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Cry1ab and Cry1f Bacillus Thuringiensis (Bt) Corn Plant-Incorporated Protectants

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Cry1ab and Cry1f Bacillus Thuringiensis (Bt) Corn Plant-Incorporated Protectants Cry1Ab and Cry1F Bt Plant-Incorporated Protectants September 2010 Biopesticides Registration Action Document BIOPESTICIDES REGISTRATION ACTION DOCUMENT Cry1Ab and Cry1F Bacillus thuringiensis (Bt) Corn Plant-Incorporated Protectants U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division Cry1Ab and Cry1F Bt Plant-Incorporated Protectants September 2010 Biopesticides Registration Action Document TABLE OF CONTENTS I. OVERVIEW.....................................................................................................................................................3 A. EXECUTIVE SUMMARY ............................................................................................................................3 B. CRY1AB AND CRY1F BT CORN PLANT-INCORPORATED PROTECTANTS ................................3 C. FOOD CLEARANCE/TOLERANCE EXEMPTION LISTINGS.............................................................6 II. SCIENCE ASSESSMENT............................................................................................................................6 A. PRODUCT CHARACTERIZATION...........................................................................................................6 1. PRODUCT CHARACTERIZATION OF BT 11 CRY1AB CORN (006444) ..........................................................11 2. PRODUCT CHARACTERIZATION OF MON810 CRY1AB CORN (006430) ....................................................13 3. PRODUCT CHARACTERIZATION OF PLANT OPTIMIZED (PO) CRY1F CORN (006481).................................15 4. PRODUCT CHARACTERIZATION OF MAIZE OPTIMIZED (MO) CRY1F CORN (006491) ...............................19 5. PRODUCT CHARACTERIZATION OF MON 810 X TC1507 (CRY1AB X CRY1F) CORN.................................22 B. HUMAN HEALTH ASSESSMENT............................................................................................................23 1. BACKGROUND ...........................................................................................................................................23 2. IN VITRO DIGESTIBILITY ASSAY ................................................................................................................24 3. AMINO ACID HOMOLOGY AND HEAT STABILITY.......................................................................................25 4. ACUTE ORAL TOXICITY.............................................................................................................................25 5. EPA RECOMMENDATION (2001) ...............................................................................................................25 6. HUMAN HEALTH ASSESSMENT OF CRY1AB CROPS, INCLUDING BUT NOT LIMITED TO:...........................25 BT11 CRY1AB BT CORN (006444) AND MON810 CRY1AB BT CORN (006430) ...........................................25 C. ENVIRONMENTAL ASSESSMENT.........................................................................................................44 1. TIERED HAZARD AND RISK ASSESSMENT PROCESS...................................................................................45 2. ENVIRONMENTAL EXPOSURE ASSESSMENT...............................................................................................48 3. NON TARGET WILDLIFE HAZARD ASSESSMENT ........................................................................................58 4. HORIZONTAL TRANSFER OF TRANSGENES FROM BT CROPS TO SOIL ORGANISMS .....................................94 5. GENE FLOW AND WEEDINESS POTENTIAL .................................................................................................94 6. IMPACTS ON THREATENED OR ENDANGERED SPECIES.............................................................................100 7. POTENTIAL INTERACTION BETWEEN CRY1AB AND CRY1F PROTEINS ....................................................101 (MRID 47677802).......................................................................................................................................101 8. ECOLOGICAL RISK ASSESSMENT CONCLUSIONS ......................................................................................101 9. REFERENCES........................................................................................................................................103 D. INSECT RESISTANCE MANAGEMENT..............................................................................................126 E. BENEFITS ASSESSMENT (2001 BT CORN ASSESSMENT).............................................................218 F. BENEFITS ASSESSMENT FOR MOCRY1F CORN (2005 CONCLUSION) ......................................238 III. REGULATORY