The Environmental Protection Agency announced the proposed risk management rule for perchloroethylene (PCE) under the Toxic Substances Control Act. This proposal would prohibit all consumer uses, use in dry cleaning, and most industrial and commercial uses of PCE. Permitted uses would be subject to a workplace chemical protection program along with recordkeeping and downstream notification requirements. The rule also provides certain time-limited exemptions.
Identity and use profile of PCE (a.k.a. tetrachlorethylene)
- EPA’s Use and Market Profile for Tetrachloroethylene describes PCE (CAS RN 127-18-4) as a colorless, nonflammable organic solvent used in a variety of applications, including aerospace applications, cleaning textiles in dry cleaning facilities, degreasing metal parts, and serving as a process solvent for desulfurizing coal.
- Consumer uses of PCE include automotive cleaners, stain removers, stone and metal polish, lubricants, arts and crafts glue, gun ammunition sealant, and inks.
- PCE was also used extensively as an intermediate in the manufacture of chlorofluorocarbon (CFC) refrigerants until the Montreal Protocol banned production of CFCs for all but explicitly permitted uses in 1995. (For a detailed list of the types of entities that will likely be affected by the EPA’s risk management rule, i.e., those that manufacture, import, process, distribute, use, or dispose of PCE, or products containing PCE, see this page of the proposed rule.)
Regulation of PCE
- EPA’s Chemical Data Reporting (CDR) under TSCA requires U.S. manufacturers and importers of PCE to provide EPA with the information on the chemicals they manufacture or import into the U.S. PCE has also been a reportable chemical on the Toxics Release Inventory (TRI), as well as the Emergency Planning and Community Right-to-know Act (EPCRA), which requires annual reporting from facilities using PCE. PCE is a designated Hazardous Air Pollutant (HAP) under the Clean Air Act (CAA), and is a hazardous substance under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). PCE is also subject to National Primary Drinking Water Regulations (NPDWR) under the Safe Drinking Water Act (SDWA), is designated as a toxic pollutant under the Clean Water Act (CWA) and, as such, is subject to effluent limitations.
- On June 22, 2016, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” was signed into law, amending the 1976 Toxics Substances Control Act ( 15 U.S.C. § 2601 et seq., 2016). TSCA Section 6(b), administered by EPA’s Office of Pollution Prevention and Toxics (OPPT), required EPA to initiate risk evaluations for 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments. TSCA then imposed additional statutory requirements to ensure that risk evaluations and potential risk management rules continue on a rolling basis as the risk evaluations are completed.
- The risk evaluation determines whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation (PESS). TSCA Section 3(12) defines “potentially exposed or susceptible subpopulation as a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.”
- As one of the first 10 chemicals subject to evaluation under the 2016 Toxic Substances Control Act (TSCA), the EPA published a Risk Evaluation for PCE in December 2020 and only determined two conditions of use that did not present an unreasonable risk of injury to health or the environment. EPA deemed the remaining conditions present an unreasonable risk of injury and would need to initiate risk management actions in accordance with TSCA section 6(a).
- On June 30, 2021, EPA announced changes in environmental policy to risk evaluations under TSCA. This new policy, the Path Forward for chemical risk evaluations, expands the review of the first 10 chemicals to undergo risk evaluations to now include the consideration of exposure pathways via air, water, and disposal, to the general population, taking into account “fenceline communities.” Also, the new policy does not assume workers will have access to, or wear personal protective equipment (PPE). Most importantly, a determination of unreasonable risk is made just once for the whole chemical when it is clear that the majority of the conditions of use warrant one determination.
PCE 2020 risk evaluation
- As one of the first 10 chemical substances, PCE was peer reviewed by the Science Advisory Committee on Chemicals (SACC). In response to this requirement, EPA prepared and published a Draft Risk Evaluation for PCE in April 2020.
