Title 42The Public Health and WelfareRelease 119-73

§285l–4 Federal agency action

Title 42 › Chapter CHAPTER 6A— - PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER III— - NATIONAL RESEARCH INSTITUTES › Part Part C— - Specific Provisions Respecting National Research Institutes › Subpart subpart 12— - national institute of environmental health sciences › § 285l–4

Last updated Apr 6, 2026|Official source

Summary

Federal agencies that run programs using acute or chronic toxicology tests must, within 180 days after ICCVAM makes a test recommendation, find any test methods in their rules or industry guidelines that currently use or push animal tests and send those to ICCVAM. They must also support creating and using non-animal alternatives when those alternatives produce at least the same amount and scientific quality of data for hazard ID, dose-response, or risk assessment. Any new or revised test (animal or alternative) must be shown valid for its intended use before the agency requires or recommends it. Within 180 days of getting an ICCVAM recommendation, an agency must review it and tell ICCVAM its decision in writing. The agency must adopt the recommendation unless it decides one of four things: the test isn’t biologically relevant for its regulatory goal; it doesn’t produce equivalent data in amount or scientific value; the agency doesn’t test that chemical class or endpoint; or the recommendation won’t meet the agency’s testing needs or its Congressional mandate.

Full Legal Text

Title 42, §285l–4

The Public Health and Welfare — Source: USLM XML via OLRC

(a)With respect to each Federal agency carrying out a program that requires or recommends acute or chronic toxicological testing, such agency shall, not later than 180 days after receiving an ICCVAM test recommendation, identify and forward to the ICCVAM any relevant test method specified in a regulation or industry-wide guideline which specifically, or in practice requires, recommends, or encourages the use of an animal acute or chronic toxicological test method for which the ICCVAM test recommendation may be added or substituted.
(b)Each Federal agency carrying out a program described in subsection (a) shall promote and encourage the development and use of alternatives to animal test methods (including batteries of tests and test screens), where appropriate, for the purpose of complying with Federal statutes, regulations, guidelines, or recommendations (in each instance, and for each chemical class) if such test methods are found to be effective for generating data, in an amount and of a scientific value that is at least equivalent to the data generated from existing tests, for hazard identification, dose-response assessment, or risk assessment purposes.
(c)Each Federal agency carrying out a program described in subsection (a) shall ensure that any new or revised acute or chronic toxicity test method, including animal test methods and alternatives, is determined to be valid for its proposed use prior to requiring, recommending, or encouraging the application of such test method.
(d)Not later than 180 days after receipt of an ICCVAM test recommendation, a Federal agency carrying out a program described in subsection (a) shall review such recommendation and notify the ICCVAM in writing of its findings.
(e)Each Federal agency carrying out a program described in subsection (a), or its specific regulatory unit or units, shall adopt the ICCVAM test recommendation unless such Federal agency determines that—
(1)the ICCVAM test recommendation is not adequate in terms of biological relevance for the regulatory goal authorized by that agency, or mandated by Congress;
(2)the ICCVAM test recommendation does not generate data, in an amount and of a scientific value that is at least equivalent to the data generated prior to such recommendation, for the appropriate hazard identification, dose-response assessment, or risk assessment purposes as the current test method recommended or required by that agency;
(3)the agency does not employ, recommend, or require testing for that class of chemical or for the recommended test endpoint; or
(4)the ICCVAM test recommendation is unacceptable for satisfactorily fulfilling the test needs for that particular agency and its respective congressional mandate.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the ICCVAM Authorization Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.

Reference

Citations & Metadata

Citation

42 U.S.C. § 285l–4

Title 42The Public Health and Welfare

Last Updated

Apr 6, 2026

Release point: 119-73