August 29, 2003
MEMORANDUM
SUBJECT: Transmittal of Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held July 17, 2003
TO: James J. Jones, Director
Office of Pesticide Programs
FROM: Steven M. Knott, 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
Joseph J. Merenda, Jr., 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 July 17, 2003. This report addresses a set of scientific issues being considered by the Environmental Protection Agency regarding the characterization of epidemiology data relating to prostate cancer and exposure to atrazine.
Attachment
cc:
Susan Hazen
Adam Sharp
Anne Lindsay
Janet Andersen
Debbie Edwards
Steven Bradbury
Jay Ellenberger
Arnold Layne
Tina Levine
Frank Sanders
Betty Shackleford
Margaret Stasikowski
Randolph Perfetti
Jerome Blondell
Esther Rinde
William Jordan
Antonio Bravo
Douglas Parsons
Sandy Evalenko
David Deegan
Vanessa Vu (SAB)
OPP Docket
FIFRA Scientific Advisory Panel Members
Christopher J. Portier, Ph.D. (Session Chair)
Stephen M. Roberts, Ph.D. (FIFRA SAP Chair)
Stuart Handwerger, M.D.
Steven G. Heeringa, Ph.D.
Gary E. Isom, Ph.D.
FQPA Science Review Board Members
Frank Bove, Sc.D.
Ellen Gold, Ph.D.
Claudia Hopenhayn, Ph.D.
Lynda Knobeloch, Ph.D.
Ray M. Merrill, Ph.D.
John S. Reif, D.V.M.
Martha S. Sandy, Ph.D.
Elaine Symanski, Ph.D.
Heather Young, Ph.D.
SAP Minutes No. 2003-02
July 17, 2003
FIFRA Scientific Advisory Panel Meeting,
held at the Sheraton Crystal City Hotel,
Arlington, Virginia
A Set of Scientific Issues Being Considered by the
Environmental Protection Agency Regarding:
Characterization of Epidemiology Data Relating to Prostate Cancer and Exposure to Atrazine
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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). These meeting minutes represent the views and recommendations of the FIFRA SAP, not the United States Environmental Protection Agency (Agency). The content of these meeting minutes do not represent information approved or disseminated by the Agency. These meeting minutes have not been reviewed for approval by the Agency and, hence, the contents of this report 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 was 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 Larry Dorsey, SAP Executive Secretary, via e-mail at dorsey.larry@.epa.gov.
In preparing these meeting minutes, the Panel carefully considered all information provided and presented by the Agency presenters, as well as information presented by public commenters. This document addresses the information provided and presented within the structure of the charge by the Agency.
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CONTENTS
PARTICIPANTS 7
INTRODUCTION 8
PUBLIC COMMENTERS 9
CHARGE 11
SUMMARY OF PANEL DISCUSSION AND RECOMMENDATIONS 12
PANEL DELIBERATIONS AND RESPONSE TO CHARGE 13
REFERENCES 26
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SAP Minutes No. 2003-02
July 17, 2003
FIFRA Scientific Advisory Panel Meeting,
Held at the Sheraton Crystal City Hotel,
Arlington, Virginia
A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding:
Characterization of Epidemiology Data Relating to Prostate Cancer and Exposure to Atrazine
Steven M. Knott, M.S. Christopher J. Portier, Ph.D.
