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Program Resources Section
Public Response and Program Resources Branch
Field Operations Division (7506C)
Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
RE: Docket Control Number OPP-300370A
The American Society for Microbiology (ASM) appreciates the opportunity to respond to Environmental Protection Agency's (EPA) request for comment on additional information it is considering regarding the treatment, as inert ingredients, of "substances introduced into the plant along with the active ingredient to confirm or ensure the presence of the active ingredient."
The ASM takes the position that selectable markers in plants, which are not part of an active ingredient, do not fit the definition of inert ingredients as used in Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or within the EPA proposed rule on plant-pesticides issued 23 November 1994. The markers are not components of a pesticide; if they were, they would be so considered. If EPA determines that the inert ingredients include selectable markers for purposes of the plant-pesticide proposed rule, then it must use the same rationale in proposing regulatory oversight for all transgenic plants using selectable markers, irrespective of the introduced trait. We do not believe it would be a sound scientific decision to regulate selectable markers unless there is scientific evidence that they present an unreasonable risk to the plants, humans, other consumers or users of the plants, or the environment. At present, we are not aware of such evidence. Furthermore, this is not in concurrence with other federal agencies that deal with transgenic plants, especially the U.S. Department of Agriculture and the U.S. Food and Drug Administration.
Please be reminded that the ASM is one of the participating and signatory societies to the report 'Appropriate Oversight for Plants with Inherited Traits for Resistance to Pests', a scientific critique that makes clear the limitations of the EPA's proposed rule on plant-pesticides.