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US Senator Mark Begich. (Photo: www.begich.senate.gov)

Congress urges FDA to halt GE salmon approval process

Click on the flag for more information about United States UNITED STATES
Friday, October 01, 2010, 04:10 (GMT + 9)

Twenty-four members of Congress are urging the US Food and Drug Administration (FDA) to stop the approval process for AquaBounty Technologies’ genetically modified (GM) AquAdvantage salmon. They are asking the FDA to wait until it painstakingly analyses and addresses some serious flaws in its approval process and incorporates more public input and scientific data.

In a similar move, US Senator Mark Begich, who has signed a letter which will be sent to the FDA, said it has been signed by another 10 senators and is supported by 52 environmental groups, consumer groups, retailers, food businesses and commercial and recreational fisheries associations, such as the Yukon River Drainage Fisheries Association, the Alaska Marine Conservation Council and Bristol Bay Regional Seafood Development.

Congressman Mike Thompson, D-St Helena and the other members of the House of Representatives addressed a letter to FDA Commissioner Margaret Hamburg affirming that the Administration should not approve the first transgenic animal for human consumption because the review process is flawed. The government officials argue that genetically engineered (GE) fish put wild populations of fish in jeopardy, as millions of farmed fish have already escaped farms and made it into the wild.

The letter envelops four grave concerns -- that the review method employed is seriously deficient; a lack of data on whether the GE salmon is safe for human consumption; probable irreversible environmental impacts; and that the FDA is not fulfilling its responsibility to consumers by failing to demand a label that states the fish is GE.

”FDA's move to approve GE salmon threatens fishing families across the country, native wild salmon, as well as the millions of federal and state dollars invested to restore salmon populations,” said Thompson. “Given the current lack of information, threats to human health, the environment and the livelihood of hard working fishing families, it would be irresponsible for the FDA to approve GE salmon.”

The representatives complain that critical information has been hidden from the public and that consequently only FDA and AquaBounty are aware of critical details regarding the approval process for the GE salmon.

“While AquaBounty filed a New Animal Drug application for AquAdvantage salmon with FDA in 2001, the Environmental Assessment compiled by AquaBounty for the FDA is inherently flawed and does not take into account the full and broad range of impacts the approval of the GE salmon could have on the environment. The FDA should have initiated a full Environmental Impact Statement (EIS) and consulted with other federal agencies responsible for managing federally listed Endangered Species,” the letter reads.

The senators, for their part, urged the FDA to “halt all proceedings” because potential human health and environmental impacts have not been fully or openly reviewed.

“One of the most serious concerns regarding AquaBounty’s application is the FDA has no adequate process to review a GE animal intended as a human food product,” they said in their letter to the FDA.

“FDA is considering this GE fish through its process for reviewing a new drug to be used by animals, not for creation of a new animal, especially one intended for human consumption. Clearly, this is inappropriate.”

Related articles:

- Consumers Union worries GE salmon is unsafe
-
Experts urge to delay approving GM salmon
-
GM salmon faces widespread opposition

By Natalia Real
[email protected]
www.fis.com


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