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« December 2010 Table of Contents

Top Story: Super salmon?

AquAdvantage has become a lightning rod for transgenic critics

Despite a barrage of criticism from consumer and environmental advocates, the U.S. Food and Drug Administration early next year could approve the first transgenic farm animal designed for human consumption - a fast-growing Atlantic salmon developed by AquaBounty Technologies.

For well over a decade, crops such as corn and soybeans have been genetically modified using precise biotechnology methods to deter pests, prevent disease and better
tolerate cold temperatures, drought and herbicides. Using that same science with animals to achieve certain traits has taken longer to develop - the common practice now is much slower and less precise selective breeding - but genetic engineering could usher in an entirely new approach to animal husbandry, whether it's farmed fish or livestock.

"The concept of genetic improvement goes back a long, long time," says Ronald Stotish, CEO of AquaBounty in Waltham, Mass., which has invested approximately $60 million to get its GM salmon approved. "Now, there is an opportunity to very precisely alter genomes for specific traits. Not only is this the latest and most precise form of genetic modification, it is also the most regulated. That should be reassuring 
to people."

But it is not. AquAdvantage Atlantic salmon eggs are at 
the leading edge of this new world in food production. As such, they've become a lightning rod for consumer, animal welfare and fishing and environmental groups critical of genetically engineered animals. Supporters say transgenic fish will make aquaculture more efficient and future supplies more abundant, but critics argue that food suppliers shouldn't be messing with nature.

Science scrutinized

AquaBounty began developing the fish to help meet worldwide demand for a high-quality source of protein without harming the environment or further depleting wild fisheries, says Stotish. What allows the AquAdvantage salmon to grow to market size in 18 months, rather than the usual 36 months required for traditional farmed Atlantic salmon, is the inclusion of a growth hormone gene from the chinook salmon, plus a genetic switch taken from the ocean pout (an Arctic, eel-like fish that produces an antifreeze protein in its liver to allow it to endure cold waters) that activates it. Salmon normally only produce growth hormone in warm weather, but AquaBounty's genetic alteration allows it to occur even in cold weather. In all other respects the fish are identical to other Atlantic salmon, farmed or wild, Stotish says.

The fish would be raised in inland tanks with sophisticated containment procedures and mechanisms, which according to AquaBounty sharply reduce the chance of environmental harm to wild species. In addition, about 98 percent of the fish would be sterile, and all of them would be female, Stotish adds.

In its detailed scientific review of the AquAdvantage salmon, the FDA, which regulates genetically engineered animals under new animal drug provisions of the Federal Food, Drug and Cosmetics Act, didn't find anything harmful to human health or to the environment. The agency must also decide if the fish should be sold with a label identifying it as a genetically modified product (see Point of View).

In September, however, the agency sent its scientific report to the Veterinary Medicine Advisory Committee, which held three days of public hearings followed by a 30-day comment period. There is no timeline on when a decision will be made on the application, says Laura Alvey, deputy director, office of communications at the FDA's Center for Veterinary Medicine. Before releasing a decision, the FDA also will publish an environmental assessment followed by a 30-day comment period.

Comprised of animal health experts, committee members did not find any evidence that contradicted the findings and conclusions of the FDA staff, but they did express concern about some of the studies 
used to support those conclusions. If the committee finds specific insufficiencies in the application that would preclude an approval, AquaBounty would be given the opportunity to address those problems, adds Alvey.

Meanwhile, the anti-GM salmon contingency has been strong. The Center for Food Safety lined up a coalition of 52 organizations opposing FDA approval of the GM salmon. At the hearings they testified that the genetically engineered salmon would pose a serious threat to wild Atlantic salmon, which is listed as an endangered species, and claimed that the science used to evaluate AquaBounty's claims about potential health impacts was "sloppy."

In addition, 11 senators, led by Sen. Mark Begich (D-Alaska), sent a letter to FDA Commissioner Margaret Hamburg criticizing the agency for the process used to evaluate the fish for human consumption.

"Given the inappropriate approval process, the lack of transparency for over 10 years regarding this particular application, and the myriad of potential human health and ecological risks associated with production and consumption of [genetically engineered] animals, we believe the AquaBounty salmon should not be approved for human consumption," Begich wrote.

Despite regulations that would only allow the fish to be grown on land, the coalition claims that approval would pose a "serious threat" to the survival of wild Atlantic salmon populations because they still fear the transgenic fish would escape and out-compete their wild cousins for food.

The coalition cited research published in the Proceedings of the National Academy of Sciences , which found that the release of 60 GM salmon into a population of 60,000 wild fish would lead to the extinction of the wild fish in less than 40 generations.

