Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA)

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2020-0720; FRL-8329-02-OCSPP]

RIN 2070-AK84

Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing to address the unreasonable risk of injury to human health presented by perchloroethylene (PCE) under its conditions of use as documented in EPA's December 2020 Risk Evaluation for PCE and December 2022 revised risk determination for PCE prepared under the Toxic Substances Control Act (TSCA). PCE is a widely used solvent in a variety of occupational and consumer applications including fluorinated compound production, petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA determined that PCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to PCE, including neurotoxicity effects from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to PCE. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. PCE, also known as perc and tetrachloroethylene, is a neurotoxicant and a likely human carcinogen. Neurotoxicity, in particular impaired visual and cognitive function and diminished color discrimination, are the most sensitive adverse effects driving the unreasonable risk of PCE, and other adverse effects associated with exposure include central nervous system depression, kidney and liver effects, immune system toxicity, developmental toxicity, and cancer. To address the identified unreasonable risk, EPA is proposing to prohibit most industrial and commercial uses of PCE; the manufacture (including import), processing, and distribution in commerce of PCE for the prohibited industrial and commercial uses; the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; and, the manufacture (including import), processing, distribution in commerce, and 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 also proposing to require a PCE workplace chemical protection program that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. EPA is also proposing to require prescriptive workplace controls for laboratory use, and to establish recordkeeping and downstream notification requirements. Additionally, EPA proposes to provide 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.

DATES:

Comments must be received on or before August 15, 2023. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 17, 2023.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0720, through the Federal eRulemaking Portal at

https://www.regulations.gov.

Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at

https://www.epa.gov/dockets/.

FOR FURTHER INFORMATION CONTACT:

For technical information contact:

Kelly Summers, Existing Chemicals Risk Management Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number (202) 564-2201; email address:

PCE.TSCA@epa.gov.

For general information contact:

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

TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may be potentially affected by the proposed action if you manufacture (defined under TSCA to include import), process, distribute in commerce, use, or dispose of PCE or products containing PCE. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities include:

• Crude Petroleum Extraction (NAICS code 211120).

• Support Activities for Oil and Gas Operations (NAICS code 213112).

• Nonwoven Fabric Mills (NAICS code 313230).

• Wood Window and Door Manufacturing (NAICS code 321911).

• Paper Bag and Coated and Treated Paper Manufacturing (NAICS code 322220).

• Commercial Screen Printing (NAICS code 323113).

• Petroleum Refineries (NAICS code 324110).

• Petroleum Lubricating Oil and Grease Manufacturing (NAICS code 324191).

• Petrochemical Manufacturing (NAICS code 325110).

• Industrial Gas Manufacturing (NAICS code 325120).

• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).

• All Other Basic Organic Chemical Manufacturing (NAICS code 325199).

• Plastics Material and Resin Manufacturing (NAICS code 325211).

• Synthetic Rubber Manufacturing (NAICS code 325212).

• Paint and Coating Manufacturing (NAICS code 325510).

• Adhesive Manufacturing (NAICS code 325520).

• Soap and Other Detergent Manufacturing (NAICS code 325611).

• Polish and Other Sanitation Good Manufacturing (NAICS code 325612).

• All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998).

• Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing (NAICS code 326113).

• All Other Plastics Product Manufacturing (NAICS code 326199).

• Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220).

• Rubber Product Manufacturing for Mechanical Use (NAICS code 326291).

• All Other Rubber Product Manufacturing (NAICS code 326299).

• Pottery, Ceramics, and Plumbing Fixture Manufacturing (NAICS code 327110).

• Glass Container Manufacturing (NAICS code 327213).

• Cement Manufacturing (NAICS code 327310).

• Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper and Aluminum) (NAICS code 331492).

• Metal Crown, Closure, and Other Metal Stamping (except Automotive) (NAICS code 332119).

• Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except Precious) Manufacturing (NAICS code 332215).

• Saw Blade and Handtool Manufacturing (NAICS code 332216).

• Other Fabricated Wire Product Manufacturing (NAICS code 332618).

• Metal Heat Treating (NAICS code 332811).

• Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers (NAICS code 332812).

• Electroplating, Plating, Polishing, Anodizing, and Coloring (NAICS code 332813).

• Industrial Valve Manufacturing (NAICS code 332911).

• Fluid Power Valve and Hose Fitting Manufacturing (NAICS code 332912).

• Plumbing Fixture Fitting and Trim Manufacturing (NAICS code 332913).

• Other Metal Valve and Pipe Fitting Manufacturing (NAICS code 332919).

• Ball and Roller Bearing Manufacturing (NAICS code 332991).

• Small Arms Ammunition Manufacturing (NAICS code 332992).

• Ammunition (except Small Arms) Manufacturing (NAICS code 332993).

• Small Arms, Ordnance, and Ordnance Accessories Manufacturing (NAICS code 332994).

• Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code 332996).

• All Other Miscellaneous Fabricated Metal Product Manufacturing (NAICS code 332999).

• Other Industrial Machinery Manufacturing (NAICS code 333249).

• Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS code 333415).

• Machine Tool Manufacturing (NAICS code 333517).

• Measuring, Dispensing, and Other Pumping Equipment Manufacturing (NAICS code 333914).

• Welding and Soldering Equipment Manufacturing (NAICS code 333992).

• Packaging Machinery Manufacturing (NAICS code 333993).

• Industrial Process Furnace and Oven Manufacturing (NAICS code 333994).

• Fluid Power Cylinder and Actuator Manufacturing (NAICS code 333995).

• Fluid Power Pump and Motor Manufacturing (NAICS code 333996).

• All Other Miscellaneous General Purpose Machinery Manufacturing (NAICS code 333999).

• Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (NAICS code 334513).

• Analytical Laboratory Instrument Manufacturing (NAICS code 334516).

• Motor Vehicle Body Manufacturing (NAICS code 336211).

• Travel Trailer and Camper Manufacturing (NAICS code 336214).

• Other Motor Vehicle Parts Manufacturing (NAICS code 336390).

• Aircraft Manufacturing (NAICS code 336411).

• Aircraft Engine and Engine Parts Manufacturing (NAICS code 336412).

• Other Aircraft Parts and Auxiliary Equipment Manufacturing (NAICS code 336413).

• Guided Missile and Space Vehicle Manufacturing (NAICS code 336414).

• Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Manufacturing (NAICS code 336415).

• Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing (NAICS code 336419).

• Ship Building and Repairing (NAICS code 336611).

• Surgical and Medical Instrument Manufacturing (NAICS code 339112).

• Jewelry and Silverware Manufacturing (NAICS code 339910).

• Sporting and Athletic Goods Manufacturing (NAICS code 339920).

• Doll, Toy, and Game Manufacturing (NAICS code 339930).

• Office Supplies (except Paper) Manufacturing (NAICS code 339940).

• Gasket, Packing, and Sealing Device Manufacturing (NAICS code 339991).

• Musical Instrument Manufacturing (NAICS code 339992).

• Fastener, Button, Needle, and Pin Manufacturing (NAICS code 339993).

• Broom, Brush, and Mop Manufacturing (NAICS code 339994).

• Burial Casket Manufacturing (NAICS code 339995).

• All Other Miscellaneous Manufacturing (NAICS code 339999).

• Motor Vehicle Supplies and New Parts Merchant Wholesalers (NAICS code 423120).

• Home Furnishing Merchant Wholesalers (NAICS code 423220).

• Industrial Supplies Merchant Wholesalers (NAICS code 423840).

• Service Establishment Equipment and Supplies Merchant Wholesalers (NAICS code 423850).

• Other Miscellaneous Durable Goods Merchant Wholesalers (NAICS code 423990).

• Grain and Field Bean Merchant Wholesalers (NAICS code 424510).

• Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690).

• Petroleum Bulk Stations and Terminals (NAICS code 424710).

• Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) (NAICS code 424720).

• New Car Dealers (NAICS code 441110).

• Used Car Dealers (NAICS code 441120).

• Other Gasoline Stations (NAICS code 447190).

• Sporting Goods Stores (NAICS code 451110).

• All Other Miscellaneous Store Retailers (except Tobacco Stores) (NAICS code 453998).

• Scheduled Passenger Air Transportation (NAICS code 481111).

• Scheduled Freight Air Transportation (NAICS code 481112).

• Pipeline Transportation of Natural Gas (NAICS code 486210).

• Teleproduction and Other Postproduction Services (NAICS code 512191).

• Other Motion Picture and Video Industries (NAICS code 512199).

• Miscellaneous Intermediation (NAICS code 523910).

• Other Financial Vehicles (NAICS code 525990).

• Lessors of Other Real Estate Property (NAICS code 531190).

• Offices of Real Estate Agents and Brokers (NAICS code 531210).

• Testing Laboratories (NAICS code 541380).

• Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (NAICS code 541715).

• Marketing Research and Public Opinion Polling (NAICS code 541910).

• All Other Professional, Scientific, and Technical Services (NAICS code 541990).

• Offices of Other Holding Companies (NAICS code 551112).

• Hazardous Waste Treatment and Disposal (NAICS code 562211).

• Solid Waste Landfill (NAICS code 562212).

• Solid Waste Combustors and Incinerators (NAICS code 562213).

• Other Nonhazardous Waste Treatment and Disposal (NAICS code 562219).

• Remediation Services (NAICS code 562910).

• Materials Recovery Facilities (NAICS code 562920).

• All Other Miscellaneous Waste Management Services (NAICS code 562998).

• General Automotive Repair (NAICS code 811111).

• Automotive Exhaust System Repair (NAICS code 811112).

• Automotive Transmission Repair (NAICS code 811113).

• Other Automotive Mechanical and Electrical Repair and Maintenance (NAICS code 811118).

• Automotive Body, Paint, and Interior Repair and Maintenance (NAICS code 811121).

• Automotive Glass Replacement Shops (NAICS code 811122).

• Automotive Oil Change and Lubrication Shops (NAICS code 811191).

• All Other Automotive Repair and Maintenance (NAICS code 811198).

• Consumer Electronics Repair and Maintenance (NAICS code 811211).

• Computer and Office Machine Repair and Maintenance (NAICS code 811212).

• Communication Equipment Repair and Maintenance (NAICS code 811213).

• Other Electronic and Precision Equipment Repair and Maintenance (NAICS code 811219).

• Commercial and Industrial Machinery and Equipment (except Automotive and Electronic) Repair and Maintenance (NAICS code 811310).

• Home and Garden Equipment Repair and Maintenance (NAICS code 811411).

• Other Personal and Household Goods Repair and Maintenance (NAICS code 811490).

• Drycleaning and Laundry Services (except Coin-Operated) (NAICS code 812320).

• Industrial Launderers (NAICS code 812332).

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final TSCA section 6(a) rule are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under

FOR FURTHER INFORMATION CONTACT

.

B. What is the Agency's authority for taking this action?

Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S. Environmental Protection Agency hereinafter EPA or “the Agency,” determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk.

C. What action is the Agency taking?

Pursuant to TSCA section 6(b), EPA determined that PCE presents an unreasonable risk of injury to health, without consideration of costs or other nonrisk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations (PESS) identified as relevant to the 2020 Risk Evaluation for PCE by EPA, under the conditions of use (Refs. 1 and 2). The term “conditions of use” is defined at TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A detailed description of the conditions of use that drive EPA's determination that PCE presents an unreasonable risk is included in Unit III.B.1. EPA notes that all TSCA conditions of use of PCE are subject to this proposal. Accordingly, to address the unreasonable risk, EPA is proposing, under TSCA section 6(a), to:

(i) Prohibit most industrial and commercial uses and the manufacture (including import), processing, and distribution in commerce, of PCE for those uses, outlined in Unit IV.A.1.;

(ii) Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use, outlined in Unit IV.A.1.;

(iii) Prohibit the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10-year phaseout, outlined in Unit IV.A.1.;

(iv) Require strict workplace controls, including a PCE Workplace Chemical Protection Program (WCPP), which would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact with PCE, for the 16 occupational conditions of use not prohibited, outlined in Unit IV.A.2.;

(v) Require prescriptive workplace controls for laboratory use, outlined in Unit IV.A.3.; and

(vi) Establish recordkeeping and downstream notification requirements, outlined in Unit IV.A.4.

(vii) Provide a 10-year time limited exemption under TSCA section 6(g) for certain emergency uses of PCE in furtherance of National Aeronautics and Space Administration's mission, for specific conditions of use which are critical or essential and for which no technically and economically feasible safer alternative is available, outlined in Unit IV.A.5.

In addition, EPA is proposing to amend the general provision of 40 CFR part 751, subpart A, to define “authorized person,” “direct dermal contact,” “ECEL,” “exposure group,” “owner or operator,” “potentially exposed person,” “regulated area,” and “retailer” so that these definitions may be commonly applied to this and other rules under TSCA section 6 that would be codified under 40 CFR part 751. EPA seeks public comment on all aspects of this proposed rule.

D. Why is the Agency taking this action?

Under TSCA section 6(a), “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the [section 6(a)] requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk.” PCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in December 2020 (2020 Risk Evaluation for PCE) (Ref. 1). In addition, EPA issued a revised unreasonable risk determination in December 2022 (Ref. 2), determining that PCE, as a whole chemical substance, presents an unreasonable risk of injury to health under the conditions of use. As a result, EPA is proposing to take action to the extent necessary so that PCE no longer presents such risk. The unreasonable risk is described in Unit III.B.2. and the conditions of use that drive the unreasonable risk for PCE are described in Unit III.B.1.

PCE's hazards are well established. EPA's 2020 Risk Evaluation for PCE considered the hazards associated with exposure to PCE and determined that PCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to PCE. While some of the risks of adverse effects from PCE exposure are associated with acute single exposures, other risks are associated with long-term repeated exposures. The most sensitive health effect driving the unreasonable risk of PCE and selected as the basis for this proposed rule is neurotoxicity, based on the best available science and weight of scientific evidence and in consideration of the severity of the hazards, magnitude of exposure, population exposed, and uncertainties in the December 2020 Risk Evaluation for PCE and December 2022 revised risk determination for PCE. The most sensitive endpoint is dependent on both the point of departure (POD) and the associated total uncertainty factor. For PCE, impaired visual and cognitive function and diminished color discrimination following chronic exposures represent the most sensitive endpoint indicating neurotoxicity, based on epidemiological data reported in two studies that identified lowest observed adverse effect levels for color confusion and impaired pattern recognition and reaction time in pattern memory. Other significant adverse outcomes include kidney and liver effects, immune system toxicity, reproductive toxicity, developmental toxicity, and cancer. For this proposed rulemaking, EPA has determined that protecting against the most sensitive endpoint would also address the risk for other acute, chronic non-cancer, and cancer endpoints. This proposed rule would eliminate the unreasonable risk to human health from the TSCA conditions of use of PCE, as identified in the 2020 Risk Evaluation for PCE and the revised unreasonable risk determination for PCE in December 2022.

