Agriculture Reference
In-Depth Information
or exempted, by the agency,
33
or bears a pesticide residue that exceeds
its EPA-set tolerance level, as discussed earlier. Thus, FDA rules pro-
vide that a food containing an additive may not be sold unless the agency
has either exempted the additive on grounds that its long-standing use
or safety studies indicates it is “generally recognized as safe” (GRAS),
or the agency has determined on the basis of safety studies that the addi-
tive can be safely used under certain specified conditions.
34
The safety
studies involve consideration of the properties of the additive and data
regarding its probable consumption, cumulative effects, and other mat-
ters regarding its safety for the uses intended. Most of this information
is provided by the company applying for approval to sell the food prod-
uct. FDA may determine that a non-GRAS additive can only be safely
used in certain quantities or within other parameters. Yet if it accords
GRAS status to the additive, no restrictions are imposed and food con-
taining the additive is no longer subject to FDA regulation because of its
additive content.
Following announcement of the Coordinated Framework, FDA
issued a policy statement that it would treat GM and non-GM food prod-
ucts in the same manner and not differentiate because of the biotechno-
logical methods used to make GM food, and regulate only when it finds
that end product attributes pose unreasonable risk to human health.
35
Thus, GMand conventional foods are subject to the same FDA approach
for regulating additives. The policy also states that FDA assumes that the
genetic material used to make a GM product “will likely be the same or
substantially similar to substances commonly found in foods, such as pro-
teins, fats and oils, and carbohydrates.” This assumption signaled that it
would, in general, accord GRAS status to the genetic material incorpo-
rated in a GM food, and that it would therefore not subject GM food to
33
FFDCA, 21 U.S.C. 402,409.
34
FFDCA,
supra,
at 201(s) and 321(s). See also 21 C.F.R. 170.3.
35
Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22984
(May 29, 1992). fda.gov/Food/Biotechnology (June 23, 2009).
