Will FDA bite on genetically modified salmon?

By Andrew Martin
Chicago Tribune

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WASHINGTON — Elliot Entis has a whopper of a fish tale to tell. Now if he could only come up with an ending.

Entis' story is about a salmon that has been genetically modified to grow to its full size of 8 pounds in 18 months, half the time for a normal fish. Entis and his backers champion the fish, the "AquAdvantage" salmon, as cheap, nutritious and environmentally friendly.

Entis hopes the Food and Drug Administration (FDA) will soon proclaim that his salmon is safe to eat, making it the first genetically modified animal allowed into the human food chain and opening the door for other biotech animals to be sold as food.

"You have two options when you go first: Either you get your head blown off or you get to the other side first and pick up the flag," said Entis, president and chief executive officer of Aqua Bounty Technologies, which is based in a Boston suburb.

"I'd like it to be an advantage to be first. My investors certainly hope so."

Americans have been eating food containing genetically modified plants for nearly a decade, ever since the FDA approved a biotech tomato, the Flavr Savr, that stays fresh longer than a regular tomato.

But it has been three years since Entis applied to the FDA, and he appears to be years away from delivering the "AquAdvantage" salmon to U.S. dinner plates.

The problem is that the FDA has yet to figure out how to regulate genetically engineered animals. The agency planned to release guidelines for regulatory approval in 2001, but Entis and other biotech entrepreneurs still are waiting.

Critics, who contend genetically engineered animals pose environmental and food-safety risks, suggest the delays show that the FDA should not be the lead agency regulating biotech animals. The critics fear that the new salmon will breed with ordinary ones and create less healthy offspring or that the super-salmon will crowd out other species with its revved-up appetite.

"It was very scary for us for FDA to be the one in charge," said Tracie Letterman, fish program director for the not-for-profit Center for Food Safety, adding that the FDA is a food-safety agency. "Environmental issues aren't their expertise."

Expect delays

But one of the inventors of a genetically modified pig that produces environmentally friendly manure said the technology is so new that delays should be expected.

"It's difficult to say what's actually needed," said Serguei Golovan, a genomics professor at the University of Guelph in Canada.

Golovan said he and his partners have asked the FDA what they need to do to turn his "Enviropig" into pork chops, but have not yet submitted a formal application.

The complexities of regulating new technology were evident in early November, when an FDA advisory panel balked at the agency's tentative finding that cloned animals are safe to eat. The panel argued that more research was needed before consumers would feel comfortable eating cloned animals.

FDA officials said the recent setback on cloned animals will not affect their review of genetically modified animals, which is a separate issue.

They acknowledged they were behind schedule in coming up with guidelines to regulate biotech animals but noted the technology is new and complex. They also said environmental and health risks may differ depending on the type of animal and the nature of the genetic change.

"We are progressing, but we are behind," said Linda Tollefson, deputy director of the FDA's Center for Veterinary Medicine. "Part of the problem is when you talk about transgenic animals, there are all sorts of different types, some used for industrial products, some for (drugs).

"In those cases, we would probably evaluate the safety of them differently than an animal that would became human food, like the transgenic fish," she said.

Tollefson said the FDA will consult the other federal agencies with environmental expertise, including the Environmental Protection Agency and the Fish and Wildlife Service, to help assess the environmental risks.

Glow-in-the-dark fish

It's not known how many other companies have sought FDA approval for genetically modified animals because the process is confidential. Critics complain that allows for no public input.

Since scientists began genetically modifying animals in the 1980s, they have discovered ways to make animals grow faster, resist diseases and produce drugs and industrial products in their milk.

Researchers have created genetically modified goats that produce spider silk in their milk, cows that create human antibodies for anthrax and fish that glow in the dark, believed to be the only commercially available biotech fish.

The U.S. government has no specific laws that regulate genetically modified plants or animals, forcing regulators to find existing laws that will cover biotech products.

As a consequence, the FDA regulates genetically modified animals as "new animal drugs," or veterinary drugs, under the Federal Food, Drug and Cosmetic Act.

But many think it's an awkward fit because the act doesn't mandate the rigorous environmental review that critics contend is necessary.

The primary environmental concern is that biotech salmon could escape into the wild and breed with native species, creating offspring that are not as healthy and ultimately die off. Even if genetically modified fish don't mate with wild salmon, some scientists worry the biotech fish will flourish in the wild and, with its voracious appetite, crowd out native species for food and habitat.

Washington, California, Oregon and Maryland already have passed laws that prohibit genetically modified fish from being raised in state waterways.

Entis said his scientists have answered the most serious environmental concerns because his fish are sterilized, ensuring they won't breed with native species.

He argued that his biotech fish would benefit the environment because they eat 20 percent less than wild salmon in growing to full size, and because farmers can double their production without increasing the amount of coastal areas devoted to fish farms.

Stumbling on the idea

Entis, 58, said he stumbled on the idea for growing genetically modified fish about a decade ago. At the time, he was starting a biotech company and hoped to use an antifreeze gene that is found in some cold-water fish to preserve human organs and tissue.

As he was walking out of a meeting with Canadian scientists, they asked him if he would be interested in a biotech fish that could grow more quickly than a regular fish.

The scientists, Garth Fletcher and Choy Hew, had spent 20 years investigating antifreeze proteins in certain fish that allow them to survive in sub-freezing water.

Once the scientists successfully transplanted the antifreeze protein gene from one fish to another that normally does not contain it, they tried different applications for the technology. They spliced a section of the antifreeze gene from an ocean pout with a growth-hormone gene from a salmon and transferred it back into the salmon.

Salmon normally only produce growth hormones during warm months. But the section of the antifreeze gene in the genetically modified salmon triggers the growth hormone in cold weather, too, meaning the fish continue to grow year-round.

"This is an all-fish transgene," Entis said, adding that his company has spent $15 million on research to prove the fish is safe. "There is nothing in there that you haven't eaten before."

Even if he wins over the FDA, Entis still faces the question: Will anyone eat a genetically engineered fish?

A survey by the Pew Initiative on Food and Biotechnology, released in September, found that Americans are more comfortable with genetic modification of plants than animals; 58 percent of the respondents opposed research into the genetic modification of animals.

Asked to rate how comfortable they were with genetically modifying animals for food, those surveyed gave it a 3.8 on a scale of 1 to 10. But the results weren't entirely negative: 45 percent of those surveyed thought that genetically modifying fish to reduce the cost was a good idea; 43 percent thought it was a bad idea.

Entis said he is confident that, with FDA approval, consumers will buy his fish. The payoff could be huge: Salmon is the third-most-popular seafood in the United States after shrimp and canned tuna, and 88 percent of the salmon sold in the United States is farm-raised, according to the National Fisheries Institute.

Copyright © 2003 The Seattle Times Company