Contents

directly to the text Petitioners
Statement of Fact
Overview of Transgenic B.t. Crops
Resistance Problems.
Gene Transfer of B.t. Gene to Non-GMO Crops.
Impact on Nontarget Beneficial Organisms.
Summary
Statement of the Law
Argument
I. Federal Insecticide, Fungicide, and Rodenticide Act.
A. The Unreasonable Adverse Effects on the Environment Caused by the Registration of Genetically Engineered Plants Expressing Bacillus Thuringiensis Requires Cancellation of All Registrations.
B. The Adverse Reproductive Effects and the Risk to the Environment Caused by the Registration of Genetically Engineered Plants Expressing Bacillus Thuringiensis Warrant Initiation of Special Review of All Registrations.
(1). Adverse Reproductive Effects Should Trigger Special Review.
(2). Risks to the Environment of Sufficient Magnitude Should Trigger Special Review.
II. The National Environmental Policy Act.
A. The EPA's Program of Registering Genetically Engineered Plants that Express Bacillus Thuringiensis Requires a Programmatic Environmental Impact Statement.
III. The Administrative Procedure Act.
A. EPA Registration of Genetically Engineered Plants that Express Bacillus Thuringiensis is Arbitrary, Capricious, and an Abuse of Discretion.
IV. Public Trust Doctrine.
A. EPA Registration of Genetically Engineered Plants that Express Bacillus Thuringiensis Violates the Public Trust Doctrine.
V. Judicial Review.
Conclusion.
APPENDICES
Table 1. Field Trials with Transgenic B.t. Crops (developing countries).
Source: Krattiger, Anatole F., Insect resistance in crops: A case study of Bacillus thuringiensis (B.t.) and its transfer to developing countries, ISAAA Briefs 2-1997 (1997), p. 15; Personal communication 8/22/97.
Table 2. Commercialization Status of Transgenic B.t. Plants.
Table 3. Centers of Origin of Various Crops & Plants.
Table 4. Competitor Situation B.t. Insect Resistant Corn.
Table 5. Competitor Situation B.t. Insect Resistant Corn - Anticipated Release.
Table 6. Insect Populations Carrying Resistance to Various B.t. Toxins.
Table 7: B.t. Pesticide Use for Select Crops.
 

GREENPEACE INTERNATIONAL
Keizersgracht 176
1016 DM Amsterdam
The Netherlands

INTERNATIONAL FEDERATION OF ORGANIC AGRICULTURE MOVEMENTS
Oekozentrum Imsbach
D-66636
Tholey-Theley
Germany

INTERNATIONAL CENTER FOR TECHNOLOGY ASSESSMENT
310 D Street, N.E.
Washington, DC 20002,
et al.,

Petitioners,

vs. Docket No.

CAROL BROWNER, in her official capacity as
Administrator of the United States
Environmental Protection Agency
401 M Street, SW
Room W1200
Washington, DC 20460

Defendant.
 
 
 

Pursuant to the Right to Petition Government Clause contained in the First Amendment of the United States Constitution,(1) the Administrative Procedure Act,(2) and Environmental Protection Agency (EPA) regulations,(3) Greenpeace International, the International Federation of Organic Agriculture Movements (IFOAM), the International Center for Technology Assessment (CTA) and the organizations and individuals listed below, file this petition with the EPA, and respectfully request the Administrator to undertake the following actions:

(1). Declare that the registration of genetically engineered plants that express Bacillus thuringiensis (B.t.) toxins causes unreasonable adverse effects on the environment;

(2). Cancel the registrations of all genetically engineered plants that express B.t. toxins registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA);

(3). Cease and desist from undertaking any new registration procedures, and/or determinations of registration, for any and all genetically engineered plants that express B.t. toxins in any manner;

(4). Pursuant to 40 C.F.R. Part 154, immediately undertake Special Review procedures for all registered genetically engineered plants that express B.t. toxins;

(5). Pursuant to 42 U.S.C. § 4332(c), complete a programmatic environmental impact statement (Programmatic EIS) assessing the agency's B.t. plant-pesticide program, including the program's specific registration of genetically engineered plants that express B.t. toxins for use in interstate commerce;
 

Petitioner Greenpeace International is located at Keizersgracht 176, 1016 DM Amsterdam, The Netherlands. Petitioner is one of the world's major environmental organizations with offices in 33 countries, including the United States of America, and over 3 million donating supporters worldwide. Greenpeace is a non­profit organization devoted to the protection of the environment with an emphasis on global environmental problems such as climate change and protection of the stratospheric ozon layer, prevention of nuclear, chemical and biological pollution, defense of biodiversity. EPA's failure to prevent B.t. resistance building and the outcrossing of B.t. tansgenic plant harms petitioners ability to reduce and eliminate the use of environmentally harmful pesticides as well as its ability to protect genetic diversity and integrity worldwide. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program also harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner International Federation of Organic Agriculture Movements is located at Oekozentrum Imsbach, D-66636, Tholey-Theley, Germany. Petitioner is the only global federation of the entire organic farming sector, with 650 member organizations in more than 100 countries, including the United States. IFOAM represents farmers, processors, certifiers, traders, scientists, educators and consumers of organic products. IFOAM has developed the "IFOAM Basic Standards,” the consensus of organic producers and consumers throughout the world about the way the organic food should be produced. Petitioner's statutory purposes are to pursue the public benefit and to further organic agriculture by informing and educating its own members and the public. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner International Center for Technology Assessment (CTA) is located at 310 D Street, N.E., Washington, DC 20002. Formed in 1994, CTA seeks to assist the public and policy makers in better understanding how technology affects society. CTA is a non-profit organization devoted to the economic, environmental, ethical, political and social impacts that can result from the application of technology or technological systems. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Sierra Club, c/o Environmental Quality Strategy Team, is located at P.O. Box 4375, Pueblo, CO 81003-0375. Petitioner is one of the world's leading conservation organizations, as well as one of the oldest, with over 550,000 members in the United States. The purposes of the Sierra Club include protecting the quality of the natural and human environment and using all lawful means to carry out its objectives. To that end, the Sierra Club has long been concerned about the proliferation of toxic chemical pesticides because of their impacts on people, agricultural systems, and the natural environment, and has long advocated for less toxic pest management. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner National Family Farm Coalition is located at 110 Maryland, NE, Suite 307, Washington, DC 20002. Petitioner represents 34 family farm based grassroots organizations in thirty states. Petitioner supports policies and practices that enable family farmers to sustain their farming operations. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's members' ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop.

Petitioner Arizona Toxics Information is located at P.O. Box 1896, Bisbee, AZ 85603. Petitioner is a non-profit research and policy organization which advocates public participation, pollution prevention and right to know in regard to hazardous materials management, including management of pesticides. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner National Campaign Against the Misuse of Pesticides (NCAMP) is located at 701 E Street, SE, Washington, DC 20003-2841. NCAMP was established in 1981 as a national membership organization to identify hazards and promote the adoption of effective and safe pest management strategies. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Organic Crop Improvement Association (Arkansas Chapter) is located at P.O. Box 392, Mt. View, AR 72560. Petitioner organization includes organic farmers and others in the organic farming community throughout the state of Arkansas. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's members' ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop.

Petitioner Rural Advancement Fund International-USA is located at P.O. Box 4672, Chapel Hill, NC 27514. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Cissy Bowman resides at 8364 S SR 39, Clayton, IN 46118-9178. Petitioner is proprietor of an organic farm in Hendricks County Indiana. Petitioner uses B.t. solutions for occasional pest control on brassicas and squash grown on her farm. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop. In addition, petitioner is an avid butterfly watcher and will be injured aesthetically by transgenic B.t. plants' impact on non-target organism, such as butterflies, that are not harmful to agricultural crops.

Petitioner Kate Burroughs is located at P.O. Box 460 Graton, CA 95444. Petitioner is an applied insect ecologist (Board Certified Entomologist), certified organic farmer and organic farm supplier. Under the name Harmony Farm Supply and Nursery, petitioner operates a certified organic apple orchard and organic farm supply business. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop. Petitioner estimates that the loss of B.t. will cost her between three and ten times as much to find adequate organic pesticide substitutes. Additionally, petitioner will suffer economic injury of lost foliar B.t. spray and compound sales through her farm supply business.

Petitioner Valecia Wadsworth-Carr resides at 1168 N CR 575 W, Greencastle, IN 46135. Petitioner is a certified organic food producer whose crop production will be impacted by increased B.t. resistance. She is also a mother of three children that seeks to provide organic food for her family. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop. Additionally, petitioner will be injure by an inability to provide organic food for her family.

Petitioner California Certified Organic Farmers (CCOF) is located at 1115 Mission Street, Santa Cruz, CA 95060. CCOF was founded in 1973 as membership organization of organic growers. Currently, CCOF has nearly 700 certified members and 350 supporting members. Its members have relied on B.t. as a secondary pest control to defer infestations. It has proven to be an effective and appropriate organic control. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's members' ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's members' crops.

Petitioner Center for Ethics and Toxics (CETOS) is located at 39141 S. Highway One, P.O. Box 39141, Gualala, CA 95445. CETOS is a non-profit organization located on the coast of Northern California. Petitioners focus on reducing the amount of chemicals used in the environment and protecting susceptible individuals from exposure to toxic chemicals. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner the Edmonds Institute is located at 20319 92nd Avenue West, Edmonds, WA 98020. The Edmonds Institute is a non­profit, public interest organization committed to the health and sustainability of ecosystems and their inhabitants. It seeks to engage in projects that foster respect for and protection of the rights and health of all communities. The Institute focuses its efforts on understanding and sharing information about environmental, human rights and human health, and economic impacts of technology and intellectual property policies. The current emphasis of its programs is on: (a) biosafety and the legally­binding international regulation of modern biotechnologies and (b) intellectual property rights, with emphasis on the protection of the rights of indigenous and Third World peoples and just policies for the maintenance and protection of biodiversity, including policies that foster recognition and nurturance of agricultural biodiversity. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Farm Verified Organic, Inc. (FVO) is located at RR#1, Box 40A, Medina, ND 58467. FVO is an international organic certification organization established in the early 1980's. Petitioners certify as "organic” over 115 family farms, cooperatives, processors, handlers and manufacturers around the world. Petitioner represents a number of organic farmers who use foliar B.t. products for emergency pest management. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's members' ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop. The possibility of gene flow of B.t. transgenes resulting from the registration of transgenic B.t. plant pesticides harms the petitioner's members' ability to certify organic foods.

