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.
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.
