---
kind: "section"
citation: "42 U.S.C. § 285l–3"
title: "42"
title_heading: "The Public Health and Welfare"
number: "285l–3"
heading: "Interagency Coordinating Committee on the Validation of Alternative Methods"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/285l-3"
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–3. Interagency Coordinating Committee on the Validation of Alternative Methods

- (a) **In general—** With respect to the interagency coordinating committee that is known as the Interagency Coordinating Committee on the Validation of Alternative Methods (referred to in sections [285l–2](/usc/42/285l–2.md) to [285l–5](/usc/42/285l–5.md) of this title as “ICCVAM”) and that was established by the [Director](/usc/42/11851.md?p=5) of the National Institute of Environmental Health Sciences for purposes of [section 285l–1(b)](/usc/42/285l–1.md?p=b) of this title, the [Director](/usc/42/11851.md?p=5) of the Institute shall designate such committee as a permanent interagency coordinating committee of the Institute under the National Toxicology [Program](/usc/42/274l–1.md?p=4) Interagency Center for the Evaluation of Alternative Toxicological Methods. Sections [285l–2](/usc/42/285l–2.md) to [285l–5](/usc/42/285l–5.md) of this title may not be construed as affecting the authorities of such [Director](/usc/42/11851.md?p=5) regarding ICCVAM that were in effect on the day before December 19, 2000, except to the extent inconsistent with sections [285l–2](/usc/42/285l–2.md) to [285l–5](/usc/42/285l–5.md) of this title.
- (b) **Purposes—** The purposes of the ICCVAM shall be to—
  - (1) increase the efficiency and effectiveness of Federal [agency](/usc/42/8262.md?p=1) test method review;
  - (2) eliminate unnecessary duplicative efforts and share experiences between Federal regulatory [agencies](/usc/42/8262.md?p=1);
  - (3) optimize utilization of scientific expertise outside the Federal Government;
  - (4) ensure that new and revised test methods are validated to meet the needs of Federal [agencies](/usc/42/8262.md?p=1); and
  - (5) reduce, refine, or replace the use of animals in testing, where feasible.
- (c) **Composition—** The ICCVAM shall be composed of the heads of the following Federal [agencies](/usc/42/8262.md?p=1) (or their designees):
  - (1) [Agency](/usc/42/8262.md?p=1) for Toxic Substances and Disease Registry.
  - (2) Consumer Product Safety Commission.
  - (3) Department of Agriculture.
  - (4) Department of Defense.
  - (5) Department of Energy.
  - (6) Department of the Interior.
  - (7) Department of Transportation.
  - (8) Environmental Protection [Agency](/usc/42/8262.md?p=1).
  - (9) Food and [Drug](/usc/42/11851.md?p=4) Administration.
  - (10) National Institute for Occupational Safety and Health.
  - (11) National Institutes of Health.
  - (12) National Cancer Institute.
  - (13) National Institute of Environmental Health Sciences.
  - (14) National Library of Medicine.
  - (15) Occupational Safety and Health Administration.
  - (16) Any other [agency](/usc/42/8262.md?p=1) that develops, or employs tests or test data using animals, or regulates on the basis of the use of animals in toxicity testing.
- (d) **Scientific Advisory Committee—**
  - (1) **Establishment—** The [Director](/usc/42/11851.md?p=5) of the National Institute of Environmental Health Sciences shall establish a Scientific [Advisory Committee](/usc/42/17061.md?p=2) (referred to in sections [285l–2](/usc/42/285l–2.md) to [285l–5](/usc/42/285l–5.md) of this title as the “SAC”) to advise ICCVAM and the National Toxicology [Program](/usc/42/274l–1.md?p=4) Interagency Center for the Evaluation of Alternative Toxicological Methods regarding ICCVAM activities. The activities of the SAC shall be subject to provisions of chapter 10 of title 5.
  - (2) **Membership—**
    - (A) **In general—** The SAC shall be composed of the following voting members:
      - (i) At least one knowledgeable representative having a history of expertise, development, or evaluation of new or revised or [alternative test methods](/usc/42/285l–2.md?p=1) from each of—
        - (I) the personal care, pharmaceutical, industrial chemicals, or agriculture industry;
