---
kind: "section"
citation: "42 U.S.C. § 285l–4"
title: "42"
title_heading: "The Public Health and Welfare"
number: "285l–4"
heading: "Federal agency action"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/285l-4"
units:
  - "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–4. Federal agency action

- (a) **Identification of tests—** With respect to each Federal [agency](/usc/42/8262.md?p=1) carrying out a [program](/usc/42/274l–1.md?p=4) that requires or recommends acute or chronic toxicological testing, such [agency](/usc/42/8262.md?p=1) shall, not later than 180 days after receiving an [ICCVAM test recommendation](/usc/42/285l–2.md?p=2), 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](/usc/42/285l–2.md?p=2) may be added or substituted.
- (b) **Alternatives—** Each Federal [agency](/usc/42/8262.md?p=1) carrying out a [program](/usc/42/274l–1.md?p=4) described in [subsection (a)](#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](/usc/42/201.md?p=d), 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) **Test method validation—** Each Federal [agency](/usc/42/8262.md?p=1) carrying out a [program](/usc/42/274l–1.md?p=4) described in [subsection (a)](#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](/usc/42/285l–2.md?p=2), a Federal [agency](/usc/42/8262.md?p=1) carrying out a [program](/usc/42/274l–1.md?p=4) described in [subsection (a)](#a) shall review such recommendation and notify the ICCVAM in writing of its findings.
- (e) **Recommendation adoption—** Each Federal [agency](/usc/42/8262.md?p=1) carrying out a [program](/usc/42/274l–1.md?p=4) described in [subsection (a)](#a), or its specific regulatory unit or units, shall adopt the [ICCVAM test recommendation](/usc/42/285l–2.md?p=2) unless such Federal [agency](/usc/42/8262.md?p=1) determines that—
  - (1) the [ICCVAM test recommendation](/usc/42/285l–2.md?p=2) is not adequate in terms of biological relevance for the regulatory goal authorized by that [agency](/usc/42/8262.md?p=1), or mandated by Congress;
  - (2) the [ICCVAM test recommendation](/usc/42/285l–2.md?p=2) does not [generate](/usc/42/2021b.md?p=8) 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](/usc/42/8262.md?p=1);
  - (3) the [agency](/usc/42/8262.md?p=1) does not employ, recommend, or require testing for that class of chemical or for the recommended test endpoint; or
  - (4) the [ICCVAM test recommendation](/usc/42/285l–2.md?p=2) is unacceptable for satisfactorily fulfilling the test needs for that particular [agency](/usc/42/8262.md?p=1) and its respective congressional mandate.

## Source credit

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

## Notes

### 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.