BY ANDREW ZAJAC, Tribune Washington Bureau August 9, 2010

WASHINGTON -- After 14 years of work, unceasing attacks from critics, and a $50 million investment without a penny of profit, a small New England biotech company stands on the doorstep of history – seemingly poised to join agriculture's "green revolution" as a game-changer in feeding the world.

Or not.

With global population pressing against food supplies and vast areas of the ocean already swept clean of fish, tiny AquaBounty Technologies of Waltham, Mass., has developed a variety of salmon that reaches market weight in half the time of other salmon.

What's more, AquaBounty not only promises to slash the ready-for-market time – and production costs -- on a hugely popular, nutritious fish that currently commands near-record prices, it plans to avoid the pollution, disease and other problems associated with today's salt-water fish farms by having its salmon raised inland.

But there's a catch: AquaBounty's salmon is genetically engineered. Indeed, it aspires to be the nation's first genetically-modified food animal of any kind.

That means the Food and Drug Administration must approve it. It also means the company and its salmon must withstand vociferous opposition from environmental and other advocacy groups, win over skeptical producers and -- possibly most difficult of all – overcome potential consumer resistance to genetic tinkering with food.

It is this combination of seemingly great promise and large obstacles that makes the company's long, costly, and still-unfulfilled effort the stuff of history.

"This is the threshold case. If it's approved, there will be others," said Eric Hallerman, head of the Department of Fisheries and Wildlife Sciences at Virginia Tech University. "If it's not, it'll have a chilling effect for years."

The FDA has completed its review of key portions of AquaBounty's application, according to CEO Ronald Stotish. Sometime in the weeks ahead, company officials expect the agency to convene an advisory committee of outside experts to weigh the evidence, collect public testimony and issue a recommendation about the fish's fitness for human consumption.

The ground-breaking nature of the proposal is reflected in the fact that the FDA is evaluating it as a new animal drug. There's nothing in the law about genetically engineered animals.

At one level, manipulation of natural processes is a longstanding fact of life in most of the world's food supplies. Cattle, hogs, poultry and most grain and vegetable crops have been extensively altered through selective breeding and hybridization -- – including turkeys with more white meat, drought and disease resistant wheat as well as fruits and vegetables that resist bruising or spoiling when shipped long distances.

One of the most important elements in the so-called "green revolution" that multiplied crop yields and banished starvation from large segments of the global was precisely this kind of scientific engineering, which in some cases involved genetic alteration of plants.

Yet so far at least, what may have been accepted in plant foods has not been accepted in food animals.

"The thought of genetic engineering sort of excites the idea that there might be a kind of boundary-crossing going on that might be yucky," said Paul Thompson, an agricultural ethicist at Michigan State University.

From the company's standpoint, the timing of an FDA approval, if one is in the offing, couldn't be better. Wholesale salmon prices are at near record highs and the share of global seafood production derived from fish farming is approaching 50 percent. .

Despite these seeming favorable circumstances, many in the industry see genetically modified salmon as a controversy they'd rather avoid.

"We do not support it…We wouldn't consider changing that unless the market demanded it and all government regulators say it's safe," said Nell Halse, president of the International Salmon Farmers Association.

"No! It is not even up for discussion," Jorgen Christiansen, director of communications for Oslo-based Marine Harvest, one of the world's largest salmon producers, wrote in an email.

Christiansen said his firm worries "that consumers would be reluctant to buy genetically modified fish, regardless of good food quality and food safety."

On the other hand, the National Fisheries Institute, the main trade association of U.S. seafood producers, supports "the use of biotechnology in the production of genetically-engineered fish," subject to FDA safety assessments, spokesman Gavin Gibbons said.

Creating an AquaBounty salmon involves taking a portion of the anti-freeze gene of an eel-like creature called the ocean pout, transplanting it into the growth gene of a Chinook salmon and injecting the blended genetic material into the fertilized eggs of a North Atlantic salmon.

Unlike ordinary salmon, the genetically modified fish grows during the winter as well as during the summer, so it reaches an 8-pound market weight in 18 months, instead of the 36 months normally required.

"This is a single gene and it's a salmon gene in a salmon," said Stotish, a biochemist and pharmaceutical researcher who joined AquaBounty in 2006 and became CEO two years later.

The salmon is identical in taste, color, proteins and other attributes of a non-engineered North Atlantic salmon, he said.

If it gets a green light from the FDA, AquaBounty intends to require producers to raise its salmon on land and the fish will be sterile to prevent cross-breeding.

Most salmon, including nearly all North Atlantic salmon, are farmed in ocean pens where wild and confined fish can spread pathogens back and forth and escapees from pens can interbreed with wild salmon, producing offspring less suited to the open ocean.

Since AqueBounty intends to have its fish raised inland, in tanks or other contained facility, the controlled conditions would limit the chances of spreading diseases and escapes.

One key to acceptance may be how the product is labeled; Stotish says he'd have no problem with a voluntary label but fears a mandatory label would look like a warning; if the FDA finds the product safe, he says, that would be unfair.

Opponents of the modified salmon point to a 1999 study suggesting genetically modified salmon could lead to less hardy hybrids . But the study's co-author, William Muir, an animal science professor at Purdue University, said the findings did not apply to the AquaBounty fish.

Based on what is currently known, "transgenic salmon don't pose any more of a threat to wild salmon than other farmed salmon," Muir said.

Muir said, however, that there are unknowns. He likened it to the introduction of a new drug, which may show side effects not anticipated in clinical trials.

"The disadvantage is that recalling a drug is a lot easier than recapturing a fish," Muir said.

"I don't see the necessity of it. We don't need to build a new fish," said Casson Trenor, of Greenpeace USA. Other critics call it the "Frankenfish."

Bioethicist Gregory Kaebnick, of the non-profit Hastings Center things the transition may actually be fairly easy.

" It's not a very dramatic transfer. It's not putting a jellyfish gene into a tomato. It's not giving it a radically new property, like making it glow," he said. "In the long run, I think people are going to get used to this kind of thing."