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N-Methyl Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis

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N-Methyl Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES April 15, 2005 MEMORANDUM SUBJECT: Transmittal of Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held February 15 - 18, 2005 on the N-methyl Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis TO: James J. Jones, Director Office of Pesticide Programs FROM: Myrta R. Christian, Designated Federal Official Joseph E. Bailey, Designated Federal Official FIFRA Scientific Advisory Panel Office of Science Coordination and Policy THRU: Larry C. Dorsey, Executive Secretary FIFRA Scientific Advisory Panel Office of Science Coordination and Policy Clifford J. Gabriel, Director Office of Science Coordination and Policy Attached, please find the meeting minutes of the FIFRA Scientific Advisory Panel open meeting held in Arlington, Virginia on February 15 - 18, 2005. This report addresses a set of scientific issues being considered by the Environmental Protection Agency pertaining to the N- methyl carbamate cumulative risk assessment: pilot cumulative analysis. Attachment 1 of 113 cc: Susan Hazen Margaret Schneider Anne Lindsay Margie Fehrenbach Janet Andersen Debbie Edwards Steven Bradbury William Diamond Arnold Layne Tina Levine Lois Rossi Frank Sanders Richard Keigwin Randolph Perfetti William Jordan Douglas Parsons Enesta Jones Vanessa Vu (SAB) Anna Lowit David J. Miller Nelson Thurman Dirk Young David Hrdy Jeff Evans Steve Nako Stephanie Padilla R. Woodrow Setzer Ginger Moser Miles Okino Jerry Blancato Fred Power Curtis Dary Tom Nolan, USGS OPP Docket 2 of 113 FIFRA Scientific Advisory Panel Members Stephen M. Roberts, Ph.D. (Chair of the FIFRA SAP) Janice E. Chambers, Ph.D. H. Christopher Frey, Ph.D. Stuart Handwerger, M.D. Steven G. Heeringa, Ph.D. Gary Isom, Ph.D. Kenneth M. Portier, Ph.D. FQPA Science Review Board Members John Adgate, Ph.D. William Brimijoin, Ph.D. George B. Corcoran, Ph.D. Lutz Edler, Ph.D. Bernard Engel, Ph.D. Scott Ferson, Ph.D. Lawrence Fischer, Ph.D. Natalie Freeman, Ph.D. Gaylia Jean Harry, Ph.D. Dale Hattis, Ph.D. James P. Kehrer, Ph.D. Chensheng Lu, Ph.D. Peter Macdonald, D. Phil. David MacIntosh, Ph.D. Robert Malone, Ph.D. Christopher Portier, Ph.D. Nu-May Ruby Reed, Ph.D., D.A.B.T. Barry Ryan, Ph.D. Michael Sohn, Ph.D. Tammo Steenhuis, Ph.D. Michael D. Wheeler, Ph.D. 3 of 113 SAP Minutes No. 2005-01 A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: N-METHYL CARBAMATE PESTICIDE CUMULATIVE RISK ASSESSMENT: PILOT CUMULATIVE ANALYSIS Session 1: Issues Related to Cumulative Hazard Assessment Session 2: Physiologically Based Pharmacokinetic/ Pharmacodynamic (PBPK/PD) Modeling for Carbaryl Session 3: Drinking Water Exposure Analysis Session 4: N-methyl Carbamate Exposure Assessment: A Pilot Case Study. FEBRUARY 15 - 18, 2005 FIFRA Scientific Advisory Panel Meeting, held at the Holiday Inn - National Airport, Arlington, Virginia 4 of 113 TABLE OF CONTENTS N-Methyl Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis Notice......................................................................................................................6 Introduction...........................................................................................................7 Public Commenters...............................................................................................8 Session 1: Issues Related to Cumulative Hazard Assessment..........................9 Session 2: Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling for Carbaryl......................................................................36 Session 3: Drinking Water Exposure Analysis................................................68 Session 4: N-methyl Carbamate Exposure Assessment: A Pilot Case Study..........................................................................................92 5 of 113 NOTICE These meeting minutes have been written as part of the activities of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP). The meeting minutes represent the views and recommendations of the FIFRA SAP, not the United States Environmental Protection Agency (Agency). The contents of the meeting minutes do not represent information approved or disseminated by the Agency. The meeting minutes have not been reviewed for approval by the Agency and, hence, the contents of these meeting minutes do not necessarily represent the views and policies of the Agency, nor of other