Compliance Guide SEPA A GUIDE TO COMPLYING WITH THE 2024 PERCHLOROETHYLENE (PCE) WORKPLACE REQUIREMENTS FOR ENERGIZED ELECTRICAL CLEANERS UNDER THE TOXIC SUBSTANCES CONTROL ACT (TSCA) (RIN 2070-AK84) U.S. Environmental Protection Agency Document Number: 740B24007, JANUARY 2025 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E This guide includes small entity compliance guidance prepared pursuant to section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996, Pub. L. 104-121 as amended by Pub. L. Number 110-28. The statutory provisions and U.S. Environmental Protection Agency (EPA) regulations described in this document contain legally binding requirements. This guide does not substitute for those provisions or regulations, nor is it a regulation itself. Thus, this guide does not, and is not intended to, impose legally binding requirements on the EPA or the regulated community, and may not apply to a particular situation based upon the circumstances. This guide is not intended, nor can it be relied upon, to create any rights enforceable by any party in litigation with the United States. The statements in this guide are intended solely as guidance to aid you in complying with the EPA regulation Perchloroethylene (PCE); Regulation under Section 6(a) of the Toxic Substances Control Act (TSCA) and the implementing regulations in 40 Code of Federal Regulations (CFR) Part 751. The EPA retains the discretion to adopt approaches on a case-by-case basis that differ from this guide where appropriate. The EPA may decide to revise this guide without public notice to reflect changes in the EPA's approach to regulating chemical substances generally, PCE under TSCA, or to clarify information and update text. To get help accessing technical resources on environmental regulations and compliance assistance information contact the EPA's Small Business Ombudsman or visit the EPA's small business resources page. For information specific to the PCE regulation, consult the EPA's PCE TSCA risk management website A fact sheet summarizing information from the regulation is at https://www.epa.gov/svstem/files/documents/2024-12/pce-fact-sheet english.pdf. The full text of the implementing regulation can be found at 40 CFR Part 751, subpart G and also in the Federal Register (89 FR 103560, December 18. 2024) and at docket EPA-HQ-OPPT-2020-0720 at https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: For PCE technical information contact: 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. Reproduction of the manual This guide may be reproduced, but if this guide is altered, it may not provide accurate information that owners or operators need to comply with the requirements of the EPA's regulation of chemical substances under TSCA, including for PCE. Additionally, altering this guide may prevent potentially exposed persons from properly informing themselves of the protections required by the EPA. The EPA may issue additional guidance about the PCE regulation and may amend the rule in the future. Please check the EPA's PCE website for further information and current amendments. This guide, titled "A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070-AK84)" and other materials related to PCE are available at https://www.epa.qov/assessinq-and-manaqinq-chemicals-under-tsca/risk-manaqement-perchloroethvlene- pee. ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E Table of Contents IV: V: VI: Overview 1 A. Does this guide apply to me? 1 B. What is your role and how might the rule affect you? 1 C. How can this compliance guide help me?....2 The EPA's Regulation of PCE Under Section 6 of TSCA 3 A. What is PCE? 3 B. What are the risks to health from PCE? 3 C. Why is the EPA regulating PCE? 3 The EPA's Workplace Requirements for PCE as an Energized Electrical Cleaner 4 A. How is the EPA regulating the use of PCE as an energized electrical cleaner? 4 B. What are the dermal protection requirements? 4 C. What are the respiratory protection requirements? 5 D. I am choosing to comply with the WCPP instead of the prescriptive workplace controls. What do I need to do? 5 E. Are the EPA's requirements consistent with existing OSHA regulations? 5 F. Are there additional requirements? 5 Self-Certification Requirements 6 A. What are the self-certification requirements for owners and operators? 6 B. What are the self-certification requirements for distributors? 6 Downstream Notification and Labeling Requirements 7 A. What are the downstream notification requirements? 7 B. What are the labeling requirements? 7 Recordkeeping Requirement 8 A. General Records Requirements 8 B. Records requirements for owners and operators of business entities that use PCE as an energized electrical cleaner. 8 C. Records that distributors of PCE as an energized electrical cleaner are required to keep 8 VII: Violations for Non-Compliance 9 A. What if the EPA discovers a violation? 9 B. How does the EPA address violations by small businesses? 9 Frequently Asked Questions (FAQs) 10 Appendix A: Abbreviation List and Glossary 11 Appendix B: Fact Sheet 14 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E I: Overview The U.S. Environmental Protection Agency (EPA) issued Perchloroethvlene (PCE): Regulation under the Toxic Substances Control Act (TSCA) on December 18, 2024, in the Federal Register. These regulations went into effect on January 17, 2025, and updated the Code of Federal Regulations (CFR) at 40 CFR Part 751, subpart G. This regulation is also referred to throughout this guide as the PCE rule. While the PCE rule regulates all uses of PCE under TSCA, this compliance guide specifically focuses on the requirements for the use of PCE as an energized electrical cleaner. More specifics on the workplace requirements for PCE as an energized electrical cleaner are in Unit III. For more information on the conditions of use of PCE other than as an energized electrical cleaner and for additional compliance guidance regarding the use of PCE in dry cleaning, see the EPA's PCE risk management webpaoe. and the final rule at 40 CFR part 751, subpart G. Words or phrases that appear in bold red text throughout this guide are defined in the glossary in . Other abbreviations are also spelled out in the Abbreviation List. A. Does this guide apply to me? You may be impacted by certain provisions of the PCE rule if you manufacture (including import), process, distribute in commerce, or use PCE (including PCE- containing products) as an energized electrical cleaner, which is a sub-use of the industrial and commercial use as an aerosol spray degreaser/cleaner.1 Energized electrical cleaner refers to aerosol products used to clean and/or degrease electrical equipment that have an electrical current or residual electrical potential (e.g., transmission lines and capacitors). This guide also provides information for