. "7. Concerns Related to Scientific Uncertainty, Policy Context, Institutional Capacity, and Social Implications." Animal Biotechnology: Science Based Concerns. Washington, DC: The National Academies Press, 2002.
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Animal Biotechnology: Science-Based Concerns
technical capacities of the agencies to address some of the novel questions posed by the technology.
Agencies and Statutes
Appendix B lists the many components of the federal government that might have jurisdiction over some aspect of animal biotechnology. They include potentially four different centers within the FDA and two agencies in the U.S. Department of Agriculture that have some jurisdiction over the animal and/or human health impacts of animal biotechnology, depending on the nature and intended use of the product involved. In addition, some of these components of government, such as the FDA’s Center for Veterinary Medicine (CVM), have said that they will regulate the environmental impacts of the technology, but there are additional agencies that also might have a role on environmental issues, such as the U.S. Army Corps of Engineers (ACE), the Environmental Protection Agency (EPA), the Fish and Wildlife Service (FWS) in the Department of the Interior, the National Marine Fisheries Service (NMFS) in the Department of Commerce, and various state-level environmental and natural resource agencies.
Each of these agencies operates under its own distinct statutory mandate and mission, which necessarily influences the nature of the scientific questions that they will consider important in carrying out their responsibilities. In the case of transgenic fish, for example, the CVM claims primary jurisdiction over environmental issues, but the ACE has jurisdiction under the Rivers and Harbors Act over the siting of aquaculture facilities in navigable waters, where net pen salmon facilities commonly are found. Under this act, which gives the ACE broad discretion on whether and how to act on environmental matters, the ACE balances a host of concerns, including conservation and environmental impacts, and, like CVM, is subject to its own assessment requirement under the National Environmental Policy Act (NEPA) in making siting decisions. The FWS and NMFS have regulatory roles under the Endangered Species Act to the extent that the siting of an aquaculture facility or any other government action could affect an animal on the endangered species list, such as Atlantic salmon. And the EPA already has invoked its Clean Water Act authority to regulate discharges from salmon aquaculture facilities in Maine (Lubber, 2000), and potentially could do so again with transgenic fish facilities.
Multiple agencies also are potentially involved in food safety aspects of animal biotechnology. While CVM claims jurisdiction over the genetic transformation of livestock under its animal drug authority, meat from slaughtered animals will be inspected by the Food Safety and Inspection Service of the U.S. Department of Agriculture. At the federal level, milk is under the jurisdiction of a different component of FDA, the Center for Food Safety and