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Risk Assessment of Genetically Modified Food and Neoliberalism: An Argument for Democratizing the Regulatory Review Protocol of the Food and Drug Administration

Abstract

The primary responsibility of the US Food and Drug Administration (FDA) 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 (GM) food. The FDA describes its regulatory review of GM food (of both the plant and the animal variety) 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 entity.

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Notes

  1. The terms “genetically modified (GM)” and “genetically engineered (GE)” are used interchangeably in this paper. They denote entities whose genetic material has been changed by means of “in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles” (WHO 2008, p. 2).

  2. While poultry and meat are the purview of the US Department of Agriculture (USDA), the FDA is expected to closely coordinate with it on food safety issues about those foods. The FDA is also obligated to work with the U.S. Environmental Protection Agency (EPA), which regulates pesticides and establishes pesticide residues limits for food.

  3. Another significant regulatory document with a distinct neoliberal orientation is the 1991 “Report on National Biotechnology Policy” published by the President’s Council on Competitiveness (see page 11). However, scrutinizing it lies beyond the scope of this essay.

  4. For a detailed account of the Reagan White House’s commitment to neoliberalism, particularly the reduction of regulatory oversight on corporations with the end of fostering business interests, see Jones (1999, pp. 225–271), also see Sheingate (2006).

  5. An earlier version of the document was published in the December 31, 1984 edition of the Federal Register (FR 49, p. 50856).

  6. The GM food was a new class of entity; there were no existing regulations that governed it. So, there was no roll-back phase of de-regulation.

  7. In instances when similarity could not be assured by means of chemical composition tests, “feeding studies or other toxicological research could be required” (Levidow et al. 2007, p. 35). The FDA does have the authority to take action against a GM food if there is evidence that it poses a demonstrable safety risk in a post-market environment (http://www.fda.gov/newsevents/testimony/ucm115032.htm). However, as there is no monitoring or tracking of GE food in the US marketplace, it is unlikely that long term post-consumption impacts will be recognized. I owe this point to J. Kuzma.

  8. Guidance documents issued by federal agencies do not have the force of law (Transcript, p. 15).

  9. This use of the WHO’s (2008) Codex guidance statement to establish the credibility of the FDA’s standard amounts to circular reasoning because the FDA was involved in establishing the WHO’s Codex GM food safety standard (Guidance 2009, p. 24). The FDA’s Guidance acknowledges that fact.

  10. The WHO Guideline does not construe GE animals as animal drugs.

  11. The Guideline construes the substantial equivalence criterion to be the starting point for evaluating “the safety of any identified differences (between the genetically modified food and its non-GM counterpart) so that the safety of the new product can be considered relative to its conventional counterpart” (WHO. 2008, p. 3). It cautions that that the safety assessment based on the substantial equivalence standard should not be understood to “imply absolute safety of the new product” (WHO 2008, p. 3).

  12. The WHO’s Guideline (2008) claims that whole food risk evaluations of GE animals are not performed because, first, few foods (GE or non-GE) have been subject to risk assessment that wholly identify all associated risks, second, upon risk evaluation a number of foods (which, presumably, are generally recognized as safe by the relevant experts would be found to contain elements that are harmful. (I wish to thank J. Kuzma for bringing this issue to my attention).

  13. Guidance (2009, pp. 5–6).

  14. Guidance (2009, p. 7).

  15. Guidance (2009, p. 4).

  16. The company voluntarily disclosed it had filed a NADA but that application (with the safety data) was not available for public scrutiny.

  17. The FDA terminated the VMAC on September 24, 2013 (FDA. Advisory Committees …).

  18. Under Executive Order 12114, the environmental assessment would have to include effects on nations that were not involved in the action but could be impacted by it (in the case of the salmon, those countries are Canada and Panama because that is where the Aqua Bounty Technologies’ sites for growing the GE salmon and harvesting their eggs are located) and the global commons (Transcript 2010, p. 236).

  19. Whether the difference between the fish is significant is unclear; it was not discussed during the meeting at any length.

