consumers might inadvertently develop symptoms of vitamin C deficiency, namely, scurvy.
As this is an undesirable effect, FDA would check a new orange for ascorbic acid content,
just to ensure that it was still present in appropriate concentrations. To date, biotech-derived
(biotechnologically derived) foods have not been found to unexpectedly lose normal nutri-
ents, and all commercialized biotech-derived foods have the same nutritional content as do
similar conventional foods. Newer transgenic foods might be specifically modified to
enhance nutritional composition. In those cases, the FDA review becomes mandatory,
and the new food will have to be labeled as such, because it would no longer fit the defi-
nition of the traditional, unmodified food.
A bigger concern is the possibility that the novel food carries an unexpected allergen.
Such an event has occurred, although the product was never commercialized and no one
was harmed. In this situation, a gene to enhance the nutritional status of soybean (which
is naturally deficient on the amino acids methionine and cysteine) was cloned from
Brazil nut and transferred to the legume. Tests showed that the transgenic soybean did
indeed express the Brazil nut gene and generate the expected protein rich in these amino
acids, thus successfully increasing the nutritional balance of the bean. Subsequent premar-
ket tests showed that the new soybean was, unfortunately, also allergenic to consumers
allergic to Brazil nut, indicating that the storage protein in Brazil nut responsible for the
good desired amino acids was also a major allergen, even when expressed in soybean
(Nordlee et al. 1996). Since the Brazil nut transgenic soybean was found to be a likely
source of allergens during the course of evaluation, it is heralded as a case showing that
regulations are effective.
Even without a mandatory premarket food safety assessment, every commercialized
rDNA crop was reviewed by FDA regulators under a voluntary consultation. In other
words, the developers of the new crops and foods wanted the FDA to review the
safety even though it was not legally required. The reasons are clear enough; developers
want help from FDA to ensure that their new products are safe before putting them on
the market. Without that safety check, a new food released onto the market and later
found to have, for example, new toxic substances would face (1) regulatory action from
FDA for releasing an adulterated food and (2) litigation from unsuspecting consumers
harmed from ingesting the adulterated food. With the dire consequences, especially of
the latter, and with the simple and sensible procedures in the “voluntary” FDA consultation,
any biotech food developer who bypassed the FDA review would be nothing short of
foolhardy.
12.3.1.3. EPA. The US Environmental Protection Agency (EPA) is concerned with
risks posed by pesticides (including herbicides). According to EPA, a pesticide can be
any substance or combination of substances intended to prevent damage by any pest,
or intended for use as a plant growth regulator. For transgenic plants, this usually
means herbicide-tolerant or insect-protected cultivars, but can include others also.
Importantly, EPA claims that it does not regulate the transgenic plant per se, but rather
any pesticidal properties associated with the transgenic plant. Because of this pesticidal
properties trigger, not all transgenic plants trigger EPA regulatory purview. For
those transgenic plants with pesticidal properties, EPA issues permits for large-scale
(.10-acre) field trials and seed increase plots, and also regulates commercial registration
for any such plant varieties sold with pesticidal claims, such asBtcorn or herbicide-
tolerant soybeans.
298 REGULATIONS AND BIOSAFETY