- EPA evaluated exposures to PCE in occupational and consumer settings for the conditions of use (COUs) included in the scope of the risk evaluation which drove the draft risk evaluation (RE). The full list of COUs for PCE are listed in Table 1-4 of the RE for PCE.
- EPA evaluated acute and chronic inhalation exposures for two subcategories of workers: occupational users (workers) and occupational non-users (ONUs). Modeling approaches were used to estimate potential inhalation exposures. Since dermal monitoring data was not reasonably available, EPA reviewed acute and chronic dermal exposures to workers from literature sources and estimated dermal doses for workers in occupational exposure scenarios. EPA also evaluated exposure in consumer settings. These analyses are described in Section 2.4 of this risk evaluation.
- EPA reviewed the environmental hazard data using the data quality review evaluation metrics and the rating criteria described in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA, 2018b). Also included are unreasonable risks to relevant PESS.
- In accordance with EPA’s Guidelines for Carcinogen Risk Assessment, EPA concluded that PCE is considered likely to be carcinogenic in humans by all routes of exposure (see section 3.2 of RE). EPA considered cancer risk estimates for workers from chronic dermal or inhalation exposures and risk estimates for occupational non-users (ONUs) from chronic inhalation exposures in the unreasonable risk determination. Health risk estimates for all COUs are listed in Tables 4-125 and 4-126 of Section 4.4.2 of this RE.
- EPA determined that the following COUs present an unreasonable risk of injury:manufacturing (domestic and import); use as a reactant /intermediate; incorporation into a formulation, mixture, or reaction product in cleaning and degreasing products, adhesive and sealant products, paint and coating products, and other chemical products and preparations; repackaging, recycling, disposal, and 19 consumer uses.
- For these unreasonable risk determinations, EPA would next initiate TSCA section 6(a) risk management actions for these conditions of use as required under TSCA section 6(c)(1) in order to eliminate the unreasonable risk.
- EPA determined two conditions of use of PCE that do not present an unreasonable risk of injury to health or the environment: distribution in commerce, and industrial and commercial use in lubricants and greases as solvent for penetrating lubricants and cutting tool coolants.
- These “no unreasonable risk” determinations are considered to be “final agency actions,” which means that the EPA does not need to take any additional action for risk management.
December 2022 risk determination for PCE
- Due to the 2021 “Path Forward” which changed EPA policy, the agency published a Draft Revised Risk Determination for PCE in June 2022, which revised the TSCA risk evaluation for PCE issued in December 2020. EPA revised and replaced section 5 of the PCE risk evaluation where the findings of unreasonable risk to health were previously made for the individual conditions of use. EPA is also withdrawing the previously issued TSCA section 6(i)(l) order for two conditions of use previously determined not to present unreasonable risk which was included in section 5.4.1 of the December 2020 PCE RE. For a full review of the June 2022 Draft Revised Risk Determination, please see this AgencyIQ’s analysis.
- The December 2022 Risk Determination for Perchloroethylene concludes that perchloroethylene as a whole chemical presents an unreasonable risk of injury to health when evaluated under its conditions of use, and does not assume the use of PPE by workers. A full review of the December risk determination may be reviewed in this AgencyIQ analysis.
Proposed regulatory action
- EPA published a proposed rule regulating PCE under TSCA to address the unreasonable risk of injury to health, without consideration of costs or other non-risk factors, including an unreasonable risk to PESS. EPA is proposing to prohibit all consumer uses of PCE, most industrial and commercial uses of PCE, and the manufacture (including import), processing, and distribution in commerce of PCE. The agency is also proposing a ban on the use of PCE in dry cleaning and related spot cleaning through a 10-year phaseout.
- For certain conditions of use that would not be subject to a prohibition, EPA is proposing to require a PCE workplace chemical protection program (WCPP) that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. For those uses, EPA is proposing monitoring, recordkeeping, and downstream notification requirements.
