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Decision
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ANALYTICAL STUDIES FOR THE U.S.
ENVIRONMENTAL PROTECTION AGENCY
VOLUME VII
Pesticide
Decision
Making
A Report to the
U.S. Environmental Protection Agency
from the
Committee on Pesticide Decision Making
Commission on Natural Resources
National Research Council
NATIONAL ACADEMY OF SCIENCES
Washington, D.C. 1978
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NOTICE
The project that is the subject of this report was
approved by the Governing Board of the National
Pesearch 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 requested and funded by the U.S.
Environmental Protection Agency.
Contract No. 68-01-2430
Library of Congress Catalog Card Number 77-94524
International Standard Book Number 0-309-02734-9
Available from
Printing and Publishing Office
National Academy of Sciences
2101 Constitution Avenue
Washington, D.C. 20418
Printed in the United States of America
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COMMITTEE ON PESTICIDE DECISION MAKING
William G. Eden, (Chairman), Lawson State College,
Birmingham, Alabama
Perry L. Adkisson, Texas ASM University, College Station,
Texas
Morris F. Cranmer, National Center for Toxicological
Research, Jefferson, Arkansas
John E. Davies, University of Miami Medical School, Miami,
Florida
Edward H. Glass, New York State Agricultural Experiment
Station, Geneva, New York
Vincent Giglio, Florida Department of Agriculture & Consumer
Services, Tallahassee, Florida
Robert E. Haraman, CIBA-GEIGY Corporation, Greensboro,
North Carolina
Joseph C. Headley, University of Missouri, Columbia,
Missouri
Joseph J. Hickey. University of Wisconsin, Madison,
Wisconsin
Charles E. Palm, Cornell University, Ithaca, New York
Tony J. Peterle, Ohio State University, Columbus, Ohio
Keith E. Shea, U.S. Department of Agriculture,
Wa sh ington, D.C.
Philip J. Spear, National Pest Control Association, Inc.,
Vienna, Virginia
Lucille F. Stickel, U.S. Fish 5 Wildlife Service, Laurel,
Maryland
A. Dan Tarlock, Indiana University, Bloomington, Indiana
Gerald T. Weekman, North Carolina State University, F.aleigh,
North Carolina
Staff
Fred W. Clayton, Principal Staff Officer
Mary Lou Button, Secretary
James E. Tavares, Staff Officer
Lawrence C. Wallace, Staff Officer
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COMMISSION ON NATURAL RESOURCES
Gordon J.F. MacDonald, (Chairman), Dartmouth College
William C. Ackermann, Illinois State Water Survey
Thomas D. Barrow, Exxon Corporation
John E. Cantlon, Michigan State University
Dayton H. Clewell, Mobil Oil Corporation, retired
Harold L. James, U.S. Geological Survey
Julius E. Johnson, Dow Chemical U.S.A.
Allen V. Kneese, University of New Mexico
C.O. McCorkle, Jr., University of California
H. William Menard, Scripps Institute of Oceanography
Norman A. Phillips, National Oceanic and Atmospheric
Administration
William K. Reilly, The Conservation Foundation
Robert M. Solow, Massachusetts Institute of Technology
E. Bright Wilson, Harvard University
Ex Officio Members
Norman Hackerman, Rice University (Chairman, Board on
Energy Studies)
Elburt F. Osborn, Carnegie Institution of Washington
(Chairman Board on Mineral Resources)
Gilbert F. White, University of Colorado (Chairman,
Environmental Studies Board)
Sylvan Wittwer, Michigan State University (Chairman,
Board on Agriculture and Renewable Resources)
Richard A. Carpenter
Executive Director
iv
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BOARD ON AGRICULTURE AND RENEWABLE RESOURCES
Sylvan Wittwer, (Chairman), Michigan State University
Martin E. Abel, University of Minnesota
Willis W. Armistead, College of Veterinary Medicine,
University of Tennessee
Thadis W. Box, College of Natural Resources, Utah State
University
Robert E. Buckman, USDA Forest Service
Marion Clawson, Resources for the Future, Inc.
James H. Copp, Texas AGM University
Ellis B. Cowling, North Carolina State University
William P. Flatt, Agricultural Experiment Stations,
University of Georgia
Robert ?. Hanson, University of Wisconsin
Clarence P. Idyll, National Oceanic and Atmospheric
Administration
A. Carl Leopold, University of Nebraska
Ralph J. McCracken, USDA Agricultural Research Service
C.F. Niven, Jr., Del Monte Corporation
Charles E. Palm, Cornell University
John A. Pino, The Rockefeller Foundation
Glenn W. Salisbury, University of Illinois
Gustav A. Swanson, Colorado State University
D. Wynne Thorne, D. Wynne Thorne and Associates
Philip Ross
Executive secretary
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CONTENTS
FOREWORD vin
PREFACE xi
ACKNOWLEDGMENTS xiii
SUMMARY 1
CHAPTER 1 PESTICIDE REGULATION 13
Introduction 13
Statement of the Problem 13
EPA Pesticide Activities 15
CHAPTER 2 THE ROLE OF DATA IN EPA DECISIONS
ON PESTICIDES 20
Registration and Reregistration 20
Classification 24
Cancellation/Suspension 25
Risk/Benefit Assessment 35
Tolerances 47
Exemptions for Federal and State Agencies 51
Permits for Experimental Uses 52
Minor Uses of Pesticides 53
Research 58
VI
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Monitoring 64
CHAPTER 3 COORDINATION AND COMMUNICATION OF
INFORMATION ON PESTICIDES 70
Information Requirements 70
Sources and Distributors of Pesticide
Information 77
CHAPTER U PERSONNEL FOR PESTICIDE REGULATION 86
CHAPTER 5 INTERNATIONAL IMPACT OF EPA PESTICIDE
DECISIONS 93
Introduction 93
Summary of Responses 94
International Cooperation 99
APPENDIX OUTLINE OF WORKSHOP ON IMPACT OF PESTICIDE
REGULATIONS AND DECISIONS 101
GLOSSARY 104
REFERENCES 105
VI1
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FOREWOP.D
This report is one of a series prepared by the
National Research Council for the U.S. Environmental
Protection Agency.
In June 1973 the Subcommittee on Agriculture,
Environmental, and Consumer Protection of the
Appropriations Committee of the U.S. House of
Representatives held extensive hearings on the
activities of the EPA. The ensuing appropriations bill
for fiscal year 1974 directed the Agency to contract
with the National Academy of Sciences for a series of
analytical advisory studies (87 Stat. 468, PL 93-135).
EPA and the Academy agreed upon a program that would
respond to the Congressional intent by exploring two
major areas: the process of acquisition and use of
scientific and technical information in environmental
regulatory decision making; and the analysis of
selected current environmental problems. The Academy
directed the National Research Council to formulate an
approach to the analytical studies, and the National
Research Council in turn designated the Commission on
Natural Resources as the unit responsible for
supervising the program.
The inside front cover of this volume lists the
other studies in the series, and the inside back cover
presents a diagram of the structure of the program.
Each of the component studies has issued a report of
its findings. Volume I of the series. Perspectives on
Technical Information for Environmental Protection, is
the report of the Steering Committee for Analytical
Studies and the Commission on Natural Resources. It
describes in detail the origins of the program and
summarizes and comments on the more detailed findings
and judgments in the other reports.
