Collapse to view only § 285l-2. Definitions
- § 285l. Purpose of Institute
- § 285l-1. Applied Toxicological Research and Testing Program
- § 285l-2. Definitions
- § 285l-3. Interagency Coordinating Committee on the Validation of Alternative Methods
- § 285l-4. Federal agency action
- § 285l-5. Application
- § 285l-6. Methods of controlling certain insect and vermin populations
§ 285l. Purpose of Institute
The general purpose of the National Institute of Environmental Health Sciences (in this subpart referred to as the “Institute”) is the conduct and support of research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly.
(July 1, 1944, ch. 373, title IV, § 463, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857; amended Pub. L. 103–43, title XIII, § 1301(b), June 10, 1993, 107 Stat. 170.)
§ 285l–1. Applied Toxicological Research and Testing Program
(a) There is established within the Institute a program for conducting applied research and testing regarding toxicology, which program shall be known as the Applied Toxicological Research and Testing Program.
(b) In carrying out the program established under subsection (a), the Director of the Institute shall, with respect to toxicology, carry out activities—
(1) to expand knowledge of the health effects of environmental agents;
(2) to broaden the spectrum of toxicology information that is obtained on selected chemicals;
(3) to develop and validate assays and protocols, including alternative methods that can reduce or eliminate the use of animals in acute or chronic safety testing;
(4) to establish criteria for the validation and regulatory acceptance of alternative testing and to recommend a process through which scientifically validated alternative methods can be accepted for regulatory use;
(5) to communicate the results of research to government agencies, to medical, scientific, and regulatory communities, and to the public; and
(6) to integrate related activities of the Department of Health and Human Services.
(July 1, 1944, ch. 373, title IV, § 463A, as added Pub. L. 103–43, title XIII, § 1301(a), June 10, 1993, 107 Stat. 169.)
§ 285l–2. Definitions
In sections 285l–2 to 285l–5 of this title:
(1) Alternative test method
The term “alternative test method” means a test method that—
(A) includes any new or revised test method; and
(B)
(i) reduces the number of animals required;
(ii) refines procedures to lessen or eliminate pain or distress to animals, or enhances animal well-being; or
(iii) replaces animals with non-animal systems or one animal species with a phylogenetically lower animal species, such as replacing a mammal with an invertebrate.
(2) ICCVAM test recommendation
(Pub. L. 106–545, § 2, Dec. 19, 2000, 114 Stat. 2721.)
§ 285l–3. Interagency Coordinating Committee on the Validation of Alternative Methods
(a) In general
(b) PurposesThe 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) CompositionThe 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
(2) Membership
(A) In generalThe 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
(e) DutiesThe 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.
(Pub. L. 106–545, § 3, Dec. 19, 2000, 114 Stat. 2721; Pub. L. 117–286, § 4(a)(235), Dec. 27, 2022, 136 Stat. 4331.)
§ 285l–4. Federal agency action
(a) Identification of tests
(b) Alternatives
(c) Test method validation
(d) Review
(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.
(Pub. L. 106–545, § 4, Dec. 19, 2000, 114 Stat. 2723.)
§ 285l–5. Application
(a) Application
(b) Use of test methods
(c) Limitation
(d) Submission of tests and data
(Pub. L. 106–545, § 5, Dec. 19, 2000, 114 Stat. 2724.)
§ 285l–6. Methods of controlling certain insect and vermin populations
The Director of the Institute shall conduct or support research to identify or develop methods of controlling insect and vermin populations that transmit to humans diseases that have significant adverse health consequences.
(July 1, 1944, ch. 373, title IV, § 463B, as added Pub. L. 108–75, § 3, Aug. 15, 2003, 117 Stat. 902.)