- Additionally, EPA proposes certain time-limited exemptions from requirements for certain critical or essential emergency uses of PCE for which no technically and economically feasible safer alternative is available
Proposal to prohibit most industrial and commercial uses and manufacturing, processing, and distribution in commerce of PCE for those uses
- This proposal to prohibit certain industrial and commercial uses and manufacturing, processing, and distribution in commerce of PCE for those uses excludes those uses that would continue under a WCPP, and laboratory uses. In addition, these bans would not apply to any of the PCE uses that are excluded from TSCA’s definition of a chemical substance such as pesticides, foods, food additives, drugs, cosmetics, or devices.
- The proposed prohibition includes the following industrial and commercial uses:
- As a processing aid in pesticide, fertilizer, and other agricultural chemical manufacturing
- In specialty Department of Defense (DOD) uses (oil analysis and water pipe repair)
- In solvent-based paints and coatings
- As a solvent for aerosol spray degreaser/cleaner
- As a solvent for cold cleaning
- In other textile processing
- In wood furniture manufacturing
- As a solvent for aerosol lubricants
- In wipe cleaning
- In other spot cleaning and spot removers, including carpet cleaning
- In automotive care products (e.g., engine degreaser and brake cleaner)
- In non-aerosol cleaner
- In metal (e.g., stainless steel) and stone polishes
- In foundry applications
- In welding
- For mold release
- As a solvent for penetrating lubricants and cutting tool coolants
- For photographic film
- In inks and ink removal products (based on printing, photocopying)
- In metal mold cleaning, release and protectant products
- EPA is also proposing to prohibit the upstream processing conditions of use for some of the prohibited industrial and commercial uses, such as processing into formulations, mixtures or reaction products in other chemical products and preparations.
- Compliance dates would be staggered for these bans and would become effective in:
- 12 months for manufacturers
- 15 months for processors
- 18 months for distributing to retailers
- 21 months for all other distributors (including retailers)
- 24 months for industrial and commercial users after the publication date of the final rule
Prohibitions of manufacturing, processing, and distribution in commerce of PCE for consumer use
- In keeping with the consumer use evaluation in the 2022 RE for PCE in which EPA determined that all these consumer uses drive unreasonable risk of injury to health, EPA is proposing to prohibit the manufacturing, processing, and distribution in commerce of PCE for all consumer uses. EPA is also proposing to phase out consumer use of PCE in dry cleaning solvent, which includes exposure to clothing or articles recently dry cleaned with PCE.
- To eliminate instances of consumer use, EPA is also proposing a ban on the manufacture, processing, and distribution in commerce of PCE for consumer use in PCE and products containing PCE from the market. This would include a ban on retailers distributing any products containing PCE to consumers.
- One caveat to the product ban is for products containing PCE at concentrations less than 0.1% by weight, which are not subject to these bans.
- EPA is proposing that the same timeline for the prohibition on consumer use of PCE as for industrial and commercial use of PCE.
Ban and phaseout of PCE in dry cleaning
- EPA is proposing to prohibit the manufacturing, processing, distribution in commerce, and industrial and commercial use of PCE for dry cleaning and spot cleaning, including in 3rd generation (dry-to-dry machines with refrigerated condenser) and 4th and 5th generation (dry-to-dry machines with refrigerated condenser and carbon adsorber process controls) machines.
- A phase-out period would take place following the publication date of the final rule and would start with a ban on the use of PCE in any dry-cleaning machine acquired six months or later after the final rule publication. Third generation machines would have three years, and 4th and 5th generation ones would have 10 years after publication of the final rule. EPA estimates that 6,000 dry cleaners still use PCE and estimates that about 60 machines are expected to still be in use at the end of the 10-year phaseout period, given the declining trend of use and age of machines.
