriate analytical method, and related records retained,
by a laboratory that complies with the GLP Standards in 40 CFR part 792
or that otherwise maintains a relevant third-party laboratory
accreditation (e.g., under the AIHA Laboratory Accreditation Programs,
LLC Policy Module 2A/B/E of Revision 17.3), or other analogous
industry-recognized programs.
Another commenter stated that EPA's proposal did not make clear
that ``personal breathing zone'' air samples to monitor exposures are
to be taken without regard to respirator use. The commenter noted that
OSHA requires exposure monitoring to be conducted without regard to
respirator use (citing as an example OSHA's definition of ``employee
exposure'' at 29 CFR 1910.1052(b)) and asserted that this important
element of OSHA's monitoring program was omitted from EPA's proposal
(Ref. 37). EPA agrees with the commenter that exposure monitoring
should be conducted without regard to respiratory protection to inform
engineering control options and respiratory protection considerations.
Therefore, EPA is finalizing this rule to explicitly state that air
sampling is required to measure ambient concentrations for CTC without
taking respiratory protections into account when being performed. This
will ensure the appropriate degree of protection to potentially exposed
persons by logging accurate ambient air concentrations of CTC, thus
empowering owners or operators to appropriately consider the hierarchy
of controls.
Additionally, as part of the WCPP, EPA proposed to require owners
and operators to re-monitor within 15 working days after receipt of any
exposure monitoring when results indicated non-detect, unless an
Environmental Professional as defined at 40 CFR 312.10 or a Certified
Industrial Hygienist reviews the monitoring results and determines re-
monitoring is not necessary. EPA received several comments disagreeing
with the proposed requirement to review non-detect air monitoring
samples. The commenters stated that facilities use accredited labs to
perform industrial hygiene sampling analysis, the results are reviewed
by industrial hygiene professionals, and it is an unnecessary step that
adds no value to reduce risk to workers (Refs. 29, 30, 31).
EPA disagrees with commenters that expressed the opinion that re-
evaluating a non-detect result adds no value and is inappropriate.
While in some cases a non-detect result may accurately indicate that
the chemical is not present and that air concentrations are below the
ECEL action level, in other cases it may not necessarily imply
negligible occupational exposure to the chemical. For example,
interference from another chemical during sampling may result in an
incorrect result of non-detect. This interference may not be recognized
at the time of sampling or analysis. Owners and/or operators also may
not be using sampling techniques or analytical procedures that are
effective or appropriate for the particular chemical of interest. In
each of these cases, non-detect results, along with supporting
documentation about the sampling and analytical methods used to get
those results, is a meaningful part of the potentially exposed person's
exposure record required under the WCPP. The WCPP in the proposed rule
and in this final rule does not require re-monitoring in all cases. Re-
monitoring may be necessary based on a professional evaluation by an
Environmental Professional as defined at 40 CFR 312.10 or a Certified
Industrial Hygienist. This flexibility allows owners or operators
options in terms of revisiting occupational sampling in the event of a
non-detect result, or evaluation by a qualified professional.
EPA determined that a non-detect sampling result when effective
sampling and analysis procedures are used is valuable to an owner/
operator in that it suggests effective implementation of exposure
controls. Potentially exposed persons may also use these records in
discussions with owner/operators, in collective bargaining situations,
or in compliance assistance inquiries to EPA or other federal agencies.
Exposure monitoring results may also improve overall workplace health
and reducing owner/operator liability in the effective detection,
treatment, and prevention of occupational disease or illness. All of
the above scenarios are valuable for
[[Page 103524]]
owner/operators, potentially exposed persons, and for effective
mitigation of occupational exposures. In consideration of these
factors, EPA has removed the air monitoring equipment malfunction from
the monitoring activities that do not require resampling based on
professional evaluation by an Environmental Professional or Certified
Industrial Hygienist. While professional discretion may be warranted in
determining whether re-monitoring is needed following results that
indicate non-detect, EPA has determined this is not appropriate in the
event of air monitoring equipment malfunction. This is due to the
importance of air monitoring in ensuring that the requirements of the
WCPP are met, and the importance of the WCPP in reducing risks from
exposures to CTC in the workplace. Monitoring results from
malfunctioning air monitoring equipment are not valid monitoring and
therefore not sufficient to meet the monitoring requirements under the
WCPP.
EPA may consider developing additional guidance regarding
occupational monitoring in the future. Therefore, EPA is finalizing the
requirement to re-monitor within 15 working days after receipt of any
exposure monitoring if results indicated non-detect unless an
Environmental Professional as defined at 40 CFR 312.10 or a Certified
Industrial Hygienist reviews the monitoring results and determines re-
monitoring is not necessary. EPA has updated the recordkeeping
requirements associated with the WCPP exposures records required under
40 CFR 751.713(b)(1) to require documentation of the determination by
the Environmental Professional as defined at 40 CFR 312.10 or a
Certified Industrial Hygienist to be maintained as a record.
Occupational monitoring (and associated recordkeeping) is an area that
EPA may develop guidance as part of final rule implementation efforts.
2. Designated Representative
EPA proposed to require owners and operators to provide potentially
exposed persons regular access to the exposure control plan, exposure
monitoring records, and PPE program implementation plan (documenting
proper application, wear, and removal of PPE). EPA requested comment on
how owners and operators could engage with potentially exposed persons
on the development and implementation of an exposure control plan and
PPE program. One commenter stated that employees should be engaged in
the development and implementation of the exposure control plan and
that the engagement is best performed during the PPE and respirator
training (Ref. 27). Another commenter urged EPA to require that owners
and operators consult with workers and their designated representatives
in developing and implementing their plans (Ref. 37).
EPA received public comment on the role of designated
representatives in the WCPP. One commenter, a group of labor unions,
urged EPA to incorporate requirements similar to OSHA's access standard
at 29 CFR 1910.1020 (entitled, ``Access to employee exposure and
medical records'') in EPA's proposed recordkeeping requirements for the
WCPP to ensure that exposure information is promptly and fully shared
with both potentially exposed persons and their designated
representatives (Ref. 37). The commenter also suggested that EPA
include a requirement that employers provide employees or their
designated representatives an opportunity to observe monitoring events.
The commenter observed that workers and their designated
representatives have a critical role to play in ensuring effective
control of toxic substances and further noted that, often, unions are
the organizations with expertise in understanding occupational exposure
information.
Following review of the comments received, EPA recognizes the
importance of having the ability for potentially exposed persons and
their designated representative(s), such as labor union
representatives, to observe exposure monitoring and have prompt access
to exposure records. EPA additionally recognizes that, in some
instances, individual workers may be hesitant to ask owners or
operators for information relating to their chemical exposure or may be
less familiar with discipline-specific industrial hygiene practices.
EPA determined that it is appropriate in this final rule to establish
requirements regarding designated representatives, consistent with
existing OSHA precedent in certain 29 CFR part 1910, subpart Z
regulations, to allow designated representatives the ability to observe
occupational exposure monitoring and have access to exposure monitoring
records. In EPA's final rule, the WCPP includes a requirement that
owners and operators provide potentially exposed persons or their
designated representatives an opportunity to observe any exposure
monitoring that is designed to characterize their exposures and is
conducted under the WCPP. EPA is also finalizing a requirement that
designated representatives have access to relevant exposure records,
similar to provisions in certain OSHA regulations under 29 CFR part
1910, subpart Z, such as 29 CFR 1910.1200 and 29 CFR 1910.1020. EPA is
requiring owners and operators to notify potentially exposed persons
and their designated representatives of the availability of the
exposure control plan and associated records of exposure monitoring and
PPE program implementation within 30 days of the date that the exposure
control plan is completed and at least annually thereafter. EPA is also
requiring, consistent with the proposed requirement for notification of
exposure monitoring results, that the notice of the availability of the
exposure control plan and associated records be provided in plain
language writing to each potentially exposed person in a language that
the person understands or posted in an appropriate and accessible
location outside the regulated area with an English-language version
and a non-English language version representing the language of the
largest group of workers who do not read English. While EPA encourages
owners or operators to consult with persons that have potential for
exposure and their designated representatives on the development and
implementation of the exposure control plan, EPA has determined that it
is not necessary to include this as a requirement in the final rule,
consistent with OSHA, because the involvement of designated
representatives in the observation of occupational monitoring and the
potential to access exposure records being finalized in this rule
provide a productive forum for communicating with owner/operators about
the exposure control plan. EPA believes that the notification of the
exposure control plan and associated records may help facilitate
participation from potentially exposed persons and their designated
representatives in the implementation and further development of that
plan.
EPA's final rule to address the unreasonable risk of PCE under TSCA
section 6(a) (RIN 2070-AK84) established the definition of ``designated
representative'' intended to apply to all TSCA section 6(a)
requirements under 40 CFR part 751 at Sec. 751.5. A recognized or
certified collective bargaining agent must be treated automatically as
a designated representative without regard to written authorization.
Additionally, with respect to Federal Government employees, EPA, like
OSHA at 29 CFR 1960.2(e), will interpret these designated
representative requirements consistent with the Federal Service Labor
Management
[[Page 103525]]
Relations Statute (5 U.S.C. 7101 et seq.), or collective bargaining or
other labor-management arrangements that cover the affected employees.
Should a request be initiated for such records by the potentially
exposed person or their designated representative(s), the owner or
operator will be required to provide the specified records at a
reasonable time, place, and manner, analogous to provisions outlined in
OSHA's 29 CFR 1910.1020(e)(1)(i). If the owner or operator is unable to
provide the requested records within 15 working days, the owner or
operator must, within those 15 days, inform the potentially exposed
person or designated representative(s) requesting the record of the
reason for the delay and the earliest date when the record will be made
available. Additionally, in the event that a designated representative
is observing exposure monitoring, the owner or operator must ensure
that designated representatives are provided with PPE appropriate for
the observation of monitoring. Finally, this rule requires owners or
operators to provide notice to potentially exposed persons and their
designated representatives of exposure monitoring results and of the
availability of the exposure control plan and associated records. For
purposes of this requirement, the owner or operator is only required to
provide notice to those designated representatives that the owner or
operator is aware of, such as representatives designated in writing or
a recognized collective bargaining agent for the owner or operator's
own employees.
3. Other Changes to the WCPP
EPA proposed various requirements under the WCPP for owners or
operators to provide PPE, including respiratory protection and dermal
protection, to potentially exposed persons and to establish a PPE
program. For greater clarity in this final rule, EPA has revised the
PPE requirements with respect to the cross-references to the relevant
OSHA regulations. While the language appears different than the
requirements included in the proposed rule, it remains EPA's intention
that owners and operators implement PPE programs that are consistent
with OSHA requirements. The PPE requirements as part of the WCPP in
this final rule are described in Unit IV.B.6.
D. CTC Unintentionally Present in Trace Quantities in Other Chemical
Substances
Several public comments on the proposed rule urged EPA to establish
an explicit ``de minimis'' weight fraction threshold or add an
exemption for impurities or other contaminants from the rule's
requirements for small levels of CTC present in other chemical
substances or mixtures (Refs. 26, 28, 29, 30, 31, 35, 38, 39). Two
commenters raised concerns that absent such exemption, the proposed
prohibition on industrial and commercial use of CTC as an industrial
processing aid in the manufacture of petrochemicals-derived products
would inadvertently prohibit the industrial and commercial use of PCE
as a processing aid in catalyst regeneration in petrochemical
manufacturing, which EPA is regulating under a WCPP in a separate TSCA
section 6(a) rulemaking for PCE, because PCE contains trace amounts of
CTC as an impurity or other contaminant (Refs. 26, 38). Two other
commenters who supported a de minimis exclusion for impurities noted
that prohibiting impurities in downstream products or CTC impurities in
feedstocks could severely hamper numerous value chains and stated that
establishing a de minimis weight fraction threshold of 0.1% by weight
for the CTC restrictions would align with existing requirements under
OSHA's Hazard Communication Standard (Refs. 30, 31). One of these
commenters stated that a member company imports a product containing a
very small amount of CTC as an impurity, then sells the sealed
container for rubber processing; this commenter urged EPA to expressly
exempt from the WCPP requirement these zero exposure and de minimis
scenarios (Ref. 31). Another commenter stated that a member uses some
raw materials that contain CTC, primarily chlorinated rubbers and
methylene chloride, in the manufacturing of adhesives and coatings, and
was concerned that this use would fall under the proposed prohibitions
(Ref. 39). Another commenter asserted that any formulated products that
contain de minimis concentrations of CTC (i.e., concentrations less
than 0.1% by weight) would not pose a risk and should not be covered by
the rule (Ref. 29). Two other commenters recommended that EPA include
both a de minimis exemption for materials in which CTC may appear at de
minimis levels of less than 0.1% by weight, and an exemption for CTC
present in a formulation, in an intermediate, or in an end product as
an impurity or byproduct, including when present as an unintentional
byproduct or impurity in an imported product (Refs. 26, 35). One
commenter suggested that EPA implement a de minimis weight fraction
threshold of 0.5% (Ref. 39).
In the final rule, EPA has excluded from the rule's requirements
CTC that is solely present unintentionally in trace quantities with
another chemical substance or mixture. This exclusion is intended to
cover circumstances in which another chemical substance or mixture
unintentionally contains trace quantities of CTC that may be present as
a manufacturing residue, unreacted feedstock, byproduct, or other
contaminant. The Agency determined that this exclusion was appropriate
because the conditions of use of CTC that were evaluated in the 2020
Risk Evaluation for Carbon Tetrachloride and determined to contribute
to the unreasonable risk presented by CTC did not include scenarios in
which trace amounts of CTC is unintentionally present in other chemical
substances or mixtures. To the contrary, Section 1.4.2.3 of the Risk
Evaluation stated that there were conditions of use that EPA concluded
in the 2018 Problem Formulation of the Risk Evaluation for Carbon
Tetrachloride would present only de minimis exposures or otherwise
insignificant risks from trace amounts of CTC and did not warrant
inclusion in the risk evaluation. This conclusion was related
specifically to industrial/commercial/consumer uses of CTC in
adhesives/sealants, paints/coatings, and cleaning/degreasing solvent
products. EPA reserves the right to assess and address potential
environmental and health risks of trace quantities of CTC under
different authorities such as CAA Title I and VI. The 2020 Risk
Evaluation for Carbon Tetrachloride explained that while CTC's use as a
process agent in the manufacturing of other chlorinated compounds may
result in trace levels of CTC as a manufacturing residue in the
chlorinated substances used to manufacture downstream products, those
trace amounts are expected to volatilize during the product
manufacturing process, such that EPA expected insignificant or
unmeasurable concentrations of CTC in the chlorinated substances in
commercially available adhesive/sealant, paint/coating, and cleaning/
degreasing products. The final rule's exclusion for CTC unintentionally
present in trace quantities with another chemical substance or mixture
is consistent with this earlier exclusion from the scope of the Risk
Evaluation for Carbon Tetrachloride. Any product with CTC
concentrations above trace quantities that falls within a condition of
use regulated under this rule will be subject to the relevant rule
provisions (e.g.,
[[Page 103526]]
WCPP, prescriptive controls, or prohibition), as appropriate based on
the condition of use of CTC.
In addition, any potential occupational risk from the presence of
trace quantities of CTC in PCE is expected to be eliminated by the
recently promulgated final risk management rule for PCE under TSCA
section 6(a) (to be codified at 40 CFR part 751, subpart G). The
occupational and consumer protections from exposures to PCE under that
final rule, which address the unreasonable risk of injury to health
presented by PCE under its conditions of use, would also have the
effect of reducing the risk from exposures to trace amounts of CTC that
may be present in PCE. For example, the final rule requires a workplace
chemical protection program with both an Existing Chemical Exposure
Limit of 0.14 ppm of PCE as an 8-hr TWA and direct dermal contact
control requirements for the industrial/commercial use of PCE as a
processing aid in catalyst regeneration in petrochemical manufacturing.
Any engineering controls or PPE used to reduce occupational exposures
to PCE for the use as a processing aid in catalyst regeneration in
petrochemical manufacturing are expected to reduce workplace exposures
to CTC. The limitations on inhalation and dermal exposures to PCE to
prevent unreasonable risk of injury to health from that chemical
substance are also expected to limit any potential exposure to trace
quantities of CTC that may be unintentionally present in the PCE,
reducing the risk of injury to health from the CTC, so that that
condition of use does not contribute to the unreasonable risk of CTC.
At this time, EPA is not establishing a specific weight fraction or
other numerical threshold value for the trace quantities exclusion in
the CTC final rule, consistent with existing exclusions of trace
quantities of remaining substances from the definitions of ``controlled
substance'' and ``transform'' under 40 CFR 82.3. Instead, the exclusion
is based on the plain meaning of the term, ``trace quantities.'' If the
CTC is intentionally retained in the chemical substance or mixture of
which it is a part and provides a desired purpose, then it is not
``present unintentionally in trace quantities'' and would not be
excluded from the rule's requirements.
E. Other Changes
EPA has revised its proposed description of industrial and
commercial use of CTC as a laboratory chemical to provide additional
clarity as suggested by a commenter (Ref. 33). The revised description
for industrial and commercial use as a laboratory chemical appears in
Unit IV.C.1. In addition, EPA has slightly modified the industrial and
commercial use descriptions in 40 CFR 751.705(b)(1)(ii)(B),
751.707(a)(8), and 751.711(c) to clarify that the industrial and
commercial use of CTC in the recovery of chlorine in tail gas from the
production of chlorine falls under the WCPP rather than the prohibition
on industrial and commercial use in the manufacture of other basic
chemicals (including manufacturing of chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings). In the proposed
rule, EPA had intended this use of CTC to be captured with the
description of ``industrial and commercial use in the elimination of
nitrogen trichloride in the production of chlorine and caustic soda,''
but EPA agrees with two public commenters that it would be clearer to
specifically list use of CTC in the recovery of chlorine in tail gas
from the production of chlorine in the regulatory text (Refs. 29, 30).
EPA has revised its proposed description of disposal. Based on
coordination across Federal programs, for the disposal COU, EPA has
determined it is appropriate that owners and operators of cleanup sites
where potentially exposed persons are involved in the disposal of CTC-
containing wastewater for the purposes of cleanup projects of CTC-
contaminated water and groundwater, including industrial pre-treatment
and industrial treatment activities, must ensure that potentially
exposed persons involved with the activity of removing the groundwater
from the location where it was found and treating the removed
groundwater on site comply with the WCPP. At cleanup sites, the WCPP,
including the ECEL, would apply to any potentially exposed person
involved in the disposal of CTC-containing groundwater, which most
likely includes a worker who is involved with the activity of removing
CTC- containing groundwater from the location where it was found and
the on-site treatment of the groundwater, typically referred to as ex
situ remediation, which is most consistent with the scope of the 2020
CTC Risk Evaluation. Ex situ remediation includes both active and
passive remediation methods that span traditional (e.g., pump and
treat) and less traditional (e.g., phytoremediation) approaches, but
only if the remediation method would be considered industrial
wastewater pretreatment, industrial wastewater treatment or discharge
to a publicly owned treatment work (POTW). EPA generally considers
workers in and around those locations to be potentially exposed persons
as that term is defined in 40 CFR 751.5. For example, EPA's
requirements would apply to protect workers conducting remediation
through pump and treat systems or workers sampling groundwater in
conjunction with groundwater extraction or treatment (e.g., remediation
or cleanup) activities. EPA considers only those treatment activities
that are performed at the cleanup site on CTC-contaminated wastewater
that has been removed from the subsurface, surface water impoundments,
or aquifers and that are recognized as industrial treatment, industrial
pretreatment, or discharge to a POTW to be covered under the provisions
described in Unit IV.B. The provisions of the WCPP for the disposal
COU, including the ECEL, are not intended to cover potentially exposed
persons who are sampling groundwater to monitor the presence of a
plume, but specifically only those sampling at the site of extraction
and treatment activities. EPA emphasizes that this standard is only for
cleanup sites involved in the active or passive ex situ treatment (or
disposal) of CTC contaminated groundwater and wastewater from cleanup
sites and that no other remedial actions at cleanup sites will be
covered or affected. Additionally, while EPA considers solid wastes as
part of the waste streams included in the disposal COU, at groundwater
remediation sites managed by the Federal government and under existing
waste disposal requirements, the WCPP requirements under this
rulemaking only apply to water contaminated with CTC, and any other
type of CTC-impacted waste will be managed according to relevant
existing requirements under RCRA, other statutes, and regulatory
agreements.
Additionally, it is not necessary to establish previously proposed
Subpart A definitions for ``authorized person,'' ``owner or operator,''
``potentially exposed person,'' and ``regulated area'' in this final
rule because EPA already established definitions for these terms at 40
CFR 751.5 in the TSCA section 6 final rule for methylene chloride (RIN
2070-AK70) (89 FR 39254, May 8, 2024 (FRL-8155-01-OCSPP)) so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified under 40 CFR part 751. Similarly, it
is not necessary to establish previously proposed Subpart A definitions
for ``direct dermal
[[Page 103527]]
contact,'' ``exposure group,'' and ``ECEL'' in this final rule because
EPA already established definitions for these terms at 40 CFR 751.5 in
the TSCA section 6 final rule for PCE (RIN 2070-AK84).
EPA proposed to require that the notification to companies to whom
CTC is shipped under 40 CFR 751.111(c) identify the uses for which CTC
is allowed to be distributed in commerce. To provide greater clarity to
downstream users of CTC regarding the provisions of this rule, EPA is
modifying the notification to identify the uses prohibited under this
regulation.
EPA also made other minor edits to the preamble and regulatory text
to provide more clarity to the requirements of the final rule.
IV. Provisions of the Final Rule
EPA intends that each provision of this rulemaking be severable. In
the event of litigation staying, remanding, or invalidating EPA's risk
management approach for one or more conditions of use in this rule, EPA
intends to preserve the risk management approaches in the rule for all
other conditions of use to the fullest extent possible. The Agency
evaluated the risk management options in TSCA section 6(a)(1) through
(7) for each condition of use and generally EPA's regulation of one
condition of use to address its contribution to the unreasonable risk
from CTC functions independently from EPA's regulation of other
conditions of use, which may have different characteristics leading to
EPA's risk management decisions. Further, the Agency crafted this rule
so that different risk management approaches are reflected in different
provisions or elements of the rule that are capable of operating
independently. Accordingly, the Agency has organized the rule so that
if any provision or element of this rule is determined by judicial
review or operation of law to be invalid, that partial invalidation
will not render the remainder of this rule invalid.
There are many permutations of the above. For example, as discussed
in Unit IV.D., this final rule prohibits both the industrial and
commercial use of CTC in metal recovery, and the industrial and
commercial use of CTC as a processing aid in the manufacture of
petrochemical-derived products except in the manufacture of vinyl
chloride (for which EPA is requiring a WCPP as described in Unit
III.A.). To the extent that a court were to find that EPA lacked
substantial evidence to support the prohibition of CTC as a processing
aid in the manufacture of petrochemical-derived products or otherwise
found legal issues with EPA's approach to that condition of use, it
would have no bearing on other similarly situated conditions of use,
such as the industrial and commercial use in metal recovery, unless the
specific issue also applies to the particular facts associated with
metal recovery. This is reflected in the structure of the rule, which
describes the prohibited conditions of use separately under 40 CFR
751.705.
As another example, for the processing of CTC as a reactant in the
production of HCFCs, HFCs, HFOs, and PCE and the industrial and
commercial use of CTC as a laboratory chemical, EPA took different risk
management approaches--application of the WCPP for the processing of
CTC as a reactant in the production of HCFCs, HFCs, HFOs, and PCE and
specific prescriptive controls for use as a laboratory chemical. To the
extent that a court were to find a legal issue with EPA's approach to
the WCPP, impacting the processing of CTC as a reactant in the
production of HCFCs, HFCs, HFOs, and PCE, it would have no bearing on
EPA's decision to require specific prescriptive controls for industrial
and commercial use as a laboratory chemical, and vice versa. This is
reflected in the structure of the rule, which organizes the WCPP and
prescriptive controls into different sections of the regulation.