Petitioner Florida Certified Organic Growers and Consumers (FOG) is located at P.O. box 12311, Gainesville, FL 32604. FOG is a non-profit organization committed to educating farmers, gardeners, the press, homeowners, agricultural information providers and consumers about organic and sustainable farming practices. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioners Jim & Mary Gerritsen reside at 49 Kinney Road, Bridgewater, ME 04735. The Gerritsen's are certified organic farmers who raise Certfied Seed and table stock potatoes. These products are sold under the name Wood Prairie Farm. Petitioners have used B.t. tenebrionis and B.t. San Diego for the past eight years in an integrated pest management program designed to control the Colorado Potato Beetle. B.t. has been the single most effective component of their IPM program. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides, including the registration of transgenic B.t. potato plant pesticides, imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop.

Petitioner Hoosier Organic Marketing Education (HOME) is located at 8364 S SR 39, Clayton, IN 46118-9178. Petitioner is a non-profit organization dedicating to providing educational information to the public about organic farming and food. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Indiana Certified Organic, Inc. (ICO) is located at 1168 N CR 575 W, Greencastle, IN 46135. Petitioner is a certifier of organic operations. ICO allows most current formulations of B.t. applications, however, it prohibits genetically engineered plants such as transgenic B.t. plant pesticides. The use of any such prohibited substance immediately ends a farms organic certification for at least three years. The possibility of gene flow of B.t. transgenes resulting from the EPA's registration of transgenic B.t. plant pesticides harms petitioner's ability to certify accurately organic crops.

Petitioner Institute for Agricultural and Trade Policy (IATP) is located at 2105 1st Avenue South, Minneapolis, MN 55404-2505. Petitioner is a research and education organization that acts locally, nationally and internationally to develop and support policies and strategies that expand choices and opportunities to farmers, farm workers and local communities around the world, regenerate the natural resource base, take a precautionary approach to the use of chemicals and genetic manipulation and avoids dependence on purchased inputs and external energy sources, and tackle the causes rather than the consequences of unsustainability, looking for positive, progressive and proactive ways of solving problems. IATP works with farmers, consumers, unions, environmental organizations, citizens groups and others both in the U.S. and around the world. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Integrated Fertility Management (IFM) is located at 333 Ohme Gardens Road, Wenatchee, WA 98801. IFM was founded in 1983 as a wholesale/retail supplier of organic fertilizers and pest controls. In particular, petitioner focuses expertise in soil analysis and organic production of fruit trees. Increasing its business consists of selling foliar B.t. Products to conventional apple growers for leafroller and cutworm control. The increased resistance to B.t. resulting from EPA's registration of transgenic B.t. plant pesticides harm petitioner's sales of over $700,000 annually.

Petitioner Maine Organic Farmers and Gardeners Association is located at P.O. Box 2176, Augusta, ME 04338-2176. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner New York Coalition for Alternatives to Pesticides is located at 353 Hamilton Street, Albany, NY 12210. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Northeast Organic Farming Association (NOFA) is located at Ruckytucks Farm, 130 Ruckytucks Road, Stillwater, NY 12170. Petitioner is the oldest organic farming association in the United States and currently has chapter organizations in NY, VT, NH, MA, RI, CT and NJ. NOFA is a diverse grass roots organization comprised of farmers, gardeners and consumers with predominantly and educational mission. The state NOFA organizations are also primary certifiers of organic farms in the Northeast. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers. Additionally, the possibility of gene flow of B.t. transgenes resulting from the EPA's registration of transgenic B.t. plant pesticides harms petitioner's state organizational members' ability to certify accurately organic crops.

Petitioner Organic Farmers Information and Education Foundation (OFIEF) is located at 8364 S SR Clayton, IN 46118. OFIEF is a non-profit foundation whose purpose is to provide public information and education on organic farming to enhance food security and the environment. EPA's failure to perform its statutorily required environmental impact review of its transgenic B.t. plant pesticide program harms and impedes petitioner's organizational goal of providing accurate, complete, and dependable information concerning the use of transgenic B.t. plant pesticides to its members, the public and policy makers.

Petitioner Organic Farmers Marketing Association (OFMA) is located at 8364 S SR 39, Clayton, IN 46118. OFMA includes members of a certified organic farming cooperative, and organizations, businesses and members of the public with direct interests in the farming, marketing and distribution of organically farmed foods. Many of OFMA's members use foliar B.t. sprays to control populations of tomato horn worms, diamond back moths, squash borer, corn borer, cucumber beetles, grape roller, codling moths and many other pests. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's members' ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's members' crop.

Petitioner Texas Organic Growers Association (TOGA) is located at P.O. Box 15211, Austin, TX 78761. Petitioner is an association of over 400 members, including major corporate growers, retail distributors of organic products, small family organic farmers and consumers. Since 1991, petitioner has actively educated farmers, consumers, public and private institutions and the business community on the benefits of organic production. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's members' crops, including cotton, melons and green vegetables.

Petitioners Rodger and Sandy Sanders reside at 9201 Lindsay Road, Bakersfield, CA 93311. Petitioners run Sanders Farming which grows 500 acres of organic cotton, approximately 1000 acres of conventional cotton, and organic fruits and vegetables on a "Community Supported Agriculture” (CSA) subscription farm. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides, including transgenic B.t. cotton plant pesticides, imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop, and directly injure their CSA subscribers' access to organic foods.

Petitioner P Marc Schwartz locates his business at W1182 Yaeger Valley Road Waumandee, WI 54622-8110. Petitioner is a principal of Organic Resources Co. and the chair of the Organic Growers and Buyers Association. He has spent 30 years marketing organic foods including $35 million direct sales. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides imminently harms petitioner's ability to market and sell organic foodstuffs.

Petitioner Mark Wilks resides at 1204 N. Ballard, Brownfield, TX 79316. Petitioner is President of Oportunidads Golpe, Inc. and Chairman of the Texas Organic Cotton Growers Association. Petitioner's farm grows organic cotton in a region where neighboring farms are using transgenic B.t. cotton plants. The rapid development of pest resistance to B.t., the possibility of transgenic B.t. gene flow, and the disturbance of soil ecology caused by EPA's registration of transgenic B.t. plant pesticides, including the registration of transgenic B.t. cotton plant pesticides, imminently harms petitioner's ability to produce, market and sell organic foodstuffs. The loss of efficacious foliar B.t. sprays and compounds would eliminate an organically acceptable pest control option that often makes the difference between success and failure of petitioner's crop.

Bacillus thuringiensis is an aerobic, Gram-positive, spore-forming bacterium found commonly in the environment. It produces a number of insect toxins, the most distinctive of which are protein crystals formed during sporulation. These crystal protein inclusions, or endotoxins, are the principal active ingredients in B.t. formulations currently in use.(4)

When certain insects ingest either the B.t. bacterium or its spores or the delta-endotoxin protein crystals produced by the bacterium, the function of their digestive system is disrupted and the insects die. Commercially available B.t. formulation do not contain active toxins but instead contain inactive protoxins that have to be activated in a multistage process by the insect pests. After solution of the protoxin crystals by alkaline pH>9-10 conditions in the insect gut, the protoxin is cleaved by digestive enzymes of the insects in a process involving up to seven different steps. A co-factor (kustakolin) enhancing the toxic effect by 30% is also present in conventional B.t. preparations.(5) The toxin's protein crystals are called "Cry" proteins, the corresponding genes "cry" genes. Today, more than 50 Cry proteins are known with sequential differences and specificities against certain insects. Bacillus thuringiensis strains can carry a variable number of plasmids each carrying genes for different toxins. These plasmids are easily exchanged by conjugation-like processes among different strains resulting in a great variety of toxins.(6)

B.t. has been registered as a foliar spray pesticide with the E.P.A. since 1961.(7) An advantage of B.t. toxins over chemical insecticides results from their specificity for pest insects and their special mode of action. The toxins have no known detrimental effect on mammals or birds and are readily degraded in the environment. In addition, the limited range of activity of the toxins toward insects means that often a particular toxin will kill pest species but have no effect on predatory or predaceous species.(8) Current practice involves spraying B.t. protoxins on plants where they are broken down under the influence of light within a few days. Time and concentration of the spray can be adjusted according to necessity, and the type of protoxin can easily be changed.

Microbial B.t. pesticides used in foliar spray are critical for many organic farming programs and have been identified by the EPA as a safer pest control method than many chemical pesticide alternatives.(9) The agency has further recognized that B.t. pesticides have low dietary, worker, and ecological risks when compared to the more hazardous alternatives that might replace B.t. pesticide should resistance develop.(10) Bacillus thuringiensis pesticide sales in the United States today amount to $60 million annually and account for the biggest share of biopesticide sales.(11) The B.t. pesticides also are important in many Integrated Pest Management (IPM) programs for a variety of crops. (See Table 7). Because of its effectiveness and safety compared to the pesticides it displaces, B.t. is probably the single most important insecticide ever discovered and the loss of such a pesticide would cause growers to switch to more harmful pest control agents.(12) Such a development would be incompatible to the demanded restrictions on the use of conventional pesticides by the Food Quality Protection Act of 1996.(13)

Overview of Transgenic B.t. Crops

The introduction of cry genes into crop plants causes a situation much different from the uses of conventional B.t. products: active toxins are produced permanently and in higher concentrations, they are expressed in all parts of the plant (but in different and not tissue specific concentrations), and - compared to the protoxin in conventional B.t. sprays - the transgenic variant is a modified one. Moreover, the concentration cannot be measured in exact doses and so far only one variant is produced by each crop. There are no co-factors present as in conventional preparations.

