Agriculture Reference
In-Depth Information
The application is usually preceded by experimental field testing. The
agency allows a developer to carry out confined, small-scale field tests to
gain data it needs to support an application, but requires a developer to
apply for an experimental use permit (EUP) for larger scale field tests.
An EUP will be granted if the applicant provides sufficient data for risk
assessment by the agency and the assessment indicates that the field test
will not cause unreasonable risk. The data needed for an EUP is less
substantial than what is required for final approval (registration) of the
pesticidal crop, but the agency may require inspection and crop destruc-
tion, and also set a food residue tolerance if the experiment involves food
production.
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The limited scope of EPA's program has been a continuing concern
to critics of GM crops and foods, and environmentalists. A report by the
Pew Foundation, as part of its “Initiative on Food and Biotechnology”
program, questions whether EPA and APHIS provide effective postmar-
ket oversight of such products to ensure their safety, address the stabil-
ity of commodity crop and food product markets, and maintain public
trust.
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These concerns have been heightened by highly publicized incidents
involving contamination of conventional crops and foods for human con-
sumption. These include the previously noted StarLink Corn incident in
which a pesticidal GM corn, approved by EPA as a product for animal
feed, was found at low levels in crops destined for human food as well as
in human food products, and the Prodigene incident in which a vaccine-
producing corn, unapproved for any food or feed use, had become mixed
with soybeans intended for human consumption.
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The Pew report also points to EPA's failure to directly regulate the
farmers who plant, harvest, and sell such pesticidal GM crops, and not
taking enforcement action against them when they fail to comply with
restrictions the agency has set for crop planting and distribution. The
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40 C.F.R. 172.
25
Michael Taylor & Jody Tick, Pew Foundation, Post-Market Oversight of Biotech
Foods-Is the System Prepared? (2003).
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Id
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