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FDA Takes First Step in Approving Genetically Engineered Meat

Posted on: Saturday, 20 September 2008, 05:25 CDT

The U.S. Food and Drug Administration on Thursday released a set of proposed guidelines that producers of genetically engineered animals would need to follow to determine any possible risks to humans.

The latest step increases the possibility of genetically engineered animals entering the nation’s food supply.

Currently, genetically modified cattle, pigs, fish and goats are being used as some produce pharmaceuticals in their milk or blood.

"Many kinds of genetically engineered animals are in development, although none has yet been approved by the agency for marketing," FDA Deputy Commissioner Randall Lutter said.

Lutter said the release of new guidelines came at a time when “the technology has evolved to a point where commercialization of these animals is no longer over the horizon."

The new guidelines face a 60-day public comment period which lasts until November 18 before they become official.

Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals, the FDA said in a statement.

U.S. supermarkets currently sell no meat from genetically engineered animals.

However, a Boston-area company called Aqua Bounty Technologies hopes to win approval next year for its faster-growing salmon and make the fish available by 2011.

Consumer groups welcomes the government’s movement to create a formal process for regulation of GE animals, but were cautious due to some missing details. For example, the Food and Drug Administration does not plan to require that all genetically engineered meat, poultry and fish be labeled as such. It would be labeled only if there was a change in the final product, such as low-cholesterol filet mignon.

"They are talking about pigs that are going to have mouse genes in them, and this is not going to be labeled?" said Jean Halloran, director of food policy for Consumers Union. "We are close to speechless on this." Consumers Union publishes Consumer Reports magazine.

Gregory Jaffe of the Center for Science in the Public Interest said the announcement is a good first step.

"This is the first time the federal government is announcing a comprehensive regulatory system that addresses the concerns from these animals," said Jaffe. "But it may not have addressed all the environmental concerns."

"Genetic engineering of animals is here and has been here for some time, " said Larisa Rudenko, a science policy adviser with the FDA's veterinary medicine center. "We intend to provide a rigorous, risk-based regulatory path for developers to follow to help ensure public health and the health of animals."

GE animals are created when scientists insert a gene from one species of animal into the DNA of another animal to reprogram some of its characteristics. For example, fish could be made to grow faster, or pigs might be re-engineered to produce less waste.

To engineer Aqua Bounty's faster-growing salmon, scientists took a snippet of DNA from an eel-like fish and stitched it into the genes of salmon. Normally, Atlantic salmon produce growth hormone only in the summer months. But with the change, salmon produce growth hormone all year long, allowing them to grow to full size in about 18 months instead of three years, said Elliot Entis, vice chairman of Aqua Bounty.

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Source: redOrbit Staff & Wire Reports

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