Agriculture Reference
In-Depth Information
are “not necessary to ensure confinement measures are met because the
information is already captured in permit conditions and pre-harvest
reports.” 12
The Audit Report identified deeper problems in the agency's regula-
tory culture that undermine its credibility. These range from the failure
of APHIS biotechnologists to document their reviews and scientific anal-
yses for approving field test applications, to the agency's failing to seek
information from companies that is missing from their reports, complet-
ing its site inspections, and not fully recording reported violations nor
providing instructions for destroying GM test crops after their harvest. 13
The National Research Council (NRC), a prominent scientific orga-
nization that frequently advises federal agencies, also evaluated APHIS
performance and found a broader range of problems, including lack of
scientific rigor and transparency in evaluating risks, failure to fully con-
sider all available scientific information and develop new gap-filling data,
and disregard for potential impacts on nontarget organisms. 14 NRC also
identified other problems that it attributed, in part, to congressional fail-
ure to amplify the agency's regulatory powers, such as APHIS' lack of
authority to carry out postmarket monitoring to identify and address
unforeseen downstream impacts, and its disregard for allergenic risk in
approving GM plants under the notification process. 15
Although APHIS has not been moved by these critiques to im-
prove its performance, it has been responsive to business losses. Fol-
lowing several loss-causing incidents involving “low level presence of
regulated genetically engineered plant materials in conventional seeds
or grains,” the agency has announced it will evaluate its program for
possible changes it may make within the scope of
its regulatory
12 Audit Report supra. at 43.
13 Audit Report, supra .at4.
14 Gregory Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Reg-
ulation of Genetically Modified Foods and Animals , 45 WMLR 2167, 2232; and Nat'l
Research Council, Environmental Effects of Transgenic Plants 37 (2002) at 148.
15 See Mandel, supra, at 2234, 2235 & n.372; See also Nat'l Research Council, Environ-
mental Effects of Transgenic Plants 37 (2002) at 111, 233.
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