The first genetically modified animal destined for the U.S. market – a GM salmon – will still have to wait awhile.
A federal advisory panel recently made its recommendation to the FDA on whether the salmon would be safe for consumers to eat, and whether or not there might be a potential environmental threat.
Both FDA staff and the salmon's maker, Aqua Bounty Technologies Inc, have said the faster growing fish appears to be the same as normal Atlantic salmon and poses no threat to the environment or diners.
But consumer advocates, environmentalists and others protested the move, saying there is not enough data to show that eating it does not cause side effects such as allergic reactions or that accidental escape will not harm other fish.
Another major area of concern is, if the salmon is approved, whether consumers will know when they are buying it.
After 11 hours of deliberation, the FDA decided to postpone its decision, the Ecologist reported on September 22, stating that:
"A spokesperson for the Food and Drug Administration (FDA) said this week that there was no timeline on a decision on the application and that a decision was likely to be months away.
As well as deciding whether it is safe for human consumption the government body is also debating about whether it should be labeled as GM."
So, the fight is certainly not over.
It may still get approved, and then the issue of labeling would take center stage.
Apparently, the FDA can't require a label on GMO food once the determination is made that the salmon, in this case, is not 'materially' different from real salmon. In addition, according to conventional food producers, the FDA makes it difficult for them to label their products as non-GMO.
The Washington Post states:
"The labeling question has emerged as the FDA determines whether to approve the fish, an Atlantic salmon known as AquAdvantage that grows twice as fast as its natural counterpart.
The decision carries great weight because, while genetically modified agriculture has been permitted for years and engineered crops are widely used in processed foods, this would be the first modified animal allowed for human consumption in the United States.
The AquAdvantage salmon has been given a gene from the ocean pout, an eel-like fish, and a growth hormone from a Chinook salmon."
Consumer advocates are concerned about how large the no-labeling problem will grow, since GM beef, pork and other fish are next in line behind salmon for FDA consideration.
Another recent article, published in the Huffington Post, recounts the "10 freakiest things" about this Frankenfish. For example, GM salmon is actually not being regulated as an animal, but as an animal drug, even though there is no therapeutic benefit of boosting its natural growth rate by inserting other animal genes.
"So, why would the FDA treat the first genetically engineered animal for human consumption like a drug?" the article asks.
"The idea came from the biotech industry. They knew that the FDA's animal drug process would keep companies' "proprietary" information secret, while limiting public participation and downplaying food safety concerns. Genius."
Huffington Post also makes a very interesting comment about the GM salmon's nutritional value, stating it has the lowest omega-3 to omega-6 value of all the salmon studied, while also having 20 to 52 percent higher allergenic potency than normal salmon, increasing your chances of having a potentially deadly allergic reaction.
That in and of itself would be reason to avoid GE salmon, but there's more...
The following commentary is written by leading GMO expert Jeffrey Smith, founder of the Institute for Responsible Technology, who is leading the movement to eliminate genetically modified foods in the United States.
By Jeffrey M. Smith
Has the FDA gone completely mad?
Why are they trying to open the flood gates to genetically engineered (GE) salmon—a move that will go down in history as one of the most asinine and dangerous ever made by our government?
What's it going to take for them to actually start protecting public health?
To help stop GE salmon, please sign a petition to the food industry and to Congress.
Frankenfish Can Promote Disease
The FDA will continue reviewing data submitted by AquaBounty, the company that spliced a growth hormone gene into Atlantic salmon, forcing it to grow up to five times faster and reach market size in about 18 months instead of 3 years. But according to the evidence, their buff salmon might have higher levels of a cancer promoting hormone IGF-1, more antibiotics, and more of a potentially life-threatening allergen(s).
The FDA failed to learn their lesson with their idiotic approval of genetically engineered bovine growth hormone. It too has higher levels of IGF-1 and more antibiotics. Now it's condemned by the American Public Health Association and the American Nurses Association, banned in most other countries, and has been banished by most US dairies.
Even Wal-Mart won't allow the stuff into their milk.
The GE soy and corn on the market, which the FDA continues to pretend is just the same as the natural stuff, also has higher levels of allergens, and has been linked to numerous disorders.
