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The Director of 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 consisted of representatives from the 15 U.S. Federal
agencies still represented on ICCVAM today.
In 1997, the ad hoc ICCVAM published its final report, Validation and Regulatory
Acceptance of Toxicological Test Methods. That same year, NIEHS established a standing ICCVAM committee
to (1) implement a process by which new test methods of agency interest could be evaluated and
(2) 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 (42 U.S.C. 285l-3 [PDF])
established ICCVAM as a permanent interagency committee of NIEHS under NICEATM, which is located
at NIEHS in Research Triangle Park, NC. 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 Act states that the purposes of ICCVAM 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
- Foster interagency and international harmonization of test method protocols that encourage reducing,
refining, and replacing of animal test methods (referred to as "the 3Rs")
- Assiste with and provide guidance on validation criteria and processes
- Promote the acceptance of scientifically valid test methods
- Promote awareness of accepted test methods
- Submit ICCVAM test recommendations to appropriate U.S. Federal agencies
- Consider requests from the public to review and evaluate new, revised, and alternative test methods for which
there is evidence of scientific validity
- Make ICCVAM's 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
(February 2012) [PDF]
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ICCVAM depends on stakeholders with appropriate capabilities and resources to carry out
alternative test method research, development, and validation studies, and to submit the results to
ICCVAM for evaluation. Following comprehensive test method evaluations, ICCVAM develops
recommendations on scientific validity of new and modified test methods, and forwards these to
regulatory agencies for acceptance decisions as required by law.
ICCVAM's stakeholders are any person or organization that uses, develops or has an interest in toxicological test
methods or the data that is generated from toxicological testing. They include:
- U.S. Federal agencies that generate toxicological data
- U.S. Federal agencies that require or use toxicological data
- Agencies within governments of other countries that use or generate toxicological data
- Researchers and Institutional Animal Care and Use Committee (IACUC) members in companies or research
institutions that perform toxicological testing
- Companies that develop toxicological tests
- Animal welfare organizations
- Consumer protection organizations
- The public
For more information about ICCVAM, please contact Dr. William Stokes, Executive Director, at niceatm@niehs.nih.gov
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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