[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Proposed Rules]
[Pages 49180-49228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15326]



[[Page 49179]]

Vol. 88

Friday,

No. 144

July 28, 2023

Part IV





Environmental Protection Agency





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40 CFR Part 751





Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances 
Control Act (TSCA); Proposed Rule

  Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / 
Proposed Rules  

[[Page 49180]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2020-0592; FRL-8206-01-OCSPP]
RIN 2070-AK82


Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances 
Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to 
address the unreasonable risk of injury to human health presented by 
carbon tetrachloride (CTC) under its conditions of use as documented in 
EPA's 2020 Risk Evaluation for Carbon Tetrachloride and 2022 Revised 
Unreasonable Risk Determination for Carbon Tetrachloride pursuant to 
the Toxic Substances Control Act (TSCA). CTC is a volatile, organic 
compound that is primarily used as a feedstock (i.e., processed as a 
reactant) in the making of products such as refrigerants, aerosol 
propellants, and foam-blowing agents. 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 determined that CTC presents an unreasonable risk of injury 
to health due to cancer from chronic inhalation and dermal exposures 
and liver toxicity from chronic inhalation, chronic dermal, and acute 
dermal exposures in the workplace. To address the identified 
unreasonable risk, EPA is proposing under TSCA to 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 
already been phased out, 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: Comments must be received on or before September 11, 2023. Under 
the Paperwork Reduction Act (PRA), comments on the information 
collection provisions are best ensured of consideration if the Office 
of Management and Budget (OMB) receives a copy of your comments on or 
before August 28, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0592, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Claudia Menasche, 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) 564-3391; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined under TSCA to include import), process, distribute in 
commerce, use, or dispose of CTC. The following list of 2022 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 
may include:
     NAICS code 325--Chemical Manufacturing;
     NAICS code 327--Nonmetallic Mineral Product Manufacturing;
     NAICS code 331--Primary Metal Manufacturing;
     NAICS code 562--Waste Management and Remediation Services;
     NAICS code 325110--Petrochemical Manufacturing;
     NAICS code 325120--Industrial Gas Manufacturing;
     NAICS code 325180--Other Basic Inorganic Chemical 
Manufacturing;
     NAICS code 325194--Cyclic Crude, Intermediate, and Gum and 
Wood Chemical Manufacturing;
     NAICS code 325199--All Other Basic Organic Chemical 
Manufacturing;
     NAICS code 325211--Plastics Material and Resin 
Manufacturing;
     NAICS code 325320--Pesticide and Other Agricultural 
Chemical Manufacturing;
     NAICS code 325998--All Other Miscellaneous Chemical 
Product and Preparation Manufacturing;
     NAICS code 327310--Cement Manufacturing;
     NAICS code 327992--Ground or Treated Mineral and Earth 
Manufacturing;
     NAICS code 331410--Nonferrous Metal (except Aluminum) 
Smelting and Refining;
     NAICS code 562211--Hazardous Waste Treatment and Disposal; 
and
     NAICS code 562213--Solid Waste Combustors and 
Incinerators.
    This action may also affect certain entities through pre-existing 
import, including import certification, and export notification rules 
under TSCA. Persons who import any chemical substance governed by a 
final TSCA section 6(a) rule are subject to the TSCA section 13 (15 
U.S.C. 2612), which requires that the Secretary of the Treasury 
``refuse entry into the customs territory of the United States'' of any 
substance, mixture, or article containing a chemical substance or 
mixture that fails to comply with any rule issued under TSCA or that 
``is offered for entry in violation'' of TSCA or certain rules or 
orders issued under TSCA, including rules issued under TSCA section 
6(a). Persons who import any chemical substance in bulk form, as part 
of a mixture, or as part of an article (if required by rule) are also 
subject to TSCA section 13 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 proposed 
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.
    If you have any questions regarding the applicability of this 
proposed action

[[Page 49181]]

to a particular entity, consult the technical information contact 
listed under FOR FURTHER INFORMATION CONTACT.

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 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 
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, under the conditions 
of use (Refs. 1, 2, and 3). A detailed description of the conditions of 
use that drive EPA's determination that CTC presents an unreasonable 
risk is provided in Unit III.B.1. Accordingly, to address the 
unreasonable risk, EPA is proposing, under TSCA section 6(a) to:
    (i) Require a CTC workplace chemical protection program (WCPP), 
which would include an existing chemical exposure limit (ECEL) of 0.03 
ppm as an 8-hour time-weighted average (TWA) to address risk from 
inhalation exposure in combination with direct dermal contact controls 
(DDCC) for the following conditions of use. EPA is also proposing 
working with the regulated community and industrial hygiene experts to 
develop methodologies to measure CTC concentrations at or below the 
ECEL. The WCPP would apply to the manufacturing (including import) of 
CTC and other conditions of use which account for essentially all of 
the production volume of CTC (Ref. 4), as outlined in Unit IV.A.1.:
     Domestic manufacture;
     Import;
     Processing as a reactant in the production of HCFCs, HFCs, 
HFOs, and perchloroethylene (PCE);
     Incorporation into formulation, mixture or reaction 
products in agricultural products 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;
     Industrial and commercial use in the elimination of 
nitrogen trichloride in the production of chlorine and caustic soda; 
and
     Disposal.
    (ii) Require use of a fume hood and dermal personal protective 
equipment (PPE) for the industrial and commercial use as a laboratory 
chemical, as outlined in Unit IV.A.2.;
    (iii) Prohibit these additional conditions of use, for which the 
Agency understands use of CTC has already been phased out, as outlined 
in Unit IV.A.3.:
     Incorporation into formulation, mixture or reaction 
products in petrochemical-derived manufacturing;
     Industrial and commercial use as an industrial processing 
aid in the manufacture of petrochemicals-derived products;
     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 (for which EPA is proposing 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).
    (iv) Require manufacturers (including importers), processors, and 
distributors to provide downstream notification of the requirements, as 
outlined in Unit IV.A.4.
    (v) Require recordkeeping, as outlined in Unit IV.A.4.
    EPA notes that not all TSCA conditions of use of CTC are subject to 
regulation under this proposal. 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 proposing 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 proposed 
regulatory action and primary alternative regulatory action include 
prohibitions on the distribution in commerce of CTC for certain 
downstream conditions of use.
    The 2020 Risk Evaluation (Ref. 1) and the 2022 Revised Unreasonable 
Risk Determination (Ref. 3) contain the full list of CTC's conditions 
of use that were evaluated for risk to health or the environment. The 
term ``conditions of use'' is defined in TSCA section 3(4) to mean the 
circumstances under which a chemical substance is intended, known, or 
reasonably foreseen to be manufactured, processed, distributed in 
commerce, used, or disposed of. As mentioned, a detailed description of 
the conditions of use that drive EPA's determination that CTC presents 
an unreasonable risk is provided in Unit III.B.1. In addition, Unit 
III.B.2. contains a description of the conditions of use that do not 
drive the unreasonable risk of CTC.
    In addition, EPA is proposing to amend the general provision of 40 
CFR part 751, subpart A, to define ``authorized person,'' ``direct 
dermal contact,'' ``ECEL,'' ``exposure group,'' ``owner or operator,'' 
``potentially exposed person,'' and ``regulated area'' 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. EPA is 
requesting public comment on all aspects of this proposal.

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 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 (2020 Risk Evaluation) (Ref. 1). In addition, 
EPA issued a revised unreasonable risk determination for CTC 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. As a result, EPA is proposing to take action to the 
extent necessary so that CTC no longer

[[Page 49182]]

presents such risk. The unreasonable risk is described in Unit III.B.3. 
and the conditions of use that drive the unreasonable risk for CTC are 
described in Unit III.B.1.
    EPA is not proposing a complete ban on CTC. 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 consumer products (excluding 
unavoidable residues not exceeding 10 ppm atmospheric concentration) in 
1970. 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 in 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, 
and 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. 5). 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 these reasons, this rule proposes to allow 
CTC's continued use with additional worker protection to address 
unreasonable risk for several conditions of use, including the 
processing of CTC as a reactant in the production of HFOs.

E. What are the estimated incremental impacts of this Action?

    EPA's Economic Analysis of the estimated incremental impacts 
associated with this rulemaking can be found in the rulemaking docket 
(Ref. 4). As described in more detail in the Economic Analysis and in 
Units VI.D. and X.D., EPA's estimate of the incremental costs of this 
proposed rule is $18.8 million per year annualized over 20-years at a 
3% discount rate and $18.5 million per year at a 7% discount rate (Ref. 
4). The estimated cost of the primary alternative regulatory action is 
$2.3 million per year annualized over 20-years at both a 3% and 7% 
discount rate. While the cost of the proposed regulatory action is 
higher than the cost of the primary alternative regulatory action, the 
proposed regulatory action is the action with the least uncertainty 
regarding the protection afforded to workers, requires regulated 
entities to consider more protective controls in the hierarchy, and 
lessens the burden on workers. Under the WCPP, regulated entities would 
be required to implement the hierarchy of controls and only consider 
respirators and dermal PPE after all other steps have been taken to 
reduce exposures using other and more effective controls in the 
hierarchy (Ref. 8). The primary alternative regulatory action, on the 
other hand, would neither allow nor require regulated entities to 
consider other, more effective exposure controls in the hierarchy. In 
addition, the Agency recognizes that workplaces have unique processes 
and equipment in place and that varying levels of respiratory APFs may 
be needed for different workplaces. Therefore, there is uncertainty as 
to whether a specific respiratory APF or a dermal PPE would be 
sufficient for all workplaces so that CTC no longer presents 
unreasonable risk. Finally, there is an unquantified cost to workers 
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. To the extent that this unquantified cost of respirator 
use applies more to prescriptive controls, it is an unmonetized benefit 
of the proposed regulatory action relative to the primary alternative 
action. More details regarding the rationale for the proposed 
regulatory action and the primary alternative regulatory action are in 
Unit IV and Unit V. The costs are estimated as incremental to baseline 
conditions, including current use of personal protective equipment. The 
costs represent a high-end cost estimate because the high estimates for 
the number of entities and workers affected by the regulation 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. These costs take into consideration the proposed 
requirements to mitigate unreasonable risk of injury to health from CTC 
under the conditions of use. Costs are higher for the proposed action 
compared to the primary alternative action because the proposed action 
would require a WCPP for many conditions of use, which includes 
monitoring and WCPP recordkeeping requirements that are more costly 
than the primary alternative action's prescriptive controls 
requirement. In the primary alternative action, facilities will not 
incur monitoring or WCPP recordkeeping costs, but will need to provide 
a respirator to all employees. The cost of the primary alternative 
action's prescriptive controls option includes the PPE. The cost 
estimates include the equipment itself, as well as the costs of a 
medical evaluation, fit testing, and equipment cleaning that ensure 
proper use and maintenance of the PPE. There is an unquantified cost to 
workers 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. To the extent that this unquantified cost of 
respirator use applies more to prescriptive controls, it is an 
unmonetized benefit of the proposed regulatory action relative to the 
primary alternative action. More details regarding the rationale for 
the proposed regulatory action and the primary alternative regulatory 
action are in Unit IV and Unit V
    Unit IV. details which actions apply to which conditions of use. 
EPA estimates that 30 firms associated with 71 sites may be 
manufacturing (including importing), processing, or releasing CTC.
    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 fume hood requirement for laboratory settings because they are 
considered to be part of baseline industry practices. All manufacturers 
(including importers),

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processors, and distributors will bear downstream notification and 
recordkeeping costs.
    EPA estimates that the proposed rule would affect at least four 
small entities. EPA compared the highest annualized per-facility cost 
of the proposed regulatory action with ultimate parent company annual 
revenues of the affected small businesses. EPA found impacts under 1% 
of annual revenues for three of the four small entities. One small 
entity was estimated to have a cost-to-revenue impact ratio greater 
than 1%, and that entity would incur a cost-to-impact ratio of between 
1% and 3%. EPA requests public comments regarding the number of small 
businesses subject to the proposed rule and the potential impacts of 
the proposed rule on these small businesses.
    EPA's Economic Analysis for the rule monetized the benefits from 
avoided cases of adrenal and liver cancers. 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 proposed regulatory action, which 
could include respiratory protection, and prescriptive workplace 
controls in the primary alternative regulatory action. The estimated 
monetized benefit of the proposed regulatory action ranges from 
approximately $0.09 to $0.1 million per year annualized over 20-years 
at a 3% discount rate and from $0.04 to $0.07 million per year at a 7% 
discount rate. The estimated monetized benefit of the primary 
alternative regulatory action is $.09 to $.1 million per year 
annualized over 20-years at a 3% discount rate and $.04 to $.07 million 
per year at a 7% discount rate. The APFs of respirators required under 
the prescriptive workplace controls primary alternative regulatory 
action are higher on average than those expected to be required based 
on projected monitoring outcomes under the ECEL as part of the WCPP 
under the proposed regulatory action. To estimate the costs and 
benefits of respirators under the ECEL, 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 APF. These estimates are subject to uncertainties, 
and there could be facilities with higher or lower air exposures than 
estimated in the Economic Analysis. In practice, the WCPP would require 
facility personnel to select appropriate PPE based on actual monitored 
levels to ensure adequate protection. Under the prescriptive workplace 
controls in the primary alternative regulatory action, the APFs of 
respirators for each condition of use are based on high-end exposure 
scenarios to ensure that workers are sufficiently protected, without 
accounting for differences in air exposures across facilities, 
including the unique processes and engineering controls that may 
already be implemented. This results in more workers wearing higher 
APFs in the primary alternative regulatory action. The quantified 
benefits from the primary alternative regulatory action are comparable 
to those of the proposed action, with a difference of less than five 
percent between the benefits of the two regulatory options.
    Using the high-end estimates for the number of entities and workers 
affected by the proposed regulation, the monetized net benefit of the 
proposed regulatory action, which is negative, is -$18.7 million per 
year annualized over 20-years at a 3% discount rate and ranges from -
$18.5 to -$18.4 million per year at a 7% discount rate. The monetized 
net benefit of the primary alternative regulatory action is also 
negative and ranges from -$2.3 to -$2.2 million per year annualized 
over 20-years at a 3% discount rate and is -$2.3 million per year at a 
7% discount rate. The range in the monetized net benefits estimate at 
each discount rate 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 potential 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 that 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 compared to the national averages. CTC facilities are 
concentrated in Texas and Louisiana, especially near Houston and Baton 
Rouge.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
https://www.regulations.gov or email. Clearly mark the part or all of 
the information that you claim to be CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. Overview of Carbon Tetrachloride

    This proposed rule applies to CTC (CASRN 56-23-5) and is 
specifically intended to address the unreasonable risks 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 
III.B.3. CTC is a volatile organic compound that is primarily used as a 
feedstock in the production of HCFCs, HFCs, and HFOs. EPA identified 
liver toxicity and 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).
    According to data collected as a result of 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 (Ref. 4). CTC's use as a feedstock in the 
production of HCFCs, HFCs, and HFOs is described in Unit III.B.1., with 
a description of proposed requirements to address the unreasonable risk 
in Unit IV.A.

[[Page 49184]]

B. Regulatory Actions Pertaining to Carbon Tetrachloride

    CTC is subject to numerous State, Federal, and international 
regulations restricting and regulating its use; a summary of the 
regulatory actions pertaining to CTC is in the docket (Refs. 1 and 6).

C. Consideration of Occupational Safety and Health Administration 
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA 
Risk Management Actions

    Although EPA must consider and factor in, to the extent 
practicable, certain non-risk factors as part of TSCA section 6(a) 
rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still 
ensure that the selected regulatory requirements apply ``to the extent 
necessary so that the chemical substance or mixture no longer presents 
[unreasonable] risk.'' 15 U.S.C. 2605(a). This requirement to eliminate 
unreasonable risk is distinguishable from approaches mandated by some 
other laws, including the Occupational Safety and Health Act (OSH Act), 
which includes both significant risk and feasibility (technical and 
economic) considerations in the setting of standards.
    Congress intended for EPA to consider occupational risks from 
chemicals it evaluates under TSCA, among other potential exposures, as 
relevant and appropriate. As noted previously, TSCA section 6(b) 
requires EPA to evaluate risks to PESS identified as relevant by the 
Administrator. TSCA section 3(12) defines the term ``potentially 
exposed or susceptible subpopulation'' as ``a group of individuals 
within the general population identified by the Administrator who, due 
to either greater susceptibility or greater exposure, may be at greater 
risk than the general population of adverse health effects from 
exposure to a chemical substance or mixture, such as infants, children, 
pregnant women, workers, or the elderly.''
    The OSH Act similarly requires OSHA to evaluate risk specific to 
workers prior to promulgating new or revised standards and requires 
OSHA standards to substantially reduce significant risk to the extent 
feasible, even if workers are exposed over a full working lifetime. See 
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum 
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
    Thus, the standards for chemical hazards that OSHA promulgates 
under the OSH Act share a broadly similar purpose with the standards 
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, as this 
section outlines, 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.
    1. OSHA Requirements.
    OSHA's mission is to ensure that employees work in safe and 
healthful conditions. The OSH Act establishes requirements that each 
employer comply with the General Duty Clause of the Act (29 U.S.C. 
654(a)), as well as with occupational safety and health standards 
issued under the Act.
    a. General Duty Clause of the OSH Act.
    The General Duty Clause of the OSH Act requires employers to keep 
their workplaces free from recognized hazards that are causing or are 
likely to cause death or serious physical harm to employees. The 
General Duty Clause is cast in general terms, and does not establish 
specific requirements like exposure limits, PPE, or other specific 
protective measures that EPA could potentially consider when developing 
its risk evaluations or risk management requirements. OSHA, under 
limited circumstances, has cited the General Duty Clause for regulating 
exposure to chemicals. To prove a violation of the General Duty Clause, 
OSHA must prove employer or industry recognition of the hazard, that 
the hazard was causing or likely to cause death or serious physical 
harm, and a feasible method to eliminate or materially reduce the 
hazard was available.
    In rare situations, OSHA has cited employers for violation of the 
General Duty Clause where exposures were below a chemical-specific 
Permissible Exposure Limit (PEL), a time weighted average (TWA) based 
on an employee's average airborne exposure in any 8-hour work shift of 
a 40-hour work week which shall not be exceeded (Ref. 7). In such 
situations, OSHA must demonstrate that the employer had actual 
knowledge that the PEL was inadequate to protect its employees from 
death or serious physical harm. Because of the heavy evidentiary burden 
on OSHA to establish violations of the General Duty Clause, it is not 
frequently used to cite employers for employee exposure to chemical 
hazards.
    b. OSHA Standards.
    OSHA standards are issued pursuant to the OSH Act and are found in 
title 29 of the CFR. There are separate standards for general industry, 
construction, maritime and agriculture sectors, and general standards 
applicable to a number of sectors (e.g., OSHA's Respiratory Protection 
standard). OSHA has numerous standards that apply to employers who 
operate chemical manufacturing and processing facilities, as well as to 
downstream employers whose employees may be occupationally exposed to 
hazardous chemicals.
    OSHA sets legally enforceable limits on the airborne concentrations 
of hazardous chemicals, referred to as PELs, established for employers 
to protect their workers against the health effects of exposure to 
hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart 
Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act, 
OSHA was permitted an initial 2-year window after the passage of the 
Act to adopt ``any national consensus standard and any established 
Federal standard.'' 29 U.S.C. 655(a). OSHA used this authority in 1971 
to establish PELs that were adopted from Federal health standards 
originally set by the U.S. Department of Labor through the Walsh-Healy 
Act, in which approximately 400 Occupational Exposure Limits (OELs) 
were selected based on the American Conference of Governmental 
Industrial Hygienists (ACGIH) 1968 list of Threshold Limit Values 
(TLVs). In addition, about 25 exposure limits recommended by the 
American Standards Association (now called the American National 
Standards Institute) (ANSI) were adopted as PELs.
    Following the 2-year window provided under section 6(a) of the OSH 
Act for the adoption of national consensus and existing Federal 
standards, OSHA issued health standards following the requirements in 
section 6(b) of the Act. OSHA has established approximately 30 PELs 
under section 6(b)(5) as part of comprehensive substance-specific 
standards that include additional requirements for protective measures 
such as use of PPE, establishment of regulated areas, exposure 
assessment, hygiene facilities, medical surveillance, and training. 
These ancillary provisions in substance-specific OSHA standards further 
mitigate residual risk that could be present due to exposure at the 
PEL.
    Many OSHA PELs have not been updated since they were established in 
1971, including the PEL for CTC. In

[[Page 49185]]

many instances, scientific evidence has accumulated suggesting that the 
current limits of many PELs are not sufficiently protective. On October 
10, 2014, OSHA published a Federal Register document in which it 
recognized that many of its PELs are outdated and inadequate for 
ensuring protection of worker health (79 FR 61384, October 14, 2014). 
In addition, health standards issued under section 6(b)(5) of the OSH 
Act must reduce significant risk only to the extent that it was 
technologically and economically feasible at the time they were issued. 
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. As described in that 
notice, while new advancements or developments in science and 
technology from the time a PEL is promulgated may improve the 
scientific basis for making findings of significant risk, technical 
feasibility or economic feasibility, OSHA has been unable to update 
most of the PELs established in 1971 and they remain frozen at levels 
at which they were initially adopted (79 FR 61384, October 10, 2014). 
One example of how industries have evolved in the intervening 50 years 
as to what is technologically and economically feasible is the 
halogenated solvent cleaning industry, which, in response to EPA's 
National Emission Standards for Hazardous Air Pollutants (NESHAP) 
promulgated under Section 112 of the 1990 CAA Amendments (see National 
Emissions Standards for Halogenated Solvent Cleaning, 40 CFR part 63, 
subpart T), has made equipment improvements that conserve solvent 
resources and reduce workplace exposure.
    In sum, the great majority of OSHA's chemical standards are 
outdated or do not sufficiently reduce 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, and because many of OSHA's chemical-
specific standards are based on outdated information regarding the 
technological and economic feasibility of the standards and the risks 
associated with exposure, 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. However, it is also appropriate that EPA 
consider the chemical standards that OSHA has already developed to 
limit the compliance burden to employers by aligning management 
approaches required by the agencies, where alignment will adequately 
address unreasonable risk to workers. The following section discusses 
EPA's consideration of OSHA standards in its risk evaluation and 
management strategies under TSCA.
    2. Consideration of OSHA standards in TSCA risk evaluations.
    When characterizing the risk during risk evaluation under TSCA, EPA 
believes it is appropriate to evaluate the levels of risk present in 
scenarios where no mitigation measures are assumed to be in place for 
the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It 
should be noted that there are some cases where scenarios may reflect 
certain mitigation measures, such as in instances where exposure 
estimates are based on monitoring data at facilities that have existing 
engineering controls in place. For example, the Chemical Manufacturing 
Area Sources NESHAP, last updated in 2012, requires that certain 
chemical manufacturing synthetic area sources that installed controls 
obtain a title V permit under the CAA, requiring sources to obtain and 
operate in compliance with an operating permit (40 CFR part 63, subpart 
VVVVVV) (77 FR 75740, December 21, 2012). Consequently, emissions 
monitoring from facilities meeting the NESHAP would reflect emissions 
reduction resulting from existing engineering controls already in place 
to meet the standards.) In addition, EPA believes it may be appropriate 
to also evaluate the levels of risk present in scenarios considering 
applicable OSHA requirements as well as scenarios considering industry 
or sector best practices for industrial hygiene that are clearly 
articulated to the Agency. EPA may evaluate risk under scenarios that 
consider industry or sector best practices for industrial hygiene that 
are clearly articulated to the Agency, when doing so serves to inform 
its risk management efforts. Characterizing risks using scenarios that 
reflect different levels of mitigation can help inform potential risk 
management actions by providing information that could be used during 
risk management to tailor risk mitigation appropriately to address any 
unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.).
    a. Risk characterization for unreasonable risk determination.
    When making unreasonable risk determinations as informed by TSCA 
risk evaluations, EPA cannot assume as a general matter that all 
workers are always equipped with and appropriately using sufficient 
PPE, although it does not question the veracity of public comments 
received on 2020 Risk Evaluation for Carbon Tetrachloride regarding the 
occupational safety practices often followed by industry respondents. 
When characterizing the risk to human health from occupational 
exposures during risk evaluation under TSCA, EPA believes it is 
appropriate to evaluate the levels of risk present in scenarios where 
PPE is not assumed to be used by workers. This approach of not assuming 
PPE use by workers considers the risk to PESS (workers and occupational 
non-users (ONUs)) who may not be covered by OSHA standards, such as 
self-employed individuals and public sector workers who are not covered 
by a State Plan. Mitigation scenarios included in the EPA risk 
evaluation in order to inform its risk management efforts (e.g., 
scenarios considering use of PPE) likely represent current practice in 
many facilities where companies effectively address worker and 
bystander safety requirements. However, the Agency cannot assume that 
all facilities across all uses of the chemical substance will have 
adopted these practices for the purposes of making the TSCA risk 
determination.
    Therefore, EPA makes its determinations of unreasonable risk based 
on scenarios that do not assume compliance with OSHA standards, 
including any applicable exposure limits or requirements for use of 
respiratory protection or other PPE. Making unreasonable risk 
determinations based on such scenarios should not be viewed as an 
indication that EPA believes there are no occupational safety 
protections in place at any location, or that there is

[[Page 49186]]

widespread noncompliance with applicable OSHA standards. Rather, it 
reflects EPA's recognition that unreasonable risk may exist for 
subpopulations of workers that may be highly exposed because they are 
not covered by OSHA standards, such as self-employed individuals and 
public sector workers who are not covered by an OSHA State Plan, or 
because their employer is out of compliance with OSHA standards, or 
because EPA finds unreasonable risk for purposes of TSCA 
notwithstanding assumed compliance with existing OSHA requirements.
    b. Risk evaluation to inform risk management requirements
    In addition to the scenarios described previously, EPA risk 
evaluations may characterize the levels of risk present in scenarios 
considering applicable OSHA requirements (e.g., chemical-specific PELs 
and/or chemical-specific health standards with PELs and additional 
ancillary provisions) as well as scenarios considering industry or 
sector best practices for industrial hygiene that are clearly 
articulated to the Agency to help inform risk management decisions.
    3. Consideration of OSHA standards in TSCA risk management actions.
    When undertaking risk management actions, EPA: (1) develops 
occupational risk mitigation measures to address any unreasonable risk 
identified by EPA, striving for compatibility with applicable OSHA 
requirements and industry best practices, including appropriate 
application of the hierarchy of controls, when those measures would 
address an unreasonable risk; and (2) ensures that EPA requirements 
apply to all potentially exposed workers in accordance with TSCA 
requirements. 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 applicability of TSCA 
while avoiding the imposition of duplicative requirements.
    Informed by the mitigation scenarios and information gathered 
during the risk evaluation and risk management process, the Agency 
might propose rules to require risk management practices that may 
already be common practice in many or most facilities. Adopting clear, 
broadly applicable regulatory standards will foster compliance across 
all facilities (ensuring a level playing field) and ensure protections 
for all affected workers, especially in cases where current OSHA 
standards may not apply to them or not be sufficient to address the 
unreasonable risk.
    For evaluation scenarios which involve OSHA chemical-specific PELs, 
EPA's risk evaluation in some cases may illustrate that limiting 
exposure to OSHA's PEL would result in acceptable levels of risk under 
TSCA under certain conditions of use. In these cases, TSCA risk 
management requirements could incorporate and reinforce requirements in 
OSHA standards and ensure that risks are addressed, including for 
circumstances where OSHA requirements are not applicable (e.g., public 
sector workers not covered by an OSHA State plan, and self-employed 
workers) by asserting TSCA compliance/enforcement as well. EPA's risk 
evaluation may also find unreasonable risk under TSCA associated with 
some occupational conditions of use, even when the applicable OSHA 
requirements are being met. In these cases, EPA would need to develop 
risk management requirements beyond those included in OSHA's standards.
    4. Carbon Tetrachloride and OSHA requirements.
    EPA incorporated the considerations described earlier in this unit 
in the 2020 Risk Evaluation (Ref. 1), the 2022 Revised Unreasonable 
Risk Determination (Ref. 3), and this rulemaking. Specifically, in the 
TSCA 2020 Risk Evaluation, EPA presented risk estimates based on 
workers' exposures with and without respiratory protection. Additional 
consideration of OSHA standards in the 2022 Revised Unreasonable Risk 
Determination is discussed further in the Federal Register document of 
December 27, 2022 (87 FR 79303) (FRL-9948-02-OCSPP), announcing the 
availability of the Final Revised Unreasonable Risk Determination for 
Carbon Tetrachloride. In Unit III.B.4. and Unit V., EPA outlines the 
importance of considering the hierarchy of controls utilized by the 
industrial hygiene community (hereafter referred to as ``hierarchy of 
controls'') when developing risk management actions in general, and 
specifically when determining if and how regulated entities may meet a 
risk-based exposure limit for CTC.
    The hierarchy of controls includes: elimination of the hazard, 
substitution with a less hazardous substance, engineering controls, 
administrative controls such as training or exclusion zones with 
warning signs, and, finally, use of PPE (Ref. 8). Under the hierarchy 
of controls, the use of respirators and dermal PPE should only be 
considered after all other steps have been taken to reduce exposures. 
As discussed in Units IV.A. and V.A.1., EPA's risk management approach 
would not rely solely or primarily on the use of respirators and dermal 
PPE to address unreasonable risk to workers; instead, EPA is proposing 
a WCPP for most conditions of use and prohibitions for certain uses. 
The WCPP would require consideration of the hierarchy of controls 
before use of respirators and other PPE. The WCPP is discussed in full 
in Units IV.A.1. and V.A.1.
    In accordance with the approach described earlier in Unit II.C.3., 
EPA intends for this regulation to be as compatible as possible with 
the existing OSHA standards, with additional requirements as necessary 
to address the unreasonable risk. One notable difference between the 
WCPP and the OSHA standards are the exposure limits. This WCPP would 
include an Existing Chemical Exposure Limit (ECEL) of 0.03 ppm as an 8-
hour TWA to address unreasonable risk for cancer and chronic toxicity 
for non-cancer effects. EPA recognizes that for CTC, the ECEL would be 
significantly lower than the 1971 OSHA PEL (10 ppm as an 8-hour TWA). 
In addition to the distinctions in statutory requirements described in 
this unit, EPA has identified several factors contributing to the 
differences in these levels, summarized here.
    The TSCA ECEL value for CTC is a lower value than the OSHA PEL (and 
other existing occupational exposure limits (OELs), discussed in Unit 
II.C.5) for many reasons, including the age of the data and studies the 
values are based on and that the values may not fully capture either 
the complete database of studies considered in the 2020 Risk Evaluation 
for Carbon Tetrachloride or more recent advances in modeling and 
scientific interpretation of toxicological data applied in the 
calculation of the CTC ECEL, in particular CTC's carcinogenicity. EPA 
considers the CTC ECEL to represent the best available science under 
TSCA section 26(h), because it was derived from information in the 2020 
Risk Evaluation for Carbon Tetrachloride, which was subject to peer 
review, and was the result of a systematic review process that 
investigated the reasonably available information in order to identify 
relevant adverse health effects (Ref. 1). Additionally, by using the 
information from the 2020 Risk Evaluation for Carbon Tetrachloride, the 
ECEL incorporates advanced modeling and peer-reviewed methodologies, 
and accounts for exposures to potentially exposed and susceptible 
subpopulations, as required by TSCA. For example, the CTC ECEL is based 
on a study conducted in 2007, which was rated a high quality study 
during the systematic review process and was the principal study used 
to derive the IRIS reference concentration for liver effects

