Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

Hayes, Keith R.; Hosack, Geoffrey R.; Dana, G.; Foster, Scott D.; Ford, Jessica H.; Thresher, Ron; Ickowicz, Adrien; Peel, David; Tizard, Mark; Barro, Paul De; Strive, Tanja; Dambacher, Jeffrey M.

doi:10.1080/23299460.2017.1415585

Cited by 51 publications

(51 citation statements)

References 89 publications

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“…Different techniques may be used to postulate pathways to harm (e.g. Wolt et al, 2010;Gray, 2012;Roberts et al, 2017;Hayes et al, 2018;Teem et al, 2019). The nature and formality of this exercise may reflect preferences and approaches of the responsible authority.…”

Section: Devising Plausible Pathways To Harmmentioning

confidence: 99%

“…Corroboration of risk hypotheses following a rigorous test gives greater 57 Stepwise/staged testing approach: As a GDMI progresses through the phased testing and deliberate release pathway, the spatial and temporal scales of the concomitant risk assessment studies increase, and the suite of tools used to identify hazards and their potential associated adverse effects changes. Relevant data gathered under controlled, contained conditions provide confidence that the GDMI can safely progress to the next testing phase (NASEM, 2016;Hayes et al, 2018;James et al, 2018). Tiered testing approach: According to the tiered approach, information collected in lower tiers directs the extent and nature of any experimentation conducted in higher tiers: hazards are evaluated within different tiers that progress from worst-case exposure scenario conditions, framed in highly controlled laboratory environments, to more realistic scenarios under semi-field or field conditions.…”

Section: Identifying Relevant Information To Test Risk Hypotheses Andmentioning

confidence: 99%

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Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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Advances in molecular and synthetic biology are enabling the engineering of gene drives in insects for disease vector/pest control. Engineered gene drives (that bias their own inheritance) can be designed either to suppress interbreeding target populations or modify them with a new genotype. Depending on the engineered gene drive system, theoretically, a genetic modification of interest could spread through target populations and persist indefinitely, or be restricted in its spread or persistence. While research on engineered gene drives and their applications in insects is advancing at a fast pace, it will take several years for technological developments to move to practical applications for deliberate release into the environment. Some gene drive modified insects (GDMIs) have been tested experimentally in the laboratory, but none has been assessed in small-scale confined field trials or in open release trials as yet. There is concern that the deliberate release of GDMIs in the environment may have possible irreversible and unintended consequences. As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are adequate and sufficient for GDMIs, primarily disease vectors, agricultural pests and invasive species, for deliberate release into the environment. Under this mandate, EFSA was not requested to develop risk assessment guidelines for GDMIs. In this Scientific Opinion, the Panel on Genetically Modified Organisms (GMO) concludes that EFSA's guidelines are adequate, but insufficient for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of GDMIs. While the MC, ERA and PMEM of GDMIs can build on the existing risk assessment framework for GMIs that do not contain engineered gene drives, there are specific areas where further guidance is needed for GDMIs.

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Section: Devising Plausible Pathways To Harmmentioning

confidence: 99%

Section: Identifying Relevant Information To Test Risk Hypotheses Andmentioning

confidence: 99%

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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“…To ensure that the development and potential deployment of a gene drive as part of a malaria eradication strategy is fully informed by an evaluation of risks to the environment and human health, researchers, donor organisations and stakeholders have embarked on a series of consultations, workshops and public engagements aimed at problem formulation for the use of gene drive‐modified mosquitoes to reduce malaria incidence (Murray et al., ; Roberts et al., ; Hayes et al., ; James et al., ).…”

Section: Problem Formulation In Practice: Case Studiesmentioning

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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“…In the face of these unknowns and controversies, observers and stakeholders alike have emphasized the importance of CSE as the technology develops [1–8]. CSE is expected to educate stakeholders or members of the public [2, 5, 22], identify the interests of relevant groups [2, 3, 8, 23], and contribute to site research in preparation for field trials [1, 2, 24]. But many commentators also see CSE as a way to build relationships, trust, and legitimacy for a technology [1, 5, 7, 24, 25], or as a means to more democratic governance by informing or constituting part of the decision-making processes that shape the technology [4–6, 22, 26, 27].…”

Section: Introductionmentioning

confidence: 99%

A typology of community and stakeholder engagement based on documented examples in the field of novel vector control

et al. 2019

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BackgroundDespite broad consensus on the importance of community and stakeholder engagement (CSE) for guiding the development, regulation, field testing, and deployment of emerging vector control technologies (such as genetically engineered insects), the types of activities pursued have varied widely, as have the outcomes. We looked to previous CSE efforts for clarity about appropriate methods and goals. Our analysis yielded a typology of CSE, and related vocabulary, that describes distinctions that funders, organizers, and scholars should make when proposing or evaluating CSE.MethodsWe compiled available formal documentation of CSE projects, starting with projects mentioned in interviews with 17 key informants. Major features of these examples, including the initiators, target groups, timing, goals, and methods were identified using qualitative coding. Based on these examples, subcategories were developed for a subset of features and applied to the identified cases of CSE in the documents. Co-occurrence of subcategorized features was examined for patterns.ResultsWe identified 14 documented examples CSE projects, which were comprised of 28 distinct CSE activities. We found no clear patterns with respect to timing. However, we found that grouping examples according to whether initiators or targets could enact the immediate desired outcome could help to clarify relationships between goals, methods, and targets.ConclusionBased on this analysis, we propose a typology that distinguishes three categories of CSE: engagement to inquire –where initiators are empowered to act on information collected through engagement with target groups; engagement to influence –where initiators engage to affect the actions of already-empowered target groups; and engagement to involve –where initiators engage to delegate authority to target groups. The proposed typology can serve as a guide for establishing the goals, identifying appropriate methods, and evaluating and reporting CSE projects by directing attention to important questions to be asked well before determining who to engage and how.

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Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

Cited by 51 publications

References 89 publications

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

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

A typology of community and stakeholder engagement based on documented examples in the field of novel vector control

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