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[genet-news] RISK ASSESSMENT & APPROVAL: What the FDA doesn’t want you to know about GE salmon



                                  PART 1


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TITLE:   WHAT THE FDA DOESN?T WANT YOU TO KNOW ABOUT GE SALMON

SOURCE:  Grist, USA

AUTHOR:  Tom Laskawy

URL:     http://www.grist.org/article/food-2010-11-12-what-the-fda-doesnt-want-you-to-know-about-ge-salmon

DATE:    12.11.2010

SUMMARY: "The Center for Food Safety has unearthed convincing evidence that the FDA is attempting to freeze out marine and fisheries experts from the U.S. Fish and Wildlife Service and National Oceanic and Atmospheric Administration in its rush to approve biotech company AquaBounty's genetically modified salmon for human consumption. According to documents obtained by the consumer group via a Freedom of Information Act request, the FDA has held only "preliminary" discussions with these agencies regarding AquaBounty's product and has not allowed government scientists to review some of the company's "confidential" data."

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WHAT THE FDA DOESN?T WANT YOU TO KNOW ABOUT GE SALMON

One of the arguments against expanding the FDA's powers over food safety is that the agency has repeatedly shown an unwillingness to enforce existing laws and to regulate aggressively in the face of corporate lobbying.

Unfortunately, we now have more evidence that the FDA may indeed be a bad-faith regulator.

The Center for Food Safety has unearthed convincing evidence that the FDA is attempting to freeze out marine and fisheries experts from the U.S. Fish and Wildlife Service and National Oceanic and Atmospheric Administration in its rush to approve biotech company AquaBounty's genetically modified salmon for human consumption.

According to documents obtained by the consumer group via a Freedom of Information Act request, the FDA has held only "preliminary" discussions with these agencies regarding AquaBounty's product and has not allowed government scientists to review some of the company's "confidential" data. According to an email sent between staffers at Fish and Wildlife and NOAA, they've been kept out of the loop for some time:

Shortly after the Atlantic salmon was listed as endangered, several of us from USFWS and NMFS spent 2 days down in Maryland meeting with AquaBounty and FDA about development of genetically modified salmon and discussion around the need for FDA to engage in Section 7 consultation with the Services. We never heard a peep out of FDA or AquaBounty after that.

It's ironic that the FDA, an agency so bureaucratically unprepared to regulate GE foods that it considers AquaBounty's salmon the same way it would a "veterinary drug" has decided that this process has no place for scientists who actually understand fish biology and marine ecosystems.

Specifically, the Center for Food Safety accuses the FDA of having "knowingly withheld a Federal Biological Opinion by the U.S. Fish and Wildlife Service (FWS) and National Oceanic and Atmospheric Administration (NOAA) prohibiting the use of transgenic salmon in open-water net pens pursuant to the U.S. Endangered Species Act."

While it's important to note that AquaBounty's system for growing genetically engineered salmon is land-based -- it has no plans to put these fish in ocean-based pens where the threat of escape is high -- it seems like a relevant point to observe that U.S. regulations currently forbid GE fish aquaculture in our coastal waters.

Moreover, government scientists have apparently established that GE salmon would out-compete native species for food, may have adaptive advantages in warming waters, and might collect environmental toxins in their flesh at higher rates than native species. This seems like useful information! But all of it was kept from the public and out of the recent FDA hearings on the safety of AquaBounty's fish.

Given that scientists at these two agencies have spent time looking into the issues surrounding GE salmon, it's deeply disturbing that the FDA has so explicitly excluded them from the approval process and suppressed their data in order to further a single corporation's interests. I guess the FDA never got the memo about all that "change we can believe in."



                                  PART 2

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TITLE:   NEWLY DISCLOSED GOVERNMENT DOCUMENTS CONCLUDE GE SALMON POSE A CRITICAL THREAT TO MARINE ENVIRONMENTS

SOURCE:  The Center for Food Safety, USA

AUTHOR:  Press Release

URL:     http://truefoodnow.org/2010/10/27/newly-disclosed-government-documents-conclude-ge-salmon-pose-a-critical-threat-to-marine-environments/

DATE:    27.10.2010

SUMMARY: "?This adds further evidence that in fact GE salmon pose a serious threat to marine environments and is another compelling reason for the FDA not to approve the fish for commercial use,? said Andrew Kimbrell, Executive Director of the Center for Food Safety. ?While the FDA applauded the company?s choice of land-based containment as responsible, it never revealed that it is illegal in the U.S. to grow genetically engineered salmon in open-water net pens.?"

