§285l–4 Federal Agency Action

Summary

Federal agencies that run programs needing or recommending acute or chronic toxicology tests must act when ICCVAM issues a test recommendation. Within 180 days of getting the recommendation, the agency must find and send ICCVAM any rules or industry guidelines that require or encourage animal tests the ICCVAM method could replace, and must review the recommendation and tell ICCVAM in writing what it decides. Agencies must encourage and use non-animal alternatives when those methods produce data equal in amount and scientific value for hazard identification, dose-response assessment, or risk assessment. Before requiring or recommending any new or changed toxicity test (animal or alternative), the agency must confirm the test is valid for its intended use. Agencies must adopt the ICCVAM recommendation unless they determine it lacks the needed biological relevance, does not produce equivalent data, does not apply to that chemical class or test endpoint, or otherwise will not meet the agency’s testing needs or legal duties.