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

Share

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.

Plant-based genetically modified food in the U.S. is not currently labelled as such. Although food companies can voluntarily label their products 'non-GMO,' there is no law compelling companies to declare the use of DNA-altering technology in food unless the item in question has a "material difference" caused by the modification (meaning a difference detectable with one of the five senses).

There have been some past exceptions to this rule, including the FDA's decision to require labelling for irradiated foods (which have been exposed to high levels of radiation to destroy microorganisms) due to the "importance to the consumer," Dr. Hansen said. Another loophole might be found in the fact that the salmon is being regulated as a veterinary drug, which are generally labelled.

AquaBounty has not publicly said whether it would oppose a GMO label. But GM advocates are opposed to the idea.

"That would be a bad precedent" and "a disadvantage to consumers," said Henry Miller, a molecular biologist who was the founding director of the FDA's Office of Biotechnology and is co-author of The Frankenfood Myth.

"This is a potentially important way to get salmon to maturity quicker, increase the supply, decrease prices and make available this high-quality source of protein at lower prices," he said.

It's not clear, however, how consumers will ultimately respond to the salmon, which offers no added health benefits beyond those of eating conventional salmon. Neilsen Research reported earlier this year that the "GMO-free" label is now the fastest growing store brand claim. This is in spite of the fact that about 80 per cent of conventional-process food sold in the United States contains GMOs, according to estimates of the Grocery Manufacturers Association.

Regardless, skeptics of AquaBounty's salmon are hoping their arguments will be convincing enough for the FDA to send the fish back to the lab for some more thorough food-related testing.

"When you have a new technology like this, what you need to do is go to the scientific community and convene a food safety committee and say, 'What are the food safety issues that ought to be addressed in order to call this new food safe?' " said Margaret Mellon, director of the food and environment program at the Union of Concerned Scientists.

"To me, we're treading on new legal, scientific and certainly consumer territory," she said. "I would say the salmon has been a long time in the oven, but it's still half-baked."