This typescript edition is an interim printing made
in limited quantity. The report will be published in a
typeset version during 1977, along with the rest of the
series, and distributed for sale by the Printing and
Publishing Office of the National Academy of Sciences,
2101 Constitution Avenue, N.W., Washington, D.C. 20418.
viii
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Components of the NRC Program of Analytical Studies for the
U.S. Environmental Protection Agency
Project
Project
Chairman
Sponsoring Unit of the NRC
Steering Committee for Analytical R. M. Solow Commission on Natural Resources
Studies (SCAS)
Environmental Decision Making J. P. Ruina
(CEDM)
Environmental Research Assess- J. M. Neuhold
ment (ERAC)
Environmental Monitoring J. W. Pratt
(SGEM)
Environmental Manpower (CSEM) E. F. Gloyna
Energy and the Environment (CEE) S. I. Auerbach
Pesticide Decision Making W. G. Eden
Multimedium Approach to H. 0. Banks
Municipal Sludge Management
Societal Consequences of Trans- W. J. Baumol
portation Noise Abatement
Disposal in the Marine Environment D. S. Gorsline
Review of Management of R. W. Berliner
EPA's Research Activities
Environmental Studies Board,
Committee on Public Engineer-
ing Policy
Environmental Studies Board
Committee on National Statistics,
Environmental Studies Board,
Numerical Data Advisory Board
Commission on Human Resources
Board on Energy Studies
Board on Agriculture and
Renewable Resources,
Environmental Studies Board a
Environmental Studies Board
Assembly of Behavioral and
Social Sciences"
Ocean Affairs Board
Commission on Natural Resources
°In cooperation with the Building Research Advisory Board.
*In cooperation with the Building Research Advisory Board and the Transportation
Research Board.
IX
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Structure of the NRC Program of Analytical Studies for the U.S. Environmental Protection Agency
National Research Council
National Academy ol Sciences
-•»•
-I*-
* 1
Environmental
Decision Making
Study Group on
Environmental
Monitoring1
1
Environmental
Research
Assessment
Committee
Panel on Sources &
Control Techniques
Panel on
Ambient
Monitoring
I I '
Panel on
Source
Monitoring
1 1
Panel on
Fates of
Pollutants
Panefof Effects
of Ambient
Environmental
Quality
1
Panel on
Environmental
Impacts of
Resources
Management
Panel on
Effects
Monitoring
1
Commission on
Natural Resources
1
Steering Committee
for Analytical Studies
1
» t
Committee for
the Study of
Environmental
Manpower2
I
Panel on
Legal Aspects
I
Panel on
Methodology &
National Data
Aspects
I
Panel on Federal
Aspects
I
Panel on State &
Local Aspects
I
Panel on
Industry &
Private Sector
Aspects
Committee on
Energy & the
Environment
|
Panel on Electric
Power (Coal &
Uranium)
I
Panel on
Automot ve
Interactions,
(Oil & Gas)
Committee on
Pesticide
Decision
Making
1
Panel on
Acquisition &
Use of Oata at
Levels
1
Panel on Impacts
of Regulatory
Decisions in
the United States
1
1
Panel on Impacts
of Regulatory
Decisions in
Other Countries
Committee on
Mult'med'um
Approach to
Sludge
Management
Committee on
Societal
Consequences of
Noise Abatement3
Ocean Disposal
Study Steering
Committee
Review Committee
on the
Management of
EPA's Research
Acitvilies
*
' AtwmUly ol Mathematical and Physical Sei*ncet
^Commit! ion on Human Reiouieei
Auemblv ol Behavioral end Social Sci«ncet
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PREFACE
A central concern of the Congress in initiating a
series of analytical studies by the National Academy of
Sciences for EPA related to the use of chemicals to
control pests in agriculture and in and around the home
(U.S. Congress, House 1973). As one of these
analytical studies, this report of the Committee on
Pesticide Decision Making and its recommendations are
directed mainly toward the EPA Office of Pesticide
Programs (OPP). Most of the data considered by the
Committee in preparing the report were collected in the
calendar year 1976. Therefore, the reader should be
cautioned that there have been recent changes in EPA's
pesticide regulatory decision-making process that were
being instituted in 1977 and are not covered in this
report.
The two main thrusts of this study are to assess:
(1) the roles of science and technology in decision
making in the regulation of pesticides, and (2) the
impact of policies and regulations on the availability
and use of pesticides and pest control mechanisms at
federal and state levels. The Committee confined its
attention to pesticides because pest control through
integrated pest management was considered in detail by
a previous Academy committee (NPC 1975b).
EPA and the Committee agreed that this study, which
was done under contract with EPA, should address these
major points: the role of scientists and technicians
in implementing the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended; the scientific input into
EPA's administrative hearings which are held to
determine whether the use of a pesticide should be
cancelled or suspended; exemptions from EPA
regulations; risk/benefit assessments in pesticide
regulation; EPA's conduct of its responsibility to
establish tolerances for pesticide residues under the
Federal Food, Drug, and Cosmetic Act; and the adequacy
of the economic data used by EPA in its regulatory
decisions on crop and other losses resulting from pests
or vector-borne disease. In addition, the Committee
XI
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did a limited investigation of the impact of EPA's
pesticide decisions on other countries.
Three Committee panels gathered and evaluated
information for certain phases of the study. These
were a Federal Panel, which was concerned with EPA's
acquisition and use of scientific and technical
information in its decision making on pesticides; a
State Panel, which was concerned with the various
relationships of state agencies in the federal
regulation of pesticides; and an International Panel,
which was responsible for the study of the impact
outside the United States of EPA decisions on
pesticides. In the development of this report, the
Committee and its Panels sought viewpoints and
recommendations from many different groups, including
environmentalists, trade associations, and professional
societies. The directors of all State Agricultural
Experiment Stations (SAES) and the chemical pesticide
coordinator in each State Cooperative Extension Service
(SCES) also were contacted. In addition, a two-day
workshop was held in which papers representing diverse
viewpoints were presented. The workshop papers are on
file at the Board on Agriculture and Renewable
Resources of the National Research Council, where they
are available for public inspection.
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ACKNOWLEDGMENTS
We wish to acknowledge the assistance of the
following individuals who worked closely with the
Committee and its staff. We are grateful for their
informed opinion and experience. They include: Fred
Abel, U.S. Energy Research and Development
Administration; Jerome Alpert, Silver Spring, Maryland;
J. Lawrence Apple, North Carolina State University;
Irwin Auerbach, EPA; Lucas Brader, Food and Agriculture
Organization of the United Nations; John F.
Copplestone, World Health Organization; Alexander C.
Davis, New York State Agricultural Experiment Station;
Arlen Davison, Washington State University; Boysie Day,
University of California; Errett Deck, U.S. Department
of Agriculture; Terry M. Dworkin, Indiana University;
K. Ross Fitzsimmons, Shell Chemical Company; Virgil H.
Freed, Oregon State University; Charles N. Frommer, New
York Department of Environmental Conservation; William
Furtick, Food and Agriculture Organization of the
United Nations; Ahmad S.K. Ghouri, Pakistan
Agricultural Research Council; Ralph F. Glasser, Shell
Oil Company; Ralph Heal, Oxford, Maryland; John C.
Hillis, California Department of Food and Agriculture;
Harold Hubbard, Pan American Health Organization;
Eugene E. Kenaga, Dow Chemical Company; Ellery Knake,
University of Illinois; Ronald J. Kuhr, New York State
Agricultural Experiment Station; Dean F. Lovitt,
Michigan Department of Agriculture; Gus Mathys,
European Plant Protection Organization; Jose A. Najera,
Pan American Health Organization; L. Dale Newsom,
Louisiana State University; John Osmun, Purdue
University; Vernon Perry, University of Florida; Donald
C. Peters, Oklahoma State University; Maurice Provost,
Florida State Board of Health; Charles Reese, EPA;
Harold T. Reynolds, University of California; John
Piss, Arlington, Virginia; Paul Schnurrenberger, Auburn
University; Edward H. Smith, Cornell University; Ely
Swisher, Rohn and Haas Company; Jay Turim, EPA; Fred H.
Tschirley, Michigan State University; Robert P.
Upchurch, University of Arizona; William Upholt, EPA;
Kenneth Walker, U.S. Department of Agriculture; Edith
Brown-Weiss, Princeton University; and Richard R.
