Back in September, the U.S. Food and Drug Administration found
that a genetically engineered fish grown in a lab was "as safe as food from conventional Atlantic salmon," and will "not have a significant impact on the quality of the human environment." Conclusions were based largely on data prepared by AquaBounty Technologies
, the company that manufactures the synthetic salmon. "There is a reasonable certainty of no harm from consumption of food from this animal," the FDA wrote.
Since then, dozens of consumer and environmental organizations, commercial and recreational fishery associations, food-safety advocates, food retailers, and chefs have been putting pressure on the FDA to continue researching the environmental and public health impacts of the fish before releasing it into the U.S. food supply. Consumer advocates argue that the FDA's decision to approve this fish could open up a pandora's box of genetically engineered animals on the market without labels and that the FDA is not taking these concerns seriously.
If the FDA approves the scientifically created salmon, a product called AquAdvantage
, it will be the first time a genetically engineered animal has been given the green light for human consumption.
The salmon is created by inserting the genetic material of two breeds of fishes, the chinook, a variety of Pacific salmon, and the ocean pout, an eel-like fish that can survive in extremely cold temperatures, into the genome of Atlantic salmon. According to AquaBounty, the AquAdvantage fish grows twice as fast as natural salmon because it can continue development in icy-cold waters. The resulting fish is purportedly a triploid
, with three sets of chromosomes instead of two, a genetic condition that makes the animal sterile.
AquaBounty plans to produce these salmon eggs in Canada, and then grow them in Panama, in controlled facilities, before shipping the salmon to the U.S. for consumption.
Last week, a coalition of 12 organizations including Union of Concerned Scientists and Food and Water Watch sent a letter
to President Obama and the FDA, urging the regulatory agency to conduct a full environmental impact statement beyond the scope of what AquaBounty prepared in support of its application.
"GE salmon could pose serious threats to biodiversity, and to the viability of wild Atlantic salmon should they escape from production facilities," the coalition wrote in its letter. AquaBounty's own data shows that the triploid sterilization process is not effective in about five percent of treated eggs. Because AquaBounty has orders for 15 million eggs, in practice, this could mean upward of 750,000 fertile, genetically engineered eggs which, when hatched, could wreak havoc on wild salmon, further threatening an already endangered population.
Another chief concern is that the science AquaBounty has conducted does not provide conclusive evidence that the AquAdvantage fish is safe, nutritious, or ecologically sound. According to an investigative report
by Jill Richardson at Alternet, partially titled 'The Creepy Science Behind Genetically Engineered "Frankenfish,"' many of AquaBounty's tests included sample sizes as small as six fish -- not large enough to be statistically significant --and samples were not chosen randomly -- deformed fish were removed from the studies.
Dr. Gary Thorgaard
, a professor at Washington State University, sat on the FDA's Veterinary Medicine Advisory Committee, which analyzed AquaBounty's application. He told Politics Daily that the science AquaBounty presented to the committee would likely not have been accepted by a peer-reviewed scientific journal. "I'm not convinced that there's really a hazard, but this is historic enough and precedent-setting enough that it deserved a full, careful analysis through an environmental impact statement." Thorgaard, who studies fish genetics, said he was involved in the early stages of developing triploid fish.
Another scientist urging closer scrutiny, and an environmental impact statement, is Dr. George Leonard, director of the aquaculture program at Ocean Conservancy
. "On the one hand, we don't have enough environmental and food safety data to conclude that the fish are unsafe. We also don't have enough data to know that they are safe. In the absence of an affirmative conclusion, we have to do a broader and more comprehensive analysis to answer to that question."
An environmental impact statement would require the FDA to enlist independent scientists to conduct research, a process that would likely be more objective and rigorous than relying on company science.
If the fears of the environmental and consumer health advocates are realized, the FDA will declare a "finding of no significant impact" (FONSI) as opposed to agreeing to conduct a full environmental impact statement.
A spokesperson for the FDA said that the agency was making the decision using comments from the Veterinary Medicine Advisory Committee as well as from the public. If a preliminary decision is made to prepare a FONSI finding, the original environmental assessment would be made available for public review and comment for an additional 30 days. That has to happen before any final decision about whether to approve the application. "None of these steps have yet been initiated," the FDA representative said.
Suzanne Turner, a spokesperson at AquaBounty Technologies, said in an email that the company stands behind the science and that "all the research was conducted and performed appropriately," adding in a phone conversation, "The FDA took 15 years to analyze and ask for more data. The FDA concluded in its own document and on its own website that these fish are the same as every other salmon. These fish are being grown in contained systems. They're not being grown in net pens or in rivers. They are sterile to over 98 percent, but it doesn't matter, because they can't get out of these facilities and escape into the wild."
