Agriculture Reference
In-Depth Information
forth by the Coordinated Framework, namely that sale and use of the
product is to be permitted by EPA unless it finds that the product poses
an “unreasonable risk to man or the environment, taking into account
the economic, social, and environmental costs and benefits of the use of
the pesticide.”
21
For GM crops with pesticidal features, the agency has narrowed its
regulatory focus to those crops containing bacterial genes that have
been incorporated in a plant, or other genetic material that has been
spliced into a plant's genome to produce pesticidal substances. By these
and other determinations, EPA has exempted genetic material that is
derived from another plant that is sexually compatible with the receiving
plant.
22
The developer of a GM crop that falls within EPA's narrowed range
of regulatory responsibility must submit an application and supporting
technical information to the agency and secure EPA approval before
selling or using the product in the United States. The agency may require
additional information or studies, and in approving the product, must
ensure that it bears a label that specifies the parameters for its safe use,
parameters that EPA has determined are necessary to prevent unreason-
able risk to health and environment.
23
Noncompliance with any of these
requirements is subject to EPA sanctions.
EPA's review of an application for approval (“registration”) involves
its evaluation of the product's active ingredients, the intended crop plant-
ing circumstances and sites, and data on the effects of such plantings
on human health, nontarget species, and environmental features such as
groundwater and surface water. Following registration of the new prod-
uct and its sale, the developer is thereafter required to report adverse
effects arising from its use, and provide additional information that EPA
may request to determine if the registration should be maintained, sus-
pended, or cancelled.
21
FIFRA,
supra
,at
136(z)(bb).
22
For details about these and other exemptions, see William L. Anderson et al., Envi-
ronmental Law Institute, Biotechnology Deskbook 36-39 (2001).
23
40 C.F.R. 156.
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