Whetstone, Shell Chemical Company.
xiii
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We also wish to acknowledge our appreciation for
the very helpful editorial assistance of Patricia
Marshall and to Mary Lou Sutton for her able and
tireless secretarial support. Appreciation is also due
to Robert C. Pooney, Philippa Shepherd, Estelle Miller,
and Claire Chow of the editorial staff who generously
provided assistance in preparing this report.
xiv
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SUMMARY
This report is concerned with how EPA acquires and
uses scientific information in its decision-making
functions for the regulation of pesticides. Under the
Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended, EPA has broad and flexible
authority. The Agency determines not only what
compounds may be registered as pesticides but also the
purposes for which they may be used and the methods of
application. Additional authority for EPA's regulation
of pesticides is provided by Sections 408 and 409 of
the Federal Food, Drug, and Cosmetic Act, as amended,
which relate to the control of pesticide residues in
food and feed products. The Office of Pesticide
Programs (OP?) is the unit within EPA with the major
responsibilities for regulating pesticides; other EPA
units have major enforcement and research
responsibilities in this area.
When OPP evaluates a pesticide and decides whether
to permit its registration or reregistration or to ban
or restrict its use, it must determine whether a
pesticide will effectively control the target species
and whether it will not result in "unreasonable adverse
effects" to humans or to the environment. The
unreasonable effects, which FIFRA, as amended, requires
the Agency to take into account in its determinations
about a pesticide, have been defined by EPA (40 CFP
162.11) in these terms: the hazard of acute toxicity
in humans, domestic animals, or wildlife; the hazard of
chronic toxicity (oncogenic effects are induced in
humans or in experimental animals, mutagenic effects
are produced in test animals, significant reductions
will occur in nontarget organisms, or fatalities will
occur in endangered species); or when there is no
antidote or other emergency treatment for toxic effects
resulting from a single exposure to the pesticide. The
OPP determination of efficacy can be made on the basis
of laboratory and field tests and other scientific
procedures. The determination of unreasonable adverse
effects is essentially an administrative determination
involving the concepts of "unreasonable" and "adverse,"
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rather than mathematical absolutes. Scientific
knowledge and data do, however, serve as a basis for
the determination of unreasonable adverse effects to
the degree that it is possible to quantify and predict
the risks to humans or to the environment that may
occur as a result of a pesticide's use.
A major problem that EPA has encountered in the
regulation of pesticides stems from questions about the
adequacy of the data that the Agency uses to make the
complex decisions involved in determinations of whether
a pesticide is likely to cause unreasonable adverse
effects, and particularly the adequacy of its data that
indicate a pesticide's potential for causing cancer.
Scientific investigations of the chronic effects of a
pesticide, such as the potential for carcinogenicity,
are relatively long-term studies that can take two to
three years, may be costly to conduct, and often
produce data that are suggestive rather than absolute.
Not only is this decision making complex, but it is
massive in scale. FIFRA, as amended, requires that in
addition to ruling on new applications for the
registration of pesticides, EPA must review 33,000
pesticides that were approved under earlier and less
stringent legislation. The deadline that was set by
Congress for this review is October 21, 1977. EPA also
must review 4000 tolerances that were set in earlier
years for residues of pesticides in food and feed.
EPA is finding it impossible to implement the
Congressional mandate for review of old registrations.
The difficulty centers on the adequacy of the data that
are needed for the reregistration process. The Agency
has rrore than one million pieces of data in its files,
going back to 1947, and it must catalog and make these
data accessible for reregistration reviews.
Furthermore, when OPP began reviewing some of the older
pesticides for reregistration, it found that in many
cases the data on these pesticides were faulty and
incomplete in terms of present scientific standards and
the requirements of current legislation. OPP proposed
that a new category of "conditional registration" be
used to permit the continued use of many of the
pesticides that are currently registered and used for
food and forage crops, and for structural,
horticultural, forestry and other purposes. The plan
was to continue these registrations on a conditional
basis so that the Agency could organize and assess the
data in its files, and registrants would have
additional time to submit the new data required by
FIFPA, as amended. The proposal met with objections in
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Congress and elsewhere on the grounds that it would
create a double standard, one for new pesticides and
the other for older products. Questions also were
raised about permitting the continued use of pesticides
in the absence of data to establish whether they might
create unreasonable adverse effects to humans or to the
environment. As a result of these problems, EPA has
halted its registration and reregistration of
pesticides.
While the Committee on Pesticide Decision Making is
sympathetic to the diversity and magnitude of the
responsibilities of the Office of Pesticide Programs,
it nevertheless believes that the urgency of the
problems in pesticide regulation calls for prompt and
workable procedures that can be relied upon by all
concerned. This complex and difficult task must be a
cooperative effort by many sectors in our society, with
imaginative and positive leadership provided by EPA.
MAJOB RECOMMENDATIONS
Long-Term Data Needs
The Committee on Pesticide Decision Making believes
that the need for adequate scientific data on which OPP
can base its decisions is a central area of concern.
FIFP.A, as amended, assigns the responsibility to the
applicant for the development of data to support a
registration or reregistration. However, in order to
assess the information that is submitted by interested
parties, OPP must have access to the most complete and
up-to-date scientific data available, and to knowledge
based on experience in the use of particular
pesticides, so that the Agency can make sound
determinations of the possible risks resulting from the
use of these pesticides.
Modern Data System
Some of the data needs can be met within the
Agency, but others will require ntultiagency efforts so
that there will be better coordination of data that are
already available relating to the use of pesticides.
(See Chapter 3.)
• OPP should take the lead in developing a
modern data system to identify important
sources of scientific and technical
information on pesticides and to provide a
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reliable method for collecting, evaluating.
validating, indexing, and computerizing data
on pesticides.
Research on Carcinogens
The Committee believes that a greater national
commitment'must be made to conduct research on
carcinogens in the environment. While such an effort
will not ease the immediate problems of EPA in the
regulation of pesticides, it is clear that this
research is essential for the longer term to address
the persistent and difficult problems of
carcinogenicity that arise in connection with the use
of pesticides. (See Chapter 2.)
• EPA should sponsor research to obtain
broad determinations of the levels of human
exposure to carcinogens in the environment.
In addition, a multiagencv effort should be
undertaken to develop national criteria for
interpreting data on carcinogens, and for
assessing the carcinogenic risks of human
exposures to pesticides.
Risk/Benefit Assessments
The judgmental aspects of EPA decisions on
pesticides are complicated further by the fact that the
Agency is required by law to balance the risks that may
result from the use of a pesticide with the benefits
that may be derived from its use. This involves such
complex issues as weighing any possible increased risks
of cancer if a pesticide is approved against the needs
for pest control measures in agriculture, forestry, and
structural uses, and the costs of food, lumber, and
buildings if damage from pests occurs. The number of
people who might be affected by a decision and the
possibility that some groups of people, such as field
workers, might be unduly affected by some decisions
also must be taken into consideration. Furthermore,
there may be trade-offs that should be made between
hazards to human health in using a pesticide and the
numbers of people who would be protected from a vector-
borne disease if that pesticide were used.
Much of the controversy regarding the use of
economic analysis in guiding pesticide regulation is
focused on the uncertainties in quantifying risks and
benefits. The balancing of risks and benefits is a
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difficult undertaking and requires the adoption of
methods and administrative procedures to ensure that
the most accurate scientific information available is
used in making such judgments. (See Chapter 2.)
• EPA should develop detailed procedures
for assessing the risks and benefits resulting
from the use of a pesticide and for analyzing
trade-offs between the risks and benefits. In
doing so, EPA should seek outside review and
comment from the scientific community.
Coordination of Data Sources
State Coordination
Much of the knowledge about the benefits to be
derived from the use of a pesticide is dispersed
throughout the State Agricultural Experiment Stations,
which do research in agriculture, the State Cooperative
Extension Services, whose educational functions keep
them in close communication with the users of
pesticides, state agencies that regulate pesticides,
public health agencies, departments of natural
resources, and other state organizations. Coordination
among these groups would serve to funnel vital data on
pesticide uses to EPA and, in turn, could serve as a
means of communicating EPA's regulatory decisions on
pesticides to user groups. (See Chapter 3.)
