[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Rules and Regulations]
[Pages 103512-103558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29517]
[[Page 103511]]
Vol. 89
Wednesday,
No. 243
December 18, 2024
Part VIII
Environmental Protection Agency
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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 https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Emilia Echeveste Brise[ntilde]o,
Existing Chemicals Risk Management Division (7404M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number (202)
566-0543; email address: [email protected].
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture (defined under TSCA
to include import), process, distribute in commerce, use, or dispose of
CTC (CASRN 56-23-5). TSCA section 3(9) defines the term ``manufacture''
to mean ``to import into customs territory of the United States (as
defined in general note 2 of the Harmonized Tariff Schedule of the
United States), produce, or manufacture''. Therefore, unless expressly
stated otherwise, importers of CTC are subject to any provisions
regulating manufacture of CTC. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
include:
Chemical Manufacturing (NAICS code 325);
Nonmetallic Mineral Product Manufacturing (NAICS code
327);
Primary Metal Manufacturing (NAICS code 331);
Waste Management and Remediation Services (NAICS code
562);
Petrochemical Manufacturing (NAICS code 325110);
Industrial Gas Manufacturing (NAICS code 325120);
Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
Cyclic Crude, Intermediate, and Gum and Wood Chemical
Manufacturing (NAICS code 325194);
All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
Plastics Material and Resin Manufacturing (NAICS code
325211);
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320);
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
Cement Manufacturing (NAICS code 327310);
Ground or Treated Mineral and Earth Manufacturing (NAICS
code 327992);
Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410);
NAICS code 562211--Hazardous Waste Treatment and Disposal
NAICS code 562211); and
Solid Waste Combustors and Incinerators (NAICS code
562213).
2. Applicability to Importers and Exporters
This action may also affect certain entities subject to import
certification, and export notification rules under TSCA (https://www.epa.gov/tsca-import-export-requirements). Persons who import any
chemical substance in bulk form, as part of a mixture, or as part of an
article (if required by rule) are subject to the TSCA section 13 (15
U.S.C. 2612) import certification requirements and the corresponding
regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28.
Those persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this final rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S.
Environmental Protection Agency, hereinafter referred to as EPA or
``the Agency'', determines through a TSCA section 6(b) risk evaluation
that a chemical substance presents an unreasonable risk of injury to
health or the environment, EPA must by rule apply one or more
requirements listed in TSCA section 6(a) to the extent necessary so
that the chemical substance or mixture no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that CTC presents an
unreasonable risk of injury to health, without consideration of costs
or other nonrisk factors, including an unreasonable risk to potentially
exposed or susceptible subpopulations (PESS) identified as relevant to
the 2020 Risk Evaluation for Carbon Tetrachloride by EPA, under the
conditions of use (Refs. 1, 2, 3). A description of the conditions of
use that contribute to EPA's determination that CTC presents an
unreasonable risk is in the proposed rule (88 FR 49190) (FRL-8206-01-
OCSPP) and Unit IV. Accordingly, to
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address the unreasonable risk, EPA is issuing this final rule under
TSCA section 6(a) to:
(1) Require a Workplace Chemical Protection Program (WCPP),
including an inhalation exposure concentration limit, direct dermal
contact controls, and related workplace exposure controls, for the
following occupational conditions of use of CTC not prohibited,
outlined in Unit IV.B.:
Domestic manufacture;
Import;
Processing as a reactant in the production of
hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), HFOs, and
perchloroethylene (PCE);
Incorporation into formulation, mixture or reaction
products in agricultural products manufacturing, vinyl chloride
manufacturing, and other basic organic and inorganic chemical
manufacturing;
Repackaging for use as a laboratory chemical;
Recycling;
Industrial and commercial use as an industrial processing
aid in the manufacture of agricultural products and vinyl chloride;
Industrial and commercial use in the elimination of
nitrogen trichloride in the production of chlorine and caustic soda and
the recovery of chlorine in tail gas from the production of chlorine;
and
Disposal.
(2) Require use of laboratory ventilation devices, such as fume
hoods or glove boxes, and dermal personal protective equipment (PPE)
for the industrial and commercial use as a laboratory chemical, as
outlined in Unit IV.C.;
(3) Prohibit these additional conditions of use, for which the
Agency understands use of CTC has already ceased, as outlined in Unit
IV.D.:
Incorporation into formulation, mixture or reaction
products in petrochemical-derived manufacturing except in the
manufacture of vinyl chloride (for which EPA is requiring a WCPP);
Industrial and commercial use as an industrial processing
aid in the manufacture of petrochemicals-derived products except in the
manufacture of vinyl chloride (for which EPA is requiring a WCPP);
Industrial and commercial use in the manufacture of other
basic chemicals (including manufacturing of chlorinated compounds used
in solvents, adhesives, asphalt, and paints and coatings), except for
use in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine (for which EPA is requiring a WCPP);
Industrial and commercial use in metal recovery;
Industrial and commercial use as an additive; and
Industrial and commercial use in specialty uses by the
U.S. Department of Defense (DoD).
(4) Require recordkeeping, as outlined in Unit IV.E.1.
(5) Require manufacturers (including importers), processors, and
distributors to provide downstream notification of the requirements, as
outlined in Unit IV.E.2.
EPA notes that not all TSCA conditions of use of CTC are subject to
this final rule. ``Conditions of use'' is defined in TSCA section 3(4)
to mean the circumstances, as determined by EPA, under which a chemical
substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
As described in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.
1) and the 2022 Revised Unreasonable Risk Determination for Carbon
Tetrachloride (Ref. 3), two conditions of use of CTC do not drive the
unreasonable risk: distribution in commerce and processing as a
reactant/intermediate in reactive ion etching. EPA is not finalizing
any restrictions for the processing of CTC as a reactant/intermediate
in reactive ion etching. However, under TSCA section 6(a), EPA may
select from among a suite of risk management requirements in TSCA
section 6(a), including requirements related to distribution in
commerce, as part of its regulatory options to address the unreasonable
risk; EPA's final regulatory action includes prohibitions on the
distribution in commerce of CTC for certain downstream conditions of
use to address unreasonable risk from those downstream conditions of
use. Additionally, as explained in Section 1.4.2.3 of the 2020 Risk
Evaluation for Carbon Tetrachloride and Section 2.2.2.1 of the 2018
Problem Formulation of the Risk Evaluation for Carbon Tetrachloride,
EPA concluded that the industrial/commercial/consumer uses of CTC in
adhesives/sealants, paints/coatings, and cleaning/degreasing solvent
products contain only trace amounts of CTC, present only de minimis
exposures or otherwise insignificant risks under TSCA, and did not
warrant inclusion in the risk evaluation. Therefore, EPA has excluded
from the rule's requirements CTC that is solely present unintentionally
in trace quantities with another chemical substance or mixture, whether
as a manufacturing residue, unreacted feedstock, byproduct, or other
contaminant. However, EPA notes that the Agency has discretion to
further assess trace quantities of CTC under other regulatory
authorities, such as the Clean Air Act. Finally, manufacture of CTC as
a byproduct was not evaluated in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1); therefore, in this final rule, WCPP
requirements applicable to the domestic manufacture of CTC do not apply
where CTC is manufactured solely as a byproduct. EPA anticipates that
any risks presented by the presence of CTC as a byproduct formed during
the manufacturing, processing or use of a parent compound will be
considered in the scope of the risk evaluation of such parent compound.
For example, EPA will assess the risks of CTC manufactured as a
byproduct during the manufacture of 1,2-dichloroethane in the TSCA risk
evaluation for 1,2-dichloroethane (Ref. 1).
D. Why is the Agency taking this action?
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' CTC was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in November 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in December 2022 (Ref.
3), determining that CTC, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. On
July 28, 2023, EPA issued a proposed rulemaking (88 FR 49180) (FRL-
8206-01-OCSPP) under TSCA section 6(a) to take action to the extent
necessary so that CTC no longer presents such risk. The Agency received
public comment on the proposal. With this action, EPA is finalizing
with modifications the July 2023 proposed rule so that CTC no longer
presents an such risk. The conditions of use that contribute to the
unreasonable risk from CTC are described in the proposed rule (88 FR
49190) (FRL-8206-01-OCSPP) and Unit IV.
CTC's hazards are well established. EPA's 2020 Risk Evaluation for
Carbon Tetrachloride considered the hazards
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associated with exposure to CTC and determined that CTC presents an
unreasonable risk of injury to health due to the significant adverse
health effects associated with the exposure of CTC. While some risks of
adverse effects from CTC exposure are associated with acute single
exposures, other risks are associated with long-term repeated
exposures. EPA identified cancer and liver toxicity adverse effects
from chronic inhalation and dermal exposures as well as liver toxicity
from acute dermal exposures to CTC (Refs. 1, 2, 3). Cancer adverse
effects (e.g., liver, pheochromocytoma, neuroblastoma) were identified
for chronic inhalation and dermal exposures. Cancer was selected based
on the best available science and weight of scientific evidence, and in
consideration of the severity of hazards, magnitude of exposure,
population exposed, and uncertainties in the November 2020 Risk
Evaluation for Carbon Tetrachloride and the December 2022 Revised Risk
Determination for Carbon Tetrachloride. EPA identified in the 2020 Risk
Evaluation for Carbon Tetrachloride a threshold cancer point of
departure (POD) for liver tumors (assuming a margin of exposure of
300), and an inhalation unit risk (IUR) for adrenal tumors, based on
effects observed in mice following inhalation exposure. The chronic
non-cancer PODs for inhalation exposures are based on a study observing
increased fatty changes in rodent livers (fatty changes in the liver
are a precursor for liver fibrosis). EPA also identified additional
risks associated with other adverse effects (e.g., immediate and
temporary depression of the central nervous system, kidney toxicity,
reproductive and developmental toxicity, irritation and sensitization,
and genetic toxicity) resulting from acute and chronic exposures. For
this action, EPA has determined that protecting against liver and
adrenal cancer would also address the risk for acute non-cancer,
chronic non-cancer, and additional cancer risks from CTC, as identified
in the 2020 Risk Evaluation for Carbon Tetrachloride and the Revised
Unreasonable Risk Determination for CTC in December 2022 (Ref. 1, 2 and
3).
CTC is primarily used as a feedstock to make products such as
refrigerants, aerosol propellants, and foam-blowing agents.
Requirements under the Montreal Protocol and Title VI of the Clean Air
Act (CAA), which were included in the CAA Amendments of 1990 and are
codified at 42 U.S.C. Chapter 85, Subchapter VI, led to a phaseout of
CTC production in the 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
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laboratory safety requirement for laboratory settings because these
requirements are part of baseline industry practices. All manufacturers
(including importers), processors, and distributors will bear
downstream notification and recordkeeping costs.
The costs are estimated as incremental to baseline conditions,
including current use of PPE. The costs represent a high-end estimate
of the number of entities and workers affected by the regulation
because the high estimates of workers and entities from the 2020 Risk
Evaluation for Carbon Tetrachloride were used. To the extent that EPA's
approach overestimates the number of entities subject to the
regulation, actual realized costs of this action will be lower. More
details regarding the provisions of the final rule are in Unit IV.
In addition to the quantified costs, there is an unquantified cost
to workers and firms associated with prolonged use of respirators,
which could interfere with work tasks. The potential for respirator use
to cause discomfort and productivity losses could lead companies to
offer higher wages as compensation, but the extent of this effect is
unknown and thus unquantified. The Economic Analysis contains
additional information about the unquantified costs in Chapter 3 and in
the Estimated Incremental Costs section of the Executive Summary (Ref.
5).
Unit IV. details which actions apply to specific conditions of use.
EPA estimates that 30 firms associated with 72 sites may be
manufacturing (including importing), processing, or releasing CTC.
EPA estimates that the final rule would affect at least seven small
entities. EPA compared the highest annualized per-facility cost of the
final regulatory action with ultimate parent company annual revenues of
the affected small businesses. EPA found impacts under 1% of annual
revenues for five of the seven small entities. Two small entities were
estimated to have a cost-to-revenue impact ratio of between one and
three percent.
In alignment with the goals of President Biden's Cancer Moonshot,
the rule will protect people from cancer and other adverse health
effects of CTC (Ref. 7). The actions in this final rule are expected to
achieve health benefits for the American public. The Economic Analysis
monetizes benefits to occupational users and non-users of avoiding
cases of adrenal and liver cancer due to reduced inhalation exposures
that result from implementation of the WCPP. The magnitude of the
cancer benefits from reduced inhalation exposure is estimated assuming
companies provide respirators to comply. It is also possible that
employees will receive respiratory benefits from other actions on
OSHA's hierarchy of controls, such as engineering controls, since
regulated entities are required first to consider other measures in the
hierarchy of controls and then to select PPE based on monitoring
results. However, the Economic Analysis does not estimate the costs of
such controls because feasible controls and their costs are site-
specific and the amount of additional exposure reduction that could be
achieved through any given type of control would depend on the extent
to which such controls are already in place, which is likely to vary
across individual facilities. This assumption is made for the purpose
of estimating costs only and is not an assumption about how facilities
would necessarily comply with WCPP requirements. Other human health
benefits, including noncancer and additional cancer benefits, while
tangible and significant, cannot be monetized due to data and
methodology limitations. These include additional cancer benefits from
avoided brain tumors, noncancer health benefits, health benefits from
avoided dermal exposure, and benefits to the environment. The
incremental improvements in health outcomes achieved by given
reductions in exposure cannot currently be quantified for non-cancer
health effects associated with CTC exposure, and therefore cannot be
converted into monetized benefits. Although some benefits cannot be
quantified, they are not necessarily less important than the quantified
benefits. The primary reason these benefits were not quantified is the
difficulty in estimating the relationship between an incremental change
in CTC use and the corresponding change to a specific health or
environmental outcome.
Adrenal and liver cancer avoidance benefits are calculated based on
reductions in inhalation exposure using the 2020 Risk Evaluation for
Carbon Tetrachloride (Ref. 1) for those uses which are continuing but
with a WCPP in place. Therefore, benefits are only calculated for the
WCPP in the final rule, which could include respiratory protection. The
estimated monetized benefit of the final rule ranges from approximately
$0.13 to $0.14 million per year annualized over 20 years at a 3%
discount rate and from $0.06 to $0.07 million per year at a 7% discount
rate. In response to the updated Circular A-4 published in November
2023, the incremental benefits at a 2% discount rate ($0.16 to $0.17
million annualized over 20 years) are provided in Appendix C of the
Economic Analysis (Ref. 5). To estimate the costs and benefits of the
WCPP, the Economic Analysis generated a likely distribution of air
monitoring outcomes at CTC facilities. This distribution was used to
project the number of facilities that would require each respirator
APF. These estimates are subject to uncertainties, and there could be
facilities with higher or lower air exposures than estimated in the
Economic Analysis.
Using the high-end estimates for the number of entities and workers
affected by the final rule, the monetized net benefit of the final
rule, which is negative, is -$19.6 million per year annualized over 20
years at a 3% discount rate and is -$18.9 million per year at a 7%
discount rate. In response to the updated Circular A-4 published in
November 2023, the incremental net benefits at a 2% discount rate (-
$19.7 million annualized over 20 years) are provided in Appendix C of
the Economic Analysis (Ref. 5). The range in the monetized net benefits
estimate at each discount rate presented in the Economic Analysis
reflects uncertainty in cancer risk reductions given the shorter
exposure durations being considered and the life stage at which the
changes in exposure occur. Although the estimated monetized net
benefits are negative, there are also non-monetized benefits due to
other avoided adverse health effects associated with CTC exposure,
including liver, reproductive, renal, developmental, and central
nervous system (CNS) toxicity endpoints. These are serious health
endpoints, even though the change in risk due to CTC exposure was not
quantified in the 2020 Risk Evaluation for Carbon Tetrachloride.
Section 6.6 of the Economic Analysis, addressing environmental
justice impacts, provides sociodemographic data on communities and
workers in industries affected by the rule and people who live in
proximity to potentially affected facilities. EPA analyzed the baseline
conditions facing communities near CTC and HFO manufacturing facilities
as well as those of workers in the same industry and county as CTC
facilities and HFO manufacturing facilities. The environmental justice
analysis found that, across the entire population within 1- and 3-miles
of CTC facilities, there are higher percentages of people who identify
as Black and living below the poverty line and a similar percentage of
people who identify as Hispanic
[[Page 103516]]
compared to the national averages. CTC facilities are concentrated in
Texas and Louisiana, especially near Houston and Baton Rouge.
II. Background
A. Overview of Carbon Tetrachloride
As described in more detail in the proposed rule, EPA identified
liver and adrenal toxicity cancer adverse effects from chronic
inhalation and dermal exposures, as well as liver toxicity from acute
dermal exposures in the workplace as the basis for the unreasonable
risk determination for CTC (Ref. 1, 2, and 3). This final rule is
specifically intended to address the unreasonable risk of injury to
health EPA identified in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1) and the 2022 Revised Unreasonable Risk
Determination for Carbon Tetrachloride (Ref. 3), as described in Unit
II.C. CTC is a volatile organic compound that is primarily used as a
feedstock in the production of HCFCs, HFCs, and HFOs.
According to data submitted for EPA's 2016 and 2020 Chemical Data
Reporting (CDR) Rule, in Reporting Years (RY) 2015 and 2019, between
100 and 250 million pounds of CTC were manufactured or imported in the
United States (Refs. 5, 8, 9). CTC's use as a feedstock in the
production of HCFCs, HFCs, and HFOs and the description of finalized
requirements to address the unreasonable risk are described in Unit
IV.B.
B. Regulatory Actions Pertaining to Carbon Tetrachloride
Because of its adverse health effects, CTC is subject to numerous
Federal laws and regulations in the United States and is also subject
to regulation by some states and other countries. A summary of EPA
regulations pertaining to CTC, as well as other Federal, State, and
international regulations, is provided in the docket (Refs. 1, 10).
As described in more detail in Unit II.C. of EPA's proposed rule
(88 FR 49184, July 28, 2023) (FRL-8206-01-OCSPP) and the Response to
Public Comments document (Ref. 11), EPA considered the adequacy of the
current occupational safety and health standards from the OSHA (29 CFR
part 1910) for protection of workers. EPA notes that the standards for
chemical hazards that OSHA promulgates under the Occupational Safety
and Health (OSH Act) share a broadly similar purpose with the worker
protection-related regulations that EPA promulgates under TSCA section
6(a). The control measures OSHA and EPA require to satisfy the
objectives of their respective statutes may also, in many
circumstances, overlap or coincide. However, there are important
differences between EPA's and OSHA's regulatory approaches and
jurisdiction, and EPA considers these differences when deciding whether
and how to account for OSHA requirements when evaluating and addressing
potential unreasonable risk to workers so that compliance requirements
are clearly explained to the regulated community. TSCA risk evaluations
are subject to statutory science standards, an explicit requirement to
consider risks to potentially exposed or susceptible subpopulations,
and a prohibition on considering costs and other non-risk factors when
determining whether a chemical presents an unreasonable risk that
warrants regulatory actions--all requirements that do not apply to
development of OSHA regulations. As such, EPA may find unreasonable
risk for purposes of TSCA notwithstanding OSHA requirements. In
addition, health standards issued under section 6(b)(5) of the OSH Act
must reduce significant risk only to the extent that it is
technologically and economically feasible. OSHA's legal requirement to
demonstrate that its section 6(b)(5) standards are technologically and
economically feasible at the time they are promulgated often precludes
OSHA from imposing exposure control requirements sufficient to ensure
that the chemical substance no longer presents a significant risk to
workers. While it is possible in some cases that the OSHA standards for
some chemicals reviewed under TSCA will eliminate unreasonable risk,
based on EPA's experience thus far in conducting occupational risk
assessments under TSCA, EPA believes that OSHA chemical standards would
in general be unlikely to address unreasonable risk to workers within
the meaning of TSCA, since TSCA section 6(b) unreasonable risk
determinations may account for unreasonable risk to more sensitive
endpoints and working populations than OSHA's risk evaluations
typically contemplate and EPA is obligated to apply TSCA section 6(a)
risk management requirements to the extent necessary so that the
unreasonable risk is no longer presented. Because the requirements and
application of TSCA and OSHA regulatory analyses differ, it is
necessary for EPA to conduct risk evaluations and, where it finds
unreasonable risk to workers, develop risk management requirements for
chemical substances that OSHA also regulates, and it is expected that
EPA's findings and requirements may sometimes diverge from OSHA's.
Additional considerations of OSHA standards in the 2022 Revised
Unreasonable Risk Determination for Carbon Tetrachloride are discussed
further in the Federal Register of December 27, 2022 (87 FR 79303).
EPA intends for this regulation to be as consistent as possible
with OSHA regulations for toxic and hazardous substances, with
additional requirements as necessary to address the unreasonable risk.
Consistent with TSCA section 9(d), EPA consults and coordinates TSCA
activities with OSHA and other relevant Federal agencies for the
purpose of achieving the maximum enforcement of TSCA while imposing the
least burdens of duplicative requirements.
C. Summary of EPA's Risk Evaluation Activities on Carbon Tetrachloride
EPA published the scope of the CTC risk evaluation in July 2017 (82
FR 31592) (FRL-9963-57), and, after receiving public comments,
published the problem formulation on June 11, 2018 (83 FR 26998) (FRL-
9978-40). In January 2020, EPA published a draft risk evaluation (85 FR
4658, January 27, 2020) (FRL-10003-92), and, after public comment and
peer review by the Science Advisory Committee on Chemicals (SACC), EPA
issued the Risk Evaluation for Carbon Tetrachloride in November 2020 in
accordance with TSCA section 6(b) (Ref. 1) (85 FR 70147, November 4,
2020) (FRL-10015-51). EPA subsequently issued a draft revised TSCA
unreasonable risk determination for CTC (87 FR 52766, August 29, 2022)
(FRL-9948-01-OCSPP), and, after public notice and receipt of comments,
published a Revised Unreasonable Risk Determination for Carbon
Tetrachloride in December 2022 (Ref. 3) (87 FR 79303, December 27,
2022) (FRL-9948-02-OCSPP). The 2020 Risk Evaluation for Carbon
Tetrachloride and supplemental materials are in docket EPA-HQ-OPPT-
2019-0499, and the December 2022 revised unreasonable risk
determination and additional materials supporting the risk evaluation
process in docket EPA-HQ-OPPT-2016-0733 available at https://www.regulations.gov.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for Carbon Tetrachloride, EPA evaluated
risks associated with 15 conditions of use within the following
categories: manufacture (including import), processing, distribution in
commerce, industrial and commercial use, and disposal (Ref. 1). The
conditions of use are described in Unit III.B.1. of the
[[Page 103517]]
proposed rule (88 FR 49190) (FRL-8206-01-OCSPP) and in Unit IV. of this
final rule. The 2020 Risk Evaluation for Carbon Tetrachloride
identified significant adverse health effects associated with short-
term and long-term exposure to CTC. A further discussion of the hazards
of CTC is presented in Unit III.B.3 of the proposed rule (88 FR 49192)
(FRL-8206-01-OCSPP) and in Unit V. of this final rule.
2. 2022 Revised Unreasonable Risk Determination
As described in more detail in the proposed rule, EPA revised the
original unreasonable risk determination based on the 2020 Risk
Evaluation for Carbon Tetrachloride and issued a final revised
unreasonable risk determination in December 2022 (Ref. 3). EPA revised
the risk determination for the 2020 Risk Evaluation for Carbon
Tetrachloride pursuant to TSCA section 6(b) and consistent with
Executive Order 13990 (titled ``Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis'') and
other Administration priorities (Refs. 12, 13, 14). The revisions
consisted of making a single risk determination for the whole-chemical
substance instead of making the risk determination for each individual
condition of use, which resulted in the revised risk determination
superseding the prior ``no unreasonable risk'' determinations for
specific conditions of use (Ref. 3), the withdrawal of the associated
TSCA section 6(i)(1) ``no unreasonable risk'' order, and clarification
that the risk determination does not reflect an assumption that all
workers are always provided and appropriately wear personal protective
equipment (PPE) (Ref. 3).
EPA determined that CTC presents an unreasonable risk of injury to
health, and EPA did not identify risks of injury to the environment
that contribute to the unreasonable risk determination for CTC. The CTC
conditions of use that contribute to EPA's determination that the
chemical substance poses unreasonable risk to health are listed in the
unreasonable risk determination (Ref. 3) and also in Unit III.B.1. of
the proposed rule, with descriptions to aid chemical manufacturers,
processors, and users in determining how their particular use or
activity would be addressed under the final regulatory action. The
descriptions of the conditions of use subject to this final rule are in
Unit IV.
The conditions of use that do not drive the unreasonable risk for
CTC (distribution in commerce and processing as a reactant/intermediate
in reactive ion etching) are also listed in the unreasonable risk
determination (Ref. 3) and in Unit III.B.2. of the proposed rule. EPA's
final rule includes prohibitions on the distribution in commerce of CTC
for certain downstream uses, but does not include any restrictions for
the processing as a reactant/intermediate in reactive ion etching.
3. Description of Unreasonable Risk
EPA has determined that CTC presents an unreasonable risk of injury
to health under the conditions of use, based on cancer and acute and
chronic toxicity for non-cancer effects. As described in more detail in
the proposed rule, the TSCA section 6(b) 2020 Risk Evaluation for
Carbon Tetrachloride, and the July 2022 errata memorandum correcting
risk estimates for acute dermal exposures, EPA identified cancer and
liver toxicity adverse effects from chronic inhalation and dermal
exposures as well as liver toxicity from acute dermal exposures to CTC
(Refs. 1, 2, 3). Cancer adverse effects (e.g., liver, pheochromocytoma,
neuroblastoma) were identified for chronic inhalation and dermal
exposures. For chronic and acute non-cancer inhalation exposure to CTC,
liver toxicity due to fatty change in the liver was indicative of
cellular damage and selected as the most sensitive non-cancer endpoint.
EPA identified additional risks associated with other adverse effects
(e.g., immediate and temporary depression of the central nervous
system, kidney toxicity, reproductive and developmental toxicity,
irritation and sensitization, and genetic toxicity) resulting from
acute and chronic exposures (Ref. 1). By establishing protections from
liver and adrenal cancer, EPA's final rule will also prevent the
unreasonable risk from other less sensitive endpoints, including acute,
chronic non-cancer, and additional cancer risks from CTC (Ref. 15).
EPA considered potentially exposed or susceptible subpopulations
identified as relevant to the risk evaluation by the Agency, which are
included in the quantitative and qualitative analyses described in the
2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) and were
considered in the determination of unreasonable risk for CTC.
4. Conditions of Use Subject to This Regulatory Action
As noted in Unit I.C., ``Conditions of use'' is defined in TSCA
section 3(4). To assist with the implementation and compliance with the
final rule, in Unit IV., EPA has provided a description of the
conditions of use subject to the WCPP and to prescriptive controls, as
well as those conditions of use prohibited by this final rule. The
descriptions provided were obtained from EPA sources such as CDR codes,
the 2020 Risk Evaluation for Carbon Tetrachloride and related
documents, as well as the Organisation for Economic Co-operation and
Development (OECD) harmonized use codes, and stakeholder engagements.
EPA received public comments requesting minor clarifications of the
descriptions for some industrial and commercial uses, and EPA has
clarified those descriptions in Unit IV. A description of the minor
changes can be found in the response to comments document (Ref. 11) and
in Unit III.E.
For the purposes of this final rule, ``occupational conditions of
use'' refers to the TSCA conditions of use described in Units IV.B.1.,
IV.C.1., and IV.D.1. of the final rule. Although EPA identified both
industrial and commercial uses in the 2020 Risk Evaluation for Carbon
Tetrachloride (Ref. 1) for purposes of distinguishing exposure
scenarios, the Agency clarified then and clarifies now that EPA
interprets the authority Congress gave to the Agency to ``regulat[e]
any manner or method of commercial use'' under TSCA section 6(a)(5) to
reach both industrial and commercial uses.
EPA further notes that this rule does not apply to any substance
excluded from the definition of ``chemical substance'' under TSCA
section 3(2)(B)(ii) through (vi). Those exclusions include, but are not
limited to, any pesticide (as defined by the Federal Insecticide,
Fungicide, and Rodenticide Act) when manufactured, processed, or
distributed in commerce for use as a pesticide; and any food, food
additive, drug, cosmetic, or device, as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic or device.
D. EPA's Proposed Rule Under TSCA Section 6(a) for Carbon Tetrachloride
1. Description of TSCA Section 6(a) Requirements
Under TSCA section 6(a), if the Administrator determines through a
TSCA section 6(b) risk evaluation that a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to potentially exposed or susceptible subpopulation
identified as relevant to
[[Page 103518]]
the Agency's risk evaluation, under the conditions of use, EPA must by
rule apply one or more of the TSCA section 6(a) requirements to the
extent necessary so that the chemical substance or mixture no longer
presents such risk.
The TSCA section 6(a) requirements can include one or more of the
following actions alone or in combination:
Prohibit or otherwise restrict the manufacturing
(including import), processing, or distribution in commerce of the
substance or mixture, or limit the amount of such substance or mixture
which may be manufactured, processed, or distributed in commerce (TSCA
section 6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
Require clear and adequate minimum warnings and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records, or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
This unit summarizes the TSCA section 6 considerations for issuing
regulations under TSCA section 6(a), and it is consistent with the
considerations and analyses presented in the proposed rule to manage
the unreasonable risk from CTC (88 FR 49180, July 28, 2023 (FRL-8206-
01-OCSPP)).
As required, EPA developed a proposed regulatory action and an
alternative regulatory action, which are described in Units IV.A. and
IV.B., respectively, of the proposed rule (88 FR 49193 through 491205
(FRL-8206-01-OCSPP)). To identify and select a regulatory action, EPA
considered the two routes of exposure driving the unreasonable risk,
inhalation and dermal, and the exposed populations. For occupational
conditions of use, EPA considered how it could directly regulate
manufacturing (including import), processing, distribution in commerce,
industrial and commercial use, or disposal to address the unreasonable
risk.
As required by TSCA section 6(c)(2), EPA considered several
factors, in addition to the identified unreasonable risk, when
selecting among possible TSCA section 6(a) regulatory requirements for
the proposed rule. EPA's considerations regarding TSCA section 6(c)(2)
and section 6(c)(2)(A) for CTC are discussed in full in Unit VI. of the
proposed rule (88 FR 49209) (FRL-8206-01-OCSPP), including the
statement of effects with respect to these considerations. After review
of the public comments received, EPA has revised its statement of
effects considerations in Unit V. of this final rule.
Additionally, as described in more detail in EPA's proposed rule in
Unit V.B. (88 FR 49209) (FRL-8206-01-OCSPP), EPA considered the
availability of alternatives when finalizing a prohibition or a
substantial restriction (TSCA section 6(c)(2)(C)), and in setting final
compliance dates in accordance with the requirements in TSCA section
6(d)(1)(B)).
To the extent information was reasonably available, EPA considered
pollution prevention strategies and the hierarchy of controls adopted
by OSHA and the NIOSH when developing its proposed rule, with the goal
of identifying risk management control methods that would be permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated
community where appropriate, and EPA took into account the information
presented in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.