        - (II) any other industry that is regulated by the Federal [agencies](/usc/42/8262.md?p=1) specified in [subsection (c)](#c); and
        - (III) a national animal protection organization established under [section 501(c)(3) of title 26](/usc/26/501.md?p=c-3).
      - (ii) Representatives (selected by the [Director](/usc/42/11851.md?p=5) of the National Institute of Environmental Health Sciences) from an academic institution, a [State](/usc/42/201.md?p=f) government [agency](/usc/42/8262.md?p=1), an international regulatory body, or any [corporation](/usc/42/2297h.md?p=2) developing or marketing new or revised or alternative test methodologies, including contract laboratories.
    - (B) **Nonvoting ex officio members—** The membership of the SAC shall, in addition to voting members under [subparagraph (A)](#d-2-A), include as nonvoting ex officio members the [agency](/usc/42/8262.md?p=1) heads specified in [subsection (c)](#c) (or their designees).
- (e) **Duties—** The ICCVAM shall, consistent with the purposes described in [subsection (b)](#b), carry out the following functions:
  - (1) Review and evaluate new or revised or [alternative test methods](/usc/42/285l–2.md?p=1), including batteries of tests and test screens, that may be acceptable for specific regulatory uses, including the coordination of technical reviews of proposed new or revised or [alternative test methods](/usc/42/285l–2.md?p=1) of interagency interest.
  - (2) Facilitate appropriate interagency and international harmonization of acute or chronic toxicological test protocols that encourage the reduction, refinement, or [replacement](/usc/42/300j–21.md?p=5) of animal test methods.
  - (3) Facilitate and provide guidance on the development of validation criteria, validation studies and processes for new or revised or [alternative test methods](/usc/42/285l–2.md?p=1) and help facilitate the acceptance of such scientifically valid test methods and awareness of accepted test methods by Federal [agencies](/usc/42/8262.md?p=1) and other stakeholders.
  - (4) Submit [ICCVAM test recommendations](/usc/42/285l–2.md?p=2) for the test method reviewed by the ICCVAM, through expeditious transmittal by the [Secretary](/usc/42/201.md?p=c) of Health and Human [Services](/usc/42/201.md?p=a) (or the designee of the [Secretary](/usc/42/201.md?p=c)), to each appropriate Federal [agency](/usc/42/8262.md?p=1), along with the identification of specific [agency](/usc/42/8262.md?p=1) guidelines, recommendations, or [regulations](/usc/42/201.md?p=d) for a test method, including batteries of tests and test screens, for chemicals or class of chemicals within a regulatory framework that may be appropriate for scientific improvement, while seeking to reduce, refine, or replace animal test methods.
  - (5) Consider for review and evaluation, petitions received from the public that—
    - (A) identify a specific regulation, recommendation, or guideline regarding a regulatory mandate; and
    - (B) recommend new or revised or [alternative test methods](/usc/42/285l–2.md?p=1) and provide valid scientific evidence of the potential of the test method.
  - (6) Make available to the public final [ICCVAM test recommendations](/usc/42/285l–2.md?p=2) to appropriate Federal [agencies](/usc/42/8262.md?p=1) and the responses from the [agencies](/usc/42/8262.md?p=1) regarding such recommendations.
  - (7) Prepare reports to be made available to the public on its progress under sections [285l–2](/usc/42/285l–2.md) to [285l–5](/usc/42/285l–5.md) of this title. The first report shall be completed not later than 12 months after December 19, 2000, and subsequent reports shall be completed biennially thereafter.

## Source credit

(Pub. L. 106–545, § 3, Dec. 19, 2000, 114 Stat. 2721; Pub. L. 117–286, § 4(a)(235), Dec. 27, 2022, 136 Stat. 4331.)

## 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.

### Amendments

2022—Subsec. (d)(1). Pub. L. 117–286 substituted “chapter 10 of title 5.” for “the Federal Advisory Committee Act.”

### Statutory Notes and Related Subsidiaries

### Termination of Advisory Committees

Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.