• State agencies regulating the
registration, distribution, and use of
pesticides should have a formal liaison,
either through a state advisory board for
pesticide regulation or through a memorandum
of agreement, with these groups; the State
Agricultural Experiment Stations; State
Cooperative Extension Services; other state
agencies; industry and trade associations; and
public health, environmental, and user groups.
EPA/USDA Coordination
FIFRA, as amended, requires EPA to notify the U.S.
Department of Agriculture (USDA) before issuing a
notice of intent to cancel a pesticide registration or
to change the classification or hold a hearing on a
pesticide. Recently, EPA and USDA signed a memorandum
of understanding to establish an administrative
mechanism for gathering and assessing information for
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benefit/risk assessments whenever EPA finds that a
pesticide meets or exceeds its criteria for
unreasonable adverse effects to humans or to the
environment. If this interagency relationship were
extended to other areas, EPA would have better access
to the extensive resources of USDA in the area of pest
management. (See Chapter 3.)
• The cooperative action undertaken by EPA
and USDA on benefit/risk assessments should be
broadened so that EPA has ready and regular
access to the extensive data resources of OSDA
on all aspects of pest management. For
example. EPA should work with USDA to develop
and conduct a survey, preferably on an annual
basis, of the nation's use of pesticides.
Coordination of Monitoring Data
Environmental monitoring might be an important
source of data for EPA decision making on pesticides.
This monitoring could provide continuous, long-term
information on the residues of pesticides and the
effects of pesticides in air, soil, water, plants, and
in humans and other nontarget species. F1FPA, as
amended, assigns to EPA the responsibility for
implementation of a National Pesticide Monitoring Plan.
Essentially, this gives statutory authority to the
National Pesticide Monitoring Program (NPMP), which
began some years ago as a cooperative effort by several
federal agencies. The effectiveness of the NPMP has
been limited, however, by a lack of coordination among
the federal agencies and a lack of operational
continuity in the program. (See Chapter 2.)
• EPA should accept and act upon its
statutory responsibility for the
implementation of a National Pesticide
Monitoring Plan by determining the data that
are needed for the regulation of pesticides
and by exerting leadership among the federal
agencies with monitoring programs to assure
that the NPMP adequately addresses these
needs.
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Regulatory Aspects
Consideration of Benefits
At present the EPA regulations on pesticides do not
require the consideration of benefits as part of the
EPA Administrator's decision to issue a notice of
intent to deny or to cancel a registration. The
disadvantage of focusing almost exclusively on risks in
the early stages of decision making is that pesticide
uses which are important to the agricultural economy,
to human health, and to protect forests and buildings
are not adequately studied or considered in initial
decisions by the Agency. (See Chapter 2.)
• EPA regulations1 should require, and not
simply permit, the consideratipn of benefits
in determinations of whether to issue a notice
of intent to deny or to cancel a registration.
This would conform with Section 2 fbbl2 of
as amended.
Evaluation by Cancer Experts
The controversy about oncogenesis and mutagenesis
in the regulation of pesticides will continue unabated
until improved methods are available for determinations
of carcinogenic activity and until scientists can agree
on procedures to be used in assessing risks to humans
and to the environment that may result from the use of
pesticide chemicals. EPA must continue to meet its
regulatory responsibilities, however, and should make
use of the most authoritative scientific information
that is now available to evaluate the carcinogenic
potential of pesticides. (See Chapter 2.)
• The carcinogenic potential of any
pesticide that exceeds EPA criteria for
chronic toxicitv (oncogenesis) should be
evaluated by cancer experts. Initially, the
EPA Carcinogen Assessment Group should make
this evaluation, and its conclusions should be
reviewed by other cancer specialists.
Restricted-Use Pesticides
If EPA does not meet the Congressional deadline of
October 21, 1977 for the reregistration and
classification of pesticides, this will severely
undermine the landmark decision of Congress to permit
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the use of some of the more toxic pesticides if they
are classified for restricted use and are applied by
trained and certified personnel so that these
pesticides will be used safely. In order for this
significant feature of FIFKA, as amended, to be
implemented, the Committee on Pesticide Decision Making
believes that EPA should give priority to the
classification of pesticides in the restricted-use
category. (See Chapter 2.)
• OPP should identify all pesticides that
are likely to be placed in a restricted-use
category and give them priority in^the
registration and reregistration process.
Minor-Use Pesticides
A special problem exists in the registration of
pesticides for minor uses. These uses may involve
major pests on minor crops or minor pests on major
crops, but the total volume that is used of these
pesticides is relatively small. The producers of these
pesticides are reluctant to seek registration for minor
uses because the market potential is not great enough
to justify the costs of developing data that are
required for registration. The fruit and vegetable and
other crops on which these pesticides are used,
however, make up a significant part of our diet even
though they are grown in relatively small quantities.
Pesticides also have minor uses in public health,
structural, institutional, vertebrate, aquatic,
ornamental, and veterinary pest control programs. The
Committee on Pesticide Decision Making believes that
EPA should explore the possibility of grouping pests
and grouping crops so that producers of pesticides that
are registered for use on similar pests and similar
crops will not be forced to supply data which in many
respects could be considered duplicative. (See Chapter
2.)
• EPA should investigate the scientific and
regulatory feasibility of adopting the concept
of grouping similar pests and similar crops
when the data on these pests and crops are
related and demonstrate the safety and
efficacy of the pesticides.
Although some relief from the problems involving
the minor uses of pesticides may be obtained through
measures of this kind, the Committee concluded that
these problems also require changes in FIFRA, as
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amended, so that there is an improved statutory basis
for dealing with pesticides that have minor uses. The
following wording has the effect of permitting the use
of a pesticide against a pest that is not specified on
the pesticide label as long as the application is made
to a crop or site that the label does specify. The
Committee recommends that this wording be part of the
changes that Congress is now considering in FIFRA, as
amended:
• EPA should define the phrase, "it shall
be unlawful...to use any registered pesticide
in a manner inconsistent with its labeling,"
as follows;
—application to a crop, animal, or site
not included in the labeling claims, or
—application of an amount of active
ingredient, product per unit area, or
space exceeding those on the labeling, or
—failure to follow restrictions or
limitations on the labeling.
Coordination of Research
The need to coordinate environmental research to
prevent duplication and to enable EPA to get maximum
benefits from the limited funding available for this
purpose is one of the greatest problems facing the
Agency. (See Chapter 2.)
• EPA should clear all contracts and grants
for research on pesticides through its Office
of Research and Development (ORD) to gain
better coordination and centralized technical
review of the research.
Although this clearance procedure might present
some problems for the administrative and technical
personnel in the Office of Pesticide Programs, these
problems are likely to be outweighed by the benefits to
be gained in time, research costs, and the coordination
of information.
Improving the Status of Scientists
The role of scientific data, and of scientists to
evaluate these data, is central to regulatory decision
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making on pesticides. It was evident during the course
of this study that EPA relies heavily upon the
information and knowledge of its scientists and
technicians in determining whether the use of a
particular pesticide is safe or if it appears to meet
or exceed the Agency's criteria of risk to humans or
the environment. In its examination of the
distribution of personnel in the Office of Pesticide
Programs, the Committee concluded, however, that there
are too few top-level positions for scientists in the
OPP divisions. (See Chapter 4).
• Each major OPP division shguld add at
least one senior scientist to its staff;
additional scientists also are needed to
increase OPP effectiveness in several
occupational categories, including toxicology,
pathology, and the mathematical, statistical,
environmental, agricultural, social, and
computer sciences.