The first transgenic B.t. plant was tobacco resistant to tobacco horn worm produced in the early 1980s by Plant Genetic Systems. It was field tested in 1986 in the USA and in France. By the end of 1990, nearly 20 trials took place in the USA alone. Subsequently, developing countries began testing B.t. technology. By the end of 1992, 12 trials of B.t. crops took place in Latin America and China. (See Table 1). To date, more than 3,600 field trials of transgenic crops have been conducted worldwide; around 18% of these trials have been conducted with transgenic B.t. plants. In the developing countries, this percentage is even higher: 26% of all transgenic crop field trials in developing countries account for insect resistance. As of early 1997, around 80 transgenic crops were approved or pending approval worldwide; 21 of them were B.t. transgenics dominated by corn/maize (11), and followed by potato (5) and cotton (5). Of the developing countries, Mexico and South Africa have commercialized transgenic B.t. crops. In the USA, B.t. transgenic crops occupy more than 3 million acres (>1.2 million ha): 1-2 million acres of Monsanto's corn/maize, 0.5 million acres of Novartis' corn/maize, 1.7 million acres of Monsanto's cotton (which accounts for appr. 12% of US cotton acreage), and over 50,000 acres of seed potatoes by Nature Mark Potatoes, a Monsanto subsidiary.(14)

Currently, the United States-based Delta and Pine Land Company, is constructing a new cotton seed conditioning and storage facility in Hebei province, of China, that will be completed by mid-November 1997. Under the terms of an agreement between D&PL China, Pte, Ltd., and the Hebei Provincial Seed Industry Group Corporation, the facility is anticipated to sell seed sufficient to plant 500,000 acres of Bollgard cotton in Hebei province in spring 1998. D&PL estimates the potential of the market for Bollgard cotton in China to exceed 10 million acres. Bollgard cotton plants contain a B.t. gene developed by Monsanto and is commercialized through a collaborative agreement between D&PL and Monsanto. The company is currently negotiating with potential venture partners in Zimbabwe, Brazil, and Argentina, and is in exploratory discussions with potential partners in India and Uzbekistan.(15)

Resistance Problems.

Resistance to insecticides is a major agricultural and public health problem. It is estimated that more than 500 insect and mite species have already acquired resistance.(16) Since 1981, the E.P.A. has been on notice that resistance to B.t. has developed in certain pests.(17) In 1986, small scale field testing of transgenic crops engineered to express B.t. toxins began.(18) These transgenic plants exert high selection pressure on pest populations. Insects have the potential to develop resistance to transgenic B.t. plants because the plants maintain a constant killing dose throughout the growing season. Therefore, unlike B.t. sprays which are inactivated over a short time, the selection pressure of transgenic B.t. plants on susceptible pest populations will be much higher.(19)

Since the initial laboratory and field tests on transgenic plants that express B.t. toxins, it has been reported that several common species of pest insects have evolved resistance to B.t. endotoxins, indicating that biological pesticides can suffer the same fate as synthetic chemicals.(20) (See Table 6). In a 1992 lab, study eight species were analyzed for resistance to B.t. endotoxins. At least one of the tested species, the diamondback moth (Plutella xylostella) developed a high level of resistance in the field as a result of B.t. use.(21)

In 1997 another study provided the first direct estimate of the field frequency of B.t.-resistant insects.(22) It was found that in tobacco budworms (Heliothis virescens), a major cotton pest, 1 in 350 individuals carried an allele for resistance to B.t. toxin, a frequency considerably higher than assumed in earlier, theoretical models. The authors predict, that with a 4% refuge as mandated by the EPA, the B.t. cotton could remain efficacious to tobacco budworm for 10 years, but with other pests such as cotton bollworm and European corn borer, the resistance could develop within 3-4 years. Thus, the risks for rapid development of insect resistance against B.t. are substantial and could outweigh any benefits of the proposed new use. The same authors also observed 20,000 fold resistance ratios.

Another recent study demonstrates that the frequency of a multiple-toxin resistance allele in susceptible populations of the diamondback moth (Plutella xylostella) is 10 times higher than the most widely cited estimate for the upper limit for the frequency of resistance alleles in susceptible populations. The allele can be preserved easily for over 100 generations in the laboratory without exposure to B.t. These findings strongly suggest that the resistance gene carries little, if any, genetic load. Hence, the resistance allele could have far higher frequencies in wild lepidopteran populations than previously thought. (23)

Emergence of B.t. resistance is a world wide problem, The diamondback moth (DBM), Plutella xylostella (L.), developed resistance to most pyrethroid and organophosphorus insecticides in 1980s in P.R. China.(24) As an alternate, the Bacillus thuringiensis (B.t.) insecticides became more important to control DBM, especially in the south of China where pyrethroids resistance in DBM was more severe. The production and application of B.t. developed quickly in late 1980s in China, with the B.t. formulation production less than 0.3 millions kg in 1985 increasing to 1.5 millions kg in 1990. About 20% of the B.t. insecticides produced were used for the control of lepidopteran pests in crucifers. The resistance of DBM to B.t. has also been reported in fields of the United States(25) and Malaysia(26), and in greenhouses in Japan.(27) All of these cases were found to be related to the extensive application of B.t. to control DBM. A study designed to detect and measure B.t. resistance in DBM in China was conducted in four selected areas, i.e. Shenzhen (B.t. used most extensively), Shanghai (extensively), Wuhan (less extensively) and Beijing (inextensively) in 1993 and confirmed that the emergence of B.t. resistance was comparable to each field's B.t. application history.(28)

Moreover, the development of resistance by an insect to a Cry protein often leads to cross-resistance, i.e. the insect is resistant to other Cry proteins as well. For example, insects selected for resistance to CryIA(c) showed resistance to CryIA(a), CryIA(b), CryIB, CryIC, and CryIIA(29). Due to the heterogeneity of the toxin binding sites in the insect's gut and insufficient knowledge about binding mechanisms such cross-resistances cannot be predicted (e. g. by sequence homologies). In addition, cross-resistance shows a different pattern in different species or even within species. Cross-resistance develops not only after treatment with heterogenous conventional B.t. preparations but in experiments using a single isolated B.t. toxin as well.(30)

Two biochemical models are discussed to explain emergence of resistance: A change in B.t. receptors or changes in the biochemical pathways of proteolytic cleavage of the protoxin. So far, studies with resistant insects point to receptor changes.(31) Resistance genes are inherited autosomal, confined to only a few loci and seem to be inherited in a recessive way.(32) However the assumption that resistance to different strains of B.t. endotoxin requires separate independent mutations is false. A recent study demonstrated that a single autosomal recessive gene conferred extremely high resistance to four B.t. endotoxins (CryIA(a), CryIA(b), CryIA(c), CryIF) in the diamond back moth (DMB).(33) Hence, if resistance develops it cannot be overcome by just switching to a different toxin. This work has even more disturbing implications for polyphagous insects feeding on different crops such as Helicoverpa zea. For example, H. zea developing resistance to CryIA(a) while feeding on transgenic B.t. cotton would also acquire resistance to the CryIA(b) endotoxin of transgenic B.t. corn as well, or vice versa. Such a population would show a high level of resistance to conventional B.t. sprays as well and could have a devastating effect to organic farmers that depend on such foliar B.t. preparations. Together with the findings that resistance gene frequencies are much higher than previously estimated the cross-resistance phenomenon demonstrates that resistance could develop far faster than previously imagined and with more severe consequences.

During the registration process for transgenic B.t. crops the EPA has demanded that CIBA and Mycogen develop standards and methods for the assessment of resistance development. To date, resistancy has been defined by EPA as progeny of sampled individuals showing a >30% survival and >25% leaf area damaged in a 5-day bioassay using CryIA(b)-positive leaf tissue and an LC50 in a standard CryIA(b) diet bioassay that exceeds the upper limit of the 95% confidence interval of the mean historical LC 50 for susceptible populations as established by an ongoing baseline monitoring program.(34) However, this definition cannot be translated easily in a resistance factor as it depends on the range of variations in resistance or tolerance in a population. This range can be surprisingly substantial, and this is not reflected in the monitoring program.(35)

Contrary to conventional B.t. preparations, transgenic B.t. plants have properties which make the development of pest resistance much more likely:

1. B.t. crops produce only a single endotoxin; and

1. B.t. crops express the toxin in a continuously high dose over a long period and thereby exert a permanent selection pressure on target pests that is not nearly reached by conventional B.t. preparations.(36)

Gene Transfer of B.t. Gene to Non-GMO Crops.

An additional environmental problem associated with transgenic B.t. plants is the possibility of gene flow from the transgenic cultivars to wild native plants which may acquire B.t. genes from cross pollination. In 1996, a study in Denmark showed that genes inserted into a transgenic crop plant could move rapidly into their wild, weedy relatives.(38) Field tests with other genetically engineered crops have also demonstrated a high frequency of gene flow to non-genetically modified variants. A recent study demonstrated that between 35% and 72% of the seeds of normal potatoes planted at distances up to 1.1 kilometers from genetically engineered potatoes contained the transgene.(39)

The transfer of B.t. genes to wild related species could enhance resistance development in pests that also feed on these wild species. Essentially, B.t.-protected weeds could function as an additional selective pressure on the insect pests and increase the rate of resistance development.(40) This problem is all the more important in countries of origin of major crop varieties and in centers of genetic diversity.

Tomatoes (Lycopersicon esculentum) originate from the South American West coast; the greatest genetic diversity today outside of this area in the Veracruz-Puebla is in Mexico. This area was very likely the source of the cultivated tomatoes of the Old World. In Peru and Ecuador the tomato plant spontaneously crosses with L. pimpinellifoli, which is both cultivated and occurs as a weed. L. pimpinellifolium is also used a source of tolerance for tomato.(41)

Maize (Zea Maize) most probably originates from teosinte (Z. mexicans) which is both cultivated and occurs as a weed in Mesoamerica. A gene flow of teosinte to maize exists where maize cultivation is primitive and teosinte is present, Maize X teosinte hybrids are actually cultivated. Extensive gene exchange in both directions can be observed around Chlco, South of Mexico City where the weedy teosinte race mimics the local race of maize in size, colour and pubescence. West of Mexico City teosinte behaves as a wild grass. (42)  Maize is particularly important to food security in Central and South America and most regions in Africa. The gene pool consists of one main cultivated species Zea mays and several related wild genera (Teosinte ssp. and Tripsacum ssp.). In Mexico and in Guatemala, 80% and 60% resp. of the areas where maize is grown is planted with traditional varieties. An in situ conservation program of teosinte has been established in a biosphere reserve in Mexico. So far teosinte and tripsacum have not been widely used in maize breeding programs but recently a Germplasm Enhancement of Maize Collaborative Project has been established to broaden the genetic base of maize breeding programs in the USA. (43)

Potato (Solanum tuberosum) originates from Central and South America; the greatest number of species is found in Peru and Bolivia. Genetic erosion is reported in the primary centers of origin. In Peru, out of 90 wild potato species once described 35 are no longer found in the wild. On-farm conservation projects have been reported in Colombia and Bolivia, but there is need to determine existing micro-centers of diversity. It has been estimated that 95% of landraces but only 40% of the wild species have been collected. Still there are gaps in potato collections, and few wild species are adequately sampled throughout their geographic area of distribution. However, potato represents one of the best examples of utilisation of wild species and primitive cultivars in plant breeding: about 20% of all crosses made at CIP between 1972 and 1986 included such plants as progenitors. Wild potato species have contributed to disease resistance, cytoplasmic male sterility, frost resistance, yield, and starch content. (44)

Cotton (Gossypium ssp.) has been domesticated in the Old World, but the bulk of cotton grown worldwide today is of the Mexican species G. hirsutum. Leading producers are the USA and GUS. Egypt, Sudan, and GUS produce most of the long-staple cotton G. barbadense originating from the New World. Both of the domesticated American cottons have weedy races that grow well without cultivation. (45)

Traditional varieties as well as progenitor plants and wild relatives could be endangered by an uncontrolled gene flow from transgenic plants. (46)  Since the transgenes have not entered the genomes via normal reproduction and they are constructed from genes of different organisms with different gene regulation patterns, their behavior during out crossing is not predictable. Rapid spread of transgenic B.t. plants to centers of biological diversity could counteract all efforts to preserve the precious gene reservoirs of these regions. (See Table 3).