EPA is not proposing a complete ban on PCE. The Agency has considered the benefits of PCE for various uses as required under TSCA section 6(c)(2)(A) and (B) and recognizes that continued use of PCE for some TSCA conditions of use may provide benefits that complement the Agency's efforts to address climate-damaging hydrofluorocarbons (HFCs) under the American Innovation and Manufacturing Act of 2020 (AIM Act) (42 U.S.C. 7675), supporting human health and environmental protection under these programs, and that for these uses, strict workplace controls to address the unreasonable risk can be implemented. Therefore, this rule proposes to allow PCE's continued use in tandem with strict workplace controls for the generation of HFC-125 and HFC-134a, two of the regulated substances that are subject to a phasedown under the AIM Act. While HFC-125 and HFC-134a are two of the regulated substances subject to the phasedown in production and consumption by 85% over the next 15 years, HFCs-134a and -125 can be mixed with other substances to make lower global warming potential blends that are likely to be used to facilitate the transition from certain other HFCs and HFC blends with higher global warming potentials in certain applications.

Additionally, the Agency recognizes that some conditions of use may be important for national security applications or for other critical needs. For example, PCE is a critical diluent (to modify the consistency or other properties in a formulation) for maskant applied to military and commercial aircraft skin panels that prevents chemical milling or industrial etching of certain areas and is also used in petrochemical manufacturing as a processing aid in catalyst regeneration for reformate and isomerate (these are gasoline blending stocks) that make up an estimated 45% of the U.S. gasoline pool. Therefore, this rule proposes to allow certain continued uses of PCE provided that sufficient worker protections are in place to address the unreasonable risk for certain occupational conditions of use. For the conditions of use for which EPA is proposing strict workplace controls under a WCPP, EPA expects that many workplaces already have stringent controls in place that reduce exposures to PCE; for some workplaces, EPA understands that these existing controls may already reduce exposures enough to meet the inhalation exposure concentration limit proposed in this rulemaking or to prevent direct dermal contact with PCE.

Accordingly, EPA is proposing strict workplace controls to address the unreasonable risk and allow continued use of PCE for several conditions of use, including for processing as a reactant/intermediate, use in vapor degreasing, use as a maskant for chemical milling, use in adhesives and sealants, use as a processing aid in catalyst regeneration in petrochemical manufacturing, and use as a laboratory chemical, which comprise more than an estimated 80% of the current production volume of PCE. EPA is proposing to ban or phaseout most conditions of use of PCE, including use in dry cleaning and spot cleaning, aerosol degreasing, paints and coatings, aerosol lubricants, and wipe cleaning, comprising less than an estimated 20% of the current production volume of PCE. Of the conditions of use that would not be prohibited, EPA expects the production volume for those conditions of use to decline over time. For example, EPA expects the industrial and commercial use of PCE as a reactant in the generation of HFC-134a and HFC-125 to decline over time, in light of the AIM Act requirements to phase down production and consumption of listed HFCs by 85% over the next 15 years. Unit IV.A. describes EPA's proposed regulatory action and Unit IV.B. describes the alternative regulatory actions as required under TSCA section 6(c)(2)(A). The rationale for the proposed regulatory action and alternative regulatory actions, including the TSCA section 6 requirements considered in developing the regulatory actions, is described in Units III.B.3. and V.

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

EPA has prepared an Economic Analysis of the potential incremental impacts associated with this rulemaking that can be found in the rulemaking docket (Ref. 3). As described in more detail in the Economic Analysis (Ref. 3) and in Units VI.D. and X.D., EPA was unable to quantify all incremental costs of this proposed rule. The quantifiable cost of the proposed rule is estimated to be $14.0 million annualized over 20 years at a 3% discount rate and $14.3 million annualized over 20 years at a 7% discount rate. These costs take compliance with implementation of a WCPP into consideration, which would include an existing chemical exposure limit (ECEL) of 0.14 ppm (0.98 mg/m

3

) for inhalation exposures as an 8-hour time-weighted average (TWA), dermal controls to prevent direct dermal contact, applicable personal protective equipment (PPE) requirements, and reformulation costs of numerous products. The most notable unquantified costs include possible costs from prohibition of use of PCE as a processing aid outside of the petrochemical industry; EPA's analysis was unable to quantify these costs, as described more fully in section 7.11 in the Economic Analysis (Ref. 3). The economic impact on users of PCE for chemical milling and vapor degreasing is also unclear because there are no clear alternatives to PCE; these users might have to use PPE to meet the requirements of a WCPP for PCE.

Chemical milling using PCE is most prominent in the aerospace industry. Vapor degreasing is used in several advanced manufacturing industries, including aerospace, automotive, energy, medical devices, and others (Ref. 3).

In addition, EPA estimates that 6,000 dry cleaners still use PCE, a majority of which are small businesses. Nevertheless, despite information EPA has sought from stakeholders, it is still unclear as to the impact of a prohibition of PCE for dry cleaning through a gradual phaseout; EPA has not been able to estimate the number of dry cleaning facility closures that may be associated with this phaseout. More information on the challenges of estimating these impacts, in part due to the age of relevant machines in use, is in the Economic Analysis (Ref. 3). Overall, EPA expects few closures because EPA estimates that only about 60 PCE machines are expected to be in use at the end of the proposed phaseout period given the age of the machines and the declining trend of use; this is detailed in section 7.7 of the Economic Analysis. Table 7-10 in that section details the age of the PCE dry cleaning machines in New York State, for which EPA has data. EPA believes that the data is generalizable to other states; industry has informed the Agency that very few PCE machines have been purchased in recent years. Based on the estimated revenues per firm presented in Table 31 of the Economic Analysis and the 6,000 estimated number of dry cleaning firms using PCE as dry cleaning solvent (see section 6.1.5 (A) of the Economic Analysis), the total revenue for dry cleaning firms using PCE as dry cleaning solvent is approximately $3.1 billion. According to IRS (2013) data, profit in this sector is about 4.8% of sales, implying that total profit of firms using PCE as dry cleaning solvent is about $148 million. However, EPA has proposed a 10-year phaseout of PCE in dry cleaning and estimates that only about 60 PCE dry cleaning machines would remain at the end of the phaseout (see section 7.7.3. of the Economic Analysis). This suggests that the proposed option would only affect about $31 million of the industry's total revenue and about $1.5 million of the industry's profit. Many of these firms would likely choose to purchase non-PCE machines or become drop shops (do dry cleaning at another site) rather than close. A detailed sensitivity analysis of varying assumptions on ages of PCE dry cleaning machines and PCE dry cleaning machine life is provided in section 11 of the Economic Analysis.

The actions proposed in this rule are expected to achieve health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot be monetized. The monetized benefits of this proposed rule are approximately $10.2 million to $46.3 million annualized over 20 years at a 3% discount rate and $4.72 million to $29.4 million annualized over 20 years at a 7% discount rate. The monetized benefits include potential reductions in risk of liver, kidney, brain, and testicular cancer. Non-monetized benefits include risk reduction of neurotoxicity, kidney toxicity, liver effects, immune/hematological effects, reproductive effects, and developmental effects (Ref. 3). Neurotoxic effects of PCE in human studies include visual deficits, impaired cognition, and decreased math scores. Also, prenatal and early childhood exposure to PCE in drinking water are associated with increases in drug, alcohol, and tobacco use (Ref. 1). Reductions in PCE exposure are therefore likely to be associated with large dollar-valued, but currently unmonetized, benefits.

Additionally, the Agency expects that the proposed dry cleaning phaseout will decrease health risks for affected populations that may own/operate or work at dry cleaning facilities. As described in more detail in the Economic Analysis, the Agency analyzed the demographic characteristics of several populations that would be impacted by this rulemaking, including for dry cleaning (Ref. 3). Based on reasonably available information, the Agency understands that a significant number of members of minority populations may own or work at dry cleaning facilities.

II. Background

A. Overview of Perchloroethylene

This proposed rule applies to PCE (CASRN 127-18-4) and is specifically intended to address the unreasonable risk of injury to health EPA has identified in the 2020 Risk Evaluation for PCE and the 2022 revised unreasonable risk determination, as described in Unit III.B.2. PCE is a colorless volatile liquid with a mildly sweet odor that is produced in and imported into the United States. PCE is manufactured, processed, distributed, used, and disposed of as part of many industrial, commercial, and consumer conditions of use.

As outlined in further detail in Unit III.B.1., PCE is used for the production of fluorinated compounds, as a solvent for dry cleaning and vapor degreasing; in catalyst regeneration in petrochemical manufacturing; and in a variety of commercial and consumer applications such as adhesives, paints and coatings, aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish and wipe cleaners. According to data submitted for the EPA's 2016 Chemical Data Reporting rule (CDR), the total aggregate annual production volume of PCE in the U.S. decreased from 388 million pounds to around 324 million pounds between 2012 and 2015 (Ref. 4). The total aggregate annual production volume ranged from 250 to 500 million pounds between 2016 and 2019 according to CDR (Ref. 5).

B. Regulatory Actions Pertaining to PCE

Because of its adverse health effects, PCE is subject to numerous Federal laws and regulations in the United States and is also subject to regulation by some States and other countries. A summary of EPA regulations pertaining to PCE, as well other Federal, state, and international regulations (Ref. 6) is in the docket and in Appendix A of the 2020 Risk Evaluation for PCE (Ref. 1).

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

Although EPA must consider and factor in, to the extent practicable, certain nonrisk factors as part of TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still ensure that the selected regulatory requirements apply “to the extent necessary so that the chemical substance or mixture no longer presents [unreasonable] risk.” 15 U.S.C. 2605(a). This requirement to eliminate unreasonable risk is distinguishable from approaches mandated by some other laws, including the Occupational Safety and Health Act (OSH Act), which includes both significant risk and feasibility (technical and economic) considerations in the setting of standards.

Congress intended for EPA to consider occupational risks from chemicals it evaluates under TSCA, among other potential exposures, as relevant and appropriate. As noted previously, TSCA section 6(b) requires EPA to evaluate risks to PESS identified as relevant by the Administrator. TSCA section 3(12) defines the term “potentially exposed or susceptible subpopulation” as “a group of individuals within the general population identified by the Administrator who, due to either greater

susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.”

The OSH Act similarly requires OSHA to evaluate risk specific to workers prior to promulgating new or revised standards and requires OSHA standards to substantially reduce significant risk to the extent feasible, even if workers are exposed over a full working lifetime.

See

29 U.S.C. 655(b)(5);

Indus. Union Dep't, AFL-CIO

v.

Am. Petroleum Inst.,

448 U.S. 607, 642 (1980) (plurality opinion).

Thus, the standards for chemical hazards that OSHA promulgates under the OSH Act share a broadly similar purpose with the standards that EPA promulgates under TSCA section 6(a). The control measures OSHA and EPA require to satisfy the objectives of their respective statutes may also, in many circumstances, overlap or coincide. However, as this section outlines, there are important differences between EPA's and OSHA's regulatory approaches and jurisdiction, and EPA considers these differences when deciding whether and how to account for OSHA requirements (Ref. 6) when evaluating and addressing potential unreasonable risk to workers so that compliance requirements are clearly explained to the regulated community.

1. OSHA Requirements

OSHA's mission is to ensure that employees work in safe and healthful conditions. The OSH Act establishes requirements that each employer comply with the General Duty Clause of the Act (29 U.S.C. 654(a)), as well as with occupational safety and health standards issued under the Act.

a. General Duty Clause of the OSH Act

The General Duty Clause of the OSH Act requires employers to keep their workplaces free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees. The General Duty Clause is cast in general terms, and does not establish specific requirements like exposure limits, PPE, or other specific protective measures that EPA could potentially consider when developing its risk evaluations or risk management requirements. OSHA, under limited circumstances, has cited the General Duty Clause for regulating exposure to chemicals. To prove a violation of the General Duty Clause, OSHA must prove employer or industry recognition of the hazard, that the hazard was causing or likely to cause death or serious physical harm, and a feasible method to eliminate or materially reduce the hazard was available. In rare situations, OSHA has cited employers for violation of the General Duty Clause where exposures were below a chemical-specific permissible exposure limit (PEL), a TWA based on an employee's average airborne exposure in any 8-hour work shift of a 40-hour work week which shall not be exceeded (Ref. 7). In such situations, OSHA must demonstrate that the employer had actual knowledge that the PEL was inadequate to protect its employees from death or serious physical harm. Because of the heavy evidentiary burden on OSHA to establish violations of the General Duty Clause, it is not frequently used to cite employers for employee exposure to chemical hazards.

b. OSHA Standards

OSHA standards are issued pursuant to the OSH Act and are found in title 29 of the CFR. There are separate standards for general industry, laboratories, construction, maritime and agriculture sectors, and general standards applicable to a number of sectors (

e.g.,

OSHA's Respiratory Protection standard). OSHA has numerous standards that apply to employers who operate chemical manufacturing and processing facilities, as well as to downstream employers whose employees may be occupationally exposed to hazardous chemicals.

OSHA sets legally enforceable limits on the airborne concentrations of hazardous chemicals, referred to as PELs, established for employers to protect their workers against the health effects of exposure to hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act, OSHA was permitted an initial 2-year window after the passage of the Act to adopt “any national consensus standard and any established Federal standard.” 29 U.S.C. 655(a). OSHA used this authority in 1971 to establish PELs that were adopted from Federal health standards originally set by the Department of Labor through the Walsh-Healy Act, in which approximately 400 occupational exposure limits (OELs) were selected based on the American Conference of Governmental Industrial Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In addition, about 25 exposure limits recommended by the American Standards Association (now called the American National Standards Institute or ANSI) were adopted as PELs.

