GMOs in the U.S. are regulated under environmental, health and safety
laws which govern conventional products, rather than under comprehensive
federal legislation. Further, regulatory agencies for GMOs can include
the Food and Drug Administration (for pharmaceutical uses), the
Environmental Protection Agency (for insecticide uses) and the United
States Department of Agriculture (for food crop uses). The regulatory
focus is on the products themselves instead of how they were produced.
Food and Drug Administration regulations
GMOs
in biological products, food and drugs are regulated by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and the Public Health Service Act. With respect to crops used
in products to be consumed by humans or animals, the FDA stated in the
early 1990s that it considered most GM crops to be “substantially
equivalent” to crops that had not been genetically modified, meaning
that the crops usually did not require pre-market approval, and were
designated “Generally Recognized as Safe” under the guidelines of the
FFDCA.
An exception to this, however, applied if the insertion
of a transgene into a food crop caused the expression of foreign
proteins that were significantly different in function, structure or
quality from natural plant proteins and possibly harmful to human
health. Under these circumstances, the FDA could exercise its authority
to apply the stricter provisions of FFDCA, requiring the pre-market
approval of food additives regardless of whether they were the products
of biotechnology.
The FDA has also engaged in a voluntary
consultation process with GM crop developers during which the
determination of “substantial equivalence” is reviewed before the crop
is marketed, including an assessment of the allergenicity or toxicity of
the gene product and the actual plant. If the food-safety data is
acceptable, the FDA clears the developer to market the crop. Some have
questioned whether the voluntary consultation process allows for
adequate assurance that GM crops are safe, because the use of food
crops, such as corn in the production of pharmaceuticals and non-food
products, falls under the FDA’s authority only if the gene product
contaminates a food crop; if so, it must be recalled as an adulterated
product. This situation has caused critics to claim that under these
circumstances the FDA may not actually perform adequate oversight until
the damage is already done.
U.S. Department of Agriculture regulations
The
U.S. Department of Agriculture regulates plant GMOs through its Animal
and Plant Health Inspection Service as provided for by the Plant
Protection Act. The type of GMO involved determines the form of
regulation. Under the Plant Protection Act, a regulated GM plant must
receive approval from the Animal and Plant Health Inspection Service
before being introduced.
Environmental Protection Agency regulations
The
Environmental Protection Agency (EPA) governs pesticides and
microorganisms pursuant to the Federal Insecticide, Fungicide and
Rodenticide Act and the Toxic Substances Control Act. Plants modified
with short sequences of genes from Bacillus thuringiensis (Bt), a
soil-dwelling bacterium commonly used as a biological pesticide, can
produce toxins in their systems to protect themselves from
non-beneficial insects. In situations where a crop has been genetically
engineered to carry a gene for a Bt toxin, the EPA demands that the
developer carry out both an analysis of food safety to ensure that the
foreign protein is not allergenic, and verify the environmental safety
of the toxin. Before registering a new pesticide, the EPA must approve
that using the pesticide “will not generally cause unreasonable adverse
effects on the environment.”