§285l–4 Federal Agency Action

Summary

Federal agencies that require or recommend animal acute or chronic toxicity tests must take action after ICCVAM makes a test recommendation. Within 180 days of getting the recommendation, an agency must find and send ICCVAM any rules or industry guidelines that call for animal acute or chronic tests that the ICCVAM method could replace or add to. In that same 180-day period the agency must review the ICCVAM recommendation and tell ICCVAM in writing what it decides. The agency must adopt the ICCVAM recommendation unless it finds the recommendation is not biologically relevant, does not produce the same amount and scientific quality of data for hazard identification, dose‑response, or risk assessment, does not apply to that chemical class or endpoint, or does not meet the agency’s specific testing needs or congressional mandate. Agencies must also promote and encourage development and use of alternative test methods when those alternatives give data at least equal in amount and scientific value for the needed assessments. Before any new or changed acute or chronic test method—animal or alternative—can be required, recommended, or encouraged, the agency must make sure it is validated for its intended use.