• TSCA authorizes EPA to promulgate rules, issue orders, or enter into consent agreements to require manufacturers (including importers) and processors to test chemical substances.
• EPA’s GLPS compliance monitoring program ensures the quality and integrity of test data submitted to the agency in support of section 5 of the TSCA and pursuant to testing consent agreements and test rules issued under section 4 of TSCA.

Under the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has broad authority to issue regulations designed to require manufacturers (including importers) or processors to test chemical substances and mixtures. EPA also works with members of the U.S. chemical industry to develop needed data via TSCA section 4 Enforceable Consent Agreements (ECAs).

This testing is required to develop data about health or environmental effects when there is insufficient data for EPA risk assessors to be able to determine whether a chemical substance or mixture presents an unreasonable risk to health or the environment.

TSCA section 4 requires manufacturers and processors of chemical substances and mixtures to conduct testing if EPA finds that the manufacture, distribution, processing, use, or disposal of a chemical substance or a mixture may present an unreasonable risk to human health or the environment. The rationale for establishing the necessity for issuing a TSCA section 4 regulatory action would be presented under the findings and/or statement of need, along with an indication of the underlying evidence, in the specific action.

In addition to the statutory testing authority previously provided under TSCA section 4, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) of 2016 amended TSCA to explicitly provide authority to issue orders. TSCA section 4(a)(2) now explicitly authorizes EPA to promulgate rules, issue orders, or enter into consent agreements to require testing to develop information that is necessary:

• To review a notice submitted under TSCA section 5;
• To perform a risk evaluation under TSCA section 6(b);
• To implement a requirement imposed in a rule, order, or consent agreement under TSCA section 5(e) or (f), or in a rule promulgated under section 6(a);
• At the request of a federal implementing authority under another federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure;
• To determine if a chemical substance or mixture manufactured, processed, or distributed in commerce solely for export presents an unreasonable risk of injury to health or the environment in the U.S., pursuant to TSCA section 12(a)(2); and
• To prioritize a chemical substance under TSCA section 6(b) (subject to certain limitations).

Manufacturers and processors who wish to assert claims of confidentiality must make them in accordance with the procedures described in 40 CFR 703.

Good laboratory practice

EPA 40 CFR 792 prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing. Part 792 is intended to ensure the quality and integrity of data submitted pursuant to testing consent agreements and test rules issued under section 4 of the Toxic Substances Control Act (TSCA).

EPA also offers several tools to assist companies submitting data under the Good Laboratory Practice Standards (GLPS). Data obtained through laboratory inspections and data audits is used by the agency to regulate the use of industrial chemicals. EPA’s GLPS compliance monitoring program ensures the quality and integrity of test data submitted to the agency in support of section 5 of the TSCA and pursuant to testing consent agreements and test rules issued under section 4 of TSCA.