WASHINGTON, Dec. 21, 2012 – The Food and Drug Administration took a big step today toward commercial approval of salmon genetically engineered to grow faster than its regular counterpart. FDA’s publication of a 158-page environmental assessment and a 5-page “finding of no significant impact” drew the expected howls from perennial critics of biotechnology.

FDA has carefully considered the potential environmental impacts of the proposed action and at this time has made a preliminary determination that this action would not have a significant effect on the quality of the human environment in the United States,” FDA’s impact statement said.

Release of the impact statements is a major victory for scientists who had worried that FDA’s work had been buried at the White House until after the election out of concern that approval would offend some of the administration’s political allies. An all-star coalition of scientists wrote President Obama in September to urge him to instruct FDA to approve the technology. “There is much more at stake here than just a fish,” said the letter, signed by more than 50 prominent names including former State Department advisor Nina Federoff and Terry Etherton of Penn State and leading genetic researchers and food policy experts at California’s Davis and Berkeley campuses.

AquaBounty Technologies, the developer of the technology, told FDA’s Center for Veterinary Medicine that the fish is to be grown in physically-contained freshwater culture facilities specified in the sponsor’s application. Called AquAdvantage salmon, the fish was first engineered in 1989 by injecting genetic material from an ocean pout antifreeze protein and a chinook salmon into fertilized eggs of wild Atlantic salmon. Subsequent selection and breeding led to a salmon line that has been propagated for eight generations. The fish “is as safe as food from conventional Atlantic salmon,” says the agency’s statement.

The notice, to appear in Monday’s Federal Register, will invite comments to be submitted for the next 60 days. However, because the substance of the draft environmental assessment has been available for nearly three years, FDA served notice that it does not intend to grant requests for extension of the comment period.

The Center for Food Safety says the decision ignores the objections of 400,000 public comments, and 40 members of Congress. “It is extremely disappointing . . . premature and misguided,” said Andrew Kimbrell, executive director of CFS. “The GE salmon has no socially redeeming value; it’s bad for the consumer, bad for the salmon industry and bad for the environment.” He said that more than 300 environmental, consumer, health, animal welfare, salmon and fishing groups and associations, food companies, chefs and restaurants filed statements opposing it.

Food and Water Watch Executive Director Wenonah Hauter said that her group “is far from alone in condemning this historic decision – one that disregards numerous polls revealing that the vast majority of consumers oppose GE salmon.” She claimed that FDA “failed to conduct the appropriate studies to determine if it is safe to eat or even if the fish can live up to AquaBounty’s claim of faster growth rates.” She expressed hope that Congress would enact legislation that would ban commercialization of the fish and said that opponents “will be examining legal options to force FDA to do a more thorough assessment of this new GE food animal.


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