formulators, manufacturers (including importers), processors, and distributors who make or sell these products. However, upstream manufacturers and processors of PCE, including those who use PCE as an energized electrical cleaner, are subject to Workplace Chemical Protection Program (WCPP) requirements under 40 CFR 751.607. and manufacturers, processors, and distributors of PCE may potentially be affected by certain prohibitions under 40 CFR 751.605. For more information on the WCPP and other requirements, which are not covered at length in this compliance guide, see the PCE rule for its requirements. If you are unsure if you make, sell, or use PCE as an energized electrical cleaner, see Unit III of this guide for more information. What is energized electrical cleaning? Energized electrical cleaning is a process that uses a product, sometimes containing PCE, to clean equipment that has an electrical current or residual electrical potential. In 40 CFR 751.803, the EPA defines an energized electrical cleaner as a product that meets both of the following criteria: • The product is labeled to clean and/or degrease electrical equipment, where cleaning and/or degreasing is accomplished when electrical current exists, or when there is a residual electrical potential from a component, such as a capacitor; and • The product label clearly displays the statements: "Energized Equipment use only. Not to be used for motorized vehicle maintenance, or their parts." The EPA recognizes that users of PCE as an energized electrical cleaner are technically sophisticated and already complying with a variety of state and federal regulations. As such, this guide assumes some technical knowledge and includes detailed compliance instructions for the 2024 EPA PCE rule under TSCA. Additionally, the FAQ at the end of this guide has additional resources and information. B. What is your role and how might the rule affect you? Persons who own or operate a business entity that uses PCE, including any PCE-containing products, for the industrial and commercial use as an energized electrical cleaner are subject to the PCE rule (see 40 CFR 751.611). The EPA has defined the phrase "owner or operator" to mean any person who owns, leases, operates, controls, or supervises a workplace (see 40 CFR 1 The provisions of the PCE rule only apply when PCE is present in a formulation at 0.1% or greater. 1 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E 751.5). While owners or operators remain responsible for ensuring compliance, they may contract with others to provide services required for compliance. For a business entity that purchases and uses PCE as an energized electrical cleaner, any person who either owns or operates the business entity is ultimately responsible for compliance with this rule. The EPA has defined the phrase "potentially exposed person" to mean any person who may be exposed to a chemical substance (in this case, PCE) or mixture in a workplace as a result of a condition of use (e.g., manufacturing (including importing), processing, distributing, or using) of that chemical substance or mixture (see 40 CFR 751.5). This includes those who work directly with the chemicals, other employees, independent contractors, employers, and all other persons in the workplace where PCE is present Additionally, in several subsections throughout the PCE rule, the EPA has required that the Occupational Safety and Health Administration (OSHA) provisions that apply to an "employee" apply equally to potentially exposed persons and the provisions that apply to an "employer" apply equally to owners and operators. Table 1 - Energized Electrical Cleaner Requirements, Who They Apply To, and Relevant Units Within This Guide Who | Relevant Units in this Guide Owners and operators of a workplace using PCE as an energized electrical cleaner Workplace controls (Unit lii) Self-certification (Unit IV.A.) Recordkeepina (Unit VI.A. and VLB.) Distributors of PCE or PCE-containing products for use as an energized electrical cleaner Self-certification (Unit IV.B.) Downstream Notification and Labelina (Unit V) Recordkeepina (Unit VI.A. and Unit VI.C.) Manufacturers (including importers) and processors of PCE or PCE-containing products for use as an energized electrical cleaner Downstream Notification and Labelina (Unit V) Recordkeepina (Unit VI.A. and Unit VI.C.) C. How can this compliance guide help me? This guidance document provides information to help you comply with the requirements of the PCE rule, with a focus on PCE as an energized electrical cleaner, it is important to note that the PCE rule covers all conditions of use of PCE; there are restrictions and prohibitions on other uses of PCE as well. For more information, visit the EPAs PCE risk management website. It is also important to note that it is a violation of Federal law to manufacture (including import), process, distribute in commerce, use, or dispose of a chemicai substance in a manner inconsistent with TSCA and the PCE rule. Violations may result in penalties and injunctive relief (e.g., preventing certain actions), as appropriate. This compliance guide: • Provides a short description of why the EPAs regulations of chemical substances are important (Unit IQ; • Helps you determine whether you need to comply with the PCE rule and what your responsibilities may be (Unit Ml); • Gives you detailed information on how to comply with the workplace requirements for PCE as an energized electrical cleaner (Unit ill); • Outlines the energized electrical cleaner compliance timeframes (Unit III.A); • Explains how important definitions affect your compliance responsibilities; and • Provides notes to help you better understand your compliance responsibilities and how the rule applies to you. 2 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E II: The EPA's Regulation of PCE Under Section 6 of TSCA This unit describes what PCE is as weil as how and why the EPA is regulating PCE under section 6 of TSCA. A. What is PCE? Perchloroethylene (CASRN 127-18-4) —also called tetrachloroethylene, tetrachloroethene, PCE, or perc— is a colorless liquid primarily used in industrial settings to produce fluorinated compounds. This chemical is also a solvent used in dry cleaning and in other industries for cleaning and degreasing, and in lubricants, adhesives, and sealants. PCE is both produced in and imported into the United States and is distributed in commerce, used, and disposed of as part of many industrial and commercial conditions of use. B, What are the risks to health from PCE? PCE's health risks are well established. Some of the adverse effects from breathing PCE or skin contact with PCE can be experienced immediately following short-term (acute) exposure or long-term (chronic) repeated exposure. Health effects include neurotoxicity, kidney and liver effects, immune system toxicity, reproductive toxicity, developmental toxicity, and cancer. C. Why is the EPA regulating PCE? The EPA determined that PCE presents an unreasonable risk of injury to health under the conditions of use, including for the use of PCE as an energized electrical cleaner. This is based on a risk evaluation under TSCA section 6(b) for PCE that the EPA issued in 2020 pursuant to TSCA section 6(b). The EPA's unreasonable risk determination was finalized in December 2022. 