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FDA has company swimming upstream

Regulators say Aquabounty's genetically modified salmon is safe

By Matthew Perrone

Associated Press

POSTED:

associated press / 2010Aquabounty Technologies has genetically modified salmon to grow twice as fast as normal, but regulatory hurdles are keeping its product from market. The genetically modified fish in the rear is the same age as the nongenetically modified salmon in the foreground.

WASHINGTON » Salmon that's been genetically modified to grow twice as fast as normal could soon show up on your dinner plate. That is, if the company that breeds the fish can stay afloat.

After weathering concerns about everything from the safety of humans eating the salmon to their impact on the environment, Aquabounty was poised to become the world's first company to sell fish whose DNA has been altered to speed up growth.

The Food and Drug Administration in 2010 concluded that Aquabounty's salmon was as safe to eat as the traditional variety. The agency also said that there's little chance that the salmon could escape and breed with wild fish, which could disrupt the fragile relationships between plants and animals in nature. But more than two years later the FDA has not approved the fish, and Aquabounty is running out of money.

"It's threatening our very survival," says CEO Ron Stotish, chief executive of the Maynard, Mass.-based company.

"We only have enough money to survive until January 2013, so we have to raise more. But the unexplained delay has made raising money very difficult."

The FDA says it's still working on the final piece of its review, a report on the potential environmental impact of the salmon that must be published for comment before an approval can be issued. That means a final decision could be months, even years away. While the delay could mean that the faster-growing salmon will never wind up on American dinner tables, there's more at stake than seafood.

Aquabounty is the only U.S. company publicly seeking approval for a genetically modified animal that's raised to be eaten by humans. And scientists worry that its experience with the FDA's lengthy review process could discourage other U.S. companies from investing in animal biotechnology, or the science of manipulating animal DNA to produce a desirable trait. That would put the U.S. at a disadvantage at a time when China, India and other foreign governments are pouring millions of dollars each year into the potentially lucrative field that could help reduce food costs and improve food safety.

Already, biotech scientists are changing their plans to avoid getting stuck in FDA-related regulatory limbo. Researchers at the University of California, Davis, have transferred an experimental herd of genetically engineered goats that produce protein-enriched milk to Brazil, due to concerns about delays at the FDA. And after investors raised concerns about the slow pace of the FDA's Aquabounty review, Canadian researchers in April pulled their FDA application for a biotech pig that would produce environmentally friendly waste.

The science behind genetic modification is not new. Biotech scientists say that genetic manipulation is a proven way to reduce disease and enrich plants and animals, raising productivity and increasing the global food supply. Genetically modified corn, cotton and soybeans account for more than four-fifths of those crops grown in the U.S., according to the National Academies of Sciences.

But there have always been critics who are wary of tinkering with the genes of living animals. They say the risk is too great that modified organisms can escape into the wild and breed with native species. Not that we don't already eat genetically altered animals. Researchers say the centuries-old practice of selective breeding is its own form of genetic engineering, producing the plumper cows, pigs and poultry we eat today.

"You drive a hybrid car because you want the most efficient vehicle you can have. So why wouldn't you want the most efficient agriculture you can have?" asks Alison Van Eenennaam, a professor of animal science at University of California, Davis.

Aquabounty executives say their aim is to make the U.S. fish farming industry, or aquaculture, more efficient, environmentally friendly and profitable. After all, the U.S. imports about 86 percent of its seafood, in part, because it has a relatively small aquaculture industry. Aquaculture has faced pushback in the U.S. because of concerns about pollution from large fish pens in the ocean, which generate fish waste and leftover food.

Aquabounty executives figure that the U.S. aquaculture industry can be transformed by speeding up the growth of seafood. The company picked Atlantic salmon because they are the most widely consumed salmon in the U.S. and are farmed throughout the world. In 2010 the U.S. imported more than 200,000 tons of Atlantic salmon, worth over $1.5 billion, from countries like Norway, Canada and Chile.

Using gene-manipulating technology, Aquabounty adds a growth hormone to the Atlantic salmon from another type of salmon called the Chinook. The process, company executives say, causes its salmon to reach maturity in about two years, compared with three to four years for a conventional salmon.

Aquabounty executives say if their fish are approved for commercial sale, there are several safeguards designed to prevent the fish from escaping and breeding with wild salmon. The salmon are bred as sterile females. They also are confined to pools where the potential for escape would be low: The inland pens are isolated from natural bodies of water.

And the company says that these pens would be affordable thanks to the fast-growing nature of Aquabounty's fish, which allows farmers to raise more salmon in less time. Overall, the company estimates that it would cost 30 percent less to grow its fish than traditional salmon.

But getting the fish to market hasn't been easy.

The company began discussions with the FDA in 1993. But the agency did not yet have a formal system for reviewing genetically modified food animals.

So Aquabounty spent the next decade conducting more than two dozen studies on everything from the molecular structure of the salmon's DNA to the potential allergic reactions in humans who would eat it. By the time the FDA completed its road map for reviewing genetically modified animals in 2009, Aquabounty was the first company to submit its data.

After reviewing the company's data, the FDA said in a public hearing in September 2010 that Aquabounty's salmon is "as safe as food from conventional Atlantic salmon." The FDA also said the fish "are not expected to have a significant impact" on the environment.

But as the company has inched toward FDA approval, it has faced increasing pushback from natural food advocates, environmentalists and politicians from salmon-producing states.






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Kalaheo1 wrote:
Remember how "crazy" Tom Berg was in favor of labeling GMO products like this Franken-Fish, but the rest of City Council shot him down? Good thing we got a City Council that's a friend and ally to to big business now, isn't it.
on December 26,2012 | 03:59AM
Kate53 wrote:
Remember when farm-raised fish were heavily contaminated with PCBs because their feed was contaminated? Without regulation, the industry would feed anything to their product as long as it was cheap, and to heck with the consumer.
on December 26,2012 | 07:58AM
kuroiwaj wrote:
Hi Kate53, Didn't the Feds control the fish feed industry? They certainly did.
on December 26,2012 | 10:25AM
false wrote:
I hear Town and Country stables is feeding expired "gummy bears" to their livestock.
on December 26,2012 | 12:03PM
eleu808 wrote:
Responding to consumer concerns, more than 200 grocers, restaurants, and seafood distributors have pledged not to purchase or sell genetically engineered fish: "'If my patrons don't want genetically engineered fish, then I certainly don't want to serve it. My customers congratulate me for signing the pledge,' said Todd Gray, award-winning chef/owner of Equinox restaurant in Washington, DC." Press Release (2002). 'Stop the Commercialization of Genetically Engineered Fish,' Say over 200 Grocers, Restaurants and Seafood Distributors, Center for Food Safety, Clean Water Action, Friends of the Earth, 18 September.
on December 26,2012 | 06:41PM
eleu808 wrote:
Unfortunately, much is still unknown about the how the consumption of GMOs (genetically modified organisms) affects humans. Since the science behind GMOs is relatively new, it may take years to learn about the adverse effects of eating these foods. This was the case with the pesticide DDT, which was in heavy use until it was found to accumulate in fish at doses harmful to humans. Allergies are also a major concern. According to the Consumers Union, AquaBounty has not conducted enough tests on this salmon to determine if it is actually safe to eat. The Consumers Union said in a statement that it is “particularly concerned that this salmon may pose an increased risk in…life-threatening allergic reactions to sensitive individuals.”
on December 26,2012 | 06:37PM
eleu808 wrote:
Responding to consumer concerns, more than 200 grocers, restaurants, and seafood distributors have pledged not to purchase or sell genetically engineered fish: "'If my patrons don't want genetically engineered fish, then I certainly don't want to serve it. My customers congratulate me for signing the pledge,' said Todd Gray, award-winning chef/owner of Equinox restaurant in Washington, DC." Press Release (2002). 'Stop the Commercialization of Genetically Engineered Fish,' Say over 200 Grocers, Restaurants and Seafood Distributors, Center for Food Safety, Clean Water Action, Friends of the Earth, 18 September.