OPP also should make it possible for its scientists
to maintain good communications with their peers
outside the Agency so that they can keep up with
developments in their specialized fields.
• EPA should expand the opportunities for
its scientists to communicate with their peers
in the greater scientific community by
encouraging participation in scientific
meetings and by increasing the opportunities
for an exchange of scientists between EPA and
universities and other institutions and
agencies.
OTHER RECOMMENDATIONS
The Committee made a number of specialized
recommendations that are included within relevant
sections of this report. These recommendations relate
to the publication of research studies on pesticides;
the publication of data from monitoring studies on
pesticide residues; the communication of information on
EPA regulatory actions on pesticides to state agencies
and other groups; the improvement of internal
communications within EPA, including the coordination
of scientific effort in the EPA Office of Pesticide
Programs; and the need for international cooperation in
the development of effective pest management and
pesticide regulation programs. Other recommendations
are concerned with procedures that deal with the
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registration of pesticides classified for restricted
use, the disposal of cancelled pesticides, and with the
need for expeditious response by EPA to requests for
experimental use permits and for exemptions from
regular EPA procedures when there are pest outbreaks of
an emergency nature.
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NOTES
40 CFR 162.11 [a] [5] [iii]: "At the time that a
registrant or applicant submits evidence in
rebuttal of the presumption, he may submit evidence
as to whether the economic, social and
environmental benefits of the use of the pesticide
subject to the presumption outweigh the risk of
use. In determining whether to issue a notice
pursuant to section 3(c)(6) or section 6 (b)(1) or
to issue notice of intent to hold a hearing to
determine whether the registration should be
cancelled or denied, in accordance with paragraph
(a)(5)(ii) of this Sec. 162.11, the Administrator
may, in his discretion, take into account staff
recommendations resulting from preliminary
analysis, if any, concerning the balancing of risks
against benefits. Any such preliminary analysis
shall be completed within one hundred and fifty
(150) days from the date notice is sent to the
applicant or registrant in accordance with
subparagraph (1) of this Sec. 162.11 (a). If based
on such analysis the staff recommendation is that
benefits appear to outweigh risks, the
Administrator may, in his discretion, issue notice
of intent to hold a hearing to determine whether
the registration should be cancelled or denied
rather than a notice pursuant to section 6(b)(1) or
section 3 (c) (6) of the Act. If the recommendation
is that benefits do not appear to outweigh the
risks, the Administrator shall issue a notice
pursuant to section 3(c)(6) or section 6(b)(1) of
the Act, as appropriate." (See Chapter 2 for a
discussion of this regulation.)
Section 2 [bb] of FIFRA, as amended: "UNSEASONABLE
ADVERSE EFFECTS ON THE ENVIRONMENT. — The term
•unreasonable adverse effects on the environment1
means any unreasonable risk to man or the
environment, taking into account the economic,
social, and environmental costs and benefits of the
use of any pesticide." (See Chapter 2 for
discussion.)
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CHAPTER j
PESTICIDE ..REGULATION
INTRODUCTION
Pesticide regulation in the United States has
evolved from narrow objectives in which the major
concern was to protect the user of pesticides to a
comprehensive concern for the short- and long-term
effects on human beings and on the environment of the
use of pesticides. The greatest changes were made in
1972, when the Federal Insecticide, Fungicide, and
Rodenticide Act of 1947 (FIFRA) was amended by FEPCA,
the Federal Environmental Pesticide Control Act (PL 92-
516). Further amendments were made to FIFRA in 1975
(PL 94-140). These changes in the law transformed
FIFRA from a registration statute that afforded some
degree of protection to the users of pesticides to a
regulatory statute under which EPA has broad and
flexible authority extending beyond the registration of
pesticides to the control of their use.
Additional EPA legislative authority for pesticide
regulation is provided by Sections 408 (21 USC 346a)
and 409 (21 USC 348) of the Federal Food, Drug, and
Cosmetic Act, which relate to the control of pesticide
residues in food and feed.
STATEMENT OF THE PROBLEM
When EPA evaluates a pesticide and decides whether
to permit its registration or reregistration or to ban
or restrict its use, the Agency must determine that a
pesticide is efficacious for the control of target
species and that it will not result in unreasonable
adverse effects on human beings or the environment.
The first determination can be made on the basis of
scientific procedures alone. The second determination
is also based on scientific data insofar as it is
possible to predict quantitatively the risks resulting
from a particular use of a pesticide; however, the
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ultimate decision of whether this use will pose an
unreasonable risk to humans or to the environment is a
judgmental decision involving determinations of what
constitutes an unreasonable risk and, often, evidence
that is suggestive rather than absolute. EPA's
administrative decisions are further complicated in
this area by the fact that the Agency is required by
law to balance such risks against the benefits to be
derived from the use of a pesticide.
The complex issues relating to benefits and risks
are at the heart of the controversy that has surrounded
EPA since the Agency banned most uses of DDT. For
example: if a particular use of a pesticide will save
farmers several million dollars that they might
otherwise incur in crop losses, if it will help to
provide additional food for thousands of people who
need it, and if it will help to keep the price of
certain foods within reach of the average person, but
at the same time it may cause some additional deaths
from cancer, should EPA permit the product to be
registered and sold? If a pesticide could save a
thousand lives from a vector-borne disease, such as
malaria, but may also cause ten deaths from cancer,
should EPA permit its use? And is it possible to
establish scientific relationships among such data?
What scientific information is available on the
oncogenicity of a pesticide product; what is the
scientific basis for EPA conclusions on potential
oncogenicity; and how and to what extent does EPA
employ scientific findings in its decision making on
pesticides?
The principle that a risk/benefit decision
ultimately is a policy or value judgment is generally
accepted. To be valid in EPA decision making, these
value choices must flow from a scientific foundation
that is carefully laid. This is particularly important
because often it is scientifically impossible or
economically infeasible to acquire information on a
pesticide before it has wide application; out of
necessity, therefore, value judgments based on
scientific information must be substituted for
conclusions that can be supported by evidence. Thus,
scientific input into the EPA decision-making process
should be maximized, and the issue becomes how this can
best be done. But this issue, which is a key to the
sound resolution of problems that are inherent in the
regulation of pesticides, tends to be ignored in the
bitter controversies that have surrounded past
decisions of EPA. Users of pesticides fear that they
will be regulated to the point where pests cannot be
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effectively controlled, with concomitant losses of
food, while opponents of the use of pesticides fear
that people are being poisoned and that irreversible
damage is being done to the environment.
The Committee on Pesticide Decision Making is
concerned about the controversy over pesticides and the
fact that opinions have become polarized over this
issue. Furthermore, many of the arguments put forward
in the controversy have failed to address the question
of how problems in the regulation of pesticides can
best be resolved.
Clearly, risk/benefit analyses must be used in
decision making on pesticide use and control. It is
not possible to state definitely the weight that should
be given to scientific information in these analyses
because of the many uncertainties and unknowns in the
factors involved. At all stages of the decision-making
process, however, EPA should have access to the best
available scientific information and should obtain
adequate peer review of the scientific information it
uses in making decisions. EPA also must aggressively
sponsor and participate in research so that society,
whose exposure to pesticides usually is involuntary,
can make decisions about acceptable risks on the basis
of improved scientific knowledge, especially in
relation to any carcinogenesis that may be caused by
the use of pesticide chemicals. These are among the
central issues discussed in this report, which
recognizes that the complex issues involved in the
nation's effort to regulate pesticides can and must be
resolved.
EPA PESTICIDE ACTIVITIES
The Environmental Protection Agency became
operative on December 2, 1970, after being established
by Reorganization Plan No. 3. The new Agency inherited
several ongoing programs, including those dealing with
pesticide registration from the U.S. Department of
Agriculture (USDA) and those dealing with the setting
of tolerances from the U.S. Department of Health,
Education, and Welfare (HEW). Later, EPA received
expanded directives from the Congress through the 1972
and 1975 Amendments to FIFRA (Public Laws 92-516 and
9i»-140). Although the Agency shares some pesticide
enforcement and related responsibilities with HEW,
USDA, the Occupational Safety and Health
Administration, and the U.S. Department of the
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Interior, under federal law the major regulatory
functions for pesticides now rest 'with EPA.
