Dataset Information

Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

ABSTRACT: Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms because subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. Unintended effects can emerge from interaction of the gene drive construct with the heterogeneous genetic background of natural populations and/or be triggered by changing environmental conditions. This is especially relevant in the case of gene drives with invasive characteristics and typically takes dozens of generations to render the desired effect. Under these circumstances, "next generation effects" can substantially increase the spatial and temporal complexity associated with a high level of uncertainty in ERA. To deal with these problems, we suggest the introduction of a new additional step in the ERA of GE gene drive organisms that takes 3 criteria into account: the biology of the target organisms, their naturally occurring interactions with the environment (biotic and abiotic), and their intended biological characteristics introduced by genetic engineering. These 3 criteria are merged to form an additional step in ERA, combining specific "knowns" and integrating areas of "known unknowns" and uncertainties, with the aim of assessing the spatiotemporal controllability of GE gene drive organisms. The establishment of assessing spatiotemporal controllability can be used to define so-called "cut-off criteria" in the risk analysis of GE gene drive organisms: If it is likely that GE gene drive organisms escape spatiotemporal controllability, the risk assessment cannot be sufficiently reliable because it is not conclusive. Under such circumstances, the environmental release of the GE gene drive organisms would not be compatible with the precautionary principle (PP). Integr Environ Assess Manag 2020;00:1-14. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

SUBMITTER: Then C

PROVIDER: S-EPMC7496464 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

Then Christoph C Kawall Katharina K Valenzuela Nina N

Integrated environmental assessment and management 20200527 5

Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms because subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. ...[more]

PMID: 32250054

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Project description:In European regulations for the deliberate release into the environment of genetically modified organisms (GMO), the objective of General Surveillance in Post-Market Environmental Monitoring is defined as the identification of the occurrence of adverse effects of the GMO or its use which were not anticipated in the environmental risk assessment (ERA). Accompanying the commercial cultivation in the EU of maize event MON 810, General Surveillance was implemented by Monsanto, the authorization holder, on a voluntary basis. We carried out a statistical analysis on the pooled results of ten years of farmer questionnaires, which were a part of this General Surveillance, amounting to 2,627 farmer fields in eight European countries in the period 2006-2015. This analysis did not reveal any unexpected adverse effects associated with the cultivation of MON 810. Results from farmer questionnaires confirmed that the cultivation of MON 810 resulted in a significant reduction in the use of pesticides, efficient protection against the target pests, and healthier, higher yielding crops compared to conventional maize. MON 810 also had reduced susceptibility to disease and pests when compared to conventional maize. Monitoring characteristics related to environment and wildlife revealed no significant differences between MON 810 and conventional maize. Literature searches, that were also conducted as part of General Surveillance, identified a comprehensive set of publications addressing environmental safety as well as food and feed safety aspects of MON 810. None of the publications indicated any adverse effect of MON 810 that was not anticipated in the initial ERA, nor did they lead to a change in the conclusions of the initial risk assessment that demonstrated the safety of MON 810. The development of resistance by the target pests (Ostrinia nubilalis, ECB and Sesamia nonagrioides, MCB) was the only potential adverse effect identified in the ERA of MON 810 cultivation in the EU. The extensive safety data package for MON 810, the robust weight of evidence demonstrating both its safety and benefits, and the history of safe use of MON 810 for 15 years in the EU, indicates that focussing the General Surveillance of MON 810 on literature searches and farmer complaint systems would be appropriately protective. This will allow the identification of potential adverse effect not anticipated in the initial ERA without the intensive effort and organizational challenges of farmer questionnaires.

Dataset Information

Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

Publications

Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

Similar Datasets

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