EPA also intends all TSCA section 6(a) risk management requirements
in this rule to be severable from each regulatory exclusion from those
requirements. For example, to the extent a court were to find a legal
issue with excluding trace quantities of CTC from the rule's
requirements pursuant to 40 CFR 751.701(b), or with excluding
manufacture of CTC as a byproduct from WCPP requirements pursuant to 40
CFR 751.707(a)(1), the underlying risk management requirements would
not be impacted. Rather, the excluded activities would become subject
to the underlying TSCA section 6(a) risk management requirements
applicable to the condition of use. EPA further notes that the specific
examples of severability described in this unit are not intended to be
exhaustive, but rather illustrative of a wide variety of scenarios that
reflect EPA's overarching intent that each provision of this rulemaking
be severable.
EPA acknowledges that after the issuance of this rule, a person or
entity may become aware of important information which indicates a
particular use, that would otherwise be prohibited, is ongoing, and
could meet the criteria of a WCPP. EPA also notes that there are
multiple avenues to ask EPA to revisit issues in this TSCA section 6(a)
rulemaking, both before and after the mandatory compliance dates are
set consistent with TSCA section 6(d). EPA has the authority under TSCA
section 6(g) to consider whether an exemption is appropriate and,
consistent with TSCA section 6(g)(1), may propose such exemptions
independently from this rulemaking. Additionally, any person could
petition EPA to request that EPA issue or amend a rule under TSCA
section 6.
A. Applicability
This final rule sets prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
commercial use, and disposal of CTC to prevent unreasonable risk of
injury to health in accordance with TSCA section 6(a), 15 U.S.C.
2605(a).
Additionally, pursuant to TSCA section 12(a)(2), this rule applies
to CTC even if being manufactured, processed, or distributed in
commerce solely for export from the United States because EPA has
determined that CTC presents an unreasonable risk to health within the
United States. Several commenters expressed concern that an unclear
statement in the proposed rule preamble appeared to indicate that all
manufacture, processing, and distribution for export would be
prohibited under the proposed rule (Refs. 29, 30, 32). This was not
EPA's intent. Rather, EPA intended to indicate that because EPA
determined that CTC presents an unreasonable risk of injury to health
within the United States, manufacturing and processing of CTC for
export would not be exempt from any otherwise-applicable TSCA section
6(a) regulatory requirements. Because distribution in commerce did not
contribute to EPA's unreasonable risk determination for CTC, and
because this final rule permits manufacturing and processing, including
recycling, for various uses to continue under the WCPP, EPA intends
this final rule to permit manufacturing and processing in compliance
with the WCPP for export, as well as distribution in commerce for
export, without regard for the intended use in the destination country.
In other words, manufacturing, processing, and distribution for the
conditions of use listed in 40 CFR 751.705(a)(1)(i) and (ii) are
prohibited where such conditions of use would occur inside the United
States, but in instances where such conditions of use would occur
solely outside of the United States after export, the upstream
manufacturing, processing, and distribution for export would not be
prohibited. EPA has clarified the regulatory text at 40 CFR
[[Page 103528]]
751.707(a) to make clear that any manufacture and processing for export
must be in accordance with the WCPP. In addition, any persons who
export or intend to export a chemical substance that is the subject of
this final rule are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
EPA is revising the description of the Disposal COU to clarify the
requirements of the WCPP at cleanup sites which would apply to any
potentially exposed person involved in the disposal of CTC-containing
groundwater to industrial treatment, industrial pre-treatment, or
POTWs. A potentially exposed person most likely includes a worker who
is involved with the activity of removing CTC-containing groundwater
from the location where it was found and the on-site treatment of the
groundwater, typically referred to as ex situ remediation, which is
most consistent with the scope of the 2020 CTC Risk Evaluation. Ex situ
remediation includes both active and passive remediation methods that
span traditional (e.g., pump and treat) and less traditional (e.g.,
phytoremediation) approaches, but only if the remediation method would
be considered industrial wastewater pretreatment, industrial wastewater
treatment or discharge to a publicly owned treatment work (POTW).
As discussed in Unit III.D, the prohibitions and restrictions
described in this unit do not apply to CTC that is solely present
unintentionally in trace quantities with another chemical substance or
mixture, whether as a manufacturing residue, unreacted feedstock,
byproduct, or other contaminant. Additionally, the provisions of this
final rule only apply to chemical substances as defined under TSCA
section 3. Notably, TSCA section 3(2) excludes from the definition of
chemical substance ``any food, food additive, drug, cosmetic, or device
(as such terms are defined in Section 201 of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic, or device'' and ``any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.])
when manufactured, processed, or distributed in commerce for use as a
pesticide.'' Additional details regarding TSCA statutory authorities
can be found in section 2 of the response to comments document (Ref.
11).
EPA uses the term ``potentially exposed person'' in Unit IV. And in
the regulatory text to include workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area where CTC is present and who may be exposed to CTC under
the conditions of use for which a WCPP or specific prescriptive
controls would apply. (EPA notes that this definition is intended to
apply to occupational workspaces as part of implementation of the WCPP
and other restrictions, and recognizes that other individuals or
communities may be exposed to CTC as members of fenceline communities
or members of the general population.) For certain conditions of use,
EPA requires a comprehensive WCPP or specific prescriptive controls to
address the unreasonable risk from CTC to workers directly handling the
chemical or in the area where the chemical is being used. Similarly,
the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) did not
distinguish between employers, contractors, or other legal entities or
businesses that manufacture, process, distribute in commerce, use, or
dispose of CTC. For this reason, EPA uses the term ``owner or
operator'' to describe the entity responsible for implementing the WCPP
or specified prescriptive controls in any workplace where an applicable
condition of use is identified in Unit IV. And subject to the WCPP or
prescriptive controls is occurring. The term includes any person who
owns, leases, operates, controls, or supervises such a workplace. While
owners or operators remain responsible for ensuring compliance with the
WCPP or prescriptive controls requirements in the workplace, they may
contract with others to provide training or implement a respiratory
protection program, for example. EPA is also clarifying its intent that
for the provisions in this rule, any requirement for an owner or
operator, or an owner and operator, is a requirement for any individual
that is either an owner or an operator.
EPA emphasizes that this approach is essential for addressing the
unreasonable risk presented by CTC, including to individuals who may
not be covered by OSHA requirements, such as, volunteers, self-employed
persons, and State, and local government workers who are not covered by
a state plan. EPA uses the term ``owner or operator'' in TSCA programs
because the term is used in other EPA programs to describe persons with
responsibilities for implementing statutory and regulatory requirements
at particular locations. See, for example, CAA section 113, 42 U.S.C.
7412, which defines ``owner or operator'' as a person who owns, leases,
operates, controls, or supervises a stationary source. There is a
similar definition in section 306 of the Clean Water Act (CWA), 33
U.S.C. 1316. EPA understands that the use of this term may result in
multiple persons' bearing responsibility for complying with provisions
of this final rule, including the WCPP. However, this is also the case
for workplaces regulated by OSHA, including those regulated under
OSHA's general industry standards at 29 CFR part 1910. OSHA's 1999
Multi-Employer Citation Policy explains which employers should be cited
for a hazard that violates an OSHA standard (Ref. 40). The Policy
describes four different roles that employers may fill at a workplace
and describes who should be cited for a violation based on factors such
as whether the employer created the hazard, had the ability to prevent
or correct the hazard, and knew or should have known about the hazard.
More than one employer may be cited for the same hazard. This final
rule will have similar results, in that more than one owner or operator
may be responsible for compliance.
The OSHA multi-employer citation policy is an example of a guidance
governing situations where more than one regulated entity is present.
EPA has received several requests for clarification of the
applicability of the term ``owner or operator'' to sites where more
than one entity owns, leases, or controls a workplace where a CTC
condition of use is ongoing and where implementation of the WCPP or
prescriptive controls is required. EPA understands that there are a
wide variety of situations where these questions could arise, and plans
to issue guidance consistent with TSCA authorities that explains how
EPA will approach the issue of responsibility for implementation of,
and compliance with, the WCPP requirements in practice.
B. Workplace Chemical Protection Program (WCPP)
1. Applicability
EPA is finalizing the WCPP for all of the conditions of use for
which it was proposed, as well as for two additional uses related to
vinyl chloride manufacturing within two conditions of use for which
prohibition was proposed. EPA is also revising the description of
industrial and commercial use of CTC related to chlorine production to
clarify that both elimination of nitrogen trichloride in the production
of chlorine and caustic soda and recovery of
[[Page 103529]]
chlorine in tail gas from the production of chlorine are subject to the
WCPP. Additionally, EPA is revising the description of the Disposal COU
to clarify the requirements of the WCPP at cleanup sites. Specifically,
EPA has determined that at groundwater cleanup sites, the WCPP would
apply to any potentially exposed person involved in the disposal of
CTC-containing groundwater to industrial treatment, industrial pre-
treatment, or POTWs. A potentially exposed person most likely includes
a worker who is involved with the activity of removing CTC-containing
groundwater from the location where it was found and the on-site
treatment of the groundwater, typically referred to as ex situ
remediation, which is most consistent with the scope of the 2020 CTC
Risk Evaluation. Ex situ remediation includes both active and passive
remediation methods that span traditional (e.g., pump and treat) and
less traditional (e.g., phytoremediation) approaches, but only if the
remediation method would be considered industrial wastewater
pretreatment, industrial wastewater treatment or discharge to a
publicly owned treatment work (POTW). EPA's descriptions of changes
from the proposed rule in Unit III. The Agency explained why the WCPP
addresses the unreasonable risk for certain conditions of use in Unit
V. of the proposed rule (88 FR 49180, July 28, 2023) (FRL 8206-01-
OCSPP).
EPA is finalizing the WCPP for the following conditions of use
where manufacture and processing are not otherwise prohibited: domestic
manufacturing (except where CTC is manufactured solely as a byproduct);
import; processing as a reactant in the production of HCFCs, HFCs,
HFOs, and PCE; processing: incorporation into formulation, mixture or
reaction product in agricultural products manufacturing, vinyl chloride
manufacturing, and other basic organic and inorganic chemical
manufacturing; processing by repackaging for use as a laboratory
chemical; recycling; industrial and commercial use as a processing aid
in the manufacture of agricultural products and vinyl chloride;
industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine; and
disposal. This unit provides a description of the conditions of use
subject to the WCPP to assist with compliance.
a. Manufacturing
i. Domestic Manufacture
This condition of use refers to making or producing a chemical
substance within the United States (including manufacturing for
export), including the extraction of a component chemical substance
from a previously existing chemical substance or a complex combination
of substances. For purposes of this rule, WCPP requirements applicable
to the manufacture of CTC do not apply where CTC is manufactured solely
as a byproduct, because manufacture of CTC as a byproduct was not
evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.
1). Under TSCA, EPA uses the term ``byproduct'' to refer to a chemical
substance produced without a separate commercial intent during the
manufacture, processing, use, or disposal of another chemical
substance(s) or mixture(s) (see, e.g., 40 CFR 710.3(d), 720.3). A
byproduct is distinguishable from a coproduct, which is a chemical
substance produced for a commercial purpose during the manufacture,
processing, use, or disposal of another chemical substance or mixture.
CTC could be manufactured as a byproduct during the manufacturing of
other chlorinated compounds. EPA anticipates that any risk presented by
the presence of CTC as a byproduct will be considered in the scope of
the risk evaluation of the parent chemical in future risk evaluations,
such as the consideration of CTC as a byproduct in the 1,2-
dichloroethane risk evaluation, as explained in Section 1.4.2.3 of the
2020 Risk Evaluation for Carbon Tetrachloride (Refs. 1, 41).
ii. Import
This condition of use refers to the act of causing a chemical
substance or mixture to arrive within the customs territory of the
United States. This condition of use includes loading/unloading and
repackaging associated with import.
b. Processing
i. Processing as a Reactant in the Production of
Hydrochlorofluorocarbons, Hydrofluorocarbons, Hydrofluoroolefins, and
Perchloroethylene
This condition of use refers to processing CTC in chemical
reactions for the manufacturing of another chemical substance or
product. Through processing as a reactant or intermediate, CTC serves
as a feedstock in the production of another chemical product via a
chemical reaction in which CTC is consumed. Currently, CTC is used as a
reactant to manufacture HCFCs, HFCs, HFOs, and PCE, which are used in
the making of a variety of products including refrigerants, aerosol
propellants, and foam-blowing agents. The specifics of the reaction
process (e.g., use and types of catalysts, reaction temperature) vary
depending on the product being produced; however, a typical reaction
process involves unloading CTC from containers and feeding into the
reaction vessel(s), where CTC either completely or partially reacts
with other raw materials to form the final product. Following the
reaction, the product may be purified to remove unreacted CTC or other
materials if needed. This condition of use includes reuse of CTC,
including CTC that is not transformed as feedstock in other
manufacturing processes, as a reactant.
ii. Processing: Incorporation Into Formulation, Mixtures, or Reaction
Products for Agricultural Products Manufacturing; Vinyl Chloride
Manufacturing; Other Basic Organic and Inorganic Chemical Manufacturing
This condition of use refers to the process of mixing or blending
several raw materials to obtain a single product or preparation or
formulation. CTC has historically been incorporated into formulation or
mixtures to manufacture hydrochloric acid (HCl), vinyl chloride,
ethylene dichloride (EDC), chloroform, hafnium tetrachloride,
thiophosgene, and methylene chloride. CTC may be incorporated into
various products and formulations at varying concentrations for further
distribution. For example, CTC may be unloaded from transport
containers either directly into mixing equipment or into an
intermediate storage vessel either manually or through automation via a
pumping system. Mixing of components can occur in either a batch or
continuous system. The mixture that contains CTC may be used as a
reactant to manufacture a chlorinated compound that is subsequently
formulated into a product or a processing aid used to aid in the
manufacture of formulated products. For the purposes of this
rulemaking, EPA is allowing under the WCPP the continued incorporation
of CTC into formulation, mixtures, or reaction products for
agricultural products manufacturing, vinyl chloride manufacturing, the
elimination of nitrogen trichloride in the production of chlorine and
caustic soda, and the recovery of chlorine in tail gas from the
production of chlorine.
[[Page 103530]]
iii. Processing: Repackaging for Use as a Laboratory Chemical
This condition of use refers to the physical transfer of a chemical
substance or mixture, as is, from one container to another container or
containers in preparation for distribution of the chemical substance or
mixture in commerce. Depending on the product, formulation products may
be filtered prior to packaging. Final packaging occurs either through
manual dispensing from transfer lines or through utilization of an
automatic system. Typically, repackaging sites receive the chemical in
bulk containers and transfer the chemical from the bulk container into
another smaller container in preparation for distribution in commerce.
iv. Processing: Recycling
This condition of use refers to the process of treating generated
spent chemical (which would otherwise be disposed of as waste) that is
collected on-site or transported to third-party sites for reclamation/
recycling. Spent chemicals can be restored to a condition that permits
reuse via reclamation/recycling. The recovery process may involve an
initial vapor recovery or mechanical separation step followed by
distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and Commercial Use as an Industrial Processing Aid in the
Manufacture of Agricultural Products and Vinyl Chloride
A processing aid is a ``chemical that is added to a reaction
mixture to aid in the manufacture or synthesis of another chemical
substance but is not intended to remain in or become part of the
product or product mixture.'' Additionally, processing agents are
intended to improve the processing characteristics or the operation of
process equipment, but not intended to affect the function of a
substance or article created. CTC is used as a processing aid/agent to
aid in the manufacture of formulated products, including agricultural
chemicals and vinyl chloride. CTC has historically been used as a
processing agent in the manufacture of chlorosulphonated polyolefin;
stryene butadiene rubber; endosulfan (insecticide); 1-1 Bis (4-
chlorophenyl) 2,2,2-trichloroethanol (dicofol insecticide); and
tralomethrin (insecticide) (Ref. 1). For the purposes of this
rulemaking, EPA is allowing under the WCPP the continued use of CTC as
an industrial processing aid in the manufacturing of agricultural
products and vinyl chloride.
ii. Industrial and Commercial Use in the Elimination of Nitrogen
Trichloride in the Production of Chlorine and Caustic Soda and the
Recovery of Chlorine in Tail Gas From the Production of Chlorine
This condition of use refers to a specific use of CTC as a
processing aid/agent in basic inorganic chemical manufacturing. For
purposes of this rulemaking, EPA is allowing under the WCPP the
continued use of CTC in the elimination of nitrogen trichloride in the
production of chlorine and caustic soda and the recovery of chlorine in
tail gas from the production of chlorine.
d. Disposal
This condition of use refers to the process of disposing waste
streams of CTC that are collected either onsite (e.g. pumped out of the
ground for treatment), or transported to a third-party site for
treatment or their final disposition, such as waste incineration or
landfilling. For this rule, the WCPP for the disposal of CTC-containing
water and groundwater for purposes of cleanup projects of CTC-
contaminated water and groundwater, including industrial pre-treatment
and industrial treatment activities, applies to removing the
groundwater from the location where it was located and treating the
removed groundwater on site. The requirements of the WCPP apply to any
potentially exposed person involved in the disposal of CTC-containing
groundwater to industrial treatment, industrial pre-treatment, or
POTWs. A potentially exposed person most likely includes a worker who
is involved with the activity of removing CTC-containing groundwater
from the location where it was found and the on-site treatment of the
groundwater, typically referred to as ex situ remediation, which is
most consistent with the scope of the 2020 CTC Risk Evaluation. Ex situ
remediation includes both active and passive remediation methods that
span traditional (e.g., pump and treat) and less traditional (e.g.,
phytoremediation) approaches, but only if the remediation method would
be considered industrial wastewater pretreatment, industrial wastewater
treatment or discharge to a publicly owned treatment work (POTW). A
remediation method would need to be considered one of these three types
of disposal to fall within the condition of use under TSCA for
remediation sites managed by the Federal government and if not, would
not be subject to the requirements of the rule. Further, while EPA
considers solid wastes as part of the waste streams included in the
disposal COU, at groundwater remediation sites managed by the Federal
government and under existing waste disposal requirements, the WCPP
requirements under this rulemaking only apply to water contaminated
with CTC, and any other type of CTC-impacted waste will be handled
according to relevant existing requirements under RCRA and other
statutes. The provisions of the WCPP for the disposal COU, including
the ECEL, are not intended to cover potentially exposed persons who are
sampling groundwater to monitor the presence of a plume, but
specifically only those sampling at the site of extraction and
treatment activities.
2. Overview
The WCPP for CTC encompasses an inhalation exposure limit and
action level, DDCC, and the associated implementation requirements
described in this unit, to ensure that the chemical substance no longer
presents unreasonable risk. Under a WCPP, owners or operators have the
ability to select controls, within the parameters outlined in this
unit, regarding how they prevent exceedances of the identified EPA
exposure limit thresholds or prevent direct dermal contact. In the case
of CTC, meeting the EPA exposure limit threshold and implementing the
DDCC requirements for certain occupational conditions of use would
address the unreasonable risk to potentially exposed persons from
inhalation and dermal exposure.
EPA is finalizing these requirements to apply beginning on June 11,
2026 for non-Federal owners or operators, or by June 21, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government, or within 30 days of introduction of CTC into the
workplace, whichever is later, at which point entities would be
required to complete initial monitoring (as described in Unit
IV.B.3.b.). Additionally, EPA requires that each owner or operator
ensure that no person is exposed to an airborne concentration of CTC
that exceeds the ECEL as an 8-hour TWA, including by providing
respirators to potentially exposed persons in the regulated area, no
later than September 9, 2026 for non-Federal owners or operators, or no
later than September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or
beginning four months after introduction of CTC into the workplace,
whichever is later. EPA also requires each owner or operator to ensure
all persons are separated, distanced,
[[Page 103531]]
physically removed, or isolated from direct dermal contact with CTC,
including by providing dermal PPE, by June 16, 2025 for non-Federal
owners or operators, or no later than September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government. EPA also requires implementation of any needed exposure
controls based on initial monitoring and development of an exposure
control plan, which requires consideration and documented application
of the hierarchy of controls, no later than December 3, 2027 (as
described in Unit IV.B.5.).
EPA's implementation of the requirement to meet an ECEL as part of
a WCPP aligns with, to the extent possible, certain elements of the
existing OSHA standards for regulating toxic and hazardous substances
under 29 CFR part 1910, subpart Z. However, EPA is finalizing as
proposed a new, lower occupational exposure limit, derived from the
TSCA 2020 Risk Evaluation for Carbon Tetrachloride (Refs. 1, 15). For
CTC, this final rule will eliminate the unreasonable risk from CTC
contributed to by the conditions of use subject to the WCPP, enable
continued industry use where appropriate, and provide the familiarity
of a pre-existing framework for the regulated community.
EPA's requirements include specific exposure limits and ancillary
requirements necessary for successful implementation of an ECEL as part
of a WCPP. Taken together, these WCPP requirements apply to the extent
necessary so that the unreasonable risk from CTC under the conditions
of use listed earlier in this unit would no longer be presented.
Unit IV. includes a summary of the WCPP, including a description of
the finalized exposure limits including an ECEL and ECEL action level;
implementation requirements including monitoring requirements; a
description of potential exposure controls in accordance with the
hierarchy of controls, including engineering controls, administrative
controls, and PPE as it relates to respirator selection; and additional
finalized requirements for recordkeeping and workplace participation.
Additionally, Unit IV.B.4. describes DDCC requirements for CTC,
including potential exposure controls, which consider the hierarchy of
controls; PPE as it relates to dermal protection; and additional
requirements finalized for recordkeeping. Unit IV. also describes
changes to the proposed compliance timeframes, changes by EPA to
certain provisions of the WCPP based on public comments, and addition
of new provisions in the WCPP based on public comments used to inform
this final rule.
3. Existing Chemical Exposure Limit (ECEL)
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from inhalation exposures to CTC
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for Carbon Tetrachloride, EPA is requiring an ECEL and
ancillary requirements for all of the conditions of use identified in
Unit IV.B.1.
a. ECEL and ECEL Action Level (AL)
EPA is finalizing as proposed an ECEL under TSCA section 6(a) of
0.03 ppm (0.2 mg/m\3\) for inhalation exposures to CTC as an 8-hour TWA
based on the threshold POD for liver cancer (assuming a margin of
exposure of 300) and the IUR for adrenal cancer. The ECEL memo includes
linear risk calculations for adrenal gland tumors in the equation for
``Cancer risk for other tumor types (e.g., adrenal glands) at the
ECEL,'' showing that the ECEL is protective of all tumor types,
including adrenal gland and brain tumors (Ref. 15). EPA has determined
that ensuring exposures remain at or below the 8-hour TWA ECEL of 0.03
ppm will eliminate the unreasonable risk of injury to health for CTC
resulting from acute and chronic inhalation exposures in an
occupational setting (Ref. 15). If ambient exposures are kept at or
below the 8-hour TWA ECEL of 0.03 ppm, a potentially exposed person
will be protected against the effects described in this unit, including
cancer, chronic non-cancer effects, and effects resulting from acute
inhalation exposures (Ref. 15). In addition to the ECEL memo, to
respond to public comments, EPA also explained that the ECEL is
protective of short-term acute inhalation exposures (Refs. 11 and 15).