Designated Federal Official FIFRA SAP, Session Chair
FIFRA Scientific Advisory Panel FIFRA Scientific Advisory Panel
Date: August 29, 2003 Date: August 29, 2003
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Federal Insecticide, Fungicide, and Rodenticide Act
Scientific Advisory Panel Meeting
July 17, 2003
Characterization of Epidemiology Data Relating to
Prostate Cancer and Exposure to Atrazine
PARTICIPANTS
FIFRA SAP, Session Chair
Christopher J. Portier, Ph.D., Director, Environmental Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC
Designated Federal Official
Mr. Steven M. Knott, FIFRA Scientific Advisory Panel Staff, Office of Science Coordination and Policy, EPA
FIFRA Scientific Advisory Panel Members
Stephen M. Roberts, Ph.D. (FIFRA SAP Chair), Professor & Program Director, University of Florida, Center for Environmental & Human Toxicology, Gainesville, FL
Stuart Handwerger, M.D., Director, Division of Endocrinology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH
Steven G. Heeringa, Ph.D., Research Scientist & Director for Statistical Design, University of Michigan, Institute for Social Research, Ann Arbor, MI
Gary E. Isom, Ph.D., Professor of Toxicology, School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, IN
FQPA Science Review Board Members
Frank Bove, Sc.D., Senior Epidemiologist, Epidemiology & Surveillance Branch, Division of Health Studies, Agency for Toxic Substances and Disease Registry, Atlanta, GA
Ellen Gold, Ph.D., Professor, Department of Epidemiology and Preventive Medicine, University of California Davis, Davis, CA
Claudia Hopenhayn, Ph.D., Assistant Professor, School of Public Health and Markey Cancer Control Program, University of Kentucky, Lexington, KY
Lynda Knobeloch, Ph.D., Research Scientist Supervisor, Research and Toxicology Unit, Bureau of Environmental Health, Wisconsin Department of Health and Family Services,
Madison WI
Ray M. Merrill, Ph.D., Associate Professor, Department of Health Science, Brigham Young University, Provo, UT
John S. Reif, D.V.M., Professor of Epidemiology, Department of Environmental Health, Colorado State University, Fort Collins, CO
Martha S. Sandy, Ph.D., Senior Toxicologist and Chief, Cancer Toxicology and Epidemiology Unit, Reproductive and Cancer Hazard Assessment, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency,
Oakland, CA
Elaine Symanski, Ph.D., Assistant Professor of Environmental Sciences, University of Texas Health Science Center at Houston, School of Public Health, University of Texas,
Houston, TX
Heather Young, Ph.D., Assistant Research Professor, George Washington University,
Washington, DC
INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP) has completed its review of the set of scientific issues being considered by the Agency pertaining to the characterization of epidemiology data relating to prostate cancer and exposure to atrazine. Advance notice of the meeting was published in the Federal Register on May 30, 2003. The review was conducted in an open Panel meeting held in Arlington, Virginia, on July 17, 2003. Dr. Christopher Portier chaired the meeting. Mr. Steven Knott served as the Designated Federal Official.
Dr. Jerome Blondell, (Health Effects Division, Office of Pesticide Programs, EPA) provided the Agency presentation on the characterization of epidemiology data relating to prostate cancer and exposure to atrazine. Dr. Blondell presented results from 3 studies: an occupational cohort study at a manufacturing plant in St. Gabriel, Louisiana; a prospective cohort study of commercial and private applicators in Iowa and North Carolina (the Agricultural Health Study); and a county based study in California that compared pesticide use with cancer incidence rates. In addition, Dr. Blondell presented the Agency's charge questions to the Panel. Ms. Margaret Stasikowski (Director, Health Effects Division, Office of Pesticide Programs, EPA) provided an introduction to the session and also participated in the meeting.
In preparing these meeting minutes, the Panel carefully considered all information provided and presented by the Agency presenters, as well as information presented by public commenters. These meeting minutes address the information provided and presented at the meeting, especially the response to the charge by the Agency.
PUBLIC COMMENTERS
Oral statements were presented as follows:
On behalf of Syngenta Crop Protection, Inc.:
Charles Breckenridge, Ph.D., Syngenta Crop Protection, Inc.
James Simpkins, Ph.D., University of North Texas Health Science Center
Jack Mandel, Ph.D., Emory University, Robert W. Woodruff Health Sciences Center
Hans-Olov Adami, M.D., Karolinska Institutet
Dimitrios Trichopoulos, M.D., Harvard School of Public Health
Patrick Hessel, Ph.D., Exponent
Thomas Smith, Ph.D., Harvard School of Public Health
Harris Pastides, Ph.D., University of South Carolina, Norman J. Arnold School of Public Health
On behalf of the Children's Environmental Health Network, Physicians for Social Responsibility, and American Public Health Association:
Ms. Carol Stroebel, Children's Environmental Health Network
On behalf of the Natural Resources Defense Council, Northwest Coalition for Alternatives to Pesticides, Consumers Union, Beyond Pesticides, American Bird Conservancy, Defenders of Wildlife, Sierra Club and Environmental Working Group:
Jennifer Sass, Ph.D., Natural Resources Defense Council
On behalf of the American Water Works Association:
Alan Roberson, P.E., American Water Works Association
On behalf of the National Center for Food and Agricultural Policy:
Mr. Leonard Gianessi, National Center for Food and Agricultural Policy
On his own behalf:
Daniel Byrd III, Ph.D., D.A.B.T.
