Hot Potato

Under pressure from advocacy groups, big-name grocers like Safeway, Kroger, Whole Foods and Trader Joe's have declared that they have no plans to carry genetically engineered salmon if the U.S. Food and Drug Administration approves a Massachusetts-based company's plan to sell it.

Most of the vegetables sold in the U.S. are genetically modified and most states don't currently require special labeling. If approved, AquaAdvantage salmon would be the first genetically modified animal sold for human consumption. The FDA has not yet determined whether the transgenic salmon would require a label.

The fish in question is an Atlantic salmon that carries a transplanted growth hormone gene from a Chinook salmon and a gene from an eel-like fish that produces an antifreeze protein. The company says their creation grows twice as fast as other farmed salmon, though opponents and competitors have questioned those claims.

Battle Lines

The FDA held its first meeting about the proposal in 2010, but after four years there's still no indication when a decision might come down.

During that time, a cluster of food policy watchdogs has galvanized against the proposal, saying the product could pose health and environmental risks that were not rigorously considered.

Supporters dismiss these objections, and say such a prolonged delay is unfair to AquaBounty, the company that developed the fish.

AquaBounty posted a $4.7 million loss in 2013, but its CEO told industry news site FoodNavigator.com that the company's board is "working on the assumption that FDA approval will be forthcoming in 2014."

Initial statements about the proposal 4 years ago seemed to indicate that the FDA would likely greenlight the proposal, but the agency's second draft environmental assessment in 2012 covered new information, and the FDA has repeatedly declared it hasn't made a decision.

Why The Wait?

The company's supporters are frustrated about the long wait, and say opponents and politics have gummed up the regulatory process.

"I think it's pretty frightening if you can have technologies just get put in the 'never-never' with no decision," said Alison Van Eenennaam, an extension specialist in animal genomics and biotechnology at the University of California, Davis. Van Eenennaam served on the FDA panel of experts that evaluated the company's proposal.

Don't act like there's a science-based regulatory system and then just have political interference stop the whole process from moving forward. Imagine if this was an AIDS drug. You think that it would sit there for four years with no decision?

"Don't act like there's a science-based regulatory system and then just have political interference stop the whole process from moving forward. Imagine if this was an AIDS drug. You think that it would sit there for four years with no decision?"

In an email exchange, a spokesperson for the company sidestepped questions about the stalled proposal and FDA reform, but expressed confidence that the plan would get approval.

"We remain hopeful the FDA will decide the issue on the basis of science and fact," AquaBounty spokesman Dave Conley wrote in an email.

But groups like Food and Water Watch, the Center for Food Safety and the Consumer's Union say studies the company conducted were sloppy, inadequate and skewed. The groups say the FDA delayed its final decision in part because new information about the company's safety record emerged since the first meeting. A Canadian investigation revealed that a strain of anemia virus broke out at the company's Prince Edward Island facility in 2009.

The FDA held another meeting and issued a revised draft environmental assessment and a preliminary "finding of no significant impact" in support of the proposal in 2012.

The U.S. Senate held a hearing about the proposal in 2011, and legislators from Alaska and other coastal communities pushed through an amendment to bar the FDA from approving it. AquaBounty dismissed the move as an example of "political gamesmanship."

Allergies

The FDA zeroed in on two potential concerns for the safety of GE salmon to consumers, but decided there were no serious risks in either case.

Using data from AquaBounty, the agency studied whether the process would make the fish more dangerous to people with fish allergies. It also looked at levels of a naturally occurring growth hormone that has been linked to cancer.

In line with international standards on genetically modified food, the FDA looked at whether adding new genes could introduce something some unsuspecting consumers would react badly to. If some of the salmon at the supermarket suddenly started including peanut proteins, for example, it would pose a hazard to people with peanut allergies. But since the AquaAdvantage salmon only includes genes from a couple of other fish, neither of which are known to cause particularly big allergic reactions, the FDA dismissed those worries.

The agency is also required to look at whether possible allergens already in the salmon might be somehow higher because of new genes. Opponents and supporters of the proposal agree that the study AquaBounty submitted has serious flaws.

"Their own data showed that the process of genetic engineering significantly increased the allergenic potency," said Michael Hansen, senior scientist with the advocacy group Consumers Union.

The FDA and watchdogs criticized the company's studies for only using a small sample and "underpowered" data.

But some geneticists have in turn criticized the whole idea of looking for unknown allergens in genetically modified food without knowing what level might be dangerous in the first place. Since there are no standards in place, there's no yardstick to measure risk, supporters say.

Hormones

The agency also considered risks from an insulin-like growth hormone known as IGF-1. Studies have shown a correlation between high levels of IGF-1 and certain types of cancer, but there isn't any consensus on a cause and effect relationship between the two. Researchers are considering ways to use the hormone as a screening tool to determine the risk of those cancers.

Some of the data on hormone levels was discarded because it was too low to detect. Supporters say the study was flawed because of that move, and would have helped the case for low risk. Food and Water Watch submitted a statistical analysis from a scientist at Johns Hopkins University that indicated a significant sample would have to include data from 31 to 41 GE salmon. In the AquaBounty study, only 6 genetically engineered fish were compared to 11 in a control group.

"You wouldn't be able to get away with that in a high school science class," Hansen said. "This is the worst safety assessment I've ever seen for an engineered organism."

Despite the flaws, the FDA found that IGF-1 levels were "well within the margin of exposure from other dietary sources of salmon."

Fugitive Fish

The FDA also looked at the potential environmental dangers. The company estimates that 95 percent of the transgenic fish would be sterile. Opponents are concerned that if some of the remaining 5 percent escaped into the wild, they could breed with other fish and create fast-growing strains that would crowd out wild species.

Industry has an enormous interest in seeing GMO salmon approved under a weak and industry-friendly regulatory process," SchwabÂ said. "It would set an extremely low bar for every future GMO animal the industry wants to bring out.

Under the current plan, the company would produce its salmon eggs at a facility in Prince Edward Island, and then the fish would be gown to maturity in a Panama nursery. The FDA's draft cited the company's controls as indicators of low risk for the fish escaping. It also said that water from surrounding rivers would be too warm to support escapees.

Van Eenennaam said the AquaAdvantage has an ecological advantage over conventionally farmed salmon, which are grown in pens in the ocean and pose a risk of greater hazards like escapees and water contamination from feed and waste. The transgenic salmon would be grown in landlocked facilities.

"I think people select their issues on whether they like a technology or not, and don't really look at it from a rational perspective," she said.

She added that conventionally-bred fish are selected for the same traits-such asÂ fast growth-as those achieved through genetic modification. For that reason, she said risks associated with fugitive fast-growing fish are greater under current methods.

Tim Schwab, a researcher for Food and Water Watch, said comparing land-based aquaculture to conventional farming methods is missing the point. He said if fertile escapees bred with local fish and made hybrids, even if 100 percent of the offspring were sterile, they could have a significant impact on other species in a watershed over their lifetime.

"The FDA hasn't even done a survey of what fish exist in the nearby watershed" in Panama, he said. "If this product is approved, and it goes into commercial production at facilities around the world, the FDA does not have the resources to do an assessment of all the local areas where this might be done, even in the U.S."

Researchers in Canada last year discovered that transgenic salmon can breed with brown trout, a closely related species.

"Industry has an enormous interest in seeing GMO salmon approved under a weak and industry-friendly regulatory process," SchwabÂ said. "It would set an extremely low bar for every future GMO animal the industry wants to bring out."

The watchdogs are calling for the FDA to start their assessment from scratch, to launch a full environmental impact statement, which would require a deeper level of study-and likely delay the decision for another few years.

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