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“Democratic deficit” of decision making on gene-edited and gene drive releases

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Published: 18 May 2022
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Large boot about to tramp row of people

Professor warns that power and control are largely in the hands of biotech developers and their funders

When it comes to unconfined environmental releases of novel gene-edited and gene drive organisms, a “democratic deficit” may put ecosystems and public health in jeopardy, warns a recent paper by Professor Jennifer Kuzma of NC State University.

Prof Kuzma writes that environmental releases of gene-edited and gene drive organisms will likely occur under conditions of high uncertainty and in complex socioecological systems. So public deliberation is especially important to account for diverse interpretations of safety, risks, and benefits; to draw on experiential and public wisdom in areas of proposed release; to mitigate the dangers of technological optimism; and to increase the public legitimacy of decisions.

Yet, Prof Kuzma observes, there is a “democratic deficit” in the United States’ oversight system for gene-edited and gene drive organisms, as unconflicted experts, publics, and skeptical stakeholders are excluded from decision making and unavailable to critically examine potential risks and benefits or raise broader concerns about socioeconomic or cultural impacts.

She points out that despite the US public's role in underwriting gene-editing technology, the public has little input into which applications get developed and presented to regulatory agencies: “Power and control are largely in the hands of biotech developers and their funders, from discovery through product development and until regulatory decision-making.”

Innovation systems for gene-edited and gene drive organisms remain largely closed to the public, and regulatory systems are only briefly open for public comment in the Federal Register, should the products come under federal oversight (they often don’t, thanks to the US government’s decision to exclude most gene-edited products from regulation). Prof Kuzma writes that ”this mode of public inclusion is inadequate to foster trust in the release of such organisms or to ensure scientific rigour and independent scrutiny”.

Prof Kuzma considers that as the process for regulatory assessment of GMOs, and now gene-edited and gene drive organisms, stands, “It is woefully lacking in scientific rigour, external peer review, and public input. Conflicted biotech enthusiasts hold the most power in decision-making spaces, and there is evidence that this leads to biased regulatory assessments upon which release decisions are predicated. Greater public involvement in oversight will be required to improve the rigour of risk assessments. Public deliberation will be required to elicit independent technical advice, draw on experiential wisdom in areas of proposed release, ameliorate dangers of technological optimism, and increase the legitimacy of decisions. Building political will for public deliberation is a near-term challenge that deserves attention.”

She argues for the need to open up decision-making for these GMOs, discusses the challenges for doing so within the current oversight framework, and proposes institutional, policy, and attitudinal changes that are important for overcoming barriers to public deliberation.
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The new paper:

Deficits of public deliberation in US oversight for gene edited organisms
Kuzma, J. (2021)
Hastings Center Report 51, p. S25-S33.
https://onlinelibrary.wiley.com/doi/10.1002/hast.1317

Abstract

Environmental releases of gene edited (GEdOs) and gene drive organisms (GDOs) will likely occur under conditions of high uncertainty and in complex socioecological systems. Therefore, public deliberation is especially important to account for diverse interpretations of safety, risks, and benefits; to draw on experiential and public wisdom in areas of proposed release; to ameliorate dangers of technological optimism; and to increase the public legitimacy of decisions. Yet there is a “democratic deficit” in the United States’ oversight system for GEdOs and GDOs, as unconflicted experts, publics, and skeptical stakeholders are most often excluded from decision-making and unavailable to critically examine potential risks and benefits or raise broader concerns about socioeconomic or cultural impacts. This article argues for the need to open up decision-making for GEdOs and GDOs, discusses the challenges for doing so within the current oversight framework, and finally, proposes institutional, policy, and attitudinal changes that are likely important for overcoming barriers to public deliberation.

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