[[Page 49187]]

(Ref. 1). The data from the 2007 study used to derive the IRIS 
reference concentration for liver effects for the CTC ECEL is more 
recent than the data OSHA had available when OSHA set the PEL for CTC 
in 1971. OSHA attempted to reduce the CTC PEL in 1989 from 10 ppm to 2 
ppm after new data about CTC cancer risk became available, but, as 
explained later in this unit, the reduced CTC PEL was later vacated by 
court order.
    For CTC, the EPA ECEL is an 8-hour occupational inhalation exposure 
limit based on liver cancer and takes into consideration the 
uncertainties identified in the 2020 Risk Evaluation for Carbon 
Tetrachloride (Ref. 9). The ECEL represents the concentration at which 
an adult human, including a member of a potentially exposed or 
susceptible subpopulation, would be unlikely to suffer adverse effects 
if exposed for a working lifetime. EPA has determined as a matter of 
risk management policy that ensuring exposures remain at or below the 
ECEL will eliminate any unreasonable risk of injury to health driven by 
inhalation exposures. In addition to the ECEL, as part of this 
rulemaking EPA is proposing an ECEL action level, a value based on two-
thirds of the ECEL, that would trigger additional monitoring to ensure 
that workers are not exposed to concentrations above the ECEL.
    For CTC, the ECEL of 0.03 ppm is based on the most sensitive point 
of departure (POD) across cancer, chronic non-cancer, and acute 
endpoints. EPA identified cancer PODs for inhalation exposures based on 
liver tumor effects observed in mice. The chronic PODs for inhalation 
exposures are based on a study observing increased fatty changes in 
rodent livers. As explained in the ECEL memo, the point of departure 
for liver cancer was the basis of the CTC ECEL. Additional information 
on the ECEL and how it was derived can be found in Unit IV.A.1.b.i. 
Overall, based on strong evidence in highly rated animal studies, the 
weight of the scientific evidence supported liver cancer effects 
following CTC exposure (Ref. 1). Monitoring data submitted via public 
comment by a trade association during the 2020 Risk Evaluation for 
Carbon Tetrachloride indicating exposures near or below the ECEL 
supports EPA's confidence that meeting the ECEL is feasible for 
facilities engaging in the use of CTC (Ref. 10).
    The OSHA PEL for CTC of 10 ppm as an 8-hour TWA was established in 
1971 (29 CFR 1910.1000 Table Z-2). OSHA is required to promulgate a 
standard that reduces significant risk to the extent that it is 
technologically and economically feasible to do so (Ref. 7). A 1989 
update to 2 ppm based on a quantitative cancer risk assessment--a level 
at which ``residual risk continues to be significant,'' according to 
OSHA's 1989 final rule preamble--was later vacated by court order, 
reverting to the original PEL of 10 ppm, because the court found OSHA 
had not made sufficiently detailed findings that the new PEL would 
eliminate significant risk and would be feasible in each industry in 
which the chemical was used (see 54 FR 2332, 2679 through2681 ; AFL-CIO 
v. OSHA, 965 F.2d 962 (11th Cir. 1992)). Most original PELs were based 
on acute health effects only observable at higher concentrations as 
more sensitive chronic studies, including the chronic exposure studies 
used to inform the CTC ECEL, were not available at the time the PEL was 
established (see, e.g., 79 FR 61383, 61388). As discussed in Units 
IV.A.1.b.i. and VII.D., the TSCA ECEL represents the best available 
science at the time of publication of the 2020 Risk Evaluation for CTC. 
As described earlier, in a 2014 request for information OSHA described 
how, while new developments in science and technology from the time the 
PEL for CTC was established in 1971 may improve the scientific basis 
for making findings of significant risk, technical feasibility, or 
economic feasibility as required under section 6(b)(5) of the OSH Act, 
OSHA has been unable to update the PEL for CTC and it remains at the 
level that was originally adopted in 1971 (79 FR 61383, October 10, 
2014).
5. Carbon Tetrachloride and Other Occupational Exposure Limits
    EPA is aware of other occupational exposure recommendations or 
limits for CTC, including the ACGIH TLV, the California Division of 
Occupational Safety and Health (Cal/OSHA) PEL, and the National 
Institute for Occupational Safety and Health (NIOSH) Recommended 
Exposure Limit (REL).
a. ACGIH TLV
    The 1996 ACGIH TLV is 5 ppm (Ref. 11). This 8-hour TWA TLV 
recommended by the ACGIH in 1996 has a different endpoint than the CTC 
ECEL and instead of being based on the 2007 study indicating a liver 
cancer endpoint is based on broad liver toxicity that was observed in 
several earlier studies in rodents, primates, and humans exposed to CTC 
concentrations of 10 ppm and above. Additionally, a PBPK model used by 
ACGIH to develop a Short-Term Exposure Limit (STEL) TLV indicated that 
acute exposure at 10 ppm results in equivalent liver metabolism as a 
chronic occupational exposure at 5 ppm, which results in a much lower 
liver concentration than the level that caused toxicity in rats. 
Therefore, ACGIH recommended an 8-hour TWA TLV of 5 ppm as long as the 
15-minute STEL did not exceed 10 ppm. However, even ACGIH's TLV report 
acknowledges that the 5 ppm value is not protective of susceptible 
subpopulations, and there were no uncertainty factors assigned to 
account for inter- or intra-species variability (Ref. 11). 
Additionally, while ACGIH designated CTC as a suspected human 
carcinogen in 2001 based on a threshold mode of action, it did not 
update its 1996 TLV to derive
    a TLV based on cancer.
    b. NIOSH REL.
    The 1975 NIOSH REL for CTC is 2 ppm was originally based on 
systemic effects and local effects on the skin and eyes. The 1975 NIOSH 
REL for CTC was a 10-hour TWA in a 40-hour work week (Ref. 12). In 
1989, as part of a joint project with OSHA, NIOSH changed the 10-hour 
TWA to a 60-minute STEL and added the Ca designation (potential 
occupational carcinogen). In general, RELs that are set as STELs or 
ceilings instead of 8- or 10-hour TWAs are typically based on concern 
for acute health effects, but in the case of CTC, NIOSH also recognized 
its carcinogenicity.
    c. Cal/OSHA PEL.
    Generally, Cal/OSHA updates its PELs every other year. The Cal/OSHA 
PEL is 2 ppm, lower than the 1971 OSHA PEL of 10 ppm, and equivalent to 
the NIOSH REL and the vacated 1989 OSHA PEL, which was based on a 
quantitative cancer risk assessment but was acknowledged by OSHA to 
leave significant residual risk. Despite the Cal/OSHA PEL being 
equivalent to the vacated 1989 OSHA PEL based on cancer, Cal/OSHA did 
not perform a quantitative cancer risk assessment, and the Cal/OSHA PEL 
cites the 1989 NIOSH 60-min STEL.
    D. Summary of EPA's Risk Evaluation Activities on Carbon 
Tetrachloride
    In December 2016, EPA selected CTC as one of the first 10 chemicals 
for risk evaluation under TSCA section 6. EPA published the Scope of 
the Risk Evaluation for Carbon Tetrachloride in July 2017 (82 FR 31592, 
July 7, 2017) (FRL-9963-57), and, after receiving public comments, 
published the problem formulation in June 2018 (83 FR 26998, June 11, 
2018) (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

[[Page 49188]]

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 Unreasonable Risk Determination for 
Carbon Tetrachloride in August 2022 (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 ID No. EPA-HQ-
OPPT-2019-0499, and the 2022 Revised Unreasonable Risk Determination 
for Carbon Tetrachloride and additional materials supporting the risk 
evaluation process in docket ID No. EPA-HQ-OPPT-2016-0733.
    1. 2020 Risk Evaluation.
    In the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1), 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. 
Descriptions of the conditions of use that drive unreasonable risk are 
in Unit III.B.1. The 2020 Risk Evaluation for Carbon Tetrachloride 
identified significant adverse health effects associated with short-
term and long-term exposure to CTC, specifically cancer and liver 
toxicity from chronic inhalation and dermal exposures. Additional risks 
associated with liver toxicity and central nervous system effects were 
identified for acute inhalation exposures. A further discussion of the 
unreasonable risk of CTC is in Unit III.B.3.
    2. 2022 Revised Unreasonable Risk Determination.
    EPA has been revisiting specific aspects of its first ten TSCA 
existing chemical risk evaluations, including the 2020 Risk Evaluation 
for Carbon Tetrachloride, to ensure that the risk evaluations upon 
which risk management decisions are made better align with TSCA's 
objective of protecting health and the environment. For CTC, EPA 
revised the original unreasonable risk determination based on the 2020 
Risk Evaluation for Carbon Tetrachloride and issued a final Revised 
Unreasonable Risk Determination for Carbon Tetrachloride 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 
Executive Order 13990, ``Protecting Public Health and the Environment 
and Restoring Science to Tackle the Climate Crisis,'' and other 
Administration priorities (Ref. 3). The revisions consisted of making 
the risk determination for the whole chemical substance rather than for 
individual conditions of use (which resulted in the revised risk 
determination superseding the prior ``no unreasonable risk'' 
determinations and the withdrawal of the associated TSCA section 
6(i)(1) ``no unreasonable risk'' order); and clarifying that the risk 
determination does not reflect an assumption that all workers are 
always provided and appropriately wear PPE (Ref. 3).
    In determining whether CTC presents unreasonable risk under the 
conditions of use, EPA considered relevant risk-related factors, 
including, but not limited to: the effects of the chemical substance on 
health (including cancer and non-cancer risks) and human exposure to 
the substance under the conditions of use (including duration, 
magnitude and frequency of exposure); the effects of the chemical 
substance on the environment and environmental exposure under the 
conditions of use; the population exposed (including any potentially 
exposed or susceptible subpopulations); the severity of hazard 
(including the nature of the hazard, the irreversibility of the 
hazard); and uncertainties, including the strengths, and limitations 
associated with the information used to calculate the risk estimates.
    EPA determined that CTC presents an unreasonable risk of injury to 
health. This unreasonable risk determination is driven by risks to 
workers and ONUs (workers who do not directly handle the chemical but 
perform work in an area where the chemical is present). EPA did not 
identify risks of injury to the environment that drive the unreasonable 
risk determination for CTC (Ref. 1). The CTC conditions of use that 
drive EPA's determination that the chemical substance poses 
unreasonable risk to health are listed in the unreasonable risk 
determination (Ref. 3) and in Unit III.B.1., with descriptions to aid 
chemical manufacturers, processors, and users in determining how their 
particular use or activity would be impacted by the proposed regulatory 
provisions. 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. EPA's 
proposed regulatory action and primary alternative regulatory action 
include prohibitions on the distribution in commerce of CTC for certain 
downstream uses, but do not include any restrictions for the processing 
as a reactant/intermediate in reactive ion etching.
    3. Fenceline Screening Analysis.
    The 2020 Risk Evaluation for Carbon Tetrachloride excluded the 
assessment of certain exposure pathways that were or could be regulated 
under another EPA-administered statute (see Section 1.4.3 of the 2020 
Risk Evaluation for Carbon Tetrachloride) (Refs. 1 and 3). This 
resulted in the surface water, drinking water, and ambient air pathways 
for CTC exposure not being assessed for human health risk to the 
general population. In June 2021, EPA made a policy announcement on the 
path forward for TSCA chemical risk evaluations, indicating that EPA 
would, among other things, examine whether the exclusion of certain 
exposure pathways from the risk evaluations could lead to a failure to 
identify and protect fenceline communities (Ref. 13). EPA then 
conducted a screening analysis to identify where there may be potential 
risks to people living near the fenceline of facilities releasing CTC.
    In order to assess the potential risk to the general population in 
proximity to a facility releasing CTC, EPA developed the TSCA Screening 
Level Approach for Assessing Ambient Air and Water Exposures to 
Fenceline Communities Version 1.0, which was presented to the SACC in 
March 2022, with a report issued by the SACC on May 18, 2022 (Ref. 14). 
This analysis and a follow up screening level analysis to consider SACC 
feedback are discussed in Unit VI.A.

III. Regulatory Approach

A. Background

    Under TSCA section 6(a), if the Administrator determines through a 
TSCA section 6(b) risk evaluation that the manufacture (including 
import), processing, distribution in commerce, use, or disposal of a 
chemical substance or mixture, or any combination of such activities, 
presents an unreasonable risk of injury to health or the environment, 
EPA must by rule apply one or more of the following requirements to the 
extent necessary so that the chemical substance or mixture no longer 
presents such risk.
     Prohibit or otherwise restrict the manufacturing, 
processing, or distribution in commerce of the substance or mixture, or 
limit the amount of such substance or mixture which may be 
manufactured, processed,

[[Page 49189]]

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)).
    As described in Unit III.B.4, EPA assessed how the TSCA section 
6(a) requirements could be applied to address the unreasonable risk 
identified in the 2020 Risk Evaluation for Carbon Tetrachloride and the 
final revised unreasonable risk determination, so that CTC no longer 
presents such unreasonable risk. EPA's proposed regulatory action and a 
primary alternative regulatory action are described in Unit IV. EPA is 
requesting public comment on all elements of the proposed regulatory 
action and the primary alternative regulatory action and is providing 
notice that based on consideration of comments and any new information 
submitted to EPA during the comment period on this proposed rule, EPA 
may in the final rule modify elements of the proposed regulatory 
action. The public should understand that the Agency's consideration of 
public comments could result in changes to elements of the proposed and 
alternative regulatory actions when this rule is finalized. For 
example, elements such as timelines for implementation could be 
lengthened or shortened, ECELs could be modified, or the WCPP could 
have conditions added or eliminated.
    Under the authority of TSCA section 6(g), EPA may consider granting 
a time-limited exemption from a requirement of a TSCA section 6(a) rule 
for a specific condition of use if EPA finds that: (1) The specific 
condition of use is a critical or essential use for which no 
technically and economically feasible, safer alternative is available, 
taking into consideration hazard and exposure; (2) compliance with the 
requirement, as applied with respect to the specific condition of use, 
would significantly disrupt the national economy, national security, or 
critical infrastructure; or (3) the specific condition of use of the 
chemical substance, as compared to reasonably available alternatives, 
provides a substantial benefit to health, the environment, or public 
safety. Based on reasonably available information, EPA has analyzed the 
need for an exemption and is not proposing to grant an exemption from 
the rule requirements at this time. EPA is requesting public comment 
regarding the need for exemptions from the rule (and under what 
specific circumstances) pursuant to the provisions of TSCA section 
6(g). Based on information submitted to EPA during the comment period 
on this proposed rule, EPA may issue a supplemental notice proposing an 
exemption under TSCA section 6(g). EPA is also requesting comment on, 
in lieu of proposing a 6(g) exemption in a separate regulatory action, 
whether any elements of the primary alternative regulatory action 
should be considered in combination with elements of the proposed 
regulatory action as EPA develops the final regulatory action.
    TSCA section 6(c)(2)(C) requires that, in deciding whether to 
prohibit or restrict in a manner that substantially prevents a specific 
condition of use and in setting an appropriate transition period for 
such action, EPA consider, to the extent practicable, whether 
technically and economically feasible alternatives that benefit health 
or the environment will be reasonably available as a substitute when 
the proposed prohibition or restriction takes effect. Unit V.B. 
includes more information regarding EPA's consideration of 
alternatives, and Unit VI. provides more information on EPA's 
considerations more broadly under TSCA section 6(c)(2).
    EPA carried out required consultations as described in this unit 
and also considered impacts on children's environmental health as part 
of its approach to developing this TSCA section 6 regulatory action.
    1. Consultations.
    EPA conducted consultations and outreach as part of development of 
this proposed regulatory action. The Agency held a federalism 
consultation from December 17, 2020, until February 17, 2021, as part 
of this rulemaking process and pursuant to Executive Order 13132 (see 
description in Unit X.E.). During the consultation, EPA met with State 
and local officials early in the process of developing the proposed 
action in order to receive meaningful and timely input into its 
development (Ref. 15). During the consultation, participants and EPA 
discussed preemption, EPA's authority under TSCA section 6 to regulate 
identified unreasonable risk, and what activities would be potentially 
regulated in the proposed rule, and the relationship between TSCA and 
existing statutes (Ref. 15). EPA received no written comments as part 
of this consultation.
    CTC is not manufactured (including imported), processed, 
distributed in commerce, or regulated by Tribal governments. However, 
EPA consulted with Tribal officials during the development of this 
proposed action (Ref. 16). 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 risk managers concerning the 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 that would be helpful to 
inform risk management, principles for transparency during the risk 
management process, and types of information EPA is seeking from Tribes 
(Ref. 16). EPA received no written comments as part of this 
consultation.
    In addition to the formal consultations, EPA also conducted 
outreach to advocates for communities that might be subject to 
disproportionate exposure to CTC, such as minority populations, low-
income populations, and indigenous peoples. EPA's Environmental Justice 
(EJ) consultation occurred from February 2, 2021, through April 2, 2021 
(Ref. 17). 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 Orders

[[Page 49190]]

12898 and 14008. EPA received one written comment following the EJ 
meeting, in addition to oral comments provided during the consultation 
(Ref. 17). 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.
    Units X.C., X.E., X.F. and X.J. provide more information regarding 
the consultations.
    2. Other stakeholder consultations.
    In addition to the formal consultations described in Unit X., EPA 
attended a Small Business Administration (SBA) Roundtable on December 
4, 2020, and held a public webinar on December 10, 2020. At both events 
EPA staff provided an overview of the TSCA risk management process and 
the findings in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 
1). Attendees of these meetings were given an opportunity to voice 
their concerns on both the risk evaluation and risk management.
    Furthermore, EPA has engaged in discussions with representatives 
from different industries, non-governmental organizations, technical 
experts, and users of CTC. A list of external meetings held during the 
development of this proposed rule is in the docket (Ref. 18); meeting 
materials and summaries are also in the docket. The purpose of these 
discussions was to hear from users, academics, manufacturers, and 
members of the public health community about practices related to 
industrial and commercial uses of CTC; public health impacts of CTC; 
the importance of CTC in the various uses subject to this proposed 
rule; frequently used substitute chemicals or alternative methods; 
engineering control measures and personal protective equipment 
currently in use or feasibly adoptable; and other risk-reduction 
approaches that may have already been adopted or considered for 
industrial or commercial uses.
    3. Children's environmental health.
    The Agency's 2021 Policy on Children's Health (Ref. 19) 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.'' Infants, children, and 
pregnant women are listed as examples of subpopulations that may be 
considered relevant ``potentially exposed or susceptible 
subpopulations'' in the TSCA section 3(12) definition of that term. 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 (including unreasonable risk to PESS).
    The 2020 Risk Evaluation for Carbon Tetrachloride considered 
impacts on workers ages 17 and older from occupational use from 
inhalation and dermal exposures, as applicable. The risk evaluation 
considered males (>16 years of age) and females of reproductive age 
(>16 years of age) for both dermal and inhalation exposures. While 
risks to children (workers 17 through 20 years of age) are not 
disproportionate, effects observed in studies include cancer and liver 
toxicity from chronic inhalation and dermal exposures and central 
nervous system impairment from acute inhalation exposure. The risks 
identified would be addressed by both the proposed regulatory action 
and primary alternative action described in Unit IV.

B. Regulatory Assessment of Carbon Tetrachloride

    1. Description of conditions of use that drive the unreasonable 
risk.
    This unit describes the TSCA conditions of use that drive EPA's 
unreasonable risk determination for the chemical substance CTC. 
Condition of use descriptions were obtained from EPA sources such as 
the 2020 Risk Evaluation for Carbon Tetrachloride and related 
documents, and include clarifications based on the CDR use codes, as 
well as the Organisation for Economic Co-operation and Development 
(OECD) harmonized use codes and feedback from stakeholders regarding 
how they describe their uses. For additional description of the 
conditions of use, including process descriptions and worker activities 
considered in the risk evaluation, see the Problem Formulation of the 
2020 Risk Evaluation for Carbon Tetrachloride, the 2020 Risk Evaluation 
for Carbon Tetrachloride, and supplemental files (Refs. 1 and 20). EPA 
acknowledges that some of the terms used in this unit may also be 
defined under other statutes; however, the descriptions in this unit 
are intended to provide clarity to the regulated entities subject to 
the provisions of this rule under TSCA section 6(a).
    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 proposed rule, this condition of 
use does not include CTC generated as a byproduct, which was not 
evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 
1). As explained in Section 1.4.2.3 of the 2020 Risk Evaluation for 
Carbon Tetrachloride, EPA anticipates that any risks presented by the 
presence of CTC generated as byproduct during the manufacture of 1,2-
dichloroethane is being assessed in the risk evaluation for 1,2-
dichloroethane (Ref. 21).
    ii. Import.
    Import 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 
hydrochlorofluorocarbon, hydrofluorocarbon, hydrofluoroolefin, and 
perchloroethylene.
    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.
    ii. Processing: Incorporation into formulation, mixtures, or 
reaction products (petrochemicals-derived manufacturing; agricultural 
products manufacturing; other basic organic and inorganic chemical 
manufacturing).

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    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 is 
incorporated into 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, 
including agricultural chemicals, petrochemicals-derived products, and 
any other basic organic and inorganic chemical manufacturing.
    iii. Processing: Repackaging for use as a laboratory chemical.
    Repackaging means 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. Certain spent chemicals, such as CTC, can be restored to a 
condition that permits reuse via reclamation/recycling. The 
reclamation/recycling process involves an initial vapor recovery (e.g., 
condensation, adsorption, and absorption) or mechanical separation step 
(e.g., decanting, filtering, draining, settling and centrifuging) 
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 petrochemical-derived products and agricultural 
products.
    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 petrochemical-derived products. The condition of use 
includes the use of CTC as a process agent in the manufacture of 
chlorosulphonated polyolefin; the use of CTC in the manufacture of 
stryene butadiene rubber; the use of CTC in the manufacture of 
endosulfan (insecticide); the use of CTC in the manufacture of 1-1 Bis 
(4-chlorophenyl) 2,2,2-trichloroethanol (dicofol insecticide); and the 
use of CTC in the production of tralomethrin (insecticide) (Ref. 1).
    ii. Industrial and commercial use in the manufacture of other basic 
chemicals (including chlorinated compounds used in solvents, adhesives, 
asphalt, paints and coatings, and elimination of nitrogen trichloride 
in the production of chlorine and caustic soda).
    In addition to the other industrial and commercial uses for CTC 
outlined in this unit, CTC is used as a processing aid/agent in basic 
organic and inorganic chemical manufacturing. CTC may 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.
    iii. Industrial and commercial use in metal recovery.
    CTC is 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 is 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.
    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.
    vi. Industrial and commercial use as a laboratory chemical.
    For laboratory uses, CTC is typically received in small containers 
and used in small quantities on a laboratory bench in a fume cupboard 
or hood. After use, waste CTC is collected and disposed or recycled.
    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.
    d. Disposal.
    This condition of use refers to the process of disposing generated 
wasted streams from each of the conditions of use of CTC, that are 
collected and transported to third-party sites, such as waste 
incineration sites, for disposal.
    e. Terminology in this proposed rule.
    For the purposes of this proposed rulemaking, ``occupational 
conditions of use'' refers to the TSCA conditions of use described in 
Units III.B.1.a. through d. Although EPA identified both industrial and 
commercial uses in the 2020 Risk Evaluation for Carbon Tetrachloride 
for purposes of distinguishing exposure scenarios, the Agency clarified 
then and clarifies now that EPA interprets the authority over ``any 
manner or method of commercial use'' under TSCA section 6(a)(5) to 
reach both. In the 2020 Risk Evaluation for Carbon Tetrachloride, EPA 
identified and assessed all known, intended, and reasonably foreseen 
uses of CTC.
    EPA is not proposing to incorporate the descriptions of known, 
intended or reasonably foreseen conditions of uses

[[Page 49192]]

of CTC presented in Unit III.B.1.a. through d. into the regulatory text 
as definitions because these conditions of use represent those 
evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride. EPA 
requests comment on whether EPA should promulgate definitions for those 
conditions of use evaluated in the 2020 Risk Evaluation for Carbon 
Tetrachloride, and, if so, whether the descriptions in this unit are 
consistent with the conditions of use evaluated in the 2020 Risk 
Evaluation for Carbon Tetrachloride and whether they provide a 
sufficient level of detail to improve the clarity and readability of 
the regulation if EPA were to promulgate a regulation that contains a 
list of all prohibited or otherwise regulated industrial and commercial 
conditions of use.
    EPA further notes that this proposed 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 (FFDCA), when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic or device. EPA did not identify any use 
of CTC that falls under the authority of the Federal Insecticide, 
Fungicide, and Rodenticide Act or the Federal Food, Drug, and Cosmetic 
Act (FFDCA).
    2. Description of conditions of use that do not drive the 
unreasonable risk.
    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 determination: distribution in commerce; 
and processing as a reactant/intermediate in reactive ion etching, 
which is a microfabrication technique used in miniature electronic 
component manufacturing that involves using ion bombardment and 
reactive gas, such as small quantities of CTC, to selectively etch 
wafers.
    As outlined in Unit II.D.2., 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 and other 
Administration priorities (Ref. 3). The 2022 Revised Risk Determination 
for Carbon Tetrachloride is based on the whole chemical substance 
instead of individual conditions of use. Consistent with the statutory 
requirements of TSCA section 6(a), EPA is proposing risk management 
regulatory action to the extent necessary so that CTC no longer 
presents an unreasonable risk. EPA's proposed risk management action 
focuses primarily on the conditions of use that drive the unreasonable 
risk (described in Unit III.B.1). However, it should be noted that, 
under TSCA section 6(a), EPA is not limited to regulating the specific 
activities found to drive unreasonable risk and may select from among a 
suite of risk management requirements in TSCA section 6(a) related to 
manufacture (including import), processing, distribution in commerce, 
commercial use, and disposal as part of its regulatory options to 
address the unreasonable risk. EPA's proposed regulatory action and 
primary alternative regulatory action, described in Unit IV.A and Unit 
IV.B., include prohibitions on the distribution in commerce of CTC for 
certain downstream conditions of use, but do not include any 
restrictions for the processing of CTC as a reactant/intermediate in 
reactive ion etching.
    3. Description of unreasonable risk under the conditions of use.
    EPA has determined that CTC presents an unreasonable risk of injury 
to human health under the conditions of use based on cancer and acute 
and chronic toxicity for non-cancer effects. As described in the 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, and 3). Cancer adverse effects 
(e.g., liver, pheochromocytoma, neuroblastoma) were identified for 
chronic inhalation and dermal exposures. In the 2020 Risk Evaluation 
for Carbon Tetrachloride, EPA presented two approaches for the 
assessment of carcinogenic risk from CTC: a linear extrapolation 
approach for adrenal gland and brain tumors in conjunction with a 
threshold approach for assessing risks for liver tumors. The approaches 
are based on conclusions on the mode of action for the different cancer 
tumors evaluated. The threshold approach used for the risk calculations 
for the POD for liver cancer were recommended during the peer review by 
the Science Advisory Committee on Chemicals (SACC). For chronic and 
acute non-cancer inhalation exposure scenarios 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. However, 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 (Ref. 1). By targeting liver cancer for 
risk management, EPA's action will also eliminate the acute, chronic 
non-cancer, and additional cancer risks from CTC (Ref. 9). Unit VI.A. 
summarizes the health effects and the magnitude of the exposures.
    To make the unreasonable risk determination for CTC, EPA evaluated 
exposures to human receptors including workers and occupational non-
users (ONUs) using reasonably available monitoring and modeling data 
for inhalation and dermal exposures. EPA did not evaluate risks to 
consumers or bystanders to consumer use because the CPSC banned the use 
of CTC in consumer products (excluding unavoidable residues not 
exceeding 10 ppm atmospheric concentration) in 1970. After the 2020 
Risk Evaluation for Carbon Tetrachloride was completed, EPA conducted a 
screening level analysis to assess potential risks from the air and 
water pathways to fenceline communities. A discussion of EPA's analysis 
and the expected effects of this rulemaking on fenceline communities is 
in Unit VI.A.
    For the 2020 Risk Evaluation for Carbon Tetrachloride, EPA 
considered PESS and identified groups of individuals with greater 
exposure to CTC relative to the general population, including: (1) 
workers of either gender (>16 years old), including pregnant women, and 
(2) individual workers who do not use CTC but may be indirectly exposed 
due to their proximity to the user who is directly handling CTC (ONUs) 
(Ref. 1). All PESS are included in the quantitative and qualitative 
analyses described in the 2020 Risk Evaluation for Carbon Tetrachloride 
and were considered in the determination of unreasonable risk for CTC. 
As discussed in Unit II.D and Unit VI.A., the 2020 Risk Evaluation for 
Carbon Tetrachloride excluded the air and water exposure pathways to 
the general population from the published risk evaluation and may have 
caused some risks to be unaccounted for in the risk evaluation. EPA 
considers people in the vicinity of facilities releasing CTC and 
exposed to CTC through ambient air and

