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FDA Says Science Around New Salmon Is Inconclusive

Posted: 09/21/10 10:00 AM ET

On Monday evening, after two days of hearings, the U.S. Food and Drug Administration concluded "that they do not yet have sufficient data to determine that a genetic modification that enables salmon to grow twice as quickly is safe for the affected fish or for consumers," according to ABC News.

The salmon in question, a product called AquAdvantage, have been genetically altered to contain a growth hormone gene from the Chinook salmon and a genetic switch from the ocean pout that turns on an antifreeze gene. The Atlantic salmon, which would be raised on farms, contain an extra growth hormone gene that allows them to grow to marketable size about twice as fast as conventional fish, enabling fisheries to increase profitability and bring salmon to market in 18 months versus the traditional 30 months.

Now the genetic manipulation and modification of our food supply isn't entirely new. This food technology which manipulates the DNA and engineers profitable characteristics and traits into food was introduced into our food supply about fifteen years ago. But it hasn't gotten a whole lot of attention in the U.S. media despite its controversial introduction in 1994, when scientists began engineering new traits into corn, milk and soy, enabling corporations to patent this newly licensed technology and the food supply, driving shareholder value and profitability.

And now, with the insertion of an "on switch" gene into the DNA of salmon, scientists at a company called AquaBounty Technologies have modified and patented the genetic makeup of salmon and engineered fish to eat year round so that it can grow twice as fast. As a result, salmon producers will be able to grow salmon more quickly, driving profitability and capitalizing on the growing demand for fish.

Approval of the salmon could pave the way for other such biotech animals to enter the food supply while no long-term human studies have been conducted to assess what the long-term health implications might be for humans. Because of a regulatory decision in the 1980s that no new laws are needed to regulate genetically engineered foods, the FDA is actually regulating the GE salmon as a drug.

"I do get heartburn when we're going to allow post-market surveillance to finalize our safety evaluation," said one committee member, Michael D. Apley, a pharmacology expert at Kansas State University, according to the New York Times.

According to the New York Times, "Ronald L. Stotish, the chief executive of AquaBounty Technologies, the company that developed the salmon, told the FDA committee that his company's salmon, known as AquAdvantage, would help the world meet rising demand for seafood without further devastating natural fisheries. Addressing environmental concerns over these fish escaping into wild salmon populations, AquaBounty Technologies shared that their intellectual property will be protected because the fish will be sterile, as they will all be triploids (fish with three complete sets of chromosomes instead of the usual two) and the company's patented and commercialized fish will all be females, making them unable to breed."

FDA committee members did not point out anything about the fish that would seem dangerous, relying on data funded and conducted by AquaBounty Technology, despite one study suggesting a possible increase in the potential to cause allergic reactions. The test showed a possible increase in the potential to cause allergic reactions that was almost statistically significant even though only six fish were used in each group in the study. In its allergenicity studies submitted to the FDA, AquaBounty converted its data into an undefined estimated measure it called "relative potency," a term the lab was unable to define when asked by the FDA.

With a fair amount of controversy around the allergenicity associated with this new technology (which created tension back in 2002 at a government meeting of the Food Biotechnology Subcommittee of the Food Advisory Committee in which the committee's acting chair, Edward N. Brandt, Jr., MD, PhD, said "Of course, we haven't worked into this some kind of test for allergencity, per se... "), the 1994 introduction of the genetic modification of our food supply, without accompanying labels alerting consumers of its presence, prompted an almost allergic reaction from renowned allergist, Dr. Fred McDaniel Atkins, who said, "To me, the logical problem is that we are going to take that stuff and feed it to the public without their informed consent."

At the same time, other nationally recognized allergists have remained relatively quiet regarding the allergenicity of genetically modified foods and some have invented patents for companies, like AquaBounty, that are responsible for the patenting and genetic modification of our food.

And while missing data appears not to bother some experts, including one of the FDA panel members who stated that "the salmon contains nothing that isn't in the human diet," Dr. Atkins' concerns over the allergenicity and long-term health implications of genetically modified foods are shared by others.

"We are missing data," said panel member James McKean, a professor at Iowa State University. He said that "leaves a cloud" over the FDA staff's analysis.

