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The Director of the National Institute of Environmental Health
Sciences (NIEHS) established an ad hoc Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM) in September 1994 to develop a report to respond
to requirements in the NIH Revitalization Act of 1993 (Public Law 103-43).
The Act required NIEHS to establish criteria for the validation and regulatory acceptance of
alternative toxicological testing methods. The Act also required that NIEHS recommend a process to achieve the regulatory acceptance of
scientifically valid alternative test methods. The ad hoc ICCVAM was comprised of representatives from the 15 U.S. Federal
agencies now represented on ICCVAM.
In 1997, the ad hoc ICCVAM published its final report, Validation and Regulatory
Acceptance of Toxicological Test Methods. In the same year, NIEHS establised a standing ICCVAM committee
to implement a process by which new test methods of agency interest could be evaluated, and
to coordinate interactions among agencies related to the development, validation, acceptance, and national and
international harmonization of toxicological test methods.
The ICCVAM Authorization Act of 2000 (Public Law 106-545, 42 U.S.C. 285l-3),
signed into law in December 2000, established ICCVAM as a permanent interagency committee of NIEHS under NICEATM, which is located
at NIEHS in Research Triangle Park. The law was enacted
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To establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory
acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the
environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness.
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The purposes of ICCVAM, as stated in the law, are to:
- Increase the efficiency and effectiveness of U.S. Federal agency test method review
- Eliminate unnecessary duplication of effort and share experience among U.S. Federal regulatory agencies
- Optimize utilization of scientific expertise outside the U.S. Federal government
- Ensure that new and revised test methods are validated to meet the needs of U.S. Federal agencies
- Reduce1, refine2, and/or replace3 the use of animals in testing where feasible
The ICCVAM Authorization Act directs ICCVAM to carry out the following duties:
- Coordinate the technical review and evaluation of new and revised test methods
- Submit ICCVAM test recommendations to appropriate U.S. Federal agencies
- Facilitate interagency and international harmonization of test protocols that encourage the reduction,
refinement, and replacement of animal test methods
- Facilitate and provide guidance on validation criteria and processes
- Facilitate the acceptance of scientifically valid test methods
- Facilitate awareness of accepted test methods
- Consider petitions from the public for review and evaluation of new and revised test methods for which
there is evidence of scientific validity
- Make ICCVAM final test recommendations available to the public
- Prepare reports on ICCVAM progress and accomplishments under the Act and make these available to the public
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View the NICEATM-ICCVAM brochure (January 2008)
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1Reduction alternative: New or modified test method/s that reduce/s the number of animals required for a
test method, while remaining consistent with sound scientific practices necessary to obtain valid results.
2Refinement alternative: New or modified test method/s that refine/s procedures to lessen or eliminate
pain or distress in animals or enhances animal well-being.
3Replacement alternative: New or modified test method/s that replace/s animals with non-animal systems
or replace/s an animal species with a phylogenetically lower species.
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