on December 26,2012 | 06:43PM
Mike174 wrote:
It could be good but it does deserve the cautious approach from the FDA. I hope they don't get influenced by pressure the industry. It's common knowledge that other countries are less critical of potentially negative impacts on us humans as long as somebody makes money.
on December 26,2012 | 05:18AM
eleu808 wrote:
Where is the test data that says GMO food is safe for human consumption? There is none. The GMO scientist wonʻt even eat this stuff.
on December 26,2012 | 05:19AM
Tony91 wrote:
Actually, there is plenty of proof GMO foods are healthy and safe to eat, just like non-GMO foods -oh wait, there is no such thing as "non-GMO" food because humankind has been playing with selective breeding, cross pollinations etc... ever since we learned agriculture several millennia ago. Man has interfered with natural selection for thousands of years, get over it. The burden of proof is on the anti-GMO folks to prove it is not safe. It is ironic that engineering species and food so that fewer pesticides, hormones or antibiotics are needed would be so opposed by the same folks who oppose GMO. The world's population is continuing to grow. Crop yields have improved and supported the world's growing population with less farmland largely thanks to technology and science.
on December 26,2012 | 06:53AM
eleu808 wrote:
Is GMO safe? The American Academy of Environmental Medicine (AAEM) doesn’t think so. The Academy reported that “Several animal studies indicate serious health risks associated with GM food,” including infertility, immune problems, accelerated aging, faulty insulin regulation, and changes in major organs and the gastrointestinal system. The AAEM asked physicians to advise patients to avoid GM foods.
on December 26,2012 | 02:58PM
Anonymous wrote:
Give them the go ahead, just label the packages.
on December 26,2012 | 05:32AM
serious wrote:
Agreed!!!
on December 26,2012 | 05:59AM
FISHMAN20 wrote:
Most of the anti-GMO crowd don't know what they are talking about, and don't want to know. There are reams of data showing there is nothing wrong with these fish and they are safe to eat. They like to imply they will be put out in the ocean when they know they will only be reared in land-based ponds far from any natural water body. Modern genetic manipulation is a tool like many others and needs to be monitored and managed like the rest, but to consider it all evil is simple-minded. The anti-GMO movement resembles some bizarre religious cult more than a group of concerned citizens.
on December 26,2012 | 05:38AM
maunalii wrote:
Please provide the links for the reams of data, preferably data from independent sources and not industry backed research. To refer to concerned citizens who want labeling or to avoid genetically modified foods as a "bizarre religious cult" is the same old dry diversion to confuse readers. GMOs are labeled in over 60 countries around the world - now that is one big bizarre religious cult. Eat wild Alaskan salmon and then try the farmed salmon. Huge difference in taste and smell. The farmed fish is nasty. If it can be labeled as being "wild" or "farmed" why not label it as "genetically modified"? And yes, genetic manipulation is a tool and you hit the point right on with "needs to be monitored and managed". Start with labeling it.
on December 26,2012 | 06:18AM
nippy68 wrote:
Genetically altered salmon? We will be turned into zombies! Ha ha ha!
on December 26,2012 | 05:40AM
BigIdeas4U wrote:
This is a great step ahead. Why do we continue to step on our own advances? The people with great ideas, hard work and sacrifice can lead us to a better future. Why don't we commission an EIS on the Administration and Congress? Economic Impact Statement, that is. Do you think it would be approved?
on December 26,2012 | 06:05AM
Kalaheo1 wrote:
Has anyone said how they plan to keep these genetically modified animals out of our rivers and oceans? Can they cross-breed with native salmon populations? Is it worth taking that risk so that Aquabounty's investors can recoup their investment?