Following the 2-year window provided under section 6(a) of the OSH Act for adoption of national consensus and existing Federal standards, OSHA has issued health standards following the requirements in section 6(b) of the Act. OSHA has established approximately 30 PELs under section 6(b)(5) as part of comprehensive substance-specific standards that include additional requirements for protective measures such as use of PPE, establishment of regulated areas, exposure assessment, hygiene facilities, medical surveillance, and training. These ancillary provisions in substance-specific OSHA standards further mitigate residual risk that could be present due to exposure at the PEL.

Many OSHA PELs have not been updated since they were established in 1971, including the PEL for PCE. In many instances, scientific evidence has accumulated suggesting that the current limits of many PELs are not sufficiently protective. On October 10, 2014, OSHA published a

Federal Register

document in which it recognized that many of its PELs are outdated and inadequate for ensuring protection of worker health (79 FR 61384). In addition, health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only to the extent that it is technologically and economically feasible. OSHA's legal requirement to demonstrate that its section 6(b)(5) standards are technologically and economically feasible at the time they are promulgated often precludes OSHA from imposing exposure control requirements sufficient to ensure that the chemical substance no longer presents a significant risk to workers. As described in that notice, while new advancements or developments in science and technology from the time a PEL is promulgated may improve the scientific basis for making findings of significant risk, technical feasibility or economic feasibility, OSHA has been unable to update most of the PELs established in 1971 and they remain frozen at levels at which they were initially adopted (79 FR 61384, October 10, 2014). One example of how industries have evolved in the intervening 50 years as to what is technologically and economically feasible is the halogenated solvent cleaning industry, which, in response to EPA's National Emission Standards for Hazardous Air Pollutants (NESHAP) promulgated under section 112 of the 1990 Clean Air Act Amendments (see National Emissions Standards for Halogenated Solvent Cleaning, 40 CFR part 63, subpart T), has made equipment

improvements that conserve solvent resources and reduce workplace exposure.

In sum, the great majority of OSHA's chemical standards are outdated or do not sufficiently reduce risk to workers. While it is possible in some cases that the OSHA standards for some chemicals reviewed under TSCA will eliminate unreasonable risk, based on EPA's experience thus far in conducting occupational risk assessments under TSCA EPA believes that OSHA chemical standards would in general be unlikely to address unreasonable risk to workers within the meaning of TSCA, since TSCA section 6(b) unreasonable risk determinations may account for unreasonable risk to more sensitive endpoints and working populations than OSHA's risk evaluations typically contemplate, and EPA is obligated to apply TSCA section 6(a) risk management requirements to the extent necessary so that the unreasonable risk is no longer presented.

Because the requirements and application of TSCA and OSHA regulatory analyses differ, and because many of OSHA's chemical-specific standards are based on outdated information regarding the technological and economic feasibility of the standards and the risks associated with exposure, it is necessary for EPA to conduct risk evaluations and, where it finds unreasonable risk to workers, develop risk management requirements for chemical substances that OSHA also regulates, and it is expected that EPA's findings and requirements may sometimes diverge from OSHA's. However, it is also appropriate that EPA consider the chemical standards that OSHA has already developed to limit the compliance burden to employers by aligning management approaches required by the agencies, where alignment will adequately address unreasonable risk to workers. The following unit discusses EPA's consideration of OSHA standards in its risk evaluation and management strategies under TSCA.

2. Consideration of OSHA Standards in TSCA Risk Evaluations

When characterizing the risk during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where no mitigation measures are assumed to be in place for the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It should be noted that there are some cases where scenarios may reflect certain mitigation measures, such as in instances where exposure estimates are based on monitoring data at facilities that have existing engineering controls in place. For example, the Halogenated Solvent Cleaning NESHAP, first promulgated in 1994 and last updated in 2007, established standards reflecting the maximum achievable control technology for major and certain area sources, standards reflecting generally available control technology for other area sources, and facility-wide emission limits for certain halogenated solvent cleaning machines. Consequently, emissions monitoring from facilities meeting the NESHAP would reflect emissions reduction resulting from existing engineering controls already in place to meet the standards.)

In addition, EPA believes it may be appropriate to also evaluate the levels of risk present in scenarios considering applicable OSHA requirements as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. EPA may evaluate risk under scenarios that consider industry or sector best practices for industrial hygiene that are clearly articulated to the Agency, when doing so serves to inform its risk management efforts. Characterizing risks using scenarios that reflect different levels of mitigation can help inform potential risk management actions by providing information that could be used during risk management to tailor risk mitigation appropriately to address any unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.).

a. Risk Characterization for Unreasonable Risk Determination

When making unreasonable risk determinations as part of TSCA risk evaluations, EPA cannot assume as a general matter that all workers are always equipped with and appropriately using sufficient PPE, although it does not question the veracity of public comments received on the 2020 Risk Evaluation for PCE regarding the occupational safety practices often followed by industry respondents. When characterizing the risk to human health from occupational exposures during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where PPE is not assumed to be used by workers. This approach of not assuming PPE use by workers considers the risk to PESS (workers and occupational non-users (ONUs)) who may not be covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan. Mitigation scenarios included in the EPA risk evaluation in order to inform its risk management efforts (

e.g.,

scenarios considering use of PPE) likely represent current practice in many facilities where companies effectively address worker and bystander safety requirements. However, the Agency cannot assume that all facilities across all uses of the chemical substance will have adopted these practices for the purposes of making the TSCA risk determination.

Therefore, EPA makes its determinations of unreasonable risk based on scenarios that do not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. Making unreasonable risk determinations based on such scenarios should not be viewed as an indication that EPA believes there are no occupational safety protections in place at any location, or that there is widespread noncompliance with applicable OSHA standards. Rather, it reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by an OSHA State Plan, or because their employer is out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding existing OSHA requirements.

b. Risk Evaluation To Inform Risk Management Requirements

In addition to the scenarios described previously, EPA risk evaluations may characterize the levels of risk present in scenarios considering applicable OSHA requirements (

e.g.,

chemical-specific PELs and/or chemical-specific health standards with PELs and additional ancillary provisions) as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency to help inform risk management decisions.

3. Consideration of OSHA Standards in TSCA Risk Management Actions

When undertaking risk management actions, EPA: (1) Develops occupational risk mitigation measures to address any unreasonable risk identified by EPA, striving for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls (Ref. 8), when those measures would address an unreasonable risk; and (2) Ensures that EPA requirements apply to all potentially exposed workers in accordance with TSCA requirements.

Consistent with TSCA section 9(d), EPA consults and coordinates TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum applicability of TSCA while avoiding the imposition of duplicative requirements.

Informed by the mitigation scenarios and information gathered during the risk evaluation and risk management process, the Agency might propose rules that require risk management practices that may be already common practice in many or most facilities. Adopting clear, broadly applicable regulatory standards will foster compliance across all facilities (ensuring a level playing field) and assure protections for all affected workers, especially in cases where current OSHA standards may not apply to them or not be sufficient to address the unreasonable risk.

For evaluation scenarios which involve OSHA chemical-specific PELs, EPA's risk evaluation in some cases may illustrate that limiting exposure to OSHA's PEL would result in acceptable levels of risk under TSCA under certain conditions of use. In these cases, TSCA risk management requirements could incorporate and reinforce requirements in OSHA standards and ensure that risks are addressed, including for circumstances where OSHA requirements are not applicable (

e.g.,

public sector workers not covered by an OSHA State plan, and self-employed workers) by asserting TSCA compliance/enforcement as well. EPA's risk evaluation may also find unreasonable risk under TSCA associated with some occupational conditions of use, even when the applicable OSHA requirements are being met. In these cases, EPA would need to develop risk management requirements beyond those included in OSHA's standards.

4. PCE and OSHA Requirements

EPA incorporated the considerations described earlier in this unit in the 2020 Risk Evaluation for PCE, the December 2022 revised unreasonable risk determination for PCE, and this rulemaking. Specifically, in the TSCA 2020 Risk Evaluation for PCE, EPA presented risk estimates based on workers' exposures with and without respiratory protection. EPA determined that even when respirators are used by workers, most of the conditions of use evaluated presented an unreasonable risk. Additional consideration of OSHA standards in the revised unreasonable risk determination is discussed further in the

Federal Register

notice announcing that document (Ref. 9). In Units III.B.3. and Unit V., EPA outlines the importance of considering the hierarchy of controls utilized by the industrial hygiene community (hereafter referred to as “hierarchy of controls”) when developing risk management actions in general, and specifically when determining if and how regulated entities may meet a risk-based exposure limit for PCE. The hierarchy of controls is a prioritization of exposure control strategies from most protective and preferred to least protective and preferred techniques. In order of precedence, they are: elimination of the hazard, substitution with a less hazardous substance, engineering controls, administrative controls such as training or exclusion zones with warning signs, and, finally, use of PPE (Ref. 8). Under the hierarchy of controls the use of respirators (and all PPE) should only be considered after all other measures have been taken to reduce exposures. As discussed in Units IV.A. and V.A.1., EPA's risk management approach would not rely solely or primarily on the use of respirators and dermal PPE to address unreasonable risk to workers; instead, EPA is proposing prohibitions for most conditions of use and a WCPP for certain occupational conditions of use. The WCPP would require consideration of the hierarchy of controls before use of respirators and other PPE. The WCPP is discussed in full in Units IV.A.2. and V.A.1.b.

In accordance with the approach described earlier in Unit II.C.3., EPA intends for this regulation to be as consistent as possible with the existing OSHA standards, with additional requirements as necessary to address the unreasonable risk. One notable difference between the WCPP and the OSHA standards are the exposure limits. The WCPP would include an ECEL of 0.14 ppm as an 8-hour TWA to address unreasonable risk for chronic cancer and non-cancer and acute non-cancer inhalation endpoints. EPA recognizes that for PCE, the ECEL would be significantly lower than the OSHA PEL (100 ppm as an 8-hour TWA). In addition to the distinctions in statutory requirements described in this unit, EPA has identified several factors contributing to the differences in these levels, outlined here.

The TSCA ECEL value for PCE is a lower value than the OSHA PEL (and other existing OELs, discussed in Unit II.C.5.) for many reasons, including the age of the data and studies the values are based on and that the values may not fully capture either the complete database of studies considered in the 2020 Risk Evaluation for PCE or more recent advances in modeling and scientific interpretation of toxicological data applied in the calculation of the PCE ECEL. EPA considers the PCE ECEL to represent the best available science under TSCA section 26(h) because it was derived from information in the 2020 Risk Evaluation for PCE, which was subject to peer review, and which is the result of a systematic review process that investigated the reasonably available information in order to identify relevant adverse health effects. Additionally, by using the information from the 2020 Risk Evaluation for PCE, the ECEL incorporates advanced modeling and peer-reviewed methodologies, and accounts for exposures to potentially exposed and susceptible subpopulations, as required by TSCA.

For PCE, the EPA ECEL is an 8-hour occupational inhalation exposure limit based on chronic non-cancer neurotoxicity effects, and takes into consideration the uncertainties identified in the 2020 Risk Evaluation for PCE (Ref. 10). The ECEL represents the concentration at which an adult human, including a member of a PESS, would be unlikely to suffer adverse effects if exposed for a working lifetime. EPA has determined as a matter of risk management policy that ensuring exposures remain at or below the ECEL will eliminate any unreasonable risk of injury to health from occupational inhalation exposures. In addition to the ECEL, as part of this rulemaking EPA is proposing an ECEL action level, a value half of the ECEL, that would trigger additional monitoring to ensure that workers are not exposed to concentrations above the ECEL.

For PCE, the ECEL of 0.14 ppm is based on the most sensitive point of departure across acute, chronic non-cancer, and cancer endpoints. Neurotoxicity based on visual and cognitive deficits following chronic exposure was the basis of the PCE ECEL based on epidemiological data from Cavalleri et al., 1994 and Echeverria et al., 1995 (Refs. 10, 1, 11, 12). The ECEL incorporates a benchmark margin of exposure of 100 to account for human variability and the absence of a no-effect level in the studies.

The OSHA PEL for PCE of 100 ppm as an 8-hour TWA was established in 1971. OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so (81 FR 16285). A 1989 update to 25 ppm based on a quantitative cancer risk assessment and technological feasibility analysis was later vacated by court order, reverting to the original PEL of 100 ppm (Ref. 13); (See also 54 FR 2332, 2686, 2688 (1989)). The basis of the 100

ppm PEL is unclear, however most original PELs were based on acute health effects only observable at higher concentrations as more sensitive chronic studies, including the chronic exposure studies used to inform the PCE ECEL, were not available at the time the PEL was established (see,

e.g.,

79 FR 61383, 61388). As discussed in Units II.D., III.B., and VII.D., the TSCA ECEL represents the best available science at time of publication of the 2020 Risk Evaluation for PCE. As described earlier, in a 2014 request for information OSHA described how, while new developments in science and technology from the time the PEL for PCE was established in 1971 may improve the scientific basis for making findings of significant risk, technical feasibility, or economic feasibility that is required under section 6(b)(5) of the OSH Act, OSHA has been unable to update the PEL for PCE and it remains frozen at the level that was originally adopted in 1971 (79 FR 61383, October 10, 2014).

5. PCE and Other Occupational Exposure Limits

EPA is aware of other OELs for PCE, including the ACGIH TLV, the California Division of Occupational Safety and Health (Cal/OSHA) PEL, and the National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL).

The 8-hour TWA TLV recommended by the ACGIH is 25 ppm. This TLV is based on “discomfort and subjective complaints” occurring at 100 ppm and above (Ref. 14). Neurological effects such as dizziness, headache, sleepiness, and incoordination were also indicated at 100 ppm and above. The TLV appears to use a four-fold “margin of safety” consistent with other TLV reports but lower than what would be recommended by EPA guidance (Ref. 15), which would support a downward adjustment of 30x-100x. The TLV report acknowledges that the liver effects were observed at as low as 9 ppm in mice after only 30 days of continuous exposure, however ACGIH determined that the exposure pattern was not representative of occupational scenarios. Additionally, quantitative risks from cancer were not considered because PCE was classified as only an animal carcinogen. Notably, the TLV report did not cite either epidemiological study used as the basis of the EPA ECEL, despite them being published 1-2 years prior to the 1996 TLV update.

The Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and equivalent to the ACGIH TLV. The 25 ppm value is also equivalent to the vacated 1989 OSHA PEL, which was based on a quantitative cancer risk assessment and technological feasibility analysis. Despite the Cal/OSHA PEL being equivalent to the vacated 1989 OSHA PEL based on cancer, Cal/OSHA did not perform a quantitative cancer risk assessment and the PEL is primarily based on non-cancer central nervous systems (CNS) effects (Ref. 16).

In 1976, the NIOSH REL for PCE was 50 ppm as a TWA for up to a 10-hour workday, 40-hour workweek (Ref. 17). This REL was considered protective of neurological effects as well as eye and respiratory tract irritation. The current REL for PCE is “Ca (potential occupational carcinogen) minimize workplace exposure concentrations” (Ref. 18). As described in NIOSH's Appendix A, this non-quantitative value is based on the lowest feasible concentration (Ref. 19).

D. Summary of EPA's Risk Evaluation Activities on PCE

In December 2016, EPA selected PCE as one of the first 10 chemicals for risk evaluation under TSCA section 6 (15 U.S.C. 2605). EPA published the scope of the PCE risk evaluation in June 2017 (82 FR 31592, July 7, 2017) (FRL-9963-57), and, after receiving public comments, published the problem formulation in June 2018 (83 FR 26998, June 11, 2018) (FRL-9978-40). In May 2020, EPA published a draft risk evaluation(85 FR 26464, May 4, 2020) (FRL-10008-63), and after public comment and peer review by the Science Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk Evaluationfor PCE in December 2020 in accordance with TSCA section 6(b) (85 FR 82474, December 18, 2020) (FRL-10017-44). EPA subsequently issued a draft revised TSCA unreasonable risk determination for PCE (87 FR 39085, June 30, 2022) (FRL-9942-01-OCSPP), and after public notice and receipt of comments, published a revised Unreasonable Risk Determination for PCE (87 FR 76481, December 14, 2022) (FRL-9942-01-OCSPP). The 2020 Risk Evaluation for PCE and supplemental materials are in docket EPA-HQ-OPPT-2019-0502, with the December 2022 revised unreasonable risk determination and additional materials supporting the risk evaluation process in docket EPA-HQ-OPPT-2016-0732, on

https://www.regulations.gov.

1. 2020 Risk Evaluation

In the 2020 Risk Evaluation for PCE, EPA evaluated risks associated with 61 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal. Descriptions of these conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for PCE identified significant adverse health effects associated with exposure to PCE, including neurotoxicity effects from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to PCE. A further discussion of the hazards of PCE is in Unit III.B.2.

2. Revised Unreasonable Risk Determination

EPA has been revisiting specific aspects of its first ten TSCA existing chemical risk evaluations, including the 2020 Risk Evaluation for PCE, to ensure that the risk evaluations upon which risk management decisions are made better align with TSCA's objective of protecting human health and the environment. For PCE, EPA revised the original unreasonable risk determination based on the 2020 Risk Evaluation for PCE and issued a final revised unreasonable risk determination in December 2022 (Ref. 2). EPA revised the risk determination for the 2020 Risk Evaluation for PCE pursuant to TSCA section 6(b) and consistent with Executive Order 13990 (entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”) and other Administration priorities (Refs. 20, 21, and 22). The revisions consisted of making the risk determination based on the whole chemical substance instead of by individual conditions of use (which resulted in the revised risk determination superseding the prior “no unreasonable risk” determinations and withdrawing the associated TSCA section 6(i)(1) “no unreasonable risk” order); and clarifying that the risk determination does not reflect an assumption that all workers are always provided and appropriately wear PPE (Ref. 2).

In determining whether PCE presents unreasonable risk under the conditions of use, EPA considered relevant risk-related factors, including, but not limited to: the effects of the chemical substance on health (including cancer and non-cancer risks) and human exposure to the substance under the conditions of use (including duration, magnitude and frequency of exposure); the effects of the chemical substance on the environment and environmental exposure under the conditions of use; the population exposed (including any PESS); the severity of hazard (including the nature of the hazard, the

irreversibility of the hazard); and uncertainties.

EPA determined that PCE presents an unreasonable risk of injury to health. The unreasonable risk determination is driven by risks to workers and ONUs (workers who do not directly handle the chemical but perform work in an area where the chemical is present) due to occupational exposures to PCE (

i.e.,

during manufacture, processing, industrial and commercial uses, or disposal); to children of employees at dry cleaning facilities due to PCE exposures at those facilities; and to consumers and bystanders associated with consumer uses of PCE due to exposures from consumer use of PCE and PCE-containing products. EPA did not identify risks of injury to the environment that drive the unreasonable risk determination for PCE. The PCE conditions of use that drive EPA's determination that the chemical substance poses unreasonable risk to health are listed in the unreasonable risk determination (Ref. 2) and also in Unit III.B.1., with descriptions to aid chemical manufacturers, processors, and users in determining how their particular use or activity would be addressed under the proposed regulatory provisions.

While the 2020 Risk Evaluation for PCE estimated different risks for occupational non-users and workers, the benchmark (and thus the ECEL value) is the same for both populations. That is, while workers and occupational non-users may have different exposure patterns, the level of exposure such that risks are no longer unreasonable is the same for both workers and occupational non-users. Thus, for the purposes of risk management, the distinction between worker and occupational non-user is no longer relevant, and both are encompassed by the definition of a potentially exposed person, as outlined in Unit IV.A.2.a.

3. Fenceline Screening Analysis

The 2020 Risk Evaluation for PCE excluded the assessment of certain exposure pathways that were or could be regulated under another EPA-administered statute (see section 1.4.2 of the December 2020 Risk Evaluation for PCE) (Refs. 1, 2). This resulted in the surface water, drinking water, and ambient air pathways for PCE exposure not being assessed for human health risk to the general population. In June 2021, EPA made a policy announcement on the path forward for TSCA chemical risk evaluations, indicating that EPA would, among other things, examine whether the exclusion of certain exposure pathways from the risk evaluations would lead to a failure to identify and protect fenceline communities (Refs. 9, 23). EPA then conducted a screening analysis to identify whether there may be potential risks to people living near the fenceline of facilities releasing PCE.

In order to assess the potential risk to the general population in proximity to a facility releasing PCE, EPA developed the TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0, which was presented to the SACC in March 2022, with a report issued by the SACC on May 18, 2022 (Ref. 24). This analysis is discussed in Unit VI.A.

III. Regulatory Approach

A. Background

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

• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture, or limit the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce (TSCA section 6(a)(1)).

• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture for a particular use or above a specific concentration for a particular use (TSCA section 6(a)(2)).

• Limit the amount of the substance or mixture which may be manufactured, processed, or distributed in commerce for a particular use or above a specific concentration for a particular use specified (TSCA section 6(a)(2)).

• Require clear and adequate minimum warning and instructions with respect to the substance or mixture's use, distribution in commerce, or disposal, or any combination of those activities, to be marked on or accompanying the substance or mixture (TSCA section 6(a)(3)).

• Require manufacturers and processors of the substance or mixture to make and retain certain records, or conduct certain monitoring or testing (TSCA section 6(a)(4)).

• Prohibit or otherwise regulate any manner or method of commercial use of the substance or mixture (TSCA section 6(a)(5)).

• Prohibit or otherwise regulate any manner or method of disposal of the substance or mixture, or any article containing such substance or mixture, by its manufacturer or processor or by any person who uses or disposes of it for commercial purposes (TSCA section 6(a)(6)).

• Direct manufacturers or processors of the substance or mixture to give notice of the unreasonable risk determination to distributors, certain other persons, and the public, and to replace or repurchase the substance or mixture (TSCA section 6(a)(7)).

As described in Unit III.B.3., EPA analyzed how the TSCA section 6(a) requirements could be applied to address the unreasonable risk found to be present in the 2020 Risk Evaluation for PCE and the final revised unreasonable risk determination, so that PCE no longer presents such unreasonable risk. EPA's proposed regulatory action and two alternative regulatory actions are described in Unit IV. EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory actions and is providing notice that based on consideration of comments and any new information submitted to EPA during the comment period on this proposed rule, EPA may in the final rule modify elements of the proposed regulatory action. The public should understand that public comments could result in changes to elements of the proposed and alternative regulatory actions when this rulemaking is finalized. For example, elements such as timelines for phase out could be lengthened or shortened, ECELs could be modified, or the WCPP could have conditions added or eliminated.

Under the authority of TSCA section 6(g), EPA may consider granting a time-limited exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use if EPA finds that: (1) The specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; (2) Compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or (3) The specific condition of use, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. Based on reasonably available information, EPA has analyzed

the need for an exemption and is proposing that a TSCA section 6(g) exemption is warranted for certain conditions of use, as detailed in Unit IV.A.5. EPA is requesting comment on the proposed rule's section 6(g) exemption provisions and rationale. In addition, EPA has found that two TSCA section 6(g) exemptions may be warranted if the second alternative regulatory action considered by EPA is adopted in the final rule. Therefore, the public should assume that if EPA were to promulgate the second alternative to the proposed regulatory action, EPA would at the same time grant an exemption from the rule requirements for two conditions of use under TSCA section 6(g). Unit IV.B.2.b. includes information regarding EPA's second alternative action that includes exemptions under TSCA section 6(g). EPA is requesting public comment regarding the need for exemptions from the rule (and under what specific circumstances), including exemptions from the proposed regulatory action (

e.g.,

a WCPP) and the primary and second alternative regulatory actions, pursuant to the provisions of TSCA section 6(g).

TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section 6(a) rules, to consider and include a statement addressing certain factors, including the costs and benefits and the cost effectiveness of the regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator. A description of all TSCA section 6 requirements considered in developing this proposed regulatory action is in Unit III.B.3., and Unit V. includes more information regarding EPA's consideration of exemptions and alternatives. TSCA section 6(c)(2)(C) requires that in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use and in setting an appropriate transition period for such action, EPA consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as substitutes when the proposed prohibition or restriction takes effect. Unit V.B. includes more information regarding EPA's consideration of alternatives, and Unit VI. provides more information on EPA's considerations more broadly under TSCA section 6(c)(2).

EPA carried out required consultations as described in this unit and also considered impacts on children's environmental health as part of its approach to developing this TSCA section 6 regulatory action.

1. Consultations

EPA conducted consultations and outreach in developing this proposed regulatory action. The Agency held a federalism consultation from July 22, 2021, until October 22, 2021, as part of this rulemaking process and pursuant to Executive Order 13132. This included a background presentation on September 9, 2020, and a consultation meeting on July 22, 2021. During the consultation, EPA met with State and local officials early in the process of developing the proposed action in order to receive meaningful and timely input into its development (Ref. 25). During the consultation, participants and EPA discussed additional reporting requirements as a risk management tool to address the unreasonable risk, EPA's consideration of safer alternatives, and potential impacts to drinking water utilities (Ref. 25).

PCE is not manufactured (including imported), processed, distributed in commerce, or regulated by Tribal governments. However, EPA consulted with Tribal officials during the development of this proposed action (Ref. 26). The Agency held a Tribal consultation from May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8, 2021. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for PCE, types of information that would be helpful to inform risk management, principles for transparency during the risk management process, and types of information EPA is seeking from Tribes (Ref. 26). EPA received no written comments as part of this consultation.

In addition to the formal consultations, EPA also conducted outreach to advocates of communities that might be subject to disproportionate risk from the exposures to PCE, such as minority populations, low-income populations, and indigenous peoples. EPA's Environmental Justice (EJ) consultation occurred from June 3, 2021, through August 20, 2021. On June 16, 2021, and July 6, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to and in compliance with Executive Orders 12898 and 14008. EPA received five written comments following the EJ meetings, in addition to oral comments provided during the consultation (Refs. 27, 28, 29, 30, 31). In general, commenters supported strong outreach to affected communities, encouraged EPA to follow the hierarchy of controls utilized by the industrial hygiene community, favored prohibitions, and noted the uncertainty, and in some cases inadequacy, of PPE. Commenters also urged EPA to address in this rulemaking ongoing releases from hazardous waste and disposal sites, in particular vapor intrusion of PCE from contaminated groundwater, soil, and indoor air. Additionally, commenters expressed concern that the adverse health impacts of PCE dry cleaning fall disproportionately to owners and employees of minority owned small businesses, noted the viability of professional wet cleaning as an alternative to PCE dry cleaning, and urged EPA to consider adverse economic impacts of the regulation and establishing a financial program to offset transition costs to local communities (Ref. 32).

As required by section 609(b) of the Regulatory Flexibility Act (RFA), EPA convened a Small Business Advocacy Review (SBAR) Panel to obtain advice and recommendations from small entity representatives (SERs) that potentially would be subject to this proposed rule's requirements (Ref. 33). EPA met with SERs before and during Panel proceedings, on September 26, 2022, and November 10, 2022. Panel recommendations are in Unit X.C. and in the Initial Regulatory Flexibility Analysis (IRFA) (Ref. 34), the Panel report is in the docket (Ref. 33). EPA requests comment on all elements of the IRFA, and, in particular, the flexibilities that EPA has identified following input from the SERs during the SBAR process. Additional requests for comment based on Panel recommendations are in Unit VIII.

Units X.C., X.E., X.F., and X.J. provide more information regarding the consultations.

2. Other Stakeholder Engagement

In addition to the formal consultations described in Unit X., EPA held a webinar on January 14, 2021, providing an overview of the TSCA risk management process and the risk evaluation findings for PCE. EPA also presented on the risk evaluation and risk management under TSCA for PCE at a Small Business Administration (SBA) Office of Advocacy Environmental roundtable on January 15, 2021. At both events, EPA staff provided an overview of the TSCA risk management process and the findings in the 2020 Risk Evaluation for PCE (Ref. 35). Attendees of these meetings were given an opportunity to voice their concerns

regarding the risk evaluation and risk management.

Furthermore, EPA engaged in discussions with representatives from different industries, non-governmental organizations, technical experts and users of PCE. A list of external meetings held during the development of this proposed rule is in the docket (Ref. 36); meeting materials and summaries are also in the docket. The purpose of these discussions was to create awareness and educate stakeholders and regulated entities on the provisions for risk management required under TSCA section 6(a); explain the risk evaluation findings; obtain input from manufacturers, processors, distributors, users, academics, advisory councils, and members of the public health community about uses of PCE; identify workplace practices, engineering controls, administrative controls, PPE, and industrial hygiene plans currently in use or feasibly adoptable to reduce exposure to PCE under the conditions of use; understand the importance of PCE in the various uses subject to this proposed rule; compile knowledge about critical uses, substitute chemicals or alternative methods; identify various standards and performance specifications; and generate potential risk reduction strategies. EPA has met with, or otherwise communicated with, a variety of companies, trade associations and non-governmental organizations to discuss the topics outlined in this paragraph; a list of external meetings held during the development of this proposed rule is in the docket (Ref. 36).