3 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E III: The EPA's Workplace Requirements for PCE as an Energized Electrical Cleaner This unit provides information on the workplace requirements for PCE as an energized electrical cleaner. A. How is the EPA regulating the use of PCE as an energized electrical cleaner? The EPA has issued a rule under TSCA that prohibits many uses of PCE, such as all consumer use and commercial use in automotive are products, and allows some uses of PCE to continue, including its industrial and commercial use as an energized electrical cleaner, subject to workplace controls. The PCE rule requires owners or operators of business entities that use PCE as an energized electrical cleaner to either: • By March 13, 2026, utilize specific prescriptive controls including dermal personal protective equipment (PPE) and (in certain instances) respiratory protection (see Unit III.C. of this guide and 40 CFR 751.611(b)(1)): or • Implement the WCPP outlined in the PCE rule, including performing initial monitoring by December 15, 2025, and providing PPE by March 13, 2026 (see 40 CFR 751.611(b)(2) and 751.607). This compliance guide discusses the specific prescriptive controls. For more information on the WCPP requirements, see 40 CFR 751.611(b)(2) and 751.607. Upstream manufacturers and processors of PCE, including for use as energized electrical cleaner, are subject to the WCPP requirements under 40 CFR 751.607, and manufacturers, processors, and distributors of PCE may potentially be affected by certain prohibitions under 40 CFR 751.605. For more information on the WCPP, which is not covered at length in this compliance guide, see the PCE rule for its requirements. B. What are the dermal protection requirements? The EPA is requiring that owners or operators provide dermal PPE and comprehensive training for each potentially exposed person using PCE, including any PCE-containing products (see 40 CFR 751.611(b)(1)(ii) and 40 CFR 751.607(f)(3)). Owners and operators must supply dermal PPE that separates and provides an impervious barrier to prevent skin contact with PCE to each person who is reasonably likely to be exposed in the work area through direct dermal contact with PCE. Direct dermal contact means direct handling of PCE (including a mixture or product containing PCE) or skin contact with surfaces that may be contaminated with PCE (e.g., equipment or materials on which PCE may be present)under routine conditions in the workplace (see 40 CFR 751.5). Owners and operators must select and provide appropriate dermal PPE based on an evaluation of the performance characteristics of the dermal PPE relative to the task(s) to be performed, conditions present, and the duration of use.2 Dermal PPE includes, but is not limited to: • Eye and face protection as defined in 29 CFR 1910.133(b): • Impervious gloves selected based on specifications from the manufacturer or supplier or by individually prepared third-party testing;3 and • impervious clothing covering the exposed areas of the body (e.g., long pants, long sleeved shirt). There are additional dermal protection requirements in the PCE rule that apply to owners and operators of a workplace using PCE as an energized electrical cleaner. To find a more thorough description of these requirements, owners and operators should see 40 CFR 751.611(b)(1)(ii) and 40 CFR 751.607(f)(3). 2 This is in alignment with the OSHA Hand Protection PPE Standard (29 CFR 1910.138). 3 For example, owners and operators can select gloves that have been tested in accordance with the American Society for Testing and Materials (ASTM) F739 "Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact." ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E C. What are the respiratory protection requirements? Owners or operators must ensure that all persons using PCE, including any PCE-containing products, are provided with respirators and training on proper use of respiratory PPE if any of the following criteria are met: • The potentially exposed person is in a confined space, as defined in 29 CFR 1910.146(b). or in an enclosed space (such as a manhole or vault), as described in 29 CFR 1910.269(e); or • The potentially exposed person approaches the exposed energized equipment closer than the employer's established minimum approach distance required under 29 CFR 1910.269(0(3) or when there is no established minimum approach distance. Under the PCE rule, owners or operators must provide all persons using PCE, including any PCE-containing products, with respiratory PPE and training in accordance with 40 CFR 751,607(fi(2'). except that instead of selecting appropriate respirators based on monitoring results, owners or operators must select from and provide one of the following types of respirators: • Any National Institute for Occupational Safety and Health (NIOSH) Approved® air-purifying full facepiece respirator equipped with organic vapor cartridges or canisters [APF 50]; • Any NIOSH Approved® power air-purifying respirator (PAPR) with a half mask equipped with organic vapor cartridges or canisters [APF 50]; • Any NIOSH Approved® supplied-air respirator (SAR) or Airline Respirator in a continuous flow mode equipped with a half mask [APF 50]; • Any NIOSH Approved® SAR or Airline Respirator operated in a pressure-demand or other positive- pressure mode with a half mask [APF 50]; • Any NIOSH Approved® self-contained breathing apparatus (SCBA) in demand-mode equipped with a full facepiece or helmet / hood [APF 50]; or • Any respirator affording a higher degree of protection. D. I am choosing to comply with the WCPP instead of the prescriptive workplace controls. What do I need to do? Owners or operators who choose to follow the WCPP as an alternative to the prescriptive workplace controls must: • Document and maintain a statement that they are electing to comply with the WCPP; and • Comply with the WCPP provisions In 40 CFR 751.607 and document compliance in accordance with 40 CFR 751.615(b). The requirements of the WCPP are described in 40 CFR 751.607. E. Are the EPA's requirements consistent with existing OSHA regulations? The EPA recognizes the importance of existing OSHA regulations and other best practices designed to protect workers from other dangers such as electric shock, electrocution, fires, and exposures. The EPA's workplace requirements to address the unreasonable