September 10, 2001

Public Information and Records Integrity Branch
Information Resources and Services Division (7502C)
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Re: OPP-00678B, Implications of Revised Bt Crops Reassessment

Dear Madam/Sir:

The data that has been assembled, taken together with the deficiency in knowledge, about the incorporation of Bacillus thuringiensis (Bt) into plants as a means of pest control supports a moratorium on its continued registration as plant pesticides under the standards of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). EPA has not received data that the use of these genetically altered plants will not cause unreasonable adverse effects on the environment," defined as "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide . . . ." In fact, the experience with the use of genetically altered Bt crops raises serious safety concerns for agriculture in at least three key areas: gene flow to wild relatives; risks of insect resistance; and risks to non-target species. Until these questions are, EPA is allowing, contrary to law, the release of a technology that may have serious ramifications on agricultural production down the road.

EPA Has Not Fully Evaluated Insect Resistance

EPA review process and its experience with insect resistance is flawed. Historically, the agency has allowed the release of synthetic toxic materials into the environment without a full assessment as to the efficacy of these products over the long term. The result has been the release of hazardous materials, including arsenic, organochlorine, organophosphate, carbamate, synthetic pyrethroid and other chemical families, that over time have severely lost efficacy, while leaving a trail of adverse toxic effects. Through a flawed conditional registration process, EPA has embarked on the same course, this time playing with DNA material and life forms that may well get out of control. As many in the scientific community have said, very slow processes may be taking place now that are inherently very unpredictable and dangerous. The molecular facts are this: biotechnology is an unpredictable industrial practice, as Barry Commoner, Ph.D. has said. Because of this unpredictability, EPA should not be issuing or extending conditional registrations or granting full registrations without full information and complete assurances about short- and long-term impacts.

EPA Has Not Fully Evaluated the Cost of Declining Bt Efficacy

Besides the direct impact of Bt plant pesticides, EPA must calculate the impact on agriculture and the growing organic agriculture market if, under one plausible scenario, target and non-target insects become resistant to the Bt toxin. In other words, what economic impact will the loss of this pesticide have on the now nearly $10 billion industry? In addition, what impact will the loss of this pesticide have on the economic viability of those agriculturalists practicing integrated pest management, a rising number in the agricultural community? Unless EPA can prove that Bt plant pesticides will have no adverse impact on the efficacy of Bt, the economic analysis performed must evaluate the economic cost of lack of efficacy.

Non-Target Impact Cannot be Dismissed as Inconsequential

Bt incorporated plants harm butterflies, such as monarchs and the endangered Karner Blue. The agency does not have sufficient data to dismiss scientific findings that show migrating monarchs exposed to Bt corn pollen at risk. The agency, similarly, does not have sufficient data to show that pollinators are not put at risk. In order to make a finding of reasonable risk under FIFRA, the agency must be proactive and definitive in looking at the short- and long-term impacts in this area.

Lack of Enforcement Capability

EPA relies on a pesticide enforcement system that is broken. Compliance with pesticide label restrictions is very low and the agency knows it. The agency does not have an enforcement plan that will ensure compliance with mitigation measures, but simply engages in writing restrictive language for which it has no to limited capability to enforce.

Human Health Effects Not Adequately Considered

EPA has failed the public in not considering the widespread allergenic effects of Bt plant pesticides. Evidence suggests that protein manipulation in plants can cause adverse reactions in humans that eat them. This area needs further study and raises some of the most serious implications for a technology that has not been fully evaluated prior to its widespread introduction into the marketplace.

In a report released on December 7, 2000, EPA's Office of Pesticide Programs Scientific Advisory Panel (SAP) announced there is a "medium likelihood" that the StarLink protein found in Aventis CropScience's genetically modified corn, which illegally entered the US food supply, is a potential food allergen. The biotech corn, which has not been approved for human consumption or export, has been showing up in taco shells and other processed foods, both in the U.S. and around the globe. In an effort to soften the blow of a costly recall, Aventis asked EPA to temporarily approve its StarLink corn, which has been genetically modified to produce the pesticide Bt, for human consumption. Beyond Pesticides argues that humans should not be used as guinea pigs, and Aventis should not be rewarded for violating the law with an after-the-fact approval of a potentially dangerous product. Japan, also angry that the StarLink corn has entered their food supply, asked the U.S. embassy to take the appropriate measure to correct the situation.

In an attempt to evaluate Aventis's request, EPA asked the SAP, comprised of experts, to provide an independent scientific assessment on the potential allergenicity, sensitization and possible exposure to StarLink corn. In a one-day meeting held in Washington, DC on November 28, 2000 the SAP probed questions regarding the allergenicity of StarLink corn to consumers, and the degree to which its proliferation in the human food supply could be a health risk to consumers. The panel heard presentations by EPA, incidence reports filed to the agency by consumers who claimed they had allergic reactions after eating StarLink, and testimony from Aventis, along with other industry and public interest groups. Both the SAP's recommendations and the public comments that were received by EPA will be used to guide the agency during the scientific evaluation of the StarLink corn.

Keith Finger, a Florida optometrist, had severe allergic reactions to StarLink corn, a genetically engineered yellow corn variety. Keith Finger is only one of seventeen people who reported having allergic reactions after eating StarLink corn products. The Center for Disease Prevention and Control reported that these seventeen people had tested positive for sensitivity of the specific protein found only in the StarLink corn. The Washington Post explains Finger's reactions to the corn, "Keith Finger showed the panel pictures of welts and rashes he says he suffered Sunday after he ate a mixture of StarLink corn and water."

This StarLink corn contains a protein, Cry9C, which breaks down slowly in the digestive tract. Last month, The Food and Drug Administration found this protein in Kash n' Karry White Corn Tortilla Chips. The Washington Post reports, "StarLink corn was never approved for human consumption because of questions about whether it was an allergen." After discovery of these products last fall, the nation announced a recall of StarLink corn products.

Scientists are now debating whether or not this corn containing Cry9C should be allowed on the market at a maximum level of 20 parts per billion, the equivalent of one StarLink kernel in every 800 kernels of corn2. Currently, the corn is withdrawn from the market. The Washington Post reports, "The Agriculture Department reported Tuesday that it had accounted for all but 720,000 of the 128 bushels of StarLink corn. Another 4.9 million bushels may have been mixed with grain that went to food processors". Aventis CropScience, the crop's developer, is pushing to have the Environmental Protection Agency allow a small amount of this variety of corn in the food supply to prevent further hassle and increased recalls.

The Washington Post reports, "The presence of StarLink in a white corn product illustrates how difficult it is to keep genetically modified crops from spreading". Although white corn is not grown or shipped with yellow corn, there are many times when the two varieties are accidentally mixed. The Industry told the Washington Post, "The mixing could happen at processing plants, during transportation and through cross-pollination in fields."

Cross Contamination Has Eluded EPA for Decades and Is Completely Unacceptable with Genetically Modified Organisms

The Cry9C protein found in the genetically engineered StarLink corn, manufactured by Aventis CropScience, has been detected in another variety of corn, raising serious questions about how it got there and how much additional corn could be contaminated. The contamination of StarLink corn, which has been approved by EPA only for animal feed based on studies showing that humans cannot properly digest it, sparked the recall of thousands of taco shells and other products containing the corn in October.

According to a statement by the manufacturer, "Aventis CropScience performed the tests after several farmers stated that corn with no known connection to StarLink was testing positive for Cry9C. Aventis CropScience does not know how Cry9C protein came to be present in a variety other than StarLink brand seeds."

We find this lack of knowledge very disturbing, and a strong argument for tighter controls on genetically modified organisms (GMOs). Because the protein found in the genetically modified StarLink corn causes the plant to produce the pesticide Bt within the cells of the plant, people would be consuming for greater quantities than ever before, exposing themselves to toxins and potential food allergies.

Farmers Are Adversely Impacted by the Uncontrolled Nature of the Technology

Farmers in Cedar Rapids, Iowa have filed a class action lawsuit on behalf of a nationwide group of farmers against Aventis for the contamination of their corn crop with the genetically modified corn. The farmers are seeking damages and calling on the company to decontaminate their farms.

According to Farm Progress, the lawsuit seeks nationwide class action status on behalf of all farmers who cultivated and harvested non-StarLink corn in the United States for commercial purposes from 1998 to the present. The lawsuit alleges that there has been widespread contamination of the United States corn crop by the StarLink product, both through cross-pollination of corn crops in farmers' fields as well as in grain elevators and other corn storage facilities. It also alleges that this contamination was directly caused by Aventis' "intentional, reckless, and/or negligent" conduct. This resulted in substantial damages to members of the class by virtue of, among other things, losses in export and domestic markets for United States corn and the consequent decline in sales prices for United States farmers' corn in these markets. EPA has not calculated this and future similar problems into its benefits analysis.

These comments provides the basis for EPA to put the brakes on Bt plant pesticides until such time as the serious questions that have been raised are answered. This technology should not be unleashed on the world given what is now scientifically known and under the standards of United States law.

Thank you for your consideration of our comments.