Only one genetically engineered animal is now being sold in the United States, the glow-in-the-dark zebra fish for aquariums. The FDA approved it because it is not eaten and its need for warm water effectively precludes its escape into the wild.
The first product likely to be sold under the new rules is a genetically engineered Atlantic salmon produced by Aqua Bounty Technologies Inc. of Waltham, Mass.
Inserted genes from two other fish allow it to reach full size in 18 months rather than the normal 30.
Aqua Bounty, along with other biotechnology companies, has been pushing the FDA to establish guidelines and hopes to win approval next year.
Technically, it is not the modified animals but the added DNA segments that are considered drugs.
Realistically, however, the only way to regulate the property-changing DNA is to regulate the animal, said Eric Flamm, a policy advisor at the agency.
That regulation will require demonstration that the modified animal itself is healthy and that a food or drug produced from it is safe for human use. The new rules do not envision feeding the products to humans in the equivalent of clinical trials for drugs.
Once an animal product has been approved, its labeling may or may not reflect its origin, the FDA said.
If the composition of meat or other food has been changed, such as by increasing its content of omega-3 fats, that will be put on its label. But if the animal simply grows faster or is more environmentally friendly without changes in composition, no mention of its genetically engineered origin is considered necessary.
The lack of labeling concerns consumer advocacy groups. Jean Halloran, director of food policy initiatives at Consumers Union, called it "incomprehensible."
"Consumers have the right to know if the ham, bacon or pork chops they are buying . . . have been engineered with mouse genes," she said.
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