Now the American Academy of Environmental Medicine has condemned genetically modified organisms (GMOs) and urged all physicians to prescribe non-GMO diets. "GMO-Free" is one of the fastest growing health claims among US brands for the past two years, and a tipping point of consumer rejection of all GE ingredients appears to be just over the horizon.
Then there is the threat of Frankenfish escaping into the wild. Here too, the FDA has ignored the lessons from GE crops which, in spite of early assurances to the contrary, have been contaminating non-GE crops and wild relatives all over the world for more than a decade.
Their self-propagating genetic pollution is irreversible; it can outlast the effects of global warming and nuclear waste. But somehow escaped GE salmon carry an even greater hazard.
Frankenfish Can Wipe Out Natural Salmon
According to a Purdue University computer model that tracked the effects of releasing just 60 Frankenfish (not salmon) into a population of 60,000, there was a shocking complete extinction in just 40 fish generations.
Apparently their bigger size, which attracted mates more easily, combined with a slight reduction in survival rates, was a killer combination.
Canadian scientists engineered their own set of fast growing salmon and tested their behavior in tanks with other fish. When there was sufficient food, all was fine.
When food stocks decreased, the Frankenfish freaked.
They became cannibals, attacking and killing other fish—whether GE or natural. Their unexpected behavior resulted in population crashes or complete extinctions in the fish tanks. The study also suggested that if released, these ravenous aggressive salmon would pursue and consume other types of fish.
I'm not sure which scenario is worse: The complete extinction of salmon, or gangs of voracious mutant freaks scouring the ocean, attacking anything that can feed their rapidly-expanding, always-hungry bodies.
Never mind that the GE AquAdvantage salmon are supposed to be grown in inland tanks and are supposed to be sterile. In reality, they won't all be sterile; and there are numerous ways that these salmon, whose eggs will regularly be shipped from Prince Edward Island, Canada to growing tanks in Panama, can escape into the ocean.
It only takes one!
Corporate Interests and Politics Run the FDA Show
US consumers have been clear for years that we don't want Frankenfish, Frankenpigs, Frankenmosquitoes, Frankenanything that walks, flies, slithers, or swims. And most Americans are now uneasy about the Frankencrops already growing in our fields. So who is clamoring for GE salmon?
Who's getting the FDA to push open the doors to GE animals against public opinion?
Thank you Union of Concerned Scientists for the answer. Your September 12th survey of 1710 FDA employees explains who is really driving the bus at the agency.
One staff member said,
"Food safety has succumbed to the higher priority of global corporate profits." In fact, 38 percent of respondents agreed or strongly agreed that "public health has been harmed by agency practices that defer to business interests."
Another employee points to political interference: "I have been here for 26 years and it still amazes me . . . how politics filter down to the lowest levels of government."
So its corporate profits and politics. Anyone surprised?
About 1 in 4 surveyed admit that they had personally experienced, either frequently or occasionally, "situations where corporate interests [or members of Congress, or special interests] have forced the withdrawal or significant modification of [an agency] policy or action designed to protect consumers or public health."
If there is one face that best captures the FDA's conflict-of-humanity's-interest, it would be Michael Taylor. Taylor is the US Food Safety Czar. You'd think that if there were significant safety concerns about the GE salmon, our Czar would step in to preserve and protect.
Don't count on it.
Back when the first Bush White House had instructed the FDA to promote biotechnology, the agency created a special position for Taylor to be in charge. He had been the outside attorney for biotech giant Monsanto, where he had dreamed up a regulatory facade that would allow GMOs to be brought to market with maximum speed and minimum oversight.
Then he took a position with the FDA where he could apparently implement it himself.
His GMO policy falsely claimed that the agency was unaware of information showing GM foods to be different. On that basis, no testing or labeling was required.
Years later, 44,000 documents made public from a lawsuit revealed that the consensus among FDA's own scientists was that GM foods were unsafe, and should be carefully tested for allergies, toxins, new diseases, and nutritional problems.
Soon after leaving the FDA, Michael Taylor went to work as Monsanto's vice president.