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NEWLY DISCLOSED GOVERNMENT DOCUMENTS CONCLUDE GE SALMON POSE A CRITICAL THREAT TO MARINE ENVIRONMENTS

FDA Declined to Disclose Evidence During September Hearings on Aquabounty Salmon

Adding a new twist to the controversy over genetically engineered (GE) salmon, the Center for Food Safety (CFS) revealed today that, in recent hearings on transgenic fish, the U.S. Food and Drug Administration (FDA) knowingly withheld a Federal Biological Opinion by the U.S. Fish and Wildlife Service (FWS) and National Oceanic and Atmospheric Administration (NOAA) prohibiting the use of transgenic salmon in open-water net pens pursuant to the U.S. Endangered Species Act (ESA).

?This adds further evidence that in fact GE salmon pose a serious threat to marine environments and is another compelling reason for the FDA not to approve the fish for commercial use,? said Andrew Kimbrell, Executive Director of the Center for Food Safety. ?While the FDA applauded the company?s choice of land-based containment as responsible, it never revealed that it is illegal in the U.S. to grow genetically engineered salmon in open-water net pens.?

The Biological Opinion and supplemental information, obtained through a Freedom of Information Act (FOIA) request, challenge claims by AquaBounty Technologies, the developer of the GE salmon, that the transgenic fish pose no threat to marine environments. The GE Atlantic salmon under consideration was engineered with growth hormone genes from an unrelated Pacific salmon (Oncorhynchus tshawytscha) and DNA from the anti-freeze genes of an eelpout (Zoarces americanus).

The Biological Opinion issued by FWS and NOAA?s National Marine Fisheries Service (NMFS) to the U.S. Army Corps of Engineers in 2003 expresses concerns that transgenic salmon would threaten and adversely affect wild Atlantic salmon, currently on the Endangered Species List. Federal agencies are required by Section 7 of the ESA to consult with the expert fisheries agencies when any action may impact a protected species.  As part of the consultation, the expert agencies draft a Biological Opinion explaining under what circumstance the proposed activity would not endanger the survival of the protected species. The Biological Opinion here analyzed the authorization of net pen salmon aquaculture and required:

?The prohibition on the use of transgenic salmonids at existing marine sites off the coast of Maine? in order to ?eliminate the potentially adverse disease and ecological risks posed by the use of transgenic salmonids in aquaculture.?

Despite this knowledge, it appears that FDA has not consulted in depth with the expert fisheries agencies regarding the current Aquabounty GE salmon. FDA acknowledges that ?preliminary? discussions have been held.  However, the documents released today by CFS also include an email from FWS staff to NOAA further revealed that:

Shortly after the Atlantic salmon was listed as endangered, several of us from USFWS and NMFS spent 2 days down in Maryland meeting with Aqua Bounty and FDA about development of genetically modified salmon and discussion around the need for FDA to engage in Section 7 consultation with the Services. We never heard a peep out of FDA or Aqua Bounty after that.

?The recent developments only add to the increasing concerns raised by the public, members of Congress and the FDA?s own Advisory Committee,? said Jaydee Hanson, Senior Policy Analyst at the Center for Food Safety. ?The documents received make clear that some data was even kept from FWS and NMFS scientists who would not sign the confidentiality agreements requested by the FDA. If the FDA won?t even share confidential company data with government scientists, what else is it keeping secret from the public?? added Hanson.

In a similar Biological Opinion issued by FWS and NMFS to the U.S. Environmental Protection Agency in 2001, also included in the material released by CFS today, the agencies noted:

It is reasonable to assume that genetically-modified salmonids, possessing a greatly accelerated growth potential and occupying the same habitat as wild fish, would have a greater displacement impact on wild fish than non-transgenic domestic strains.

Conversations between NOAA and FWS staff in 2009 highlight a Swedish study that found that in simulated escapes, transgenic fish have a ?considerably greater effect on the natural environment than hatchery-reared, non-transgenic fish when they escape.? The study further noted that genetically modified fish survive better when there is a shortage of food, benefit more than non-transgenic fish from increasing water temperatures, and can be more resistant to environmental toxins that may ultimately end up in consumers.

?Today the public gains much needed insight about the risks of GE fish, we hope that FDA will take heed,? added Kimbrell. ?We strongly oppose the approval of these genetically engineered salmon and urge FDA to reject this application.?

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The Center for Food Safety is a national, non-profit, membership organization founded in 1997 to protect human health and the environment by curbing the use of harmful food production technologies and by promoting organic and other forms of sustainable agriculture. CFS currently represents over 125,000 members across the nation. Materials about GE fish including fact sheets, sign-on letters and testimony delivered to the VMAC, and full EPA and Army Corps Biological Opinions are available on the web at: www.ge-fish.org




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