|An AquAdvantage® Salmon (back)|
& a non-transgenic Atlantic salmon (front)
of the same age. (From AquaBounty)
The Food and Drug Administration (FDA) seems to be close to allowing the sale of genetically modified (GM) salmon. This would be the first GM animal ever allowed into the U.S. food supply, and as such could be an important precedent.
No final decision has officially been made, pending public comment (see below for contact details) but the FDA has tentatively concluded that the fish is safe, on what seems to be shaky evidence.
The FDA seems to be trying to minimize publicity: Friday is the best day to publish documents you'd rather not talk about, and the Friday before Christmas (in the midst of a noisy Washington stand-off over taxes) is about as good as it gets. That's when the agency released its "Preliminary Finding of No Significant Impact" (pdfs linked here) on the subject of AquAdvantage® Salmon, a modified Atlantic salmon made by AquaBounty that includes genes from two other species.
This transparently political piece of timing followed, and may have been provoked by, a transparently political complaint that the failure until then to release a report that is still dated May 4th was transparently political. Well, of course it was. So is the fact that the FDA's Environmental Assessment (EA) report is severely limited in scope, as it explicitly acknowledges (pdf, p. 10):
Social, economic, and cultural effects have not been analyzed and evaluated in this draft EA.
And why is that? On one level, it's because the salmon, though aimed at the U.S. market by a company incorporated in Delaware, will be grown in Panama from Canadian eggs (pp. 1–6, 49–64). So the environmental impact in the U.S., narrowly considered, is zero. Unless, of course, some of the humans or other inhabitants (animal, vegetable or mineral) become ill. But that likely won't happen because, best they can tell, these GM salmon are just like ordinary Atlantic salmon (pp. 2, 26–34). Except that they grow unusually fast. Oh, and the ones they are thinking about putting on the market are triploid: they have three sets of chromosomes, instead of the usual two.
Triploidy does admittedly produce "abnormalities" (Briefing Packet, 2010 [BP, pdf], pp. 25–33). But there's a good reason for inducing it, via pressure shock treatment applied to the fertilized eggs (BP, p. 52):
Female triploid salmon are effectively reproductively incompetent, providing additional environmental and intellectual property safeguards.
Aha! It's a kind of Terminator technology. However, skip ahead to p. 57:
We have confidence that the method will provide triploid rates greater than 98% for most inductions.
Wonderful. So one or two of every 100 fish will not be "reproductively incompetent." But, hey, what are the odds they'll escape, breed and terrify New York by climbing up the Empire State Building? Well, every year millions of farmed salmon do escape, and cause environmental damage and genetic contamination. Have these been genetically modified for docility? They don't say so.
The FDA is ready to conclude that "there is a reasonable certainty of no harm from consumption of food from triploid ABT salmon" but not for the diploid version, "due to uncertainties regarding the allergenicity of the tested tissue in a study of low quality" (BP, p. 109). Really? Oh, yes, and the other studies are not much better, notes Michael Hansen of the Consumers Union,
"FDA has allowed this fish to move forward based on tests of allergenicity of only six engineered fish, tests that actually did show an increase in allergy-causing potential."
See also BP, p. 103, and this article by Martha Rosenberg in Food Consumer, which cites several academics raising more questions about the studies on which the FDA relied.
Let's face it, salmon raised in containment in Panama from eggs made in Prince Edward Island are not going to feed the world. At best, this is a niche product. So why is Intrexon, a synthetic biology company, investing in and trying to buy AquaBounty, which was recently said to be close to bankruptcy? For that matter, why is the Genetic Literacy Project taking to both Slate and Forbes to hype up this product and accuse the White House of ethics violations? Well, as AquaBounty CEO Ron Stotish told the AP,
"This is about more than Aquabounty and more than salmon."
Indeed it is. This is politics, and it's a high-stakes game for the whole biotechnology industry. That's a significant reason why the environmental assessment process is so limited; it's also why the FDA is still hedging its bets:
"The release of these materials is not a decision on whether food from AquAdvantage Salmon requires additional labeling; nor is it a decision on the new animal drug application currently under review. It also does not provide a final food safety determination."
Every move to label GM food is, of course, fought tooth and nail by the industry, but they may actually be losing that struggle. In California, they had to spend at least $46 million to beat Proposition 37, whose proponents raised $9 million and barely lost, 49–51 [pdf]. The closeness of that race seems to have encouraged activists in Washington, Vermont, Iowa, New Mexico, and elsewhere. The FDA could really stir the pot by requiring labeling of GM salmon.
Meanwhile, the FDA is accepting comments on the AquAdvantage® Salmon, either electronic or written, until February 25, 2013. Comments, which should reference Docket No. FDA-2011-N-0899, can be posted via www.regulations.gov, or mailed to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
To make it easier, the Center for Food Safety has a petition to sign (as do the Organic Consumers Association, Food & Water Watch, Food Democracy Now, and likely others), and may fight any approval in court if necessary. Andrew Kimbrell, of CFS, gets the last word:
"The GE salmon has no socially redeeming value. It's bad for the consumer, bad for the salmon industry and bad for the environment."
Previously on Biopolitical Times:
Posted in Animal Technologies, Biotech & Pharma, Pete Shanks's Blog Posts, The States, US Federal
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