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FDA News

September 18, 2008

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Siobhan DeLancey, 301-827-0857
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FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
Public comment invited on application of new animal drug provisions of the Federal Food Drug and Cosmetic Act

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals.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.

The comment period for the draft guidance, titled “The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs,” runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at

The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA’s intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.

The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.

For more information, see

Comment from the AP News story:

Reaction from consumer groups was mixed. They welcomed the government’s decision to regulate genetically altered animals, but they cautioned that crucial details remain to be spelled out. For example, the Food and Drug Administration does not plan to require that all genetically engineered meat, poultry and fish be labeled as such. It would be labeled only if there was a change in the final product, such as low-cholesterol filet mignon.

“They are talking about pigs that are going to have mouse genes in them, and this is not going to be labeled?” said Jean Halloran, director of food policy for Consumers Union. “We are close to speechless on this.” Consumers Union publishes Consumer Reports magazine.

Nonetheless, Gregory Jaffe, who heads the biotechnology project at the Center for Science in the Public Interest called the FDA’s move a “good first step.”