PRE-MARKET ENVIRONMENTAL RISK ASSESSMENT OF TRANSGENIC PLANTS A CASE-STUDY APPROACH UTILIZING MON 15985 COTTON AUGUST 2007 This publication was produced for review by the United States Agency for International Development. It was prepared by DAI. PRE-MARKET ENVIRONMENTAL RISK ASSESSMENT OF TRANSGENIC PLANTS A CASE-STUDY APPROACH UTILIZING MON 15985 COTTON Program Title: Short-Term Assistance in Biotechnology Sponsoring USAID Office: EGAT/ESP/IRM Contract Number: EDH-I-00-05-00004-00/01 Contractor: DAI Date of Publication: August 2007 Author: AGBIOS The authors’ views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the United States Government. PRE-MARKET ENVIRONMENTAL RISK ASSESSMENT OF TRANSGENIC PLANTS: A CASE-STUDY APPROACH UTILIZING MON 15985 COTTON MON 15985 Cotton Case Study The development and translation of this case study has been supported by funding from the USAID RAISE-Plus award. August 2007 page 2 of 107 MON 15985 Cotton Case Study TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................ 3 TABLES.......................................................................................................................................... 5 FIGURES ........................................................................................................................................ 6 Introduction ..................................................................................................................................... 7 Environmental Risk Assessment ..................................................................................................... 8 1. Risk Assessment Principles .................................................................................................... 8 1.A Hazard.............................................................................................................................9 1.B Exposure .........................................................................................................................9 1.C Risk Characterization....................................................................................................10 2. Risk Management and Decision Making.............................................................................. 10 3. Environmental Risk Assessment Applied to Transgenic Crops ........................................... 11 International Standards for Environmental Risk Assessment of Transgenic Plants...................... 13 4. The Organization for Economic Cooperation and Development ......................................... 13 4.A Categories of Information .............................................................................................15 4.A-1 Background Information.......................................................................................... 15 4.A-2 Product Characterization ......................................................................................... 16 4.A-3 Environmental Consequences.................................................................................. 17 5. The Cartagena Protocol on Biosafety ................................................................................... 19 6. International Plant Protection Convention............................................................................ 22 Cotton Event MON 15985 Case Study ......................................................................................... 25 7. Introduction to the Case Study.............................................................................................. 25 8. Background Information....................................................................................................... 26 8.A The Host Organism .......................................................................................................26 8.A-1 Taxonomic Description ........................................................................................... 26 8.A-2 Centres of Origin and Genetic Diversity for Cotton................................................ 27 8.A-3 Ploidy of Cotton, its Progenitors and any Sexually Compatible Species ................ 27 8.A-4 Cotton Breeding, Seed Production, and Agronomic Practices ................................ 27 8.A-5 Consumption and uses of Cotton............................................................................. 28 8.A-6 Reproductive Biology.............................................................................................. 28 8.A-7 Distribution of Related Species, including any Evidence of Weediness ................. 31 8.A-8 Common Pests and Diseases of Cotton ................................................................... 32 8.A-9 Potential Interactions with other Organisms............................................................ 34 8.B The Donor Organism(s) ................................................................................................34 page 3 of 107 MON 15985 Cotton Case Study 8.B-1 Identification of Donor Organisms.......................................................................... 34 8.B-2 Safety of the Donor Organisms ............................................................................... 34 8.C The Receiving Environment .........................................................................................36 8.C-1 Occurrence of Sexually Compatible Species, including Feral Populations............. 36 8.C-2 Agronomic Practices................................................................................................ 36 9. Product Characterization ...................................................................................................... 37 9.A Molecular-Genetic Characterization .............................................................................37 9.A-1 Common Methods of Plant Transformation ............................................................ 38 9.A-2 Event MON 531 Transformation Method ............................................................... 41 9.A-3 Event MON 15985 Transformation Method ........................................................... 43 9.A-4 Characterization of the Introduced DNA................................................................. 46 9.A-5 Genetic Stability and Inheritance............................................................................. 54 9.B Expressed Material........................................................................................................56 9.B-1 Protein Expression Levels in Different Plant Tissues ............................................. 57 9.B-2 Protein Equivalency Studies.................................................................................... 62 9.C Phenotypic Characterization .........................................................................................67 9.C-1 Agronomic and Morphological Characteristics....................................................... 67 9.C-2 Efficacy.................................................................................................................... 70 10. Environmental Consequences of Introduction...................................................................... 71 10.A Consequences of Potential Gene Transfer to Related Plants ........................................71 10.B Potential for Establishment and Persistence .................................................................73 10.C Potential Secondary and Non-target Adverse Effects...................................................76 10.C-1 Non-Target Test Organisms .................................................................................... 76 10.C-2 Effects on non-target organisms .............................................................................. 78 10.C-3 Endangered Species Considerations in the United States........................................ 83 10.C-4 Combined effects of Cry1Ac and Cry2Ab2 proteins............................................... 84 10.D Environmental Fate of and Exposure of Expressed Proteins ........................................86 11. Other Considerations ............................................................................................................87 11.A Residual Uncertainties ..................................................................................................87 11.B Insect Resistance Management and Product Stewardship ............................................89 11.C Impacts on Agriculture, Including Benefits of Adoption..............................................89 11.D Surveillance and Monitoring.........................................................................................93 Concluding Comments .................................................................................................................. 94 References ..................................................................................................................................... 95 page 4 of 107 MON 15985 Cotton Case Study TABLES Table 1 Comparison of information requirements under the Cartagena Protocol risk assessment procedure and under OECD guidelines ...............................................20 Table 2 Summary of regulatory approvals for event MON 15985 (June 2007)......................26 Table 3 Cotton growth stages (BIO, 2006)..............................................................................28