2024-29517. Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA)

Table 1—Periodic Monitoring Requirements
Air concentration condition	Periodic monitoring requirement
If initial exposure monitoring is below the ECEL action level (<0.02 ppm 8-hour TWA)	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 three months of the most recent exposure monitoring.
If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level but at or below the ECEL (≥0.02 ppm 8-hour TWA, ≤0.03 ppm 8-hour TWA)	Periodic exposure monitoring is required within six 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 five 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.
Note : Additional scenarios in which monitoring may be required are discussed in Unit IV.B.3.b.iv.

iv. Additional Exposure Monitoring

EPA is finalizing that each owner or operator conduct additional exposure monitoring within a reasonable timeframe after there has been a change in the production, process, control equipment, personnel or work practices may reasonably be expected to result in new or additional exposures at or above the ECEL, or when the owner or operator has any reason to believe that new or additional exposures at or above the ECEL action level have occurred, for example if an owner or operator receives information from potentially exposed person(s) suggesting that such new or additional exposures may have occurred. In the event of start-up or shutdown, or ruptures, malfunctions or other breakdowns or unexpected releases that may lead to exposure to potentially exposed persons, EPA is finalizing that each owner or operator must conduct exposure monitoring of potentially exposed persons (using personal breathing zone sampling) within a reasonable timeframe after the conclusion of the start-up or shutdown and/or the cleanup, repair or remedial action of the malfunction or other breakdown or unexpected release. EPA is also requiring that the owner or operator document that additional monitoring was completed within a reasonable timeframe. At this time, EPA is not finalizing a specific compliance timeframe for completion of additional monitoring when there has been a change in the production, process, control equipment, personnel or work practices, or in the event of start-up or shutdown, or ruptures, malfunctions or other breakdowns or unexpected releases that may lead to exposure to potentially exposed persons; however, other TSCA section 6(a) rules are finalizing a compliance timeframe of 30 days for additional monitoring in these cases, and such timeframe would be an indication of what EPA considers likely to be reasonable in most cases when these changes are made at facilities that use CTC or in the event of these potential releases of CTC. An additional exposure monitoring event may result in an increased frequency of periodic monitoring. For example, if the initial monitoring results from a workplace are above the ECEL action level, but below the ECEL, periodic monitoring is required every six months. If additional monitoring is performed because increased exposures are suspected, and ( print page 103534) the results are above the ECEL, subsequent periodic monitoring would have to be performed every three months. The required additional exposure monitoring should not delay implementation of any necessary cleanup or other remedial action to reduce the exposures to persons in the workplace.

c. Regulated Area

EPA is finalizing its requirement that the owner or operator demarcate any area where airborne concentrations of CTC exceed, or are reasonably expected to exceed the ECEL. To provide more clarity regarding how regulated areas must be demarcated, EPA has incorporated the language analogous to OSHA's regulated area requirements under the standards for toxic and hazardous substances (29 CFR part 1910, subpart Z) into this final rule. Owners and operators must demarcate regulated areas from the rest of the workplace in any manner that adequately establishes and alerts potentially exposed persons to the boundaries of the area and minimizes the number of authorized persons exposed to CTC within the regulated area. This can be accomplished using administrative controls ( e.g., highly visible signifiers) in multiple languages as appropriate ( e.g., when potentially exposed persons who primarily speak a language other than English are present, owners and operators should post additional highly visible signifiers in the language of the largest group of workers who cannot readily comprehend or read English), placed in conspicuous areas. The owner or operator is required to restrict access to the regulated area from any potentially exposed person that lacks proper training or is otherwise unauthorized to enter.

d. Notification of Monitoring Results

EPA is finalizing the requirement that the owner or operator must, within 15 working days after the receipt of the results of any exposure monitoring, notify each potentially exposed person whose exposure is represented by that monitoring and their designated representatives in writing, either individually to each potentially exposed person or by posting the information in an appropriate and accessible location, such as public spaces or common areas, for potentially exposed persons outside of the regulated area. The notice would be required to identify the exposure monitoring results, the ECEL and ECEL action level and what they mean in plain language, statement of whether the monitored airborne concentration of CTC exceeds the ECEL and ECEL action level, and any corresponding respiratory protection required. If the ECEL is exceeded, the notice must also include a description of the actions taken by the owner or operator to reduce inhalation exposures to or below the ECEL. The notice must also include the quantity, location, manner of CTC use, and identified releases of CTC that could result in exposure to CTC at the time of monitoring. The notice must be posted in multiple languages if necessary ( e.g., notice must be in a language that the potentially exposed person understands, including a non-English language version representing the language of the largest group of workers who cannot readily comprehend or read English).

4. Direct Dermal Contact Control (DDCC) Requirements

To reduce exposures in the workplace and address the unreasonable risk of injury to health resulting from dermal exposures to CTC identified under the occupational conditions of use in the TSCA 2020 Risk Evaluation for CTC, EPA is finalizing DDCC requirements for all of the conditions of use identified in Unit IV.B.1. EPA is finalizing its requirements that owners or operators must separate, distance, physically remove, or isolate all person(s) from direct handling of CTC or from skin contact with surfaces that may be contaminated with CTC ( i.e., equipment or materials on which CTC may be present) under routine conditions in the workplace (hereafter referred to as direct dermal contact) within 180 days after the date of publication of the final rule in the Federal Register ( i.e., June 16, 2025) for non-Federal owners or operators, or within 1,005 days after the date of publication of the final rule in the Federal Register ( i.e., September 20, 2027) for Federal agencies and Federal contractors acting for or on behalf of the Federal government. The 2020 Risk Evaluation for Carbon Tetrachloride identified that unreasonable risk to workers is also driven by the dermal exposure, specifically from direct skin contact with CTC; risk exceeding the benchmark was identified even when considering use of chemically resistant gloves in most commercial and industrial conditions of use. EPA has determined that preventing direct dermal contact will eliminate the unreasonable risk of injury to health resulting from dermal exposures for certain occupational conditions of use of CTC. See the proposed rule for EPA's description of how the requirements related to DDCC would address the unreasonable risk resulting from dermal exposures and the rationale for this regulatory approach in Units III.B.4. and V.A. of the proposed rule. and V.A. of the proposed rule.

5. Exposure Control Plan

EPA is finalizing its requirement that entities implementing the WCPP adopt feasible exposure controls, including one or a combination of elimination, substitution, engineering controls, and administrative controls, prior to requiring the use of PPE ( i.e., respirators or gloves) as a means of controlling exposures below EPA's ECEL and/or prevent directing dermal contact with CTC for all potentially exposed persons, in accordance with the hierarchy of controls (Ref. 6). If an owner or operator chooses to replace CTC with a substitute, EPA recommends careful review of the available hazard and exposure information on the potential substitutes to avoid a substitute chemical that might later be found to present an unreasonable risk of injury to health or the environment under its conditions of use or be subject to regulation (sometimes referred to as a “regrettable substitution”). EPA expects that, for conditions of use for which EPA is finalizing a WCPP, compliance at most workplaces would be part of an established industrial hygiene program that aligns with the hierarchy of controls.

Examples of engineering controls that may prevent or reduce the potential for direct dermal contact include automation, physical barriers between contaminated and clean work areas, enclosed transfer liquid lines (with purging mechanisms in place ( e.g., nitrogen, aqueous) for operations such as product changes or cleaning), and design of tools ( e.g., a closed-loop container system providing contact-free connection for unloading fresh and collecting spent solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples of administrative controls that may prevent or reduce the potential for direct dermal contact include adjusting work practices ( i.e., implementing policies and procedures) such as providing safe working distances from areas where direct handling of CTC may occur.

EPA is finalizing the requirement that regulated entities use the hierarchy of controls, instituting one or a combination of controls to the extent feasible, and supplement such protections using PPE, where necessary, including respirators for potentially exposed persons at risk of inhalation exposure above the ECEL and dermal PPE for persons potentially exposed through direct dermal contact to CTC. If efforts of elimination, substitution, ( print page 103535) engineering controls, and administrative controls are not sufficient to reduce exposures to or below the ECEL or prevent direct dermal contact for all potentially exposed persons in the workplace, EPA requires that the owner or operator use feasible controls to reduce CTC concentrations in the workplace to the lowest levels achievable and supplement these controls with respiratory protection and dermal PPE as needed to achieve the ECEL or prevent direct dermal contact. In such cases, EPA requires that the owner or operator provide potentially exposed persons reasonably likely to be exposed to CTC by inhalation to concentrations above the ECEL with respirators affording sufficient protection against inhalation risk and appropriate training on the proper use of such respirators, to ensure that their exposures do not exceed the ECEL as described in Unit IV. EPA also requires that the owner or operator provides potentially exposed persons reasonably likely to be exposed to CTC by direct dermal contact with dermal protection affording sufficient protection against dermal risk and appropriate training on the proper use of dermal protection, as described in this unit. As part of the training requirement, the owner or operator is required to provide information and comprehensive training in an understandable manner ( i.e., plain language), considering factors such as the skills required to perform the work activity and the existing skill level of the staff performing the work, and in multiple languages as appropriate ( e.g., based on languages spoken by potentially exposed persons) to potentially exposed persons. This training must be provided prior to or at the time of initial assignment to a job involving potential exposure to CTC. Furthermore, EPA also requires that the owner or operator document their efforts in using elimination, substitution, engineering controls, and administrative controls to reduce exposure to or below the ECEL in an exposure control plan.

The Agency understands that certain engineering controls can reduce exposures to people inside the workplace but may lead to increased ventilation of CTC outside of the workplace. Increasing CTC releases to the ambient air could lead to increasing risks to people in fenceline communities of adverse health effects from exposures to CTC in ambient air. Therefore, as proposed, and considering the effects of CTC on health and the magnitude of the exposure of human beings, as required by TSCA section 6(c)(2)(A)(i), EPA is prohibiting increased releases of CTC to outdoor air associated with the implementation of the WCPP/ECEL. This requirement is intended to avoid unintended increases in exposures to people from CTC emissions to ambient air. Owners and operators are required to attest in their WCPP/ECEL exposure control plan that engineering controls selected do not increase emissions of CTC to ambient air outside of the workplace and document in their exposure control plan whether additional equipment was installed to capture emissions of CTC to ambient air. Owners and operators may institute air emissions monitoring or modeling to assist with meeting this requirement.

EPA is finalizing its requirement that the owner or operator include and document in the exposure control plan or through any existing documentation of the facility's safety and health program developed as part of meeting OSHA requirements or other safety and health standards, the following:

Identification in the exposure control plan of available exposure controls that were considered and rationale for using or not using available exposure controls in the following sequence (i.e., elimination and substitution, then engineering controls and administrative controls) to reduce exposures in the workplace to either at or below the ECEL or to the lowest level achievable and to prevent or reduce direct dermal contact with CTC in the workplace;
For each exposure control considered, exposure controls selected based on feasibility, effectiveness, and other relevant considerations;
A description of actions the owner or operator must take to implement exposure controls selected, including proper installation, regular inspections, maintenance, training, or other steps taken;
A description of regulated areas, how they are demarcated, and persons authorized to enter the regulated areas;
Attestation that exposure controls selected do not increase emissions of CTC to ambient air outside of the workplace and whether additional equipment was installed to capture or otherwise prevent increased emissions of CTC to ambient air;
A description of activities conducted by the owner or operator to review and update the exposure control plan to ensure effectiveness of the exposure controls, identify any necessary updates to the exposure controls, and confirm that all persons are properly implementing the exposure controls; and
An explanation of the procedures for responding to any change that may reasonably be expected to introduce additional sources of exposure to CTC, or otherwise result in increased exposure to CTC, including procedures for implementing corrective actions to mitigate exposure to CTC.

Under this final rule, owners or operators are prohibited from using rotating work schedules to comply with the ECEL 8-hour TWA, in alignment with certain elements of existing OSHA's standards for toxic substances under 29 CFR part 1910, subpart Z. Owners or operators must maintain the effectiveness of any engineering and administrative controls instituted as part of the exposure control plan. They must also review and update the exposure control plan as necessary, but at least every five years, to reflect any significant changes in the status of the owner or operator's approach to compliance with the exposure control requirements. EPA intends that the exposure control plan identify the available exposure controls and, for the exposure controls not selected, document the efforts identifying why these are not feasible, not effective, or otherwise not implemented. For entities for which significant amounts of time are needed to verify suitability of alternatives or procure funds or authorization for additional engineering controls, for example, EPA expects that as those controls become available the exposure control plan would be updated accordingly. EPA requires that the exposure control plan be revisited under certain conditions (and at least every five years) and encourages updates as more sophisticated controls are available.