Impact on Nontarget Beneficial Organisms.

The widespread use of transgenic B.t. plant pesticides may also substantially impact soil ecology. Studies on impacts of B.t.-expressing plants on natural nontarget organisms have not been required by the EPA, but have been submitted voluntarily by the registrant. Although the studies have revealed potentially negative impacts on natural nontarget insect populations, no further investigations have been demanded by the EPA. According to the EPA's Pesticide Fact Sheet on CIBA Seeds B.t. corn, a study on the impact of B.t. toxin produced by transgenic corn on nontarget beneficial organisms plants demonstrated that the CryIA(b) protein, when added to an artificial soil mix, caused significant mortality to Collembola and significantly reduced reproduction of the survivors. The LD50 was 240 mg B.t. maize leaf protein/kg of soil (95% CL 210-280). The LOEL (lowest observed effect level) was 250 mg/kg, and the NOEL (no observed effect level) was 125 mg/kg. The MATC (maximum acceptable toxicant concentration) was between 125 mg/kg and 250 mg/kg, with geometric mean of 180 mg/kg. While 125 mg/kg is regarded a very high application, new studies provide hints that high concentrations could be reached by accumulation of B.t. toxin in certain soils.

Previous safety testing on spray B.t., a much larger protein than the one found in transgenic B.t. crops, has found no effect on nontarget organisms because the bacterial protoxin is in an inactivate state and requires the targeted organism to cleave or activate the toxin. In contrast, genetically manipulated maize plants, which contain an artificial, truncated B.t. gene (1), produce a toxin-like protein which is already about half the size of the bacterial protoxin. It only needs a minor step to turn it into the active toxin. Additionally, it seems that there is no need for a high pH for this step to happen. According to Ciba/Novartis' own documentation, the truncated B.t. gene in maize produces three more B.t. proteins. Whether any of these B.t. proteins acts as an already active B.t. toxin is not known. No further examinations have been reported. (47)  It is therefore highly probable, that the toxin-like protein of the manipulated maize can also be activated in insects with non-alkaline intestines. As a result, the toxin might also have effects on earthworms and other insects with non-alkaline intestines.

A recent study suggests that transgenic B.t. plants may indeed create serious impacts on nontarget organisms that feed on pests exposed to the transgenic toxins. At the Swiss Research Institute for Agroecology and Agriculture, researchers fed corn borers Novartis' transgenic B.t. corn. These "exposed,” dead corn borers were then fed to their enemies, the beneficial lacewing larvae. The larvae, having ingested the toxin through the corn borer died at twice the normal rate. (48)  A second experiment found that African cottonworm was able to survive the B.t. toxin for unknown reasons, however, when the "exposed,” live cottonworms were fed to lacewing larvae, the larvae again died at twice the rate. (49)  As a result, the transgenic B.t. toxin appears to be able to jump over a link in the foodchain and kill beneficial insects.

Furthermore, the corn plants produce B.t. toxins (or toxin-like proteins) throughout their lives and in all parts. Decomposition of plant after harvest may result in the accumulation of B.t. toxins in soil at concentrations high enough to constitute a hazard to nontarget organisms, such as beneficial insects (e.g., pollinators, parasites, and predators of insect pests) and other animal classes. This could result in the selection and enrichment of toxin-resistant insects. (50)

Differences between the fate of toxins from B.t.-bacteria and B.t.-plants have been demonstrated in a recent study. The addition of purified bacterial B.t.-protoxins to soil did not cause any detectable effects on examined soil bacteria, fungi and other microorganisms. In contrast, the addition of some transgenic B.t.-cotton plants frequently caused significant although transient stimulation of culturable, aerobic bacteria and fungal populations. The reason for this difference is unclear. (51)

A further question is how quickly toxins decompose in the soil. Here, too, striking differences between the manipulated B.t. plants and the B.t. bacteria have been found. Purified B.t. toxins, as produced by transgenic plants, continue to be active for a surprisingly long time in some soils and keep their toxic effects. Active B.t. toxins in the soil have been found even nine months after the toxins had been released. Toxins are bound on soil constituents (e.g. clay-particles) and are thus protected against decomposition and microbial degradation. B.t. protoxins within bacteria, on the other hand, decompose on average twice to three times as quickly as do the active toxins. (52)  Widespread growing of transgenic plants containing B.t. toxins could lead to the accumulation of B.t. toxin in the soil with severe and incalculable consequences for insects, soil organisms and their very complex networks.

Summary

In early 1995 E.P.A. allowed the limited FIFRA registration of transgenic B.t. plant pesticides for plant propagation. (53)  Registration of these plant pesticides for use in interstate commerce soon followed. (54)  Despite these regulatory approvals, the EPA has failed to fully analyze the cumulative environmental impacts that may result from accelerated B.t. resistance and has approved transgenic plants expressing B.t. toxins in an arbitrary and capricious manner.

In sum, there is a significant risk that the commercialization and widespread use of B.t. crops will lead to the following adverse environmental effects:

1. Development of B.t. (multiple) resistance in major pests within a relatively short period of time (2 to 10 years). This would result in a valuable, non-toxic and biodegradable biopesticide becoming non-functional. Such as result would be a serious blow to sustainable agriculture and IPM efforts, and especially to organic farmers especially. For organic farmers there is no alternative. From this perspective, the approval of B.t. crops can be viewed as wanton destruction of the world's only biological pesticide;

1. Adverse effects due to out crossing of B.t. traits to progenitor plants and wild relatives; and

1. Disturbance of soil ecology by harmful effects on nontarget and decomposing organism.

Administrative Procedure Act, 5 U.S.C. § 551, et seq.
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136, et seq.
National Environmental Policy Act, 42 U.S.C. § 4321, et seq.
Council on Environmental Quality, 40 C.F.R. §§ 1500 - 1508 (1996).
Environmental Protection Agency, 40 C.F.R. §§ 6.100 - 6.1007 (1996).
Environmental Protection Agency, 40 C.F.R. §§ 150 - 189 (1996).
All other applicable statutes and regulations.

I. Federal Insecticide, Fungicide, and Rodenticide Act.

The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. (55)  FIFRA requires that all pesticides, including insecticides and herbicides, be registered prior to distribution or sale, unless exempt by EPA regulation. Accordingly, microbial pesticides, i.e. foliar B.t. sprays, containing the active ingredient of B.t. have been regulated by the EPA under existing regulations. In cases in which genetically engineered (56)  plants allow for a new or different use pattern for a herbicide or pesticide, such as expression of an active ingredient derived from B.t., the EPA must approve the new or different use. (57)
 

Under 7 U.S.C. § 136d(b), if it appears to the Administrator that a registered pesticide generally causes unreasonable adverse effects on the environment, the Administrator may cancel a pesticide's registration. FIFRA defines "unreasonable adverse effects on the environment” as:
 

Any unreasonable risk to man or the environment, taking into account the economic, social, and environmental benefits of the use of any pesticide. (58)

In the case of transgenic B.t. plant pesticides, the EPA has granted registrations for five genetically engineered plants that express active agents or endotoxins derived from B.t. The registration of these plant pesticides has created an unreasonable risk to the environment that outweighs any economic, social and environmental benefits, and as such the Administrator should withdraw all of the transgenic B.t. plant pesticide FIFRA registrations.

As noted supra, the registration of transgenic B.t. plant pesticides presents several unreasonable risks to the environment. These plant pesticides will cause the evolution of B.t. resistant pest species, (60)  may create novel, B.t. resistant weedy plant relatives, (61)  and may impact nontarget beneficial organisms. (62)  Indeed, the agency itself has stated:
 

The risks [of multiple- and cross-resistance] are substantial and [EPA's Biopesticide and Pollution Prevention Division] has concluded that risks, if unchecked, would outweigh the benefits of the proposed new use. (63)

The adverse environmental impacts resulting from use of genetically engineered B.t. plant pesticides will have enormous and detrimental economic impact on farmers and food consumers.

Currently, farmers (conventional and organic) and consumers are highly dependent on the availability of crops grown with conventional B.t. foliar sprays. (See Table 7). As previously noted, the widespread use of transgenic B.t. crops will accelerate and cause the development of B.t. resistant pests there by eliminating farmers use of foliar B.t. sprays. The loss of this effective biopesticide will be an economic disaster both for growers and consumers. It is currently estimated that U.S. agricultural losses caused by pest resistance to pesticides are between $400 - $1,500 million annually. (65)  Given the increasing use of B.t. products, the development of resistance will significantly add to these losses. Conventional and organic farmers will also face the additional costs of using alternative strategies to suppress pest populations. These costs would include additional outlays for supplies used in pest suppression and alterations in harvesting resulting from greater infestations. Moreover, U.S. consumers of all foods are likely to face higher retail food prices as production costs are passed onto to the retail level.

The loss of B.t. will also have a specific and negative impact on many of the social aspects of organic farming. As noted, B.t. foliar sprays have been a principal element in organic farming practices. (66)  While the loss of B.t. resistance will have economic impacts on many farmers, it will also threaten the sustainability of organic farming. Organic farming represents a unique agricultural sector based upon the principle that food should be grown with only low impact, environmentally benign inputs. The loss of B.t. threatens the continued success of this method and its sustainable approach to food production. This threat to the continued viability of organic farming represents a serious social impact upon a unique and growing sector of U.S. agriculture.

