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Regulating
Pesticides
A Report Prepared by the
COMMITTEE ON PROTOTYPE
EXPLICIT ANALYSES FOR PESTICIDES
Environmental Studies Board
Commission on Natural Resources
National Research Council
NATIONAL ACADEMY OF SCIENCES
Washington, D.C. 1980
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NOTICE: The project that is the subject of this report was approved by the Governing Board
of the National Research Council, whose members are drawn from the Councils of the
National Academy of Sciences, the National Academy of Engineering, and the Institute of
Medicine. The members of the Committee responsible for the report were chosen for their
special competences and with regard for appropriate balance.
This report has been reviewed by a group other than the authors according to
procedures approved by a Report Review Committee consisting of members of the
National Academy of Sciences, the National Academy of Engineering, and the Institute of
Medicine.
This study was supported by the Office of Research and Development, U.S. Environmental
Protection Agency, under Contract No. 68-01-3962.
Library of Confess Catalog n Publication Data
National Research Council. Committee on Prototype
Explicit Analyses for Pesticides.
Regulating pesticides.
Bibliography: p.
1. Pesticides policy-United States-Evaluation.
2. Pesticides-Law and legislation-United States.
3. Pesticides-Evaluation. 4. Pesticides-
Environmental aspects. 5. Environmental impact
analysis. I. Title.
SB970.4.USN37 1980
ISBN 0-309-02946-5
A bailable from
Office of Publications
National Academy of Sciences
2101 Constitution Avenue, N.W.
Washington, D.C. 20418
Printed in the United States of America
363.7'384 8~1 1 103
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COMMITTEE ON PROTOTYPE EXPLICIT
ANALYSES FOR PESTICIDES
ROBERT DORFMAN (Chairman), Department of Economics, Harvard
University
VIRGIL H. FREED, Department of Agricultural Chemistry, Oregon State
University
JOSEPH C. HEADLEY, Department of Agricultural Economics, University
of Missouri
DAVID G. KAUFMAN, Department of Pathology, School of Medicine,
University of North Carolina
DAVID P~ENTEL, Department of Entomology, Cornell University
EUGENE P. SESKIN, Resources for the Future, Washington, D.C.
JOSEPH C. STREET, Department of Animal Science, Chemistry, and
Biochemistry, Utah State University
A. DAN TARtOCK, School of Law, Indiana University
Consultants to the Committee
ROBERT BUKANTIS, Cornell University
JOHN KR~EL, Cornell University
Staff
ADELE L. KING, Principal Staff Officer
CONNIE REGES, Project Secretary
RUSSELL SETTLE, Stan Officer (on loan from University of Delaware)
LAWRENCE C. WALLACE, Stan Officer
. . .
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COMMISSION ON NATURAL RESOURCES
GILBERT F. WHITE (Chairman), University of Colorado
WILLIAM C. ACKERMAN, Illinois State Water Survey, Urbana
THOMAS D. BARROW,* Exxon Corporation, New York
JOHN E. CANTLON, Michigan State University
DAYTON H. CLEWELL, Darien, Connecticut
ELLIS B. COWLING, North Carolina State University
JULIUS E. JOHNSON, Dow Chemical U.S.A., Midland, Michigan
ALLEN V. KNEESE, University of New Mexico
CHARLES I. MANKIN, Oklahoma Geological Survey, Norman
PERRY L. McCARTY, Stanford University
CHESTER O. McCORKLE, JR., University of California, Berkeley
H. WILLIAM MENARD, Scripps Institute of Oceanography
NORTON NELSON, New York University Medical Center
WILLIAM K. REILLY, The Conservation Foundation, Washington, D.C.
ALVIN M. WEINBERG, Oak Ridge Associated Universities
E. BRIGHT WILSON, Harvard University
WALLACE D. BOWMAN, Executive Director
*Resigned effective November 22, 1978.
