Also contributing to this post is David Love, PhD, science director of CLF’s Public Health & Sustainable Aquaculture Project.

In a few weeks, the FDA will stop accepting comments from the public and decide whether to approve the sale of genetically engineered (GE) salmon to U.S. consumers. If GE salmon is approved, we will have a new and alarming precedent for dealing with genetically engineered animals destined for our dinner table. (Read CLF’s comment to FDA here.)

The fish, called AquAdvantage salmon and produced by AquaBounty Technologies, is genetically engineered to grow faster than farm-raised Atlantic salmon. And the FDA is trying to approve the fish with a review process that is both inadequate and inappropriate.

The review process being used by FDA is the same process used to approve new animal drugs—but, obviously, AquAdvantage salmon is not a drug. It’s a new, genetically engineered animal, and GE food animals require a new, distinct approval process. The fact is, there is no existing review process for genetically engineered food animals, because AquAdvantage salmon would be the first. (Milk from GE cows is sold for human consumption, but the salmon would be the first transgenic animal that we would eat.)

Also, while FDA is reviewing plans for a hatchery in Canada and a grow-out facility in Panama—only two facilities—the agency is not taking into consideration how the GE salmon industry may grow in the future. There may be a low likelihood of AquAdvantage salmon escaping the proposed hatchery or grow-out facility—but when AquaBounty expands production, sales, and distribution of salmon eggs or fry, the risk increases significantly. It’s very likely that the salmon could escape, establish, and perturb the physical environment. If FDA had done a more comprehensive environmental impact statement (EIS), instead of an environmental assessment (EA), these environmental risks would be more evident.

Food safety issues have taken a back seat in the review process. The evidence being used by FDA is problematic; there are questions regarding sample size, study duration, and the overall quality of the research. These questions limit our understanding of food safety claims, including potential toxicity and allergenicity of the salmon. Furthermore, the evidence being used is supplied by Aquabounty, the company applying for approval of AquAdvantage salmon. The data are not published or publicly available, so the scientific community is not able to determine whether adequate rigor and appropriate methods were used to generate the original data.

Finally, clearly labeling food that has been genetically altered is critical. Clear labeling allows us to evaluate potential human health effects. GE foods are not labeled in the U.S., which means that if there are human health impacts, it is virtually impossible to study and track them. There is a strong likelihood that AquAdvantage salmon could be sold in the U.S. with no label, and this is especially concerning for potentially sensitive populations, such as children and people with food allergies. And when we lack data, we do not know if there are health effects at the population level. In addition to public health concerns, a lack of labeling of GE foods severely restricts consumer autonomy and poses an ethical dilemma. People may consider a variety of issues when deciding what to eat, and it should be an option for consumers to avoid GE foods if they wish.

The FDA, along with additional experts and other federal agencies, should develop a specific review process for GE food animals that requires food safety studies performed by independent scientists. This current review, which posits that GE salmon is a new animal drug, could set a precedent for future approvals of GE food animals with lax requirements for food safety data and limited-scope environmental assessments. But if, instead, GE salmon was reviewed through a rigorous, comprehensive, and transparent process, public health professionals like us would be more confident that human health risks had been properly assessed. If approved, labeling of GE food products should be required in order to facilitate tracking of adverse health impacts and to allow consumers the option to avoid GE foods.