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

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.

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:

CarbonTetrachlorideTSCA@epa.gov.

For general information contact:

The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address:

TSCA-Hotline@epa.gov.

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

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

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),

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.

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

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

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 an8-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

(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

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,

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

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

m

anufacture.

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).

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

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

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

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

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

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

Air concentration condition

Periodic exposure monitoring requirement

If all initial exposure monitoring is below the ECEL action level (<0.02 ppm 8-hour TWA)

Periodic exposure monitoring is required at least once every five years.

If the most recent exposure monitoring indicates that airborne exposure is above the ECEL (>0.03 ppm 8-hour TWA)

Periodic exposure monitoring is required within 3 months of the most recent exposure monitoring.

If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level but at or below the ECEL (≥0.02 ppm 8-hour TWA, ≤0.03 ppm 8-hour TWA)

Periodic exposure monitoring is required within 6 months of the most recent exposure monitoring.

If the two most recent (non-initial) exposure monitoring measurements, taken at least seven days apart within a 6-month period, indicate exposure is below the ECEL action level (<0.02 ppm 8-hour TWA)

Periodic exposure monitoring is required within 5 years of the most recent exposure monitoring.

If the owner or operator engages in a condition of use for which WCPP ECEL would be required but does not manufacture, process, use, or dispose of CTC in that condition of use over the entirety of time since the last required monitoring event

The owner or operator may forgo the next periodic monitoring event. However, documentation of cessation of use of CTC is required; and periodic monitoring would be required when the owner or operator resumes the condition of use.

(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

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

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.

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

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

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

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