|
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 responsive
to the 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 and to 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 Committee published its final report, Validation and Regulatory
Acceptance of Toxicological Test Methods. An ICCVAM consisting of 15 U.S. Federal agencies was established as a
standing committee in 1997 to implement a process by which new test methods of agency interest could be evaluated and
to coordinate cross-agency interactions related to issues on the development, validation, acceptance, and national and
international harmonization of toxicological test methods.
With enactment of the ICCVAM Authorization Act of 2000 (Public Law 106-545, 42 U.S.C. 285l-3),
signed into law by the President
on December 19, 2000, ICCVAM was established as a permanent interagency committee of NIEHS under NICEATM, which is located
at NIEHS in Research Triangle Park. The law was enacted
|
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.
|
|
|
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
|
View the NICEATM-ICCVAM brochure (January 2008)
|
When adequate information is available for a new test method, peer review panels are
convened; these panels are composed of expert scientists from national
and international industry, academia, and government. Peer review
panels are charged with developing a scientific consensus on the
validation status of the proposed test method, including its usefulness
for generating information for specific human health and/or ecological
risk assessment purposes.
Workshops and expert panel meetings are
convened as needed to evaluate the adequacy of current methods for
assessing specific toxicities, to identify areas in need of improved or
new methods, to assess the current validation status of methods, and to
recommend additional research, development, and validation activities.
In assessing the validation status of a method, panels consider
available information for a specific test method and evaluate the extent
to which the ICCVAM validation and acceptance criteria have been
addressed. Panel deliberations are conducted in public session and the
opportunity for public comment is provided before and during meetings.
Published reports of panel evaluations and ICCVAM recommendations
regarding scientific validity and potential acceptability of test
methods are forwarded to agencies for their consideration. Each Federal
agency then determines the regulatory acceptability of a method
according to its statutory mandates.
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.
|
Regulatory Acceptance of Alternative Methods