42 U.S.C. § 285l–4 — Federal agency action

submitted 26 years ago by Pub. L. 106-545 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 429 words · no verdicts yet

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Federal agencies must respond to ICCVAM's test recommendations within 180 days. They must review each recommendation and report their findings. Agencies must adopt it unless they have specific listed reasons not to.

(a) Identification of tests: Any federal agency that requires or recommends toxicological testing must, within 180 days of getting an ICCVAM test recommendation, find any test method in its own regulations or industry guidelines that requires, recommends, or encourages animal testing where the ICCVAM recommendation could be added or used instead. The agency must send that information to ICCVAM. (b) Alternatives: Where it makes sense, the agency must promote and encourage using alternatives to animal testing — including groups of tests — to meet federal laws, rules, or guidelines, as long as those alternatives produce data that is at least as good and as useful as the data from existing tests for judging hazards, dose-response, or risk. (c) Test method validation: Before requiring, recommending, or encouraging any new or revised toxicity test method — animal or alternative — the agency must make sure that method has been proven valid for its intended use. (d) Review: Within 180 days of getting an ICCVAM test recommendation, the agency must review it and tell ICCVAM in writing what it decided. (e) Recommendation adoption: The agency must adopt the ICCVAM recommendation unless it decides one of these is true: (1) the recommendation isn't biologically relevant enough to that agency's regulatory goal or its mandate from Congress; (2) the recommendation doesn't produce data as good and useful as what the current test method produces; (3) the agency doesn't test that class of chemical or that test result at all; or (4) the recommendation simply can't meet that agency's testing needs and its mandate from Congress.

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

(a) Identification of tests

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) Alternatives

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.

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) Review

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) Recommendation adoption

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.

Source credit: (Pub. L. 106–545, § 4, Dec. 19, 2000, 114 Stat. 2723.)

history & why it existsrecord from the source credit

2000Enacted · Pub. L. 106-545 · 114 Stat. 2723

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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