Additionally, the agency's registration of B.t. expressing plants will have a detrimental impact on the environment. While B.t. itself has been chosen as a pest control option because of its low impact on the environment, the registration of transgenic B.t. plant pesticides threatens this environmental benefit. The evolution of B.t. resistance, the potential development of B.t. resistant weedy relative and the possible long-term effect on non target organism caused by the introduction of transgenic B.t. plants far outweighs the immediate environmental gains of using these plants over a short period of time. As B.t. is lost as a pest control option, the agricultural sector will be forced to resume the use of synthetic pesticides. This will result in greater adverse impacts on the environment as farmers seek to replace the pest control properties of foliar B.t. sprays, and greater exposure to synthetic pesticide residues by consumers. Indeed, the agency is already on notice of how B.t. resistance will lead to greater synthetic pesticide usage. On May 16, 1997 the agency granted an emergency tolerance exemption under FIFRA section 18 for residues of the insecticide emamectin benzoate in or on head and Napa (Chinese) cabbage in Hawaii. (67)  The emergency exemption was granted, in part, because of Diamond back moth's resistance to B.t.

Thus, the registration of genetically engineered plant expressing B.t. has created unreasonable adverse effect of the environment. The past and future registration of these plant pesticides will also result in significant negative economic, social and environmental impacts. As a result, the petitioners request the Administrator to exercise the discretion granted to her in 7 U.S.C. § 136d(b) and cancel the registration of all genetically engineered plants expressing Bacillus thuringiensis.

Pursuant to 40 C.F.R. § 154.10, the Administrator may evaluate the registrations of genetically engineered plants expressing B.t. under a Special Review process upon the suggestion of any interested person. (68)  The registration of transgenic B.t. plant pesticides meet the criteria for initiating special review.

Pursuant to 40 C.F.R. § 154.7(a)(3), the registration of genetically engineered plants expressing B.t. may result in residues in the environment impacting nontarget organisms that produces adverse reproductive effects on such organism. (69)

Pursuant to 40 C.F.R. § 154.7(a)(6), the registration of genetically engineered plants expressing B.t. present risks to the environment of sufficient magnitude to trigger special review.

The cumulative environmental impacts of transgenic B.t. plant pesticides approvals are of sufficient magnitude to trigger the special review. As noted, the development of B.t. tolerant pests would have a detrimental impact on the environment. For example, the EPA is well aware of how the loss biorational of pesticides like B.t. can trigger the use of more synthetic pesticides. On May 16, 1997 the agency granted an emergency tolerance exemption under FIFRA section 18 for residues of the insecticide emamectin benzoate in or on Head and Napa (Chinese) cabbage in Hawaii. (70)  The emergency exemption was granted, in part, because of Diamond back moth's resistance to B.t.. In making its determination the agency stated:
 

Growers using these products have experienced significant yield reductions due to feeding damage by DBM larvae. Bacillus thuringiensis (B.t.) based insecticides were once very effective, but in 1990 scientists at the University of Hawaii documented DBM resistance to first generation B.t. products; more recently these same scientists have documented a 20-fold resistance to B.t. toxin CryIC. Based on these trends, it is expected that the DBM will quickly develop resistance to these second generation B.t. products if they are overused. (71)

Petitioners remind the agency that in making a Special Review determination, the Administrator shall be guided by the principle that the burden of persuasion that genetically engineered plants expressing B.t. are entitled to registration is always on the proponent of registration. (72)  Petitioners believe that the proponents can not meet this burden, and the Administrator should begin proceedings to cancel the registrations of all genetically engineered plants expressing B.t.

II. The National Environmental Policy Act.

In 1994, the EPA proposed to amend existing regulations and to create new regulations to clarify the relationship between "plant pesticide” (73)  and their regulatory status under FIFRA. (74)  This proposed rule marked the beginning of a comprehensive agency program to clarify, define, exempt and regulate, inter alia, pesticidal substances produced in plants through genetic engineering. An example of this new "plant pesticide” is a plant designed to produce an insecticidal delta endotoxin produced in B.t. (75)  As of the date of this petition, the proposed rules have yet to be finalized and the agency has been using existing pesticide regulations to register B.t. plant pesticide under FIFRA. (76)

By the agency's own admission, existing regulations are not appropriate for the unique properties of plant pesticide. (77)  The characteristics of plant pesticide such as their production and use in plants; their biological properties; and their potential to spread and increase in quantity in the environment distinguishes them from traditional, chemical pesticides. (78)  Despite these admitted regulatory shortcomings, the EPA has embarked on a systematic program of registering and approving transgenic B.t. plant pesticide for commercial use. As a result, the registration of B.t. plant pesticide is a new regulatory program representing a major federal action that identifies the new and novel possibility of significant adverse effects on the environment. Despite this major agency initiative, the EPA has yet to undertake the "hard look” environmental analysis of the cumulative impacts of its transgenic B.t. plant pesticide registration program as required by the National Environmental Policy Act (NEPA).
 

NEPA, section 102(c) specifically states:

The Congress authorizes and directs that, to the fullest extent possible: ... (2) all agencies of the Federal Government shall- (C) include in every recommendation or report on proposals for legislation and other major Federal actions significantly affecting the quality of the human environment, a detailed statement by the responsible official on -- (i) the environmental impact of the proposed action, (ii) any adverse environmental effects which cannot be avoided should the proposal be implemented, (iii) alternatives to the proposed action, (iv) the relationship between local short-term uses of man's environment and the maintenance and enhancement of long-term productivity, and (v) any irreversible and irretrievable commitments of resources which would be involved in the proposed action should it be implemented.  (79)

The failure of the EPA to perform a programmatic EIS for its B.t. plant pesticide program arbitrarily and capriciously also ignores federal regulations promulgated by the Council on Environmental Quality (CEQ) requiring agencies to undertake a NEPA analysis. (80)  These regulations specifically address the need for the EPA to prepare an environmental impact statement (EIS) for all major federal actions including:
 

Adoption of programs, such as a group of concerted actions to implement a specific policy or plan; systematic and connected agency decisions allocating agency resources to implement specific statutory program or executive directive. (81)

The agency's B.t. plant pesticide program represents a broad federal action that will have adverse environmental impacts. As stated previously, the registration of several transgenic B.t. plant pesticides will result in adverse impacts on the environment including, but not limited to, increase pest resistance to delta endotoxins from B.t. and increased pesticide usage as pest B.t. resistance requires farmers to utilize chemical alternatives. At a minimum, the registration of B.t. plant pesticides marks a series of related actions that will have a cumulative environmental impact. As when several proposals for related actions that will have a cumulative or synergistic environmental impact upon a region, the successive registration of B.t. plant pesticides by an agency means that their environmental consequences must be considered together. (84)

The CEQ regulations defining "scope” also provide guidance by advising the preparation of a programmatic impact statement on "cumulative actions, which when viewed with other proposed actions have cumulatively significant impacts and should therefore be discussed in the same impact statement.” (85)  The relevant CEQ regulation defines cumulative environmental impacts that should be assessed:
 

"Cumulative impact" is the impact on the environment which results from the incremental impact of the action when added to other past, present, and reasonably foreseeable future actions regardless of what agency (Federal or non-Federal) or person undertakes such other actions. Cumulative impacts can result from individually minor but collectively significant actions taking place over a period of time. (86)

III. The Administrative Procedure Act.

Since the first transgenic B.t. plant pesticide, Monsanto's New Leaf potato plant, was granted marketing approval, the EPA has required companies to submit resistance management plans (RMPs) prior to a B.t. plant pesticide's final FIFRA registration. However, the EPA has granted transgenic B.t. plant pesticides FIFRA approvals without adequately assessing resistance management strategies or RMP enforcement. With the EPA on notice that B.t. plant pesticides pose a risk of creating resistance, the registration of transgenic B.t. plant pesticides under FIFRA without adequately developing and/or assessing the adequacy of RMP is arbitrary, capricious and an abuse of discretion.

Resistance management plans for transgenic B.t. plant pesticides are based on two interacting premises. First, the transgenic plant must express a high dose of B.t. toxin so that virtually all target pests are killed. Second, the planting of transgenic B.t. plant pesticides will be interspersed with refugia of non-genetically engineered plants that produce susceptible insects capable of mating with any insects surviving the high dose of B.t. toxin from the genetically engineered crops. While forming the basis for EPA's "conditional” approval of B.t. plant pesticides, neither of these two premises has been scientifically validated in a manner which ensures the prevention of B.t. resistant pests.

The high dose toxin production requirement from transgenic B.t. plant pesticides has not been adequately understood or assessed. (90)  In the summer of 1996, cotton growers in Texas using Monsanto's transgenic B.t. cotton, known as Bollgard cotton, reported significant damage from cotton bollworm. Bollgard plants were specifically designed to protect cotton from bollworm. The
losses experienced by the farmers in Texas indicate that transgenic B.t. cotton has failed to produce the high dose toxin necessary to kill cotton bollworm at mortality rates adequate for successful RMPs. Additional analysis revealed that adequate transgenic B.t.-induced mortality rates also were not achieved for the following pests - corn earworm, pink bollworm, helicoverpa armigera, and perhaps tobacco budworm. Further reports indicate that data indicating transgenic B.t. cotton's susceptibility to bollworm infestations during field testing were summarily ignored in 1994. (91)

New research also suggests that extant pest populations have the inherent ability to discriminate among tissues with varying concentrations of toxin within a plant. (92)  Thus, the high dose strategy fails to prevent conditions that will lead to the evolution of B.t. resistance. Current transgenic B.t. plants are unable to consistently produce high levels of toxin and pest populations have the inherently ability to avoid high dose tissues. Despite these known and unresolved problems, the EPA continues to base FIFRA B.t. plant pesticide registrations upon the high dose strategy.

In addition to ignoring the B.t. plant pesticides' inability to meet the high dose requirement, the EPA has allowed FIFRA registrations to be based upon RMPs with arbitrary levels of refugia. To date, there exists no scientific consensus on the temporal and geographical arrangement or the size of effective refuges. Some scientists have argued for as little as 4 to 5% of acreage while others believe that over 50% of acreage is necessary. (93)  Other researchers suggest that refugia may even speed up resistance development in cases where dispersal of resistant insects from transgenic area into the refuge is high enough to effectively pass the resistance gene to the susceptible population. (94)  Despite this lack of scientific agreement on the size and capabilities of refugia, the EPA has registered transgenic B.t. plant pesticides based in part upon RMPs that call for minimal (4 to 5%) refugia acreage.