risk for PCE as an energized electrical cleaner are consistent to the extent possible with existing regulations and best practices for work in electrical spaces. Some existing practices protect workers from the dangers of energized electrical cleaning, such as maintaining a minimum approach distance from exposed energized parts and using a hotstick with an aerosol spray can holder adapter or other live-line tools to clean energized electrical equipment. F. Are there additional requirements? In addition to the PCE rule under TSCA section 6(a), federal, state, or local statutes or regulations on energized electrical equipment may also be relevant to you. Some examples: • OSHA standards: — Construction standards (see 29 CFR part 1926, subparts E. K. and V) i — Electrical Standard (see 29 CFR part 1910. subpart S); — Electric Power Generation, Transmission, and Distribution Standard (see 29 CFR part 1910. subpart R): and — Electrical Protective Equipment Standard (see 29 CFR part 1910. subpart D. Other standards may apply to energized electrical equipment, such as the National Fire Protection Association (NFPA) for Electrical Safety in the Workplace (see NFPA 70E). 5 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E IV: Self-Certification Requirements A. What are the self-certification requirements for owners and operators? Self-certification requires that owners or operators attest that they are complying with the energized electrical cleaner provisions of the PCE rule. Starting on March 13, 2026, the owner or operator of the business entity purchasing and using PCE, including any PCE-containing products, for the industrial and commercial use of PCE as an energized electrical cleaner must self-certify that use is in compliance with the workplace protection requirements of the rule. The certification states that use is in compliance with the requirements in 40 CFR 751.611(b) (discussed in detail in Unit III of this guide). The following written statement must be included in the self-certification: I certify each of the following statements under penalty of law. This document was prepared under my direction and supervision. This energized electrical cleaner will be used for energized equipment use only. This business entity has implemented and complies with the EPA requirements for the use of energized electrical cleaner that contains perchloroethylene under 40 CFR § 751.611 and only trained and qualified persons will handle the energized electrical cleaner. Based on my inquiry of the person or persons who manages this business entity and/or those persons directly responsible for implementing the EPA requirements for energized electrical cleaner that contains perchloroethylene, and to the best of my knowledge and belief, this business entity is in compliance with the EPA requirements for energized electrical cleaner. I am aware that there are significant penalties, including the possibility of civil penalties for failing to comply with these requirements and criminal fines and imprisonment, for knowingly failing to comply with these requirements. I understand that this certification shall serve as a certification that this business entity will properly implement and comply with the EPA requirements for energized electrical cleaner consistent with the applicable regulatory timelines. Additional Self-Certification Requirements The self-certification must also include the following: • Printed name and signature, job classification, title, email address, and phone number of the owner or operator who is self-certifying; • Date of self-certification; • Name and address of the business entity; and • Indication of whether this is the business entity's first purchase of PCE, including PCE-containing products, after publication of the final rule. Owners or operators (or persons specifically authorized by the owner or operator to purchase an energized electrical cleaner) must provide a copy of the self-certification statement for each business entity to the distributor from whom PCE, including PCE- containing products, is being purchased (see 40 CFR 751.611(d)(3)). This is required for every purchase. Owners or operators must retain the self-certification statement for at least 5 years from the date the statement is created (see 40 CFR 751.615(f)). B, What are the self-certification requirements for distributors? Distributors of PCE, including PCE-containing products, must review the self-certification statement to ensure it is appropriately completed and includes the owner or operator's and the business entity's required information (see 40 CFR 751.611(d)(4)). Distributors of PCE, including PCE-containing products, must have a complete and valid self-certification statement in accordance with this section for each sale of PCE, including PCE-containing products, for use as an energized electrical cleaner to demonstrate compliance with regulations if necessary (see 40 CFR 751.611(d)(5)). Distributors must retain the self- certification statement for at least 5 years from the date the statement is created (see 40 CFR 751.615(f)). 6 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E V: Downstream Notification and Labeling Requirements This unit provides information about downstream notification and labeling requirements for manufacturers, processors, and distributors that are relevant to owners and operators of a workplace using PCE as an energized electrical cleaner. A. What are the downstream notification requirements? The EPA requires that manufacturers (including importers), processors, and distributors of PCE and PCE-containing products for any use, including as an energized electrical cleaner, provide downstream notification of certain prohibitions by updating language in safety data sheets (SDSs) that are provided with the PCE or any PCE-containing product. Manufacturers (including importers) of PCE, for any use, must update relevant SDSs by February 18, 2025. Processors and distributors of PCE for any use must update relevant SDSs by June 16, 2025. For downstream notification, any product containing PCE must have the following text (see box below) added to two places in the product SDS (to section 1(c) and section 15). This text describes the restrictions in the rule and must be provided in writing prior to or with the shipment of the PCE (see 40 CFR 751.613): B. What are the labeling requirements? By March 13, 2026, all manufacturers (including importers), processors, and distributors in commerce of PCE or PCE-containing products for industrial and commercial use as an energized electrical cleaner must provide a label securely attached to each product (see 40 CFR 751.611(c)). Label information must be prominently displayed in an easily readable font size. The label must include the following sentences: "This product contains perchloroethylene (PCE) (CASRN 127- 