1), input from stakeholders, insight received during consultations, and
anticipated compliance strategies from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and alternative action described in Unit II.D.3. The
proposed rule presents additional details related to how the
requirements described in Unit II.D.1. of this document were
incorporated into development of the proposed rule and primary
alternative action.
2. Consultations and Other Engagement
a. Consultations
EPA conducted consultations and outreach as part of development of
the July 28, 2023 proposed rule (88 FR 49180) (FRL-8206-01-OCSPP). The
Agency held a federalism consultation from December 17, 2020, until
February 17, 2021, as part of the rulemaking process and pursuant to
Executive Order 13132 (Ref. 16).
EPA also consulted with Tribal officials (Ref. 17). The Agency held
a Tribal consultation from December 7, 2020, through March 12, 2021,
with meetings held on January 6 and 12, 2021 (Ref. 17). EPA received no
written comments as part of this consultation.
EPA's Environmental Justice (EJ) consultation occurred from
February 2, 2021, through April 2, 2021 (Ref. 18). On February 2 and
18, 2021, EPA held public meetings as part of this consultation. These
meetings were held pursuant to Executive Orders 12898 and 14008. EPA
received one written comment following the EJ meeting, in addition to
oral comments provided during the consultation (Ref. 18).
More information regarding the consultations is presented in Units
VIII.E., VIII.F. and VIII.J.
b. Other Stakeholder Consultations
In addition to the formal consultations described in Unit
II.D.2.a., EPA held a webinar on December 10, 2020, providing an
overview of the TSCA risk management processes and the risk evaluation
findings for CTC (Ref. 19). EPA also presented on the TSCA risk
management process and the findings in the 2020 Risk Evaluation for
Carbon Tetrachloride at a Small Business Administration (SBA)
Roundtable on December 4, 2020 (Ref. 20). Attendees of these meetings
were given an opportunity to voice their concerns on both the risk
evaluation and risk management.
Furthermore, during development of the proposed and final rule, EPA
engaged in discussions with representatives from different industries,
non-governmental organizations, organized labor, technical experts, and
users of CTC, including a
[[Page 103519]]
webinar providing an overview of the proposed rule. A list of external
meetings held during the development of the 2023 proposed and final
rule is available in the docket (Ref. 21); meeting materials and
summaries are also in the docket.
c. Children's Environmental Health
The Agency's 2021 Policy on Children's Health (Ref. 22) requires
EPA to protect children from environmental exposures by consistently
and explicitly considering early life exposures (from conception,
infancy, early childhood and through adolescence until 21 years of age)
and lifelong health in all human health decisions through identifying
and integrating children's health data and information when conducting
risk assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct
risk evaluations ``to determine whether a chemical substance presents
an unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' In addition, TSCA section
6(a) requires EPA to apply one or more risk management requirements
under TSCA section 6(a) so that CTC no longer presents an unreasonable
risk (which includes unreasonable risk to any relevant potentially
exposed or susceptible subpopulation). Information on how the Policy
was applied and on the health and risk assessments supporting this
action is available under Units II.C. II.D. and V.A., as well as in
Unit III.A.3. of the July 2023 proposed rule (88 FR 49184 through
49188, 49205 through 49208 and 49190) (FRL-8206-01-OCSPP), the 2020
Risk Evaluation for Carbon Tetrachloride, and the Economic Analysis for
this rule (Refs. 1, 5).
3. Proposed Regulatory Action
EPA's proposed rule under TSCA section 6(a) to address the
unreasonable risk presented by CTC under its conditions of use included
the following:
Requirements for strict workplace controls, including a
CTC WCPP, which would include requirements to meet an inhalation
exposure concentration limit and prevent direct dermal contact with
CTC, for 9 occupational conditions of use;
Requirements for prescriptive workplace controls for
laboratory use; and
Prohibition of certain processing, industrial, and
commercial conditions of use and the manufacture, processing, and
distribution for those uses.
The proposed rule included timeframes for implementation. The
prohibitions EPA proposed would take effect six months after the date
of publication of the final rule, except for the prohibition of the
industrial and commercial use of CTC in specialty uses by the
Department of Defense, which would take effect one year after the date
of publication of the final rule. Likewise, for the WCPP, EPA proposed
timeframes for phases of compliance, beginning with monitoring at six
months and full implementation after 12 months, as described in Unit
IV.A.1. of the proposed rule. EPA also proposed a compliance timeframe
of six months for prescriptive controls for laboratory use.
Under TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA is
mandated to consider one or more alternative regulatory actions. The
primary alternative regulatory action was included in the proposed rule
in Unit IV.B. (88 FR 49204) (FRL-8206-01-OCSPP). Similar to the
proposed regulatory action, the primary alternative regulatory action
combined requirements for a WCPP and prescriptive controls to address
the unreasonable risk from CTC under its conditions of use.
The primary alternative regulatory action included prescriptive
workplace controls, specifically respirators and dermal PPE, for the
conditions of use for which EPA had proposed a WCPP. The primary
alternative action also included a WCPP for processing, industrial, and
commercial uses of CTC that EPA had proposed to prohibit. At the time
of proposal, EPA did not have reasonably available information
indicating that any of the uses proposed for prohibition were ongoing.
EPA requested comment on whether any of the uses the Agency proposed to
prohibit are ongoing and if EPA should consider a WCPP for those
conditions of use of CTC. For the industrial and commercial use of CTC
as a laboratory chemical, the primary alternative regulatory action
considered by EPA included the implementation of only the requirements
of Direct Dermal Contact Controls (DDCC) of the WCPP in combination
with the use of fume hoods in workplace laboratory settings and
advanced engineering controls specifically for DoD's use of CTC as a
laboratory chemical in chemical weapons destruction. The compliance
timeframes for the controls as part of the primary alternative
regulatory action were the same as the timeframes proposed.
For a comprehensive overview of the primary alternative regulatory
action refer to Unit IV.B. of the proposed rule, with the rationale for
the primary alternative regulatory action provided in Unit V.A.4. of
the proposed rule (88 FR 49205 through 49208) (FRL-8206-01-OCSPP).
4. Public Comments Received
EPA requested comment on all aspects of the proposed rule. During
the public comment period, EPA held a webinar on August 15, 2023,
providing an overview of the proposed rule and TSCA section 6; during
the webinar, members of the public had the opportunity to share their
perspectives (Ref. 23). The comment period closed on September 11,
2023. EPA received 23 public comments, with a majority received from
industry trade organizations. The public comments also include comments
from chemical manufacturers, advocacy organizations, laboratory users,
a union, an academic institution, members of the regulated community,
and individual residents. A summary of the comments as well as EPA's
responses is in the docket for this rulemaking (Ref. 11). Additionally,
Unit III. contains summaries of public comments that informed EPA's
regulatory approach in this final rule.
After the close of the public comment period for the proposed rule,
stakeholders, including affected industry and interested groups,
requested meetings with EPA. Topics of these meetings included exposure
controls, process descriptions, monitoring data, and specific
conditions of use. EPA received data as part of and following these
stakeholder meetings and has made the information available to the
public in the rulemaking docket (EPA-HQ-OPPT-2020-0592) (Ref. 21).
After review of the public comments received from the proposed
rule, EPA revised certain preliminary considerations that impacted
which conditions of use were proposed by EPA to be prohibited or that
could continue under the WCPP or prescriptive controls (Ref. 11).
Similarly, based on public comments received, EPA modified for this
final rule several proposed compliance timeframes, with details in Unit
III.
III. Changes From the Proposed Rule
Unit III. summarizes the main changes from the proposed rule to the
final rule, based on the consideration of the public comments.
A. Changes to Requirements for Certain Conditions of Use
As described in Unit III.A.1., when compared to the proposed rule,
EPA's final rule no longer prohibits two sub-
[[Page 103520]]
uses, under two separate conditions of use that were proposed for
prohibition, and now allows them to continue under the WCPP. In
addition, this final rule broadens the type of prescriptive controls
required for one condition of use (Unit III.A.2.), as compared to the
proposed rule. The rationale for these changes is described in this
unit. EPA emphasizes that implementation of the WCPP or prescriptive
controls can fully address the unreasonable risk from CTC for these
conditions of use, and that these changes do not significantly impact
the production volume of CTC expected to remain in commerce when
compared to the proposed regulatory action. Taken together, EPA
estimates that there are 10 facilities involved in the changes of the
requirements to the conditions of use described in Units III.A.1. and
2., nine of which use CTC for the industrial and commercial use as a
laboratory chemical. In addition, EPA understands that small quantities
of CTC are used for the sub-uses that will continue under the WCPP
instead of the proposed prohibition (Ref. 24). The two sub-uses which
will continue under the WCPP account for approximately 0.4% to 1% of
total production volume, based on a comparison of 2019 CDR data on CTC
production volume (between 100 million and 250 million lbs.) and
information reported to EPA regarding the two sub-uses (Ref. 5, Ref.
24).
1. Changes to the Prohibition of Certain Conditions of Use
EPA's primary alternative regulatory action described in the
proposed rule considered regulating several conditions of use under the
WCPP as an alternative to the proposed prohibition, including
incorporation into formulation, mixtures, or reaction products in
petrochemicals-derived manufacturing, and industrial and commercial use
as an industrial processing aid in the manufacture of petrochemicals-
derived products. In addition, EPA requested comment on whether the
Agency should require a WCPP or prescriptive controls, including
respirators and dermal PPE, for any of the conditions of use EPA
proposed to prohibit.
EPA is finalizing a WCPP for incorporation into formulation,
mixtures, or reaction products in vinyl chloride manufacturing and the
industrial and commercial use as an industrial processing aid in the
manufacture of vinyl chloride, as included in the primary alternative
regulatory action of EPA's proposal under the broader categories of
processing: incorporation into formulation, mixtures, or reaction
products in petrochemical-derived manufacturing and industrial and
commercial use as an industrial processing aid in the manufacture of
petrochemical-derived products. EPA proposed to prohibit these sub-uses
of CTC due to the lack of information indicating that these uses are
ongoing, but requested comment on whether CTC is still used in these
and other conditions of use EPA proposed to prohibit, and stated that
if EPA received information indicating the continued use of CTC for
these conditions of use, the Agency would consider regulating these
uses rather than prohibiting them (88 FR at 49202 through 49203, 49205,
and 49218). EPA received comments from one entity indicating that the
incorporation of CTC into formulation, mixtures, or reaction products
in vinyl chloride manufacturing and the industrial and commercial use
of CTC as an industrial processing aid in the manufacture of vinyl
chloride are ongoing (Ref. 24). The entity indicated that switching to
an alternative chemical or process would require replacement of
existing infrastructure and result in the temporary loss of revenue.
The entity using CTC for these uses provided manufacturing data used in
the 2020 Risk Evaluation for Carbon Tetrachloride, indicating that CTC
is used by this entity in industrialized and standardized settings that
can meet the requirements of the WCPP. Therefore, EPA understands that
the entity is able to meet the WCPP requirements for processing:
incorporation into formulation, mixtures, or reaction products in vinyl
chloride manufacturing and the industrial and commercial use as an
industrial processing aid in the manufacture of vinyl chloride as well.
Furthermore, EPA understands as a general matter that these uses would
occur in highly industrialized settings and controlled and closed
processes, suggesting a WCPP could be successfully implemented such
that risk of injury to health presented by CTC is no longer
unreasonable. CTC was used in other petrochemical-derived manufacturing
(other than vinyl chloride manufacturing); however, based on the
reasonably available information, such uses of CTC do not appear to be
ongoing. Therefore, EPA has concluded that industry has already found
feasible alternatives to CTC for these uses, EPA is prohibiting
processing: incorporation into formulation, mixtures, or reaction
products in the remainder of petrochemical-derived manufacturing and
the industrial and commercial use of CTC as a processing aid in the
manufacture of remaining petrochemical-derived products, as proposed,
to address the unreasonable risk contributed by these conditions of
use.
2. Changes to Restrictions: Prescriptive Controls for Industrial and
Commercial Use as a Laboratory Chemical
In general, EPA is finalizing the prescriptive control requirements
for the industrial and commercial use of CTC as a laboratory chemical
as proposed, with some modifications based on consideration of public
comments. As described in the proposed rule, to address the
unreasonable risk of injury to health resulting from dermal exposures
to CTC for the industrial and commercial use as a laboratory chemical,
EPA proposed to require dermal PPE in combination with comprehensive
training for tasks related to the use of CTC in a laboratory setting
for each potentially exposed person in direct dermal contact with CTC.
EPA also proposed to require the use of fume hoods to codify the
assumption of existing good laboratory practices that EPA relied upon
as a key basis for its evaluation of risk from this condition of use
(Ref. 1). EPA requested comment relative to the ability of owners and
operators to implement laboratory chemical fume hood and dermal PPE
related requirements within six months of publication of the final
rule. Under the primary alternative regulatory action, EPA included
DDCC for laboratory use and solicited comment on non-prescriptive
requirements of DDCC as compared to the prescriptive workplace controls
of dermal PPE.
EPA received several comments regarding the industrial and
commercial use as a laboratory chemical. One commenter stated that the
proposed regulation would result in confusion and duplication with the
OSHA standard for occupational exposure to hazardous chemicals in
laboratories under 29 CFR 1910.1450 that is already in effect (Ref.
25). A couple of commenters urged EPA to align its requirements for
laboratory use of CTC more closely with the OSHA's laboratory standard
to reduce compliance burden (Refs. 25, 26). Commenters also requested
that EPA include flexibility for engineering controls beyond a fume
hood for consistency with the OSHA lab standard, stating that, while
fume hoods are considered best practice and commonly used to reduce
exposure in laboratories, experiment designs utilizing CTC may not be
able to be accommodated within a fume hood (Refs. 25, 27). Commenters
described other alternative controls that can be
[[Page 103521]]
designed and implemented to reduce exposure, such as glove boxes,
exhausted enclosures, ducted biosafety cabinets, and filtration
devices.
Based on information provided by commenters related to exposure
mitigation controls to comply with the OSHA laboratory standard and
best management practices available to laboratories, EPA has determined
that requiring laboratory ventilation devices such as fume hoods or
glove boxes, would better align with the OSHA laboratory standard and
existing good laboratory practices. As described in Unit V.A.2. the
proposed rule (88 FR 49201, July 28, 2023) (FRL-8206-01-OCSPP), EPA
proposed to require fume hoods in laboratory settings to codify
assumptions made in the 2020 Risk Evaluation for CTC, where EPA's risk
estimates and determination that inhalation exposures from the
industrial and commercial use of CTC as a laboratory chemical did not
contribute to the unreasonable risk were predicated on its findings
that expected safety practices of using CTC in small amounts under a
fume hood reduce the potential for inhalation exposures (Ref. 1). In
addition to fume hoods, EPA has determined that other types of
ventilation systems or containment devices, when used in compliance
with the OSHA laboratory standard at 29 CFR 1910.1450(e)(3), may
minimize inhalation exposures in a laboratory setting consistent with
the qualitative assumption in the 2020 Risk Evaluation for CTC that the
potential for inhalation exposure is low due to expected use of a fume
hood. For the industrial and commercial use as a laboratory chemical,
EPA concurs with the commenters that indicated EPA's requirements
should align more closely with the OSHA laboratory standard wherever
possible to prevent confusion. The requirement in this final rule that
laboratory ventilation safety devices, such as fume hoods or glove
boxes, are in use and functioning properly and that specific measures
are taken to ensure proper and adequate performance of such equipment
to minimize exposures to persons in the area when CTC is used in a
laboratory setting aligns with existing requirements from the OSHA
laboratory standard at 29 CFR 1910.1450(e)(3)(iii) while remaining
consistent with the assumptions made in the 2020 Risk Evaluation.
As detailed in Unit IV.C. of this final rule, EPA is finalizing the
requirements for dermal PPE in combination with comprehensive training
for tasks related to the use of CTC in a laboratory setting as
proposed. EPA believes these requirements align with OSHA's laboratory
standard and OSHA's General Requirements for Personal Protective
Equipment at 29 CFR 1910.132 to the extent possible while still
addressing the unreasonable risk of injury to health resulting from
dermal exposures to CTC identified for the industrial and commercial
use as a laboratory chemical.
B. Changes to WCPP Timeframes
For the conditions of use for which EPA proposed the WCPP, EPA
proposed several compliance timeframes, including the following
requirements: that initial exposure monitoring be conducted within six
months of publication of the final rule in the Federal Register (or
within 30 days of introduction of CTC into the workplace if CTC use
commences at least six months after the date of publication); that each
owner or operator ensure that the exposure to CTC does not exceed the
ECEL as an 8-hour TWA for all potentially exposed persons within nine
months of publication of the final rule in the Federal Register; and
that owners and operators implement an exposure control plan within 12
months of publication of the final rule in the Federal Register. EPA
requested comment regarding the ability of owners or operators to
comply with the various provisions of the WCPP, including initial
exposure monitoring, within the compliance timelines included in the
proposal, and anticipated timelines necessary for any procedural
adjustments needed to comply with the establishment of a respiratory
protection program and development of an exposure control plan. EPA
also requested comment regarding the amount of time, if any, it would
take the regulated community to develop a method to measure at or below
the ECEL over an entire work shift and information on what levels of
detection are possible over an entire work shift based on existing
monitoring methods, justification for the timeframe of the specific
steps needed to develop a more sensitive monitoring method, cost
associated with a more sensitive monitoring method, and any additional
detailed information related to establishing a monitoring program to
reliably measure CTC at or below the ECEL.
Public comments highlighted challenges with the proposed timeframes
and suggested longer timeframes for initial exposure monitoring. For
example, one commenter stated that the proposed 6-month timeframe to
conduct initial exposure monitoring may not be possible because CTC use
may be infrequent and only occur annually or even less frequently, such
as maintenance exercises (Ref. 28). Other commenters expressed concern
that requirements to comply with a new exposure limit will stress
industrial hygiene consultants and laboratories that analyze the
samples, and urged EPA to ensure that there is adequate time for
consultant firms and laboratories to establish sufficient capacity
(Refs. 29, 30, 31). Several commenters stated that the proposed 6-month
timeframe for initial monitoring would be untenable and suggested that
the deadline be extended to 18 months (Refs. 29, 30, 32). One commenter
stated that owners or operators should be given sufficient time to
implement any new requirements which could involve substantial
investments (Ref. 27). Two of the commenters reasoned that,
particularly for CTC, at least 18 months is necessary to revalidate
methods and determine whether revision to corporate exposure assessment
strategy is necessary to address the new ECEL, including to address the
specific implementation and technical feasibility challenges of
measuring the CTC ECEL for both full shift and task measurements (Refs.
29, 30). One commenter indicated that they need to develop methods to
achieve the detection limit for the proposed ECEL and ECEL action
level, to procure professional services to implement the requirements,
and most likely require laboratory analytical support (Ref. 33).
Additionally, one commenter expressed concern that corporate and
facility industrial hygiene resources as well as third party
laboratories may also be conducting a reassessment and analysis for the
methylene chloride and PCE rules recently promulgated under TSCA
section 6(a), thereby requiring additional time for CTC (Ref. 29).
In consideration of public comments and the challenges of
initiating the WCPP, even for facilities with industrial hygiene
programs in place, and the difference in the occupational exposure
limits between the OSHA permissible exposure limit (PEL) and the EPA
ECEL and the challenges associated with monitoring to new, lower EPA
exposure thresholds that may spur an increase in the need for
monitoring or other exposure control assessment infrastructure, EPA has
determined that a longer compliance deadline of 540 days is as soon as
practicable to conduct initial monitoring for CTC, which likely would
require regulated entities to contract new services or realign current
industrial hygiene professionals towards WCPP compliance. Providing 540
days
[[Page 103522]]
for initial monitoring is intended to (1) prevent professional safety
service sectors from being overwhelmed by new EPA requirements; (2)
provide time to procure the necessary services while ensuring the
preservation of safety quality, standards, and practices; and (3)
provide sufficient time for a comprehensive exposure evaluation,
increasing the likelihood of successful implementation of the WCPP.
Following initial monitoring, EPA is finalizing the requirement that
each owner or operator supply a respirator to each person who enters a
regulated area within three months after the receipt of any exposure
monitoring that indicates exposures exceeding the ECEL. Therefore, each
owner or operator must ensure that the exposures to CTC do not exceed
the ECEL as an 8-hour TWA for all potentially exposed persons,
including by providing respiratory protection, no later than 630 days
after December 18, 2024. Given the full WCPP requirements (including
the exposure control plan) are required after owners or operators are
required to ensure that no person is exposed to an airborne
concentration that exceeds the TWA ECEL, EPA acknowledges that
compliance with the ECEL may include temporary PPE use (e.g.,
respiratory protection) until comprehensive engineering and
administrative controls are fully implemented. As described in the
proposed rule, EPA believes that three months after receipt of exposure
monitoring results is as soon as practicable, while also providing a
reasonable transition period for entities to evaluate exposure
monitoring results, acquire the correct respiratory protection, and
establish the PPE program, including training, fit-testing, and medical
evaluation.
EPA also received public comment regarding the compliance timeframe
for full implementation of the WCPP, including detailing the evaluation
steps that would be required to assess a facility and develop,
document, and implement an exposure control plan. To allow time for
orderly transitions and training to comply with an ECEL (0.03 ppm (8-hr
TWA)) that is significantly lower than the OSHA PEL of 10 ppm (8-hr
TWA) and the American Conference of Governmental Industrial Hygienists
(ACGIH) threshold limit value (TLV) of 5 ppm (8-hr TWA) for CTC, two
commenters suggested that EPA adopt a graduated implementation approach
for ECEL implementation by first requiring entities that already meet
the OSHA PEL to comply with the ACGIH TLV within two years from the
effective date of the final rule and then permitting those facilities
meeting the ACGIH standard three years to transition to the ECEL (Refs.
34, 35). Two commenters expressed concern that the proposed timeframes
would be insufficient for owners or operators to document their efforts
to implement the hierarchy of controls as required under the WCPP, and
recommended that the time required to develop the exposure control plan
be extended to two years from completion of initial monitoring, for a
total of 24 to 36 months from the effective date of the final rule, to
provide adequate time for entities to evaluate and implement
appropriate compliance approaches that provide flexibility and are the
most effective for protecting workers (Refs. 29, 30).
Based on comments, outreach, reasonably available information, and
existing OSHA standards, EPA maintains that the majority of the
exposure reduction and worker safety infrastructure needed for
compliance is currently in place, but recognizes the fundamental
challenge of building a new exposure control strategy around the new,
lower EPA exposure limit. Additionally, based on consideration of
public comment and given that OSHA has not promulgated a detailed
standard specific to CTC, EPA has determined that a longer compliance
timeframe of 1080 days for development and implementation of an
exposure control plan is as soon as practicable to ensure that the
regulated community has adequate time to evaluate monitoring data,
assess and develop an exposure strategy, procure appropriate control
technology and PPE, and implement the required chemical safety program
for CTC.
Therefore, EPA is finalizing the compliance timeframes for the WCPP
provisions as follows: (1) The requirements for each owner or operator
to conduct initial baseline monitoring must be met within 540 days
after December 18, 2024, or within 30 days of introduction of CTC into
the workplace, whichever is later; (2) the requirements for each owner
or operator to ensure that exposure to CTC does not exceed the ECEL as
an 8-hour TWA for all potentially exposed persons, including by
providing respiratory protection to all potentially exposed persons in
the regulated area must be met within 630 days after December 18, 2024,
or within three months after receipt of the results of any exposure
monitoring that indicates exposures exceeding the ECEL; and (3) the
requirements for development and implementation of an exposure control
plan must be met within 1,080 days after December 18, 2024. For greater
clarity in this final rule, EPA is also finalizing with slight
modification the requirement that owners and operators institute a
training and information program for potentially exposed persons and
assure their participation in the training and information program, and
that this requirement be met within 630 days after December 18, 2024
(see Unit IV.B.7.a.).
EPA understands that certain departments and agencies of the
Federal government, as well as Federal contractors acting for or on
behalf of the Federal government, need additional time to comply with
these timeframes. For example, complying with these timeframes could
impact the ability of the Department of Energy (DOE) to perform
sampling and groundwater treatment at contaminated plumes and
wastewater treatment facilities. While, for example, 29 CFR part 1960
sets forth procedures and guidelines for ensuring that Federal workers
are protected in comparable ways to their non-Federal counterparts, EPA
believes that compliance with this final rule will require increased
and different preparations on the part of Federal agencies. For
example, Federal agencies must follow procurement requirements, which
will likely result in increased compliance timelines. In addition,
these requirements will require support in the Federal budget, which,
for some agencies, is a multi-year process. Therefore, EPA is providing
additional time for agencies of the Federal government and their
contractors, when acting for or on behalf of the Federal government, to
comply with the WCPP provisions as follows: (1) The requirements for
each owner or operator to conduct initial baseline monitoring must be
met within 915 days after December 18, 2024, or within 30 days of
introduction of CTC into the workplace, whichever is later; (2) the
requirements for each owner or operator to ensure that exposure to CTC
does not exceed the ECEL as an 8-hour TWA for all potentially exposed
persons, including by providing respiratory protection to all
potentially exposed persons in the regulated area, must be met within
1,005 days after December 18, 2024, or within three months after
receipt of the results of any exposure monitoring that indicates
exposures exceeding the ECEL; (3) the requirements for each owner or
operator to ensure all persons are separated, distanced, physically
removed, or isolated from direct dermal contact with CTC, including by
providing dermal PPE, must be met within 1,005 days after December 18,
2024; (4) the requirements for
[[Page 103523]]
development and implementation of an exposure control plan must be met
within 1,080 days after December 18, 2024; and (5) the requirement that
owners or operators of workplaces subject to the WCPP institute a
training and information program for potentially exposed persons and
assure their participation in the training and information program
within 1,005 days after the date of publication of the final rule in
the Federal Register (i.e., no later than September 20, 2027).
C. Changes to WCPP Requirements
1. Exposure Monitoring Requirements
As part of the WCPP, EPA proposed to require owners or operators
meet certain documentation requirements for each monitoring event of
CTC, including compliance with the Good Laboratory Practice (GLP)
Standards in accordance with 40 CFR part 792.
Numerous commenters expressed concern regarding the requirement
that the WCPP include compliance with the GLP Standards (Refs. 28, 29,
30, 31, 35, 36). Commenters stated that it is atypical, for industrial
hygiene purposes, to use this standard for air sampling of CTC (Refs.
29, 30, 31). According to the commenters, it is common practice within
the industrial hygiene community to have analyses performed by American
Industrial Hygiene Association (AIHA) accredited labs (Ref. 29). One
commenter added that collection of occupational monitoring samples need
not be conducted under the GLP Standards where planning and collection
is overseen by a Certified Industrial Hygienist or Environmental
Professional as defined at 40 CFR 312.10 (Refs. 30, 31). Commenters
also suggested applying the policy described in typical TSCA section
5(e) orders that establish a New Chemical Exposure Limit (NCEL) under
the TSCA New Chemicals Program, which states that compliance with GLP
Standards is not required where exposure monitoring samples are
analyzed by a laboratory accredited by either: (A) the AIHA Industrial
Hygiene Laboratory Accreditation Program; or (B) another comparable
program approved in advance in writing by EPA (Refs. 29, 30, 31).
Another commenter reasoned that GLP Standards were not intended for air
monitoring in a workplace when compliance with such standards would
mean that real-time assessments could not be made, as air samples would
need to be processed and analyzed in a laboratory (Ref. 28).
EPA agrees with the commenter that the WCPP is incompletely served
by solely relying on the GLP Standards initially put forth in the July
29, 2023 proposed rule (88 FR 49180) (FRL-8206-01-OCSPP). Given the
concern from commenters regarding potential increases in demand for
professional safety services and sampling laboratories having a
negative impact due to anticipated industry strain and sampling
limitations (Refs. 29, 30, 31), EPA has broadened the scope of
laboratory accreditation accordingly. EPA has considered this
laboratory capacity issue, in addition to other revisions for
finalization in this rule, so that the additional infrastructure is in
place for the regulated community to successfully implement the WCPP.
For the final rule, EPA is requiring that exposure samples be analyzed
using an appropriate analytical method, and related records retained,
by a laboratory that complies with the GLP Standards in 40 CFR part 792
or that otherwise maintains a relevant third-party laboratory
accreditation (e.g., under the AIHA Laboratory Accreditation Programs,
LLC Policy Module 2A/B/E of Revision 17.3), or other analogous
industry-recognized programs.
Another commenter stated that EPA's proposal did not make clear
that ``personal breathing zone'' air samples to monitor exposures are
to be taken without regard to respirator use. The commenter noted that
OSHA requires exposure monitoring to be conducted without regard to
respirator use (citing as an example OSHA's definition of ``employee
exposure'' at 29 CFR 1910.1052(b)) and asserted that this important
element of OSHA's monitoring program was omitted from EPA's proposal
(Ref. 37). EPA agrees with the commenter that exposure monitoring
should be conducted without regard to respiratory protection to inform
engineering control options and respiratory protection considerations.
Therefore, EPA is finalizing this rule to explicitly state that air
sampling is required to measure ambient concentrations for CTC without
taking respiratory protections into account when being performed. This
will ensure the appropriate degree of protection to potentially exposed
persons by logging accurate ambient air concentrations of CTC, thus
empowering owners or operators to appropriately consider the hierarchy
of controls.
Additionally, as part of the WCPP, EPA proposed to require owners
and operators to re-monitor within 15 working days after receipt of any
exposure monitoring when results indicated non-detect, unless an
Environmental Professional as defined at 40 CFR 312.10 or a Certified
Industrial Hygienist reviews the monitoring results and determines re-
monitoring is not necessary. EPA received several comments disagreeing
with the proposed requirement to review non-detect air monitoring
samples. The commenters stated that facilities use accredited labs to
perform industrial hygiene sampling analysis, the results are reviewed
by industrial hygiene professionals, and it is an unnecessary step that
adds no value to reduce risk to workers (Refs. 29, 30, 31).
EPA disagrees with commenters that expressed the opinion that re-
evaluating a non-detect result adds no value and is inappropriate.
While in some cases a non-detect result may accurately indicate that
the chemical is not present and that air concentrations are below the
ECEL action level, in other cases it may not necessarily imply
negligible occupational exposure to the chemical. For example,
interference from another chemical during sampling may result in an
incorrect result of non-detect. This interference may not be recognized
at the time of sampling or analysis. Owners and/or operators also may
not be using sampling techniques or analytical procedures that are
effective or appropriate for the particular chemical of interest. In
each of these cases, non-detect results, along with supporting
documentation about the sampling and analytical methods used to get
those results, is a meaningful part of the potentially exposed person's
exposure record required under the WCPP. The WCPP in the proposed rule
and in this final rule does not require re-monitoring in all cases. Re-
monitoring may be necessary based on a professional evaluation by an
Environmental Professional as defined at 40 CFR 312.10 or a Certified
Industrial Hygienist. This flexibility allows owners or operators
options in terms of revisiting occupational sampling in the event of a
non-detect result, or evaluation by a qualified professional.
EPA determined that a non-detect sampling result when effective
sampling and analysis procedures are used is valuable to an owner/
operator in that it suggests effective implementation of exposure
controls. Potentially exposed persons may also use these records in
discussions with owner/operators, in collective bargaining situations,
or in compliance assistance inquiries to EPA or other federal agencies.