3. Children's Environmental Health

The EPA 2021 Policy on Children's Health (Ref. 37) requires EPA to protect children from environmental exposures by consistently and explicitly considering early life exposures (from conception, infancy, early childhood and through adolescence until 21 years of age) and lifelong health in all human health decisions through identifying and integrating children's health data and information when conducting risk assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk evaluations “to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment . . . including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.” Infants, children, and pregnant women are listed as examples of subpopulations that may be considered relevant “potentially exposed or susceptible subpopulations” in the TSCA section 3(12) definition of that term. In addition, TSCA section 6(a) requires EPA to apply one or more risk management requirements under TSCA section 6(a) so that PCE no longer presents an unreasonable risk (including unreasonable risk to PESS).

The 2020 Risk Evaluation for PCE evaluated the hazards of PCE to toddlers and older children (11-15 years and 16-20 years) and did not find disproportionate adverse health impacts to these groups (Ref. 1). Evidence of hazards to infants and males and females of reproductive age was found for reproductive and developmental toxicity. The reproductive and developmental health effects of concern related to exposures to PCE are reduced sperm quality, spontaneous abortion, and decreased fetal/placental weight. The most sensitive non-cancer hazard driving the unreasonable risk for PCE is neurotoxicity (CNS effects). Early lifestage development of the nervous system can be a sensitive period, however the studies on PCE do not provide sufficient evidence of greater sensitivity to neurotoxicity in early lifestages than later lifestages, such as during adulthood. While the literature contains methodological limitations in human studies, animal studies were considered adequate to represent reproductive and development effects in the 2020 Risk Evaluation for PCE.

The 2020 Risk Evaluation for PCE released in December 2020 considered impacts on both children and adults from occupational and consumer use from inhalation and dermal exposures, as applicable. For occupational use, the risk evaluation considered males (>16 years of age) and females of reproductive age (>16 years of age to less than 50 years of age) for both dermal and inhalation exposures. Additionally, because many dry cleaners are family owned and operated, the risk evaluation assumed children of employees may spend the full workday at dry cleaning facilities, in particular those too young to be in school, during which time they may be exposed to similar air concentration levels as ONUs. The risk evaluation considered inhalation exposures to children of employees present at dry cleaners by evaluating central nervous system effects for the most sensitive lifestage: infants less than one year old. Children of employees present at dry cleaners would be exposed to higher PCE concentrations than children who live or attend daycare or school above or adjacent to dry cleaners, and EPA therefore expects that risks to those populations are covered by evaluation of children within dry cleaning facilities. For consumer use, EPA evaluated dermal exposures for children ages 11 to 15 and 16 to 20 years of age and adults >20 years of age, and the evaluation of bystander exposure from inhalation exposures includes infants, toddlers and older children. While risks to children are not disproportionate, effects observed in studies include central nervous system effects from acute inhalation exposure.

B. Regulatory Assessment of PCE

1. Description of Conditions of Use

This unit describes the TSCA conditions of use that drive EPA's unreasonable risk determination for the chemical substance PCE. Condition of use descriptions were obtained from EPA sources such as CDR use codes, the 2020 Risk Evaluation for PCE and related documents, as well as the Organisation for Economic Co-operation and Development harmonized use codes and stakeholder engagements. For additional description of the conditions of use, including process descriptions and worker activities considered in the risk evaluation, see the Problem Formulation of the 2020 Risk Evaluation for PCE, the 2020 Risk Evaluation for PCE, and supplemental files (Refs. 38, 1, 39). EPA acknowledges that some of the terms in this unit may be defined under other statutes, however the descriptions here are intended to provide clarity to the regulated entities who will implement the provisions of this rulemaking under TSCA section 6(a).

a. Manufacturing (Including Import)

i.

Domestic manufacture.

This condition of use refers to the making or producing of a chemical substance within the United States (including manufacturing for export), or the extraction of a component chemical substance from a previously existing chemical substance or a complex combination of substances. This description does not apply to PCE production as a byproduct, including during the manufacture of 1,2-dichloroethane which EPA intends to consider in the risk evaluation for 1,2-dichloroethane (Ref. 40).

ii.

Import.

This condition of use refers to the act of causing a chemical substance or mixture to arrive within the customs territory of the United States.

b. Processing

i.

Processing as a reactant/intermediate.

This condition of use refers to processing PCE in chemical reactions for the manufacturing of

another chemical substance or product. Through processing as a reactant or intermediate, PCE serves as a feedstock in the production of another chemical product via a chemical reaction in which PCE is completely consumed. For example, PCE is used as a reactant in the production of HFCs, hydrochlorofluorocarbons (HCFCs), and chlorofluorocarbons (CFCs). This condition of use includes reuse of PCE, including PCE originally generated as a byproduct or residual PCE as a reactant.

ii.

Processing into formulation, mixture or reaction product in cleaning and degreasing products.

This condition of use refers to when PCE is added to a cleaning or degreasing product (or product mixture) prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate cleaning or degreasing products that are used to remove dirt and dissolve oils, greases, and similar materials from textiles, glassware, metal surfaces, furniture, furnishings, and other articles, or to cleanse, sanitize, bleach, scour, polish, protect, or improve the appearance of surfaces.

iii.

Processing into formulation, mixture or reaction product in adhesive and sealant products.

This condition of use refers to when PCE is added to an adhesive or sealant product (or product mixture) prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate products that promote bonding between other substances, promote adhesion of surfaces, or prevent seepage of moisture or air.

iv.

Processing into formulation, mixture or reaction product in paint and coating products.

This condition of use refers to when PCE is added to a paint or coating product (or product mixture) prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate paint and coating products that are applied to surfaces to enhance properties such as water repellency, gloss, fade resistance, ease of application, or foam prevention. Additionally, PCE is incorporated into coating products, such as maskant, that protect a substrate during exposure to a chemical process such as chemical milling, plating, and anodizing.

v.

Processing into formulation, mixture or reaction product in other chemical products and preparations.

This condition of use refers to when PCE is added to other chemical products (or product mixtures) or preparations prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate inks, toners, colorants, photographic supplies, lubricants, greases, mold releases, and other products.

vi.

Processing by repackaging.

This condition of use refers to the preparation of a chemical substance or mixture for distribution in commerce in a different form, state, or quantity. This includes transferring of PCE from a bulk container into smaller containers.

vii.

Recycling.

This condition of use refers to processing waste streams of PCE at a third-party site for the purpose of recovering materials or otherwise preparing the waste for reuse instead of disposal. Waste solvents can be restored via solvent reclamation/recycling. The recovery process may involve an initial vapor recovery or mechanical separation step followed by distillation, purification, and final packaging.

c. Industrial and Commercial Use

i.

Industrial and commercial use as solvent for open-top batch vapor degreasing.

This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through the process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using batch open-top vapor degreaser machines.

ii.

Industrial and commercial use as solvent for closed-loop batch vapor degreasing.

This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through the process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using batch closed-loop degreaser machines.

iii.

Industrial and commercial use as solvent for in-line conveyorized vapor degreasing.

This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through the process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using in-line conveyorized vapor degreaser machines.

iv.

Industrial and commercial use as solvent for in-line web cleaner vapor degreasing.

This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through a process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using web vapor degreaser machines.

v.

Industrial and commercial use as solvent for cold cleaning.

This condition of use refers to the industrial and commercial use of PCE as a non-boiling solvent in cold cleaning machines, including simple spray sinks and dip tanks, to remove dirt, oils, greases, and other surface contaminants from metal and other parts.

vi.

Industrial and commercial use as solvent for aerosol spray degreaser/cleaner.

This condition of use refers to the industrial and commercial use of PCE as a solvent in degreasing and cleaning products to remove dirt, grease, stains, spots, and foreign matter through a process that uses an aerosolized solvent spray, typically applied from a pressurized can, to remove residual contaminants from electronics, metals, and other fabricated materials. This description includes use of PCE in products for energized electrical cleaning for equipment with an electrical current running through it, such as electric motors, armatures, relays, electric panel, generators, and other equipment. This description does not apply to use of PCE in products intended for automotive care, welding, or mold cleaning, which are described in different conditions of use.

vii.

Industrial and commercial use as a solvent for aerosol lubricants.

This condition of use refers to the industrial and commercial use of PCE in aerosolized products to reduce friction, heat generation and wear between solid surfaces.

viii.

Industrial and commercial use as a solvent for penetrating lubricants and cutting tool coolants.

This condition of use refers to the industrial and commercial use of PCE in liquid products such as metalworking, cutting, and tapping fluids, including penetrating lubricants and cutting tool coolants, to reduce friction, heat generation and wear between solid surfaces.

ix.

Industrial and commercial use in solvent-based adhesives and sealants.

This condition of use refers to the industrial and commercial use of PCE as a solvent in adhesive and sealant products to promote bonding between other substances, promote adhesion of surfaces, or prevent seepage of moisture or air.

x.

Industrial and commercial use in solvent-based paints and coatings.

This condition of use refers to the industrial and commercial use of PCE as a solvent in paint and coating, including maskant, that is applied to surfaces to enhance properties such as water repellence, increased gloss, improved fade

resistance, ease of application, and foam prevention. This description does not apply to the use of PCE in maskant for chemical milling, which is described in a different condition of use

xi.

Industrial and commercial use in maskant for chemical milling.

This condition of use refers to the industrial and commercial use of PCE as a solvent in maskants or elastomer-based coatings that are used to protect a substrate during exposure to a chemical process, such as chemical milling, plating and anodizing.

xii.

Industrial and commercial use as a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing.

This condition of use refers to the industrial and commercial use of PCE to improve the processing characteristics or the operation of process equipment or to alter or buffer the pH of the substance of mixture during the production of non-pesticidal products used to increase the productivity and quality of plant, animal and forestry crops produced on a commercial scale. Processing aids are added to a reaction mixture to aid in the manufacture or synthesis or another chemical substance but are not intended to remain in or become part of the product or product mixture or affect the function of a substance or article created.

xiii.

Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing.

This condition of use refers to the industrial and commercial use of PCE to improve processing characteristics or the operation of process equipment during the production of oil, gas, and other similar products. For example, PCE is used in both reforming and isomerization processes at refineries. In the reforming process, PCE is added directly to a regenerator in a Continuous Catalytic Regeneration reforming unit, and in the isomerization process, PCE is added to the hydrocarbon feed. In both processes, PCE provides chlorine ions to regenerate the catalysts and is consumed in the process.

xiv.

Industrial and commercial use in wipe cleaning.

This condition of use refers to the industrial and commercial use of PCE in non-aerosol degreasing and cleaning products to remove dirt, grease, stains, spots, and foreign matter from furniture and furnishings or to cleanse, sanitize, bleach, scour, polish, protect, or improve the appearance of surfaces through wipe cleaning.

xv.

Industrial and commercial use in other spot cleaning and spot removers, including carpet cleaning.

This condition of use refers to the industrial and commercial use of PCE in products to remove dirt, grease, stains, spots, and foreign matter from furniture and furnishes, including carpets and rugs. This description does not apply to the use of PCE as a spot cleaner at dry cleaning facilities, which is described under other conditions of use.

xvi.

Industrial and commercial use in mold release.

This condition of use refers to the industrial and commercial use of PCE in products to remove dirt, grease, stains, spots, and foreign matter, including release agent residues, from molds and casting surfaces.

xvii.

Industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning.

This condition of use refers to industrial and commercial use of PCE in products for spot cleaning and as a solvent in degreasing and cleaning applications to remove dirt, grease, stains, spots, and foreign matter from garments at dry cleaning facilities that use PCE dry cleaning machines after the promulgation of the 2006 PCE NESHAP for Dry Cleaning Facilities (40 CFR part 63, subpart M). This includes dry cleaning facilities using third generation (dry-to-dry, non-vented machines with refrigerated condensers), fourth generation (dry-to-dry, non-vented machines with both refrigerated condensers and carbon adsorbers as secondary vapor controls), or fifth generation (dry-to-dry, non-vented machines with secondary vapor controls, a monitor inside the machine drum, and an interlocking system to ensure the concentration is below approximately 300 ppm before the loading door can be opened) PCE dry cleaning machines.

xviii.

Industrial and commercial use in dry cleaning and spot cleaning 4th/5th gen only dry cleaning.

This condition of use refers to industrial and commercial use of PCE in products for spot cleaning and as a solvent in degreasing and cleaning applications to remove dirt, grease, stains, spots, and foreign matter from garments at dry cleaning facilities that use fourth generation or fifth generation PCE machines. In addition to use as a solvent in dry cleaning equipment, PCE is found in products to spot clean garments to remove stains or spots before and after dry cleaning treatment.

xix.

Industrial and commercial use in automotive care products (e.g., engine degreaser and brake cleaner).

This condition of use refers to the industrial and commercial use of PCE in aerosolized products to remove dirt, grease, stains, and foreign matter from interior and exterior vehicle surfaces. This description includes use of products for motorized vehicle maintenance and their parts, but does not include energized electrical cleaners, which is covered by the industrial and commercial use as a solvent for aerosol spray degreaser/cleaner. Additionally, this description does not include use of non-aerosolized products intended for automotive care, which are covered by different conditions of use.

xx.

Industrial and commercial use in non-aerosol cleaner.

This condition of use refers to the industrial and commercial use of PCE in non-aerosol products to remove dirt, grease, stains, and foreign matter from furniture, furnishings, interior or exterior vehicles, and other materials, or to clean, sanitize, bleach scour, polish, or improve the appearance of surfaces in all other applications not specified elsewhere in this section.

xxi.

Industrial and commercial use in metal (e.g., stainless steel) and stone polishes.

This condition of use refers to the industrial and commercial use of PCE in non-aerosolized products for metal (

e.g.,

stainless steel) and stone polishing applications, including stone and marble cleaner and wax.

xxii.

Industrial and commercial use in laboratory chemicals.

