I recently spoke with Kapuscinski about the state of the approval process of AquAdvantage salmon, a fast-growing genetically modified fish poised to become the first GM animal approved for human consumption. Under the proposal being considered by the Food and Drug Administration, AquAdvantage eggs would be produced in Prince Edward Island, Canada, and grown to market size in tanks at a small facility in Panama, with none of the production steps allowed to take place in the United States.
All told, this approval process has dragged on for nearly two decades. But in recent history, one event in particular needs mention as it is referred to several times in the interview. In Sept. 2010 there was a public meeting of the FDA’s Veterinary Medicine Advisory Committee, or VMAC, to discuss the human health and environmental safety threats posed by AquAdvantage salmon. The environmental issues had been described in an environmental assessment that the FDA had released a few weeks earlier.
Following the VMAC meeting, the agency was to make a decision: it would either move forward with the environmental assessment, incorporating input from the VMAC meeting and elsewhere, or the agency would instead produce an environmental impact statement, which would take a more comprehensive look at the environmental risks posed by the fish. The FDA ultimately chose to continue with the environmental assessment, moving AquAdvantage salmon toward approval via the path of least resistance.
A new draft of this environmental assessment was released Dec. 21, 2012, the Friday before Christmas vacation. A public comment period began then, and will remain open until Feb. 25.
Anne Kapuscinski: I want to start by saying my role in this public discussion, as a scientist, is to advocate for scientific integrity, scientific quality and scientific reliability of the methods used for risk assessment and risk management. What I bring to this discussion is expertise in risk assessment science. I’m not here to advocate for or against the fish, but for the quality of the science in the FDA’s draft environmental assessment, which is especially important in this case because this is a precedent-setting case."
What are your thoughts on the revised environmental assessment that the FDA released in December?
AK: They didn’t change very much from the company’s version of a draft environmental assessment that the FDA asked the Veterinary Medicine Advisory Committee to discuss in Sept. 2010. Dr. Fred Sundström and I submitted extensive scientific comments to the FDA for that committee’s meeting. The FDA didn’t change the basic structure of the argument from the 2010 version. Its conclusion of “no significant impact” hinges on multiple confinement measures to prevent fish from escaping or reproducing in nature.
What the FDA did do was make a key strategic change. The agency came out clearly saying that the National Environmental Policy Act does not require it to assess effects on environments of other countries. So the FDA is limiting the assessment to the question: “Could the production of these fish in the hatchery in Prince Edward Island and the small grow-out facility in Panama have effects on the environment of the United States?”
The FDA has stated that other fish farms that wish to grow AquAdvantage salmon and sell it to the United States will apply for permission via a supplemental application to the current one, with details filled in from the fish farm in question.
AK: One concern I have is that the FDA is not required to shared future applications with the public. The agency perhaps made a strategic decision that it would be in its interest to release some information to the public about this first application. We have no guarantee that future applications for larger-scale farming of these fish, which might have weaker confinement and be more risky than this one, will be shared with the public, and therefore if this application’s weak scientific standards for assessing consequences of fish escaping confinement are accepted, staff inside the agency could assume that this standard is okay. As an ecological risk assessment scientist, I don’t think that it’s okay.
The FDA doesn’t have to share any of this with the public because the law used to exercise its authority over the commercialization of genetically modified animals is the Food, Drug, and Cosmetic Act. And they’re using the drug provision, which has strict requirements for the agency to keep everything confidential. They’re not required to share information with the public. In this case, AquaBounty had to give the FDA an okay to share some information with the public.
But without the applicant’s permission, the FDA can’t even divulge if it has received an application. There could be another applicant out there that has submitted another application for the commercialization of a genetically engineered animal, and we wouldn’t even know.
If the FDA does approve these fish, the final environmental assessment is going to be the standard, it’s going to set the precedent for future approvals. So it absolutely has to have the best scientific reliability and quality, especially given that future applications may not be shared with the public.