42 U.S.C. § 285l–5 — Application

submitted 26 years ago by Pub. L. 106-545 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 198 words · no verdicts yet

in plain englishAI-generated · not legal advice

These rules on alternative testing don't apply to disease research. Agencies still decide for themselves how to use ICCVAM's recommendations. No manufacturer is forced into new animal testing or repeat tests.

(a) Application: Sections 285l–2 through 285l–5 do not apply to research — including research using biotechnology — into the causes, diagnosis, treatment, control, or prevention of physical or mental diseases or impairments in humans or animals. (b) Use of test methods: Nothing in these sections stops a federal agency from keeping final say over how it uses ICCVAM's recommended test methods. (c) Limitation: Nothing in these sections forces a manufacturer, who isn't currently required to do animal testing, to start doing it. Nothing in these sections forces a manufacturer to run duplicate tests for the same endpoint. (d) Submission of tests and data: Nothing in these sections stops anyone from sending a test method or scientific data straight to a federal agency for use in that agency's regulatory program.

the actual law source: uscode.house.gov ↗public domain

(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.

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.

Source credit: (Pub. L. 106–545, § 5, Dec. 19, 2000, 114 Stat. 2724.)

history & why it existsrecord from the source credit

2000Enacted · Pub. L. 106-545 · 114 Stat. 2724

A history note hasn’t been published yet. The record shows enactment by Pub. L. 106-545 on 2000-12-19.

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