This condition of use refers to the industrial and commercial use of PCE, 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.

xxiii.

Industrial and commercial use in welding.

This condition of use refers to the industrial and commercial use of PCE in welding applications. For example, PCE can be found in aerosolized products that cast or join materials, promote the fusing of minerals, and prevent oxide formation, including products that reduce welding spatter or prevent the spatter from sticking to surfaces.

xxiv.

Industrial and commercial use in other textile processing.

This condition of use refers to the industrial and commercial use of PCE in processing textile products not described elsewhere. For example, PCE is used as a scourer and for sizing and finishing of cloth.

xxv.

Industrial and commercial use in wood furniture manufacturing.

This condition of use refers to the industrial and commercial use of PCE in the manufacture of wood furniture or wood furniture components (including household furniture, wood office furniture, wood containers and pallets,

and all other wood products) not described elsewhere.

xxvi.

Industrial and commercial use in foundry applications.

This condition of use refers to the industrial and commercial use of PCE in metal foundry, smelting, and metallurgical applications not described elsewhere, such as soldering/desoldering, at nonferrous metal foundries (except die-casting), nonferrous metal diecasting foundries, aluminum foundries, and iron foundries.

xxvii.

Industrial and commercial use in specialty Department of Defense uses (oil analysis and water pipe repair).

During the risk evaluation, the Department of Defense (DOD) provided monitoring data for PCE in various uses, including for oil analysis and water pipe repair. This condition of use refers to the industrial and commercial use of PCE in specialty DOD uses in oil analysis and water pipe repair. After the risk evaluation was published, DOD determined there is no current data to indicate that PCE is required for these specialty uses.

xxviii.

Commercial use in inks and ink removal products (based on printing).

This condition of use refers to the commercial use of PCE in ink and ink removal products used in printing for writing, printing, or creating an image on paper and other substrates, applied to substrates to change their color or hide images, or to remove dirt and other contaminants from substrates such as cleaning machines or printing plates, at print shops.

xxix.

Commercial use in inks and ink removal products (based on photocopying).

This condition of use refers to the commercial use of PCE in ink and ink removal products used in photocopying for writing, printing, creating an image on paper and other substrates, applied to substrates to change their color or hide images, or to remove dirt and other contaminants from substrates such as cleaning machines or printing plates.

xxx.

Commercial use in photographic film.

This condition of use refers to the commercial use of PCE in photographic supplies, film, photoprocessing chemicals, and photographic paper. For example, PCE is used as a liquid-gate fluid to help protect scratching of optical negatives during filming.

xxxi.

Commercial use in metal mold cleaning, release and protectant products.

This condition of use refers to the commercial use of PCE in mold release products to create barriers to prevent certain materials from adhering to each other. This description does not apply to the use of PCE in mold cleaning products that remove residual coatings from mold release, which is described under a different condition of use.

d. Consumer Use

i.

Consumer use in cleaners and degreasers (other).

This condition of use refers to the consumer use of PCE as a solvent in degreasing and cleaning products use to remove dirt, grease, stains, spots, and foreign matter through a process that uses an aerosolized solvent spray, typically applied from a pressurized can, to remove residual contaminants from electronics, metals, and other fabricated materials not described elsewhere in this section.

ii.

Consumer use in dry cleaning solvent.

This condition of use refers to consumer exposure to PCE used to remove dirt, grease, stains, spots, and foreign matter from garments via dry cleaning, in particular the transportation, storage, and wear of articles that were dry cleaned with PCE. For example, garments that are dry cleaned at facilities that use PCE as a dry cleaning solvent have residual concentrations of PCE remaining in the article after a dry cleaning event.

iii.

Consumer use in automotive care products (brake cleaner).

This condition of use refers to the consumer use of PCE in aerosolized products to remove dirt, grease, stains, and foreign matter from interior and exterior vehicle surfaces, including brake cleaner.

iv.

Consumer use in automotive care products (parts cleaner).

This condition of use refers to the consumer use of PCE in non-aerosolized products that are to remove dirt, grease, stains, and foreign matter from interior and exterior vehicle surfaces, including parts cleaner.

v.

Consumer use in aerosol cleaner (vandalism mark and stain remover).

This condition of use refers to the consumer use of PCE in aerosolized products for cleaning and furniture care, including vandalism mark and stain remover.

vi.

Consumer use in non-aerosol cleaner (e.g., marble and stone polish).

This condition of use refers to the consumer use of PCE in non-aerosolized products for cleaning and furniture care, typically in the form of a solid or liquid cleaner not described elsewhere in this section, including liquid marble and stone polish.

vii.

Consumer use in lubricants and greases (cutting fluid).

This condition of use refers to the consumer use of PCE in non-aerosolized products to reduce friction, heat generation and wear between solid surfaces, including cutting fluid.

viii.

Consumer use in lubricants and greases (lubricants and penetrating oils).

This condition of use refers to the consumer use of PCE in aerosolized products to reduce friction, heat generation and wear between solid surfaces, including lubricant and penetrating oils.

ix.

Consumer use in adhesives for arts and crafts (including industrial adhesive, arts and crafts adhesive, gun ammunition sealant).

This condition of use refers to the consumer use of PCE as an adhesive in arts, crafts, and hobby products to promote bonding between other substances, promote adhesion of surfaces, or prevent seepage of moisture or air, in particular industrial adhesive, adhesive for arts and crafts, and gun ammunition sealant. For example, PCE may be used in gun ammunition sealant products to ensure no moisture gets into ammunition casings.

x.

Consumer use in adhesives for arts and crafts (livestock grooming adhesive).

This condition of use refers to the consumer use of PCE in livestock grooming adhesive spray.

xi.

Consumer use in adhesives for arts and crafts (column adhesive, caulk and sealant).

This condition of use refers to the consumer use of PCE for column adhesive, caulk and sealant.

xii.

Consumer use in solvent-based paints and coatings (outdoor water shield (liquid)).

This condition of use refers to the consumer use of PCE in solvent-based non-aerosol paint and coating products to enhance properties such as water repellence, increased gloss, improved fade resistance, ease of application, or foam prevention, in particular the use in outdoor water shield sealants and coatings.

xiii.

Consumer use in solvent-based paints and coatings (coating and primers (aerosol)).

This condition of use refers to the consumer use of PCE in solvent-based paint and coating aerosol products to enhance properties such as water repellence, increased gloss, improved fade resistance, ease of application, or foam prevention, in particular the use in aerosolized coating and primers.

xiv.

Consumer use in solvent-based paints and coatings (rust primer and sealant (liquid)).

This condition of use refers to the consumer use of PCE in solvent-based paint and coating liquid products to enhance properties such as water repellence, increased gloss, improved fade resistance, ease of application, or foam prevention, in particular the use in liquid rust primer and sealant.

xv.

Consumer use in solvent-based paints and coatings (metallic overglaze).

This condition of use refers to the consumer use of PCE in solvent-based paint and coating products to enhance

properties such as water repellence, increased gloss, improved fade resistance, ease of application, or foam prevention, in particular the use in solvent based metallic overglaze for ceramics.

xvi.

Consumer use in metal (e.g., stainless steel) and stone polishes.

This condition of use refers to the consumer use of PCE in liquid wax-based products for metal (

e.g.,

stainless steel) and stone polishing.

xvii.

Consumer use in inks and ink removal products.

This condition of use refers to the consumer use of PCE in ink and ink removal products for writing, printing, creating an image on paper and other substrates, applied to substrates to change their color or hide images, or to remove dirt and other contaminants from substrates.

xviii.

Consumer use in welding.

This condition of use refers to the consumer use of PCE in products that cast or join materials, promote the fusing of minerals, or prevent oxide formation, including products that reduce welding spatter or prevent the spatter from sticking to surfaces.

xix.

Consumer use in metal mold cleaning, release and protectant products.

This condition of use refers to the consumer use of PCE in products to create barriers to prevent certain materials from adhering to each other and assist in the removal of dirt, grease, oils, and other contaminants from metal molds, machinery, electrical and electronic equipment, pins, and mechanical equipment.

e. Disposal

This condition of use refers to the process of disposing generated waste streams of PCE that are collected and transported to a third-party site for their final disposition, such as waste incineration or landfilling.

f. Terminology in This Proposed Rule

For purposes of this proposed rulemaking “occupational conditions of use” refers to the TSCA conditions of use described in Units III.B.1.a., b., c., and e. Although EPA identified both industrial and commercial uses in the 2020 Risk Evaluation for PCE for purposes of distinguishing scenarios, the Agency clarified then and clarifies now that EPA interprets the authority Congress gave to the Agency to “regulat[e] any manner or method of commercial use” under TSCA section 6(a)(5) to reach both industrial and commercial uses.

Additionally, in the 2020 Risk Evaluation for the chemical substance PCE, EPA identified and assessed all known, intended, and reasonably foreseen industrial, commercial, and consumer uses of PCE in order to determine whether PCE as a whole chemical substance presents unreasonable risks to health and the environment. EPA determined that all industrial, commercial, and consumer uses of PCE evaluated in the 2020 Risk Evaluation for PCE drive the EPA determination that PCE presents unreasonable risk of injury to health. As such, for purposes of this risk management rulemaking, “consumer use” refers to all consumer uses including known, intended, and reasonably foreseen consumer uses of PCE. Likewise, for the purpose of this risk management rulemaking, “industrial and commercial use” refers to all industrial and commercial uses, including known, intended, or reasonably foreseen PCE industrial and commercial use.

EPA is not proposing to incorporate the descriptions of known, intended or reasonably foreseen conditions of use in Unit III.B.1.a through e into the regulatory text as definitions because these conditions of use represent those evaluated in the 2020 Risk Evaluation for PCE whereas the regulatory text applies to all TSCA consumer and industrial/commercial uses. EPA requests comment on whether EPA should promulgate definitions for those conditions of use evaluated in the 2020 Risk Evaluation for PCE that would not be prohibited, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for PCE and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation if EPA were to promulgate a regulation that contains a list of the industrial and commercial conditions of use evaluated in the 2020 Risk Evaluation for PCE.

EPA further notes that this proposed rule does not apply to any substance excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but are not limited to, any pesticide (as defined by the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; and any food, food additive, drug, cosmetic, or device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA), when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device.

2. Description of Unreasonable Risk Under the Conditions of Use

EPA has determined that PCE presents an unreasonable risk of injury to human health under the conditions of use based on acute and chronic non-cancer risks and chronic cancer risks (Ref. 2). As described in the TSCA section 6(b) 2020 Risk Evaluation for PCE, EPA identified non-cancer adverse effects from acute and chronic inhalation and dermal exposures to PCE, and cancer from chronic inhalation and dermal exposures to PCE (Ref. 1). EPA identified neurotoxicity as the most robust and sensitive endpoint for non-cancer adverse effects from acute inhalation and dermal exposures and as the most robust and sensitive endpoint for non-cancer adverse effects from chronic inhalation and dermal exposures for all conditions of use (Ref. 1). Additional risks associated with other adverse effects (

e.g.,

kidney, liver, immune system, and developmental toxicity) were identified for acute and chronic exposures. EPA also concluded, based on EPA's Guidelines for Carcinogen Risk Assessment (Ref. 41), that PCE is likely to be carcinogenic to humans by all routes of exposure and calculated cancer risks from chronic inhalation and dermal exposures. Unit VI.A. summarizes the health effects and the magnitude of exposures (Ref. 1).

To make the unreasonable risk determination for PCE, EPA evaluated exposures to workers, ONUs, children of workers at dry cleaners, consumer users, and bystanders to consumer use using reasonably available monitoring and modeling data for inhalation and dermal exposures (Ref. 2). EPA conducted a screening level analysis to assess potential risks from the air and water pathways to fenceline communities. A discussion of EPA's analysis and the expected effects of this rulemaking on fenceline communities is in Unit VI.A.

For the 2020 Risk Evaluation for PCE, EPA considered PESS. EPA identified the following groups as PESS: workers, ONUs, children of workers at dry cleaners, consumers, bystanders, developing fetuses (and by extension, women of childbearing age), and those with certain pre-existing health conditions, higher body fat content, or particular genetic polymorphisms (Ref. 1). All PESS are included in the quantitative and qualitative analyses described in the risk evaluation, and were considered in the determination of unreasonable risk for PCE. As discussed in Unit II.D. and Unit VI.A., the 2020 Risk Evaluation for PCE excluded the air and water exposure pathways to the general population from the published

risk evaluations and may have caused some risks to be unaccounted for in the risk evaluation. EPA considers these receptors a subset of the general population and categorizes them as fenceline communities; they may also be considered PESS. See Unit VI.A. for further discussion on assessing and protecting against risk to fenceline communities.

3. Description of TSCA Section 6 Requirements for Risk Management

EPA examined the TSCA section 6(a) requirements (listed in Unit III.A.) to identify which ones have the potential to eliminate the unreasonable risk for PCE. This Unit summarizes the TSCA section 6 considerations for issuing regulations under TSCA section 6(a). Unit V. outlines how EPA applied these considerations specifically to managing the unreasonable risk from PCE.

As required, EPA developed a proposed regulatory action and one or more primary alternative regulatory actions, which are described in Units IV.A. and IV.B., respectively. To identify and select a regulatory action, EPA considered the two routes of exposure driving the unreasonable risk, inhalation and dermal, and the exposed populations. For occupational conditions of use (see Unit III.B.1.f.), EPA considered how it could directly regulate manufacturing (including import), processing, distribution in commerce, industrial and commercial use, or disposal to address the unreasonable risk. EPA does not have direct authority to regulate consumer use. Therefore, EPA considered how it could exercise its authority under TSCA to regulate the manufacturing (including import), processing, and/or distribution in commerce of PCE at different points in the supply chain to eliminate exposures or restrict the availability of PCE and PCE-containing products for consumer use in order to address the unreasonable risk.

As required by TSCA section 6(c)(2), EPA considered several factors, in addition to identified unreasonable risk, when selecting among possible TSCA section 6(a) requirements. To the extent practicable, EPA factored into its decisions: (i) The effects of PCE on health and the environment; (ii) The magnitude of exposure to PCE of human beings and the environment; (iii) The benefits of PCE for various uses; and (iv) The reasonably ascertainable economic consequences of the rule. In evaluating the reasonably ascertainable economic consequences of the rule, EPA considered: (i) The likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (ii) The costs and benefits of the proposed regulatory action and one or more primary alternative regulatory actions considered; and (iii) The cost effectiveness of the proposed regulatory action and of the one or more primary alternative regulatory actions considered. See Unit VI. for further discussion related to TSCA section 6(c)(2)(A) considerations, including the statement of effects of the proposed rule with respect to these considerations.

