The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drives

Romeis, Jörg; Collatz, Jana; Glandorf, Boet; Bonsall, Michael B.

doi:10.1016/j.envsci.2020.02.016

Cited by 28 publications

(57 citation statements)

References 224 publications

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“…In the case of preventative SIT, sterile males are released in anticipation of a potential outbreak of an exotic pest, mating with any females of the target pest that may enter the area (Hendrichs et al, 2005). Effectiveness of SIT is associated with the fitness of the sterilised males as related to their dispersal ability, longevity and ability to compete with wild-type males for mating wild-type females (Dyck et al, 2005;Romeis et al, 2020). SIT is self-limiting, as the sterile factor disappears from the target population with each release generation (radiation or chemosterilisation) or its immediate progeny (inherited lethality), and is maintained only by periodic release of additional sterile males (Alphey, 2014).…”

Section: Release Of Sterilised Insectsmentioning

confidence: 99%

“…Several publications have previously proposed risks on broad protection goals (such as human and animal health, and the environment) associated with the deliberate release of GDMIs (e.g. NASEM, 2016; Roberts et al, 2017;James et al, 2018James et al, , 2020Collins et al, 2019;CSS-ENSSER-VDW, 2019;Rode et al, 2019;Teem et al, 2019;Dolezel et al, 2020a,b;Romeis et al, 2020;Smets and R € udelsheim, 2020;. Some of these previously proposed risks are listed below in Table 5.…”

Section: Risksmentioning

confidence: 99%

“…The release of radiation-sterilised insects is a widely accepted form of insect pest control (Dyck et al, 2005;HSCP, 2018;Romeis et al, 2020;WHO and IAEA, 2020). Formal ERA procedures are dependent on each country's general environmental regulatory framework.…”

Section: Release Of Radiation-sterilised Insectsmentioning

confidence: 99%

“…Another consideration in CBC is that the suppression effect on the target organism does not have a wider indirect impact on the food web, where non-target organisms with wider value have become dependent on the target pest (van Lenteren et al, 2006). The application of CBC could serve as a partial model for ERA of GDMIs; Romeis et al (2020) describe some similarities in pathways to harm in the problem formulation for risk assessments for CBC and engineered gene drive systems. Shaw et al (2011) provide lessons on the application of EU and Member State plant health regulations and risk assessment procedures to license the field release of a CBC agent for Fallopia japonica in the United Kingdom.…”

Section: Biological Controlmentioning

confidence: 99%

“…In some jurisdictions (e.g. New Zealand), a risk/benefit analysis is conducted as part of the ERA, along with an assessment of the effects of alternative pest control methods (Romeis et al, 2020). 4.5.5.…”

Section: Biological Controlmentioning

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: Release Of Sterilised Insectsmentioning

confidence: 99%

Section: Risksmentioning

confidence: 99%

Section: Release Of Radiation-sterilised Insectsmentioning

confidence: 99%

Section: Biological Controlmentioning

confidence: 99%

Section: Biological Controlmentioning

confidence: 99%

See 3 more Smart Citations

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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Larval mosquito management and risk to aquatic ecosystems: A comparative approach including current tactics and gene-drive Anopheles techniques

Peterson

Rolston

2022

Transgenic Res

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Genetic engineering of mosquitoes represents a promising tactic for reducing human suffering from malaria. Gene-drive techniques being developed that suppress or modify populations of Anopheles gambiae have the potential to be used with, or even possibly obviate, microbial and synthetic insecticides. However, these techniques are new and therefore there is attendant concern and uncertainty from regulators, policymakers, and the public about their environmental risks. Therefore, there is a need to assist decision-makers and public health stewards by assessing the risks associated with these newer mosquito management tactics so the risks can be compared as a basis for informed decision making. Previously, the effect of gene-drive mosquitoes on water quality in Africa was identified as a concern by stakeholders. Here, we use a comparative risk assessment approach for the effect of gene-drive mosquitoes on water quality in Africa. We compare the use of existing larvicides and the proposed genetic techniques in aquatic environments. Based on our analysis, we conclude that the tactic of gene-drive Anopheles for malaria management is unlikely to result in risks to aquatic environments that exceed current tactics for larval mosquitoes. As such, these new techniques would likely comply with currently recommended safety standards.

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Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission

James

Dass

Quemada³

2023

Transgenic Res

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Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.

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The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drives

Cited by 28 publications

References 224 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

Larval mosquito management and risk to aquatic ecosystems: A comparative approach including current tactics and gene-drive Anopheles techniques

Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission

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