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[genet-news] RISK ASSESSMENT & APPROVAL: More revelations of FDA bad behavior around GE salmon



                                  PART 1


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TITLE:   MORE REVELATIONS OF FDA BAD BEHAVIOR AROUND GE SALMON

SOURCE:  Grist, USA

AUTHOR:  Tom Laskawy

URL:     http://www.grist.org/article/food-2010-11-16-fda-bad-behavor-over-ge-salmon

DATE:    16.11.2010

SUMMARY: "Last week the Center for Food Safety reported that the FDA had frozen out the U.S. Fish and Wildlife Service and National Oceanic and Atmospheric Administration in its rush to approve AquaBounty's transgenic salmon for human consumption. [...] new revelations show that the government's fisheries and marine experts were explicitly concerned about the FDA's behavior - and that the agency seems to be intentionally understating the real risks of AquaBounty's salmon."

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MORE REVELATIONS OF FDA BAD BEHAVIOR AROUND GE SALMON

Last week the Center for Food Safety reported that the FDA had frozen out the U.S. Fish and Wildlife Service and National Oceanic and Atmospheric Administration in its rush to approve AquaBounty's transgenic salmon for human consumption. Some have since suggested that this wasn't a problem, since the two agencies' concerns weren't specific to AquaBounty's indoor-only system and relied on old studies. Now, new revelations show that the government's fisheries and marine experts were explicitly concerned about the FDA's behavior -- and that the agency seems to be intentionally understating the real risks of AquaBounty's salmon.

Food & Water Watch (FWW) has posted a new set of emails from Fish and Wildlife Service officials that indicate deep concerns about the safety of the GE salmon. Even worse, they believe the FDA to be skirting the law in its approval process for the fish. According to FWW, "high-ranking officials" complained that, though the Endangered Species Act requires the FDA to consult with Fish and Wildlife over anything that would affect wild Atlantic salmon, the agency never set up a process by which to do it.

These officials also raised concerns that despite AquaBounty's claim that its fish are sterile (and thus unable to reproduce with wild salmon), the genetic manipulation techniques the company uses are not foolproof: up to 3 percent of its fish may indeed be fertile and thus capable of reproducing with wild fish in the event of an escape.

As one Fish and Wildlife Service scientist wrote in an incredulous email: "Maybe they [the FDA] should watch Jurassic Park."

How would they escape? Would these new salmon miraculously sprout legs? No need: turns out AquaBounty is considering building a facility to grow its fish that would discharge water into the ocean off the Maine coast -- prime Atlantic salmon habitat. As one Fish and Wildlife official put it, "No matter what precautions you take, fish escape and once they do, there is no closing that door ... I think it is very bad precedent to set."

Some of this rush to approval -- the FDA may rule in favor of the GE salmon as soon as Nov. 23 -- clearly comes from the FDA's strongly held belief that so-called "tail risk" doesn't exist with GE salmon. Tail risk is the au courant term for "highly unlikely but potentially devastating" events, the end of a curving risk graph. The last industry to ignore tail risk was the financial sector. And we all know how that turned out.

Apparently, the FDA feels perfectly comfortable playing roulette with an endangered species in order to help a single company's bottom line.

Introducing a sustainable new taste sensation: Arctic salmon!

But really this all comes from an attempt to ignore an even larger reality. Instead of insisting on eating a fish whose stock is fast disappearing in the wild and is unsuitable to environmentally sustainable aquaculture, we could -- as Four Fish author Paul Greenberg suggests -- switch over to another delicious, pink-fleshed fish that is closely related to salmon: the Artic char.

Unlike salmon, which are carnivorous (requiring lots of fish to grow big) and raised in ocean-based pens that can wreak environmental havoc, Arctic char is raised in land-based, freshwater systems that aren't nearly as resource intensive. Even Monterey Bay Aquarium's Seafood Watch rates farm-raised char as a "Best Choice."

Here's an idea: Rather than spend $50 million a pop genetically engineering endangered species, how about getting some marketing whiz to rebrand Arctic char as, I don't know, Arctic salmon? All we'd have to do is print up some new, attractive in-store displays, and we could leave the fish's genome alone. A simple name change was enough to drive the homely Patagonian toothfish to near-extinction once it was known to consumers as Chilean sea bass. Farmed Arctic char, however, can handle the pressure. Maybe a "re-launch" is in order? How's that for thinking outside the box?

The FDA/AquaBounty fiasco is in fact a bizarre attempt to maintain the fish-market status quo, and consequences -- especially unintended ones -- be damned. And if the worst does happen, and AquaBounty fish escape and start pushing native salmon to the brink of extinction? Well, the FDA and company officials will likely echo the titans of finance who, when faced with a similarly epic disaster, simply shook their heads and said, "No one could've predicted such a perfect storm."



