Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (2016) / Chapter Skim
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6 Assessing Risks of Gene-Drive Modified Organisms
6 Assessing Risks of Gene-Drive Modified Organisms
Pages 112-130
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From page 112... ...
This chapter focuses on why and how ecological risk assessment should be used to inform decisions around the development and application of gene-drive modified organisms, from understanding the efficacy and safety of gene drives created in the laboratory, to validating assessments in contained field trials, to assessing the risks of releasing gene-drive modified organisms into the open environment.
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From page 113... ...
For example, an ecological risk assessment of a fish farm will be informed by requirements of the Clean Water Act regarding the concentration of chemicals or bacteria in the water and runoff, the size of the fishery, and the concentration of mercury in the fish. Local jurisdictions may also impost other requirements, rules to protect the community from flooding and to preserve local parks, roadways, or historical sites.
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From page 114... ...
Ecological risk assessment, which is not currently required under NEPA but is used in several other regulatory frameworks, represents a more robust and appropriate framework for assessing the potential ecological harms and benefits of gene-drive modified organisms. Processes Under the National Environmental Policy Act Under NEPA, the two established processes for assessing impact as a component of formal decision making are environmental assessment (EA)
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Analyses conducted as part of the NEPA process are not required to be probabilistic or report quantitatively on uncertainty. These gaps would make it very difficult to create testable hypothesis to conduct further research on gene-drive modified organisms and inform decision making.
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However, EPA conducts ecological risk assessments under other circumstances; for example, when evaluating the potential effects of pesticides on the environment or on endangered species. Examples of regulations that describe and require ecological risk assessment processes include the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
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From page 117... ...
It may also be that a combination of a gene drive and conventional methodologies would be more effective, and at lower risk, than either approach alone -- another possible consideration during planning and scoping the ecological risk assessment process. Other key considerations about gene-drive modified organisms that will need to be accounted for in risk calculations include how the modified genetic elements move into populations, the efficiency with which the pass down from each generation to the next, and whether they are designed to affect population dynamics.
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From page 118... ...
Although the overall framework of ecological risk assessment is useful in the context of gene drives, gene-drive modified organisms have important distinguishing features that necessitate analytical tools not typically part used in conventional methods of assessing risk. Three distinguishing features are (1)
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. Specifications that would likely benefit ecological risk assessments for gene-drive modified organisms include the following: Build a digital map of the study site that includes land use, topography, and the loca tions of sources, stressors, habitats, and endpoints.
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The last node, impact, is the endpoints of interest. Some proposed uses of gene-drive modified organisms include reducing in the spread of human disease, controlling invasive species, and preserving endangered species.
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FIGURE 6-1 Basic structure of a cause-effect mode The model includes five main nodes: sou E el. s urce, stressor, habitat, e effect, and impact.
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The pro s, e fied e ased ovided examples are ba in part on Landis (2004) and ot ther examples of risk a assessments performed for invasive species an forestry managemen (Ayre and Landis, 2012)
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. ILLUSTRATING A CONCEPTUAL CAUSE-EFFECT MODEL USING TWO CASE STUDIES This section describes two hypothetical examples of ecological risk assessments on how gene-drive modified organisms might be used.
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. First is the release of sterile male Aedes aegypti mosquitoes developed using a gene drive technique.
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FIGURE 6-3 Conceptual cause-effect model for Case Study 1.
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From page 126... ...
Although they are widely acknowledge as valuable in other contexts, the environmental assessments and the environmental impact statements required by the National Environmental Protection Act are inappropriate tools to characterize the risks of gene-drive modified organisms. Instead, ecological risk assessment would be beneficial to gene drive research because this method can be used to estimate the probability of immediate and long-term environmental and public health harms and benefits.
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FIGURE 6-4 Conceptual cause-effect model for Case Study 4.
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As of April 2016, no ecological risk assessment has yet been conducted for a gene-drive modified organism. Recommendation 6-1: Researchers, regulators and other decision makers should use eco logical risk assessment to estimate the probability of immediate and long-term environ mental and public health effects of gene-drive modified organisms and to inform decisions about gene drive research, policy, and applications.
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Pp. 11-36 in Regional Scale Ecological Risk Assessment Using the Relative Risk Model, W.G.
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2013. Deriving criteria to select arthropod species for laboratory tests to assess the ecological risks from cultivating arthropod-resistant genetically engineered crops.
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