POSITION ON BT CORN .........................................................................................243 A. OVERVIEW (2001 CONCLUSIONS).....................................................................................................243 B. GENERAL FINDING (2001 CONCLUSIONS).......................................................................................246 C. INSECT RESISTANCE MANAGEMENT (IRM) PROGRAM (2001 CONCLUSIONS) .................247 D. 2010 UPDATE..............................................................................................................................................249 2 Cry1Ab and Cry1F Bt Plant-Incorporated Protectants September 2010 Biopesticides Registration Action Document I. Overview A. EXECUTIVE SUMMARY EPA made the decision to amend the registrations of eighteen (18) expiring Bt corn PIP registrations to extend the expiration dates. We conducted comprehensive assessments of each of these registrations, considering all toxicity and environmental effects data, data from insect resistance monitoring, and insect resistance refuge compliance reports, received and obtained since the last comprehensive evaluation of these products in 2001. Based upon our comprehensive assessment, we reached significant conclusions regarding the positive environmental impact of Bt corn PIPs, and we took several actions to strengthen the insect resistance management requirements to ensure continued success in the prevention of the evolution of resistance in target pests. Since the commercialization of Bt crops, there have been a significant number of published field studies that, combined with the post-registration field studies required to be submitted to the Agency, have demonstrated that non-target invertebrates are generally more abundant in Bt cotton and Bt corn fields than in non-transgenic fields managed with chemical insecticides. Thus, these published and registrant-produced studies demonstrate that, not only are the Bt crops not causing any unreasonable adverse effects in the environment, but, arthropod prevalence and diversity is greater in Bt crop fields. To strengthen insect resistance management of these corn PIPs and to address reports that compliance with the mandated refuge requirements has been decreasing, EPA is requiring enhanced compliance assurance programs (CAPs), and a phased requirement for seed bag labeling that clearly shows the refuge requirements. Also, given the increasing variety of PIP products and combinations, and the differing risk of resistance evolution that the various products represent, we are granting registrations for the corn PIP products for different time frames, based on assessments of their likelihood of forestalling the evolution of insect resistance. We are registering differing categories of products for differing time periods to reflect the assessed level of risk of resistance posed by the various corn PIP products. The scheme that we are following includes registration periods generally of five, eight, and twelve years; with the possibility of a fifteen-year registration period for products that are demonstrated to meet specified criteria. We retain, however, the discretion to register products for time periods differing from these defaults where circumstances warrant. B. Cry1Ab AND Cry1F Bt CORN PLANT-INCORPORATED PROTECTANTS 1. Bt11, Cry1Ab Bt Corn OPP Chemical Code: 006444 3 Cry1Ab and Cry1F Bt Plant-Incorporated Protectants September 2010 Biopesticides Registration Action Document Pesticide Name: Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material (via elements of vector pZO1502) necessary for its production in corn (SYN-BTØ11-1) Trade and Other Names: Bt11, YieldGard, Agrisure®, Attribute™ Uses: Full Commercial Use in Field Corn and Sweet Corn Registrant: Syngenta Seeds, Inc P.O. Box 12257 Research Triangle Park, NC 27709-2257 Registrations: 67979-1 Bt Corn Event Bt11 with Cry 1Ab (Field Corn) 65268-1 Bt Corn Event Bt11 with Cry 1Ab (Sweet Corn) 2. MON810, Cry1Ab Bt Corn OPP Chemical Code: 006430 Pesticide Name: Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material lnecessary for its production (Vestor PV-ZMCT01) in event MON 810 corn (OECD Unique Identifier: MON-ØØ81Ø-6) Trade and Other Names: MON 810, Yieldgard® Uses: Full Commercial Use in Field Corn Registrants: Monsanto Company 700 Chesterfield Parkway North St. Louis, MO 63198 Pioneer Hi-Bred International, Inc. P.O. Box 1000 Johnston, Iowa 50131-1000 Registrations: 524-489 Bt Corn Event MON 810 Cry1Ab 29964-7 1507 (POCry1F) x MON 810 (Cry1Ab) 3. TC1507, Cry1F Bt corn OPP Chemical Code: 006481 4 Cry1Ab and Cry1F Bt Plant-Incorporated Protectants September 2010 Biopesticides Registration Action Document Pesticide Name: Bacillus thuringiensis Cry1F protein and the genetic material (plasmid insert PHI8999A) necessary for its
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