[[Page 49193]]

drinking or surface water pathways to constitute a subset of the 
general population and categorizes them as fenceline communities; they 
may also be considered PESS. See Unit VI.A. for further discussion on 
assessing risk to fenceline communities.
    4. Description of TSCA section 6 requirements for risk management.
    EPA considered the TSCA section 6(a) requirements (listed in Unit 
III.A.) to identify which ones have the potential to eliminate the 
unreasonable risk for CTC.
    As required under TSCA, EPA developed a proposed regulatory action 
and one primary alternative regulatory action, which are described in 
Units IV.A. and IV.B., respectively. 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 (see Unit III.B.1.), 
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 identified unreasonable risk, when selecting 
among possible TSCA section 6(a) requirements. To the extent 
practicable, EPA factored into its decisions: (i) The effects of CTC on 
health and the magnitude of exposure of human beings to CTC, (ii) the 
effects of CTC on the environment and the magnitude of exposure of the 
environment to CTC, (iii) the benefits of CTC for various uses, and 
(iv) the reasonably ascertainable economic consequences of the rule. In 
evaluating the reasonably ascertainable economic consequences of the 
rule, EPA considered: (i) The likely effect of the rule on the national 
economy, small business, technological innovation, the environment, and 
public health, (ii) the costs and benefits of the proposed regulatory 
action and of the primary alternative regulatory action considered, and 
(iii) the cost effectiveness of the proposed regulatory action and of 
the primary alternative regulatory action considered. See Unit VI. for 
further discussion related to TSCA section 6(c)(2)(A) considerations, 
including the statement of effects of the proposed rule with respect to 
these considerations.
    EPA also considered the regulatory authorities under statutes 
administered by other agencies such as OSHA's implementation of the OSH 
Act, as well as other EPA-administered statutes to examine: (1) whether 
there are opportunities for all or part of this risk management action 
to be addressed under other statutes, such that a referral may be 
warranted under TSCA sections 9(a) or 9(b); or (2) whether TSCA section 
6(a) regulation could include alignment of requirements and definitions 
in and under existing statutes and regulations to minimize confusion to 
the regulated entities and the general public.
    In addition, EPA followed other TSCA requirements such as 
considering the availability of alternatives when contemplating a 
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as 
outlined in Unit V.B.), and setting proposed compliance dates in 
accordance with the requirements in TSCA section 6(d)(1)(B) (described 
in the proposed and alternative regulatory action in Units IV.A and 
IV.B.).
    To the extent information was reasonably available, EPA considered 
pollution prevention strategies and the hierarchy of controls adopted 
by OSHA and NIOSH when selecting regulatory actions, with the goal of 
identifying risk management control methods that are permanent, 
feasible, and effective. EPA also considered how to address the 
unreasonable risk while providing flexibility to the regulated entity, 
where appropriate, and took into account the information presented in 
the 2020 Risk Evaluation for Carbon Tetrachloride, as well as 
additional input from stakeholders (as described in Unit III.A.) and 
anticipated compliance strategies from regulated entities.
    Taken together, these considerations led EPA to the proposed 
regulatory action and primary alternative regulatory action described 
in Unit IV. Additional details related to how the requirements in this 
unit were incorporated into development of those actions are in Unit V.

IV. Proposed Regulatory and Alternative Regulatory Actions

    This unit describes the proposed regulatory action by EPA so that 
CTC will no longer present an unreasonable risk of injury to health. In 
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider 
the costs and benefits and the cost-effectiveness of the proposed 
regulatory action and one or more primary alternative regulatory 
actions. In the case of CTC, the proposed regulatory action is 
described in Unit IV.A. and the primary alternative regulatory action 
considered is described in Unit IV.B. This unit also describes the 
proposed compliance timeframes. The rationale for the proposed and 
alternative regulatory actions and associated compliance timeframes are 
discussed in this unit and in more detail in Unit V.A.

A. Proposed Regulatory Action

    EPA is proposing under TSCA section 6(a) to: (1) Require a WCPP, 
including an ECEL and DDCC requirements, for the manufacturing 
(including import) of CTC and for other conditions of use (accounting 
for essentially all of the production volume of CTC manufactured 
annually) that occur in industrial settings or in tightly controlled, 
closed systems, where monitoring data submitted for the 2020 Risk 
Evaluation for Carbon Tetrachloride indicate values below the ECEL, or 
where technically and economically feasible safer alternatives may not 
be reasonably available, or where industry has indicated a reliance on 
CTC and EPA has found that an ECEL and DDCC requirements would address 
the unreasonable risk; (2) Require prescriptive controls for one 
condition of use, industrial and commercial use as a laboratory 
chemical, where codifying existing practices of use of a fume hood for 
all laboratory uses (and for DoD's use of CTC as a laboratory chemical 
codifying advanced engineering controls) and requiring dermal PPE would 
address the unreasonable risk; and (3) Prohibit certain processing, 
industrial, and commercial conditions of use and the manufacture, 
processing, and distribution for those uses, which the Agency 
understands have already been phased out. EPA is also proposing to 
require recordkeeping and to require manufacturers (including 
importers), processors, and distributors of CTC for any use to provide 
downstream notification of regulatory requirements. As the manufacture 
and processing of CTC presents an unreasonable risk to health in the 
United States, the manufacture and processing of CTC for export would 
also be prohibited or restricted in accordance with TSCA section 
12(a)(2).
    1. Workplace Chemical Protection Program (WCPP) for certain 
manufacturing, processing, industrial and commercial uses, and 
disposal.
    a. Overview.
    As described in Unit III.B.4, under TSCA section 6(a), EPA is 
required to issue a regulation applying one or more of the TSCA section 
6(a) requirements to the extent necessary so that the unreasonable risk 
of injury to human health or the environment from a chemical substance 
is no longer present. The TSCA section 6(a) requirements provide EPA 
the authority to limit or prohibit a number of activities, including, 
but not limited to, restricting

[[Page 49194]]

or regulating the manufacture, processing, distribution in commerce, 
commercial use, or disposal of the chemical substance. Given this 
statutory authority, EPA may find it appropriate in certain 
circumstances to propose a WCPP for certain occupational conditions of 
use (i.e., manufacturing, processing, distribution in commerce, 
industrial and commercial use, or disposal). This unit describes the 
proposed WCPP, which consists of an ECEL and DDCC requirements, and 
ancillary provisions necessary for successful implementation such as 
periodic monitoring, consideration of the hierarchy of controls, an 
exposure control plan, and respirators and dermal PPE programs (if 
applicable). Under a WCPP, owners or operators would have some 
flexibility, 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 limits 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 uses the term ``potentially exposed person'' in this unit 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 would apply. EPA's intention is 
to require a comprehensive WCPP that would address the unreasonable 
risk from CTC to potentially exposed persons directly handling the 
chemical or in the work area where the chemical is being used. 
Similarly, the 2020 Risk Evaluation for Carbon Tetrachloride 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 
in any workplace where an applicable condition of use described in 
Units III.B.1.a. through d. and subject to the WCPP is occurring. The 
term includes any person who owns, leases, operates, controls, or 
supervises such a workplace.
    EPA is proposing a WCPP for manufacturing (including import) of CTC 
and the following other conditions of use which account for essentially 
all of the production volume of CTC manufactured annually:
     Processing as a reactant in the production of HCFCs, HFCs, 
HFOs, and PCE;
     Processing: Incorporation into a formulation, mixture or 
reaction product in agricultural products manufacturing and other basic 
organic and inorganic chemical manufacturing;
     Processing: Repackaging for use as a laboratory chemical;
     Processing: Recycling;
     Industrial and commercial use as an industrial processing 
aid in the manufacture of agricultural products;
     Industrial and commercial use in the elimination of 
nitrogen trichloride in the production of chlorine and caustic soda; 
and
     Disposal.
    EPA recognizes that CTC may be a minor input in the production of 
HCFCs, HFCs, and PCE. EPA understands that CTC may still be used to 
manufacture HCFCs and HFCs, including HFC-245fa, HFC-365mfc, and HFC-
236fa; however, more recently industry has expressed particular 
reliance on CTC for the manufacture of HFOs. In addition, CTC may be a 
minor input when recycled to make additional PCE. Therefore, EPA is 
soliciting comments on the expected need for a WCPP with an ECEL and 
DDCC requirements for these uses, whether prescriptive controls, 
including respirators and dermal PPE, should be required for these uses 
(as outlined in Unit IV.B.1. in the primary alternative regulatory 
action), or whether the Agency should instead consider prohibiting 
these uses because they will likely phase out, including timing for 
such expected phaseout.
    EPA is proposing to exclude from WCPP requirements for 
manufacturers those workplaces that manufacture CTC solely as a 
byproduct. Section 1.4.2.3 of the 2020 Risk Evaluation for Carbon 
Tetrachloride stated that EPA excluded from the scope of the risk 
evaluation conditions of use associated with CTC generated as a 
byproduct (Ref. 1). In addition, EPA is assessing the manufacture of 
CTC as a byproduct during the manufacture of 1,2-dichloroethane in the 
risk evaluation for 1,2-dichloroethane (Ref. 21).
    b. Workplace Chemical Protection Program (WCPP) requirements.
    i. Existing Chemical Exposure Limit (ECEL) and ECEL Action Level.
    To reduce exposures in the workplace and address the unreasonable 
risk of injury to health resulting from inhalation exposures to CTC 
identified under the conditions of use in the TSCA Risk Evaluation, EPA 
is proposing an ECEL of 0.03 parts per million (ppm) (0.2 mg/m\3\) for 
inhalation exposures to CTC as an 8-hour time-weighted average (TWA) 
and, based on industrial hygiene practices, owners and operators may 
implement various controls to consider different lengths of exposure at 
the workplace. This ECEL is based on the POD for liver 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. 9). EPA has determined, 
as a matter of risk management policy, that ensuring exposures remain 
at or below the ECEL would eliminate the contribution to the 
unreasonable risk of injury to health for CTC resulting from inhalation 
exposures in an occupational setting. If ambient exposures are kept at 
or below the 8-hour TWA ECEL of 0.03 ppm, EPA expects that a 
potentially exposed person in the workplace would also be protected 
against all non-cancer effects resulting from occupational inhalation 
exposures, as well as excess risk of cancer (Ref. 9).
    EPA is also proposing to establish an ECEL action level of 0.02 ppm 
as an 8-hour TWA for CTC. Air concentrations at or above the action 
level would trigger more frequent periodic monitoring of exposures to 
CTC, as described in this unit. EPA is proposing to adopt the action 
level approach in implementing the TSCA ECEL, similar to the action 
level approach utilized by OSHA in most of their standards. As 
explained by OSHA, due to the variable nature of employee exposures, 
compliance with an action level (which OSHA generally establishes at 
half the 8-hour TWA exposure limit) provides employers with greater 
assurance that their employees will not be exposed to concentrations 
above the PELs (62 FR 1494, January 10, 1997). EPA agrees with this 
reasoning and, like OSHA, expects the inclusion of an ECEL action level 
at a value below the ECEL will stimulate innovation within industry to 
reduce exposures to levels below the action level. In this case EPA is 
proposing an action level for CTC of 0.02 ppm which is two-thirds of 
the ECEL rather than 0.015 ppm (the value that represents half the 
ECEL). Because EPA's understanding of current industry practices is 
that it may be more feasible for owners or operators to measure 
concentrations with values closer to the ECEL, such as within 10% of 
the ECEL, EPA is soliciting comment regarding an ECEL action level that 
is two-thirds the ECEL, including considerations for a different ECEL 
action level value, and any associated or alternative provisions

[[Page 49195]]

related to the ECEL action level since the ECEL is significantly lower 
than the OSHA PEL.
    EPA acknowledges that the values of the ECEL and the ECEL action 
level outlined in this unit may mean that some entities that are 
currently in compliance with OSHA requirements would have to do more in 
order to achieve compliance with the requirements being proposed in 
this action. It may be necessary to implement engineering controls to 
reduce exposures to the extent feasible, increase the frequency of 
periodic exposure monitoring (Unit IV.A.1.b.ii.), implement respiratory 
protection (Unit IV.A.1.e.i.), and provide notification of monitoring 
results (Unit IV.A.1.g.), and EPA is soliciting comment on these 
actions and the cost associated with them. Nevertheless, as discussed 
further in Unit V.A.1.c., based on monitoring data submitted by 
industry for the 2020 Risk Evaluation for Carbon Tetrachloride 
indicating industry was already achieving values below the ECEL, EPA 
has confidence that requirements to meet an ECEL can be implemented in 
highly standardized and industrialized settings, including those where 
CTC is manufactured, processed, and used (EPA-HQ-OPPT-2016-0733-0101).
    Each owner or operator of a workplace where these conditions of use 
occur would be responsible for compliance with the ECEL and the 
associated requirements. EPA's description for how the requirements 
related to an ECEL would address the unreasonable risk resulting from 
inhalation exposures and the rationale for this regulatory approach is 
outlined in Units III.B.3 and V.A. The proposed requirements of the 
WCPP ECEL are not applicable to owners and operators of workplaces 
where manufacturing and processing solely for the industrial and 
commercial conditions of use that EPA is proposing to prohibit occurs, 
as described Unit IV.A.3.
    In summary, EPA is proposing that each owner or operator of a 
workplace subject to the ECEL must ensure that no person is exposed to 
airborne concentration of CTC in excess of 0.03 ppm (0.2 mg/m\3\) as an 
8-hour TWA (ECEL), with an action level identified as 0.02 ppm (0.13 
mg/m\3\) as an 8-hour TWA (ECEL action level). For conditions of use 
for which the requirements to meet an ECEL are being proposed, EPA 
expects that the regulated community can measure CTC at the ECEL and 
ECEL action level because they are above the level of detection for air 
sampling analytical methods for CTC, which are as low as 4 micrograms 
per sample (Ref. 9). Nevertheless, EPA understands that the regulated 
community may have difficulty measuring at or below the ECEL 
consistently over an entire work shift (Ref. 22). Therefore, EPA is 
requesting 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. EPA is interested in 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.
    EPA expects that many workplaces already have stringent controls in 
place that reduce exposures to CTC; for some workplaces, EPA 
understands that these existing controls may already reduce CTC air 
concentration levels to levels near or below the ECEL. As noted 
previously in this unit, EPA expects that, if inhalation exposures for 
affected occupational conditions of use are kept at or below the ECEL, 
potentially exposed persons reasonably likely to be exposed in the 
workplace would be protected from unreasonable risk. EPA is also 
proposing to require owners or operators to comply with additional 
requirements under the WCPP that would be needed to ensure successful 
implementation of the ECEL.
    ii. Monitoring Requirements for the ECEL.
    (A) Overview.
    Monitoring requirements are a key component of implementing EPA's 
proposed ECEL. Initial exposure monitoring for CTC is critical for 
establishing a baseline of exposure for potentially exposed persons; 
similarly, periodic exposure monitoring ensures continued compliance so 
that potentially exposed persons in the workplace are not exposed to 
levels that would result in an unreasonable risk of injury. Periodic 
exposure monitoring frequency could change if certain conditions are 
met, which are described in this unit. Additionally, in some cases, a 
change in workplace conditions with the potential to impact exposure 
levels would warrant additional exposure monitoring, which is also 
described. This unit also describes the proposed monitoring records 
required.
    (B) Initial exposure monitoring.
    Under the proposed regulation, each owner or operator of a 
workplace where any condition of use listed earlier in this unit is 
occurring would be required to perform initial exposure monitoring for 
all persons who may be exposed to CTC to establish a baseline of the 
magnitude of exposure within 180 days after date of publication of the 
final rule in the Federal Register or within 30 days of the 
introduction of CTC into the workplace, whichever is later. Initial 
exposure monitoring would notify owner or operators of the magnitude of 
exposures to their potentially exposed persons with respect to their 
unique work conditions and environments. The results from the initial 
exposure monitoring would determine the frequency of future periodic 
exposure monitoring and whether additional exposure controls are 
necessary (such as engineering controls, administrative controls, and/
or respiratory protection), and whether the owner or operator would 
need to demarcate a regulated area as described in this unit.
    Where CTC is present in the workplace, each owner or operator would 
be required to determine each potentially exposed person's exposure by 
either taking a personal breathing zone air sample of each potentially 
exposed person or taking personal breathing zone air samples that are 
representative of each potentially exposed person's exposure performing 
the same or substantially similar operations in each work shift, in 
each job classification, in each work area (hereinafter identified as 
an ``exposure group''). Representative 8-hour TWA exposures must be 
determined based on one or more samples representing full-shift 
exposures for each shift for each person in each job classification in 
each work area. Monitoring samples must be taken when and where the 
operating conditions are best representative of each potentially 
exposed person's full-shift exposures. EPA expects that owners and 
operators would attempt to monitor exposures for all of the tasks 
during the same timeframe; however, EPA understands that certain tasks 
occur less frequently, and EPA is soliciting comments regarding the 
timing of the initial exposure monitoring so that it is representative 
of all tasks involving CTC where exposures may approach the ECEL. If 
the owner or operator chooses a representative sample, such sampling 
must include persons that are the closest to the source of CTC, so that 
the monitoring results are representative of the most highly exposed 
persons in the workplace. EPA is also soliciting comments regarding use 
of area source monitoring instead of

[[Page 49196]]

personal breathing zone as a representative sample of exposures.
    EPA also recognizes that some entities may already have exposure 
monitoring data. If the owner or operator has monitoring data conducted 
within five years prior to the effective date of the final rule and the 
monitoring satisfies all other proposed requirements, 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.
    (C) Periodic exposure monitoring.
    Based on the results of the initial exposure monitoring, EPA is 
proposing to require each owner or operator to conduct, for those 
exposure groups that result in the following airborne concentration 
levels, the following periodic monitoring:
     If all samples taken during the initial exposure 
monitoring reveal a concentration below the ECEL action level (0.02 ppm 
8-hr TWA), the owner or operator must repeat the periodic exposure 
monitoring at least once every five years.
     If the most recent exposure monitoring reveals a 
concentration above the ECEL (0.03 ppm 8-hr TWA), the owner or operator 
must repeat the periodic exposure monitoring at least every 3 months.
     If the most recent exposure monitoring reveals a 
concentration at or above the ECEL action level (0.02 ppm 8-hr TWA) but 
at or below the ECEL (0.03 ppm 8-hr TWA), the owner or operator must 
repeat the periodic exposure monitoring at least every 6 months.
     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 6 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 5 years.
    Additionally, in instances where an owner or operator does not 
manufacture, process, use, or dispose of CTC for a condition of use for 
which the restrictions would be in place over the entirety of time 
since the last required periodic exposure monitoring event, EPA is 
proposing that the owner or operator may forgo the next periodic 
exposure monitoring event. However, documentation of cessation of use 
of CTC must be maintained and periodic exposure monitoring would be 
required to resume should the condition of use restart.
    The proposed periodic exposure monitoring requirements are also 
outlined in Table 1. EPA requests comment on the timeframes for 
periodic exposure monitoring outlined in this unit. EPA may finalize 
significantly shorter, longer or different timeframes based on 
consideration of public comments.

                Table 1--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 3 months of
 above the ECEL (>0.03 ppm 8-hour TWA).   the most recent exposure
                                          monitoring.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is at   required within 6 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 5 years of the
 taken at least seven days apart within   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.
------------------------------------------------------------------------

    (D) Additional exposure monitoring.
    In addition to the initial and periodic exposure monitoring, EPA is 
proposing that each owner or operator conduct additional exposure 
monitoring whenever: (i) A change in the production, process, control 
equipment, personnel, work practices may reasonably be expected to 
result in new or additional exposures at or above the ECEL action 
level, or (ii) the owner or operator has any reason to believe that new 
or additional exposures at or above the ECEL action level have 
occurred. In the event of start-up, shutdown, malfunctions or other 
breakdowns that may lead to exposure to any person in the workplace, 
EPA is proposing that each owner or operator must conduct additional 
exposure monitoring (using personal breathing zone sampling) after the 
cleanup, repair or remedial action to ensure that exposures are below 
the ECEL or the ECEL action level. An additional exposure monitoring 
event may result in an increased frequency of periodic exposure 
monitoring. For example, if the initial exposure monitoring results 
from a workplace are above the ECEL action level, but below the ECEL, 
periodic exposure monitoring is required every 6 months. If additional 
exposure monitoring is performed because increased exposures are 
suspected, and the results are above the ECEL, subsequent periodic 
exposure monitoring would have to be performed every 3 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. The additional exposure 
monitoring is also included in Table 1. EPA requests comment on the 
timeframes and frequency for additional exposure monitoring outlined in 
this unit.
    (E) Other exposure monitoring requirements.
    For each exposure monitoring event, EPA is proposing to require 
that owners or operators ensure that their analytical methods be 
accurate, to a confidence level of 95 percent, to within plus or minus 
25 percent for airborne concentrations of CTC at an appropriate level 
of detection for the ECEL and ECEL action level. Also, EPA is proposing 
to require use of appropriate sampling and analytical methods used to 
determine CTC exposure, including as relevant: (A) Use of an analytical

[[Page 49197]]

method already approved by EPA, OSHA or NIOSH, or another analytical 
method that has been demonstrated to meet the proposed accuracy 
requirement at an appropriate level of detection for the ECEL and ECEL 
action level; (B) Compliance with the Good Laboratory Practice 
Standards at 40 CFR part 792. Also, EPA is proposing to require owners 
and operators to re-monitor within 15 working days after receipt of the 
results of any exposure monitoring when results indicate non-detect or 
air monitoring equipment malfunction, unless an Environmental 
Professional as defined at 40 CFR 312.10 or a Certified Industrial 
Hygienist reviews the exposure monitoring results and determines that 
re-monitoring is not necessary.
    EPA is also proposing to require that each owner or operator 
maintain exposure monitoring records that include the following 
information for each exposure monitoring event:
     Dates, duration, and results of each sample taken.
     All measurements that may be necessary to determine the 
conditions that may affect the exposure monitoring results.
     Name, workplace address, work shift, job classification, 
and work area of the person monitored; documentation of all other 
persons whose exposures the monitoring is intended to represent if 
using a representative sample; and type of respiratory protective 
device worn by the monitored person, if any.
     Use of appropriate sampling and analytical methods, such 
as analytical methods already approved by EPA, OSHA or NIOSH, or 
compliance with an analytical method verification procedure.
     Compliance with the Good Laboratory Practice Standards at 
40 CFR part 792.
     Information regarding air monitoring equipment, including: 
type, maintenance, performance tests, and any malfunctions.
    iii. Direct Dermal Contact Control (DDCC) Requirements.
    DDCC requirements are a process-based set of provisions to address 
unreasonable risk driven by direct dermal contact in the workplace. 
DDCC requirements would include controls to prevent direct dermal 
contact in the workplace by separating, distancing, physically 
removing, or isolating all person(s) from direct handling of CTC or 
from 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).
    EPA requests comment on available methods to measure the 
effectiveness of controls in preventing or reducing the potential for 
direct dermal contact to CTC. EPA is also requesting comment on 
available monitoring methods, such as charcoal patch testing, as 
feasible or effective methods to measure potential direct dermal 
contact with CTC.
    As discussed further in Unit V.A.1., EPA expects that many 
workplaces already have stringent controls in place that reduce dermal 
exposures to CTC; for some workplaces, EPA understands that these 
existing controls may already prevent or reduce direct dermal contact 
with CTC.
    c. Incorporation of the Hierarchy of Controls.
    EPA recommends and encourages the use of pollution prevention as a 
means of controlling exposures whenever practicable. Pollution 
prevention, also known as source reduction, is any practice that 
reduces, eliminates, or prevents pollution at its source (e.g., 
elimination and substitution). Similarly, the hierarchy of controls 
includes elimination, substitution, engineering controls, and 
administrative controls, prior to relying on PPE as a means of 
controlling exposures (Ref. 8). EPA is proposing to require owners or 
operators to reduce inhalation exposures below the ECEL and implement 
DDCC requirements in accordance with the hierarchy of controls. The 
establishment of an ECEL and DDCC requirements is intended to allow 
more flexibility to owners and operators to choose their controls when 
compared with requiring specific prescriptive controls. EPA is 
soliciting comment regarding the exposure control strategies required 
under the WCPP and documented in the exposure control plan, including 
the implementation of additional engineering controls, increase 
frequency of exposure monitoring, implementation of respiratory and 
dermal protection and notification of monitoring, and associated costs 
with the WCPP exposure control strategies implementation.
    EPA expects owners or operators to identify and implement feasible 
exposure controls such as elimination, substitution, engineering 
controls, and administrative controls. If these controls are not 
sufficient to reduce exposures to or below the ECEL and/or prevent 
direct dermal contact with CTC in the workplace, EPA proposes to 
require each owner or operator to use such controls to reduce CTC air 
concentrations in the workplace and/or to prevent direct dermal contact 
to the extent achievable, and supplement these controls using 
respiratory protection and/or dermal PPE before persons are permitted 
to enter a regulated area, as described in this unit. If an owner or 
operator chooses to replace CTC with a substitute, EPA recommends that 
they carefully review the available hazard and exposure information on 
the potential substitute to avoid a regrettable substitution. In 
addition, EPA proposes that a regulated entity would be prohibited from 
rotating work schedules of potentially exposed persons to comply with 
these requirements, similar to OSHA's Methylene Chloride Standard (29 
CFR 1910.1052). EPA expects that, for conditions of use where EPA is 
proposing these requirements, compliance at most workplaces would be 
part of an existing industrial hygiene program. EPA is soliciting 
comment on whether any of the requirements for the exposure control 
strategies, including EPA's proposed prohibition of rotating work 
schedules for potentially exposed persons, should be modified and 
considered in the final rule.
    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 reduce inhalation exposures or 
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.
    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, thereby increasing risks 
to people in fenceline communities of adverse health effects from 
exposures to CTC in ambient air. Therefore, EPA is proposing to 
prohibit increased releases of CTC to outdoor air associated with the 
implementation of the WCPP/ECEL. This proposed requirement is intended 
to avoid unintended increases in exposures to people from CTC emissions 
to ambient air. The proposed rule would require owners and operators to 
attest in their WCPP/ECEL

[[Page 49198]]

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. EPA requests 
comment on how this proposed requirement may impact the availability, 
feasibility, or cost of engineering controls as a means to reduce 
workplace exposures to or below the proposed ECEL.
    d. Regulated area.
    Based on the exposure monitoring, EPA is proposing to require that 
owners or operators of workplaces subject to a WCPP demarcate any area 
where airborne concentrations of CTC exceed or are reasonably expected 
to exceed the ECEL. Regulated areas would be demarcated using 
administrative controls, such as warning signs or highly visible 
signifiers, in multiple languages as appropriate (e.g., based on 
languages spoken by potentially exposed persons), placed in conspicuous 
areas, and documented through training and recordkeeping. The owner or 
operator would be required to restrict access to the regulated area 
from any potentially exposed person that lacks proper training, is not 
wearing required PPE as described in this unit or is otherwise 
unauthorized to enter. EPA is proposing to require owners and operators 
demarcate a regulated area beginning 9 months after the date of 
publication of the final rule, or within 3 months after receipt of any 
exposure monitoring that indicates exposures exceeding the ECEL. EPA is 
soliciting comment on requiring warning signs to demarcate regulated 
areas, such as the requirements found in OSHA's General Industry 
Standard for Beryllium (29 CFR 1910.1024(m)(2)).
    e. Exposure Control Plan.
    EPA proposes to require that owners and operators document their 
exposure control strategy, implementation and compliance with the WCPP, 
including ECEL and DDCC requirements, in an exposure control plan. An 
exposure control plan may include relevant existing documentation of 
the facility's safety and health program that may already be developed 
as part of meeting OSHA requirements or other safety and health 
standards (Ref. 23). EPA proposes to require that the exposure control 
plan documentation include the following:
    (i) Identification and rationale of exposure controls selected 
including: elimination of CTC, substitution of CTC, engineering 
controls, and administrative controls selected and used to reduce 
inhalation 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, and the rationale explaining why 
each exposure control was selected (e.g., the hierarchy of controls, 
feasibility, effectiveness, or other relevant considerations);
    (ii) For any category of exposure control not selected, document 
the efforts identifying why these are not feasible, not effective, or 
otherwise not implemented;
    (iii) Actions taken to implement exposure controls selected, 
including proper installation, maintenance, training or other steps 
taken;
    (iv) Description of any regulated area and how it is demarcated, 
and identification of authorized persons; and description of when the 
owner or operator expects exposures may be likely to exceed the ECEL;
    (v) 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;
    (vi) Regular inspections, evaluations, and updating of the exposure 
controls no less frequent than every five years to ensure effectiveness 
and confirm that all persons are implementing them as required;
    (vii) Occurrence and duration of any change in the production, 
process, control equipment, personnel or work practices and explanation 
of why the owner or operator may expect to result in new or additional 
exposures above the ECEL or not, and occurrence and duration of any 
other change that may result in new or additional exposures above the 
ECEL have occurred;
    (viii) Occurrence and duration of any start-up, shutdown, or 
malfunction of the facility that causes air concentrations above the 
ECEL and/or direct dermal contact with CTC and subsequent corrective 
actions taken during start-up, shutdown, or malfunctions to mitigate 
exposures to CTC; and
    (ix) Availability of the exposure control plan and associated 
records for potentially exposed persons.
    EPA may require more, less, or different documentation regarding 
exposure control strategies in the final rule based on public comment.
    f. 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 proposing to 
require implementation of a PPE program in alignment with OSHA's 
General Requirements for Personal Protective Equipment at 29 CFR 
1910.132. Consistent with 29 CFR 1910.132, owners and operators would 
be required to provide PPE, including respiratory protection and dermal 
protection selected in accordance with the guidelines described in this 
unit, that is of safe design and construction for the work to be 
performed. EPA is proposing to require owners and operators ensure each 
potentially exposed person who is required by this unit to wear PPE to 
use and maintain PPE in a sanitary, reliable, and undamaged condition. 
Owners and operators would be required to select and provide PPE that 
properly fits each potentially exposed person who is required by this 
unit to use PPE and communicate PPE selections to each affected person.
    i. Required Respiratory Protection.
    EPA is proposing to require a respiratory protection program with 
worksite-specific procedures and elements for required respirator use. 
The respiratory protection program proposed by EPA would be implemented 
when the most recent exposure monitoring concentration measured as an 
8-hour TWA is above the ECEL and after exhausting all other feasible 
controls as described in this unit. The proposed program must be 
administered by a suitably trained administrator. EPA is proposing to 
require each owner or operator to select respiratory protection in 
accordance with the requirements described in this unit and also to 
comply with OSHA's general PPE training requirements at 29 CFR 
1910.132(f) and 29 CFR 1910.134(a) through (1), except (d)(1)(iii), for 
selection, proper use, maintenance, fit-testing, medical evaluation, 
and training when using respirators. EPA is proposing that owners and 
operators would provide PPE training to each potentially exposed person 
who is required by this unit to wear PPE prior to or at the time of 
initial assignment to a job involving potential exposure to CTC. Owners 
and operators would also 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 not proposing to cross reference 29 CFR 
1910.134(d)(1)(iii) because the WCPP contains requirements for 
identifying CTC respiratory hazards in the workplace.