18-4), a chemical determined by the Environmental Protection Agency to present unreasonable risk of injury to health under the Toxic Substances Control Act (TSCA), based on neurotoxicity and other adverse health effects. The use of PCE. is restricted under 40 CFR part 751, Subpart G. This product is for Energized Equipment use only. Not to be used for motorized vehicle maintenance, or their parts." After December 8, 2026 this chemical substance (as defined in TSCA section 3(2))/product cannot be distributed in commerce to retailers for any use. After March 8, 2027, this chemical substance (as defined in TSCA section 3(2))/product is and can only be distributed in commerce or processed with a concentration of PCE equal to or greater than 0.1% by weight for the following purposes: (1) Processing as a reactant/'intermediate; (2) Processing into formulation, mixture or reaction product; (3) Processing by repackaging; (4) Recycling; (5) Industrial and commercial use as solvent in open-top batch vapor degreasing; (6) Industrial and commercial use as solvent in closed-loop batch vapor degreasing; (7) Industrial and commercial use in maskant for chemical milling; (8) Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing; (9) Industrial and commercial use as a processing aid in sectors other than petrochemical manufacturing; (10) Industrial and commercial use as solvent for cold cleaning of tanker vessels; (11) Industrial and commercial use as energized electrical cleaner; (12) Industrial and commercial use in laboratory chemicals; (13) Industrial and commercial use in solvent-based adhesives and sealants; (14) Industrial and commercial use in dry cleaning in 3rd generation machines until December 20, 2027; (15) Industrial and commercial use in all dry cleaning and related spot cleaning until December 19, 2034; (16) Export; and (17) Disposal. 7 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E VI: Recordkeeping Requirement This unit provides information about recordkeeping requirements for owners and operators of a workplace using PCE as an energized electrical cleaner. This unit also includes information about recordkeeping requirements for manufacturers, processors, and distributors that are relevant to owners and operators of a workplace using PCE as an energized electrical cleaner. A. General Records Requirements If you manufacture (including import), process, distribute, or use PCE, there are general requirements for recordkeeping for ordinary business records regarding PCE. There are also specific records owners and operators and distributors must maintain to demonstrate compliance with the EPA's workplace requirements for energized electrical cleaners, which are described in Unit VLB, and VI.C. below. Manufacturers (including importers), processors, distributors, and industrial/commercial users are required to maintain ordinary business records that demonstrate compliance with the EPA's regulation of PCE under TSCA (see 40 CFR 751.615CaY). These records are necessary to demonstrate that PCE is being manufactured, processed, distributed, used, or disposed of only in compliance with the restrictions of the PCE rule. These records must be maintained for 5 years from the date the record is created (see 40 CFR 751.615(f)). This requirement begins on February 18, 2025. Examples of ordinary business records: • Bills-of-lading; • Invoices; • Receipts; and • Downstream notifications. B, Records requirements for owners and operators of business entities that use PCE as an energized electrical cleaner. In accordance with 40 CFR 751.615(d)(Th persons who own or operate a business entity that purchases and uses PCE, including any PCE-containing products, for the industrial and commercial use as an energized electrical cleaner must retain records of the following: • Statement regarding whether the owner or operator is complying with the prescriptive PPE requirements or with the WCPP (see Unit III for more information); • Dermal and respiratory protection used by each potentially exposed person and program implementation (see 40 CFR 751.611 (WT;') or WCPP records (see 40 CFR 751.615(b^: • Labels used (see Unit V.B. of this guide and 40 CFR 751.611 (cY): and • Self-certification statements provided (see Unit IV.A. of this guide and 40 CFR 751.611 ftTO. C. Records that distributors of PCE as an energized electrical cleaner are required to keep. In accordance with 40 CFR 751.615(d)(2). distributors of PCE, including PCE-containing products, for use as an energized electrical cleaner must retain sale records, including: • Name of purchaser; • Date of sale; • Quantity of PCE or PCE-containing products sold; • Self-certification statement for each purchase of PCE; and • Copies of labels required as discussed in Unit V.B. of this guide (see 40 CFR 751.611(c)). 8 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E VII: Violations for Non-Compliance This unit describes violations of the PCE rule for use of PCE as an energized electrical cleaner, including for small businesses. A. What if the EPA discovers a violation? In accordance with section 15 of TSCA, it is unlawful to fail or refuse to comply with any requirement under TSCA, or with any rule promulgated under TSCA. Therefore, any failure to comply with the final rule would be a violation of section 15 of TSCA. It is also unlawful under section 15 of TSCA for any person to use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of TSCA section 6. In addition, under section 15 of TSCA, it is unlawful for any person to; 1. fail or refuse to establish or maintain records as required by the final rule or other regulations promulgated under this chapter; 2. fail or refuse to permit access to or copying of records, as required by TSCA; or 3. fail or refuse to permit entry or inspection as required by section 11 of TSCA. Violators of the regulations under TSCA section 6 may be subject to both civil and criminal liability. • Under the penalty provision of section 16 of TSCA, any person who violates section 15 could be subject to a civil penalty for each violation. Each day in violation of the final rule could constitute a separate violation. • Knowing or willful violations could lead to the imposition of criminal penalties for each day of violation and imprisonment. In addition, other remedies are available to the EPA under TSCA. It is unlawful to knowingly and willfully make or submit in writing materially false, fictitious, or fraudulent statements. Individuals, as well as companies, could be subject to enforcement actions. Sections 15 and 16 of TSCA apply to "any person" who violates various provisions of TSCA. The EPA may, at its discretion and where appropriate, proceed against individuals as well as companies. B. How does the EPA address violations by small businesses? To maximize compliance, the EPA implements a balanced