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A risk-based approach to the regulation of genetically engineered organisms

Current regulatory regimes for genetically engineered crops fail to use a scientifically defensible approach or tailor the degree of regulatory review to the level of actual hazard or risk. We describe a rational way forward.

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Figure 1: Label originally proposed by the EPA for virus-resistant plum.
Figure 2: Different technologies have been implemented over history (time) in the plant breeding process.
Figure 3: Tabular algorithm used to classify GMOs into the Stanford Model environmental risk categories for regulatory purposes.
Figure 4: EPSPS from different plants and microbes.


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Correspondence to Henry Miller.

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Competing interests

D.K. is a retired law professor who has represented clients and served as an expert witness in matters relating to agricultural biotechnology. G.C. is at the Competitive Enterprise Institute, which has received non-directed contributions from Monsanto, Syngenta, and the Biotechnology Innovation Organization. W.P. performs public-sector-funded research with genetically modified crops and has done public outreach under the auspices of the ILSI International Food Biotechnology Committee and CropLife International. H.M. has been an expert consultant in litigation involving agribusiness companies

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Conko, G., Kershen, D., Miller, H. et al. A risk-based approach to the regulation of genetically engineered organisms. Nat Biotechnol 34, 493–503 (2016).

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