Bloomberg Press
Genetically Engineered Animals May Get U.S. Rules
By Jamie McGee
Sept. 18 (Bloomberg) -- Genetically engineered animals would be regulated by the U.S. Food and Drug Administration under proposed rules backed by the biotechnology industry and opposed by consumer advocates.
Products from the animals, given extra genes by scientists, would be reviewed on a case-by-case basis for safety, FDA officials said today on a conference call with reporters. Food products from genetically engineered animals wouldn't have to be labeled unless the agency finds the process changed their substance.
Animals are being genetically engineered to improve food quality and production, bolster their disease resistance and create replacement organs and medicines for people, according to the FDA. Under draft rules to be published in the Federal Register, the agency would use its existing authority over animal drugs to regulate the growing field.
``Technology has evolved to the point where commercialization of these animals is no longer over the horizon,'' said Randall Lutter, the FDA's deputy commissioner for policy, on the conference call. ``We want the producers of these animals to understand their legal and regulatory responsibilities.''
The rules will clear up uncertainty about oversight of the emerging science, said Barb Glenn, managing director of animals at the Biotechnology Industry Organization, a Washington-based trade group.
``This allows us to move forward,'' Glenn said in a telephone interview. ``We needed published guidance.''
`That's Outrageous'
Consumers Union of Yonkers, New York, the publisher of Consumer Reports magazine, denounced the FDA's decision.
``That's outrageous,'' said Michael Hansen, senior scientist with the organization. ``Labeling is not just about safety issues.'' Consumers want full disclosure, in some cases because they object to changes in food on religious or other personal grounds, he said.
The FDA may lack the expertise needed to evaluate the environmental risks of genetically engineered animals, said Gregory Jaffe, biotechnology director at the Center for Science in the Public Interest, an advocacy group in Washington.
``What happens if genetically engineered salmon gets out into the native habitat?'' Jaffe asked.
Working With Industry
The FDA will work with industry ``to ensure appropriate risk-mitigation policies are implemented prior to approval,'' said Larisa Rudenko, senior adviser for biotechnology at the agency's Center for Veterinary Medicine, on the conference call.
The FDA said it would continue to exempt from its pre- approval review altered animals that pose little risk, as it did with an aquarium fish that was genetically engineered to glow in the dark.
The FDA's new rules wouldn't apply to clones -- identical copies of animals created by science -- unless genes from other sources are added, the agency said. The agency found in January that cloned livestock are as safe as those bred naturally and can be sold in the U.S., bringing criticism from consumer advocates.
Plants that are genetically modified have been regulated by the Agriculture Department since 1986. About 80 percent of all U.S. corn, 86 percent of cotton and 92 percent of soybeans planted this year are from varieties that were altered through biotechnology, according to the department.
The Agriculture Department today requested information on research planned into genetically engineered animals and sought public comment on what should be taken into account when such animals are imported or moved.
