Rule2024-29517
Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
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Published
December 18, 2024
Effective
January 17, 2025
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29517]
[[Page 103511]]
Vol. 89
Wednesday,
No. 243
December 18, 2024
Part VIII
Environmental Protection Agency
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#60230112020f0e340514120103080c0f1209040534332321200510014e070f16"><span class="__cf_email__" data-cfemail="074466756568695362737566646f6b68756e6362535444464762776629606871">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: <a href="/cdn-cgi/l/email-protection#27737464660a6f48534b4e49426742574609404851"><span class="__cf_email__" data-cfemail="4410170705690c2b30282d2a21042134256a232b32">[email protected]</span></a>.
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:
<bullet> Chemical Manufacturing (NAICS code 325);
<bullet> Nonmetallic Mineral Product Manufacturing (NAICS code
327);
<bullet> Primary Metal Manufacturing (NAICS code 331);
<bullet> Waste Management and Remediation Services (NAICS code
562);
<bullet> Petrochemical Manufacturing (NAICS code 325110);
<bullet> Industrial Gas Manufacturing (NAICS code 325120);
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
<bullet> Cyclic Crude, Intermediate, and Gum and Wood Chemical
Manufacturing (NAICS code 325194);
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
<bullet> Plastics Material and Resin Manufacturing (NAICS code
325211);
<bullet> Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320);
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
<bullet> Cement Manufacturing (NAICS code 327310);
<bullet> Ground or Treated Mineral and Earth Manufacturing (NAICS
code 327992);
<bullet> Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410);
<bullet> NAICS code 562211--Hazardous Waste Treatment and Disposal
NAICS code 562211); and
<bullet> 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 (<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>). 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.:
<bullet> Domestic manufacture;
<bullet> Import;
<bullet> Processing as a reactant in the production of
hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), HFOs, and
perchloroethylene (PCE);
<bullet> Incorporation into formulation, mixture or reaction
products in agricultural products manufacturing, vinyl chloride
manufacturing, and other basic organic and inorganic chemical
manufacturing;
<bullet> Repackaging for use as a laboratory chemical;
<bullet> Recycling;
<bullet> Industrial and commercial use as an industrial processing
aid in the manufacture of agricultural products and vinyl chloride;
<bullet> 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
<bullet> 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.:
<bullet> 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);
<bullet> 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);
<bullet> 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);
<bullet> Industrial and commercial use in metal recovery;
<bullet> Industrial and commercial use as an additive; and
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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:
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
<bullet> 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)).
<bullet> 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:
<bullet> 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;
<bullet> Requirements for prescriptive workplace controls for
laboratory use; and
<bullet> 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:
<bullet> Dates, duration, and results of each sample taken.
<bullet> The quantity, location(s) and manner of use of CTC at the
time of each monitoring event.
<bullet> 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.
<bullet> Name, workplace address, work shift, job classification,
work area, and type of respiratory protection (if any) of each
monitored person.
<bullet> Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample.
<bullet> Use of appropriate sampling and analytical methods.
<bullet> 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.
<bullet> Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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;
<bullet> For each exposure control considered, exposure controls
selected based on feasibility, effectiveness, and other relevant
considerations;
<bullet> 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;
<bullet> A description of regulated areas, how they are demarcated,
and persons authorized to enter the regulated areas;
<bullet> 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;
<bullet> 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
<bullet> 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):
<bullet> If the measured exposure concentration is at or below 0.03
ppm: no respiratory protection is required.
<bullet> 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].
<bullet> 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].
<bullet> 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].
<bullet> 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].
<bullet> 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].
<bullet> 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:
<bullet> 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;
<bullet> 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);
<bullet> Appropriately sized PPE and training on proper
application, wear, and removal of PPE, and proper care/disposal of PPE;
<bullet> 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
<bullet> Training described in this unit.
7. Additional Finalized Requirements
a. Workplace Information and Training
EPA is also finalizing
[…truncated; see source link]Indexed from Federal Register on December 18, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.