About ICCVAM
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is a permanent committee of NIEHS. Formally established in 2000 by the ICCVAM Authorization Act (42 U.S.C. 285l-3), ICCVAM is composed of representatives from U.S. federal regulatory and research agencies. These regulatory and research agencies require, use, generate, or disseminate toxicological and safety testing information.
The ICCVAM Authorization Act outlines the following purposes of ICCVAM:
- 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.
- Reduce, refine, or replace the use of animals in testing where feasible.
The ICCVAM Authorization Act named the 15 federal agencies originally represented on ICCVAM. The National Institute of Standards and Technology joined ICCVAM in 2017, and the Department of Veterans Affairs Office of Research and Development joined in 2020.
A new ICCVAM document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies,” is available. The document was developed by the ICCVAM Validation Workgroup with input from stakeholders. The document describes an approach to NAMs validation that reflects modern toxicity testing, placing less emphasis on replacement of an in vivo test with a single alternative method and more emphasis on integrating results from multiple in vitro and in chemico assays and in silico approaches.
ICCVAM Activities
ICCVAM activities include:
- Facilitating interagency and international collaborations promoting the development, regulatory acceptance, and use of alternative tests that encourage the reduction, refinement, or replacement of animal test methods.
- Providing guidance to test method developers.
- Evaluating recommendations from expert peer reviews of alternative toxicological test methods and making recommendations on the use of reviewed test methods to appropriate federal agencies.
Strategic Roadmap
In January 2018, "A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States" was published. ICCVAM coordinated development of the strategic roadmap, a resource to guide U.S. federal agencies and stakeholders seeking to adopt new approaches to safety and risk assessment of substances.
ICCVAM's Stakeholders
ICCVAM relies on stakeholders to carry out alternative test method research, development, and validation studies. These stakeholders include:
- U.S. federal agencies that generate, require, or use toxicological data.
- Agencies within governments of other countries that use or generate toxicological data.
- Researchers and IACUC members in companies or research institutions that perform toxicological testing.
- Companies that develop toxicological tests.
- Animal welfare organizations.
- Consumer protection organizations.
- The public.
ICCVAM facilitates international collaboration on the development of alternative test methods through its membership in the International Cooperation on Alternative Test Methods and participation in the Test Guidelines Programme of the Organisation for Economic Co-operation and Development.
As a permanent committee of NIEHS, ICCVAM falls under the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).
The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), a standing NTP advisory committee, provides additional advice and guidance. SACATM members include stakeholders from regulated industries, animal protection organizations, academia, U.S. state or international regulatory bodies, and companies or organizations that develop, market, or use test methods.