Exposure monitoring results may also improve overall workplace health
and reducing owner/operator liability in the effective detection,
treatment, and prevention of occupational disease or illness. All of
the above scenarios are valuable for
[[Page 103524]]
owner/operators, potentially exposed persons, and for effective
mitigation of occupational exposures. In consideration of these
factors, EPA has removed the air monitoring equipment malfunction from
the monitoring activities that do not require resampling based on
professional evaluation by an Environmental Professional or Certified
Industrial Hygienist. While professional discretion may be warranted in
determining whether re-monitoring is needed following results that
indicate non-detect, EPA has determined this is not appropriate in the
event of air monitoring equipment malfunction. This is due to the
importance of air monitoring in ensuring that the requirements of the
WCPP are met, and the importance of the WCPP in reducing risks from
exposures to CTC in the workplace. Monitoring results from
malfunctioning air monitoring equipment are not valid monitoring and
therefore not sufficient to meet the monitoring requirements under the
WCPP.
EPA may consider developing additional guidance regarding
occupational monitoring in the future. Therefore, EPA is finalizing the
requirement to re-monitor within 15 working days after receipt of any
exposure monitoring if results indicated non-detect unless an
Environmental Professional as defined at 40 CFR 312.10 or a Certified
Industrial Hygienist reviews the monitoring results and determines re-
monitoring is not necessary. EPA has updated the recordkeeping
requirements associated with the WCPP exposures records required under
40 CFR 751.713(b)(1) to require documentation of the determination by
the Environmental Professional as defined at 40 CFR 312.10 or a
Certified Industrial Hygienist to be maintained as a record.
Occupational monitoring (and associated recordkeeping) is an area that
EPA may develop guidance as part of final rule implementation efforts.
2. Designated Representative
EPA proposed to require owners and operators to provide potentially
exposed persons regular access to the exposure control plan, exposure
monitoring records, and PPE program implementation plan (documenting
proper application, wear, and removal of PPE). EPA requested comment on
how owners and operators could engage with potentially exposed persons
on the development and implementation of an exposure control plan and
PPE program. One commenter stated that employees should be engaged in
the development and implementation of the exposure control plan and
that the engagement is best performed during the PPE and respirator
training (Ref. 27). Another commenter urged EPA to require that owners
and operators consult with workers and their designated representatives
in developing and implementing their plans (Ref. 37).
EPA received public comment on the role of designated
representatives in the WCPP. One commenter, a group of labor unions,
urged EPA to incorporate requirements similar to OSHA's access standard
at 29 CFR 1910.1020 (entitled, ``Access to employee exposure and
medical records'') in EPA's proposed recordkeeping requirements for the
WCPP to ensure that exposure information is promptly and fully shared
with both potentially exposed persons and their designated
representatives (Ref. 37). The commenter also suggested that EPA
include a requirement that employers provide employees or their
designated representatives an opportunity to observe monitoring events.
The commenter observed that workers and their designated
representatives have a critical role to play in ensuring effective
control of toxic substances and further noted that, often, unions are
the organizations with expertise in understanding occupational exposure
information.
Following review of the comments received, EPA recognizes the
importance of having the ability for potentially exposed persons and
their designated representative(s), such as labor union
representatives, to observe exposure monitoring and have prompt access
to exposure records. EPA additionally recognizes that, in some
instances, individual workers may be hesitant to ask owners or
operators for information relating to their chemical exposure or may be
less familiar with discipline-specific industrial hygiene practices.
EPA determined that it is appropriate in this final rule to establish
requirements regarding designated representatives, consistent with
existing OSHA precedent in certain 29 CFR part 1910, subpart Z
regulations, to allow designated representatives the ability to observe
occupational exposure monitoring and have access to exposure monitoring
records. In EPA's final rule, the WCPP includes a requirement that
owners and operators provide potentially exposed persons or their
designated representatives an opportunity to observe any exposure
monitoring that is designed to characterize their exposures and is
conducted under the WCPP. EPA is also finalizing a requirement that
designated representatives have access to relevant exposure records,
similar to provisions in certain OSHA regulations under 29 CFR part
1910, subpart Z, such as 29 CFR 1910.1200 and 29 CFR 1910.1020. EPA is
requiring owners and operators to notify potentially exposed persons
and their designated representatives of the availability of the
exposure control plan and associated records of exposure monitoring and
PPE program implementation within 30 days of the date that the exposure
control plan is completed and at least annually thereafter. EPA is also
requiring, consistent with the proposed requirement for notification of
exposure monitoring results, that the notice of the availability of the
exposure control plan and associated records be provided in plain
language writing to each potentially exposed person in a language that
the person understands or posted in an appropriate and accessible
location outside the regulated area with an English-language version
and a non-English language version representing the language of the
largest group of workers who do not read English. While EPA encourages
owners or operators to consult with persons that have potential for
exposure and their designated representatives on the development and
implementation of the exposure control plan, EPA has determined that it
is not necessary to include this as a requirement in the final rule,
consistent with OSHA, because the involvement of designated
representatives in the observation of occupational monitoring and the
potential to access exposure records being finalized in this rule
provide a productive forum for communicating with owner/operators about
the exposure control plan. EPA believes that the notification of the
exposure control plan and associated records may help facilitate
participation from potentially exposed persons and their designated
representatives in the implementation and further development of that
plan.
EPA's final rule to address the unreasonable risk of PCE under TSCA
section 6(a) (RIN 2070-AK84) established the definition of ``designated
representative'' intended to apply to all TSCA section 6(a)
requirements under 40 CFR part 751 at Sec. 751.5. A recognized or
certified collective bargaining agent must be treated automatically as
a designated representative without regard to written authorization.
Additionally, with respect to Federal Government employees, EPA, like
OSHA at 29 CFR 1960.2(e), will interpret these designated
representative requirements consistent with the Federal Service Labor
Management
[[Page 103525]]
Relations Statute (5 U.S.C. 7101 et seq.), or collective bargaining or
other labor-management arrangements that cover the affected employees.
Should a request be initiated for such records by the potentially
exposed person or their designated representative(s), the owner or
operator will be required to provide the specified records at a
reasonable time, place, and manner, analogous to provisions outlined in
OSHA's 29 CFR 1910.1020(e)(1)(i). If the owner or operator is unable to
provide the requested records within 15 working days, the owner or
operator must, within those 15 days, inform the potentially exposed
person or designated representative(s) requesting the record of the
reason for the delay and the earliest date when the record will be made
available. Additionally, in the event that a designated representative
is observing exposure monitoring, the owner or operator must ensure
that designated representatives are provided with PPE appropriate for
the observation of monitoring. Finally, this rule requires owners or
operators to provide notice to potentially exposed persons and their
designated representatives of exposure monitoring results and of the
availability of the exposure control plan and associated records. For
purposes of this requirement, the owner or operator is only required to
provide notice to those designated representatives that the owner or
operator is aware of, such as representatives designated in writing or
a recognized collective bargaining agent for the owner or operator's
own employees.
3. Other Changes to the WCPP
EPA proposed various requirements under the WCPP for owners or
operators to provide PPE, including respiratory protection and dermal
protection, to potentially exposed persons and to establish a PPE
program. For greater clarity in this final rule, EPA has revised the
PPE requirements with respect to the cross-references to the relevant
OSHA regulations. While the language appears different than the
requirements included in the proposed rule, it remains EPA's intention
that owners and operators implement PPE programs that are consistent
with OSHA requirements. The PPE requirements as part of the WCPP in
this final rule are described in Unit IV.B.6.
D. CTC Unintentionally Present in Trace Quantities in Other Chemical
Substances
Several public comments on the proposed rule urged EPA to establish
an explicit ``de minimis'' weight fraction threshold or add an
exemption for impurities or other contaminants from the rule's
requirements for small levels of CTC present in other chemical
substances or mixtures (Refs. 26, 28, 29, 30, 31, 35, 38, 39). Two
commenters raised concerns that absent such exemption, the proposed
prohibition on industrial and commercial use of CTC as an industrial
processing aid in the manufacture of petrochemicals-derived products
would inadvertently prohibit the industrial and commercial use of PCE
as a processing aid in catalyst regeneration in petrochemical
manufacturing, which EPA is regulating under a WCPP in a separate TSCA
section 6(a) rulemaking for PCE, because PCE contains trace amounts of
CTC as an impurity or other contaminant (Refs. 26, 38). Two other
commenters who supported a de minimis exclusion for impurities noted
that prohibiting impurities in downstream products or CTC impurities in
feedstocks could severely hamper numerous value chains and stated that
establishing a de minimis weight fraction threshold of 0.1% by weight
for the CTC restrictions would align with existing requirements under
OSHA's Hazard Communication Standard (Refs. 30, 31). One of these
commenters stated that a member company imports a product containing a
very small amount of CTC as an impurity, then sells the sealed
container for rubber processing; this commenter urged EPA to expressly
exempt from the WCPP requirement these zero exposure and de minimis
scenarios (Ref. 31). Another commenter stated that a member uses some
raw materials that contain CTC, primarily chlorinated rubbers and
methylene chloride, in the manufacturing of adhesives and coatings, and
was concerned that this use would fall under the proposed prohibitions
(Ref. 39). Another commenter asserted that any formulated products that
contain de minimis concentrations of CTC (i.e., concentrations less
than 0.1% by weight) would not pose a risk and should not be covered by
the rule (Ref. 29). Two other commenters recommended that EPA include
both a de minimis exemption for materials in which CTC may appear at de
minimis levels of less than 0.1% by weight, and an exemption for CTC
present in a formulation, in an intermediate, or in an end product as
an impurity or byproduct, including when present as an unintentional
byproduct or impurity in an imported product (Refs. 26, 35). One
commenter suggested that EPA implement a de minimis weight fraction
threshold of 0.5% (Ref. 39).
In the final rule, EPA has excluded from the rule's requirements
CTC that is solely present unintentionally in trace quantities with
another chemical substance or mixture. This exclusion is intended to
cover circumstances in which another chemical substance or mixture
unintentionally contains trace quantities of CTC that may be present as
a manufacturing residue, unreacted feedstock, byproduct, or other
contaminant. The Agency determined that this exclusion was appropriate
because the conditions of use of CTC that were evaluated in the 2020
Risk Evaluation for Carbon Tetrachloride and determined to contribute
to the unreasonable risk presented by CTC did not include scenarios in
which trace amounts of CTC is unintentionally present in other chemical
substances or mixtures. To the contrary, Section 1.4.2.3 of the Risk
Evaluation stated that there were conditions of use that EPA concluded
in the 2018 Problem Formulation of the Risk Evaluation for Carbon
Tetrachloride would present only de minimis exposures or otherwise
insignificant risks from trace amounts of CTC and did not warrant
inclusion in the risk evaluation. This conclusion was related
specifically to industrial/commercial/consumer uses of CTC in
adhesives/sealants, paints/coatings, and cleaning/degreasing solvent
products. EPA reserves the right to assess and address potential
environmental and health risks of trace quantities of CTC under
different authorities such as CAA Title I and VI. The 2020 Risk
Evaluation for Carbon Tetrachloride explained that while CTC's use as a
process agent in the manufacturing of other chlorinated compounds may
result in trace levels of CTC as a manufacturing residue in the
chlorinated substances used to manufacture downstream products, those
trace amounts are expected to volatilize during the product
manufacturing process, such that EPA expected insignificant or
unmeasurable concentrations of CTC in the chlorinated substances in
commercially available adhesive/sealant, paint/coating, and cleaning/
degreasing products. The final rule's exclusion for CTC unintentionally
present in trace quantities with another chemical substance or mixture
is consistent with this earlier exclusion from the scope of the Risk
Evaluation for Carbon Tetrachloride. Any product with CTC
concentrations above trace quantities that falls within a condition of
use regulated under this rule will be subject to the relevant rule
provisions (e.g.,
[[Page 103526]]
WCPP, prescriptive controls, or prohibition), as appropriate based on
the condition of use of CTC.
In addition, any potential occupational risk from the presence of
trace quantities of CTC in PCE is expected to be eliminated by the
recently promulgated final risk management rule for PCE under TSCA
section 6(a) (to be codified at 40 CFR part 751, subpart G). The
occupational and consumer protections from exposures to PCE under that
final rule, which address the unreasonable risk of injury to health
presented by PCE under its conditions of use, would also have the
effect of reducing the risk from exposures to trace amounts of CTC that
may be present in PCE. For example, the final rule requires a workplace
chemical protection program with both an Existing Chemical Exposure
Limit of 0.14 ppm of PCE as an 8-hr TWA and direct dermal contact
control requirements for the industrial/commercial use of PCE as a
processing aid in catalyst regeneration in petrochemical manufacturing.
Any engineering controls or PPE used to reduce occupational exposures
to PCE for the use as a processing aid in catalyst regeneration in
petrochemical manufacturing are expected to reduce workplace exposures
to CTC. The limitations on inhalation and dermal exposures to PCE to
prevent unreasonable risk of injury to health from that chemical
substance are also expected to limit any potential exposure to trace
quantities of CTC that may be unintentionally present in the PCE,
reducing the risk of injury to health from the CTC, so that that
condition of use does not contribute to the unreasonable risk of CTC.
At this time, EPA is not establishing a specific weight fraction or
other numerical threshold value for the trace quantities exclusion in
the CTC final rule, consistent with existing exclusions of trace
quantities of remaining substances from the definitions of ``controlled
substance'' and ``transform'' under 40 CFR 82.3. Instead, the exclusion
is based on the plain meaning of the term, ``trace quantities.'' If the
CTC is intentionally retained in the chemical substance or mixture of
which it is a part and provides a desired purpose, then it is not
``present unintentionally in trace quantities'' and would not be
excluded from the rule's requirements.
E. Other Changes
EPA has revised its proposed description of industrial and
commercial use of CTC as a laboratory chemical to provide additional
clarity as suggested by a commenter (Ref. 33). The revised description
for industrial and commercial use as a laboratory chemical appears in
Unit IV.C.1. In addition, EPA has slightly modified the industrial and
commercial use descriptions in 40 CFR 751.705(b)(1)(ii)(B),
751.707(a)(8), and 751.711(c) to clarify that the industrial and
commercial use of CTC in the recovery of chlorine in tail gas from the
production of chlorine falls under the WCPP rather than the prohibition
on industrial and commercial use in the manufacture of other basic
chemicals (including manufacturing of chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings). In the proposed
rule, EPA had intended this use of CTC to be captured with the
description of ``industrial and commercial use in the elimination of
nitrogen trichloride in the production of chlorine and caustic soda,''
but EPA agrees with two public commenters that it would be clearer to
specifically list use of CTC in the recovery of chlorine in tail gas
from the production of chlorine in the regulatory text (Refs. 29, 30).
EPA has revised its proposed description of disposal. Based on
coordination across Federal programs, for the disposal COU, EPA has
determined it is appropriate that owners and operators of cleanup sites
where potentially exposed persons are involved in the disposal of CTC-
containing wastewater for the purposes of cleanup projects of CTC-
contaminated water and groundwater, including industrial pre-treatment
and industrial treatment activities, must ensure that potentially
exposed persons involved with the activity of removing the groundwater
from the location where it was found and treating the removed
groundwater on site comply with the WCPP. At cleanup sites, the WCPP,
including the ECEL, would apply to any potentially exposed person
involved in the disposal of CTC-containing groundwater, which most
likely includes a worker who is involved with the activity of removing
CTC- containing groundwater from the location where it was found and
the on-site treatment of the groundwater, typically referred to as ex
situ remediation, which is most consistent with the scope of the 2020
CTC Risk Evaluation. Ex situ remediation includes both active and
passive remediation methods that span traditional (e.g., pump and
treat) and less traditional (e.g., phytoremediation) approaches, but
only if the remediation method would be considered industrial
wastewater pretreatment, industrial wastewater treatment or discharge
to a publicly owned treatment work (POTW). EPA generally considers
workers in and around those locations to be potentially exposed persons
as that term is defined in 40 CFR 751.5. For example, EPA's
requirements would apply to protect workers conducting remediation
through pump and treat systems or workers sampling groundwater in
conjunction with groundwater extraction or treatment (e.g., remediation
or cleanup) activities. EPA considers only those treatment activities
that are performed at the cleanup site on CTC-contaminated wastewater
that has been removed from the subsurface, surface water impoundments,
or aquifers and that are recognized as industrial treatment, industrial
pretreatment, or discharge to a POTW to be covered under the provisions
described in Unit IV.B. The provisions of the WCPP for the disposal
COU, including the ECEL, are not intended to cover potentially exposed
persons who are sampling groundwater to monitor the presence of a
plume, but specifically only those sampling at the site of extraction
and treatment activities. EPA emphasizes that this standard is only for
cleanup sites involved in the active or passive ex situ treatment (or
disposal) of CTC contaminated groundwater and wastewater from cleanup
sites and that no other remedial actions at cleanup sites will be
covered or affected. Additionally, while EPA considers solid wastes as
part of the waste streams included in the disposal COU, at groundwater
remediation sites managed by the Federal government and under existing
waste disposal requirements, the WCPP requirements under this
rulemaking only apply to water contaminated with CTC, and any other
type of CTC-impacted waste will be managed according to relevant
existing requirements under RCRA, other statutes, and regulatory
agreements.
Additionally, it is not necessary to establish previously proposed
Subpart A definitions for ``authorized person,'' ``owner or operator,''
``potentially exposed person,'' and ``regulated area'' in this final
rule because EPA already established definitions for these terms at 40
CFR 751.5 in the TSCA section 6 final rule for methylene chloride (RIN
2070-AK70) (89 FR 39254, May 8, 2024 (FRL-8155-01-OCSPP)) so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified under 40 CFR part 751. Similarly, it
is not necessary to establish previously proposed Subpart A definitions
for ``direct dermal
[[Page 103527]]
contact,'' ``exposure group,'' and ``ECEL'' in this final rule because
EPA already established definitions for these terms at 40 CFR 751.5 in
the TSCA section 6 final rule for PCE (RIN 2070-AK84).
EPA proposed to require that the notification to companies to whom
CTC is shipped under 40 CFR 751.111(c) identify the uses for which CTC
is allowed to be distributed in commerce. To provide greater clarity to
downstream users of CTC regarding the provisions of this rule, EPA is
modifying the notification to identify the uses prohibited under this
regulation.
EPA also made other minor edits to the preamble and regulatory text
to provide more clarity to the requirements of the final rule.
IV. Provisions of the Final Rule
EPA intends that each provision of this rulemaking be severable. In
the event of litigation staying, remanding, or invalidating EPA's risk
management approach for one or more conditions of use in this rule, EPA
intends to preserve the risk management approaches in the rule for all
other conditions of use to the fullest extent possible. The Agency
evaluated the risk management options in TSCA section 6(a)(1) through
(7) for each condition of use and generally EPA's regulation of one
condition of use to address its contribution to the unreasonable risk
from CTC functions independently from EPA's regulation of other
conditions of use, which may have different characteristics leading to
EPA's risk management decisions. Further, the Agency crafted this rule
so that different risk management approaches are reflected in different
provisions or elements of the rule that are capable of operating
independently. Accordingly, the Agency has organized the rule so that
if any provision or element of this rule is determined by judicial
review or operation of law to be invalid, that partial invalidation
will not render the remainder of this rule invalid.
There are many permutations of the above. For example, as discussed
in Unit IV.D., this final rule prohibits both the industrial and
commercial use of CTC in metal recovery, and the industrial and
commercial use of CTC as a processing aid in the manufacture of
petrochemical-derived products except in the manufacture of vinyl
chloride (for which EPA is requiring a WCPP as described in Unit
III.A.). To the extent that a court were to find that EPA lacked
substantial evidence to support the prohibition of CTC as a processing
aid in the manufacture of petrochemical-derived products or otherwise
found legal issues with EPA's approach to that condition of use, it
would have no bearing on other similarly situated conditions of use,
such as the industrial and commercial use in metal recovery, unless the
specific issue also applies to the particular facts associated with
metal recovery. This is reflected in the structure of the rule, which
describes the prohibited conditions of use separately under 40 CFR
751.705.
As another example, for the processing of CTC as a reactant in the
production of HCFCs, HFCs, HFOs, and PCE and the industrial and
commercial use of CTC as a laboratory chemical, EPA took different risk
management approaches--application of the WCPP for the processing of
CTC as a reactant in the production of HCFCs, HFCs, HFOs, and PCE and
specific prescriptive controls for use as a laboratory chemical. To the
extent that a court were to find a legal issue with EPA's approach to
the WCPP, impacting the processing of CTC as a reactant in the
production of HCFCs, HFCs, HFOs, and PCE, it would have no bearing on
EPA's decision to require specific prescriptive controls for industrial
and commercial use as a laboratory chemical, and vice versa. This is
reflected in the structure of the rule, which organizes the WCPP and
prescriptive controls into different sections of the regulation.
EPA also intends all TSCA section 6(a) risk management requirements
in this rule to be severable from each regulatory exclusion from those
requirements. For example, to the extent a court were to find a legal
issue with excluding trace quantities of CTC from the rule's
requirements pursuant to 40 CFR 751.701(b), or with excluding
manufacture of CTC as a byproduct from WCPP requirements pursuant to 40
CFR 751.707(a)(1), the underlying risk management requirements would
not be impacted. Rather, the excluded activities would become subject
to the underlying TSCA section 6(a) risk management requirements
applicable to the condition of use. EPA further notes that the specific
examples of severability described in this unit are not intended to be
exhaustive, but rather illustrative of a wide variety of scenarios that
reflect EPA's overarching intent that each provision of this rulemaking
be severable.
EPA acknowledges that after the issuance of this rule, a person or
entity may become aware of important information which indicates a
particular use, that would otherwise be prohibited, is ongoing, and
could meet the criteria of a WCPP. EPA also notes that there are
multiple avenues to ask EPA to revisit issues in this TSCA section 6(a)
rulemaking, both before and after the mandatory compliance dates are
set consistent with TSCA section 6(d). EPA has the authority under TSCA
section 6(g) to consider whether an exemption is appropriate and,
consistent with TSCA section 6(g)(1), may propose such exemptions
independently from this rulemaking. Additionally, any person could
petition EPA to request that EPA issue or amend a rule under TSCA
section 6.
A. Applicability
This final rule sets prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
commercial use, and disposal of CTC to prevent unreasonable risk of
injury to health in accordance with TSCA section 6(a), 15 U.S.C.
2605(a).
Additionally, pursuant to TSCA section 12(a)(2), this rule applies
to CTC even if being manufactured, processed, or distributed in
commerce solely for export from the United States because EPA has
determined that CTC presents an unreasonable risk to health within the
United States. Several commenters expressed concern that an unclear
statement in the proposed rule preamble appeared to indicate that all
manufacture, processing, and distribution for export would be
prohibited under the proposed rule (Refs. 29, 30, 32). This was not
EPA's intent. Rather, EPA intended to indicate that because EPA
determined that CTC presents an unreasonable risk of injury to health
within the United States, manufacturing and processing of CTC for
export would not be exempt from any otherwise-applicable TSCA section
6(a) regulatory requirements. Because distribution in commerce did not
contribute to EPA's unreasonable risk determination for CTC, and
because this final rule permits manufacturing and processing, including
recycling, for various uses to continue under the WCPP, EPA intends
this final rule to permit manufacturing and processing in compliance
with the WCPP for export, as well as distribution in commerce for
export, without regard for the intended use in the destination country.
In other words, manufacturing, processing, and distribution for the
conditions of use listed in 40 CFR 751.705(a)(1)(i) and (ii) are
prohibited where such conditions of use would occur inside the United
States, but in instances where such conditions of use would occur
solely outside of the United States after export, the upstream
manufacturing, processing, and distribution for export would not be
prohibited. EPA has clarified the regulatory text at 40 CFR
[[Page 103528]]
751.707(a) to make clear that any manufacture and processing for export
must be in accordance with the WCPP. In addition, any persons who
export or intend to export a chemical substance that is the subject of
this final rule are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
EPA is revising the description of the Disposal COU to clarify the
requirements of the WCPP at cleanup sites which would apply to any
potentially exposed person involved in the disposal of CTC-containing
groundwater to industrial treatment, industrial pre-treatment, or
POTWs. A potentially exposed person most likely includes a worker who
is involved with the activity of removing CTC-containing groundwater
from the location where it was found and the on-site treatment of the
groundwater, typically referred to as ex situ remediation, which is
most consistent with the scope of the 2020 CTC Risk Evaluation. Ex situ
remediation includes both active and passive remediation methods that
span traditional (e.g., pump and treat) and less traditional (e.g.,
phytoremediation) approaches, but only if the remediation method would
be considered industrial wastewater pretreatment, industrial wastewater
treatment or discharge to a publicly owned treatment work (POTW).
As discussed in Unit III.D, the prohibitions and restrictions
described in this unit do not apply to CTC that is solely present
unintentionally in trace quantities with another chemical substance or
mixture, whether as a manufacturing residue, unreacted feedstock,
byproduct, or other contaminant. Additionally, the provisions of this
final rule only apply to chemical substances as defined under TSCA
section 3. Notably, TSCA section 3(2) excludes from the definition of
chemical substance ``any food, food additive, drug, cosmetic, or device
(as such terms are defined in Section 201 of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic, or device'' and ``any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.])
when manufactured, processed, or distributed in commerce for use as a
pesticide.'' Additional details regarding TSCA statutory authorities
can be found in section 2 of the response to comments document (Ref.
11).
EPA uses the term ``potentially exposed person'' in Unit IV. And in
the regulatory text to include workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area where CTC is present and who may be exposed to CTC under
the conditions of use for which a WCPP or specific prescriptive
controls would apply. (EPA notes that this definition is intended to
apply to occupational workspaces as part of implementation of the WCPP
and other restrictions, and recognizes that other individuals or
communities may be exposed to CTC as members of fenceline communities
or members of the general population.) For certain conditions of use,
EPA requires a comprehensive WCPP or specific prescriptive controls to
address the unreasonable risk from CTC to workers directly handling the
chemical or in the area where the chemical is being used. Similarly,
the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) did not
distinguish between employers, contractors, or other legal entities or
businesses that manufacture, process, distribute in commerce, use, or
dispose of CTC. For this reason, EPA uses the term ``owner or
operator'' to describe the entity responsible for implementing the WCPP
or specified prescriptive controls in any workplace where an applicable
condition of use is identified in Unit IV. And subject to the WCPP or
prescriptive controls is occurring. The term includes any person who
owns, leases, operates, controls, or supervises such a workplace. While
owners or operators remain responsible for ensuring compliance with the
WCPP or prescriptive controls requirements in the workplace, they may
contract with others to provide training or implement a respiratory
protection program, for example. EPA is also clarifying its intent that
for the provisions in this rule, any requirement for an owner or
operator, or an owner and operator, is a requirement for any individual
that is either an owner or an operator.
EPA emphasizes that this approach is essential for addressing the
unreasonable risk presented by CTC, including to individuals who may
not be covered by OSHA requirements, such as, volunteers, self-employed
persons, and State, and local government workers who are not covered by
a state plan. EPA uses the term ``owner or operator'' in TSCA programs
because the term is used in other EPA programs to describe persons with
responsibilities for implementing statutory and regulatory requirements
at particular locations. See, for example, CAA section 113, 42 U.S.C.
7412, which defines ``owner or operator'' as a person who owns, leases,
operates, controls, or supervises a stationary source. There is a
similar definition in section 306 of the Clean Water Act (CWA), 33
U.S.C. 1316. EPA understands that the use of this term may result in
multiple persons' bearing responsibility for complying with provisions
of this final rule, including the WCPP. However, this is also the case
for workplaces regulated by OSHA, including those regulated under
OSHA's general industry standards at 29 CFR part 1910. OSHA's 1999
Multi-Employer Citation Policy explains which employers should be cited
for a hazard that violates an OSHA standard (Ref. 40). The Policy
describes four different roles that employers may fill at a workplace
and describes who should be cited for a violation based on factors such
as whether the employer created the hazard, had the ability to prevent
or correct the hazard, and knew or should have known about the hazard.
More than one employer may be cited for the same hazard. This final
rule will have similar results, in that more than one owner or operator
may be responsible for compliance.
The OSHA multi-employer citation policy is an example of a guidance
governing situations where more than one regulated entity is present.
EPA has received several requests for clarification of the
applicability of the term ``owner or operator'' to sites where more
than one entity owns, leases, or controls a workplace where a CTC
condition of use is ongoing and where implementation of the WCPP or
prescriptive controls is required. EPA understands that there are a
wide variety of situations where these questions could arise, and plans
to issue guidance consistent with TSCA authorities that explains how
EPA will approach the issue of responsibility for implementation of,
and compliance with, the WCPP requirements in practice.
B. Workplace Chemical Protection Program (WCPP)
1. Applicability
EPA is finalizing the WCPP for all of the conditions of use for
which it was proposed, as well as for two additional uses related to
vinyl chloride manufacturing within two conditions of use for which
prohibition was proposed. EPA is also revising the description of
industrial and commercial use of CTC related to chlorine production to
clarify that both elimination of nitrogen trichloride in the production
of chlorine and caustic soda and recovery of
[[Page 103529]]
chlorine in tail gas from the production of chlorine are subject to the
WCPP. Additionally, EPA is revising the description of the Disposal COU
to clarify the requirements of the WCPP at cleanup sites. Specifically,
EPA has determined that at groundwater cleanup sites, the WCPP would
apply to any potentially exposed person involved in the disposal of
CTC-containing groundwater to industrial treatment, industrial pre-
treatment, or POTWs. A potentially exposed person most likely includes
a worker who is involved with the activity of removing CTC-containing
groundwater from the location where it was found and the on-site
treatment of the groundwater, typically referred to as ex situ
remediation, which is most consistent with the scope of the 2020 CTC
Risk Evaluation. Ex situ remediation includes both active and passive
remediation methods that span traditional (e.g., pump and treat) and
less traditional (e.g., phytoremediation) approaches, but only if the
remediation method would be considered industrial wastewater
pretreatment, industrial wastewater treatment or discharge to a
publicly owned treatment work (POTW). EPA's descriptions of changes
from the proposed rule in Unit III. The Agency explained why the WCPP
addresses the unreasonable risk for certain conditions of use in Unit
V. of the proposed rule (88 FR 49180, July 28, 2023) (FRL 8206-01-
OCSPP).
EPA is finalizing the WCPP for the following conditions of use
where manufacture and processing are not otherwise prohibited: domestic
manufacturing (except where CTC is manufactured solely as a byproduct);
import; processing as a reactant in the production of HCFCs, HFCs,
HFOs, and PCE; processing: incorporation into formulation, mixture or
reaction product in agricultural products manufacturing, vinyl chloride
manufacturing, and other basic organic and inorganic chemical
manufacturing; processing by repackaging for use as a laboratory
chemical; recycling; industrial and commercial use as a processing aid
in the manufacture of agricultural products and vinyl chloride;
industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine; and
disposal. This unit provides a description of the conditions of use
subject to the WCPP to assist with compliance.
a. Manufacturing
i. Domestic Manufacture
This condition of use refers to making or producing a chemical
substance within the United States (including manufacturing for
export), including the extraction of a component chemical substance
from a previously existing chemical substance or a complex combination
of substances. For purposes of this rule, WCPP requirements applicable
to the manufacture of CTC do not apply where CTC is manufactured solely
as a byproduct, because manufacture of CTC as a byproduct was not
evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.
