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Elliot Entis doesn't much like to think of himself as a pioneer. And aside from a single framed photo of a salmon hanging on the wall, Entis' tiny office in Waltham, Mass., offers barely a hint of what has been a labor of love since 1992. His company, Aqua Bounty Technologies, has created a breed of salmon that grows twice as fast as normal farmed salmon, because they carry part of the genetic code of another type of fish, the ocean pout.
Aqua Bounty is in the final stages of a five-year battle to get the product approved by the Food & Drug Administration, which has yet to approve any transgenic animal for human consumption. If the company succeeds, Entis' salmon could become the first such product on the market. He hopes to achieve that milestone by 2008.
TOUGH QUESTIONS.Entis' salmon grow so fast because of a change made to one of the roughly 40,000 genes in their DNA. In normal salmon, the gene that controls the production of growth hormone is activated by light, so the fish generally grow only during the sunny summer months. But by attaching what's known as a "promoter sequence" -- part of a specific gene -- from the pout, Aqua Bounty ended up with salmon that make growth hormone all year round.
These genetically modified fish won't look or taste any different to consumers, but they could make an ocean of difference to fish farmers. Entis estimates they'll allow the average salmon producer to cut costs 35% per fish while doubling output. "It's like improving the mileage in your car," he explains.
While it may sound simple, the FDA has come up with a litany of tough questions for Entis. The agency has asked for a complete description of the transgene, a map of exactly where it sits in the salmon's chromosome, and proof that the location of the tweaked gene won't change as it's passed down from generation to generation. The agency needs that information to ensure consistency in the final product and to guarantee that the fish remain healthy.
MATING SEASON.Aqua Bounty's toughest challenge has been to allay fears that if the supersalmon escape into the ocean, they could start mating with their wild counterparts, ultimately wiping out the world's entire population of wild salmon. The company may decide only to seek approval for sterile fish or for fish that are grown indoors -- making such scenarios impossible. Still, to answer concerned environmentalists, AquaBounty has been collecting data that predict what might happen if their fish escaped.
Some studies, including independent research done at Purdue University, use a combination of controlled experiments with laboratory fish and mathematical modeling to determine what characteristics a genetically modified fish would need to have to overtake wild populations. For one, male transgenic fish would need to be bigger than wild salmon to gain any advantage during mating season.
AquaBounty's fish grow faster, but not bigger, than regular salmon, and they're all female anyway. All in all, says Entis, "our fish would be lousy survivors [in the wild]." The company predicts that fewer than 1% of genetically modified salmon that escape would survive to adulthood in the wild.
SCRAPING BY.As is the case with most new ideas in biotech, though, some critics remain unconvinced. Jeremy Rifkin, president of the Foundation of Economic Trends in Washington, D.C., and a longtime critic of genetic modification, is afraid that mixing up genes from different species could have unpredictable consequences over the long run.
"We know genes cross borders, but what we have here is a radical speeding up of that journey," he says. "We're introducing so many radical changes into the physiology of the ecosystem. The environmental implications could be enormous."
If the pioneers of genetically modified meat fail to allay such fears, their inventions may face a tough marketing challenge. Entis says the fish farmers who would ultimately adapt Aqua Bounty's technology are reluctant to commit to it until the FDA weighs in. The privately held company is scraping by on funding from private investors, as well as revenues from other fish-related products.
But other inventors of genetically modified food are desperate for financial support from meat producers, and they're coming up empty-handed. Three scientists at the University of Guelph in Ontario, Canada, for example, have been looking for a financial partner to help bring a new type of pig through the regulatory process and to market.
COSTLY ENZYME.Their Enviropig has been genetically modified to produce less phosphorous in its manure than normal pigs do. The creature could solve one of the biggest environmental threats in modern agriculture: so many pigs producing so much phosphorous that the chemical is building up in soil and running off into groundwater.
Pork producers cut the phosphorous output by feeding pigs an enzyme called phytase, which chews up some phosphorous while it's still in their stomachs. But adding phytase can be costly. Enviropigs are born with the ability to produce phytase naturally in their saliva.
Still, the fears about genetic modification seem to outweigh the near-universal consensus that the pork industry needs to fix the phosphorous problem. "What we're hearing from large producers is they don't want their trademarks tainted with genetically modified animals because consumers aren't ready for it," said Cecil W. Forsberg, professor of microbiology at Guelph and one of the Enviropig's inventors, in an interview at the annual meeting of the Biotechnology Industry Organization.
FACT VS. MYTH.He fears that if they can't raise money to advance the project soon, the Enviropig will become an endangered species. "In view of the increasing cost of energy, which [increases] the cost of adding phytase enzyme to the pig ration, we would like to think that the industry will begin showing interest in pigs that bypass the need for the third most expensive nutrient in their diet," he griped in a follow-up e-mail.
To win the confidence of consumers, pioneers of transgenics will have to educate the public on the facts vs. the myths of genetic modification. Entis is trying to do his part. Whenever he hears someone say "genetically modified," he urges them to use the term "advanced hybrid" instead. His reasoning: Crossing a salmon with a pout is really no different from selectively breeding desirable traits into cows to make a tastier prime rib.
There are plenty of examples in the fish industry as well. The sunshine bass, for example, is a cross between a fresh water white bass and salt water striped bass. "I can tell you, they don't meet in nature," Entis says. "That's crossing the species barrier."
ROAD MAP.Like many entrepreneurs in the field of transgenics, Entis is eagerly awaiting the FDA's guidance on milk and meat derived from cloned animals. The agency is expected to declare that products from cloned animals are safe, and that could provide a boost of confidence for transgenics-derived foods. If Entis succeeds in gaining the FDA's confidence, he plans to release all the data from the studies his company conducted to get the approval -- in the hopes it will provide a road map for other companies working on transgenic animals.
Aqua Bounty is now completing what Entis believes will be the final major study it needs to do to meet the FDA's food-safety requirements. The study is designed to prove the modified fish don't touch off allergic reactions any more than normal salmon do. Entis says he has come to accept the long approval process. "We want the public to accept this, and they won't if there's not an air-tight review." That review will likely pave the regulatory pathway for all the transgenics critters yet to come. By Arlene Weintraub in New York