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FDA Approves 1st Genetically Engineered Salmon for Human Consumption



November 20, 2015
Friday PM

(SitNews) - The U.S. Food and Drug Administration announced Thursday it is taking several important steps regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon.

The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from genetically engineered plants.

The FDA approved AquaBounty Technologies’ application for AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-GE farm-raised Atlantic salmon. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.

jpg FDA Approves 1st Genetically Engineered Salmon for Human Consumption

Atlantic Salmon
Graphic courtesy

“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

In addition to approving AquaBounty Technologies’ application for GE salmon, the FDA issued draft guidance for manufacturers wanting to voluntarily label their products as containing GE or non-GE ingredients. Under this guidance, additional labeling of AquAdvantage Salmon would not be required because the FDA says it found no material difference from its natural counterpart. Manufacturers could voluntarily label their food products as “not genetically engineered” or other variations under the FDA’s guidance.

“We recognize that some consumers are interested in knowing whether food ingredients are derived from GE sources,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA is issuing two guidance documents that explain how food companies that want to voluntarily label their products can provide this information to consumers.”

After years of pushback from consumers, scientific experts and fishing interests, the Alaska Congressional Delegation, who has consistently fought to keep genetically engineered (GE) fish off the nation’s dinner plates and away from our nation’s oceans, shared their disappointment in the FDA’s ill-advised decision.

“I am livid at the FDA’s announcement to approve genetically engineered ‘salmon’ - what seems to be more science experiment than fish or food,” said Senator Lisa Murkowski (R-AK). “I have adamantly opposed the approval of GE salmon, both for the health of Americans and the sustainability of our fisheries, but now that the decision has been made, the next step must be to ensure that Americans know what they are consuming. I have introduced both a bill and provision in the appropriations process to mandate the labeling of Frankenfish, and it is more imperative than ever, after this potentially disastrous decision, to make sure they become law.”

“I am extremely disappointed in [Thursday’s] decision by the FDA,” said Senator Dan Sullivan (R-AK). “Genetically Engineered (GE) salmon has no business on our dinner plates. I remain committed to ensuring that at minimum, these newly approved Frankenfish are properly labeled so that Americans know exactly where their salmon came from. Wild Alaskan salmon is an abundant, sustainably managed resource, and despite this misguided decision, will continue to be one of the healthiest and tastiest foods in the world.”

"This harebrained decision goes to show that our federal agencies are incapable of using commonsense,” said Congressman Don Young (R-AK). “From the beginning, I’ve said the FDA’s process fails to consider the threats GE fish pose to natural salmon fisheries, including genetic contamination, interbreeding, and direct competition. By embarking on this science experiment, the FDA ignores fundamental risk questions related to our wild fish species and food safety. I will continue to push back against this decision that puts all our wild fisheries at risk. At the bare minimum, we must ensure that GE salmon are labeled so consumers know exactly what they are purchasing and feeding to their families.”

The Alaska Delegation has sponsored and supported numerous pieces of legislation to eliminate the threat of GE fish, including efforts to effectively ban the shipment and sale of such products, and others that would require labeling of GE salmon.

Since 1996, AquaBounty Technologies has been developing GE salmon with the hopes of receiving FDA approval to sell it for human consumption. The specific process splices genetic material from the Chinook (King) salmon with that of a pout fish and Atlantic salmon. The resulting organism, the company claims, would grow to the size of an Alaskan King salmon in a shorter period of time than found in nature.

The FDA said they determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act based on a comprehensive analysis of the scientific evidence. Among the requirements the sponsor had to meet are that food from the fish is safe to eat; the rDNA construct (the piece of DNA that makes the salmon grow faster) is safe for the fish itself; and the AquAdvantage Salmon meets the sponsor’s claim about faster growth. In addition, the FDA determined that food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.

According to the FDA, AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States. In fact, under this approval, no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers. As required by the National Environmental Policy Act, the FDA completed an environmental assessment to determine whether approval of the application would result in significant effects on the quality of the human environment in the United States. The FDA has determined that the approval of the AquAdvantage Salmon application would not have a significant environmental impact because of the multiple and redundant measures being taken to contain the fish and prevent their escape and establishment in the environment.

The FDA says these measures include a series of multiple and redundant levels of physical barriers placed in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. Finally, the AquAdvantage Salmon are reproductively sterile so that even in the highly unlikely event of an escape, they would be unable to interbreed or establish populations in the wild.

The FDA will maintain regulatory oversight over the production and facilities, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments will also be conducting inspections of the facilities.

The FDA held a Veterinary Medicine Advisory Committee meeting on the sufficiency of the scientific review and a hearing to gather opinions on labeling of food from AquAdvantage Salmon. The agency received and reviewed comments from these two meetings. In addition, the agency released a draft environmental assessment and preliminary finding of no significant impact for public comment; these comments were also reviewed prior to the agency’s final decision.

“The FDA’s action is another dangerous step into a new world of genetically modified foods,” said Representative Geran Tarr (D-Anchorage). “The FDA ignored the concerns that these Frankenfish will negatively impact the markets for Alaska’s abundant wild salmon. These fish will be created in Canada, raised in South America, and sold in the U.S. At some point a Frankenfish could escape into the wild. Because of human intervention these fish could possibly out compete wild salmon. That’s an unacceptable risk. I for one don’t want to eat a fish that goes from the laboratory to the factory and then to the plate.”

In 2013 Rep. Tarr sponsored House Joint Resolution 5 opposing allowing genetically modified fish to be sold for human consumption. The resolution, which was cosponsored by Representative Scott Kawasaki (D-Fairbanks), passed the Alaska House and Senate without opposition.

“Alaska’s wild salmon supports thousands of jobs and feeds millions of people across the globe,” said Rep. Kawasaki. “The FDA is risking this sustainable resource so a company can make a profit by selling a product that would not and could not exist in nature. I strongly support protecting people over the gross profits of a few corporations.”

“Alaska protects and preserves our salmon resource, which is why we have thriving commercial, sport and subsistence salmon fisheries that are second to none worldwide,” said Representative Scott Kawasaki (D-Fairbanks). “I don’t agree with the FDA’s Frankenfish decision. The risk to our wild salmon is just too great.”

This year over 263 million salmon were harvested commercially in Alaska, which was the second largest salmon harvest on record. The largest salmon fishery in the world is in Alaska’s Bristol Bay. Last month the Alaska Department of Fish and Game released the 2016 forecast, which anticipates a return of over 46.5 million sockeye salmon. This year the total sockeye run to Bristol Bay was 58 million fish.

To date, over 60 retailers, including several large grocery store chains, have pledged not to sell genetically modified fish. Additionally, 60 countries impose severe restrictions or outright bans on genetically modified foods. In Alaska genetically modified foods can be sold but thanks to legislation passed by the Alaska Legislature they must be properly labeled.

“Increasingly the United States is the international outlier when it comes to genetically modified foods because the federal government is embracing the concept while much of the rest of the world is rejecting it,” said Rep. Tarr. “Labeling is critical and I’m glad we require labeling of Frankenfish sold in Alaska. As more and more genetically modified foods are considered we must have good labeling laws because people demand to know what’s in their food.”

The agency will be accepting public comment for 60 days starting on November 23, 2015 on Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon. Click here (FDA)


On the Web:

Comment online: Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon

Documents related to this approval by the FDA's of the new animal drug application concerning AquAdvantage Salmon, a genetically engineered Atlantic salmon.
Click here (FDA)

Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon
Click here (FDA)


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