The Food and Drug Administration on Thursday opened the way for a bevy of genetically engineered salmon, cows and other animals to leap from the laboratory to the marketplace, unveiling an approval process that would treat the modified creatures like drugs.
The guidelines for the first time make explicit the regulatory hoops companies would have to jump through to sell engineered salmon that grow twice as fast as wild fish; pigs with high levels of healthy omega-3 fatty acids in their meat; or goats that produce beneficial proteins, such as insulin, in their milk.
"It's about time the federal government has acknowledged that these animals are on its doorstep and need to be regulated to ensure their safety," said Greg Jaffe, biotechnology director at the Center for Science in the Public Interest in Washington.
Many experts, however, say the proposed regulations may not go far enough to protect the public. In particular, they argue that the approval process would be highly secretive to guard the commercial interests of the companies involved, and that the new rules do not place sufficient weight on the potential environmental effect of what many consider to be Frankenstein animals.
Animals can't be treated exactly like drugs, said Jaydee Hanson, a policy analyst at the Center for Food Safety in Washington. "Drugs don't go out and breed with each other. When a drug gets loose, you figure you can control it. When a bull gets loose, it would be harder to corral."
The animals are genetically modified for a variety of purposes.
Some are designed to be more disease-resistant, such as the cow that is not susceptible to mad cow disease. Others are more nutritious or grow faster, enhancing profits.
Researchers are considering modified animals as sources of organs for human transplants.
Another idea involves so-called biopharm animals, which would be used to produce drugs such as insulin.
"There are very compelling and real benefits for humans and animals" from genetic engineering, said William Flynn of the FDA's Center for Veterinary Medicine.
"But we must show that they are safe before they enter the marketplace."
The new regulations do not cover cloned animals, most pets or research animals. The FDA has already determined that clones -- genetic replicas -- are safe. Pets and research animals are unlikely to enter the food chain.
