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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

Authors
  • Then, Christoph1
  • Kawall, Katharina2
  • Valenzuela, Nina1
  • 1 Testbiotech e.V., Institute for Independent Impact Assessment of Biotechnology, Germany , (Germany)
  • 2 Fachstelle Gentechnik und Umwelt, Germany , (Germany)
Type
Published Article
Journal
Integrated Environmental Assessment and Management
Publisher
Wiley (John Wiley & Sons)
Publication Date
May 27, 2020
Volume
16
Issue
5
Pages
555–568
Identifiers
DOI: 10.1002/ieam.4278
PMID: 32250054
PMCID: PMC7496464
Source
PubMed Central
Keywords
License
Unknown
External links

Abstract

We introduce the concept of spatiotemporal controllability of genetically engineered (GE) gene drive organisms: This approach uses specific knowns to decide upon known unknowns as a new step in the environmental risk assessment (ERA) of GE gene drive organisms. Three criteria are considered: the biology of the target organisms, their natural interactions with the environment, and their intended biological characteristics as introduced by GE. If there is a plausible risk that GE gene drive organisms can escape spatiotemporal controllability without effective means to control dispersal or persistence, a sufficiently reliable risk assessment will not be possible because it is not conclusive. We propose the spatiotemporal controllability as a cut‐off criterion in ERA of GE gene drive organisms: If a sufficiently reliable risk assessment is not possible in virtue of the absence of spatiotemporal controllability, the environmental release of the GE gene drive organism could not be allowed.

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