1). Under TSCA, EPA uses the term ``byproduct'' to refer to a chemical
substance produced without a separate commercial intent during the
manufacture, processing, use, or disposal of another chemical
substance(s) or mixture(s) (see, e.g., 40 CFR 710.3(d), 720.3). A
byproduct is distinguishable from a coproduct, which is a chemical
substance produced for a commercial purpose during the manufacture,
processing, use, or disposal of another chemical substance or mixture.
CTC could be manufactured as a byproduct during the manufacturing of
other chlorinated compounds. EPA anticipates that any risk presented by
the presence of CTC as a byproduct will be considered in the scope of
the risk evaluation of the parent chemical in future risk evaluations,
such as the consideration of CTC as a byproduct in the 1,2-
dichloroethane risk evaluation, as explained in Section 1.4.2.3 of the
2020 Risk Evaluation for Carbon Tetrachloride (Refs. 1, 41).
ii. Import
This condition of use refers to the act of causing a chemical
substance or mixture to arrive within the customs territory of the
United States. This condition of use includes loading/unloading and
repackaging associated with import.
b. Processing
i. Processing as a Reactant in the Production of
Hydrochlorofluorocarbons, Hydrofluorocarbons, Hydrofluoroolefins, and
Perchloroethylene
This condition of use refers to processing CTC in chemical
reactions for the manufacturing of another chemical substance or
product. Through processing as a reactant or intermediate, CTC serves
as a feedstock in the production of another chemical product via a
chemical reaction in which CTC is consumed. Currently, CTC is used as a
reactant to manufacture HCFCs, HFCs, HFOs, and PCE, which are used in
the making of a variety of products including refrigerants, aerosol
propellants, and foam-blowing agents. The specifics of the reaction
process (e.g., use and types of catalysts, reaction temperature) vary
depending on the product being produced; however, a typical reaction
process involves unloading CTC from containers and feeding into the
reaction vessel(s), where CTC either completely or partially reacts
with other raw materials to form the final product. Following the
reaction, the product may be purified to remove unreacted CTC or other
materials if needed. This condition of use includes reuse of CTC,
including CTC that is not transformed as feedstock in other
manufacturing processes, as a reactant.
ii. Processing: Incorporation Into Formulation, Mixtures, or Reaction
Products for Agricultural Products Manufacturing; Vinyl Chloride
Manufacturing; Other Basic Organic and Inorganic Chemical Manufacturing
This condition of use refers to the process of mixing or blending
several raw materials to obtain a single product or preparation or
formulation. CTC has historically been incorporated into formulation or
mixtures to manufacture hydrochloric acid (HCl), vinyl chloride,
ethylene dichloride (EDC), chloroform, hafnium tetrachloride,
thiophosgene, and methylene chloride. CTC may be incorporated into
various products and formulations at varying concentrations for further
distribution. For example, CTC may be unloaded from transport
containers either directly into mixing equipment or into an
intermediate storage vessel either manually or through automation via a
pumping system. Mixing of components can occur in either a batch or
continuous system. The mixture that contains CTC may be used as a
reactant to manufacture a chlorinated compound that is subsequently
formulated into a product or a processing aid used to aid in the
manufacture of formulated products. For the purposes of this
rulemaking, EPA is allowing under the WCPP the continued incorporation
of CTC into formulation, mixtures, or reaction products for
agricultural products manufacturing, vinyl chloride manufacturing, the
elimination of nitrogen trichloride in the production of chlorine and
caustic soda, and the recovery of chlorine in tail gas from the
production of chlorine.
[[Page 103530]]
iii. Processing: Repackaging for Use as a Laboratory Chemical
This condition of use refers to the physical transfer of a chemical
substance or mixture, as is, from one container to another container or
containers in preparation for distribution of the chemical substance or
mixture in commerce. Depending on the product, formulation products may
be filtered prior to packaging. Final packaging occurs either through
manual dispensing from transfer lines or through utilization of an
automatic system. Typically, repackaging sites receive the chemical in
bulk containers and transfer the chemical from the bulk container into
another smaller container in preparation for distribution in commerce.
iv. Processing: Recycling
This condition of use refers to the process of treating generated
spent chemical (which would otherwise be disposed of as waste) that is
collected on-site or transported to third-party sites for reclamation/
recycling. Spent chemicals can be restored to a condition that permits
reuse via reclamation/recycling. The recovery process may involve an
initial vapor recovery or mechanical separation step followed by
distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and Commercial Use as an Industrial Processing Aid in the
Manufacture of Agricultural Products and Vinyl Chloride
A processing aid is a ``chemical that is added to a reaction
mixture to aid in the manufacture or synthesis of another chemical
substance but is not intended to remain in or become part of the
product or product mixture.'' Additionally, processing agents are
intended to improve the processing characteristics or the operation of
process equipment, but not intended to affect the function of a
substance or article created. CTC is used as a processing aid/agent to
aid in the manufacture of formulated products, including agricultural
chemicals and vinyl chloride. CTC has historically been used as a
processing agent in the manufacture of chlorosulphonated polyolefin;
stryene butadiene rubber; endosulfan (insecticide); 1-1 Bis (4-
chlorophenyl) 2,2,2-trichloroethanol (dicofol insecticide); and
tralomethrin (insecticide) (Ref. 1). For the purposes of this
rulemaking, EPA is allowing under the WCPP the continued use of CTC as
an industrial processing aid in the manufacturing of agricultural
products and vinyl chloride.
ii. Industrial and Commercial Use in the Elimination of Nitrogen
Trichloride in the Production of Chlorine and Caustic Soda and the
Recovery of Chlorine in Tail Gas From the Production of Chlorine
This condition of use refers to a specific use of CTC as a
processing aid/agent in basic inorganic chemical manufacturing. For
purposes of this rulemaking, EPA is allowing under the WCPP the
continued use of CTC in the elimination of nitrogen trichloride in the
production of chlorine and caustic soda and the recovery of chlorine in
tail gas from the production of chlorine.
d. Disposal
This condition of use refers to the process of disposing waste
streams of CTC that are collected either onsite (e.g. pumped out of the
ground for treatment), or transported to a third-party site for
treatment or their final disposition, such as waste incineration or
landfilling. For this rule, the WCPP for the disposal of CTC-containing
water and groundwater for purposes of cleanup projects of CTC-
contaminated water and groundwater, including industrial pre-treatment
and industrial treatment activities, applies to removing the
groundwater from the location where it was located and treating the
removed groundwater on site. The requirements of the WCPP apply to any
potentially exposed person involved in the disposal of CTC-containing
groundwater to industrial treatment, industrial pre-treatment, or
POTWs. A potentially exposed person most likely includes a worker who
is involved with the activity of removing CTC-containing groundwater
from the location where it was found and the on-site treatment of the
groundwater, typically referred to as ex situ remediation, which is
most consistent with the scope of the 2020 CTC Risk Evaluation. Ex situ
remediation includes both active and passive remediation methods that
span traditional (e.g., pump and treat) and less traditional (e.g.,
phytoremediation) approaches, but only if the remediation method would
be considered industrial wastewater pretreatment, industrial wastewater
treatment or discharge to a publicly owned treatment work (POTW). A
remediation method would need to be considered one of these three types
of disposal to fall within the condition of use under TSCA for
remediation sites managed by the Federal government and if not, would
not be subject to the requirements of the rule. Further, while EPA
considers solid wastes as part of the waste streams included in the
disposal COU, at groundwater remediation sites managed by the Federal
government and under existing waste disposal requirements, the WCPP
requirements under this rulemaking only apply to water contaminated
with CTC, and any other type of CTC-impacted waste will be handled
according to relevant existing requirements under RCRA and other
statutes. The provisions of the WCPP for the disposal COU, including
the ECEL, are not intended to cover potentially exposed persons who are
sampling groundwater to monitor the presence of a plume, but
specifically only those sampling at the site of extraction and
treatment activities.
2. Overview
The WCPP for CTC encompasses an inhalation exposure limit and
action level, DDCC, and the associated implementation requirements
described in this unit, to ensure that the chemical substance no longer
presents unreasonable risk. Under a WCPP, owners or operators have the
ability to select controls, within the parameters outlined in this
unit, regarding how they prevent exceedances of the identified EPA
exposure limit thresholds or prevent direct dermal contact. In the case
of CTC, meeting the EPA exposure limit threshold and implementing the
DDCC requirements for certain occupational conditions of use would
address the unreasonable risk to potentially exposed persons from
inhalation and dermal exposure.
EPA is finalizing these requirements to apply beginning on June 11,
2026 for non-Federal owners or operators, or by June 21, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government, or within 30 days of introduction of CTC into the
workplace, whichever is later, at which point entities would be
required to complete initial monitoring (as described in Unit
IV.B.3.b.). Additionally, EPA requires that each owner or operator
ensure that no person is exposed to an airborne concentration of CTC
that exceeds the ECEL as an 8-hour TWA, including by providing
respirators to potentially exposed persons in the regulated area, no
later than September 9, 2026 for non-Federal owners or operators, or no
later than September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or
beginning four months after introduction of CTC into the workplace,
whichever is later. EPA also requires each owner or operator to ensure
all persons are separated, distanced,
[[Page 103531]]
physically removed, or isolated from direct dermal contact with CTC,
including by providing dermal PPE, by June 16, 2025 for non-Federal
owners or operators, or no later than September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government. EPA also requires implementation of any needed exposure
controls based on initial monitoring and development of an exposure
control plan, which requires consideration and documented application
of the hierarchy of controls, no later than December 3, 2027 (as
described in Unit IV.B.5.).
EPA's implementation of the requirement to meet an ECEL as part of
a WCPP aligns with, to the extent possible, certain elements of the
existing OSHA standards for regulating toxic and hazardous substances
under 29 CFR part 1910, subpart Z. However, EPA is finalizing as
proposed a new, lower occupational exposure limit, derived from the
TSCA 2020 Risk Evaluation for Carbon Tetrachloride (Refs. 1, 15). For
CTC, this final rule will eliminate the unreasonable risk from CTC
contributed to by the conditions of use subject to the WCPP, enable
continued industry use where appropriate, and provide the familiarity
of a pre-existing framework for the regulated community.
EPA's requirements include specific exposure limits and ancillary
requirements necessary for successful implementation of an ECEL as part
of a WCPP. Taken together, these WCPP requirements apply to the extent
necessary so that the unreasonable risk from CTC under the conditions
of use listed earlier in this unit would no longer be presented.
Unit IV. includes a summary of the WCPP, including a description of
the finalized exposure limits including an ECEL and ECEL action level;
implementation requirements including monitoring requirements; a
description of potential exposure controls in accordance with the
hierarchy of controls, including engineering controls, administrative
controls, and PPE as it relates to respirator selection; and additional
finalized requirements for recordkeeping and workplace participation.
Additionally, Unit IV.B.4. describes DDCC requirements for CTC,
including potential exposure controls, which consider the hierarchy of
controls; PPE as it relates to dermal protection; and additional
requirements finalized for recordkeeping. Unit IV. also describes
changes to the proposed compliance timeframes, changes by EPA to
certain provisions of the WCPP based on public comments, and addition
of new provisions in the WCPP based on public comments used to inform
this final rule.
3. Existing Chemical Exposure Limit (ECEL)
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from inhalation exposures to CTC
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for Carbon Tetrachloride, EPA is requiring an ECEL and
ancillary requirements for all of the conditions of use identified in
Unit IV.B.1.
a. ECEL and ECEL Action Level (AL)
EPA is finalizing as proposed an ECEL under TSCA section 6(a) of
0.03 ppm (0.2 mg/m\3\) for inhalation exposures to CTC as an 8-hour TWA
based on the threshold POD for liver cancer (assuming a margin of
exposure of 300) and the IUR for adrenal cancer. The ECEL memo includes
linear risk calculations for adrenal gland tumors in the equation for
``Cancer risk for other tumor types (e.g., adrenal glands) at the
ECEL,'' showing that the ECEL is protective of all tumor types,
including adrenal gland and brain tumors (Ref. 15). EPA has determined
that ensuring exposures remain at or below the 8-hour TWA ECEL of 0.03
ppm will eliminate the unreasonable risk of injury to health for CTC
resulting from acute and chronic inhalation exposures in an
occupational setting (Ref. 15). If ambient exposures are kept at or
below the 8-hour TWA ECEL of 0.03 ppm, a potentially exposed person
will be protected against the effects described in this unit, including
cancer, chronic non-cancer effects, and effects resulting from acute
inhalation exposures (Ref. 15). In addition to the ECEL memo, to
respond to public comments, EPA also explained that the ECEL is
protective of short-term acute inhalation exposures (Refs. 11 and 15).
EPA is finalizing requirements that each owner or operator ensure that
the airborne concentration of CTC does not exceed the ECEL for all
potentially exposed persons within 1,005 days after the date of
publication of the final rule (i.e., no later than September 20, 2027)
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, 630 days after the date of publication of the
final rule in the Federal Register (i.e., no later than September 9,
2026) for non-Federal owners and operators, or beginning four months
after introduction of CTC into the workplace if CTC use commences at
least 540 days after the date of publication (i.e., the use commences
on or after June 11, 2026).
EPA is finalizing an ECEL action level at 0.02 ppm as an 8-hour TWA
for CTC. Below the ECEL action level, certain compliance activities,
such as periodic monitoring, would be required less frequently, as
described further in this unit. In this way, EPA's WCPP for CTC is
consistent with the familiar framework that is in place in OSHA
standards for regulating toxic and hazardous substances under 29 CFR
1910 Subpart Z that establish an action level, although the values
differ due to differing statutory authority. As explained by OSHA, the
action level provides employers and employees with greater assurance
that their employees will not be exposed to concentrations above the
PELs (Ref. 42).
In summary, EPA is finalizing as proposed with slight modification
that owners or operators must ensure the airborne concentration of CTC
within the personal breathing zone of potentially exposed persons
remains at or below 0.03 ppm as an 8-hour TWA ECEL, with an action
level finalized as 0.02 ppm as an 8-hour TWA. For purposes of this
rulemaking, the personal breathing zone is consistent with how OSHA
defines it as a hemispheric area forward of the shoulders within a six-
to-nine-inch radius of a worker's nose and mouth and requires that
exposure monitoring air samples be collected from within this space
(Ref. 43). EPA is finalizing the ECEL for most occupational conditions
of use to ensure that no person is exposed to inhalation of CTC in
excess of these concentrations resulting from those conditions of use.
EPA recognizes that the regulated community has the ability to detect
the values for the ECEL because of viable detection limits and
analytical methods of CTC for monitoring devices that are available in
commerce, currently in use, which are as low as 4 micrograms per sample
(Refs. 15, 44). For the purposes of this TSCA section 6(a) rulemaking,
EPA will consider the use of methods for exposure monitoring (i.e.,
NIOSH Method 1003) that produce results that are accurate, to a
confidence level of 95 percent and within 25 percent (plus or minus) of
airborne concentrations of CTC above 0.03 ppm ECEL, to be in compliance
with this rule. EPA recognizes that current analytical methods may not
measure CTC to below the action level of 0.02 ppm, particularly for
short-term tasks; therefore, owners and operators will be required to
monitor more frequently, as described further in this unit, until
monitoring methods that measure to or below the action level become
available.
[[Page 103532]]
b. Monitoring Requirements
i. Exposure Sampling
Initial monitoring for CTC is critical for establishing a baseline
of exposure for potentially exposed persons; similarly, periodic
exposure monitoring assures continued compliance over time so that
potentially exposed persons are not exposed to levels that would result
in an unreasonable risk of injury to health. Exposure monitoring could
be suspended if certain conditions described in Unit IV. are met. Also,
in some cases, a change in workplace conditions with the potential to
impact exposure levels would warrant additional monitoring, which is
also described.
EPA is finalizing with modifications from proposal its requirement
that owners or operators determine each potentially exposed person's
exposure by taking a personal breathing zone air sample of each
potentially exposed person's exposure or by taking personal breathing
zone air samples that are representative of each potentially exposed
person with a similar exposure profile to chemical substance or mixture
based on substantial similarity of tasks performed, the manner in which
the tasks are performed, and the materials and processes with which
they work (hereinafter identified as an ``exposure group''). Personal
breathing zone air samples are representative of the 8-hour TWA of all
potentially exposed persons in an exposure group if the samples are of
the full shift-exposure of at least one person who represents the
highest potential CTC exposures in that exposure group. In addition,
the initial monitoring will be required when and where the operating
conditions are best representative of each potentially exposed person's
full-shift exposures. Personal breathing zone air samples taken during
one work shift may be used to represent potentially exposed person
exposures on other work shifts where the owner or operator can document
that the tasks performed and conditions in the workplace are similar
across shifts. Additionally, air sampling is required to measure
ambient concentrations for CTC without taking respiratory protections
into account as sampling is being performed. For purposes of exposure
monitoring requirements, owners and operators are only required to
monitor potentially exposed persons that are expected to be present in
the workplace.
EPA is also finalizing requirements that the owner or operator
ensure that their exposure monitoring methods are accurate to a
confidence level of 95% and are within (plus or minus) 25% of airborne
concentrations of CTC above the 8-hour TWA ECEL. To ensure compliance
for monitoring activities, EPA is finalizing recordkeeping requirements
and will require that owners or operators document their choice of
monitoring method outlined in this unit. As described in Unit III.C.1.,
EPA is finalizing the requirement that owners or operators meet certain
documentation requirements for each monitoring event of CTC, including
compliance with GLP Standards in accordance with 40 CFR part 792 or use
of a laboratory accredited by the AIHA (e.g., AIHA LAP, LLC Policy
Module 2A/B/E of Revision 17.3), or other analogous industry-recognized
program. Additionally, as described in Unit III.C.1., EPA is finalizing
the requirement that owners or operators must re-monitor within 15
working days after receipt of any exposure monitoring when results
indicate non-detect, unless an Environmental Professional as defined at
40 CFR 312.10 or a Certified Industrial Hygienist reviews the
monitoring results and determines re-monitoring is not necessary.
EPA is also finalizing the requirement that each owner or operator
maintain exposure monitoring records that include the following
information for each monitoring event:
Dates, duration, and results of each sample taken.
The quantity, location(s) and manner of use of CTC at the
time of each monitoring event.
All measurements that may be necessary to determine the
conditions (e.g., work site temperatures, humidity, ventilation rates,
monitoring equipment type and calibration dates) that may affect the
monitoring results.
Name, workplace address, work shift, job classification,
work area, and type of respiratory protection (if any) of each
monitored person.
Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample.
Use of appropriate sampling and analytical methods.
Compliance with GLP Standards in accordance with 40 CFR
part 792 or use of a laboratory accredited by AIHA (e.g., AIHA LAP, LLC
Policy Module 2A/B/E of Revision 17.3), or another analogous industry-
recognized program.
Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
Notification of exposure monitoring results to each person
whose exposures are monitored or who is part of a monitored exposure
group.
ii. Initial Exposure Monitoring
Under the final regulation, each non-Federal owner or operator of a
facility that is engaged in one or more of the conditions of use listed
in Unit IV.B.1. will be required to perform initial exposure monitoring
within 540 days after publication of the final rule in the Federal
Register (i.e., no later than June 11, 2026) or within 30 days of
introduction of CTC into the workplace, whichever is later, to
determine the extent of exposure of potentially exposed persons to CTC.
As discussed in Unit III.B., EPA is providing additional time for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government to comply with the provisions of the WCPP, so they
will be required to conduct initial monitoring within 915 days after
publication (i.e., no later than June 21, 2027). Initial monitoring
will notify owners and operators of the magnitude of possible exposures
to potentially exposed persons with respect to their work conditions
and environments. Based on the magnitude of possible exposures in the
initial exposure monitoring, the owner or operator may need to increase
or decrease the frequency of future periodic monitoring or adopt new
exposure controls (such as engineering controls, administrative
controls, and/or a respiratory protection program), as indicated in
table 1. In addition, the initial monitoring will be required when and
where the operating conditions are best representative of each
potentially exposed person's work-shift exposures. If the owner or
operator chooses to use a sample that is representative of potentially
exposed persons' full shift exposures (rather than monitor every
individual), such sampling should be representative (i.e., taken from
the breathing zone of potentially exposed persons and reflect duration-
appropriate exposure) of the most highly exposed persons in the
workplace. Additionally, EPA expects that owners and operators will
conduct initial exposure monitoring representative of all tasks that a
potentially exposed person will be expected to do. EPA understands that
certain tasks may occur less frequently or may reflect accidental
exposure (for example, due to malfunction).
EPA also recognizes that some entities may already have objective
exposure monitoring data. If the owner or operator has monitoring data
conducted within five years prior to 60 days following publication of
the final rule in the Federal Register and the monitoring
[[Page 103533]]
satisfies all other requirements in Unit IV., including the requirement
that the data represents the highest CTC exposures likely to occur
under reasonably foreseeable conditions of use, the owner or operator
may rely on such earlier monitoring results for the initial baseline
monitoring sample. Prior monitoring data cannot be used where there has
been a change in work conditions or practices that is expected to
result in new or additional exposures.
As described in more detail later in Unit IV., the owner or
operator must conduct periodic monitoring at least once every five
years since its last monitoring. This periodic monitoring must be
representative of all the potentially exposed persons in the workplace
and the tasks that they are expected to do.
iii. Periodic Exposure Monitoring
EPA is finalizing the following periodic monitoring for owners or
operators. These finalized requirements are also outlined in Table 1.
If samples taken during the initial exposure monitoring
reveal a concentration below the ECEL action level (<0.02 ppm 8-hour
TWA), the owner or operator must repeat the periodic exposure
monitoring at least once every five years.
If the most recent exposure monitoring indicates that
airborne exposure is above the ECEL (>0.03 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within three
months of the most recent exposure monitoring.
If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (>=0.02 ppm 8-
hour TWA) but at or below the ECEL (<=0.03 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within six
months of the most recent exposure monitoring.
If the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the ECEL action level, the
owners or operators must repeat such monitoring within six months of
the most recent monitoring until two consecutive monitoring
measurements, taken at least seven days apart, are below the ECEL
action level (<0.02 ppm 8-hour TWA), at which time the owner or
operator must repeat the periodic exposure monitoring at least once
every five years.
In instances where an owner or operator does not
manufacture, process, use, or dispose of CTC for a condition of use for
which the WCPP is required over the entirety of time since the last
required periodic monitoring event, EPA is requiring that the owner or
operator would be permitted to forgo the next periodic monitoring
event. However, documentation of cessation of use of CTC would be
required and periodic monitoring would be required to resume when the
owner or operator restart any of the conditions of use listed in Unit
IV.B.1.
Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
the ECEL action level (<0.02 ppm 8- required at least once every
hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (>0.03 ppm 8-hour TWA). of the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.02 ppm 8-hour monitoring.
TWA, <=0.03 ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a 6-month period, indicate exposure is monitoring.
below the ECEL action level (<0.02 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic monitoring
would be required but does not event. However, documentation
manufacture, process, use, or dispose of cessation of use of CTC is
of CTC in that condition of use over required and periodic
the entirety of time since the last monitoring would be required
required monitoring event. when the owner or operator
resumes the condition of use.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
discussed in Unit IV.B.3.b.iv.
iv. Additional Exposure Monitoring
EPA is finalizing that each owner or operator conduct additional
exposure monitoring within a reasonable timeframe after there has been
a change in the production, process, control equipment, personnel or
work practices may reasonably be expected to result in new or
additional exposures at or above the ECEL, or when the owner or
operator has any reason to believe that new or additional exposures at
or above the ECEL action level have occurred, for example if an owner
or operator receives information from potentially exposed person(s)
suggesting that such new or additional exposures may have occurred. In
the event of start-up or shutdown, or ruptures, malfunctions or other
breakdowns or unexpected releases that may lead to exposure to
potentially exposed persons, EPA is finalizing that each owner or
operator must conduct exposure monitoring of potentially exposed
persons (using personal breathing zone sampling) within a reasonable
timeframe after the conclusion of the start-up or shutdown and/or the
cleanup, repair or remedial action of the malfunction or other
breakdown or unexpected release. EPA is also requiring that the owner
or operator document that additional monitoring was completed within a
reasonable timeframe. At this time, EPA is not finalizing a specific
compliance timeframe for completion of additional monitoring when there
has been a change in the production, process, control equipment,
personnel or work practices, or in the event of start-up or shutdown,
or ruptures, malfunctions or other breakdowns or unexpected releases
that may lead to exposure to potentially exposed persons; however,
other TSCA section 6(a) rules are finalizing a compliance timeframe of
30 days for additional monitoring in these cases, and such timeframe
would be an indication of what EPA considers likely to be reasonable in
most cases when these changes are made at facilities that use CTC or in
the event of these potential releases of CTC. An additional exposure
monitoring event may result in an increased frequency of periodic
monitoring. For example, if the initial monitoring results from a
workplace are above the ECEL action level, but below the ECEL, periodic
monitoring is required every six months. If additional monitoring is
performed because increased exposures are suspected, and
[[Page 103534]]
the results are above the ECEL, subsequent periodic monitoring would
have to be performed every three months. The required additional
exposure monitoring should not delay implementation of any necessary
cleanup or other remedial action to reduce the exposures to persons in
the workplace.
c. Regulated Area
EPA is finalizing its requirement that the owner or operator
demarcate any area where airborne concentrations of CTC exceed, or are
reasonably expected to exceed the ECEL. To provide more clarity
regarding how regulated areas must be demarcated, EPA has incorporated
the language analogous to OSHA's regulated area requirements under the
standards for toxic and hazardous substances (29 CFR part 1910, subpart
Z) into this final rule. Owners and operators must demarcate regulated
areas from the rest of the workplace in any manner that adequately
establishes and alerts potentially exposed persons to the boundaries of
the area and minimizes the number of authorized persons exposed to CTC
within the regulated area. This can be accomplished using
administrative controls (e.g., highly visible signifiers) in multiple
languages as appropriate (e.g., when potentially exposed persons who
primarily speak a language other than English are present, owners and
operators should post additional highly visible signifiers in the
language of the largest group of workers who cannot readily comprehend
or read English), placed in conspicuous areas. The owner or operator is
required to restrict access to the regulated area from any potentially
exposed person that lacks proper training or is otherwise unauthorized
to enter.
d. Notification of Monitoring Results
EPA is finalizing the requirement that the owner or operator must,
within 15 working days after the receipt of the results of any exposure
monitoring, notify each potentially exposed person whose exposure is
represented by that monitoring and their designated representatives in
writing, either individually to each potentially exposed person or by
posting the information in an appropriate and accessible location, such
as public spaces or common areas, for potentially exposed persons
outside of the regulated area. The notice would be required to identify
the exposure monitoring results, the ECEL and ECEL action level and
what they mean in plain language, statement of whether the monitored
airborne concentration of CTC exceeds the ECEL and ECEL action level,
and any corresponding respiratory protection required. If the ECEL is
exceeded, the notice must also include a description of the actions
taken by the owner or operator to reduce inhalation exposures to or
below the ECEL. The notice must also include the quantity, location,
manner of CTC use, and identified releases of CTC that could result in
exposure to CTC at the time of monitoring. The notice must be posted in
multiple languages if necessary (e.g., notice must be in a language
that the potentially exposed person understands, including a non-
English language version representing the language of the largest group
of workers who cannot readily comprehend or read English).
4. Direct Dermal Contact Control (DDCC) Requirements
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from dermal exposures to CTC
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for CTC, EPA is finalizing DDCC requirements for all of
the conditions of use identified in Unit IV.B.1. EPA is finalizing its
requirements that owners or operators must separate, distance,
physically remove, or isolate all person(s) from direct handling of CTC
or from skin contact with surfaces that may be contaminated with CTC
(i.e., equipment or materials on which CTC may be present) under
routine conditions in the workplace (hereafter referred to as direct
dermal contact) within 180 days after the date of publication of the
final rule in the Federal Register (i.e., June 16, 2025) for non-
Federal owners or operators, or within 1,005 days after the date of
publication of the final rule in the Federal Register (i.e., September
20, 2027) for Federal agencies and Federal contractors acting for or on
behalf of the Federal government. The 2020 Risk Evaluation for Carbon
Tetrachloride identified that unreasonable risk to workers is also
driven by the dermal exposure, specifically from direct skin contact
with CTC; risk exceeding the benchmark was identified even when
considering use of chemically resistant gloves in most commercial and
industrial conditions of use. EPA has determined that preventing direct
dermal contact will eliminate the unreasonable risk of injury to health
resulting from dermal exposures for certain occupational conditions of
use of CTC. See the proposed rule for EPA's description of how the
requirements related to DDCC would address the unreasonable risk
resulting from dermal exposures and the rationale for this regulatory
approach in Units III.B.4. and V.A. of the proposed rule. and V.A. of
the proposed rule.
5. Exposure Control Plan
EPA is finalizing its requirement that entities implementing the
WCPP adopt feasible exposure controls, including one or a combination
of elimination, substitution, engineering controls, and administrative
controls, prior to requiring the use of PPE (i.e., respirators or
gloves) as a means of controlling exposures below EPA's ECEL and/or
prevent directing dermal contact with CTC for all potentially exposed
persons, in accordance with the hierarchy of controls (Ref. 6). If an
owner or operator chooses to replace CTC with a substitute, EPA
recommends careful review of the available hazard and exposure
information on the potential substitutes to avoid a substitute chemical
that might later be found to present an unreasonable risk of injury to
health or the environment under its conditions of use or be subject to
regulation (sometimes referred to as a ``regrettable substitution'').
EPA expects that, for conditions of use for which EPA is finalizing a
WCPP, compliance at most workplaces would be part of an established
industrial hygiene program that aligns with the hierarchy of controls.
Examples of engineering controls that may prevent or reduce the
potential for direct dermal contact include automation, physical
barriers between contaminated and clean work areas, enclosed transfer
liquid lines (with purging mechanisms in place (e.g., nitrogen,
aqueous) for operations such as product changes or cleaning), and
design of tools (e.g., a closed-loop container system providing
contact-free connection for unloading fresh and collecting spent
solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples
of administrative controls that may prevent or reduce the potential for
direct dermal contact include adjusting work practices (i.e.,
implementing policies and procedures) such as providing safe working
distances from areas where direct handling of CTC may occur.
EPA is finalizing the requirement that regulated entities use the
hierarchy of controls, instituting one or a combination of controls to
the extent feasible, and supplement such protections using PPE, where
necessary, including respirators for potentially exposed persons at
risk of inhalation exposure above the ECEL and dermal PPE for persons
potentially exposed through direct dermal contact to CTC. If efforts of
elimination, substitution,
[[Page 103535]]
engineering controls, and administrative controls are not sufficient to
reduce exposures to or below the ECEL or prevent direct dermal contact
for all potentially exposed persons in the workplace, EPA requires that
the owner or operator use feasible controls to reduce CTC
concentrations in the workplace to the lowest levels achievable and
supplement these controls with respiratory protection and dermal PPE as
needed to achieve the ECEL or prevent direct dermal contact. In such
cases, EPA requires that the owner or operator provide potentially
exposed persons reasonably likely to be exposed to CTC by inhalation to
concentrations above the ECEL with respirators affording sufficient
protection against inhalation risk and appropriate training on the
proper use of such respirators, to ensure that their exposures do not
exceed the ECEL as described in Unit IV. EPA also requires that the
owner or operator provides potentially exposed persons reasonably
likely to be exposed to CTC by direct dermal contact with dermal
protection affording sufficient protection against dermal risk and
appropriate training on the proper use of dermal protection, as
described in this unit. As part of the training requirement, the owner
or operator is required to provide information and comprehensive
training in an understandable manner (i.e., plain language),
considering factors such as the skills required to perform the work
activity and the existing skill level of the staff performing the work,
and in multiple languages as appropriate (e.g., based on languages
spoken by potentially exposed persons) to potentially exposed persons.