EPA is finalizing requirements that each owner or operator ensure that
the airborne concentration of CTC does not exceed the ECEL for all
potentially exposed persons within 1,005 days after the date of
publication of the final rule (i.e., no later than September 20, 2027)
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, 630 days after the date of publication of the
final rule in the Federal Register (i.e., no later than September 9,
2026) for non-Federal owners and operators, or beginning four months
after introduction of CTC into the workplace if CTC use commences at
least 540 days after the date of publication (i.e., the use commences
on or after June 11, 2026).
EPA is finalizing an ECEL action level at 0.02 ppm as an 8-hour TWA
for CTC. Below the ECEL action level, certain compliance activities,
such as periodic monitoring, would be required less frequently, as
described further in this unit. In this way, EPA's WCPP for CTC is
consistent with the familiar framework that is in place in OSHA
standards for regulating toxic and hazardous substances under 29 CFR
1910 Subpart Z that establish an action level, although the values
differ due to differing statutory authority. As explained by OSHA, the
action level provides employers and employees with greater assurance
that their employees will not be exposed to concentrations above the
PELs (Ref. 42).
In summary, EPA is finalizing as proposed with slight modification
that owners or operators must ensure the airborne concentration of CTC
within the personal breathing zone of potentially exposed persons
remains at or below 0.03 ppm as an 8-hour TWA ECEL, with an action
level finalized as 0.02 ppm as an 8-hour TWA. For purposes of this
rulemaking, the personal breathing zone is consistent with how OSHA
defines it as a hemispheric area forward of the shoulders within a six-
to-nine-inch radius of a worker's nose and mouth and requires that
exposure monitoring air samples be collected from within this space
(Ref. 43). EPA is finalizing the ECEL for most occupational conditions
of use to ensure that no person is exposed to inhalation of CTC in
excess of these concentrations resulting from those conditions of use.
EPA recognizes that the regulated community has the ability to detect
the values for the ECEL because of viable detection limits and
analytical methods of CTC for monitoring devices that are available in
commerce, currently in use, which are as low as 4 micrograms per sample
(Refs. 15, 44). For the purposes of this TSCA section 6(a) rulemaking,
EPA will consider the use of methods for exposure monitoring (i.e.,
NIOSH Method 1003) that produce results that are accurate, to a
confidence level of 95 percent and within 25 percent (plus or minus) of
airborne concentrations of CTC above 0.03 ppm ECEL, to be in compliance
with this rule. EPA recognizes that current analytical methods may not
measure CTC to below the action level of 0.02 ppm, particularly for
short-term tasks; therefore, owners and operators will be required to
monitor more frequently, as described further in this unit, until
monitoring methods that measure to or below the action level become
available.
[[Page 103532]]
b. Monitoring Requirements
i. Exposure Sampling
Initial monitoring for CTC is critical for establishing a baseline
of exposure for potentially exposed persons; similarly, periodic
exposure monitoring assures continued compliance over time so that
potentially exposed persons are not exposed to levels that would result
in an unreasonable risk of injury to health. Exposure monitoring could
be suspended if certain conditions described in Unit IV. are met. Also,
in some cases, a change in workplace conditions with the potential to
impact exposure levels would warrant additional monitoring, which is
also described.
EPA is finalizing with modifications from proposal its requirement
that owners or operators determine each potentially exposed person's
exposure by taking a personal breathing zone air sample of each
potentially exposed person's exposure or by taking personal breathing
zone air samples that are representative of each potentially exposed
person with a similar exposure profile to chemical substance or mixture
based on substantial similarity of tasks performed, the manner in which
the tasks are performed, and the materials and processes with which
they work (hereinafter identified as an ``exposure group''). Personal
breathing zone air samples are representative of the 8-hour TWA of all
potentially exposed persons in an exposure group if the samples are of
the full shift-exposure of at least one person who represents the
highest potential CTC exposures in that exposure group. In addition,
the initial monitoring will be required when and where the operating
conditions are best representative of each potentially exposed person's
full-shift exposures. Personal breathing zone air samples taken during
one work shift may be used to represent potentially exposed person
exposures on other work shifts where the owner or operator can document
that the tasks performed and conditions in the workplace are similar
across shifts. Additionally, air sampling is required to measure
ambient concentrations for CTC without taking respiratory protections
into account as sampling is being performed. For purposes of exposure
monitoring requirements, owners and operators are only required to
monitor potentially exposed persons that are expected to be present in
the workplace.
EPA is also finalizing requirements that the owner or operator
ensure that their exposure monitoring methods are accurate to a
confidence level of 95% and are within (plus or minus) 25% of airborne
concentrations of CTC above the 8-hour TWA ECEL. To ensure compliance
for monitoring activities, EPA is finalizing recordkeeping requirements
and will require that owners or operators document their choice of
monitoring method outlined in this unit. As described in Unit III.C.1.,
EPA is finalizing the requirement that owners or operators meet certain
documentation requirements for each monitoring event of CTC, including
compliance with GLP Standards in accordance with 40 CFR part 792 or use
of a laboratory accredited by the AIHA (e.g., AIHA LAP, LLC Policy
Module 2A/B/E of Revision 17.3), or other analogous industry-recognized
program. Additionally, as described in Unit III.C.1., EPA is finalizing
the requirement that owners or operators must re-monitor within 15
working days after receipt of any exposure monitoring when results
indicate non-detect, unless an Environmental Professional as defined at
40 CFR 312.10 or a Certified Industrial Hygienist reviews the
monitoring results and determines re-monitoring is not necessary.
EPA is also finalizing the requirement that each owner or operator
maintain exposure monitoring records that include the following
information for each monitoring event:
Dates, duration, and results of each sample taken.
The quantity, location(s) and manner of use of CTC at the
time of each monitoring event.
All measurements that may be necessary to determine the
conditions (e.g., work site temperatures, humidity, ventilation rates,
monitoring equipment type and calibration dates) that may affect the
monitoring results.
Name, workplace address, work shift, job classification,
work area, and type of respiratory protection (if any) of each
monitored person.
Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample.
Use of appropriate sampling and analytical methods.
Compliance with GLP Standards in accordance with 40 CFR
part 792 or use of a laboratory accredited by AIHA (e.g., AIHA LAP, LLC
Policy Module 2A/B/E of Revision 17.3), or another analogous industry-
recognized program.
Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
Notification of exposure monitoring results to each person
whose exposures are monitored or who is part of a monitored exposure
group.
ii. Initial Exposure Monitoring
Under the final regulation, each non-Federal owner or operator of a
facility that is engaged in one or more of the conditions of use listed
in Unit IV.B.1. will be required to perform initial exposure monitoring
within 540 days after publication of the final rule in the Federal
Register (i.e., no later than June 11, 2026) or within 30 days of
introduction of CTC into the workplace, whichever is later, to
determine the extent of exposure of potentially exposed persons to CTC.
As discussed in Unit III.B., EPA is providing additional time for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government to comply with the provisions of the WCPP, so they
will be required to conduct initial monitoring within 915 days after
publication (i.e., no later than June 21, 2027). Initial monitoring
will notify owners and operators of the magnitude of possible exposures
to potentially exposed persons with respect to their work conditions
and environments. Based on the magnitude of possible exposures in the
initial exposure monitoring, the owner or operator may need to increase
or decrease the frequency of future periodic monitoring or adopt new
exposure controls (such as engineering controls, administrative
controls, and/or a respiratory protection program), as indicated in
table 1. In addition, the initial monitoring will be required when and
where the operating conditions are best representative of each
potentially exposed person's work-shift exposures. If the owner or
operator chooses to use a sample that is representative of potentially
exposed persons' full shift exposures (rather than monitor every
individual), such sampling should be representative (i.e., taken from
the breathing zone of potentially exposed persons and reflect duration-
appropriate exposure) of the most highly exposed persons in the
workplace. Additionally, EPA expects that owners and operators will
conduct initial exposure monitoring representative of all tasks that a
potentially exposed person will be expected to do. EPA understands that
certain tasks may occur less frequently or may reflect accidental
exposure (for example, due to malfunction).
EPA also recognizes that some entities may already have objective
exposure monitoring data. If the owner or operator has monitoring data
conducted within five years prior to 60 days following publication of
the final rule in the Federal Register and the monitoring
[[Page 103533]]
satisfies all other requirements in Unit IV., including the requirement
that the data represents the highest CTC exposures likely to occur
under reasonably foreseeable conditions of use, the owner or operator
may rely on such earlier monitoring results for the initial baseline
monitoring sample. Prior monitoring data cannot be used where there has
been a change in work conditions or practices that is expected to
result in new or additional exposures.
As described in more detail later in Unit IV., the owner or
operator must conduct periodic monitoring at least once every five
years since its last monitoring. This periodic monitoring must be
representative of all the potentially exposed persons in the workplace
and the tasks that they are expected to do.
iii. Periodic Exposure Monitoring
EPA is finalizing the following periodic monitoring for owners or
operators. These finalized requirements are also outlined in Table 1.
If samples taken during the initial exposure monitoring
reveal a concentration below the ECEL action level (<0.02 ppm 8-hour
TWA), the owner or operator must repeat the periodic exposure
monitoring at least once every five years.
If the most recent exposure monitoring indicates that
airborne exposure is above the ECEL (>0.03 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within three
months of the most recent exposure monitoring.
If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (>=0.02 ppm 8-
hour TWA) but at or below the ECEL (<=0.03 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within six
months of the most recent exposure monitoring.
If the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the ECEL action level, the
owners or operators must repeat such monitoring within six months of
the most recent monitoring until two consecutive monitoring
measurements, taken at least seven days apart, are below the ECEL
action level (<0.02 ppm 8-hour TWA), at which time the owner or
operator must repeat the periodic exposure monitoring at least once
every five years.
In instances where an owner or operator does not
manufacture, process, use, or dispose of CTC for a condition of use for
which the WCPP is required over the entirety of time since the last
required periodic monitoring event, EPA is requiring that the owner or
operator would be permitted to forgo the next periodic monitoring
event. However, documentation of cessation of use of CTC would be
required and periodic monitoring would be required to resume when the
owner or operator restart any of the conditions of use listed in Unit
IV.B.1.
Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
the ECEL action level (<0.02 ppm 8- required at least once every
hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (>0.03 ppm 8-hour TWA). of the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.02 ppm 8-hour monitoring.
TWA, <=0.03 ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a 6-month period, indicate exposure is monitoring.
below the ECEL action level (<0.02 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic monitoring
would be required but does not event. However, documentation
manufacture, process, use, or dispose of cessation of use of CTC is
of CTC in that condition of use over required and periodic
the entirety of time since the last monitoring would be required
required monitoring event. when the owner or operator
resumes the condition of use.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
discussed in Unit IV.B.3.b.iv.
iv. Additional Exposure Monitoring
EPA is finalizing that each owner or operator conduct additional
exposure monitoring within a reasonable timeframe after there has been
a change in the production, process, control equipment, personnel or
work practices may reasonably be expected to result in new or
additional exposures at or above the ECEL, or when the owner or
operator has any reason to believe that new or additional exposures at
or above the ECEL action level have occurred, for example if an owner
or operator receives information from potentially exposed person(s)
suggesting that such new or additional exposures may have occurred. In
the event of start-up or shutdown, or ruptures, malfunctions or other
breakdowns or unexpected releases that may lead to exposure to
potentially exposed persons, EPA is finalizing that each owner or
operator must conduct exposure monitoring of potentially exposed
persons (using personal breathing zone sampling) within a reasonable
timeframe after the conclusion of the start-up or shutdown and/or the
cleanup, repair or remedial action of the malfunction or other
breakdown or unexpected release. EPA is also requiring that the owner
or operator document that additional monitoring was completed within a
reasonable timeframe. At this time, EPA is not finalizing a specific
compliance timeframe for completion of additional monitoring when there
has been a change in the production, process, control equipment,
personnel or work practices, or in the event of start-up or shutdown,
or ruptures, malfunctions or other breakdowns or unexpected releases
that may lead to exposure to potentially exposed persons; however,
other TSCA section 6(a) rules are finalizing a compliance timeframe of
30 days for additional monitoring in these cases, and such timeframe
would be an indication of what EPA considers likely to be reasonable in
most cases when these changes are made at facilities that use CTC or in
the event of these potential releases of CTC. An additional exposure
monitoring event may result in an increased frequency of periodic
monitoring. For example, if the initial monitoring results from a
workplace are above the ECEL action level, but below the ECEL, periodic
monitoring is required every six months. If additional monitoring is
performed because increased exposures are suspected, and
[[Page 103534]]
the results are above the ECEL, subsequent periodic monitoring would
have to be performed every three months. The required additional
exposure monitoring should not delay implementation of any necessary
cleanup or other remedial action to reduce the exposures to persons in
the workplace.
c. Regulated Area
EPA is finalizing its requirement that the owner or operator
demarcate any area where airborne concentrations of CTC exceed, or are
reasonably expected to exceed the ECEL. To provide more clarity
regarding how regulated areas must be demarcated, EPA has incorporated
the language analogous to OSHA's regulated area requirements under the
standards for toxic and hazardous substances (29 CFR part 1910, subpart
Z) into this final rule. Owners and operators must demarcate regulated
areas from the rest of the workplace in any manner that adequately
establishes and alerts potentially exposed persons to the boundaries of
the area and minimizes the number of authorized persons exposed to CTC
within the regulated area. This can be accomplished using
administrative controls (e.g., highly visible signifiers) in multiple
languages as appropriate (e.g., when potentially exposed persons who
primarily speak a language other than English are present, owners and
operators should post additional highly visible signifiers in the
language of the largest group of workers who cannot readily comprehend
or read English), placed in conspicuous areas. The owner or operator is
required to restrict access to the regulated area from any potentially
exposed person that lacks proper training or is otherwise unauthorized
to enter.
d. Notification of Monitoring Results
EPA is finalizing the requirement that the owner or operator must,
within 15 working days after the receipt of the results of any exposure
monitoring, notify each potentially exposed person whose exposure is
represented by that monitoring and their designated representatives in
writing, either individually to each potentially exposed person or by
posting the information in an appropriate and accessible location, such
as public spaces or common areas, for potentially exposed persons
outside of the regulated area. The notice would be required to identify
the exposure monitoring results, the ECEL and ECEL action level and
what they mean in plain language, statement of whether the monitored
airborne concentration of CTC exceeds the ECEL and ECEL action level,
and any corresponding respiratory protection required. If the ECEL is
exceeded, the notice must also include a description of the actions
taken by the owner or operator to reduce inhalation exposures to or
below the ECEL. The notice must also include the quantity, location,
manner of CTC use, and identified releases of CTC that could result in
exposure to CTC at the time of monitoring. The notice must be posted in
multiple languages if necessary (e.g., notice must be in a language
that the potentially exposed person understands, including a non-
English language version representing the language of the largest group
of workers who cannot readily comprehend or read English).
4. Direct Dermal Contact Control (DDCC) Requirements
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from dermal exposures to CTC
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for CTC, EPA is finalizing DDCC requirements for all of
the conditions of use identified in Unit IV.B.1. EPA is finalizing its
requirements that owners or operators must separate, distance,
physically remove, or isolate all person(s) from direct handling of CTC
or from skin contact with surfaces that may be contaminated with CTC
(i.e., equipment or materials on which CTC may be present) under
routine conditions in the workplace (hereafter referred to as direct
dermal contact) within 180 days after the date of publication of the
final rule in the Federal Register (i.e., June 16, 2025) for non-
Federal owners or operators, or within 1,005 days after the date of
publication of the final rule in the Federal Register (i.e., September
20, 2027) for Federal agencies and Federal contractors acting for or on
behalf of the Federal government. The 2020 Risk Evaluation for Carbon
Tetrachloride identified that unreasonable risk to workers is also
driven by the dermal exposure, specifically from direct skin contact
with CTC; risk exceeding the benchmark was identified even when
considering use of chemically resistant gloves in most commercial and
industrial conditions of use. EPA has determined that preventing direct
dermal contact will eliminate the unreasonable risk of injury to health
resulting from dermal exposures for certain occupational conditions of
use of CTC. See the proposed rule for EPA's description of how the
requirements related to DDCC would address the unreasonable risk
resulting from dermal exposures and the rationale for this regulatory
approach in Units III.B.4. and V.A. of the proposed rule. and V.A. of
the proposed rule.
5. Exposure Control Plan
EPA is finalizing its requirement that entities implementing the
WCPP adopt feasible exposure controls, including one or a combination
of elimination, substitution, engineering controls, and administrative
controls, prior to requiring the use of PPE (i.e., respirators or
gloves) as a means of controlling exposures below EPA's ECEL and/or
prevent directing dermal contact with CTC for all potentially exposed
persons, in accordance with the hierarchy of controls (Ref. 6). If an
owner or operator chooses to replace CTC with a substitute, EPA
recommends careful review of the available hazard and exposure
information on the potential substitutes to avoid a substitute chemical
that might later be found to present an unreasonable risk of injury to
health or the environment under its conditions of use or be subject to
regulation (sometimes referred to as a ``regrettable substitution'').
EPA expects that, for conditions of use for which EPA is finalizing a
WCPP, compliance at most workplaces would be part of an established
industrial hygiene program that aligns with the hierarchy of controls.
Examples of engineering controls that may prevent or reduce the
potential for direct dermal contact include automation, physical
barriers between contaminated and clean work areas, enclosed transfer
liquid lines (with purging mechanisms in place (e.g., nitrogen,
aqueous) for operations such as product changes or cleaning), and
design of tools (e.g., a closed-loop container system providing
contact-free connection for unloading fresh and collecting spent
solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples
of administrative controls that may prevent or reduce the potential for
direct dermal contact include adjusting work practices (i.e.,
implementing policies and procedures) such as providing safe working
distances from areas where direct handling of CTC may occur.
EPA is finalizing the requirement that regulated entities use the
hierarchy of controls, instituting one or a combination of controls to
the extent feasible, and supplement such protections using PPE, where
necessary, including respirators for potentially exposed persons at
risk of inhalation exposure above the ECEL and dermal PPE for persons
potentially exposed through direct dermal contact to CTC. If efforts of
elimination, substitution,
[[Page 103535]]
engineering controls, and administrative controls are not sufficient to
reduce exposures to or below the ECEL or prevent direct dermal contact
for all potentially exposed persons in the workplace, EPA requires that
the owner or operator use feasible controls to reduce CTC
concentrations in the workplace to the lowest levels achievable and
supplement these controls with respiratory protection and dermal PPE as
needed to achieve the ECEL or prevent direct dermal contact. In such
cases, EPA requires that the owner or operator provide potentially
exposed persons reasonably likely to be exposed to CTC by inhalation to
concentrations above the ECEL with respirators affording sufficient
protection against inhalation risk and appropriate training on the
proper use of such respirators, to ensure that their exposures do not
exceed the ECEL as described in Unit IV. EPA also requires that the
owner or operator provides potentially exposed persons reasonably
likely to be exposed to CTC by direct dermal contact with dermal
protection affording sufficient protection against dermal risk and
appropriate training on the proper use of dermal protection, as
described in this unit. As part of the training requirement, the owner
or operator is required to provide information and comprehensive
training in an understandable manner (i.e., plain language),
considering factors such as the skills required to perform the work
activity and the existing skill level of the staff performing the work,
and in multiple languages as appropriate (e.g., based on languages
spoken by potentially exposed persons) to potentially exposed persons.
This training must be provided prior to or at the time of initial
assignment to a job involving potential exposure to CTC. Furthermore,
EPA also requires that the owner or operator document their efforts in
using elimination, substitution, engineering controls, and
administrative controls to reduce exposure to or below the ECEL in an
exposure control plan.
The Agency understands that certain engineering controls can reduce
exposures to people inside the workplace but may lead to increased
ventilation of CTC outside of the workplace. Increasing CTC releases to
the ambient air could lead to increasing risks to people in fenceline
communities of adverse health effects from exposures to CTC in ambient
air. Therefore, as proposed, and considering the effects of CTC on
health and the magnitude of the exposure of human beings, as required
by TSCA section 6(c)(2)(A)(i), EPA is prohibiting increased releases of
CTC to outdoor air associated with the implementation of the WCPP/ECEL.
This requirement is intended to avoid unintended increases in exposures
to people from CTC emissions to ambient air. Owners and operators are
required to attest in their WCPP/ECEL exposure control plan that
engineering controls selected do not increase emissions of CTC to
ambient air outside of the workplace and document in their exposure
control plan whether additional equipment was installed to capture
emissions of CTC to ambient air. Owners and operators may institute air
emissions monitoring or modeling to assist with meeting this
requirement.
EPA is finalizing its requirement that the owner or operator
include and document in the exposure control plan or through any
existing documentation of the facility's safety and health program
developed as part of meeting OSHA requirements or other safety and
health standards, the following:
Identification in the exposure control plan of available
exposure controls that were considered and rationale for using or not
using available exposure controls in the following sequence (i.e.,
elimination and substitution, then engineering controls and
administrative controls) to reduce exposures in the workplace to either
at or below the ECEL or to the lowest level achievable and to prevent
or reduce direct dermal contact with CTC in the workplace;
For each exposure control considered, exposure controls
selected based on feasibility, effectiveness, and other relevant
considerations;
A description of actions the owner or operator must take
to implement exposure controls selected, including proper installation,
regular inspections, maintenance, training, or other steps taken;
A description of regulated areas, how they are demarcated,
and persons authorized to enter the regulated areas;
Attestation that exposure controls selected do not
increase emissions of CTC to ambient air outside of the workplace and
whether additional equipment was installed to capture or otherwise
prevent increased emissions of CTC to ambient air;
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
An explanation of the procedures for responding to any
change that may reasonably be expected to introduce additional sources
of exposure to CTC, or otherwise result in increased exposure to CTC,
including procedures for implementing corrective actions to mitigate
exposure to CTC.
Under this final rule, owners or operators are prohibited from
using rotating work schedules to comply with the ECEL 8-hour TWA, in
alignment with certain elements of existing OSHA's standards for toxic
substances under 29 CFR part 1910, subpart Z. Owners or operators must
maintain the effectiveness of any engineering and administrative
controls instituted as part of the exposure control plan. They must
also review and update the exposure control plan as necessary, but at
least every five years, to reflect any significant changes in the
status of the owner or operator's approach to compliance with the
exposure control requirements. EPA intends that the exposure control
plan identify the available exposure controls and, for the exposure
controls not selected, document the efforts identifying why these are
not feasible, not effective, or otherwise not implemented. For entities
for which significant amounts of time are needed to verify suitability
of alternatives or procure funds or authorization for additional
engineering controls, for example, EPA expects that as those controls
become available the exposure control plan would be updated
accordingly. EPA requires that the exposure control plan be revisited
under certain conditions (and at least every five years) and encourages
updates as more sophisticated controls are available.
This final rule requires owners or operators to make the exposure
control plan and associated records, including ECEL exposure monitoring
records, ECEL compliance records, DDCC compliance records, and
workplace participation records, available to potentially exposed
persons and their designated representatives. Owners or operators must
notify potentially exposed persons and their designated representatives
of the availability of the exposure control plan and associated records
within 30 days of the date that the exposure control plan is completed
and at least annually thereafter. The notice of the availability of the
plan and associated records must be provided in plain language writing
to each potentially exposed person in a language that the person
understands or posted in an appropriate and accessible location outside
the regulated area with an English-language version and a non-
[[Page 103536]]
English version representing the language of the largest group of
workers who do not read English. This final rule also requires the
owner or operator to provide the exposure control plan and associated
records at a reasonable time, place, and manner to a potentially
exposed person or their designated representative upon request. As
explained in Unit III.C.2., if the owner or operator is unable to
provide the specified records within 15 days, the owner or operator
must inform the potentially exposed person or designated representative
requesting the record within 15 days that reason for the delay and the
earliest date when the record will be made available.