EPA also considered the regulatory authority under TSCA and other statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and other EPA-administered statutes to examine: (1) Whether there are opportunities for all or part of risk management action on PCE to be addressed under other statutes, such that a referral may be warranted under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a) regulation could include alignment of requirements and definitions in and under existing statutes to minimize confusion to the regulated entities and the general public.

In addition, EPA followed other TSCA requirements such as considering the availability of alternatives when contemplating prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as outlined in Unit V.B.), and setting proposed compliance dates in accordance with the requirements in TSCA section 6(d)(1) (described in the proposed and alternative regulatory actions in Unit IV.).

To the extent information was reasonably available, when selecting regulatory actions, EPA considered pollution prevention and the hierarchy of controls adopted by OSHA and NIOSH, with the goal of identifying risk management control methods that are permanent, feasible, and effective. EPA also considered how to address the unreasonable risk while providing flexibility to the regulated entities where appropriate. EPA considered the information presented in the 2020 Risk Evaluation for PCE, as well as additional input from stakeholders (as described in Unit III.A.), and anticipated compliance strategies from regulated entities.

Taken together, these considerations led EPA to the proposed regulatory action and primary alternative regulatory actions described in Unit IV. Additional details related to how the requirements in this unit were incorporated into development of those actions are in Unit V.

As demonstrated by the number of distinct programs addressed in this rulemaking and the structure of this proposed rule in addressing them independently, EPA generally intends the rule's provisions to be severable from each other. EPA expects to provide additional detail on severability in the final rule once the Agency has considered public comments and finalized the regulatory language.

IV. Proposed and Alternative Regulatory Actions

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

A. Proposed Regulatory Action

EPA is proposing under TSCA section 6(a) to: Prohibit most industrial and commercial uses and the manufacture (including import), processing, and distribution in commerce of PCE for those uses, outlined in Unit IV.A.1.a.; Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use, outlined in Unit IV.A.1.b.; Prohibit the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10-year phaseout, outlined in Unit IV.A.1.c.; Require strict workplace controls, including a PCE WCPP, which would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact with PCE, for 16 occupational conditions of use not prohibited, outlined in Unit IV.A.2.; Require prescriptive workplace controls for laboratory use, outlined in Unit IV.A.3.; Establish recordkeeping and downstream notification requirements, outlined in Unit IV.A.4; and Provide a 10-year time limited exemption under TSCA section 6(g) for certain critical or essential emergency uses of PCE for which no technically and economically feasible safer alternative is available, outlined in Unit IV.A.5. As the manufacture and processing of PCE presents an unreasonable risk to health in the

United States, the manufacture and processing of PCE for export would also be prohibited or restricted in accordance with TSCA section 12(a)(2).

1. Prohibitions of Manufacturing, Processing, Distribution in Commerce, and Use

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

EPA is proposing to prohibit the manufacturing, processing, distribution in commerce, and use of PCE for industrial and commercial uses, except for those uses which would continue under the WCPP (as described in Unit IV.A.2.), and laboratory use (as described in Unit IV.A.3.). The proposed prohibitions under TSCA would not apply to any use of PCE that is excluded from TSCA's definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi). This proposed prohibition would include a prohibition on the manufacturing, processing, distribution in commerce, and use of PCE for the following industrial and commercial uses:

• As a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing;

• In specialty DOD uses (oil analysis and water pipe repair);

• In solvent-based paints and coatings;

• As solvent for aerosol spray degreaser/cleaner;

• As 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);

• In inks and ink removal products (based on photocopying); and

• In metal mold cleaning, release and protectant products.

EPA is also proposing to prohibit the following condition of use, which is the upstream processing condition of use for some of the prohibited industrial and commercial uses: processing into formulation, mixture or reaction product in other chemical products and preparations. EPA is also proposing to phase out the use of PCE at industrial and commercial dry cleaning facilities as described in Unit IV.A.1.c.

EPA has considered the sensitive nature of the DOD applications for which EPA received monitoring data for the 2020 Risk Evaluation for PCE, including for the industrial and commercial use in specialty DOD uses (oil analysis and water pipe repair). The Agency understands that DOD has no current data that indicate PCE is required for these specialty uses and EPA has not identified any other entities using PCE in this way. Because there are no known entities engaged in this condition of use, EPA believes a prohibition is reasonable and would prevent any future entities from engaging in this use. EPA is therefore proposing to prohibit the manufacturing, processing, distribution in commerce, and use of PCE for the industrial and commercial use in specialty DOD uses (oil analysis and water pipe repair).

As discussed in Units III.B.3. and V.A., based on consideration of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the feasibility of exposure reduction to sufficiently address the unreasonable risk across the broad range of work environments and activities, and the irreversible health effects associated with PCE exposures, EPA has determined that prohibition is the best way to address the unreasonable risk from PCE driven in part by the conditions of use identified in this unit. As noted in Unit III.B.1.f., this proposal does not apply to any substance excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi). EPA requests comment on the impacts, if any, a prohibition on the processing of PCE into a formulation, mixture or reaction product in other chemical products and preparations, or other aspects of this proposal, may have on the production and availability of any pesticide or other substance excluded from the TSCA definition of “chemical substance.”

EPA is proposing to stagger the compliance dates for the proposed prohibitions described in this unit, such that the requirements would come into effect in 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, 21 months for all other distributors (including retailers), and 24 months for industrial and commercial users after the publication date of the final rule. When proposing these compliance dates as required under TSCA section 6(d), EPA considered irreversible health effects and risks associated with PCE exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time is needed for products to clear the channels of trade. However, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the use of substitutes; comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time required to identify, test, and qualify substitutes with supporting documentation. EPA also requests comment on whether these are the appropriate types of information for use in evaluating compliance requirements, and whether there are other considerations that should apply. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

Additionally, EPA recognizes that there may be instances where an ongoing use of PCE that has implications for national security or critical infrastructure as it relates to other Federal agencies (

e.g.,

DOD, NASA) is identified after the PCE rule is finalized, but the final rule prohibits that use. For instances like that, EPA requests comments on an appropriate, predictable, process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued using the tools available under TSCA, aligning with the requirements of section 6(g). One example of an approach could be the establishment by rulemaking of a Federal agency category of use that would require implementation of the WCPP and periodic reporting to EPA on details of the use as well as progress in discontinuing the use or finding a suitable alternative. To utilize the category of use a Federal agency would petition EPA, supported by documentation describing the specific use (including documentation of the specific need, service life of any relevant equipment, and specific identification of any applicable regulatory requirements or

certifications, as well as the location and quantity of the chemical being used); the implications of cessation of this use for national security or critical infrastructure (including how the specific use would prevent injuries/fatalities or otherwise provide life-supporting functions); exposure control plan; and, for Federal agency uses where similar adoption by the commercial sector may be likely, concrete steps taken to identify, test, and qualify substitutes for the uses (including details on the substitutes tested and the specific certifications that would require updating; and estimates of the time required to identify, test, and qualify substitutes with supporting documentation). EPA requests comment on whether these are the appropriate types of information for use in evaluating this type of category of use, and whether there are other considerations that should apply. EPA would make a decision on the petition within 30 days and publish the decision in the

Federal Register

shortly after. Additionally, during the year following the petition, EPA would take public comment on the approved petition and no later than 180 days after submitting the petition to EPA, the requesting agency would submit monitoring data indicating compliance with the WCPP at each relevant location as well as documentation of efforts to identify or qualify substitutes. In the absence of that confirmatory data, the utilization of the generic Federal agency category of use would expire within one year of the date of receipt by EPA of the petition. EPA could undertake a section 6(g) rulemaking for those instances where the Federal agency could not demonstrate compliance with the WCPP. This is just one example of a potential process. EPA requests comments on a process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued.

b. Prohibition of Manufacturing, Processing and Distribution in Commerce of PCE for Consumer Use

In the 2020 Risk Evaluation for PCE, EPA evaluated consumer use of PCE:

• In cleaners and degreasers (other);

• In automotive care products (brake cleaner);

• In automotive care products (parts cleaner);

• In aerosol cleaner (vandalism mark and stain remover);

• In non-aerosol cleaner (

e.g.,

marble and stone polish);

• In lubricants and greases (cutting fluid);

• In lubricants and greases (lubricants and penetrating oils);

• In adhesives for arts and crafts (including industrial adhesive, arts and crafts adhesive, gun ammunition sealant);

• In adhesives for arts and crafts (livestock grooming adhesive);

• In adhesives for arts and crafts (column adhesive, caulk and sealant);

• In solvent-based paints and coatings (outdoor water shield (liquid));

• In solvent-based paints and coatings (coatings and primers (aerosol));

• In solvent-based paints and coatings (rust primer and sealant (liquid));

• In solvent-based paints and coatings (metallic overglaze);

• In metal (

e.g.,

stainless steel) and stone polishes;

• In inks and ink removal products;

• In welding; and

• In metal mold cleaning, release and protectant products.

The consumer uses evaluated in the 2020 Risk Evaluation for PCE constitute all known, intended, and reasonably foreseen consumer uses of PCE. EPA determined that all of these consumer uses drive unreasonable risk of injury to health. As such, for purposes of this risk management rulemaking, “consumer use” refers to all consumer uses, including all known, intended, and reasonably foreseen consumer uses of PCE. EPA is proposing to prohibit the manufacturing, processing, and distribution in commerce of PCE for all consumer use. EPA is proposing to phase out consumer use in dry cleaning solvent (

i.e.,

exposure to clothing or articles recently dry cleaned with PCE as described in Unit III.B.1.d.ii.) by phasing out the use of PCE at industrial and commercial dry cleaning facilities as described in Unit IV.A.1.c.; thus, consumer use of clothing and articles that have been commercially dry cleaned with PCE would not be subject to the prohibitions and compliance timeframes described in this unit.

As discussed in Units III.B.3. and V.A., based on consideration of the severity of the hazards of PCE in conjunction with the limited options available to adequately address the identified unreasonable risk to consumers and bystanders under TSCA section 6(a), EPA is proposing to address the unreasonable risk from consumer use by prohibiting the manufacturing (including import), processing, and distribution in commerce of PCE for consumer use in order to remove PCE and products containing PCE from the market, thereby effectively eliminating instances of consumer use.

Additionally, EPA is proposing to prohibit retailers from distributing in commerce PCE, including any PCE-containing products, in order to prevent products intended for industrial and commercial use under the WCPP outlined in Unit IV.A.2. from being purchased by consumers. A retailer is any person or business entity that distributes or makes available products to consumers, including through e-commerce internet sales or distribution. If a person or business entity distributes or makes available any product to at least one consumer, then it is considered a retailer (as EPA proposes to define that term in 40 CFR 751.5). For a distributor not to be considered a retailer, the distributor must distribute or make available chemical substances solely to commercial or industrial end-users or businesses. Prohibiting manufacturers (including importers), processors, and distributors from distributing PCE, or any products containing PCE, to retailers would prevent retailers from making these products available to consumers, which would help address that part of the unreasonable risk driven by consumer use of PCE.

EPA is proposing that the prohibition described in this unit would take effect in 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, and 21 months for all other distributors (including retailers) after the publication date of the final rule in the

Federal Register

. EPA considered irreversible health effects and risks associated with PCE exposure when proposing compliance dates. EPA has no reasonably available information indicating these proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time is needed for products to clear the channels of trade. However, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

c. Prohibition 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/5th generation (dry-to-dry machines with refrigerated condenser and carbon adsorber process controls) machines.

As discussed in Units III.B.3. and V.A., based on a consideration of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the feasibility of exposure reduction to sufficiently address the unreasonable risk across the broad range of work environments and activities, and the irreversible health effects associated with PCE exposures, EPA has determined that prohibition is the best way to address the unreasonable risk. A prohibition on the manufacturing, processing, distribution in commerce, and industrial and commercial use of PCE in dry cleaning and spot cleaning would address the unreasonable risk for the following conditions of use evaluated in the 2020 Risk Evaluation and described further in Unit III.B.1:

• Industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning;

• Industrial and commercial use in dry cleaning and spot cleaning 4th/5th generation only dry cleaning; and

• Consumer use in dry cleaning solvent (

i.e.,

exposure to clothing or articles recently dry cleaned with PCE).