The FDA will hold its next public hearing Tuesday, September 21, 2010, as it considers whether to label the salmon as genetically modified. If approval does go through, the first genetically modified salmon could begin entering U.S. supermarkets within about two years, upon which the FDA will be relying on market surveillance measures similar to those currently being used by the egg and beef industry to assess post-market health implications.

Editor's note: An earlier version of this post stated that an 11-person panel consulted on the issue of GM salmon was composed of FDA employees. In fact, they were outside experts. Also, the headline stated that the science was 'unsatisfactory,' when in fact a more appropriate categorization is that it is inconclusive.

 

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On Monday evening, after two days of hearings, the U.S. Food and Drug Administration concluded "that they do not yet have sufficient data to determine that a genetic modification that enables salmon t...
On Monday evening, after two days of hearings, the U.S. Food and Drug Administration concluded "that they do not yet have sufficient data to determine that a genetic modification that enables salmon t...
 
 
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HUFFPOST SUPER USER
organicconnect
04:29 PM on 10/05/2010
The FDA viewing the science behind GM Salmon as "inconclusive" is at least a glimmer of hope. It really shows that they are in the process of being "sold" a bill of goods. http://organicconnectmag.com/wp/2010/10/the-case-against-genetically-modified-salmon/
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HUFFPOST SUPER USER
MorganT
11:28 PM on 09/24/2010
I heard about this from a documentary. I also heard that if these salmon escaped into the wild and bred with some wild populations it would only be a decade or so before those salmon went extinct.
11:59 AM on 09/24/2010
If it's inconclusive then it ought to go away until real and responsible research is done.

The sad comment that the data is "inconclusive" is a euphemism for "I want to be sure I have a job with the GMO lobby when I rotate out of the FDA or USDA". The majority of the folks running and creating policy in the USDA & FDA came from the big food industry. Most will return to it when they are done gerrymandering the idea of safe food to include that which is completely untested, of in this case an n=6. Statistically this is a non-entity and should be laughed out of the room. Instead we are being told that the data is inconclusive. It is also good to recall that the industry is allowed to do their testing secretly and not provide any information to the public about the methodology, the cohort, the data or the actual conclusions. We are supposed to trust these folks, who want to own all sources of food production through patents, to tell us the truth about the newest salvation for humanity from which they stand to make billions (literally). Since when can we trust greed?

It should be noted that big AG and farm pays large salaries to their advisory board of sell-out scientists to question and create controversy over any data that reflects poorly on them, no matter how well researched. So the common term is that any research questioning their opinion is "controversial".
11:46 AM on 09/24/2010
In reading through the comments below a couple of things stand out. First, many believe we're destroying wild salmon and other fish due to over fishing. Second, many of the same people believe fish farming is a bad thing.

Why is it so rare that we can't see one of these -- fish farming -- solves the other?

When Target or another store agrees to only sell wild caught fish, they are basically agreeing to further reduce the populations of fish that are already low. Or is the plan to continuously raise prices for wild-caught fish so consumption goes down and only high-income people can afford to buy it?

We've got to get beyond this idea that farmed fish (or farmed anything) is bad/evil/controlled by corporations and so on. Perhaps salmon from AquAdvantage isn't the way to go -- but maybe it is. In the end, the marketplace can decide.

And who knows, maybe 10 or 20 years down the road we'll come to realize that adopting technology and food production methods that result in more food with less harm to the environment is the best best choice.
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Victoria-nola
There is no way to peace; peace is the way.--Muste
12:58 AM on 09/25/2010
And maybe we'll find out that the allergenicity is devastating to the human organism, and that the DNA of the fish mutate after they escape from the fish hatcheries to allow them to breed. They want us to believe in its safety, they claim, because 1) they can't escape, except that millions of salmon escape every year from fish farms. 2) They are sterile, except that DNA mutates on its own and we can't control it and scientists believe they could mutate to breed because DNA is hardwired to reproduce. 3) Even though it hasn't been tested as a food in humans, it's safe because each element is already in the diet. Perhaps each element is, but they've been combined synergistically and non-naturally, and there is no way to know or predict what that will lead to. 4) Increase food supply. Predicted increases in harvests have not materialized for GMO plants. The biggest change is that farmers can't save seeds and have to buy all seeds and chemicals from one company. Food security is at risk because food is being monopolized.