6. Personal Protective Equipment (PPE)
Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL and/or prevent direct dermal contact
with CTC for all potentially exposed persons, EPA is finalizing as
proposed with slight modifications to improve clarity or for greater
consistency with OSHA's regulations to require owners and operators to
provide PPE, including respiratory protection and dermal protection
selected in accordance with the guidelines described in this unit, and
to implement a PPE program. This unit includes a description of the PPE
program, including required PPE as it relates to respiratory
protection, required PPE as it relates to dermal protection, and other
requirements such as additional training for respirators and
recordkeeping to support implementation of a PPE program.
a. Respiratory Protection
Where elimination, substitution, engineering, and administrative
controls are not feasible or sufficiently protective to reduce the air
concentration to or below the ECEL, or if inhalation exposure above the
ECEL is still reasonably likely, EPA is finalizing, with slight
modification from the proposal, minimum respiratory PPE requirements
based on an owner or operator's most recent measured air concentration
for one or more potentially exposed persons and the level of PPE needed
to reduce exposure to or below the ECEL. In those circumstances, EPA is
finalizing the requirements for a respiratory protection PPE program
with worksite-specific procedures and elements for required respirator
use. Owners or operators must develop and administer a written
respiratory protection program in accordance with OSHA's respiratory
protection standard under 29 CFR 1910.134(c)(1), (c)(3), and (c)(4).
EPA is finalizing requirements that owners and operators provide
training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k) prior to or at the time of initial
assignment to a job involving potential exposure to CTC. Owners and
operators must retrain all persons required to use PPE at least
annually, or whenever the owner or operator has reason to believe that
a previously trained person does not have the required understanding
and skill to properly use PPE, or when changes in the workplace or in
PPE to be used render the previous training obsolete.
EPA is finalizing requirements that each owner or operator supply a
respirator, selected in accordance with requirements described in this
unit, to each person who enters a regulated area within 1,005 days
after the date of publication of the final rule in the Federal Register
(i.e., no later than September 20, 2027) for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
630 days after the date of publication of the final rule in the Federal
Register (i.e., no later than September 9, 2026) for non-Federal owners
and operators, or within three months after the receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, and thereafter
must ensure that all persons within the regulated area are using the
provided respirators whenever CTC exposures exceed or can reasonably be
expected to exceed the ECEL.
EPA is also finalizing requirements that owners or operators who
are required to administer a respiratory protection PPE program must
supply a respirator based on a medical evaluation consistent with the
requirements of 29 CFR 1910.134(e). If a potentially exposed person
cannot use a negative-pressure respirator, then the owner or operator
must provide that person with an alternative respirator. The
alternative respirator must have less breathing resistance than the
negative-pressure respirator and provide equivalent or greater
protection. If the person is unable to use an alternative respirator,
then the person must not be permitted to enter the regulated area.
Additionally, EPA is requiring owners and operators to select
respiratory protection that properly fits each affected person and
communicate respirator selections to each affected person in accordance
with the requirements of 29 CFR 1910.134(f). Consistent with
requirements of 29 CFR 1910.134(g) through (j), EPA is requiring owners
and operators to provide, ensure use of, and maintain (in a sanitary,
reliable, and undamaged condition) respiratory protection that is of
safe design and construction. EPA is also requiring owners and
operators to provide training to all persons required to use
respiratory protection consistent with the requirements of 29 CFR
1910.134(k).
EPA is finalizing the requirements to establish minimum respiratory
protection requirements, such that any respirator affording a higher
degree of protection than the following requirements may be used. In
instances where respiratory protection is appropriate, NIOSH
Approved[supreg] equipment must be used. NIOSH Approved is a
certification mark of the U.S. Department of Health and Human Services
(HHS) registered in the United States and several international
jurisdictions. EPA is finalizing the following requirements for
respiratory protection, based on the most recent exposure monitoring
concentration results measured as an 8-hour TWA that exceed the ECEL
(0.03 ppm):
If the measured exposure concentration is at or below 0.03
ppm: no respiratory protection is required.
If the measured exposure concentration is above 0.03 ppm
and less than or equal to 0.3 ppm (10 times ECEL): Any NIOSH Approved
air-purifying half mask respirator equipped with organic vapor
cartridges or canisters; or any NIOSH Approved Supplied-Air Respirator
(SAR) or Airline Respirator operated in demand mode equipped with a
half mask; or any NIOSH Approved Self-Contained Breathing Apparatus
(SCBA) in a demand mode equipped with a half mask [APF 10].
If the measured exposure concentration is above 0.3 ppm
and less than or equal to 0.75 ppm (25 times ECEL): Any NIOSH Approved
Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting
facepiece or hood/helmet equipped with organic vapor cartridges or
canisters; or any NIOSH Approved SAR or Airline Respirator in a
continuous-flow mode equipped with a loose-fitting facepiece or helmet/
hood [APF 25].
If the measured exposure concentration is above 0.75 ppm
and less than or equal to 1.5 ppm (50 times ECEL): Any NIOSH Approved
air-purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved PAPR with a half mask
equipped with organic vapor cartridges or canisters; any NIOSH Approved
SAR or Airline Respirator in a continuous flow mode equipped with a
half mask; any NIOSH Approved SAR or Airline Respirator
[[Page 103537]]
operated in a pressure-demand or other positive-pressure mode with a
half mask; or any NIOSH Approved SCBA in demand-mode equipped with a
full facepiece or helmet/hood [APF 50].
If the measured exposure concentration is above 1.5 ppm
and less than or equal to 30 ppm (1,000 times ECEL): Any NIOSH Approved
PAPR equipped with a full facepiece equipped with organic vapor
cartridges or canisters; any NIOSH Approved SAR or Airline Respirator
in a continuous-flow mode equipped with full facepiece; any NIOSH
Approved SAR or Airline Respirator in pressure-demand or other
positive-pressure mode equipped with a full facepiece and an auxiliary
self-contained air supply; or any NIOSH Approved SAR or Airline
Respirator in a continuous-flow mode equipped with a helmet or hood and
has been tested to demonstrate performance at a level of a protection
of APF 1,000 or greater. [APF 1,000].
If the measured exposure concentration is greater than 30
ppm (1,000+ times ECEL): Any NIOSH Approved SCBA equipped with a full
facepiece, hood, or helmet and operated in a pressure demand or other
positive pressure mode [APF 10,000].
If the exposure concentration is unknown: Any NIOSH
Approved combination supplied air respirator equipped with a full
facepiece and operated in pressure demand or other positive pressure
mode with an auxiliary self-contained air supply; or any NIOSH Approved
SCBA operated in pressure demand or other positive pressure mode and
equipped with a full facepiece or hood/helmet [APF 1000+].
Additionally, EPA is finalizing requirements that owners or
operators select and provide respirators in accordance with the
requirements of 29 CFR 1910.134(d)(1)(iv) and with consideration of
workplace and user factors that affect respirator performance and
reliability.
EPA is requiring that the owner or operator must ensure that all
filters, cartridges, and canisters used in the workplace are labeled
and color coded per NIOSH requirements and that the label is not
removed and remains legible. Consistent with 29 CFR
1910.134(d)(3)(iii), EPA is requiring either the use of NIOSH Approved
respirators with an end-of-life service indicator for the contaminant,
in this case CTC, or implementation of a change schedule for canisters
and cartridges that ensures that they are changed before the end of
their service life. EPA is also requiring owners and operators to
ensure that respirators are used in compliance with the terms of the
respirator's NIOSH approval.
EPA is finalizing requirements that owners and operators must
conduct regular evaluations of the workplace, including consultations
with potentially exposed persons using respiratory protection,
consistent with the requirements of 29 CFR 1910.134(l), to ensure that
the provisions of the written respiratory protection program described
in this unit are being effectively implemented.
EPA is finalizing the requirement that owners and operators
document respiratory protection used and PPE program implementation.
EPA is finalizing requirements that owners and operators document in
the exposure control plan or other documentation of the facility's
safety and health program information relevant to the respiratory
program, including records on the name, workplace address, work shift,
job classification, work area, and type of respirator worn (if any) by
each potentially exposed person, maintenance, fit-testing, and training
as described in this unit.
b. Dermal Protection
As described in this unit EPA is finalizing requirements that each
owner or operator supply dermal PPE that separates and provides a
barrier to prevent direct dermal contact with CTC, selected in
accordance with requirements described in this unit, to each person who
is reasonably likely to be dermally exposed in the work area through
direct dermal contact within 1,005 days after the date of publication
of the final rule in the Federal Register (i.e., no later than
September 20, 2027) for Federal agencies and Federal contractors acting
for or on behalf of the Federal government, or 180 days after the date
of publication of the final rule in the Federal Register (i.e., no
later than June 16, 2025) for non-Federal owners and operators. Where
elimination, substitution, engineering controls, and administrative
controls are not feasible or sufficient to fully prevent direct dermal
contact with CTC, EPA is finalizing requirements that appropriate
dermal PPE be provided by owners and operators to, and be worn by,
persons potentially exposed to direct dermal contact with CTC. EPA is
requiring owners and operators to provide dermal PPE that is of safe
design and construction for the work to be performed. EPA is also
requiring owners and operators ensure each potentially exposed person
who is required to wear PPE to use and maintain PPE in a sanitary,
reliable, and undamaged condition. Additionally, EPA is requiring
owners and operators to select and provide PPE that properly fits each
potentially exposed person who is required to use PPE and communicate
PPE selections to each affected person.
In choosing appropriate dermal PPE, EPA is requiring owners and
operators to select gloves, clothing, and protective gear (which covers
any exposed dermal area of arms, legs, torso, and face) based on
specifications from the manufacturer or supplier or individually
prepared third party testing that demonstrate an impervious barrier to
CTC during expected durations of use and normal conditions of exposure
within the workplace, accounting for potential chemical permeation or
breakthrough times. EPA is also requiring that owners and operators
demonstrate that the selected PPE will be impervious for the expected
duration and conditions of exposure, such as using the format specified
in ASTM F1194-99(2010) ``Standard Guide for Documenting the Results of
Chemical Permeation Testing of Materials Used in Protective Clothing
Materials,'' reporting cumulative permeation rate as a function of
time, or equivalent manufacturer- or supplier-provided testing. In
alignment with the OSHA Hand Protection PPE Standard (29 CFR 1910.138),
EPA is requiring owners and operators to select dermal PPE based on an
evaluation of the performance characteristics of the PPE relative to
the task(s) to be performed, conditions present, and the duration of
use. EPA is also requiring owners and operators to consider likely
combinations of chemical substances to which the clothing may be
exposed in the work area when selecting the appropriate PPE such that
the PPE will prevent direct dermal contact to CTC.
For example, owners and operators can select gloves that have been
tested in accordance with the American Society for Testing and
Materials (ASTM) F739 ``Standard Test Method for Permeation of Liquids
and Gases through Protective Clothing Materials under Conditions of
Continuous Contact.'' EPA is finalizing that PPE be provided for use
for a time period only to the extent and no longer than the time period
for which testing has demonstrated that the PPE will be impervious
during expected durations of use and conditions of exposure. EPA is
finalizing requirements that owners and operators also consider other
factors when selecting appropriate PPE, including effectiveness of
glove type when preventing exposures from CTC alone and in likely
combination with other chemical substances used in the work area or
when used with glove liners, permeation, degree of dexterity
[[Page 103538]]
required to perform task, and temperature, as identified in the Hand
Protection section of OSHA's Personal Protective Equipment Guidance
(Ref. 45).
EPA is finalizing that owners and operators establish, either
through manufacturer or supplier-provided documentation or individually
prepared third party testing that the selected PPE will be impervious
for the expected duration and conditions of exposure, such as using the
format specified in ASTM F1194-99(2010) ``Standard Guide for
Documenting the Results of Chemical Permeation Testing of Materials
Used in Protective Clothing Materials,'' reporting cumulative
permeation rate as a function of time, or equivalent manufacturer- or
supplier- provided testing. EPA is also requiring owners and operators
to consider likely combinations of chemical substances to which the
clothing may be exposed in the work area when selecting the appropriate
PPE such that the PPE will prevent direct dermal contact to CTC.
Degradation may also be appropriate to consider in the context of
combination chemical exposures, as some glove types and materials may
demonstrate efficient permeation barrier results but may not be fully
resistant to degradation from the chemical exposure. Degradation can be
evaluated using standard test methods such as select test methods
within ASTM Method D 471 Standard Test Method for Rubber Property--
Effect of Liquids (e.g., ASTM D412 Standard Test Methods for Vulcanized
Rubber and Thermoplastic Elastomers-Tension). EPA is finalizing
requirements that PPE must be immediately provided and replaced if any
person is dermally exposed to CTC longer than the breakthrough time
period for which testing has demonstrated that the PPE will be
impermeable or if there is a chemical permeation or breakage of the
PPE.
Additionally, EPA is finalizing requirements that owners and
operators subject to this rule comply with provisions of 29 CFR
1910.133(b) for requirements on selection and use of eye and face
protection.
Additionally, as part of the PPE program, EPA is also finalizing
that owners and operators must comply with OSHA's general PPE training
requirements at 29 CFR 1910.132(f) for application of a PPE training
program, including providing training on proper use of dermal PPE
(e.g., when and where PPE is necessary, proper application, wear, and
removal of PPE, maintenance, useful life and disposal of PPE). EPA is
finalizing that owners and operators provide PPE training to all
persons required to use dermal PPE prior to or at the time of initial
assignment to a job involving potential exposure to CTC. Owners and
operators have to re-train each affected person at least once annually
or whenever the owner or operator has reason to believe that a
previously trained person does not have the required understanding and
skill to properly use PPE, or when changes in the workplace or in the
PPE to be used render the previous training obsolete.
EPA is also finalizing requirements that owners and operators
retain records of dermal PPE used and program implementation. EPA is
requiring that owners and operators document in the exposure control
plan or other documentation of the facility's safety and health
program, information relevant to any dermal PPE program, as applicable,
including:
The name, workplace address, work shift, job
classification, and work area of each person reasonably likely to
directly handle CTC or handle equipment or materials on which CTC may
present and the type of PPE selected to be worn by each of these
persons;
The basis for specific PPE selection (e.g., demonstration
based on permeation testing or manufacturer specifications that each
item of PPE selected provides an impervious barrier to prevent exposure
during expected duration and conditions of exposure, including the
likely combinations of chemical substances to which the PPE may be
exposed in the work area);
Appropriately sized PPE and training on proper
application, wear, and removal of PPE, and proper care/disposal of PPE;
Occurrence and duration of any direct dermal contact with
CTC that occurs during any activity or malfunction at the workplace
that causes direct dermal exposures to occur and/or glove breakthrough,
and corrective actions to be taken during and immediately following
that activity or malfunction to prevent direct dermal contact to CTC;
and
Training described in this unit.
7. Additional Finalized Requirements
a. Workplace Information and Training
EPA is also finalizing its requirements to implement a training
program in alignment with the OSHA Hazard Communication Standard (29
CFR 1910.1200) and the OSHA General Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with CTC
exposure, EPA is finalizing as proposed with slight modification to
require that owners or operators of workplaces subject to the WCPP
institute a training and information program for potentially exposed
persons and assure their participation in the training and information
program within 1,005 days after the date of publication of the final
rule in the Federal Register (i.e., no later than September 20, 2027)
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or 630 days after the date of publication of
the final rule in the Federal Register (i.e., no later than September
9, 2026) for non-Federal owners and operators. For purposes of
workplace information and training, owners and operators are only
required to train potentially exposed persons that are expected to be
present in the workplace or to directly handle CTC or handle equipment
or materials on which CTC may present.
As part of the training and information program, the owner or
operator is required to provide information and comprehensive training
in an understandable manner (i.e., plain language) and in multiple
languages as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons prior to or
at the time of initial assignment to a job involving potential exposure
to CTC. Owners and operators are required to provide information and
training, as referenced in the OSHA Hazard Communication Standard, to
all potentially exposed persons that includes:
The requirements of the CTC WCPP and how to access or
obtain a copy of the requirements of the WCPP, including but not
limited to the exposure control plan, monitoring requirements, and PPE
program;
The quantity, location, manner of use, release, and
storage of CTC and the specific operations in the workplace that could
result in CTC exposure, particularly noting where each regulated area
is located;
Principles of safe use and handling of CTC in the
workplace, including specific measures the owner or operator has
implemented to reduce inhalation exposure at or below the ECEL or
prevent dermal contact with CTC, such as work practices and PPE used;
The methods and observations that may be used to detect
the presence or release of CTC in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance or odor of CTC when being released, etc.); and
[[Page 103539]]
The acute and chronic health hazards of CTC as detailed on
relevant Safety Data Sheets (SDSs).
In addition to providing training at the time of initial assignment
to a job involving potential exposure to CTC, owners and operators
subject to the CTC WCPP are required to re-train each potentially
exposed person as necessary, but at a minimum annually, to ensure they
understand the principles of safe use and handling of CTC in the
workplace. The owner or operator would consider factors such as the
skills required to perform the work activity and the existing skill
level of the staff performing the work. EPA is finalizing its
requirements that owners and update the training as necessary whenever
there are changes in the workplace, such as new tasks or modifications
of tasks, in particular, whenever there are changes in the workplace
that increase exposure to CTC or where potentially exposed persons'
exposure to CTC can reasonably be expected to exceed the action level
or increase the potential for direct dermal contact with CTC. To
support compliance, EPA is finalizing that each owner or operator of a
workplace subject to the WCPP would be required to provide to the EPA,
upon request, all available materials related to workplace information
and training.
b. Workplace Participation
EPA encourages owners and operators to consult with potentially
exposed persons and their designated representative on the development
and implementation of exposure control plans and PPE/respirator
programs. EPA is finalizing a requirement that owners and operators
provide potentially exposed persons and their designated
representatives regular access to the exposure control plans, exposure
monitoring records, and PPE program implementation records. To ensure
compliance with workplace participation, EPA is finalizing a
requirement that the owner or operator document the notice to and
ability of any potentially exposed person that may reasonably be
affected by CTC exposure to readily access the exposure control plans,
facility exposure monitoring records, PPE program implementation
records, or any other information relevant to CTC exposure in the
workplace.
c. Recordkeeping
For owners and operators to demonstrate compliance with the WCPP
provisions, EPA is requiring that owners and operators retain
compliance records for five years (although this requirement does not
supplant any longer recordkeeping retention time periods such as those
required under 29 CFR 1910.1020, or other applicable regulations). EPA
is requiring the owner or operator to retain records of:
Exposure control plan;
PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
Information and training provided to each person prior to
or at the time of initial assignment and any retraining.
In addition, EPA is finalizing requirements that owners and
operators subject to the WCPP ECEL requirements maintain records to
include:
Regulated areas and authorized personnel;
The exposure monitoring records;
Notification of exposure monitoring results; and
To the extent that the owner or operator relies on prior
exposure monitoring data, records that demonstrates that it meets all
of the requirements of this section.
The owners and operators, upon request by EPA, are required to make
all records that are maintained as described in Unit IV. available to
EPA for examination and copying in accordance with EPA requirements.
EPA emphasizes that all records required to be maintained can be kept
in the most administratively convenient form; electronic record form or
paper form.
8. Compliance Timeframes
EPA is finalizing the requirement that owners or operators of
workplaces subject to the WCPP implement the DDCC requirements as
outlined in this unit within 1,005 days after December 18, 2024 for
Federal agencies or Federal contractors acting for or on behalf of the
Federal government, 180 days after December 18, 2024 for non-Federal
owners and operators, or within 30 days of introduction of CTC into the
workplace, whichever is later. With regard to the compliance timeframe
for the WCPP provisions related to the ECEL, EPA is not finalizing the
timeframes proposed. Rather, as discussed in Unit III.B., based on
consideration of public comments and reasonably available information,
EPA is finalizing longer timeframes for compliance with provisions
related to the ECEL for non-Federal owners or operators, and is
providing Federal agencies and Federal contractors acting for or on
behalf of the Federal government additional time to comply with each of
the provisions of the WCPP. Specifically, EPA is finalizing its
requirement that non-Federal owners and operators perform initial
exposure monitoring according to the process outlined in this unit
within 540 days after date of publication of the final rule in the
Federal Register (i.e., no later than June 11, 2026) or within 30 days
of introduction of CTC into the workplace, whichever is later. Federal
agencies and Federal contractors acting for or on behalf of the Federal
government must conduct initial exposure monitoring within 915 days
after the date of publication (i.e., no later than June 21, 2027), or
within 30 days of introduction of CTC into the workplace, whichever is
later. EPA is also finalizing its requirement that each non-Federal
owner or operator ensure that exposure to CTC does not exceed the ECEL
as an 8-hour TWA for all potentially exposed persons within 630 days
after the date of publication of the final rule in the Federal Register
(i.e., no later than September 9, 2026), while Federal agencies and
Federal contractors acting for or on behalf of the Federal government
must comply with the ECEL within 1,005 days after the date of
publication (i.e., no later than September 20, 2027). If applicable,
each owner or operator must provide respiratory protection sufficient
to reduce inhalation exposures to below the ECEL to all potentially
exposed persons in the regulated area within three months after receipt
of the results of any exposure monitoring that indicates an exceedance
of the ECEL. For non-Federal owners or operators, this will be within
630 days after the date of publication of the final rule in the Federal
Register (i.e., no later than September 9, 2026). For Federal agencies
and Federal contractors acting for or on behalf of the Federal
government, this will be within 1,005 after the date of publication of
the final rule in the Federal Register (i.e., no later than September
20, 2027). EPA is also finalizing the requirement that owners and
operators demarcate a regulated area within three months after receipt
of any exposure monitoring that indicates exposures exceeding the ECEL.
Owners and operators shall proceed accordingly to implement an exposure
control plan, including institution of feasible exposure controls other
than PPE, within 1,080 days after date of publication of the final rule
in the Federal Register (i.e., no later than December 3, 2027).
C. Prescriptive Controls Required for Laboratory Use
In contrast to the non-prescriptive requirements of the WCPP,
including the DDCC, where regulated entities would have the ability to
select controls
[[Page 103540]]
in accordance with the hierarchy of controls to comply with the
parameters outlined in Unit IV.B., EPA has found it appropriate in
certain circumstances to require specific prescriptive controls for
certain occupational conditions of use. In general, EPA is finalizing
prescriptive controls, for the industrial and commercial use of CTC as
a laboratory chemical, as described in Unit III.A.2. This unit provides
a description of the industrial and commercial use of CTC as a
laboratory chemical subject to specific prescriptive controls, the
specific prescriptive control requirements, and the compliance
timeframe for the requirements.
1. Applicability
The industrial and commercial use of CTC as a laboratory chemical
refers to the industrial or commercial use of CTC, often in small
quantities, 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.
After the risk evaluation was published, DoD did further analysis
and provided additional information clarifying their current use of CTC
as a laboratory chemical and risk management measures implemented. DoD
provided information on their use of CTC as a laboratory chemical in
chemical weapons destruction, indicating that CTC is used in small
amounts in a confined, laboratory-like setting with advanced
engineering controls. There is no waste CTC generated during this
process.
EPA recognizes that potentially exposed persons in a laboratory
setting may include students, researchers, visiting scholars, or others
whose job classifications may vary, such as depending on the academic
period in university laboratories. The requirements described in this
unit apply to all potentially exposed persons in all laboratory
settings, including academic and research laboratories, regardless of
job classification.