  20. Aqua Bounty Technologies’ study design and data do not permit reliable conclusions about those subjects.

  21. While protecting the environment is not one of the FDA’s primary goals, in taking on the responsibility of regulating a class of entities that could affect the environment, it incurred that obligation. Whether it has the relevant expertise to address environmental issues is a contested issue (Hoffman 2011).

  22. Aqua Bounty Technologies has other GM fish under development (Unknown. Wall Street Journal (press release) 2013).

  23. As noted earlier, the FDA permits developers of GM food to design their own safety studies.

  24. It is arguable if the FDA’s position can be classified as one with which positivists such as Carl Hempel would be willing to align themselves. The positivists had a fairly complex understanding to the integral role of values in scientific inquiry. For instance, Hempel acknowledged that values played a critical role in context of discovery and crucially determined the questions that were taken up for inquiry (2001, pp. 372–373, 1966, p. 16). It is unclear that the FDA’s stance is cognizant of that reality. The fact that contextual values may be embedded in background assumptions that mediate the relationship between hypotheses and evidence claims (Longino 1990) is not acknowledged by the agency. (The positivists too failed to recognize that.).

  25. In 2014, the National Institute of Health mandated that this practice of exclusion be discontinued (Rabin 2014).

  26. Dunsby relies on Jasanoff’s research (1991) to justify his claim about the variation in trust in experts between the US and the UK publics. Jasanoff’s Designs on nature (2005) contains detailed case studies that trace the significant events that shaped public attitudes towards experts in the two countries (for a summary of her findings based on the case studies about the differences see p. 259). However, they do not flesh out the role played by (allegedly) neutral experts in “encouraging” populations to adopt neoliberal values and practices. While it lies beyond the limited scope of this paper to explore that issue, Tania Murray Li’s The will to improve: Governmentality, development, and the practice of politics (2007) and Nikolas Rose’s Powers of freedom (1999) usefully illuminate that link.

  27. While the category of “laypersons” and “scientists” are generally considered to be distinct, it is not the case. “Laypersons” can include scientists, depending on the context. For instance, the holder of a doctorate in a specific scientific subfield, for all intents and purposes, qualifies as a layperson with respect to another scientific discipline or sub-discipline with which she/he has little or no familiarity.

  28. This argument is based on L.H. Nelson’s notion of epistemic communities (1993).

  29. It should be noted that this is not an argument for democratizing the regulatory review of pharmaceutical products. While there are serious problems with the FDA’s review of drugs, it lies beyond the scope of this paper to engage with them.

  30. In the US, elected representatives cannot be relied on to represent the interests of the average person because the economic elite and corporations have an undue influence on politicians, while average citizens have little influence on public policy (Gilens and Page 2014).

  31. An extended examination of the benefits and limitations of including layperson representatives on risk assessment committees for new GM food lies beyond the modest scope of this paper. But the literature on the impact of inclusion of laypersons in other kinds of committees, such as institutional review boards and hospital ethics committees is likely to provide useful insight.

  32. This idea draws on Anderson’s work (Anderson 2006).

  33. The FDA terminated the VMAC on September 24, 2013 (FDA 2103, Advisory Committees …), so the website is no longer accessible.

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Acknowledgments

Research for this paper was funded by a Career Enhancement Grant from the University of Rhode Island’s Council for Research. I would also like to thank Jeffrey Burkhardt, the editor, for kindly extending the deadline for submitting the revised paper and the two anonymous reviewers for their comments.

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Correspondence to Zahra Meghani.

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This paper draws on and builds on earlier papers, especially Meghani and Kuzma (2011), Meghani (2009), and Meghani and de Melo-Martín (2009).

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Meghani, Z. Risk Assessment of Genetically Modified Food and Neoliberalism: An Argument for Democratizing the Regulatory Review Protocol of the Food and Drug Administration. J Agric Environ Ethics 27, 967–989 (2014). https://doi.org/10.1007/s10806-014-9511-1

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Keywords

  • Genetically modified (GM) food
  • Genetically engineered (GE) animals
  • Neoliberalism
  • Democracy
  • US Food and Drug Administration (FDA)
  • GM salmon