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Groups Petition FDA To Classify Genetically Engineered Salmon As Food Additive For Rigorous Review
Posted on Friday, February 10, 2012 (PST)

This week consumer groups Food & Water Watch, Consumers Union, and the Center for Food Safety submitted a formal petition asking the Food and Drug Administration to classify and evaluate AquaBounty’s “AquAdvantage” genetically engineered salmon and all of its components as a food additive.


The groups’ legal petition contends that the current agency review process that treats GE salmon only as a new animal drug is insufficient to protect public health, and that the agency is required by law to review the GE salmon under what should be a more rigorous process for any novel substance added to food.


“The data FDA has on GE salmon, which were supplied by Aquabounty, are incomplete, biased, and cannot be relied upon to show that the GE salmon is safe to consume,” said Food & Water Watch Executive Director Wenonah Hauter. “Aquabounty’s own study showed that GE salmon may contain increased levels of IGF-1, a hormone that helps accelerate the growth of the transgenic fish and is linked to breast, colon, prostate, and lung cancer.”


The groups warn that the potential health risks of GE salmon are no different from a number of food additives the FDA has banned in the past, including those that are cancer causing.


“FDA’s choice to allow the first proposed transgenic animal for food to somehow only be reviewed as a drug is contrary to law, science and common sense,” said George Kimbrell, senior attorney for the Center for Food Safety.  “Public health and transparency should be championed, not skirted, particularly when contemplating such an unprecedented approval.”


In order to create the transgenic fish, Aquabounty genetically engineered an Atlantic salmon by inserting a chinook salmon growth-hormone gene, as well as a gene sequence from an ocean pout. The company claims this engineering causes the GE salmon to undergo an increase in growth rate that allows the fish to reach market size in half the normal time.


Aquabounty has submitted an application to FDA for approval of the transgenic salmon under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act. 


The consumer groups’ petition asserts that the process used to create the GE salmon substantially alters its composition -- including its nutrition value -- and demand that the fish and its components be treated as a food additive pursuant to FDA’s guidelines.  As a food additive, AquaBounty’s GE salmon would be considered unsafe for consumption unless the company’s data overwhelmingly proved otherwise, say the consumer groups.  


“If FDA actually evaluated GE salmon as a food additive, including allergy-causing potential, they would not likely be able to approve it because of the health risks that have can already be seen in an incomplete set of data,” said Michael Hansen, senior scientist with Consumers Union, the advocacy arm of Consumer Reports.


The groups assert that a proper review process would require GE salmon to undergo comprehensive toxicological studies, specifically those developed to ensure that foods entering the market are safe to consume and are properly labeled.


Last year U.S. Rep. Don Young of Alaska introduced legislation that would require the labeling of genetically engineered fish and another that would impose an outright ban such fish in the United States.


The legislation was in response to AquaBounty Technologies’ proposal now currently under consideration by the FDA. If the proposal to manipulate Atlantic salmon genetics to produce faster growing fish is approved, it would be the first transgenic animal ever approved for sale in the country for human consumption.


“Frankenfish are uncertain and unnecessary,” Young said. “The assessments of these ‘fish’ are flawed at best and the threat to the population of our wild salmon stock is unacceptable. Additionally, consumers have the right to know that they are eating a supposedly sterile fish spliced with the growth hormone of a chinook and the genetic code of an ocean pout. We cannot allow these alien fish to infect our stocks and I will put forth every effort to ensure they stay in the labs where they belong. I choose Alaskan wild salmon every time.”


Also last year, Alaska's senators, Mark Begich and Lisa Murkowski, introduced a bill co-sponsored by Sen. Patty Murray of Washington to ban genetically engineered salmon. The senators also introduced a second bill co-sponsored by Murray and Sen. Ron Wyden of Oregon that would require labeling of GE salmon in the event that such fish are approved for consumption.


Aqua Bounty Technologies of Waltham, Mass., has pioneered the genetic modification of salmon to grow the fish to full-size in half the time it now takes for natural salmon. The fish would get a growth gene from the Pacific chinook salmon and genetic material from the ocean pout, an eel-like fish, that would allow it to grow in the summer and winter.


The developer had to file a new animal drug application with FDA because the process alters the structure and/or function of the animal.


An FDA preliminary analysis in 2010 concluded that the salmon are safe to eat and not expected to have a significant impact on the environment.


The company says that the risk of escapement, and the potential intermingling with wild salmon stocks, is eliminated with geographical and geophysical containment provided by the location of the egg production and grow-out sites. The environment surrounding the egg-production site in a hatchery on Prince Edward Island off the east coast of Canada is inhospitable to early-life stages of Atlantic salmon due to high salinity.


And, the environment downstream of the grow-out site in Panama’s highlands is inhospitable to all life stages of Atlantic salmon due to high water temperatures, poor habitat, and physical barriers (e.g., several hydro-electric facilities).


Biological containment is accomplished through the production of all-female triploid (sterile) fish, which reduces the chance of breeding with native species, and significantly reduces the risk of transgene propagation in the environment, the company says.


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