TSCA Title I: Control of toxic substances

Scope

TSCA Title I applies to all manufacturers, importers, and processors of non-exempt chemical substances and mixtures. However, EPA may regulate a chemical’s unreasonable risks at any stage of its life-cycle — manufacturing, processing, distribution in commerce, use, or disposal.

The following chemical substances are excluded:

• Pesticides when manufactured, processed, or distributed in commerce for use as a pesticide;
• Tobacco and tobacco products;
• Certain radioactive materials;
• Firearms (including pistols and revolvers), shells, cartridges, and their components; and
• Food (including poultry, meat, and eggs), food additives (including food contact substances), drugs, cosmetics, and medical devices.

Although the definition of a chemical substance excludes mixtures, multiple TSCA provisions apply to mixtures.

Regulatory citations

• 15 U.S.C. 2601 to 2629 — Control of toxic substances
• 40 CFR 700-799 — Toxic substances control act
• 19 CFR 12.118 to 12.127 — Chemical substances in bulk and as part of mixtures and articles
• 19 CFR 127.28 — Special merchandise

Key definitions

While the terms below are from 40 CFR 704.3, or in the case of chemical substance 710.3, be sure to check the definitions for the regulatory part to which you are complying to be certain of the meaning. Also, see TSCA, as amended, at 15 U.S.C. 2602.

• Chemical substance: Any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical; except that “chemical substance” does not include: (1) Any mixture; (2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide; (3) Tobacco or any tobacco product, but not including any derivative products; (4) Any source material, special nuclear material, or byproduct material; (5) Any pistol, firearm, revolver, shells, and cartridges; and (6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
• Import for commercial purposes: To import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities also are imported for commercial purposes.
• Importer: (1) any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes: (i) The person primarily liable for the payment of any duties on the merchandise, or (ii) An authorized agent acting on his behalf. (2) Importer also includes, as appropriate: (i) The consignee. (ii) The importer of record. (iii) The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141.20. (iv) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR 144. (3) For the purposes of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.

• Manufacture for commercial purposes: (1) To import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes among other things, such “manufacture” of any amount of a chemical substance or mixture: (i) For commercial distribution, including for test marketing. (ii) For use by the manufacturer, including use for product research and development, or as an intermediate. (2) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.

• Manufacturer: A person who imports, produces, or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance.

• Process for commercial purposes: The preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes.
• Processor: Any person who processes a chemical substance or mixture.
• Substance: Either a chemical substance or mixture unless otherwise indicated.

Summary of requirements

• TSCA Inventory — Consult the TSCA Chemical Substance Inventory to determine if a chemical substance is new, active, or inactive. Submit a Bona Fide Intent to Manufacture or Import Notice (bona fide notice) if a substance you intend to manufacture or import is not on the public Inventory but you think it may be in commerce based on a confidential Inventory listing. See 40 CFR 720.25.

