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article imageFDA: Genetically modified salmon may be approved in 2013

By Igor I. Solar     May 7, 2013 in Science
Boquete - The US-Food and Drug Administration has completed the phase of public consultation prior to making a decision on allowing commercial production of AquaBounty’s genetically modified salmon and the fish going to market for human consumption.
In 2010, the United States Food and Drug Administration (FDA) said that AquaBounty’s genetically modified salmon (GM salmon; AquAdvantage Salmon) is safe to eat. In 2012, the FDA released a “Draft Environmental Assessment” (EA) and a “Preliminary Finding of No Significant Impact” (FONSI) in connection with the potential environmental impact of GM salmon. Both documents contain a “no effect” determination. The FDA says in its assessment:
“…The AquAdvantage Salmon will not jeopardize the continued existence of United States populations of threatened or endangered Atlantic salmon, or result in the destruction or adverse modification of their critical habitat, when produced and reared under the conditions described…” “FDA has carefully considered the potential environmental impacts of the proposed action and at this time has made a preliminary determination that this action would not have a significant effect on the quality of the human environment in the United States.”
On February 13, 2013, FDA announced the extension for 60 days of the comment period for the draft Environmental Assessment (EA) and preliminary Finding of No Significant Impact (FONSI) pertaining to AquaBounty Technologies’ application for AquAdvantage Salmon. The public-comment period concluded on 26 April. Now, once the FDA has closed public deliberation on whether the fish can be approved for human consumption, the company hopes to start soon producing the first genetically modified fish for human consumption: a bigger, faster growing salmon, reports The Guardian.
Size comparison of an AquAdvantage® Salmon (background) vs. a non-transgenic Atlantic salmon siblin...
Size comparison of an AquAdvantage® Salmon (background) vs. a non-transgenic Atlantic salmon sibling (foreground) of the same age.
Photo courtesy of AquaBounty
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The research and prospects of having the GM salmon in the market has led to a heated debate which has lasted for several years. Opponents in the US Congress are proposing a bill that would ban GM salmon completely. This may prevent AquaBounty from entering the U.S. market. Among those who question the product are retailers, consumer groups, environmental organizations and commercial fishermen; they are not interested in selling the GM fish and have vowed to boycott the product.
Opponents point out that not enough studies and independent research have been conducted to demonstrate that this GM salmon and other genetically modified foods, such as corn and soybeans, are safe for human consumption and have no adverse health effects. Furthermore, some have accused the FDA of refusing to conduct studies on consumption of GM salmon and its possible side effects on human health.
Among the detractors, there are those who insist that further testing is necessary to ensure long-term public health before approving commercial production and marketing of the GM salmon. According to some opponents only AquaBounty has been involved in studies on the safety aspects of transgenic salmon, which may cause bias on the results and emphasizes the need for additional independent, peer-reviewed studies.
However, other segments of public opinion do not see a problem with the GM fish. Some GM food supporters claim that injecting the genes of other fish to salmon, making possible faster growth during most of the year, and allowing the fish to attain a larger size in less time, is similar to selective breeding, except faster and more efficient and economic. Biotechnology researchers insist that many opponents among the general public do not understand the science behind this process and that lack of understanding causes rejection. Furthermore, there will be redundant security barriers to avoid the GM fish escaping culture facilities and the genetically modified fish will also be sterile which should preclude the potential interbreeding of the GM fish with wild Atlantic salmon, where they exist.
Farming of juvenile salmon.
Farming of juvenile salmon.
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The AquAdvantage Salmon founder population was generated in 1989 by micro-injecting a recombinant deoxyribonucleic acid (rDNA) construct (opAFP-GHc2), composed of a promoter from an ocean pout antifreeze protein (opAFP) gene and a protein-coding sequence from a Chinook salmon growth hormone (GHc2) gene into the fertilized eggs of wild Atlantic salmon. Subsequent selection and breeding led to the establishment of the AquAdvantage Salmon line, which has been reproduced for eight generations.
AquaBounty Technologies has continued investigating the production of genetically modified salmon called “AquAdvantage salmon”, under tight security in the locality of Boquete, in a remote tropical forest of Panama, 1,500 meters above sea level. Even if the verdict of the FDA is positive to AquaBounty’s objectives, the experimental fish will be terminated before commercial production starts.
The Panama grow-out site recently received a shipment of about 25,000 eggs from AquaBounty’s laboratory in Prince Edward Island, Canada. These fish are expected to reach market size within about 18 months, after which they could be destined for American supermarkets, reports The Guardian.
Nevertheless, production of the AquaAdvantage salmon in the Panamanian facility may be initially very limited. Because of capacity limitations, volume may not be much higher than 100 tons a year, according to a report in Nature. Such amount is tiny compared to the production of standard Atlantic salmon in Norway (1.15 million tons) or in Chile (about 500,000 tons).
Atlantic salmon is not the only fish species considered for commercial production using genetic engineering. A report from FAO published in 2003 indicates that since 1982 research is underway in various
Adult tilapia broodfish in a tank.
Adult tilapia broodfish in a tank.
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countries on genetic modification for commercial production of about 20 fish species including Coho and Chinook salmon, rainbow trout, tilapia, common carp, channel catfish, African catfish, and seabream, among others.
China is among the leading countries actively working on production of GM fish and other farm animals destined for human consumption. According to Nature, AquaBounty’s chief executive Ronald Stotish says that in the event the FDA does not give the go ahead to market the AquaAdvantage salmon, “I think we will end up eating genetically modified animals of a variety of species, but they’ll come from other countries.”
I invite readers of this article to express their opinion in connection with this issue in the comment section below.
More about GM salmon, Fda, AquaBounty Tecnologies, Aquadvantage salmon, Boquete Panama
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