2. Workplace Requirements
To address the unreasonable risk of injury to health resulting from
dermal exposures to CTC identified for the industrial and commercial
use as a laboratory chemical, including DoD's use of CTC as a
laboratory chemical in chemical weapons destruction, EPA is requiring
dermal PPE, including impermeable gloves and protective clothing, in
combination with comprehensive training for tasks particularly related
to the use of CTC in a laboratory setting as specified in this unit for
each potentially exposed person with direct dermal contact to CTC in
the work area through direct handling of the substance or from contact
with surfaces that may be contaminated with CTC. For dermal PPE, EPA is
requiring that each owner or operator comply with the requirements
outlined in Units IV.B.6.b. for selection of dermal PPE and training
for all potentially exposed persons. EPA's description for how the
requirements for the industrial and commercial use as a laboratory
chemical address the unreasonable risk resulting from dermal exposures
under the conditions of use and the rationale for this regulatory
approach is outlined in Unit V. of the proposed rule (88 FR 49205, July
28, 2023) (FRL-8206-01-OCSPP).
In addition, EPA is requiring the use of laboratory ventilation
devices, such as fume hoods, glove boxes, air handling units, exhaust
fans, biological safety devices, airflow controls, and other local
exhaust devices, in workplace laboratory settings for the industrial
and commercial use of CTC as a laboratory chemical, except for DoD's
use of CTC as a laboratory chemical in chemical weapons destruction, to
codify existing good laboratory practices. EPA is requiring each owner
or operator of a workplace laboratory setting, except for DoD's use of
CTC as a laboratory chemical in chemical weapons destruction, to ensure
laboratory ventilation devices are in use and functioning properly to
minimize exposures to persons in the area where CTC is used as a
laboratory chemical. EPA suggests owners or operators refer to OSHA's
29 CFR 1910.1450, Appendix A, for National Research Council
recommendations concerning laboratory chemical hood ventilation system
characteristics and practices and to ANSI's and ASSP's Z9.5-2022 for
recommendations on additional laboratory ventilation controls to
minimize exposures to potentially exposed persons in the work area.
EPA understands that DoD uses CTC in small amounts in a confined,
laboratory-like setting with advanced engineering controls (Ref. 46).
Therefore, for DoD's industrial and commercial use of CTC as a
laboratory chemical in chemical weapons destruction, EPA is requiring
advanced engineering controls that essentially codify existing
practices at DoD facilities. EPA is not requiring a WCPP, specifically
with monitoring requirements, for DoD's industrial and commercial use
of CTC as a laboratory chemical in chemical weapons destruction.
3. Recordkeeping
To support and demonstrate compliance, EPA is requiring that each
owner or operator of a laboratory workplace subject to the requirements
of this unit retain compliance records for five years. In alignment
with 29 CFR 1910.1450(e)(3)(ii) and (iii) and 29 CFR 1910.132(d)(2),
EPA is requiring that owners and operators must retain records of:
Dermal protection used by each potentially exposed person
and PPE program implementation as outlined in this unit;
Criteria that the owner or operator will use to determine
and implement control measures to reduce potentially exposed persons'
exposure to CTC including laboratory ventilation devices as outlined in
this unit;
Implementation of properly functioning laboratory
ventilation devices using manufacturer's instructions for installation,
use, and maintenance of the systems, including inspections, tests,
development of maintenance procedures, the establishment of criteria
for acceptable test results, and documentation of test and inspection
results, except for DoD's use of CTC as a laboratory chemical in
chemical weapons destruction; and
For DoD's industrial and commercial use of CTC as a
laboratory chemical in chemical weapons destruction, implementation of
advanced engineering controls that are in use and functioning properly
and specific measures taken to ensure proper and adequate performance.
Owners or operators must maintain records for five years. EPA expects
owners or operators ensure that records reflect actions taken within
the last five years to comply with the requirements of this unit.
4. Compliance Timeframes
With regards to the compliance timeframe, EPA is requiring that
each owner or operator of a workplace engaged in the industrial and
commercial of CTC as a laboratory chemical ensure laboratory
ventilation devices are in use and functioning properly and that dermal
PPE is provided to all potentially exposed persons with direct dermal
contact with CTC within 180 days after publication of the final rule.
Similarly, EPA is requiring that DoD facilities engaged in the
industrial and
[[Page 103541]]
commercial use of CTC as a laboratory chemical in chemical weapons
destruction ensure that advanced engineering controls are in use and
functioning properly and dermal PPE is provided to all potentially
exposed persons with direct dermal contact with CTC within 365 days
after publication of the final rule.
EPA understands that certain departments and agencies of the
Federal government, as well as Federal contractors acting for or on
behalf of the Federal government, need additional time to comply with
these timeframes. For example, ensuring compliance with the
prescriptive controls could be challenging due to changing contracting,
procurement decisions and other processes in Federal facilities.
Similarly, EPA is requiring for that agencies of the Federal government
and their contractors, when acting for or on behalf of the Federal
government, that are engaged in the industrial and commercial use of
CTC as a laboratory chemical ensure laboratory ventilation devices are
in use and functioning properly, and that dermal PPE and training on
proper use of PPE is provided to all potentially exposed persons with
direct dermal contact with CTC within 365 days after publication of the
final rule.
D. Prohibition of Manufacture, Processing, Distribution, and Use of CTC
1. Applicability
EPA is finalizing the prohibitions for most of the conditions of
use for which prohibition was proposed. Prohibitions will address the
contribution to the unreasonable risk determined to be presented by CTC
in the 2020 Risk Evaluation for Carbon Tetrachloride and 2022 Revised
Unreasonable Risk Determination for Carbon Tetrachloride from
industrial and commercial uses of CTC, and reasonably available
information indicates that industry has already transitioned away from
CTC and found technically and economically feasible alternatives to CTC
for these uses. Unit V. of the proposed rule and the Response to
Comments document present further discussion of EPA's rationale for why
these conditions of use are being prohibited (88 FR 49205) (FRL-8206-
01-OCSPP). EPA's description of the uses proposed to be prohibited for
which the Agency is finalizing a WCPP (processing: incorporation into
formulation, mixtures, or reaction products in vinyl chloride
manufacturing and the industrial and commercial use as an industrial
processing aid in the manufacture of vinyl chloride) are in Units
III.A.1. and IV.B.1. The rule prohibits manufacture, processing,
distribution in commerce, and use of CTC for the following industrial
and commercial uses of CTC: industrial and commercial use as a
processing aid in the manufacture of petrochemical-derived products
except in the manufacture of vinyl chloride (for which EPA is
finalizing a WCPP); industrial and commercial use in the manufacture of
other basic chemicals (including chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings), except for use
in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine (for which EPA is finalizing a WCPP);
industrial and commercial use in metal recovery; industrial and
commercial use as an additive; and industrial and commercial use in
specialty uses by the U.S. Department of Defense. EPA is also
finalizing the explicit prohibition for processing: incorporation into
formulation, mixture or reaction products in petrochemical-derived
manufacturing except in the manufacture of vinyl chloride (the upstream
processing condition of use for the industrial and commercial use of
CTC as a processing aid in the manufacture of petrochemicals-derived
products except in the manufacture of vinyl chloride). This unit
provides a description of the uses subject to the prohibitions to
assist with compliance.
a. Processing: Incorporation Into Formulation, Mixture or Reaction
Products in Petrochemical-Derived Manufacturing Except in the
Manufacture of Vinyl Chloride
Incorporation into formulation, mixture, or reaction products
refers to the process of mixing or blending several raw materials to
obtain a single product or preparation or formulation. CTC has
historically been incorporated into formulation or mixtures to
manufacture hydrochloric acid (HCl), vinyl chloride, ethylene
dichloride (EDC), chloroform, hafnium tetrachloride, thiophosgene, and
methylene chloride. CTC may be incorporated into various products and
formulations at varying concentrations for further distribution. For
example, CTC may be unloaded from transport containers either directly
into mixing equipment or into an intermediate storage vessel either
manually or through automation via a pumping system. Mixing of
components can occur in either a batch or continuous system. The
mixture that contains CTC may be used as a reactant to manufacture a
chlorinated compound that is subsequently formulated into a product or
a processing aid used to aid in the manufacture of petrochemicals-
derived products. For the purposes of this rulemaking, EPA is
specifically prohibiting the incorporation into formulation, mixture or
reaction products in petrochemical-derived manufacturing except in the
manufacture of vinyl chloride. Incorporation into formulation, mixture
or reaction products in agricultural products manufacturing, vinyl
chloride manufacturing, the elimination of nitrogen trichloride in the
production of chlorine and caustic soda, and the recovery of chlorine
in tail gas from the production of chlorine is being regulated under
the WCPP, as described in Unit IV.B.
b. Industrial and Commercial Use
i. Industrial and Commercial Use as an Industrial Processing aid in the
Manufacture of Petrochemicals-Derived Products Except in the
Manufacture of Vinyl Chloride.
A processing aid is a ``chemical that is added to a reaction
mixture to aid in the manufacture or synthesis of another chemical
substance but is not intended to remain in or become part of the
product or product mixture.'' Additionally, processing agents are
intended to improve the processing characteristics or the operation of
process equipment, but not intended to affect the function of a
substance or article created. CTC has traditionally been used as a
processing aid/agent to aid in the manufacture of petrochemical-derived
products (Ref. 1). The condition of use includes the use of CTC that
has historically been used as a processing agent in the manufacture of
chlorosulphonated polyolefin; stryene butadiene rubber; endosulfan
(insecticide); 1-1 Bis (4-chlorophenyl) 2,2,2-trichloroethanol (dicofol
insecticide); and tralomethrin (insecticide). For the purposes of this
rulemaking, EPA is specifically prohibiting the industrial and
commercial use of CTC as an industrial processing aid in the
manufacture of petrochemicals-derived products, except in the
manufacture of vinyl chloride. The industrial and commercial use as an
industrial processing aid in the manufacture of agricultural products
and vinyl chloride is being regulated under the WCPP, as described in
Unit IV.B.
[[Page 103542]]
ii. Industrial and Commercial Use in the Manufacture of Other Basic
Chemicals (Including Manufacturing of Chlorinated Compounds Used in
Solvents, Adhesives, Asphalt, and Paints and Coatings), Except for Use
in the Elimination of Nitrogen Trichloride in the Production of
Chlorine and Caustic Soda and the Recovery of Chlorine in Tail Gas From
the Production of Chlorine
CTC has historically been used as a processing aid/agent in basic
organic and inorganic chemical manufacturing. CTC could be used as a
processing agent in the manufacturing of chlorinated compounds that are
subsequently used in the formulation of solvents, adhesives, asphalt,
and paints and coatings; in the manufacturing of chlorinated paraffins
(e.g., plasticizer in rubber, paints, adhesives, sealants, plastics),
and chlorinated rubber (e.g., additive in paints, adhesives); and in
the manufacturing of inorganic chlorinated compounds, such as in the
production of chlorine and caustic soda and the recovery of chlorine in
tail gas from the production of chlorine. For the purposes of this
rulemaking, EPA is specifically prohibiting the industrial and
commercial use in the manufacture of other basic chemicals (including
manufacturing of chlorinated compounds used in solvents, adhesives,
asphalt, and paints and coatings), except for use in the elimination of
nitrogen trichloride in the production of chlorine and caustic soda and
the recovery of chlorine in tail gas from the production of chlorine.
The industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine is
being regulated under the WCPP, as described in Unit IV.B.
iii. Industrial and Commercial Use in Metal Recovery
CTC has historically been used as a processing aid or agent to aid
in metal recovery.
iv. Industrial and Commercial Use as an Additive
Additives are chemicals combined with a chemical product to enhance
the properties of the product. Additives typically stay mixed within
the finished product and remain unreacted. The risk evaluation examined
the use of CTC as an additive for the manufacture of petrochemical-
derived products and agricultural products. CTC has historically been
used as an additive in fuel and in plastic components used in the
automotive industry.
v. Industrial and Commercial Use in Specialty Uses by the U.S.
Department of Defense (DoD)
During the risk evaluation, DoD provided monitoring data for CTC
uses in various processes that include worker activities such as
cleaning and sampling residual metal and ash; destruction of munitions
and storage of resulting liquid waste; and sampling of energetics with
solvent. The unreasonable risk determination for CTC further determined
that this condition of use contributed to the unreasonable risk. The
Agency understands that DoD has successfully phased out the use of CTC
for this condition of use.
As discussed in Unit II.C.4., the prohibitions do not apply to any
substance that is excluded from the definition of ``chemical
substance'' under TSCA section 3(2)(B)(ii) through (vi).
2. Compliance Timeframes
EPA is finalizing that the prohibitions apply as of 180 days after
the date of publication of the final rule for the manufacturing,
processing, distribution in commerce, and use of CTC for the following:
incorporation of CTC into formulation, mixture or reaction products in
petrochemical-derived manufacturing except in the manufacture of vinyl
chloride; the industrial and commercial use of CTC as a processing aid
in the manufacture of petrochemical-derived products except in the
manufacture of vinyl chloride; the industrial and commercial use of CTC
in the manufacture of other basic chemicals (including chlorinated
compounds used in solvents, adhesives, asphalt, and paints and
coatings), except for use in the elimination of nitrogen trichloride in
the production of chlorine and caustic soda and the recovery of
chlorine in tail gas from the production of chlorine; the industrial
and commercial use of CTC in metal recovery; and the industrial and
commercial use of CTC as an additive.
EPA is also finalizing the prohibitions for the manufacturing,
processing, distribution in commerce, and use of CTC for the industrial
and commercial use in specialty uses by the DoD to apply as of 365 days
after the date of publication of the final rule.
E. Other Requirements
1. Recordkeeping
For conditions of use that are not otherwise prohibited under this
final rule, EPA is finalizing the requirement that manufacturers,
processors, distributors, and commercial users maintain ordinary
business records, such as invoices and bills-of-lading, that
demonstrate compliance with the prohibitions, restrictions, and other
provisions of this final regulation; and to maintain such records for a
period of 5 years from the date the record is generated. This
requirement begins on February 18, 2025. For enforcement purposes, EPA
will have access to such businesses records plus additional records
required under 40 CFR 751.713. Recordkeeping requirements would ensure
that owners or operators can demonstrate compliance with the
regulations if necessary.
2. Downstream Notification
For conditions of use that are not otherwise prohibited under this
final regulation, EPA is finalizing requirements that manufacturers
(including importers), processors, and distributors of CTC provide
downstream notification of the prohibitions through the SDSs by adding
to sections 1(c) and 15 of the SDS the following language:
After June 16, 2025, this chemical substance (as defined in TSCA
section 3(2)) may not be distributed in commerce or processed in
greater than trace quantities for the following purposes:
Incorporation into formulation, mixture or reaction products in
petrochemical-derived manufacturing except in the manufacture of
vinyl chloride; Industrial and commercial use as an industrial
processing aid in the manufacture of petrochemicals-derived products
except in the manufacture of vinyl chloride; Industrial and
commercial use in the manufacture of other basic chemicals
(including manufacturing of chlorinated compounds used in solvents,
adhesives, asphalt, and paints and coatings), except for use in the
elimination of nitrogen trichloride in the production of chlorine
and caustic soda and the recovery of chlorine in tail gas from the
production of chlorine; Industrial and commercial use in metal
recovery; Industrial and commercial use as an additive; and
beginning December 18, 2025, industrial and commercial specialty
uses by the U.S. Department of Defense.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA's final rule
requires manufacturers to revise their SDS within two months of rule
publication and processors and distributors to revise their SDS within
six months of rule publication. EPA did not receive public comments
asserting that these compliance dates for updating the SDS were
impracticable, and is therefore finalizing the compliance dates as
proposed. The intention of downstream notification is to spread
awareness throughout the supply chain of the
[[Page 103543]]
restrictions on CTC under TSCA and to provide information to commercial
end-users about prohibited uses of CTC.
V. TSCA Section 6(c)(2) Considerations
A. Health Effects of Carbon Tetrachloride and the Magnitude of Human
Exposure to Carbon Tetrachloride
EPA's analysis of the health effects of CTC and the magnitude of
human exposure to CTC are in the 2020 Risk Evaluation for CTC and the
2022 Revised Unreasonable Risk Determination for CTC (Refs. 1, 3). A
summary is presented here.
The 2020 Risk Evaluation for CTC identified potential health
effects of CTC including carcinogenicity, liver toxicity,
neurotoxicity, kidney toxicity, reproductive and developmental
toxicity, irritation and sensitization, and genetic toxicity. Acute
inhalation exposures to CTC at relatively high concentrations induce
immediate and temporary depression of the central nervous-system, with
effects consisting of escape-impairing symptoms such as dizziness. For
chronic non-cancer inhalation exposure scenarios to CTC, liver toxicity
is identified as the most sensitive adverse effect contributing to the
unreasonable risk of CTC exposure due to fatty changes to the liver
indicative of cellular damage. Under EPA's Guidelines for Carcinogen
Risk Assessment (Ref. 47), CTC is classified as ``Likely to be
Carcinogenic in Humans.'' CTC has been shown to cause pheochromocytomas
(tumors of the adrenal glands) in male and female mice by oral and
inhalation exposures, and a strong association between neuroblastoma
and CTC in a single well-conducted epidemiological study in the same
organ raises concern for potential carcinogenic effects in human. In
addition, a general correlation has been observed in animal studies
with CTC between hepatocellular cytotocity and regenerative hyperplasia
and the induction of liver tumors (Ref. 1).
Populations exposed to CTC include workers ages 17 and older of
either gender, including pregnant women and individuals who do not use
CTC but may be indirectly exposed due to their proximity to the user
who is directly handling CTC (occupational non-users, or ONUs). EPA
estimates that, annually, there are approximately between 852 and 9,554
workers and between 500 and 4,144 ONUs at between 30 and 71 facilities
either manufacturing, processing, or using CTC for industrial and
commercial conditions of use (Ref. 5).
In addition to these estimates of numbers of workers and
occupational non-users directly exposed to CTC, EPA recognizes there is
exposure to the general population from air and water pathways for CTC
(fenceline communities are a subset of the general population who may
be living in proximity to a facility where CTC is being used in an
occupational setting). EPA separately conducted a screening approach to
assess whether there may be potential risks to the general population
from these exposure pathways. This analysis is summarized in the
proposed rule, which includes information on the SACC peer review. This
unit addresses those areas where some risk was indicated at the
fenceline, and the conditions of use will be continuing under this
final rule.
EPA's methodological approach to assessing potential exposures to
fenceline communities of chemicals undergoing risk evaluation under
TSCA section 6 was presented to the SACC peer review panel in March
2022, and EPA is including SACC recommendations, as appropriate, in
assessing general population exposures in upcoming risk evaluations.
EPA's fenceline analysis for the water pathway for CTC, based on
methods presented to the SACC, did not find risks from drinking water,
incidental oral ingestion of ambient water, or incidental dermal
exposure of surface water (Ref. 48).
Standard cancer benchmarks used by EPA and other regulatory
agencies are an increased cancer risk above benchmarks ranging from 1
in 1,000,000 to 1 in 10,000 (i.e., 1 x 10-6 to 1 x
10-4). For example, when setting standards under section
112(f)(2) of the CAA, EPA uses a two-step process, with ``an analytical
first step to determine an `acceptable risk' that considers all health
information, including risk estimation uncertainty, and includes a
presumptive limit on maximum individual risk (MIR) of approximately 1-
in-10 thousand'' (Ref. 49, referencing the interpretation set forth in
the 1989 final National Emission Standards for Benzene rule (54 FR
38044 Sept. 14, 1989)). In the screening level fenceline analysis for
the ambient air pathway for CTC, EPA calculated its risk estimates to
certain populations within the general population living or working
near particular facilities and compared those risk estimates to a 1 in
1,000,000 (i.e., 1 x 10-6) benchmark value for cancer risk.
There are still uncertainties where the calculated risk exceeds this
cancer risk benchmark value. The benchmark values are not a bright
line, and the Agency considers a number of factors when determining
unreasonable risk, such as the endpoint under consideration, the
reversibility of effect, and exposure-related considerations (e.g.,
duration, magnitude, aggregate or cumulative impacts, or frequency of
exposure, or size of population exposed, including PESS).
The screening level fenceline analysis for CTC calculated risk
estimates to select populations within the general population living or
working near particular facilities exceeding the 1 x 10-6
benchmark value (Ref. 50). However, EPA has not determined based on
this screening level analysis whether these risks to the general
population contribute to the unreasonable risk presented by CTC. After
considering the results, limitations, and uncertainties of the
screening-level analysis, EPA determined as a matter of policy that
reopening the TSCA section 6(b) risk evaluation for CTC for further
evaluation of risk to the general population, and consequently delaying
the promulgation of this TSCA section 6(a) rule, was not warranted. The
Agency believes it is important to expeditiously promulgate this final
rule to protect the public from the unreasonable risk determined in
accordance with TSCA section 6(b)(4)(A), which was driven by
occupational exposures.
The ambient air analysis for the multi-year fenceline analysis
identified 19 facilities (in addition to 6 facilities solely
manufacturing CTC as a byproduct, which were excluded because, as
described earlier, the 2020 Risk Evaluation for Carbon Tetrachloride
did not include the manufacture of CTC as a byproduct as a condition of
use) with risk estimates above one in a million, with one facility with
risk estimates above one in ten thousand, at 100 meters representing
five conditions of use. Under the final regulatory action described in
Unit IV., all of the ongoing conditions of use with an indication of
potential risk to fenceline communities (with the exception of
manufacture of CTC as a byproduct) would be required to establish a
WCPP. Furthermore, EPA is prohibiting increased emissions associated
with WCPP requirements, and in the WCPP exposure control plan
facilities need to evaluate controls to determine how to reduce
releases and exposures to potentially exposed persons in the workplace
and attest that engineering controls selected do not increase emissions
of CTC to ambient air outside of the workplace and whether additional
equipment was installed to capture emissions of CTC to
[[Page 103544]]
ambient air. EPA anticipates that this analysis would help facilities
to determine the most effective ways to reduce releases, including
possible engineering controls or elimination/substitution of CTC, and
therefore may also reduce the overall risk to fenceline communities.
EPA recognizes, as was described in the 2020 Risk Evaluation for
Carbon Tetrachloride, that CTC is highly persistent in the atmosphere
with an estimated tropospheric half-life exceeding 330 years. Thus, CTC
has notable global background concentrations due to its long half-life,
despite having limited air releases in the US, as noted in both the
EPA's Air Toxic Screening Assessment modeling technical support
document and in a recent EPA publication comparing the national air
toxics modeling to regional monitoring data (Refs. 51, 52). The risk
estimates from the fenceline analysis do not account for the background
concentrations from historical emissions, which are persistent in the
atmosphere.
In the instances where manufacturing, processing, or use of CTC may
increase, EPA expects that potential additional exposure from emissions
to ambient air to be limited as a result of the prohibition on the
increased ventilation of CTC to ambient air and existing National
Emission Standards for Hazardous Air Pollutants (NESHAPs) that cover
CTC for these conditions of use under the CAA. Applicable NESHAPs
include: 40 CFR part 63, subparts F, G, H, and I, Organic HAP from the
Synthetic Organic Chemical Manufacturing Industry and Other Processes
Subject to the Negotiated Regulation for Equipment Leaks.
The CAA establishes a two-phase process for the EPA's development,
review, and potential revision of NESHAP that impose emission standards
and work practice requirements on subject categories of sources of
hazardous air pollutants. First, the EPA sets technology-based or
performance-based standards reflecting the maximum achievable control
technology (MACT) for major sources (CAA section 112(d)(2) and (3)) and
generally available control technology (GACT) for area or non-major
sources (CAA section 112(d)(5)). In the second phase, eight years after
adoption of the first phase standards, the EPA performs a residual risk
review of major source MACT standards to ensure that they provide an
ample margin of safety to protect public health (CAA section
112(f)(2)), and a technology review of all NESHAP to account for
developments in practices, processes and control technologies (CAA
section 112(d)(6)). The CAA only requires the EPA to conduct the
residual risk review one time for each MACT standard, although the EPA
has discretion to conduct additional risk reviews where warranted. The
technology review, instead, is a recurring duty, and the EPA must
perform it no less often than every eight years.
