The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was established as a temporary advisory body under the NIH Revitalization Act of 1993, which sought multi-agency input into a federal plan to "conduct or support research into the [3Rs]; for establishing the validity and reliability of [3Rs methods]; for encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable; and for training scientists in the use of such methods..." In 2000, the ICCVAM Authorization Act (42 U.S.C. 285l-3) established ICCVAM as a permanent interagency committee, administered by the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) at the National Institute of Environmental Health Sciences (NIEHS). NICEATM is charged with providing administrative and scientific support to ICCVAM, including the review of test method nominations, organization of peer reviews and workshops, and communication with ICCVAM stakeholders.
Composition
ICCVAM is comprised of the following 15 US federal regulatory and research agencies:
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Consumer Product Safety Commission (CPSC)
- Department of Agriculture (USDA)
- Department of Defense (DoD)
- Department of Energy (DOE)
- Department of the Interior (DOI)
- Department of Transportation (DOT)
- Environmental Protection Agency (EPA)
- Food and Drug Administration (FDA)
- National Cancer Institute (NCI)
- National Institute of Environmental Health Sciences (NIEHS)
- National Institute of Occupational Safety and Health (NIOSH)
- National Institutes of Health (NIH)
- National Library of Medicine (NLM)
- Occupational Safety and Health Administration (OSHA)
Validation & Acceptance Criteria
ICCVAM criteria for test method validity and regulatory acceptance have been articulated in the following documents:
Statutory Mandate
ICCVAM's mandate under law is to:
- "increase the efficiency and effectiveness of Federal agency test method review;"
- "eliminate unnecessary duplicative efforts and share experiences between 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 Federal agencies; and"
- "reduce, refine, or replace the use of animals in testing, where feasible."
In contrast to its European counterpart, the European Centre for the Validation of Alternative Methods (ECVAM), ICCVAM is not mandated to participate directly in test method prevalidation and validation, per se. Rather, ICCVAM is responsible for coordinating the technical review and evaluation of new and revised test methods, as appropriate, and for facilitating US acceptance of scientifically valid test methods. For example, in the case of a new or revised toxicity test that has undergone validation but has not already been peer reviewed elsewhere, ICCVAM may convene a panel of expert scientists to independently evaluate the test's relevance and reliability according to ICCVAM validation criteria and provide recommendations regarding the regulatory context(s) in which it can be used to reduce, refine or replace animal use.
If the conclusions and recommendations of an expert panel favor the regulatory use of a particular alternative method, and if ICCVAM concurs, draft test method recommendations are published in the Federal Register for public review and comment. The ICCVAM Authorization Act requires that final test recommendations be forwarded to federal agencies, which are obligated to review and respond to such recommendations within six months.
Past & Future Activities
To date, ICCVAM-NICEATM have evaluated 3Rs methods germane to the following toxicological endpoints and/or regulatory sectors: acute oral toxicity; biologics; developmental toxicity; endocrine disruption; eye corrosion/irritation; genetic toxicity; pyrogenicity; skin corrosion; and skin sensitization.
In 2007, ICCVAM-NICEATM were directed by Congress to develop a Five-Year Plan to:
- "Research, develop, translate, and validate new and revised non-animal and other alternative assays for integration of relevant and reliable methods into Federal agency testing programs."
- "Identify areas of high priority for new and revised non-animal and alternative assays or batteries of those assays to create a path forward for the replacement, reduction, and refinement of animal tests, when this is scientifically valid and appropriate."
A draft plan was release in 2007 and the final plan is expected to be released in 2008.
Scientific Advisory Committee
Pursuant to the ICCVAM Authorization Act, a Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) was created to advise ICCVAM, NICEATM and the NIEHS Director regarding "priorities and activates related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods." SACATM operates under the rules of the Federal Advisory Committee Act, and includes representation from state government, academia, industry and the animal protection community.
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