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Title 42, The Public Health and WelfareRelease 119-110

§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 Sep 22, 2026|Official source

Summary

Exempts research work — including biotechnology — and any research about the causes, diagnosis, treatment, control, or prevention of physical or mental diseases or injuries in people or animals from the related rules. Gives each federal agency the final choice about using test methods recommended by ICCVAM. It does not make a maker who is not now required to do animal testing start doing it. It also does not force duplicate animal tests for the same result. Anyone may send a test method or scientific data straight to a federal agency for use in a regulatory program.

Full Legal Text

Title 42, §285l–5

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

(a)Application
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)Use of test methods
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)Limitation
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)Submission of tests and data
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

Sep 22, 2026

Release point: 119-110