For those uses of PCE that are not banned, EPA is proposing to require WCPPs
- WCCPs would be required for the use of PCE in:
- Manufacturing (domestic and import)
- Processing as a reactant/intermediate
- Processing into formulation, mixture, or reaction product in cleaning and degreasing products, paint and coating products, and adhesive and sealant products
- Processing by repackaging
- Industrial and commercial use as a solvent for:
- Open-top batch vapor degreasing
- Closed-loop batch vapor degreasing
- In-line conveyorized vapor degreasing
- In-line web cleaner vapor degreasing
- Industrial and commercial use:
- In maskant for chemical milling
- In solvent-based adhesives and sealants
- As a processing aid in catalyst regeneration in petrochemical manufacturing.
- For these uses of PCE, EPA will require a WCPP that would address the unreasonable risk from perchloroethylene to workers directly handling the chemical or in the area where the chemical is being used. EPA has established separate workplace requirements for laboratory use.
- EPA proposes to require that owners and operators document their exposure control strategy and implementation in an exposure control plan or through adding EPA-required information to any existing documentation of the facility’s safety and health program developed as part of meeting Occupational Health and Safety Administration (OSHA) requirements or other safety and health standards
- The WCPP would include inhalation exposure limit and action level, Direct Dermal Contact Control (DDCC) requirements, and the associated implementation requirements to ensure that PCE no longer presents an unreasonable risk. EPA is also proposing DDCC requirements for recycling and disposal of PCE and products and materials containing PCE.
- Additionally, the WCPP would include an Existing Chemical Exposure Limit (ECEL) which is a risk-based inhalation exposure threshold of 0.14 parts per million (ppm)(0.98 mg/m3) for inhalation exposures to PCE as an 8-hour time weighted average (TWA), with an ECEL action level identified as 0.07 ppm (0.47 mg/m3) (ECEL action level) for numerous uses.
- In its determination, EPA utilizes the NIOSH Hierarchy of Controls which prioritizes exposure control strategies from most protective and preferred to least protective and preferred techniques. In order of precedence, they are the elimination of the hazard, substitution with a less hazardous substance, engineering controls, administrative controls such as training or exclusion zones with warning signs, and finally, the use of PPE. The use of respirators (and all PPE) should only be considered after all other measures have been taken to reduce exposures.
- A WCPP also includes monitoring and recordkeeping requirements to verify that the established inhalation thresholds are not exceeded, and may include other components, such as dermal protection, to ensure that the chemical substance no longer presents unreasonable risk.
- EPA uses the term “potentially exposed person” to include workers, occupational non-users, employees, independent contractors, employers, and all other persons in the work area where PCE is present and who may be exposed to methylene chloride under the conditions of use for which a WCPP would apply.
- In keeping with the hierarchy of controls where PPE would be a final protective measure, EPA is proposing to require that the owner or operator comply with OSHA’s General Requirements for PPE standard for application of a PPE program, including provisions and use of chemically resistant gloves, among others. EPA is also proposing to establish minimum respiratory protection requirements. EPA does not anticipate that respirators beyond an Assigned Protection Factor (APF) 25 will be widely or regularly used to address unreasonable risk, particularly when other controls are put in place.
Monitoring and recordkeeping
- EPA is proposing to require that owners or operators perform an initial exposure monitoring to determine the extent of potentially exposed persons to PCE within six months of the publication date of the final rule, or within 30 days of introduction of PCE in the workplace.
- Owners or operators would then conduct periodic monitoring for those exposure groups that exceed airborne concentration levels at least once every five years if above 0.07 ppm/8-hour TWA, and every three months if above 0.14 ppm/8-hour TWA. If the exposure is above 0.07 ppm and below 0.014 ppm/8-hour TWA, periodic monitoring must be repeated within six months of the most recent exposure monitoring. Additional requirements are listed in Table 1.
- EPA is proposing recordkeeping for PCE in keeping with OSHA requirements. In addition, EPA is proposing to require documentation whenever monitoring for the WCPP is required under TSCA section 6(a). Each owner or operator of a workplace subject to WCPP would have to retain compliance records for five years.
