FDA addresses GE animals
September 18, 2008
OMAHA (DTN) – Genetically-engineered (GE) technology may be coming to your backyard grill very soon. The U.S. Food and Drug Administration announced Thursday that the agency has released for public comment draft guidance on the regulation of GE animals.
The emerging science of GE animals, which can include livestock, companion animals and laboratory animals, is one that FDA has been examining for a while and will be closely watching in the future, according to Randall Lutter, deputy commissioner for policy for FDA.
“Genetically-engineered animals hold great promise for improving human medicine, agriculture, the environment and the production of new materials, and the FDA has been involved in their scientific evaluation,” Lutter said in a Thursday morning teleconference.
GE animals are any animals with new traits added that can either help the animal, humans or environment. Examples of GE animals would be pigs produced to have higher levels of the good Omega-3 fatty acid in their meat, animals resistant to such disease as mastitis and animals with a trait to limit the amount of manure produced, he said.
Genetic engineering is already used widely in agriculture to make crops resistant to pests or herbicides. The science is also used in medicine to develop microbes that produce drugs and other therapeutic products for humans and in the food industry to produce microorganisms that aid in baking, brewing and cheese-making.
The FDA has been working with developers of GE animals to help ensure that food from these animals does not enter the U.S. food supply until the FDA has allowed it, said Larisa Rudenko, senior adviser for biotechnolgy for FDA’s Center for Veterinary Medicine (CVM).
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“Not all the details have been worked out yet, but we will address each GE animal produced on a case-by-case basis to assure it is safe for consumers,” Rudenko said.
If the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA animals. Codex is a worldwide food safety organization sponsored by the United Nations.
Coupled with the FDA regulations, the USDA announced Thursday that the department would begin seeking information on whether more regulation is needed on the movement of genetically-engineered livestock, including the importation of those animals.
One scenario Rudenko addressed during the conference was the issue of GE animals interbreeding with non-GE animals and the effect this could have on the U.S. food supply. Critics have been alarmed at what could possibly happen if the two animal groups mated.
Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the USDA and with other federal departments and agencies, such as the Environmental Protection Agency (EPA), in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology.
USDA has published in the same issue of the Federal Register 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. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock.
The FDA document, titled “The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs”, will be open for comment for 60 days ending Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm, according to a press release by FDA.
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