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

Abstract

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. ARTICLE HISTORY

Vulnerability Analysis of Ecological Systems

“…However, these developments are highly debatable. Gene drives can be used to transform, suppress or even eliminate specific species (Meghani and Kuzma 2017) that act as disease vectors, reduce biodiversity or have become agricultural pests. Currently, one of the greatest threats to biodiversity is the establishment of invasive species (Scalera 2010).…”

Barriers to inclusive deliberation and democratic governance of genetic technologies at the science-policy interface

“…These philosophies and imaginations undermined efforts to involve residents in discussions in meaningful ways, and manifested across multiple sites of stakeholder engagement. Matters were further complicated by the underlying market frameworks that shape the production, regulation, and communication of new biotechnologies, like genetically modified organisms [Meghani and Kuzma, 2018]. These issues are explored below, using stakeholder statements from two Florida Keys town hall meetings (2012 and 2014).…”

“…As previously mentioned, at the time the town hall meetings were held, regulatory decisions surrounding the use of Oxitec's mosquitoes in the Keys were playing out under the FDA's guidance and oversight. Meghani and Kuzma [2018] conducted an in-depth analysis of the FDA's regulatory procedures as they pertained to Oxitec's GM mosquitoes, and are critical of the fact that the FDA made the decision not to assess field trial plans at the most stringent level of a 3-category environmental review system. This would have mandated increased requirements of detail and rigor in assessment.…”

“…-Public comment [Catherine, 2014] The degree to which institutional confidence was placed in Oxitec's ability to define, assess, self-regulate, and accurately report on the risks of its product speaks to the centrality of scientific authority in policy matters, and was a common concern raised by residents throughout the controversy. The FDA's deference to scientific authority was matched by its commitment to neoliberal agendas articulated in the long-standing 1986 Coordinated Framework on the Regulation of Biotechnology [Meghani and Kuzma, 2018]. This framework institutionalized the market-based logic of substantial equivalence in biotechnology regulation, stating that it would allow the U.S. to be a global leader in biotech development and commercialization by facilitating the pipeline from industry to market.…”

‘Mapping research and governance needs for gene drives’

“…Acknowledging the significant uncertainties that surround how the U.S. regulatory system will govern field trials and potential environmental releases of gene drive modified organisms, Meghani and Kuzma (2017) analyze the Food and Drug Administration's (FDA) oversight of Oxitec's genetically engineered (GE) mosquito -an organism that does not contain a gene drive but raises a similar set of issues for risk assessment. They illustrate multiple instances in which the FDA's decisions and practices show favor to corporate interests over the public interest, including problematic assumptions about the ability of GE mosquitoes to spread and persist in the environment, and a failure to take seriously the possibility of harm to non-target species.…”