On behalf of the Triazine Network:
Mr. Jere White, Triazine Network
Donald Ridley, Ph.D., CANTOX Health Sciences International
On behalf of CropLife America:
James Stevens, Ph.D., Wake Forest University, School of Medicine
On behalf of the National Grain Sorghum Producers Association:
Mr. Edward Gray, law firm of McDermott, Will, and Emery
On behalf of the Hawaii Agriculture Research Center:
Ms. Stephanie Whalen, Hawaii Agriculture Research Center
On behalf of the Center for Regulatory Effectiveness:
Mr. Scott Slaughter, Center for Regulatory Effectiveness
On behalf of the Weed Science Society of America:
Mr. Robert Hedberg, Weed Science Society of America
Written statements were provided by or on behalf of the following groups and individuals:
American Bird Conservancy
American Public Health Association
American Water Works Association
Beyond Pesticides
Daniel Byrd III, Ph.D., D.A.B.T.
Children's Environmental Health Network
Consumers Union
CropLife America
Consultants in Toxicology, Risk Assessment and Product Safety
Defenders of Wildlife
Hawaii Agriculture Research Center
James Huff, Ph.D.
National Center for Food and Agricultural Policy
National Grain Sorghum Producers Association
Natural Resources Defense Council
Northwest Coalition for Alternatives to Pesticides
Physicians for Social Responsibility
Steve Sheffield, Ph.D.
Sierra Club
Syngenta Crop Protection, Inc.
Triazine Network
Weed Science Society of America
CHARGE
Multiple epidemiologic studies have been performed on the herbicide atrazine. These studies have looked at various cancer endpoints, including prostate cancer. The results of a cancer epidemiology study of manufacturing workers found an excess of prostate cancer, but there is strong evidence that some or all of this finding could be an effect of increased screening of workers.
The National Cancer Institute (NCI) and EPA are cooperating on a prospective cohort study of about 90,000 pesticide applicators and their spouses in Iowa and North Carolina. Published results from this study did not find an excess of prostate cancer among commercial or private applicators, primarily in agricultural settings. However, these workers would be expected to have lower exposure to atrazine, at least in terms of duration of exposure, compared to workers at the manufacturing plant.
Question 1
After reviewing the study of manufacturing workers at the Syngenta St. Gabriel plant; the comments of EPA external peer reviewers; public comments from the Syngenta sponsored peer review and the Natural Resources Defense Council; and the supplemental exposure analysis conducted for the St. Gabriel plant workers, EPA has concluded that the increase in prostate cancer observed in the St. Gabriel manufacturing plant workers could be explained by the increase in PSA screening for these workers. Due to the lack of a detailed exposure analysis based on job history and the limited statistical power due to the small sample size, atrazine could not be ruled out as a potential cause but a role for atrazine seems unlikely. Please comment on EPA's conclusion. Please identify any additional data or analyses of the St. Gabriel cohort that the Agency should consider before reaching a final conclusion.
Question 2
Other available studies may assist the assessment of the potential association between atrazine exposure and prostate cancer. Agricultural workers generally have a much shorter duration of exposure compared to workers at a manufacturing plant. In addition, agricultural workers are expected to have a different pattern of exposure compared to manufacturing workers (e.g., intensity, seasonality, routes of exposure). Please comment on comparing the results of the epidemiology study of prostate cancer conducted in the St. Gabriel plant to the results of the Agricultural Health Study, considering that the participants in these two studies were likely to have experienced different exposures. Discuss what such a comparison indicates about the relationship between exposure to atrazine and prostate cancer.
SUMMARY OF PANEL DISCUSSION AND RECOMMENDATIONS
The Panel concluded that the increase in Prostate Specific Antigen (PSA) screening at the St. Gabriel plant likely led to an increase in the detection of cases of prostate cancer. The younger mean age of the cases and the shift to earlier stage at diagnosis compared to the comparison population lend support to this conclusion. However, the Panel also concluded that the evidence presented does not clearly indicate that all of the observed increase in prostate cancer can be attributed to the intensive PSA screening program offered to the St. Gabriel workers. Likewise, the Panel could not rule out the possibility that atrazine exposure may be a contributing factor in the observed increase in prostate cancer incidence. Given the limitations in both the study design and the analysis of the cohort study, at this time a role for atrazine as a potential cause of prostate cancer cannot be considered unlikely.
The St. Gabriel cohort study suffered from several limitations that could lead to negative findings in epidemiologic studies of similar design, particularly with regard to the very small sample size, which can greatly hinder the statistical power to detect an effect, and the limited exposure assessment data and methodology, which could lead to misclassification of worker exposure. Finally, some characteristics of the cohort, particularly its relative young age and the short follow-up period, also limit interpretation of the findings.