Risk assessment of genetically modified food and neoliberalism: An argument for democratizing the regulatory review protocol of the Food and Drug Administration

The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the FDA’s policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entit

Regulations Matter: Epistemic Monopoly, Domination, Patents, and the Public Interest

This paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency (EPA) to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner

Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis

Background: In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. Method: From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. Results: The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. Conclusion: Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations

Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives

This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self-determination. The environmental release of such animals has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political-economic-legal problems that would arise with the environmental release of such organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected

Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, as well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives

Genetically engineered mosquitoes, Zika and other arboviruses, community engagement, costs, and patents: Ethical issues

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.

The impact of vertical public health initiatives on gendered familial care work: public health and ethical issues

Rigorous evaluations of the effects of vertical public health enterprises on the health systems of low-income countries usefully identify the public health and ethical costs of those initiatives. They reveal that such narrowly focused public health ventures undermine the efforts of those countries to establish and maintain adequately resourced and well-developed national health systems, including comprehensive primary care programs. This paper argues that the scope of assessments of vertical public health ventures should be broadened to include gender as an additional axis of analysis. When members of socio-economically marginalized populations are sick with conditions that are not covered by fragmented and inadequate public health programs or disease-specific vertical public health schemes, their untreated illnesses add to the gendered familial caregiving responsibilities of the female members of their households. Those women and girls have to perform their ‘normal’ familial care work, work outside the home for pay, and take care of the unwell family members for whom the household cannot afford treatment. Given that women and girls from low-income households already shoulder a disproportionate amount of care work for their families, their health and life prospects are further affected by the amplification of their caregiving responsibilities. This paper argues that analyses of the impact of vertical public health initiatives should also track this gendered consequence of those enterprises because it is a crucial public health and ethical matter

Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations

The US\u27 Food and Drug Administration, normativity of risk assessment, GMOs, and American democracy

The process of risk assessment of biotechnologies, such as genetically modified organisms (GMOs), has normative dimensions. However, the US\u27 Food and Drug Administration (FDA) seems committed to the idea that such evaluations are objective. This essay makes the case that the agency\u27s regulatory approach should be changed such that the public is involved in deciding any ethical or social questions that might arise during risk assessment of GMOs. It is argued that, in the US, neither aggregative nor deliberative (representative) democracy ought to be used to make such determinations. Instead, participatory (deliberative) democracy should be the means by which members of the polity decide which normative concerns ought to underlie FDA\u27s assessment of GMOs. This paper uses a hypothetical case involving a new GM seed to make that argument. © Springer Science+Business Media B.V. 2008