B. Environmental Effects of Carbon Tetrachloride and the Magnitude of
Environmental Exposure to Carbon Tetrachloride
EPA's analysis of the environmental effects of CTC and the
magnitude of exposure of the environment to CTC are in the 2020 Risk
Evaluation for Carbon Tetrachloride (Ref. 1). The unreasonable risk
determination for CTC is based solely on risks to human health; based
on the TSCA 2020 Risk Evaluation for Carbon Tetrachloride, EPA
determined that exposures to the environment did not drive the
unreasonable risk. A summary is presented here in Unit V.
Exposures to terrestrial organisms from the suspended soils and
biosolids pathway was qualitatively evaluated. Due to its physical-
chemical properties, EPA expects that CTC does not bioaccumulate in
fish or sediments; and CTC could be mobile in soil and migrate to water
or volatilize to air (Ref. 1).
EPA concluded in the 2020 Risk Evaluation for Carbon Tetrachloride
that CTC poses a hazard to environmental aquatic receptors. Amphibians
were the most sensitive taxa for acute and chronic exposures. Acute
exposures of CTC to fish, freshwater aquatic invertebrates, and
sediment invertebrates resulted in hazard values as low as 10.4 mg/L,
11.1 mg/L, and 2 mg/L, respectively. For chronic exposures, CTC has a
hazard value for amphibians of 0.03 mg/L based on teratogenesis and
lethality in frog embryos and larvae. Furthermore, chronic exposures of
CTC to fish, freshwater aquatic invertebrates, and sediment
invertebrates resulted in hazard values as low as 1.97 mg/L, 1.1 mg/L,
and 0.2 mg/L, respectively. In algal studies, CTC has hazard values
ranging from 0.07 to 23.59 mg/L (Ref. 1).
In addition to the environmental effects assessed in the 2020 Risk
Evaluation for Carbon Tetrachloride, EPA recognizes that CTC is an
ozone-depleting substance with a 100-year GWP of 1730 (energy the
emissions of one ton of gas will absorb over 100 years, relative to the
emissions of one ton of carbon dioxide (CO2)) (Ref. 53). As
a result of its ozone-depleting effects, the Montreal Protocol and
Title VI of the CAA led to a phase-out of CTC production in the United
States for most non-feedstock domestic uses. EPA did not evaluate the
effect of CTC or this rule on ozone depletion. In addition, while the
Agency understands that the use of CTC is expected to increase to
produce low GWP HFOs, replacing many of the higher GWP HFCs, there is
uncertainty in the change in volume of CTC that will be manufactured
and used to produce HFOs. In the final rule, EPA is requiring owners/
operators to ensure that any engineering controls instituted under the
WCPP do not increase emissions of CTC to ambient air. EPA expects that
potential additional exposure from emissions to ambient air would be
limited as a result of the existing NESHAPs that cover CTC. However,
EPA did not evaluate whether a possible increase of CTC emissions with
a GWP of 1730 would offset emissions of the HFCs replaced by the lower
GWP HFOs manufactured with CTC, or the overall global warming impact of
CTC use.
C. Benefits of Carbon Tetrachloride for Various Uses
As described in the proposed rule, CTC is primarily used as a
feedstock in the production of HCFCs, HFCs, and HFOs. Other conditions
of use include regulated use as a processing agent in the manufacture
of petrochemicals-derived and agricultural products and other
chlorinated compounds such as chlorinated paraffins, chlorinated rubber
and others that may be used downstream in the formulation of solvents
for adhesives, asphalt, paints and coatings. Requirements under the
Montreal Protocol and Title VI of the CAA led to a phaseout of CTC
production in the United States for most non-feedstock domestic uses in
1996 and the CPSC banned the use of CTC in household products
(excluding unavoidable residues not exceeding 10 ppm atmospheric
concentration) in 1970.
CTC is a major feedstock for generation of lower-GWP alternative
fluorocarbon products in the United States (Ref. 54). EPA anticipates
that many entities currently using HFCs with higher global warming
potential will transition to alternatives with lower global warming
potential as requirements under the AIM Act begin to apply. The
manufacturing of CTC is predicted to increase as a result of the
transition from HFCs to lower-GWP HFOs that use CTC as a feedstock,
such as HFO-1234yf used in motor vehicle AC and HFO-1234ze used in some
types of aerosols and foam-blowing agents.
[[Page 103545]]
D. Reasonably Ascertainable Economic Consequences of the Final Rule
1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health
With respect to the anticipated effects of this rule on the
national economy, the economic impact of a regulation on the national
economy generally only becomes measurable if the economic impact of the
regulation reaches 0.25 percent to 0.5 percent of Gross Domestic
Product (GDP) (Ref. 55). Given the current GDP of $23.17 trillion, this
is equivalent to a cost of $58 billion to $116 billion which is
considerably higher than the estimated cost of this rule. EPA
considered the number of businesses, facilities, and workers that would
be affected and the costs and benefits to those businesses and workers
and society at large and did not find that there would be a measurable
effect on the national economy. In addition, EPA considered the
employment impacts of this final rule. For businesses subject to the
WCPP, including the ECEL and DDCC requirements, and prescriptive
workplace control requirements, EPA estimates the marginal cost of
labor will increase. This may lead to small negative employment
effects. Costs of prohibition in the final rule are not quantified,
since EPA expects the prohibited uses are not ongoing. However, there
may be employment effects proportionate to the extent to which CTC is
still being used in the prohibited conditions of use.
EPA has determined that the rule will not have a significant impact
on a substantial number of small entities. EPA estimates that the rule
would affect at least seven small entities, and that the cost would
only exceed 1 percent of annual revenues for two of these small
entities. EPA expects that the final rule will not hinder technological
innovation. Innovative applications of CTC in recent years have
occurred in the production of HFOs. The regulatory options with
requirements for certain conditions of use, including processing as a
reactant in the production of refrigerants (such as HFOs), are not
expected to inhibit innovation since they permit the continued use of
CTC with appropriate controls. With respect to those conditions of use
where prohibition is the requirement in the final action, EPA did not
find evidence of ongoing use of CTC and thus there are no expected
effects on innovation.
The effects of this rule on public health are estimated to be
positive, due to the avoided incidence of adverse health effects
attributable to CTC exposure, including adrenal and liver cancer.
2. Costs and Benefits of the Regulatory Action and of the 1 or More
Primary Alternative Regulatory Actions Considered by the Administrator
The costs and benefits that can be monetized for this rule are
described at length in in the Economic Analysis (Ref. 5). The total
cost of the final rule is $19.7 million dollars annualized over 20
years at a 3% discount rate and $19 million dollars at a 7% discount
rate. EPA's Economic Analysis for the rule quantified the benefits from
avoided cases of adrenal and liver cancers. Cancer benefits are
calculated based on inhalation exposure estimates from the Final Risk
Evaluation. The estimated monetized benefit of the final rule ranges
from approximately $0.13 to $0.14 million per year annualized over 20
years at a 3% discount rate and from $0.06 to $0.07 million per year at
a 7% discount rate.
There are also unquantified benefits due to other avoided
significant adverse health effects associated with CTC exposure,
including liver, reproductive, renal, developmental, and CNS toxicity
end points. EPA believes that the balance of costs and benefits of this
final rule cannot be fairly described without considering the
additional, non-monetized benefits of mitigating the non-cancer adverse
effects. The non-cancer adverse effects from CTC exposure can
significantly impact an individual's quality of life. The incremental
improvements in health outcomes achieved by given reductions in
exposure cannot currently be quantified for non-cancer health effects
associated with CTC exposure, and therefore cannot be converted into
monetized benefits. The qualitative discussion throughout this
rulemaking and in the Economic Analysis highlights the importance of
these non-cancer effects, which are not able to be monetized in the way
that EPA is able to for cancer. These effects include not only cost of
illness but also personal costs such as emotional and mental stress
that are hard to measure appropriately. Considering only monetized
benefits significantly underestimates the impacts of CTC adverse
outcomes and underestimates the benefits of this final rule.
Net benefits were calculated by subtracting the costs from the
quantified benefits. The net benefit of the final rule action is -$19.6
million dollars annualized over 20 years at a 3% discount rate and -
$18.9 million dollars at a 7% discount rate.
Industry would bear monitoring, PPE, and notification and
recordkeeping burdens and costs associated with the ECEL. While
companies may comply with the rule using engineering controls, when
estimating costs and benefits the Economic Analysis assumes firms will
provide PPE to employees when monitoring thresholds are exceeded. EPA
estimated monitoring results based on a log normal distribution
estimated from the median and 95th percentile 8-hour time-weighted
average exposure outcomes presented in the 2020 Risk Evaluation for
Carbon Tetrachloride. PPE, recordkeeping, and monitoring costs after
initial monitoring vary by industry and by projected initial monitoring
result. Industry is expected to incur planning, recordkeeping and PPE
costs associated with DDCC requirements. Industry would incur costs
associated with developing an exposure control plan, performing
inspections, documenting efforts to reduce exposure and occurrences of
exposure, respiratory protection and dermal PPE, and training on the
use of respiratory protection and dermal PPE.
EPA also considered the estimated costs of alternative regulatory
actions to regulated entities. Estimated costs for regulatory
alternatives can be found in the Economic Analysis for this final rule
(Ref. 5).
A sensitivity analysis was conducted based on the low estimates of
the number of affected entities in the 2020 Risk Evaluation for Carbon
Tetrachloride. Based on these estimates, the total cost of the final
rule is $2.1 million dollars annualized over 20 years at both a 3 and
7% discount rate. The total benefit of the final rule is estimated to
range from $0.016 million dollars to $0.018 million dollars annualized
over 20 years at a 3% period discount rate, and ranges from $0.008
million dollars to $0.009 million dollars annualized over 20 years at a
7 percent discount rate. The net benefit of the rule under this
sensitivity analysis is -$2.1 million dollars annualized over 20 years
at a 3% discount rate and a 7% discount rate. At a 2% discount rate,
the cost of the rule assuming the low number of affected entities is
$2.1 million, the benefit is $0.02 million, and the net benefit is -
$2.1 million.
3. Cost Effectiveness of the Regulatory Action and of 1 or More Primary
Alternative Regulatory Actions Considered by the Administrator
For the COUs that EPA determined drive the unreasonable risk of
injury to health from CTC, both the final rule and the primary
alternative action, which is analyzed in the Economic Analysis,
[[Page 103546]]
reduce unreasonable risk to the extent necessary such that unreasonable
risk is no longer presented. In achieving this result, however, the
estimated costs of the final rule and the primary alternative
regulatory action differ as described in Units I.E. and V.D.2. The
costs of achieving the desired outcome via the final rule or the
primary alternative regulatory action can be compared to evaluate cost-
effectiveness. The measure of cost-effectiveness considered is the
annualized cost of each regulatory option per microrisk reduction in
cancer cases estimated to occur as a result of each regulatory option,
where a microrisk refers to a one in one million reduction in the risk
of a cancer case. The cost-effectiveness of the final rule ranges from
$681 to $1,000 dollars per microrisk reduction at a 3% discount rate,
and from $656 to $963 dollars per microrisk reduction at a 7% discount
rate. The cost-effectiveness of the primary alternative regulatory
action ranges from $611 to $897 dollars per microrisk reduction at a 3%
discount rate, and from $778 to $1,142 dollars at a 7% discount rate.
The primary difference between the final and primary alternative
option is that the alternative requires prescriptive controls for
conditions of use which fall under the WCPP in the final rule. For two
such conditions of use (Processing by incorporation into formulation,
mixture, or reaction products in agricultural products manufacturing,
vinyl chloride manufacturing, and other basic organic and inorganic
chemical manufacturing; and Industrial and commercial use as a
processing aid in the manufacture of agricultural products and vinyl
chloride), the Economic Analysis analyzed a primary alternative action
of prohibition for the vinyl chloride sub-uses only. In the proposed
rule, EPA proposed prohibition for these sub-uses of vinyl chloride
that at the time EPA did not have reasonably available information to
indicate the uses were ongoing but later received public comments from
one entity indicating that the incorporation of CTC into formulation,
mixtures, or reaction products in vinyl chloride manufacturing and the
industrial and commercial use of CTC as an industrial processing aid in
the manufacture of vinyl chloride were ongoing. While the final rule
requires a WCPP for these sub-uses, the primary alternative analyzes
the costs and benefits of prohibiting these sub-uses of vinyl chloride.
Since the regulated universe in both the final and primary
alternative regulatory actions is identical, the cost-effectiveness of
the regulatory actions varies based on the differences in the
requirements of each action. Section 3.9 of the Economic Analysis
provides a summary of the unquantified costs and uncertainties in the
cost estimates that may impact the respective cost-effectiveness of the
final rule and the primary alternative regulatory action considered.
VI. TSCA Section 9 Analysis and Section 26 Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. TSCA section 9(a)
describes additional procedures and requirements to be followed by EPA
and the other Federal agency following submission of any such report.
As discussed in this unit, the Administrator does not determine that
unreasonable risk from CTC under the conditions of use may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA. EPA's TSCA section 9(a) analysis is
presented in Unit VII.A. of the proposed rule (88 FR 49215, July 28,
2023) (FRL-8206-01-OCSPP), and responses to comments about that
analysis can be found in the Response Agree. Comments, Section 10.1
(Ref. 11).
TSCA section 9(d) instructs the Administrator to consult and
coordinate TSCA activities with other Federal agencies for the purpose
of achieving the maximum enforcement of TSCA while imposing the least
burden of duplicative requirements. For this rulemaking, EPA has
coordinated with appropriate Federal executive departments and
agencies, including OSHA, to, among other things, identify their
respective authorities, jurisdictions, and existing laws with regard to
risk evaluation and risk management of CTC.
As discussed in more detail in the proposed rule, OSHA requires
that employers provide safe and healthful working conditions by setting
and enforcing standards and by providing training, outreach, education,
and assistance. OSHA, in 1971, established a PEL for CTC of 10 ppm of
air as an 8-hour TWA with an acceptable ceiling concentration of 25 ppm
and an acceptable maximum peak above the acceptable ceiling
concentration for an eight-hour shift of 200 ppm, maximum duration of 5
minutes in any 4 hours. However, the exposure limits established by
OSHA are higher than the exposure limit that EPA determined would be
sufficient to address the unreasonable risk identified under TSCA from
occupational inhalation exposures associated with certain conditions of
use. Gaps exist between OSHA's authority to set workplace standards
under the OSH Act and EPA's obligations under TSCA section 6 to
eliminate unreasonable risk presented by chemical substances under the
conditions of use, as further discussed in Units II.C. and VII.A. of
the proposed rule.
EPA concludes that TSCA is the only regulatory authority able to
prevent or reduce unreasonable risk of CTC to a sufficient extent
across the range of conditions of use, exposures, and populations of
concern. An action under TSCA is able to address occupational
unreasonable risk and would reach entities that are not subject to
OSHA. Moreover, the timeframe and any exposure reduction as a result of
updating OSHA regulations for CTC cannot be estimated, while TSCA
imposes a much more accelerated two-year statutory timeframe for
proposing and finalizing requirements to address unreasonable risk.
Finally, as discussed in greater detail in the proposed rule, the 2016
amendments to TSCA altered both the manner of identifying unreasonable
risk and EPA's authority to address unreasonable risk, such that risk
management is increasingly distinct from provisions of the OSH Act (88
FR 49180) (FRL-8206-01-OCSPP). For these reasons, in the
Administrator's discretion, the Administrator has analyzed this issue
and does not determine that unreasonable risk presented by CTC may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA.
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk
``unless the Administrator determines, in the Administrator's
discretion, that it is in the public interest to protect against such
risk'' under TSCA. In making such a public interest finding, TSCA
section 9(b)(2) states: ``the Administrator shall consider, based on
information reasonably available to the Administrator, all relevant
aspects of
[[Page 103547]]
the risk . . . and a comparison of the estimated costs and efficiencies
of the action to be taken under this title and an action to be taken
under such other law to protect against such risk.''
Although several EPA statutes have been used to limit CTC exposure
(Ref. 10), regulations under those EPA statutes largely regulate
releases to the environment, rather than the occupational exposures.
While these limits on releases to the environment may be protective in
the context of their respective statutory authorities, regulation under
TSCA is also appropriate for occupational exposures and in some cases
can provide upstream protections that would prevent the need for
release restrictions required by other EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA), CAA, CWA). Updating regulations
under other EPA statutes would not be sufficient to address the
unreasonable risk of injury to the health of workers and occupational
non-users who are exposed to CTC under its conditions of use. EPA's
TSCA section 9(b) analysis is presented in the proposed rule (88 FR
49216) (FRL-8206-01-OCSPP), and responses to comments on that analysis
can be found in the Response to Comments, section 10.2 (Ref. 11).
For these reasons, the Administrator does not determine that
unreasonable risk from CTC under its conditions of use, as evaluated in
the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.1), could be
eliminated or reduced to a sufficient extent by actions taken under
other Federal laws administered in whole or in part by EPA.
C. TSCA Section 14 Requirements
EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI. Under TSCA
sections 14(a) and 14(b)(4), if EPA promulgates a rule pursuant to TSCA
section 6(a) that establishes a ban or phase-out of a chemical
substance, the protection from disclosure of any CBI regarding that
chemical substance and submitted pursuant to TSCA will be ``presumed to
no longer apply,'' subject to the limitations identified in TSCA
section 14(b)(4)(B)(i) through (iii). Pursuant to TSCA section
14(b)(4)(B)(iii), the presumption against protection from disclosure
will apply only to information about the specific conditions of use
that this rule prohibits. Manufacturers or processors seeking to
protect such information may submit a request for nondisclosure as
provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for
nondisclosure must be submitted within 30 days after receipt of notice
from EPA under TSCA section 14(g)(2)(A) stating EPA will not protect
the information from disclosure. EPA anticipates providing such notice
via the Central Data Exchange (CDX).
D. TSCA Section 26 Considerations
As explained in the 2023 proposed rule (88 FR 49216, July 29, 2023)
(FRL-8206-01-OCSPP), EPA fulfilled TSCA section 26(h) by using
scientific information, technical procedures, measures, methods,
protocols, methodologies, and models consistent with the best available
science. Comments received on the proposed rule about whether EPA
adequately assessed reasonably available information under TSCA section
26 on the risk evaluation, and responses to those comments, can be
found in Section 10.4 of the Response to Comments document (Ref. 11).
VII. 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. Risk Evaluation for Carbon Tetrachloride (Methane,
Tetrachloro-). EPA Document #EPA-740-R1-8014. October 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0061.
2. EPA. Correction of Dermal Acute Hazard and Risk Values in the
Final Risk Evaluation for Carbon Tetrachloride. July 2022. (EPA-HQ-
OPPT-2019-0499). https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0064.
3. EPA. Carbon Tetrachloride; Revision to Toxic Substances Control
Act (TSCA) Risk Determination. December 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0733-0120.
4. EPA. Memorandum of Communication between Syngenta and EPA
Regarding Risk Management of Carbon Tetrachloride. October 2021.
https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0024.
5. EPA. Carbon Tetrachloride (CTC); Regulation Under the Toxic
Substances Control Act (TSCA); Economic Analysis.
6. NIOSH. Hierarchy of Controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html (accessed April 2024).
7. President Joseph R. Biden. The White House. The President and
First Lady's Cancer Moonshot: Ending Cancer As We Know It. https://www.whitehouse.gov/cancermoonshot/ (accessed February 26, 2024).
8. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last
Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
9. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16,
2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
10. EPA. Regulatory Actions Pertaining to Carbon Tetrachloride
(CTC). June 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0055.
11. EPA. Carbon Tetrachloride (CTC); Regulation Under the Toxic
Substances Control Act (TSCA); Response to Public Comments.
12. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
13. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
14. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
15. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Carbon Tetrachloride. February 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0113.
16. EPA. Federalism Consultation on Risk Management Rulemakings for
HBCD and Carbon Tetrachloride. December 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0033.
17. EPA. Tribal Consultations on Risk Management Rulemakings for
HBCD and Carbon Tetrachloride. January 6, 2021 and January 12, 2021.
https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0041.
18. EPA. Environmental Justice Consultations Risk Management
Rulemakings for HBCD and Carbon Tetrachloride. February 2, 2021 and
February 18, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0034.
19. EPA. Public Webinar on Carbon Tetrachloride: Risk Evaluation and
Risk Management under TSCA Section 6. December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0006.
20. EPA. Small Business Administration Small Business Environmental
Roundtable Risk Evaluation and Risk Management under TSCA Section 6
for Carbon Tetrachloride. December 4, 2020.
21. EPA. Updated Stakeholder Meeting List for Rulemaking for Carbon
Tetrachloride under TSCA Section 6(a). 2024.
22. EPA. EPA's Policy on Children's Health. October 5, 2021. https://www.epa.gov/children/childrens-health-policy-and-plan#A1.
23. EPA. Public Webinar Carbon Tetrachloride: Risk Evaluation and
Risk Management under TSCA Section 6. August 15, 2023.
[[Page 103548]]
24. EPA. Meeting with Olin 11.20.23. December 7, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0148.
25. Christopher M. Kolodziej. Christopher M. Kennedy Comment. EPA-
HQ-OPPT-2020-0592-0135. September 11, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0135.
26. Michael Kennedy. American Petroleum Institute (API) Comment.
EPA-HQ-OPPT-2020-0592-0129. September 7, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0129.
27. Mark Ames. AIHA Comment. EPA-HQ-OPPT-2020-0592-0126. August 29,
2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0126.
28. Danielle Jones. The Chemours Company Comment. EPA-HQ-OPPT-2020-
0592-0134. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0134.
29. W. Caffey Norman. Halogenated Solvents Industry Alliance, Inc.
(HSIA) Comment. EPA-HQ-OPPT-2020-0592-0133. September 11, 2023.
https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0133.
30. LeaAnne Forest. American Chemistry Council (ACC) Comment. EPA-
HQ-OPPT-2020-0592-0140. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0140.
31. Paul DeLeo. American Chemistry Council (ACC) Comment. EPA-HQ-
OPPT-2020-0592-0142. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0142.
32. Martin J. Durbin. US Chamber of Commerce Comment. EPA-HQ-OPPT-
2020-0592-0137. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0137.
33. Melanie Barrett, Nancy Kahl. MilliporeSigma Comment. EPA-HQ-
OPPT-2020-0592-0128. September 5, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0128.
34. Lawrence E. Culleen. Chemical Users Coalition (CUC) Comment.
EPA-HQ-OPPT-2020-0592-0130. September 8, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0130.
35. Michael Kelly. Honeywell International Inc. (Honeywell) Comment.
EPA-HQ-OPPT-2020-0592-0144. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0144.
36. Scott Sutton. Olin Comment. EPA-HQ-OPPT-2020-0592-0127. August
31, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0127.
37. American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO) and United Steelworkers (USW). AFL-CIO and
USW Comment. EPA-HQ-OPPT-2020-0592-0138. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0138.
38. James Cooper. American Fuel & Petrochemical Manufacturers (AFPM)
Comment. EPA-HQ-OPPT-2020-0592-0143. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0143.
39. William E. Allmond IV. Adhesive and Sealant Council (ASC)
Comment. EPA-HQ-OPPT-2020-0592-0139. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0139.
40. OSHA. OSHA 1999 Multi-Employer Citation Policy. Accessed 10/27/
2023. https://www.osha.gov/enforcement/directives/cpl-02-00-124.
41. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane
(CASRN 107-06-2). August 2020. (EPA-HQ-OPPT-2018-0427-0048). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0071.