- The owner or operator would be required, within 15 working days after receipt of the results of any exposure monitoring, to notify each person whose exposure is represented by that monitoring in writing, and must include the exposure monitoring results, identification and explanation of the ECEL and ECEL action level, among other information.
- The WCPP requirements would take effect 60 days after publication of the final rule. Entities would then be required to conduct initial monitoring and the implementation of any needed exposure controls based on initial monitoring and development of an exposure control plan within one year of publication of the final rule.
- EPA is proposing the downstream notification for conditions of use that are not prohibited by this proposed regulation. Manufacturers (including importers), processors, and distributors, excluding retailers, of PCE and PCE-containing products would be required to provide downstream notification of certain prohibitions through safety data sheets (SDSs) by adding to sections 1(c) and 15 of the SDS this statement. The statement provides the purposes for which PCE may be used. These uses correspond to the permitted uses and time-limited exemptions proposed in this regulatory action. To provide adequate time to update the SDS and ensure that all products in the supply chain include the revised SDS, EPA is proposing a 2-month period for manufacturers and a 6-month period for processors and distributers to implement the proposed SDS changes following publication of the final rule.
- TSCA section 6(g)(2) requires EPA to analyze the need for an exemption. Based on discussions with and information provided by the National Aeronautics and Space Administration (NASA), EPA has analyzed the need for an exemption for certain uses of PCE in an emergency in the furtherance of NASA’s mission and is proposing to grant it.
- EPA proposes a 10-year emergency exemption for the use of PCE by NASA and its contractors from the requirements of this rule because it is a critical or essential use. This means that (1) there is an emergency; and (2) NASA selected PCE because there are no technically and economically feasible safer alternatives available during the emergency. The exemption for NASA is specifically for industrial and commercial use of PCE as a solvent for cold cleaning and industrial and commercial use in wipe cleaning.
- NASA and its contractors must provide notice to the EPA Administrator of each instance of emergency use within 15 days and would have to comply with the WCPP.
- An additional 10-year exemption would be granted by EPA for the industrial and commercial use of PCE in vapor degreasing of aerospace parts for commercial jetliners and defense, space, and security systems, as well as DOD, and NASA uses. A process of identifying a replacement solvent that can adequately clean, cause no harm to parts, and is not an equally toxic material to PCE is ongoing.
Use of PCE for hydrofluorocarbons under the AIM Act of 2020
- EPA recognizes that PCE may assist in addressing climate damaging hydrofluorocarbons (HFCs). PCE is used as a reactant in the production of hydrochlorofluorocarbons (HCFCs) and chlorofluorocarbons (CFCs) (HFC-125 and HFC-134a). This condition of use includes reuse of PCE, including PCE originally generated as a byproduct or residual PCE as a reactant.
- EPA’s response is to allow the use of PCE to address climate-damaging hydrofluorocarbons (HFCs) under the American Innovation and Manufacturing Act of 2020 (AIM Act) with additional worker protections. EPA explains that workplace controls can be implemented to address unreasonable risks of these HFC-related, reactant processing uses.
Primary alternative regulatory action
- EPA is also proposing a primary alternative regulatory action (PARA) which combines prohibitions, requirements for a WCPP, and prescriptive controls to address the unreasonable risk from PCE driven by the various conditions of use. This regulatory alternative would subject more conditions of use to a WCPP, instead of prohibition
- The PARA also includes longer compliance timeframes for prohibitions and implementation of WCPP and prescriptive controls.
- The PARA would still prohibit numerous uses of PCE that the proposed regulatory action prohibits, such as industrial and commercial use as solvent for cold cleaning and for aerosol lubricants, in other textile processing, in wood furniture manufacturing, in wipe cleaning, in other spot cleaning and spot removers, including carpet cleaning, among others.