This final rule requires owners or operators to make the exposure control plan and associated records, including ECEL exposure monitoring records, ECEL compliance records, DDCC compliance records, and workplace participation records, available to potentially exposed persons and their designated representatives. Owners or operators must notify potentially exposed persons and their designated representatives of the availability of the exposure control plan and associated records within 30 days of the date that the exposure control plan is completed and at least annually thereafter. The notice of the availability of the plan and associated records must be provided in plain language writing to each potentially exposed person in a language that the person understands or posted in an appropriate and accessible location outside the regulated area with an English-language version and a non- ( print page 103536) English version representing the language of the largest group of workers who do not read English. This final rule also requires the owner or operator to provide the exposure control plan and associated records at a reasonable time, place, and manner to a potentially exposed person or their designated representative upon request. As explained in Unit III.C.2., if the owner or operator is unable to provide the specified records within 15 days, the owner or operator must inform the potentially exposed person or designated representative requesting the record within 15 days that reason for the delay and the earliest date when the record will be made available.

6. Personal Protective Equipment (PPE)

Where elimination, substitution, engineering controls, and administrative controls are not feasible to reduce the air concentration to or below the ECEL and/or prevent direct dermal contact with CTC for all potentially exposed persons, EPA is finalizing as proposed with slight modifications to improve clarity or for greater consistency with OSHA's regulations to require owners and operators to provide PPE, including respiratory protection and dermal protection selected in accordance with the guidelines described in this unit, and to implement a PPE program. This unit includes a description of the PPE program, including required PPE as it relates to respiratory protection, required PPE as it relates to dermal protection, and other requirements such as additional training for respirators and recordkeeping to support implementation of a PPE program.

a. Respiratory Protection

Where elimination, substitution, engineering, and administrative controls are not feasible or sufficiently protective to reduce the air concentration to or below the ECEL, or if inhalation exposure above the ECEL is still reasonably likely, EPA is finalizing, with slight modification from the proposal, minimum respiratory PPE requirements based on an owner or operator's most recent measured air concentration for one or more potentially exposed persons and the level of PPE needed to reduce exposure to or below the ECEL. In those circumstances, EPA is finalizing the requirements for a respiratory protection PPE program with worksite-specific procedures and elements for required respirator use. Owners or operators must develop and administer a written respiratory protection program in accordance with OSHA's respiratory protection standard under 29 CFR 1910.134(c)(1), (c)(3), and (c)(4). EPA is finalizing requirements that owners and operators provide training to all persons required to use respiratory protection consistent with 29 CFR 1910.134(k) prior to or at the time of initial assignment to a job involving potential exposure to CTC. Owners and operators must retrain all persons required to use PPE at least annually, or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in PPE to be used render the previous training obsolete.

EPA is finalizing requirements that each owner or operator supply a respirator, selected in accordance with requirements described in this unit, to each person who enters a regulated area within 1,005 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 20, 2027) for Federal agencies and Federal contractors acting for or on behalf of the Federal government, 630 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 9, 2026) for non-Federal owners and operators, or within three months after the receipt of any exposure monitoring that indicates exposures exceeding the ECEL, and thereafter must ensure that all persons within the regulated area are using the provided respirators whenever CTC exposures exceed or can reasonably be expected to exceed the ECEL.

EPA is also finalizing requirements that owners or operators who are required to administer a respiratory protection PPE program must supply a respirator based on a medical evaluation consistent with the requirements of 29 CFR 1910.134(e). If a potentially exposed person cannot use a negative-pressure respirator, then the owner or operator must provide that person with an alternative respirator. The alternative respirator must have less breathing resistance than the negative-pressure respirator and provide equivalent or greater protection. If the person is unable to use an alternative respirator, then the person must not be permitted to enter the regulated area. Additionally, EPA is requiring owners and operators to select respiratory protection that properly fits each affected person and communicate respirator selections to each affected person in accordance with the requirements of 29 CFR 1910.134(f). Consistent with requirements of 29 CFR 1910.134(g) through (j), EPA is requiring owners and operators to provide, ensure use of, and maintain (in a sanitary, reliable, and undamaged condition) respiratory protection that is of safe design and construction. EPA is also requiring owners and operators to provide training to all persons required to use respiratory protection consistent with the requirements of 29 CFR 1910.134(k).

EPA is finalizing the requirements to establish minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the following requirements may be used. In instances where respiratory protection is appropriate, NIOSH Approved® equipment must be used. NIOSH Approved is a certification mark of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions. EPA is finalizing the following requirements for respiratory protection, based on the most recent exposure monitoring concentration results measured as an 8-hour TWA that exceed the ECEL (0.03 ppm):

If the measured exposure concentration is at or below 0.03 ppm: no respiratory protection is required.
If the measured exposure concentration is above 0.03 ppm and less than or equal to 0.3 ppm (10 times ECEL): Any NIOSH Approved air-purifying half mask respirator equipped with organic vapor cartridges or canisters; or any NIOSH Approved Supplied-Air Respirator (SAR) or Airline Respirator operated in demand mode equipped with a half mask; or any NIOSH Approved Self-Contained Breathing Apparatus (SCBA) in a demand mode equipped with a half mask [APF 10].
If the measured exposure concentration is above 0.3 ppm and less than or equal to 0.75 ppm (25 times ECEL): Any NIOSH Approved Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting facepiece or hood/helmet equipped with organic vapor cartridges or canisters; or any NIOSH Approved SAR or Airline Respirator in a continuous-flow mode equipped with a loose-fitting facepiece or helmet/hood [APF 25].
If the measured exposure concentration is above 0.75 ppm and less than or equal to 1.5 ppm (50 times ECEL): Any NIOSH Approved air-purifying full facepiece respirator equipped with organic vapor cartridges or canisters; any NIOSH Approved PAPR with a half mask equipped with organic vapor cartridges or canisters; any NIOSH Approved SAR or Airline Respirator in a continuous flow mode equipped with a half mask; any NIOSH Approved SAR or Airline Respirator ( print page 103537) operated in a pressure-demand or other positive-pressure mode with a half mask; or any NIOSH Approved SCBA in demand-mode equipped with a full facepiece or helmet/hood [APF 50].
If the measured exposure concentration is above 1.5 ppm and less than or equal to 30 ppm (1,000 times ECEL): Any NIOSH Approved PAPR equipped with a full facepiece equipped with organic vapor cartridges or canisters; any NIOSH Approved SAR or Airline Respirator in a continuous-flow mode equipped with full facepiece; any NIOSH Approved SAR or Airline Respirator in pressure-demand or other positive-pressure mode equipped with a full facepiece and an auxiliary self-contained air supply; or any NIOSH Approved SAR or Airline Respirator in a continuous-flow mode equipped with a helmet or hood and has been tested to demonstrate performance at a level of a protection of APF 1,000 or greater. [APF 1,000].
If the measured exposure concentration is greater than 30 ppm (1,000+ times ECEL): Any NIOSH Approved SCBA equipped with a full facepiece, hood, or helmet and operated in a pressure demand or other positive pressure mode [APF 10,000].
If the exposure concentration is unknown: Any NIOSH Approved combination supplied air respirator equipped with a full facepiece and operated in pressure demand or other positive pressure mode with an auxiliary self-contained air supply; or any NIOSH Approved SCBA operated in pressure demand or other positive pressure mode and equipped with a full facepiece or hood/helmet [APF 1000+].

Additionally, EPA is finalizing requirements that owners or operators select and provide respirators in accordance with the requirements of 29 CFR 1910.134(d)(1)(iv) and with consideration of workplace and user factors that affect respirator performance and reliability.

EPA is requiring that the owner or operator must ensure that all filters, cartridges, and canisters used in the workplace are labeled and color coded per NIOSH requirements and that the label is not removed and remains legible. Consistent with 29 CFR 1910.134(d)(3)(iii), EPA is requiring either the use of NIOSH Approved respirators with an end-of-life service indicator for the contaminant, in this case CTC, or implementation of a change schedule for canisters and cartridges that ensures that they are changed before the end of their service life. EPA is also requiring owners and operators to ensure that respirators are used in compliance with the terms of the respirator's NIOSH approval.

EPA is finalizing requirements that owners and operators must conduct regular evaluations of the workplace, including consultations with potentially exposed persons using respiratory protection, consistent with the requirements of 29 CFR 1910.134(l), to ensure that the provisions of the written respiratory protection program described in this unit are being effectively implemented.

EPA is finalizing the requirement that owners and operators document respiratory protection used and PPE program implementation. EPA is finalizing requirements that owners and operators document in the exposure control plan or other documentation of the facility's safety and health program information relevant to the respiratory program, including records on the name, workplace address, work shift, job classification, work area, and type of respirator worn (if any) by each potentially exposed person, maintenance, fit-testing, and training as described in this unit.

b. Dermal Protection

As described in this unit EPA is finalizing requirements that each owner or operator supply dermal PPE that separates and provides a barrier to prevent direct dermal contact with CTC, selected in accordance with requirements described in this unit, to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact within 1,005 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 20, 2027) for Federal agencies and Federal contractors acting for or on behalf of the Federal government, or 180 days after the date of publication of the final rule in the Federal Register ( i.e., no later than June 16, 2025) for non-Federal owners and operators. Where elimination, substitution, engineering controls, and administrative controls are not feasible or sufficient to fully prevent direct dermal contact with CTC, EPA is finalizing requirements that appropriate dermal PPE be provided by owners and operators to, and be worn by, persons potentially exposed to direct dermal contact with CTC. EPA is requiring owners and operators to provide dermal PPE that is of safe design and construction for the work to be performed. EPA is also requiring owners and operators ensure each potentially exposed person who is required to wear PPE to use and maintain PPE in a sanitary, reliable, and undamaged condition. Additionally, EPA is requiring owners and operators to select and provide PPE that properly fits each potentially exposed person who is required to use PPE and communicate PPE selections to each affected person.

In choosing appropriate dermal PPE, EPA is requiring owners and operators to select gloves, clothing, and protective gear (which covers any exposed dermal area of arms, legs, torso, and face) based on specifications from the manufacturer or supplier or individually prepared third party testing that demonstrate an impervious barrier to CTC during expected durations of use and normal conditions of exposure within the workplace, accounting for potential chemical permeation or breakthrough times. EPA is also requiring that owners and operators demonstrate that the selected PPE will be impervious for the expected duration and conditions of exposure, such as using the format specified in ASTM F1194-99(2010) “Standard Guide for Documenting the Results of Chemical Permeation Testing of Materials Used in Protective Clothing Materials,” reporting cumulative permeation rate as a function of time, or equivalent manufacturer- or supplier-provided testing. In alignment with the OSHA Hand Protection PPE Standard (29 CFR 1910.138), EPA is requiring owners and operators to select dermal PPE based on an evaluation of the performance characteristics of the PPE relative to the task(s) to be performed, conditions present, and the duration of use. EPA is also requiring owners and operators to consider likely combinations of chemical substances to which the clothing may be exposed in the work area when selecting the appropriate PPE such that the PPE will prevent direct dermal contact to CTC.

For example, owners and operators can select gloves that have been tested in accordance with the American Society for Testing and Materials (ASTM) F739 “Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact.” EPA is finalizing that PPE be provided for use for a time period only to the extent and no longer than the time period for which testing has demonstrated that the PPE will be impervious during expected durations of use and conditions of exposure. EPA is finalizing requirements that owners and operators also consider other factors when selecting appropriate PPE, including effectiveness of glove type when preventing exposures from CTC alone and in likely combination with other chemical substances used in the work area or when used with glove liners, permeation, degree of dexterity ( print page 103538) required to perform task, and temperature, as identified in the Hand Protection section of OSHA's Personal Protective Equipment Guidance (Ref. 45).

EPA is finalizing that owners and operators establish, either through manufacturer or supplier-provided documentation or individually prepared third party testing that the selected PPE will be impervious for the expected duration and conditions of exposure, such as using the format specified in ASTM F1194-99(2010) “Standard Guide for Documenting the Results of Chemical Permeation Testing of Materials Used in Protective Clothing Materials,” reporting cumulative permeation rate as a function of time, or equivalent manufacturer- or supplier- provided testing. EPA is also requiring owners and operators to consider likely combinations of chemical substances to which the clothing may be exposed in the work area when selecting the appropriate PPE such that the PPE will prevent direct dermal contact to CTC. Degradation may also be appropriate to consider in the context of combination chemical exposures, as some glove types and materials may demonstrate efficient permeation barrier results but may not be fully resistant to degradation from the chemical exposure. Degradation can be evaluated using standard test methods such as select test methods within ASTM Method D 471 Standard Test Method for Rubber Property—Effect of Liquids ( e.g., ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension). EPA is finalizing requirements that PPE must be immediately provided and replaced if any person is dermally exposed to CTC longer than the breakthrough time period for which testing has demonstrated that the PPE will be impermeable or if there is a chemical permeation or breakage of the PPE.

Additionally, EPA is finalizing requirements that owners and operators subject to this rule comply with provisions of 29 CFR 1910.133(b) for requirements on selection and use of eye and face protection.

