FS Calls upon FDA to Recognize VMAC’s Concerns and Reject GE Salmon Approval

 The Center for Food Safety today commended the U.S. Food and Drug Administration’s (FDA) Veterinary Medicine Advisory Committee (VMAC) for taking a critical look at whether FDA should approve the long-shelved AquaBounty transgenic salmon as the first genetically engineered (GE) animal intended for human consumption.
 
“While several presentations and comments during the meetings today show just how beholden the FDA, including members of the Advisory Committee, is to the biotechnology industry,” said Andrew Kimbrell, Executive Director for the Center for Food Safety, “Other members of the VMAC criticized the poor science done by AquaBounty and demanded FDA require full and more comprehensive food safety and environmental reviews including a full environmental impact statement (EIS).”  One Committee member noted that there lacks adequate evidence to determine if this fish is truly safe. 
In comments delivered to the VMAC today, Jaydee Hanson, Senior Policy Analyst at the Center for Food Safety, noted that “FDA should have developed a more fulsome novel foods approach that included adequate feeding trials assessing this animal as a human and animal food.” FDA itself even details problems with the AquaBounty data and at times described it to be of limited value. “The environmental assessment presented by AquaBounty is a wholly inadequate review for this fish,” added Hanson.
 
The meetings, which began yesterday and ended today, are part of an approval process announced by FDA on August 25, 2010, which gave the public a narrow window of opportunity to review the limited data made available and provide public comment regarding the environmental and food safety concerns associated with the transgenic salmon. FDA plans to approve the GE salmon as a “veterinary drug,” a review process conceived before GE products became a reality. If the GE fish is approved, Agency officials are undecided as to whether they will require product labeling.

“The public comments given today underscored the numerous environmental, food safety, and economic risks and concerns this GE fish may pose,” said Jaydee Hanson, Senior Policy Analyst for the Center for Food Safety. Dr. Gary Thorgaard, the only member of the Committee with expertise on fisheries, called on FDA to conduct an Environmental Impact Statement, a sentiment echoed by other members of the Committee during the discussion period. “The Committee raised many of its own concerns regarding small sample sizes, incomplete data, culling practices, and poor scientific assessments over the past two days, and pointed to the complexity and numerous uncertainties that remain,” added Hanson.
 
Over 300 environmental, consumer, health, and animal welfare organizations, along with salmon and fishing groups and associations, food companies, chefs and restaurants signed joint letters to the FDA opposing the approval of AquaBounty’s GE salmon. CFS and a coalition of allied groups also submitted over 160,000 comments from individuals opposing the approval. In addition, 14 members of the California State Legislature sent a letter to FDA and President Obama requesting that FDA deny the approval until the full suite of environmental and food safety concerns are addressed.

The genetically engineered Atlantic salmon being considered 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 production of growth-hormone year-round, creating a fish the company claims grows at twice the normal rate, allowing factory fish farms to crowd fish into pens and still get high production rates.
 
Genetically engineered fish pose serious risk to wild populations of fish. Each year millions of farmed salmon escape into the wild, outcompeting native populations for resources and straining ecosystems. “We believe any approval of the salmon would represent a serious threat to the survival of native salmon populations already teetering on the brink of extinction,” said Kimbrell. In a presentation before the VMAC today, AquaBounty CEO Ronald Stotish reasserted the company’s desire to raise fish closer to populations and consumption centers, a comment that had to be redacted by FDA staff. “Stotish’s comments to VMAC today further exemplify the backdoor approval process that we feared from FDA.”
 
AquaBounty filed a New Animal Drug (NAD) application for AquAdvantage salmon with FDA in 2001, yet the agency chose not to disclose any data relating to its decision until just 10 working days before the public meeting. Hanson noted, “The data FDA provided to the public on food safety is altogether deficient given that the FDA has had 10 years to review the product.”
 
If FDA approves the GE salmon, the fish would be bred in the broodstock facility in Canada and fertilized, triploid eggs would be shipped to the grow-out facility in Panama, where they would be raised to market size. Yet the stipulation that the FDA tries to place on the approval, namely that the eggs be raised in Canada and the fish raised in Panama, ignores the easy transfer of a material like eggs in the international market. A full environmental impact statement should be required before the approval of the fish.
 
FDA announced yesterday that after the VMAC meetings, the Agency plans to publish the final environmental assessment (EA) as well as issue a notice in the Federal Register establishing a 30-day public comment period on the EA. A second FDA public meeting is scheduled for tomorrow, September 21, 2010 to discuss the labeling of food from the transgenic salmon. A 60-day public comment period on the labeling issue will be open until November 22, 2010.

In light of the numerous unknowns raised throughout the two day meeting, FDA officials announced that any approval will require post-market review and data requirements. Yet the VMAC expressed its concerns with FDA’s plan to require post-market reviews as sufficient for gaps in current safety data. “If there are concerns about safety then they should be addressed before going on the market, not after,” one Committee member stated.
 
“Today the public provided a resounding objection to GE fish and we hope that FDA will take heed,” said Kimbrell. “We strongly oppose the approval of these genetically engineered salmon and urge FDA to reject this application.”

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The Center for Food Safety is a national, non-profit, membership organization founded in 1997 to protect human health and the environment by curbing the use of harmful food production technologies and by promoting organic and other forms of sustainable agriculture. CFS currently represents over 125,000 members across the nation. Materials about GE fish including fact sheets, sign-on letters and testimony delivered to the VMAC are available on the web at: www.ge-fish.org

*CFS has worked with many states to pass laws and regulations on GE fish: California, Washington, Oregon, Maryland, Michigan, Florida and Alaska have all passed laws or rules regulating GE salmon, and Alaska requires labeling for any GE fish product.