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Caught in troubled waters

Firm’s genetically engineered salmon facing fierce opposition

By Adrianne Appel
Globe Correspondent / February 20, 2012
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AquaBounty Technologies, a Waltham company that has created a genetically engineered Atlantic salmon, is treading water while it waits for the Food and Drug Administration to decide whether it can sell its fast-growing fish to the public.

The already lengthy federal approval process has grown longer and more complicated in the face of strong opposition to the AquAdvantage salmon, the nation’s first genetically engineered food fish, by environmental groups, consumer advocates, and some lawmakers.

But these efforts are shortsighted, said the company’s president and chief executive, Ronald L. Stotish.

“If anti-[genetically engineered] food activists succeed, the unintended consequence is that we will still one day be eating [genetically engineered] animal food - it will be produced elsewhere,’’ he said in a statement.

AquaBounty is also facing the challenge of shaky finances.

On Jan. 27, it told stockholders it would sell more shares and cut its operating expenses by 30 percent, so it could continue operating into June.

The company said it would reduce operating costs by “restructuring the organization.’’

The company declined to comment on whether the cutbacks include layoffs at its Waltham office or its laboratory on Prince Edward Island, Canada, where it develops genetically engineered salmon eggs. The eggs are then shipped to Panama, where the fish are raised. Raising the fish in the United States, something AquaBounty wants to do, would require a review by the National Oceanic and Atmospheric Agency to determine whether it posed any threat to wild Atlantic salmon, an endangered species.

AquaBounty’s fiscal struggles are not unusual for a biotechnology start-up awaiting federal approval, said H. David Sherman, professor of accounting at Northeastern University. Many young companies have a similar profile, he said.

“Their financial statements often look the same,’’ Sherman said.

As of June 30, AquaBounty had $3.8 million in cash and marketable securities and a net loss of $2.8 million, according to a Sept. 30 interim financial report, the latest available.

More than $60 million has been invested in AquaBounty since it was launched in 1991, and that amount includes support from the United States and Canadian governments. In 2011, it received $494,162 from the USDA’s National institute of Food and Agriculture.

The company’s fish grows twice as fast as an Atlantic salmon. It is the product of combining genes from two other fish, the Chinook salmon and the ocean pout, an eel-like fish. The Chinook salmon gene stimulates the body to make growth hormone, while the ocean pout gene sequence, called a promoter, keeps the growth gene working constantly. The result is a very large salmon in half the time.

An AquaBounty salmon weighs an average of 13.3 pounds, according to the company, while a nonengineered salmon would weigh about 5.5 pounds.

Two years ago, the FDA declared the AquAdvantage fish safe to eat and the company predicted it would soon receive FDA approval to begin production.

But how the fish would be labeled and what environmental impact it might have must be determined before the agency can decide whether the fish can be sold, said FDA spokeswoman Siobhan DeLancey. The FDA has no deadline.

On Feb. 7, the Center for Food Safety and two other consumer advocacy groups petitioned the FDA to begin a new safety review. That set in motion a process that requires the FDA to respond to the request before it makes any decision about approving the fish.

“Given the data we have seen thus far, this fish is not suitable for people to eat and could well be dangerous to the environment,’’ said Jaydee Hanson, senior policy analyst at the Center for Food Safety.

When the FDA did a safety review two years ago, it did so as if the fish were a new animal drug, with the review for safety conducted by the FDA’s Veterinary Medicine Advisory Committee.

Instead, the fish should be reviewed as a food additive, which offers a more rigorous and transparent process, the consumer groups say.

“By conducting the review as a new animal drug there are whole levels of secrecy,’’ Hanson said.

But Stotish said the FDA already concluded the AquAdvantage salmon is identical to other salmon, and there is no need for more review.

“This petition is nothing more than a ‘hail Mary’ pass to further delay and undermine the approval of any [genetically modified] animal food,’’ Stotish said in a statement. “Their goal is not public protection, but the death of this technology in the United States.’’

Environmental groups, including Earthjustice and the Sierra Club, also urge the FDA to halt the approval process and conduct a thorough environmental review, citing concerns about salmon escaping and carrying diseases to or breeding with wild Atlantic salmon.

AquaBounty has said the breeding issue is not a threat because about 98 percent of its fish, which are all female, are sterile.

Some federal lawmakers, too, are lining up against AquAdvantage. Bills are pending in the Senate and House to halt its approval and to require special labeling if it is marketed.

But not in Massachusetts. When eight senators, led by Mark Begich of Alaska, wrote to FDA Commissioner Margaret Hamburg in July to halt the approval process, Bay State lawmakers jumped in. Representatives Edward Markey, Barney Frank, and James P. McGovern, wrote on Aug. 17, urging that the commissioner allow the process to continue unchanged.

“We believe that fair consideration should be given to this new technology and encourage you to proceed with the science-based evaluation and review of AquaBounty’s application,’’ the letter said.

Begich plans to push legislation to address what he views as a threat to the Alaskan salmon industry, his spokesman said.

Adrianne Appel can be reached at appel.writer@gmail.com.

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