Assessing the risk of GM salmon

by Ari LeVaux

Anne Kapuscinski is a professor of sustainability science at Dartmouth College. She recently led a team of 53 scientists in writing a book on the subject of risk-assessment science as applied to genetically modified fish.

I recently spoke with professor Kapuscinski about 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 FDA, AquAdvantage eggs would be produced in Prince Edward Island, Canada, and grown to market size at a small, inland facility in Panama. None of the production steps would take place in the United States.
All told, this approval process has dragged on for nearly two decades. In recent history, one event in particular is referred to several times in my interview with her, a public meeting of the FDA’s Veterinary Medicine Advisory Committee (VMAC) in September 2010. The VMAC’s purpose was to discuss the human health and environmental 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, FDA was to make a decision: it would either move forward with the EA debated at the meeting, presumably with input from the VMAC and elsewhere, or the agency would instead produce a 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 EA, a new draft of which was released Dec. 21, 2012. The public comment period on the EA goes until Feb. 25.

Professor 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.”

Question: What are your thoughts on the revised EA released on Dec. 21?

Kapuscinski: They didn’t change very much from the company’s version of a draft environmental assessment that FDA asked the Veterinary Medicine Advisory Committee to discuss in September 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 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 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?”

Question: 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.

Kapuscinski: One concern I have is that future applications don’t necessarily have to be shared with the public. We need to remember that the FDA is not required to share any of this 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. Therefore, if this application’s weak scientific standards for assessing consequences of fish escaping confinement are accepted, staff inside the agency could assume this standard is OK. As an ecological risk-assessment scientist, I don’t think it’s OK.

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 FDA an OK 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 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.

Question: What’s the biggest problem with the science in the current EA?
Kapuscinski: Risk assessment normally has three steps. One, you identify what the hazard is. Two, you figure out what the consequences would be to the environment if the hazard were to be realized. And the third step is, you say, “well, can we somehow manage the risk, can we do something to prevent the consequences from happening?”

What FDA has done, in both the 2010 draft and 2012 draft EA, is essentially skip to step three, the risk management step. Both versions are saying: We have so many different kinds of confinement, so we are concluding that the chances of any of these fish escaping and being able to establish a reproducing population is virtually zero.

The FDA has not changed much about that, compared to the 2010 EA, except for a few details. They’re still hanging their whole conclusion on this risk management – that is, multiple confinement systems for the fish. But what they still haven’t done is what Dr. Sundström and I asked for, which is a quantitative failure mode analysis. If this is what their entire conclusion really rests on, and if they are correct that the levels of confinement are so great all in combination, a quantitative failure mode analysis should actually come to that same conclusion. And it would be a much more scientifically reliable way of substantiating the conclusion. As said before in our written comments, it’s a standard practice in risk assessment and risk management to do a failure mode analysis, and it should be as quantitative as possible