Regulating Transgenic Animals (Following the Risks) Fred H. Degnan [email protected] Coordinated Framework: Key Concept: A Federal “Safety Net” Subject all transgenic crops and animals to science-based regulation
Animal Health Protection Act (AHPA) Framework for Regulating Products of Biotechnology
The fundamental focus of the new animal drug rubric is threefold:
If a new animal drug is used without FDA approval
A substance is an animal “drug” if
If a substance is an animal drug it must, by law, go through a pre-market approval system unless it is “generally recognized” by qualified experts as safe (“GRAS”) and effective (“GRAE”) for its intended use(s).
“GRAS” and “GRAE” status are only granted when there are adequate publicly available data and information supporting expert recognition.
“Follow the Risk”
FDA relies on “safety” authority to require that use, manufacture or disposal must not pose a significant environmental impact:
FDA has stated that, under the FDC Act, it may: