Guidance on Regulations Issued Under the Toxic Substances Control Act (TSCA)
On this page:
- Overview
- Workplace Chemical Protection Program Requirements
- Methylene Chloride Risk Management Rule
- Perchloroethylene Risk Management Rule
- Trichloroethylene Risk Management Rule
- Meaning of "Consumer Products"
Overview
This webpage provides guidance to assist the regulated community in complying with policies or regulations that EPA has issued under TSCA.
Disclaimer: The materials on this webpage are intended as guidance only. They describe statutory provisions and EPA regulations that contain legally binding requirements but are not a substitute for the Toxic Substances Control Act (TSCA) or related regulations. The contents of this webpage do not establish legally enforceable responsibilities and instead describe the Agency's current thinking on these topics.
Workplace Chemical Protection Program Requirements
EPA released a guide to assist the regulated community in complying with Workplace Chemical Protection Program requirements for chemicals regulated under section 6 of TSCA. A Workplace Chemical Protection Program is a chemical protection program designed to address unreasonable risk posed by chemical exposure to persons in occupational settings. The guide provides an overview of typical Workplace Chemical Protection Program requirements that the regulated community may be subject to as part of a TSCA section 6(a) rulemaking.
Methylene Chloride Risk Management Rule
In April 2024, EPA finalized prohibitions and workplace protections under TSCA for methylene chloride to protect human health.
- FACT SHEET: Regulation of Methylene Chloride Under TSCA (pdf)
- COMPLIANCE GUIDE: Regulation of Methylene Chloride Under TSCA (pdf)
Learn more about the methylene chloride final rule.
Perchloroethylene Risk Management Rule
In December 2024, EPA issued a final rule regulating perchloroethylene (PCE) under TSCA. The rule bans many uses of PCE and establishes workplace controls, including a Workplace Chemical Protection Program and prescriptive controls, for those uses not prohibited.
- FACT SHEET: Regulation of PCE Under TSCA (pdf)
- FACT SHEET: Regulation of PCE Under TSCA [Korean] (pdf)
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FACT SHEET: Regulation of PCE Under TSCA [Spanish] (pdf)
- COMPLIANCE GUIDE: Regulation of PCE for Dry Cleaning Under TSCA (pdf)
- COMPLIANCE GUIDE: Regulation of PCE for Dry Cleaning Under TSCA [Korean] (pdf)
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COMPLIANCE GUIDE: Regulation of PCE for Dry Cleaning Under TSCA [Spanish] (pdf)
- COMPLIANCE GUIDE: Regulation of PCE for Energized Electrical Cleaning Under TSCA (pdf)
Learn more about the PCE final rule.
Trichloroethylene Risk Management Rule
In December 2024, EPA issued a final rule regulating trichloroethylene (TCE) under TSCA. The rule bans the manufacture (including import), processing, and distribution in commerce of TCE for all uses, with longer compliance timeframes and stringent worker protections for some processing and industrial and commercial uses until the prohibitions come into effect.
Learn more about the TCE final rule.
Meaning of "Consumer Products"
The following guidance discusses the meaning of "consumer products" as it relates to TSCA section 5 Significant New Use Rules (SNURs).
- What does EPA consider a consumer product under TSCA?
For purposes of SNURs issued pursuant to TSCA, consumer product is defined at 40 CFR 721.3 as ". . . a chemical substance that is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation."
- Does EPA consider any product a consumer may buy a TSCA consumer product?
No, to meet the definition at 40 CFR 721.3, a consumer product must be a chemical substance “sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation.” EPA provided examples in the Ethylene Glycol Ethers SNUR’s (79 FR 74639) Response to Comment document.
- "However, EPA would not consider ethylene glycol ethers to have been 'sold or made available to consumers for their use’ merely because they have been sold or made available to automobile manufacturers or commercial auto service establishments (for their use in manufacturing or maintaining customers' motor vehicles). By contrast, ethylene glycol ethers that are sold or made available to a consumer, for the consumer’s own use in maintaining his or her own motor vehicle (e.g., as part of an aftermarket brake fluid) would fall within the definition of ‘consumer product.’”
"For purposes of defining the scope of the significant new use, EPA has determined that the use of ethylene glycol ethers in sealed lithium batteries (whether primary or secondary) is not use in a consumer product. An ethylene glycol ether is not being 'sold or made available to consumers for their use,' 40 CFR 721.3, merely because it is contained in the electrolyte of sealed lithium batteries, which are themselves used by consumers. With this clarification, EPA is finalizing the significant new use for monoethylene glycol dimethyl ether as "any use in a consumer product."
- "However, EPA would not consider ethylene glycol ethers to have been 'sold or made available to consumers for their use’ merely because they have been sold or made available to automobile manufacturers or commercial auto service establishments (for their use in manufacturing or maintaining customers' motor vehicles). By contrast, ethylene glycol ethers that are sold or made available to a consumer, for the consumer’s own use in maintaining his or her own motor vehicle (e.g., as part of an aftermarket brake fluid) would fall within the definition of ‘consumer product.’”
- Do commercial products fall within the definition of a consumer product?
A chemical substance which is a consumer product can also be a commercial product.
- Does the consumer product definition take into account bystander or incidental exposures during commercial applications?
The consumer product definition is not based on exposure, but takes into account location, and the entity to whom the chemical substance/mixture is made available for use.
- Where the significant new use for a SNUR chemical is use in a consumer product, and a consumer product containing the SNUR chemical is manufactured in multiple steps by different producers, at what point in the supply chain does the product become subject to the SNUR?
The fact that the chemical substance is in a consumer product does not limit the downstream notification at 40 CFR 721.5. The Significant New Use Notice (SNUN) submission requirement applies at the earliest point where a person intends to manufacture (including import), or process for commercial purposes the chemical substances for a significant new use (e.g., use in a consumer product). In addition, a person who intends to manufacture (including import) or process the chemical substance for commercial purposes and intends to distribute the substance in commerce must submit a SNUN unless they follow one of the alternatives described at 40 CFR 721.5(a)(2) (e.g., downstream notifications).
- Where EPA has recognized a particular use of a SNUR chemical in a product as ongoing, and therefore has not made the use subject to the SNUR, is a reformulation of that product for the same general use considered a new use of the SNUR chemical?
If a significant new use contains a maximum content threshold (e.g., use at greater than a given level in a mixture), any reformulations that would cause that subject chemical substance to be greater than the specified level would be subject to the SNUR.
A specific example is the SNUR for dipropylene glycol dimethyl ether at 40 § CFR 721.3550 that states that "Formulations or mixtures containing the PMN substance in concentrations at or below 10 percent by weight or volume are exempt from the provisions of this rule." Reformulations that meet the definition of the significant new use and increase the concentration above ten percent by weight or volume would require a SNUN. Reformulations that do not increase the concentration above ten percent by weight or volume would not require a SNUN.
If 1) the significant new use identified in the SNUR is not concentration limited, 2) the reformulation is not associated with a different use, and 3) the use is an ongoing use, then the reformulation in itself would not be subject to the SNUR because it would not be considered a significant new use.
Download Questions for EPA Interpretive Guidance (PDF)