Whether concerned with inconclusive science or unnerved by the thought of genetically altered fish being sold unlabeled at supermarkets, there has been a surge of public support for further investigation by the FDA. Eric Hoffman, a biotechnology policy campaigner at Friends of the Earth, said that 171,645 public comments were sent to FDA in just two weeks, asking the agency to be more discriminating in its approval process for AquAdvantage.
But the FDA's two-week window for public comments is small, (the FDA has had AquaBounty's application since 1999) and the agency only recently released over 200 pages of technical information, he argued. "It is unclear why all of the sudden the FDA is expediting the approval process for this fish."
It's not just the public that is apprehensive.
The consumer advocacy group Food & Water Watch
obtained internal e-mails from the U.S. Department of Interior's Fish & Wildlife Service through a public document request that indicated several federal scientists question whether the FDA should have the authority to regulate GE animals at all. Jeff Adams, a branch chief at the wildlife service wrote, "The proposal [to approve AquaBounty salmon] also presents a situation where FDA, whose jurisdiction is not focused on natural resources, is entrusted with the authority to approve an application which poses a threat to the country's natural resources."
and at least 30 House members and 13 senators from both sides of the aisle have expressed concern with the FDA's review process, with many calling for the prohibition of genetically manipulated salmon. In a letter to Dr. Margaret Hamburg, commissioner of the FDA, 13 members of the California legislature wrote that the "FDA's decision-making process fails to provide the public with sufficient time or access to the necessary data to allow for meaningful participation and a transparent and robust decision."
Sibohan DeLancey, a spokesperson at the FDA, told Politics Daily she was not familiar with that particular letter from the California legislature. "Our review process is not complete, and it would be preliminary to comment on methodology," she said. She took issue with the claim that the approval process was not transparent. "Normally when a company makes an application for approval, we don't release anything to the public. In this case, there were open comment periods and an open public hearing in which we provided three days for the public to comment, listen to our conclusions, and make their own conclusions."
Representatives from AquaBounty have been dismayed by the amount of negative attention their engineered salmon has received. CEO Ronald Stotish wrote, "The distortions and outright lies being spread by opponents of new technologies are a measure of desperation. Cherry picked e-mails do not discount the rigorous and careful scientific review conducted by the Food and Drug Administration. "
AquaBounty spokeswoman Turner said the negative media attention "is like having your hands tied behind you and being beaten up. We are a very small company. We don't have the resources the opposition has. People are lying about a product, and it's a product that could be helpful. The benefit to the consumer, the benefit to the planet, is that the oceans are on the verge of a complete collapse. If we are going to continue to have seafood, we have to use all of our tools in the tool kit to figure out ways to meet the need." She did not comment on whether the company would support further study of the fish by the FDA.
Genetically engineered animals will continue to be developed. AquaBounty is also currently developing a GE trout and a GE tilapia. Other companies are working on a GE pig and a GE cow. Jaydee Hansen, senior policy analyst at the Center for Food Safety
, recommended that the public submit comments to the FDA website, asking that the agency conduct a full environmental impact assessment before allowing products like AquAdvantage, that have not undergone rigorous testing, to go to market. Comments can be submitted at regulations.gov
or at the Center for Food Safety
, and a petition can be signed at Change.org
. In addition, he suggested that consumers call their representatives and ask them to support the legislation introduced by Rep. Dennis J. Kucinich (D-Ohio), which requires labeling for genetically engineered food in the U.S., and Rep. Donald Young (R-Alaska), which prevents the approval of genetically engineered fish.
The window for the public to express concern is closing fast. Monday, Nov. 22, the FDA will officially stop accepting comments.
What will happen after then remains unclear.
Dr. Thorgaard predicts that the FDA will approve the AquAdvantage salmon without further study. "I was the only one of the 12 panel members who called for an environmental impact assessment," he said.
But food safety advocate Hanson thinks otherwise
. "Frankly, this is a very small company that made a bad bet that they could get this approved." Combine resistance from other federal agencies, overwhelming opposition from the public, and Republican and Democratic congressional legislation against it, and it seems that the FDA is going to have to make a much better argument for why the agency is approving this fish, he said. "We are not unilaterally against [genetically engineered] animals. We are just looking for the first GE product that actually brings value to the consumer. In my mind, this fish was developed so you could crowd more of them in and get them to gain weight faster."
The FDA is poised to put the first genetically engineered salmon on our dinner plates despite the fact that 91 percent of Americans feel that genetically engineered fish and meat should not be allowed into the marketplace
. That so many Americans oppose what will likely be a milestone decision about the future of seafood should be sounding alarm bells at the FDA.
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