FDA Says Science Around New Salmon Is Inconclusive

On Monday, after two days of hearings, U.S. FDA concluded there is not "sufficient data to determine that a genetic modification that enables salmon to grow twice as quickly is safe for the fish or for consumers."
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On Monday evening, after two days of hearings, the U.S. Food and Drug Administration concluded "that they do not yet have sufficient data to determine that a genetic modification that enables salmon to grow twice as quickly is safe for the affected fish or for consumers," according to ABC News.

The salmon in question, a product called AquAdvantage, have been genetically altered to contain a growth hormone gene from the Chinook salmon and a genetic switch from the ocean pout that turns on an antifreeze gene. The Atlantic salmon, which would be raised on farms, contain an extra growth hormone gene that allows them to grow to marketable size about twice as fast as conventional fish, enabling fisheries to increase profitability and bring salmon to market in 18 months versus the traditional 30 months.

Now the genetic manipulation and modification of our food supply isn't entirely new. This food technology which manipulates the DNA and engineers profitable characteristics and traits into food was introduced into our food supply about fifteen years ago. But it hasn't gotten a whole lot of attention in the U.S. media despite its controversial introduction in 1994, when scientists began engineering new traits into corn, milk and soy, enabling corporations to patent this newly licensed technology and the food supply, driving shareholder value and profitability.

And now, with the insertion of an "on switch" gene into the DNA of salmon, scientists at a company called AquaBounty Technologies have modified and patented the genetic makeup of salmon and engineered fish to eat year round so that it can grow twice as fast. As a result, salmon producers will be able to grow salmon more quickly, driving profitability and capitalizing on the growing demand for fish.

Approval of the salmon could pave the way for other such biotech animals to enter the food supply while no long-term human studies have been conducted to assess what the long-term health implications might be for humans. Because of a regulatory decision in the 1980s that no new laws are needed to regulate genetically engineered foods, the FDA is actually regulating the GE salmon as a drug.

"I do get heartburn when we're going to allow post-market surveillance to finalize our safety evaluation," said one committee member, Michael D. Apley, a pharmacology expert at Kansas State University, according to the New York Times.

According to the New York Times, "Ronald L. Stotish, the chief executive of AquaBounty Technologies, the company that developed the salmon, told the FDA committee that his company's salmon, known as AquAdvantage, would help the world meet rising demand for seafood without further devastating natural fisheries. Addressing environmental concerns over these fish escaping into wild salmon populations, AquaBounty Technologies shared that their intellectual property will be protected because the fish will be sterile, as they will all be triploids (fish with three complete sets of chromosomes instead of the usual two) and the company's patented and commercialized fish will all be females, making them unable to breed."

FDA committee members did not point out anything about the fish that would seem dangerous, relying on data funded and conducted by AquaBounty Technology, despite one study suggesting a possible increase in the potential to cause allergic reactions. The test showed a possible increase in the potential to cause allergic reactions that was almost statistically significant even though only six fish were used in each group in the study. In its allergenicity studies submitted to the FDA, AquaBounty converted its data into an undefined estimated measure it called "relative potency," a term the lab was unable to define when asked by the FDA.

With a fair amount of controversy around the allergenicity associated with this new technology (which created tension back in 2002 at a government meeting of the Food Biotechnology Subcommittee of the Food Advisory Committee in which the committee's acting chair, Edward N. Brandt, Jr., MD, PhD, said "Of course, we haven't worked into this some kind of test for allergencity, per se... "), the 1994 introduction of the genetic modification of our food supply, without accompanying labels alerting consumers of its presence, prompted an almost allergic reaction from renowned allergist, Dr. Fred McDaniel Atkins, who said, "To me, the logical problem is that we are going to take that stuff and feed it to the public without their informed consent."

At the same time, other nationally recognized allergists have remained relatively quiet regarding the allergenicity of genetically modified foods and some have invented patents for companies, like AquaBounty, that are responsible for the patenting and genetic modification of our food.

And while missing data appears not to bother some experts, including one of the FDA panel members who stated that "the salmon contains nothing that isn't in the human diet," Dr. Atkins' concerns over the allergenicity and long-term health implications of genetically modified foods are shared by others.

"We are missing data," said panel member James McKean, a professor at Iowa State University. He said that "leaves a cloud" over the FDA staff's analysis.

The FDA will hold its next public hearing Tuesday, September 21, 2010, as it considers whether to label the salmon as genetically modified. If approval does go through, the first genetically modified salmon could begin entering U.S. supermarkets within about two years, upon which the FDA will be relying on market surveillance measures similar to those currently being used by the egg and beef industry to assess post-market health implications.

Editor's note: An earlier version of this post stated that an 11-person panel consulted on the issue of GM salmon was composed of FDA employees. In fact, they were outside experts. Also, the headline stated that the science was 'unsatisfactory,' when in fact a more appropriate categorization is that it is inconclusive.

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