Opponents particularly challenged two studies AquaBounty conducted on health aspects of the fish. The company reported slightly elevated levels of insulin-like growth factor 1. The presence of high levels of this hormone in the human bloodstream may increase cancer risk, according to some studies. But the question of whether food has any impact on these hormone levels in the bloodstream has not yet been determined. FDA analysis found that even if people ate large quantities of the fish, the amount of hormone they might consume would be insignificant.

The other potential health issue that worries critics is whether there is a higher risk of increasing the allergenic potential in the salmon because they've been genetically modified.

Jaydee Hanson, a policy analyst at the Center for Food Safety, called the sample sizes used in some of the GM salmon studies woefully inadequate.

"The FDA advisory committee said 'you guys didn't do a good job. You may think this is safe, but your studies don't show that,'" Hanson says.

"The FDA shoehorned these big fish into their animal drug rubric instead of creating a new testing protocol for these genetically engineered fish. I would have thought both the FDA and company would have made sure the statistical information was impeccable, not weak as this is," he adds.

Michael Hansen, senior scientist at Consumer Union, the organization that publishes Consumer Reports, adds that the company and FDA reached conclusions about health issues using testing methods that weren't sensitive enough, which he says is just bad science.

"There were a lot of things that should have been done, which weren't. Small sample sizes, insensitive testing methods and failure to conduct tests based on fish production," Hansen says. "This is going to set the bar for all that comes after it. You cannot make conclusions in the absence of data. I was actually surprised that the quality of the reports was so poor."

Just the facts, please

Twenty years after GM salmon were first developed by researchers Garth Fletcher and Choi Hew, and 14 after AquaBounty (under a different company name), purchased the technology, Stotish is frustrated by some of the allegations and criticism leveled at AquaBounty in the public debate surrounding FDA review of the company's application.

Some of the charges misrepresent the facts, are alarmist and deliberately inflammatory, and "appear to be maliciously aimed at creating fear in the public," he says.

On the environmental issues, for example, Stotish says AquaBounty produces its eggs at a facility on Prince Edward Island, Canada, and then ships them to another facility in Panama where they are raised. Fish will only be raised in closed-containment facilities. If the FDA does approve the technology for commercial use, that will be a mandatory condition. In addition, the company is working on a process that will make 100 percent of 
the GM salmon sterile.

With the allergy concerns, Stotish says the company asked one of the world's experts on this issue to review the company's study and findings. His analysis coincided with FDA conclusions, which were that the AquaBounty salmon does not appear to be any different from the traditional farmed salmon.

"This product will be very tightly regulated and the oversight will be substantive," Stotish says.

He does, however, appreciate that the issue of genetic engineering is an emotional one for many people. So were earlier technologies that are now widely accepted, such as selective breeding and artificial insemination. When these techniques were first introduced, however, some critics not only considered them ungodly, they said the practices involved the abuse of animals. But those social mores changed with time, he says.

"I think these salmon have been looked at more closely than any other salmon in history," says L. Val Giddings, president of PrometheusAB, a biotechnology-consulting 
 firm in Silver Spring, Md. Giddings founded the firm after stints as VP of the Biotechnology Industry Organization, and at the U.S. Department of Agriculture where he was senior staff geneticist and international team leader. He also worked with AquaBounty on some matters unrelated to GM salmon.

Giddings first heard about the possibility of a genetically engineered salmon from AquaBounty co-founder Elliot Entis at a conference in Europe 15 years ago, and admits he was skeptical.

"At the time I thought, 'The last thing we need is another threat to the wild salmon,'" Giddings recalls, but as time passed and he learned more about the work the company was doing, his views changed.

Because AquAdvantage salmon will have to be raised in closed-containment land-based facilities, the danger of escape into the wild is extremely remote, Giddings says. "That issue has been taken off the table, and it's just not honest for these people to claim that these salmon will pose a threat to the wild population.

"At this point, every reasonable question about this fish has not only been asked, but satisfactorily answered," Giddings adds. "It is no different from any other salmon except that it grows faster."

Most of the Atlantic salmon currently sold in the United States is imported, which means high shipping costs make the fish expensive and give it a large carbon footprint. The long distances from farm to store also have an impact on quality. By the time salmon reach display cases, they've already been out of the water at least a week, Giddings says.

In a recent article in the Natural Resource Report, James Greenwood, president and CEO of the Biotechnology Industry Organization, points out that faster-growing genetically engineered salmon could help restore America's languishing domestic fish-farming industry.

AquaBounty envisions farming operations located near major population centers, which would trim costs, lower energy consumption and deliver a fresher product to supermarkets.

"I'll be stunned if this salmon doesn't take off and sell like hotcakes," says Giddings.