Office of Pesticide Programs
The EPA component with decision-making functions in
the regulation of pesticides is the Office of Pesticide
Programs (OPP), one of five units that was under the
EPA Assistant Administrator for Water and Hazardous
Materials. The line of administrative responsibility
for the regulation of pesticides now runs from the
Deputy Assistant Administrator of OPP to the Assistant
Administrator for Toxic Substances and Pesticides, and
then ascends to the EPA Deputy Administrator and to the
EPA Administrator. Other branches of EPA that assist
OPP in carrying out some of its responsibilities are
the Office of the Assistant Administrator for
Enforcement, the Office of the Assistant Administrator
for Research and Development, the Office of General
Counsel, and, on occasion, the Office of Solid Waste
Management Programs.
The OPP has eleven functional components (see
Figure 1.1). OPP responsibilities include the
development of strategic plans for the regulation of
pesticides by EPA and by other federal agencies, or by
state, local, and private sectors; establishment of
guidelines and standards for the examination of
pesticide products; the setting of tolerance levels for
pesticide residues occurring in or on food; development
of monitoring requirements for the pesticide program;
review of pesticide formulations and of relevant data
on both the efficacy of a pesticide and any hazards to
human beings or to the environment that may result from
its use; establishment of restrictions governing the
sale and use of pesticides; registration,
reregistration, or denial or cancellation of pesticide
registrations; monitoring of residue levels of
pesticides in food, humans, nontarget species, and the
environment; investigation of pesticide incidents and
accidents; preparation of model legislation for use by
states and other levels of government in developing
more effective programs to regulate pesticides;
provision of program policy direction for technical and
manpower training activities in the area of pesticides;
and identification of research needs for the regulation
of pesticides.
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Deputy Assistant Administrator
for Pesticide Programs
Office of Program Development,
Evaluation, and Administration
Office of Regulatory
and Policy Affairs
Office of Special
Pesticide Reviews
Operations
Division
Assistant for Liaison
Assistant for
Environmental Affairs
Chief, External Affairs
Secretary, Scientific
Advisory Panel
Technical Services
Division
Criteria and
Evaluation Division
Registration
Division
SOURCE: U.S. EPA.
FIGURE 1.1 Organization of EPA Office of Pesticide Programs.
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OPP Divisions and Offices
The OPP units with the principal administrative
responsibilities for the day-to-day operation of the
EPA pesticide program are the Registration Division,
Criteria and Evaluation Division, Technical Services
Division, Operations Division, and the Office of
Special Pesticide Reviews.
The Registration Division has the primary role in
the regulation of pesticides. It is responsible for
the registration of pesticides; the classification of
pesticides for either general or restricted use;
establishment of tolerance levels for pesticide
residues in food and feed; and technical support for
EPA enforcement actions.
The Office of Special Pesticide Reviews (OSPR) was
set up within OPP late in 1975 to review pesticides for
which there is a Rebuttable Presumption Against
Registration (RPAR). A rebuttable presumption occurs
when a pesticide, its metabolites, or its degradation
products meet or exceed the criteria that EPA has
established to determine when a pesticide has
unreasonable adverse effects on humans or the
environment. This office performs in-depth analyses of
the risks and benefits of pesticides that are suspected
of causing unreasonable adverse effects.
The OPP Criteria and Evaluation Division
establishes the standards and criteria used by OPP to
evaluate the safety and efficacy of pesticides in the
registration and reregistration process and to set
tolerances for residues of pesticides in food and feed;
reviews registered pesticide chemicals and assesses the
environmental, human safety, and risk/benefit aspects
of their continued use; provides technical support in
the conduct of regulatory actions and statutory
appeals; and develops guidelines, standards, criteria,
and monitoring requirements for the regulation of
pesticides.
The Technical Services Division operates computer
data systems and provides computer programming support
to meet OPP operating needs; provides information to
other federal and state agencies on the registered uses
of pesticides and on the tolerances for pesticide
residues in food and feed; collects data from pesticide
monitoring programs; produces scientific publications
and provides specialized library and reference
services; supervises OPP laboratory operations; and
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develops analytical reference standards to support
regulatory activities relating to pesticides.
The Operations Division provides program policy
direction for technical assistance and training
programs relating to pesticides; develops model
legislation on pesticides for use by states and helps
states to develop and improve their pesticide programs;
participates in federal interagency activities on
pesticides; and conducts investigations of pesticide
incidents and accidents.
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CHAPTER 2
THE_ROLE OF DATA
EN EPA DECISIONS ON PESTICIDES
Registration is the key procedure in the regulation
of pesticides in the United States. In order to be
marketed, a new pesticide must be registered by EPA for
a restricted or a general use under the provisions of
FIFRA, as amended. The 33,000 pesticides that were
registered by USDA before EPA was set up in 1970, and
by EPA prior to the amendments to FIFRA in 1972 and the
establishment of new registration regulations in 1975,
must be reregistered. This legislation also reguires
that every five years a registered pesticide must
undergo an EPA review similar to that for new
registrations. Thus, in time, all pesticides sold and
used in the United States must have met the
requirements of FIFRA, as amended, and be effective in
their stated use; they must not have unreasonable
adverse effects on human beings or the environment; and
they must be registered by EPA.
In determining whether to register a pesticide use
or to cancel a use already registered, EPA depends upon
the development, evaluation, and use of scientific
data. This chapter is concerned with the vital role of
data in EPA decisions and evaluates how the Agency
gathers and uses data in a number of procedures
involved in pesticide regulation.
REGISTRATION AND REREGISTRATION
Under FIFRA, as amended, data supporting the
registration of pesticides are generated by interested
parties. These data usually are developed by or for
chemical manufacturing firms and are then submitted to
EPA with applications for registration. In compliance
with Section 3(c)(2) of FIFRA, as amended, the Office
of Pesticide Programs is developing guidelines, which
describe the types of data needed for registration and
reregistration, and appendices to these guidelines,
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which contain examples of test procedures that are
acceptable to EPA. The guidelines were published as
proposed informal rules in the Federal Register in June
1975 (U.S. EPA 1975).
The rank's of variables in the proposed guidelines
is expected to apply to most pesticide registrations.
In publishing these proposals, however, EPA stated:
Neither the Guidelines themselves nor the
Appendices are static documents. They will be
expanded and revised periodically to reflect
new scientific knowledge, new trends in
pesticide development, and new Agency
policies...Any applicant who considers that
certain provisions of the Guidelines may not
be appropriate for a particular pesticide
should submit a written statement of his
position, and consult with the Office to
determine what data are necessary in his
particular case.
Proposed registrations of pesticides are routed to
an evaluation team in the OPP Registration Division.
This team is chiefly interested in the chemical aspects
of a pesticide: the common name, if any; the chemical
structure; an assay of its active ingredients and
principal impurities and the methods used for such
determinations; the method of manufacture; the physical
and chemical properties; and other pertinent chemical
information. If this review discloses deficiencies in
the information that has been submitted for
registration, the applicant is notified and asked to
provide whatever additional information is needed.
Next, the application goes to a product manager
team in the Registration Division. The functions of
these teams were outlined in EPA regulations (40 CFR
162.46) :
...each product is assigned to a single team
headed by a Product Manager...Assignment is
generally by active ingredient and use: for
example, one Product Manager handles all
quaternary ammonium disinfectants; another,
all chlorinated hydrocarbons; and a third,
most fumigant-type products. With minor
exceptions, the team to which the product is
assigned handles all registration or other
actions relating to the product, including
registration, amendments to registration,
resubmissions, renewals, petitions for
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tolerance, and, if necessary, cancellations or
suspensions. Exceptions include enforcement
case reviews, distributor brand applications,
and experimental use permits; even in these
cases, the Product Manager is kept informed of
actions affecting his product.
