42 U.S.C. § 285l–3: Interagency Coordinating…

§285l–3 Interagency Coordinating Committee on the Validation of Alternative Methods

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–3

Last updated Sep 22, 2026|Official source

Summary

The Director of the National Institute of Environmental Health Sciences must make ICCVAM a permanent interagency committee under the National Toxicology Program’s center. The Director keeps the same powers over ICCVAM that they had before December 19, 2000, unless those powers conflict with these rules. ICCVAM is made up of the heads (or their designees) of 15 named federal agencies and any other agency that uses or regulates animal tests. A Scientific Advisory Committee (SAC) will advise ICCVAM. SAC includes voting members from industry, animal protection groups, academia, state governments, international regulators, and companies that develop test methods, plus nonvoting agency representatives. ICCVAM must work to make federal test method review faster and less duplicated, use outside science, make sure new test methods are properly validated, and when possible reduce, refine, or replace animal testing. It must review and recommend new or revised test methods, help harmonize tests across agencies and countries, guide validation studies, and send recommendations to the proper federal agencies through the Secretary of Health and Human Services. ICCVAM will consider public petitions that point to a regulation and offer scientific evidence for an alternative test. Final recommendations and agency responses must be made public. The first public progress report is due not later than 12 months after December 19, 2000, and later reports are due every two years.

Title 42, §285l–3

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

(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 to 285l–5 of this title as “ICCVAM”) and that was established by the Director of the National Institute of Environmental Health Sciences for purposes of section 285l–1(b) of this title, the Director of the Institute shall designate such committee as a permanent interagency coordinating committee of the Institute under the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. Sections 285l–2 to 285l–5 of this title may not be construed as affecting the authorities of such Director regarding ICCVAM that were in effect on the day before December 19, 2000, except to the extent inconsistent with sections 285l–2 to 285l–5 of this title.

(b)Purposes

The purposes of the ICCVAM shall be to—

(1)increase the efficiency and effectiveness of Federal agency test method review;

(2)eliminate unnecessary duplicative efforts and share experiences between Federal regulatory agencies;

(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; 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 (or their designees):

(1)Agency 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.

(9)Food and Drug 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 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 of the National Institute of Environmental Health Sciences shall establish a Scientific Advisory Committee (referred to in sections 285l–2 to 285l–5 of this title as the “SAC”) to advise ICCVAM and the National Toxicology Program 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 from each of—

(I)the personal care, pharmaceutical, industrial chemicals, or agriculture industry;

(II)any other industry that is regulated by the Federal agencies specified in subsection (c); and

(III)a national animal protection organization established under section 501(c)(3) of title 26.

(ii)Representatives (selected by the Director of the National Institute of Environmental Health Sciences) from an academic institution, a State government agency, an international regulatory body, or any corporation 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), include as nonvoting ex officio members the agency heads specified in subsection (c) (or their designees).

(e)Duties

The ICCVAM shall, consistent with the purposes described in subsection (b), carry out the following functions:

(1)Review and evaluate new or revised or alternative test methods, 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 of interagency interest.

(2)Facilitate appropriate interagency and international harmonization of acute or chronic toxicological test protocols that encourage the reduction, refinement, or replacement 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 and help facilitate the acceptance of such scientifically valid test methods and awareness of accepted test methods by Federal agencies and other stakeholders.

(4)Submit ICCVAM test recommendations for the test method reviewed by the ICCVAM, through expeditious transmittal by the Secretary of Health and Human Services (or the designee of the Secretary), to each appropriate Federal agency, along with the identification of specific agency guidelines, recommendations, or regulations 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 and provide valid scientific evidence of the potential of the test method.

(6)Make available to the public final ICCVAM test recommendations to appropriate Federal agencies and the responses from the agencies regarding such recommendations.

(7)Prepare reports to be made available to the public on its progress under sections 285l–2 to 285l–5 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.

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.

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 CommitteesAdvisory 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.