[[Page 49199]]

    EPA is proposing to require each owner or operator supply a 
respirator, selected in accordance with this unit, to each potentially 
exposed person who enters a regulated area within 3 months after the 
receipt of any exposure monitoring that indicates exposures exceeding 
the ECEL or 6 months after publication of the final rule if initial 
monitoring was completed prior to publication of the rule, and to 
ensure that all potentially exposed persons within the regulated area 
are using the provided respirators whenever CTC exposures exceed or can 
reasonably be expected to exceed the ECEL. EPA recognizes that 
implementing exposure controls and a respiratory protection program 
meeting the requirements outlined in this unit may require different 
compliance timeframes depending on existing health and safety programs 
at various facilities. EPA is soliciting comment on whether 6 months is 
a reasonable timeframe to implement a respiratory protection program or 
if a different timeframe is needed. Additionally, EPA is proposing that 
the owner or operator must ensure that all filters, cartridges and 
canisters used in the workplace are labeled and color coded with the 
NIOSH approval label and that the label is not removed and remains 
legible. EPA is requesting comment on whether there should be a 
requirement to replace cartridges or canisters after a certain number 
of hours, such as the requirements found in OSHA's General Industry 
Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a requirement for 
a minimum service life of non-powered air-purifying respirators such as 
the requirements found in OSHA's General Industry Standard for Benzene 
(29 CFR 1910.1028(g)(3)(D)).
    EPA is proposing the following requirements for respiratory 
protection, based on the exposure monitoring concentrations measured as 
an eight-hour TWA that exceed the ECEL (0.03 ppm). EPA is proposing to 
establish minimum respiratory protection requirements, such that any 
respirator affording a higher degree of protection than the following 
proposed requirements may be used. While this unit includes respirator 
selection requirements for respirators of APF of 1,000 or greater, EPA 
does not anticipate that respirators beyond APF 50 will be widely or 
regularly used to address unreasonable risk, particularly when other 
controls are put in place.
     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-certified 
air-purifying half mask respirator equipped with NIOSH-approved organic 
vapor cartridges or canisters; or any negative pressure (demand mode) 
supplied-air respirator 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-certified 
powered air-purifying respirator with a loose-fitting hood or helmet 
equipped with NIOSH-approved organic vapor cartridges or canisters; or 
any NIOSH-certified continuous flow supplied-air respirator equipped 
with a hood or helmet (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-certified 
air-purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; any NIOSH-certified powered air-
purifying respirator equipped with a tight-fitting half or full 
facepiece and NIOSH-approved organic vapor cartridges or canisters; any 
NIOSH-certified negative pressure (demand mode) supplied-air respirator 
equipped with a full facepiece; any NIOSH-certified continuous flow 
supplied-air respirator equipped with a tight-fitting half or full 
facepiece; or any NIOSH-certified negative pressure (demand mode) self-
contained respirator equipped with a full facepiece (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-
certified powered air-purifying respirator equipped with a tight-
fitting full facepiece and NIOSH-approved organic vapor cartridges or 
canisters; or any NIOSH-certified supplied air respirator equipped with 
a full facepiece and operated in a continuous flow mode or pressure 
demand or other positive pressure mode (APF 1,000).
     If the measured exposure concentration is greater than 30 
ppm (1,000 times ECEL) or the concentration is unknown: Any NIOSH-
certified self-contained breathing apparatus equipped with a full 
facepiece and operated in a pressure demand or other positive pressure 
mode (APF 10,000).
    ii. Required Dermal Personal Protective Equipment (PPE).
    Where elimination, substitution, engineering controls, and 
administrative controls are not feasible or sufficient to fully prevent 
direct dermal contact with CTC, EPA is proposing to require a dermal 
protection program with worksite-specific procedures and elements for 
required dermal PPE, and administered by a suitably trained 
administrator. In choosing appropriate dermal PPE, owners and operators 
would be required 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 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.
    For example, owners and operators can select gloves that have been 
tested in accordance with the American Society for Testing Material 
(ASTM) F739 ``Standard Test Method for Permeation of Liquids and Gases 
through Protective Clothing Materials under Conditions of Continuous 
Contact.'' EPA is proposing that dermal 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 dermal PPE will be impermeable 
during expected durations of use and conditions of exposure. EPA is 
proposing to require that owners and operators also consider other 
factors when selecting appropriate dermal 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 required 
to perform task, and temperature, as identified in the Hand Protection 
section of OSHA's Personal Protective Equipment guidance (Ref. 24).
    EPA is proposing that owners and operators would be required to 
establish, either through manufacturer or supplier-provided 
documentation or individually prepared third party testing, that the 
selected dermal 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. Owners 
and operators would also be required 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

[[Page 49200]]

CTC. EPA is proposing that dermal 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.
    And compatible with the OSHA Hand Protection PPE Standard (29 CFR 
1910.138), owners and operators would be required 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. In addition, EPA recommends that owners and operators 
consider 29 CFR 1910.133(b) for the selection and use of eye and face 
protection.
    EPA proposes to require that owners and operators document in the 
dermal protection program the following information, as applicable:
    (A) 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 dermal PPE selected to be worn by each of these persons;
    (B) The basis for specific dermal 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); and
    (C) Appropriately sized PPE and training on proper application, 
wear, and removal of dermal PPE, and proper care/disposal of dermal 
PPE.
    EPA is soliciting comments on the requirements proposed for 
appropriate dermal PPE selection, the effectiveness of PPE in 
preventing direct dermal contact with CTC in the workplace, and general 
absorption and permeation effects to PPE from direct dermal exposure. 
In addition, EPA understands that some workplaces rinse and reuse PPE 
after minimal use and is therefore soliciting comments on the impact on 
effectiveness of rinsing and reusing certain types of PPE, either 
gloves or protective clothing and gear. EPA also requests comment on 
the degree to which additional guidance related to use of dermal PPE 
might be appropriate.
    EPA is proposing to require each owner or operator supply dermal 
PPE, selected in accordance with this unit, to each potentially exposed 
person within 6 months after publication of the final rule.
    g. Workplace Information and training.
    To ensure that potentially exposed persons in the workplace are 
informed of the hazards associated with CTC exposure, EPA is proposing 
to require that owners or operators of workplaces subject to an ECEL 
and DDCC requirements institute a training program for all potentially 
exposed persons. EPA is proposing to require implementation of a 
training program compatible 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 proposing to require that owners or operators of 
workplaces subject to the WCPP institute a training and information 
program for potentially exposed persons and ensure their participation 
in the training and information program.
    As part of the training and information program, the owner or 
operator would be required to provide information and comprehensive 
training in an understandable manner (i.e., in 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 
or direct dermal contact to CTC. Compatible with the OSHA Hazard 
Communication Standard, owners and operators would be required to 
provide information and training to all potentially exposed persons 
that includes:
    (i) The requirements of the CTC WCPP and how to access or obtain a 
copy of the requirements of the WCPP;
    (ii) The quantity, location, manner of use, release, and storage of 
CTC and the specific operations in the workplace that could result in 
CTC exposure;
    (iii) Principles of safe use and handling of CTC in the workplace, 
including specific measures the owner or operator has implemented to 
reduce inhalation exposures to at or below the ECEL or prevent direct 
dermal contact with CTC, such as work practices and PPE used;
    (iv) 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
    (v) The health hazards associated with exposure with CTC.
    In addition to providing training at the time of initial assignment 
to a job involving potential inhalation exposure or direct dermal 
contact to CTC, and similar to annual retraining requirements in the 
OSHA General Industry Standard for Beryllium (29 CFR 1910.1024), owners 
and operators subject to an ECEL and DDCC requirements would be 
required to retrain each potentially exposed person at minimum annually 
to ensure employees understand the principles of safe use and handling 
of CTC in the workplace. Owners and operators would also need to 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, where 
exposure to CTC can reasonably be expected to exceed the ECEL action 
level, or whenever there are changes in the workplace that may result 
in direct dermal contact to CTC without appropriate PPE use. To support 
compliance, EPA is proposing 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.
    h. Workplace participation.
    EPA encourages owners or operators subject to ECEL and DDCC 
requirements to consult with potentially exposed persons on the 
development and implementation of an exposure control plan and 
respirator and dermal PPE program. EPA is proposing to require owners 
or operators to provide potentially exposed persons regular access to 
the exposure control plan, exposure monitoring records, and respirator 
and dermal PPE program implementation plan (documenting proper 
application, wear, and removal of PPE). To ensure compliance with the 
requirement for workplace access to the exposure control plan and PPE 
program documentation, EPA is proposing that owners or operators 
document the notice to and ability of any potentially exposed person 
that may reasonably be affected by inhalation exposure and/or direct 
dermal contact to CTC to readily access the exposure control plans, 
facility exposure monitoring records, respiratory protection program 
documentation, dermal PPE program documentation, or any other 
information relevant to CTC exposure in the workplace. EPA is 
requesting comment on how owners and operators can engage with 
potentially exposed persons on the development and

[[Page 49201]]

implementation of an exposure control plan and PPE program.
    EPA proposes that the owner or operator must, within 15 work days 
after receipt of the results of any exposure monitoring, notify each 
person whose exposure is represented by that monitoring in writing, 
either individually to each potentially exposed person or by posting 
the information in an appropriate and accessible location accessible to 
all persons whose exposure is represented by the monitoring, such as 
public spaces or common areas, outside the regulated area. This notice 
must include the exposure monitoring results, identification and 
explanation of the ECEL and ECEL action level in plain language, any 
corresponding required respiratory protection, if applicable, the 
quantity, location, manner of CTC use and identified releases of CTC 
that could result in exposure to CTC, and whether the airborne 
concentration of CTC exceeds the ECEL. The notice must also include a 
description of actions taken by the owner or operator to reduce 
inhalation exposures to or below the ECEL, if applicable, or refer to a 
document available to the potentially exposed persons which would state 
the actions to be taken to reduce exposures and would be posted in 
multiple languages if necessary.
    i. Recordkeeping.
    To support and demonstrate compliance, EPA is proposing that owners 
and operators of a workplace subject to an ECEL and DDCC requirements 
retain compliance records for five years. These proposed requirements 
are not intended to supersede or otherwise relieve regulated entities 
from any recordkeeping requirement imposed by other federal laws or 
regulations. EPA is proposing to require records to include:
    (A) The exposure control plan;
    (B) PPE program implementation and documentation, including as 
necessary, respiratory protection and dermal protection used and 
related PPE training; and
    (C) Information and training provided to each person prior to or at 
the time of initial assignment and any retraining.
    In addition, EPA is proposing that owners and operators subject to 
the WCPP ECEL requirements maintain records to include:
    (A) The exposure monitoring records;
    (B) Notification of exposure monitoring results; and
    (C) If the owner or operator relies on exposure monitoring data 
generated within the last five years as their initial exposure 
monitoring, records that demonstrate that it meets all of the 
requirements of this section.
    The owners and operators, upon request by EPA, would be required to 
make all records maintained by this unit available to EPA for 
examination and copying. All records required to be maintained by this 
unit could be kept in the most administratively convenient form 
(electronic or paper).
    j. Compliance Timeframes.
    EPA is proposing to require owners or operators of workplaces 
subject to these restrictions to conduct initial exposure monitoring 
for an ECEL and implement the DDCC requirements as outlined in this 
unit within 6 months after the date 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 6 months after the date of 
publication. EPA is proposing to require that each owner or operator 
ensure that the airborne concentration of CTC does not exceed the ECEL 
for all potentially exposed persons within 9 months after the date of 
publication of the final rule in the Federal Register, or beginning 4 
months after introduction of CTC into the workplace if CTC use 
commences at least 6 months after the date of publication. EPA is also 
proposing to require owners and operators demarcate a regulated area 
wherever exposures exceed or can reasonably be expected to exceed the 
ECEL beginning 9 months after the date of publication of the final rule 
in the Federal Register, or beginning 4 months after introduction of 
CTC into the workplace if CTC use commences at least 6 months after the 
date of publication. If applicable, EPA is also proposing that 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 3 months after the receipt 
of the results of any exposure monitoring that indicates exposures 
exceeding the ECEL or, if using monitoring data conducted within five 
years prior to the effective date of this rule that satisfies all other 
requirements of this section, within 9 months after the date of 
publication of the final rule in the Federal Register. Regulated 
entities should then proceed accordingly to implement an exposure 
control plan within 12 months after date of publication of the final 
rule in the Federal Register. EPA is also proposing to require each 
owner or operator to provide information and training for each person 
prior to or at the time of initial assignment to a job involving 
potential exposure to CTC within 6 months after the date of initial 
exposure monitoring or within 6 months after the date of publication of 
the final rule in the Federal Register if initial exposure monitoring 
was completed prior to publication of the rule. EPA will consider 
compliance timeframes that may be substantially longer or shorter than 
the proposed timeframes for owners or operators to conduct initial 
exposure monitoring for the ECEL, implement the ECEL and DDCC 
requirements, and any procedural adjustments needed to comply with the 
requirements outlined in this unit, and is requesting comment on the 
feasibility of the proposed compliance timeframes, as well as longer or 
shorter timeframes.
    2. Prescriptive Workplace Controls: Fume Hood and Dermal PPE.
    a. Overview.
    In contrast to the proposed non-prescriptive requirements of the 
ECEL and DDCC where regulated entities would have flexibility to select 
controls in accordance with the hierarchy of controls to comply with 
the parameters outlined in this unit, EPA may also find it appropriate 
in certain circumstances to require specific prescriptive controls for 
certain conditions of use with occupational exposures. In the 2020 Risk 
Evaluation for Carbon Tetrachloride, EPA identified certain workplace 
controls that reduce exposures from the industrial and commercial use 
of CTC as a laboratory chemical. Therefore, EPA is proposing to require 
specific prescriptive controls for the industrial and commercial use of 
CTC as a laboratory chemical, as described in this unit. This unit 
describes proposed requirements for a fume hood and dermal PPE for the 
industrial and commercial use of CTC as a laboratory chemical and 
advanced engineering controls specifically for DoD's industrial and 
commercial use of CTC as a laboratory chemical in chemical weapons 
destruction, including additional requirements proposed for 
recordkeeping. This unit also describes compliance timeframes for these 
proposed requirements. Each owner or operator of a workplace where the 
industrial and commercial use as a laboratory chemical occurs would be 
responsible for compliance with the requirements outlined in this unit.
    b. Workplace Requirements for Laboratory Use.
    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 proposing 
to require dermal PPE, including impermeable gloves and

[[Page 49202]]

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 to direct 
dermal contact in the work area to CTC through direct handling of the 
substance or from contact with surfaces that may be contaminated with 
CTC. For dermal PPE, EPA is proposing to require that each owner or 
operator comply with the requirements outlined in Units IV.A.1.e.ii. 
and IV.A.1.f. 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 would 
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.
    In addition, EPA is proposing to require the use of fume hoods 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 that EPA relied upon as a key basis for its 
evaluation of risk from this condition of use. EPA is proposing to 
require 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 fume hoods 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 to minimize exposures to workers in the 
area. As noted in these non-mandatory recommendations, which are based 
on the National Research Council's 2011 edition of ``Prudent Practices 
in the Laboratory: Handling and Management of Chemical Hazards,'' 
recommended practices for laboratory chemical hoods include, but are 
not limited to, regularly inspecting and maintaining the ventilation 
system, ensuring a negative pressure differential between the amount of 
air exhausted from the laboratory and the amount supplied to the 
laboratory to prevent uncontrolled chemical vapors from leaving the 
laboratory, and preventing laboratory air from recirculating back into 
the laboratory (29 CFR 1910.1450, Appendix A). EPA requests comment on 
whether it should incorporate in the rule best practices to ensure 
proper and adequate performance of laboratory fume hoods, such as those 
identified in OSHA's 29 CFR 1910.1450, Appendix A National Research 
Council Recommendations Concerning Chemical Hygiene in Laboratory. EPA 
recognizes that there are several types of fume hoods used in a 
laboratory setting with differences in design and specifications to 
meet performance standards. The Agency is requesting comment on whether 
it should incorporate in the rule specific requirements for laboratory 
hoods, such as design characteristics and/or a range of face 
velocities, or some other type of performance standard.
    Rather than fume hoods, EPA understands that DoD uses CTC in small 
amounts in a confined, laboratory-like setting with advanced 
engineering controls (Ref. 25). Therefore, for DoD's industrial and 
commercial use of CTC as a laboratory chemical in chemical weapons 
destruction, EPA is proposing to require advanced engineering controls 
that essentially codify existing practices at DoD facilities. EPA is 
not proposing to require a WCPP, specifically with monitoring 
requirements, for DoD's industrial and commercial use of CTC as a 
laboratory chemical in chemical weapons destruction.
    To support and demonstrate compliance, EPA is proposing that each 
owner or operator of a laboratory workplace subject to the requirements 
of this unit retain compliance records for five years. EPA is proposing 
to require records of:
    (A) PPE program implementation and documentation as outlined in 
this unit; and
    (B) Implementation of a properly functioning fume hood using 
manufacturer's instructions for installation, use, and maintenance of 
the fume hood, including inspections, tests, development of maintenance 
procedures, the establishment of criteria for acceptable test results, 
and documentation of test and inspection results. Every five years, the 
owner or operator would be required to re-assess and update these 
records.
    With regards to the compliance timeframe, EPA is proposing to 
require that each owner or operator of a workplace engaged in the 
industrial and commercial of CTC as a laboratory chemical ensure fume 
hoods are in use and functioning properly and that dermal PPE is 
provided to all potentially exposed persons with direct dermal contact 
with CTC within 6 months after publication of the final rule. While EPA 
is proposing requirements within 6 months of publication of the final 
rule, the Agency will consider compliance timeframes that may be 
substantially longer or shorter than the proposed timeframe and is 
soliciting comments on the feasibility of the proposed compliance 
timeframes, as well as longer or shorter timeframes.
    Similarly, EPA is proposing to require that DoD facilities engaged 
in the industrial and 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 
12 months after publication of the final rule.
    3. Prohibition of manufacturing, processing, distribution in 
commerce, and use of CTC for certain industrial and commercial uses.
    EPA is proposing to prohibit the manufacturing, processing, 
distribution in commerce, and use of CTC for the following industrial 
and commercial uses:
     Industrial and commercial use as a processing aid in the 
manufacture of petrochemical-derived products;
     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 (for which EPA is proposing a WCPP);
     Industrial and commercial use in metal recovery; and
     Industrial and commercial use as an additive.
    EPA is also proposing to explicitly prohibit:
     Processing: Incorporation into formulation, mixture or 
reaction products in petrochemical-derived manufacturing (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).
    EPA has attempted to identify users of CTC for the conditions of 
use the Agency is proposing to prohibit; however, the Agency has not 
found any ongoing users of CTC for these conditions of use. EPA expects 
that this is a result of the phaseout of CTC manufacturing in the 
United States for most non-feedstock domestic uses due to the Montreal 
Protocol and Title VI of the CAA, and EPA believes it is reasonable to 
assume that industry has found alternatives for these uses.

[[Page 49203]]

Therefore, the Agency understands that CTC is no longer needed for 
these uses and is proposing that the prohibitions described in this 
unit would take effect 180 days after the publication date of the final 
rule. EPA has no reasonably available information indicating that the 
proposed compliance dates are not practicable or that additional time 
is needed. However, EPA requests comment on whether CTC is still used 
in any of the conditions of use EPA is proposing to prohibit, and if 
so, whether additional time is needed to cease use, whether the 
compliance dates should be staggered by lifecycle, whether the proposed 
prohibitions would impact the production and availability of any 
pesticide, drug, or other substance excluded from the definition of 
``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi), or 
any other reason for additional compliance time. EPA is also requesting 
comment on whether the Agency should require a WCPP (as outlined in the 
Unit IV.B.2. in the primary alternative regulatory action) or 
prescriptive controls, including respirators and dermal PPE, for any of 
the conditions of use EPA is proposing to prohibit.
    EPA is also proposing to prohibit the manufacturing, processing, 
distribution in commerce, and use of CTC for the industrial and 
commercial use of CTC in specialty uses by the DoD. EPA received 
monitoring data for the industrial and commercial of CTC in specialty 
uses by the DoD, which was used in the 2020 Risk Evaluation for Carbon 
Tetrachloride. The Agency understands that DoD has successfully phased 
out the use of CTC for this condition of use and is therefore proposing 
that the prohibition for specialty uses by the DoD would take effect 
365 days after the publication date of the final rule. EPA is 
requesting comments on whether a shorter timeframe for prohibition 
would be practicable.
    After the risk evaluation was published, DoD did further analysis 
and provided additional information clarifying their ongoing use of CTC 
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. 
Therefore, EPA is proposing not to prohibit this use and instead to 
regulate this use under the condition of use of industrial and 
commercial use of CTC as a laboratory chemical. Unit IV.A.2. provides 
details on the proposed prescriptive controls for DoD's use of CTC as a 
laboratory chemical in chemical weapons destruction.
    Additionally, EPA recognizes that there may be instances where an 
ongoing use of CTC that has implications for national security or 
critical infrastructure as it relates to other Federal agencies (e.g., 
DOD, NASA) is identified after the CTC rule is finalized, but the final 
rule prohibits that use. For instances like that, EPA requests comments 
on an appropriate, predictable, process that could expedite 
reconsideration for uses that Federal agencies or their contractors 
become aware of after the final rule is issued using the tools 
available under TSCA, aligning with the requirements of TSCA section 
6(g). One example of an approach could be the establishment by 
rulemaking of a Federal agency category of use that would require 
implementation of the WCPP and periodic reporting to EPA on details of 
the use as well as progress in discontinuing the use or finding a 
suitable alternative. To utilize the category of use a Federal agency 
would petition EPA, supported by documentation describing the specific 
use (including documentation of the specific need, service life of any 
relevant equipment, and specific identification of any applicable 
regulatory requirements or certifications, as well as the location and 
quantity of the chemical being used); the implications of cessation of 
this use for national security or critical infrastructure (including 
how the specific use would prevent injuries/fatalities or otherwise 
provide life-supporting functions); exposure control plan; and, for 
Federal agency uses where similar adoption by the commercial sector may 
be likely, concrete steps taken to identify, test, and qualify 
substitutes for the uses (including details on the substitutes tested 
and the specific certifications that would require updating; and 
estimates of the time required to identify, test, and qualify 
substitutes with supporting documentation). EPA requests comment on 
whether these are the appropriate types of information for use in 
evaluating this type of category of use, and whether there are other 
considerations that should apply. EPA would make a decision on the 
petition within 30 days and publish the decision in the Federal 
Register shortly after. Additionally, during the year following the 
petition, EPA would take public comment on the approved petition and no 
later than 180 days after submitting the petition to EPA, the 
requesting agency would submit monitoring data indicating compliance 
with the WCPP at each relevant location as well as documentation of 
efforts to identify or qualify substitutes. In the absence of that 
confirmatory data, the utilization of the generic Federal agency 
category of use would expire within one year of the date of receipt by 
EPA of the petition. EPA could undertake a TSCA section 6(g) rulemaking 
for those instances where the Federal agency could not demonstrate 
compliance with the WCPP. This is just one example of a potential 
process. EPA requests comments on a transparent process that could 
expedite reconsideration for uses that Federal agencies or their 
contractors become aware of after the final rule is issued.
    4. Other requirements.
    a. Recordkeeping.
    EPA is proposing that manufacturers, processors, distributors, and 
industrial and commercial users of CTC maintain ordinary business 
records, such as invoices and bills-of-lading, that demonstrate 
compliance with the prohibitions, restrictions, and other provisions of 
this proposed regulation; and maintain such records for a period of 5 
years from the date the record is generated. EPA is proposing that this 
requirement begin at the effective date of the final rule, which is 
expected to be set as the date 60 days after date of publication of the 
final rule in the Federal Register. Recordkeeping requirements would 
ensure that owners or operators can demonstrate compliance with the 
regulations if necessary.
    b. Downstream Notification.
    For conditions of use that are not otherwise prohibited under this 
proposed regulation, EPA is proposing that manufacturers (including 
importers), processors, and distributors of CTC provide downstream 
notification of the prohibitions through Safety Data Sheets (SDSs) by 
adding to sections 1(c) and 15 of the SDS the following language:

    After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE 
IN THE Federal Register], this chemical is and may only be 
distributed in commerce or processed for the following purposes: 
Processing as a reactant/intermediate; Repackaging for use as a 
laboratory chemical; Recycling; Incorporation into formulation, 
mixture or reaction products in agricultural products manufacturing 
and other basic organic and inorganic chemical manufacturing; 
Industrial and commercial use as an industrial processing aid in the 
manufacture of agricultural products; Industrial and commercial use 
in the elimination of nitrogen trichloride in the production of 
chlorine and caustic soda; Industrial and commercial use as a 
laboratory

[[Page 49204]]

chemical; Industrial and commercial specialty uses by the U.S. 
Department of Defense until [DATE 365 DAYS AFTER DATE OF PUBLICATION 
OF THE FINAL RULE IN THE Federal Register]; and Disposal.

    The intention of downstream notification is to spread awareness 
throughout the supply chain of the restrictions on use of CTC under 
TSCA as well as provide information to end users about allowable TSCA 
uses of CTC.
    In order to provide adequate time to undertake the changes to the 
SDS and ensure that all users in the supply chain receive the revised 
SDS, EPA is proposing a 6-month period for manufacturers, processors, 
and distributors to implement the proposed SDS changes following 
publication of the final rule.
    EPA requests comments on the timeframes for recordkeeping and 
downstream notification requirements described in this unit.

