Editing nature: Local roots of global governance

Kofler, Natalie; Collins, James P.; Kuzma, Jennifer; Marris, Emma; Esvelt, Kevin M.; Nelson, Michael Paul; Newhouse, Andrew E.; Rothschild, Lynn J.; Vigliotti, Vivian S.; Semenov, Misha; Jacobsen, Rowan; Dahlman, James E.; Prince, Shannon Joyce; Caccone, Adalgisa; Brown, Timothy H.; Schmitz, Oswald J.

doi:10.1126/science.aat4612

Cited by 74 publications

(59 citation statements)

References 11 publications

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“…The idea of an independent body of representative stakeholders to evaluate genome‐edited organisms prior to release into the wild has gained significant traction in the last few years (Jasanoff & Hurlbut ; Kofler et al. ; Montoliu et al. ).…”

Section: Ethical Considerations Of Editing Organisms For Conservationmentioning

confidence: 99%

Transforming ecology and conservation biology through genome editing

Phelps

Seeb

2019

Conservation Biology

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As the conservation challenges increase, new approaches are needed to help combat losses in biodiversity and slow or reverse the decline of threatened species. Genome-editing technology is changing the face of modern biology, facilitating applications that were unimaginable only a decade ago. The technology has the potential to make significant contributions to the fields of evolutionary biology, ecology, and conservation, yet the fear of unintended consequences from designer ecosystems containing engineered organisms has stifled innovation. To overcome this gap in the understanding of what genome editing is and what its capabilities are, more research is needed to translate genome-editing discoveries into tools for ecological research. Emerging and future genome-editing technologies include new clustered regularly interspaced short palindromic repeats (CRISPR) targeted sequencing and nucleic acid detection approaches as well as species genetic barcoding and somatic genome-editing technologies. These genome-editing tools have the potential to transform the environmental sciences by providing new noninvasive methods for monitoring threatened species or for enhancing critical adaptive traits. A pioneering effort by the conservation community is required to apply these technologies to real-world conservation problems.

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Section: Ethical Considerations Of Editing Organisms For Conservationmentioning

confidence: 99%

Transforming ecology and conservation biology through genome editing

Phelps

Seeb

2019

Conservation Biology

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“…However, in a recent open letter, a group of more than 100 scientists, including many studying gene drives, urged governments to reject this moratorium. Others have called for the establishment of different forms of governance so that any gene drive releases are done safely and responsibly, and with early input into the decision-making process by all concerned parties (NASEM, 2016;Kofler et al, 2018;Bartumeus et al, 2019;Brossard et al, 2019;Hartley et al, 2019;Kuzma, 2019;Thizy et al, 2019).…”

Section: Case Studymentioning

confidence: 99%

Using problem formulation for fit‐for‐purpose pre‐market environmental risk assessments of regulated stressors

Devos

Devlin

Ippolito

et al. 2019

EFS2

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Pre-market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally devising plausible pathways to harm that describe how the deployment of a regulated stressor could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with existing information be insufficient for decision-making. Here, we apply problem formulation to the assessment of possible adverse effects of RNA interference-based insecticidal genetically modified (GM) plants, GM growth hormone coho salmon, gene drive-modified mosquitoes and classical biological weed control agents on non-target organisms in a prospective manner, and of neonicotinoid insecticides on bees in a retrospective manner. In addition, specific considerations for the problem formulation for the ERA of nanomaterials and for landscape-scale population-level ERAs are given. We argue that applying problem formulation to ERA maximises the usefulness of ERA studies for decision-making, through an iterative process, because: (1) harm is defined explicitly from the start; (2) the construction of risk hypotheses is guided by policy rather than an exhaustive attempt to address any possible differences; (3) existing information is used effectively; (4) new data are collected with a clear purpose; (5) risk is characterised against well-defined criteria of hypothesis corroboration or falsification; and (6) risk assessment conclusions can be communicated clearly. However, problem formulation is still often hindered by the absence of clear policy goals and decision-making criteria (e.g. definition of protection goals and what constitutes harm) that are needed to guide the interpretation of scientific information. We therefore advocate further dialogue between risk assessors and risk managers to clarify how ERAs can address policy goals and decision-making criteria. Ideally, this dialogue should take place for all classes of regulated stressors, as this can promote alignment and consistency on the desired level of protection and maximum tolerable impacts across regulated stressors.

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“…As mentioned above, the regulatory systems that govern biotechnology are ill-equipped to effectively manage gene drive organisms. While gene drive organisms will indeed be released at the local scale and should thus be governed accordingly, global governing bodies are also an important scale to set broader norms around their governance [93]. Decisions about how to regulate gene drives at the global scale [94], how to consider field trials [96], and how to meaningfully operate with free, prior and informed consent [97] are all in progress, and are all important for the broader governance of gene drive technologies.…”

Section: Regulatory Stakeholder and Community Engagementmentioning

confidence: 99%

Rodent gene drives for conservation: opportunities and data needs

et al. 2019

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Invasive rodents impact biodiversity, human health and food security worldwide. The biodiversity impacts are particularly significant on islands, which are the primary sites of vertebrate extinctions and where we are reaching the limits of current control technologies. Gene drives may represent an effective approach to this challenge, but knowledge gaps remain in a number of areas. This paper is focused on what is currently known about natural and developing synthetic gene drive systems in mice, some key areas where key knowledge gaps exist, findings in a variety of disciplines relevant to those gaps and a brief consideration of how engagement at the regulatory, stakeholder and community levels can accompany and contribute to this effort. Our primary species focus is the house mouse, Mus musculus , as a genetic model system that is also an important invasive pest. Our primary application focus is the development of gene drive systems intended to reduce reproduction and potentially eliminate invasive rodents from islands. Gene drive technologies in rodents have the potential to produce significant benefits for biodiversity conservation, human health and food security. A broad-based, multidisciplinary approach is necessary to assess this potential in a transparent, effective and responsible manner.

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Editing nature: Local roots of global governance

Abstract: Environmental gene editing demands collective oversight

Cited by 74 publications

References 11 publications

Transforming ecology and conservation biology through genome editing

Transforming ecology and conservation biology through genome editing

Using problem formulation for fit‐for‐purpose pre‐market environmental risk assessments of regulated stressors

Rodent gene drives for conservation: opportunities and data needs

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