Agriculture Reference
In-Depth Information
under the Federal Food Drug and Cosmetic Act (FFDCA) for residues of pesticidal
substances in or on food and feed crops like
Bt
maize or cotton (C. Wozniak, U.S.
Environmental Protection Agency Biopesticides and Pollution Prevention Division,
Washington, DC, personal communication).
3. The FDA examines the toxicity and allergenicity of GM plants under the FFDCA.
This includes oversight of food plants that contain transgenic proteins that are not
normally found in that food source (e.g., an animal gene expressed in plants). When
the FDA conducts safety evaluations of GM crops, it evaluates both the final prod-
uct and the techniques used to develop it. The FDA's process, however, is voluntary;
the FDA's approach is a comparative one based on a compositional analysis of the
GM plant and its non-GM counterpart (C. Wozniak, U.S. Environmental Protection
Agency Biopesticides and Pollution Prevention Division, Washington, DC, personal
communication). The FDA also enforces the tolerances set by the EPA in the event
tolerance limits are exceeded.
It should be noted and emphasized here that the U.S. regulatory agencies do not gener-
ally conduct risk assessment studies themselves; the regulatory agencies review the data
that biotechnology companies provide (which is often from work conducted by indepen-
dent third-party laboratories), and to get a new GM plant approved for commercial use, the
product must show minimal risk to nontarget organisms, human health, and the environ-
ment. It takes many years (usually > 6) for seed companies to go from the discovery phase
to commercial sales and distribution (Monsanto, 2011). Usually, early contact is made with
the regulatory agencies, and a reiterative dialogue between the biotechnology company
and the regulatory agencies takes place early in the registration process (C. Wozniak,
U.S. Environmental Protection Agency Biopesticides and Pollution Prevention Division,
Washington, DC, personal communication, October 3, 2011). Data are then submitted to
the EPA PIP products division for an experimental use permit a few years before reg-
istration occurs (C. Wozniak, U.S. Environmental Protection Agency Biopesticides and
Pollution Prevention Division, Washington, DC, personal communication, October 3,
2011). Once a new crop line advances to the prelaunch phase, there is a 90% chance that it
will be introduced into the commercial marketplace (Monsanto, 2011). In this final phase
of development, the regulatory data are submitted to the EPA, large quantities of seeds
are generated, and the premarket advertising campaign begins. After health and safety
data have passed EPA guidelines, the product is approved for commercial sales, and the
product is launched.
Some types of GM crops that receive EPA approval have restrictions that limit how
and where a particular crop can be grown. For example, to plant
Bt
crops, farmers are
required to keep 5-20% of their land (depending on the
Bt
product in use) in a non-
Bt
refuge to help minimize the rate of resistance of targeted pests (EPA, 2010). The EPA also
monitors the potential for gene flow between GM plants and wild-type relatives and gen-
erally does not approve GM crops that have wild-type relatives that grow in close proxim-
ity to GM crop regions. For the major GM crops that have been developed thus far (corn,
soy, canola, cotton), there is little risk for cross-pollination in the United States as the wild
relatives of most of these crops are found primarily in tropical areas. In the case of
Bt
cot-
ton, however, where the potential for gene flow to wild cotton relatives does exist in the
United States (i.e., Hawaii, Florida south of State Route 60, Puerto Rico, and the U.S. Virgin
Islands), the EPA has restricted sales and distribution of
Bt
cotton within these areas (EPA,
2010). However, even when there is little chance for gene flow between transgenic and feral
or indigenous sexually compatible wild relatives (SCWRs) in the United States, there is a
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