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Scanned Document cc: Eric Bohnenblust Alexandra Dunn Cheryl Dunton Michael Goodis Arnold Layne Anna Lowit Autumn Metzger Jennifer Saunders OPP Docket FIFRA Scientific Advisory Panel: Robert E. Chapin, PhD Joseph Shaw, PhD Sonya K. Sobrian, PhD Clifford P. Weisel, PhD Raymond S.H. Yang, PhD FQPA Science Review Board Members: Arthur Appel, PhD Michael J. Daniels, ScD Marion Ehrich, PhD Jerome Hogsette, PhD Eric Kwok, PhD Lisa Murphy, VMD Weste Osbrink, PhD Michael K. Rust, PhD Jeffrey G Scott, PhD Keith Shockley, PhD Daniel E. Snyder, DVM, PhD Larisa Vredevoe, PhD 2 FIFRA Scientific Advisory Panel Meeting Minutes and Final Report No. 2019-02 Peer Review on EPA Office of Pesticide Programs’ Proposed Guidelines for Efficacy Testing of Topically Applied Pesticides Used Against Certain Ectoparasitic Pests on Pets June 11-14, 2019 FIFRA Scientific Advisory Panel Meeting Held at U.S. Environmental Protection Agency Conference Center Lobby Level One Potomac Yard (South Bldg.) 2777 S. Crystal Drive, Arlington, VA 22202 3 Page Blank 4 NOTICE The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) is a federal advisory committee operating in accordance with the Federal Advisory Committee Act and established under the provisions of FIFRA as amended by the Food Quality Protection Act (FQPA) of 1996. The FIFRA SAP provides advice, information, and recommendations to the U.S. Environmental Protection Agency (EPA or Agency) Administrator on pesticides and pesticide-related issues regarding the impact of regulatory actions on health and the environment. The SAP serves as a primary scientific peer review mechanism of the EPA, Office of Pesticide Programs (OPP), and is structured to provide balanced expert assessment of pesticide and pesticide-related matters facing the Agency. The FQPA Science Review Board members serve the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP. The meeting minutes and final report are provided as part of the activities of the FIFRA SAP. The FIFRA SAP carefully considered all information provided and presented by the Agency, as well as information presented by the public. The minutes represent the views and recommendations of the FIFRA SAP and do not necessarily represent the views and policies of the Agency, nor of other agencies in the Executive Branch of the federal government. The mention of trade names or commercial products does not constitute an endorsement or recommendation for use. The meeting minutes and final report do not create nor confer legal rights nor impose legally binding requirements on the EPA or any other party. The meeting minutes and final report of the June 11-14, 2019, FIFRA SAP meeting represent the SAP’s consideration and review of scientific issues associated with the “Proposed Guidelines for Efficacy Testing of Topically Applied Pesticides Used Against Certain Ectoparasitic Pests on Pets.” Steven Knott, MS, FIFRA SAP Executive Secretary, reviewed the minutes and final report. Robert E. Chapin, PhD, FIFRA SAP Chair, and Suhair Shallal, PhD, Designated Federal Official, certified the minutes and final report that is publicly available on the SAP website at http://www.epa.gov/sap under the heading of “Meetings” and in the public e-docket, Docket No. EPA-HQ-OPP-2019-0161, accessible through the docket portal: http://www.regulations.gov. Further information about FIFRA SAP reports and activities can be obtained from its website at http://www.epa.gov/sap. Interested persons are invited to contact Steven Knott, MS, FIFRA SAP Executive Secretary, via e-mail at [email protected]. 5 TABLE OF CONTENTS NOTICE .......................................................................................................................................... 5 LIST OF ACRONYMS AND ABBREVIATIONS ..................................................................... 10 INTRODUCTION ........................................................................................................................ 11 PUBLIC COMMENTERS ........................................................................................................... 11 EXECUTIVE SUMMARY .......................................................................................................... 12 DETAILED PANEL DELIBERATIONS AND RESPONSE TO CHARGE .............................. 18 LITERATURE CITED ................................................................................................................. 