program of compliance assistance, compliance incentives, and traditional law enforcement. Compliance assistance information and technical advice like this guide help small businesses to understand and meet their regulatory requirements of protecting potentially exposed persons' health and the environment. Compliance incentives, such as the EPA's Small Business Policy, apply to businesses with 100 or fewer employees and encourage persons to voluntarily discover, disclose, and correct violations before they are identified by the government (more information about the EPA's Small Business Policy is available at https://www.epa.gov/enforcement/small- businesses-and-enforcemenf). The EPA's enforcement program is aimed at protecting the public by ensuring compliance with regulations under TSCA section 6. The EPA encourages small businesses to work with the Agency to discover, disclose, and correct violations. The EPA's Audit Policy, which provides incentives for regulated entities to voluntarily discover and fix violations of federal environmental laws and regulations, may be helpful for this process. The Agency has developed self-disclosure, small business, and small community policies to mitigate penalties for small and large entities that cooperate with the EPA to address compliance problems. For more information on compliance assistance and other EPA programs for small businesses, please contact the EPA's Small Business Ombudsman Program via their toll-free hotline at 800-368-5888 or by email at asbo@epa.gov. You can also find technical environmental compliance assistance in your state through the Small Business Environmental Assistance Program (SBEAP) here: States I National Small Business Environmental Program (nationalsbeap.org). 9 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E Frequently Asked Questions (FAQs) Where can I go if I have questions or need further assistance? Please contact the EPA's TSCA Hotline with questions by telephone at (202) 554-1404 or by email at tsca- hotline@epa.gov or PCE.TSCA@epa.qov. For small businesses, please see the EPA's Small Business Ombudsman Website. Small businesses may find the helpful for providing resources and information about this PCE regulation. For direct technical assistance related to this rule and other state-specific environmental regulations, the National SBEAP can provide free one-on-one consultations in most states to help consider your small business environmental compliance responsibilities and to assist in pollution prevention opportunities. Should I follow the prescriptive workplace controls or the WCPP, or both? The PCE rule allows for the owner or operator of a business entity purchasing and using PCE, including any PCE-containing products, for the industrial and commercial use as an energized electrical cleaner to choose whether to follow the prescriptive workplace controls or the WCPP (see 40 CFR 751.611(b)'). Owners or operators are not required to follow both, although there are some overlapping provisions. Depending on the specific circumstances of a business entity, the owner or operator may find one easier or more suitable to implement than the other. Where can I find more information? More information on how the EPA is addressing the unreasonable risk from chemical substances can be found at https://www.epa.gov/assessinq-and- managing-chemicals-under-tsca/risk-management- existinq-chemicals-under-tsca. You may also contact the EPA's TSCA Hotline by telephone at (202) 554- 1404 or by email at tsca-hotline@epa.gov. For PCE, additional information is available at https://www.epa.gov/assessinq-and-manaQinq- chemicals-under-tsca/risk-manaqement- perchloroethvlene-pce. The regulations can be found in the Federal Register Notice at https://www.federalregister.gOv/documents/2024/12/18/ 2024-30117/perchloroethvlene-pce-regulation-under- the-toxic-substances-control-act-tsca or at docket EPA-HQ-OPPT-2020-0720 at https://www.regulations.gov. You can also email PCE.TSCA@epa.gov with information or questions. Is this guide updated? This manual is the first version of the compliance guide. The EPA will ensure that the latest updated compliance guides are available at https://www.epa.gov/assessing-and-managing- chemicals-under-tsca/risk-management- perchloroethvlene-pce. What if I become aware of a violation? To report a violation, please see instructions at https://www.epa.gov/report-violation. The EPA's Audit Policy, which provides incentives for regulated entities to voluntarily discover and fix violations of federal environmental laws and regulations, may also be helpful for this process. 10 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) oE Appendix A: Abbreviation List and Glossary Abbreviation List ASBO Asbestos and Small Business Ombudsman CAS RN Chemical Abstracts Service (CAS) Registry Number CFR Code of Federal Regulations EPA Environmental Protection Agency FAQs Frequently Asked Questions NFPA National Fire Protection Association NIOSH National Institute for Occupational Safety and Health OSHA Occupational Safety and Health Administration PAPR Power air-purifying respirator PCE Perchloroethylene PPE Personal protective equipment SAR Supplied-air respirator SBEAP Small Business Environmental Assistance Program SCBA Self-contained breathing apparatus SDS Safety data sheet TSCA Toxic Substances Control Act WCPP Workplace Chemical Protection Program 11 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E Glossary Chemical substance - Defined in TSCA section 3(2) to mean organic or inorganic substance of a particular molecular identity, including: (1) Any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and (2) Any element or uncombined radical. Such term does not include: (i) any mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide, (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954 (determined without regard to any exemptions from such tax provided by section 4182 or 4221 or any other provision of such Code) and any component of such an article (limited to shot shells, cartridges, and components of shot shells and cartridges), and (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The term "food" as used in clause (vi) of this subparagraph includes poultry and poultry products (as defined in sections 4(e) and 4(f) of the Poultry Products Inspection Act), meat and meat food products (as defined in section 1(j) of the Federal Meat Inspection Act), and eggs and egg products (as defined in section 4 of the Egg Products Inspection Act). Condition of use - Defined in TSCA section 3(4) to mean the circumstances, as determined by EPA, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. Direct dermal contact - (40 CFR § 751.5) Direct handling of a chemical substance or mixture (such as PCE) or skin contact with surfaces that may be contaminated with a chemical substance or mixture (such as PCE). Effective Date - The date on which a regulation takes effect and becomes enforceable. In this case, the effective date is on January 17, 2025. Energized electrical cleaner - (40 CFR § 751.603) The EPA defines an energized electrical cleaner as a product that meets both of the following criteria: • The product is labeled to clean and/or degrease electrical equipment, where cleaning and/or degreasing is accomplished when electrical current exists, or when there is a residual electrical potential from a component, such as a capacitor; and • The product label clearly displays the statements: "Energized Equipment use only. Not to be used for motorized vehicle maintenance, or their parts." Owner or operator - (40 CFR § 751.5) Any person who owns, leases, operates, controls, or supervises a workplace. 