This training must be provided prior to or at the time of initial
assignment to a job involving potential exposure to CTC. Furthermore,
EPA also requires that the owner or operator document their efforts in
using elimination, substitution, engineering controls, and
administrative controls to reduce exposure to or below the ECEL in an
exposure control plan.
The Agency understands that certain engineering controls can reduce
exposures to people inside the workplace but may lead to increased
ventilation of CTC outside of the workplace. Increasing CTC releases to
the ambient air could lead to increasing risks to people in fenceline
communities of adverse health effects from exposures to CTC in ambient
air. Therefore, as proposed, and considering the effects of CTC on
health and the magnitude of the exposure of human beings, as required
by TSCA section 6(c)(2)(A)(i), EPA is prohibiting increased releases of
CTC to outdoor air associated with the implementation of the WCPP/ECEL.
This requirement is intended to avoid unintended increases in exposures
to people from CTC emissions to ambient air. Owners and operators are
required to attest in their WCPP/ECEL exposure control plan that
engineering controls selected do not increase emissions of CTC to
ambient air outside of the workplace and document in their exposure
control plan whether additional equipment was installed to capture
emissions of CTC to ambient air. Owners and operators may institute air
emissions monitoring or modeling to assist with meeting this
requirement.
EPA is finalizing its requirement that the owner or operator
include and document in the exposure control plan or through any
existing documentation of the facility's safety and health program
developed as part of meeting OSHA requirements or other safety and
health standards, the following:
Identification in the exposure control plan of available
exposure controls that were considered and rationale for using or not
using available exposure controls in the following sequence (i.e.,
elimination and substitution, then engineering controls and
administrative controls) to reduce exposures in the workplace to either
at or below the ECEL or to the lowest level achievable and to prevent
or reduce direct dermal contact with CTC in the workplace;
For each exposure control considered, exposure controls
selected based on feasibility, effectiveness, and other relevant
considerations;
A description of actions the owner or operator must take
to implement exposure controls selected, including proper installation,
regular inspections, maintenance, training, or other steps taken;
A description of regulated areas, how they are demarcated,
and persons authorized to enter the regulated areas;
Attestation that exposure controls selected do not
increase emissions of CTC to ambient air outside of the workplace and
whether additional equipment was installed to capture or otherwise
prevent increased emissions of CTC to ambient air;
A description of activities conducted by the owner or
operator to review and update the exposure control plan to ensure
effectiveness of the exposure controls, identify any necessary updates
to the exposure controls, and confirm that all persons are properly
implementing the exposure controls; and
An explanation of the procedures for responding to any
change that may reasonably be expected to introduce additional sources
of exposure to CTC, or otherwise result in increased exposure to CTC,
including procedures for implementing corrective actions to mitigate
exposure to CTC.
Under this final rule, owners or operators are prohibited from
using rotating work schedules to comply with the ECEL 8-hour TWA, in
alignment with certain elements of existing OSHA's standards for toxic
substances under 29 CFR part 1910, subpart Z. Owners or operators must
maintain the effectiveness of any engineering and administrative
controls instituted as part of the exposure control plan. They must
also review and update the exposure control plan as necessary, but at
least every five years, to reflect any significant changes in the
status of the owner or operator's approach to compliance with the
exposure control requirements. EPA intends that the exposure control
plan identify the available exposure controls and, for the exposure
controls not selected, document the efforts identifying why these are
not feasible, not effective, or otherwise not implemented. For entities
for which significant amounts of time are needed to verify suitability
of alternatives or procure funds or authorization for additional
engineering controls, for example, EPA expects that as those controls
become available the exposure control plan would be updated
accordingly. EPA requires that the exposure control plan be revisited
under certain conditions (and at least every five years) and encourages
updates as more sophisticated controls are available.
This final rule requires owners or operators to make the exposure
control plan and associated records, including ECEL exposure monitoring
records, ECEL compliance records, DDCC compliance records, and
workplace participation records, available to potentially exposed
persons and their designated representatives. Owners or operators must
notify potentially exposed persons and their designated representatives
of the availability of the exposure control plan and associated records
within 30 days of the date that the exposure control plan is completed
and at least annually thereafter. The notice of the availability of the
plan and associated records must be provided in plain language writing
to each potentially exposed person in a language that the person
understands or posted in an appropriate and accessible location outside
the regulated area with an English-language version and a non-
[[Page 103536]]
English version representing the language of the largest group of
workers who do not read English. This final rule also requires the
owner or operator to provide the exposure control plan and associated
records at a reasonable time, place, and manner to a potentially
exposed person or their designated representative upon request. As
explained in Unit III.C.2., if the owner or operator is unable to
provide the specified records within 15 days, the owner or operator
must inform the potentially exposed person or designated representative
requesting the record within 15 days that reason for the delay and the
earliest date when the record will be made available.
6. Personal Protective Equipment (PPE)
Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL and/or prevent direct dermal contact
with CTC for all potentially exposed persons, EPA is finalizing as
proposed with slight modifications to improve clarity or for greater
consistency with OSHA's regulations to require owners and operators to
provide PPE, including respiratory protection and dermal protection
selected in accordance with the guidelines described in this unit, and
to implement a PPE program. This unit includes a description of the PPE
program, including required PPE as it relates to respiratory
protection, required PPE as it relates to dermal protection, and other
requirements such as additional training for respirators and
recordkeeping to support implementation of a PPE program.
a. Respiratory Protection
Where elimination, substitution, engineering, and administrative
controls are not feasible or sufficiently protective to reduce the air
concentration to or below the ECEL, or if inhalation exposure above the
ECEL is still reasonably likely, EPA is finalizing, with slight
modification from the proposal, minimum respiratory PPE requirements
based on an owner or operator's most recent measured air concentration
for one or more potentially exposed persons and the level of PPE needed
to reduce exposure to or below the ECEL. In those circumstances, EPA is
finalizing the requirements for a respiratory protection PPE program
with worksite-specific procedures and elements for required respirator
use. Owners or operators must develop and administer a written
respiratory protection program in accordance with OSHA's respiratory
protection standard under 29 CFR 1910.134(c)(1), (c)(3), and (c)(4).
EPA is finalizing requirements that owners and operators provide
training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k) prior to or at the time of initial
assignment to a job involving potential exposure to CTC. Owners and
operators must retrain all persons required to use PPE at least
annually, or whenever the owner or operator has reason to believe that
a previously trained person does not have the required understanding
and skill to properly use PPE, or when changes in the workplace or in
PPE to be used render the previous training obsolete.
EPA is finalizing requirements that each owner or operator supply a
respirator, selected in accordance with requirements described in this
unit, to each person who enters a regulated area within 1,005 days
after the date of publication of the final rule in the Federal Register
(i.e., no later than September 20, 2027) for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
630 days after the date of publication of the final rule in the Federal
Register (i.e., no later than September 9, 2026) for non-Federal owners
and operators, or within three months after the receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, and thereafter
must ensure that all persons within the regulated area are using the
provided respirators whenever CTC exposures exceed or can reasonably be
expected to exceed the ECEL.
EPA is also finalizing requirements that owners or operators who
are required to administer a respiratory protection PPE program must
supply a respirator based on a medical evaluation consistent with the
requirements of 29 CFR 1910.134(e). If a potentially exposed person
cannot use a negative-pressure respirator, then the owner or operator
must provide that person with an alternative respirator. The
alternative respirator must have less breathing resistance than the
negative-pressure respirator and provide equivalent or greater
protection. If the person is unable to use an alternative respirator,
then the person must not be permitted to enter the regulated area.
Additionally, EPA is requiring owners and operators to select
respiratory protection that properly fits each affected person and
communicate respirator selections to each affected person in accordance
with the requirements of 29 CFR 1910.134(f). Consistent with
requirements of 29 CFR 1910.134(g) through (j), EPA is requiring owners
and operators to provide, ensure use of, and maintain (in a sanitary,
reliable, and undamaged condition) respiratory protection that is of
safe design and construction. EPA is also requiring owners and
operators to provide training to all persons required to use
respiratory protection consistent with the requirements of 29 CFR
1910.134(k).
EPA is finalizing the requirements to establish minimum respiratory
protection requirements, such that any respirator affording a higher
degree of protection than the following requirements may be used. In
instances where respiratory protection is appropriate, NIOSH
Approved[supreg] equipment must be used. NIOSH Approved is a
certification mark of the U.S. Department of Health and Human Services
(HHS) registered in the United States and several international
jurisdictions. EPA is finalizing the following requirements for
respiratory protection, based on the most recent exposure monitoring
concentration results measured as an 8-hour TWA that exceed the ECEL
(0.03 ppm):
If the measured exposure concentration is at or below 0.03
ppm: no respiratory protection is required.
If the measured exposure concentration is above 0.03 ppm
and less than or equal to 0.3 ppm (10 times ECEL): Any NIOSH Approved
air-purifying half mask respirator equipped with organic vapor
cartridges or canisters; or any NIOSH Approved Supplied-Air Respirator
(SAR) or Airline Respirator operated in demand mode equipped with a
half mask; or any NIOSH Approved Self-Contained Breathing Apparatus
(SCBA) in a demand mode equipped with a half mask [APF 10].
If the measured exposure concentration is above 0.3 ppm
and less than or equal to 0.75 ppm (25 times ECEL): Any NIOSH Approved
Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting
facepiece or hood/helmet equipped with organic vapor cartridges or
canisters; or any NIOSH Approved SAR or Airline Respirator in a
continuous-flow mode equipped with a loose-fitting facepiece or helmet/
hood [APF 25].
If the measured exposure concentration is above 0.75 ppm
and less than or equal to 1.5 ppm (50 times ECEL): Any NIOSH Approved
air-purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved PAPR with a half mask
equipped with organic vapor cartridges or canisters; any NIOSH Approved
SAR or Airline Respirator in a continuous flow mode equipped with a
half mask; any NIOSH Approved SAR or Airline Respirator
[[Page 103537]]
operated in a pressure-demand or other positive-pressure mode with a
half mask; or any NIOSH Approved SCBA in demand-mode equipped with a
full facepiece or helmet/hood [APF 50].
If the measured exposure concentration is above 1.5 ppm
and less than or equal to 30 ppm (1,000 times ECEL): Any NIOSH Approved
PAPR equipped with a full facepiece equipped with organic vapor
cartridges or canisters; any NIOSH Approved SAR or Airline Respirator
in a continuous-flow mode equipped with full facepiece; any NIOSH
Approved SAR or Airline Respirator in pressure-demand or other
positive-pressure mode equipped with a full facepiece and an auxiliary
self-contained air supply; or any NIOSH Approved SAR or Airline
Respirator in a continuous-flow mode equipped with a helmet or hood and
has been tested to demonstrate performance at a level of a protection
of APF 1,000 or greater. [APF 1,000].
If the measured exposure concentration is greater than 30
ppm (1,000+ times ECEL): Any NIOSH Approved SCBA equipped with a full
facepiece, hood, or helmet and operated in a pressure demand or other
positive pressure mode [APF 10,000].
If the exposure concentration is unknown: Any NIOSH
Approved combination supplied air respirator equipped with a full
facepiece and operated in pressure demand or other positive pressure
mode with an auxiliary self-contained air supply; or any NIOSH Approved
SCBA operated in pressure demand or other positive pressure mode and
equipped with a full facepiece or hood/helmet [APF 1000+].
Additionally, EPA is finalizing requirements that owners or
operators select and provide respirators in accordance with the
requirements of 29 CFR 1910.134(d)(1)(iv) and with consideration of
workplace and user factors that affect respirator performance and
reliability.
EPA is requiring that the owner or operator must ensure that all
filters, cartridges, and canisters used in the workplace are labeled
and color coded per NIOSH requirements and that the label is not
removed and remains legible. Consistent with 29 CFR
1910.134(d)(3)(iii), EPA is requiring either the use of NIOSH Approved
respirators with an end-of-life service indicator for the contaminant,
in this case CTC, or implementation of a change schedule for canisters
and cartridges that ensures that they are changed before the end of
their service life. EPA is also requiring owners and operators to
ensure that respirators are used in compliance with the terms of the
respirator's NIOSH approval.
EPA is finalizing requirements that owners and operators must
conduct regular evaluations of the workplace, including consultations
with potentially exposed persons using respiratory protection,
consistent with the requirements of 29 CFR 1910.134(l), to ensure that
the provisions of the written respiratory protection program described
in this unit are being effectively implemented.
EPA is finalizing the requirement that owners and operators
document respiratory protection used and PPE program implementation.
EPA is finalizing requirements that owners and operators document in
the exposure control plan or other documentation of the facility's
safety and health program information relevant to the respiratory
program, including records on the name, workplace address, work shift,
job classification, work area, and type of respirator worn (if any) by
each potentially exposed person, maintenance, fit-testing, and training
as described in this unit.
b. Dermal Protection
As described in this unit EPA is finalizing requirements that each
owner or operator supply dermal PPE that separates and provides a
barrier to prevent direct dermal contact with CTC, selected in
accordance with requirements described in this unit, to each person who
is reasonably likely to be dermally exposed in the work area through
direct dermal contact within 1,005 days after the date of publication
of the final rule in the Federal Register (i.e., no later than
September 20, 2027) for Federal agencies and Federal contractors acting
for or on behalf of the Federal government, or 180 days after the date
of publication of the final rule in the Federal Register (i.e., no
later than June 16, 2025) for non-Federal owners and operators. Where
elimination, substitution, engineering controls, and administrative
controls are not feasible or sufficient to fully prevent direct dermal
contact with CTC, EPA is finalizing requirements that appropriate
dermal PPE be provided by owners and operators to, and be worn by,
persons potentially exposed to direct dermal contact with CTC. EPA is
requiring owners and operators to provide dermal PPE that is of safe
design and construction for the work to be performed. EPA is also
requiring owners and operators ensure each potentially exposed person
who is required to wear PPE to use and maintain PPE in a sanitary,
reliable, and undamaged condition. Additionally, EPA is requiring
owners and operators to select and provide PPE that properly fits each
potentially exposed person who is required to use PPE and communicate
PPE selections to each affected person.
In choosing appropriate dermal PPE, EPA is requiring owners and
operators to select gloves, clothing, and protective gear (which covers
any exposed dermal area of arms, legs, torso, and face) based on
specifications from the manufacturer or supplier or individually
prepared third party testing that demonstrate an impervious barrier to
CTC during expected durations of use and normal conditions of exposure
within the workplace, accounting for potential chemical permeation or
breakthrough times. EPA is also requiring that owners and operators
demonstrate that the selected PPE will be impervious for the expected
duration and conditions of exposure, such as using the format specified
in ASTM F1194-99(2010) ``Standard Guide for Documenting the Results of
Chemical Permeation Testing of Materials Used in Protective Clothing
Materials,'' reporting cumulative permeation rate as a function of
time, or equivalent manufacturer- or supplier-provided testing. In
alignment with the OSHA Hand Protection PPE Standard (29 CFR 1910.138),
EPA is requiring owners and operators to select dermal PPE based on an
evaluation of the performance characteristics of the PPE relative to
the task(s) to be performed, conditions present, and the duration of
use. EPA is also requiring owners and operators to consider likely
combinations of chemical substances to which the clothing may be
exposed in the work area when selecting the appropriate PPE such that
the PPE will prevent direct dermal contact to CTC.
For example, owners and operators can select gloves that have been
tested in accordance with the American Society for Testing and
Materials (ASTM) F739 ``Standard Test Method for Permeation of Liquids
and Gases through Protective Clothing Materials under Conditions of
Continuous Contact.'' EPA is finalizing that PPE be provided for use
for a time period only to the extent and no longer than the time period
for which testing has demonstrated that the PPE will be impervious
during expected durations of use and conditions of exposure. EPA is
finalizing requirements that owners and operators also consider other
factors when selecting appropriate PPE, including effectiveness of
glove type when preventing exposures from CTC alone and in likely
combination with other chemical substances used in the work area or
when used with glove liners, permeation, degree of dexterity
[[Page 103538]]
required to perform task, and temperature, as identified in the Hand
Protection section of OSHA's Personal Protective Equipment Guidance
(Ref. 45).
EPA is finalizing that owners and operators establish, either
through manufacturer or supplier-provided documentation or individually
prepared third party testing that the selected PPE will be impervious
for the expected duration and conditions of exposure, such as using the
format specified in ASTM F1194-99(2010) ``Standard Guide for
Documenting the Results of Chemical Permeation Testing of Materials
Used in Protective Clothing Materials,'' reporting cumulative
permeation rate as a function of time, or equivalent manufacturer- or
supplier- provided testing. EPA is also requiring owners and operators
to consider likely combinations of chemical substances to which the
clothing may be exposed in the work area when selecting the appropriate
PPE such that the PPE will prevent direct dermal contact to CTC.
Degradation may also be appropriate to consider in the context of
combination chemical exposures, as some glove types and materials may
demonstrate efficient permeation barrier results but may not be fully
resistant to degradation from the chemical exposure. Degradation can be
evaluated using standard test methods such as select test methods
within ASTM Method D 471 Standard Test Method for Rubber Property--
Effect of Liquids (e.g., ASTM D412 Standard Test Methods for Vulcanized
Rubber and Thermoplastic Elastomers-Tension). EPA is finalizing
requirements that PPE must be immediately provided and replaced if any
person is dermally exposed to CTC longer than the breakthrough time
period for which testing has demonstrated that the PPE will be
impermeable or if there is a chemical permeation or breakage of the
PPE.
Additionally, EPA is finalizing requirements that owners and
operators subject to this rule comply with provisions of 29 CFR
1910.133(b) for requirements on selection and use of eye and face
protection.
Additionally, as part of the PPE program, EPA is also finalizing
that owners and operators must comply with OSHA's general PPE training
requirements at 29 CFR 1910.132(f) for application of a PPE training
program, including providing training on proper use of dermal PPE
(e.g., when and where PPE is necessary, proper application, wear, and
removal of PPE, maintenance, useful life and disposal of PPE). EPA is
finalizing that owners and operators provide PPE training to all
persons required to use dermal PPE prior to or at the time of initial
assignment to a job involving potential exposure to CTC. Owners and
operators have to re-train each affected person at least once annually
or whenever the owner or operator has reason to believe that a
previously trained person does not have the required understanding and
skill to properly use PPE, or when changes in the workplace or in the
PPE to be used render the previous training obsolete.
EPA is also finalizing requirements that owners and operators
retain records of dermal PPE used and program implementation. EPA is
requiring that owners and operators document in the exposure control
plan or other documentation of the facility's safety and health
program, information relevant to any dermal PPE program, as applicable,
including:
The name, workplace address, work shift, job
classification, and work area of each person reasonably likely to
directly handle CTC or handle equipment or materials on which CTC may
present and the type of PPE selected to be worn by each of these
persons;
The basis for specific PPE selection (e.g., demonstration
based on permeation testing or manufacturer specifications that each
item of PPE selected provides an impervious barrier to prevent exposure
during expected duration and conditions of exposure, including the
likely combinations of chemical substances to which the PPE may be
exposed in the work area);
Appropriately sized PPE and training on proper
application, wear, and removal of PPE, and proper care/disposal of PPE;
Occurrence and duration of any direct dermal contact with
CTC that occurs during any activity or malfunction at the workplace
that causes direct dermal exposures to occur and/or glove breakthrough,
and corrective actions to be taken during and immediately following
that activity or malfunction to prevent direct dermal contact to CTC;
and
Training described in this unit.
7. Additional Finalized Requirements
a. Workplace Information and Training
EPA is also finalizing its requirements to implement a training
program in alignment with the OSHA Hazard Communication Standard (29
CFR 1910.1200) and the OSHA General Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with CTC
exposure, EPA is finalizing as proposed with slight modification to
require that owners or operators of workplaces subject to the WCPP
institute a training and information program for potentially exposed
persons and assure their participation in the training and information
program within 1,005 days after the date of publication of the final
rule in the Federal Register (i.e., no later than September 20, 2027)
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or 630 days after the date of publication of
the final rule in the Federal Register (i.e., no later than September
9, 2026) for non-Federal owners and operators. For purposes of
workplace information and training, owners and operators are only
required to train potentially exposed persons that are expected to be
present in the workplace or to directly handle CTC or handle equipment
or materials on which CTC may present.
As part of the training and information program, the owner or
operator is required to provide information and comprehensive training
in an understandable manner (i.e., plain language) and in multiple
languages as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons prior to or
at the time of initial assignment to a job involving potential exposure
to CTC. Owners and operators are required to provide information and
training, as referenced in the OSHA Hazard Communication Standard, to
all potentially exposed persons that includes:
The requirements of the CTC WCPP and how to access or
obtain a copy of the requirements of the WCPP, including but not
limited to the exposure control plan, monitoring requirements, and PPE
program;
The quantity, location, manner of use, release, and
storage of CTC and the specific operations in the workplace that could
result in CTC exposure, particularly noting where each regulated area
is located;
Principles of safe use and handling of CTC in the
workplace, including specific measures the owner or operator has
implemented to reduce inhalation exposure at or below the ECEL or
prevent dermal contact with CTC, such as work practices and PPE used;
The methods and observations that may be used to detect
the presence or release of CTC in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance or odor of CTC when being released, etc.); and
[[Page 103539]]
The acute and chronic health hazards of CTC as detailed on
relevant Safety Data Sheets (SDSs).
In addition to providing training at the time of initial assignment
to a job involving potential exposure to CTC, owners and operators
subject to the CTC WCPP are required to re-train each potentially
exposed person as necessary, but at a minimum annually, to ensure they
understand the principles of safe use and handling of CTC in the
workplace. The owner or operator would consider factors such as the
skills required to perform the work activity and the existing skill
level of the staff performing the work. EPA is finalizing its
requirements that owners and update the training as necessary whenever
there are changes in the workplace, such as new tasks or modifications
of tasks, in particular, whenever there are changes in the workplace
that increase exposure to CTC or where potentially exposed persons'
exposure to CTC can reasonably be expected to exceed the action level
or increase the potential for direct dermal contact with CTC. To
support compliance, EPA is finalizing that each owner or operator of a
workplace subject to the WCPP would be required to provide to the EPA,
upon request, all available materials related to workplace information
and training.
b. Workplace Participation
EPA encourages owners and operators to consult with potentially
exposed persons and their designated representative on the development
and implementation of exposure control plans and PPE/respirator
programs. EPA is finalizing a requirement that owners and operators
provide potentially exposed persons and their designated
representatives regular access to the exposure control plans, exposure
monitoring records, and PPE program implementation records. To ensure
compliance with workplace participation, EPA is finalizing a
requirement that the owner or operator document the notice to and
ability of any potentially exposed person that may reasonably be
affected by CTC exposure to readily access the exposure control plans,
facility exposure monitoring records, PPE program implementation
records, or any other information relevant to CTC exposure in the
workplace.
c. Recordkeeping
For owners and operators to demonstrate compliance with the WCPP
provisions, EPA is requiring that owners and operators retain
compliance records for five years (although this requirement does not
supplant any longer recordkeeping retention time periods such as those
required under 29 CFR 1910.1020, or other applicable regulations). EPA
is requiring the owner or operator to retain records of:
Exposure control plan;
PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
Information and training provided to each person prior to
or at the time of initial assignment and any retraining.
In addition, EPA is finalizing requirements that owners and
operators subject to the WCPP ECEL requirements maintain records to
include:
Regulated areas and authorized personnel;
The exposure monitoring records;
Notification of exposure monitoring results; and
To the extent that the owner or operator relies on prior
exposure monitoring data, records that demonstrates that it meets all
of the requirements of this section.
The owners and operators, upon request by EPA, are required to make
all records that are maintained as described in Unit IV. available to
EPA for examination and copying in accordance with EPA requirements.
EPA emphasizes that all records required to be maintained can be kept
in the most administratively convenient form; electronic record form or
paper form.
8. Compliance Timeframes
EPA is finalizing the requirement that owners or operators of
workplaces subject to the WCPP implement the DDCC requirements as
outlined in this unit within 1,005 days after December 18, 2024 for
Federal agencies or Federal contractors acting for or on behalf of the
Federal government, 180 days after December 18, 2024 for non-Federal
owners and operators, or within 30 days of introduction of CTC into the
workplace, whichever is later. With regard to the compliance timeframe
for the WCPP provisions related to the ECEL, EPA is not finalizing the
timeframes proposed. Rather, as discussed in Unit III.B., based on
consideration of public comments and reasonably available information,
EPA is finalizing longer timeframes for compliance with provisions
related to the ECEL for non-Federal owners or operators, and is
providing Federal agencies and Federal contractors acting for or on
behalf of the Federal government additional time to comply with each of
the provisions of the WCPP. Specifically, EPA is finalizing its
requirement that non-Federal owners and operators perform initial
exposure monitoring according to the process outlined in this unit
within 540 days after date of publication of the final rule in the
Federal Register (i.e., no later than June 11, 2026) or within 30 days
of introduction of CTC into the workplace, whichever is later. Federal
agencies and Federal contractors acting for or on behalf of the Federal
government must conduct initial exposure monitoring within 915 days
after the date of publication (i.e., no later than June 21, 2027), or
within 30 days of introduction of CTC into the workplace, whichever is
later. EPA is also finalizing its requirement that each non-Federal
owner or operator ensure that exposure to CTC does not exceed the ECEL
as an 8-hour TWA for all potentially exposed persons within 630 days
after the date of publication of the final rule in the Federal Register
(i.e., no later than September 9, 2026), while Federal agencies and
Federal contractors acting for or on behalf of the Federal government
must comply with the ECEL within 1,005 days after the date of
publication (i.e., no later than September 20, 2027). If applicable,
each owner or operator must provide respiratory protection sufficient
to reduce inhalation exposures to below the ECEL to all potentially
exposed persons in the regulated area within three months after receipt
of the results of any exposure monitoring that indicates an exceedance
of the ECEL. For non-Federal owners or operators, this will be within
630 days after the date of publication of the final rule in the Federal
Register (i.e., no later than September 9, 2026). For Federal agencies
and Federal contractors acting for or on behalf of the Federal
government, this will be within 1,005 after the date of publication of
the final rule in the Federal Register (i.e., no later than September
20, 2027). EPA is also finalizing the requirement that owners and
operators demarcate a regulated area within three months after receipt
of any exposure monitoring that indicates exposures exceeding the ECEL.
Owners and operators shall proceed accordingly to implement an exposure
control plan, including institution of feasible exposure controls other
than PPE, within 1,080 days after date of publication of the final rule
in the Federal Register (i.e., no later than December 3, 2027).
C. Prescriptive Controls Required for Laboratory Use
In contrast to the non-prescriptive requirements of the WCPP,
including the DDCC, where regulated entities would have the ability to
select controls
[[Page 103540]]
in accordance with the hierarchy of controls to comply with the
parameters outlined in Unit IV.B., EPA has found it appropriate in
certain circumstances to require specific prescriptive controls for
certain occupational conditions of use. In general, EPA is finalizing
prescriptive controls, for the industrial and commercial use of CTC as
a laboratory chemical, as described in Unit III.A.2. This unit provides
a description of the industrial and commercial use of CTC as a
laboratory chemical subject to specific prescriptive controls, the
specific prescriptive control requirements, and the compliance
timeframe for the requirements.
1. Applicability
The industrial and commercial use of CTC as a laboratory chemical
refers to the industrial or commercial use of CTC, often in small
quantities, in a laboratory process or in specialized laboratory
equipment for instrument calibration/maintenance, chemical analysis,
chemical synthesis, extracting and purifying other chemicals,
dissolving other substances, executing research, development, test and
evaluation methods, and similar activities, such as use as a solvent,
reagent, analytical standard, or other experimental use.
After the risk evaluation was published, DoD did further analysis
and provided additional information clarifying their current use of CTC
as a laboratory chemical and risk management measures implemented. DoD
provided information on their use of CTC as a laboratory chemical in
chemical weapons destruction, indicating that CTC is used in small
amounts in a confined, laboratory-like setting with advanced
engineering controls. There is no waste CTC generated during this
process.
EPA recognizes that potentially exposed persons in a laboratory
setting may include students, researchers, visiting scholars, or others
whose job classifications may vary, such as depending on the academic
period in university laboratories. The requirements described in this
unit apply to all potentially exposed persons in all laboratory
settings, including academic and research laboratories, regardless of
job classification.
2. Workplace Requirements
To address the unreasonable risk of injury to health resulting from
dermal exposures to CTC identified for the industrial and commercial
use as a laboratory chemical, including DoD's use of CTC as a
laboratory chemical in chemical weapons destruction, EPA is requiring
dermal PPE, including impermeable gloves and protective clothing, in
combination with comprehensive training for tasks particularly related
to the use of CTC in a laboratory setting as specified in this unit for
each potentially exposed person with direct dermal contact to CTC in
the work area through direct handling of the substance or from contact
with surfaces that may be contaminated with CTC. For dermal PPE, EPA is
requiring that each owner or operator comply with the requirements
outlined in Units IV.B.6.b. for selection of dermal PPE and training
for all potentially exposed persons. EPA's description for how the
requirements for the industrial and commercial use as a laboratory
chemical address the unreasonable risk resulting from dermal exposures
under the conditions of use and the rationale for this regulatory
approach is outlined in Unit V. of the proposed rule (88 FR 49205, July
28, 2023) (FRL-8206-01-OCSPP).
In addition, EPA is requiring the use of laboratory ventilation
devices, such as fume hoods, glove boxes, air handling units, exhaust
fans, biological safety devices, airflow controls, and other local
exhaust devices, in workplace laboratory settings for the industrial
and commercial use of CTC as a laboratory chemical, except for DoD's
use of CTC as a laboratory chemical in chemical weapons destruction, to
codify existing good laboratory practices. EPA is requiring each owner
or operator of a workplace laboratory setting, except for DoD's use of
CTC as a laboratory chemical in chemical weapons destruction, to ensure
laboratory ventilation devices are in use and functioning properly to
minimize exposures to persons in the area where CTC is used as a
laboratory chemical. EPA suggests owners or operators refer to OSHA's
29 CFR 1910.1450, Appendix A, for National Research Council
recommendations concerning laboratory chemical hood ventilation system
characteristics and practices and to ANSI's and ASSP's Z9.5-2022 for
recommendations on additional laboratory ventilation controls to
minimize exposures to potentially exposed persons in the work area.
EPA understands that DoD uses CTC in small amounts in a confined,
laboratory-like setting with advanced engineering controls (Ref. 46).
