Genetically engineered animals and the FDA

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Are there concerns beyond what the FDA can regulate?

Gregory Jaffe, who follows biotechnology for the consumer advocacy group Center for Science in the Public Interest, says the adopted guidelines are a good start "in the sense that the federal government has acknowledged that these animals are on the horizon and there needs to be oversight to ensure their safety."

But, he adds, genes are not the same as drugs. Drugs may have long-lasting effects on an individual, but they wouldn't get passed on to future generations. In the case of biotech animals, however, "you're altering the DNA of that animal, which gets carried on to its offspring." (Aqua Bounty says all the fish it markets will be sterile.)

Such lasting effects may have implications for preventing escape of the genes to natural populations, Jaffe says -- an issue that is beyond the FDA's expertise or authority.

Jaffe thinks the safety review should be more open and transparent. "Our regulatory processes for drugs" -- including animal drugs -- "are, on the whole, secret and done behind closed doors," he says. By law, the company controls what information is made public.

Other regulatory processes, such as those for pesticides at the Environmental Protection Agency, have been opened in past decades to invite public participation.

"Genetically engineered animals are highly controversial," Jaffe says. "I think that they [the FDA] need to have a transparent and participatory regulatory system -- where the public can review safety data and . . . expert scientists can provide comments to the agency."

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Why did the FDA decide that food from genetically engineered animals doesn't have to be labeled?

The FDA labels food based on nutritional content, not manufacturing process, says the agency's DeLancey.

"So, if the food product is 'materially different' from a conventional product, then FDA can require that it be labeled. But the FDA doesn't require that a pork chop label specify whether it came from a pig produced through artificial insemination versus conventional breeding."

And similarly, now, if it came from genetically engineered animals. "We understand that consumers want transparency and labeling, but we are constrained by the regulations put in place by Congress," DeLancey says.

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How will I know if the food I buy is from genetically engineered animals?

Pork from an omega-3 pig, should it gain approval, will be labeled because nutritional enhancement is a selling point -- and because the product is different from regular pork.

In other cases you may not know, although producers can voluntarily label their products. Researchers at the University of Guelph in Canada, who developed the so-called Enviropig with "greener" manure, say they intend to do so.

The U.S. Department of Agriculture has guidelines for labeling "natural meats," which would allow meat from non-transgenic animals to call attention to that fact.

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