The Risk of Genetically Engineered Accidents

FDA’s New Animal Drug Application approval for genetically engineered Atlantic salmon showcases the poverty of its statistical thinking in projecting probable and possible impacts.

The FDA’s decision to license the first genetically engineered food animal for consumption in the US garnered little attention last week at its issuance.

That by itself is odd: though perhaps small, there is a confident and vocal cohort of Americans who oppose the use of “genetically modified organisms” (GMOs) in general.  What is even more curious, though, is FDA’s seeming indifference to some real possibilities of bad outcomes from the approval and eventual marketing of this animal at scale.

Thinking About Risk

GMOs have a lot of up sides.  And they have some down sides.  But calculating how big and how probable the down sides are (or may be) is vital to social choices about their use.  The most plausible risks that GMOs introduce, typically, is the risk that the engineered genes will “escape,” finding their way into the wider environment and causing some bad consequences.  It is that unknown, typically, powering the objections to their use.  And as with most unknowns, it’s very hard to quantify or otherwise analyze in a rational way, making the splits over the relative magnitudes of the risk(s) involved contentious. {See our story on genetically modified alfalfa’s use.}

Now comes the first genetically engineered fish.  {Insert biblical joke here about teaching a man to engineer his own fish.}  FDA’s statute and regulations delimit the scope of any NADA approval to the conditions specified therein.  See 21 U.S.C. § 360b(a)(1).  That is the agency’s “action” in real terms and, thus, the risks it must assess for NEPA purposes.  Here, those conditions were tailored very carefully to rule out possible environmental harms, i.e., escape and interbreeding, and conclude that the risks were insignificant.  First,

[u]nder the specific conditions of the NADA for AquAdvantage Salmon, these fish are [sterile], all-female populations that would be produced as eyed-eggs at a single specific facility on Prince Edward Island in Canada. Eyed-eggs would be shipped to a single, specific land-based grow-out facility in the highlands of Panama, where they would be reared to market size and harvested for processing for food use (e.g., preparation of eviscerated whole fish, fish fillets, steaks, etc.) in Panama prior to retail sale in the U.S.

FDA AquAdvantage FONSI at 2-3.

Production by this Boston firm—curiously—is all slated to take place outside the territory of the US.  Of course, applicant promises are not necessarily reality.  And FDA’s responsibilities under NEPA should’ve forced the agency to at least acknowledge as much in any finding of no significant impact.  But is FDA correct that the extraterritoriality of the grow operations renders any potential impacts therefrom irrelevant for NEPA purposes?

The Risk Assessments of Transgenic Fish Are Still Primitive

While FDA may lack the tools needed to quantify the probabilities that AquAdvantage fish escape and then create environmental consequences, others have long been at work fashioning precisely those tools. At the very least it entails estimating the probability of escape, survival within the ecosystem, and the organism’s capacity to transfer its genetic makeup.  A recent review of the evidence by Devlin, Sundström and Leggatt in BioScience concluded as follows:

Scientifically based ecological risk-assessment processes require empirical information to best estimate fitness components and the consequences on ecosystem members and also must evaluate the uncertainty associ­ated with those data which, to date, have been generated in artificial environments rather than in nature. Currently, a high degree of uncertainty remains regarding the potential for [growth hormone] transgenic fish to survive in nature and cause eco­system consequences. Primarily, this is due to the remark­able phenotypic plasticity displayed for life history traits by these organisms, which generates variable experimental data in a range of developmental stages and environmental conditions.

In short, quantifying the risks has evaded best efforts to date.  But there is reason to believe they are non-negligible.

Jurassic Fish Tale?

Jurassic Fish Tail?

Knowing what they’re facing, the firm that developed the fish recently assured NPR that the risk of harm is negligible:

“Virtually impossible,” says Dave Conley, director of corporate communications for AquaBounty. “We have in essence mitigated all the possible risk scenarios by combining biological and physical methods to reduce those risks to essentially zero” . . . . AquaBounty grows its salmon in tanks on land, rather than in open-ocean tanks. According to the FDA’s environmental assessment of AquaBounty’s fish, an additional combination of screens, filters and netting block access to drains and pipes that might provide means of escape. What’s more, AquaBounty says its salmon will be all-female and sterile, so if they do escape, they will fail to reproduce.

But as skeptics have pointed out—as anyone who’s watched Jurassic Park could point out—this kind of confidence is simply unwarranted. As Dana Perls of Friends of the Earth argued to NPR:

“Land-based doesn’t mean not near a river.” A fish egg production facility on Prince Edward Island is located next to an estuary, while another facility in Panama, where the fish are allowed to mature, is close to a river, according to the FDA documents. She calls escapes “an unavoidable consequence” of fish farming.  There are also questions about the process used to render the fish sterile. It carries a very small rate of failure, but if a large number of fish escaped at once, a few fertile fish could introduce the transgenes into the wild population.