Additionally, as part of the PPE program, EPA is also finalizing that owners and operators must comply with OSHA's general PPE training requirements at 29 CFR 1910.132(f) for application of a PPE training program, including providing training on proper use of dermal PPE ( e.g., when and where PPE is necessary, proper application, wear, and removal of PPE, maintenance, useful life and disposal of PPE). EPA is finalizing that owners and operators provide PPE training to all persons required to use dermal PPE prior to or at the time of initial assignment to a job involving potential exposure to CTC. Owners and operators have to re-train each affected person at least once annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in the PPE to be used render the previous training obsolete.

EPA is also finalizing requirements that owners and operators retain records of dermal PPE used and program implementation. EPA is requiring that owners and operators document in the exposure control plan or other documentation of the facility's safety and health program, information relevant to any dermal PPE program, as applicable, including:

The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle CTC or handle equipment or materials on which CTC may present and the type of PPE selected to be worn by each of these persons;
The basis for specific PPE selection (e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area);
Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE;
Occurrence and duration of any direct dermal contact with CTC that occurs during any activity or malfunction at the workplace that causes direct dermal exposures to occur and/or glove breakthrough, and corrective actions to be taken during and immediately following that activity or malfunction to prevent direct dermal contact to CTC; and
Training described in this unit.

7. Additional Finalized Requirements

a. Workplace Information and Training

EPA is also finalizing its requirements to implement a training program in alignment with the OSHA Hazard Communication Standard (29 CFR 1910.1200) and the OSHA General Industry Standard for Methylene Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons in the workplace are informed of the hazards associated with CTC exposure, EPA is finalizing as proposed with slight modification to require that owners or operators of workplaces subject to the WCPP institute a training and information program for potentially exposed persons and assure their participation in the training and information program within 1,005 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 20, 2027) for Federal agencies and Federal contractors acting for or on behalf of the Federal government, or 630 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 9, 2026) for non-Federal owners and operators. For purposes of workplace information and training, owners and operators are only required to train potentially exposed persons that are expected to be present in the workplace or to directly handle CTC or handle equipment or materials on which CTC may present.

As part of the training and information program, the owner or operator is required to provide information and comprehensive training in an understandable manner ( i.e., plain language) and in multiple languages as appropriate ( e.g., based on languages spoken by potentially exposed persons) to potentially exposed persons prior to or at the time of initial assignment to a job involving potential exposure to CTC. Owners and operators are required to provide information and training, as referenced in the OSHA Hazard Communication Standard, to all potentially exposed persons that includes:

The requirements of the CTC WCPP and how to access or obtain a copy of the requirements of the WCPP, including but not limited to the exposure control plan, monitoring requirements, and PPE program;
The quantity, location, manner of use, release, and storage of CTC and the specific operations in the workplace that could result in CTC exposure, particularly noting where each regulated area is located;
Principles of safe use and handling of CTC in the workplace, including specific measures the owner or operator has implemented to reduce inhalation exposure at or below the ECEL or prevent dermal contact with CTC, such as work practices and PPE used;
The methods and observations that may be used to detect the presence or release of CTC in the workplace (such as monitoring conducted by the owner or operator, continuous monitoring devices, visual appearance or odor of CTC when being released, etc.); and ( print page 103539)
The acute and chronic health hazards of CTC as detailed on relevant Safety Data Sheets (SDSs).

In addition to providing training at the time of initial assignment to a job involving potential exposure to CTC, owners and operators subject to the CTC WCPP are required to re-train each potentially exposed person as necessary, but at a minimum annually, to ensure they understand the principles of safe use and handling of CTC in the workplace. The owner or operator would consider factors such as the skills required to perform the work activity and the existing skill level of the staff performing the work. EPA is finalizing its requirements that owners and update the training as necessary whenever there are changes in the workplace, such as new tasks or modifications of tasks, in particular, whenever there are changes in the workplace that increase exposure to CTC or where potentially exposed persons' exposure to CTC can reasonably be expected to exceed the action level or increase the potential for direct dermal contact with CTC. To support compliance, EPA is finalizing that each owner or operator of a workplace subject to the WCPP would be required to provide to the EPA, upon request, all available materials related to workplace information and training.

b. Workplace Participation

EPA encourages owners and operators to consult with potentially exposed persons and their designated representative on the development and implementation of exposure control plans and PPE/respirator programs. EPA is finalizing a requirement that owners and operators provide potentially exposed persons and their designated representatives regular access to the exposure control plans, exposure monitoring records, and PPE program implementation records. To ensure compliance with workplace participation, EPA is finalizing a requirement that the owner or operator document the notice to and ability of any potentially exposed person that may reasonably be affected by CTC exposure to readily access the exposure control plans, facility exposure monitoring records, PPE program implementation records, or any other information relevant to CTC exposure in the workplace.

c. Recordkeeping

For owners and operators to demonstrate compliance with the WCPP provisions, EPA is requiring that owners and operators retain compliance records for five years (although this requirement does not supplant any longer recordkeeping retention time periods such as those required under 29 CFR 1910.1020, or other applicable regulations). EPA is requiring the owner or operator to retain records of:

Exposure control plan;
PPE program implementation and documentation, including as necessary, respiratory protection and dermal protection used and related PPE training; and
Information and training provided to each person prior to or at the time of initial assignment and any retraining.

In addition, EPA is finalizing requirements that owners and operators subject to the WCPP ECEL requirements maintain records to include:

Regulated areas and authorized personnel;
The exposure monitoring records;
Notification of exposure monitoring results; and
To the extent that the owner or operator relies on prior exposure monitoring data, records that demonstrates that it meets all of the requirements of this section.

The owners and operators, upon request by EPA, are required to make all records that are maintained as described in Unit IV. available to EPA for examination and copying in accordance with EPA requirements. EPA emphasizes that all records required to be maintained can be kept in the most administratively convenient form; electronic record form or paper form.

8. Compliance Timeframes

EPA is finalizing the requirement that owners or operators of workplaces subject to the WCPP implement the DDCC requirements as outlined in this unit within 1,005 days after December 18, 2024 for Federal agencies or Federal contractors acting for or on behalf of the Federal government, 180 days after December 18, 2024 for non-Federal owners and operators, or within 30 days of introduction of CTC into the workplace, whichever is later. With regard to the compliance timeframe for the WCPP provisions related to the ECEL, EPA is not finalizing the timeframes proposed. Rather, as discussed in Unit III.B., based on consideration of public comments and reasonably available information, EPA is finalizing longer timeframes for compliance with provisions related to the ECEL for non-Federal owners or operators, and is providing Federal agencies and Federal contractors acting for or on behalf of the Federal government additional time to comply with each of the provisions of the WCPP. Specifically, EPA is finalizing its requirement that non-Federal owners and operators perform initial exposure monitoring according to the process outlined in this unit within 540 days after date of publication of the final rule in the Federal Register ( i.e., no later than June 11, 2026) or within 30 days of introduction of CTC into the workplace, whichever is later. Federal agencies and Federal contractors acting for or on behalf of the Federal government must conduct initial exposure monitoring within 915 days after the date of publication ( i.e., no later than June 21, 2027), or within 30 days of introduction of CTC into the workplace, whichever is later. EPA is also finalizing its requirement that each non-Federal owner or operator ensure that exposure to CTC does not exceed the ECEL as an 8-hour TWA for all potentially exposed persons within 630 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 9, 2026), while Federal agencies and Federal contractors acting for or on behalf of the Federal government must comply with the ECEL within 1,005 days after the date of publication ( i.e., no later than September 20, 2027). If applicable, each owner or operator must provide respiratory protection sufficient to reduce inhalation exposures to below the ECEL to all potentially exposed persons in the regulated area within three months after receipt of the results of any exposure monitoring that indicates an exceedance of the ECEL. For non-Federal owners or operators, this will be within 630 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 9, 2026). For Federal agencies and Federal contractors acting for or on behalf of the Federal government, this will be within 1,005 after the date of publication of the final rule in the Federal Register ( i.e., no later than September 20, 2027). EPA is also finalizing the requirement that owners and operators demarcate a regulated area within three months after receipt of any exposure monitoring that indicates exposures exceeding the ECEL. Owners and operators shall proceed accordingly to implement an exposure control plan, including institution of feasible exposure controls other than PPE, within 1,080 days after date of publication of the final rule in the Federal Register ( i.e., no later than December 3, 2027).

C. Prescriptive Controls Required for Laboratory Use

In contrast to the non-prescriptive requirements of the WCPP, including the DDCC, where regulated entities would have the ability to select controls ( print page 103540) in accordance with the hierarchy of controls to comply with the parameters outlined in Unit IV.B., EPA has found it appropriate in certain circumstances to require specific prescriptive controls for certain occupational conditions of use. In general, EPA is finalizing prescriptive controls, for the industrial and commercial use of CTC as a laboratory chemical, as described in Unit III.A.2. This unit provides a description of the industrial and commercial use of CTC as a laboratory chemical subject to specific prescriptive controls, the specific prescriptive control requirements, and the compliance timeframe for the requirements.

1. Applicability

The industrial and commercial use of CTC as a laboratory chemical refers to the industrial or commercial use of CTC, often in small quantities, in a laboratory process or in specialized laboratory equipment for instrument calibration/maintenance, chemical analysis, chemical synthesis, extracting and purifying other chemicals, dissolving other substances, executing research, development, test and evaluation methods, and similar activities, such as use as a solvent, reagent, analytical standard, or other experimental use.

After the risk evaluation was published, DoD did further analysis and provided additional information clarifying their current use of CTC as a laboratory chemical and risk management measures implemented. DoD provided information on their use of CTC as a laboratory chemical in chemical weapons destruction, indicating that CTC is used in small amounts in a confined, laboratory-like setting with advanced engineering controls. There is no waste CTC generated during this process.

EPA recognizes that potentially exposed persons in a laboratory setting may include students, researchers, visiting scholars, or others whose job classifications may vary, such as depending on the academic period in university laboratories. The requirements described in this unit apply to all potentially exposed persons in all laboratory settings, including academic and research laboratories, regardless of job classification.

2. Workplace Requirements

To address the unreasonable risk of injury to health resulting from dermal exposures to CTC identified for the industrial and commercial use as a laboratory chemical, including DoD's use of CTC as a laboratory chemical in chemical weapons destruction, EPA is requiring dermal PPE, including impermeable gloves and protective clothing, in combination with comprehensive training for tasks particularly related to the use of CTC in a laboratory setting as specified in this unit for each potentially exposed person with direct dermal contact to CTC in the work area through direct handling of the substance or from contact with surfaces that may be contaminated with CTC. For dermal PPE, EPA is requiring that each owner or operator comply with the requirements outlined in Units IV.B.6.b. for selection of dermal PPE and training for all potentially exposed persons. EPA's description for how the requirements for the industrial and commercial use as a laboratory chemical address the unreasonable risk resulting from dermal exposures under the conditions of use and the rationale for this regulatory approach is outlined in Unit V. of the proposed rule (88 FR 49205, July 28, 2023) (FRL-8206-01-OCSPP).

In addition, EPA is requiring the use of laboratory ventilation devices, such as fume hoods, glove boxes, air handling units, exhaust fans, biological safety devices, airflow controls, and other local exhaust devices, in workplace laboratory settings for the industrial and commercial use of CTC as a laboratory chemical, except for DoD's use of CTC as a laboratory chemical in chemical weapons destruction, to codify existing good laboratory practices. EPA is requiring each owner or operator of a workplace laboratory setting, except for DoD's use of CTC as a laboratory chemical in chemical weapons destruction, to ensure laboratory ventilation devices are in use and functioning properly to minimize exposures to persons in the area where CTC is used as a laboratory chemical. EPA suggests owners or operators refer to OSHA's 29 CFR 1910.1450, Appendix A, for National Research Council recommendations concerning laboratory chemical hood ventilation system characteristics and practices and to ANSI's and ASSP's Z9.5-2022 for recommendations on additional laboratory ventilation controls to minimize exposures to potentially exposed persons in the work area.

EPA understands that DoD uses CTC in small amounts in a confined, laboratory-like setting with advanced engineering controls (Ref. 46). Therefore, for DoD's industrial and commercial use of CTC as a laboratory chemical in chemical weapons destruction, EPA is requiring advanced engineering controls that essentially codify existing practices at DoD facilities. EPA is not requiring a WCPP, specifically with monitoring requirements, for DoD's industrial and commercial use of CTC as a laboratory chemical in chemical weapons destruction.

