WASHINGTON _ The Environmental Protection Agency (EPA)will issue proposed regulations later this week to define and clarifythe scope of its jurisdiction over plants genetically engineered toresist pests. The agency intends to formally register certain pesticidalinsertions into plants as "plant-pesticides."

The EPA has defined plant-pesticides as "the novel pesticidalsubstances genetically introduced into plants for the purpose ofprotecting the plants against pests and diseases" and "the geneticmaterial necessary to produce those substances." Its proposedregulations will address only plant-pesticides, not the plantsthemselves. A 60-day comment period will follow publication of theproposed new rules in the Federal Register.

According to Elizabeth Milewski, the EPA's special assistant forbiotechnology, it took four years to develop the proposedregulations. In addition, the EPA has organized three public hearingson the topic. Five announcements will be published this week: one ofthem a general policy statement dealing with the new plant-pesticidedesignation and four others essentially describing exemptions to thepolicy.

The law that gives the EPA authority to register (the equivalent ofproduct licensure for drugs) and regulate pesticides is the FederalInsecticide, Fungicide and Rodenticide Act (FIFRA). In addition,under the Federal Food, Drug and Cosmetic Act (FFDCA), the EPAestablishes "tolerances," the maximum residue limits in foods, andexemptions from tolerances. Although the EPA has not regulatedplants in the past, it has regulated substances extracted from plants.

The EPA is proposing to exempt three categories of plant-pesticidesfrom regulation under FIFRA:

* Plant-pesticides derived from a closely related plant (e.g., apesticidal substance taken from one corn plant and engineered intoanother corn plant);

* Plant-pesticides that would not produce adverse effects on non-target organisms because they act primarily by affecting the plant(e.g., plants engineered to produce a thicker cuticle or a thicker layerof wax);

* Coat proteins from plant viruses when produced in plants for virus-coat protein mediated resistance (plants in which a piece of geneticmaterial from a virus which encodes for the coat protein is insertedinto the plant allowing it to produce the protein and protect itselfagainst future viral infections.)

Under FFDCA, EPA is proposing to exempt the following plant-pesticides from tolerance requirements:

* Plant-pesticides derived from closely related plants;

* Plant-pesticides that are not derived from closely related plants butfor which there is experience with dietary exposure because bothplants are part of the food supply (e.g., plant-pesticides taken from awidely consumed crop such as corn and engineered into anotherhighly consumed crop such as wheat);

* Coat proteins from plant viruses.

Technology Means Reduced Pesticide Use

EPA administrator Carol Browner praised plant-pesticide technology in a statement issued with the proposedregulations last Wednesday. "This pesticide technology holds apromise of reduced use of pesticides because the plant will produceits own defense against pests," she said. "[These proposedregulations] will establish a program that will ensure the safety of thefood supply and safeguard the environment."

Genetically engineered foods are formally and informally reviewedin various ways by the FDA, the EPA and the U.S. Department ofAgriculture's Animal and Plant Health Inspection Service. Industryhas complained that the amorphous, overlapping regulatory structuremakes product planning and development difficult. Regulations suchas those proposed by the EPA could remove some uncertainty fromthe process.

"The agencies are all now codifying their approach so there won't beany ambiguities," said Alan Goldhammer, director of technicalaffairs at the Biotechnology Industry Organization. n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.