Therefore, for DoD's industrial and commercial use of CTC as a
laboratory chemical in chemical weapons destruction, EPA is requiring
advanced engineering controls that essentially codify existing
practices at DoD facilities. EPA is not requiring a WCPP, specifically
with monitoring requirements, for DoD's industrial and commercial use
of CTC as a laboratory chemical in chemical weapons destruction.
3. Recordkeeping
To support and demonstrate compliance, EPA is requiring that each
owner or operator of a laboratory workplace subject to the requirements
of this unit retain compliance records for five years. In alignment
with 29 CFR 1910.1450(e)(3)(ii) and (iii) and 29 CFR 1910.132(d)(2),
EPA is requiring that owners and operators must retain records of:
Dermal protection used by each potentially exposed person
and PPE program implementation as outlined in this unit;
Criteria that the owner or operator will use to determine
and implement control measures to reduce potentially exposed persons'
exposure to CTC including laboratory ventilation devices as outlined in
this unit;
Implementation of properly functioning laboratory
ventilation devices using manufacturer's instructions for installation,
use, and maintenance of the systems, including inspections, tests,
development of maintenance procedures, the establishment of criteria
for acceptable test results, and documentation of test and inspection
results, except for DoD's use of CTC as a laboratory chemical in
chemical weapons destruction; and
For DoD's industrial and commercial use of CTC as a
laboratory chemical in chemical weapons destruction, implementation of
advanced engineering controls that are in use and functioning properly
and specific measures taken to ensure proper and adequate performance.
Owners or operators must maintain records for five years. EPA expects
owners or operators ensure that records reflect actions taken within
the last five years to comply with the requirements of this unit.
4. Compliance Timeframes
With regards to the compliance timeframe, EPA is requiring that
each owner or operator of a workplace engaged in the industrial and
commercial of CTC as a laboratory chemical ensure laboratory
ventilation devices are in use and functioning properly and that dermal
PPE is provided to all potentially exposed persons with direct dermal
contact with CTC within 180 days after publication of the final rule.
Similarly, EPA is requiring that DoD facilities engaged in the
industrial and
[[Page 103541]]
commercial use of CTC as a laboratory chemical in chemical weapons
destruction ensure that advanced engineering controls are in use and
functioning properly and dermal PPE is provided to all potentially
exposed persons with direct dermal contact with CTC within 365 days
after publication of the final rule.
EPA understands that certain departments and agencies of the
Federal government, as well as Federal contractors acting for or on
behalf of the Federal government, need additional time to comply with
these timeframes. For example, ensuring compliance with the
prescriptive controls could be challenging due to changing contracting,
procurement decisions and other processes in Federal facilities.
Similarly, EPA is requiring for that agencies of the Federal government
and their contractors, when acting for or on behalf of the Federal
government, that are engaged in the industrial and commercial use of
CTC as a laboratory chemical ensure laboratory ventilation devices are
in use and functioning properly, and that dermal PPE and training on
proper use of PPE is provided to all potentially exposed persons with
direct dermal contact with CTC within 365 days after publication of the
final rule.
D. Prohibition of Manufacture, Processing, Distribution, and Use of CTC
1. Applicability
EPA is finalizing the prohibitions for most of the conditions of
use for which prohibition was proposed. Prohibitions will address the
contribution to the unreasonable risk determined to be presented by CTC
in the 2020 Risk Evaluation for Carbon Tetrachloride and 2022 Revised
Unreasonable Risk Determination for Carbon Tetrachloride from
industrial and commercial uses of CTC, and reasonably available
information indicates that industry has already transitioned away from
CTC and found technically and economically feasible alternatives to CTC
for these uses. Unit V. of the proposed rule and the Response to
Comments document present further discussion of EPA's rationale for why
these conditions of use are being prohibited (88 FR 49205) (FRL-8206-
01-OCSPP). EPA's description of the uses proposed to be prohibited for
which the Agency is finalizing a WCPP (processing: incorporation into
formulation, mixtures, or reaction products in vinyl chloride
manufacturing and the industrial and commercial use as an industrial
processing aid in the manufacture of vinyl chloride) are in Units
III.A.1. and IV.B.1. The rule prohibits manufacture, processing,
distribution in commerce, and use of CTC for the following industrial
and commercial uses of CTC: industrial and commercial use as a
processing aid in the manufacture of petrochemical-derived products
except in the manufacture of vinyl chloride (for which EPA is
finalizing a WCPP); industrial and commercial use in the manufacture of
other basic chemicals (including chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings), except for use
in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine (for which EPA is finalizing a WCPP);
industrial and commercial use in metal recovery; industrial and
commercial use as an additive; and industrial and commercial use in
specialty uses by the U.S. Department of Defense. EPA is also
finalizing the explicit prohibition for processing: incorporation into
formulation, mixture or reaction products in petrochemical-derived
manufacturing except in the manufacture of vinyl chloride (the upstream
processing condition of use for the industrial and commercial use of
CTC as a processing aid in the manufacture of petrochemicals-derived
products except in the manufacture of vinyl chloride). This unit
provides a description of the uses subject to the prohibitions to
assist with compliance.
a. Processing: Incorporation Into Formulation, Mixture or Reaction
Products in Petrochemical-Derived Manufacturing Except in the
Manufacture of Vinyl Chloride
Incorporation into formulation, mixture, or reaction products
refers to the process of mixing or blending several raw materials to
obtain a single product or preparation or formulation. CTC has
historically been incorporated into formulation or mixtures to
manufacture hydrochloric acid (HCl), vinyl chloride, ethylene
dichloride (EDC), chloroform, hafnium tetrachloride, thiophosgene, and
methylene chloride. CTC may be incorporated into various products and
formulations at varying concentrations for further distribution. For
example, CTC may be unloaded from transport containers either directly
into mixing equipment or into an intermediate storage vessel either
manually or through automation via a pumping system. Mixing of
components can occur in either a batch or continuous system. The
mixture that contains CTC may be used as a reactant to manufacture a
chlorinated compound that is subsequently formulated into a product or
a processing aid used to aid in the manufacture of petrochemicals-
derived products. For the purposes of this rulemaking, EPA is
specifically prohibiting the incorporation into formulation, mixture or
reaction products in petrochemical-derived manufacturing except in the
manufacture of vinyl chloride. Incorporation into formulation, mixture
or reaction products in agricultural products manufacturing, vinyl
chloride manufacturing, the elimination of nitrogen trichloride in the
production of chlorine and caustic soda, and the recovery of chlorine
in tail gas from the production of chlorine is being regulated under
the WCPP, as described in Unit IV.B.
b. Industrial and Commercial Use
i. Industrial and Commercial Use as an Industrial Processing aid in the
Manufacture of Petrochemicals-Derived Products Except in the
Manufacture of Vinyl Chloride.
A processing aid is a ``chemical that is added to a reaction
mixture to aid in the manufacture or synthesis of another chemical
substance but is not intended to remain in or become part of the
product or product mixture.'' Additionally, processing agents are
intended to improve the processing characteristics or the operation of
process equipment, but not intended to affect the function of a
substance or article created. CTC has traditionally been used as a
processing aid/agent to aid in the manufacture of petrochemical-derived
products (Ref. 1). The condition of use includes the use of CTC that
has historically been used as a processing agent in the manufacture of
chlorosulphonated polyolefin; stryene butadiene rubber; endosulfan
(insecticide); 1-1 Bis (4-chlorophenyl) 2,2,2-trichloroethanol (dicofol
insecticide); and tralomethrin (insecticide). For the purposes of this
rulemaking, EPA is specifically prohibiting the industrial and
commercial use of CTC as an industrial processing aid in the
manufacture of petrochemicals-derived products, except in the
manufacture of vinyl chloride. The industrial and commercial use as an
industrial processing aid in the manufacture of agricultural products
and vinyl chloride is being regulated under the WCPP, as described in
Unit IV.B.
[[Page 103542]]
ii. Industrial and Commercial Use in the Manufacture of Other Basic
Chemicals (Including Manufacturing of Chlorinated Compounds Used in
Solvents, Adhesives, Asphalt, and Paints and Coatings), Except for Use
in the Elimination of Nitrogen Trichloride in the Production of
Chlorine and Caustic Soda and the Recovery of Chlorine in Tail Gas From
the Production of Chlorine
CTC has historically been used as a processing aid/agent in basic
organic and inorganic chemical manufacturing. CTC could be used as a
processing agent in the manufacturing of chlorinated compounds that are
subsequently used in the formulation of solvents, adhesives, asphalt,
and paints and coatings; in the manufacturing of chlorinated paraffins
(e.g., plasticizer in rubber, paints, adhesives, sealants, plastics),
and chlorinated rubber (e.g., additive in paints, adhesives); and in
the manufacturing of inorganic chlorinated compounds, such as in the
production of chlorine and caustic soda and the recovery of chlorine in
tail gas from the production of chlorine. For the purposes of this
rulemaking, EPA is specifically prohibiting the industrial and
commercial use in the manufacture of other basic chemicals (including
manufacturing of chlorinated compounds used in solvents, adhesives,
asphalt, and paints and coatings), except for use in the elimination of
nitrogen trichloride in the production of chlorine and caustic soda and
the recovery of chlorine in tail gas from the production of chlorine.
The industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine is
being regulated under the WCPP, as described in Unit IV.B.
iii. Industrial and Commercial Use in Metal Recovery
CTC has historically been used as a processing aid or agent to aid
in metal recovery.
iv. Industrial and Commercial Use as an Additive
Additives are chemicals combined with a chemical product to enhance
the properties of the product. Additives typically stay mixed within
the finished product and remain unreacted. The risk evaluation examined
the use of CTC as an additive for the manufacture of petrochemical-
derived products and agricultural products. CTC has historically been
used as an additive in fuel and in plastic components used in the
automotive industry.
v. Industrial and Commercial Use in Specialty Uses by the U.S.
Department of Defense (DoD)
During the risk evaluation, DoD provided monitoring data for CTC
uses in various processes that include worker activities such as
cleaning and sampling residual metal and ash; destruction of munitions
and storage of resulting liquid waste; and sampling of energetics with
solvent. The unreasonable risk determination for CTC further determined
that this condition of use contributed to the unreasonable risk. The
Agency understands that DoD has successfully phased out the use of CTC
for this condition of use.
As discussed in Unit II.C.4., the prohibitions do not apply to any
substance that is excluded from the definition of ``chemical
substance'' under TSCA section 3(2)(B)(ii) through (vi).
2. Compliance Timeframes
EPA is finalizing that the prohibitions apply as of 180 days after
the date of publication of the final rule for the manufacturing,
processing, distribution in commerce, and use of CTC for the following:
incorporation of CTC into formulation, mixture or reaction products in
petrochemical-derived manufacturing except in the manufacture of vinyl
chloride; the industrial and commercial use of CTC as a processing aid
in the manufacture of petrochemical-derived products except in the
manufacture of vinyl chloride; the industrial and commercial use of CTC
in the manufacture of other basic chemicals (including chlorinated
compounds used in solvents, adhesives, asphalt, and paints and
coatings), except for use in the elimination of nitrogen trichloride in
the production of chlorine and caustic soda and the recovery of
chlorine in tail gas from the production of chlorine; the industrial
and commercial use of CTC in metal recovery; and the industrial and
commercial use of CTC as an additive.
EPA is also finalizing the prohibitions for the manufacturing,
processing, distribution in commerce, and use of CTC for the industrial
and commercial use in specialty uses by the DoD to apply as of 365 days
after the date of publication of the final rule.
E. Other Requirements
1. Recordkeeping
For conditions of use that are not otherwise prohibited under this
final rule, EPA is finalizing the requirement that manufacturers,
processors, distributors, and commercial users maintain ordinary
business records, such as invoices and bills-of-lading, that
demonstrate compliance with the prohibitions, restrictions, and other
provisions of this final regulation; and to maintain such records for a
period of 5 years from the date the record is generated. This
requirement begins on February 18, 2025. For enforcement purposes, EPA
will have access to such businesses records plus additional records
required under 40 CFR 751.713. Recordkeeping requirements would ensure
that owners or operators can demonstrate compliance with the
regulations if necessary.
2. Downstream Notification
For conditions of use that are not otherwise prohibited under this
final regulation, EPA is finalizing requirements that manufacturers
(including importers), processors, and distributors of CTC provide
downstream notification of the prohibitions through the SDSs by adding
to sections 1(c) and 15 of the SDS the following language:
After June 16, 2025, this chemical substance (as defined in TSCA
section 3(2)) may not be distributed in commerce or processed in
greater than trace quantities for the following purposes:
Incorporation into formulation, mixture or reaction products in
petrochemical-derived manufacturing except in the manufacture of
vinyl chloride; Industrial and commercial use as an industrial
processing aid in the manufacture of petrochemicals-derived products
except in the manufacture of vinyl chloride; Industrial and
commercial use in the manufacture of other basic chemicals
(including manufacturing of chlorinated compounds used in solvents,
adhesives, asphalt, and paints and coatings), except for use in the
elimination of nitrogen trichloride in the production of chlorine
and caustic soda and the recovery of chlorine in tail gas from the
production of chlorine; Industrial and commercial use in metal
recovery; Industrial and commercial use as an additive; and
beginning December 18, 2025, industrial and commercial specialty
uses by the U.S. Department of Defense.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA's final rule
requires manufacturers to revise their SDS within two months of rule
publication and processors and distributors to revise their SDS within
six months of rule publication. EPA did not receive public comments
asserting that these compliance dates for updating the SDS were
impracticable, and is therefore finalizing the compliance dates as
proposed. The intention of downstream notification is to spread
awareness throughout the supply chain of the
[[Page 103543]]
restrictions on CTC under TSCA and to provide information to commercial
end-users about prohibited uses of CTC.
V. TSCA Section 6(c)(2) Considerations
A. Health Effects of Carbon Tetrachloride and the Magnitude of Human
Exposure to Carbon Tetrachloride
EPA's analysis of the health effects of CTC and the magnitude of
human exposure to CTC are in the 2020 Risk Evaluation for CTC and the
2022 Revised Unreasonable Risk Determination for CTC (Refs. 1, 3). A
summary is presented here.
The 2020 Risk Evaluation for CTC identified potential health
effects of CTC including carcinogenicity, liver toxicity,
neurotoxicity, kidney toxicity, reproductive and developmental
toxicity, irritation and sensitization, and genetic toxicity. Acute
inhalation exposures to CTC at relatively high concentrations induce
immediate and temporary depression of the central nervous-system, with
effects consisting of escape-impairing symptoms such as dizziness. For
chronic non-cancer inhalation exposure scenarios to CTC, liver toxicity
is identified as the most sensitive adverse effect contributing to the
unreasonable risk of CTC exposure due to fatty changes to the liver
indicative of cellular damage. Under EPA's Guidelines for Carcinogen
Risk Assessment (Ref. 47), CTC is classified as ``Likely to be
Carcinogenic in Humans.'' CTC has been shown to cause pheochromocytomas
(tumors of the adrenal glands) in male and female mice by oral and
inhalation exposures, and a strong association between neuroblastoma
and CTC in a single well-conducted epidemiological study in the same
organ raises concern for potential carcinogenic effects in human. In
addition, a general correlation has been observed in animal studies
with CTC between hepatocellular cytotocity and regenerative hyperplasia
and the induction of liver tumors (Ref. 1).
Populations exposed to CTC include workers ages 17 and older of
either gender, including pregnant women and individuals who do not use
CTC but may be indirectly exposed due to their proximity to the user
who is directly handling CTC (occupational non-users, or ONUs). EPA
estimates that, annually, there are approximately between 852 and 9,554
workers and between 500 and 4,144 ONUs at between 30 and 71 facilities
either manufacturing, processing, or using CTC for industrial and
commercial conditions of use (Ref. 5).
In addition to these estimates of numbers of workers and
occupational non-users directly exposed to CTC, EPA recognizes there is
exposure to the general population from air and water pathways for CTC
(fenceline communities are a subset of the general population who may
be living in proximity to a facility where CTC is being used in an
occupational setting). EPA separately conducted a screening approach to
assess whether there may be potential risks to the general population
from these exposure pathways. This analysis is summarized in the
proposed rule, which includes information on the SACC peer review. This
unit addresses those areas where some risk was indicated at the
fenceline, and the conditions of use will be continuing under this
final rule.
EPA's methodological approach to assessing potential exposures to
fenceline communities of chemicals undergoing risk evaluation under
TSCA section 6 was presented to the SACC peer review panel in March
2022, and EPA is including SACC recommendations, as appropriate, in
assessing general population exposures in upcoming risk evaluations.
EPA's fenceline analysis for the water pathway for CTC, based on
methods presented to the SACC, did not find risks from drinking water,
incidental oral ingestion of ambient water, or incidental dermal
exposure of surface water (Ref. 48).
Standard cancer benchmarks used by EPA and other regulatory
agencies are an increased cancer risk above benchmarks ranging from 1
in 1,000,000 to 1 in 10,000 (i.e., 1 x 10-6 to 1 x
10-4). For example, when setting standards under section
112(f)(2) of the CAA, EPA uses a two-step process, with ``an analytical
first step to determine an `acceptable risk' that considers all health
information, including risk estimation uncertainty, and includes a
presumptive limit on maximum individual risk (MIR) of approximately 1-
in-10 thousand'' (Ref. 49, referencing the interpretation set forth in
the 1989 final National Emission Standards for Benzene rule (54 FR
38044 Sept. 14, 1989)). In the screening level fenceline analysis for
the ambient air pathway for CTC, EPA calculated its risk estimates to
certain populations within the general population living or working
near particular facilities and compared those risk estimates to a 1 in
1,000,000 (i.e., 1 x 10-6) benchmark value for cancer risk.
There are still uncertainties where the calculated risk exceeds this
cancer risk benchmark value. The benchmark values are not a bright
line, and the Agency considers a number of factors when determining
unreasonable risk, such as the endpoint under consideration, the
reversibility of effect, and exposure-related considerations (e.g.,
duration, magnitude, aggregate or cumulative impacts, or frequency of
exposure, or size of population exposed, including PESS).
The screening level fenceline analysis for CTC calculated risk
estimates to select populations within the general population living or
working near particular facilities exceeding the 1 x 10-6
benchmark value (Ref. 50). However, EPA has not determined based on
this screening level analysis whether these risks to the general
population contribute to the unreasonable risk presented by CTC. After
considering the results, limitations, and uncertainties of the
screening-level analysis, EPA determined as a matter of policy that
reopening the TSCA section 6(b) risk evaluation for CTC for further
evaluation of risk to the general population, and consequently delaying
the promulgation of this TSCA section 6(a) rule, was not warranted. The
Agency believes it is important to expeditiously promulgate this final
rule to protect the public from the unreasonable risk determined in
accordance with TSCA section 6(b)(4)(A), which was driven by
occupational exposures.
The ambient air analysis for the multi-year fenceline analysis
identified 19 facilities (in addition to 6 facilities solely
manufacturing CTC as a byproduct, which were excluded because, as
described earlier, the 2020 Risk Evaluation for Carbon Tetrachloride
did not include the manufacture of CTC as a byproduct as a condition of
use) with risk estimates above one in a million, with one facility with
risk estimates above one in ten thousand, at 100 meters representing
five conditions of use. Under the final regulatory action described in
Unit IV., all of the ongoing conditions of use with an indication of
potential risk to fenceline communities (with the exception of
manufacture of CTC as a byproduct) would be required to establish a
WCPP. Furthermore, EPA is prohibiting increased emissions associated
with WCPP requirements, and in the WCPP exposure control plan
facilities need to evaluate controls to determine how to reduce
releases and exposures to potentially exposed persons in the workplace
and attest that engineering controls selected do not increase emissions
of CTC to ambient air outside of the workplace and whether additional
equipment was installed to capture emissions of CTC to
[[Page 103544]]
ambient air. EPA anticipates that this analysis would help facilities
to determine the most effective ways to reduce releases, including
possible engineering controls or elimination/substitution of CTC, and
therefore may also reduce the overall risk to fenceline communities.
EPA recognizes, as was described in the 2020 Risk Evaluation for
Carbon Tetrachloride, that CTC is highly persistent in the atmosphere
with an estimated tropospheric half-life exceeding 330 years. Thus, CTC
has notable global background concentrations due to its long half-life,
despite having limited air releases in the US, as noted in both the
EPA's Air Toxic Screening Assessment modeling technical support
document and in a recent EPA publication comparing the national air
toxics modeling to regional monitoring data (Refs. 51, 52). The risk
estimates from the fenceline analysis do not account for the background
concentrations from historical emissions, which are persistent in the
atmosphere.
In the instances where manufacturing, processing, or use of CTC may
increase, EPA expects that potential additional exposure from emissions
to ambient air to be limited as a result of the prohibition on the
increased ventilation of CTC to ambient air and existing National
Emission Standards for Hazardous Air Pollutants (NESHAPs) that cover
CTC for these conditions of use under the CAA. Applicable NESHAPs
include: 40 CFR part 63, subparts F, G, H, and I, Organic HAP from the
Synthetic Organic Chemical Manufacturing Industry and Other Processes
Subject to the Negotiated Regulation for Equipment Leaks.
The CAA establishes a two-phase process for the EPA's development,
review, and potential revision of NESHAP that impose emission standards
and work practice requirements on subject categories of sources of
hazardous air pollutants. First, the EPA sets technology-based or
performance-based standards reflecting the maximum achievable control
technology (MACT) for major sources (CAA section 112(d)(2) and (3)) and
generally available control technology (GACT) for area or non-major
sources (CAA section 112(d)(5)). In the second phase, eight years after
adoption of the first phase standards, the EPA performs a residual risk
review of major source MACT standards to ensure that they provide an
ample margin of safety to protect public health (CAA section
112(f)(2)), and a technology review of all NESHAP to account for
developments in practices, processes and control technologies (CAA
section 112(d)(6)). The CAA only requires the EPA to conduct the
residual risk review one time for each MACT standard, although the EPA
has discretion to conduct additional risk reviews where warranted. The
technology review, instead, is a recurring duty, and the EPA must
perform it no less often than every eight years.
B. Environmental Effects of Carbon Tetrachloride and the Magnitude of
Environmental Exposure to Carbon Tetrachloride
EPA's analysis of the environmental effects of CTC and the
magnitude of exposure of the environment to CTC are in the 2020 Risk
Evaluation for Carbon Tetrachloride (Ref. 1). The unreasonable risk
determination for CTC is based solely on risks to human health; based
on the TSCA 2020 Risk Evaluation for Carbon Tetrachloride, EPA
determined that exposures to the environment did not drive the
unreasonable risk. A summary is presented here in Unit V.
Exposures to terrestrial organisms from the suspended soils and
biosolids pathway was qualitatively evaluated. Due to its physical-
chemical properties, EPA expects that CTC does not bioaccumulate in
fish or sediments; and CTC could be mobile in soil and migrate to water
or volatilize to air (Ref. 1).
EPA concluded in the 2020 Risk Evaluation for Carbon Tetrachloride
that CTC poses a hazard to environmental aquatic receptors. Amphibians
were the most sensitive taxa for acute and chronic exposures. Acute
exposures of CTC to fish, freshwater aquatic invertebrates, and
sediment invertebrates resulted in hazard values as low as 10.4 mg/L,
11.1 mg/L, and 2 mg/L, respectively. For chronic exposures, CTC has a
hazard value for amphibians of 0.03 mg/L based on teratogenesis and
lethality in frog embryos and larvae. Furthermore, chronic exposures of
CTC to fish, freshwater aquatic invertebrates, and sediment
invertebrates resulted in hazard values as low as 1.97 mg/L, 1.1 mg/L,
and 0.2 mg/L, respectively. In algal studies, CTC has hazard values
ranging from 0.07 to 23.59 mg/L (Ref. 1).
In addition to the environmental effects assessed in the 2020 Risk
Evaluation for Carbon Tetrachloride, EPA recognizes that CTC is an
ozone-depleting substance with a 100-year GWP of 1730 (energy the
emissions of one ton of gas will absorb over 100 years, relative to the
emissions of one ton of carbon dioxide (CO2)) (Ref. 53). As
a result of its ozone-depleting effects, the Montreal Protocol and
Title VI of the CAA led to a phase-out of CTC production in the United
States for most non-feedstock domestic uses. EPA did not evaluate the
effect of CTC or this rule on ozone depletion. In addition, while the
Agency understands that the use of CTC is expected to increase to
produce low GWP HFOs, replacing many of the higher GWP HFCs, there is
uncertainty in the change in volume of CTC that will be manufactured
and used to produce HFOs. In the final rule, EPA is requiring owners/
operators to ensure that any engineering controls instituted under the
WCPP do not increase emissions of CTC to ambient air. EPA expects that
potential additional exposure from emissions to ambient air would be
limited as a result of the existing NESHAPs that cover CTC. However,
EPA did not evaluate whether a possible increase of CTC emissions with
a GWP of 1730 would offset emissions of the HFCs replaced by the lower
GWP HFOs manufactured with CTC, or the overall global warming impact of
CTC use.
C. Benefits of Carbon Tetrachloride for Various Uses
As described in the proposed rule, CTC is primarily used as a
feedstock in the production of HCFCs, HFCs, and HFOs. Other conditions
of use include regulated use as a processing agent in the manufacture
of petrochemicals-derived and agricultural products and other
chlorinated compounds such as chlorinated paraffins, chlorinated rubber
and others that may be used downstream in the formulation of solvents
for adhesives, asphalt, paints and coatings. Requirements under the
Montreal Protocol and Title VI of the CAA led to a phaseout of CTC
production in the United States for most non-feedstock domestic uses in
1996 and the CPSC banned the use of CTC in household products
(excluding unavoidable residues not exceeding 10 ppm atmospheric
concentration) in 1970.
CTC is a major feedstock for generation of lower-GWP alternative
fluorocarbon products in the United States (Ref. 54). EPA anticipates
that many entities currently using HFCs with higher global warming
potential will transition to alternatives with lower global warming
potential as requirements under the AIM Act begin to apply. The
manufacturing of CTC is predicted to increase as a result of the
transition from HFCs to lower-GWP HFOs that use CTC as a feedstock,
such as HFO-1234yf used in motor vehicle AC and HFO-1234ze used in some
types of aerosols and foam-blowing agents.
[[Page 103545]]
D. Reasonably Ascertainable Economic Consequences of the Final Rule
1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health
With respect to the anticipated effects of this rule on the
national economy, the economic impact of a regulation on the national
economy generally only becomes measurable if the economic impact of the
regulation reaches 0.25 percent to 0.5 percent of Gross Domestic
Product (GDP) (Ref. 55). Given the current GDP of $23.17 trillion, this
is equivalent to a cost of $58 billion to $116 billion which is
considerably higher than the estimated cost of this rule. EPA
considered the number of businesses, facilities, and workers that would
be affected and the costs and benefits to those businesses and workers
and society at large and did not find that there would be a measurable
effect on the national economy. In addition, EPA considered the
employment impacts of this final rule. For businesses subject to the
WCPP, including the ECEL and DDCC requirements, and prescriptive
workplace control requirements, EPA estimates the marginal cost of
labor will increase. This may lead to small negative employment
effects. Costs of prohibition in the final rule are not quantified,
since EPA expects the prohibited uses are not ongoing. However, there
may be employment effects proportionate to the extent to which CTC is
still being used in the prohibited conditions of use.
EPA has determined that the rule will not have a significant impact
on a substantial number of small entities. EPA estimates that the rule
would affect at least seven small entities, and that the cost would
only exceed 1 percent of annual revenues for two of these small
entities. EPA expects that the final rule will not hinder technological
innovation. Innovative applications of CTC in recent years have
occurred in the production of HFOs. The regulatory options with
requirements for certain conditions of use, including processing as a
reactant in the production of refrigerants (such as HFOs), are not
expected to inhibit innovation since they permit the continued use of
CTC with appropriate controls. With respect to those conditions of use
where prohibition is the requirement in the final action, EPA did not
find evidence of ongoing use of CTC and thus there are no expected
effects on innovation.
The effects of this rule on public health are estimated to be
positive, due to the avoided incidence of adverse health effects
attributable to CTC exposure, including adrenal and liver cancer.
2. Costs and Benefits of the Regulatory Action and of the 1 or More
Primary Alternative Regulatory Actions Considered by the Administrator
The costs and benefits that can be monetized for this rule are
described at length in in the Economic Analysis (Ref. 5). The total
cost of the final rule is $19.7 million dollars annualized over 20
years at a 3% discount rate and $19 million dollars at a 7% discount
rate. EPA's Economic Analysis for the rule quantified the benefits from
avoided cases of adrenal and liver cancers. Cancer benefits are
calculated based on inhalation exposure estimates from the Final Risk
Evaluation. The estimated monetized benefit of the final rule ranges
from approximately $0.13 to $0.14 million per year annualized over 20
years at a 3% discount rate and from $0.06 to $0.07 million per year at
a 7% discount rate.
There are also unquantified benefits due to other avoided
significant adverse health effects associated with CTC exposure,
including liver, reproductive, renal, developmental, and CNS toxicity
end points. EPA believes that the balance of costs and benefits of this
final rule cannot be fairly described without considering the
additional, non-monetized benefits of mitigating the non-cancer adverse
effects. The non-cancer adverse effects from CTC exposure can
significantly impact an individual's quality of life. The incremental
improvements in health outcomes achieved by given reductions in
exposure cannot currently be quantified for non-cancer health effects
associated with CTC exposure, and therefore cannot be converted into
monetized benefits. The qualitative discussion throughout this
rulemaking and in the Economic Analysis highlights the importance of
these non-cancer effects, which are not able to be monetized in the way
that EPA is able to for cancer. These effects include not only cost of
illness but also personal costs such as emotional and mental stress
that are hard to measure appropriately. Considering only monetized
benefits significantly underestimates the impacts of CTC adverse
outcomes and underestimates the benefits of this final rule.
Net benefits were calculated by subtracting the costs from the
quantified benefits. The net benefit of the final rule action is -$19.6
million dollars annualized over 20 years at a 3% discount rate and -
$18.9 million dollars at a 7% discount rate.
Industry would bear monitoring, PPE, and notification and
recordkeeping burdens and costs associated with the ECEL. While
companies may comply with the rule using engineering controls, when
estimating costs and benefits the Economic Analysis assumes firms will
provide PPE to employees when monitoring thresholds are exceeded. EPA
estimated monitoring results based on a log normal distribution
estimated from the median and 95th percentile 8-hour time-weighted
average exposure outcomes presented in the 2020 Risk Evaluation for
Carbon Tetrachloride. PPE, recordkeeping, and monitoring costs after
initial monitoring vary by industry and by projected initial monitoring
result. Industry is expected to incur planning, recordkeeping and PPE
costs associated with DDCC requirements. Industry would incur costs
associated with developing an exposure control plan, performing
inspections, documenting efforts to reduce exposure and occurrences of
exposure, respiratory protection and dermal PPE, and training on the
use of respiratory protection and dermal PPE.
EPA also considered the estimated costs of alternative regulatory
actions to regulated entities. Estimated costs for regulatory
alternatives can be found in the Economic Analysis for this final rule
(Ref. 5).
