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GM Salmon Gets Tentative FDA Approval
Final approval awaits public comment period … submit your sentiments by Feb. 25
12/27/2012
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By Craig Weatherby
 
A U.S. company called AquaBounty has spent 17 years and more than $60 million working to create and market genetically modified (GM) Atlantic salmon.
 
This would be the very first GM animal food sold … an event that drew nearer last week, when the FDA issued a positive environmental and health impact statement.
 
The FDA’s environmental assessment approval may rescue AquaBounty from bankruptcy.
 
Earlier this month, AquaBounty said it would only have enough capital to continue operations until March 2013.
 
We’ve covered this issue since 2010 … see “GM Salmon Postponed by FDA Panel”, “GM Salmon Barred by U.S. House”, and “GM Salmon Hit by Consumers Union, Congress”.
 
And we covered the recent (failed) fight to require labeling of GM foods in California … see “Help the Campaign to Force GM Food Labeling”.
 
FDA clears the way for final approval of GM salmon
On December 21, the FDA said that the AquAdvantage salmon “will not have any significant impacts on the quality of the human environment of the United States.”
 
Importantly, the FDA also found that the genetically modified (GM) salmon is unlikely to harm populations of natural salmon.
 
The FDA issued two documents – an environmental assessment (EA) and a preliminary “finding of no significant impact,” or FONSI – on Dec. 26, which will be available for public comment for 60 days (through February 25, 2013).
 
The FDA could finalize the FONSI, paving the way toward ultimate approval of the salmon … or it could decide to do a more detailed environmental analysis.
 
FDA will review the comments it receives regarding the draft Environmental Assessment and preliminary FONSI before making a decision on whether to prepare a final Environmental Assessment and FONSI, or to prepare an Environmental Impact Statement.
 
The FDA’s findings clearly pave the way towards final approval of the first GM fish in the world.
 
To make your views known, submit either electronic or written comments on the Agency’s draft EA and preliminary FONSI by Monday, February 25, 2013.
 
Make it clear that your comments apply to Docket No. FDA–2011–N–0899.
 
Submit electronic comments at:
http://www.regulations.gov (Note: this page often takes a very long time to load.)
 
Submit written comments to:
The Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
 
For more information, contact:
Eric Silberhorn
Center for Veterinary Medicine (HFV–162)
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
240–276–8247
 
Our policies prohibit GM salmon
Vital Choice will not sell GM salmon, for four reasons.
 
First, we simply don’t sell farm-raised salmon (Only wild Pacific salmon, frozen and canned).
 
Second, we mistrust the FDA, which has proven amenable to industry pressures to overlook or downplay food and drug health concerns.
 
Third, farmed salmon are nutritionally inferior.
 
Compared with wild salmon, farmed salmon are as high or higher in omega-3s, but much higher in competing, pro-inflammatory omega-6 fats from grain and soybeans, and much lower in vitamin D. (See “Farmed Fish Possess Unhealthful Fat Profiles” and “Wild Salmon Beats Farmed for Vitamin D (Again)”.)
 
Finally, we favor natural and organic foods very strongly.
 
With regard to GM foods, that preference is underscored by concerns about the notably weak oversight exercised by the U.S. Congress and the FDA. (See “Gene-Modified Food Fears Fueled by Secrets”.)  
 
Eco groups critique FDA move
Wenonah Hauter, Executive Director of Food & Water Watch criticized the environmental assessment approval:
“The FDA, which has been tasked with protecting consumer safety, failed to conduct the appropriate studies to determine if it is safe to eat or even if the fish can live up to AquaBounty’s claim of faster growth rates. And, by releasing an environmental assessment instead of a more thorough environmental impact statement, the FDA failed to fully consider the threat this controversial new fish could pose to wild fish populations”. (F&WW 2012)
 
Food & Water Watch is also concerned that, if AquAdvantage is approved, the FDA will not require labeling identifying that it is GM salmon:
“To add insult to injury, this product may be hitting the market without labeling, meaning that concerned consumers who have demanded labeling will be unable to identify GE from non-GE salmon.” (F&WW 2012)
 
More than 40 members of Congress and scientists at other federal agencies, including the National Oceanic and Atmospheric Administration and the U.S. Fish & Wildlife Service, have also voiced strong opposition to GE salmon, citing the lack of scientific rigor and expertise at the FDA.
 
Any upside to GM salmon?
The engineered AquAdvantage Atlantic salmon contains an active growth hormone from a Chinook (king) salmon that allows it to reach market weight in 18 months instead of 36.
 
AquAdvantage Atlantic salmon is modified by inserting a gene from Chinook salmon, which carries instruction for making growth hormone. That gene is attached to and activated by a piece of DNA from an ocean pout.
 
The hybrid DNA was microinjected into fertilized salmon eggs back in 1989, to create the first “founder” GM fish.
 
Potential benefit #1: Reduced use of small wild fish as feed
Because of the growth hormone supplied by the added gene, the salmon reaches smolt stage in its lifestyle faster than other Atlantic salmon. (Smolt is the stage when the salmon becomes silvery and would be ready to migrate to the ocean.)
 
Faster growth time to smolt cuts down on feed volume and costs and time-to-market and thus would allegedly make land-based salmon farming more economical.
 
If true, a major move to farming GM salmon might reduce use of the small, environmentally critical “forage” fish used to make fish meal and oil for farmed salmon (e.g., herring, sardines, and menhaden).
 
The GM salmon are being kept in enclosed, inland tanks in Panama, to prevent the small risk that the nearly sterile females will breed with wild salmon.
 
Fertilized eggs would be grown in inland tanks on Canada’s Prince Edward Island, and the eggs would be transported to an inland facility in Panama.
 
The farmed fish would be 100 percent female and virtually 100 percent sterile, though it is possible for a rare GM salmon to be fertile.
 
They would be processed in Panama, and salmon fillets and steaks would then be transported to the U.S.
 
There are concerns that fish farmers will file for permits to keep the salmon in nets in the open ocean in order to lower costs.
 
Potential benefit #2: Reduced threat to wild salmon
Currently, all farmed salmon are raised in offshore pens ... a crowded, unnatural situation that's proven to promote disease and generate parasites that can devastate wild salmon swimming in the area.
 
If GM salmon proves a success, and reduced production costs prompt salmon farmers to raise them in onshore tanks, that move would virtually eliminate the threat posed by offshore salmon farms.
 
Frankly, such a move to onshore salmon farming seems a very unlikely prospect, given consumer resistance to GM foods, and the huge investments that corporations have made in offshore farms.
 
AquaBounty says that it will only sell their GM salmon to farmers who will raise them in enclosed inland tanks.
 
And the FDA has said that if AquaBounty changes its mind on that pledge, it would have to apply for permission to sell them to producers using ocean pens.
 
Can we trust those assurances? We remain dubious.
 
 
Sources
  • Food & Water Watch (F&WW). FDA Moves towards Approval of First Genetically Engineered Food Animal Despite Strong Opposition and Questionable Research. December 21, 2012. Accessed at http://www.foodandwaterwatch.org/pressreleases/fda-moves-towards-approval-of-first-genetically-engineered-food-animal-despite-strong-opposition-and-questionable-research/
  • Maxem A. Transgenic fish wins US regulatory backing. Nature.com. December 22, 2012. Accessed at http://www.nature.com/news/transgenic-fish-wins-us-regulatory-backing-1.12130
  • SciTechDaily. FDA Approves AquaBounty Transgenic Fish. December 26, 2012. Accessed at http://scitechdaily.com/fda-approves-aquabounty-transgenic-fish/
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