42 U.S.C. § 285l–3 — Interagency Coordinating Committee on the Validation of Alternative Methods

(a) In general: This section makes the Interagency Coordinating Committee on the Validation of Alternative Methods ("ICCVAM") — a committee the Director of the National Institute of Environmental Health Sciences already created — into a permanent interagency committee. It sits inside the Institute's National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. This section does not change the Director's existing authority over ICCVAM from before December 19, 2000, except where this section conflicts with that authority. (b) Purposes: ICCVAM exists to (1) make federal agencies' review of test methods more efficient and effective; (2) stop agencies from duplicating each other's work, and get them sharing what they learn; (3) make the best use of scientific expertise found outside the federal government; (4) make sure new or revised test methods are proven valid before agencies need them; and (5) reduce, refine, or replace the use of animals in testing wherever that's possible. (c) Composition: ICCVAM is made up of the heads (or their designees) of these federal agencies: the Agency for Toxic Substances and Disease Registry, the Consumer Product Safety Commission, the Department of Agriculture, the Department of Defense, the Department of Energy, the Department of the Interior, the Department of Transportation, the Environmental Protection Agency, the Food and Drug Administration, the National Institute for Occupational Safety and Health, the National Institutes of Health, the National Cancer Institute, the National Institute of Environmental Health Sciences, the National Library of Medicine, the Occupational Safety and Health Administration, and any other agency that develops or uses animal tests or test data, or regulates based on animal toxicity testing. (d) Scientific Advisory Committee: (1) The Director of the National Institute of Environmental Health Sciences must create a Scientific Advisory Committee ("SAC") to advise ICCVAM and the Center on ICCVAM's work. The SAC must follow the federal advisory-committee rules in title 5, chapter 10. (2) Membership: The SAC's voting members must include at least one expert in new, revised, or alternative test methods from each of: the personal care, pharmaceutical, industrial chemicals, or agriculture industry; any other industry regulated by the agencies listed in subsection (c); and a national animal-protection organization set up under section 501(c)(3) of the tax code. It must also include representatives — chosen by the Director — from an academic institution, a state government agency, an international regulatory body, or a company that develops or sells alternative test methods, including contract labs. In addition, the agency heads named in subsection (c) (or their designees) serve as nonvoting members. (e) Duties: ICCVAM must (1) review and evaluate new, revised, or alternative test methods — including groups of tests — and coordinate technical reviews across agencies; (2) help agencies and countries align their toxicological test rules in ways that encourage reducing, refining, or replacing animal tests; (3) give guidance on how to set validation standards and run validation studies, and help get validated methods accepted and known; (4) send its official test recommendations, through the Secretary of Health and Human Services, to each relevant federal agency, along with notes on which of that agency's guidelines or rules the recommendation could improve; (5) consider petitions from the public that point to a specific rule and propose a new or alternative test method backed by real scientific evidence; (6) make its final test recommendations public, along with each agency's response to them; and (7) publish progress reports — the first one within 12 months of December 19, 2000, and then every two years after that.