Section E. Toxic Substances Control Act
Law: Toxic Substances Control Act, 15 U.S.C. Sections 2601 to 2692 (Regulations found at 40 CFR 700 to 799)
The Toxic Substances Control Act (TSCA), originally passed in 1976 and subsequently amended, applies to the manufacturers, processors, importers, distributors, users, and disposers of chemical substances or mixtures. The major sections of interest to this report, and their areas of coverage, are:
- Section 4, which authorizes EPA to require testing of certain chemical substances or mixtures to determine their potential risk to human health or the environment;
- Section 5, which grants EPA the authority to regulate the manufacture, processing, distribution in commerce, use, and disposal and to require testing of new chemical substances or significant new uses of existing chemical substances;
- Section 6, which provides EPA with the authority to regulate the manufacture, processing, distribution in commerce, and use and disposal of chemical substances;
- Section 8, which requires manufacturers and others to keep certain records and to submit reports to EPA;
- Section 12, which requires exporters to notify EPA when exporting certain chemicals; and
- Section 13, which requires importers to certify the TSCA status of the chemicals in an import shipment.
Development of Test Data (Section 4)
Manufacturers, importers, and processors of specific chemicals may be required to conduct health effect, environmental effect, or chemical fate testing under a test rule or enforceable consent agreement and order (40 CFR 799). Companies subject to section 4 testing requirements may also be required to submit to EPA, under TSCA Section 8(d), unpublished health and safety studies on the chemical(s).
Premanufacture Notification Requirements (Section 5)
Any person who manufactures or imports a new chemical substance, or that manufactures, imports, or processes a chemical substance for a significant new use, must notify EPA at least 90 days before manufacturing, importing, or processing the substance (40 CFR 720 to 723). Upon review of this notice, EPA may issue an order regulating the manufacture, processing, use, or disposal of the substance. EPA may promulgate a significant new use rule regulating activities by manufacturers, importers, or processors of a chemical, either in response to a premanufacture notice or independently (i.e., on a chemical that is already in commerce). EPA may also require a manufacturer or importer of a new chemical or a manufacturer, importer, or processor of a chemical subject to a significant new use rule to develop test data.
Chemical Regulation (Section 6)
Section 6(a) of TSCA gives the EPA Administrator broad authority to issue rules regulating a chemical substance or mixture if "there is a reasonable basis to conclude" that its manufacture, distribution in commerce, use, or disposal "presents or will present an unreasonable risk of injury to health or the environment." Under Section 6, the EPA Administrator may take a variety of actions to control or mitigate the risk posed by a chemical, including prohibiting the manufacture, import, processing, or distribution of a chemical substance. Chemicals regulated under Section 6 include chlorofluorocarbons (prohibiting their use as aerosol propellants), asbestos, and certain substances in metalworking fluids. EPA regulates polychlorinated biphenyls under Section 6(e).
Reporting and Recordkeeping for Identified Chemical Substances (Sections 8(a) and 8(b))
Under TSCA Section 8(a), any person (except a "small business") who imports, manufactures, or processes chemical substances identified by EPA by rule must report information on production volume, environmental releases, and/or chemical uses. EPA implements Section 8(a) by adding chemical substances to the Preliminary Assessment Information Rule (PAIR) and Comprehensive Assessment Information Rule (CAIR) (40 CFR 712 and 704, respectively). Small businesses are required to report such information in some situations. Section 8(b) of TSCA requires EPA to compile and maintain a list (the TSCA Inventory) of all chemical substances manufactured or processed in the United States, and every four years chemical manufacturers and importers are required to report the information necessary to allow EPA to develop and maintain the inventory (40 CFR 710).
Records of Significant Adverse Reactions to Health or the Environment (Section 8(c))
Any person who manufactures, imports, or processes chemical substances and mixtures must keep records of significant adverse reactions to health or the environment, as specified in 40 CFR 717.
Reports of Unpublished Health and Safety Studies (Section 8(d))
Any person who manufactures, imports, or processes, or proposes to manufacture, import, or process a chemical substance or mixture identified by rule in 40 CFR 716 must submit to EPA copies of certain unpublished health and safety studies with respect to that substance or mixture.
Notice of Substantial Risk of Injury to Health or the Environment Reporting Requirement (Section 8(e))
Any person who (1) manufactures, imports, processes, or distributes in commerce a chemical substance or mixture, and (2) obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment, must promptly report the information to EPA, unless the person has actual knowledge that EPA has been adequately informed of the information (see 43 Federal Register 11110 (1978) and 58 Federal Register 37735 (1993)).
Export Notification (Section 12(b))
A business that intends to export a chemical substance or mixture for which rules or orders have been issued under certain sections of TSCA (sections 4, 5, 6, or 7) must notify EPA within seven days of exporting or forming the intent to export the chemical, whichever is earlier, for the first time to a particular country in a calendar year (40 CFR 707). For chemicals subject to TSCA section 4, exporters must notify EPA only once for each country, rather than once per calendar year per country.
Import Certification (Section 13)
Because the definition of "manufacture" under TSCA includes importation, importers of chemical substances must comply with all TSCA requirements applicable to manufacturers. In addition, importers must comply with an import certification requirement established by the United states Customs Service under the authority of TSCA section 13 (40 CFR 707 and 19 CFR 12). The importer must certify for every import shipment that all of the chemical substances in the shipment (1) are subject to TSCA and comply with all applicable rules and orders, or (2) are not subject to TSCA.