12 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E Potentially exposed person - (40 CFR Part § 751.5) Any person who may be exposed to a chemical substance or mixture in a workplace as a result of a condition of use of that chemical substance or mixture. This includes those who work directly with the chemicals, other employees, independent contractors, employers, and all other persons in the workplace where PCE is present. Products - (40 CFR § 751.5) The chemical substance, a mixture containing the chemical substance, or any object that contains the chemical substance or mixture containing the chemical substance that is not an article. Worker-A person who performs work in areas where PCE is present, including both those who handle PCE and those who do not directly handle PCE. Workplace Chemical Protection Program (WCPP) - A program to protect workers from unreasonable risk posed by exposure to a regulated substance for certain conditions of use under TSCA. The WCPP includes a suite of measures to work together to create a workplace safety program for PCE. WCPP provisions include a regulatory ECEL, initial and periodic monitoring, respirator selection criteria, recordkeeping, and downstream notification for PCE to ensure that workers are no longer at risk. 13 ------- A Guide to Complying with the 2024 Perchloroethylene (PCE) Workplace Requirements for Energized Electrical Cleaners under the Toxic Substances Control Act (TSCA) (RIN 2070 AK84) v>E Appendix B: Fact Sheet The next page reproduces the EPA's fact sheet providing an overview of the 2024 regulation of PCE under TSCA. The fact sheet is available at https://www.epa.aov/assessina-and-manaaina-chemicals-under-tsca/risk-manaaement- perchloroethvlene-pce. 14 ------- FACT SHEET 2024 Final Risk Management Rule for Perchloroethylene under TSCA oEPA What is perchloroethylene (PCE)? Perchloroethylene (CASRN 127-18-4) - also called PCE or perc- is a colorless liquid and a volatile chemical with a mildly sweet odor. PCE is a solvent that is widely used for consumer uses such as brake cleaners and adhesives, in commercial applications such as dry cleaning, and in many industrial settings. For example, PCE is used as a chemical intermediate in the production of refrigerants and as a processing aid at petroleum refineries. In December 2024, EPA issued a final rule regulating PCE under the Toxic Substances Control Act (TSCA) to protect people from health risks such as damage to the kidney, liver, and immune system, neurotoxicity and reproductive toxicity, and cancer from inhalation or dermal exposures. Who is subject to the PCE regulation? Anyone who manufactures (including imports), processes, distributes in commerce, uses, or disposes of PCE or products containing PCE may be impacted by EPA's regulation of the chemical.1 The table below is a summary of key points; full details are in the final rule. What is the PCE regulation2 under TSCA? PCE Workplace Chemical Protection Program A workplace chemical protection program (WCPP) is required for several occupational conditions of use of PCE. These include: Domestic manufacturing. Import. Processing as a reactant. Processing into formulation, mixture, or reaction product. Repackaging. Use in maskant for chemical milling. Use in petrochemical manufacturing as a processing aid in catalyst regeneration. Use in solvent-based adhesives and sealants. Use as a processing aid in sectors other than petrochemical manufacturing. Use as a solvent for open-top batch and closed-loop batch vapor degreasing. Use as a solvent for cold cleaning of tanker vessels. Recycling. Disposal. The WCPP requires that owners and operators of facilities using PCE take appropriate measures to meet a new inhalation exposure limit (0.14 ppm as an 8-hour time weighted average),3 prevent skin contact, and develop and implement an exposure control plan, among other requirements. Additional details on the WCPP requirements and compliance timeframes are available on page 3. Recordkeeping and Downstream Notification Manufacturers, processors, and distributors are required to update Safety Data Sheets to spread awareness throughout the supply chain. Relevant SDS must be updated by February 18, 2025 for manufacturers and June 16, 2025 for processors and distributors. Manufacturers, processors, distributors, and users are required to maintain ordinary business records that demonstrate compliance with the rule. Prohibitions for Consumer Uses of PCE Distributing PCE for consumer use will be phased out, with distribution by retailers for all such uses prohibited after March 8, 2027. Prohibitions for Commercial Uses of PCE4 Most commercial uses will be phased out, with all such uses prohibited after June 7, 2027. Prohibitions for PCE in Dry Cleaning Use of PCE for dry cleaning and spot cleaning will be phased out in stages beginning June 16, 2025, with all such uses prohibited after December 19, 2034. Workplace Controls for PCE in Energized Electrical Cleaning After March 13, 2026, owners and operators must provide dermal and (in certain cases) respiratory protection (or comply with the WCPP) and self-certify compliance with the rule to purchase and use PCE for energized electrical cleaning. Manufacturers, processors, and distributors of PCE-containing energized electrical cleaner must include a warning label on each product, as specified at§ 751.611(c). Workplace Controls for PCE in Laboratory Use After December 15, 2025, owners and operators must use laboratory ventilation devices and provide dermal protection in laboratory settings. 1 Products containing PCE up to 0.1% by weight are excluded from this regulation. 2 Details of these requirements are in 40 CFR Part 751, subpart G, available at https://www.federalreqister.gov/documents/2024/12/18/2024- 30117/perchloroethvlene-pce-requlation-under-the-toxic-substances-control-act-tsca. 3 The inhalation exposure limit and related requirements do not apply to recycling and disposal. All other WCPP requirements apply. 