agencies in the Executive Branch of the Federal government. Nor does mention of trade names or commercial products constitute a recommendation for use. The FIFRA 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 Agency Administrator on pesticides and pesticide-related issues regarding the impact of regulatory actions on health and the environment. The Panel serves as the 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. Food Quality Protection Act Science Review Board members serve the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP. Further information about FIFRA SAP reports and activities can be obtained from its website at http://www.epa.gov/scipoly/sap/ or the OPP Docket at (703) 305-5805. Interested persons are invited to contact Myrta R. Christian or Joseph E. Bailey, SAP Designated Federal Officials, via e-mail at [email protected] or [email protected]. In preparing the meeting minutes, the Panels carefully considered all information provided and presented by the Agency, as well as information presented by public commenters. This document addresses the information provided and presented by the Agency within the structure of the charge. 6 of 113 INTRODUCTION The FIFRA SAP has completed its review of the set of scientific issues being considered by the Agency pertaining to the N-methyl carbamate pesticide cumulative risk assessment: pilot cumulative analysis. Advance notice of the meeting was published in the Federal Register on January 6, 2005. The review was conducted in an open Panel meeting held in Arlington, Virginia, on February 15 - 18, 2005. The meeting included four separate sessions as follows. • Session 1 - Issues Related to Cumulative Hazard Assessment • Session 2 - Physiologically Based Pharmacokinetic/ Pharmacodynamic (PBPK/PD) Modeling for Carbaryl • Session 3 - Drinking Water Exposure Analysis • Session 4 - N-methyl Carbamate Exposure Assessment: A Pilot Case Study Sessions 1 and 2 were chaired by Dr. Gary Isom and Myrta R. Christian served as the Designated Federal Official. Sessions 3 and 4 were chaired by Dr. Steven Heeringa and Joseph E. Bailey served as Designated Federal Official. A public comment period was held at the beginning of the 4-day meeting on February 15, 2005. 7 of 113 PUBLIC COMMENTERS Oral statements were presented as follows: On behalf of the Natural Resources Defense Council: Jennifer Sass, Ph.D., Natural Resources Defense Council On behalf of Bayer Crop Science: Abraham Tobias, Ph.D. 8 of 113 SAP Minutes No. 2005-01 A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: N-METHYL CARBAMATE PESTICIDE CUMULATIVE RISK ASSESSMENT: PILOT CUMULATIVE ANALYSIS SESSION 1: ISSUES RELATED TO CUMULATIVE HAZARD ASSESSMENT FEBRUARY 15, 2005 FIFRA Scientific Advisory Panel Meeting, held at the Holiday Inn - National Airport, Arlington, Virginia Myrta R. Christian, M.S. Gary Isom, Ph.D. Designated Federal Official FIFRA SAP Session Chair FIFRA Scientific Advisory Panel FIFRA Scientific Advisory Panel Date: April 15, 2005 Date: April 15, 2005 9 of 113 Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel Meeting February 15, 2005 N-METHYL CARBAMATE PESTICIDE CUMULATIVE RISK ASSESSMENT: PILOT CUMULATIVE ANALYSIS SESSION 1: ISSUES RELATED TO CUMULATIVE HAZARD ASSESSMENT PARTICIPANTS FIFRA SAP Session Chair Gary Isom, Ph.D., Professor of Toxicology, School of Pharmacy & Pharmacal Sciences, Purdue University, West Lafayette, IN Designated Federal Official Myrta R. Christian, M.S., FIFRA Scientific Advisory Panel Staff, Office of Science Coordination and Policy, EPA FIFRA Scientific Advisory Panel Members Stuart Handwerger, M.D., Professor of Pediatrics, University of Cincinnati, Children's Hospital Medical Center, Cincinnati, OH Steven G. Heeringa, Ph.D., Research Scientist & Director for Statistical Design, University of Michigan, Institute for Social Research, Ann Arbor, MI Kenneth M. Portier, Ph.D., Associate Professor, Statistics, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL FQPA Science Review Board Members William Brimijoin, Ph.D., Chair, Pharmacology, Mayo Clinic and Medical School, Rochester, MN George B. Corcoran, Ph.D., Professor & Chairman, Department of Pharmaceutical Sciences, Eugene Applebaum College of Pharmacy & Health Sciences, Wayne State University, Detroit, MI Lutz Edler, Ph.D., Head, Biostatistics Unit C060, German Cancer Research Center, Heidelberg, Germany 10 of 113 Scott Ferson, Ph.D., Senior Scientist, Applied Biomathematics, Setauket, NY Lawrence Fischer, Ph.D.,
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