Sometime this summer or soon after, the federal Food and Drug Administration may finally approve the first-ever genetically modified animal for human consumption -- a fast-growing Atlantic salmon that has taken 17 years to reach the threshold of American consensus. The man to thank -- or blame, depending on how you feel about these things -- is a former Soviet biologist who is bankrolling the endeavor with an eye on becoming a U.S. salmon farmer.
"I have no doubt the FDA will approve a genetically modified animal at some point," says Kakha Bendukidze, who has laid out millions of dollars bankrolling AquaBounty Technologies, a Boston-area biotech company that wants to bring its genetically altered AquAdvantage Salmon to American dinner tables and supermarkets. "Whether it's this fish or some other animal, it has to do this, or it risks America losing its biotechnology edge to countries like China."
More than 33,000 fishermen, environmentalists and food safety advocates have written to the FDA to oppose the approval. Among their worries: that this genetically engineered fish might cause unique allergic reactions in humans; that it might escape and mix with wild salmon and ultimately out breed and out eat them; and that the fast-growing broods could flood the market and cripple the wild salmon fishing industry in coastal states like Alaska, Oregon and Washington.
Even though the FDA concluded three years ago that the fish posed no threat in the wild or to humans, a tide of criticism has slowed the FDA's approval process to a crawl. As a result, AquaBounty, which has spent $67 million on this fish -- its only product in the pipeline -- has burned through millions just trying to stay afloat. Last year, it was forced to lay off more than half of its workforce -- from 27 to 12 people. It had earlier managed to raise $2 million to stay solvent, nearly half of that coming from Bendukidze. As part of the deal, it had to sell its research and development arm to him. Bendukidze had been the company's largest shareholder until this past November when his investment fund sold its shares to Intrexon, a Maryland-based biotech firm. He has retained the lucrative R&D unit, its staff and the lease on its labs.
Despite its small size, AquaBounty is the only animal biotechnology company in the United States trying to gain approval for a gene-altered animal to enter the human food chain. But it has dozens of biotech behemoths supporting it and cheering it on from the sidelines. "It's important to them that this first one get through," says Alison Van Eenennaam, professor of animal science at the University of California, Davis. "The question is: Can a company get through this review process and get to market? We have a situation where special interest groups are forcing the FDA's hand. That's not what I expect a capitalist system to do."
Van Eenennaam and other scientists, as well as biotech executives and shareholders, worry that if the United States can't approve a gene-altered animal for consumption, U.S. industries will lose out to nations that will. "The [FDA] delays are a major challenge to business," says Dr. Helen Sang, a geneticist at the University of Edinburgh in Scotland, who has studied the issues on both sides of the Atlantic. "This is extremely off-putting for others who are considering applying for permission to produce other GM foods."
Already in China, researchers are working on the same type of fast-growth salmon, as well as attempting to breed cattle that are resistant to foot and mouth disease and pigs that contain heart-healthy omega 3 fatty acids. In the meantime, crucial research work in the United States is now going begging overseas.
One of the most promising is a program in Van Eenennaam's department. It is aimed at genetically altering goats so their milk contains high levels of an antimicrobial enzyme to help infants ward off stomach infections, a problem that plagues the developing world's children. It is headed to Brazil, where the government has put up $3.5 million to help fund it. Professor James Murray, who developed the technique, has said one factor in moving the study was that it took the FDA a decade just to decide how to regulate bio-engineered food and dairy animals. By the time the agency finally issued guidelines, in 2009, Murray had already made his decision and wasn't looking back.
"Emerging economies like Brazil are jumping into this game with tons of money," Van Eenennaam says.
"China is already working on a growth hormone for farmed fish."
Creating the Frankenfish
The AquAdvantage salmon is a voracious over-eater, like a cow with fins. It carries two bits of foreign DNA: a growth hormone from a Chinook salmon and a genetic "switch" from an eel-like fish, called an ocean pout, that trips this gorge-and-grow gene. It matures twice as fast as Atlantic salmon, can grow year round, and can survive in frigid waters. Critics have dubbed it "Frankenfish." Politicians from Alaska, Oregon and Washington, who feel their wild salmon fisheries would be threatened by this new breed, have been particularly harsh in their condemnation and have vigorously tried to block the FDA from approving the fish. Lisa Murkowski, a Republican senator from Alaska, has lead the fight, saying that approving the fish "is messing with Mother Nature in a very serious and big way."
Producing this transgenic fish indeed sounds freakish. In addition to gene splicing, AquaBounty produces only what are known as triploid eggs, an abnormality in the chromosomes that stop female fish from reproducing.
plans to sterilize embryos in Canada before shipping them to Panama, where scientists would expose males to estrogen to be sex reversed. Bendukidze, 57, whose San Diego lab scientists are genetically engineering zebra fish to try out other alterations in commercial seafood, says 95 to 99 percent of the AquAdavantage salmon will be sterile and raised in tanks in the remote hills of the Panama rain forest. There is little chance they will escape into the wild, and even if they did, less chance they could breed.
