The FDA's regulatory role in the ICCVAM process

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a permanent body set forth in the ICCVAM Authorization Act of 2000 (Public Law 106-545), is charged with establishing criteria and processes for the validation and regulatory acceptance of toxicological test methods of interest to Federal agencies, including alternative methods that reduce, refine, or replace the use of animals for research and testing purposes. In response to that mandate, 15 Federal regulatory and research agencies and programmes that would consider utilising such methods or the results derived from them, now participate in cross-agency efforts directed toward the identification, standardisation, validation, acceptance, regulatory implementation and international harmonisation and adoption of such test methods. As an integral member of ICCVAM since its inception, the US Food and Drug Administration (FDA) has established processes for responding to ICCVAM issues and recommendations. The participating FDA units include all FDA research and product-based centres and oversight offices. FDA product centres respond to distinct regulatory mandates and regulate different products. Upon completion of a validation effort, ICCVAM forwards its recommendations to member Government agencies regarding the validity and technical acceptability of a method. The FDA's response consists of the conclusions reached by each of its regulatory components and addresses such factors as their concurrence with ICCVAM's conclusions, the practical applicability of the method to the products they regulate and the feasibility of implementation of an accepted method to supplement or supplant those currently used. Each centre/office independently determines which of the ICCVAM-recommended tests are appropriate for implementation to satisfy its regulatory obligations to ensure product safety and to protect human health. The adoption of a method triggers a notification process to announce the availability and utility of a method, encourage its use, and inform, educate and train end-users and regulatory review staff.