Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581 www.regulations.gov Clothianidin and Thiamethoxam Proposed Interim Registration Review Decision Case Numbers 7620 and 7614 January 2020 Approved by: __ _ Elissa Reaves, Ph.D. Acting Director Pesticide Re-evaluation Division Date: __ 1-22-2020 ___ Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581 www.regulations.gov Table of Contents I. INTRODUCTION ................................................................................................................. 4 A. Summary of Clothianidin and Thiamethoxam Registration Review ............................... 5 B. Summary of Public Comments on the Draft Risk Assessments and Agency Responses 9 II. USE AND USAGE ............................................................................................................. 17 III. SCIENTIFIC ASSESSMENTS ........................................................................................... 18 A. Human Health Risks ....................................................................................................... 18 1. Risk Summary and Characterization .......................................................................... 19 2. Human Incidents and Epidemiology ........................................................................... 24 3. Tolerances ................................................................................................................... 25 4. Human Health Data Needs .......................................................................................... 27 B. Ecological Risks ............................................................................................................. 27 1. Risk Summary and Characterization .......................................................................... 28 2. Ecological Incidents .................................................................................................... 41 i. Pollinator Incidents ................................................................................................. 41 ii. Aquatic and Non-Pollinator Terrestrial Incidents .................................................. 42 3. Ecological and Environmental Fate Data Needs ........................................................ 43 C. Benefits Assessment ....................................................................................................... 43 IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION .................................... 50 A. Proposed Risk Mitigation and Regulatory Rationale ..................................................... 50 1. Cancellation of Clothianidin Uses on Bulb Vegetables .............................................. 52 2. Thiamethoxam Use Restrictions for Risks to Occupational Handlers ........................ 52 3. Glove and Respirator Requirements for Certain Occupational Handlers ................... 53 4. Closed System Requirement for Thiamethoxam Corn Seed Treatments ................... 56 5. Poultry House Use Requirements for Clothianidin .................................................... 56 6. Application Rate Reductions ...................................................................................... 57 i. Clothianidin ............................................................................................................ 57 ii. Thiamethoxam ........................................................................................................ 60 7. Crop Stage Restrictions ............................................................................................... 62 i. Clothianidin ............................................................................................................ 62 ii. Thiamethoxam ........................................................................................................ 64 8. Advisory Statements for Clothianidin and Thiamethoxam Seed Treatment Uses ..... 67 9. Residential Ornamental Advisory ............................................................................... 67 2 Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581 www.regulations.gov 10. Spray Drift Reduction and Runoff Reduction ............................................................ 68 11. Pesticide Resistance Management .............................................................................. 73 B. Stewardship .................................................................................................................... 74 C. Tolerance Actions .......................................................................................................... 75 D. Proposed Interim Registration Review Decision ........................................................... 76 E. Data Requirements ......................................................................................................... 76 V. NEXT STEPS AND TIMELINE ........................................................................................ 76 A. Proposed Interim Registration Review Decision ........................................................... 76 B. Implementation of Mitigation Measures ........................................................................ 77 Appendix A: Summary of Proposed Actions for Clothianidin and Thiamethoxam ................. 78 Table 1: Summary of Proposed Actions for Clothianidin ................................................... 78 Table 2: Summary of Proposed Actions for Thiamethoxam ............................................... 79 Appendix B: Proposed Labeling Changes for Clothianidin and Thiamethoxam Products ...... 80 Table 1: Proposed Labeling Changes for Clothianidin Products ........................................ 80 Table 2: Proposed Labeling Changes for Thiamethoxam Products .................................... 91 Appendix C: Endangered Species Assessment ....................................................................... 103 Appendix D: Endocrine Disruptor Screening Program .......................................................... 104 Appendix E: Summary of Proposed Tolerance Actions ............................................................. 106 3 Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581 www.regulations.gov I. INTRODUCTION This document is the Environmental Protection Agency’s (EPA or the agency) Proposed Interim Registration Review Decision (PID) for clothianidin and thiamethoxam (PC Codes 044309 and 060109, case numbers 7620 and 7614, respectively), and is being issued pursuant to 40 CFR §§ 155.56 and 155.58. Clothianidin is a registered pesticide active ingredient but is also a major metabolite and degradate of thiamethoxam. Therefore, the ecological risks for these two chemicals were assessed together and both are included in this combined PID. A registration review decision is the agency's determination whether a pesticide continues to meet, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. Additional information on clothianidin and thiamethoxam, can be found in the EPA’s public docket (EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581) at www.regulations.gov. FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the continuous review of existing pesticides. All pesticides distributed or sold in the United States must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the agency periodically re-evaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at http://www.epa.gov/pesticide-reevaluation. In 2006, the agency implemented the registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The EPA is issuing a PID for clothianidin and thiamethoxam so that it can (1) move forward with aspects of the registration review that are complete and (2) implement interim risk mitigation (see Appendices A and B). The agency is currently working with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (together, the Services) to develop methodologies for conducting national threatened and endangered (listed) species assessments for pesticides in accordance with the Endangered Species Act (ESA) § 7. Therefore, although the EPA has not yet fully evaluated risks to listed species, the agency will complete its listed species assessment and any necessary consultation