42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride.
Federal Register (62 FR 1494, January 10, 1997). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0073.
43. OSHA. OSHA Technical Manual (OTM) Section II: Chapter 1.
Personal Sampling for Air Contaminants. Last updated on September
14, 2023. https://www.osha.gov/otm/section-2-health-hazards/chapter-1.
44. NIOSH. Letter to Claudia Menasche from J. Raymond Wells. EPA's
Carbon Tetrachloride Risk Management Rule under TSCA Section 6. June
28, 2024.
45. OSHA. Personal Protective Equipment. May 4, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0087.
46. The Program Executive Office, Assembled Chemical Weapons
Alternatives (PEO ACWA). U.S. Chemical Weapons Destruction 2018. May
2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0020.
47. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
48. EPA. Carbon Tetrachloride: Fenceline Technical Support--Water
Pathway. October 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0047.
49. EPA. Final Rule. National Emission Standards for Hazardous Air
Pollutants: Carbon Black Production and Cyanide Chemicals
Manufacturing Residual Risk and Technology Reviews, and Carbon Black
Production Area Source Technology Review. Federal Register (86 FR
66096, November 19, 2021).
50. EPA. Carbon Tetrachloride: Fenceline Technical Support--Ambient
Air Pathway. October 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0050.
51. EPA. Technical Support Document EPA's Air Toxics Screening
Assessment 2018 AirToxScreen TSD. Document number EPA-452/B-22-002.
August 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0042.
52. Weitekamp. C. et al. 2021. An Examination of National Cancer
Risk Based on Monitored Hazardous Air Pollutants. Environmental
Health Perspectives. Vol. 129., No. 3. https://ehp.niehs.nih.gov/doi/full/10.1289/EHP8044.
53. Myhre, G., D. Shindell, F.-M. Br[eacute]on, W. Collins, J.
Fuglestvedt, J. Huang, D. Koch, J.-F. Lamarque, D. Lee, B. Mendoza,
T. Nakajima, A. Robock, G. Stephens, T. Takemura and H. Zhang, 2013:
Anthropogenic and Natural Radiative Forcing. In: Climate Change
2013: The Physical Science Basis. Contribution of Working Group I to
the Fifth Assessment Report of the Intergovernmental Panel on
Climate Change [Stocker, T.F., D. Qin, G.-K. Plattner, M. Tignor,
S.K. Allen, J. Boschung, A. Nauels, Y. Xia, V. Bex and P.M. Midgley
(eds.)]. Cambridge University Press, Cambridge, United Kingdom and
New York, NY, USA. https://www.ipcc.ch/site/assets/uploads/2018/02/WG1AR5_Chapter08_FINAL.pdf.
54. Halogenated Solvents Industry Alliance, Inc. (HSIA). Comments
submitted to EPA on the Carbon Tetrachloride Risk Evaluation and the
Risk Management Process. April 28, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0003.
55. Office of Management and Budget. March 31, 1995. OMB M-95-09,
Memorandum for the Heads of Executive Departments and Agencies.
Guidance for Implementing Title II of S. 1. https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/1995-1998/m95-09.pdf.
56. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of Carbon
Tetrachloride under TSCA Section 6(a) (Final Rule; RIN 2070-AK82).
2024.
57. Kevin Ashley. 2015. Harmonization of NIOSH Sampling and
Analytical Methods with Related International Voluntary Consensus
Standards. J Occup Environ Hyg. 12(7): D107-15. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0032.
VIII. 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 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
Executive Order 12866
[[Page 103549]]
review. Documentation of any changes made in response to the Executive
Order 12866 review is available in the docket. EPA prepared an analysis
of the potential costs and benefits associated with this action. This
analysis, Economic Analysis of the Regulation of Carbon Tetrachloride
Under TSCA Section 6(a) (Ref. 5), is available in the docket and
summarized in Units I.E. and V.D.
B. Paperwork Reduction Act (PRA)
The information collection activities in this final rule have been
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2744.02 and OMB Control No. 2070-0228 (Ref.
56). You can find a copy of the ICR in the docket for this rule, and it
is briefly summarized here. The information collection requirements are
not enforceable until OMB approves them. There are two primary
provisions of the final rule that may increase burden under the PRA.
The first is downstream notification, which would be carried out by
updates to the relevant SDS and which will required for manufacturers,
processors, and distributors in commerce of CTC, who will provide
notice to companies downstream upon shipment of CTC about the
prohibitions. The information submitted to downstream companies through
the SDS will provide knowledge and awareness of the restrictions to
these companies.
The second primary provision of the final rule that may increase
burden under the PRA is WCPP-related information generation,
recordkeeping, and notification requirements (including development of
exposure control plans; exposure level monitoring and related
recordkeeping; development of documentation for a PPE program and
related recordkeeping; development of documentation for a respiratory
protection program and related recordkeeping; development and
notification to potentially exposed persons (employees and others in
the workplace) about how they can access the exposure control plans,
exposure monitoring records, PPE program implementation documentation,
and respirator program documentation; ordinary business records, such
as invoices and bills-of-lading related to the continued distribution
of CTC in commerce, as well as records documenting compliance with the
proposed workplace chemical protection program requirements and
proposed restrictions on the laboratory use of CTC.
Respondents/affected entities: Persons that manufacture, process,
use, distribute in commerce or dispose of carbon tetrachloride (see
Unit I.A.).
Respondent's obligation to respond: Mandatory under TSCA section
6(a) and 40 CFR part 751.
Estimated number of respondents: 72.
Frequency of response: On occasion.
Total estimated burden: 86,186 hours per year. Burden is defined at
5 CFR 1320.3(b).
Total estimated cost: $14,800,653 per year, including $9,360,626 in
annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control number for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. 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. The small entities subject to the requirements of
this action are small businesses that manufacture/import, process, or
distribute the chemicals subject to this final rule. The Agency
identified seven small firms in the small entity analysis that are
potentially subject to the rule. The names and NAICS codes of these
entities can be found in Section 6.2.2 of the Economic Analysis (Ref.
5). It is estimated that five of the seven small companies would incur
a rule cost-to-company revenue impact ratio of less than one percent,
and two companies would experience an impact of between one and three
percent. The companies estimated to experience a greater than one
percent rule cost-to-revenue impact would potentially be subject to the
rule under the Disposal and the Manufacturing conditions of use, both
of which would require a WCPP under the final rule. To avoid
understating impacts to small entities, EPA used the highest per-
facility cost presented in the EA ($615,457). Per-facility costs were
estimated by dividing the total costs by the number of affected
facilities for each use. Details of this analysis are in the Economic
Analysis (Ref. 5), which is in the docket for this action. Based on the
low number of affected small entities and the low impact, EPA does not
expect this action to have a significant impact on a substantial number
of small entities.
D. 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 action will affect entities that
use CTC. It is not expected to affect State, local or Tribal
governments because the use of CTC by government entities is minimal.
The costs involved in this action are estimated not to exceed $183
million in 2023$ ($100 million in 1995$ adjusted for inflation using
the GDP implicit price deflator) or more in any one year. The total
quantified annualized social cost of the final rule is $19,736,400 (at
3% discount rate) and $18,995,752 (at 7% discount rate).
E. Executive Order 13132: Federalism
EPA has concluded that this action has federalism implications, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulation under TSCA section 6(a) may preempt State law. EPA
provides the following preliminary federalism summary impact statement.
The Agency consulted with State and local officials early in the
process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included a
consultation meeting on December 17, 2020. EPA invited the following
national organizations representing State and local elected officials
to this meeting: National Governors Association; National Conference of
State Legislatures, Council of State Governments, National League of
Cities, U.S. Conference of Mayors, National Association of Counties,
International City/County Management Association, National Association
of Towns and Townships, County Executives of America, and Environmental
Council of States. A summary of the meeting with these organizations,
including the views that they expressed, is available in the docket
(Ref. 16). EPA provided an opportunity for these organizations to
provide follow-up comments in writing but did not receive any such
comments.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive
[[Page 103550]]
Order 13175 (65 FR 67249, November 9, 2000) because it will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal Government and the Indian Tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes. CTC is not manufactured, processed, or
distributed in commerce by Tribes, and therefore, this rulemaking would
not impose substantial direct compliance costs on Tribal governments.
Thus, Executive Order 13175 does not apply to this action.
Notwithstanding the lack of Tribal implications as specified by
Executive Order 13175, EPA consulted with Tribal officials during the
development of this action, consistent with the EPA Policy on
Consultation and Coordination with Indian Tribes, which EPA applies
more broadly than Executive Order 13175.
The Agency held a Tribal consultation from December 7, 2020,
through March 12, 2021, with meetings held on January 6 and 12, 2021.
Tribal officials were given the opportunity to meaningfully interact
with EPA concerning the current status of risk management. During the
consultation, EPA discussed risk management under TSCA section 6(a),
findings from the 2020 Risk Evaluation for Carbon Tetrachloride, types
of information to inform risk management, principles for transparency
during risk management, and types of information EPA sought from Tribes
(Ref. 17). EPA briefed Tribal officials on the Agency's risk management
considerations and Tribal officials raised no related issues or
concerns to EPA during or in follow-up to those meetings (Ref. 17). EPA
received no written comments as part of this consultation.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health and safety
standards and explain why the regulation is preferable to potentially
effective and reasonably feasible alternatives. This action is not
subject to 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 EPA does not believe that the
environmental health or safety risks addressed by this action will have
a disproportionate risk to children as reflected by the conclusions of
the CTC risk evaluation. This action's health and risk assessments and
impacts on both children and adults from occupational use from
inhalation and dermal exposures are described in Units II.C.3, V.A.,
and the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1). While
the Agency found risks to children and adults from occupational use,
the Agency determined that risks to children were not disproportionate.
EPA's Policy on Children's Health applies to this action. Information
on how the Policy was applied and on the action's health and risk
assessments are contained in Unit II.D.2.c., and the 2020 Risk
Evaluation for CTC and the Economic Analysis for this final rule (Refs.
1, 5).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not been designated by the Administrator of
the Office of Information and Regulatory Affairs as a significant
energy action.
I. 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 rulemaking involves environmental monitoring or
measurement, specifically for occupational inhalation exposures to CTC.
Consistent with the Agency's Performance Based Measurement System
(PBMS), EPA will not 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 rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
CTC at the ECEL and the ECEL action level. Some examples of methods
which meet the criteria are included in the appendix of the ECEL memo
(Ref. 15). EPA recognizes that there may be voluntary consensus
standards that meet the proposed criteria (Ref. 57).
J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All
EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionate and adverse human health or environmental effects on
communities with environmental justice concerns in accordance with
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR
25251, April 26, 2023). As described more fully in the Economic
Analysis for this rulemaking (Ref. 5), EPA analyzed the baseline
conditions facing communities near CTC and HFO manufacturing facilities
as well as those of workers in the same industry and county as CTC
facilities and HFO manufacturing facilities. The analysis of local
demographics found that, across the entire population within 1- and 3-
miles of CTC facilities, there are higher percentages of people who
identify as Black and living below the poverty line and a similar
percentage of people who identify as Hispanic compared to the national
averages. CTC facilities are concentrated in Texas and Louisiana,
especially near Houston and Baton Rouge. As summarized in Unit V.A.,
the screening level fenceline analysis for CTC calculated risk
estimates to select populations within the general population living or
working near particular facilities exceeding the 1 x 10-6
benchmark value (Ref. 49). In cases where communities with
environmental justice concerns are also fenceline communities, EPA
expects that the finalized prohibition of increased emissions
associated with WCPP requirements would prevent an increase in health
and environmental impacts due to this rule.
The worker analysis was performed at the county and industry level.
In eight of the 12 counties with CTC facilities that reported Basic
Chemical Manufacturing, workers who identify as Black were over-
represented compared to their percentage of the national demographics
for that industry; at the national level, 11% of workers in the Basic
Chemical Manufacturing industry identify as Black. In addition, there
were eight counties with CTC facilities that reported Waste Treatment
and Disposal; workers in that industry in those counties were more
likely to earn less than the national average for that industry across
several demographic
[[Page 103551]]
groups, as outlined in the Economic Analysis.
EPA believes that it is not practicable to assess whether this
action is likely to result in disproportionate and adverse effects on
communities with environmental justice concerns. EPA was unable to
quantify the distributional effects of the regulatory action under
consideration and compare them to baseline conditions for several
reasons. Limitations include a lack of data regarding exposure
reductions that will occur as a result of the rule and on the
sociodemographic characteristics of workers in CTC facilities. Another
key limitation that prevents evaluation of the distributional effects
of the rule is a lack of knowledge of the actions regulated entities
will take in response to the rule.
EPA additionally identified and addressed environmental justice
concerns by conducting outreach to advocates of communities that might
be subject to disproportionate exposure to CTC. On February 2 and 18,
2021, EPA held public meetings as part of this consultation. These
meetings were held pursuant to and in compliance with Executive Order
12898 and Executive Order 14008, entitled ``Tackling the Climate Crisis
at Home and Abroad'' (86 FR 7619, February 1, 2021). EPA received one
written comment following these public meetings, in addition to oral
comments provided during the meetings (Ref. 18). Commenters supported
strong regulation of CTC to protect lower-income communities and
workers. In addition, commenters recommended EPA conduct analysis of
additional exposure pathways, including air and water.
The information supporting this Executive Order review is contained
in Units I.E., II.D., V.D., VI.A. and in the Economic Analysis (Ref.
5). EPA's presentations and fact sheets for the environmental justice
consultations related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of
the consultation are also available in the public docket for this
rulemaking.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and the
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.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended to read 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. Add subpart H to read as follows:
Subpart H--Carbon Tetrachloride
Sec.
751.701 General.
751.703 Definitions.
751.705 Prohibition of Certain Industrial and Commercial Uses and
Manufacturing, Processing, and Distribution in Commerce of Carbon
Tetrachloride for those Uses.
751.707 Workplace Chemical Protection Program (WCPP).
751.709 Workplace Restrictions for the Industrial and Commercial Use
as a Laboratory Chemical, Including the Use of Carbon Tetrachloride
as a Laboratory Chemical by the U.S. Department of Defense.
751.711 Downstream Notification.
751.713 Recordkeeping Requirements.
Sec. 751.701 General.
(a) Applicability. This subpart sets certain restrictions on the
manufacture (including import), processing, distribution in commerce,
use, or disposal of carbon tetrachloride (CASRN 56-23-5) to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
(b) Trace quantities exclusion. Unless otherwise specified in this
subpart, the prohibitions and restrictions of this subpart do not apply
to carbon tetrachloride that is solely present unintentionally in trace
quantities with another chemical substance or mixture.
(c) Owner and operator requirements. Any requirement for an owner
or operator, or an owner and operator, is a requirement for any
individual that is either an owner or an operator.
Sec. 751.703 Definitions.
The definitions in subpart A of this part apply to this Subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
ECEL has the same meaning as in Sec. 751.5 and for CTC, is an
airborne concentration of carbon tetrachloride of 0.03 parts per
million (ppm) calculated as an eight (8)-hour time-weighted average
(TWA).
ECEL action level means a concentration of airborne carbon
tetrachloride of 0.02 parts per million (ppm) calculated as an eight
(8)-hour time-weighted average (TWA).
Sec. 751.705 Prohibition of Certain Industrial and Commercial Uses
and Manufacturing, Processing, and Distribution in Commerce of Carbon
Tetrachloride for Those Uses.
(a) Prohibitions. (1) After June 16, 2025, all persons are
prohibited from manufacturing, processing, distributing in commerce
(including making available) and using carbon tetrachloride for the
following conditions of use:
(i) Processing condition of use: Incorporation into formulation,
mixture or reaction products in petrochemical-derived manufacturing
except in the manufacture of vinyl chloride.
(ii) Industrial and commercial conditions of use:
(A) Industrial and commercial use as an industrial processing aid
in the manufacture of petrochemicals-derived products except in the
manufacture of vinyl chloride.
(B) Industrial and commercial use in the manufacture of other basic
chemicals (including manufacturing of chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings), except for use
in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine.
(C) Industrial and commercial use in metal recovery.
(D) Industrial and commercial use as an additive.
(2) After December 18, 2025, all persons are prohibited from
manufacturing, processing, distributing in commerce (including making
available) and using carbon tetrachloride for industrial and commercial
specialty uses by the U.S. Department of Defense except as provided in
Sec. 751.709.
(b) [Reserved].
Sec. 751.707 Workplace Chemical Protection Program (WCPP).
(a) Applicability. The provisions of this section apply to the
following conditions of use of carbon tetrachloride, including
manufacturing and processing for export, except to the
[[Page 103552]]
extent the conditions of use are prohibited by Sec. 751.705:
(1) Domestic manufacture, except where carbon tetrachloride is
manufactured solely as a byproduct.
(2) Import.
(3) Processing as a reactant in the production of
hydrochlorofluorocarbons, hydrofluorocarbons, hydrofluoroolefins and
perchloroethylene.
(4) Processing: Incorporation into formulation, mixture, or
reaction products for agricultural products manufacturing, vinyl
chloride manufacturing, and other basic organic and inorganic chemical
manufacturing.
(5) Processing: Repackaging for use as a laboratory chemical.
(6) Processing: Recycling.
(7) Industrial and commercial use as an industrial processing aid
in the manufacture of agricultural products and vinyl chloride.
(8) Industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine.
(9) Disposal.
(b) Existing chemical exposure limit (ECEL)--(1) Eight-hour time-
weighted average (TWA) ECEL. Beginning September 20, 2027 for Federal
agencies or Federal contractors acting for or on behalf of the Federal
government, or by September 9, 2026 for non-Federal owners and
operators, or beginning four months after introduction of carbon
tetrachloride into the workplace if carbon tetrachloride commences
after June 11, 2026, the owner or operator must ensure that no person
is exposed to an airborne concentration of carbon tetrachloride in
excess of the ECEL, consistent with the requirements of paragraph
(d)(1)(i) of this section and, if necessary, paragraph (f) of this
section.
(2) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure, without regard to
respiratory protection, by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each exposure group.
(B) Personal breathing zone air samples are representative of the
8-hour TWA of all potentially exposed persons in an exposure group if
the samples are of at least one person's full-shift exposure who
represents the highest potential carbon tetrachloride exposures in that
exposure group. Personal breathing zone air samples taken during one
work shift may be used to represent potentially exposed person
exposures on other work shifts where the owner or operator can document
that the tasks performed and conditions in the workplace are similar
across shifts.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good
Laboratory Practice Standards in 40 CFR part 792 or a laboratory
accredited by the American Industrial Hygiene Association (AIHA) or
another industry-recognized program.
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of carbon tetrachloride.
(E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect, unless an Environmental Professional as defined at 40 CFR
312.10 or a Certified Industrial Hygienist reviews the exposure
monitoring results and determines re-monitoring is not necessary.
(ii) Initial monitoring. By June 21, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
or by June 11, 2026 for non-Federal owners and operators, or within 30
days of introduction of carbon tetrachloride into the workplace,
whichever is later, each owner or operator covered by this section must
perform initial monitoring of potentially exposed persons. Where the
owner or operator has monitoring results from monitoring conducted
within five years prior to February 18, 2025 and the monitoring
satisfies all other requirements of this section, the owner or operator
may rely on such earlier monitoring results to satisfy the requirements
of this paragraph (b)(2)(ii).
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
carbon tetrachloride in accordance with Table 1.
Table 1 to Sec. 751.707(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Periodic exposure monitoring
Air concentration condition requirement
------------------------------------------------------------------------
If all initial exposure monitoring is Periodic exposure monitoring is
below the ECEL action level (<0.02 ppm required at least once every
8-hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (> 0.03 ppm 8-hour TWA). of the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.02 ppm 8-hour monitoring.
TWA, <=0.03 ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a 6-month period, indicate exposure is monitoring.
below the ECEL action level (<0.02 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic exposure
would be required but does not monitoring event. However,
manufacture, process, use, or dispose documentation of cessation of
of carbon tetrachloride in that use of carbon tetrachloride is
condition of use over the entirety of required; and periodic
time since the last required monitoring would be required
monitoring event. when the owner or operator
resumes the condition of use.
------------------------------------------------------------------------
(iv) Additional exposure monitoring. (A) The owner or operator must
conduct additional exposure monitoring within a reasonable timeframe
whenever there has been a change in the production, process, control
equipment, personnel or work practices that may reasonably be expected
to result in new or additional exposures above the ECEL or when the
owner or operator has any reason to believe that new or additional
exposures above the ECEL action level have occurred.
(B) Whenever start-ups or shutdowns, or ruptures, malfunctions or
other breakdowns or unexpected releases occur that may lead to exposure
to
[[Page 103553]]
potentially exposed persons, the owner or operator must conduct the
additional exposure monitoring within a reasonable timeframe after the
conclusion of the start-up or shutdown and/or the cleanup, repair or
remedial action of the malfunction or other breakdown or unexpected
release. Prior monitoring data cannot be used to meet this requirement.
(v) Observation of monitoring. (A) Owners and operators must
provide potentially exposed persons or their designated representatives
an opportunity to observe any monitoring of occupational exposure to
CTC that is conducted under this section and designed to characterize
their exposure.
(B) When monitoring observation requires entry into a regulated
area, the owner or operator must provide the observers with the
required PPE.
(C) Only persons who are authorized to have access to facilities
classified in the interest of national security must be permitted to
observe exposure monitoring conducted in such facilities.
(vi) Notification of monitoring results. (A) The owner or operator
must inform each person whose exposures are monitored or who is part of
a monitored exposure group and their designated representatives of any
monitoring results within 15 working days of receipt of those
monitoring results.
(B) This notification must include the following:
(1) Exposure monitoring results;
(2) Identification and explanation of the ECEL and ECEL action
level;
(3) Statement of whether the monitored airborne concentration of
carbon tetrachloride exceeds the ECEL action level or ECEL;
(4) If the ECEL is exceeded, descriptions of any exposure controls
implemented by the owner or operator to reduce exposures to or below
the ECEL, as required by paragraph (d)(1) of this section;
(5) Explanation of any required respiratory protection provided in
accordance with paragraphs (b)(3)(iv), (d)(1)(i), and (f) of this
section;
(6) Quantity of carbon tetrachloride in use at the time of
monitoring;
(7) Location of carbon tetrachloride use at the time of monitoring;
(8) Manner of carbon tetrachloride use at the time of monitoring;
and
(9) Identified releases of carbon tetrachloride;
(C) Notice must be written in plain language and either provided to
each potentially exposed person and their designated representatives
individually in a language that the person understands, or posted in an
appropriate and accessible location outside the regulated area with an
English-language version and a non-English language version
representing the language of the largest group of workers who do not
read English.
(3) Regulated areas--(i) Establishment. By September 20, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government, or by September 9, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, the owner or
operator must establish and maintain a regulated area wherever airborne
concentrations of carbon tetrachloride exceeds or can reasonably be
expected to exceed the ECEL.
(ii) Access. The owner or operator must limit access to regulated
areas to authorized persons.
(iii) Demarcation. The owner or operator must demarcate regulated
areas from the rest of the workplace in a manner that adequately
establishes and alerts persons to the boundaries of the area and
minimizes the number of authorized persons exposed to carbon
tetrachloride within the regulated area.
(iv) Provisions of respirators. (A) The owner or operator must
ensure that each person who enters a regulated area is supplied with a
respirator selected in accordance with paragraph (f) of this section
and must ensure that all persons within the regulated area are using
the provided respirators whenever carbon tetrachloride exposures may
exceed the ECEL.
(B) An owner or operator who has implemented all feasible controls
as required in paragraph (d)(1)(i) of this section, and who has
established a regulated area as required by paragraph (b)(3)(i) of this
section where carbon tetrachloride exposure can be reliably predicted
to exceed the ECEL only on certain days (for example, because of work
or process schedule) must have persons use respirators in that
regulated area on those days.