V
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Contents
PREFACE
Acknowledgments, xi
1 SUMMARY AND MAJOR RECOMMENDATIONS
Introduction, 1
Summary and Major Recommendations, 4
Concluding Remarks, 14
References, 16
FIFRA AND THE RPAR PROCESS
Legislative Framework, 18
The RPAR Process: A Description, 28
References, 44
3 SELECTING AND SCHEDULING COMPORTS
FOR ASSESSMENT
Introduction, 46
Current Approach, 47
Recommendations for Establishing a
Preliminary RPAR Queue, 50
Modifications to the Preliminary Ranking:
The Role of Alternative Pesticides, 58
References, 63
4 RISK ASSESSMENT
Introduction, 65
Hazards to Human Health, 66
Analysis of Environmental Risks, 94
vi
1X
18
46
65
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Risks to Structures, Materials, and Crops, 96
Overall Assessment of Risks, 96
References, 96
5 BENEFIT ASSESSMENT
Introduction, 99
Analysis of Pesticide Productivity, 101
Estimating Changes in Pest Control Costs, 105
Economic Evaluation of Productivity and
Cost Effects, 107
References, 129
6 EVALUATION OF THE ~GULATORY OPTIONS:
WEIGHING THE RISKS AND BENEFITS
Introduction, 131
Developing Regulatory Options, 131
Selection of Regulatory Options, 135
References, 153
APPLICATION TO CHLOROBENZILATE
Introduction, 154
Background, 155
Analysis and Assessment of the Risks, 156
An Economic Evaluation of the Benefits, 190
Comparison of RegulatoIy Options, 218
References, 233
APPENDIXES
A Scientific Limitations to Extrapolating Data on Cancer
Risk from Animals to Humans, 239
B The Carcinogenic Activity Indicator, 253
C Estimates of the Carcinogenicity of Chlorobenzilate, 258
D Literature Search on the Biological Aspects of the Use
of the Pesticide Dimethoate, 262
E Estimates of Acre-Treatments for Chlorobenzilate
Substitutes, 279
F Construction of Confidence Intervals for Mathematical
Combinations of Random Variables, 283
G List of Abbreviations Used in This Work, 287
vii
99
131
154
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Preface
Recent years have seen a growing public awareness and concern about
the erects of widespread pesticide use on public health and on ecological
conditions. At the same time it is realized that pesticides make a great
contribution to our ability to produce food and vegetable fibers, to the
amenities afforded by parks and decorative plants of all sorts, and to the
control of pest borne diseases. These opposing realizations have led to
our current policy of regulating the use of pesticides so as to permit it
when the beneficial erects are deemed to outweigh the hazards, but not
otherwise. This policy, in turn, has required the U.S. Environmental
Protection Agency to assess the beneficial erects and the risks entailed in
the use of specific pesticides in specific circumstances, so as to determine
whether regulation was called for and, if so, which specific regulations
would service the public best. In 1970, EPA established the Office of
Pesticide Programs (oPP) for discharging this responsibility. Ever since
then oPP has been developing and applying methods of analysis that
would enable it to reach sound and justifiable judgments. Their
procedures are still evolving.
The National Research Council's Environmental Studies Board has
recently conducted several studies on environmental decision making
(Decision Making for Regulating Chemicals in the Environment and
Principles for Evaluating Chemicals in the Environment) and decision
making in EPA in particular (Decision Making in the Environmental
Protection Agency and Pesticide Decision Making, Volumes II and VII,
IX
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x
Preface
respectively, in Analytical Studies for the U.S. Environmental Protection
Agency). The reports suggest that a methodology that makes explicit the
benefits and risks involved can be applied to environmental decision
making, although with some difficulties. In the early summer of 1977,
therefore, EPA'S Office of Research and Development requested that the
NRC put their previous recommendations to a practical test and attempt
explicit analyses for pesticides that are actually under consideration for
registration or reregistration. The Committee on Prototype Explicit
Analyses for Pesticides (PEAP) was established in early 1978 by the
Environmental Studies Board within the NRC'S Commission on Natural
Resources to respond to EPA'S request.
The Committee was charged originally with implementing three
prototype explicit analyses independently of EPA'S Office of Pesticide
Programs. The Committee soon realized, however, that the study would
be substantially more elective if the Committee and oPP worked closely
together, with oPP providing data and its analyses and the Committee
providing advice and consultation. In this way, the Committee would be
aware of the data and resource constraints under which oPP must work
and would be in a position to recommend methodologies that could be
replicated in the future by EPA without NRC assistance.
Thus, before the Committee first met in April 1978, its charge was
revised. The Committee was asked to provide a single report (instead of
three) describing the procedures and methods it would recommend to
oPP and to include illustrations of the recommendations only where
oPP's reports deviated from the recommended methodology. By agree-
ment between EPA and the NRC, the pesticide chlorobenzilate was chosen
as the illustrative example.
The study was conducted in two phases: an initial period of
observation and self-education followed by the formulation of conclu-
sions and recommendations and their illustration. Between the first
meeting in April and its second in September 1978, individual Commit-
tee members attended EPA working meetings and met in subgroups to
exchange observations and ideas. Committee stab gathered information
and briefed the Committee. In August, the Committee divided into risk
and benefit subgroups, each to focus on its respective aspect of pesticide
assessment.
From September through the end of the study the subgroups met a
total of four times and the full Committee met an additional three times
to discuss risk and benefit assessment methodologies and the weighing of
the two and to develop recommendations to EPA. The Committee's
November meeting was held in the citrus-growing region of Texas, so
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Preface
Xl
that the Committee could meet with individuals directly involved with
chlorobenzilate (a miticide used mainly on citrus).