- For those uses, the PARA would require a WCPP with an ECEL and DDCC, for numerous conditions of use as well as prescriptive workplace controls. The primary alternative regulatory action additionally includes longer compliance timeframes for prohibitions and implementation of WCPP and prescriptive controls.
- For the PARA, the effective dates for the manufacturing, processing, distribution in commerce, and use of PCE for certain occupational conditions of use would take effect 18 months for manufacturers, 21 months for processors, 24 months for distributing to retailers, 27 months for all other distributors (including retailers), and 30 months for industrial and commercial uses after the publication date of the final rule.
- As an example of additional prescriptive controls and concentration limits, the PARA would limit the concentration of PCE in adhesive and sealant products to 1% by weight. Any percentage of PCE greater than 1% by weight would be prohibited for the industrial and commercial use of solvent-based adhesive and sealant products. Additionally, the PARA would prohibit the import, processing, and distribution in commerce of adhesive and sealant products containing PCE at concentrations greater than 1% by weight.
Second alternative regulatory action
- The second alternative regulatory action (SARA) is also a combination of prohibition and a WCPP to address the unreasonable risk from PCE driven by the various conditions of use. The SARA differs from the PARA by prohibiting some conditions of use that would have requirements for a WCPP under the proposed regulatory action. Like both the PARA and the proposed regulation, the SARA would prohibit the manufacture, processing, and distribution of PCE for consumer use.
- The SARA also has shorter and more stringent compliance timeframes for prohibitions and a WCPP. The prohibitions for the manufacturing, processing, distribution in commerce, and use for certain industrial and commercial uses described in this section would take effect 12 months after the publication date of the final rule.
- It would also prohibit more occupational conditions of use than the proposed regulatory action and would prohibit the use of PCE for dry cleaning but have different phaseout timeframes.
- The SARA provides exemptions for defense and aerospace programs that are essential to national security and critical infrastructure. Specifically, an 10-year exemption would be granted for a PCE-based maskant for chemical milling. PCE-based maskant chemical milling is used in the Boeing fuselage manufacturing program for the 737, 747, 767, and 777 and in defense products for the Bell V-280 Valor, Boeing P-8, Sikorsky CH-53K, Boeing KC-46, and Northrop Grumman B-21. The use of PCE is required to meet certain performance requirements that alternatives are unable to meet. Efforts have been on-going for 30 years to develop a new maskant but have not resulted in finding a substitute. The SARA also proposes a time-limited exemption from prohibition for the industrial and commercial use of PCE for vapor degreasing. Recordkeeping, documentation of engineering controls and PPE would be required for this exemption.
- The three proposed regulatory actions are set out in a side-by-side comparison table (Table 2).
- The proposed rule will be open for comment for 60 days with reference to Docket No. EPA-HQ-OPPT-2020-0720 once published in the Federal Register.
- EPA has requested public comment on all aspects of this proposal, including the proposed and alternative regulatory actions, the staggered compliance dates, and 46 specific elements of the proposed rule.
- EPA is also requesting comment for instances where an ongoing use of perchloroethylene has implications for national security or critical infrastructure, but the final rule prohibits that use. In this case, the federal agency would petition EPA, supported by documentation describing the specific use and implications of the ban, among other details, and request a TSCA 6(g) exemption.
Featuring previous research by Patricia Iscaro.
Key Documents and Dates
- Proposed Rule – Perchloroethylene (PCE) Regulation under the Toxic Substances Control Act (TSCA) (pre-publication notice)
- Notice of June 30, 2022 Draft Revised Risk Evaluation (87 FR 39085)
- 2022 Draft Revised Unreasonable Risk Determination, Section 5
- 2020 Risk Evaluation for Perchloroethylene
- Frank R. Lautenberg Chemical Safety for the 21st Century Act amending the 1976 Toxics Substances Control Act (15 U.S.C. § 2601 et seq., 2016)
- Executive Order 13990 of January 20, 2021, Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (86 FR 7037)
- Executive Order 13985 of January 25, 2021, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government