B. Primary Alternative Regulatory Action

    As indicated by TSCA section 6(c)(2)(A)(iv)(II) and (III), EPA must 
consider and publish a statement based on reasonably available 
information with respect to the reasonably ascertainable economic 
consequences of the rule, including consideration of the costs and 
benefits and the cost effectiveness of the proposed regulatory action 
and one or more primary alternative regulatory actions considered by 
the Agency.
    The primary alternative regulatory action described in this unit 
and considered by EPA combines requirements for a WCPP and prescriptive 
workplace controls to address the unreasonable risk from CTC driven by 
the various conditions of use. The primary alternative regulatory 
action would allow a WCPP, including requirements to meet an ECEL and 
DDCC, for those conditions of use that would be prohibited under the 
proposed regulatory action, and prescriptive controls for those 
conditions of use where an ECEL and DDCC are the proposed regulatory 
action and where PPE may address the unreasonable risk. EPA requests 
comment on this primary alternative regulatory action and whether any 
elements of the primary alternative regulatory action described in this 
unit should be considered in combination with elements of the proposed 
regulatory action as EPA develops the final regulatory action. Examples 
of possible combinations in approaches may include, but are not limited 
to: adoption of the primary alternative regulatory action for certain 
conditions of use and the proposed regulatory action for other 
conditions of use; allowing regulated entities to opt out of 
requirements described in the proposed regulatory action by complying 
with requirements described in the primary alternative regulatory 
action; or allowing regulated entities to opt out of requirements 
described in the primary alternative regulatory action by complying 
with requirements described in the proposed regulatory action.
    1. Prescriptive workplace controls.
    The primary alternative regulatory action would require 
prescriptive workplace controls, specifically respirators and dermal 
PPE, for manufacturing (including import) of CTC and for the following 
other conditions of use, which account for essentially all of the 
production volume of CTC manufactured annually, where the proposed 
regulatory action is a WCPP:
     Processing as a reactant in the production of HCFCs, HFCs, 
HFOs, and PCE;
     Processing: Incorporation into formulation, mixtures, or 
reaction products for agricultural products manufacturing and other 
basic organic and inorganic chemical manufacturing;
     Processing: Repackaging for use as a laboratory chemical;
     Processing: Recycling;
     Industrial and commercial use as an industrial processing 
aid in the manufacture of agricultural products;
     Industrial and commercial use in the elimination of 
nitrogen trichloride in the production of chlorine and caustic soda; 
and
     Disposal.
    In the risk evaluation, EPA identified respirators and gloves that 
would reduce inhalation and dermal exposures to CTC. Under the primary 
alternative regulatory action, EPA considered requiring dermal PPE as 
described in Unit IV.A.1.f.ii. This approach differs from the proposed 
regulatory action because it would not require the use of elimination, 
substitution, engineering controls, and administrative controls, in 
accordance with the hierarchy of controls, to the extent feasible as a 
means of controlling dermal exposures to comply with DDCC requirements. 
Rather, this approach would require dermal PPE in combination with 
comprehensive training for tasks where dermal exposure may occur from 
direct handling of CTC or from contact with surfaces that may be 
contaminated with CTC (i.e., equipment or materials on which CTC may be 
present). EPA recognizes that resorting to the use of dermal PPE does 
not consider other, more protective controls in the hierarchy, as a 
WCPP does. By using other controls in the hierarchy, owners and 
operators may be more easily able to prevent direct dermal contact.
    For inhalation exposures in the risk evaluation, EPA identified 
assigned protection factors (APF) for respirators for each condition of 
use that would mitigate the unreasonable risk. EPA expects that 
workplaces engaged in the conditions of use described in Unit III.B.1. 
may be able to implement prescriptive controls as part of an industrial 
hygiene program. Under the primary alternative regulatory action, EPA 
considered requiring that owners or operators implement all aspects of 
a respiratory protection program (e.g., training, fitting, medical 
surveillance, etc.). This approach differs from the proposed regulatory 
action because it does not require the use of elimination, 
substitution, engineering controls, and administrative controls, in 
accordance with the hierarchy of controls, to the extent feasible as a 
means of controlling inhalation exposures to comply with an ECEL, or 
require monitoring to determine the airborne concentration in the 
workplace. As discussed in Unit V.A.1., EPA understands that there are 
several uncertainties regarding the applicability of respirators, such 
as the inability to use respirators by some workers due to respiratory 
concerns, issues with fit-testing, and interference with work 
efficiency. In addition, the APFs for the respirators are based on 
monitoring data that included 12-hour and 8-hour shifts as well as 
monitoring data from the DoD provided during the risk evaluation (Ref. 
1). EPA recognizes that workers and ONUs are not typically exposed to 
CTC for their entire work shifts; rather, exposures to CTC tend to 
occur intermittently and the level of respiratory APF needed may vary 
throughout each work shift (Ref. 26). In addition, EPA understands that 
workplaces have unique processes and equipment in place and that 
varying levels of respiratory APFs may be needed for different 
workplaces. Due to these uncertainties, EPA is proposing prescriptive 
workplace controls as the primary alternative regulatory action. 
However, the Agency also understands that requiring specific 
respirators may be more cost-effective and easier to implement for 
regulated entities since it would not require monitoring for an ECEL. 
Based on the 2020 Risk Evaluation for Carbon Tetrachloride, EPA 
determined that the use of respirators with an APF of 50 could control 
CTC air concentration to levels that eliminate the unreasonable risk

[[Page 49205]]

from inhalation exposures based on high-end exposures during a 12-hour 
work shift driven by the following conditions of use: domestic 
manufacture; processing as a reactant in the production of HCFCs, HFCs, 
HFOs, and PCE; incorporation into formulation, mixture, or reaction 
products for agricultural products manufacturing and other basic 
organic and inorganic chemical manufacturing; and industrial and 
commercial use in the elimination of nitrogen trichloride in the 
production of chlorine and caustic soda. EPA also determined that the 
use of respirators with an APF of 25 could control CTC air 
concentration to levels that eliminate the unreasonable risk from 
inhalation exposures based on high-end exposures during an 8-hour work 
shift driven by the following conditions of use: import; repackaging of 
CTC for use as a laboratory chemical; recycling; industrial and 
commercial use of CTC as an industrial processing aid in the 
manufacture of agricultural products; and disposal. The alternative 
regulatory action would require that owners or operators require the 
use of respirators with an APF 25 or 50, as described in this 
paragraph, as well as dermal PPE, for any person reasonably likely to 
be exposed to CTC from the conditions of use described in this unit 
(Unit IV.B.1.). EPA recognizes that the length of work shifts and the 
inhalation exposures to CTC throughout a specific work shift may vary 
across facilities and that monitoring may be helpful to identify the 
respirators required to eliminate unreasonable risk driven by 
inhalation exposures. Therefore, the Agency is soliciting comments on 
information to support the consideration of other APFs that are also 
protective of the highest possible lengths of exposures and on whether 
or how monitoring should be considered for the alternative regulatory 
action.
    EPA understands that many workplaces already have engineering 
controls or administrative controls in place that reduce exposures to 
CTC, in particular highly standardized and industrialized workplaces or 
where CTC is used in a closed system. However, EPA does not have 
reasonably available information on engineering controls and 
administrative controls that would mitigate unreasonable risk across a 
wide variety of workplaces for most conditions of use. EPA is 
requesting comment on specific controls that mitigate the unreasonable 
risk from CTC and that could be included as part of a prescriptive 
workplace controls requirement, which could be considered as EPA 
develops the final regulatory action. Specifically, EPA is soliciting 
comment on engineering controls and administrative controls that reduce 
inhalation exposures to at or below the ECEL of 0.03 ppm as an 8-hr TWA 
or prevent dermal exposure from direct handling of CTC or from contact 
with surfaces that may be contaminated with CTC and any associated cost 
related to these controls. Examples of potential controls and workplace 
practices include a closed system transfer, purging liquid lines with 
nitrogen, and limiting frequency and duration of exposure to CTC. EPA 
is also soliciting comment on combinations of engineering controls, 
administrative controls, and PPE that would reduce inhalation exposures 
to at or below the ECEL of 0.03 ppm as an 8-hr TWA or prevent direct 
dermal contact for all regulated entities and any associated cost 
related to these controls.
    2. Workplace Chemical Protection Program (WCPP).
    As discussed in Unit IV.A.3., EPA understands that the conditions 
of use the Agency is proposing to prohibit have been phased out. 
However, if EPA receives information indicating the continued use of 
CTC for these conditions of use, the Agency may consider regulating 
these uses rather than prohibiting them. Therefore, the primary 
alternative regulatory action considered by EPA would require the 
implementation of a WCPP, including an ECEL and DDCC requirements, for 
the following processing, industrial, and commercial uses of CTC:
     Processing: Incorporation into formulation, mixtures, or 
reaction products in petrochemicals-derived manufacturing;
     Industrial and commercial use as an industrial processing 
aid in the manufacture of petrochemicals-derived products;
     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;
     Industrial and commercial use in metal recovery;
     Industrial and commercial use as an additive; and
     Industrial and commercial use in specialty uses by the 
DoD.
    EPA understands that, if these uses are ongoing, they would occur 
in highly industrialized settings and controlled and closed processes, 
suggesting a WCPP could be implemented. Unit IV.A.1. provides details 
on the WCPP that EPA would require to be implemented for these uses. 
For the industrial and commercial use of CTC as a laboratory chemical, 
the primary alternative regulatory action considered by EPA would 
require the implementation of only the DDCC requirements of the WCPP in 
combination with the use of fume hoods in workplace laboratory settings 
(requiring fume hoods would make mandatory the current existing good 
laboratory practices) and advanced engineering controls specifically 
for DoD's use of CTC as a laboratory chemical in chemical weapons 
destruction (requiring advanced engineering controls would make 
mandatory the existing practices at DoD facilities). EPA is soliciting 
comment on non-prescriptive DDCC requirements as compared to the 
prescriptive workplace controls of dermal PPE EPA is proposing in Unit 
IV.A.2.
    3. Other requirements.
    The primary alternative regulatory action will also require 
recordkeeping and downstream notification similar to the proposed 
regulatory action as described in Unit IV.A.4.
    4. Compliance timeframes.
    The timeframes for the controls outlined as part of the primary 
alternative regulatory action, including ECEL, DDCC, and prescriptive 
controls, would remain the same as the timeframes outlined in the 
proposed regulatory action in Unit IV.A. In addition, the timeframes 
for recordkeeping and downstream notification requirements described in 
this unit also do not differ from the timeframes for the recordkeeping 
and downstream notification requirements in the proposed regulatory 
action described in Unit IV.A.

V. Rationale for the Proposed Regulatory and Primary Alternative 
Regulatory Actions

    This unit describes how the considerations described in Unit 
III.B.4 were applied when selecting among the TSCA section 6(a) 
requirements to arrive at the proposed and primary alternative 
regulatory actions described in Unit IV.A and IV.B.

A. Consideration of Risk Management Requirements Available Under TSCA 
Section 6(a)

    1. Workplace Chemical Protection Program.
    One option EPA considered for occupational conditions of use was 
establishing a WCPP, which would include a combination of restrictions 
to address unreasonable risk driven by inhalation and dermal exposures 
in the

[[Page 49206]]

workplace. A WCPP for CTC would encompass restrictions on certain 
occupational conditions of use and could include provisions for an 
ECEL, DDCC, and ancillary requirements to support implementation of 
these restrictions.
    A WCPP was considered for certain conditions of use for which there 
are compelling reasons not to prohibit the activity and for which EPA 
has found that a regulatory action would address the unreasonable risk. 
For example, CTC is a major feedstock in the generation of lower GWP 
HFOs, which is important to the Agency's efforts to address climate-
damaging HFCs. Another example is the use of CTC as an industrial 
processing aid in the manufacture of agricultural products, where 
industry has described its efforts to explore alternatives, but lack of 
success in finding a suitable replacement for CTC (Ref. 5). Similarly, 
for the use of CTC in the elimination of nitrogen trichloride in the 
production of chlorine and caustic soda, where industry has indicated 
that alternatives are not as efficient and/or have not been 
demonstrated to be effective in decomposing nitrogen trichloride (Ref. 
27). Therefore, for these uses, EPA considered regulatory requirements 
other than prohibition, such as a WCPP, that would reduce exposures in 
occupational settings so that the unreasonable risk is no longer 
present.
a. Existing Chemical Exposure Limit.
    One option considered by EPA was establishing an ECEL and related 
required implementation measures, such as monitoring, as a component of 
a WCPP. The EPA ECEL requirement for CTC would be non-prescriptive, in 
the sense that regulated entities would not be required to use specific 
equipment or engineering controls, or any other type of control, to 
achieve the exposure concentration limit. Rather, it would be a 
performance-based exposure limit that would enable owner or operators 
to determine how to most effectively meet the exposure limits based on 
conditions at their workplace following the hierarchy of controls.
    Exposures remaining at or below the ECEL would eliminate any 
unreasonable risk of injury to health driven by inhalation exposures 
for occupational conditions of use.
    In the case of CTC, EPA has calculated the ECEL for CTC to be 0.03 
ppm (0.2 mg/m\3\) for inhalation exposures as an 8-hour TWA in 
workplace settings, based on the cancer human equivalent concentration 
for liver toxicity from chronic inhalation exposures. This is the 
concentration at which an adult human, including a member of a 
susceptible subpopulation, would be unlikely to suffer adverse effects 
if exposed for a working lifetime (Ref. 9). The differences between the 
ECEL and the OSHA PEL are discussed in more detail in Unit II.C.1.b. 
EPA chose the cancer liver toxicity endpoint as the basis for this 
exposure limit, and this exposure limit will be protective of both 
acute and chronic non-cancer inhalation endpoints over the course of a 
working day and lifetime.
    In deciding whether setting an ECEL would appropriately address 
unreasonable risk, EPA considered factors including the prevalence of 
use of the chemical substance, prevalence or lack of alternatives, 
efficacy, and factors related to work activities that may make it 
difficult to comply with an ECEL, particularly at the low levels EPA 
has identified. Examples include work activities in conditions of use 
that require a high range of motion or for some other reason create 
challenges for the implementation of respiratory PPE, and the type of 
PPE that may be needed to meet the ECEL in the absence of, or in 
addition to, other feasible exposure controls, based on analysis in the 
risk evaluation describing expected exposures with and without use of 
PPE.
    EPA also considered the feasibility of exposure reduction 
sufficient to address the unreasonable risk even in facilities 
currently complying with OSHA PELs. EPA acknowledges the regulated 
community's expected familiarity with OSHA PELs generally, as well as 
facilities' past and ongoing actions to implement the CTC PEL and 
corresponding methods of compliance outlined in OSHA standards. Since 
the level of EPA's exposure limits is two orders of magnitude lower 
than the OSHA PEL (the differences between the ECEL and the OSHA PEL 
are discussed in more detail in Unit II.C.4; more information on other 
OELs is in Unit II.C.5.), the ECEL requirement creates some uncertainty 
as to the ability of facilities engaging in most conditions of use to 
meet the ECEL and associated action level without relying on the use of 
PPE, and, therefore, whether exposures could be reduced in a manner 
aligned with the hierarchy of controls.
    EPA understands that this uncertainty extends to the applicability 
of respirators as well. Although respirators could reduce exposures to 
levels that are protective of cancer and non-cancer risks, not all 
workers may be able to wear respirators. Individuals with impaired lung 
function due to asthma, emphysema, or chronic obstructive pulmonary 
disease, for example, may be physically unable to wear a respirator. 
OSHA requires that a determination regarding the ability to use a 
respirator be made by a physician or other licensed health-care 
professional, and annual fit testing is required for tight-fitting, 
full-face piece respirators to provide the required protection. 
Individuals with facial hair, such as beards or sideburns that 
interfere with a proper face-to-respirator seal, cannot wear tight 
fitting respirators. In addition, respirators may also present 
communication problems, vision problems, worker fatigue, and reduced 
work efficiency (63 FR 1152, January 8, 1998). According to OSHA, 
``improperly selected respirators may afford no protection at all (for 
example, use of a dust mask against airborne vapors), may be so 
uncomfortable as to be intolerable to the wearer, or may hinder vision, 
communication, hearing, or movement and thus pose a risk to the 
wearer's safety or health.'' (63 FR 1189 through 1190, January 8, 
1998).
    b. Direct Dermal Contact Control (DDCC) Requirements.
    Another restriction considered by EPA to include in a WCPP for CTC 
to address unreasonable risk driven by dermal exposures was requiring 
direct dermal contact controls (DDCC). DDCC requirements under WCPP 
would be a process-based set of provisions to address unreasonable risk 
driven by dermal exposure by preventing direct dermal contact in the 
workplace by separating, distancing, physically removing, or isolating 
potentially exposed persons from direct handling of CTC or from contact 
with equipment or materials on which CTC may exist under routine 
conditions (exceptions may be needed in the event of incidental 
exposure or equipment malfunction). Similar to the ECEL, DDCC is non-
prescriptive, in the sense that it does not require a specific control 
to prevent direct dermal contact; rather, it would enable regulated 
entities to determine how to most effectively prevent direct dermal 
contact based on what works best for their workplace, in accordance 
with the hierarchy of controls.
    In deciding whether DDCC requirements under a WCPP would 
appropriately address the unreasonable risk driven by dermal exposures, 
EPA considered factors including the prevalence of use of the chemical 
substance; availability of technically and economically feasible 
alternatives; efficacy; and factors related to work activities that may 
make it difficult to prevent direct dermal contact. Examples include 
work activities that require a high dexterity or precise use of hands 
and fingers or for some other reason create challenges for the

[[Page 49207]]

implementation of dermal PPE, and the type of PPE that would be needed 
to prevent direct dermal contact, based on analysis in the risk 
evaluation describing expected exposures with and without use of PPE. 
EPA also considered whether exposures could be reduced in a manner 
aligned with the hierarchy of controls.
    c. CTC Workplace Chemical Protection Program.
    Taking into account these considerations, EPA is proposing that 
certain conditions of use would be allowed to continue if regulated 
entities could ensure exposures remain at or below the ECEL, direct 
dermal contact is prevented, and other requirements are met in the CTC 
WCPP. In contrast to considerations that would weigh against the 
likelihood of a facility within a condition of use to successfully 
implement WCPP, there are certain considerations that indicate a 
condition of use is a good fit for effective risk management via WCPP. 
Based on reasonably available information, including monitoring data, 
and information related to considerations described previously in this 
unit, EPA's confidence that requirements to meet an ECEL can be 
implemented is highest in the highly standardized and industrialized 
settings, such as where CTC is used in a closed system (Ref. 10). 
Additionally, the 2020 Risk Evaluation for Carbon Tetrachloride 
supports EPA's conclusion that only small reductions in exposure are 
needed for WCPP ECEL compliance for the conditions of use. Also, for 
dermal exposures, reasonably available information indicates that 
controls may already be in place at some workplaces to prevent or 
reduce direct dermal contact with CTC, including enclosed transfer 
liquid lines with a nitrogen purging mechanism, closed loop samplers, 
and impervious glove liners in addition to chemically resistant gloves 
(Refs. 26 and 28).
    For example, one condition of use where a WCPP may be implemented 
is the processing of CTC as a reactant in the production of HFOs, which 
are in lower global warming potential products, including refrigerants, 
aerosol propellants, and foam-blowing agents, potentially replacing 
many of the higher global warming potential products containing HFCs, 
which are subject to a phasedown in production and consumption of HFCs 
under the AIM Act and the Kigali Amendment to the Montreal Protocol. 
Among other things, the AIM Act authorizes EPA to address listed HFCs 
in three main ways: phasing down HFC production and consumption through 
an allowance allocation program, facilitating sector-based transitions 
to next-generation technologies, and issuing certain regulations for 
purposes of maximizing reclamation and minimizing releases of HFCs from 
equipment and ensuring the safety of technicians and consumers. EPA 
anticipates that many entities currently using HFCs with higher global 
warming potential will transition to alternatives with lower GWP as 
requirements under the AIM Act take effect. By allowing for the 
continued, controlled use of CTC in the production of lower-GWP HFOs, 
efforts to shift to chemicals with lower GWP would not be impeded by 
this rulemaking. In addition, CTC may be used in closed reactors to 
make feedstocks, including refrigerants, aerosol propellants, and foam-
blowing agents (e.g., HCFCs and HFCs), used to produce HFOs (Ref. 29).
    Additionally, the 2020 Risk Evaluation for Carbon Tetrachloride 
indicates that readily achievable reductions in exposure are needed for 
WCPP compliance for all the conditions of use driving the unreasonable 
risk from inhalation exposures. Based on analysis in the 2020 Risk 
Evaluation for Carbon Tetrachloride describing expected exposures with 
and without use of PPE, EPA identified an air-supplied respirator of 
APF 10, 25, and 50, depending on the condition of use, as the minimum 
respiratory PPE that is sufficient to mitigate the unreasonable risk. 
This suggests that, for the conditions of use that would be subject to 
a WCPP, the reductions in exposure required to achieve a level that 
would not present unreasonable risk may be achievable, which, together 
with other considerations previously described, including monitoring 
data submitted via public comment by the Halogenated Solvents Industry 
Alliance (HSIA) during the 2020 Risk Evaluation for Carbon 
Tetrachloride indicating exposures near or below the ECEL, adds to 
EPA's confidence that facilities engaging in the use of CTC could meet 
the WCPP requirements (EPA-HQ-OPPT-2016-0733-0101).
    Pursuant to TSCA section 6(c)(2)(A)(i), EPA is considering 
reasonably available information regarding the adverse effects of CTC 
on human health and the magnitude of exposure of human beings to CTC. 
EPA recognizes that people at workplaces that manufacture, process, 
use, or dispose of CTC may also live in the fenceline communities 
surrounding these facilities and consequently may be potentially 
exposed to CTC through ambient air outside of working hours. In 
addition, 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, thereby 
increasing risks to people in fenceline communities of adverse health 
effects from exposures to CTC in ambient air. Therefore, pursuant to 
TSCA section 6(c)(2)(B), EPA is considering the potential adverse 
effects on health of people in fenceline communities posed by emissions 
of CTC to ambient air described in Unit VI as a factor when proposing 
to prohibit increased releases of CTC to outdoor air associated with 
the implementation of the WCPP/ECEL. This proposed requirement is 
intended to avoid unintended increases in exposures to people from CTC 
emissions to ambient air. The proposed rule would require owners and 
operators 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.
    2. Prescriptive controls.
    Another option EPA considered was requiring specific, prescribed 
controls--such as engineering controls, administrative controls, and 
PPE--to reduce exposures to CTC in occupational settings. Prescriptive 
controls could include respirators and dermal PPE. The Agency 
identified that PPE could reduce exposures in support of risk 
management efforts for CTC. However, for most conditions of use, except 
for the use of CTC in a laboratory setting, resorting to the use of PPE 
does not consider other, more protective controls in the hierarchy, 
including elimination, substitution, engineering, and administrative 
controls. EPA also understands that workplaces have unique processes 
and equipment in place and that varying levels of respiratory APFs may 
be needed for different workplaces. Therefore, there is uncertainty in 
prescribing specific respiratory APFs and selecting an APF based on the 
monitoring required as part of an ECEL is likely more protective 
because there is more certainty in the level of exposure protection 
required as a result of regular monitoring requirements. In addition, 
the Agency recognizes that many of the largely industrialized and 
standardized facilities that use CTC monitor workers to determine the 
APFs needed to protect workers, and that the APFs identified to address 
the unreasonable risk in the primary alternative regulatory action may 
differ from the APFs needed at many of these facilities due to the 
variation in processes and equipment in

[[Page 49208]]

place. As a result of monitoring, many workplaces may also identify 
that respirators are not needed for large portions of the day, 
particularly when CTC is not in use. EPA recognizes that requiring 
specific APFs to be used over the entire work shifts, rather than tasks 
throughout the workday, is not the norm for most facilities, given how 
respirators could interfere with physiological and phycological aspects 
of task performance and might reduce productivity or necessitate 
offering higher wages to workers who must wear respirators for long 
periods of time.
    Nevertheless, based on the 2020 Risk Evaluation for Carbon 
Tetrachloride, EPA considered the industrial and commercial use in 
laboratory chemicals as a strong candidate for prescriptive controls. 
Inhalation exposures from the industrial and commercial use of CTC as a 
laboratory chemical did not drive the unreasonable risk determination 
for CTC due to risk estimates that were predicated on expected safety 
practices of using CTC in small amounts under a fume hood, which 
reduces the potential for inhalation exposures. To codify assumptions 
made in the 2020 Risk Evaluation for Carbon Tetrachloride regarding the 
use of fume hoods in laboratory settings, EPA is proposing to require 
fume hoods in laboratory settings that use CTC. This proposed 
requirement would protect workers in laboratory settings by ensuring 
that good laboratory practices that reduce the potential for inhalation 
exposures are consistently applied and enforceable. Additionally, the 
2020 Risk Evaluation for Carbon Tetrachloride determined that dermal 
exposures from the industrial and commercial use of CTC as a laboratory 
chemical drive the unreasonable risk determination for CTC. The 2020 
Risk Evaluation for Carbon Tetrachloride identifies several 
uncertainties regarding the use of chemically resistant gloves and the 
dermal model. For example, the risk evaluation does not consider actual 
frequency, type and effectiveness of glove use in specific workplaces. 
In addition, the risk evaluation does not describe the ``specific 
activity training'' associated with the dermal protection factor model, 
beyond that it covers procedure for glove removal and disposal. EPA 
understands that impermeable gloves in combination with comprehensive 
training for particular tasks specific to CTC use can reduce the 
potential for dermal exposures in occupational settings. EPA is 
requesting comment on whether preventing dermal contact with CTC 
through dermal PPE and comprehensive training would adequately address 
the unreasonable risk from dermal exposures for the industrial and 
commercial use in laboratory chemicals.
    3. Prohibition.
    EPA considered a prohibition as a regulatory option and is 
proposing it for certain conditions of use where information indicates 
uses have been phased out (Unit IV.A.3). The lack of information 
indicating ongoing use for some CTC uses has led EPA to propose 
prohibitions, rather than a WCPP, for those conditions of use.
    4. Primary alternative regulatory action.
    EPA acknowledges that for the conditions of use that it is 
proposing to prohibit, the types of facilities that would use CTC if 
these uses were ongoing would likely be able to implement a WCPP, as 
these conditions of use occur in highly controlled and industrial 
settings. Therefore, for EPA's primary alternative regulatory action, 
described in Unit IV.B., EPA is requesting comment on whether any of 
the uses the Agency is proposing to prohibit are ongoing and is 
considering a WCPP--including requirements to ensure exposures remain 
below an ECEL and DDCC requirements--as an alternative regulatory 
action for some conditions of use of CTC.
    As discussed in this unit, in the Risk Evaluation, EPA identified 
that PPE could reduce exposures in support of risk management efforts 
for CTC and is therefore proposing to consider prescriptive controls, 
specifically respirators and dermal PPE, as part of the alternative 
regulatory option for those conditions of use where the proposed 
regulatory option is a WCPP. Resorting to the use of PPE, however, does 
not provide assurance that the owner or operator considered other, more 
protective controls in the hierarchy, including elimination, 
substitution, engineering, and administrative controls. In addition, 
this option does not take into account distinctions in processes and 
equipment in all facilities, which may result in varying levels and 
types of respiratory and dermal PPE needed.
    While the use of dermal PPE is typical for the use of CTC as a 
laboratory chemical, EPA recognizes the potential for there to be other 
forms of controls to prevent direct dermal contact in a laboratory 
setting. Therefore, as part of the alternative regulatory action, EPA 
considered DDCC requirements for the industrial and commercial use of 
CTC as a laboratory chemical.
    5. Risk management requirements considered but not proposed.
    An option that EPA considered but is not feasible for CTC is 
setting a concentration limit. Because the vast majority of CTC is 
processed as a reactant, a concentration limit is not practicable. 
Limiting product container size is also an ineffective option for 
reducing unreasonable risk from CTC, as it is mostly transported in 
large tank and rail cars (Ref. 26).
    6. Additional considerations.
    After considering the different regulatory options under TSCA 
section 6(a), lack of alternatives (described in Unit V.B.), compliance 
dates, and other requirements under TSCA section 6(c), EPA developed 
the proposed regulatory action described in Unit IV.A. to address the 
unreasonable risk from CTC. To ensure successful implementation of this 
proposed regulatory action, EPA considered other requirements to 
support compliance with the proposed regulations, such as requiring 
monitoring and recordkeeping to demonstrate compliance with the WCPP, 
or downstream notification regarding the prohibition on manufacturing, 
processing, and distribution in commerce of CTC. These proposed 
requirements are described in Unit IV.A.4.
    Under TSCA section 6(g)(1), EPA may grant an exemption from a 
requirement of a TSCA section 6(a) rule for a specific condition of use 
of a chemical substance or mixture if the Administrator finds that 
certain criteria are met (for example, if compliance with the 
requirement would significantly disrupt the national economy, national 
security, or critical infrastructure). Based on reasonably available 
information, EPA has found that a TSCA section 6(g) exemption is not 
warranted at this time. Therefore, EPA is not proposing to grant 
exemptions from the rule requirements under TSCA section 6(g). As 
discussed in Unit III.A. the Agency is requesting comment on whether to 
grant a TSCA section 6(g) exemption for CTC.
    As required under TSCA section 6(d), any rule under TSCA section 
6(a) must specify mandatory compliance dates, which shall be as soon as 
practicable with a reasonable transition period, but no later than five 
years after the date of promulgation of the rule (except in the case of 
a use exempted under TSCA section 6(g) or for full implementation of 
ban or phaseout requirements). These compliance dates are detailed in 
Units IV.A. and IV.B. As discussed in Units IV.A. and IV.B., the Agency 
is requesting comment on whether shorter or longer compliance 
timeframes should be considered.