72 6 signatures redacted signatures redacted Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel Meeting June 11-14, 2019 Peer Review of Proposed Guidelines for Efficacy Testing of Topically Applied Pesticides Used Against Certain Ectoparasitic Pests on Pets PARTICIPANTS FIFRA SAP Chair Robert E. Chapin, PhD, Independent Consultant, Preston, Connecticut Designated Federal Official Suhair Shallal, PhD, Environmental Scientist/Designated Federal Official US. Environmental Protection Agency, Washington, District of Columbia 202-564-2057, [email protected] FIFRA Scientific Advisory Panel Members Joseph R. Shaw, PhD, Associate Professor, School of Public and Environmental Affairs, Indiana University, Bloomington, Indiana Sonya K. Sobrian, PhD, Associate Professor, Howard University College of Medicine, Howard University, Washington, District of Columbia Clifford P. Weisel, PhD, Professor, Rutgers University, Piscataway, New Jersey Raymond S.H. Yang, PhD, Professor (Emeritus), College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado FQPA Science Review Board Members Arthur Appel, PhD, Professor of Entomology, Department of Entomology and Plant Pathology, Auburn University, Auburn, Alabama Michael J. Daniels, ScD, Professor, Chair, and Andrew Banks Family Endowed Chair, Department of Statistics, University of Florida, Gainesville, Florida Marion Ehrich, PhD, DABT, Professor of Pharmacology/Toxicology, Virginia-Maryland College of Veterinary Medicine, Blacksburg, Virginia Jerome Hogsette, PhD, Lead Scientist and Research Entomologist, Center for Medical, Agricultural and Veterinary Entomology, U. S. Department of Agriculture, Gainesville, Florida 8 Eric S. C. Kwok, PhD, DABT, Senior Toxicologist, Exposure Assessment Section and Human Exposure & Health Effect Modeling Section, California Department of Pesticide Regulation, Sacramento, California Lisa Murphy, VMD, DABT, Associate Professor of Toxicology, School of Veterinary Medicine University of Pennsylvania, Kennett Square, Pennsylvania Weste Osbrink, PhD, Research Entomologist, U.S. Department of Agriculture-Agricultural Research Service, Knipling-Bushland U.S. Livestock Insect Research Lab, Kerrville, Texas Michael K. Rust, PhD, Distinguished Professor of Entomology and the Graduate Division, University of California Riverside, Riverside, California Jeffrey G. Scott, PhD, Professor of Pesticide Toxicology, Cornell University, Ithaca, New York Keith Shockley, PhD, Staff Scientist, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina Daniel E. Snyder DVM, PhD, Dipl ACVM, EVPC, Owner and Managing Principal, Daniel E. Snyder DVM, PhD Consulting, LLC, Indianapolis, Indiana Larisa Vredevoe, PhD, Professor, Biological Sciences Department, California Polytechnic State University, San Luis Obispo, California 9 LIST OF ACRONYMS AND ABBREVIATIONS ACRONYMS DESCRIPTION a.i. Active ingredient ECHA European Chemicals Agency ELISA Enzyme-Linked Immunosorbent Assay EMEA European Medicines Agency EPA or Agency U.S. Environmental Protection Agency FDA Food and Drug Administration FFDCA Federal Food, Drug and Cosmetics Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPS Food Quality Protection Act GLMM Generalized Linear Mixed Model ICCVAM Interagency Coordinating Committee on the Validation of Alternative Methods NAMS New Approach Methodologies OCSPP Office of Chemical Safety and Pollution Prevention OPP Office of Pesticide Programs OPPTS Office of Prevention, Pesticides and Toxic Substances PBPK Physiologically Based Pharmacokinetic PCR Polymerase-Chain Reaction SAP Scientific Advisory Panel WAAVP World Association for the Advancement of Veterinary Parasitology 10 INTRODUCTION The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) completed its peer review of the set of scientific issues being considered by the U.S. Environmental Protection Agency (EPA or Agency) regarding a new proposed guideline for efficacy testing of topically applied pesticides used against certain ectoparasitic pests on pets. The meeting minutes and final report of the June 11-14, 2019 FIFRA SAP meeting represent the SAP’s consideration and review of scientific issues associated with this topic. Advanced notice of the meeting was published in the Federal Register on April 15, 2019. The review was conducted in an open public meeting held in Arlington, Virginia. The Agency position paper, Charge Questions, and related documents in support of the SAP meeting are posted in the public e-docket at http://www.regulations.gov (ID: EPA-HQ-OPP-2019-0161). Dr. Robert E. Chapin chaired the meeting. Dr. Suhair Shallal served as the Designated Federal Official. In preparing these meeting minutes and final report, the Panel carefully considered all information provided and presented by the Agency presenters, as well as information presented by public commenters. The meeting minutes and final report address the information provided and
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