Depending on the background and experience of
individual team members, the review by the product
manager teams includes a study of the efficacy,
phytotoxicity, human safety, and some ecological
effects of the pesticide. The amount of review depends
in part on the quantity and quality of the data
presented in support of the registration, on the
magnitude of changes proposed in the pattern of use,
and on the formulation of the pesticide product and the
presence or absence of any known toxic agents. In
doing these reviews, the product manager teams rely
heavily upon consultation with their peers, comparison
of the data that have been submitted with data in EPA
files for previously registered pesticides that are
identical or similar, and upon their own judgment.
If the proposed registration survives this review,
the application proceeds on its way to registration.
But if the review indicates that the pesticide may have
unreasonable adverse effects on humans or on the
environment, as defined by EPA criteria, the product is
then referred to the O?P Office of Special Pesticide
Reviews (OSPR) who may in turn issue a Rebuttable
Presumption Against Registration (RPAR). The applicant
must then rebut the OPP findings of unreasonable
adverse effects in order to get the pesticide
registered or reregistered. The criteria that trigger
the RPAR process and the process itself are described
in the Cancellation/Suspension section of this chapter.
Congress has directed EPA to review, by October 21,
1977, all pesticides that were registered before the
amendments to FIFRA were enacted and to subject these
pesticides to a reregistration process. The purpose
for this review is to place all pesticides under the
standards for safety of the FIFRA amendments, which are
more stringent than the standards that were in
existence under earlier legislation. This review of
older pesticide products is in addition to EPA's
ongoing responsibilities for processing new
applications for pesticide registration and for the
review of more than 4,000 existing tolerances for
pesticide residues in food or feed (see the section on
Tolerances in this chapter).
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EPA has had many problems in implementing these
Congressional mandates on pesticides. Much of the
difficulty centers on "data gaps" that became apparent
when EPA began reviewing pesticides for reregistration.
In many cases, the available data on older pesticide
products were found to be faulty and incomplete both in
terms of current scientific standards and in terms of
the requirements of FIFRA, as amended, that a pesticide
should not cause any unreasonable adverse effects to
humans or to the environment.
EPA has more than one million pieces of data, going
back to 1947, in its files. These are still being
cataloged for reference purposes and, until a catalog
is available, it is virtually impossible for the Agency
to verify a reference for a piece of data and to
validate these data according to today's standards.
The problems involved in this undertaking also are
great because it is now necessary for the Agency to
assess the oncogenic effects of a pesticide, a major
criterion for the determination of unreasonable adverse
effects under the FIFKA amendments. Oncogenic
potential, and particularly the potential for causing
cancer, is difficult to establish in terms of absolute
scientific proof. Generally, oncogenesis is determined
on the basis of laboratory tests and on an
extrapolation of the results to possible effects in
humans. Much controversy surrounds this entire issue
(see the Cancellation/Suspension section of this
chapter for a more complete discussion of the problem).
In May 1976, EPA attempted to expedite its
reregistration process by creating a new category of
conditional registration for older products that lacked
necessary data. This type of registration would have
permitted pesticides to be sold while laboratory
testing was undertaken to provide the necessary
additional data. At the same time, EPA would require
that new products coming before it for registration for
the first time would need to satisfy all the data
required by FIFRA, as amended. There were widespread
objections to the EPA plan for conditionally
reregistering pesticides on the grounds that it would
continue the double standard for products being
registered and those registered earlier under the old
regulations of FIFEA.
EPA halted its registration and reregistration of
pesticides in August 1976, and it is difficult to
determine how long this situation will continue to
exist. One prediction was made by Dr. Andrew
Breidenbach, then Assistant Administrator of EPA for
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Water and Hazardous Materials, who testified before the
Senate Committee on Agriculture and Forestry in the
spring of 1977 that, "Registration including data
validation for all products will take, at the current
resource level, 10-15 years."
CLASSIFICATION
FIFRA, as amended, requires that all pesticides be
classified for either general or restricted use; this
occurs during registration or reregistration. An EPA
spokesman (Quarles 1975) said classification is:
...one of the most significant innovations in
the history of pesticide
legislation...restricting the use of the more
toxic pesticides to persons of demonstrated
competence enables us to allow the continued
use of chemicals whose adverse effects under
general use conditions could have led to their
cancellation under the 1947 FIFRA [the
legislation before amendment in 1972 and
1975].
Despite continued delays in the EPA reregistration
and classification of pesticides, the certification of
applicators for restricted-use pesticides is proceeding
at a reasonable pace. By April 1, 1977, there were
160,710 commercial applicators and 624,415 private
applicators who had been trained for certification
under plans approved by EPA (personal communication
from L.C. Gibbs, Program Leader for Pesticide
Chemicals, Extension Service, USDA).
If EPA does not meet the Congressional deadline of
October 21, 1977 for the reregistration and
classification of pesticides, this will severely
undermine the landmark decision of Congress to permit
the use of some of the more toxic pesticides if they
are classified for restricted use and are applied by
trained and certified personnel so that they will be
used safely. The publication in December 1976 of a
list of candidates for the restricted-use category of
pesticides has, to some degree, eased the problems
faced by states in completing certification programs
for pesticide applicators. However, this list of
pesticide candidates does not represent a full review
of all pesticide products and does not, therefore,
satisfy the requirement of Congress that EPA classify
all pesticide uses by the October 1977 deadline. In
order for this significant feature of FIFRA, as
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amended, to be implemented, the Committee on Pesticide
Decision Making believes that EPA should give priority
to the classification of pesticides in the restricted-
use category.
Recommendation
• OPP should identify all pesticides that
are likely to be placed in a restricted-use
category and give their priority in the
registration and reregistration process.
CANCELLATION/SUSPENSION
FIFRA, as amended, provides that the registration
of a pesticide will be automatically cancelled five
years after its initial registration unless the
registrant requests an extension. This legislation
also gives the Administrator the authority to cancel
the registration of a pesticide or to change its
classification when there is information indicating
that the product does not comply with provisions of the
Act. Before making a decision of this kind, the
Administrator may hold a hearing to determine whether
action should be taken. A hearing must be held,
however, when an Agency decision to cancel or change
the classification of a pesticide is contested by the
registrant. When a notice is issued of the Agency's
intent to take such action, the Administrator may
suspend the use of the pesticide if it poses an
imminent hazard to human beings or the environment.
Rebuttable Presumption Against Registration
In 1975, EPA issued regulations containing the
criteria and procedures by which pesticides are
screened for possible cancellation and suspension.
These criteria are an administrative determination of
what constitutes "unreasonable adverse effects" under
FIFRA, as amended, and they provide the regulatory
framework for EPA's Rebuttable Presumption Against
Registration (RPAR) process. A rebuttable presumption
exists when a pesticide's ingredients, metabolites, or
degradation products meet or exceed these stated
criteria of risk (HO CFR 162.11):
• when there is a hazard of acute toxicity in
humans, domestic animals, or wildlife (measured by
formulas for lethal doses);
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• when there is a hazard of chronic toxicity—
oncogenic effects (i.e., any tumor) are induced zn
humans or in experimental animals as a result ot oral,
inhalation, or dermal exposure; mutagenic effects are
induced, as determined by multitest evidence; any other
chronic effect is produced in test animals; or it is
expected that the pesticide will significantly reduce
nontarget organisms or be fatal to endangered species;
or
• when there is no antidote or other emergency
treatment for toxic effects in humans from a single
exposure to the pesticide.