• Testing — EPA may require you, by regulation, to test new and existing chemical substances or mixtures that may present an unreasonable risk to human health or the environment if available data on such substances or mixtures is inadequate to determine risk. Test and submit information as required.
• Fees — Pay appropriate fees to EPA as required or specified under 40 CFR 700 to 799.
• Recordkeeping — Maintain records required by EPA under TSCA and permit access to, or copying of, records required under TSCA.
• Reporting — Submit reports, notices, or other information required by EPA under TSCA. Examples include, but are not limited to:
  • Listed chemical reporting and recordkeeping — Meet the reporting and recordkeeping procedures of 40 CFR 704 if you are a manufacturer, importer, or processor of chemical substances and mixtures that are identified in 40 CFR 704 subpart B. Note: This subpart includes several chemicals. Asbestos, found at 704.180, has a three-month data submission period beginning February 24, 2024, and ending May 24, 2024.
  • Imports — Importers must certify that imported chemicals either comply with TSCA (positive certification) or, if not otherwise clearly identified as a chemical excluded from TSCA, are not subject to TSCA (negative certification). Imports of chemical substances, mixtures, or articles that contain a chemical substance or mixture must comply with TSCA in order to enter the U.S. See 40 CFR 707.
  • Exports — Exporters must notify EPA (per 40 CFR 707) if they export or intend to export a chemical substance or mixture for which (1) The submission of data is required under TSCA sections 4 or 5(b); (2) An order has been issued under TSCA section 5; (3) A rule has been proposed or promulgated under TSCA sections 5 or 6; or (4) An action is pending, or relief has been granted under TSCA sections 5 or 7. Note: Notification of export is generally not required for articles per 40 CFR 707.60(b) and for specified de minimis concentrations per 40 CFR 707.60(c).
  • Notice of activity involving inactive substance — Submit the Notice of Activity Form B under 40 CFR 710.25(c) before manufacturing or processing an “inactive” substance on the TSCA Inventory, but not more than 90 days prior to the anticipated date of manufacturing or processing. See 40 CFR 710.
  • Chemical data reporting (CDR) — Submit the chemical data report to EPA every four years if you are a manufacturer (including importer) that meets certain production volume thresholds, generally 25,000 pounds or more of a chemical substance at any single site. See 40 CFR 711.
  • Preliminary assessment information — Submit the “Manufacturer’s Report—Preliminary Assessment Information” (Form 7710-35) for each plant site at which you manufactured or imported in bulk form one or more chemical substances listed at 40 CFR 712.30 within 60 days after the effective date of the chemical listing.
  • Health and safety data — Submit lists and copies of health and safety studies on chemical substances and mixtures selected for priority consideration for testing rules, if 40 CFR 716 applies.
  • Premanufacture notice (PMN) — Provide a PMN to EPA if you plan to manufacture (including import) a new chemical substance for a non-exempt commercial purpose. A chemical substance not listed in the TSCA Inventory is considered new. See 40 CFR 720 and 723.
  • Significant new use notice (SNUN) —Submit a SNUN to EPA before using chemical substances and mixtures in new ways that might create concerns. See 40 CFR 721.
  • Microbial commercial activity notice (MCAN) — Persons who wish to commercialize an intergeneric microorganism must submit a MCAN to EPA at least 90 days prior to commercialization. See 40 CFR 725.
  • Substantial risk notification — Submit this notification within 30 calendar days of obtaining substantial risk information, which is information that reasonably supports the conclusion that their substances or mixtures present a substantial risk of injury to health or the environment. See TSCA section 8(e).
  • Significant adverse reaction notice — Manufacturers (including importers) and processors of chemical substances and mixtures must keep records of “significant adverse reactions” alleged to have been caused by such substances or mixtures. The regulation also prescribes the conditions under which a firm must submit or make records available to a duly designated representative of EPA. See 40 CFR 717.
  • Confidentiality claims — Submitters may claim information submitted to the EPA under TSCA as confidential business information (CBI). CBI claims must be asserted and substantiated concurrently with the submission of the information, except for those types of information exempt under TSCA section 14(c)(2). See 40 CFR 703.
• Substance-specific provisions — Comply with substance-specific provisions, including:
  • 40 CFR 705 — Reporting and Recordkeeping Requirements for Certain Per- and Polyfluoroalkyl Substances;
  • 40 CFR 713 — Reporting requirements for the TSCA Inventory of mercury supply, use, and trade;
  • 40 CFR 725 — Reporting requirements and review processes for microorganisms;
  • 40 CFR 745 — Lead-based paint poisoning prevention in certain residential structures;
  • 40 CFR 747 — Metalworking fluids;
  • 40 CFR 749 — Water treatment chemicals;
  • 40 CFR 751 — Regulation of certain chemical substances and mixtures under section 6 of the Toxic Substances Control Act (includes methylene chloride);
  • 40 CFR 761 — Polychlorinated biphenyls (PCBs) manufacturing, processing, distribution in commerce, and use prohibitions;
  • 40 CFR 763 — Asbestos; and
  • 40 CFR 766 — Dibenzo-para-dioxins/dibenzofurans.
  Note: While solely authorized by Title VI, not Title I, of TSCA, EPA’s regulation 40 CFR 770 regulates formaldehyde in composite wood products.