This part sets forth requirements under section 6(a) of the Toxic Substances Control Act, 15 U.S.C. 2605(a), regulating the manufacture (including import), processing, distribution in commerce, use, or disposal of certain chemical substances and mixtures in order to address unreasonable risks to the extent necessary so that the chemical substance or mixture no longer presents such risk.
The definitions in section 3 of the Toxic Substances Control Act, 15 U.S.C. 2602,apply.
Act or TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during manufacture;
(2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use; and
(3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.
Authorized person means any person specifically authorized by the owner or operator to enter, and whose duties require the person to enter, a regulated area.
CASRN means Chemical Abstracts Service Registry Number.
EPA means the U.S. Environmental Protection Agency.
Owner or operator means any person who owns, leases, operates, controls, or supervises a workplace covered by this part.
Person means any natural person, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business entity; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality of the Federal government.
Potentially exposed person means 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.
Product means 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.
Regulated area means an area established by the regulated entity to demarcate areas where airborne concentrations of a specific chemical substance exceed, or there is a reasonable possibility they may exceed, the applicable Existing Chemical Exposure Limit (ECEL) or the EPA Short Term Exposure Limit (EPA STEL).
Retailer means a person who distributes in commerce or makes available a chemical substance or mixture to consumer end users, including e-commerce internet sales or distribution. Any distributor with at least one consumer end user customer is considered a retailer. A person who distributes in commerce or makes available a chemical substance or mixture solely to commercial or industrial end users or solely to commercial or industrial businesses is not considered a retailer.
[84 FR 11435, Mar. 27, 2019, as amended at 89 FR 39296, May 8, 2024]
(a) Exports. Persons who intend to export a chemical substance identified in any subpart under this part are subject to the export notification provisions of section 12(b) of the Act. The regulations that interpret section 12(b) appear at 40 CFR part 707, subpart D.
(b) Imports. Persons who import a substance identified in any subpart under this part are subject to the import certification requirements under section 13 of the Act, which are codified at 19 CFR 12.118 through 12.127. See also 19 CFR 127.28.
(a) Enforcement. (1) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(b) Inspections. EPA may conduct inspections under section 11 of the Act (15 U.S.C. 2610) to ensure compliance with this part.