ACKNOWLEDGMENTS
The nature of this study required exceptional efforts and contributions
on the part of the Committee's stab. The stab consisted of Adele King,
Principal Staff Officer; Connie Reges, Project Secretary; Russell Settle,
Stab Officer; and Lawrence Wallace, Stab Officer. All four were
confronted with unexpected responsibilities for contributing to the work
of the Committee and discharged them admirably. In fact, in addition to
the normal support functions, the stab was called upon to perform most
of the research and much of the writing required to prepare our report.
Anonymity should not be preserved in these conditions. The appropri-
ate credits follow.
Chapter 2. Ms. King gathered most of the factual material used in the
chapter and wrote about half of it.
Chapter 3. All the factual material was gathered by Ms. King, Dr.
Settle, and Mr. Wallace. Ms. King and Dr. Settle collaborated in writing
the entire chapter, including the discussion and explanations of the
recommendations reached by the Committee. Dr. Settle contributed
significantly to the discussion on the role of alternative pesticides.
Chapter 4. The description of the procedures currently followed is the
work primarily of Ms. King. Mr. Wallace provided early drafts of the
discussion of the methods used to estimate human and other exposures.
Much of the responsibility for writing the chapter and for explaining the
Committee's recommendations was borne by Ms. King.
Chapter 5. This chapter is essentially the work of Dr. Settle, who both
formulated the analysis and prepared the final draft with the benefit (or
impediment) of general guidance from members of the Committee.
Chapter 6. The description of the procedures currently followed in oPP
was prepared and written by Ms. King and Dr. Settle.
Chapter 7. The test of chlorobenzilate was conducted and written by
Ms. King, Dr. Settle, and Mr. Wallace under the general supervision of
members of the Committee.
Ms. Connie Rege~s earned the Committee's gratitude by her cheerful
and expeditious discharge of the voluminous paperwork, and by the
unconquerable patience she exhibited in communicating with the
Committee and in coordinating the numerous drafts of this long report.
We also appreciate the assistance from the CNR Editorial Office and the
Manuscript Processing Unit.
It might seem from the forgoing that with such a staff the Committee
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. .
X11
Preface
had nothing to do. This was far from the case, and as Chairman I want
to record my gratitude for the many hours that the members of the
Committee devoted to their tasks, and for their patience in teaching me
the many things that the Chairman of such a Committee has to know
about matters far removed from his own field of specialization.
The Committee expresses its gratitude to EPA'S Office of Pesticide
Programs for its generous cooperation. In particular we thank Deputy
Assistant Administrator Edwin L. Johnson for his support of the
Committee's purpose; Fred Arnold for his willingness to share his
knowledge of oPP's Rebuttable Presumption Against Registration (RPAR)
procedure; and Kevin Keaney, who attended Committee meetings, kept
the Committee current on oPP's activities, and responded patiently to
frequent requests from the Committee and stab for documents and data
from oPP. Others in EPA'S pesticide program and Carcinogen Assessment
Group (CAG) gave freely of their time in thoughtful discussion, among
them Elizabeth Anderson, Arnold Aspelin, Kyle Barbehenn, Nancy
Beach, Joe Boyd, Christen Chaisson, Harold Gaede, Mark Luttner,
David Severn, Ellen Siegler, and Bill Waugh. There were many others.
Our special appreciation is due Roy Albert, Chairman of EPA'S Cancer
Assessment Group; Nathan Karch, Acting Senior Staff for Toxic
Substances and Environmental Health for the Council on Environmen-
tal Quality; and Umberto Saffiotti, Chief of NCI'S Experimental Patholo-
gy Laboratory, for their thoughtful discussions with Committee members
and their suggestions regarding the Committee's recommended cancer
risk assessment methodology. It should be noted that the help of any of
the individuals singled out for thanks above does not imply their
endorsement of Committee findings.
We also thank Michael Wallace, Executive Vice President of Texas
Citrus Mutual, who arranged for the Committee to meet in McAllen,
Texas, with entomologists, researchers, growers, market specialists, and
others directly involved with the pesticide chlorobenzilate and the Texas
citrus industry. Drs. Jon Allen, Robert Brooks, and Joseph Knapp also
attended this meeting, in addition to providing other intonation.
John Krummel searched the literature on biological aspects of
chlorobenzilate which provided background for the section in Chapter 7
on yield ejects. Bob Bukantis did the same for biological aspects of
dimethoate, as presented in Appendix D.
Dr. Alan Carlin, EPA'S Project Officer in charge of our contract,
attended most of our meetings and contributed valuable insights to our
discussion. He was a supportive and understanding colleague throughout
this study, even when its focus shifted from the area he originally
intended, when the Committee reached conclusions that conflicted with
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Preface
. . .
X111
his own convictions, and when the study threatened to continue
endlessly in bland disregard of his deadlines. Needless to say, Dr. Carlin
bears no responsibility for our findings in spite of his indispensable
contributions to our work.
ROBERT DORFMAN, Chairman
Committee on Prototype
Explicit Analyses for Pesticides
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