FDA approves guidelines for genetically engineered meat
Fast-growing salmon. Heart-healthy pigs. Nutrient-packed milk. These and other genetically engineered products have gotten one step closer to store shelves.
The Food and Drug Administration on Thursday announced final guidelines that will help producers clear the regulatory hurdles as they try to bring genetically engineered meat to the marketplace. The guidelines, though themselves not legally binding, will help companies meet mandated regulations.
"This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy," said Randall Lutter, the agency’s deputy commissioner for policy.
The products will undergo a mandatory safety review, the agency said.
But consumer groups quickly criticized the FDA’s decision Thursday, saying the application process should be more transparent and that genetically engineered products should be labeled as such.
"FDA claims these foods are not different from conventional food, and therefore don’t need to be labeled," said Jean Halloran, a director at Consumers Union, publisher of Consumer Reports, in a statement. "This flies in the face of consumer opinion and common sense."
A genetically engineered animal is one whose DNA has been altered with DNA from another animal to produce a desirable trait. In some cases, animals are engineered to produce milk that contains medicines — so called "biopharm" animals — and in others, to provide fast-growing or more nutritious food.
Under current rules, a genetically engineered product requires only a label saying it has new nutritional content. For example, if milk were engineered to have more vitamins, a label would have to say only that it has more vitamins, not that it was genetically engineered.
The agency and the biotech industry have agreed that a label isn’t required because the animals aren’t any different from regular animals.
"There’s opposition to labeling because we support FDA policy on labeling which says labels must be truthful and not misleading," said Karen Batra of the Biotech Industry Organization, which represents companies developing genetically engineered meat, milk and other products. "If you identify a nongenetically engineered product, then you insinuate there is some sort of health or safety concern, and that’s not the case faxless payday loan."
Get more business news, blogs and opinionSome consumer groups argue with that notion, saying that shoppers, who may oppose the technology on ethical grounds, need the information to make an informed choice.
"The are recommending labeling only when there’s a new health claim made, or it’s got a different nutritional profile," said Jaydee Hanson of the Center for Food Safety. "We would say that an animal that’s got a gene that wasn’t in it before has got a different nutritional profile."
Hanson noted that the U.S. Department of Agriculture requires any milk other than cow’s milk to be labeled. "If I’ve got to tell you that it’s goat’s milk, why shouldn’t I have to tell you it’s genetically engineered milk?" Hanson said.
The FDA has been reviewing genetically engineered animals since the early 1990s but had never formally clarified the approval process. Last fall, it issued draft guidelines, followed by a 60-day public comment period. During that period, some 28,000 people weighed in.
According to the agency, companies have submitted as many as 50 applications to bring their genetically engineered products to the market. Agency officials will not say which companies’ applications are under review. So far, none has been approved, though last week, an FDA committee recommended that the agency approve a genetically engineered goat that produces human blood thinner in its milk.
President-elect Barack Obama has said he favors labeling genetically engineered food products — a preference consumer groups are banking on.