So while it should’ve been obvious to FDA that the applicant’s promises aren’t necessarily a good gauge of actual environmental risk, FDA may have suffered from a familiar kind of NEPA blindness caused by its own operating procedures: heavy reliance for information in licensing schemes on the very parties most predisposed to minimize the risks of granting licenses.  This article due out soon in the Columbia Journal of Environmental Law explains these and similar breakdowns in too much NEPA compliance and suggests several reforms to make NEPA decision-making more probabilistic.

As for FDA’s conclusion that locating these operations in Canada and Panama can categorically exclude their risks from its NEPA review, the analysis only raises more questions.  At one point in FDA’s environmental assessment (EA), they note that they have consulted with Canada and that Canada thinks the risks are low:

The Canadian officials concluded that the potential for both acute failure of physical containment and chronic release of AquAdvantage Salmon is negligible at the PEI facility and low for the Panamanian facility, with at least reasonable certainty. Given this very low likelihood of escape, survival, and establishment in the environments local to the PEI and Panamanian facilities, it is also highly unlikely that AquAdvantage Salmon could disperse and migrate such that there would be an exposure pathway to the environment of the United States

FDA AquAdvantage EA at 6.  At another point, though, they cite two cases that actually provide no authority to maintain that NEPA does not require agencies to consider effects like those at issue in this case, id. at 3 n.6, and then guidance of CEQ’s on “transboundary” effects of projects being executed within the US.  Here, no such projects are being undertaken.  It is, rather, a decision being made by FDA that will set those projects in motion in Canada and Panama.  So that guidance isn’t on point.  And there is real judicial authority to suggest that the causal chain imputes the risks in Canada and Panama to FDA’s actions here.  See, e.g., Hirt v. Richardson, 127 F. Supp.2d 833 (W.D. Mich. 1999).

Executive Order 12114 issued by President Carter in 1979 does not absolve FDA of its NEPA responsibilities to consider all “reasonably foreseeable” effects of its actions.  President Carter ordered agencies to scrutinize actions with potential environmental risks abroad by putting them into the proper legal categories, it is true.  But that order did nothing to sever the causal chains of actions taken by US agencies right at the border, so to speak.  So even if failures of security for the fish in transit are somehow impossible, the extraterritoriality of the permitted activities is not a categorical bar to real NEPA review of this NADA. It should be interesting to see where the law suit in this matter goes.

{Image: the AquAdvantage™ Salmon}

I teach environmental, natural resources, and administrative law at Penn State Law. Before teaching I was an enforcement lawyer at U.S. EPA. Along the way I've done work for environmental nonprofits and written a fair bit about NEPA.
One Comment

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  • Paulo Andrade
    22 November 2015 at 00:36 -

    Dear Jamison.

    Your text is one of the few that try to clarify the risks from an accidental release of the transgenic salmon. However, the risks are not clear. For the sake of clarity, let us divide the scenario in two areas: Prince Edward Island and the Panama facility (in Boquete).

    In PEI normal, diploid animals, both male and female, will be reared. According to FDA, a complex set of physical constraints has been embedded in the facility to reduce the probability of an accidental escape to very low figures. I agree it may happen, though. So what? A few fish may reach the ocean. Will they find wild salmons to mate before been predated or dead for other reasons? This will depend on season, further mitigation actions and many factors. Do the new genes somehow increase the fitness in nature? The answer, according to all available data, is no; I have not yet read a good argument pointing towards a plausible mechanism by which the fast growth could render these salmons more competitive. How many GM salmons are needed to minimally change the genetic composition of wild salmon populations (there are many..)? In real life, except in cases where a clear, strong selection pressure is exerted on the hybrids, population changes are minimal, if any. You cite some papers, but they are just theoretical considerations (as well as mine…) and detached from the common experience of population geneticists. I therefore support FDA conclusions.

    In Panama the constrains are insurmountable: although Boquete has cold waters, running down from high mountains, the river near the facility flows in a tropical basin and the warm waters ultimately will reach the Pacific ocean. Salmons are Atlantic fish, do not survive in waters warmer than 16 oC and, in this specific case, are triploid females. Dana Perls of Friends of the Earth certainly has this info, but insists in arguing on the possible escapes of GM salmons from the Panama facility. When you cite Mrs, Perls, you look as you agree with her, what I surely can´t believe and do not expect.

    In conclusion, the uncertainties contained in this specific risk assessment are minor and I still wait for convincing argumentation,
    Paulo Paes deAndrade
    Department of Genetics
    Federal University of Pernambuco
    Recife Brazil