Regulation of Agricultural Biotechnology
USDA – Determines if something is safe to grow
EPA –Determines if something is safe for the
environment
FDA – Determines if something is safe to eat
Currently, the
United States regulates Genetically Modified Organisms (GMO) through existing
statutory frameworks that apply to
GMOs and non-GMOs alike.
Food:
Regulation of GMO
food is handled by the Food and Drug Administration (FDA) through the Federal Food Drug and
Cosmetic Act (FFDCA) which treats GMO food no differently than non-GMO
food. Those introducing GMO foods into the market are under obligation to
ensure that the products are safe, but are not obligated to gain pre-approval
for the product. If, however, the product proves unsafe after it is introduced
sans FDA approval, the company would be held liable and would open itself to
criminal prosecution. [1]
Pesticides:
GMO plants which
are engineered to contain pesticides are regulated through the Environmental
Protection Agency (EPA). The EPA gains this power through the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the FFDCA. Unlike the FDAs lax regulation
requirements for GMO food, the FIFRA requires manufacturers of pesticides or
plants imbued with pesticide qualities to apply for and gain approval from the
FDA before introducing the product into the market. Under the FFDCA, the EPA
requires products to fall below a maximum tolerance level for pesticide
substances in foods. Additionally, before
these products can be introduced into the market, notice must be given
to the EPA.[2]
Weed Creation Control:
The U.S.
Department of Agriculture (USDA) regulates biotechnology products including plant pests, plants, and
veterinary biologics . As GMOs are often modified to be stronger
than their previous iterations, there is the potential that they will
negatively affect other plants. This effectively creates the potential for
super weeds. Under the USDA, the Animal Plant and Health Inspection Service (APHIS) is charged with regulating this
possibility. Aphis gains this
regulatory power through the
Plant Protection Act. Producers of GMOs must petition for non-regulation
status from APHIS before, or be subject to rules which largely prohibit
unchecked planting.
Tort Law: Negligence and
Nuisance
Currently, the law
applicable to GMOs is well settled, with the federal regulatory agencies
already dealing with non-GMOs proving capable of handling GMOs. However,
conflicts still arise which require the court. In
2002, a U.S. District Court was presented with the problem of genetically
modified plants cross-pollinating with other crops to produce unintended
negative results. [3]
In light of the
push for ethanol production, Starlink had developed a GMO corn which had
various pesticide properties, making it extremely resilient to insects. The
corn also tested positive for various human allergens, but was allowed to be
grown and sold because it was meant solely for ethanol production.
Starlink began
selling farmers this seed but it eventually began cross-pollinating with other
types of corn being grown by the farmers which were meant for sale as
foodstuffs. The court found that the farmers had valid actions for negligence
and nuisance, although their claim for failure to warn was preempted by FIFRA
(above).
In the wake of
Starlink and cases like it, problems like the one illustrated by here have
largely been rectified by the use of proper warnings (even though Starlink was
not held liable for failure to warn) and protective measures on the part of
growers.
International
Law
In
an attempt to apply regulation on a global scale, the Global Industry Coalition
was formed to establish a Òharmonized regulatory system to protect biological diversity.Ó[4] This Coalition now represents
over 2,200 firms located in 130 countries and spanning sectors such as plant
and animal agriculture, food production, human and animal health care, and the
environment. While the Coalition does not have any legal teeth through which to
enforce any regulatory agenda, it does signify an interest in the responsible
advancement of biotechnology in much of the developed world.
[1] Statement of Policy: Foods derived from new plant varieties, 57 Fed. Reg. 22987-22989
[2] 15 U.S.C. S2603(d)
[3] In re StarLink Corn Products Liability Litigation, (2002) 212 F.Supp.2d 828
[4]GLOBAL INDUSTRY COALITION REAFFIRMS ITS SUPPORT OF A SUCCESSFUL BIOSAFETY PROTOCOL, http://www.prnewswire.co.uk/cgi/news/release?id=14244