Transgenic Plants - EPA Regulations

EPA Regulation of Transgenic Plants


Team Bean

Gary Vallad
Roger Effertz
Jocelyn Ehlis

Coyright 1996

Authority of EPA to Regulate Transgenic Plants

There are two acts passed by congress which authorize the EPA to regulate the use of transgenic plants, specifically those engineered with pesticide producing capabilities. They are:

Under FIFRA, congress imposed the responsibility of regulating the distribution, sale, use, and testing of pesticides in order to protect humans and the environment. Meanwhile, FFDCA allows the EPA to set tolerances for pesticide residues in or on food crops.

The EPA will not regulate the plant itself, but will instead regulate certain categories of plant-pesticides, focusing on plant-pesticides that are most likely to result in new environmental exposures or those which have the greatest potential for adversely affecting other beneficial organisms. The guidelines that the EPA uses to evaluate these questionable plant-pesticides, under FIFRA and FFDCA, were determined by a Science Advisory Panel on December 18,1992, and can be obtained from the Office of Pesticide Programs (OPP) in public document #OPP 00343.

Conditons Requiring EPA Approval

The EPA has established guidelines, found in document #OPP00343, for producers of food plants that produce pesticides. If any of the following conditions exist, then the producer would be obligated to consult with the EPA for review under FFDCA. These conditions are:

  1. The pesticide is not derived from a known food source.
  2. The pesticide is derived from a known food source and transferred to a new food source, yet the route by which it enters the human diet has been altered by a modification to the pesticide or other substance to produce a pesticide, the transfer of the pesticide from a previously inedible section to an edible section of the plant, or the shear quantity consumed as compared to the original source.
  3. The pesticide has modified structure, function, or composition other than that of its already naturally occurring parallel.

EPA Review Process

If the EPA does decide that the food plant needs to be reviewed under FFDCA it has two options on how to handle it. It could either set a tolerance for the particular pesticide from which to regulate it, or it could make the pesticide exempt from the requirement of a tolerance. The EPA usually will formally review a product when a company decides to undergo large-scale tests of 10 acres or more, in which an Experimental Use Permit (EUP) may be required, as with traditional pesticides in the U. S. In addition, one may inquire with Product Manager 18 for insecticide products and Product Manager 21 for fungicide or herbicide products to answer questions concerning the testing of transgenic plants.

EUPs are issued by the EPA, under section 5 of FIFRA, to allow for the generation of the necessary information and data to register a transgenic plant-pesticide as a pesticide under section 3 of FIFRA. EUPs are generally required when a particular pesticide is not registered with the EPA, or the application of a registered pesticide is in a manner which is not registered with EPA.

Pesticides of any nature can not be sold or distributed to those not participating in the approved experimental use program. They also may only be used in the designated test sites in accordance with the terms and conditions of the EUP.

There have been accesses to this site since April 24, 1996. accesses have been from outside the North Dakota higher education system.

Return to Regulating Transgenic Plants in the U.S. Homepage

Return to Plant Molecular Genetics Homepage