Agriculture Reference
In-Depth Information
Finally, as noted earlier, EPA is also mandated to ensure that
any pesticide residues in foods do not cause “unreasonable adverse
effects.”
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It implements this responsibility by determining safe dietary
levels and tolerances for the residues, unless it finds this unnecessary to
protect consumer health, in which case it exempts the pesticide residue.
Thus, if the pesticidal residue of a GM crop has not been exempted or
approved by EPA as falling within a tolerance level, the crops sold that
bear such residues will be considered “adulterated” food products by
the FDA and subject to enforcement action and sanctions by the FDA
to prevent their further sale.
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Obviously, this is another complex and
contentious aspect of EPA's regulation of pesticidal GM crops.
Food andDrug Administration
The FDA is authorized by the Food, Drug, and Cosmetic Act to pro-
tect public health by ensuring that foods are safe, sanitary, and properly
described to consumers.
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It is also directed by the Coordinated Frame-
work to encompass GM food products within its regulatory program.
Although the main features of its regulatory programwere designed long
before the advent of biotechnology, Congress and the agency have made
few modifications to deal with the special characteristics and uncertain-
ties of GM food products and have essentially ignored controversies that
have arisen about their safety and desirability. Thus, the agency's over-
sight of both GM and non-GM foods alike is mainly focused on whether
the food product is “adulterated” by an unapproved additive or pesti-
cide residue, and “misbranded” by a misleading product label or other
promotional material used by its manufacturer.
According to its statutory mandate, FDA is not empowered to con-
duct pre-market review of a new food product unless the product con-
tains an additive that has not been previously evaluated and approved
30
FFDCA, 21 U.S.C. 346a.
31
Id.
32
21 U.S.C. 301-397.