4 There is a 10-year TSCA section 6(g) exemption for the emergency use of PCE for NASA in furtherance of its mission-critical needs. Only NASA and its contractors are exempted for a narrow set of conditions of use. 15 December 2024 EPA Document #740F24014 ------- FACT SHEET 2024 Final Risk Management Rule for Perchloroethylene under TSCA Compliance Timelines for Prohibitions EPA prohibits manufacturing (including importing), processing, and distributing in commerce PCEforall consumer and most industrial and commercial uses. The final rule imposes prohibitions in a staggered timeframe, beginning at the top of the supply chain. Requirement* Compliance Date Prohibition on manufacturing Manufacturers All persons are prohibited from manufacturing (including importing) PCE except for (including industrial and commercial uses that will continue under the WCPP or other workplace importers) controls and drv cleaning (see § 751.605(b)(1)). June 11,2026 Prohibition on processing Processors All persons are prohibited from processing PCE, including any PCE-containing products, except for industrial and commercial uses that will continue under the WCPP or other workplace controls and drv cleaning (see § 751.605(b)(2)). September 9, 2026 Prohibition on all distributors Distributors All persons are prohibited from distributing in commerce (including making available) PCE, including any PCE-containing products, to retailers for any use other than dry cleaning (see § 751.605(b)(3)). December 8, 2026 All persons are prohibited from distributing in commerce (including making available) PCE, including any PCE-containing products, except for industrial and commercial uses that will continue under the WCPP or other workplace controls and dry cleaning (see § 751.605(b)(5)). March 8, 2027 Prohibition on distribution by retailers Retailers All retailers are prohibited from distributing in commerce (including making available) PCE. including anv PCE-containing products (see § 751.605(b)(4)). March 8, 2027 Prohibition on industrial and commercial use Industrial and All persons are prohibited from industrial or commercial use of PCE, including any PCE- commercial containing products, except for uses that will continue under the WCPP or other users workplace controls and drv cleaning (see § 751.605(b)(6)). June 7, 2027 Prohibition on use of PCE in newly acquired dry cleaning machines Dry cleaners All persons are prohibited from industrial or commercial use of PCE in dry cleaning machines acguired after June 16. 2025 (see § 751.605(b)(7)). June 16,2025 Prohibition on dry cleaning and related spot cleaning in 3rd generation machines Dry cleaners All persons are prohibited from industrial or commercial use of PCE in dry cleaning and and spot related spot cleaning in 3rd generation machines (see § 751.605(b)(8)). cleaners December 20, 2027 Prohibition on all dry cleaning and related spot cleaning Dry cleaners All persons are prohibited from manufacturing (including importing), processing, December 19, 2034 and spot distribution in commerce, or industrial or commercial use of PCE for dry cleaning and spot cleaners cleaning (see § 751.605(b)(9)). * These prohibitions do not apply to the manufacturing, processing, or distribution of PCE solely for export. Additionally, there is an extended timeframe for prohibitions related to industrial or commercial use of PCE in an emergency by NASA or its contractors (see § 751.605(b)(10)). vvEPA 16 December 2024 EPA Document #740F24014 ------- FACT SHEET 2024 Final Risk Management Rule for Perchloroethylene under TSCA &EPA Compliance Timelines* for the Workplace Chemical Protection Program Initial Monitoring Exposure Limit and Dermal Protections Workplace Information and Training Exposure Control Plan Other Exposure Monitoring Complete initial monitoring to determine airborne concentration of PCE in the workplace that persons may be exposed to. Demarcate regulated area within 3 months of initial monitoring data. Existing Facilities Before December 15, 2025 (360 days after final rule publication). New Facilities Within 30 days of initiating the use of PCE for a condition of use allowed to continue under the rule. Ensure that PCE inhalation exposures do not exceed the ECEL for all potentially exposed persons (e.g., workers and others in the workplace). Ensure all persons are separated, distanced, physically removed, or isolated from direct dermal contact with PCE. Provide respiratory and/or dermal protection as applicable. Existing Facilities Before March 13, 2026 (450 days after final rule publication). New Facilities Within 4 months of initiating PCE use. All Facilities Respiratory protection within 3 months of exposure monitoring indicating ECEL exceedance. Develop and implement a program to train potentially exposed persons (e.g., workers and others in the workplace) on the rule's requirements. Ensure potentially exposed persons (e.g., workers and others in the workplace) participate in a training and information program by March 13, 2026 (450 days after final rule publication). Develop and implement an exposure control plan. Notify potentially exposed persons (e.g., workers and others in the workplace) of the availability of exposure control plan within 30 days of its completion. Potentially exposed persons can request certain records that must generally be provided within 15 working days of request. Existing Facilities Before June 7, 2027 (900 days after final rule publication). All Facilities Update at least every 5 years or when circumstances change significantly. Periodic Monitoring Conduct at a minimum every 5 years, but could occur as frequently as every 3 months, dependent upon initial monitoring or most recent exposure monitoring results. As Needed Monitoring Conduct additional monitoring within 30 days after any change that may result in new or additional PCE exposures. f There are longer timeframes for Federal agencies and contractors acting for or on behalf of those agencies. See final rule for details. For More Information • For information or questions on the regulation of PCE under TSCA, and for additional compliance guidance that the EPA intends to release regarding the use of PCE in dry cleaning and energized electrical cleaning, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-perchloroethvlene-pce or contact PCE.TSCA@epa.gov. • For general questions and document requests about TSCA requirements, contact the TSCA Hotline at 1-800-471-7127 or tsca-hotline@epa.gov. • To read a non-technical summary of the risk evaluation for PCE. visit https://www.epa.gov/svstem/files/documents/2022-12/PCE Non%20Technical%20Summarv 12-5-22-final.pdf. • For general information or questions on environmental regulations and compliance for small business owners, visit https://www.epa.gov/resources-small-businesses or contact asbo@epa.gov. 17 December 2024 EPA Document #740F24014 ------- |