Application of GMOs in the U.S.: EPA research & regulatory considerations related to soil systems |
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Authors: | Phil Sayre Ramon J Seidler |
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Institution: | (1) Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW Washington, DC, 20460, USA;(2) Western Ecology Division, U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory, 200 S W 35th Street, 18600 Plainview Road, Corvallis, Bend, OR 97333, 97701, USA |
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Abstract: | During the last 20 years recombinant biotechnology has resulted in the development of organisms with unique genetic compositions,
some of which are for intentional release to the environment. While concerns have been raised that such organisms may be capable
of inducing transient unintended environmental effects, longer-term perturbations to soil processes and non-target species
effects have yet to be demonstrated. In parallel with the growth of the commercial biotechnology industry has come a significant
growth in regulatory review processes intended to evaluate the risks of these GMO products. Under the Toxic Substances Control
Act (TSCA), certain new microbial products that undergo pre-manufacture review are examined for human and environmental risks
using data and other information received in accordance with the U.S. Environmental Protection Agency’s (EPA’s) “Points to
Consider” guidance document. In the risk assessment process, carried out under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) authorities, EPA evaluates both microbial pesticide products
and plants with pesticidal properties to determine if Federal safety standards are met. For all pesticide products, including
genetically engineered pesticides, EPA receives testing of product composition and chemical properties, human health effects,
environmental effects on non-target pests, and the fate of the pesticide in the environment. The EPA’s Office of Research
and Development supports risk assessment research related to such GMO products. This paper focuses on relevant EPA research
and regulatory examples related to soil effects considerations for GMOs. |
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Keywords: | Bacillus thuringiensis Burkholderia cepacia genetically modified organism (GMO) regulation of GMOs risk assessment transgenes transgenic crops |
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