Literature review and analysis SENSITIVITY OF WILD PLANT AND CROP SPECIES IN CONTEXT OF 1107/2009 Author: Heino Christl on behalf of the SETAC workshop on “Non-target terrestrial plants” Title: Comparative assessment of the sensitivity of wild plant and crop species to plant protection products and their active substances, evaluated in laboratory and field tests, published data and regulatory (unpublished) studies, in context of Regulation 1107/2009 and the upcoming new Terrestrial Guidance document An initiative of the SETAC tripartite workshop on Terrestrial plants held in Wageningen, April 1-3, 2014 (and extended after the second workshop) Data Requirement Regulation (EC) No 1107/2009, SANCO/10329/2002 rev 2 final (17 October 2002) Realisation: tier3 solutions GmbH Kolberger Strasse 61-63 D-51381 Leverkusen Germany tier3 report number: <B14037 - B15060> Date of Finalisation: 2017-05-19 (yyyy-mm-dd) Sponsors: Responsibilities Sponsors B14037_NTTP Species sensitivity wild plants/crop May 2017 Review of published & confidential data on potential differences in sensitivity between wild plant species and crop species European Crop Protection Association ADAMA Agan Ltd BASF SE Bayer CropScience Dow AgroSciences DuPont Crop Protection FMC Corporation Monsanto Company Realisation Heino Christl tier3 solutions GmbH Kolberger Strasse 61-63 D-51381 Leverkusen Germany Signature and Approval This literature review was written to the current state of scientific knowledge. 2017-05-19 ……………………………………………. Date (yyyy-mm-dd) Dr. Heino Christl Team leader Risk Assessment tier3 solutions GmbH Kolberger Strasse 61-63 D-51381 Leverkusen Germany Phone + 49 (0) 2171 55997 14 page 2 of 227 B14037_NTTP Species sensitivity wild plants/crop May 2017 Review of published & confidential data on potential differences in sensitivity between wild plant species and crop species Table of Contents 1 SUMMARY ............................................................................................................................................... 5 2 INTRODUCTION ....................................................................................................................................... 7 3 MATERIAL AND METHODS....................................................................................................................... 9 3.1 INITIAL STEPS ............................................................................................................................................. 9 3.2 SELECTION CRITERIA .................................................................................................................................. 14 3.3 PRINCIPLE OF COMPARISON ........................................................................................................................ 18 3.4 AUXILIARY ANALYSES ................................................................................................................................. 23 3.5 MULTIPLE REGRESSION ............................................................................................................................. 23 3.6 ADDITIONAL STATISTICAL ANALYSIS (JOHN W. GREEN) .................................................................................... 25 3.7 ABBREVIATIONS FREQUENTLY USED .............................................................................................................. 25 4 RESULTS ................................................................................................................................................ 27 4.1 GENERAL OUTCOME AND INITIAL CONSIDERATIONS ......................................................................................... 27 4.2 SUMMARY OF RESULTS .............................................................................................................................. 28 4.3 MULTIPLE REGRESSION ANALYSIS ................................................................................................................. 33 4.4 FURTHER DETAILS OF THE COMPARISON OF CROPS’ AND WILD PLANT SPECIES’ SENSITIVITY (AUXILIARY ANALYSES) ....... 41 5 DISCUSSION ........................................................................................................................................... 49 5.1 RETRIEVAL OF ENDPOINTS FROM THE LITERATURE ........................................................................................... 49 5.2 QUALITY OF LITERATURE DATA .................................................................................................................... 49 5.3 TEST CONDITIONS ..................................................................................................................................... 51 5.4 WHICH MEASURE OF SENSITIVITY (LOWEST OR AVERAGE ENDPOINTS) TO BE USED ................................................. 53 5.5 OVERALL QUOTIENT APPROACH ................................................................................................................... 54 5.6 HETEROGENEITY OF ENDPOINTS AND SELECTION OF FINAL DATASET .................................................................... 54 5.7 DIFFERENCES IN SENSITIVITY BETWEEN LAB AND FIELD TEST SYSTEMS .................................................................. 56 5.8 BACKGROUND INFORMATION ON THE TWO MOST EXTREME DATASETS. ............................................................... 56 5.9 MULTIPLE REGRESSION ANALYSIS ................................................................................................................. 58 5.10 PROBLEMS CAUSED BY CENSORED ENDPOINTS ................................................................................................ 60 5.11 GERMINABILITY OF CROP AND WILD SPECIES .................................................................................................. 62 5.12 FURTHER ASPECTS POTENTIALLY RELEVANT FOR THE PROTECTION GOAL BUT NOT ASSESSED IN THIS REVIEW ................ 63 5.13 DEFICIENCIES ........................................................................................................................................... 65 5.14 OUTLOOK ............................................................................................................................................... 65 6 CONCLUSION ......................................................................................................................................... 67 7 REFERENCES .......................................................................................................................................... 68 8 APPENDIX 1 - BRIEF SUMMARIES OF THE MOST RELEVANT PAPERS AND THEIR USE FOR THE PRESENT REVIEW .......................................................................................................................................................... 80 9 APPENDIX 2 – LIST OF ACTIVE SUBSTANCES .......................................................................................... 94 10 APPENDIX 3 – LIST OF SPECIES FOR WHICH NUMERIC ENDPOINTS WERE FOUND IN THE LITERATURE OR IN GLP DATA SUBMITTED FOR REGISTRATION ............................................................................................... 96 11 APPENDIX 4 – LIST OF ALL AVAILABLE DATA SETS ................................................................................ 103 12 APPENDIX 5 - LISTS OF TABLES AND FIGURES ...................................................................................... 108 page 3 of 227 B14037_NTTP Species sensitivity wild plants/crop May 2017 Review of published & confidential data on potential differences in sensitivity between wild plant species and crop species 13 APPENDIX 6 - INDIVIDUAL DATA SETS PRESENTED AS FIGURES AND SUMMARIZED IN TABLES ........... 120 14 APPENDIX 6 - ADDITIONAL STATISTICAL ANALYSIS OF CROP AND WILD PLANTS (MULTIPLE REGRESSION) Z. GAO ET AL. ......................................................................................................................... 168 TODOS ......................................................................................................................................................... 168 INTRODUCTION ........................................................................................................................................... 168 RESULTS ....................................................................................................................................................... 168 MDD CALCULATION ........................................................................................................................................... 198 MIXED EFFECT MODELS ....................................................................................................................................... 204 CONCLUSION ............................................................................................................................................... 205 DISCUSSION ................................................................................................................................................. 207 REFERENCES ................................................................................................................................................. 208 USEFUL LINKS .............................................................................................................................................. 208 15 APPENDIX 7 - ADDITIONAL STATISTICAL ANALYSIS OF CROP AND WILD PLANTS (COMPARISONS OF DISTRIBUTIONS – JOHN W. GREEN) ............................................................................................................