the regulatory review, usually after an announcement in theFederal Registerdetailing a
particular product under review.
12.3.1.1. USDA. The office within USDA responsible for regulatory oversight of agri-
cultural products of rDNA is the Animal and Plant Health Inspection Service (APHIS),
office of Biotechnology Regulatory Service (BRS). Regulators in BRS claim legislative
authority to capture and regulate rDNA-derived plants under the Plant Protection Act of
- The main concern in BRS is that the “regulated article” (i.e., rDNA-derived plant)
might become a “plant pest” (defined broadly) and negatively impact the environment,
so they focus their assessments on pest characteristics. USDA assesses whether the regu-
lated article (product of rDNA breeding) might directly or indirectly cause disease or
other damage to a plant. Regulated articles can include rDNA-produced plants, microbes,
and animals. Of course, the primary regulated articles to date are herbicide-tolerant crops,
insect-protected crops, and a handful of other transgenic plants (late-ripening tomatoes,
disease-resistant papaya, potatoes, etc.), as well as some transgenic microbes. BRS controls
not only prospective releases to the open environment but also the international importation
and interstate transport of transgenic organisms.
BRS allows environmental releases of transgenic plants through two routes: notification
and permit. Notifications are used for specified low-risk crops and traits, while a permit is
required for those transgenic organisms posing greater apparent risk, such as species less
familiar to BRS or those producing pharmaceutical compounds. Eventually, after the evalu-
ations are complete, and if the data support it, the developer may petition for “unregulated”
status. BRS conducts an environmental assessment to ensure that the product is indeed not a
potential plant pest, and also seeks public comment before issuing the decision. Once a
“regulated article” acquires “nonregulated” status, it can be grown, sold, and distributed
much like any other nontransgenic variety.
12.3.1.2. FDA. The Food and Drug Administration (FDA), operating within the depart-
ment of Health and Human Services (HHS), concerns itself with the safety of foods and
feeds. Interestingly, unlike the case in USDA, in FDA the trigger for mandatory capture
for regulatory assessment is not the process of rDNA but the physical composition of the
food or feed in question. This is the basis of considerable debate, as some people
demand that FDA conduct safety assessments of all foods derived from biotech plants,
animals, and microbes, even those with chemical compositions identical to those of
current foods of the same type.
The FDA review focuses on three questions:
- Does the novel food or feed contain any new allergens?
- Does the novel food or feed contain any new toxic substances?
- Has the novel food or feed changed the nutritional composition in any way, either
increasing or decreasing nutrients, antinutritional substances, or other components?
Problems from ingesting food result from the presence of damaging substances such as
allergens in sensitive people, or toxicants. In the long term, problems can also arise from
the absence or diminution of nutrients ordinarily present in a given food. For example,
many people enjoy orange juice and benefit from the rich source of vitamin C. If for
some transgenic reason oranges ceased to produce ascorbic acid (vitamin C), some
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