This paper examines the formulation of regulatory policy for the approval of novel technology- specifically the creation of regulatory policy by the FDA for market approval of transgenic animals. According to the regulatory framework under which transgenic animals are now subject, the FDA relies on a hierarchical, risk-based approach for assessing the effectiveness and safety of the technology for market approval. This study examines the reliance on science within the policy framework to represent the “objective” world of nature and to evaluate known and potential risks. In doing so, this paper attempts to uncover implicit cultural values and interests that inform regulation policy construction. In looking at the formation of regulation for the particular technology of transgenic animals, this paper will discuss regulatory cases of the AquaAdvantage Salmon, the ATryn goat, and the Enviropig. Because no clear regulatory process existed at the time these products were presented for regulatory approval, regulatory policy construction occurred simultaneous to their approval process. This has resulted in an ambiguous territory that merits closer examination of how regulatory authority must make decisions within institutionally complex settings.
|Presenter:||Priscilla Bennett (SUNY Binghamton) -- email@example.com
|Time:||1:45 pm (Session III)|