A sensitivity analysis was conducted based on the low estimates of
the number of affected entities in the 2020 Risk Evaluation for Carbon
Tetrachloride. Based on these estimates, the total cost of the final
rule is $2.1 million dollars annualized over 20 years at both a 3 and
7% discount rate. The total benefit of the final rule is estimated to
range from $0.016 million dollars to $0.018 million dollars annualized
over 20 years at a 3% period discount rate, and ranges from $0.008
million dollars to $0.009 million dollars annualized over 20 years at a
7 percent discount rate. The net benefit of the rule under this
sensitivity analysis is -$2.1 million dollars annualized over 20 years
at a 3% discount rate and a 7% discount rate. At a 2% discount rate,
the cost of the rule assuming the low number of affected entities is
$2.1 million, the benefit is $0.02 million, and the net benefit is -
$2.1 million.
3. Cost Effectiveness of the Regulatory Action and of 1 or More Primary
Alternative Regulatory Actions Considered by the Administrator
For the COUs that EPA determined drive the unreasonable risk of
injury to health from CTC, both the final rule and the primary
alternative action, which is analyzed in the Economic Analysis,
[[Page 103546]]
reduce unreasonable risk to the extent necessary such that unreasonable
risk is no longer presented. In achieving this result, however, the
estimated costs of the final rule and the primary alternative
regulatory action differ as described in Units I.E. and V.D.2. The
costs of achieving the desired outcome via the final rule or the
primary alternative regulatory action can be compared to evaluate cost-
effectiveness. The measure of cost-effectiveness considered is the
annualized cost of each regulatory option per microrisk reduction in
cancer cases estimated to occur as a result of each regulatory option,
where a microrisk refers to a one in one million reduction in the risk
of a cancer case. The cost-effectiveness of the final rule ranges from
$681 to $1,000 dollars per microrisk reduction at a 3% discount rate,
and from $656 to $963 dollars per microrisk reduction at a 7% discount
rate. The cost-effectiveness of the primary alternative regulatory
action ranges from $611 to $897 dollars per microrisk reduction at a 3%
discount rate, and from $778 to $1,142 dollars at a 7% discount rate.
The primary difference between the final and primary alternative
option is that the alternative requires prescriptive controls for
conditions of use which fall under the WCPP in the final rule. For two
such conditions of use (Processing by incorporation into formulation,
mixture, or reaction products in agricultural products manufacturing,
vinyl chloride manufacturing, and other basic organic and inorganic
chemical manufacturing; and Industrial and commercial use as a
processing aid in the manufacture of agricultural products and vinyl
chloride), the Economic Analysis analyzed a primary alternative action
of prohibition for the vinyl chloride sub-uses only. In the proposed
rule, EPA proposed prohibition for these sub-uses of vinyl chloride
that at the time EPA did not have reasonably available information to
indicate the uses were ongoing but later received public comments from
one entity indicating that the incorporation of CTC into formulation,
mixtures, or reaction products in vinyl chloride manufacturing and the
industrial and commercial use of CTC as an industrial processing aid in
the manufacture of vinyl chloride were ongoing. While the final rule
requires a WCPP for these sub-uses, the primary alternative analyzes
the costs and benefits of prohibiting these sub-uses of vinyl chloride.
Since the regulated universe in both the final and primary
alternative regulatory actions is identical, the cost-effectiveness of
the regulatory actions varies based on the differences in the
requirements of each action. Section 3.9 of the Economic Analysis
provides a summary of the unquantified costs and uncertainties in the
cost estimates that may impact the respective cost-effectiveness of the
final rule and the primary alternative regulatory action considered.
VI. TSCA Section 9 Analysis and Section 26 Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. TSCA section 9(a)
describes additional procedures and requirements to be followed by EPA
and the other Federal agency following submission of any such report.
As discussed in this unit, the Administrator does not determine that
unreasonable risk from CTC under the conditions of use may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA. EPA's TSCA section 9(a) analysis is
presented in Unit VII.A. of the proposed rule (88 FR 49215, July 28,
2023) (FRL-8206-01-OCSPP), and responses to comments about that
analysis can be found in the Response Agree. Comments, Section 10.1
(Ref. 11).
TSCA section 9(d) instructs the Administrator to consult and
coordinate TSCA activities with other Federal agencies for the purpose
of achieving the maximum enforcement of TSCA while imposing the least
burden of duplicative requirements. For this rulemaking, EPA has
coordinated with appropriate Federal executive departments and
agencies, including OSHA, to, among other things, identify their
respective authorities, jurisdictions, and existing laws with regard to
risk evaluation and risk management of CTC.
As discussed in more detail in the proposed rule, OSHA requires
that employers provide safe and healthful working conditions by setting
and enforcing standards and by providing training, outreach, education,
and assistance. OSHA, in 1971, established a PEL for CTC of 10 ppm of
air as an 8-hour TWA with an acceptable ceiling concentration of 25 ppm
and an acceptable maximum peak above the acceptable ceiling
concentration for an eight-hour shift of 200 ppm, maximum duration of 5
minutes in any 4 hours. However, the exposure limits established by
OSHA are higher than the exposure limit that EPA determined would be
sufficient to address the unreasonable risk identified under TSCA from
occupational inhalation exposures associated with certain conditions of
use. Gaps exist between OSHA's authority to set workplace standards
under the OSH Act and EPA's obligations under TSCA section 6 to
eliminate unreasonable risk presented by chemical substances under the
conditions of use, as further discussed in Units II.C. and VII.A. of
the proposed rule.
EPA concludes that TSCA is the only regulatory authority able to
prevent or reduce unreasonable risk of CTC to a sufficient extent
across the range of conditions of use, exposures, and populations of
concern. An action under TSCA is able to address occupational
unreasonable risk and would reach entities that are not subject to
OSHA. Moreover, the timeframe and any exposure reduction as a result of
updating OSHA regulations for CTC cannot be estimated, while TSCA
imposes a much more accelerated two-year statutory timeframe for
proposing and finalizing requirements to address unreasonable risk.
Finally, as discussed in greater detail in the proposed rule, the 2016
amendments to TSCA altered both the manner of identifying unreasonable
risk and EPA's authority to address unreasonable risk, such that risk
management is increasingly distinct from provisions of the OSH Act (88
FR 49180) (FRL-8206-01-OCSPP). For these reasons, in the
Administrator's discretion, the Administrator has analyzed this issue
and does not determine that unreasonable risk presented by CTC may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA.
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk
``unless the Administrator determines, in the Administrator's
discretion, that it is in the public interest to protect against such
risk'' under TSCA. In making such a public interest finding, TSCA
section 9(b)(2) states: ``the Administrator shall consider, based on
information reasonably available to the Administrator, all relevant
aspects of
[[Page 103547]]
the risk . . . and a comparison of the estimated costs and efficiencies
of the action to be taken under this title and an action to be taken
under such other law to protect against such risk.''
Although several EPA statutes have been used to limit CTC exposure
(Ref. 10), regulations under those EPA statutes largely regulate
releases to the environment, rather than the occupational exposures.
While these limits on releases to the environment may be protective in
the context of their respective statutory authorities, regulation under
TSCA is also appropriate for occupational exposures and in some cases
can provide upstream protections that would prevent the need for
release restrictions required by other EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA), CAA, CWA). Updating regulations
under other EPA statutes would not be sufficient to address the
unreasonable risk of injury to the health of workers and occupational
non-users who are exposed to CTC under its conditions of use. EPA's
TSCA section 9(b) analysis is presented in the proposed rule (88 FR
49216) (FRL-8206-01-OCSPP), and responses to comments on that analysis
can be found in the Response to Comments, section 10.2 (Ref. 11).
For these reasons, the Administrator does not determine that
unreasonable risk from CTC under its conditions of use, as evaluated in
the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.1), could be
eliminated or reduced to a sufficient extent by actions taken under
other Federal laws administered in whole or in part by EPA.
C. TSCA Section 14 Requirements
EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI. Under TSCA
sections 14(a) and 14(b)(4), if EPA promulgates a rule pursuant to TSCA
section 6(a) that establishes a ban or phase-out of a chemical
substance, the protection from disclosure of any CBI regarding that
chemical substance and submitted pursuant to TSCA will be ``presumed to
no longer apply,'' subject to the limitations identified in TSCA
section 14(b)(4)(B)(i) through (iii). Pursuant to TSCA section
14(b)(4)(B)(iii), the presumption against protection from disclosure
will apply only to information about the specific conditions of use
that this rule prohibits. Manufacturers or processors seeking to
protect such information may submit a request for nondisclosure as
provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for
nondisclosure must be submitted within 30 days after receipt of notice
from EPA under TSCA section 14(g)(2)(A) stating EPA will not protect
the information from disclosure. EPA anticipates providing such notice
via the Central Data Exchange (CDX).
D. TSCA Section 26 Considerations
As explained in the 2023 proposed rule (88 FR 49216, July 29, 2023)
(FRL-8206-01-OCSPP), EPA fulfilled TSCA section 26(h) by using
scientific information, technical procedures, measures, methods,
protocols, methodologies, and models consistent with the best available
science. Comments received on the proposed rule about whether EPA
adequately assessed reasonably available information under TSCA section
26 on the risk evaluation, and responses to those comments, can be
found in Section 10.4 of the Response to Comments document (Ref. 11).
VII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Risk Evaluation for Carbon Tetrachloride (Methane,
Tetrachloro-). EPA Document #EPA-740-R1-8014. October 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0061.
2. EPA. Correction of Dermal Acute Hazard and Risk Values in the
Final Risk Evaluation for Carbon Tetrachloride. July 2022. (EPA-HQ-
OPPT-2019-0499). https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0064.
3. EPA. Carbon Tetrachloride; Revision to Toxic Substances Control
Act (TSCA) Risk Determination. December 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0733-0120.
4. EPA. Memorandum of Communication between Syngenta and EPA
Regarding Risk Management of Carbon Tetrachloride. October 2021.
https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0024.
5. EPA. Carbon Tetrachloride (CTC); Regulation Under the Toxic
Substances Control Act (TSCA); Economic Analysis.
6. NIOSH. Hierarchy of Controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html (accessed April 2024).
7. President Joseph R. Biden. The White House. The President and
First Lady's Cancer Moonshot: Ending Cancer As We Know It. https://www.whitehouse.gov/cancermoonshot/ (accessed February 26, 2024).
8. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last
Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
9. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16,
2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
10. EPA. Regulatory Actions Pertaining to Carbon Tetrachloride
(CTC). June 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0055.
11. EPA. Carbon Tetrachloride (CTC); Regulation Under the Toxic
Substances Control Act (TSCA); Response to Public Comments.
12. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
13. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
14. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
15. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Carbon Tetrachloride. February 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0113.
16. EPA. Federalism Consultation on Risk Management Rulemakings for
HBCD and Carbon Tetrachloride. December 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0033.
17. EPA. Tribal Consultations on Risk Management Rulemakings for
HBCD and Carbon Tetrachloride. January 6, 2021 and January 12, 2021.
https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0041.
18. EPA. Environmental Justice Consultations Risk Management
Rulemakings for HBCD and Carbon Tetrachloride. February 2, 2021 and
February 18, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0034.
19. EPA. Public Webinar on Carbon Tetrachloride: Risk Evaluation and
Risk Management under TSCA Section 6. December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0006.
20. EPA. Small Business Administration Small Business Environmental
Roundtable Risk Evaluation and Risk Management under TSCA Section 6
for Carbon Tetrachloride. December 4, 2020.
21. EPA. Updated Stakeholder Meeting List for Rulemaking for Carbon
Tetrachloride under TSCA Section 6(a). 2024.
22. EPA. EPA's Policy on Children's Health. October 5, 2021. https://www.epa.gov/children/childrens-health-policy-and-plan#A1.
23. EPA. Public Webinar Carbon Tetrachloride: Risk Evaluation and
Risk Management under TSCA Section 6. August 15, 2023.
[[Page 103548]]
24. EPA. Meeting with Olin 11.20.23. December 7, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0148.
25. Christopher M. Kolodziej. Christopher M. Kennedy Comment. EPA-
HQ-OPPT-2020-0592-0135. September 11, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0135.
26. Michael Kennedy. American Petroleum Institute (API) Comment.
EPA-HQ-OPPT-2020-0592-0129. September 7, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0129.
27. Mark Ames. AIHA Comment. EPA-HQ-OPPT-2020-0592-0126. August 29,
2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0126.
28. Danielle Jones. The Chemours Company Comment. EPA-HQ-OPPT-2020-
0592-0134. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0134.
29. W. Caffey Norman. Halogenated Solvents Industry Alliance, Inc.
(HSIA) Comment. EPA-HQ-OPPT-2020-0592-0133. September 11, 2023.
https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0133.
30. LeaAnne Forest. American Chemistry Council (ACC) Comment. EPA-
HQ-OPPT-2020-0592-0140. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0140.
31. Paul DeLeo. American Chemistry Council (ACC) Comment. EPA-HQ-
OPPT-2020-0592-0142. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0142.
32. Martin J. Durbin. US Chamber of Commerce Comment. EPA-HQ-OPPT-
2020-0592-0137. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0137.
33. Melanie Barrett, Nancy Kahl. MilliporeSigma Comment. EPA-HQ-
OPPT-2020-0592-0128. September 5, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0128.
34. Lawrence E. Culleen. Chemical Users Coalition (CUC) Comment.
EPA-HQ-OPPT-2020-0592-0130. September 8, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0130.
35. Michael Kelly. Honeywell International Inc. (Honeywell) Comment.
EPA-HQ-OPPT-2020-0592-0144. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0144.
36. Scott Sutton. Olin Comment. EPA-HQ-OPPT-2020-0592-0127. August
31, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0127.
37. American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO) and United Steelworkers (USW). AFL-CIO and
USW Comment. EPA-HQ-OPPT-2020-0592-0138. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0138.
38. James Cooper. American Fuel & Petrochemical Manufacturers (AFPM)
Comment. EPA-HQ-OPPT-2020-0592-0143. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0143.
39. William E. Allmond IV. Adhesive and Sealant Council (ASC)
Comment. EPA-HQ-OPPT-2020-0592-0139. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0139.
40. OSHA. OSHA 1999 Multi-Employer Citation Policy. Accessed 10/27/
2023. https://www.osha.gov/enforcement/directives/cpl-02-00-124.
41. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane
(CASRN 107-06-2). August 2020. (EPA-HQ-OPPT-2018-0427-0048). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0071.
42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride.
Federal Register (62 FR 1494, January 10, 1997). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0073.
43. OSHA. OSHA Technical Manual (OTM) Section II: Chapter 1.
Personal Sampling for Air Contaminants. Last updated on September
14, 2023. https://www.osha.gov/otm/section-2-health-hazards/chapter-1.
44. NIOSH. Letter to Claudia Menasche from J. Raymond Wells. EPA's
Carbon Tetrachloride Risk Management Rule under TSCA Section 6. June
28, 2024.
45. OSHA. Personal Protective Equipment. May 4, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0087.
46. The Program Executive Office, Assembled Chemical Weapons
Alternatives (PEO ACWA). U.S. Chemical Weapons Destruction 2018. May
2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0020.
47. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
48. EPA. Carbon Tetrachloride: Fenceline Technical Support--Water
Pathway. October 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0047.
49. EPA. Final Rule. National Emission Standards for Hazardous Air
Pollutants: Carbon Black Production and Cyanide Chemicals
Manufacturing Residual Risk and Technology Reviews, and Carbon Black
Production Area Source Technology Review. Federal Register (86 FR
66096, November 19, 2021).
50. EPA. Carbon Tetrachloride: Fenceline Technical Support--Ambient
Air Pathway. October 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0050.
51. EPA. Technical Support Document EPA's Air Toxics Screening
Assessment 2018 AirToxScreen TSD. Document number EPA-452/B-22-002.
August 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0042.
52. Weitekamp. C. et al. 2021. An Examination of National Cancer
Risk Based on Monitored Hazardous Air Pollutants. Environmental
Health Perspectives. Vol. 129., No. 3. https://ehp.niehs.nih.gov/doi/full/10.1289/EHP8044.
53. Myhre, G., D. Shindell, F.-M. Br[eacute]on, W. Collins, J.
Fuglestvedt, J. Huang, D. Koch, J.-F. Lamarque, D. Lee, B. Mendoza,
T. Nakajima, A. Robock, G. Stephens, T. Takemura and H. Zhang, 2013:
Anthropogenic and Natural Radiative Forcing. In: Climate Change
2013: The Physical Science Basis. Contribution of Working Group I to
the Fifth Assessment Report of the Intergovernmental Panel on
Climate Change [Stocker, T.F., D. Qin, G.-K. Plattner, M. Tignor,
S.K. Allen, J. Boschung, A. Nauels, Y. Xia, V. Bex and P.M. Midgley
(eds.)]. Cambridge University Press, Cambridge, United Kingdom and
New York, NY, USA. https://www.ipcc.ch/site/assets/uploads/2018/02/WG1AR5_Chapter08_FINAL.pdf.
54. Halogenated Solvents Industry Alliance, Inc. (HSIA). Comments
submitted to EPA on the Carbon Tetrachloride Risk Evaluation and the
Risk Management Process. April 28, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0003.
55. Office of Management and Budget. March 31, 1995. OMB M-95-09,
Memorandum for the Heads of Executive Departments and Agencies.
Guidance for Implementing Title II of S. 1. https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/1995-1998/m95-09.pdf.
56. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of Carbon
Tetrachloride under TSCA Section 6(a) (Final Rule; RIN 2070-AK82).
2024.
57. Kevin Ashley. 2015. Harmonization of NIOSH Sampling and
Analytical Methods with Related International Voluntary Consensus
Standards. J Occup Environ Hyg. 12(7): D107-15. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0032.
VIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
Executive Order 12866
[[Page 103549]]
review. Documentation of any changes made in response to the Executive
Order 12866 review is available in the docket. EPA prepared an analysis
of the potential costs and benefits associated with this action. This
analysis, Economic Analysis of the Regulation of Carbon Tetrachloride
Under TSCA Section 6(a) (Ref. 5), is available in the docket and
summarized in Units I.E. and V.D.
B. Paperwork Reduction Act (PRA)
The information collection activities in this final rule have been
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2744.02 and OMB Control No. 2070-0228 (Ref.
56). You can find a copy of the ICR in the docket for this rule, and it
is briefly summarized here. The information collection requirements are
not enforceable until OMB approves them. There are two primary
provisions of the final rule that may increase burden under the PRA.
The first is downstream notification, which would be carried out by
updates to the relevant SDS and which will required for manufacturers,
processors, and distributors in commerce of CTC, who will provide
notice to companies downstream upon shipment of CTC about the
prohibitions. The information submitted to downstream companies through
the SDS will provide knowledge and awareness of the restrictions to
these companies.
The second primary provision of the final rule that may increase
burden under the PRA is WCPP-related information generation,
recordkeeping, and notification requirements (including development of
exposure control plans; exposure level monitoring and related
recordkeeping; development of documentation for a PPE program and
related recordkeeping; development of documentation for a respiratory
protection program and related recordkeeping; development and
notification to potentially exposed persons (employees and others in
the workplace) about how they can access the exposure control plans,
exposure monitoring records, PPE program implementation documentation,
and respirator program documentation; ordinary business records, such
as invoices and bills-of-lading related to the continued distribution
of CTC in commerce, as well as records documenting compliance with the
proposed workplace chemical protection program requirements and
proposed restrictions on the laboratory use of CTC.
Respondents/affected entities: Persons that manufacture, process,
use, distribute in commerce or dispose of carbon tetrachloride (see
Unit I.A.).
Respondent's obligation to respond: Mandatory under TSCA section
6(a) and 40 CFR part 751.
Estimated number of respondents: 72.
Frequency of response: On occasion.
Total estimated burden: 86,186 hours per year. Burden is defined at
5 CFR 1320.3(b).
Total estimated cost: $14,800,653 per year, including $9,360,626 in
annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control number for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are small businesses that manufacture/import, process, or
distribute the chemicals subject to this final rule. The Agency
identified seven small firms in the small entity analysis that are
potentially subject to the rule. The names and NAICS codes of these
entities can be found in Section 6.2.2 of the Economic Analysis (Ref.
5). It is estimated that five of the seven small companies would incur
a rule cost-to-company revenue impact ratio of less than one percent,
and two companies would experience an impact of between one and three
percent. The companies estimated to experience a greater than one
percent rule cost-to-revenue impact would potentially be subject to the
rule under the Disposal and the Manufacturing conditions of use, both
of which would require a WCPP under the final rule. To avoid
understating impacts to small entities, EPA used the highest per-
facility cost presented in the EA ($615,457). Per-facility costs were
estimated by dividing the total costs by the number of affected
facilities for each use. Details of this analysis are in the Economic
Analysis (Ref. 5), which is in the docket for this action. Based on the
low number of affected small entities and the low impact, EPA does not
expect this action to have a significant impact on a substantial number
of small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(in 1995 dollars and adjusted annually for inflation) or more as
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The action will affect entities that
use CTC. It is not expected to affect State, local or Tribal
governments because the use of CTC by government entities is minimal.
The costs involved in this action are estimated not to exceed $183
million in 2023$ ($100 million in 1995$ adjusted for inflation using
the GDP implicit price deflator) or more in any one year. The total
quantified annualized social cost of the final rule is $19,736,400 (at
3% discount rate) and $18,995,752 (at 7% discount rate).
E. Executive Order 13132: Federalism
EPA has concluded that this action has federalism implications, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulation under TSCA section 6(a) may preempt State law. EPA
provides the following preliminary federalism summary impact statement.
The Agency consulted with State and local officials early in the
process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included a
consultation meeting on December 17, 2020. EPA invited the following
national organizations representing State and local elected officials
to this meeting: National Governors Association; National Conference of
State Legislatures, Council of State Governments, National League of
Cities, U.S. Conference of Mayors, National Association of Counties,
International City/County Management Association, National Association
of Towns and Townships, County Executives of America, and Environmental
Council of States. A summary of the meeting with these organizations,
including the views that they expressed, is available in the docket
(Ref. 16). EPA provided an opportunity for these organizations to
provide follow-up comments in writing but did not receive any such
comments.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive
[[Page 103550]]
Order 13175 (65 FR 67249, November 9, 2000) because it will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal Government and the Indian Tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes. CTC is not manufactured, processed, or
distributed in commerce by Tribes, and therefore, this rulemaking would
not impose substantial direct compliance costs on Tribal governments.
Thus, Executive Order 13175 does not apply to this action.
Notwithstanding the lack of Tribal implications as specified by
Executive Order 13175, EPA consulted with Tribal officials during the
development of this action, consistent with the EPA Policy on
Consultation and Coordination with Indian Tribes, which EPA applies
more broadly than Executive Order 13175.
The Agency held a Tribal consultation from December 7, 2020,
through March 12, 2021, with meetings held on January 6 and 12, 2021.
Tribal officials were given the opportunity to meaningfully interact
with EPA concerning the current status of risk management. During the
consultation, EPA discussed risk management under TSCA section 6(a),
findings from the 2020 Risk Evaluation for Carbon Tetrachloride, types
of information to inform risk management, principles for transparency
during risk management, and types of information EPA sought from Tribes
(Ref. 17). EPA briefed Tribal officials on the Agency's risk management
considerations and Tribal officials raised no related issues or
concerns to EPA during or in follow-up to those meetings (Ref. 17). EPA
received no written comments as part of this consultation.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health and safety
standards and explain why the regulation is preferable to potentially
effective and reasonably feasible alternatives. This action is not
subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because
it is not a significant regulatory action under section 3(f)(1) of
Executive Order 12866, and because EPA does not believe that the
environmental health or safety risks addressed by this action will have
a disproportionate risk to children as reflected by the conclusions of
the CTC risk evaluation. This action's health and risk assessments and
impacts on both children and adults from occupational use from
inhalation and dermal exposures are described in Units II.C.3, V.A.,
and the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1). While
the Agency found risks to children and adults from occupational use,
the Agency determined that risks to children were not disproportionate.
EPA's Policy on Children's Health applies to this action. Information
on how the Policy was applied and on the action's health and risk
assessments are contained in Unit II.D.2.c., and the 2020 Risk
Evaluation for CTC and the Economic Analysis for this final rule (Refs.
1, 5).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not been designated by the Administrator of
the Office of Information and Regulatory Affairs as a significant
energy action.
I. National Technology Transfer and Advancement Act (NTTAA)
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272, the Agency has
determined that this rulemaking involves environmental monitoring or
measurement, specifically for occupational inhalation exposures to CTC.
Consistent with the Agency's Performance Based Measurement System
(PBMS), EPA will not require the use of specific, prescribed analytic
methods. Rather, the Agency will allow the use of any method that meets
the prescribed performance criteria. The PBMS approach is intended to
be more flexible and cost-effective for the regulated community; it is
also intended to encourage innovation in analytical technology and
improved data quality. EPA is not precluding the use of any method,
whether it constitutes a voluntary consensus standard or not, as long
as it meets the performance criteria specified.
For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
CTC at the ECEL and the ECEL action level. Some examples of methods
which meet the criteria are included in the appendix of the ECEL memo
(Ref. 15). EPA recognizes that there may be voluntary consensus
standards that meet the proposed criteria (Ref. 57).
J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All
EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionate and adverse human health or environmental effects on
communities with environmental justice concerns in accordance with
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR
25251, April 26, 2023). As described more fully in the Economic
Analysis for this rulemaking (Ref. 5), EPA analyzed the baseline
conditions facing communities near CTC and HFO manufacturing facilities
as well as those of workers in the same industry and county as CTC
facilities and HFO manufacturing facilities. The analysis of local
demographics found that, across the entire population within 1- and 3-
miles of CTC facilities, there are higher percentages of people who
identify as Black and living below the poverty line and a similar
percentage of people who identify as Hispanic compared to the national
averages. CTC facilities are concentrated in Texas and Louisiana,
especially near Houston and Baton Rouge. As summarized in Unit V.A.,
the screening level fenceline analysis for CTC calculated risk
estimates to select populations within the general population living or
working near particular facilities exceeding the 1 x 10-6
benchmark value (Ref. 49). In cases where communities with
environmental justice concerns are also fenceline communities, EPA
expects that the finalized prohibition of increased emissions
associated with WCPP requirements would prevent an increase in health
and environmental impacts due to this rule.
The worker analysis was performed at the county and industry level.
In eight of the 12 counties with CTC facilities that reported Basic
Chemical Manufacturing, workers who identify as Black were over-
represented compared to their percentage of the national demographics
for that industry; at the national level, 11% of workers in the Basic
Chemical Manufacturing industry identify as Black. In addition, there
were eight counties with CTC facilities that reported Waste Treatment
and Disposal; workers in that industry in those counties were more
likely to earn less than the national average for that industry across
several demographic
[[Page 103551]]
groups, as outlined in the Economic Analysis.
EPA believes that it is not practicable to assess whether this
action is likely to result in disproportionate and adverse effects on
communities with environmental justice concerns. EPA was unable to
quantify the distributional effects of the regulatory action under
consideration and compare them to baseline conditions for several
reasons. Limitations include a lack of data regarding exposure
reductions that will occur as a result of the rule and on the
sociodemographic characteristics of workers in CTC facilities. Another
key limitation that prevents evaluation of the distributional effects
of the rule is a lack of knowledge of the actions regulated entities
will take in response to the rule.
EPA additionally identified and addressed environmental justice
concerns by conducting outreach to advocates of communities that might
be subject to disproportionate exposure to CTC. On February 2 and 18,
2021, EPA held public meetings as part of this consultation. These
meetings were held pursuant to and in compliance with Executive Order
12898 and Executive Order 14008, entitled ``Tackling the Climate Crisis
at Home and Abroad'' (86 FR 7619, February 1, 2021). EPA received one
written comment following these public meetings, in addition to oral
comments provided during the meetings (Ref. 18). Commenters supported
strong regulation of CTC to protect lower-income communities and
workers. In addition, commenters recommended EPA conduct analysis of
additional exposure pathways, including air and water.
The information supporting this Executive Order review is contained
in Units I.E., II.D., V.D., VI.A. and in the Economic Analysis (Ref.
5). EPA's presentations and fact sheets for the environmental justice
consultations related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of
the consultation are also available in the public docket for this
rulemaking.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and the
EPA will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended to read as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Add subpart H to read as follows:
Subpart H--Carbon Tetrachloride
Sec.
751.701 General.
751.703 Definitions.
751.705 Prohibition of Certain Industrial and Commercial Uses and
Manufacturing, Processing, and Distribution in Commerce of Carbon
Tetrachloride for those Uses.
751.707 Workplace Chemical Protection Program (WCPP).
751.709 Workplace Restrictions for the Industrial and Commercial Use
as a Laboratory Chemical, Including the Use of Carbon Tetrachloride
as a Laboratory Chemical by the U.S. Department of Defense.
751.711 Downstream Notification.
751.713 Recordkeeping Requirements.
Sec. 751.701 General.
(a) Applicability. This subpart sets certain restrictions on the
manufacture (including import), processing, distribution in commerce,
use, or disposal of carbon tetrachloride (CASRN 56-23-5) to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
(b) Trace quantities exclusion. Unless otherwise specified in this
subpart, the prohibitions and restrictions of this subpart do not apply
to carbon tetrachloride that is solely present unintentionally in trace
quantities with another chemical substance or mixture.
(c) Owner and operator requirements. Any requirement for an owner
or operator, or an owner and operator, is a requirement for any
individual that is either an owner or an operator.
Sec. 751.703 Definitions.
The definitions in subpart A of this part apply to this Subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
ECEL has the same meaning as in Sec. 751.5 and for CTC, is an
airborne concentration of carbon tetrachloride of 0.03 parts per
million (ppm) calculated as an eight (8)-hour time-weighted average
(TWA).
ECEL action level means a concentration of airborne carbon
tetrachloride of 0.02 parts per million (ppm) calculated as an eight
(8)-hour time-weighted average (TWA).
Sec. 751.705 Prohibition of Certain Industrial and Commercial Uses
and Manufacturing, Processing, and Distribution in Commerce of Carbon
Tetrachloride for Those Uses.
(a) Prohibitions. (1) After June 16, 2025, all persons are
prohibited from manufacturing, processing, distributing in commerce
(including making available) and using carbon tetrachloride for the
following conditions of use:
(i) Processing condition of use: Incorporation into formulation,
mixture or reaction products in petrochemical-derived manufacturing
except in the manufacture of vinyl chloride.
(ii) Industrial and commercial conditions of use:
(A) Industrial and commercial use as an industrial processing aid
in the manufacture of petrochemicals-derived products except in the
manufacture of vinyl chloride.
(B) Industrial and commercial use in the manufacture of other basic
chemicals (including manufacturing of chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings), except for use
in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine.
(C) Industrial and commercial use in metal recovery.
(D) Industrial and commercial use as an additive.
(2) After December 18, 2025, all persons are prohibited from
manufacturing, processing, distributing in commerce (including making
available) and using carbon tetrachloride for industrial and commercial
specialty uses by the U.S. Department of Defense except as provided in
Sec. 751.709.
(b) [Reserved].
Sec. 751.707 Workplace Chemical Protection Program (WCPP).
(a) Applicability. The provisions of this section apply to the
following conditions of use of carbon tetrachloride, including
manufacturing and processing for export, except to the
[[Page 103552]]
extent the conditions of use are prohibited by Sec. 751.705:
(1) Domestic manufacture, except where carbon tetrachloride is
manufactured solely as a byproduct.
(2) Import.
(3) Processing as a reactant in the production of
hydrochlorofluorocarbons, hydrofluorocarbons, hydrofluoroolefins and
perchloroethylene.
(4) Processing: Incorporation into formulation, mixture, or
reaction products for agricultural products manufacturing, vinyl
chloride manufacturing, and other basic organic and inorganic chemical
manufacturing.
(5) Processing: Repackaging for use as a laboratory chemical.
(6) Processing: Recycling.
(7) Industrial and commercial use as an industrial processing aid
in the manufacture of agricultural products and vinyl chloride.
(8) Industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine.
(9) Disposal.
(b) Existing chemical exposure limit (ECEL)--(1) Eight-hour time-
weighted average (TWA) ECEL. Beginning September 20, 2027 for Federal
agencies or Federal contractors acting for or on behalf of the Federal
government, or by September 9, 2026 for non-Federal owners and
operators, or beginning four months after introduction of carbon
tetrachloride into the workplace if carbon tetrachloride commences
after June 11, 2026, the owner or operator must ensure that no person
is exposed to an airborne concentration of carbon tetrachloride in
excess of the ECEL, consistent with the requirements of paragraph
(d)(1)(i) of this section and, if necessary, paragraph (f) of this
section.
(2) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure, without regard to
respiratory protection, by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each exposure group.
(B) Personal breathing zone air samples are representative of the
8-hour TWA of all potentially exposed persons in an exposure group if
the samples are of at least one person's full-shift exposure who
represents the highest potential carbon tetrachloride exposures in that
exposure group. Personal breathing zone air samples taken during one
work shift may be used to represent potentially exposed person
exposures on other work shifts where the owner or operator can document
that the tasks performed and conditions in the workplace are similar
across shifts.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good
Laboratory Practice Standards in 40 CFR part 792 or a laboratory
accredited by the American Industrial Hygiene Association (AIHA) or
another industry-recognized program.
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of carbon tetrachloride.
(E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect, unless an Environmental Professional as defined at 40 CFR
312.10 or a Certified Industrial Hygienist reviews the exposure
monitoring results and determines re-monitoring is not necessary.
(ii) Initial monitoring. By June 21, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
or by June 11, 2026 for non-Federal owners and operators, or within 30
days of introduction of carbon tetrachloride into the workplace,
whichever is later, each owner or operator covered by this section must
perform initial monitoring of potentially exposed persons. Where the
owner or operator has monitoring results from monitoring conducted
within five years prior to February 18, 2025 and the monitoring
satisfies all other requirements of this section, the owner or operator
may rely on such earlier monitoring results to satisfy the requirements
of this paragraph (b)(2)(ii).
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
carbon tetrachloride in accordance with Table 1.
Table 1 to Sec. 751.707(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Periodic exposure monitoring
Air concentration condition requirement
------------------------------------------------------------------------
If all initial exposure monitoring is Periodic exposure monitoring is
below the ECEL action level (<0.02 ppm required at least once every
8-hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (> 0.03 ppm 8-hour TWA). of the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.02 ppm 8-hour monitoring.
TWA, <=0.03 ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a 6-month period, indicate exposure is monitoring.
below the ECEL action level (<0.02 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic exposure
would be required but does not monitoring event. However,
manufacture, process, use, or dispose documentation of cessation of
of carbon tetrachloride in that use of carbon tetrachloride is
condition of use over the entirety of required; and periodic
time since the last required monitoring would be required
monitoring event. when the owner or operator
resumes the condition of use.
------------------------------------------------------------------------
(iv) Additional exposure monitoring. (A) The owner or operator must
conduct additional exposure monitoring within a reasonable timeframe
whenever there has been a change in the production, process, control
equipment, personnel or work practices that may reasonably be expected
to result in new or additional exposures above the ECEL or when the
owner or operator has any reason to believe that new or additional
exposures above the ECEL action level have occurred.
(B) Whenever start-ups or shutdowns, or ruptures, malfunctions or
other breakdowns or unexpected releases occur that may lead to exposure
to
[[Page 103553]]
potentially exposed persons, the owner or operator must conduct the
additional exposure monitoring within a reasonable timeframe after the
conclusion of the start-up or shutdown and/or the cleanup, repair or
remedial action of the malfunction or other breakdown or unexpected
release. Prior monitoring data cannot be used to meet this requirement.
(v) Observation of monitoring. (A) Owners and operators must
provide potentially exposed persons or their designated representatives
an opportunity to observe any monitoring of occupational exposure to
CTC that is conducted under this section and designed to characterize
their exposure.
(B) When monitoring observation requires entry into a regulated
area, the owner or operator must provide the observers with the
required PPE.
(C) Only persons who are authorized to have access to facilities
classified in the interest of national security must be permitted to
observe exposure monitoring conducted in such facilities.
(vi) Notification of monitoring results. (A) The owner or operator
must inform each person whose exposures are monitored or who is part of
a monitored exposure group and their designated representatives of any
monitoring results within 15 working days of receipt of those
monitoring results.
(B) This notification must include the following:
(1) Exposure monitoring results;
(2) Identification and explanation of the ECEL and ECEL action
level;
(3) Statement of whether the monitored airborne concentration of
carbon tetrachloride exceeds the ECEL action level or ECEL;
(4) If the ECEL is exceeded, descriptions of any exposure controls
implemented by the owner or operator to reduce exposures to or below
the ECEL, as required by paragraph (d)(1) of this section;
(5) Explanation of any required respiratory protection provided in
accordance with paragraphs (b)(3)(iv), (d)(1)(i), and (f) of this
section;
(6) Quantity of carbon tetrachloride in use at the time of
monitoring;
(7) Location of carbon tetrachloride use at the time of monitoring;
(8) Manner of carbon tetrachloride use at the time of monitoring;
and
(9) Identified releases of carbon tetrachloride;
(C) Notice must be written in plain language and either provided to
each potentially exposed person and their designated representatives
individually in a language that the person understands, or posted in an
appropriate and accessible location outside the regulated area with an
English-language version and a non-English language version
representing the language of the largest group of workers who do not
read English.
(3) Regulated areas--(i) Establishment. By September 20, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government, or by September 9, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, the owner or
operator must establish and maintain a regulated area wherever airborne
concentrations of carbon tetrachloride exceeds or can reasonably be
expected to exceed the ECEL.
(ii) Access. The owner or operator must limit access to regulated
areas to authorized persons.
(iii) Demarcation. The owner or operator must demarcate regulated
areas from the rest of the workplace in a manner that adequately
establishes and alerts persons to the boundaries of the area and
minimizes the number of authorized persons exposed to carbon
tetrachloride within the regulated area.
(iv) Provisions of respirators. (A) The owner or operator must
ensure that each person who enters a regulated area is supplied with a
respirator selected in accordance with paragraph (f) of this section
and must ensure that all persons within the regulated area are using
the provided respirators whenever carbon tetrachloride exposures may
exceed the ECEL.
(B) An owner or operator who has implemented all feasible controls
as required in paragraph (d)(1)(i) of this section, and who has
established a regulated area as required by paragraph (b)(3)(i) of this
section where carbon tetrachloride exposure can be reliably predicted
to exceed the ECEL only on certain days (for example, because of work
or process schedule) must have persons use respirators in that
regulated area on those days.
(v) Prohibited activities. (A) The owner or operator must ensure
that, within a regulated area, persons do not engage in non-work
activities which may increase CTC exposure.
(B) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities which interfere with respirator performance.
(c) Direct dermal contact controls (DDCC). Beginning September 20,
2027 for Federal agencies or Federal contractors acting for or on
behalf of the Federal government, or by June 16, 2025 for non-Federal
owners and operators, or within 30 days of introduction of carbon
tetrachloride into the workplace, whichever is later, owners or
operators must ensure that all persons are separated, distanced,
physically removed, or isolated to prevent direct dermal contact with
carbon tetrachloride or from contact with equipment or materials on
which carbon tetrachloride may exist consistent with the requirements
of paragraph (d)(1)(ii) of this section and, if necessary, paragraph
(f) of this section.
(d) Exposure control procedures and plan--(1) Methods of
compliance--(i) ECEL. (A) By December 3, 2027, the owner or operator
must institute one or a combination of elimination, substitution,
engineering controls, or administrative controls to reduce exposure to
or below the ECEL except to the extent that the owner or operator can
demonstrate that such controls are not feasible, in accordance with the
hierarchy of controls.
(B) If the feasible controls required under paragraph (d)(1)(i)(A)
of this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL, then the owner or
operator must use such controls to reduce exposure to the lowest levels
achievable by these controls and must supplement those controls with
the use of respiratory protection that complies with the requirements
of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate exposure to
carbon tetrachloride has been reduced to or below the ECEL through the
use of controls required under paragraphs (d)(1)(i)(A) and (B) of this
section, and has not demonstrated that it has appropriately
supplemented with respiratory protection that complies with the
requirements of paragraph (f) of this section, this will constitute a
failure to comply with the ECEL.
(D) The owner or operator must ensure that any engineering controls
instituted under paragraph (d)(1)(i)(A) of this section do not increase
emissions of carbon tetrachloride to ambient air outside the workplace.
(ii) Direct dermal contact controls (DDCC). (A) The owner or
operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
prevent all persons from direct dermal contact with carbon
tetrachloride except to the extent that the owner or operator can
demonstrate that such controls are not feasible.
(B) If the feasible controls required under paragraph (d)(1)(ii)(A)
of this section that can be instituted do not
[[Page 103554]]
prevent direct dermal contact with carbon tetrachloride, then the owner
or operator must use such controls to reduce direct dermal contact to
the extent achievable by these controls and must supplement those
controls by the use of dermal protection that complies with the
requirements of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate that direct
dermal contact to carbon tetrachloride is prevented through the use of
controls required under paragraphs (d)(1)(ii)(A) and (B) of this
section, and has not demonstrated that it has appropriately
supplemented with dermal protection that complies with the requirements
of paragraph (f) of this section, this will constitute a failure to
comply with the DDCC requirements.
(2) Exposure control plan. By December 3, 2027, each owner and
operator must establish and implement an exposure control plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraphs (d)(1)(i)(A) and (d)(1)(ii)(A) of this section, in the
following sequence: elimination, substitution, engineering controls and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement exposure controls selected, including proper installation,
regular inspections, maintenance, training or other actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
(E) Attestation that exposure controls selected do not increase
emissions of carbon tetrachloride to ambient air outside of the
workplace and whether additional equipment was installed to capture or
otherwise prevent increased emissions of carbon tetrachloride to
ambient air;
(F) Description of activities conducted by the owner or operator to
review and update the exposure control plan to ensure effectiveness of
the exposure controls, identify any necessary updates to the exposure
controls, and confirm that all persons are properly implementing the
exposure controls;
(G) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to carbon tetrachloride, or otherwise result in increased
exposure to carbon tetrachloride, including procedures for implementing
corrective actions to mitigate exposure to carbon tetrachloride.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls instituted under this paragraph (d).
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every five years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (b) through (d) of this section.
(iii) Availability of exposure control plan. (A) Owners or
operators must make the exposure control plan and associated records,
including ECEL exposure monitoring records, ECEL compliance records,
DDCC compliance records, and workplace participation records described
in Sec. 751.713(b), available to potentially exposed persons and their
designated representatives.
(B) Owners or operators must notify potentially exposed persons and
their designated representatives of the availability of the exposure
control plan and associated records within 30 days of the date that the
exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and
associated records must be provided in plain language writing to each
potentially exposed person in a language that the person understands or
posted in an appropriate and accessible location outside the regulated
area with an English-language version and a non-English language
version representing the language of the largest group of workers who
do not read English.
(D) Upon request by the potentially exposed person or their
designated representative(s), the owner or operator must provide the
specified records at a reasonable time, place, and manner. If the owner
or operator is unable to provide the requested records within 15 days,
the owner or operator must, within those 15 days, inform the
potentially exposed person or designated representative(s) requesting
the record(s) of the reason for the delay and the earliest date when
the record will be made available.
(e) Workplace information and training. (1) By September 20, 2027
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or by September 9, 2026 for non-Federal owners
and operators, the owner or operator must institute a training program
and ensure that persons potentially exposed to carbon tetrachloride
participate in the program according to the requirements of this
paragraph (e).
(2) The owner or operator must ensure that each potentially exposed
person is trained prior to or at the time of a potential exposure to
carbon tetrachloride.
(3) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained and in multiple languages as appropriate, such as, based
on languages spoken by potentially exposed persons in the workplace.
(4) The following information and training must be provided to all
persons potentially exposed to carbon tetrachloride:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
carbon tetrachloride and the specific operations in the workplace that
could result in exposure to carbon tetrachloride, particularly noting
where each regulated area is located;
(iii) Methods and observations that may be used to detect the
presence or release of carbon tetrachloride in the workplace (such as
monitoring conducted by the owner or operator, continuous monitoring
devices, visual appearance or odor of carbon tetrachloride when being
released);
(iv) The acute and chronic health hazards of carbon tetrachloride
as detailed on relevant Safety Data Sheets; and
(v) The principles of safe use and handling of carbon tetrachloride
and measures potentially exposed persons can take to protect themselves
from carbon tetrachloride, including specific procedures the owner or
operator has implemented to protect potentially exposed persons from
exposure to carbon tetrachloride, such as appropriate work practices,
emergency procedures, and personal protective equipment to be used.
(5) The owner or operator must re-train each potentially exposed
person as necessary, but at minimum annually, to ensure that each such
person maintains the requisite understanding of the principles of safe
use and handling of carbon tetrachloride in the workplace.
[[Page 103555]]
(6) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase exposure, and where such exposure exceeds or can reasonably be
expected to exceed the ECEL action level or increase potential for
direct dermal contact with carbon tetrachloride, the owner or operator
must update the training as necessary to ensure that each potentially
exposed person is re-trained.
(f) Personal protective equipment (PPE). (1) General. The
provisions of this paragraph (f) apply to any owner or operator that is
required to provide respiratory protection pursuant to paragraphs
(b)(3)(iv) or (d)(1)(i)(B) of this section or dermal protection
pursuant to paragraphs (c) or (d)(1)(ii)(B) of this section or Sec.
751.709(b)(3) or (4).
(2) Respiratory protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by September 9, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, if an owner or
operator is required to provide respiratory protection pursuant to
paragraph (f)(1) of this section, the owner or operator must ensure
that each potentially exposed person is provided with a respirator
according to the requirements of this section.
(ii) For purposes of this paragraph (f)(2), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are
defined in 29 CFR 1910.134(b) have the meaning assigned to them in that
paragraph.
(iii) By September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
September 9, 2026 for non-Federal owners and operators, or within three
months after receipt of any exposure monitoring that indicates
exposures exceeding the ECEL, if an owner or operator is required to
provide respiratory protection pursuant to (f)(1) of this section, the
owner or operator must develop and administer a written respiratory
protection program consistent with the requirements of 29 CFR
1910.134(c)(1), (c)(3) and (c)(4).
(iv) Owners and operators must select respiratory protection
required by paragraph (f)(2)(i) of this section based on a medical
evaluation consistent with the requirements of 29 CFR 1910.134(e). If a
potentially exposed person cannot use a negative-pressure respirator
that would otherwise be required by paragraph (f)(1) of this section,
then the owner or operator must provide that person with an alternative
respirator. The alternative respirator must have less breathing
resistance than the negative-pressure respirator and provide equivalent
or greater protection. If the person is unable to use an alternative
respirator, then the person must not be permitted to enter the
regulated area.
(v) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator
selections to each affected person consistent with the requirements of
29 CFR 1910.134(f).
(vi) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(vii) Prior to or at the time of initial assignment to a job
involving potential exposure to carbon tetrachloride, owners and
operators must provide training to all persons required to use
respiratory protection consistent with 29 CFR 1910.134(k).
(viii) Owners and operators must retrain all persons required to
use PPE at least annually, or whenever the owner or operator has reason
to believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(ix) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
(A) If the measured exposure concentration is at or below the 0.03
ppm: no respiratory protection is required.
(B) If the measured exposure concentration is above 0.03 ppm and
less than or equal to 0.3 ppm (10 times ECEL): Any National Institute
for Occupational Safety and Health (NIOSH)-Approved air-purifying half
mask respirator equipped with organic vapor cartridges or canisters; or
any NIOSH Approved Supplied-Air Respirator (SAR) or Airline Respirator
operated in demand mode equipped with a half mask; or any NIOSH
Approved Self-Contained Breathing Apparatus (SCBA) in demand mode
equipped with a half mask [APF 10].
(C) If the measured exposure concentration is above 0.3 ppm and
less than or equal to 0.75 ppm (25 times ECEL): Any NIOSH Approved
Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting
facepiece or hood/helmet equipped with organic vapor cartridges or
canisters; any NIOSH Approved continuous flow supplied air respirator
equipped with a loose-fitting facepiece; or any NIOSH Approved
Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-
flow mode equipped with a loose-fitting facepiece or helmet/hood [APF
25].
(D) If the measured exposure concentration is above 0.75 ppm and
less than or equal to 1.5 ppm (50 times ECEL): Any NIOSH Approved air-
purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved PAPR with a half mask
equipped with organic vapor cartridges or canisters; any NIOSH Approved
SAR or Airline Respirator in a continuous flow mode equipped with a
half mask; any NIOSH Approved SAR or Airline Respirator operated in a
pressure-demand or other positive-pressure mode with a half mask; or
any NIOSH Approved SCBA in demand-mode equipped with a full facepiece
or helmet/hood [APF 50].
(E) If the measured exposure concentration is above 1.5 ppm and
less than or equal to 30 ppm (1,000 times ECEL): Any NIOSH Approved
PAPR equipped with a full facepiece equipped with organic vapor
cartridges or canisters; any NIOSH Approved SAR or Airline Respirator
in a continuous-flow mode equipped with full facepiece; any NIOSH
Approved SAR or Airline Respirator in pressure-demand or other
positive-pressure mode equipped with a full facepiece and an auxiliary
self-contained air supply; or any NIOSH Approved SAR or Airline
Respirator in a continuous-flow mode equipped with a helmet or hood and
that has been tested to demonstrated performance at a level of a
protection of APF 1,000 or greater [APF 1000].
(F) If the measured exposure concentration is greater than 30 ppm
(1,000 times ECEL): Any NIOSH Approved SCBA in a pressure-demand or
other positive-pressure mode equipped with a full facepiece helmet/hood
[APF 10,000].
(G) If the exposure concentration is unknown: Any NIOSH Approved
combination supplied air respirator equipped with a full facepiece and
operated in pressure demand or other positive pressure mode with an
auxiliary self-contained air supply; or any NIOSH Approved SCBA
operated in
[[Page 103556]]
pressure demand or other positive pressure mode and equipped with a
full facepiece or helmet/hood [APF 1000+].
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(2) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators who select air-purifying respirators must
either:
(A) Select respirators that have an end-of-service-life indicator
(ESLI) that is NIOSH Approved[supreg] for carbon tetrachloride; or
(B) Implement a change schedule for canisters and cartridges based
on objective information or data that ensures that canisters and
cartridges are changed before the end of their service life. The
written respiratory protection program required by paragraph
(f)(2)(iii) of this section must include a description of the
information and data relied upon, the basis for reliance on the
information and data, and the basis for the canister and cartridge
change schedule.
(xii) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xiii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29
CFR 1910.134(l), to ensure that the provisions of the written
respiratory protection program required under paragraph (f)(2)(iii) of
this section are being effectively implemented.
(xiv) The respiratory protection requirements in this paragraph
(f)(2) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(3) Dermal protection. (i) Beginning September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by June 16, 2025 for non-Federal owners and operators,
if an owner or operator is required to provide dermal protection
pursuant to paragraph (f)(1), the owner or operator must ensure that
each potentially exposed person is provided with dermal PPE according
to the requirements of this section.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with carbon tetrachloride in the specific work area
where it is selected for use, selected in accordance with this
paragraph and provided in accordance with 29 CFR 1910.132(h), to each
person who is reasonably likely to be dermally exposed in the work area
through direct dermal contact with carbon tetrachloride. For the
purposes of this subsection, provisions in 29 CFR 1910.132(h) applying
to an ``employee'' also apply equally to potentially exposed persons,
and provisions applying to an ``employer'' also apply equally to owners
or operators.
(iii) Owners or operators must select and provide dermal PPE in
accordance with 29 CFR 1910.133(b) and additionally as specified in
this paragraph (f)(3) to each person who is reasonably likely to be
dermally exposed in the work area through direct dermal contact with
carbon tetrachloride. For the purposes of this paragraph (f)(3)(iii),
provisions in 29 CFR 1910.133(b) applying to an ``employer'' also apply
equally to owners or operators.
(iv) Owners or operators must select and provide to persons
appropriate dermal PPE based on an evaluation of the performance
characteristics of the PPE relative to the task(s) to be performed,
conditions present, and the duration of use. Replacement PPE must be
provided immediately if any person is dermally exposed to CTC longer
than the breakthrough time period for which testing has demonstrated
that the PPE will be impermeable or if there is a chemical permeation
or breakage of the PPE. Dermal PPE must include, but is not limited to,
the following items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier or by individually prepared third-party
testing.
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(v) Owners or operators must demonstrate that each item of gloves
and other clothing selected provides an impervious barrier to prevent
direct dermal contact with carbon tetrachloride during normal and
expected duration and conditions of exposure within the work area by
evaluating the specifications from the manufacturer or supplier or
individually prepared third-party testing of the dermal PPE, or of the
material used in construction of the dermal PPE, to establish that the
dermal PPE will be impervious to carbon tetrachloride alone and in
likely combination with other chemical substances in the work area.
(vi) Dermal PPE that is of safe design and construction for the
work to be performed must be provided, used, and maintained in a
sanitary, reliable, and undamaged condition. Owners and operators must
select PPE that properly fits each affected person and communicate PPE
selections to each affected person.
(vii) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to carbon tetrachloride. For the purposes of this paragraph
(f)(3)(vii), provisions in 29 CFR 1910.132(f) applying to an
``employee'' also apply equally to potentially exposed persons, and
provisions applying to an ``employer'' also apply equally to owners or
operators.
(viii) Owners and operators must retrain each person required to
use dermal protection at least annually or whenever the owner or
operator has reason to believe that a previously trained person does
not have the required understanding and skill to properly use dermal
protection, or when changes in the workplace or in dermal protection to
be used render the previous training obsolete.
Sec. 751.709 Workplace Restrictions for the Industrial and Commercial
Use as a Laboratory Chemical, Including the Use of Carbon Tetrachloride
as a Laboratory Chemical by the U.S. Department of Defense.
(a) Applicability. The provisions of this section apply to the
industrial and commercial use of carbon tetrachloride as a laboratory
chemical, including the U.S. Department of Defense's industrial and
commercial use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction.
(b) Laboratory chemical requirements. (1) After December 18, 2025
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or after June 16, 2025 for non-Federal owners
and operators, owners or operators must ensure laboratory ventilation
devices such as fume hoods or glove boxes are in use and functioning
properly and that specific measures are taken to ensure proper and
adequate performance of such equipment to minimize exposures to
potentially exposed persons in the area when carbon tetrachloride is
used as a laboratory chemical, except for the U.S. Department of
Defense's use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction.
(2) After December 18, 2025, the U.S. Department of Defense must
ensure that
[[Page 103557]]
advanced engineering controls are in use and functioning properly and
that specific measures are taken to ensure proper and adequate
performance of such equipment to minimize exposures to potentially
exposed persons in the area during the industrial/commercial use of
carbon tetrachloride as a laboratory chemical in chemical weapons
destruction.
(3) After December 18, 2025 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or after
June 16, 2025 for non-Federal owners and operators, owners or operators
must ensure that all persons reasonably likely to be exposed from
direct dermal contact to carbon tetrachloride when carbon tetrachloride
is used as a laboratory chemical, except for the U.S. Department of
Defense's industrial and commercial use of carbon tetrachloride as a
laboratory chemical in chemical weapons destruction, are provided with
dermal PPE and training on proper use of PPE in a manner consistent
with Sec. 751.707(f)(3).
(4) After December 18, 2025, U.S. Department of Defense must ensure
that all persons reasonably likely to be exposed from direct dermal
contact to carbon tetrachloride through the industrial and commercial
use of carbon tetrachloride as a laboratory chemical in chemical
weapons destruction are provided with dermal PPE and training on proper
use of PPE in a manner consistent with Sec. 751.707(f)(3), except that
the date listed in paragraph (f)(3)(i) does not apply.
Sec. 751.711 Downstream Notification.
(a) Beginning on February 18, 2025, each person who manufactures
(including imports) carbon tetrachloride for any use must, prior to or
concurrent with the shipment, notify companies to whom carbon
tetrachloride is shipped, in writing, of the restrictions described in
this Subpart in accordance with paragraph (c) of this section.
(b) Beginning on June 16, 2025, each person who processes or
distributes in commerce carbon tetrachloride for any use must, prior to
or concurrent with the shipment, notify companies to whom carbon
tetrachloride is shipped, in writing, of the restrictions described in
this Subpart in accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in Sections 1(c) and
15 of the Safety Data Sheet (SDS) provided with the carbon
tetrachloride:
After June 16, 2025, this chemical substance (as defined in TSCA
section 3(2)) may not be distributed in commerce or processed in
greater than trace quantities for the following purposes:
Incorporation into formulation, mixture or reaction products in
petrochemical-derived manufacturing except in the manufacture of
vinyl chloride; Industrial and commercial use as an industrial
processing aid in the manufacture of petrochemicals-derived products
except in the manufacture of vinyl chloride; Industrial and
commercial use in the manufacture of other basic chemicals
(including manufacturing of chlorinated compounds used in solvents,
adhesives, asphalt, and paints and coatings), except for use in the
elimination of nitrogen trichloride in the production of chlorine
and caustic soda and the recovery of chlorine in tail gas from the
production of chlorine; Industrial and commercial use in metal
recovery; Industrial and commercial use as an additive; and
beginning December 18, 2025, industrial and commercial specialty
uses by the U.S. Department of Defense.
Sec. 751.713 Recordkeeping Requirements.
(a) General records. After February 18, 2025, all persons who
manufacture (including import), process, distribute in commerce, or
engage in industrial or commercial use of carbon tetrachloride must
maintain ordinary business records, such as downstream notifications,
invoices and bills-of-lading related to compliance with the
prohibitions, restrictions, and other provisions of this subpart.
(b) Workplace Chemical Protection Program compliance--(1) ECEL
exposure monitoring. For each monitoring event, owners or operators
subject to the ECEL described in Sec. 751.707(b) must document and
retain records of the following:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of use of carbon
tetrachloride in use at the time of each monitoring event;
(iii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iv) Name, workplace address, work shift, job classification, work
area, and type of respiratory protection (if any) by each monitored
person;
(v) Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample, consistent with Sec. 751.707(b)(2)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in Sec.
751.707(b)(2)(i)(D);
(vii) Compliance with the Good Laboratory Practice Standards in 40
CFR part 792, or use of laboratory accredited by the AIHA or another
industry-recognized program, as required by Sec. 751.707(b)(2)(i)(C);
and
(viii) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions;
(ix) Re-monitoring determinations conducted by an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist, if results indicated non-detect; and
(x) Notification of exposure monitoring results in accordance with
Sec. 751.707(b)(2)(v).
(2) ECEL compliance. Owners or operators subject to the ECEL
described in Sec. 751.707(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.707(d)(2);
(ii) Implementation of the exposure control plan as described in
Sec. 751.707(d)(2), including:
(A) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure
controls; and
(C) Each occurrence and duration of any start-up, shutdown,
ruptures, or malfunction of the facility that causes an exceedance of
the ECEL, any subsequent corrective actions taken by the owner or
operator during the start-up, shutdown, ruptures, or malfunctions to
mitigate exposures to CTC, and documentation indicating that additional
monitoring was completed within a reasonable timeframe.
(iii) Respiratory protection used by each potentially exposed
person and PPE program implementation as described in Sec.
751.707(f)(2) including:
(A) The name, workplace address, work shift, job classification,
work area of each potentially exposed person, and the type of
respiratory protection provided to each potentially exposed person;
(B) The basis for the specific respiratory protection selection in
accordance with Sec. 751.707(f)(2); and
(C) Fit testing and training in accordance with Sec.
751.707(f)(2).
(iv) Information and training as required in Sec. 751.707(e).
(3) DDCC compliance. Owners or operators subject to DDCC
requirements described in Sec. 751.707(c) must retain records of:
(i) Exposure control plan as described in Sec. 751.707(d)(2);
(ii) Dermal protection used by each potentially exposed person and
PPE program implementation as described in Sec. 751.707(f)(3),
including:
(A) The name, workplace address, work shift, job classification,
and work area of each person reasonably likely to
[[Page 103558]]
directly handle carbon tetrachloride or handle equipment or materials
on which carbon tetrachloride may be present and the type of PPE
selected to be worn by each of these persons;
(B) The basis for specific PPE selection (e.g., demonstration based
on permeation testing or manufacturer specifications that each item of
PPE selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(C) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE;
(D) Occurrence and duration of any direct dermal contact with
carbon tetrachloride that occurs during any activity or malfunction at
the workplace that causes direct dermal exposures to occur and/or glove
breakthrough, and corrective actions to be taken during and immediately
following that activity or malfunction to prevent direct dermal contact
to carbon tetrachloride; and
(E) Training in accordance with Sec. 751.707(f)(3).
(iii) Information and training provided as required in Sec.
751.707(e).
(4) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person that may
reasonably be affected by carbon tetrachloride inhalation exposure or
direct dermal contact and their designated representatives to readily
access the exposure control plans, facility exposure monitoring
records, PPE program implementation records, or any other information
relevant to carbon tetrachloride exposure in the workplace.
(c) Workplace requirements for laboratory use compliance. Owners
and operators subject to the laboratory chemical requirements described
in Sec. 751.709 must retain records of:
(1) Dermal protection used by each potentially exposed person and
PPE program implementation, as described in Sec. 751.713(b)(3)(ii);
and
(2) Documentation identifying criteria that the owner or operator
will use to determine and implement control measures to reduce
potentially exposed persons' exposure to carbon tetrachloride including
laboratory ventilation devices;
(3) Documentation identifying: implementation of a properly
functioning laboratory ventilation devices using manufacturer's
instructions for installation, use, and maintenance of the devices
including inspections, tests, development of maintenance procedures,
the establishment of criteria for acceptable test results, and
documentation of test and inspection results, except for the U.S.
Department of Defense's use of carbon tetrachloride as a laboratory
chemical in chemical weapons destruction; and
(4) For the U.S. Department of Defense's use of carbon
tetrachloride as a laboratory chemical in chemical weapons destruction,
documentation identifying implementation of advanced engineering
controls that are in use and functioning properly and specific measures
taken to ensure proper and adequate performance.
(d) Retention. Owners or operators must retain the records required
under this section for a period of five years from the date that such
records were generated.
[FR Doc. 2024-29517 Filed 12-17-24; 8:45 am]
BILLING CODE 6560-50-P