NOTE: We think US consumers may be surprised to discover that this GM fish seems to be about to gain FDA approval without any animal, let alone human, safety testing ever having been done.

Incidentally, there's an excellent interview about this GM salmon available online: http://t.co/Cr1ZXiE

EXTRACT: Aqua Bounty has submitted all the FDA-required data, Stotish said, but has done no animal or human clinical trials. It has, however, conducted several taste tests, and Stotish says people like it just fine.
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Is genetically altered fish OK? FDA to decide
Susan Heavey
Reuters, August 31 2010
http://www.reuters.com/article/idUSTRE67T5OX20100831

WASHINGTON - U.S. health officials are set to rule on whether a faster-growing, genetically engineered fish is safe to eat in a decision that could deliver the first altered animal food to consumers' dinner plates.

The fish, made by Aqua Bounty Technologies Inc, is manipulated to grow twice as fast as traditional Atlantic salmon, something the company says could boost the nation's fish sector and reduce pressure on the environment.

But consumer advocates and food safety experts are worried that splicing and dicing fish genes may have the opposite effect, leading to more industrial farming and potential escapes into the wild. Side effects from eating such fish are also unknown, with little data to show it is safe, they say.

"They're basically putting the fish on permanent growth hormone so it grows faster ... so they can sell bigger fish faster," said Jaydee Hanson, a policy analyst for the nonprofit Center for Food Safety.

It also raises questions about the industrialization of the nation's food supply at a time when consumers -- exasperated by massive egg and other food recalls -- are growing increasingly concerned and seeking more locally produced meals.

The small Massachusetts-based biotechnology company is seeking Food and Drug Administration approval to sell its salmon, called AquAdvantage, to fish farmers nationwide.

If given the green light, the salmon could be followed by the company's engineered trout and tilapia. Other scientists are also developing altered pigs and cows for food. The United States already allows genetically modified plants.

On September 19, the FDA kicks off a three-day meeting to discuss whether to approve the salmon. Outside advisers will weigh available data and offer advice, although the FDA will later make the final call.

"This is an Atlantic salmon in every measurable way," said Aqua Bounty Chief Executive Ronald Stotish. "When you look at the fish, it's impossible to see the difference."

[Image caption: This handout photo, released August 30 2010, compares the size of its genetically engineered AquAdvantage Salmon (background) to an Atlantic salmon of the same age (foreground). The U.S. Food and Drug Administration will hold a three-day meeting starting September 19, 2010 to discuss whether to approve the altered fish for U.S. consumers to eat. Credit: Reuters/Barrett & McKay Photo/AquaBounty Technologies/Handout]

Whether consumers accept such genetic tinkering could make or break the biotech, which has staked its future on the technology since filing for U.S. approval in 1995. In 2009, it saw a $4.8 million net loss after restructuring in 2008 to preserve cash and focus on completing FDA's approval process.

The company has seen its shares rise 75 percent this year in the run-up to the FDA's decision to a year high of 10.50 British pounds ($16).

TASTES 'GREAT'

Stotish said the company has analyzed its salmon and found no differences that warrant any kind of special labeling.

Using technology developed by Canadian researchers, AquAdvantage grows to full size in less than 250 days compared with about 400 days for a traditional Atlantic salmon, according to the biotech.

But some groups say little is known about hazards -- such as allergies or potential digestive problems. And they have criticized the FDA for not releasing any data. The agency has said it hopes to make data public by Friday but that by law it does not have to release it until two days before the meeting.

Aqua Bounty has submitted all the FDA-required data, Stotish said, but has done no animal or human clinical trials. It has, however, conducted several taste tests, and Stotish says people like it just fine.

An FDA biotech official, who asked not to be named because Aqua Bounty's bid is pending, said testing whole foods' impact on animals would be impossible because of the massive amounts they would have to be fed.

"I've eaten the fish, and it tastes great," said Stotish, whom the company promoted to the top slot in 2008 to try to push approval worldwide, except in Europe where it would face a certain cultural backlash.

Stotish, who trained in biochemistry, has a long history serving in research and development roles at companies focusing on genetics and livestock health products.

PRESSURE ON THE ENVIRONMENT

Until the early 1800s, U.S. Atlantic salmon was abundant in the rivers of the country's Northeast.

But pollution and overfishing took their toll, and despite restoration efforts, much of the Atlantic salmon consumed in the United States is imported. In 2009, the nation spent nearly $1.4 billion buying from Chile, Canada, Norway and elsewhere.

Aqua Bounty says its fish can help reduce the pressure on wild salmon populations and curb costly imports. "We're not saying if they approve our salmon we're going to feed the world," Stotish told Reuters, but "there's a general consensus that overfishing is a fact of life."

Farming fish is already a controversial endeavor, with critics concerned about the methods used and commercial feed.

Food & Water Watch's fish program director, Marianne Cufone, said food supply issues are a concern, "but there are better ways to produce fish in the United States." Her group and others also worry the salmon may escape and harm other fish.

Even if the salmon wins FDA approval, it is not clear how soon U.S. consumers would see it on store shelves.

Few fish farmers in the United States cultivate salmon, according to Stotish, who hopes farmers will convert their facilities to try the altered salmon.

September's salmon meeting marks just the second time the FDA has publicly considered a genetically engineered animal.

Last year, the agency approved GTC Biotherapeutics Inc's modified goats used to produce its anti-clotting drug Atryn for patients with a rare inherited disorder.

Other engineered food animals could be on the way.

Canadian researchers are seeking FDA approval for their Enviropig with more environmentally friendly manure. Hematech Inc, part of Kirin Holdings Co Ltd's Kyowa Hakko Kirin Co, is also developing "mad cow" disease-resistant cattle.

Center for Food Safety's Hanson said such animals are the exact opposite of what U.S. consumers want. "All of these are not to make our food healthier ... All of these are to make it profitable for companies to grow animals in less-healthy conditions, more industrial conditions," he said.

$1 = 0.6468 pound

(Reporting by Susan Heavey, editing by Matthew Lewis)