Agriculture Reference
In-Depth Information
“Substantially equivalent” doesn't mean it's safe, only that
it's no less safe than non-GM food. There are three criteria by
which substantial equivalence is verified. In regards to crops,
one criterion is whether the plant looks and behaves like the
non-GM plant. Does it mature and flower about the same
time, and is it resistant to the same diseases in roughly the
same way? These are examples of observational data the FDA
might request from the seed company. A second criterion con-
cerns the chemical composition of the final product. For a GM
canola variety, for example, the FDA may request information
on the seed's triglyceride and fatty acid content. Finally, the
third criterion involves information on the nutrients, antinu-
trients, toxicants, and allergens of the entire plant (even the
part not eaten). Because of the variety of crops being geneti-
cally modified, there is no one established system of assessing
their safety. The FDA reviews each variety on a case-by-case
basis, collecting similar data in the beginning but involving
different questions as the consultation process proceeds. All of
this requires extensive data collection on the part of the seed
If the FDA is concerned about the safety of a GM crop, it
may place restrictions on how the crop is used, request animal
feeding trials, or oppose the product entirely. Every GM prod-
uct that has been produced and used in the United States has
undergone this consultation process with the FDA (in addition
to similar interactions with the USDA and the EPA), so regula-
tion of GMOs is in fact extensive, expensive, and comprehen-
sive. In our opinion, it is also effective.
The concept of substantial equivalence is then the foun-
dation of GMO regulation. Why did the FDA adopt the rule
of substantial equivalence? Supporters of the technology
will claim that it is because the most prestigious scientific
institution—the National Academy of Sciences—supports the
notion. The Academy concludes that the method by which a
plant's DNA is altered is irrelevant, and thus taking a gene
from a bacterium and inserting it into a canola seed is not
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