So the person who lied about GMO safety to push them on the market now sits above the folks that are looking at GE Salmon. Not a comforting thought.
Stacking the Deck for Approving GE Salmon
How else does corporate influence play out in the current FDA debacle?
Consider Alison L. Van Eenennaam. She too used to work for Monsanto, and now has been added as a temporary voting member on the committee that advises the FDA about the salmon. She also advises the USDA and promotes GE animals on Youtube.
Kevin G. Wells was also added as a temporary voting member for salmon. He works at Revivicor, a company that genetically engineers pigs.
Do you suppose there is any conflict of interest for him establishing an easy ride for GE animal approvals?
Gregory Jaffe was also imported into the committee as their supposed consumer advocate. In reality, he is with the pro-GMO Center for Science in the Public Interest (CSPI), an organization that consistently ignores the mounting evidence of adverse health impacts from GE crops. Jaffe even filed a complaint to the FDA in 2001 complaining of companies that label their products as non-GMO.
What further qualified Jaffe for his committee position was his published article Questions About Genetically Engineered Animals, where he touts the environmental benefits of AquAdvantage salmon.
The engineered bias of the FDA advisory committee is made even more clear by who is absent.
There are no experts on allergies or hormones who can address the possible health damaging effects of the fish, and no fish ecologists who can figure out whether our grandchildren will live in a world without wild salmon.
But even before the committee was picked, the deck was stacked in favor of approvals. In 2008, the Bush administration rolled out a policy in which GE animals would be approved as if they were animal drugs. This latest square peg is part of a continuing effort to regulate GMOs without asking Congress to pass any new laws. So, since 1992, the government has been jerry-rigging inadequate pre-existing laws to handle the unique and complex safety and environmental considerations of genetically engineered organisms.
Even if GE animals weren't infinitely more complex than some drug compound, using the FDA drug approval process shouldn't give us great confidence.
Between 1976 and 1985, for example, more than half of their drug approvals turned out to have lethal or serious side effects, forcing withdrawal or added label warnings.
Try conducting a recall of GE salmon from the ocean.
Failing Grades All Around
Even with stacked committee membership, an antiquated approval policy, and an agency that is officially mandated to promote biotechnology, the Frankenfish did not swim past the advisory committee on September 19th and 20th.
That's because the committee agreed with safety experts like Dr. Michael Hansen of the Consumers Union (they publish Consumer Reports) that the evidence presented by AquaBounty was abysmal and insufficient.
Using a sample size of only 6 fish, employing insensitive detection methods that could easily miss cancer-promoting hormones or allergens, and testing fish that were raised in a completely different climate than what is planned, were among the sloppy science that the FDA had accepted. (See addendum below for examples.)
In fact the only person on the committee who had any experience with fish, Gary Thorgaard, completely disagreed with the FDA's conclusion that the Frankenfish didn't threaten the environment. He called for a full Environmental Impact Statement.
Hansen says, "The data and analysis of food safety risks from the AquAdvantage Salmon are so sloppy and inadequate that, if this were an undergraduate paper, it would get a failing grade. No self-respecting scientist could conclude that these data demonstrate that AquAdvantage salmon are safe to eat."
Thus, in spite of the fact that the company had been submitting data to the FDA for more than ten years, the advisory committee concluded that the evidence was insufficient to conclude that GE salmon was safe for the environment and for human health.
They told AquaBounty to go back and to do more testing.
I propose a different recommendation.
This little exercise made it perfectly clear that AquaBounty is either completely incompetent to evaluate the safety of their own creation, or they're intentionally hiding evidence. In either case, let's not send the same folks back to do more research, hoping they'll get it right. Instead, tell these jokers that they have proved to the world that they are never ever ever to be trusted with the future of salmon or the safety of the human food supply.
And what about the FDA—the brain cell behind the Don't-ask-don't-tell food safety assessments?
They have again demonstrated that they too are not competent to protect the public from the unique unpredictable dangers of genetically engineered foods.
If you want to GE salmon stopped for good, now is the time to raise your voice.