3. Recordkeeping

To support and demonstrate compliance, EPA is requiring that each owner or operator of a laboratory workplace subject to the requirements of this unit retain compliance records for five years. In alignment with 29 CFR 1910.1450(e)(3)(ii) and (iii) and 29 CFR 1910.132(d)(2), EPA is requiring that owners and operators must retain records of:

Dermal protection used by each potentially exposed person and PPE program implementation as outlined in this unit;
Criteria that the owner or operator will use to determine and implement control measures to reduce potentially exposed persons' exposure to CTC including laboratory ventilation devices as outlined in this unit;
Implementation of properly functioning laboratory ventilation devices using manufacturer's instructions for installation, use, and maintenance of the systems, including inspections, tests, development of maintenance procedures, the establishment of criteria for acceptable test results, and documentation of test and inspection results, except for DoD's use of CTC as a laboratory chemical in chemical weapons destruction; and
For DoD's industrial and commercial use of CTC as a laboratory chemical in chemical weapons destruction, implementation of advanced engineering controls that are in use and functioning properly and specific measures taken to ensure proper and adequate performance. Owners or operators must maintain records for five years. EPA expects owners or operators ensure that records reflect actions taken within the last five years to comply with the requirements of this unit.

4. Compliance Timeframes

With regards to the compliance timeframe, EPA is requiring that each owner or operator of a workplace engaged in the industrial and commercial of CTC as a laboratory chemical ensure laboratory ventilation devices are in use and functioning properly and that dermal PPE is provided to all potentially exposed persons with direct dermal contact with CTC within 180 days after publication of the final rule.

Similarly, EPA is requiring that DoD facilities engaged in the industrial and ( print page 103541) commercial use of CTC as a laboratory chemical in chemical weapons destruction ensure that advanced engineering controls are in use and functioning properly and dermal PPE is provided to all potentially exposed persons with direct dermal contact with CTC within 365 days after publication of the final rule.

EPA understands that certain departments and agencies of the Federal government, as well as Federal contractors acting for or on behalf of the Federal government, need additional time to comply with these timeframes. For example, ensuring compliance with the prescriptive controls could be challenging due to changing contracting, procurement decisions and other processes in Federal facilities. Similarly, EPA is requiring for that agencies of the Federal government and their contractors, when acting for or on behalf of the Federal government, that are engaged in the industrial and commercial use of CTC as a laboratory chemical ensure laboratory ventilation devices are in use and functioning properly, and that dermal PPE and training on proper use of PPE is provided to all potentially exposed persons with direct dermal contact with CTC within 365 days after publication of the final rule.

D. Prohibition of Manufacture, Processing, Distribution, and Use of CTC

1. Applicability

EPA is finalizing the prohibitions for most of the conditions of use for which prohibition was proposed. Prohibitions will address the contribution to the unreasonable risk determined to be presented by CTC in the 2020 Risk Evaluation for Carbon Tetrachloride and 2022 Revised Unreasonable Risk Determination for Carbon Tetrachloride from industrial and commercial uses of CTC, and reasonably available information indicates that industry has already transitioned away from CTC and found technically and economically feasible alternatives to CTC for these uses. Unit V. of the proposed rule and the Response to Comments document present further discussion of EPA's rationale for why these conditions of use are being prohibited (88 FR 49205) (FRL-8206-01-OCSPP). EPA's description of the uses proposed to be prohibited for which the Agency is finalizing a WCPP (processing: incorporation into formulation, mixtures, or reaction products in vinyl chloride manufacturing and the industrial and commercial use as an industrial processing aid in the manufacture of vinyl chloride) are in Units III.A.1. and IV.B.1. The rule prohibits manufacture, processing, distribution in commerce, and use of CTC for the following industrial and commercial uses of CTC: industrial and commercial use as a processing aid in the manufacture of petrochemical-derived products except in the manufacture of vinyl chloride (for which EPA is finalizing a WCPP); industrial and commercial use in the manufacture of other basic chemicals (including chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings), except for use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine (for which EPA is finalizing a WCPP); industrial and commercial use in metal recovery; industrial and commercial use as an additive; and industrial and commercial use in specialty uses by the U.S. Department of Defense. EPA is also finalizing the explicit prohibition for processing: incorporation into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride (the upstream processing condition of use for the industrial and commercial use of CTC as a processing aid in the manufacture of petrochemicals-derived products except in the manufacture of vinyl chloride). This unit provides a description of the uses subject to the prohibitions to assist with compliance.

a. Processing: Incorporation Into Formulation, Mixture or Reaction Products in Petrochemical-Derived Manufacturing Except in the Manufacture of Vinyl Chloride

Incorporation into formulation, mixture, or reaction products refers to the process of mixing or blending several raw materials to obtain a single product or preparation or formulation. CTC has historically been incorporated into formulation or mixtures to manufacture hydrochloric acid (HCl), vinyl chloride, ethylene dichloride (EDC), chloroform, hafnium tetrachloride, thiophosgene, and methylene chloride. CTC may be incorporated into various products and formulations at varying concentrations for further distribution. For example, CTC may be unloaded from transport containers either directly into mixing equipment or into an intermediate storage vessel either manually or through automation via a pumping system. Mixing of components can occur in either a batch or continuous system. The mixture that contains CTC may be used as a reactant to manufacture a chlorinated compound that is subsequently formulated into a product or a processing aid used to aid in the manufacture of petrochemicals-derived products. For the purposes of this rulemaking, EPA is specifically prohibiting the incorporation into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride. Incorporation into formulation, mixture or reaction products in agricultural products manufacturing, vinyl chloride manufacturing, the elimination of nitrogen trichloride in the production of chlorine and caustic soda, and the recovery of chlorine in tail gas from the production of chlorine is being regulated under the WCPP, as described in Unit IV.B.

b. Industrial and Commercial Use

i. Industrial and Commercial Use as an Industrial Processing aid in the Manufacture of Petrochemicals-Derived Products Except in the Manufacture of Vinyl Chloride.

A processing aid is a “chemical that is added to a reaction mixture to aid in the manufacture or synthesis of another chemical substance but is not intended to remain in or become part of the product or product mixture.” Additionally, processing agents are intended to improve the processing characteristics or the operation of process equipment, but not intended to affect the function of a substance or article created. CTC has traditionally been used as a processing aid/agent to aid in the manufacture of petrochemical-derived products (Ref. 1). The condition of use includes the use of CTC that has historically been used as a processing agent in the manufacture of chlorosulphonated polyolefin; stryene butadiene rubber; endosulfan (insecticide); 1-1 Bis (4-chlorophenyl) 2,2,2-trichloroethanol (dicofol insecticide); and tralomethrin (insecticide). For the purposes of this rulemaking, EPA is specifically prohibiting the industrial and commercial use of CTC as an industrial processing aid in the manufacture of petrochemicals-derived products, except in the manufacture of vinyl chloride. The industrial and commercial use as an industrial processing aid in the manufacture of agricultural products and vinyl chloride is being regulated under the WCPP, as described in Unit IV.B. ( print page 103542)

ii. Industrial and Commercial Use in the Manufacture of Other Basic Chemicals (Including Manufacturing of Chlorinated Compounds Used in Solvents, Adhesives, Asphalt, and Paints and Coatings), Except for Use in the Elimination of Nitrogen Trichloride in the Production of Chlorine and Caustic Soda and the Recovery of Chlorine in Tail Gas From the Production of Chlorine

CTC has historically been used as a processing aid/agent in basic organic and inorganic chemical manufacturing. CTC could be used as a processing agent in the manufacturing of chlorinated compounds that are subsequently used in the formulation of solvents, adhesives, asphalt, and paints and coatings; in the manufacturing of chlorinated paraffins ( e.g., plasticizer in rubber, paints, adhesives, sealants, plastics), and chlorinated rubber ( e.g., additive in paints, adhesives); and in the manufacturing of inorganic chlorinated compounds, such as in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine. For the purposes of this rulemaking, EPA is specifically prohibiting the industrial and commercial use in the manufacture of other basic chemicals (including manufacturing of chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings), except for use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine. The industrial and commercial use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine is being regulated under the WCPP, as described in Unit IV.B.

iii. Industrial and Commercial Use in Metal Recovery

CTC has historically been used as a processing aid or agent to aid in metal recovery.

iv. Industrial and Commercial Use as an Additive

Additives are chemicals combined with a chemical product to enhance the properties of the product. Additives typically stay mixed within the finished product and remain unreacted. The risk evaluation examined the use of CTC as an additive for the manufacture of petrochemical-derived products and agricultural products. CTC has historically been used as an additive in fuel and in plastic components used in the automotive industry.

v. Industrial and Commercial Use in Specialty Uses by the U.S. Department of Defense (DoD)

During the risk evaluation, DoD provided monitoring data for CTC uses in various processes that include worker activities such as cleaning and sampling residual metal and ash; destruction of munitions and storage of resulting liquid waste; and sampling of energetics with solvent. The unreasonable risk determination for CTC further determined that this condition of use contributed to the unreasonable risk. The Agency understands that DoD has successfully phased out the use of CTC for this condition of use.

As discussed in Unit II.C.4., the prohibitions do not apply to any substance that is excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi).

2. Compliance Timeframes

EPA is finalizing that the prohibitions apply as of 180 days after the date of publication of the final rule for the manufacturing, processing, distribution in commerce, and use of CTC for the following: incorporation of CTC into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride; the industrial and commercial use of CTC as a processing aid in the manufacture of petrochemical-derived products except in the manufacture of vinyl chloride; the industrial and commercial use of CTC in the manufacture of other basic chemicals (including chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings), except for use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine; the industrial and commercial use of CTC in metal recovery; and the industrial and commercial use of CTC as an additive.

EPA is also finalizing the prohibitions for the manufacturing, processing, distribution in commerce, and use of CTC for the industrial and commercial use in specialty uses by the DoD to apply as of 365 days after the date of publication of the final rule.

E. Other Requirements

1. Recordkeeping

For conditions of use that are not otherwise prohibited under this final rule, EPA is finalizing the requirement that manufacturers, processors, distributors, and commercial users maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this final regulation; and to maintain such records for a period of 5 years from the date the record is generated. This requirement begins on February 18, 2025. For enforcement purposes, EPA will have access to such businesses records plus additional records required under 40 CFR 751.713. Recordkeeping requirements would ensure that owners or operators can demonstrate compliance with the regulations if necessary.

2. Downstream Notification

For conditions of use that are not otherwise prohibited under this final regulation, EPA is finalizing requirements that manufacturers (including importers), processors, and distributors of CTC provide downstream notification of the prohibitions through the SDSs by adding to sections 1(c) and 15 of the SDS the following language:

After June 16, 2025, this chemical substance (as defined in TSCA section 3(2)) may not be distributed in commerce or processed in greater than trace quantities for the following purposes: Incorporation into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride; Industrial and commercial use as an industrial processing aid in the manufacture of petrochemicals-derived products except in the manufacture of vinyl chloride; Industrial and commercial use in the manufacture of other basic chemicals (including manufacturing of chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings), except for use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine; Industrial and commercial use in metal recovery; Industrial and commercial use as an additive; and beginning December 18, 2025, industrial and commercial specialty uses by the U.S. Department of Defense.

To provide adequate time to update the SDS and ensure that all products in the supply chain include the revised SDS, EPA's final rule requires manufacturers to revise their SDS within two months of rule publication and processors and distributors to revise their SDS within six months of rule publication. EPA did not receive public comments asserting that these compliance dates for updating the SDS were impracticable, and is therefore finalizing the compliance dates as proposed. The intention of downstream notification is to spread awareness throughout the supply chain of the ( print page 103543) restrictions on CTC under TSCA and to provide information to commercial end-users about prohibited uses of CTC.

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

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

EPA's analysis of the health effects of CTC and the magnitude of human exposure to CTC are in the 2020 Risk Evaluation for CTC and the 2022 Revised Unreasonable Risk Determination for CTC (Refs. 1, 3). A summary is presented here.

The 2020 Risk Evaluation for CTC identified potential health effects of CTC including carcinogenicity, liver toxicity, neurotoxicity, kidney toxicity, reproductive and developmental toxicity, irritation and sensitization, and genetic toxicity. Acute inhalation exposures to CTC at relatively high concentrations induce immediate and temporary depression of the central nervous-system, with effects consisting of escape-impairing symptoms such as dizziness. For chronic non-cancer inhalation exposure scenarios to CTC, liver toxicity is identified as the most sensitive adverse effect contributing to the unreasonable risk of CTC exposure due to fatty changes to the liver indicative of cellular damage. Under EPA's Guidelines for Carcinogen Risk Assessment (Ref. 47), CTC is classified as “Likely to be Carcinogenic in Humans.” CTC has been shown to cause pheochromocytomas (tumors of the adrenal glands) in male and female mice by oral and inhalation exposures, and a strong association between neuroblastoma and CTC in a single well-conducted epidemiological study in the same organ raises concern for potential carcinogenic effects in human. In addition, a general correlation has been observed in animal studies with CTC between hepatocellular cytotocity and regenerative hyperplasia and the induction of liver tumors (Ref. 1).