The EPAs RMP strategy has failed to address several critical issues beyond high dose and refugia strategies. First, the occurrence of multiple pest species on crops presents many complex issue that require further study of effective lethal dose B.t. expression prior to any agency conclusion concerning the adequacy of RMPs. In this regard, USDA/APHIS continues to study nontarget effects of transgenic B.t. and the persistence of organism subject to B.t. in the environment. (95)  Second, the FIFRA registration process has not included, and does not include, any enforcement protocols which will ensure compliance with the RMPs. Thus, the voluntary nature of compliance with RMPs provides no assurance that EPA's "conditional” transgenic B.t. plant pesticides approvals will have any impact on preventing rapid B.t. resistance.

In sum, the development of adequate RMPs is a critical component to the EPA's registration of B.t. plant pesticides. Indeed, the agency has stated that its FIFRA findings of no unreasonable adverse effects on the environment are based in part on the use RMPs. (96)  However, the EPA has based its RMP requirements upon inadequate and arbitrary standards. Despite knowing that transgenic B.t. plant pesticides cannot be relied upon to produce adequate toxin levels, the agency maintains that currently registered plants will meet high dose B.t. expression as the first critical component of RMPs. In addition, the EPA has a establish level for refugia prior to any scientific consensus on refugia's effectiveness or geographical and temporal characteristics of adequate refugia. Therefore, the EPA has registered B.t. plant pesticides based upon an RMP strategy whose two interdependent step are inadequate. Such agency action is arbitrary and capricious, and an abuse of discretion.
 

IV. Public Trust Doctrine.

Bacillus thuringiensis is a family of naturally occurring bacteria, and thus a product of nature, upon which direct ownership cannot be granted. (97)  In general, plant pests are susceptible to the use of B.t. as a biopesticide because the pests contain genes that confer susceptibility to specific endotoxins produce by B.t. The registration of transgenic B.t. plant pesticides threatens the continued susceptibility of pests to B.t. endotoxins. The overuse of B.t. resulting from the EPA's FIFRA registration of transgenic B.t., plant pesticides will result in the natural selection of other genes, "resistance genes,” which will allow pests to circumvent human attempts to kill them with B.t. endotoxins. (98)

Under federal common law the Public Trust Doctrine has a long history of preventing federal and state governmental entities from expropriating natural resources in a manner contrary to the public interest. The doctrine's central tenet is that "when a state holds a resource which is available for the free use of the general public, a court will look with considerable skepticism upon any governmental conduct which calculated either to reallocate that resource to more restricted uses or to subject public uses to the self-interest of private parties.” (99)  The Supreme Court has recognize the validity of the public trust doctrine. (100)

Ultimately, the doctrine stands for the proposition that the "public domain is held by the Government as part of its trust. The government is charged with the duty and clothed with the power to protect it from trespass and unlawful appropriation.” (101)  Federal or state hold in trust all land in resources in its possession for future generations.

At its core the public trust doctrine is the principle that navigable waters are held by the sovereign (usually a state) in trust for certain public uses. (102)  However, the doctrine has been expanded and applied to actions of the federal Government (103)  and diverse resource issues such as the protection of additional water-related uses such as swimming and similar recreation, aesthetic enjoyment of rivers and lakes and preservation of flora and fauna indigenous to public trust lands. (104)  Recent actions by the National Park Service defining wildlife as including microorganisms indicates that the doctrine also extends to the preservation of bacteria such as B.t. (105)

The susceptibility to B.t. endotoxins is a characteristic held by numerous plant pests geographically dispersed throughout the United States, including pests that are present on national park lands. Indeed, governmental entities managing our national lands, such as the U.S. Forest Service, depends upon plant pests genetic susceptibility to B.t. endotoxins when engaging in pest management activities. (106)  As such, B.t. susceptibility genes in pests are a natural resource that is subject to the public trust doctrine. Their natural existence benefits all of mankind by providing an opportunity for humans to suppress particular pest populations and thereby protecting food and fiber. All of society will suffer the consequences of the genetic over-exploitation of B.t. susceptibility genes.

The public doctrine has developed in a consistent manner with courts scrutinizing any conveyance [of a public resource] to determine if it is in complete congruence with the fiduciary duties owed to the public by the sovereign. If the conveyance represents a deliberate and reasonable decision of the sovereign that the transaction of which the conveyance is part affirmatively promotes the public interest, the courts have deferred to the sovereign's decision. In making this determination, courts and commentators have established a several criteria in analyzing when a transaction violations of the public trust doctrine occur: (107)  (1) whether the public property has been disposed of at less than market value where there is no obvious reason for subsidy; (2) whether the governmental action grants a private interest the authority to make resource-use decisions that may subordinate broad public resource uses to that private interest; (3) whether an attempt has been made to reallocate diffuse public uses either to private uses or public uses which have less breadth; and (4) whether the resource is being used for its natural purpose.

In applying this analysis to the registration of transgenic B.t. plant pesticides it becomes evident that the EPA's actions of granting registration approval for transgenic B.t. plant pesticides violates the public trust. As stated previously, the registration of transgenic B.t. plant pesticides threatens to create widespread resistance to B.t. endotoxins. (108)  In allowing the commercial use of transgenic B.t. producing plants the EPA has granted several private entities the right to exploit, and "use up,” B.t. susceptibility genes - a natural resource entrusted to be protect for the benefit of all U.S. citizens. In particular, registering transgenic B.t. plant pesticides under FIFA is a violation of all of the major tenets of the public trust doctrine.

First, the registration of transgenic B.t. plant pesticides has granted private corporations the ability to "use” up B.t. susceptibility genes at less than market value. As the widespread use of B.t. foliar sprays in all types of agriculture demonstrates, the presence B.t. susceptibility genes has a tremendous value. (See Table 7). The registration of transgenic B.t. plant pesticides under FIFRA has been allocated to Monsanto, Ciba Geigy, Mycogen and Northrup King the ability to use resistance genes and limit their future existence at no direct cost to the companies. As a result, the EPA has transferred a national entrusted resource to private corporations for absolutely no market value in return.

Second, the FIFRA registration of transgenic B.t. plant pesticides grants the power to deplete the B.t. susceptibility gene pool in a manner that subordinates the federal government and broad public uses of B.t. susceptibility. In registering B.t. plant pesticides, the EPA has granted several companies to use susceptibility genes over the next several years based upon self-enforce resistant management plans. This grant of power allows the registered companies the ability to make resource decisions over how and to what extent a natural resource entrusted to the federal government, B.t. susceptibility, will be used. Ultimately, the use of transgenic B.t. plant pesticides allow for the evolution of resistance and a company to determine the period over which B.t. susceptibility genes will remain effective. As result, the EPA has violated the public trust doctrine by allowing private entities to prioritize its use of a natural resource over public use.

In conclusion, the EPA's registration of transgenic B.t. plant pesticides has violated the public trust doctrine. The commercial approval of these plant pesticides has transferred a natural resource to private entities below market cost and has subordinated public use of B.t. susceptibility genes to their use by private companies.
 

V. Judicial Review.

Pursuant to, inter alia, the APA, 5 U.S.C. § 702, and FIFRA, 7 U.S.C. § 136n(a), the refusal of the Administrator to cancel all genetically engineered plants expressing B.t., engage in Special Review registration, perform a Programmatic EIS, and/or take other final actions requested by petitioners are entitled to judicial review. As required by law, the EPA is required to give this petition prompt consideration. Petitioners are requesting a substantive response to this petition within ninety (90) calendar days. In the absence of an affirmative response, petitioners will be compelled to consider litigation in order to achieve the agency actions requested

Conclusion.

WHEREFORE, petitioners request that the Administrator to:

(1). Declare that the registration of genetically engineered plants that express the pesticide Bacillus thuringiensis (B.t.) cause an unreasonable adverse effect on the environment;

(2). Cancel the registrations of all genetically engineered plants that express the pesticide B.t. registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA);

(3). Cease and desist from undertaking any new registration procedures and/or determinations of registration for any genetically engineered plants that express the pesticide B.t. in any manner;

(4). Pursuant to 40 C.F.R. Part 154, immediately undertake Special Review procedures for all registered genetically engineered plants that express the pesticide B.t.;

(5). Pursuant to 42 U.S.C. § 4332(c), complete a programmatic environmental impact statement (Programmatic EIS) analyzing the agency's major federal action of registering genetically engineered plant pesticides that express the pesticide B.t. into interstate commerce;

(6). Grant such other relief as the Administrator deems just and proper.
 
 
 
 
 
 

Respectfully submitted,

Joseph Mendelson, III Andrew C. Kimbrell

Int'l. Ctr. for Technology Assessment Int'l. Ctr. for Technology Assessment

310 D Street, N.E. 310 D Street, N.E.

Washington, DC 20002 Washington, DC 20002

ATTORNEYS FOR PETITIONERS

APPENDICES

Table 6. Insect Populations Carrying Resistance to Various B.t. Toxins. back in the text

Species   (Common Name)	Selected with	Resistance Factor
Coleoptera (Beetles)
Chrysomela scripta (Cotton woodleaf beetle)	CryIIIA	3,000
Leptinotarsa decemillineata  (Colorado potato beetle)	CryIIIA	900
Diptera (Flies)
Aedes aegypti (malaria mosquito)	B.t. israeliensis	2
Culex quinquefasciatus (mosquito)	CryIVD	15-70
Lepidoptera (Butterflies)
Cadra cautella (Almond moth)	B.t. kurstaki	3-8
Choristoneura fumiferana (Eastern sprice budworm)	B.t. sotto	4
Heliothis virescens (Tobacco budworm)	CryIA	13-10,000
	CryIF	3,700
Homeosoma electellum (sunflower moth)	B.t. kurstaki	2
Plodia interpunctella (Indian Meal moth)	B.t. kurstaki	8-305
	B.t. aizawai	28-94
	B.t. entomocidus	32
	CryIA	13-128
	CryIC	6
Plutella xylostella (Diamond back moth)	B.t. kurstaki	15-66
	CryIA	59-200
Spodoptera exigua (Beet armyworm/small mottled willow)	B.t. kurstaki	3
	CryIC	1,000
Spodoptera littoralis (Egyptian cotton leafworm)	B.t. kurstaki	1.4
	CryIC	10-500
Trichoplusia ni (Cabbage lopper)	CryIA	31

Sources: Bauer LS (1995), Resistance: A Threat to the Insecticidal Crystal Proteins of Bacillus thuringiensis, Florida Entomologist 78:414-443; Ferré J et al. (1995), Biochemistry and Genetics of Insect Resistance to Bacillus thuringiensis Insecticidal Crystal Proteins, FEMS Microbiology Letters 132:1-7; Müller-Cohn J et al. (1996), Spodoptera littoralis (Lepidoptera: Noctuidae) Resistance to CryIC and Cross-Resistance to Other Bacillus thuringiensis Crystal Toxins, Journal of Economic Entomology 89:791-797.