[[Page 49209]]

B. Consideration of Alternatives in Deciding Whether To Prohibit or 
Substantially Restrict CTC

    Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or 
restrict in a manner that substantially prevents a specific condition 
of use of a chemical substance or mixture, and in setting an 
appropriate transition period for such action, EPA must consider, to 
the extent practicable, whether technically and economically feasible 
alternatives that benefit human health or the environment will be 
reasonably available as a substitute when the proposed prohibition or 
other restriction takes effect.
    EPA is proposing to prohibit those conditions of use where 
information indicates uses of CTC are phasing out or have already been 
phased out: the industrial and commercial use of CTC as a processing 
aid in the manufacture of petrochemicals-derived products; 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 (for which 
EPA is proposing a WCPP); industrial and commercial use of CTC as an 
additive; industrial and commercial use of CTC in metal recovery; and 
industrial and commercial use of CTC in specialty uses by the DoD. 
Since these uses seem to have been phased out, it is reasonable to 
assume industry has found alternatives. The transition to these 
alternatives has taken place since CTC was restricted under the CAA in 
1990 and therefore, while EPA has not identified specific alternatives, 
the Agency has concluded that technically and economically feasible 
alternatives are reasonably available for CTC; however, the Agency was 
unable to examine the health and environmental effects of other 
potential alternatives or substitute methods.
    For other conditions of use of CTC for which EPA is proposing 
restrictions rather than prohibition, EPA held several outreach 
meetings with current users of CTC and carried out thorough research to 
determine if technically and economically feasible alternatives and 
substitute methods are available. For the processing of CTC as a 
reactant in the production of HFOs, the Agency understands that there 
are routes of production with feedstocks that do not use CTC. However, 
industry has explained that these routes are not as cost-effective or 
efficient as CTC and would require replacement or significant 
modification of existing production technology (Ref. 30). In addition, 
current processes that use CTC to manufacture HCFCs and HFCs, including 
HFC-245fa, HFC-365mfc, and HFC-236fa, do not seem to have substitutes 
readily available, particularly because these facilities have CTC-
specific infrastructure in place and replacing the infrastructure at 
these facilities to use an alternative feedstock would require large 
investments (Ref. 30). In terms of PCE production, CTC does not appear 
to be a major feedstock in the production of PCE; rather, CTC may be a 
minor input when recycled to make additional PCE (Ref. 31). The 
recycling of CTC for production of PCE prevents additional disposal and 
wasting of CTC. With regard to the use of CTC as an industrial 
processing aid in the manufacture of agricultural products, EPA was 
informed that, despite past research and development efforts, a 
suitable replacement for CTC that would not react with the process 
gases in the manufacture of agricultural products has not been 
identified (Ref. 5). For the use of CTC in the elimination of nitrogen 
trichloride (NTC) in the production of chlorine and caustic soda, 
industry has indicated that the alternatives are not as efficient 
because they require more of an alternative chemical, require more 
energy usage, and/or have not been demonstrated to be effective in 
decomposing NTC (Ref. 27). For example, one alternative is refluxing 
cold liquid chlorine; more liquid chlorine than CTC would be required 
per pound of NTC absorbed, and NTC removal with CTC allows for storage 
capacity of the purge stream, while chlorine does not (Ref. 27). EPA 
has also not identified technically and economically feasible 
alternatives for the specific uses of CTC in a laboratory setting.
    The Agency is requesting comment on the availability of technically 
and economically feasible alternatives that are beneficial to health or 
the environment compared to CTC.

VI. TSCA Section 6(c)(2) Considerations

A. Health Effects of Carbon Tetrachloride and the Magnitude of Human 
Exposure to Carbon Tetrachloride

    The human health hazards to CTC include 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 effect due 
to fatty changes to the liver indicative of cellular damage. Under 
EPA's Guidelines for Carcinogen Risk Assessment, 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 hepatocellylar 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 (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. 4).
    In addition to these estimates 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. As mentioned in 
Unit II.D., EPA has separately conducted a screening approach to assess 
whether there may be potential risks to the general population from 
these exposure pathways. The screening approach was developed in order 
to allow EPA to determine--with confidence--situations which present no 
unreasonable risk to fenceline communities or where further 
investigation would be needed to develop a more-refined estimate of 
risk. The fenceline technical support memos for the ambient air pathway 
and the water pathway provide the Agency with a quantitative assessment 
of exposure. For CTC, the results from applying this screening approach 
did not allow EPA to rule out unreasonable risk to fenceline 
communities. After doing an initial screen (the single year ambient air 
screening analysis) that did not rule out unreasonable risk, EPA 
conducted additional analysis (the multi-year ambient air analysis) 
from which it

[[Page 49210]]

derived risk estimates that are mostly within the cancer benchmarks 
used by EPA and other regulatory agencies of 1 in 10,000 to 1 in 
1,000,000. The single year ambient air screening analysis and the 
multi-year ambient air analysis allow EPA to mathematically calculate a 
cancer risk in fenceline communities. While EPA feels confident about 
there being no significant risk where calculated risks do not exceed 1 
x 10-\6\ (as is the case for two conditions of use) there 
are still limitations and uncertainties where the calculated risk 
exceeds the 1 in 1,000,000 cancer risk benchmark value as is the case 
for five conditions of use, which are described further in this unit. 
This unit summarizes the results of the fenceline analysis of the water 
pathway and also for the ambient air pathway for CTC, which expands the 
original single year ambient air screening approach to include a multi-
year assessment in light of peer review comments on the initial 
methodology.
    As described in Unit II.D., EPA's fenceline analysis methodology 
was presented to the SACC peer review panel in March 2022, and EPA 
considered SACC feedback (including the SACC recommendation to EPA to 
consider multiple years of release data to estimate exposures and 
associated risks) when applying the fenceline analysis to CTC. EPA also 
plans to consider SACC feedback and make decisions regarding how to 
build upon the screening approach so that EPA can more accurately 
assess and quantify general population exposures in upcoming risk 
evaluations, such as for the 1,4-dioxane supplement and for the 
forthcoming 20 High Priority Substances. For CTC, EPA recognizes that a 
key input into the fenceline assessment of the ambient air pathway was 
data on releases from a single year of Toxics Release Inventory (TRI) 
release data (2019 TRI reporting year) and that the use of more than 
one year of data could result in different conclusions. Accordingly, in 
this unit, EPA presents the results of its analysis based on CTC 
releases reported to TRI over a single reporting year as well as over 
multiple years (Ref. 32).
    EPA's fenceline analysis for the air pathway for CTC indicates that 
EPA cannot rule out unreasonable risk to fenceline communities with 
confidence, described further in this unit. Estimates of cancer risk to 
fenceline communities were calculated and compared to 1 x 10\-\\6\ as a 
benchmark value for cancer risk in fenceline communities. Cancer 
benchmark values used by EPA and other regulatory agencies in 
interpreting the significance of cancer risk range from 1 in 1,000,000 
to 1 in 10,000 (i.e., 1 x 10-\6\ to 1 x 10-\4\) 
depending on the subpopulation exposed (Ref. 3). Benchmark values help 
inform decisions regarding the significance of risk and the Agency 
considers a number of other factors when determining whether risks are 
significant, such as the endpoint under consideration, the 
reversibility of effect, and exposure-related considerations (e.g., 
duration, magnitude, or frequency of exposure, or population exposed).
    The ambient air fenceline analysis organizes facilities and 
associated risks by occupational exposure scenario (OES) and generally 
crosswalks each OES with the associated condition of use of CTC (Ref. 
32). Due to limited information on activities and use of CTC reported 
under TRI, there is uncertainty if the facilities associated with a 
specific OES were correctly cross-walked to the appropriate condition 
of use, or whether some OESs indicating increased cancer risk from 
ambient air exposures to CTC in the air fenceline analysis should be 
associated with more than one condition of use of CTC.
    The ambient air fenceline analysis was divided into four steps: (a) 
a single-year ambient air analysis, (b) a single-year land use 
analysis, (c) a multi-year ambient air analysis, and (d) a multi-year 
land use analysis. EPA conducted an ambient air analysis for a single 
year and multiple years to determine whether EPA-generated risk 
estimates exceeded benchmarks for cancer risk for real and generic 
facilities at multiple distances. The Agency then conducted a land use 
analysis as part of both the single-year and multi-year analyses to 
determine if EPA can reasonably expect an exposure to fenceline 
communities to occur within the modeled distances for facilities where 
there was an indication of risk above one in a million. This review 
consisted of a visual analysis using aerial imagery and interpreting 
land/use zoning practices around the facility to identify where 
residential, industrial/commercial businesses, or other public spaces 
are present within those radial distances indicating risk (as opposed 
to uninhabited areas), as well as whether the radial distances lie 
outside the boundaries of the facility.
1. CTC Fenceline Analysis of the Ambient Air Pathway
    a. Single year ambient air full-screening results for CTC.
    EPA's single-year (using 2019 TRI data) fenceline analysis for the 
ambient air pathway was based on methods presented to the SACC to 
identify expected exposure and estimate associated cancer risk to 
people who live in fenceline communities within select distances 
evaluated from 5 to 10,000 meters from the respective releasing 
facility. Where there was an indication of risk above one in a million 
in the single year fenceline analysis from a facility, EPA conducted a 
land use analysis to determine if the Agency can reasonably expect an 
exposure to fenceline communities to occur within the modeled distances 
from the respective releasing facility. The land use analysis for the 
single-year ambient air analysis is described in Unit VI.A.b. Risk 
estimates exceeded one in a million for cancer risk for 31 of the 47 
real or generic, or modeled, facilities evaluated, at multiple 
distances (between 5 and 2,500 meters from a releasing facility), 
representing five OES. One OES had one generic facility evaluated which 
showed risk above one in a million, but no land use analysis could be 
performed. The remaining four OES included real facilities for which a 
land use analysis was conducted.
    b. Single-year land use analysis for CTC.
    The land use analysis for the single-year analysis identified 21 
real facilities where cancer risk estimates exceeded one in a million 
and there is an expected exposure to fenceline communities.
    c. Multi-year ambient air analysis.
    Following SACC feedback, EPA evaluated 6 years of facility specific 
CTC release data as reported to TRI (2015 through 2020 TRI data as well 
as the arithmetic average of that data). The multi-year analysis 
evaluated 60 real facilities. Cancer risk estimates exceeded one in a 
million for cancer for 25 of those 60 facilities at 100 meters from the 
releasing facility. Out of these 25 facilities, 6 facilities solely 
producing CTC as a byproduct were excluded (because, as described 
earlier, the 2020 Risk Evaluation for Carbon Tetrachloride did not 
include the production of CTC as a byproduct as a condition of use), 
resulting in 19 facilities. Based on the multi-year analysis, 4 of the 
25 facilities either have cancer risk estimates above one in a million 
at distances farther out when compared to the single-year analysis or 
are facilities that were not captured in the single-year analysis 
(e.g., did not report in 2019 TRI). When excluding facilities producing 
CTC as a byproduct, the multi-year analysis found 3 of 19 facilities 
have cancer risk estimates above one in a million at distances farther 
out when compared to the single-year analysis or are facilities that 
were not captured in the single-year analysis. Although the multi-year 
analysis did identify several additional

[[Page 49211]]

facilities with cancer risk estimates above one in a million for cancer 
that were not captured by the single-year fenceline analysis data set, 
the multi-year analysis did not change the number of conditions of use 
with cancer risk estimates above one in a million at the distances 
evaluated.
    Overall, the ambient air analysis for the multi-year fenceline 
analysis identified 19 facilities with risk estimates above one in a 
million, with only one facility with risk estimates above one in ten 
thousand, at 100 meters representing 5 conditions of use. The potential 
risks identified for those conditions of use without consideration of 
the land use analysis to determine whether there is exposure to 
fenceline communities are:
     Manufacturing (8 out of 8 facilities evaluated, with the 
highest risk estimate of 4 x 10-\5\);
     Processing as a reactant in the production of HCFCs, HFCs, 
HFOs, and PCE (5 of 5 facilities evaluated, with the highest risk 
estimate of 7 x 10-\5\);
     Processing: Incorporation into formulation, mixtures, or 
reaction products (petrochemicals-derived manufacturing; agricultural 
products manufacturing; other basic organic and inorganic chemical 
manufacturing) (1 of 1 facility evaluated, with the highest risk 
estimate of 8 x 10-\5\);
     Industrial and commercial use as an industrial processing 
aid in the manufacture of petrochemicals-derived products and 
agricultural products (4 of 8 facilities evaluated, with the highest 
risk estimate of 2 x 10-\4\); and
     Disposal (1 of 15 facilities evaluated, with the highest 
risk estimate of 3 x 10-\6\).
    d. Multi-year land use analysis.
    The land use analysis for the multi-year analysis was limited to 4 
additional facilities identified in the multi-year ambient air analysis 
which had cancer risk estimates that exceeded one in a million at 
distances farther out than the single-year analysis or were new 
facilities not captured by the single-year analysis. Therefore, the 
multi-year land use analysis was conducted for these 4 additional 
facilities and found only 1 facility had cancer risk estimates that 
exceeded one in a million and an expected exposure to fenceline 
communities, although that one facility was identified as a facility 
producing CTC as a byproduct.
    e. Fenceline analysis of the ambient air pathway conclusions.
    Under the proposed regulatory action described in Unit IV.A., all 
of the conditions of use with an indication of potential risk to 
fenceline communities would be required to establish a WCPP. [However, 
it is important to note that EPA understands that two uses evaluated in 
the risk evaluation, along with the manufacturing and processing for 
these uses, have ceased and these uses are therefore not expected to be 
contributing sources to the ambient air releases in the fenceline 
analysis. These two uses are the industrial and commercial use as a 
processing aid in the manufacture of petrochemical-derived products and 
the industrial and commercial use in the manufacture of most 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 are proposed for prohibition]. Under the proposed 
WCPP requirements, facilities would need to monitor CTC air 
concentrations by taking personal breathing zone air samples of 
potentially exposed persons, which would allow facilities to better 
understand and manage the total releases of CTC within the facility and 
potentially stack and fugitive emissions. Furthermore, EPA is proposing 
to prohibit increased emissions associated with WCPP requirements, and 
in the WCPP exposure control plan facilities would 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 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.
    Although both the single year fenceline analysis, based on methods 
presented to the SACC, and the multi-year fenceline analysis conducted 
for CTC, which expands upon the fenceline analysis in response to SACC 
feedback, indicated potential exposure and associated risks to select 
receptors within the general population at particular facilities, there 
are some uncertainties associated with the fenceline analysis. The TRI 
dataset used for the single- and the multi-year fenceline analysis and 
land use analysis does not include actual release point locations, 
which can affect the estimated concentrations of the chemical at 
varying distances modeled. To identify the release location for each 
facility, EPA used a local-coordinate system based on latitude/
longitude coordinates reported in TRI. The latitude/longitude 
coordinates may represent the mailing address location of the office 
building associated with a very large facility or some other area of 
the facility rather than the actual release location (e.g., a specific 
process stack). This discrepancy between the coordinates reported in 
TRI and the actual release point could result in an exposure 
concentration that does not represent the actual distance where 
fenceline communities may be exposed.
    For the multi-year analysis, there were a few additional 
uncertainties. The multi-year analysis evaluated a conservative 
exposure scenario that consists of a facility that operates year-round 
(365 days per year, 24 hours per day, 7 days per week) in a South 
Coastal meteorologic region and a rural topography setting (Ref. 32). 
Therefore, the modeled exposures to receptors may be overestimated if 
there are fewer exposure days per year or hours per day. Another 
uncertainty for the multi-year analysis is the distribution and volume 
of releases to stack and fugitive emissions. Further, there were 
certain assumptions and uncertainties related to the model used for the 
multi-year analysis, for example, the multi-year analysis used high-end 
and central tendency meteorological data contained within the model, 
which may differ from the meteorological data utilized in the single 
year fenceline analysis. Another uncertainty is that the emission 
scenario assumed may or may not represent actual operating conditions 
of a given facility. Finally, there is uncertainty in the stack 
parameters used and whether they represent actual stack parameters or 
conditions of the modeled facilities, including stack height, diameter, 
temperature, and other factors.
    EPA also 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. 33 
and 34). The risk estimates from the fenceline analysis do not account 
for the background concentrations from

[[Page 49212]]

historical emissions, which are persistent in the atmosphere.
    EPA believes that the exposures from which these risk estimates 
were derived come from five conditions of use. For these five 
conditions of use identified in the multi-year ambient air analysis, 
the proposed rule would require strict workplace exposure controls via 
implementation of a WCPP as described in Unit IV.A.1. In the instances 
where efforts to reduce exposures in the workplace to levels below the 
ECEL could lead to adoption of engineering controls that ventilate more 
CTC outside, EPA believes this potential additional exposure would be 
limited as a result of the existing National Emission Standards for 
Hazardous Air Pollutants (NESHAPs) for CTC for these conditions of use 
under the CAA. Applicable NESHAPs include: 40 CFR part 63, subpart 
VVVVVV, Chemical Manufacturing Area Sources, and 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. In addition, as part of the 
proposed controls outlined in Unit IV, EPA is proposing to prohibit 
increased releases of CTC to outdoor air associated with the 
implementation of the WCPP/ECEL to avoid unintended increases in 
exposures to people from CTC emissions to ambient air by requiring 
owners and operators 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 or 
otherwise prevent increased emissions of CTC to ambient air. EPA is 
requesting comment on the types and costs of technologies firms would 
adopt to comply with the prohibition on increased releases of CTC to 
outdoor air associated with engineering controls used in the 
implementation of the WCPP/ECEL. In addition, EPA requests comment on 
whether and to what extent these technologies would reduce CTC 
emissions at facilities that adopt them below emissions levels that 
existed prior to implementation of the WCPP/ECEL.
    Because EPA believes that the proposed controls outlined in Unit IV 
on the five conditions of use will reduce the exposure values used in 
the calculation of these fenceline risk estimates, EPA does not intend 
at this time to revisit the air pathway for CTC as part of a 
supplemental risk evaluation. EPA is seeking comment on its 
conclusions, and the expectation that this proposed action in 
combination with the emissions standards resulting from existing NESHAP 
requirements would reduce risk sufficiently to the general population 
and fenceline communities, and whether, consistent with TSCA section 
9(b), any other statutory authorities administered by EPA should be 
used to take additional regulatory action identified as necessary to 
protect against such risk. EPA is also soliciting comment on whether 
EPA should require ambient air monitoring at fenceline locations or 
facility emissions source monitoring to demonstrate compliance with the 
proposed requirement that engineering controls implemented as part of a 
WCPP/ECEL under this rule would not result in the ventilation of more 
CTC outside. The Agency recognizes that owners and operators may have 
difficulty distinguishing between emission increases due to 
implementation of the WCPP/ECEL and emissions increases resulting from 
other factors such as increased manufacturing, processing, or use of 
CTC, although monitoring at both upwind and downwind locations could 
help them do so. In addition, EPA understands the difficulty in 
distinguishing between background levels of CTC and emissions from 
facilities. Therefore, EPA is soliciting comment on the need for and 
associated costs of ambient air monitoring at fenceline locations or 
facility emissions source monitoring, as well as information on the 
frequency and nature of air monitoring EPA should consider including as 
requirements in the final rule (such as a detection limit for CTC). EPA 
is also soliciting comment on whether, if EPA does not finalize the 
proposed prohibition on increased releases of CTC to ambient air 
outside of the workplace associated with implementation of the WCPP/
ECEL, EPA should require monitoring to alert EPA to any increased 
emissions to ambient air associated with WCPP/ECEL implementation so 
that the Agency may take appropriate action.
    2. CTC Fenceline Analysis of the Water Pathway
    EPA's fenceline analysis for the water pathway for CTC, based on 
methods presented to the SACC, assesses exposure via drinking water, 
incidental oral ingestion of ambient water, and incidental dermal 
exposure to ambient water for communities in proximity to waterbodies 
receiving direct or indirect releases of CTC from facilities that use 
CTC (``fenceline communities'') (Ref. 35). EPA's screening level 
analysis did not find potential risk to fenceline communities from the 
water pathway. Further, EPA has a Safe Drinking Water Act National 
Primary Drinking Water Regulation for CTC that applies to public water 
systems to protect public health on a national level.

B. Environmental Effects of Carbon Tetrachloride and the Magnitude of 
Exposure of the Environment to Carbon Tetrachloride

    EPA did not identify risks of injury to the environment that drive 
the unreasonable risk determination for CTC (Refs. 1 and 3). In the 
2020 Risk Evaluation for Carbon Tetrachloride, EPA identified and 
evaluated CTC environmental hazard data for fish, aquatic 
invertebrates, amphibians, and algae across acute and chronic exposure 
durations.
    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 (Ref. 36). As a 
result of its ozone-depleting effects, the Montreal Protocol and Title 
VI of the CAA led to a phase-out of CTC manufacturing in the United 
States for most non-feedstock domestic uses. EPA did not evaluate the 
effect of 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 HFCs with higher GWP, EPA did not 
evaluate whether emissions of CTC would increase because of this rule 
and the overall

[[Page 49213]]

impact on the GWP emissions. In other words, EPA did not evaluate if 
the 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.

C. Benefits of Carbon Tetrachloride for Various Uses

    CTC is primarily used as a feedstock in the production of HCFCs, 
HFCs, and HFOs. Other conditions of use include regulated use as a 
process 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 consumer products (excluding unavoidable residues not 
exceeding 10 ppm atmospheric concentration) in 1970.
    According to data collected in EPA's 2020 CDR, between 100 and 250 
million pounds of CTC were produced or imported in the U.S. in CDR 
Reporting Year 2019. Eight sites were reported as domestic 
manufacturers of CTC in 2020 CDR. According to private databases, 
between 2017 and 2021 there were up to forty possible import/
repackaging sites dealing with small volumes of CTC (Ref. 4). Most HFCs 
do not require CTC for their manufacture. However, CTC is used as a 
feedstock to produce HFC-245fa and HFC-365mfc. As stated in the 2020 
Risk Evaluation for Carbon Tetrachloride, the production of HFC-245fa 
and HFC-365mfc accounted for 71% and 23%, respectively, of total CTC 
consumption in 2016 (Ref. 37). More recently, industry has expressed 
particular reliance on CTC for HFOs, such as HFO-1234yf, which are 
replacing some of the HFCs currently being used (Ref. 38).
    CTC is a major feedstock for generation of lower-GWP alternative 
fluorocarbon products in the United States (Ref. 26). 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 take effect. 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.

D. Reasonably Ascertainable Economic Consequences of the Proposed 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. 39). 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 proposal. 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 are not quantified, and 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 four small entities, and that the cost would only 
exceed 1% of annual revenues for one of these small entities.
    EPA expects that the proposed 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 proposed regulatory 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 proposed regulatory action and of the 
1 or more primary alternative regulatory actions considered by the 
Administrator.
    EPA is proposing to prohibit the manufacturing, processing, 
distribution in commerce, and use of CTC for the following industrial 
and commercial uses: industrial and commercial use of CTC as a 
processing aid in the manufacture of petrochemicals-derived products; 
industrial and commercial use of CTC in 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; 
industrial and commercial use of CTC in metal recovery; industrial and 
commercial use of CTC as an additive; and industrial and commercial use 
of CTC in specialty uses by the DoD. EPA is also proposing to 
explicitly prohibit processing into formulation, mixture or reaction 
products in petrochemical-derived manufacturing, which is the upstream 
processing condition of use for one of the prohibited industrial and 
commercial uses. EPA did not estimate the costs of prohibiting CTC in 
certain conditions of use because reasonably available information 
indicates that those conditions of use have been phased out. There will 
therefore be unquantified costs only to the extent to which CTC is 
still being used in the prohibited conditions of use.
    EPA is also proposing a WCPP, including an ECEL of 0.03 ppm in 
combination with DDCC requirements for: domestic manufacture; import; 
processing as a reactant in the production of HCFCs, HFCs, HFOs, and 
PCE; repackaging of CTC for use as a laboratory chemical; recycling; 
incorporation into a formulation, mixture or reaction product in 
agricultural products manufacturing and other basic organic and 
inorganic chemical manufacturing; industrial and commercial use of CTC 
as an industrial processing aid in the manufacture of agricultural 
products; industrial and commercial use in the elimination of NTC in 
the production of chlorine and caustic soda; and disposal. 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

[[Page 49214]]

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 is also proposing to require dermal PPE in combination with 
comprehensive training for tasks pertaining to the use of CTC in a 
laboratory setting for each person potentially exposed to direct dermal 
contact with CTC in the work area through direct handling of the 
substance or from contact with surfaces that may be contaminated with 
CTC. In addition, EPA is proposing to require the use of fume hoods in 
workplace laboratory settings to codify existing good laboratory 
practices. EPA assumes that industry would not incur equipment costs 
associated with the fume hood requirement for laboratory settings 
because fume hoods are already considered to be good laboratory 
practices. Industry is expected to incur costs associated with the 
dermal PPE requirement.
    Assuming the high-end estimates for number of affected entities and 
workers and compared to the baseline trend, the total cost of the 
proposed regulatory action is $18.8 million dollars annualized over 20-
years at a 3% discount rate and $18.5 million dollars at a 7% discount 
rate. However, to improve these estimates, EPA is requesting comment on 
the types and costs of administrative and engineering controls that 
facilities could use to control exposures in the workplace. EPA is also 
requesting comment on the baseline use of each identified control. In 
addition, EPA is requesting comment regarding the effectiveness of any 
existing administrative and engineering in controlling and/or reducing 
exposures. Also, EPA requests comment on whether these administrative 
and engineering controls would increase or reduce annual costs as 
compared to the annualized costs per facility estimated in the proposed 
regulatory action. For example, Executive Summary table ES-4 of the 
Economic Analysis includes an average annual estimated cost per 
facility of the proposed regulatory action in the ``manufacturing'' 
condition of use of approximately $605,000 based on an estimate of 300 
workers per site. The average annual estimated cost per facility for 
the ``processing as a reactant'' condition of use is approximately 
$232,000 based on an estimate of 113 workers per site. These estimated 
costs, which are annualized over a 20-year period at a 3% discount 
rate, are composed of facility- and employee-based expenditures based 
largely on monitoring requirements and use of PPE. It is possible these 
ongoing costs could be affected by upfront expenditures on engineering 
and administrative controls, and EPA seeks comment on this topic.
    Under the primary alternative option, EPA would require 
prescriptive controls of a Supplied Air Respirator (SAR) at either APF 
25 or APF 50. A respirator with an APF of 50 would be required for the 
following conditions of use: domestic manufacture; processing as a 
reactant in the production of HCFCs, HFCs, HFOs, and PCE; incorporation 
into formulation, mixture, or reaction products for agricultural 
products manufacturing and other basic organic and inorganic chemical 
manufacturing; and industrial and commercial use in the elimination of 
nitrogen trichloride in the production of chlorine and caustic soda. A 
respirator with an APF of 25 would be required for the following 
conditions of use: import; repackaging of CTC for use as a laboratory 
chemical; recycling; industrial and commercial use of CTC as an 
industrial processing aid in the manufacture of agricultural products; 
and disposal.
    A WCPP, including an ECEL and DDCC requirements, would be required 
for the following conditions of use in the primary alternative 
regulatory action: processing of CTC for incorporation into 
formulation, mixture or reaction products in petrochemical-derived 
manufacturing; industrial and commercial use of CTC as an industrial 
processing aid in the manufacture of petrochemicals-derived products; 
industrial and commercial use of CTC 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); industrial and commercial use of CTC in 
metal recovery; industrial and commercial use of CTC as an additive; 
and in industrial and commercial use of CTC in specialty uses by the 
DoD.
    For the industrial and commercial use of CTC as a laboratory 
chemical, the primary alternative regulatory action considered by EPA 
would require the implementation of DDCC requirements in workplace 
laboratory settings and require the use of fume hoods in workplace 
laboratory settings to codify existing good laboratory practices.
    Assuming the high-end estimates for number of affected entities and 
workers, the total cost of the primary alternative regulatory action is 
$2.3 million dollars annualized over 20-years at both a 3% and 7% 
discount rate. Costs are higher for the proposed action compared to the 
primary alternative action. Under the WCPP, facilities will bear 
monitoring and recordkeeping costs in addition to respirators and 
dermal PPE. However, facilities only need to provide a respirator to 
employees with a sufficiently high projected monitoring outcome. In the 
primary alternative action, facilities will not incur monitoring or 
WCPP recordkeeping costs, but will need to provide a respirator to all 
employees.
    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. Therefore, benefits are only calculated for the ECEL, which 
could require respiratory protection, and prescriptive workplace 
control options. The estimated monetized benefit of the proposed 
regulatory action ranges from approximately $0.09 to $0.1 million per 
year annualized over 20-years at a 3% discount rate and from $0.04 to 
$0.07 million per year at a 7% discount rate. The estimated monetized 
benefit of the primary alternative regulatory action is $.09 to $.1 
million per year annualized over 20-years at a 3% discount rate and 
$.04 to $.07 million per year at a 7% discount rate. There are also 
unquantified benefits due to other avoided adverse health effects 
associated with CTC exposure, including liver, reproductive, renal, 
developmental, and CNS toxicity end points.
    Net benefits were calculated by subtracting the costs from the 
quantified benefits. Based on the high-end estimates for number of 
affected entities and workers, the net benefit of the proposed 
regulatory action is -$18.7 million dollars annualized over 20-years at 
a 3% discount rate and ranges from -$18.5 to -$18.4 million dollars at 
a 7% discount rate. Based on the high-end estimates for number of 
affected entities

[[Page 49215]]

and workers, the net benefit of the primary alternative option ranges 
from -$2.3 to -$2.2 million dollars annualized over 20-years at a 3% 
discount rate and is -$2.3 million dollars at a 7% discount rate. The 
range in the net benefits estimate at each discount rate reflects 
uncertainty in cancer risk reductions given the shorter exposure 
durations being considered and the life stage at which the changes in 
exposure occur.
    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 proposed 
regulatory action is $2 million dollars annualized over 20-years at 
both a 3% and a 7% discount rate. The total cost of the primary 
alternative option is $0.3 million dollars annualized over 20-years at 
both a 3% and 7% discount rate. The total benefit of the proposed 
regulatory action is estimated to range from $.01 million dollars to 
$.02 million dollars annualized over 20-years at a 3% period discount 
rate, and ranges from $.005 million dollars to $.009 million dollars 
annualized over 20-years at a 7 percent discount rate. The total 
benefit of the primary alternative regulatory action is estimated to 
range from $.01 million dollars to $.02 million dollars annualized over 
20-years at a 3% period discount rate and from $.005 million dollars to 
$.009 million dollars annualized over 20-years at a 7 percent discount 
rate. The net benefit of the proposed regulatory action under this 
sensitivity analysis is -$2 million dollars annualized over 20-years at 
both a 3% and a 7% discount rate. The net benefit of the primary 
alternative option is -$0.3 million dollars annualized over 20-years at 
both a 3% and 7% discount rate.
    3. Cost effectiveness of the proposed regulatory action and of the 
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 proposed regulatory action and the 
primary alternative action 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 proposed 
regulatory action and the primary alternative regulatory action differ 
as described in Units I.E and VI.D.2. The costs of achieving the 
desired outcome via the proposed regulatory action 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 proposed regulatory 
action ranges from $698 to $1,024 dollars per microrisk reduction at a 
3% discount rate, and from $687 to $1,008 dollars per microrisk 
reduction at a 7% discount rate. The cost-effectiveness of the primary 
alternative regulatory action ranges from $83 to $122 dollars per 
microrisk reduction at both a 3% and 7% discount rate. Since the 
regulated universe in both the proposed and primary alternative 
regulatory actions is identical, the cost-effectiveness of the 
regulatory actions varies based on the individual requirements 
comprising each proposed regulatory 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 each proposed regulatory action.
    4. Request for comments regarding the reasonably ascertainable 
economic consequences of the proposed rule.
    EPA requests comment on its analyses of the number of affected 
firms, facilities, and occupational users and non-users. EPA requests 
comment on whether CTC is still being used in any of the conditions of 
use EPA is proposing to prohibit. Finally, EPA requests comment on the 
costs firms would incur as a result of the proposed rule, as well as 
information that the Agency could use to improve these estimates.

