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Pallone Requests Thorough Review of FDA's Approval of Genetically Engineered Salmon


Location: Washington, DC

Congressman Frank Pallone, Jr., Chairman of the Energy and Commerce Committee's Health Subcommittee, on Friday requested more information from Food and Drug Administration's Commissioner Margaret Hamburg regarding the safety of genetically engineered salmon for public consumption. Pallone made this request after FDA officials indicated they are moving forward with the approval process to allow for the sale of genetically modified salmon in grocery stores.

"Putting genetically modified salmon in grocery stores would open up the marketplace for a new industry of genetically altered animals on dinner plates," said Pallone. "Before we cross this boundary, I want to see the FDA has done a thorough review of these genetically altered products. Up until this point, I don't believe FDA's review has been comprehensive enough to move forward with the approval process."

Under FDA's current regulatory procedures, genetically engineered salmon goes through the veterinary medicine approval process dedicated to reviewing the safety of drugs and feed for animal consumption. Pallone urged the FDA to reconsider this decision.

Pallone's letter to the FDA commissioner also expressed concern about the potential environmental side effects of genetically modified salmon which are largely unknown. Like farmed salmon, the production of genetically engineered salmon could move to offshore sites where wild and GE salmon may breed and cause disastrous results.

"At this point, there are too many unknowns for the FDA to move forward with putting this salmon on the market," added Pallone.

Congressman Pallone is also a member of the Natural Resources Insular Affairs Oceans & Wildlife subcommittee which has regulatory authority over our Nation's fisheries.

The text of the letter appears below.

September 24, 2010

Margaret Hamburg, M.D.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

I am writing to express my concern regarding the Food and Drug Administration's (FDA) current review of the AquaBounty Technologies (ABT) AquaAdvantage salmon. FDA is nearing a decision on whether to allow the first genetically engineered (GE) animal to be introduced to the public for human consumption. It does not appear that the FDA has considered all human and environmental impacts thoroughly enough and I ask that you suspend the approval and food labeling process until a full examination of the issues has been completed.

At a meeting from September 19-20, the FDA's Veterinary Medicine Advisory Committee (VMAC) considered Aqua Bounty's application. The FDA announced that the VMAC would, "consider issues regarding the safety and effectiveness of the new animal drug that is the subject of new animal drug application concerning AquAdvantage salmon produced by AquaBounty Technologies, Inc." Clearly, this meeting and the consideration it provided did not include a framework in which human consumption and its potential impacts could be fully vetted.

I remain concerned that the existing regulatory framework that FDA is using for the approval process as well as the information provided by the existing studies does not give the tools FDA needs to determine whether AquaAdvantage salmon warrants approval. Approval would represent the first GE animal allowed for human consumption and the safety and protection of consumers and environmental impacts require further study.

Furthermore, the FDA must not use a veterinary medicine approval process for GE animals that would be used for human consumption. The FDA needs to evaluate whether this particular GE salmon and all further GE animals warrant approval through a framework that uses studies and data that support its safety for human consumption. Concerns over human health risks continue to surround the approval of the AquaAdvantage salmon and because documents were recently released these risks have not been available for the scientific community to evaluate.

Furthermore, the FDA's approval of the AquaAdvantage salmon also poses environmental risks that have yet to be fully understood. Although, the current application is for inland tanks and in order to pursue off-shore aquaculture of GE salmon additional FDA approval would be required, I believe this decision could lead to future hazards. The National Oceanographic and Atmospheric Administration (NOAA) is currently developing a new national policy for marine aquaculture in an effort to expand its usage. With the expansion of off-shore aquaculture and the continued development of new species of GE fish there will greater pressure to allow GE fish into areas where they would threaten the marine life and environment. With Aqua Bounty's own data showing about a five percent fertility rate in their salmon, our wild salmon populations could quickly interbreed leading to devastating results. The unknown potential for the spread of infectious diseases into the natural environment is also of concern.

It is vital that we thoroughly consider all of the human health and environmental impacts before the FDA approves the AquaAdvantage salmon. With the risk that this approval poses to the public we can not use post-market surveillance to guide how we ensure safety. The FDA is setting precedent in allowing human consumption of a GE animal and it can not be rushed.

I strongly encourage you to suspend the decision on AquaAdvantage salmon until the FDA is able to develop a framework in which the human health and environmental impacts can be more thoroughly studied and reviewed.

Thank you for attention and assistance in this matter.


Member of Congress

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