On This Page:

Regulation of biopesticides
Regulation of companion herbicides
Clarification of EPA regulatory policy (7/20/01)

The US Environmental Protection Agency (EPA) under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), requires registration and licensing of all new pesticides. Following EPA guidelines, the pesticide developer must submit data that demonstrate the pesticide will not harm human health or the environment when used as labeled. The data are reviewed by the Office of Pesticide Programs (OPP), and the pesticide may not be marketed until the OPP approves the product's registration.

The EPA classifies pesticides produced by genetically engineered plants as biopesticides. This category also includes other naturally occurring chemicals produced by microbes, plants, and animals (and some minerals). To date, only two classes of GE plants fall under the EPA purview: plants containing Bt toxins and those expressing resistance to viruses. The EPA regulates the pesticide contained within a GE plant in the same way it regulates a pesticide applied to a plant, but not actually the plant itself. This is often garbled by activists, who imagine that the EPA considers a GE food itself to be a pesticide-- who would want to eat something the EPA says is no longer a food, but a pesticide?

"…even though a Bt potato is plainly a food, for the purposes of regulation it is not a food, but a pesticide and therefore falls under the jurisdiction of the EPA… But isn't turning a food into a pesticide a material change?"
--Michael Pollan, "Playing God in the Garden" NY Times 10/25/98

Part of the confusion lies in the relationship between the EPA and the FDA. The FDA is responsible for food safety, and the EPA is responsible for the safety of the pesticide on human health and the environment. If a plant has been genetically engineered to contain a pesticide (a deliberately toxic compound), the FDA defers to the EPA to evaluate safety of the pesticide. All other aspects of food safety-- such as altered nutritional value, changes in natural toxin levels, etc-- are still the responsibility of the FDA.

GE crops expressing the Bt toxin fall under the regulatory authority of the EPA. The safety of Starlink, the Bt corn developed by Aventis, was reviewed by the EPA. Citing concerns about potential allergenicity of the specific version of Bt contained in Starlink, the EPA did not approve Starlink for human consumption. Starlink was grown for feed and industrial uses in the 1999 and 2000 growing seasons, however, and it was soon discovered that it had entered the human food supply. More recently, the EPA is considering the analysis of its scientific advisory panel, in response to Aventis' request to reconsider approval of Starlink.
[top of page]

The EPA has an additional, indirect role in the regulation of GE varieties. When a GE plant has been engineered to be resistant to a specific "companion" herbicide, this implies that the conventional varieties of the plant are not normally sprayed with the herbicide. The EPA must then consider the health and environmental safety of applying the herbicide to a new crop. If the new application is approved, the EPA must establish new tolerances for residues of the herbicide on the crop, and adjust herbicide labeling to allow the new crop to be sprayed. When bromoxynil-resistant GE cotton was first developed, the EPA restricted the application of bromoxynil to only 1% of all cotton acres, but this limit has since been increased to 10%.
[top of page]

On July 20, 2001, the EPA released its final ruling on the regulation of genetically engineered crops, clarifying its current policy (technically, the EPA had been acting upon "proposed" policy for the previous 7 years). The new policy made several clarifications:

• Both novel DNA and proteins genetically engineered into plants with the intent to protect the plant against pests are considered to be "plant incorporated protectants" or PIPs, and will be regulated exactly as other pesticides.
• This regulation includes the pre-market evaluation of both environmental and food safety impacts. The EPA continues to be responsible for the food safety of the PIPs (not the FDA) in the same way that the EPA evaluates the safety of all other pesticides.
• Marker genes and other elements not directly related to the pesticidal property will be considered "inert ingredients" and also be regulated accordingly.
• DNA itself, although technically classifed as a pesticide by EPA legal definitions, is exempt from formal safety review, as all food contains DNA without any indications of health risk.
• Naturally-occurring PIPs-- the chemical defenses of plants already present or enhanced by traditional plant breeding-- are technically included in the legal definition of "pesticide," but are exempted from formal safety review (these fall under the post-market purview of the FDA). Natural chemicals extracted from plants that are applied as pesticides (such as some of the treatments used by organic farmers) are still subject to safety review.