VII. 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, for this proposed rule, the Administrator 
proposes to exercise the Administrator's discretion not to 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.
    In addition, 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. EPA routinely consults 
with other relevant Federal agencies, and for this proposed rule, EPA 
has and continues to coordinate with appropriate Federal executive 
departments and agencies, including OSHA and NIOSH, to, among other 
things, identify their respective authorities, jurisdictions, and 
existing laws with regard to risk evaluation and risk management of 
CTC, which are summarized in this unit, and described in Units II.B. 
and C. The following information relating to TSCA section 9(a) analysis 
reflects consultation and coordination efforts with OSHA and NIOSH.
    OSHA requires that employers provide safe and healthful working 
conditions by setting and enforcing standards and by providing 
training, outreach, education, and assistance. 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. Health 
standards issued under section 6(b)(5) of the OSH Act must reduce 
significant risk only ``to the extent feasible.'' 29 U.S.C. 655(b)(5). 
As noted previously, to set PELs for chemical exposure, OSHA must first 
establish that the new standards are economically and technologically 
feasible (79 FR 61384, Oct. 10, 2014). OSHA also does not have direct 
authority over State and local employees, and it has no authority over 
the working conditions of State and local employees in States that have 
no OSHA-approved State Plan under 29 U.S.C. 667.
    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. EPA risk evaluations under TSCA section 6(b) must 
determine, without consideration of costs or other nonrisk factors, 
whether an unreasonable risk of injury to health or the environment is 
presented, including an unreasonable risk to a relevant potentially 
exposed or susceptible subpopulation. In a TSCA section 6 risk 
management rule,

[[Page 49216]]

following such an unreasonable risk determination, EPA must apply risk 
management requirements to the extent necessary so that the chemical no 
longer presents unreasonable risk and only consider costs and benefits 
of the regulatory action to the extent practicable, 15 U.S.C. 2605(a), 
(c)(2). EPA's substantive burden under TSCA section 6(a) is to apply 
requirements to the extent necessary so that the chemical substance no 
longer presents the unreasonable risk that was determined in accordance 
with TSCA section 6(b)(4)(A) without consideration of cost or other 
nonrisk factors.
    EPA therefore concludes that TSCA is the most appropriate 
regulatory authority able to prevent or reduce unreasonable risk of CTC 
to a sufficient extent across the conditions of use, exposures, and 
populations of concern. This unreasonable risk can be addressed in a 
more coordinated, efficient, and effective manner under TSCA than under 
different laws implemented by different agencies. Moreover, the 
timeframe and any exposure reduction as a result of updating OSHA 
regulations cannot be estimated, while TSCA imposes a much more 
accelerated statutory timeframe for proposing and finalizing 
requirements to address unreasonable risk. Further, as discussed in 
detail in Unit II.C., there are key differences between the finding 
requirements of TSCA and those of the OSH Act. 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 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. 6), regulations under those EPA statutes largely regulate 
releases to the environment, rather than the occupational exposures 
that drive EPA's unreasonable risk determination for CTC in its 2020 
risk evaluation under TSCA. 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., RCRA, CAA, CWA).
    The primary exposures and unreasonable risk to workers and 
occupational non-users would be addressed by EPA's proposed 
prohibitions and restrictions under TSCA section 6(a). In contrast, the 
timeframe and any exposure reduction as a result of updating 
regulations for CTC under RCRA, CAA, or CWA, for example, cannot be 
estimated, nor would they address the direct human exposure to workers 
and occupational non-users from the conditions of use evaluated in the 
2020 Risk Evaluation for Carbon Tetrachloride. The Agency recognizes 
that the CAA Amendments of 1990 have reduced emissions from CTC 
production and use. However, of the laws administered by EPA, only TSCA 
provides EPA the authority to regulate the manufacture (including 
import), processing, distribution in commerce, commercial use, and 
disposal of CTC as necessary to address the unreasonable risk 
identified under TSCA from CTC under its conditions of use.
    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, 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 confidential 
business information that may occur if this rule is finalized as 
proposed. Under TSCA section 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 confidential 
business information 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). If this rule is finalized as proposed, then pursuant to TSCA 
section 14(b)(4)(B)(iii), the presumption against protection from 
disclosure would apply only to information about the specific 
conditions of use that this rule would prohibit. Manufacturers or 
processors seeking to protect such information would be able to submit 
a request for nondisclosure as provided by TSCA sections 14(b)(4)(C) 
and 14(g)(1)(E). Any request for nondisclosure would need to be 
submitted within 30 days after receipt of notice from EPA under TSCA 
section 14(g)(2)(A). EPA anticipates providing such notice via the 
Central Data Exchange (CDX).

D. TSCA Section 26 Considerations

    In accordance with TSCA section 26(h), EPA has used scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, and models consistent with the best available science. 
As in the case of the unreasonable risk determination, risk management 
decisions for this proposed rule, as discussed in Units III.B.3. and 
V., were based on a risk evaluation that was subject to public comment 
and independent, expert peer review, and was developed in a manner 
consistent with the best available science and based on the weight of 
the scientific evidence as required by TSCA sections 26(h) and (i) and 
40 CFR 702.43 and 702.45. In particular, the ECEL value incorporated 
into the WCPP is derived from the analysis in the 2020 Risk Evaluation 
for Carbon Tetrachloride; it likewise represents decisions based on the 
best available science and the weight of the scientific evidence (Ref. 
9). The ECEL value of 0.03 ppm as an 8-hour TWA is based on the point 
of departure for liver cancer identified in the 2020 Risk Evaluation 
for Carbon Tetrachloride, which is the concentration at which an adult 
human would be unlikely to suffer adverse effects if exposed for a 
working lifetime, including susceptible subpopulations.
    The extent to which the various information, procedures, measures, 
methods, protocols, methodologies, or models, as applicable, used in 
EPA's decisions have been subject to independent verification or peer 
review is adequate to justify their use, collectively, in the record 
for this rule. Additional information on the peer review and public 
comment process, such as the peer review plan, the peer review report, 
and the Agency's

[[Page 49217]]

response to public comments, can be found at EPA's risk evaluation 
docket (Docket ID No. EPA-HQ-OPPT-2019-0499).

VIII. Requests for Comment

    While EPA is requesting public comment on all aspects of this 
proposal, the Agency is soliciting feedback from the public on specific 
issues throughout this proposed rule. This unit summarizes those 
specific requests for comments.
    1. EPA is requesting public comment on the proposed regulatory 
action and alternative regulatory action.
    2. EPA is requesting public comment regarding the need for 
exemptions from the rule (and under what specific circumstances) 
pursuant to the provisions of TSCA section 6(g).
    3. EPA is requesting comment on, in lieu of proposing a 6(g) 
exemption in a separate regulatory action, whether any elements of the 
primary alternative regulatory action should be considered in 
combination with elements of the proposed regulatory action as EPA 
develops the final regulatory action.
    4. EPA requests public comments regarding the number of small 
businesses subject to the rule, including conditions of use for which 
EPA did not identify any affected small businesses and the potential 
impacts of the rule on these small businesses.
    5. EPA is requesting comment on the proposed rule's rationale.
    6. EPA is soliciting comment regarding an ECEL action level that is 
two-thirds the ECEL and any associated provisions related to the ECEL 
action level when the ECEL is significantly lower than the OSHA PEL.
    7. EPA is requesting 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. EPA is interested in 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.
    8. EPA requests comment on whether EPA should promulgate 
definitions for the conditions of use covered by the 2020 Risk 
Evaluation for Carbon Tetrachloride, and, if so, whether the 
descriptions in Unit III.B.1. are consistent with the conditions of use 
evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride and 
whether they provide a sufficient level of detail such that they would 
improve the clarity and readability of the regulation if promulgated.
    9. EPA is requesting comment on whether a shorter timeframe for 
prohibition of the industrial and commercial use of CTC in DoD 
specialty uses should be considered.
    10. As a result of the AIM Act/Kigali Amendment and to improve the 
economic analysis, EPA is requesting comment on how much CTC production 
and use will increase as a result of the move to HFOs; how quickly the 
decline in HFCs will lead to increased production of CTC (for HFOs); 
how much industry currently relies on CTC for HFOs; and whether 
alternatives to CTC for HFOs could be developed. EPA is also requesting 
comment on how possible increases in CTC use for larger HFO production 
would affect operations. Would facilities hire more workers, shift 
current workers to different tasks, build more sites, or run existing 
at higher capacity? Also, EPA is requesting comment on whether the 
Agency should prohibit the use of CTC in the production of HCFCs, HFCs, 
and PCE instead of requiring an WCPP with an ECEL and DDCC requirements 
or whether the Agency should require prescriptive controls, including 
respirators and dermal PPE, for these uses.
    11. EPA is requesting comment on whether CTC is still being used in 
any of the conditions of use EPA is proposing to prohibit, if 
additional time is needed, for example, if CTC is still being used and 
additional time is needed to cease use, and on whether the effective 
dates should be staggered by lifecycle.
    12. EPA is requesting 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 is proposing to prohibit.
    13. EPA is requesting comment on the proposed implementation 
timeframe for the WCPP requirements; EPA proposes that they would take 
effect 180 days after publication of the final rule, at which point 
entities would be required to conduct initial exposure monitoring and 
develop an exposure control plan.
    14. EPA is soliciting comments regarding when and how owners and 
operators could conduct initial exposure monitoring to ensure that it 
is representative of all tasks likely to be conducted by potentially 
exposed persons.
    15. EPA is soliciting comments regarding the proposed requirement 
for recurring 5-year initial exposure monitoring, which differs from 
OSHA's existing monitoring requirements under 29 CFR 1910.1052.
    16. EPA requests comment on the timeframes for periodic and 
additional exposure monitoring outlined in Unit IV.A.1.b.ii.
    17. EPA is requesting public comments on the proposed conditions 
for discontinuation of periodic exposure monitoring for the CTC ECEL as 
part of implementation of the WCPP.
    18. EPA requests comment on the use of area source monitoring 
instead of personal breathing zone as a representative sample of 
exposures when monitoring for the ECEL.
    19. EPA requests comment on available methods to measure the 
effectiveness of controls in preventing or reducing the potential for 
direct dermal contact to CTC.
    20. EPA is requesting comment on available monitoring methods, such 
as charcoal patch testing, as feasible or effective methods to measure 
potential direct dermal contact with CTC.
    21. EPA requests comment on how the proposed prohibition of 
increased releases of CTC to outdoor air associated with the 
implementation of the WCPP/ECEL may impact the availability, 
feasibility, or cost of engineering controls as a means to reduce 
workplace exposures to or below the proposed ECEL.
    22. EPA is soliciting comment on requiring warning signs to 
demarcate regulated areas, such as the requirements found in OSHA's 
General Industry Standard for Beryllium.
    23. EPA is soliciting comment on whether any of the requirements 
for the exposure control strategies, including EPA's proposed 
prohibition of rotating work schedules for potentially exposed persons, 
should be modified and considered in the final rule.
    24. EPA requests comment on the requirements proposed for 
appropriate PPE selection, the effectiveness of PPE in preventing 
direct dermal contact with CTC in the workplace, and general absorption 
and permeation effects to PPE from direct dermal exposure.
    25. EPA requests comment on the impact on effectiveness of rinsing 
and reusing certain types of PPE, either gloves or protective clothing 
and gear.
    26. EPA is requesting comment on whether there should be a 
requirement to replace cartridges or canisters of respirators after a 
certain number of hours, such as the requirements found in OSHA's 
General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a 
requirement for a minimum service life of non-powered

[[Page 49218]]

air-purifying respirators such as the requirements found in OSHA's 
General Industry Standard for Benzene (29 CFR 1910.1028(g)(3)(D)).
    27. EPA is soliciting comment on whether 9 months is a reasonable 
timeframe to implement a respiratory protection program or if 
additional time is needed.
    28. EPA requests comment on the degree to which additional guidance 
related to use of dermal PPE might be appropriate.
    29. EPA is requesting comment on how owners and operators can 
engage with potentially exposed persons on the development and 
implementation of an exposure control plan and PPE program.
    30. EPA requests comment on the 15-day timeframe for notification 
of potentially exposed persons of monitoring results and the 
possibility for a shorter timeframe, such as 5 days.
    31. EPA will consider compliance timeframes that may be 
substantially longer or shorter than the proposed timeframes for owners 
or operators to conduct initial exposure monitoring for the ECEL, 
implement the DDCC requirements, and any procedural adjustments needed 
to comply with the requirements outlined as part of the WCPP, and is 
requesting comment on the feasibility of the proposed compliance 
timeframes, as well as longer or shorter timeframes.
    32. EPA is soliciting comment regarding the exposure control 
strategies required under the WCPP and documented in the exposure 
control plan, including the implementation of additional engineering 
controls, increase frequency of exposure monitoring, implementation of 
respiratory and dermal protection and notification of monitoring, and 
associated costs with the WCPP exposure control strategies 
implementation.
    33. EPA is requesting comment on the types and costs of 
administrative and engineering controls that potentially regulated 
facilities use or could potentially use to control exposures in the 
workplace. EPA is also requesting comment on the baseline use of each 
identified control. In addition, EPA is requesting comment regarding 
the effectiveness of any existing administrative and engineering in 
controlling and/or reducing exposures. EPA requests comment on whether 
any engineering and administrative controls known by potentially 
affected sites would have higher or lower per-facility costs than the 
annualized per-facility costs in the proposed regulatory action. For 
example, Executive Summary table ES-4 of the Economic Analysis shows 
that, annualized over 20 years at a 3% discount rate, the per-facility 
cost of the proposed regulatory action in the Manufacturing condition 
of use would be $604,787 (this condition of use has an average of 300 
workers per site), and the per-facility cost for the Processing as a 
reactant condition of use would be $231,954 (this condition of use has 
an average of 113 workers per site).
    34. EPA is soliciting comment on non-prescriptive DDCC requirements 
as compared to the prescriptive workplace controls of dermal PPE EPA is 
proposing in Unit IV.A.2.
    35. EPA requests comment on whether it should incorporate in the 
rule best practices to ensure proper and adequate performance of 
laboratory fume hoods, such as those identified in OSHA's 29 CFR 
1910.1450, Appendix A National Research Council Recommendations 
Concerning Chemical Hygiene in Laboratory.
    36. EPA is requesting comment on whether it should incorporate in 
the rule specific requirements for laboratory hoods, such as design 
characteristics and/or a range of face velocities, or some other type 
of performance standard.
    37. EPA is proposing to require that each owner or operator of a 
workplace engaged in the industrial and commercial of CTC as a 
laboratory chemical ensure fume hoods are in use and functioning 
properly and that dermal PPE is provided to all potentially exposed 
persons with direct dermal contact with CTC within 6 months after 
publication of the final rule. While EPA is proposing requirements 
within 6 months of publication of the final rule, the Agency will 
consider compliance timeframes that may be substantially longer or 
shorter than the proposed timeframe and is soliciting comments on the 
feasibility of the proposed compliance timeframes, as well as longer or 
shorter timeframes.
    38. EPA is proposing that the prohibition of certain industrial and 
commercial uses described in Unit IV.A.3 would occur 180 days after the 
publication date of the final rule for manufacturers, processors, 
distributors, and industrial and commercial uses. EPA requests comment 
on whether CTC is still used in any of these conditions of use and 
whether additional time is needed or if prohibitions should be 
staggered by lifecycle, for example, for products affected by proposed 
restrictions to clear the channels of trade.
    39. EPA requests comments on the appropriateness of identified 
compliance timeframes for recordkeeping and downstream notification 
requirements described in Unit IV.A.4.
    40. Primary alternative regulatory action: EPA requests comment on 
the primary alternative regulatory action and whether any elements of 
the primary alternative regulatory action should be considered in 
combination with elements of the proposed regulatory action as EPA 
develops the final regulatory action. Examples of possible combinations 
in approaches may include, but are not limited to: adoption of the 
primary alternative regulatory action for certain conditions of use and 
the proposed regulatory action for other conditions of use; allowing 
regulated entities to opt out of requirements described in the proposed 
regulatory action by complying with requirements described in the 
primary alternative regulatory action; or allowing regulated entities 
to opt out of requirements described in the primary alternative 
regulatory action by complying with requirements described in the 
proposed regulatory action.
    41. Primary alternative regulatory action: EPA requests comment on 
engineering controls, administrative controls, PPE, and any 
combinations of these controls that reduce inhalation exposures to at 
or below the ECEL or prevent dermal exposure from direct handling of 
CTC or from contact with surfaces that may be contaminated with CTC and 
any associated cost related to these controls.
    42. Primary alternative regulatory action: EPA is soliciting 
comments on information to support the consideration of other APFs that 
are also protective of the highest possible lengths of exposures and on 
whether or how monitoring should be considered for the alternative 
regulatory action.
    43. Primary alternative regulatory action: EPA is requesting 
comment on whether any of the uses the Agency is proposing to prohibit 
are ongoing and if EPA should consider a WCPP for those conditions of 
use of CTC.
    44. Primary alternative regulatory action: EPA is requesting 
comment on non-prescriptive DDCC requirements as compared to the 
prescriptive workplace controls of dermal PPE EPA is proposing in Unit 
IV.A.2.
    45. The Agency is requesting comment on the availability of 
technically and economically feasible alternatives that are comparably 
beneficial to health or the environment for CTC.
    46. EPA is requesting comment on the types and costs of 
technologies firms would adopt to comply with the prohibition on 
increased releases of CTC

[[Page 49219]]

to outdoor air associated with engineering controls used in the 
implementation of the WCPP/ECEL.
    47. EPA requests comment on whether and to what extent these 
technologies would reduce CTC emissions at facilities that adopt them 
to or below emissions levels that existed prior to implementation of 
the WCPP/ECEL.
    48. EPA is seeking comment on its conclusions that its proposed 
action in combination with the emissions standards resulting from 
existing NESHAP requirements would reduce risk sufficiently to the 
general population and fenceline communities, and whether, consistent 
with TSCA section 9(b), any other statutory authorities administered by 
EPA should be used to take additional regulatory action identified as 
necessary to protect against such risk.
    49. EPA is soliciting comment on whether EPA should require ambient 
air monitoring at fenceline locations or facility emissions source 
monitoring to demonstrate compliance with the proposed requirement that 
engineering controls that are implemented as part of a WCPP/ECEL under 
this rule would not result in the ventilation of more CTC outside.
    50. EPA is soliciting comment on the need for and associated costs 
of ambient air monitoring at fenceline locations or facility emissions 
source monitoring, as well as information on the frequency and nature 
of air monitoring EPA should consider including as requirements in the 
final rule (such as a detection limit for CTC).
    51. EPA is soliciting comment on whether, if EPA does not finalize 
the proposed prohibition on increased releases of CTC to ambient air 
outside of the workplace associated with implementation of the WCPP/
ECEL, EPA should require monitoring to alert EPA to any increased 
emissions to ambient air associated with WCPP/ECEL implementation so 
that the Agency may take appropriate action.

IX. 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. November 2020. 
(EPA-HQ-OPPT-2019-0499-0047).
2. EPA. Correction of Dermal Acute Hazard and Risk Values in the 
Final Risk Evaluation for Carbon Tetrachloride. August 4, 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. (EPA-HQ-OPPPT-2016-
0733-0120).
4. EPA. Economic Analysis of the Proposed Regulation of Carbon 
Tetrachloride. June 2023.
5. EPA. Email correspondence with Syngenta on Carbon Tetrachloride 
Alternatives. October 2021.
6. EPA. Regulatory Actions Pertaining to Carbon Tetrachloride. 2022.
7. Department of Labor, Occupational Safety and Health 
Administration. Permissible Exposure Limits--Annotated Tables. 
https://www.osha.gov/annotated-pels (accessed March 2023).
8. National Institute for Occupational Safety and Health. Hierarchy 
of Controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html 
(accessed March 2023).
9. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational Use 
of Carbon Tetrachloride. February 2021. (EPA-HQ-OPPT-2020-0592-
0007). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0007.
10. Halogenated Solvents Industry Alliance, Inc. (HSIA). Comments 
submitted to EPA on the Draft Risk Assessment for Carbon 
Tetrachloride. January 24, 2020.
11. American Conference of Governmental Industrial Hygienists 
(ACGIH). Carbon Tetrachloride. 2001.
12. National Institute for Occupational Safety and Health (NIOSH). 
Criteria for a Recommended Standard: Occupational Exposure to Carbon 
Tetrachloride. 1975.
13. EPA. EPA Announces Path Forward for TSCA Chemical Risk 
Evaluations. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
14. EPA. Science Advisory Committee on Chemicals Meeting Minutes and 
Final Report ``Draft TSCA Screening Level Approach for Assessing 
Ambient Air and Water Exposures to Fenceline Communities Version 
1.0.'' No. 2022-01. May 2022. (EPA-HQ-OPPT-2021-0415-0095). https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0415-0095.
15. EPA. Federalism Consultation on Forthcoming Proposed Rulemaking 
for Carbon Tetrachloride under TSCA Section 6(a). February 17, 2021.
16. EPA. Tribal Consultations on Forthcoming Proposed Rulemaking for 
Carbon Tetrachloride. January 6, 2021 and January 12, 2021.
17. EPA. Environmental Justice Consultations on Forthcoming Proposed 
Rulemaking for Carbon Tetrachloride under TSCA Section 6(a). 
February 2, 2021 and February 18, 2021.
18. EPA. Stakeholder Meeting List. 2023.
19. EPA. EPA's Policy on Children's Health. October 2021. https://www.epa.gov/children/childrens-health-policy-and-plan#A1.
20. EPA. Problem Formulation of the Risk Evaluation for Carbon 
Tetrachloride. June 2018. (EPA-HQ-OPPT-2016-0733). https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0733-0068.
21. 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-2018-0427-0048.
22. EPA. Meeting with the American Chemistry Council (ACC) on Risk 
Management under TSCA section 6, Carbon Tetrachloride. January 2023.
23. Occupational Safety and Health Administration. Recommended 
Practices for Safety and Health Programs. OSHA 3885 October 2016. 
https://www.osha.gov/sites/default/files/publications/OSHA3885.pdf.
24. Occupational Safety and Health Administration. Personal 
Protective Equipment. OSHA 3151-02R 2023. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
25. The Program Executive Office, Assembled Chemical Weapons 
Alternatives (PEO ACWA). U.S. Chemical Weapons Destruction 2018. May 
2018. https://www.youtube.com/watch?v=MaLz0dX_c78.
26. Halogenated Solvents Industry Alliance, Inc. (HSIA). Comments 
submitted to EPA on the Carbon Tetrachloride Risk Evaluation and the 
Risk Management Process. April 28, 2021.
27. Occidental Chemical Corporation. Comments submitted to EPA on 
the Risk Management of Carbon Tetrachloride. February 15, 2022.
28. Chemours Company. Comments submitted to EPA on Carbon 
Tetrachloride (CASRN 56-23-5); Draft Revision to TSCA Risk 
Determination. September 30, 2022.
29. Alliance for Responsible Atmospheric Policy. Comments submitted 
to EPA on the Draft Revision to Toxic Substances Control Act (TSCA) 
Risk Determinations for Perchloroethylene (PCE); Methylene Chloride; 
Trichloroethylene (TCE); and Carbon Tetrachloride. September 9, 
2022.
30. EPA. Meeting with Honeywell on Risk Management under TSCA 
section 6, Carbon Tetrachloride. July 2021.
31. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Tetrachloroethylene 
(Perchloroethylene). February 10, 2017. (EPA-HQ-OPPT-2016-0732). 
https://www.regulations.gov/docket/EPA-HQ-OPPT-2016-0732.
32. EPA. Carbon Tetrachloride: Fenceline Technical Support--Ambient 
Air Pathway. October 2022.
33. U.S. EPA. August 2022. Technical Support Document EPA's Air 
Toxics Screening Assessment 2018 AirToxScreen TSD. Document number

[[Page 49220]]

EPA-452/B-22-002. https://www.epa.gov/system/files/documents/2023-02/AirToxScreen_2018%20TSD.pdf.
34. 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.
35. EPA. Carbon Tetrachloride: Fenceline Technical Support--Water 
Pathway. October 2022.
36. Intergovernmental Panel on Climate Change (IPCC). 2014. Climate 
Change 2013. The Physical Science Basis. https://www.ipcc.ch/site/assets/uploads/2018/02/WG1AR5_all_final.pdf.
37. Luceta McRoy. February 10, 2017. Factors Associated with Asthma 
ED Visit Rates among Medicaid-enrolled Children: A Structural 
Equation Modeling Approach. https://pubmed.ncbi.nlm.nih.gov/30519630/.
38. EPA. Meeting with Halogenated Solvents Industry Alliance (HSIA) 
on the Use of Carbon Tetrachloride, Trichloroethylene, and 
Perchloroethylene and the Risk Management Process. August 2021.
39. Office of Management and Budget. March 31, 1995. 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.
40. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA): Carbon Tetrachloride; 
Regulation under the Toxic Substances Control Act (TSCA) (Proposed 
Rule; RIN 2070-AK82). June 2023.
41. Kevin Ashley. 2015. Harmonization of NIOSH Sampling and 
Analytical Methods with Related International Voluntary Consensus 
Standards. J Occup Environ Hyg. 12(7): D107-15.

X. 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 OMB for Executive Order 12866 review. 
Documentation of any changes made in response to the Executive Order 
12866 review is available in the docket.
    EPA prepared an economic analysis of the potential costs and 
benefits associated with this action, which is also available in the 
docket and summarized in Units I.E. and VI.D. (Ref. 4).