                                  PART 2

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TITLE:   TROUBLING EMAILS REVEAL FEDERAL SCIENTISTS FEAR FDA APPROVAL OF GENETICALLY ENGINEERED SALMON: ?MAYBE THEY [THE FDA] SHOULD WATCH JURASSIC PARK.?

SOURCE:  Food & Water Watch, USA

AUTHOR:  Press Release

URL:     http://www.foodandwaterwatch.org/press/press-releases/troubling-emails-reveal-federal-scientists-fear-fda-approval-of-genetically-engineered-salmon/

DATE:    15.11.2010

SUMMARY: "After submitting a Freedom of Information Act request, the consumer advocacy group Food & Water Watch received numerous recent internal documents and emails from the U.S. Department of Interior?s Fish & Wildlife Service exposing startling concerns with AquaBounty salmon ? a controversial genetically engineered fish the FDA may soon approve as the first GE food animal for human consumption."

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TROUBLING EMAILS REVEAL FEDERAL SCIENTISTS FEAR FDA APPROVAL OF GENETICALLY ENGINEERED SALMON: ?MAYBE THEY [THE FDA] SHOULD WATCH JURASSIC PARK.?

U.S. Fish & Wildlife Emails Disclose Numerous Environmental, Procedural Concerns; FDA may Approve Genetically Engineered Salmon as Soon as Nov. 23

Washington, DC ? After submitting a Freedom of Information Act request, the consumer advocacy group Food & Water Watch received numerous recent internal documents and emails from the U.S. Department of Interior?s Fish & Wildlife Service (FWS) exposing startling concerns with AquaBounty salmon ? a controversial genetically engineered (GE) fish the FDA may soon approve as the first GE food animal for human consumption.

The documents reveal that, as late as last month, the FDA had not adequately fulfilled a requirement under the Endangered Species Act to consult with both FWS and another federal agency, the National Marine Fisheries Service (NMFS), to determine whether approval of AquaBounty?s salmon might impact wild, endangered Atlantic salmon.

?Nice work Greg,? Denise Hawkins, PhD, FWS Regional Geneticist wrote to a coworker in September. ?Especially pointing out that there is no data to support the claims of low survival in the event of escape, which I agree with you all is a big concern.  I also agree?that using triploid fish [which AquaBounty claim have undergone a sterilization process] is not foolproof.  Maybe they [the FDA] should watch Jurassic Park.?

Despite AquaBounty?s claim to produce only sterile salmon, the company admitted that up to 5 percent of their GE salmon eggs could be fertile, prompting the FDA to label the company?s claims ?potentially misleading?.

According to FWS internal emails, contrary to AquaBounty?s claims that GE salmon would be grown in closed systems (and therefore unable to escape), FWS employees received news of a proposal to grow the fish in a facility that would discharge into the ocean off the coast of Maine. It appears that the proposal, discussed with FWS employees last month, is from Joe McGonigle, former vice president of Aquabounty (as of February 2008).

?No matter what precautions you take, fish escape and once they do, there is no closing that door. So, that being said, I think it is very bad precedent to set,? said one FWS program supervisor.

At least 30 House members and 13 senators have expressed concern with the FDA?s review process, with many calling for the outright prohibition of GE salmon. Despite the outcry, the FDA is closing a public comment period on Nov. 22 and could approve the product as soon as Nov. 23.

In the documents, high-ranking FWS employees, including Jeff Adams, a branch chief, complain of the FDA?s failure to consult with FWS as required by law.

?The proposal [to approve AquaBounty salmon] also presents a situation where FDA, whose jurisdiction is not focused on natural resources, is entrusted with the authority to approve an application which poses such a threat to the country?s natural resources,? Adams said.

Regarding the FDA?s level of consultation with FWS, one assistant regional director was quoted as saying, ?It?s a little hazy to me how we are supposed to be engaged.?

?Hazy to me, too,? replied Gary Frazer, FWS Assistant Director for Endangered Species.

The FDA is required by law (under the National Environmental Policy Act) to conduct an environmental impact statement for any regulatory action that could negatively affect the human environment. The agency has not done so yet.

A large part of AquaBounty?s success hinges on GE salmon. The company has invested $50 million in the product, while posting zero sales and almost five million dollars in net losses in 2009.

The FDA has allowed the company to conduct three of the four studies on whether the product is safe for human consumption. AquaBounty?s scientists have been criticized widely for using only six GE salmon to determine the potential for allergies.

For more information, see Food & Water Watch?s letter to the FDA to halt GE salmon based on the actual Fish & Wildlife Service internal emails. 




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