on December 26,2012 | 07:48AM
eleu808 wrote:
At least 30 House members and 14 senators have written the Obama administration either expressing serious concerns about the manner in which the FDA conducted its review of Aquabounty’s GE salmon, or calling for the outright prohibition of its approval for human consumption.
on December 26,2012 | 06:31PM
psimmons wrote:
With man it's all about making a fast buck. But who looks after the interests of wildlife who might consume this engineered fish? It wasn't that long ago the bald eagle and many other wildlife were threatened by the misdeeds of man. We can only hope history will not repeat itself. God bless all creatures, big and small.
on December 26,2012 | 06:25AM
808comp wrote:
Thank you,but i'll stick to wild salmon whenever possible.
on December 26,2012 | 07:26AM
kalaoa wrote:
The problem with the feed is not potential rare contamination; it is that the feed comes from other living things, especially other fish (by-catch), and with the conversion factor of food to flesh of perhaps 20 per cent, you are using five times the wild caught fish for food for aquaculture to produce fish that we will eat. That is not sustainable: going down the food chain to artificially support the "desired" product. Using less wild caught fish to produce the fish we eat is ecologically responsible. There are many layers to the food you see or eat; whether wild or farmed (or any sort, vegetable, animal, fish or shellfish).
on December 26,2012 | 08:14AM
Kate53 wrote:
The problems still remains with farm raised salmon -- living in pens, in their own filth and eating feed that has been known in the past to be contaminated with some nasty stuff like PCBs, which of course contaminates the fish. They won't want labeling either, so people won't know they're buying frankenfish.
on December 26,2012 | 07:57AM
kalaoa wrote:
If the process takes long enough, then the people who really need the lower cost proteins to survive, or thrive will be dead...no longer a problem or necessary. Affluent people again foisting their fears on the poor countries.
on December 26,2012 | 08:09AM
Ronin006 wrote:
Fears about genetically modified fish are unfounded. No chemicals used. A natural substance is taken from one fish and injected in its natural form into another species to make it grow faster. Lots of substances from plants and animals are injected into our bodies to prevent, treat or cure diseases. It is hypocritical to do that and then object to genetically modifying fish or other foods to make them grow faster or prevent disease.
on December 26,2012 | 08:46AM
eleu808 wrote:
Genetically engineered fish pose serious risks to wild populations of fish and our marine environment. Each year millions of farmed salmon escape from open-water net pens, outcompeting wild populations for resources and straining ecosystems. Even in land-based facilities salmon have the ability to escape where they will be virtually impossible to recover. Oregon Rules on Genetically Engineered Fish: The Oregon Department of Fish and Wildlife considers releases of transgenic fish to pose a serious risk to wild populations. Under this rule, the Department does not authorize the release of transgenic fish into locations where such fish may gain access to wild fish populations. (Oregon Administrative Rules 635-007-0595.)
on December 26,2012 | 06:26PM
livinginhawaii wrote:
Face it - there is no way to stop the release of GMO products that are in full production into the wild. This will eventually happen at some point in time. GMO products that are not in full production so far have been controlled. Personally, I would think that glowing UH mice would be a good thing to release as they would be easier to catch...
on December 26,2012 | 08:47AM
kuroiwaj wrote:
Outstanding decision by the FDA after some 17 years of testing. I'm certain the investment $ will pour in to make the operation survive and be successful. Let's see some GMO research gains with Ahi and blue fin tuna.
on December 26,2012 | 10:24AM
Dragonman wrote:
Its all about politics. Lot of money at stake here folks. Wild caught & farm raised vs genetically grown fish that grow twice as fast and eat 1/2 the food while growing as compared to other stocks of salmon. Do you think the industry as a whole is against this project and is lobbying hard to make it go away.
on December 26,2012 | 11:21AM
eleu808 wrote:
AquaBounty’s CEO, Ronald L. Stotish, tries to create the image that their purpose is to benefit humanity. He has said that the GM fish would help grow food for the world with fewer resources. Of course, it ignores the massive amount of food the fish will need to grow so fast, the land required to provide the feed for the fish, transportation for getting feed to the fish, and the use of land that might grow vegetables or grass to graze animals for far less efficient food production in the fish. With so little basis in reality on this point, it’s difficult to believe any of AquaBounty’s statements about safety, health, or environmental standards.
on December 27,2012 | 03:22AM
false wrote:
I hope they could GMO a salt water Tilapia.
on December 26,2012 | 12:01PM
BTO wrote:
They already modified our wheat, corn, soybeans, papaya, sugar, etc.... what is new. That is why our food is not as nutritious as years past. We are eating fillers that look and feel like the real thing. But like our lawn mowers trying to run on corn fuel it gets all clogged up.
on December 26,2012 | 03:36PM
eleu808 wrote:
Unfortunately, much is still unknown about the how the consumption of GMOs (genetically modified organisms) affects humans. Since the science behind GMOs is relatively new, it may take years to learn about the adverse effects of eating these foods. This was the case with the pesticide DDT, which was in heavy use until it was found to accumulate in fish at doses harmful to humans. Allergies are also a major concern. According to the Consumers Union, AquaBounty has not conducted enough tests on this salmon to determine if it is actually safe to eat. The Consumers Union said in a statement that it is “particularly concerned that this salmon may pose an increased risk in…life-threatening allergic reactions to sensitive individuals.”
on December 26,2012 | 06:37PM
eleu808 wrote:
AquaBounty’s CEO, Ronald L. Stotish, tries to create the image that their purpose is to benefit humanity. He has said that the GM fish would help grow food for the world with fewer resources. Of course, it ignores the massive amount of food the fish will need to grow so fast, the land required to provide the feed for the fish, transportation for getting feed to the fish, and the use of land that might grow vegetables or grass to graze animals for far less efficient food production in the fish. With so little basis in reality on this point, it’s difficult to believe any of AquaBounty’s statements about safety, health, or environmental standards.
on December 27,2012 | 03:20AM
Hapa_Haole_Boy wrote:
This total process has taken almost 20 years and counting. The FDA should really look at itself in the mirror.... Selling out to industry is one question (which I don't believe is at issue here), but bureaucratic morass is something else entirely. Good gawd, they should really be ashamed of themselves.
on December 27,2012 | 10:04AM
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