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This handout photo compares the size of a genetically engineered AquAdvantage Salmon, back, to an Atlantic salmon of the same age. Barrett & McKay Photo/AquaBounty Technologies/Reuters - This handout photo compares the size of a genetically engineered AquAdvantage Salmon, back, to an Atlantic salmon of the same age. | Barrett & McKay Photo/AquaBounty Technologies/Reuters

This handout photo compares the size of a genetically engineered AquAdvantage Salmon, back, to an Atlantic salmon of the same age.

This handout photo compares the size of a genetically engineered AquAdvantage Salmon, back, to an Atlantic salmon of the same age. Barrett & McKay Photo/AquaBounty Technologies/Reuters - This handout photo compares the size of a genetically engineered AquAdvantage Salmon, back, to an Atlantic salmon of the same age. | Barrett & McKay Photo/AquaBounty Technologies/Reuters
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Food Safety

A drug with gills? U.S. agency reshapes debate on biotech fish

From Monday's Globe and Mail

Are AquAdvantage salmon food or drugs?

That is the central question swirling among consumer groups getting ready for this week’s public hearings in the United States over the safety of the genetically modified salmon that is poised to become the first gene-altered animal to enter the North American food chain.

After a 10-year struggle over how to handle the fish, which was designed in a laboratory on Canada’s Prince Edward Island to grow twice as fast as its wild counterparts, the United States Food and Drug Administration decided to regulate the salmon using rules for veterinary drugs – as opposed to new food products.

A coalition of consumer groups preparing to speak out at the hearings, which began Sunday in Rockville, Md., are concerned that the drug-evaluation process – designed for pharmaceutical companies – hasn’t allowed for sufficient scientific examination of the food-safety issues surrounding human consumption of the fish.

Owned by the publicly traded biotech firm AquaBounty Technologies, the salmon could make its way to grocery shelves within the next two years if regulators approve. The FDA said last month that the salmon appear “as safe to eat as food as other Atlantic salmon,” after a preliminary analysis of the scientific documentation provided by the biotech firm, which has been working for a decade to win approval for their creation.

If the salmon wins final FDA approval, it would effectively pave the way for other scientifically engineered animals to enter the food chain in the U.S. In Canada, AquaBounty requires Canadian Food Inspection Agency approval to sell its product, but the company is only in the very early stages of that process.

Consumer advocates south of the border are trying to convince the FDA’s Veterinary Medicine Advisory Committee this week that the science behind AquaBounty’s food safety assessments was not nearly rigorous enough to meet the FDA’s standards for product approval.

Most critical is the fact that some of the studies submitted by AquaBounty on the safety of the fish flesh and the potential for it to cause allergic reactions are based on insufficient sample sizes – in some cases, as few as half a dozen fish, said Michael Hansen, a senior staff scientist with the non-profit U.S.-based Consumers Union.

Since the early 1990s, Dr. Hansen has sat on various U.S. federal and state level advisory committees on biotechnology as well as on a joint United Nations/World Health Organization panel on genetically engineered animals.

“Some of us have been saying for years that with genetic engineering, the [increased] allergenicity risk is serious and must be looked at. This is a perfect example,” he said.

“They could shut up people like me if they put forward really good science that showed there was no problem,” he said, adding: “This is pathetic science.”

Ronald Stotish, the CEO of AquaBounty, has repeatedly defended his company’s creation, which was originally conceived at Memorial University in Newfoundland. Raised in fresh water indoors, the salmon are bred to be infertile and thus carry low risk of escaping into the ocean and contaminating wild stocks. Dr. Stotish also maintains the salmon is safe to eat.

“This is an Atlantic salmon that is identical in every regard to wild Atlantic salmon. The nutrition is the same, the texture and so forth,” he told The Globe and Mail in an interview last month. “If we were to prepare our fish and other fish of the same size from other sources, you could not tell the difference.”

That’s exactly what some GMO-fearing consumers are afraid of.

The third day of public hearings, slated for Tuesday, will deal with the question of whether the salmon’s genetically modified traits merit special grocery store labelling.