(v) Prohibited activities. (A) The owner or operator must ensure
that, within a regulated area, persons do not engage in non-work
activities which may increase CTC exposure.
(B) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities which interfere with respirator performance.
(c) Direct dermal contact controls (DDCC). Beginning September 20,
2027 for Federal agencies or Federal contractors acting for or on
behalf of the Federal government, or by June 16, 2025 for non-Federal
owners and operators, or within 30 days of introduction of carbon
tetrachloride into the workplace, whichever is later, owners or
operators must ensure that all persons are separated, distanced,
physically removed, or isolated to prevent direct dermal contact with
carbon tetrachloride or from contact with equipment or materials on
which carbon tetrachloride may exist consistent with the requirements
of paragraph (d)(1)(ii) of this section and, if necessary, paragraph
(f) of this section.
(d) Exposure control procedures and plan--(1) Methods of
compliance--(i) ECEL. (A) By December 3, 2027, the owner or operator
must institute one or a combination of elimination, substitution,
engineering controls, or administrative controls to reduce exposure to
or below the ECEL except to the extent that the owner or operator can
demonstrate that such controls are not feasible, in accordance with the
hierarchy of controls.
(B) If the feasible controls required under paragraph (d)(1)(i)(A)
of this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL, then the owner or
operator must use such controls to reduce exposure to the lowest levels
achievable by these controls and must supplement those controls with
the use of respiratory protection that complies with the requirements
of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate exposure to
carbon tetrachloride has been reduced to or below the ECEL through the
use of controls required under paragraphs (d)(1)(i)(A) and (B) of this
section, and has not demonstrated that it has appropriately
supplemented with respiratory protection that complies with the
requirements of paragraph (f) of this section, this will constitute a
failure to comply with the ECEL.
(D) The owner or operator must ensure that any engineering controls
instituted under paragraph (d)(1)(i)(A) of this section do not increase
emissions of carbon tetrachloride to ambient air outside the workplace.
(ii) Direct dermal contact controls (DDCC). (A) The owner or
operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
prevent all persons from direct dermal contact with carbon
tetrachloride except to the extent that the owner or operator can
demonstrate that such controls are not feasible.
(B) If the feasible controls required under paragraph (d)(1)(ii)(A)
of this section that can be instituted do not
[[Page 103554]]
prevent direct dermal contact with carbon tetrachloride, then the owner
or operator must use such controls to reduce direct dermal contact to
the extent achievable by these controls and must supplement those
controls by the use of dermal protection that complies with the
requirements of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate that direct
dermal contact to carbon tetrachloride is prevented through the use of
controls required under paragraphs (d)(1)(ii)(A) and (B) of this
section, and has not demonstrated that it has appropriately
supplemented with dermal protection that complies with the requirements
of paragraph (f) of this section, this will constitute a failure to
comply with the DDCC requirements.
(2) Exposure control plan. By December 3, 2027, each owner and
operator must establish and implement an exposure control plan.
(i) 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
paragraphs (d)(1)(i)(A) and (d)(1)(ii)(A) of this section, in the
following sequence: elimination, substitution, engineering controls 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 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) Attestation that exposure controls selected do not increase
emissions of carbon tetrachloride to ambient air outside of the
workplace and whether additional equipment was installed to capture or
otherwise prevent increased emissions of carbon tetrachloride to
ambient air;
(F) 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;
(G) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to carbon tetrachloride, or otherwise result in increased
exposure to carbon tetrachloride, including procedures for implementing
corrective actions to mitigate exposure to carbon tetrachloride.
(ii) 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 this paragraph (d).
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every five years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (b) through (d) of this section.
(iii) Availability of exposure control plan. (A) Owners or
operators must make the exposure control plan and associated records,
including ECEL exposure monitoring records, ECEL compliance records,
DDCC compliance records, and workplace participation records described
in Sec. 751.713(b), available to potentially exposed persons and their
designated representatives.
(B) Owners or operators must notify potentially exposed persons and
their designated representatives of the availability of the exposure
control plan and associated records within 30 days of the date that the
exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and
associated records must be provided in plain language writing to each
potentially exposed person in a language that the person understands or
posted in an appropriate and accessible location outside the regulated
area with an English-language version and a non-English language
version representing the language of the largest group of workers who
do not read English.
(D) Upon request by the potentially exposed person or their
designated representative(s), 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 or designated representative(s) requesting
the record(s) of the reason for the delay and the earliest date when
the record will be made available.
(e) Workplace information and training. (1) By September 20, 2027
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or by September 9, 2026 for non-Federal owners
and operators, the owner or operator must institute a training program
and ensure that persons potentially exposed to carbon tetrachloride
participate in the program according to the requirements of this
paragraph (e).
(2) The owner or operator must ensure that each potentially exposed
person is trained prior to or at the time of a potential exposure to
carbon tetrachloride.
(3) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained and in multiple languages as appropriate, such as, based
on languages spoken by potentially exposed persons in the workplace.
(4) The following information and training must be provided to all
persons potentially exposed to carbon tetrachloride:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
carbon tetrachloride and the specific operations in the workplace that
could result in exposure to carbon tetrachloride, particularly noting
where each regulated area is located;
(iii) Methods and observations that may be used to detect the
presence or release of carbon tetrachloride in the workplace (such as
monitoring conducted by the owner or operator, continuous monitoring
devices, visual appearance or odor of carbon tetrachloride when being
released);
(iv) The acute and chronic health hazards of carbon tetrachloride
as detailed on relevant Safety Data Sheets; and
(v) The principles of safe use and handling of carbon tetrachloride
and measures potentially exposed persons can take to protect themselves
from carbon tetrachloride, including specific procedures the owner or
operator has implemented to protect potentially exposed persons from
exposure to carbon tetrachloride, such as appropriate work practices,
emergency procedures, and personal protective equipment to be used.
(5) The owner or operator must re-train each potentially exposed
person as necessary, but at minimum annually, to ensure that each such
person maintains the requisite understanding of the principles of safe
use and handling of carbon tetrachloride in the workplace.
[[Page 103555]]
(6) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase exposure, and where such exposure exceeds or can reasonably be
expected to exceed the ECEL action level or increase potential for
direct dermal contact with carbon tetrachloride, the owner or operator
must update the training as necessary to ensure that each potentially
exposed person is re-trained.
(f) Personal protective equipment (PPE). (1) General. The
provisions of this paragraph (f) apply to any owner or operator that is
required to provide respiratory protection pursuant to paragraphs
(b)(3)(iv) or (d)(1)(i)(B) of this section or dermal protection
pursuant to paragraphs (c) or (d)(1)(ii)(B) of this section or Sec.
751.709(b)(3) or (4).
(2) Respiratory protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by September 9, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, if an owner or
operator is required to provide respiratory protection pursuant to
paragraph (f)(1) of this section, the owner or operator must ensure
that each potentially exposed person is provided with a respirator
according to the requirements of this section.
(ii) For purposes of this paragraph (f)(2), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are
defined in 29 CFR 1910.134(b) have the meaning assigned to them in that
paragraph.
(iii) By September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
September 9, 2026 for non-Federal owners and operators, or within three
months after receipt of any exposure monitoring that indicates
exposures exceeding the ECEL, if an owner or operator is required to
provide respiratory protection pursuant to (f)(1) of this section, the
owner or operator must develop and administer a written respiratory
protection program consistent with the requirements of 29 CFR
1910.134(c)(1), (c)(3) and (c)(4).
(iv) Owners and operators must select respiratory protection
required by paragraph (f)(2)(i) of this section based on a medical
evaluation consistent with the requirements of 29 CFR 1910.134(e). If a
potentially exposed person cannot use a negative-pressure respirator
that would otherwise be required by paragraph (f)(1) of this section,
then the owner or operator must provide that person with an alternative
respirator. The alternative respirator must have less breathing
resistance than the negative-pressure respirator and provide equivalent
or greater protection. If the person is unable to use an alternative
respirator, then the person must not be permitted to enter the
regulated area.
(v) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator
selections to each affected person consistent with the requirements of
29 CFR 1910.134(f).
(vi) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(vii) Prior to or at the time of initial assignment to a job
involving potential exposure to carbon tetrachloride, owners and
operators must provide training to all persons required to use
respiratory protection consistent with 29 CFR 1910.134(k).
(viii) Owners and operators must retrain all persons required to
use PPE at least annually, or whenever the owner or operator has reason
to believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(ix) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
(A) If the measured exposure concentration is at or below the 0.03
ppm: no respiratory protection is required.
(B) If the measured exposure concentration is above 0.03 ppm and
less than or equal to 0.3 ppm (10 times ECEL): Any National Institute
for Occupational Safety and Health (NIOSH)-Approved air-purifying half
mask respirator equipped with organic vapor cartridges or canisters; or
any NIOSH Approved Supplied-Air Respirator (SAR) or Airline Respirator
operated in demand mode equipped with a half mask; or any NIOSH
Approved Self-Contained Breathing Apparatus (SCBA) in demand mode
equipped with a half mask [APF 10].
(C) If the measured exposure concentration is above 0.3 ppm and
less than or equal to 0.75 ppm (25 times ECEL): Any NIOSH Approved
Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting
facepiece or hood/helmet equipped with organic vapor cartridges or
canisters; any NIOSH Approved continuous flow supplied air respirator
equipped with a loose-fitting facepiece; or any NIOSH Approved
Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-
flow mode equipped with a loose-fitting facepiece or helmet/hood [APF
25].
(D) If the measured exposure concentration is above 0.75 ppm and
less than or equal to 1.5 ppm (50 times ECEL): Any NIOSH Approved air-
purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved PAPR with a half mask
equipped with organic vapor cartridges or canisters; any NIOSH Approved
SAR or Airline Respirator in a continuous flow mode equipped with a
half mask; any NIOSH Approved SAR or Airline Respirator operated in a
pressure-demand or other positive-pressure mode with a half mask; or
any NIOSH Approved SCBA in demand-mode equipped with a full facepiece
or helmet/hood [APF 50].
(E) If the measured exposure concentration is above 1.5 ppm and
less than or equal to 30 ppm (1,000 times ECEL): Any NIOSH Approved
PAPR equipped with a full facepiece equipped with organic vapor
cartridges or canisters; any NIOSH Approved SAR or Airline Respirator
in a continuous-flow mode equipped with full facepiece; any NIOSH
Approved SAR or Airline Respirator in pressure-demand or other
positive-pressure mode equipped with a full facepiece and an auxiliary
self-contained air supply; or any NIOSH Approved SAR or Airline
Respirator in a continuous-flow mode equipped with a helmet or hood and
that has been tested to demonstrated performance at a level of a
protection of APF 1,000 or greater [APF 1000].
(F) If the measured exposure concentration is greater than 30 ppm
(1,000 times ECEL): Any NIOSH Approved SCBA in a pressure-demand or
other positive-pressure mode equipped with a full facepiece helmet/hood
[APF 10,000].
(G) If the exposure concentration is unknown: Any NIOSH Approved
combination supplied air respirator equipped with a full facepiece and
operated in pressure demand or other positive pressure mode with an
auxiliary self-contained air supply; or any NIOSH Approved SCBA
operated in
[[Page 103556]]
pressure demand or other positive pressure mode and equipped with a
full facepiece or helmet/hood [APF 1000+].
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(2) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators who select air-purifying respirators must
either:
(A) Select respirators that have an end-of-service-life indicator
(ESLI) that is NIOSH Approved[supreg] for carbon tetrachloride; or
(B) Implement a change schedule for canisters and cartridges based
on objective information or data that ensures that canisters and
cartridges are changed before the end of their service life. The
written respiratory protection program required by paragraph
(f)(2)(iii) of this section must include a description of the
information and data relied upon, the basis for reliance on the
information and data, and the basis for the canister and cartridge
change schedule.
(xii) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xiii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29
CFR 1910.134(l), to ensure that the provisions of the written
respiratory protection program required under paragraph (f)(2)(iii) of
this section are being effectively implemented.
(xiv) The respiratory protection requirements in this paragraph
(f)(2) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(3) Dermal protection. (i) Beginning September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by June 16, 2025 for non-Federal owners and operators,
if an owner or operator is required to provide dermal protection
pursuant to paragraph (f)(1), the owner or operator must ensure that
each potentially exposed person is provided with dermal PPE according
to the requirements of this section.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with carbon tetrachloride in the specific work area
where it is selected for use, selected in accordance with this
paragraph and provided in accordance with 29 CFR 1910.132(h), to each
person who is reasonably likely to be dermally exposed in the work area
through direct dermal contact with carbon tetrachloride. For the
purposes of this subsection, provisions in 29 CFR 1910.132(h) applying
to an ``employee'' also apply equally to potentially exposed persons,
and provisions applying to an ``employer'' also apply equally to owners
or operators.
(iii) Owners or operators must select and provide dermal PPE in
accordance with 29 CFR 1910.133(b) and additionally as specified in
this paragraph (f)(3) to each person who is reasonably likely to be
dermally exposed in the work area through direct dermal contact with
carbon tetrachloride. For the purposes of this paragraph (f)(3)(iii),
provisions in 29 CFR 1910.133(b) applying to an ``employer'' also apply
equally to owners or operators.
(iv) Owners or operators must select and provide to persons
appropriate dermal PPE based on an evaluation of the performance
characteristics of the PPE relative to the task(s) to be performed,
conditions present, and the duration of use. Replacement PPE must be
provided immediately if any person is dermally exposed to CTC longer
than the breakthrough time period for which testing has demonstrated
that the PPE will be impermeable or if there is a chemical permeation
or breakage of the PPE. Dermal PPE must include, but is not limited to,
the following items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier or by individually prepared third-party
testing.
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(v) Owners or operators must demonstrate that each item of gloves
and other clothing selected provides an impervious barrier to prevent
direct dermal contact with carbon tetrachloride during normal and
expected duration and conditions of exposure within the work area by
evaluating the specifications from the manufacturer or supplier or
individually prepared third-party testing of the dermal PPE, or of the
material used in construction of the dermal PPE, to establish that the
dermal PPE will be impervious to carbon tetrachloride alone and in
likely combination with other chemical substances in the work area.
(vi) Dermal PPE that is of safe design and construction for the
work to be performed must be provided, used, and maintained in a
sanitary, reliable, and undamaged condition. Owners and operators must
select PPE that properly fits each affected person and communicate PPE
selections to each affected person.
(vii) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to carbon tetrachloride. For the purposes of this paragraph
(f)(3)(vii), provisions in 29 CFR 1910.132(f) applying to an
``employee'' also apply equally to potentially exposed persons, and
provisions applying to an ``employer'' also apply equally to owners or
operators.
(viii) Owners and operators must retrain each person required to
use dermal protection at least annually or whenever the owner or
operator has reason to believe that a previously trained person does
not have the required understanding and skill to properly use dermal
protection, or when changes in the workplace or in dermal protection to
be used render the previous training obsolete.
Sec. 751.709 Workplace Restrictions for the Industrial and Commercial
Use as a Laboratory Chemical, Including the Use of Carbon Tetrachloride
as a Laboratory Chemical by the U.S. Department of Defense.
(a) Applicability. The provisions of this section apply to the
industrial and commercial use of carbon tetrachloride as a laboratory
chemical, including the U.S. Department of Defense's industrial and
commercial use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction.
(b) Laboratory chemical requirements. (1) After December 18, 2025
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or after June 16, 2025 for non-Federal owners
and operators, owners or operators must ensure laboratory ventilation
devices such as fume hoods or glove boxes are in use and functioning
properly and that specific measures are taken to ensure proper and
adequate performance of such equipment to minimize exposures to
potentially exposed persons in the area when carbon tetrachloride is
used as a laboratory chemical, except for the U.S. Department of
Defense's use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction.
(2) After December 18, 2025, the U.S. Department of Defense must
ensure that
[[Page 103557]]
advanced engineering controls are in use and functioning properly and
that specific measures are taken to ensure proper and adequate
performance of such equipment to minimize exposures to potentially
exposed persons in the area during the industrial/commercial use of
carbon tetrachloride as a laboratory chemical in chemical weapons
destruction.
(3) After December 18, 2025 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or after
June 16, 2025 for non-Federal owners and operators, owners or operators
must ensure that all persons reasonably likely to be exposed from
direct dermal contact to carbon tetrachloride when carbon tetrachloride
is used as a laboratory chemical, except for the U.S. Department of
Defense's industrial and commercial use of carbon tetrachloride as a
laboratory chemical in chemical weapons destruction, are provided with
dermal PPE and training on proper use of PPE in a manner consistent
with Sec. 751.707(f)(3).
(4) After December 18, 2025, U.S. Department of Defense must ensure
that all persons reasonably likely to be exposed from direct dermal
contact to carbon tetrachloride through the industrial and commercial
use of carbon tetrachloride as a laboratory chemical in chemical
weapons destruction are provided with dermal PPE and training on proper
use of PPE in a manner consistent with Sec. 751.707(f)(3), except that
the date listed in paragraph (f)(3)(i) does not apply.
Sec. 751.711 Downstream Notification.
(a) Beginning on February 18, 2025, each person who manufactures
(including imports) carbon tetrachloride for any use must, prior to or
concurrent with the shipment, notify companies to whom carbon
tetrachloride is shipped, in writing, of the restrictions described in
this Subpart in accordance with paragraph (c) of this section.
(b) Beginning on June 16, 2025, each person who processes or
distributes in commerce carbon tetrachloride for any use must, prior to
or concurrent with the shipment, notify companies to whom carbon
tetrachloride is shipped, in writing, of the restrictions described in
this Subpart in accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in Sections 1(c) and
15 of the Safety Data Sheet (SDS) provided with the carbon
tetrachloride:
After June 16, 2025, this chemical substance (as defined in TSCA
section 3(2)) may not be distributed in commerce or processed in
greater than trace quantities for the following purposes:
Incorporation into formulation, mixture or reaction products in
petrochemical-derived manufacturing except in the manufacture of
vinyl chloride; Industrial and commercial use as an industrial
processing aid in the manufacture of petrochemicals-derived products
except in the manufacture of vinyl chloride; Industrial and
commercial use in the manufacture of other basic chemicals
(including manufacturing of chlorinated compounds used in solvents,
adhesives, asphalt, and paints and coatings), except for use in the
elimination of nitrogen trichloride in the production of chlorine
and caustic soda and the recovery of chlorine in tail gas from the
production of chlorine; Industrial and commercial use in metal
recovery; Industrial and commercial use as an additive; and
beginning December 18, 2025, industrial and commercial specialty
uses by the U.S. Department of Defense.
Sec. 751.713 Recordkeeping Requirements.
(a) General records. After February 18, 2025, all persons who
manufacture (including import), process, distribute in commerce, or
engage in industrial or commercial use of carbon tetrachloride must
maintain ordinary business records, such as downstream notifications,
invoices and bills-of-lading related to compliance with the
prohibitions, restrictions, and other provisions of this subpart.
(b) Workplace Chemical Protection Program compliance--(1) ECEL
exposure monitoring. For each monitoring event, owners or operators
subject to the ECEL described in Sec. 751.707(b) must document and
retain records of the following:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of use of carbon
tetrachloride in use at the time of each monitoring event;
(iii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iv) Name, workplace address, work shift, job classification, work
area, and type of respiratory protection (if any) by each monitored
person;
(v) Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample, consistent with Sec. 751.707(b)(2)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in Sec.
751.707(b)(2)(i)(D);
(vii) Compliance with the Good Laboratory Practice Standards in 40
CFR part 792, or use of laboratory accredited by the AIHA or another
industry-recognized program, as required by Sec. 751.707(b)(2)(i)(C);
and
(viii) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions;
(ix) Re-monitoring determinations conducted by an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist, if results indicated non-detect; and
(x) Notification of exposure monitoring results in accordance with
Sec. 751.707(b)(2)(v).
(2) ECEL compliance. Owners or operators subject to the ECEL
described in Sec. 751.707(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.707(d)(2);
(ii) Implementation of the exposure control plan as described in
Sec. 751.707(d)(2), including:
(A) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure
controls; and
(C) Each occurrence and duration of any start-up, shutdown,
ruptures, or malfunction of the facility that causes an exceedance of
the ECEL, any subsequent corrective actions taken by the owner or
operator during the start-up, shutdown, ruptures, or malfunctions to
mitigate exposures to CTC, and documentation indicating that additional
monitoring was completed within a reasonable timeframe.
(iii) Respiratory protection used by each potentially exposed
person and PPE program implementation as described in Sec.
751.707(f)(2) including:
(A) The name, workplace address, work shift, job classification,
work area of each potentially exposed person, and the type of
respiratory protection provided to each potentially exposed person;
(B) The basis for the specific respiratory protection selection in
accordance with Sec. 751.707(f)(2); and
(C) Fit testing and training in accordance with Sec.
751.707(f)(2).
(iv) Information and training as required in Sec. 751.707(e).
(3) DDCC compliance. Owners or operators subject to DDCC
requirements described in Sec. 751.707(c) must retain records of:
(i) Exposure control plan as described in Sec. 751.707(d)(2);
(ii) Dermal protection used by each potentially exposed person and
PPE program implementation as described in Sec. 751.707(f)(3),
including:
(A) The name, workplace address, work shift, job classification,
and work area of each person reasonably likely to
[[Page 103558]]
directly handle carbon tetrachloride or handle equipment or materials
on which carbon tetrachloride may be present and the type of PPE
selected to be worn by each of these persons;
(B) The basis for specific PPE selection (e.g., demonstration based
on permeation testing or manufacturer specifications that each item of
PPE selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(C) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE;
(D) Occurrence and duration of any direct dermal contact with
carbon tetrachloride that occurs during any activity or malfunction at
the workplace that causes direct dermal exposures to occur and/or glove
breakthrough, and corrective actions to be taken during and immediately
following that activity or malfunction to prevent direct dermal contact
to carbon tetrachloride; and
(E) Training in accordance with Sec. 751.707(f)(3).
(iii) Information and training provided as required in Sec.
751.707(e).
(4) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person that may
reasonably be affected by carbon tetrachloride inhalation exposure or
direct dermal contact and their designated representatives to readily
access the exposure control plans, facility exposure monitoring
records, PPE program implementation records, or any other information
relevant to carbon tetrachloride exposure in the workplace.
(c) Workplace requirements for laboratory use compliance. Owners
and operators subject to the laboratory chemical requirements described
in Sec. 751.709 must retain records of:
(1) Dermal protection used by each potentially exposed person and
PPE program implementation, as described in Sec. 751.713(b)(3)(ii);
and
(2) Documentation identifying criteria that the owner or operator
will use to determine and implement control measures to reduce
potentially exposed persons' exposure to carbon tetrachloride including
laboratory ventilation devices;
(3) Documentation identifying: implementation of a properly
functioning laboratory ventilation devices using manufacturer's
instructions for installation, use, and maintenance of the devices
including inspections, tests, development of maintenance procedures,
the establishment of criteria for acceptable test results, and
documentation of test and inspection results, except for the U.S.
Department of Defense's use of carbon tetrachloride as a laboratory
chemical in chemical weapons destruction; and
(4) For the U.S. Department of Defense's use of carbon
tetrachloride as a laboratory chemical in chemical weapons destruction,
documentation identifying implementation of advanced engineering
controls that are in use and functioning properly and specific measures
taken to ensure proper and adequate performance.
(d) Retention. Owners or operators must retain the records required
under this section for a period of five years from the date that such
records were generated.
[FR Doc. 2024-29517 Filed 12-17-24; 8:45 am]
BILLING CODE 6560-50-P