"Maybe it's safe" is not good enough for me. This is the food supply. This is the earth and all its species, including the human species.
HUFFPOST SUPER USER
ddanimal
12:49 AM on 09/24/2010
So this A-hole company is trying to convince people their fish is safe based on a study that used SIX fish?

OF COURSE the company is not interested in doing rigorous studies of its product. Why are they even allowed to be in control of the studies used for regulatory approvel? Such studies should be done independently.

"The test showed a possible increase in the potential to cause allergic reactions that was almost statistically significant even though only six fish were used in each group in the study. "
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Victoria-nola
There is no way to peace; peace is the way.--Muste
12:59 AM on 09/25/2010
The fact that the allergenicity showed up with only 6 fish in the study shows that it is very likely to increase if a larger sample was used.
05:07 PM on 09/23/2010
You don't like the science? Wait until you taste it!

Let's preserve our Oceans and Salmon Runs. We can do it. This idea is sickly cynical.
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HUFFPOST SUPER USER
boyer37212
I am a petite Doberman. Not a wiener dog!
02:21 PM on 09/23/2010
Those super salmon just don't look right. I get the same feeling in my gut as when I see a cockroach run across my floor.

That's my body telling me "stay away."
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HUFFPOST SUPER USER
The other mike
06:19 PM on 09/22/2010
It's too bad restaurants and food processors are allowed to use the harmless-sounding name "Atlantic Salmon" to designate farmed salmon. You probably get as much Omega-3 from chicken as you do from farmed salmon.
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blinkthink
Tax Wall Street Trades Now
03:17 PM on 09/22/2010
I never eat farmed salmon. My favorite wild salmon, sockeye, is under siege by human greed. Here's the sad reality:

http://www.nytimes.com/2008/10/22/us/politics/22mining.html?_r=1

A source of certified sustainable fisheries that is recommended by numerous physicians:

http://www.vitalchoice.com/index.cfm
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HUFFPOST SUPER USER
Neutralino
Opposing pseudoscience 24/7
09:03 AM on 09/22/2010
Easter Island is recognized globally as a prime example of how people wreck their environment by demanding too much from it. I sometimes wonder what was going through the mind of the guy who cut down the last tree on Easter Island.

It must have been like what we see in this post by Robyn O'Brien, who has a long list of reasons to justify her unwillingness to make even the slightest compromise when it comes to filling her belly. We've devastated most wild salmon stocks from overfishing. Only remote Alaska has a semblance of a wild population left, but we'll eat it all eventually.

The magnificent bluefin tuna will go extinct sometime in the next decade. Fish that were once plentiful - from cod and halibut to swordfish and steelhead trout - are either gone or so rare that only the most affluent can afford them. The species this GMO fish was intended to save - the chinook salmon - has all but vanished. Blocking this version of farmed chinook helps guarantee that the species will disappear completely.

Clearly, however, we pampered Americans are fully in the grip of Easter Island Syndrome. So let's just pretend that something will somehow change and some unforeseen action will somehow save the few remaining wild fish.

Don't let worries about the death of the oceans interfere with your appetite. Just keep doing things the way we've always done them, and expect a different result.
10:37 AM on 09/23/2010
I don't understand the intentions of this post.

Are you trying to argue that using this GM salmon is equivalent to man-made ecological disasters like Easter island, or that NOT using this fish is equivalent to such disasters?

The point of the fish, after all, is to create a sustainable population of farmed fish, that can be brought to market more quickly, which will hopefully reduce the demand for wild caught fish.
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HUFFPOST SUPER USER
Neutralino
Opposing pseudoscience 24/7
03:50 PM on 09/23/2010
My point exactly.

Robyn O'Brien is arguing that we stick with the old technology, which involves fishing salmon until they go extinct. According to a study published in SCIENCE, 90 percent of ocean species will be extinct by the year 2048. Folks like O'Brien want us to stay the course, doing nothing to stop this ongoing catastrophe.

I re-read my comment. In retrospect, it still seems pretty obvious to me.
08:06 AM on 09/22/2010
The oceans have been wrecked by overfishing. We desperately need better forms of fish farming.