Since the FDA has been ignoring US citizens in favor of business interests and politics, please join me in inviting the food industry and Congress to stop in and stop this madness.
Addendum: How Not to Do a Food Safety Assessment
The FDA's evaluation of GE salmon is the first of its kind. Because it will set a precedent for all future GE animal approvals, the bar should be set very high. According to Dr. Michael Hansen, who testified at the FDA advisory committee meeting on behalf of Consumers Union, the FDA set the bar a foot off the ground.
When AquaBounty looked for potentially dangerous growth hormones in the salmon, for example, they used a detection method so insensitive, it couldn't find any hormones in any fish. The FDA therefore concluded that there was no relevant difference in hormone levels in GE salmon.
Dr. Hansen told the committee, "This would be like the police using a radar gun that cannot detect speeds below 120 mph and concluding that there is no 'relevant difference' in the speed of cars versus bicycles."
Because the company also used an insensitive test to measure cancer-promoting insulin-like growth hormone factor one (IGF-1), levels were detected in only a few fish. Of these, the GE salmon was 40% higher. Again, insufficient data combined with faulty reasoning allowed the FDA to conclude that IGF-1 from GE salmon is not a problem.
Even then, these test results were not from the type of GE salmon that the company plans to market. Instead, the tests were conducted on the GE salmon variety that will produce the fish eggs in Canada. The DNA of these "egg-layers" have the normal two sets of chromosomes (diploid).
The GE salmon to be grown from their eggs in Panama, however, end up with three sets of chromosomes (triploid)—so that most will be sterile. It's the Panama-grown triploid variety that will go onto our dinner table if the FDA has their way.
So what was the response by the FDA and AquaBounty when asked for the IGF-1 levels of the actual fish (raised in the actual conditions) that people would actually eat?
"Well…er….uhm…we'll get back to you."
The situation with allergies is worse. According to Hansen, the tests conducted by AquaBounty confirmed that "the act of genetic engineering did lead to an increase in allergenic potency." In fact, when the flesh from egg-laying (diploid) fish was exposed to the blood (sera) of people who are allergic to salmon, there was a whopping 52% increase in reaction levels!
Furthermore, the specific allergen that had increased in the Frankenfish was not supposed to be affected. It did not come from the inserted gene. Rather, the increase in this potentially life-threatening allergen was just one of the unpredictable side-effects that can result from the process of genetic engineering itself.
The FDA decided this time to ignore this troublesome finding, since it was from the egg-laying diploids. The company did test the allergic reaction to the triploids (the ones we'll eat), but used fish that were raised in Canada, not Panama. This should have disqualified the fish study, according to Hansen, since the composition of GE salmon can obviously be affected by water temperature, and growing conditions.
Still, the Canadian raised Frankenfish elicited an allergic response level that was 20% higher than normal salmon. But the FDA dismissed this figure since it was not statistically significant and concluded that the GE salmon was safe to eat.
But of course it wasn't statistically significant. They used just six fish in the sample size!
The easiest way to prevent statistical significance is by using a pathetically small number of subjects in your experiment.
"To base a conclusion of no additional risk on exactly six engineered fish, when those data themselves suggest a possible problem, is not responsible science or responsible risk assessment. FDA owes it to the thousands of Americans who are allergic to finfish to demand more data on the allergenicity of these engineered salmon from AquaBounty."
Thank you Dr. Hansen for helping to protect us from the bungling Frankenfish promoters. Let's hope they will listen.
Please, remember to sign the petition to the food industry and to Congress.
About the Author
Jeffrey M. Smith is the leading consumer advocate promoting healthier non-GMO choices. His book, Seeds of Deception: Exposing Industry and Government Lies about the Safety of Genetically Engineered Foods, is the world's #1 and bestselling book on the subject. His book Genetic Roulette documents the health risks of the GM foods already on our plates, and how industry and government assessments are not competent to protect the public.
Mr. Smith is the Executive Director of the Institute for Responsible Technology, who's Campaign for Healthier Eating is designed to create a tipping point of consumer rejection of GMOs—to force them out of the market. See www.ResponsibleTechology.org, and www.NonGMOShoppingGuide.com.