EPA recognizes that the transition to an alternative dry cleaning process or solvent could require significant time and investment from dry cleaning facilities; therefore, EPA is proposing a phaseout period to take place following the publication date of the final rule. The phaseout would start with a prohibition on the use of PCE in any dry cleaning machine acquired 6 months or later after the publication date of the rule, followed by a prohibition on the use of PCE in 3rd generation machines 3 years after the publication date of the rule. Full implementation of the phaseout would be achieved with a prohibition on the use of PCE in all dry cleaning and spot cleaning, including in 4th and 5th generation machines, 10 years after the publication date of the final rule and a prohibition on the manufacturing, processing, and distribution in commerce of PCE for use in dry cleaning solvent 10 years after the publication date of the final rule. When proposing these compliance dates, EPA considered reasonably available information, including market research, existing State actions restricting the use of PCE in dry cleaning (Title 17, California Code of Regulations 39109 and 93110; Minnesota HF 91; 6 NYCRR Part 232), and engagement with industry, trade associations, and State and local agencies. Based on this reasonably available information, EPA understands that the use of PCE in dry cleaning is currently declining and that very few PCE machines are being produced or sold in the U.S. market (Ref. 33). As described more fully in the Economic Analysis (Ref. 3), EPA assumes dry cleaning machines are retired 15 to 25 years after the manufactured date. Therefore, EPA assumes most dry cleaning machines manufactured and installed before 2005, such as for 3rd generation machines, would be beyond their projected useful life by the proposed phaseout dates outlined in this Unit. A 3-year phaseout of the use of PCE in 3rd generation dry cleaning machines takes into consideration the age of existing 3rd generation dry cleaning machines as well as public comments submitted on the proposed amendments to the PCE Dry Cleaning NESHAP (December 27, 2021, 86 FR 73207) recommending a 3- to 5-year compliance timeframe at minimum to account for supply issues related to those machines. A 10-year phaseout of the use of PCE in dry cleaning and spot cleaning takes into account that, while the average projected useful lifespan of dry cleaning machines is 15 to 25 years, the purchase of new PCE dry cleaning machines has been in decline. As described more fully in the Economic Analysis, 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. EPA believes that the proposed 6-month and 3-year compliance dates for the start of the phaseout, and the proposed 10-year compliance date for full implementation of the phaseout, are consistent with requirements in TSCA section 6(d)(1)(C) and (D), respectively, to specify mandatory compliance dates for the start of phaseout requirements that are as soon as practicable but not later than 5 years after the date of promulgation of the rule, and to specify mandatory compliance dates for full implementation of phaseout requirements that are as soon as practicable. EPA also believes that these compliance dates provide for a reasonable transition period, consistent with TSCA section 6(d)(1)(E). EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited. However, EPA requests comment on the amount of time needed, for example, for dry cleaners to transition to an alternative process or solvent. EPA also requests comment regarding the number of entities that could potentially close as well as associated costs with a 10-year phaseout of PCE for use in dry cleaning as identified in this unit. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

d. De Minimis Level

To aid the regulated community with implementing the prohibitions, and to account for de minimis levels of PCE as an impurity in products, EPA is proposing that products containing PCE at concentrations less than 0.1% by weight are not subject to the prohibitions described in this unit. EPA has determined that the prohibitions are only necessary for products containing PCE at levels equal to or greater than 0.1% by weight in order to eliminate the unreasonable risk of injury resulting from inhalation and dermal exposures from PCE-containing products during occupational and consumer conditions of use. EPA's description for how allowing for a concentration of PCE up to 0.1% would address the unreasonable risk associated with PCE-containing products and rationale for this regulatory approach are in Unit V.A. EPA requests comment on allowing this de minimis level of PCE in products to account for impurities.

2. Workplace Chemical Protection Program (WCPP)

a. Overview

As described in Unit III.B.3., under TSCA section 6(a), EPA is required to issue a regulation applying one or more of the TSCA section 6(a) requirements to the extent necessary so that the unreasonable risk of injury to health or the environment from a chemical substance is no longer presented. The TSCA section 6(a) requirements provide EPA the authority to limit or restrict a number of activities, alone or in combination, including the manufacture, processing, distribution in commerce, commercial use, and disposal of the chemical substance. Given this authority, EPA may find it appropriate in certain circumstances to propose requirements under a WCPP for certain occupational (

i.e.,

manufacturing, processing, industrial and commercial use, and disposal) conditions of use. A WCPP for PCE would encompass the inhalation exposure limit and action level, Direct Dermal Contact Control (DDCC) requirements, and the associated implementation requirements described in this unit to ensure that the chemical substance no longer presents unreasonable risk. Under a WCPP, owners or operators would have some flexibility, within the parameters outlined in this unit, regarding how they prevent exceedances of the

identified EPA exposure limit thresholds or prevent direct dermal contact. In the case of PCE, meeting the EPA exposure limits and implementing the DDCC requirements for certain occupational conditions of use would address unreasonable risk to potentially exposed persons from inhalation and dermal exposure.

EPA uses the term “potentially exposed person” in this unit and in the regulatory text to include workers, ONUs, employees, independent contractors, employers and all other persons in the work area where PCE is present and who may be exposed to PCE under the conditions of use for which a WCPP would apply. EPA's intention is to require a comprehensive WCPP that would address the unreasonable risk from PCE to potentially exposed persons directly handling the chemical or in the area where the chemical is being used.

Similarly, the 2020 risk evaluation for PCE did not distinguish between employers, contractors, or other legal entities or businesses that manufacture, process, distribute in commerce, use, or dispose of PCE. EPA uses the term “owner or operator” to describe the entity responsible for implementing the WCPP for workplaces where an applicable condition of use is occurring and PCE is present. The term includes any person who owns, leases, operates, controls, or supervises such a workplace.

An ECEL is a risk-based inhalation exposure threshold. The ECEL would be accompanied by monitoring, training, recordkeeping and other requirements to help ensure that the threshold is not exceeded. With an ECEL, regulated entities have some flexibility, within certain parameters outlined in this unit, for preventing exceedances of the identified exposure threshold. Therefore, EPA generally refers to the ECEL and ancillary requirements as a non-prescriptive approach. In the case of PCE, the exposure threshold identified by EPA for certain occupational conditions of use would mitigate unreasonable risk from inhalation exposure driven by those conditions of use for potentially exposed persons.

DDCC requirements are process-based approaches to prevent direct dermal contact with PCE and associated implementation requirements described in this unit to ensure that the chemical substance no longer presents unreasonable risk from dermal exposure. As with the ECEL, DDCC requirements allow regulated entities some flexibility within certain parameters outlined in this unit for preventing direct dermal contact with PCE. In the case of PCE, EPA has preliminarily determined that preventing direct dermal contact through DDCC requirements for certain conditions of use would mitigate unreasonable risk from dermal exposure driven by those conditions of use for potentially exposed persons.

This unit includes a summary of the proposed PCE WCPP, including a description of the ECEL; proposed implementation requirements and an EPA ECEL action level; proposed monitoring requirements; a description of potential exposure controls, which consider the hierarchy of controls; information that may be used to inform respirator selection; and additional requirements proposed for recordkeeping, and worker training, participation, and notification. This unit also describes proposed DDCC requirements for PCE, including potential exposure controls, which consider the hierarchy of controls; proposed PPE as it relates to dermal protection; and additional requirements proposed for recordkeeping. This unit also describes compliance timeframes for these proposed requirements.

b. Existing Chemical Exposure Limit (ECEL)

i.

ECEL and ECEL action level.

To reduce exposures in the workplace and address the unreasonable risk of injury to health resulting from inhalation exposures to PCE identified under the occupational conditions of use in the TSCA 2020 Risk Evaluation for PCE, EPA is proposing an ECEL of 0.14 parts per million (ppm) (0.98 mg/m3) for inhalation exposures to PCE as an 8-hour TWA. This ECEL is based on the occupational chronic, non-cancer human equivalent concentration (HEC) for neurotoxicity (Ref. 10). EPA has determined, as a matter of risk management policy, that ensuring exposures remain at or below the ECEL would eliminate the contribution to the unreasonable risk of injury to health for PCE resulting from inhalation exposures in an occupational setting. EPA is proposing to establish requirements to meet an ECEL as part of the WCPP for:

• Manufacturing (domestic manufacturing);

• Manufacturing (import);

• Processing as a reactant/intermediate;

• Processing into formulation, mixture, or reaction product in cleaning and degreasing products;

• Processing into formulation, mixture, or reaction products in paint and coating products;

• Processing into formulation, mixture, or reaction products in adhesive and sealant products;

• Processing by repackaging;

• Industrial and commercial use as solvent for open-top batch vapor degreasing;

• Industrial and commercial use as solvent for closed-loop batch vapor degreasing;

• Industrial and commercial use as solvent for in-line conveyorized vapor degreasing;

• Industrial and commercial use as solvent for in-line web cleaner vapor degreasing;

• Industrial and commercial use in maskant for chemical milling;

• Industrial and commercial use in solvent-based adhesives and sealants; and

• Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing.

Each owner or operator of a workplace where these conditions of use occur would be responsible for compliance with the ECEL and the associated requirements. EPA's description for how the requirements related to an ECEL would address the unreasonable risk resulting from inhalation exposures and the rationale for this regulatory approach are outlined in Units III.B.3. and V.A.

If ambient exposures are kept at or below the 8-hour ECEL of 0.14 ppm, EPA expects that a potentially exposed person in the workplace would be protected against non-cancer effects resulting from occupational exposures, as well as excess risk of cancer (Ref. 10).

EPA is also proposing to establish an ECEL action level of 0.07 ppm as an 8-hour TWA for PCE. Air concentrations at or above the action level would trigger more frequent periodic monitoring of exposures to PCE, as described in this unit. EPA is proposing to adopt the action level approach in implementing the TSCA ECEL, consistent with the action level approach utilized by OSHA in the implementation of OSHA standards, although the values differ due to differing statutory authorities. As explained by OSHA, due to the variable nature of employee exposures, compliance with an action level provides employers with greater assurance that their employees will not be exposed to concentrations above the PELs (Ref. 42). EPA agrees with this reasoning and, like OSHA, expects the inclusion of an ECEL action level will stimulate innovation within industry to reduce exposures to levels below the action level. Therefore, EPA has identified a need for an action level for

PCE and is proposing a level that would be half the 8-hour ECEL, which is in alignment with the precedented approach established under most OSHA standards. EPA is soliciting comment regarding an ECEL action level that is half the ECEL and any associated provisions related to the ECEL action level when the ECEL is significantly lower than the OSHA PEL.

In summary, EPA is proposing that each owner or operator of a workplace subject to the ECEL must ensure that no person is exposed to airborne concentration of PCE in excess of 0.14 ppm (0.98 mg/m3) as an 8-hour TWA (ECEL), with an action level identified as 0.07 ppm (0.47 mg/m3) (ECEL action level). For conditions of use for which the requirements to meet an ECEL are being proposed, EPA expects that the regulated community can detect the ECEL and ECEL action level as they are above the threshold of PCE air sampling analytical methods that are widely available in commerce, currently in use, and approved by OSHA and NIOSH, which can range from ≤0.5 parts per billion (ppb) to 9 ppm (Ref. 10). The Agency has also identified personal breathing zone air sampling devices with a minimum limit of quantitation and level of detection below the ECEL action level (Ref. 43). EPA is requesting comment on issues around the viability of current analytical methods and detection limits for occupational perchloroethylene sampling and/or monitoring methods. EPA's methodology and inputs for the ECEL value are directly derived from the peer reviewed analysis in the December 2020 Risk Evaluation, which was also subject to public comment. As with all aspects of this rulemaking, the public is welcome to comment on the methodology for the ECEL value.

EPA expects that many workplaces already have stringent controls in place that reduce exposures to PCE; for some workplaces, EPA understands that these existing controls may already reduce PCE air concentration levels to near or below the ECEL. As discussed further in Unit V.A.1., for some conditions of use for which EPA is proposing the ECEL, data were submitted during the risk evaluation that indicate inhalation exposures may already be near or below the ECEL for some facilities, indicating that such facilities may already be in compliance with the proposed ECEL. As noted previously in this unit, EPA expects that, if inhalation exposures for affected occupational conditions of use are kept at or below the ECEL, potentially exposed persons reasonably likely to be exposed in the workplace would be protected from the unreasonable risk. EPA is also proposing to require owners or operators to comply with additional requirements under the WCPP that would be needed to ensure successful implementation of the ECEL.

ii.

Monitoring requirements. Overview.

Monitoring requirements are a key component of implementing EPA's proposed WCPP. Initial monitoring for PCE is critical for establishing a baseline of exposure for potentially exposed persons; similarly, periodic exposure monitoring assures continued compliance so that potentially exposed persons in the workplace are not exposed to levels that would result in an unreasonable risk of injury. Periodic exposure monitoring frequency could change if certain conditions are met, which are described in this unit. Additionally, in some cases, a change in workplace conditions with the potential to impact exposure levels would warrant additional monitoring, which is also described. To ensure compliance with monitoring activities, EPA proposes exposure monitoring recordkeeping requirements outlined in this unit.

Initial exposure monitoring.

Under the proposed regulation, each owner or operator of a workplace where any condition of use listed earlier in this unit is occurring would be required to perform initial exposure monitoring to determine the extent of exposure of potentially exposed persons to PCE. Initial monitoring would notify owner or operators of the magnitude of possible exposures to their potentially exposed persons with respect to their unique work conditions and environments. The results of the initial exposure monitoring would determine the frequency of future periodic monitoring, whether additional exposure controls are necessary (such as engineering controls, administrative controls, and/or respiratory protection), and whether the owner or operator would need to demarcate a regulated area as described in this unit.

EPA is proposing to require each owner or operator to establish an initial baseline monitoring sample to determine the magnitude of exposure for all persons who may be exposed to PCE within 6 months after the date of publication of the final rule in the

Federal Register

or within 30 days of introduction of PCE into the workplace, whichever is later. Where PCE is present in the workplace, each owner or operator would be required to determine each potentially exposed person's exposure by either taking a personal breathing zone air sample of each potentially exposed person or taking personal breathing zone air samples that are representative of each potentially exposed person's exposure performing the same or substantially similar operations in each work shift, in each job classification, and in each work area (hereinafter identified as an “exposure group”). Representative 8-hour TWA exposures must be determined based on one or more samples representing full-shift exposures for each shift for each person in each job classification in each work area. Monitoring samples must be taken when and where the operating conditions are best representative of each potentially exposed person's full-shift exposures. EPA expects that owners and operators would attempt to monitor a baseline for all of the tasks during the same timeframe; however, EPA understands that certain tasks occur less frequently, and EPA is soliciting comments regarding the timing of the initial exposure monitoring so that it would be representative of all tasks involving PCE where exposures may approach the ECEL. If the owner or operator chooses a representative sample, such sampling must include persons that are the closest to the source of PCE, so that the monitoring results are representative of the most highly exposed persons in the workplace. EPA is also soliciting comments regarding use of area sampling instead of personal breathing zone as a representative sample of exposures.

EPA also recognizes that some entities may already have exposure monitoring data. If the owner or operator has monitoring data conducted within five years prior to the effective date of the final rule and the monitoring satisfies all other requirements of this section, including the requirement that the data represents the highest PCE exposures likely to occur under reasonably foreseeable conditions of use, the owner or operator may rely on such earlier monitoring results for the initial baseline monitoring sample.

Periodic exposure monitoring.

EPA is proposing to require each owner or operator to conduct, for those exposure groups that exceed the following airborne concentration levels, the following periodic monitoring:

• If all samples taken during the initial exposure monitoring reveal a concentration below the ECEL action level (<0.07 ppm 8-hour TWA), the owner or operator must repeat the periodic exposure monitoring at least once every five years.

• If the most recent exposure monitoring indicates that airborne exposure is above the ECEL (>0.14 ppm 8-hour TWA), the owner or operator

must repeat the periodic exposure monitoring within 3 months of the most recent exposure monitoring.

• If the most recent exposure monitoring indicates that airborne exposure is at or abo

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