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PID Template.FY18Q2.Draft.1.16.18 Docket Number EPA-HQ-OPP-2016-0031 www.regulations.gov Flumethrin Interim Registration Review Decision Case Number 7456 March 2020 Approved by: Elissa Reaves, Ph.D. Acting Director Pesticide Re-evaluation Division Date: 03-17-2020 Docket Number EPA-HQ-OPP-2016-0031 www.regulations.gov Table of Contents I. INTRODUCTION .................................................................................................................. 3 A. Updates since the Proposed Interim Decision was Issued ............................................... 4 B. Summary of Flumethrin Registration Review ................................................................. 4 C. Summary of Public Comments on the Proposed Interim Decision and Agency Responses .................................................................................................................................... 6 II. USE AND USAGE ................................................................................................................. 8 III. SCIENTIFIC ASSESSMENTS .............................................................................................. 8 A. Human Health Risks ......................................................................................................... 8 1. Pyrethroids FQPA Safety Factor Determination .......................................................... 9 2. Risk Summary and Characterization .......................................................................... 11 3. Human Incidents and Epidemiology .......................................................................... 13 4. Tolerances ................................................................................................................... 14 5. Human Health Data Needs ......................................................................................... 14 B. Ecological Risks ............................................................................................................. 14 C. Pet Incidents ................................................................................................................... 15 D. Benefits Assessment ....................................................................................................... 15 IV. INTERIM REGISTRATION REVIEW DECISION............................................................ 16 A. Risk Mitigation and Regulatory Rationale ..................................................................... 16 B. Interim Registration Review Decision ........................................................................... 16 C. Data Requirements ......................................................................................................... 17 V. NEXT STEPS AND TIMELINE .......................................................................................... 17 A. Interim Registration Review Decision ........................................................................... 17 B. Implementation of Mitigation Measures ........................................................................ 17 APPENDICES .............................................................................................................................. 18 Appendix A: Endangered Species Act Determination ................................................................. 18 Appendix B: Endocrine Disruptor Screening Program ............................................................... 19 2 Docket Number EPA-HQ-OPP-2016-0031 www.regulations.gov I. INTRODUCTION This document is the Environmental Protection Agency’s (EPA or the agency) Interim Registration Review Decision (ID) for flumethrin (PC Code 036007 case 7456), and is being issued pursuant to 40 CFR §§ 155.56 and 155.58. 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 flumethrin can be found in the EPA’s public docket (EPA-HQ-OPP- 2016-0031) 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 an ID for flumethrin so that it can move forward with aspects of the registration review that are complete. However, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) § 408(p), the agency will complete endocrine screening for flumethrin before completing registration review. See Appendix B for additional information on the endocrine screening for the flumethrin registration review. Flumethrin (RS)-α-cyano-4-fluoro-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-(EZ)-3-(β,4- dichlorostyryl)-2,2-dimethylcyclopropanecarboxylate; (CAS No. 69770-45-2) is a synthetic pyrethroid insecticide. Flumethrin (first registered in 2012) is contained in a technical grade active ingredient (TGAI) and in one end-use product registered for use as a pet collar (EPA Reg. No. 11556-155) which also includes the neonicotinoid insecticide imidacloprid (CAS 138261- 41-3; PC Code 129099). Flumethrin was not subject to the reregistration requirements of FIFRA, because it was registered in 2012. Flumethrin is contained in pet collars used for the prevention and treatment of ticks, fleas, and lice on dogs and cats. The collars are intended to be left in place for up to 8 months. Flumethrin is a member of the pyrethroids and pyrethrins class of insecticides, which share the same mode 3 Docket Number EPA-HQ-OPP-2016-0031 www.regulations.gov of action. The pyrethroids and pyrethrins work by altering nerve function, causing paralysis in target insect pests, eventually resulting in death of the target pest. The agency has determined that the pyrethroids and pyrethrins share a common mechanism group (http://www.regulations.gov; EPA-HQ-OPP-2008-0489-0006). A screening-level cumulative risk assessment to assess human health risks was completed in 2011. This analysis did not identify cumulative risks of concern for children and adults. For further information, please see the cumulative risk assessment for the pyrethroids/pyrethrins, published on November 9, 2011 (USEPA, 2011a) (available at http://www.regulations.gov; EPA-HQ-OPP-2011-0746). In addition to this flumethrin ID document, in September 2019 the EPA also published its Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals, which summarizes the ecological risk assessment approach and outlines EPA’s mitigation to address potential ecological risks for pyrethroids as a whole. For specific information on the basis for the proposed ecological mitigation measures for the pyrethroids, please refer to the Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals located in the Special Docket for Pyrethroids, Pyrethrins, and Synergists (located at http://www.regulations.gov; EPA-HQ- OPP-2008-0331). However, for flumethrin, there is no reasonable expectation for any registered use to cause direct or indirect adverse effects to federally listed threatened and endangered species. No adverse modification of critical habitat for federally listed species is expected from the use of flumethrin. Due to the nature of the product’s use and low likelihood of exposure for terrestrial and aquatic organisms, the EPA has made a “No Effect” (NE) finding and a “No Modification” (NM) of designated critical habitat determination under the Endangered Species Act (ESA), and is not proposing mitigation for flumethrin. This document is organized in five sections: the Introduction, which includes this summary and a summary of public comments and the EPA’s responses; Use and Usage, which describes how and why flumethrin is used and summarizes data on its use; Scientific Assessments, which summarizes the EPA’s risk and benefits assessments, updates or revisions to previous risk assessments, and provides broader context with a discussion of risk characterization; the Interim Registration Review Decision,
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