Abstract
A risk-based proposal for regulating field trials—of any kind of organism—that is adaptable to any form of government regulation or institutional oversight
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For example, there is limited gene flow from maize to teosinte (and vice versa), and such gene flow appears neither to be detrimental to the teosintes nor to change their basic nature as distinctive wild races and species (22). Thus, even in areas where teosinte is present, maize could be categorized as of negligible risk (Category 1). By contrast, distinct varieties of oilseed (canola) rape (Brassica napus) with widely differing concentrations of erucic acid and intended for different applications should be kept segregated to avoid outcrossing between varieties; thus, high-erucic acid canola could be classified as category 1 in regions where that variety of the plant is grown but perhaps category 4 where low-erucic acid canola is grown.
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Under the U. S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA), the EPA has not traditionally required case by case reviews for small scale field trials. Under FIFRA, field trials of chemicals or microorganisms on less than 10 acres were considered automatically not to require EPA's review and were exempt from regulation. There was a similar exemption under TSCA of chemicals or microorganisms for “small quantities solely for R&D.” While these approaches can hardly be said to be risk-based—they exempted both low-risk and other organisms alike—there was a certain logic: Namely, that small-scale experiments generally are not of great safety concern. Under these exemptions, R&D was performed on thousands of microorganisms, for purposes as varied as pesticides, frost prevention, enhanced artificial snowmaking, promoting the growth of plants, mining, oil recovery, bioremediation, and sewage treatment.
The traditional U. S. Plant Pest Act regulations contain a single inclusive list of proscribed plant pathogens, without any sub-stratification. More recent regulations under the Plant Pest Act (11) do contain a subcategory that requires only notification rather than an environmental assessment, but the subcategory is not defined according to risk-based criteria (25,26).
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Miller, H., Altman, D., Barton, J. et al. An Algorithm for the Oversight of Field Trials in Economically Developing Countries. Nat Biotechnol 13, 955–959 (1995). https://doi.org/10.1038/nbt0995-955
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DOI: https://doi.org/10.1038/nbt0995-955
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