Title 42, The Public Health and WelfareRelease 119-73not60

§285l–5 Application

Title 42 › Chapter 6A— PUBLIC HEALTH SERVICE › Subchapter III— NATIONAL RESEARCH INSTITUTES › Part C— Specific Provisions Respecting National Research Institutes › Subpart 12— national institute of environmental health sciences › § 285l–5

Last updated Apr 5, 2026|Official source

Summary

The rules do not apply to research, including biotech, into causes, diagnosis, treatment, control, or prevention of diseases or impairments in people or animals. Federal agencies keep final authority on ICCVAM methods. Manufacturers are not required to start or repeat animal testing, and anyone may submit methods or scientific data directly to an agency.

Full Legal Text

Title 42, §285l–5

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

(a)Sections 285l–2 to 285l–5 of this title shall not apply to research, including research performed using biotechnology techniques, or research related to the causes, diagnosis, treatment, control, or prevention of physical or mental diseases or impairments of humans or animals.

(b)Nothing in sections 285l–2 to 285l–5 of this title shall prevent a Federal agency from retaining final authority for incorporating the test methods recommended by the ICCVAM in the manner determined to be appropriate by such Federal agency or regulatory body.

(c)Nothing in sections 285l–2 to 285l–5 of this title shall be construed to require a manufacturer that is currently not required to perform animal testing to perform such tests. Nothing in sections 285l–2 to 285l–5 of this title shall be construed to require a manufacturer to perform redundant endpoint specific testing.

(d)Nothing in sections 285l–2 to 285l–5 of this title precludes a party from submitting a test method or scientific data directly to a Federal agency for use in a regulatory program.

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–5

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60