- The FDA should have given more consideration to the risks genetically modified AquAdvantage salmon posed to wild populations before approving the new breed of fish, a federal judge ruled last week. U.S. District Judge Vince Chhabria ordered the agency to reconsider the environmental assessment for the salmon, but did not withdraw FDA approval.
- AquaBounty, the company that created and produces AquAdvantage, is still on track to start selling the genetically modified fish at the end of this year. "While we were disappointed with some of the conclusions reached in the judge's decision regarding the environmental assessment conducted by the U.S. Food and Drug Administration (FDA), we remain confident in the robust scientific studies and review that resulted in the 2015 FDA approval," AquaBounty President and CEO Sylvia Wulf said in an emailed statement.
- The FDA first greenlit AquAdvantage salmon five years ago, following a contentious battle over the unconventional way it was created. In 2016, while the federal government worked on labeling guidelines for genetically modified foods, FDA temporarily prohibited import of the eggs of the GMO salmon, which are developed in Canada. After the labeling guidelines were finalized last year, the FDA lifted its import alert.
Genetically modified food — which will be labeled as "bioengineered," per the federal labeling law — has been a flashpoint of controversy throughout the last decade. But this court decision could easily be seen as a win for both sides. AquaBounty got most of what it wanted, and the FDA approval of GMO salmon still stands. But opponents secured a victory by forcing more stringent environmental consideration for new GMO food.
This lawsuit was filed soon after FDA granted its approval for AquAdvantage, which can grow twice as fast as wild salmon, and is raised in tanks at a facility in Indiana. The salmon, which has a growth hormone gene from the Pacific Chinook variety and a gene from the ocean pout species, is the first GMO species that has been approved for human consumption. And, according to The Counter, these GMO salmon are "effectively sterile."
Groups representing fishermen, environmental and salmon advocates and food sustainability challenged FDA's approval in court, arguing not enough consideration had gone into the decision. Plaintiffs — who are represented by the Center for Food Safety and Earthjustice and include the Institute for Fisheries Resources, Pacific Coast Federation of Fishermen's Associations, Center for Biological Diversity, Ecology Action Centre and Friends of the Earth — successfully convinced the court that FDA did not spend enough time analyzing what threat would be posed to existing salmon populations if this GM salmon breed were able to establish itself in the wild.
"Today's decision is a vital victory for endangered salmon and our oceans," Center for Food Safety Legal Director George Kimbrell said in a statement. "Genetically engineered animals create novel risks and regulators must rigorously analyze them using sound science, not stick their head in the sand as officials did here. In reality, this engineered fish offers nothing but unstudied risks. The absolute last thing our planet needs right now is another human-created crisis like escaped genetically engineered fish running amok."
But the ruling isn't stopping AquAdvantage salmon from reaching grocery shelves and menus. It isn't even slowing the company's efforts. In August, AquaBounty announced it was building a new 10,000 metric ton facility in Kentucky for its salmon. This is a capacity about 10 times larger than the company currently has at its Indiana fish farm, and the company expects production to begin there in 2023. The publicly traded company is not yet profitable, but Wulf said in a release that accompanied AquaBounty's most recent quarterly results last week that it is in a good position. The company is preparing to start sending samples of AquAdvantage to potential clients for pricing and evaluation, she said in the release.
What this court ruling does accomplish is raising the bar for future GM meat approval from FDA. The approval for AquAdvantage salmon was given after long and careful study about the chances of the GM fish escaping into the wild and interfering with existing salmon populations. And with controlled indoor farming in far inland facilities with a species that is unable to reproduce, there is not much of a chance an escape will happen right now. But, the judge wrote, a proper and detailed assessment of the risks posed by AquAdvantage to the wild — which was not done because of the remote possibility it would occur — needs to be in the official record.
"With every new facility built, the possibility of exposure grows," the order says. "Understanding the harm that could result from that exposure — and having an explanation of it on record — will only become more important. And if that issue is not properly assessed at the outset, it may never be."
Since AquAdvantage salmon is the first GM animal species to go through the FDA's approval process, it's blazing a new trail for others to follow. The salmon was first developed in 1989, so bringing it to the precipice of the market has been a long process. Now that there is a process to get products to market in place — even if it is a bit longer and involves a detailed analysis of the long-term consequences of remote possibilities — others are likely to be on their way. Though consumer opinion of GMOs seems to have modulated, this decision both means that the approval process for new products will be rigorous, and the products are destined to get to consumers.