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 harmonized regulatory system to protect biological diversity.[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