The Food and Drug Administration (FDA) last week released draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.
At the same time, USDA’s Animal and Plant Health Inspection Service (APHIS) published a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance.
GE animals have new characteristics or traits introduced through their DNA, which can include increased disease and parasite resistance. This can mean fewer infections, fewer veterinary visits, fewer dietary supplements, and an overall increase in health and well-being for the animals.
Under the draft guidance, FDA will ensure that GE animal products are safe and do what they are intended to do; the documents released by both FDA and USDA are intended to ensure the health of animals and public health. If the GE animal is a food production animal, then FDA will require that the animal or its products are proven safe to eat in order to enter the food supply. FDA intends to conduct a full food and feed safety evaluation if the animal or the product is intended for food.
Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.
Comments on this draft guidance can be submitted until Nov. 18, 2008. The document is available online at www.fda.gov/cvm/GEAnimals.htm.
Additionally, more info is available on GE animals on BIO's GE Animals Web Resource Page, available at www.bio.org. Users can view and download resource materials related to this issue including fact sheets, answers to frequently asked questions and other information.
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