Principles of Plant Genetics and Breeding

270 CHAPTER 15
Inspection Service (APHIS) conducts the USDA biotech
evaluation. The EPA ensures the safety of pesticides and
enforces FIFRA (to regulate the distribution, sale, use,
and testing of plants and microbes producing pesticidal
substances) and FFDCA (to set tolerance limits or
exemptions from tolerances for pesticides used in food,
and feed production). The FDA is part of the Department
of Health and Human Services, and enforces the
FDA’s regulations (to regulate foods and feeds derived
from new plant varieties).
USDA-APHIS
APHIS is authorized to regulate the confined release,
in particular the interstate movement importation and
field testing, of organisms and products altered or produced
through biotechnology processes that are plant
pests or are suspected of being so, or have incorporated
genetic components from organisms that are plant pests.
An individual or an entity seeking to conduct any of the
above-mentioned activities must apply for and receive
one of the permits from APHIS before proceeding.
1 Permit for movement and importation. This
requires the applicant to disclose the nature of the
organism, its origin, and its intended use.
2 Permit for release into the environment. APHIS
oversees field testing of biotech products. The applicant
is required to provide information on the plant
(including new genes and new gene products), their
origin, the purpose of the test, experimental design,
and precautions to be taken to prevent escape of pollen,
plants, or plant parts from the experimental site.
For low risk or familiar organisms or classes of modification,
the developer may apply for an expedited permit
through the notification process. Furthermore, in order
to be allowed to release a previously regulated organism
or product in an unconfined manner and commercially
sell the organism, the developer must petition APHIS
for non-regulated status. When evaluating petitions for
non-regulated status, APHIS considers the potential
risks to agriculture due to release of the organism, under
the Plant Protection Act, and to the environment, under
NEPA and the Threatened and Endangered Species Act.
FDA
The decision to subject all biotech products to the same
standards of regulation of traditional products was made
by the FDA in 1997. In the Federal Register, Vol. 57,
the FDA directs that companies or researchers whose
products meet one of the following criteria should submit
them for testing:
1 Unexpected effects: that is, the product produces
unexpected genetic effects.
2 Known toxicants: the product has higher than normal
levels of toxicants in other edible varieties of the
same species.
3 Nutrient level: the product has altered levels of
essential nutrients.
4 New substances: the chemical composition of the
product is significantly different from the existing
normal products.
5 Allergenicity: the product contains proteins that
have allergenic properties.
6 Antibiotic resistance selectable marker: the product
is produced by a biotech process that utilizes
genetic markers that could adversely impact current
clinically useful antibiotics.
7 Plants developed to make specialty non-food substance:
plants are engineered to produce pharmaceuticals
or industrial compounds.
8 Issues specific to animal feed: the product’s chemical
composition regarding nutrient and toxins is
significantly different from levels in similar products
used for feed.
In addition to these federal regulatory activities, individual
states are at liberty to develop and implement
additional regulations. Exempted from premarket
approval are products that are classified as GRAS (“generally
recognized as safe”). Such food products may
have been engineered to express proteins. However, a
GRAS substance is excluded from the definition of a
food additive. FDA encourages developers of engineered
foods and feeds to consult with them throughout the
development process to ensure that the product does
not need to be regulated by the FDA.
EPA
The EPA regulates pesticides through a registration
process. Its definition of a pesticide is any substance
or mixture of substances intended for preventing, destroying,
repelling, or mitigating pests. A new category
of pesticides is the plant incorporated protectants
(PIPs). These are substances that have been genetically
engineered into plants so that the plant becomes
protected from pests by producing the substance