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NOVEMBER 23, 2015 by MARCO TORRES
Federal Regulators Clear First Genetically Altered Animal Approved For Human Consumption And It Will Be Unlabeled

Against the advice of experts, federal regulators have approved a genetically engineered salmon as fit for consumption, making it the first genetically altered animal to be cleared for grocery retailers. The Food and Drug Administration (FDA) said the salmon would not have to be labeled as genetically modified (GM).

AquaBounty is headquartered in the U.S. but the GM salmon is based on a gene construct patented by two Canadian university professors. The company also has research facilities in Prince Edward Island, Canada where it grows GM fish for experimentation and testing.

The approval by the Food and Drug Administration caps a long struggle for AquaBounty Technologies, a small company that first approached the FDA about approval in the 1990s. The agency made its initial determination that the fish would be safe to eat and for the environment more than five years ago.

The approval of the salmon has been fiercely opposed by some consumer and environmental groups, which have argued that the safety studies were inadequate and that wild salmon populations might be affected if the engineered fish were to escape into the oceans and rivers.

Just four years ago a Purdue University scientist urged federal officials to decide favorably on allowing genetically engineered salmon into the food supply arguing that not doing so may set back scientific efforts to increase food production. The argument came in direct contradiction to statements made by the same scientist who found that releasing a transgenic fish to the wild could damage native populations even to the point of extinction.

Marcus Sheldon who operates a conventional fish farm in B.C says that genetically modified salmon could accelerate toxicity levels. "That's just not natural," said Sheldon. "Twice the growth is likely twice the toxicity as well if you consider artificially inflated hormonal levels which we don't know the long term effects of."

"This unfortunate, historic decision disregards the vast majority of consumers, many independent scientists, numerous members of Congress and salmon growers around the world, who have voiced strong opposition," Wenonah Hauter, executive director of Food & Water Watch, said in a statement.

Within hours of the agency's decision, one consumer advocacy group, the Center for Food Safety, said it and other organizations would file a lawsuit challenging the approval.

The AquAdvantage salmon, as it is known, is an Atlantic salmon that has been genetically modified so that it grows to market size faster than a non-engineered farmed salmon, in as little as half the time.

The aquaculture industry does not support the commercialization of GM fish and has stated that there is no market demand. Across North America, grocery stores are now pledging not to use GM seafood.

"The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty regarding the AquAdvantage salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat," Bernadette Dunham, director of the agency's Center for Veterinary Medicine, said in a statement.

FDA officials said that the process took so long because it was the first approval of its kind. People involved in the application suspect that the Obama administration delayed approval because it was wary of a political backlash.

Agency officials explained that the law required labeling of "material" aspects of food, and that use of genetic engineering per se is not material. A significant change in the nutritional content of a food would be an example of a material change, and that altered nutritional profile would have to be on the label, but not the fact that it was produced by genetic engineering. (In the case of the salmon, the agency said there were no material differences between the genetically engineered salmon and a conventional counterpart.)

The FDA issued draft guidance for voluntarily labeling salmon and final guidance for voluntarily labeling foods made from bioengineered crops.

Despite the approval, it is likely to be at least two years before any of the salmon reaches supermarkets, and at first it will be in tiny amounts.

For now, the fish are being raised in Panama, from eggs produced in Prince Edward Island. If the salmon were bred or raised elsewhere, for marketing to Americans, that would require separate approvals.

"This is a concrete environmental risk now that's coming directly from Canada," said Lucy Sharratt of the Canadian Biotechnology Action Network.

However, moving beyond Canada and Panama seems to be the plan, according to a regulatory filing by AquaBounty a year ago. It said at that time that after winning FDA approval it would look to build a hatchery in the United States and expand the one in Canada to sell more eggs to fish farmers, who would then grow the salmon to market size. AquaBounty said it might also grow salmon from the eggs itself. In addition to the United States, it said it eventually hoped to sell the salmon in Canada, Argentina, Brazil and China.

The approval could help other efforts to develop genetically modified animals. Scientists and biotechnology industry executives have complained that the long, unexplained delay in approving the salmon was a deterrent to the field. Several other attempts to develop genetically engineered animals for consumption, like a pig whose manure would be less polluting, have fallen by the wayside.

Now, however, there has been a surge of interest in developing new genetically altered farm animals and pets because new techniques, including one known as Crispr-Cas9, allow scientists to edit animal genomes rather than add genes from other species. That has made it far easier to create altered animals.

Scientists in China, for instance, recently created goats with more muscle and longer hair. Researchers in Scotland used gene editing to create pigs resistant to African swine fever. It is not yet clear whether animals created this way would fall under FDA regulation.

The AquAdvantage salmon contains a growth hormone gene from the Chinook salmon and a genetic switch from the ocean pout, an eel-like creature, that keeps the transplanted gene continuously active, whereas the salmon's own growth hormone gene is active only parts of the year. The company has said the fish can grow to market weight in 18 to 20 months, compared with 28 to 36 months for conventionally farmed salmon.

Opponents of the fish say that if the bigger fish were to escape, they could outcompete wild salmon for food or mates. Among the opponents have been members of Alaska's congressional delegation, who say they are worried about the effects on the image and health of wild salmon.

"This harebrained decision goes to show that our federal agencies are incapable of using common sense," Representative Don Young, a Republican, said in a statement.

The FDA regulates genetically engineered animals as veterinary drugs, using the argument that the gene inserted into the animal meets the definition of a drug. Critics have branded this an inadequate solution intended to squeeze a new technology into an old regulatory framework. They say the FDA is not as qualified as other government agencies to do environmental assessments. The White House is now reviewing the entire framework for regulating genetically engineered products.

The FDA said that to approve the salmon, it determined that the fish was safe to eat, that the inserted genetic elements did not harm the fish itself, and that the company had adequately proved that the salmon grew faster.

Few or no companies want to voluntarily label their products as being genetically engineered since that might hurt sales, and many have lobbied heavily against mandatory labeling. But as consumer pressure for transparency about ingredients grows, an increasing number of companies are labeling their nonengineered products.

The labeling issue is heading for a showdown.

Sources:
cban.ca
nytimes.com
montrealgazette.com

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