The regulatory framework and the questions agencies will ask will vary depending the nature of the modification and the intended use of the resulting product(s).

AGENCIES

The Animal and Plant Health Inspection Service (APHIS) of USDA has jurisdiction over livestock used in biomedical research, teaching, or testing, to oversee compliance with the regulations for animal care and use promulgated by APHIS under the Animal Welfare Act (9 CFR Parts 1–4).

The Office of Laboratory Animal Welfare of the National Institutes of Health (NIH) has responsibility for the general administration and coordination of the Public Health Service Policy (1996) on the Humane Care and Use of Laboratory Animals, including livestock and poultry used in biomedically-related research activities.

The Center for Veterinary Medicine (CVM) in the Food and Drug Administration (FDA) has asserted primary jurisdiction over the first two categories of anticipated products of animal biotechnology noted in the background section above for purposes of making market access decisions, and setting conditions of use, but CVM’s jurisdiction is not exclusive.

The Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) in FDA also have jurisdiction over the products in category 2 to the extent they involve human drugs or biologics.

The Center for Veterinary Biologics in the USDA’s Animal and Plant Health Inspection Service (APHIS) has jurisdiction over products in category 2 to the extent they are modified to produce animal biologics.

The Center for Food Safety and Applied Nutrition (CFSAN) in FDA has jurisdiction over milk, eggs and other edible products (other than meat and poultry products) to oversee compliance with limits on residues in the edible tissue and ensure the general wholesomeness and safety of the food.

The Food Safety and Inspection Service (FSIS) in USDA has jurisdiction over meat and poultry derived from genetically modified animals to oversee compliance with residue limits and ensure the general wholesomeness and safety of the food.

It is unclear whether any agency has jurisdiction to make market access decisions or establish conditions of use for cloned animals. FDA has said that it may have jurisdiction over human cloning through its new drug authority and that it expects human cloning experiments to be covered by investigational new drug applications (IND’s). CVM has not taken a public position on its regulatory jurisdiction over animal cloning, but it is for now constrained not to take a position that is different in principle from the FDA position on human cloning. CFSAN and FSIS have jurisdiction to oversee the general



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