This technology provides a much-needed way to produce food sustainably. Alas, the only thing most westerners care about is feeding themselves, no matter how much environmental damage is done in the process.
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HUFFPOST BLOGGER
Susan Yager
11:46 AM on 09/22/2010
These salmon will be unable to reproduce. "Sustainable" seems, therefore, an inappropriate choice of words, no? As far as saving the environment, how exactly is a genetically modified fish with T4-Thyroid levels that indicate an even more unpleasant, non "fishy" life going to do that?
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HUFFPOST SUPER USER
Neutralino
Opposing pseudoscience 24/7
08:22 AM on 09/23/2010
It seems pretty obvious to me.

This technology provides salmon without threatening the dwindling population of wild salmon. It takes less energy, produces fewer carbon emission, emits less pollution, and damages less habitat.

Obviously, this is much more sustainable than killing the fish that are clinging to life in the damaged, overfished habitats that remain. You can increase fish harvests by simply growing more fish instead of wrecking more wild populations.
10:43 AM on 09/23/2010
"Sustainable" and "self-sustaining" are two different things.

Take for example the grazing system set up by Joel Salatin (featured in Michael Pollan's 'The Omnivores Dilemma'): Joel uses a rotational pattern or cows grazing on grass, chickens eating on grazed grass, and a plot of grass that grows back, as a sustainable method of raising beef, poultry, and eggs. This is a "sustainable" method, but one could easily argue that this is not a "self-sustaining" system (like an ocean is a self-sustaining ecology), because without humans there to move the cows and chickens, the land might quickly become barren and unusable, like it was when the Salatin family found it.

This is a "sustainable" system because it can be sustained, even though it requires human interaction, just like all other farming systems do.

Lastly, what are you talking about with the "T4-Thyroid levels"? (I'm ignorant of this subject)
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HUFFPOST SUPER USER
Chad Osterhoudt
07:56 AM on 09/22/2010
You can trust the FDA to do the right thing. Ha Ha
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HUFFPOST SUPER USER
MorganT
11:30 PM on 09/24/2010
Exactly! and considering most of them have worked for GMO companies at one time or another.
06:12 AM on 09/22/2010
How can they say there is no difference between GM salmon and natural salmon yet still own a patent on their GM salmon? Clearly these fish are different from their natural counterparts so they should be labeled. People should have the right to decide for themselves if they want to buy and eat these creations. If you would like to help pressure for mandatory labeling of GM foods please consider joining the Food Bloc page on votingbloc.org here:

http://www.votingbloc.org/Food_Bloc.php
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Victoria-nola
There is no way to peace; peace is the way.--Muste
01:04 AM on 09/25/2010
Thank you so much for the information. I'm extremely worried about labeling GMOs. Your point is so well taken: if they aren't different, why do they own a patent?
01:28 AM on 09/22/2010
I won't eat any salmon with genes from an "eel-lke fish". Nor do I eat "Atlantic Salmon", because it is all raised in tanks.

It is getting harder to find real food as time goes by.
03:09 AM on 09/22/2010
Atlantic salmon are NOT raised in tanks.  They're raised in open nets in the coastal estuaries of rivers.  That's how salmon farms infect the food chain with parasites such as sea lice that affect salmon growing in high-density monocultures.

Fish that are farmed using tanks or inland ponds with closed recirculating pump systems are much more sustainable, and several species farmed in this manner are recommended by the Monterrey Bay Aquarium and other ecological advocacy groups.

If you're going to hate on fish farming, you should at least have an understanding that transcends the most superficial kind of alarmism.  Farmed salmon is unsustainable and ecologically harmful, but it's important to understand why this kind of farming is so undesirable.
09:04 AM on 09/22/2010
Right, I thought that's how it was done. I got thrown off by the news reports showing those FRANKENFISH swimming around in tanks.

I did know about the sea lice and dangers of infecting others.

Guess I had a Senior Moment about the tanks.

Thanks. I do hate fish farming. As I said, it is getting harder to find real food. GMO stuff. Farmed fish... who the hell would have ever thought fish would be farmed? Stocking lakes is one thing; producing salmon with the genes of Ocean Palp is quite another.
11:35 PM on 09/21/2010
I want mandatory food labelling. I want COOL enforced and I want to know which foods are GMO