I hereby certify that a copy of this Petition for Rulemaking and Collateral Relief all materials in support thereof, was served this day of September 1997, by courier and first class mail to:

Joseph Mendelson, III

References

(1)The right to petition for redress of grievances is among the most precious of the liberties safeguarded by the Bill of Rights. United Mine Workers of America, Dist. 12 v. Illinois State Bar Association, 389 U.S. 217, 222, 88 S. Ct. 353, 356, 19 L. Ed. 2d 426 (1967). It shares the "preferred place” accorded in our system of government to the First Amendment freedoms, and has a sanctity and a sanction not permitting dubious intrusions. Thomas v. Collins, 323 U.S. 516, 530, 65 S. Ct. 315, 322, 89 L. Ed. 430 (1945). Any attempt to restrict those First Amendment liberties must be justified by clear public interest, threatened not doubtful or remotely, but by clear and present danger." Id. The Supreme Court has recognized that the right to petition is logically implicit in, and fundamental to, the very idea of a republican form of government. United States v. Cruikshank, 92 U.S. (2 Otto) 542, 552, 23 L. Ed. 588 (1875)back to the text

(2)5 U.S.C. § 553(e) (1995). back to the text

(3)40 C.F.R. § 154.10 (1996). back to the text

(4)(8)William H. McGaughey and Mark E. Whalon, "Managing Insect resistance to Bacillus thuringiensis Toxins,” Science 258: 27 November 1992 at 1451.back to the text back in the text (8)

(5)Asano S, Hori H (1995), Applied Entomology and Zoology 30(2):369-374, cited from: Kumar PA et al. (1997) The insecticidal proteins of Bacillus thuringiensis, in: Advances in Applied Microbiology 42:1-43. .back to the text

(6)List of toxin genes: http://epunix.biols.susx.ac.uk/Home/Neil_Crickmore/Bt/index.html; Toxin Specificity Database, http://www.glfc.forestr.ca/english/res/netintro.html. back to the text

(7)U.S. Environmental Protection Agency. Pesticide Fact Sheet. "Bacillus thuringiensis CryIA(b) Endotoxin and the Genetic Material Necessary for Its Production (Plasmid Vector pCIB4431) in Corn.” (1995) at 3. back to the text

(9)Janet L. Anderson, Acting Director Biopesticide and Pollution Prevention Division, Decision Memorandum, "Consideration of Section 3(c)(7)(B) Conditional Amendment for Nothrup King's Bt Corn Plant-pesticide,” August 2, 1996 at 2. back in the text

(10)Id.

(11)Gianessi l (1995), An economic profile of the U.S. crop protection pesticide industry, National Center for Food and Agricultural Policy, Washington, DC. back in the text

(12)Id.

(13)Pub. L. No. 104-107 (1996). back in the text

(14)Krattiger, Anatole F., Insect resistance in crops: A case study of Bacillus thuringiensis (Bt) and its transfer to developing countries, ISAAA Briefs 2-1997 (1997).

(15)Delta & Pine Land Co., Quarterly Report (SEC form 10-Q), July 15, 1997. back to the text

(16)McGaughey & Whalon 1992. (4) back to the text

(17)46 Fed. Reg. 14445 (February 27, 1981) (noting that cabbage loopers and diamondback moth caterpillars have developed resistance to B.t.). back to the text

(18)51 Fed Reg. 6035 (February 19, 1986) (Application of Monsanto Co. For transgenic corn engineered to express B.t.); See also, 51 Fed Reg 9888 (March 1986) (SAP on corn); See also, 50 Fed Reg. 7644 (February 25, 1985) (Scientific Advisory Panel concerning Monsanto's transgenic B.t. bacteria in soil.). back to the text

(19)See generally, Mark E. Whalon & Deborah L. Norris, "Resistance Management for Transgenic Bacillus thuringiensis plants,” Biotechnology and Development Monitor, pp. 8-12, December 1996. back to the text

(20)McGaughey & Whalon 1992. back to the text

(21)Id. back to the text

(22)Gould F. et al. (1997), "Initial frequency of alleles for resistance to Bacillus thuringiensis toxins in field populations of Heliothis virescens", Proc. Natl. Acad. Sci., USA 94: 3519-3523. back to the text

(23)Bruce E. Tabashnik, et al. (1997), One gene in diamondback moth confers resistance to four Bacillus thuringiensis toxins, Proc. Natl. Acad. Sci. USA 94:1640-1644. back to the text

(24)Zhu, G.R. et al. 1991, Insecticide resistance and management of diamondback moth and imported cabbage worm in P.R. China, in: Resistant Pest Management Newsletter 3(2):25-26.). back to the text

(25)Tabashnik, B.E. et al. 1990. Field development of resistance to Bacillus thuringiensis in diamondback moth. J. Econ. Entomol. 83:1671-1676; Shelton, A.M. et al. 1993. Resistance of Diamondback moth to Bacillus thuringiensis subspecies in the field. J. Econ. Entomol. 86:697-705. back to the text

(26)Syed, A.R. 1992. Insecticide resistance in diamondback moth in Malaysia, pp. 437-442. In N.S. Talekar [ed.]. Management of Diamondback Moth and Other Pests: Proceedings of the 2nd International workshop. AVRDC, Taiwan. back to the text

(27)Tanaka, H. 1992, Occurrence of resistance to Bacillus thuringiensis in diamondback moth, and results of trials for integrated control in a watercress greenhouse, pp. 165-173. In N.S. Talekar [ed.]. Management of Diamondback Moth and Other Crucifer Pests: Proceedings of the 2nd International Workshop. AVRDC, Taiwan. back to the text

(28)Zhao, J.Z. et al. 1993. On-farm insecticide resistance monitoring methods for diamondback moth. Acta Agriculturae Sinica 1(1). back to the text

(29)McGaughey WH, Whalon ME (1992), Managing Insect Resistance to Bacillus thuringiensis Toxins, Science 258:1451-1455; Bruce E. Tabashnik, et al. (1997), One gene in diamondback moth confers resistance to four Bacillus thuringiensis toxins, Proc. Natl. Acad. Sci. USA, Vol. 94, pp.1640-1644. back to the text

(30)Bauer LS (1995), Resistance: A Threat to the Insecticidal Crystal Proteins of Bacillus thuringiensis, Florida Entomologist 78:414-443) back to the text

(31)Van Rie J et al. (1990), Mechanism of Insect Resistance to the Microbial Insecticide Bacillus thuringiensis, Science 229:193-195; Ferré J et al. (1995), Biochemistry and Genetics of Insect Resistance to Bacillus thuringiensis Insecticidal Crystal Proteins, FEMS Microbiology Letters 132:1-7). back to the text

(32)McGaughey WH, Whalon ME (1992), Managing Insect Resistance to Bacillus thuringiensis Toxins, Science 258:1451-1455; Bauer LS (1995), Resistance: A Threat to the Insecticidal Crystal Proteins of Bacillus thuringiensis, Florida Entomologist 78:414-443) back to the text

(33)Tabashnik B et al. (1997), One gene in diamondback moth confers resistance to four Bacillus thuringiensis toxins, Proceedings of the National Academy of Sciences (USA) 94:1640-1644). back to the text

(34)EPA (1995), Pesticide Fact Sheet: Bacillus thuringiensis CryIA(b) -Endotoxin and the Genetic Material Necessary for Its Production (Plasmid Vector pCIB4431) in Corn, p. 13, EPA (1995), Pesticide Fact Sheet: Bacillus thuringiensis kurstaki CryIA© -Endotoxin and Its Controlling Sequences as Expressed in Cotton, p. 13). back to the text

(35)Siegfried et al. (1995), Susceptibility of Filed Populations of the European Corn Borer, Ostrinia nubilalis (Hübner) (Lepidoptera: Pyralidae), to Bacillus thuringiensis (Berliner), Journal of Agricultural Entomology 12:267-273.  back to the text

(36)Dent DR (1993), The Use of Bacillus thuringiensis as an Insecticide. Exploitation of Microorganisms, London: p. 19-44; Bauer LS (1995), Resistance: A Threat to the Insecticidal Crystal Proteins of Bacillus thuringiensis, Florida Entomologist 78:414-443.  back to the text

(37)Tabashnik, B.E. et al. 1990. Field development of resistance to Bacillus thuringiensis in diamondback moth. J. Econ. Entomol. 83:1671-1676.  back to the text

(38)Jorgensen, RB and B. Andersen (1994), Spontaneous hybridization between oilseed rape (Brassica napus) and weedy B. campestris: A risk of growing genetically modified oilseed rape., in: American Journal of Botany 82, 1620-1626; Mikkelsen, T.R., B. Andersen and RB Jorgensen (1996), The risk of crop transgene spread, in: Nature 380, 31; Timmons, AM et al. (1996), Risks from transgenic crops, in: Nature 380, 487. back to the text

(39)Skogsmyr I. (1994), Gene dispersal from transgenic potatoes to conspecifics: A field trial, Theor. Appl. Genet. 88: 770-774).   back to the text

(40)Id.  back to the text

(41)Zeven AC, De Wet JMJ (1982), Dictionary of Cultivated Plants and their Regions of Diversity, Wageningen, p. 181; Harlan JR (1992), Crops and Man 2nd ed.225-226.  back to the text

(42)Zeven AC, De Wet JMJ (1982), Dictionary of Cultivated Plants and their Regions of Diversity, Wageningen, p. 190-192; Harlan JR (1992), Crops and Man 2nd ed.222-223.  back to the text

(43)FAO (1996), State of the World's Plant Genetic Resources for Food and Agriculture.  back to the text

(44)GAO, State of the World's Plant Genetic Resources for Food and Agriculture.  back to the text

(45)Harlan JR (1992), Crops and Man 2nd ed. 229-230.  back to the text

(46)FAO Seed Review 1984-1985, p. 368, 381; Hruska A (ed), Transgenic Bacillus thuringiensis crops in Mesoamerica agriculture: Present and future, Tegucigalpa/Honduras 1997.  back to the text

