FDA Issues Guidelines for Genetically Engineered Animals

More than 20 years after the first genetically engineered (GE) animals were created, the U.S. Food and Drug Administration (FDA) is proposing guidelines to regulate their commercial use. FDA is especially interested in animals that might be eaten or whose blood or milk might be used to make drugs. Consumer groups and scientists are relieved that the agency is taking a stand, but some say the new guidance doesn't go far enough to safeguard human health or the environment.

"FDA's announcement is a good first start," but "it does not address the risks that GE animals might pose," said the Center for Science in the Public Interest, a nonprofit watchdog group, in a statement.

Many crops are genetically engineered to make them resistant to pests or to confer other benefits. Companies have also developed cattle resistant to mad cow disease, pigs that contain high levels of healthy omega-3 fatty acids, and salmon that reach market size more quickly than their natural brethren. Still others, called "biopharm animals," may be modified to produce proteins that can treat human diseases. None of these animals have been allowed on the market.

Even as companies have developed animals like these, many scientists have voiced concern about their potential impact on ecosystems if they escape. Six years ago, the U.S. National Academies' National Research Council warned that genetically engineered animals, such as fish and insects, pose a major threat to the environment because they might crowd out or genetically disrupt native species if they breed with them (Science, 23 August 2002, p. 1257).

In its new guidelines, FDA proposes regulating the genetic modifications as "animal drugs" because, as with traditional drugs, they alter the animal. The agency wants to know whether the genetic change is safe for animals and for humans if the animals are destined for the slaughterhouse. Companies will need to show that the additional DNA doesn't contain sequences that can hurt animals or humans, either on its own or by recombining with other DNA. "The technology has evolved to a point where commercialization of these animals is no longer over the horizon," said Randall Lutter, FDA's deputy commissioner for policy, in a press conference today. The public comment period closes 18 November.

FDA promises to examine the environmental impact of the animals, but that pledge doesn't satisfy everyone. "I'm very worried this is not good enough," says Anne Kapuscinski, a conservation biologist at the University of Minnesota, St Paul, who has studied how genetically engineered fish can affect the environment. Kapuscinski notes that such environmental assessments require scientists from many disciplines and a process that's more open than FDA seems to be planning. But William Muir, a population geneticist at Purdue University in West Lafayette, Indiana, thinks the document represents a "huge" change for FDA. Muir, who disagrees with Kapuscinski's assessment, says it "really addresses every concern that people have voiced."