Populations exposed to CTC include workers ages 17 and older of either gender, including pregnant women and individuals who do not use CTC but may be indirectly exposed due to their proximity to the user who is directly handling CTC (occupational non-users, or ONUs). EPA estimates that, annually, there are approximately between 852 and 9,554 workers and between 500 and 4,144 ONUs at between 30 and 71 facilities either manufacturing, processing, or using CTC for industrial and commercial conditions of use (Ref. 5).

In addition to these estimates of numbers of workers and occupational non-users directly exposed to CTC, EPA recognizes there is exposure to the general population from air and water pathways for CTC (fenceline communities are a subset of the general population who may be living in proximity to a facility where CTC is being used in an occupational setting). EPA separately conducted a screening approach to assess whether there may be potential risks to the general population from these exposure pathways. This analysis is summarized in the proposed rule, which includes information on the SACC peer review. This unit addresses those areas where some risk was indicated at the fenceline, and the conditions of use will be continuing under this final rule.

EPA's methodological approach to assessing potential exposures to fenceline communities of chemicals undergoing risk evaluation under TSCA section 6 was presented to the SACC peer review panel in March 2022, and EPA is including SACC recommendations, as appropriate, in assessing general population exposures in upcoming risk evaluations.

EPA's fenceline analysis for the water pathway for CTC, based on methods presented to the SACC, did not find risks from drinking water, incidental oral ingestion of ambient water, or incidental dermal exposure of surface water (Ref. 48).

Standard cancer benchmarks used by EPA and other regulatory agencies are an increased cancer risk above benchmarks ranging from 1 in 1,000,000 to 1 in 10,000 ( i.e., 1 × 10⁻⁶ to 1 × 10⁻⁴). For example, when setting standards under section 112(f)(2) of the CAA, EPA uses a two-step process, with “an analytical first step to determine an `acceptable risk' that considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual risk (MIR) of approximately 1-in-10 thousand” (Ref. 49, referencing the interpretation set forth in the 1989 final National Emission Standards for Benzene rule (54 FR 38044 Sept. 14, 1989)). In the screening level fenceline analysis for the ambient air pathway for CTC, EPA calculated its risk estimates to certain populations within the general population living or working near particular facilities and compared those risk estimates to a 1 in 1,000,000 ( i.e., 1 × 10⁻⁶) benchmark value for cancer risk. There are still uncertainties where the calculated risk exceeds this cancer risk benchmark value. The benchmark values are not a bright line, and the Agency considers a number of factors when determining unreasonable risk, such as the endpoint under consideration, the reversibility of effect, and exposure-related considerations ( e.g., duration, magnitude, aggregate or cumulative impacts, or frequency of exposure, or size of population exposed, including PESS).

The screening level fenceline analysis for CTC calculated risk estimates to select populations within the general population living or working near particular facilities exceeding the 1 × 10⁻⁶ benchmark value (Ref. 50). However, EPA has not determined based on this screening level analysis whether these risks to the general population contribute to the unreasonable risk presented by CTC. After considering the results, limitations, and uncertainties of the screening-level analysis, EPA determined as a matter of policy that reopening the TSCA section 6(b) risk evaluation for CTC for further evaluation of risk to the general population, and consequently delaying the promulgation of this TSCA section 6(a) rule, was not warranted. The Agency believes it is important to expeditiously promulgate this final rule to protect the public from the unreasonable risk determined in accordance with TSCA section 6(b)(4)(A), which was driven by occupational exposures.

The ambient air analysis for the multi-year fenceline analysis identified 19 facilities (in addition to 6 facilities solely manufacturing CTC as a byproduct, which were excluded because, as described earlier, the 2020 Risk Evaluation for Carbon Tetrachloride did not include the manufacture of CTC as a byproduct as a condition of use) with risk estimates above one in a million, with one facility with risk estimates above one in ten thousand, at 100 meters representing five conditions of use. Under the final regulatory action described in Unit IV., all of the ongoing conditions of use with an indication of potential risk to fenceline communities (with the exception of manufacture of CTC as a byproduct) would be required to establish a WCPP. Furthermore, EPA is prohibiting increased emissions associated with WCPP requirements, and in the WCPP exposure control plan facilities need to evaluate controls to determine how to reduce releases and exposures to potentially exposed persons in the workplace and attest that engineering controls selected do not increase emissions of CTC to ambient air outside of the workplace and whether additional equipment was installed to capture emissions of CTC to ( print page 103544) ambient air. EPA anticipates that this analysis would help facilities to determine the most effective ways to reduce releases, including possible engineering controls or elimination/substitution of CTC, and therefore may also reduce the overall risk to fenceline communities.

EPA recognizes, as was described in the 2020 Risk Evaluation for Carbon Tetrachloride, that CTC is highly persistent in the atmosphere with an estimated tropospheric half-life exceeding 330 years. Thus, CTC has notable global background concentrations due to its long half-life, despite having limited air releases in the US, as noted in both the EPA's Air Toxic Screening Assessment modeling technical support document and in a recent EPA publication comparing the national air toxics modeling to regional monitoring data (Refs. 51, 52). The risk estimates from the fenceline analysis do not account for the background concentrations from historical emissions, which are persistent in the atmosphere.

In the instances where manufacturing, processing, or use of CTC may increase, EPA expects that potential additional exposure from emissions to ambient air to be limited as a result of the prohibition on the increased ventilation of CTC to ambient air and existing National Emission Standards for Hazardous Air Pollutants (NESHAPs) that cover CTC for these conditions of use under the CAA. Applicable NESHAPs include: 40 CFR part 63, subparts F, G, H, and I, Organic HAP from the Synthetic Organic Chemical Manufacturing Industry and Other Processes Subject to the Negotiated Regulation for Equipment Leaks.

The CAA establishes a two-phase process for the EPA's development, review, and potential revision of NESHAP that impose emission standards and work practice requirements on subject categories of sources of hazardous air pollutants. First, the EPA sets technology-based or performance-based standards reflecting the maximum achievable control technology (MACT) for major sources (CAA section 112(d)(2) and (3)) and generally available control technology (GACT) for area or non-major sources (CAA section 112(d)(5)). In the second phase, eight years after adoption of the first phase standards, the EPA performs a residual risk review of major source MACT standards to ensure that they provide an ample margin of safety to protect public health (CAA section 112(f)(2)), and a technology review of all NESHAP to account for developments in practices, processes and control technologies (CAA section 112(d)(6)). The CAA only requires the EPA to conduct the residual risk review one time for each MACT standard, although the EPA has discretion to conduct additional risk reviews where warranted. The technology review, instead, is a recurring duty, and the EPA must perform it no less often than every eight years.

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

EPA's analysis of the environmental effects of CTC and the magnitude of exposure of the environment to CTC are in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1). The unreasonable risk determination for CTC is based solely on risks to human health; based on the TSCA 2020 Risk Evaluation for Carbon Tetrachloride, EPA determined that exposures to the environment did not drive the unreasonable risk. A summary is presented here in Unit V.

Exposures to terrestrial organisms from the suspended soils and biosolids pathway was qualitatively evaluated. Due to its physical-chemical properties, EPA expects that CTC does not bioaccumulate in fish or sediments; and CTC could be mobile in soil and migrate to water or volatilize to air (Ref. 1).

EPA concluded in the 2020 Risk Evaluation for Carbon Tetrachloride that CTC poses a hazard to environmental aquatic receptors. Amphibians were the most sensitive taxa for acute and chronic exposures. Acute exposures of CTC to fish, freshwater aquatic invertebrates, and sediment invertebrates resulted in hazard values as low as 10.4 mg/L, 11.1 mg/L, and 2 mg/L, respectively. For chronic exposures, CTC has a hazard value for amphibians of 0.03 mg/L based on teratogenesis and lethality in frog embryos and larvae. Furthermore, chronic exposures of CTC to fish, freshwater aquatic invertebrates, and sediment invertebrates resulted in hazard values as low as 1.97 mg/L, 1.1 mg/L, and 0.2 mg/L, respectively. In algal studies, CTC has hazard values ranging from 0.07 to 23.59 mg/L (Ref. 1).

In addition to the environmental effects assessed in the 2020 Risk Evaluation for Carbon Tetrachloride, EPA recognizes that CTC is an ozone-depleting substance with a 100-year GWP of 1730 (energy the emissions of one ton of gas will absorb over 100 years, relative to the emissions of one ton of carbon dioxide (CO₂)) (Ref. 53). As a result of its ozone-depleting effects, the Montreal Protocol and Title VI of the CAA led to a phase-out of CTC production in the United States for most non-feedstock domestic uses. EPA did not evaluate the effect of CTC or this rule on ozone depletion. In addition, while the Agency understands that the use of CTC is expected to increase to produce low GWP HFOs, replacing many of the higher GWP HFCs, there is uncertainty in the change in volume of CTC that will be manufactured and used to produce HFOs. In the final rule, EPA is requiring owners/operators to ensure that any engineering controls instituted under the WCPP do not increase emissions of CTC to ambient air. EPA expects that potential additional exposure from emissions to ambient air would be limited as a result of the existing NESHAPs that cover CTC. However, EPA did not evaluate whether a possible increase of CTC emissions with a GWP of 1730 would offset emissions of the HFCs replaced by the lower GWP HFOs manufactured with CTC, or the overall global warming impact of CTC use.

C. Benefits of Carbon Tetrachloride for Various Uses

As described in the proposed rule, CTC is primarily used as a feedstock in the production of HCFCs, HFCs, and HFOs. Other conditions of use include regulated use as a processing agent in the manufacture of petrochemicals-derived and agricultural products and other chlorinated compounds such as chlorinated paraffins, chlorinated rubber and others that may be used downstream in the formulation of solvents for adhesives, asphalt, paints and coatings. Requirements under the Montreal Protocol and Title VI of the CAA led to a phaseout of CTC production in the United States for most non-feedstock domestic uses in 1996 and the CPSC banned the use of CTC in household products (excluding unavoidable residues not exceeding 10 ppm atmospheric concentration) in 1970.

CTC is a major feedstock for generation of lower-GWP alternative fluorocarbon products in the United States (Ref. 54). EPA anticipates that many entities currently using HFCs with higher global warming potential will transition to alternatives with lower global warming potential as requirements under the AIM Act begin to apply. The manufacturing of CTC is predicted to increase as a result of the transition from HFCs to lower-GWP HFOs that use CTC as a feedstock, such as HFO-1234yf used in motor vehicle AC and HFO-1234ze used in some types of aerosols and foam-blowing agents. ( print page 103545)

D. Reasonably Ascertainable Economic Consequences of the Final Rule

1. Likely Effect of the Rule on the National Economy, Small Business, Technological Innovation, the Environment, and Public Health

With respect to the anticipated effects of this rule on the national economy, the economic impact of a regulation on the national economy generally only becomes measurable if the economic impact of the regulation reaches 0.25 percent to 0.5 percent of Gross Domestic Product (GDP) (Ref. 55). Given the current GDP of $23.17 trillion, this is equivalent to a cost of $58 billion to $116 billion which is considerably higher than the estimated cost of this rule. EPA considered the number of businesses, facilities, and workers that would be affected and the costs and benefits to those businesses and workers and society at large and did not find that there would be a measurable effect on the national economy. In addition, EPA considered the employment impacts of this final rule. For businesses subject to the WCPP, including the ECEL and DDCC requirements, and prescriptive workplace control requirements, EPA estimates the marginal cost of labor will increase. This may lead to small negative employment effects. Costs of prohibition in the final rule are not quantified, since EPA expects the prohibited uses are not ongoing. However, there may be employment effects proportionate to the extent to which CTC is still being used in the prohibited conditions of use.

EPA has determined that the rule will not have a significant impact on a substantial number of small entities. EPA estimates that the rule would affect at least seven small entities, and that the cost would only exceed 1 percent of annual revenues for two of these small entities. EPA expects that the final rule will not hinder technological innovation. Innovative applications of CTC in recent years have occurred in the production of HFOs. The regulatory options with requirements for certain conditions of use, including processing as a reactant in the production of refrigerants (such as HFOs), are not expected to inhibit innovation since they permit the continued use of CTC with appropriate controls. With respect to those conditions of use where prohibition is the requirement in the final action, EPA did not find evidence of ongoing use of CTC and thus there are no expected effects on innovation.

The effects of this rule on public health are estimated to be positive, due to the avoided incidence of adverse health effects attributable to CTC exposure, including adrenal and liver cancer.

2. Costs and Benefits of the Regulatory Action and of the 1 or More Primary Alternative Regulatory Actions Considered by the Administrator

The costs and benefits that can be monetized for this rule are described at length in in the Economic Analysis (Ref. 5). The total cost of the final rule is $19.7 million dollars annualized over 20 years at a 3% discount rate and $19 million dollars at a 7% discount rate. EPA's Economic Analysis for the rule quantified the benefits from avoided cases of adrenal and liver cancers. Cancer benefits are calculated based on inhalation exposure estimates from the Final Risk Evaluation. The estimated monetized benefit of the final rule ranges from approximately $0.13 to $0.14 million per year annualized over 20 years at a 3% discount rate and from $0.06 to $0.07 million per year at a 7% discount rate.

