FDA’s Incomplete Data Release is “Too Little, Too Late” — Fails to Uphold President Obama’s Call for Openness and Transparency

A broad coalition of consumer and environmental groups, along with community fishing organizations and food retailers, declared today’s partial data release by the U.S. Food and Drug Administration (FDA) on the genetically engineered salmon up for approval as a human food product insufficient and unacceptable.

“For the millions of consumers, fishermen, and stakeholders who will be affected by the FDA’s decision, FDA’s release of incomplete information today is simply too little, too late,” said Andrew Kimbrell, Executive Director for the Center for Food Safety.  “FDA’s fundamentally flawed process flies directly in the face of President Obama’s executive order for openness and transparency in government.” 

Materials made available today on FDA’s website relate to an announcement by FDA officials on August 25 that the agency will potentially approve the long-shelved AquAdvantage transgenic salmon as the first genetically engineered (GE) animal intended for human consumption.  The data provided by FDA today is rather scant given that the FDA has had 10 years to review the product. The study on changes in the morphology of the new GE salmon involved only 12 fish. The limited study on possible allergic reactions involved only 6 fertile GE fish and 6 infertile fish. These small sample sizes are inadequate for a full review of the health and safety of these fish when they are raised in a commercial operation. Rather than tell the company to run new studies with adequate samples sizes, the FDA is recommending the fish not be raised in the US, but that the eggs be produced in Canada and the fish be grown in Panama and imported into the US.

In a letter sent today to FDA Principle Deputy Commissioner Joshua Sharfstein, Rep. Dennis Kucinich called on FDA to slow down its process and ensure that the public has sufficient time and all available data to provide meaningful and informed public comment.  The letter requests FDA delay its public meetings by 30 days as well as provide a 90-day public comment period, currently absent from the GE salmon approval process.  Rep. Kucinich is the Chairman of the House Domestic Policy Subcommittee, which has broad jurisdiction over many federal agencies, including FDA.

The GE Atlantic salmon under consideration was developed by AquaBounty Technologies, which artificially combined growth hormone genes from an unrelated Pacific salmon, (Oncorhynchus tshawytscha) with DNA from the anti-freeze genes of an eelpout (Zoarces americanus).  This modification causes continuous production of growth-hormone year-round, creating a fish the company claims grows to full size at twice the normal rate of non-GE farmed salmon. This could allow factory fish farms to crowd fish and still get high production rates despite the stressful conditions found there.

While some materials released today relate to the transfer of the genes and DNA construct, and the chemistry of small samples of the flesh of the GE fish were compared to that of other farmed salmon, no data from long-term clinical feeding trials were required.  “Without the required testing and safety data we have no way to prove the transgenic salmon is safe to eat,” said Michael Hansen, Senior Scientist at Consumers Union.  Moreover, while the FDA is only recommending approval of sterile females for meat, the data released today show that up to 5 percent of the eggs produced may be fertile.   They did not list what protocols they will require of the company to assure that only infertile eggs are shipped to produce the salmon. Moreover, there is no discussion of potential sex changes in the fish.

One of the most serious issues regarding AquaBounty’s GE salmon is that FDA currently has no adequate means to assess the fish as a GE animal intended as a human food product. Rather than developing an appropriate evaluation method, FDA is currently proceeding to approve the GE fish through its process for reviewing a new animal drug. “By choosing to use the animal drug process for reviewing this GE fish, basic health and safety data was kept a secret until just before the hearing on its approval,” said Wenonah Hauter, Executive Director of Food & Water Watch. “It is outrageous to keep this vital information secret – consumers have a right to know what FDA is trying to allow into our food supply.”  Additionally, the materials released by FDA may not include anything claimed by AquaBounty as “confidential business information.”

“This is not a process that leads to full and informed public participation,” said Charles Margulis, Food Program Director at the Center for Environmental Health.  “After 10 years of this application sitting at the FDA, failure to give the public all available data in a timely manner shows just how misguided and deficient FDA’s approval process truly is.”

 “No new data was included in today’s materials relating to the environmental and economic risks that transgenic salmon will pose if they escape into the wild” said Erich Pica, President of Friends of the Earth US.  Despite being slated for widespread commercial production, the Environmental Assessment conducted by AquaBounty only focuses on two locations – Canada and Panama.  If approved, GE fish could be the last blow to wild Atlantic salmon stocks.  The FDA maintains the fiction that producing the eggs on a Canadian island in a gulf of the Atlantic Ocean will assure that the fertile fish won’t escape into the wild. “This conclusion is based on a flawed assessment completed by Aquabounty itself and wrongly assumes nothing will go wrong when in reality there are countless points where GE salmon can escape into the wild from this system,” added Pica.

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The statement was signed by: CENTER FOR FOOD SAFETY, FOOD AND WATER WATCH, GO WILD CAMPAIGN, ALLIANCE FOR NATURAL HEALTH, NATIONAL COOPERATIVE GROCERS ASSOCIATION, CONSUMERS UNION, FRIENDS OF THE EARTH, CENTER FOR ENVIRONMENTAL HEALTH, NORTHEAST ORGANIC FARMING ASSOCIATION AND THE MANGROVE ACTION PROJECT