Transgenic Plants - EPA Regulations
EPA Regulation of 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 Federal Insecticide, Fungicide, Rodenticide Act (FIFRA)
- The Federal Food, Drug, and Cosmetic Act (FFDCA).
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.
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:
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.
- The pesticide is not derived from a known food source.
- 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.
- The pesticide has modified structure, function, or composition other than that of its
already naturally occurring parallel.
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.
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