There are also unquantified benefits due to other avoided significant adverse health effects associated with CTC exposure, including liver, reproductive, renal, developmental, and CNS toxicity end points. EPA believes that the balance of costs and benefits of this final rule cannot be fairly described without considering the additional, non-monetized benefits of mitigating the non-cancer adverse effects. The non-cancer adverse effects from CTC exposure can significantly impact an individual's quality of life. The incremental improvements in health outcomes achieved by given reductions in exposure cannot currently be quantified for non-cancer health effects associated with CTC exposure, and therefore cannot be converted into monetized benefits. The qualitative discussion throughout this rulemaking and in the Economic Analysis highlights the importance of these non-cancer effects, which are not able to be monetized in the way that EPA is able to for cancer. These effects include not only cost of illness but also personal costs such as emotional and mental stress that are hard to measure appropriately. Considering only monetized benefits significantly underestimates the impacts of CTC adverse outcomes and underestimates the benefits of this final rule.

Net benefits were calculated by subtracting the costs from the quantified benefits. The net benefit of the final rule action is −$19.6 million dollars annualized over 20 years at a 3% discount rate and −$18.9 million dollars at a 7% discount rate.

Industry would bear monitoring, PPE, and notification and recordkeeping burdens and costs associated with the ECEL. While companies may comply with the rule using engineering controls, when estimating costs and benefits the Economic Analysis assumes firms will provide PPE to employees when monitoring thresholds are exceeded. EPA estimated monitoring results based on a log normal distribution estimated from the median and 95th percentile 8-hour time-weighted average exposure outcomes presented in the 2020 Risk Evaluation for Carbon Tetrachloride. PPE, recordkeeping, and monitoring costs after initial monitoring vary by industry and by projected initial monitoring result. Industry is expected to incur planning, recordkeeping and PPE costs associated with DDCC requirements. Industry would incur costs associated with developing an exposure control plan, performing inspections, documenting efforts to reduce exposure and occurrences of exposure, respiratory protection and dermal PPE, and training on the use of respiratory protection and dermal PPE.

EPA also considered the estimated costs of alternative regulatory actions to regulated entities. Estimated costs for regulatory alternatives can be found in the Economic Analysis for this final rule (Ref. 5).

A sensitivity analysis was conducted based on the low estimates of the number of affected entities in the 2020 Risk Evaluation for Carbon Tetrachloride. Based on these estimates, the total cost of the final rule is $2.1 million dollars annualized over 20 years at both a 3 and 7% discount rate. The total benefit of the final rule is estimated to range from $0.016 million dollars to $0.018 million dollars annualized over 20 years at a 3% period discount rate, and ranges from $0.008 million dollars to $0.009 million dollars annualized over 20 years at a 7 percent discount rate. The net benefit of the rule under this sensitivity analysis is −$2.1 million dollars annualized over 20 years at a 3% discount rate and a 7% discount rate. At a 2% discount rate, the cost of the rule assuming the low number of affected entities is $2.1 million, the benefit is $0.02 million, and the net benefit is −$2.1 million.

3. Cost Effectiveness of the Regulatory Action and of 1 or More Primary Alternative Regulatory Actions Considered by the Administrator

For the COUs that EPA determined drive the unreasonable risk of injury to health from CTC, both the final rule and the primary alternative action, which is analyzed in the Economic Analysis, ( print page 103546) reduce unreasonable risk to the extent necessary such that unreasonable risk is no longer presented. In achieving this result, however, the estimated costs of the final rule and the primary alternative regulatory action differ as described in Units I.E. and V.D.2. The costs of achieving the desired outcome via the final rule or the primary alternative regulatory action can be compared to evaluate cost-effectiveness. The measure of cost-effectiveness considered is the annualized cost of each regulatory option per microrisk reduction in cancer cases estimated to occur as a result of each regulatory option, where a microrisk refers to a one in one million reduction in the risk of a cancer case. The cost-effectiveness of the final rule ranges from $681 to $1,000 dollars per microrisk reduction at a 3% discount rate, and from $656 to $963 dollars per microrisk reduction at a 7% discount rate. The cost-effectiveness of the primary alternative regulatory action ranges from $611 to $897 dollars per microrisk reduction at a 3% discount rate, and from $778 to $1,142 dollars at a 7% discount rate.

The primary difference between the final and primary alternative option is that the alternative requires prescriptive controls for conditions of use which fall under the WCPP in the final rule. For two such conditions of use (Processing by incorporation into formulation, mixture, or reaction products in agricultural products manufacturing, vinyl chloride manufacturing, and other basic organic and inorganic chemical manufacturing; and Industrial and commercial use as a processing aid in the manufacture of agricultural products and vinyl chloride), the Economic Analysis analyzed a primary alternative action of prohibition for the vinyl chloride sub-uses only. In the proposed rule, EPA proposed prohibition for these sub-uses of vinyl chloride that at the time EPA did not have reasonably available information to indicate the uses were ongoing but later received public comments from one entity indicating that the incorporation of CTC into formulation, mixtures, or reaction products in vinyl chloride manufacturing and the industrial and commercial use of CTC as an industrial processing aid in the manufacture of vinyl chloride were ongoing. While the final rule requires a WCPP for these sub-uses, the primary alternative analyzes the costs and benefits of prohibiting these sub-uses of vinyl chloride.

Since the regulated universe in both the final and primary alternative regulatory actions is identical, the cost-effectiveness of the regulatory actions varies based on the differences in the requirements of each action. Section 3.9 of the Economic Analysis provides a summary of the unquantified costs and uncertainties in the cost estimates that may impact the respective cost-effectiveness of the final rule and the primary alternative regulatory action considered.

VI. TSCA Section 9 Analysis and Section 26 Considerations

A. TSCA Section 9(a) Analysis

TSCA section 9(a) provides that, if the Administrator determines, in the Administrator's discretion, that an unreasonable risk may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA, the Administrator must submit a report to the agency administering that other law that describes the risk and the activities that present such risk. TSCA section 9(a) describes additional procedures and requirements to be followed by EPA and the other Federal agency following submission of any such report. As discussed in this unit, the Administrator does not determine that unreasonable risk from CTC under the conditions of use may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA. EPA's TSCA section 9(a) analysis is presented in Unit VII.A. of the proposed rule (88 FR 49215, July 28, 2023) (FRL-8206-01-OCSPP), and responses to comments about that analysis can be found in the Response Agree. Comments, Section 10.1 (Ref. 11).

TSCA section 9(d) instructs the Administrator to consult and coordinate TSCA activities with other Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burden of duplicative requirements. For this rulemaking, EPA has coordinated with appropriate Federal executive departments and agencies, including OSHA, to, among other things, identify their respective authorities, jurisdictions, and existing laws with regard to risk evaluation and risk management of CTC.

As discussed in more detail in the proposed rule, OSHA requires that employers provide safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education, and assistance. OSHA, in 1971, established a PEL for CTC of 10 ppm of air as an 8-hour TWA with an acceptable ceiling concentration of 25 ppm and an acceptable maximum peak above the acceptable ceiling concentration for an eight-hour shift of 200 ppm, maximum duration of 5 minutes in any 4 hours. However, the exposure limits established by OSHA are higher than the exposure limit that EPA determined would be sufficient to address the unreasonable risk identified under TSCA from occupational inhalation exposures associated with certain conditions of use. Gaps exist between OSHA's authority to set workplace standards under the OSH Act and EPA's obligations under TSCA section 6 to eliminate unreasonable risk presented by chemical substances under the conditions of use, as further discussed in Units II.C. and VII.A. of the proposed rule.

EPA concludes that TSCA is the only regulatory authority able to prevent or reduce unreasonable risk of CTC to a sufficient extent across the range of conditions of use, exposures, and populations of concern. An action under TSCA is able to address occupational unreasonable risk and would reach entities that are not subject to OSHA. Moreover, the timeframe and any exposure reduction as a result of updating OSHA regulations for CTC cannot be estimated, while TSCA imposes a much more accelerated two-year statutory timeframe for proposing and finalizing requirements to address unreasonable risk. Finally, as discussed in greater detail in the proposed rule, the 2016 amendments to TSCA altered both the manner of identifying unreasonable risk and EPA's authority to address unreasonable risk, such that risk management is increasingly distinct from provisions of the OSH Act (88 FR 49180) (FRL-8206-01-OCSPP). For these reasons, in the Administrator's discretion, the Administrator has analyzed this issue and does not determine that unreasonable risk presented by CTC may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA.

B. TSCA Section 9(b) Analysis

If EPA determines that actions under other Federal laws administered in whole or in part by EPA could eliminate or sufficiently reduce a risk to health or the environment, TSCA section 9(b) instructs EPA to use these other authorities to protect against that risk “unless the Administrator determines, in the Administrator's discretion, that it is in the public interest to protect against such risk” under TSCA. In making such a public interest finding, TSCA section 9(b)(2) states: “the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of ( print page 103547) the risk . . . and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.”

Although several EPA statutes have been used to limit CTC exposure (Ref. 10), regulations under those EPA statutes largely regulate releases to the environment, rather than the occupational exposures. While these limits on releases to the environment may be protective in the context of their respective statutory authorities, regulation under TSCA is also appropriate for occupational exposures and in some cases can provide upstream protections that would prevent the need for release restrictions required by other EPA statutes ( e.g., Resource Conservation and Recovery Act (RCRA), CAA, CWA). Updating regulations under other EPA statutes would not be sufficient to address the unreasonable risk of injury to the health of workers and occupational non-users who are exposed to CTC under its conditions of use. EPA's TSCA section 9(b) analysis is presented in the proposed rule (88 FR 49216) (FRL-8206-01-OCSPP), and responses to comments on that analysis can be found in the Response to Comments, section 10.2 (Ref. 11).

For these reasons, the Administrator does not determine that unreasonable risk from CTC under its conditions of use, as evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref.1), could be eliminated or reduced to a sufficient extent by actions taken under other Federal laws administered in whole or in part by EPA.

C. TSCA Section 14 Requirements

EPA is also providing notice to manufacturers, processors, and other interested parties about potential impacts to CBI. Under TSCA sections 14(a) and 14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that establishes a ban or phase-out of a chemical substance, the protection from disclosure of any CBI regarding that chemical substance and submitted pursuant to TSCA will be “presumed to no longer apply,” subject to the limitations identified in TSCA section 14(b)(4)(B)(i) through (iii). Pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against protection from disclosure will apply only to information about the specific conditions of use that this rule prohibits. Manufacturers or processors seeking to protect such information may submit a request for nondisclosure as provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure must be submitted within 30 days after receipt of notice from EPA under TSCA section 14(g)(2)(A) stating EPA will not protect the information from disclosure. EPA anticipates providing such notice via the Central Data Exchange (CDX).

D. TSCA Section 26 Considerations

As explained in the 2023 proposed rule (88 FR 49216, July 29, 2023) (FRL-8206-01-OCSPP), EPA fulfilled TSCA section 26(h) by using scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science. Comments received on the proposed rule about whether EPA adequately assessed reasonably available information under TSCA section 26 on the risk evaluation, and responses to those comments, can be found in Section 10.4 of the Response to Comments document (Ref. 11).

VII. References

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

1. EPA. Risk Evaluation for Carbon Tetrachloride (Methane, Tetrachloro-). EPA Document #EPA-740-R1-8014. October 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0061.

2. EPA. Correction of Dermal Acute Hazard and Risk Values in the Final Risk Evaluation for Carbon Tetrachloride. July 2022. (EPA-HQ-OPPT-2019-0499). https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0064.

3. EPA. Carbon Tetrachloride; Revision to Toxic Substances Control Act (TSCA) Risk Determination. December 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0733-0120.

4. EPA. Memorandum of Communication between Syngenta and EPA Regarding Risk Management of Carbon Tetrachloride. October 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0024.

5. EPA. Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA); Economic Analysis.

6. NIOSH. Hierarchy of Controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html (accessed April 2024).

7. President Joseph R. Biden. The White House. The President and First Lady's Cancer Moonshot: Ending Cancer As We Know It. https://www.whitehouse.gov/cancermoonshot/ (accessed February 26, 2024).

8. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.

9. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.

10. EPA. Regulatory Actions Pertaining to Carbon Tetrachloride (CTC). June 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0055.

11. EPA. Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA); Response to Public Comments.

12. Executive Order 13985. Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. Federal Register (86 FR 7009, January 25, 2021).

13. Executive Order 13990. Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. Federal Register (86 FR 7037, January 25, 2021).