(47)Application for placing on the market a genetically modified plant (maize protecting itself against corn borers), according to part C of directive 90/220/EC and Commission Decision 92/146/EC, Part A, submitted by Société Anonyme Ciba-Geigy to Commission d'étude de la dissémination des produits issus du génie biomoléculaire, Ministère de l'Agriculture et de la Pêche, France, November 1994, B 13, C 1.3.1., appendix C-8.  back to the text

(48)Gaby Schweizer, "Useful Animals Poisoned By Genetech Corn,” Facts 34: 1997.  back to the text

(49)Id.  back to the text

(50)Venkateswerlu G, Stotzky G (1992), Binding of the Protoxin and Toxin Proteins of Bacillus thuringiensis subsp. kurstaki on Clay Minerals, in: Curr. Microbiol. 25: 225-233.  back to the text

(51)Donegan, K. K. et al (1995), Applied Soil Ecology 2, 111-124).  back to the text

(52)Stotzky G (1980), Surface interactions between clay minerals and microbes, viruses, and soluble organics, and the probable importance of these interactions to the ecology of microbes in soil, in: Berkeley RCM, Lynch JM, Melling J, Rutter RP, Vincent B (eds), Microbial adhesion to surfaces, Chichester: Horwood, S. 231-249; Venkatesverlu G, Stotzky G (1992), op. cit.; Tapp H. and Stotzky G. (1995), Insecticidal Activity of the Toxins from Bacillus thuringiensis subspecies kurstaki and tenebrionis Adsorbed and Bound on Pure and Soil Clays, Appl. Environm. Microbiol., 61, 602-609).  back to the text

(53)60 Fed. Reg. 4910 (January 25, 1995); See also, FIFRA SAP meeting 60 F.R. 4910 (January 25, 1995)(concerning Monsanto's application for registration.)   back to the text

(54)See, e.g., 60 Fed. Reg. 55575 (November 1, 1995).  back to the text

(55)7 U.S.C. § 136, et seq. (1995).  back to the text

(56)As adopted by the National Organic Standards Board, genetically engineered means made with techniques that alter the molecular or cell biology of an organism by means that are not possible under natural conditions or processes. Genetic engineering includes recombinant DNA and RNA techniques, cell fusion, micro- and macro- encapsulation, gene deletion and doubling, introducing a foreign gene and changing the positions of genes. It shall not include breeding, conjugation, fermentation, hybridization, in-vitro fertilization and tissue culture. National Organic Standards Board, "Definitions and Interpretations,” Final Recommendation Addendum Number 25 (November 1, 1995).  back to the text

(57)See generally, 1983 EPA Memo saying FIFRA cover transgenic crops. (Get cite)  back to the text

(58)7 U.S.C. § 136 (bb) (1995).  back to the text

(59)Merrel v. Thomas, 807 F.2d 776, 780 (9th Cir. 1986).  back to the text

(60)See supra, Petition at "Statement of Facts: 1. Resistance Problems.”     back to the text

(61)See supra, Petition at "Statement of Facts: 2. Gene Transfer of B.t. Gene to Non-GMO Crops.”

(62)See supra, Petition at "Statement of Facts: 3. Impact on Nontarget Beneficial Organisms.”    back to the text

(63)Memorandum from Janet L. Andersen, Acting Director, BPPD, to Daniel M. Barolo, Director, OPP, entitled "Consideration of Section 3(c)(7)(B) Conditional Amendment for Northrup King's B.t. Corn Plant-pesticide: Bacillus thruingiensis CryIA(b) Delta-Endotoxin and the Genetic Material Necessary for Its Production in Corn (Plasmid Vector pZ01502) (EPA Registration No. 67979-E),” (August 2, 1996).  back to the text

(64)See infra, Petition at "IV. The Administrative Procedure Act.”  back to the text

(65)Letter from Mark E. Whalon, ed. Resistant Pest Management Newsletter (E.Lansing, MI) "Comment on EPA Registration of B.t.-Transgenic Plants” to Janet Anderson, EPA, Director, Biopesticides and Pollution Prevention Division, March 15, 1997.  back to the text

(66)See e.g., The National Organic Standards Board recommendations allow for the use of B.t.  back to the text

(67)62 Fed. Reg. 26941 (May 16, 1997).  back to the text

(68)Petitioners meet the legal criteria of "interested person.” 40 C.F.R. § 154.1(f) defines person as "an applicant, registrant, manufacturer, pesticide user, environmental group, labor union, or other individual or group of individuals interested in pesticide regulation.  back to the text

(69)See supra, Petition at "Statement of Facts.”  back to the text

(70)62 Fed. Reg. 26941 (May 16, 1997).  back to the text

(71)62 Fed. Reg. 26941, 26942 (May 16, 1997).  back to the text

(72)40 C.F.R. § 154.5 (1996).  back to the text

(73)The proposed regulations define plant pesticide as a pesticidal substance that is produced in a living plant and the genetic material necessary for the production of the substance, where the substance is intended for use in the living plant. 59 Fed. Reg. 60519, 60533, Proposed 40 C.F.R. § 152.3 (November 23, 1994).  back to the text

(74)59 Fed. Reg. 60519 (November 23, 1994).  back to the text

(75)59 Fed. Reg, 60519, 60520 (November 23, 1994). back to the text

(76)59 Fed. Reg 60519, 60520 (November 23, 1994).  back to the text

(77)59 Fed. Reg. 60519, 60520 (November 23, 1994).  back to the text

(78)59 Fed. Reg. 60519, 60520 (November 23, 1994).  back to the text

(79)42 U.S.C. 4332(c).  back to the text

(80)40 C.F.R. §§ 1500-1508 (1996).  back to the text

(81)40 C.F.R. § 1508.18(b)(3) (1996).  back to the text

(82)40 C.F.R. § 1502.4(b) (1996).  back to the text

(83)40 C.F.R. § 1502.4(c)(2) (1996).  back to the text

(84) Kleppe v. Sierra Club, 427 U.S. 390, 409 (1976).  back to the text

(85)40 C.F.R. § 1508.25 (a)(2) (1996).  back to the text

(86)40 C.F.R. § 1508.7 (1996).  back to the text

(87)Scientific Advisory Panels where held ....  back to the text

(88)See, 40 C.F.R. §1500.3 (July 1, 1996); C.E.Q. issued its regulations implementing NEPA in response to President Carter's Executive Order 11991 (1977). See, Andrus v. Sierra Club, 442 U.S. 347, 357 (1979). The Executive Order directed federal agencies to "comply with the regulations issued by the Council." See id., quoting Executive Order No. 11991. The E.P.A. has adopted the C.E.Q. NEPA regulations. 40 C.F.R. § 6.100, et seq.(July 1, 1996); The Supreme Court has held that the regulations are entitled to substantial deference by the courts. Andrus v. Sierra Club at 358; See, also, Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 372 (1989).  back to the text

(89)40 C.F.R. § 1508.18 (1996).  back to the text

(90)See e.g., Gould, F., "Potential and Problems With High Dose Strategies for Pesticidal Engineered Crops,” Biocontrol Science and Technology, 4: 451-461.  back to the text

(91)Bradley, Jr., J.R., "Controlling Cotton Pests,” Science, September 27, 1996.  back to the text

(92)Harris, Marvin, "Controlling Cotton Pests,” Science, September 27, 1996. back to the text

(93)See generally, USDA Forum on Insect Resistance to Bacillus thuringiensis, Bethesda, MD (April 1996); See also, Roush, R.T. "Designing Resistance Management Programs; How Can You Choose,” Pesticide Science,26, 423-441.  back to the text

(94)Whalon & Norris, Resistance Management for Transgenic Bacillus thuringiensis Plants,” Biotechnology and Development Monitor, 29: 8-12, December 1996.  back to the text

(95)See, 62 Fed. Reg. 16434 (April 4, 1997).  back to the text

(96)See, e.g., 60 Fed. Reg. 8657, 8658 (February 15, 1995) (Limited registration of Monsanto's using Bacillus thuringiensis var. kurstaki delta endotoxin as produced by the Cry1A© gene and its controlling sequences in cotton plant).  back to the text

(97)See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 U.S.P.Q. 193 (1980) ("a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter”); See also, Dennis v. Pitner, 106 F.2d 142 (19??). back to the text

(98)See supra, Petition at "Statement of Facts: 1. Resistance Problems.”  back to the text

(99)Joseph L. Sax, The Public Trust Doctrine in Natural Resource: Effective Judicial Intervention, 68 MICH. L. REV. 471, 490 (1970).  back to the text

(100)Phillips Petroleum Co. v. Mississippi, 484 U.S. 469, 98 L.Ed.2d 877, 108 S.Ct. 791 (1988).  back to the text

(101)United States v. Beebe, 127 U.S. 338, 342, 32 L.Ed. 121, 8 S.Ct. 1083 (1888); See also, Light v. United States, 220 U.S. 523, 537, 55 L.Ed. 570, 31 S.Ct. 485 (1911) (public lands held in trust of all of the people); United States v. Trinidad Coal Company, 137 U.S. 160, 170, 34 L.Ed. 640, 11 S.Ct. 57 (1890) (United States land held in trust of all of the people).  back to the text

(102)District of Columbia v. Air Florida, 750 F.2d 1077, 1081 (D.C. Cir. 1984).  back to the text

(103)United States v. Burlington Northern Railroad Co., 710 F.Supp 1286, 1287 (1989); United States v. 1.58 Acres of Land, 523 F.Supp. 120 (D.Mass. 1981) (where the court concluded, in reliance upon the public trust doctrine, that "the federal government is as restricted as the Commonwealth in its ability to abdicate to private individuals its sovereign jus publicum in the land.”); In re Steuart Transportation Co., 495 F.Supp. 38 (E.D.Va. 1980); See also, District of Columbia v. Air Florida, Inc. 750 F.2d 1077, 1084 (D.D.C. 1984) (where the court, after discussing the public trust doctrine, declined to expressly state whether or not it applied to the United States).  back to the text

(104)District of Columbia v. Air Florida, 750 F.2d 1077, 1082 (D.C Cir. 1984).  back to the text

(105)See e.g., Cooperative Research and Development Agreement between Yellowstone National Park/National Park Service and Diversa Corporation, August 17, 1997 (defining wildlife as including but not limited to microorganisms).

(106)See, e.g., 56 Fed. Reg. 10407 (March 12, 1991) (describing in part Forest Service's five year history of using B.t. foliar applications for suppression of gypsy moths).  back to the text

(107)See, Sax 562-65.  back to the text

(108)See supra, Petition at "Statement of Facts.”  back to the text

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Barbara.Kuepper@greenpeace.de