A Strategy for Integrating Science into Regulatory Decision-Making for GMOs

Ndolo, Dennis Obonyo; Tepfer, Mark

doi:10.1017/9781316585269.004

Cited by 4 publications

(6 citation statements)

References 12 publications

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“…Early in the ERA, in a step called "Problem Formulation, " the protection goals set by environmental policy need to be identified, and operational protection goals and plausible pathways on how the stressor of concern could harm those protection goals (i.e., pathways to harm) are defined (Raybould, 2006;Gray, 2012;Craig et al, 2017;Raybould et al, 2019). Based on these "Pathways to Harm, " testable risk hypotheses can be derived, existing relevant information is collected and required data are identified.…”

Section: Environmental Risk Assessmentmentioning

confidence: 99%

Assessing the Risks of Topically Applied dsRNA-Based Products to Non-target Arthropods

Romeis

Widmer

2020

Front. Plant Sci.

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RNA interference (RNAi) is a powerful technology that offers new opportunities for pest control through silencing of genes that are essential for the survival of arthropod pests. The approach relies on sequence-specificity of applied double-stranded (ds) RNA that can be designed to have a very narrow spectrum of both the target gene product (RNA) as well as the target organism, and thus allowing highly targeted pest control. Successful RNAi has been reported from a number of arthropod species belonging to various orders. Pest control may be achieved by applying dsRNA as foliar sprays. One of the main concerns related to the use of dsRNA is adverse environmental effects particularly on valued non-target species. Arthropods form an important part of the biodiversity in agricultural landscapes and contribute important ecosystem services. Consequently, environmental risk assessment (ERA) for potential impacts that plant protection products may have on valued non-target arthropods is legally required prior to their placement on the market. We describe how problem formulation can be used to set the context and to develop plausible pathways on how the application of dsRNA-based products could harm valued non-target arthropod species, such as those contributing to biological pest control. The current knowledge regarding the exposure to and the hazard posed by dsRNA in spray products for non-target arthropods is reviewed and suggestions are provided on how to select the most suitable test species and to conduct laboratorybased toxicity studies that provide robust, reliable and interpretable results to support the ERA.

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Section: Environmental Risk Assessmentmentioning

confidence: 99%

Assessing the Risks of Topically Applied dsRNA-Based Products to Non-target Arthropods

Romeis

Widmer

2020

Front. Plant Sci.

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“…Roberts et al, 2017;James et al, 2018;Teem et al, 2019). These types of consultation provide a helpful format to identify relevant protection goals (Craig et al, 2017;Hokanson et al, 2018) and frame ERA (Murphy et al, 2010;Kolopack et al, 2015;Murray et al, 2016). If risk managers consider that such engagement is useful to define and agree on protection goals, they may want to explore how it should be best designed, and whether it should be performed on single applications, groups of applications or on the technology per se.…”

Section: Additional Considerationsmentioning

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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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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“…impact a protected value adversely); (2) formulating risk hypotheses (i.e. hypotheses of no more harm or risk than the existing activity) 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 (Raybould, ; Craig et al., ). In this context, it is important to consider whether a proposed activity may lead to new harms, or only to different ways of causing harm that already result from current practice.…”

Section: Problem Formulation In Theory: Conceptsmentioning

confidence: 99%

“…To further frame ERA, plausible pathways (also called conceptual models) are constructed to describe how the proposed activity could lead to possible harm to operational protection goals (Raybould, , , ; Johnson et al., ; Nickson, ; Wolt et al., ; Gray, ; Tepfer et al., ; Layton et al., ; Sauve‐Ciencewicki et al., ). As with adverse outcome pathways (Lanzoni et al., ), a pathway to harm is a causal chain of events that need to occur for a harm to be realised (Tepfer et al., ; Craig et al., ).…”

Section: Problem Formulation In Theory: Conceptsmentioning

confidence: 99%

“…A careful first scrutiny of the pathway, based on existing expert knowledge, can usually help identify which of the step(s) may be the most decisive or easiest to test in attempting to disrupt the pathway with the highest degree of certainty (Craig et al., ). Corroboration of risk hypotheses will build confidence that risk is negligible via the pathway in question, and corroboration following a rigorous test gives greater confidence than does a weak test (Raybould, , ).…”

Section: Problem Formulation In Theory: Conceptsmentioning

confidence: 99%

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

Devos

Devlin

Ippolito

et al. 2019

EFS2

Self Cite

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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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A Strategy for Integrating Science into Regulatory Decision-Making for GMOs

Cited by 4 publications

References 12 publications

Assessing the Risks of Topically Applied dsRNA-Based Products to Non-target Arthropods

Assessing the Risks of Topically Applied dsRNA-Based Products to Non-target Arthropods

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

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