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted to OMB for review and comment 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. 2744.01 (Ref. 40). You can find 
a copy of the ICR in the docket, and it is briefly summarized here.
    The information collection requirements contained in the proposed 
rule include:
     The preparation and retention of an exposure control plan 
in accordance with proposed 40 CFR 751.707(d);
     The preparation and delivery of exposure monitoring result 
notifications to exposed persons in accordance with proposed 40 CFR 
751.707(b)(3)(v);
     Third-party downstream notifications in accordance with 
proposed 40 CFR 751.711 from companies that ship CTC to companies 
downstream in the supply chain through the SDS to communicate the 
proposed prohibitions; and
     The preparation and retention of related records in 
accordance with proposed 40 CFR 751.713, including 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: Manufacturers (including importers), 
processors, distributors, and industrial and commercial users of carbon 
tetrachloride. See Unit I.A. and the ICR for more details.
    Respondent's obligation to respond: Mandatory (15 U.S.C. 2605).
    Estimated number of respondents: 71.
    Frequency of response: On occasion.
    Total estimated burden: 85,676 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $13,172,979 (per year), includes $8,516,686 
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. After display in the Federal 
Register when approved, the OMB control numbers for EPA regulations in 
40 CFR are listed in 40 CFR part 9 and displayed on the form and 
instructions or collection portal, as applicable.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to the EPA using the docket identified at 
the beginning of this proposed rule. You may also send your ICR-related 
comments to OMB's Office of Information and Regulatory Affairs using 
the interface at https://www.reginfo.gov/public/do/PRAMain. Find this 
particular information collection by selecting ``Currently under 
Review--Open for Public Comments'' or by using the search function. OMB 
must receive comments no later than August 28, 2023. EPA will respond 
to any ICR-related comments in the 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 proposed rule. The Agency 
identified four small firms in the small entity analysis that are 
potentially subject to the proposed rule. It is estimated that three of 
the four small companies would incur a rule cost-to-company revenue 
impact ratio of less than one percent, and one company would experience 
an impact of 2.3 percent. The company estimated to experience a 2.3 
percent rule cost-to-revenue impact would potentially be subject to the 
proposed rule under the disposal condition of use, which would require 
a WCPP under the proposed regulatory action or prescriptive controls 
(PPE) under the primary alternative regulatory action. Of the other 
three companies, one falls under the disposal COU, one under the 
manufacturing/import COU, and one could not be determined based on 
available information. To avoid understating impacts to small entities, 
EPA used the highest per-facility cost presented in the EA ($604,787). 
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. 4), 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

[[Page 49221]]

to have a significant impact on a substantial number of small entities. 
EPA requests public comments regarding on the number of small 
businesses subject to the rule, including use categories for which EPA 
did not identify any affected small businesses, and on the potential 
impacts of the rule on these small businesses.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and would not 
significantly or uniquely affect small governments. The action would 
affect entities that use CTC; it is not expected to affect State, local 
or Tribal governments because the use of carbon tetrachloride by 
government entities is minimal. The total quantified annualized social 
cost for the proposed rule under the proposed option is $18,804,794 (at 
3% discount rate) and $18,503,723 (at 7% discount rate), which does not 
exceed the unfunded mandate threshold of $100 million.

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. As 
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA 
section 6(a) to address the unreasonable risk presented by a chemical 
substance has the potential to trigger preemption of laws, criminal 
penalties, or administrative action by a State or political subdivison 
of a State that are: (1) Applicable to the same chemical substance as 
the rule under TSCA section 6(a); and (2) designed to prohibit or 
otherwise restrict the manufacture, processing, or distribution in 
commerce or use of that same chemical. TSCA section 18(c)(3) applies 
that preemption only to the ``hazards, exposures, risks, and uses or 
conditions of use'' of such chemical included in the final TSCA section 
6(a) rule.
    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. 18). 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 Order 13175 (65 FR 67249, November 9, 2000). This rulemaking 
would not have substantial direct effects on Tribal governments because 
CTC is not manufactured, processed, or distributed in commerce by 
Tribes and would not impose substantial direct compliance costs on 
Tribal governments. Thus, Executive Order 13175 does not apply to this 
action. EPA nevertheless consulted with Tribal officials during the 
development of this action, consistent with the EPA Policy on 
Consultation and Coordination with Indian Tribes. Consistent with the 
EPA Policy on Consultation and Coordination with Indian Tribes, EPA 
consulted with Tribal officials during the development of this action. 
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 
risk managers 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 is 
seeking from Tribes (Ref. 16). 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. 16). Tribal members were encouraged to provide 
additional comments after the teleconferences.

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 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 
risk addressed by this action will have a disproportionate effect on 
children. 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 III.A.3, III.B.3, VI.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. However, 
EPA's Policy on Children's Health applies to this action. Information 
on how the Policy was applied is available under Unit III.A.3.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' under 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), the Agency proposes not to require the use of specific, 
prescribed analytic methods. Rather, the Agency plans to 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

[[Page 49222]]

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 
carbon tetrachloride 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. 9). EPA recognizes that there may be 
voluntary consensus standards that meet the proposed criteria (Ref. 
41). EPA requests comments on whether it should incorporate such 
voluntary consensus standards in the rule and seeks information in 
support of such comments regarding the availability and applicability 
of voluntary consensus standards that may achieve the sampling and 
analytical requirements of the rule in lieu of the PBMS approach.

J. Executive Orders 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
Federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color and/or indigenous 
peoples) and low-income populations.
    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 
people of color, low-income populations and/or indigenous peoples. 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 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. In cases where environmental justice communities are also 
fenceline communities, EPA expects that the proposed prohibition of 
increased emissions associated with WCPP requirements would prevent new 
health and environmental impacts due to this proposed action.
    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 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 
people of color, low-income populations, and/or indigenous peoples. EPA 
was unable to quantify the distributional effects of the regulatory 
action under consideration and compare them to baseline conditions. 
Current uncertainties and lack of data regarding exposure reductions 
proposed in this action limit EPA's ability to assess risk reductions 
compared to baseline conditions. One limitation to assessing whether 
the action is likely to result in disproportionate and adverse effects 
on people of color, low-income populations, and/or indigenous peoples 
is a lack of data 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, such as minority 
populations, low-income populations, and indigenous peoples. 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. 17). 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 the review under Executive Order 12898 
is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic 
Analysis (Ref. 4). 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 (Ref. 17).

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, EPA proposes to 
amend 40 CFR Chapter I as follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority: 15 U.S.C. 2605, 15 U.S.C 2625(l)(4).

0
2. Amend Sec.  751.5 by adding in alphabetical order definitions for 
``Authorized person,'' ``Direct dermal contact'', ``ECEL'', ``Exposure 
group'', ``Owner or operator'', ``Potentially exposed person'', and 
``Regulated area'' to read as follows:


Sec.  751.5  Definitions.

* * * * *
    Authorized person means any person specifically authorized by the 
owner or operator to enter, and whose duties require the person to 
enter, a regulated area.
* * * * *
    Direct dermal contact means direct handling of a chemical substance 
or mixture or skin contact with surfaces that may be contaminated with 
a chemical substance or mixture.

[[Page 49223]]

    ECEL is an Existing Chemical Exposure Limit and means an airborne 
concentration generally calculated as an eight (8)-hour time-weighted 
average (TWA).
* * * * *
    Exposure group means a group consisting of every person performing 
the same or substantially similar operations in each work shift, in 
each job classification, in each work area where inhalation exposure to 
chemical substances or mixtures is reasonably likely to occur and be 
similar.
    Owner or operator means any person who owns, leases, operates, 
controls, or supervises a workplace covered by this subpart.
* * * * *
    Potentially exposed person means any person who may be 
occupationally exposed to a chemical substance or mixture in a 
workplace as a result of a condition of use of that chemical substance 
or mixture.
    Regulated area means an area established by the regulated entity to 
demarcate areas where airborne concentrations of a specific chemical 
substance exceed, or there is a reasonable possibility they may exceed, 
the ECEL or the EPA Short-Term Exposure Limit (STEL).
0
3. Add new 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 (WCCP).
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.

    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.


Sec.  751.703  Definitions.

    The definitions in subpart A of part 751 apply to this subpart 
unless otherwise specified in this section. In addition, the following 
definitions apply to this subpart:
    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 [DATE 180 DAYS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register], 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.
    (ii) Industrial and commercial conditions of use:
    (A) Industrial and commercial use as an industrial processing aid 
in the manufacture of petrochemicals-derived products.
    (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.
    (C) Industrial and commercial use in metal recovery.
    (D) Industrial and commercial use as an additive.
    (b) Other prohibitions. After [DATE 365 DAYS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register], 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.


Sec.  751.707  Workplace Chemical Protection Program (WCPP).

    (a) Applicability. The provisions of this section apply to 
workplaces engaged in the following conditions of use of carbon 
tetrachloride, except to the 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 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.
    (8) Industrial and commercial use in the elimination of nitrogen 
trichloride in the production of chlorine and caustic soda.
    (9) Disposal.
    (b) Existing chemical exposure limit. (1) Eight-hour time-weighted 
average (TWA) ECEL. Beginning [9 MONTHS AFTER DATE OF PUBLICATION OF 
THE FINAL RULE IN THE Federal Register], or beginning 4 months after 
introduction of carbon tetrachloride into the workplace if carbon 
tetrachloride commences after [DATE 6 MONTHS AFTER DATE OF PUBLICATION 
OF THE FINAL RULE IN THE Federal Register], the owner or operator must 
ensure that no person is exposed to an airborne concentration of carbon 
tetrachloride in excess of 0.03 parts of carbon tetrachloride per 
million parts of air (0.03 ppm) as an eight (8)-hour TWA, in accordance 
with the requirements of paragraph (d)(1)(i) of this section and, as 
applicable, paragraph (f) of this section.
    (2) ECEL action level. The owner or operator must establish an ECEL 
action level of 0.02 parts of carbon tetrachloride per million parts of 
air (0.02 ppm) as an eight (8)-hour TWA for purposes of monitoring the 
ECEL.
    (3) Exposure monitoring.
    (i) General.
    (A) Owners or operators must determine each potentially exposed 
person's exposure 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 potentially exposed person or 
of each potentially exposed person's exposure performing the same or 
substantially similar operations in each work shift, in each job 
classification, in each work area.
    (B) Representative 8-hour TWA exposures must be determined on the 
basis of one or more samples representing full-shift exposure of at 
least one person that represents, and does not underestimate, the 
potential exposure of every person in each exposure group and that 
represents the most highly exposed person under

[[Page 49224]]

reasonably foreseeable conditions of use.
    (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.
    (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 at an appropriate level of 
detection for the ECEL and ECEL action level.
    (E) Owners and operators must re-monitor within 15 working days 
after receipt of any exposure monitoring when results indicate non-
detect or air monitoring equipment malfunction, 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 exposure monitoring.
    (A) Each owner or operator who has a workplace or work operation 
covered by this section, except as provided for in paragraph 
(b)(3)(ii)(B) of this section, must perform initial exposure monitoring 
of potentially exposed persons regularly working in areas where carbon 
tetrachloride is present.
    (B) The initial exposure monitoring required in paragraph 
(b)(3)(ii)(A) of this section must be completed for workplaces 
manufacturing, processing, or using carbon tetrachloride as of [DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register] by [DATE 180 
DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal 
Register] or, for workplaces that begin using carbon tetrachloride 
after [DATE OF PUBLICATION OF FINAL RULE IN THE Federal Register], 
within 30 days of introduction of carbon tetrachloride into the 
workplace, whichever is later. Where the owner or operator used carbon 
tetrachloride and has monitoring within five years prior to [DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register] 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 paragraph (b)(3)(ii)(A) of this section.
    (iii) Periodic exposure monitoring. The owner or operator must 
establish an exposure monitoring program for periodic monitoring of 
exposure to carbon tetrachloride in accordance with table 1 to this 
paragraph (b)(3)(iii).

 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 3 months of
 above the ECEL (>0.03 ppm 8-hour TWA).   the most recent exposure
                                          monitoring.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is at   required within 6 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 5 years of the
 taken at least seven days apart within   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 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 action 
level 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-up, shutdown, malfunctions or other breakdowns 
occur that may lead to exposure to potentially exposed persons, the 
owner or operator must conduct additional exposure monitoring (using 
personal breathing zone sampling) after the cleanup, repair or remedial 
action.
    (v) Notification of exposure monitoring results.
    (A) The owner or operator must inform persons whose exposures are 
represented by the monitoring of the monitoring results within 15 
working days.
    (B) This notification must include the following:
    (1) Exposure monitoring results;
    (2) Identification and explanation of the ECEL and ECEL action 
level in plain language;
    (3) Explanation of corresponding required respiratory protection as 
described in paragraph (f) of this section;
    (4) Descriptions of actions taken by the owner or operator to 
reduce exposure to or below the ECEL;
    (5) Quantity of carbon tetrachloride in use;
    (6) Location of carbon tetrachloride use;
    (7) Manner of carbon tetrachloride use;
    (8) Identified releases of carbon tetrachloride; and
    (9) Whether the airborne concentration of carbon tetrachloride 
exceeds the ECEL.
    (C) Notice must be provided in plain language writing, in a 
language that the person understands, to each potentially exposed 
person 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.
    (4) Regulated areas.
    (i) Beginning [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE Federal Register], or beginning 4 months after introduction 
of carbon tetrachloride into the workplace in carbon tetrachloride use 
commences after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE Federal Register], the owner or operator must establish and 
maintain a regulated area wherever any person's exposure to airborne 
concentrations of carbon tetrachloride exceeds or can reasonably be 
expected to exceed the ECEL.

[[Page 49225]]

    (ii) The owner or operator must limit access to regulated areas to 
authorized persons.
    (iii) 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) The owner or operator must supply a respirator that complies 
with the requirements of 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.
    (v) An owner or operator who has implemented all feasible 
engineering, work practice and administrative controls as required in 
paragraph (d)(1)(i) of this section, and who has established a 
regulated area as required by paragraph (b)(4)(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.
    (vi) The owner or operator must ensure that, within a regulated 
area, persons do not engage in non-work activities which may increase 
carbon tetrachloride exposure.
    (vii) 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 seal or performance.
    (c) Direct dermal contact controls (DDCC). Beginning [DATE 180 DAYS 
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register] or 
within 30 days of introduction of carbon tetrachloride into the 
workplace, 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 in accordance with 
the requirements of paragraph (d)(1)(ii) of this section and, as 
applicable, paragraph (f) of this section.
    (d) Exposure control procedures and plan. (1) Methods of 
compliance. (i) ECEL.
    (A) The owner or operator must institute 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.
    (B) Wherever the feasible exposure controls, including elimination, 
substitution, engineering controls, and administrative controls, which 
can be instituted are not sufficient to reduce exposure to or below the 
ECEL, the owner or operator must use them to reduce exposure to the 
lowest levels achievable by these controls and must supplement them by 
the use of respiratory protection that complies with the requirements 
of paragraph (f) of this section. Where an owner or operator cannot 
demonstrate exposure below the ECEL, including through the use of 
engineering controls or work practices, and has not demonstrated that 
it has supplemented feasible exposure controls with respiratory 
protection that complies with the requirements of paragraph (f) of this 
section, this will constitute a failure to comply with the ECEL.
    (C) The owner or operator must maintain the effectiveness of 
engineering controls and administrative controls instituted under 
paragraph (d)(1)(i)(A) of this section.
    (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.
    (E) The owner or operator must not implement a schedule of 
personnel rotation as a means of compliance with the ECEL.
    (F) The owner or operator must document their exposure control 
strategy and implementation in an exposure control plan in accordance 
with this paragraph (d).
    (ii) Direct dermal contact controls (DDCC).
    (A) The owner or operator must institute elimination, substitution, 
engineering controls, or administrative controls to prevent direct 
dermal contact with carbon tetrachloride except to the extent that the 
employer owner or operator can demonstrate that such controls are not 
feasible.
    (B) Wherever the feasible exposure controls, including elimination, 
substitution, engineering controls, and administrative controls, which 
can be instituted are not sufficient to prevent direct dermal contact 
with carbon tetrachloride, the owner or operator must use them to 
reduce direct dermal contact to the extent achievable by these controls 
and must supplement them by the use of dermal protection that complies 
with the requirements of paragraph (f) of this section. Where an owner 
or operator cannot demonstrate that direct dermal contact is prevented, 
including through the use of engineering controls or work practices, 
and has not demonstrated that it has supplemented feasible exposure 
controls with dermal protective equipment that complies with the 
requirements of paragraph (f) of this section, this will constitute a 
failure to comply with the DDCC requirements.
    (C) The owner or operator must maintain the effectiveness of 
engineering controls and administrative controls instituted under 
paragraph (d)(1)(ii)(A) of this section.
    (2) Exposure control plan requirements. Beginning [DATE 12 MONTHS 
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register] 
owners and operators must include and document in an exposure control 
plan the following:
    (i) Identification and rationale of exposure controls selected: 
elimination of carbon tetrachloride, substitution of carbon 
tetrachloride, engineering controls, and administrative controls to 
reduce inhalation 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 carbon tetrachloride in the workplace, and the 
rationale explaining why each exposure control was selected (e.g., the 
hierarchy of controls, feasibility, effectiveness, or other relevant 
considerations);
    (ii) If elimination of carbon tetrachloride, substitution of carbon 
tetrachloride, engineering controls or administrative controls were not 
selected, document the efforts identifying why these are not feasible, 
not effective, or otherwise not implemented;
    (iii) Actions taken to implement exposure controls selected, 
including proper installation, maintenance, training or other steps 
taken;
    (iv) Description of any regulated area and how it is demarcated, 
and identification of authorized persons; and description of when the 
owner or operator expects exposures may be likely to exceed the ECEL;
    (v) 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;
    (vi) Regular inspections, evaluations, and updating of the exposure 
controls no less frequent than every five years to ensure effectiveness 
and confirmation that all persons are implementing them accordingly; 
and

[[Page 49226]]

    (vii) Occurrence and duration of any change in the production, 
process, control equipment, personnel or work practices and explanation 
of why the owner or operator may expect such change to result in new or 
additional exposures above the ECEL or not and occurrence and duration 
of any other change that may result in new or additional exposures 
above the ECEL have occurred;
    (viii) Occurrence and duration of any start-up, shutdown, or 
malfunction of the facility that causes air concentrations to be above 
the ECEL or any direct dermal contact with carbon tetrachloride to 
occur during use of the substance and subsequent corrective actions 
taken during start-up, shutdown, or malfunctions to mitigate exposures 
to carbon tetrachloride; and
    (ix) Availability of the exposure control plan, exposure monitoring 
records, respiratory protection program documentation, dermal PPE 
program documentation, and any other associated records relevant to 
carbon tetrachloride exposure in the workplace for potentially exposed 
persons.
    (e) Workplace information and training. (1) Within six months after 
the date of initial monitoring or by [DATE 180 DAYS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register] if initial 
monitoring was completed prior to publication of the rule, the owner or 
operator must provide information and training for each person prior to 
or at the time of initial assignment to a job involving potential 
exposure to carbon tetrachloride.
    (2) 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.
    (3) The following information and training must be provided to all 
persons assigned to a job involving potential exposure 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; and
    (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 exposures may be above the ECEL or where there is potential for 
direct dermal contact with carbon tetrachloride;
    (iii) The principles of safe use and handling of carbon 
tetrachloride in the workplace, including specific measures the owner 
or operator has implemented to reduce inhalation exposures to at or 
below the ECEL or prevent direct dermal contact with CTC, such as work 
practices and PPE used;
    (iv) The health hazards associated with exposure to carbon 
tetrachloride in the workplace;
    (v) 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, etc.).
    (4) The owner or operator must retrain each potentially exposed 
person as necessary, but at minimum annually, to ensure that each such 
person maintains the requisite understanding of the principles of safe 
use and handling of carbon tetrachloride in the workplace.
    (5) Whenever there are workplace changes, such as modifications of 
tasks or procedures or the institution of new tasks or procedures, 
which increase exposure, and where those exposures exceed the ECEL 
action level or increase the potential for direct dermal contact with 
carbon tetrachloride, based on monitoring results or the analysis 
documented in the exposure control plan, the owner or operator must 
update the training as necessary to ensure that each potentially 
exposed person has the requisite proficiency.
    (f) Personal protective equipment (PPE). (1) Applicability. The 
provisions of this paragraph (f) apply to any owner or operator that is 
required to provide respiratory protection pursuant to paragraph 
(d)(1)(i)(B) of this section or dermal PPE pursuant to paragraphs (c) 
and (d)(1)(ii)(B) of this section.
    (2) Use and maintenance. Personal protective equipment 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.
    (3) Training. Owners and operators must provide training in 
accordance with 29 CFR 1910.132(f) to all persons required to use PPE 
prior to or at the time of initial assignment to a job involving 
potential exposure to carbon tetrachloride. For the purposes of this 
paragraph (f)(3), 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.
    (4) Refresher training. Owners and operators must retrain each 
potentially exposed person required to use PPE 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.
    (5) Respiratory protection.
    (i) Beginning [DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE Federal Register], or within 3 months after receipt of any 
exposure monitoring that indicates exposures exceeding the ECEL, or for 
those instances when the initial exposure monitoring is based on 
exposure monitoring data conducted within five years prior to 
publication of the rule and satisfies all other requirements of this 
section [DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN 
THE Federal Register], the owner or operator must supply a respirator 
where it is selected for use, selected in accordance with this 
paragraph (f), to each person who enters a regulated area and must 
ensure that all persons within the regulated area are using the 
provided respirators whenever carbon tetrachloride exposures exceed or 
can reasonably be expected to exceed the ECEL.
    (ii) Owners or operators must provide respiratory protection in 
accordance with 29 CFR 1910.134(a) through (l) except (d)(1)(iii) and 
as specified in this paragraph for persons exposed or who may be 
exposed to carbon tetrachloride in concentrations above the ECEL. For 
the purpose of this paragraph (f), the maximum use concentration (MUC) 
as used in 29 CFR 1910.134 must be calculated by multiplying the 
assigned protection factor (APF) specified for a respirator by the 
ECEL. For the purposes of this paragraph (f), provisions in 29 CFR 
1910.134(a) through (l) (except (d)(1)(iii)) 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 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 NIOSH-certified air-
purifying half mask or full facepiece respirator equipped with NIOSH-

[[Page 49227]]

approved organic vapor cartridges or canisters.
    (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-certified 
air-purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; any NIOSH-certified powered air-
purifying respirator equipped with NIOSH-approved organic vapor 
cartridges; or any NIOSH-certified continuous flow supplied air 
respirator equipped with a hood or helmet.
    (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-certified air-
purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; or any NIOSH-certified powered 
air-purifying respirator equipped with a tight-fitting facepiece and a 
NIOSH-approved organic vapor cartridge.
    (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-certified 
supplied air respirator equipped with a half mask or full facepiece and 
operated in a pressure demand or other positive pressure mode.
    (F) If the measured exposure concentration is greater than 30 ppm 
(1,000 times ECEL) or the concentration is unknown: Any NIOSH-certified 
self-contained breathing apparatus equipped with a full facepiece and 
operated in a pressure demand or other positive pressure mode; or any 
NIOSH-certified supplied air respirator equipped with a full facepiece 
and operated in a pressure demand or other positive pressure mode in 
combination with an auxiliary self-contained breathing apparatus 
operated in a pressure demand or other positive pressure mode.
    (iv) The respiratory protection requirements in this paragraph 
represent the minimum respiratory protection requirements, such that 
any respirator affording a higher degree of protection than the 
required respirator may be used.
    (v) When a person whose job requires the use of a respirator cannot 
use a negative-pressure respirator, the owner or operator must provide 
that person with a respirator that has less breathing resistance than 
the negative-pressure respirator, such as a powered air-purifying 
respirator or supplied-air respirator, when the person is able to use 
it and if it provides the person with adequate protection.
    (6) Dermal protection.
    (i) Beginning [DATE 180 DAYS AFTER THE DATE OF PUBLICATION OF THE 
FINAL RULE IN THE Federal Register] or within 30 days of introduction 
of carbon tetrachloride into the workplace, the owner or operator 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 workplace 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 paragraph (f)(6)(i), provisions 
in 29 CFR 1910.132(h) applying to an ``employer'' also applies equally 
to owners or operators.
    (ii) Owners or operators must select and provide dermal PPE in 
accordance with 29 CFR 1910.133(b) and additionally as specified in 
this paragraph 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)(6)(ii), 
provisions in 29 CFR 1910.133(b) applying to an ``employer'' also apply 
equally to owners or operators.
    (iii) 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. Dermal PPE must include, 
but is not limited to, the following items:
    (A) Impervious gloves selected based on specifications from the 
manufacturer or supplier.
    (B) Impervious clothing (e.g., long pants, long sleeved shirt) and 
protective gear covering the exposed areas of the body (e.g., arms, 
legs, torso and face).
    (iv) 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 of the 
clothing, or of the material used in construction of the clothing, or 
individually prepared third party testing, to establish that the 
clothing will be impervious to carbon tetrachloride alone and in 
combination with other chemical substances likely to be present in the 
work area.


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 
workplaces engaged in the industrial or 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 [DATE 180 DAYS 
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register], 
owners or operators must ensure fume hoods 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 work area during the industrial/commercial use of carbon 
tetrachloride 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 [DATE 365 DAYS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE Federal Register], the U.S. Department of Defense must 
ensure that 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 persons 
in the area during the industrial/commercial use of carbon 
tetrachloride as a laboratory chemical in chemical weapons destruction.
    (3) After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE Federal Register], owners or operators must ensure that all 
persons reasonably likely to be dermally exposed to carbon 
tetrachloride in a laboratory setting, 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 as outlined in Sec.  751.707(f)(2) and (6) and training on 
proper use of dermal PPE as outlined in Sec.  751.707(f)(3) and (4).
    (4) After [DATE 365 DAYS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE Federal Register], U.S. Department of Defense must ensure 
that all persons reasonably likely to be dermally exposed to carbon 
tetrachloride through the industrial and commercial use of carbon 
tetrachloride

[[Page 49228]]

as a laboratory chemical in chemical weapons destruction are provided 
with dermal PPE as outlined in Sec.  751.707(f)(2) and (6) and training 
on proper use of dermal PPE as outlined in Sec.  751.707(f)(3) and (4).


Sec.  751.711  Downstream Notification.

    (a) Beginning on [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE 
FINAL RULE IN THE Federal Register]. Each person who manufactures 
(including imports) carbon tetrachloride for any use must, prior to or 
concurrent with the shipment, notify persons 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 [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE 
FINAL RULE IN THE Federal Register], 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 [DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE 
IN THE Federal Register], this chemical is and may only be 
distributed in commerce or processed for the following purposes: 
Processing as a reactant/intermediate; Repackaging for use as a 
laboratory chemical; Recycling; Incorporation into formulation, 
mixture or reaction products in agricultural products manufacturing 
and other basic organic and inorganic chemical manufacturing; 
Industrial and commercial use as an industrial processing aid in the 
manufacture of agricultural products; Industrial and commercial use 
in the elimination of nitrogen trichloride in the production of 
chlorine and caustic soda; Industrial and commercial use as a 
laboratory chemical; Industrial and commercial specialty uses by the 
U.S. Department of Defense until [DATE 365 DAYS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register]; and 
Disposal.


Sec.  751.713  Recordkeeping Requirements.

    (a) General records. After [DATE 60 DAYS AFTER DATE OF PUBLICATION 
OF THE FINAL RULE IN THE Federal Register], all persons who 
manufacture, process, or 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(a) must 
document the following:
    (i) Dates, duration, and results of each sample taken;
    (ii) All measurements that may be necessary to determine the 
conditions that may affect the monitoring results;
    (iii) Name, workplace address, work shift, job classification, and 
work area of the person monitored; or identification of all persons 
represented by the representative sampling monitoring, indicating which 
persons were actually monitored; and any type of respiratory protective 
device worn by the monitored person, if any;
    (iv) Use of appropriate sampling and analytical methods, such as 
analytical methods already approved by EPA, OSHA or NIOSH, or 
compliance with an analytical method verification procedure;
    (v) Compliance with the Good Laboratory Practice Standards in 40 
CFR part 792; and
    (vi) Information regarding air monitoring equipment, including: 
type, maintenance, calibrations, performance tests, limits of 
detection, and any malfunctions.
    (2) ECEL compliance. Owners or operators subject to the ECEL 
described in Sec.  751.707(b)(1) must retain records of:
    (i) Exposure control plan as described in paragraph Sec.  
751.707(d);
    (ii) Facility exposure monitoring records;
    (iii) Respiratory protection used and program implementation;
    (iv) Notifications of exposure monitoring results; and
    (v) Information and training provided by the owner or operator to 
each person prior to or at the time of initial assignment to a job 
involving potential exposure to carbon tetrachloride.
    (3) DDCC compliance. Owners or operators subject to DDCC described 
in Sec.  751.707(c) must retain records of:
    (i) Exposure control plan as described in paragraph Sec.  
751.707(d);
    (ii) Dermal personal protective equipment (PPE) used and program 
implementation as described in Sec.  751.707(e), including:
    (A) The name, workplace address, work shift, job classification, 
and work area of each person reasonably likely to directly handle 
carbon tetrachloride or handle equipment or materials on which carbon 
tetrachloride may 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); and
    (C) Appropriately sized PPE and training on proper application, 
wear, and removal of PPE, and proper care/disposal of PPE;
    (D) Training in accordance with Sec.  751.707(e); and
    (iii) Information and training provided by the regulated entity to 
each person prior to or at the time of initial assignment to a job 
involving potential direct dermal contact with carbon tetrachloride.
    (c) Laboratory chemical compliance. The applicable owners and 
operators subject to the laboratory chemical requirements described in 
Sec.  751.709 must retain records of:
    (i) Personal protective equipment (PPE) used and program 
implementation; and
    (ii) Documentation identifying: implementation of a properly 
functioning fume hood using manufacturer's instructions for 
installation, use, and maintenance of the fume hood, 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.
    (iii) 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 compliance records required 
under this section for a period of 5 years from the date that such 
records were generated.

[FR Doc. 2023-15326 Filed 7-27-23; 8:45 am]
BILLING CODE 6560-50-P


