Tuesday, September 23, 2008

Approval process for genetically engineered animals


FDA proposes approval process for genetically engineered animals
The regulations would treat the creatures like drugs. Critics fear that environmental concerns aren't being given proper weight.
By Karen Kaplan and Thomas H. Maugh II, Los Angeles Times Staff Writers
September 18, 2008

The Food and Drug Administration today 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 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 in their milk.

"It's about time the federal government has acknowledged that these animals are on [the] doorstep and need to be regulated to ensure their safety," said Greg Jaffe, director of the project on biotechnology at the Center for Science in the Public Interest in Washington.

Many experts, however, fear that the proposed regulations do not go far enough to protect and reassure the public. In particular, they argue that the approval process would be highly secretive to protect the commercial interests of the companies involved and that the new rules do not place sufficient weight on the environmental impact 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 draft guidelines represent an effort to formalize procedures that the agency is already following, said Randall Lutter, a deputy commissioner for policy at the FDA. They show "how we have been and how we will continue to regulate genetically engineered animals," he said.

The genetically modified animals have a variety of potential uses. Some, like many agricultural crops now in use, are more disease resistant. One company, for example, has produced a cow that is not susceptible to mad cow disease.

Others are more nutritious or grow faster, improving the diet and enhancing farmers' profits. Some would serve as sources for organs for human transplants, expanding the small pool of donor organs now available. Others, called biopharm animals, would be used to produce drugs such as insulin, which are now manufactured in yeast or bacteria.

"There are very compelling and real benefits for humans and animals" from genetic engineering, said William Flynn of 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 and research animals. Clones are genetic replicas of existing animals, and the FDA has already determined that they are safe. Pets and research animals are unlikely to enter the food chain.

Only one genetically engineered animal is now being sold in the United States, a glow-in-the dark aquarium fish called a zebra. The FDA approved it because it is not eaten and its need for warm water effectively precludes it from escaping confinement.

Technically, the modified animals are not considered drugs. Instead, the segment of DNA that is added to them to change their properties is the drug. Realistically, however, the only way to regulate the DNA is to regulate the animal, said Eric Flamm, a policy advisor at the agency.

That regulation will entail a series of procedures that demonstrate that the modified animal itself is healthy and then that a food or drug produced from it is safe for human use. The new rules do not, however, envision feeding the products to humans in the equivalent of clinical trials for drugs.

"It's a complex and detailed process" that has been proved for a variety of other products, said Larisa Rudenko, a senior advisor for biotechnology at the FDA's Center for Veterinary Medicine.

Once an animal product has been approved, its labeling may or may not reflect its origin, Lutter 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 reflected in its labeling. But if the animal simply grows faster or is more environmentally friendly without changes in composition, that will not.



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