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EPA To Hold Public Workshop On Genetically Engineered Plants
Scheduled for February 10-11, 2004 in Crystal City, Virginia
(Beyond Pesticides, February 9, 2004)
EPA is holding a public workshop on genetically engineered plants, which it calls PIPs ("plant-incorporated protectants"), and regulates like pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA). To field test these genetically engineered plant materials, EPA issues experimental use permits (EUPs) which could be tested in a field near you.

EUPs are required for PIPs tested on a cumulative total of over 10 acres and/or when insufficient containment is present to prevent the PIP from entering food and feed supplies [40 CFR 172.3(c)]. EUPs are generally not required for laboratory or greenhouse tests [40 CFR 172.3(b)(1)]. Limited replicated field trials on a cumulative total of less than 10 acres do not require an EUP provided that a tolerance or exemption from a tolerance has been established for the PIP or adequate containment is in place to prevent the PIP from entering the food and feed supply [40 CFR 172.3(c)(1)(ii)]. The crop can be destroyed or fed to experimental animals also, but the pesticide must not end up in any food or feed intended for general consumption. These are the same regulations that apply to all other pesticides except pheromones.

For synthetic pesticides, the agency may waive the requirement to establish a tolerance or tolerance exemption for an experimental pesticide if the applicant can guarantee that all food and feed commodities produced in the field test will be prevented from entering commerce (destroyed, fed to experimental animals, or held for future testing).

For PIPs, containment is more difficult. The harvested crop must not enter commerce and outcrossing of PIP pollen to surrounding crops must be prevented. Without a tolerance or tolerance exemption, prevention of outcrossing is necessary regardless of the acreage being tested in the field. The requirement is the same whether the test is 0.5 acres or 5000 acres. PIP containing food or feed is adulterated when there is no tolerance or tolerance exemption and is subject to seizure by the Food and Drug Administration.

The public workshop will review the EPA process and practices and give the public both an opportunity to learn about the procedures and discuss whether there are adequate safeguards in place. According to the agency, "EPA recognizes that some PIP EUP regulatory issues require review and clarification, and is seeking public participation and input to help identify the best approaches to regulatory improvements pertaining to PIP EUPs." See Federal Register notice (69 FR 2351, January 15, 2004).

Meanwhile, environmentalists, consumer advocates and food industry groups in November filed a federal lawsuit to force USDA to impose stricter regulations on pharmaceutical crops, fearing the unapproved plants could accidentally slip into the food supply. The case was filed in Hawaii, one of the top producing pharmaceutical crops. Biotech companies like Dow Chemical Co. and Monsanto Co. are experimenting with corn, soybeans, tobacco, rice and sugar crops as a cheaper way to mass produce medicines to treat a range of human ailments. The coalition, which includes Friends of the Earth and Center for Food Safety, accused the USDA of allowing the experimental crops to be planted in open fields without assessing the risk to other crops, wildlife and humans. "The existing regulatory system merely assumes that growing these crops is harmless, even in places where they can contaminate the environment and get into the food supply," said Joseph Mendelson, legal director for Center for Food Safety.

The meeting will be held on February 10 and 11, 2004 from 8:30 a.m. to 5 p.m. The meeting will be held at the Crystal City Hilton, 2399 Jefferson Davis Hwy, Arlington, VA 22202. Telephone number: (703) 418-6800. Requests to participate in the meeting may be submitted to Karen Heisler, Region 9 (CMD-1) 75 Hawthorne St., San Francisco, CA 94105; telephone number: 415-947-4240; fax number: 415-947-3583; e-mail address: Heisler.Karen@epa.gov. To preregister, contact Teresa Bullock at American Farmland Trust by e-mail: tbullock@niu.edu,by telephone: 815-753-9347 or by fax: (815) 753-9348). If you would like to attend with Beyond Pesticides staff, please contact Eileen Gunn, egunn@beyondpesticides.org, 202-543-5450. More information on the workshop and background material can be read on EPA's website.