14. Executive Order 14008. Tackling the Climate Crisis at Home and Abroad. Federal Register (86 FR 7619, February 1, 2021).

15. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational Use of Carbon Tetrachloride. February 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0113.

16. EPA. Federalism Consultation on Risk Management Rulemakings for HBCD and Carbon Tetrachloride. December 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0033.

17. EPA. Tribal Consultations on Risk Management Rulemakings for HBCD and Carbon Tetrachloride. January 6, 2021 and January 12, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0041.

18. EPA. Environmental Justice Consultations Risk Management Rulemakings for HBCD and Carbon Tetrachloride. February 2, 2021 and February 18, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0034.

19. EPA. Public Webinar on Carbon Tetrachloride: Risk Evaluation and Risk Management under TSCA Section 6. December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0006.

20. EPA. Small Business Administration Small Business Environmental Roundtable Risk Evaluation and Risk Management under TSCA Section 6 for Carbon Tetrachloride. December 4, 2020.

21. EPA. Updated Stakeholder Meeting List for Rulemaking for Carbon Tetrachloride under TSCA Section 6(a). 2024.

22. EPA. EPA's Policy on Children's Health. October 5, 2021. https://www.epa.gov/children/childrens-health-policy-and-plan#A1.

23. EPA. Public Webinar Carbon Tetrachloride: Risk Evaluation and Risk Management under TSCA Section 6. August 15, 2023. ( print page 103548)

24. EPA. Meeting with Olin 11.20.23. December 7, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0148.

25. Christopher M. Kolodziej. Christopher M. Kennedy Comment. EPA-HQ-OPPT-2020-0592-0135. September 11, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0135.

26. Michael Kennedy. American Petroleum Institute (API) Comment. EPA-HQ-OPPT-2020-0592-0129. September 7, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0129.

27. Mark Ames. AIHA Comment. EPA-HQ-OPPT-2020-0592-0126. August 29, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0126.

28. Danielle Jones. The Chemours Company Comment. EPA-HQ-OPPT-2020-0592-0134. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0134.

29. W. Caffey Norman. Halogenated Solvents Industry Alliance, Inc. (HSIA) Comment. EPA-HQ-OPPT-2020-0592-0133. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0133.

30. LeaAnne Forest. American Chemistry Council (ACC) Comment. EPA-HQ-OPPT-2020-0592-0140. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0140.

31. Paul DeLeo. American Chemistry Council (ACC) Comment. EPA-HQ-OPPT-2020-0592-0142. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0142.

32. Martin J. Durbin. US Chamber of Commerce Comment. EPA-HQ-OPPT-2020-0592-0137. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0137.

33. Melanie Barrett, Nancy Kahl. MilliporeSigma Comment. EPA-HQ-OPPT-2020-0592-0128. September 5, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0128.

34. Lawrence E. Culleen. Chemical Users Coalition (CUC) Comment. EPA-HQ-OPPT-2020-0592-0130. September 8, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0130.

35. Michael Kelly. Honeywell International Inc. (Honeywell) Comment. EPA-HQ-OPPT-2020-0592-0144. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0144.

36. Scott Sutton. Olin Comment. EPA-HQ-OPPT-2020-0592-0127. August 31, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0127.

37. American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) and United Steelworkers (USW). AFL-CIO and USW Comment. EPA-HQ-OPPT-2020-0592-0138. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0138.

38. James Cooper. American Fuel & Petrochemical Manufacturers (AFPM) Comment. EPA-HQ-OPPT-2020-0592-0143. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0143.

39. William E. Allmond IV. Adhesive and Sealant Council (ASC) Comment. EPA-HQ-OPPT-2020-0592-0139. September 11, 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2020-0592-0139.

40. OSHA. OSHA 1999 Multi-Employer Citation Policy. Accessed 10/27/2023. https://www.osha.gov/enforcement/directives/cpl-02-00-124.

41. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane (CASRN 107-06-2). August 2020. (EPA-HQ-OPPT-2018-0427-0048). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0071.

42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride. Federal Register (62 FR 1494, January 10, 1997). https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0073.

43. OSHA. OSHA Technical Manual (OTM) Section II: Chapter 1. Personal Sampling for Air Contaminants. Last updated on September 14, 2023. https://www.osha.gov/otm/section-2-health-hazards/chapter-1.

44. NIOSH. Letter to Claudia Menasche from J. Raymond Wells. EPA's Carbon Tetrachloride Risk Management Rule under TSCA Section 6. June 28, 2024.

45. OSHA. Personal Protective Equipment. May 4, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0087.

46. The Program Executive Office, Assembled Chemical Weapons Alternatives (PEO ACWA). U.S. Chemical Weapons Destruction 2018. May 2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0020.

47. EPA. Guidelines for Carcinogen Risk Assessment. March 2005. https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.

48. EPA. Carbon Tetrachloride: Fenceline Technical Support—Water Pathway. October 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0047.

49. EPA. Final Rule. National Emission Standards for Hazardous Air Pollutants: Carbon Black Production and Cyanide Chemicals Manufacturing Residual Risk and Technology Reviews, and Carbon Black Production Area Source Technology Review. Federal Register (86 FR 66096, November 19, 2021).

50. EPA. Carbon Tetrachloride: Fenceline Technical Support—Ambient Air Pathway. October 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0050.

51. EPA. Technical Support Document EPA's Air Toxics Screening Assessment 2018 AirToxScreen TSD. Document number EPA-452/B-22-002. August 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0042.

52. Weitekamp. C. et al. 2021. An Examination of National Cancer Risk Based on Monitored Hazardous Air Pollutants. Environmental Health Perspectives. Vol. 129., No. 3. https://ehp.niehs.nih.gov/doi/full/10.1289/EHP8044.

53. Myhre, G., D. Shindell, F.-M. Bréon, W. Collins, J. Fuglestvedt, J. Huang, D. Koch, J.-F. Lamarque, D. Lee, B. Mendoza, T. Nakajima, A. Robock, G. Stephens, T. Takemura and H. Zhang, 2013: Anthropogenic and Natural Radiative Forcing. In: Climate Change 2013: The Physical Science Basis. Contribution of Working Group I to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change [Stocker, T.F., D. Qin, G.-K. Plattner, M. Tignor, S.K. Allen, J. Boschung, A. Nauels, Y. Xia, V. Bex and P.M. Midgley (eds.)]. Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA. https://www.ipcc.ch/site/assets/uploads/2018/02/WG1AR5_Chapter08_FINAL.pdf.

54. Halogenated Solvents Industry Alliance, Inc. (HSIA). Comments submitted to EPA on the Carbon Tetrachloride Risk Evaluation and the Risk Management Process. April 28, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0003.

55. Office of Management and Budget. March 31, 1995. OMB M-95-09, Memorandum for the Heads of Executive Departments and Agencies. Guidance for Implementing Title II of S. 1. https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/1995-1998/m95-09.pdf.

56. EPA. Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA); Regulation of Carbon Tetrachloride under TSCA Section 6(a) (Final Rule; RIN 2070-AK82). 2024.

57. Kevin Ashley. 2015. Harmonization of NIOSH Sampling and Analytical Methods with Related International Voluntary Consensus Standards. J Occup Environ Hyg. 12(7): D107-15. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0592-0032.

VIII. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review

This action is a “significant regulatory action” as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 ( print page 103549) review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis, Economic Analysis of the Regulation of Carbon Tetrachloride Under TSCA Section 6(a) (Ref. 5), is available in the docket and summarized in Units I.E. and V.D.

B. Paperwork Reduction Act (PRA)

The information collection activities in this final rule have been submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2744.02 and OMB Control No. 2070-0228 (Ref. 56). You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them. There are two primary provisions of the final rule that may increase burden under the PRA. The first is downstream notification, which would be carried out by updates to the relevant SDS and which will required for manufacturers, processors, and distributors in commerce of CTC, who will provide notice to companies downstream upon shipment of CTC about the prohibitions. The information submitted to downstream companies through the SDS will provide knowledge and awareness of the restrictions to these companies.

The second primary provision of the final rule that may increase burden under the PRA is WCPP-related information generation, recordkeeping, and notification requirements (including development of exposure control plans; exposure level monitoring and related recordkeeping; development of documentation for a PPE program and related recordkeeping; development of documentation for a respiratory protection program and related recordkeeping; development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, exposure monitoring records, PPE program implementation documentation, and respirator program documentation; ordinary business records, such as invoices and bills-of-lading related to the continued distribution of CTC in commerce, as well as records documenting compliance with the proposed workplace chemical protection program requirements and proposed restrictions on the laboratory use of CTC.

Respondents/affected entities: Persons that manufacture, process, use, distribute in commerce or dispose of carbon tetrachloride (see Unit I.A.).

Respondent's obligation to respond: Mandatory under TSCA section 6(a) and 40 CFR part 751.

Estimated number of respondents: 72.

Frequency of response: On occasion.

Total estimated burden: 86,186 hours per year. Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $14,800,653 per year, including $9,360,626 in annualized capital or operation and maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are small businesses that manufacture/import, process, or distribute the chemicals subject to this final rule. The Agency identified seven small firms in the small entity analysis that are potentially subject to the rule. The names and NAICS codes of these entities can be found in Section 6.2.2 of the Economic Analysis (Ref. 5). It is estimated that five of the seven small companies would incur a rule cost-to-company revenue impact ratio of less than one percent, and two companies would experience an impact of between one and three percent. The companies estimated to experience a greater than one percent rule cost-to-revenue impact would potentially be subject to the rule under the Disposal and the Manufacturing conditions of use, both of which would require a WCPP under the final rule. To avoid understating impacts to small entities, EPA used the highest per-facility cost presented in the EA ($615,457). Per-facility costs were estimated by dividing the total costs by the number of affected facilities for each use. Details of this analysis are in the Economic Analysis (Ref. 5), which is in the docket for this action. Based on the low number of affected small entities and the low impact, EPA does not expect this action to have a significant impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million (in 1995 dollars and adjusted annually for inflation) or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action will affect entities that use CTC. It is not expected to affect State, local or Tribal governments because the use of CTC by government entities is minimal. The costs involved in this action are estimated not to exceed $183 million in 2023$ ($100 million in 1995$ adjusted for inflation using the GDP implicit price deflator) or more in any one year. The total quantified annualized social cost of the final rule is $19,736,400 (at 3% discount rate) and $18,995,752 (at 7% discount rate).

E. Executive Order 13132: Federalism

EPA has concluded that this action has federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because regulation under TSCA section 6(a) may preempt State law. EPA provides the following preliminary federalism summary impact statement. The Agency consulted with State and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development. This included a consultation meeting on December 17, 2020. EPA invited the following national organizations representing State and local elected officials to this meeting: National Governors Association; National Conference of State Legislatures, Council of State Governments, National League of Cities, U.S. Conference of Mayors, National Association of Counties, International City/County Management Association, National Association of Towns and Townships, County Executives of America, and Environmental Council of States. A summary of the meeting with these organizations, including the views that they expressed, is available in the docket (Ref. 16). EPA provided an opportunity for these organizations to provide follow-up comments in writing but did not receive any such comments.

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have Tribal implications as specified in Executive ( print page 103550) Order 13175 (65 FR 67249, November 9, 2000) because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. CTC is not manufactured, processed, or distributed in commerce by Tribes, and therefore, this rulemaking would not impose substantial direct compliance costs on Tribal governments. Thus, Executive Order 13175 does not apply to this action.

Notwithstanding the lack of Tribal implications as specified by Executive Order 13175, EPA consulted with Tribal officials during the development of this action, consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, which EPA applies more broadly than Executive Order 13175.

The Agency held a Tribal consultation from December 7, 2020, through March 12, 2021, with meetings held on January 6 and 12, 2021. Tribal officials were given the opportunity to meaningfully interact with EPA concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for Carbon Tetrachloride, types of information to inform risk management, principles for transparency during risk management, and types of information EPA sought from Tribes (Ref. 17). EPA briefed Tribal officials on the Agency's risk management considerations and Tribal officials raised no related issues or concerns to EPA during or in follow-up to those meetings (Ref. 17). EPA received no written comments as part of this consultation.

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal agencies to include an evaluation of the health and safety effects of the planned regulation on children in Federal health and safety standards and explain why the regulation is preferable to potentially effective and reasonably feasible alternatives. This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866, and because EPA does not believe that the environmental health or safety risks addressed by this action will have a disproportionate risk to children as reflected by the conclusions of the CTC risk evaluation. This action's health and risk assessments and impacts on both children and adults from occupational use from inhalation and dermal exposures are described in Units II.C.3, V.A., and the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1). While the Agency found risks to children and adults from occupational use, the Agency determined that risks to children were not disproportionate. EPA's Policy on Children's Health applies to this action. Information on how the Policy was applied and on the action's health and risk assessments are contained in Unit II.D.2.c., and the 2020 Risk Evaluation for CTC and the Economic Analysis for this final rule (Refs. 1, 5).