But no fish will appear in supermarkets any time soon. Even if the FDA does approve them, the earliest GM salmon could be on the market is 2013 because of the growout period.

Farming for the future

Although the idea of eating genetically modified animals is frightening to many people around the world, most food-security experts recognize that in order to adequately feed a world population expected to hit 9 billion people by 2050, genetically modified food and biotechnology will have to be part of a global strategy.

In an article published in the journal Science earlier this year, a group of 10 scientists outlined the global needs and challenges. They said world food production in the next 40 years must increase between 70 and 100 percent.

"Growing competition for land, water and energy, in addition to the overexploitation of fisheries, will affect our ability to produce food, as will the urgent requirement to reduce the impact of the food system on the environment. The effects of climate change are a further threat," the scientists said in the article, published Feb. 12.

The United Nations in May added to that grim assessment with a study saying 80 percent of world fish stocks are fully exploited or overexploited. Unless these trends are reversed, by mid-century fisheries could collapse worldwide.

Nearly half of all seafood consumed worldwide is now farmed, but new projections for the industry about rising demand far exceed earlier studies based solely on population growth, according to the Global Aquaculture Alliance, an industry trade group in St. Louis.

"Rising global demand for seafood, driven mainly by a rapidly growing middle class in China and other Asian nations, is putting new pressure on the aquaculture industry to find sustainable ways to increase productivity," according to new data experts presented at the group's annual GOAL meeting of international aquaculture and seafood industry leaders in Kuala Lumpur, Malaysia, 
in October.

Economist Ragnar Tveteras told conference attendees that China, the world's largest aquaculture producer, is increasingly importing seafood to meet domestic demand. He says the country will shift from being a net seafood exporter to a net seafood importer next year, and per-capita consumption is expected to double between 2008 and 2020.

To sustainably increase seafood production to meet rising demand, producers must adopt improved technologies that produce more seafood with fewer resources, says George Chamberlain, GAA president.

During the conference, 132 industry leaders were asked their opinion about GM salmon and 58 percent said exploration of the technology should continue using carefully monitored and controlled land-based systems.

"Judicious and responsible incorporation of GM technology has the potential to be good news for consumers and the environment," Chamberlain says. "However, insufficient data is available about AquaBounty salmon to make a full assessment. If proper safeguards are in place to prevent escapes, commercial trials would help answer questions about economic viability in land-based systems and consumer acceptance."

If the FDA does approve the salmon for human consumption, consumers will have the ultimate say about its success or failure.

Red Lobster, a subsidiary of Darden Restaurants in Orlando, Fla., is the world's largest casual-dining seafood restaurant with nearly 700 stores in the United States and Canada. It is also the largest overnight shipper of fresh fish in the restaurant industry, and could be a retail market maker if it agrees to sell the GM salmon. But no such decision has been made yet, a Darden spokesman says.

"It's too early in the game for us to know whether we will consider this product," says Rich Jeffers.

Sam King of King's Seafood Co., which has restaurants primarily
in California and operates its own seafood distribution company, says the company 
will consider selling the GM salmon if it gets approved.

"I think we need to be careful and the FDA needs to be careful, but this sounds like one of those moments that could change the course of history once we figure out how to do things," King says. "This is going to change aquaculture."

With surging population growth and rapidly declining fish stocks throughout the world's oceans, the only way to meet global dietary needs in the future is if technology improves.

"We have the tools to feed the world if we choose to use them," Stotish says. "We're hopeful because the science is good that the FDA will eventually approve this product."

What's next?

For now, everyone is in a holding pattern awaiting the FDA's final decision - AquaBounty, critics, other biotech companies and companies interested in starting commercial farming operations, including AquaBounty's Entis.

If the FDA suddenly reverses course and decides to reject AquaBounty's applications, the reasons would have to be detailed in a letter.

At that point, the company would request a meeting to discuss the issues, "and attempt to address any agency concerns in a constructive and responsive manner," Stotish says.

If the fish is approved and other companies want to open facilities, a supplement to AquaBounty's application would have to be filed. The supplement would include site-specific information on design, containment, size and an environmental assessment would be prepared.

FDA inspectors would visit the site and determine if it conformed to the submission information, and prepare a report. Only after the review, inspection and administrative approval of the new location would AquaBounty be able 
to ship eggs to the site for growout.

This process is analogous to the evaluation and addition of alternate manufacturing sites for a veterinary drug, Stotish says.

Less clear is what options opponents will have if the salmon is approved. They likely won't have any avenue for appeal to the FDA, which means their only recourse would be legal action.

AquaBounty will likely never win over its most ardent critics. But the company may be able to assuage the public outcry, especially if it persuades companies that sell its GM salmon with labels that clearly identify the fish as such. For now, the food industry waits for the FDA's final word.