"It's like releasing a cow into nature -- it does not know how to survive, much less procreate," says Bendukidze, who started his career as a molecular biologist before becoming the economics minister of the Republic of Georgia and finally a biotech entrepreneur. "It's the same with fish who live in a lab. They cannot survive in the wild."
But critics point out that since the company plans to grow 15 million AquAdvantage eggs, that 1 to 5 percent could amount to 750,000 fertile fish. If any were to escape, they fear an ecological domino effect of devastation. The company's investor background material note that their fish eat five times the food as wild salmon do and have less fear of predators.
"The FDA drew their assessment on the narrow grounds of containment in Panama and didn't look at the impact we think they should look at," says Patty Lovera, assistant director of the consumer watchdog group Food and Water Watch, just one of the 300 groups that oppose the fish. "What if you sell these fish to somebody else who wants to raise them in open ocean pen systems, which is how most farmed salmon are raised?" The company has in fact talked about interest from China, Argentina, Chile and Canada, where farmers hope to buy the company's fish eggs and cultivate them themselves for sale.
The market for heart-healthy salmon, which contains EPA and DHA, the building blocks of omega-3 fatty acids that help keep the heart and arteries clean and functioning, has boomed in recent years as Americans face an obesity and heart-disease epidemic. Last November, salmon overtook shrimp as the second most consumed seafood in the United States, just behind tuna. Some 91 percent of all seafood eaten in this country is imported, and nearly half of that is from aquaculture.
AquaBounty, which would be a tiny player in this field, says its salmon could help meet demand and boost productivity in the $100 billion commercial aquaculture industry, the fastest growing segment of the worldwide food industry. "What we are doing is not so different than what any animal breeder has done for years, and what nature itself does, is try to make a more efficient animal," Bendukidze says. "It’s like selective breeding in cattle to increase milk production or produce more beef per pound. These salmon are 20 percent more efficient than other salmon."
How should food be labeled?
Even if the FDA approves the fish, as many expect it will, there's a secondary battle looming: how to label it. AquaBounty says it simply should be called Atlantic salmon, because that's what breed it is. But consumer advocates and the wild salmon industry want it labeled genetically modified. They want to let consumers know what they are eating and protect the business interests of wild salmon farmers, who claim their product is superior to any farm-raised fish. Such a label would actually bestow a premium on wild salmon for consumers who look for natural food items and are willing to pay more for it.
In June, at the urging of Murkowski and others, a Senate committee narrowly agreed to add language to a spending bill to require that genetically modified salmon be labeled. The amendment now faces an uncertain battle on the senate floor in the coming weeks.
The political call for labeling genetically engineered foods, also known as genetically modified organisms, or GMOs, is picking up steam in statehouses across the United States. This year alone, 28 states have introduced legislation for mandatory labeling of such foods. In June, the Maine legislature became the second state after Connecticut to pass such a bill. Both bills stipulate that other states around it, including at least one border state, pass similar bills.
The measures have been a major setback to seed giants like Monsanto who argue that GMOs -- like those that produce crops resistant to disease -- are necessary to feed a growing planet and pose no harm to humans or the environment. Critics claims otherwise, even though Monsanto argues that no legitimate, peer-reviewed studies have proven this. (The European Union has required such labeling for nearly a decade.)
But "food movement" designees like Michael Pollen continue to press for change. And the tide in this country indeed seems to be turning. In March, the Huffington Post and YouGov asked a political cross-section of Americans what they thought of the debate. It found a majority, some 82 percent, favored mandatory labeling, even as they admit that they didn't know for sure whether GMOs harm humans or the environment. Little wonder that the biotech companies are worried. A June ABC News poll found that 52 percent of the respondents felt GMO food was unsafe to eat, and slightly more said they’d be less likely to buy foods labeled as genetically modified or bio-engineered.
Animal scientist Van Eenennaam says the market indeed is the best predictor of what the public wants and what it will tolerate. But she thinks the trend in locavore politics has damaged people's ideas of how the democratic process and the capitalist system should work.
"We have politicians literally saying they want to put this company out of business," she says. "That is not how this works. It's fine if people want to eat grass-fed beef and only what's grown within 100 miles of their homes. But they should not tell the rest of us what to eat. These people want to take us back to the 19th century. Is someone in New York never supposed to eat an orange because they grow in Florida? Or eat beef that's been selectively bred to grow fast? It's the whole premise of global trade."
Photo: Flickr/U.S. Fish and Wildlife Service