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

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.

I. National Technology Transfer and Advancement Act (NTTAA)

Pursuant to the NTTAA section 12(d), 15 U.S.C. 272, the Agency has determined that this rulemaking involves environmental monitoring or measurement, specifically for occupational inhalation exposures to CTC. Consistent with the Agency's Performance Based Measurement System (PBMS), EPA will not require the use of specific, prescribed analytic methods. Rather, the Agency will allow the use of any method that meets the prescribed performance criteria. The PBMS approach is intended to be more flexible and cost-effective for the regulated community; it is also intended to encourage innovation in analytical technology and improved data quality. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified.

For this rulemaking, the key consideration for the PBMS approach is the ability to accurately detect and measure airborne concentrations of CTC at the ECEL and the ECEL action level. Some examples of methods which meet the criteria are included in the appendix of the ECEL memo (Ref. 15). EPA recognizes that there may be voluntary consensus standards that meet the proposed criteria (Ref. 57).

J. Executive Orders 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All

EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns in accordance with Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR 25251, April 26, 2023). As described more fully in the Economic Analysis for this rulemaking (Ref. 5), EPA analyzed the baseline conditions facing communities near CTC and HFO manufacturing facilities as well as those of workers in the same industry and county as CTC facilities and HFO manufacturing facilities. The analysis of local demographics found that, across the entire population within 1- and 3-miles of CTC facilities, there are higher percentages of people who identify as Black and living below the poverty line and a similar percentage of people who identify as Hispanic compared to the national averages. CTC facilities are concentrated in Texas and Louisiana, especially near Houston and Baton Rouge. As summarized in Unit V.A., the screening level fenceline analysis for CTC calculated risk estimates to select populations within the general population living or working near particular facilities exceeding the 1 × 10⁻⁶ benchmark value (Ref. 49). In cases where communities with environmental justice concerns are also fenceline communities, EPA expects that the finalized prohibition of increased emissions associated with WCPP requirements would prevent an increase in health and environmental impacts due to this rule.

The worker analysis was performed at the county and industry level. In eight of the 12 counties with CTC facilities that reported Basic Chemical Manufacturing, workers who identify as Black were over-represented compared to their percentage of the national demographics for that industry; at the national level, 11% of workers in the Basic Chemical Manufacturing industry identify as Black. In addition, there were eight counties with CTC facilities that reported Waste Treatment and Disposal; workers in that industry in those counties were more likely to earn less than the national average for that industry across several demographic ( print page 103551) groups, as outlined in the Economic Analysis.

EPA believes that it is not practicable to assess whether this action is likely to result in disproportionate and adverse effects on communities with environmental justice concerns. EPA was unable to quantify the distributional effects of the regulatory action under consideration and compare them to baseline conditions for several reasons. Limitations include a lack of data regarding exposure reductions that will occur as a result of the rule and on the sociodemographic characteristics of workers in CTC facilities. Another key limitation that prevents evaluation of the distributional effects of the rule is a lack of knowledge of the actions regulated entities will take in response to the rule.

EPA additionally identified and addressed environmental justice concerns by conducting outreach to advocates of communities that might be subject to disproportionate exposure to CTC. On February 2 and 18, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to and in compliance with Executive Order 12898 and Executive Order 14008, entitled “Tackling the Climate Crisis at Home and Abroad” (86 FR 7619, February 1, 2021). EPA received one written comment following these public meetings, in addition to oral comments provided during the meetings (Ref. 18). Commenters supported strong regulation of CTC to protect lower-income communities and workers. In addition, commenters recommended EPA conduct analysis of additional exposure pathways, including air and water.

The information supporting this Executive Order review is contained in Units I.E., II.D., V.D., VI.A. and in the Economic Analysis (Ref. 5). EPA's presentations and fact sheets for the environmental justice consultations related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of the consultation are also available in the public docket for this rulemaking.

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5 U.S.C. 801 et seq., and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 751

Environmental protection
Chemicals
Export notification
Hazardous substances
Import certification
Reporting and recordkeeping

Michael S. Regan,

Administrator.

Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended to read as follows:

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

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

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

2. Add subpart H to read as follows:

Subpart H—Carbon Tetrachloride

751.701: General.
751.703: Definitions.
751.705: Prohibition of Certain Industrial and Commercial Uses and Manufacturing, Processing, and Distribution in Commerce of Carbon Tetrachloride for those Uses.
751.707: Workplace Chemical Protection Program (WCPP).
751.709: Workplace Restrictions for the Industrial and Commercial Use as a Laboratory Chemical, Including the Use of Carbon Tetrachloride as a Laboratory Chemical by the U.S. Department of Defense.
751.711: Downstream Notification.
751.713: Recordkeeping Requirements.

§ 751.701

General.

(a) Applicability. This subpart sets certain restrictions on the manufacture (including import), processing, distribution in commerce, use, or disposal of carbon tetrachloride (CASRN 56-23-5) to prevent unreasonable risk of injury to health in accordance with TSCA section 6(a).

(b) Trace quantities exclusion. Unless otherwise specified in this subpart, the prohibitions and restrictions of this subpart do not apply to carbon tetrachloride that is solely present unintentionally in trace quantities with another chemical substance or mixture.

(c) Owner and operator requirements. Any requirement for an owner or operator, or an owner and operator, is a requirement for any individual that is either an owner or an operator.

§ 751.703

Definitions.

The definitions in subpart A of this part apply to this Subpart unless otherwise specified in this section. In addition, the following definitions apply:

ECEL has the same meaning as in § 751.5 and for CTC, is an airborne concentration of carbon tetrachloride of 0.03 parts per million (ppm) calculated as an eight (8)-hour time-weighted average (TWA).

ECEL action level means a concentration of airborne carbon tetrachloride of 0.02 parts per million (ppm) calculated as an eight (8)-hour time-weighted average (TWA).

§ 751.705

Prohibition of Certain Industrial and Commercial Uses and Manufacturing, Processing, and Distribution in Commerce of Carbon Tetrachloride for Those Uses.

(a) Prohibitions. (1) After June 16, 2025, all persons are prohibited from manufacturing, processing, distributing in commerce (including making available) and using carbon tetrachloride for the following conditions of use:

(i) Processing condition of use: Incorporation into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride.

(ii) Industrial and commercial conditions of use:

(A) Industrial and commercial use as an industrial processing aid in the manufacture of petrochemicals-derived products except in the manufacture of vinyl chloride.

(B) Industrial and commercial use in the manufacture of other basic chemicals (including manufacturing of chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings), except for use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine.

(D) Industrial and commercial use as an additive.

(2) After December 18, 2025, all persons are prohibited from manufacturing, processing, distributing in commerce (including making available) and using carbon tetrachloride for industrial and commercial specialty uses by the U.S. Department of Defense except as provided in § 751.709.

(b) [Reserved].

§ 751.707

Workplace Chemical Protection Program (WCPP).

(a) Applicability. The provisions of this section apply to the following conditions of use of carbon tetrachloride, including manufacturing and processing for export, except to the ( print page 103552) extent the conditions of use are prohibited by § 751.705:

(1) Domestic manufacture, except where carbon tetrachloride is manufactured solely as a byproduct.

(2) Import.

(3) Processing as a reactant in the production of hydrochlorofluorocarbons, hydrofluorocarbons, hydrofluoroolefins and perchloroethylene.

(4) Processing: Incorporation into formulation, mixture, or reaction products for agricultural products manufacturing, vinyl chloride manufacturing, and other basic organic and inorganic chemical manufacturing.

(5) Processing: Repackaging for use as a laboratory chemical.

(6) Processing: Recycling.

(7) Industrial and commercial use as an industrial processing aid in the manufacture of agricultural products and vinyl chloride.

(8) Industrial and commercial use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine.

(9) Disposal.

(b) Existing chemical exposure limit (ECEL)— (1) Eight-hour time-weighted average (TWA) ECEL. Beginning September 20, 2027 for Federal agencies or Federal contractors acting for or on behalf of the Federal government, or by September 9, 2026 for non-Federal owners and operators, or beginning four months after introduction of carbon tetrachloride into the workplace if carbon tetrachloride commences after June 11, 2026, the owner or operator must ensure that no person is exposed to an airborne concentration of carbon tetrachloride in excess of the ECEL, consistent with the requirements of paragraph (d)(1)(i) of this section and, if necessary, paragraph (f) of this section.

(2) Exposure monitoring— (i) General. (A) Owners or operators must determine each potentially exposed person's exposure, without regard to respiratory protection, by either:

( 1) Taking a personal breathing zone air sample of each potentially exposed person's exposure; or

( 2) Taking personal breathing zone air samples that are representative of the 8-hour TWA of each exposure group.

(B) Personal breathing zone air samples are representative of the 8-hour TWA of all potentially exposed persons in an exposure group if the samples are of at least one person's full-shift exposure who represents the highest potential carbon tetrachloride exposures in that exposure group. Personal breathing zone air samples taken during one work shift may be used to represent potentially exposed person exposures on other work shifts where the owner or operator can document that the tasks performed and conditions in the workplace are similar across shifts.

(C) Exposure samples must be analyzed using an appropriate analytical method by a laboratory that complies with the Good Laboratory Practice Standards in 40 CFR part 792 or a laboratory accredited by the American Industrial Hygiene Association (AIHA) or another industry-recognized program.

(D) Owners or operators must ensure that methods used to perform exposure monitoring produce results that are accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of carbon tetrachloride.

(E) Owners and operators must re-monitor within 15 working days after receipt of any exposure monitoring when results indicate non-detect, unless an Environmental Professional as defined at 40 CFR 312.10 or a Certified Industrial Hygienist reviews the exposure monitoring results and determines re-monitoring is not necessary.

(ii) Initial monitoring. By June 21, 2027 for Federal agencies and Federal contractors acting for or on behalf of the Federal government, or by June 11, 2026 for non-Federal owners and operators, or within 30 days of introduction of carbon tetrachloride into the workplace, whichever is later, each owner or operator covered by this section must perform initial monitoring of potentially exposed persons. Where the owner or operator has monitoring results from monitoring conducted within five years prior to February 18, 2025 and the monitoring satisfies all other requirements of this section, the owner or operator may rely on such earlier monitoring results to satisfy the requirements of this paragraph (b)(2)(ii).

(iii) Periodic monitoring. The owner or operator must establish an exposure monitoring program for periodic monitoring of exposure to carbon tetrachloride in accordance with Table 1.

Table 1 to § 751.707( b )(3)( iii )—Periodic Monitoring Requirements
Air concentration condition	Periodic exposure monitoring requirement
If all initial exposure monitoring is below the ECEL action level (<0.02 ppm 8-hour TWA)	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 three months of the most recent exposure monitoring.
If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level but at or below the ECEL (≥0.02 ppm 8-hour TWA, ≤0.03 ppm 8-hour TWA)	Periodic exposure monitoring is required within six 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 five 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 carbon tetrachloride 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 exposure monitoring event. However, documentation of cessation of use of carbon tetrachloride is required; and periodic monitoring would be required when the owner or operator resumes the condition of use.

Visit the Official Version

Document Information

Effective Date:: 1/17/2025
Published:: 12/18/2024
Department:: Environmental Protection Agency
Entry Type:: Rule
Action:: Final rule.
Document Number:: 2024-29517
Dates:: This final rule is effective on January 17, 2025.
Pages:: 103512-103558 (47 pages)
Docket Numbers:: EPA-HQ-OPPT-2020-0592, FRL-8206-02-OCSPP
RINs:: 2070-AK82: Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA)
RIN Links:: https://www.federalregister.gov/regulations/2070-AK82/carbon-tetrachloride-ctc-regulation-under-the-toxic-substances-control-act-tsca-
Topics:: Chemicals, Environmental protection, Hazardous substances, Reporting and recordkeeping requirements
PDF File:: 2024-29517.pdf
Supporting Documents:: » Intergovernmental Panel on Climate Change (IPCC). Anthropogenic and Natural Radiative Forcing. In: Climate Change 2013: The Physical Science Basis; » OSHA Technical Manual (OTM) - Section II Chapter 1 Occupational Safety and Health Administration; » Weitekamp et al 2021 An Examination of National Cancer Risk; » The White House. Cancer Moonshot. Ending Cancer As We Know It; » EPA Guidelines for Carcinogen Risk Assessment March 2005; » Carbon Tetrachloride SBA Small Business Environmental Roundtable 12.04.2020; » Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA): Regulation of Carbon Tetrachloride under TSCA Section 6(a) (Proposed Rule; RIN 2070-AK82); » Use of Ozone Depleting Substances in Laboratories; » The aquatic toxicity of organic compounds to embryo-larval stages of fish and amphibians; » SOPs for Personal Protection at CTC Manufacturing Sites
CFR: (1): 40 CFR 751