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FDA: Change process for approval of GE salmon

September 16, 2010

Consumers Union Asks FDA to Change Process For Approval of Genetically Engineered Salmon

Yonkers, N.Y.—As a national day of action and protest gets under way today to stop the Food and Drug Administration (FDA) from approving genetically engineered (GE) salmon, Consumers Union (CU), the non-profit publisher of Consumer Reports magazine, sent a letter to FDA expressing concern about the FDA review process of Aquavantage’s application for approval of GE salmon, which would be the first GE animal approved for human consumption. FDA is scheduled to hold a meeting of the Veterinary Medicine Advisory Committee (VMAC) September 19-20.
CU’s letter to FDA Commissioner Dr. Margaret Hamburg and Principal Deputy Commissioner Joshua Sharfstein states that the current 14-day review period on the safety assessment of the GE salmon, ending next Monday September 20, is far too short. CU is requesting that it be extended to a more common review period, such as 60 days. It also objects to the current composition of the VMAC, announced last week. A copy of the letter can be found here: http://www.consumersunion.org/pub/core_food_safety/016884.html
“When CU, the Center for Food Safety, and the Union of Concerned Scientists met with FDA officials in May, we were assured that even though approval of a veterinary drug is not normally a matter on which FDA solicits public input, the agency would allow for public input in this matter given that a decision on GE salmon is an important and unusual use of FDA’s authority on veterinary drugs, and because of the widespread public interest in this landmark decision,” Dr. Michael Hansen, Senior Scientist at Consumers Union, writes in the letter.
CU notes that while it appreciates that FDA released a summary of the scientific data underlying the FDA’s review, it has strong concerns about giving the public just two weeks to review the data on the human and environmental safety of the GE salmon, contained in 255 pages of technical information.
“The VMAC currently lacks any scientists whose primary expertise is in food allergies, growth hormones, endocrinology or fish ecology, the main topics on which the VMAC will have to render judgments in order to conclude that the salmon is safe,” states Dr. Hansen. CU is also strongly urging FDA not to make a decision on the safety of the first GE animal to be approved for human consumption without the input of scientists in these fields or without wider public input.
“We believe that without the extension of the review period, and the addition of certain scientific experts to the VMAC, the Committee’s findings will not have the needed credibility with the public. We also believe that without these experts, FDA will fail to get the sound scientific advice it needs and deserves,” Jean Halloran, CU’s Director of Food Policy Initiatives, writes in the letter. CU urges FDA to delay next week’s VMAC meeting for two months, to allow a standard 60-day public review period of the data that has been released, and to allow FDA to add the necessary and appropriate expertise to the VMAC.

Dr. Michael Hansen