When the RPAR process has been set in motion, the
registrant or the reregistrant of the pesticide has the
burden of proving that the anticipated exposure of
persons who use the pesticide or of nontarget organisms
is unlikely to result in any significant adverse
effects of an acute nature. Registrants and
reregistrants must also offer proof that, when the
pesticide is used according to commonly recognized
practices and with proposed restrictions on its use, it
will not concentrate, persist, or accumulate to levels
in humans or in the environment which will result in
any significant adverse effects of a chronic nature.
In addition, the applicant may submit evidence that the
economic, social, and environmental benefits to be
derived from the use of the pesticide outweigh the
risks of its use. Furthermore, in making a decision to
cancel or change the classification of a pesticide, the
Administrator must take into account the impact of this
action on the agricultural economy and on retail food
prices.
The RPAR process is a somewhat involved procedure
which permits a detailed examination of the effects of
using pesticide chemicals that appear to meet or exceed
EPA criteria for "unreasonable adverse effects."
However, it would be a misuse of this procedure, which
is usually lengthy, to employ it for pesticides whose
proposed uses are such that there would not be
unreasonable adverse effects if their registration were
restricted to certain uses.
Recommendation
• The OPP Registration Division should
resolve registration and rereqistration
problems whenever possible before resorting to
the RPAR process if a pesticide will have a
26
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restricted use or when its pattern of use will
not create unreasonable adverse effects.
EPA Criteria for Carcinogenesis
The District of Columbia Circuit Court of Appeals
has had a major role in shaping EPA's interpretation of
its legislative mandate to protect human beings and the
environment from unreasonable adverse effects resulting
from the use of pesticides. Since 1970, this court has
rendered a series of far-reaching decisions on the
regulation of pesticides in which EPA cancellation and
suspension orders were reviewed. In effect, the court
told the Agency to develop a general policy for
interpreting data on risks of cancer resulting from the
use of pesticides. In 1974, the Agency began to
develop principles on which to base its criteria for
the interpretation of such data, and the court has
since held that these principles are part of the
Agency's scientific expertise. Thus, the Agency may
use these principles to interpret data submitted for
use in the EPAE process.
A major controversy over the EPA regulations for
the BPAR process concerns questions about evidence that
a pesticide may have oncogenic effects. Should the
Agency deny or cancel a registration, for example,
because extrapolations from data on mice and other
rodents show carcinogenic potential? Should the Agency
take into account scientific judgments that, even
though there is evidence of a risk of oncogenesis, the
particular use sought for a pesticide would not pose an
unreasonable adverse effect to humans or to the
environment? Given the judgment that "there is no
battery of tests, however elaborate, which can prove
beyond challenge the complete safety of a chemical"
(NEC 1975c), it is difficult for an applicant or
registrant to rebut a presumption of oncogenesis, or
more specifically, of Carcinogenesis, because methods
are not available to quantify the risk. It should be
noted, however, that EPA has not always cancelled all
uses of a pesticide solely on the basis of data showing
a possible risk of oncogenesis. In a few cases,
specific uses of a pesticide have been judged as not
causing unreasonable adverse effects because effective
alternatives were generally not available, the risk of
exposure arising from that specific use was minimal,
and the benefits of the use outweighed the risk.
EPA has organized a Carcinogen Assessment Group
(CAG), made up of senior scientists from the Agency and
27
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experts on cancer from major medical and research
centers, to advise the EPA Administrator on the risks
to health associated with suspected carcinogens. The
CAG meets in response to problems of carcinogenicity
that arise in connection -with any of the Agency's
regulatory programs.
Recommendati on
• The carcinogenic potential of any
pesticide that exceeds EPA criteria for
chronic toxicitv (oncoqenesis) should be
evaluated by cancer experts. Initially, the
EPA Cancer Assessment Group should make this
evaluation, and its conclusions should be
reviewed by other cancer specialists.
Research Needed On Carcinogenesis
Adequate epidemiological data on cancer victims to
detect possible relationships to pesticide use are not
available. Moreover, no toxicological methodology has
been developed which will assure that a pesticide that
induces tumors will—or will not—necessarily induce
cancer. While the relative carcinogenic potential of a
pesticide can be assumed with reasonable accuracy from
the induction of preneoplastic lesions and neoplastic
growth in laboratory mammals, this method of assessing
cancer risks poses many difficulties. Among these
difficulties are problems in estimating risks to human
populations with data derived in tests on rodents and
other small mammals, in extrapolating from experiments
in which massive doses were administered over short
periods of time to form conclusions about the effects
of small doses that are received over long periods of
time, and in identifying a threshold for the
physiological action of a chemical.
More recently, data and information have been
acquired on the use of bacterial, cell culture, tissue
culture, and other in vitro techniques. These
techniques have serious drawbacks in determining the
carcinogenic potential of a pesticide. For example,
the in vitro results, obtained in an artificial
setting, may bear no direct relationship to the in vivo
effects of pesticides in human beings. Despite these
limitations, in vitro and in vivo tests offer the best
available mechanism of prescreening for prediction of
carcinogenic potential.
28
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The problem of estimating cancer risks to humans
due to exposures to chemicals is not unique to EPA/OPP,
and it goes far beyond the regulation of pesticides.
There are fundamental similarities in the problems
encountered by EPA and other federal regulatory
agencies in estimating the risks to humans from
exposures to vinyl chloride, asbestos, DDT,
diethylstilbestrol residues in beef. Red Dyes #2 and
#40, benzene, nitrosamines, aflatoxin, chloroform, and
other chemicals.
The controversy about oncogenesis and mutagenesis
in the regulation of pesticides will continue unabated
until improved methods are available for determinations
of carcinogenic activity and until scientists agree on
procedures to be used to assess risks to humans and to
the environment resulting from the use of chemicals.
Research supported by FDA and EPA at the National
Center for Toxicological Research is directed at some
of the data requirements for the regulation of
pesticide chemicals. It is unlikely, however, that the
controversy over oncogenesis can be resolved without a
more extensive national research effort to obtain the
information needed by federal regulatory agencies in
the evaluation of data on carcinogenicity. Until this
effort is made, EPA should fund research to develop
relative determinations of carcinogenic risk to humans
and the environment as a result of pesticide use.
Recommendation
• EPA should sponsor research to obtain
broad determinations of the levels of human
exposure to carcinogens in the environment.
In addition, a multiaqency effort should be
undertaken to develop national criteria for
interpreting data on carcinogens, and for
assessing the carcinogenic risks of human
exposures to pesticides.
In the proposed multiagency research effort, the
research should develop data in these important areas:
• the biological significance of oncogenic
responses in various test systems as a basis for
predicting carcinogenic risks to humans;
• the relationships between dose and response in
appropriate in vivo systems with correlations over a
wide range of doses and, preferentially, of
29
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relationships that fall within the relevant ranges of
human exposure;
• critical evaluation of mathematical
probability models for predicting estimates of
carcinogenic risk when extrapolations are made from
high test doses of chemicals given over a short span of
time to low human exposures received over a long span
of time;
• the quantitative relationships between in
vitro tests, such as the Ames test (Ames et al. 1973,
McCann et al. 1975), and in vivo bioassays, and the
relevance of these relationships in establishing human
risks of cancer;
• the existence, distribution, and estimated
margin of safety of susceptible population groups; and
• the additive effects of various carcinogens
and the effects of cocarcinogens, promoters, and
modifiers on the total carcinogenic insult to humans.
Procedural Aspects of the RPAR Process
Soon after the administration of FIFEA was
transferred from USDA to EPA in 1970, and before the
RPAR process was set up, the OPP Criteria and
Evaluation Division began compiling a list of
pesticides suspected of being hazardous to humans or
the environment. Initially, these suspect chemicals
were selected on the basis of information in various
scientific reports, including the Mrak report (U.S.
DHEW 1969). The information was used primarily by the
EPA Office of General Counsel in the development of
strategy for cancellation proceedings against DDT,
aldrin, dieldrin, chlordane, heptachlor, and 2,4,5-T.
with implementation of the RPAR process, which was
begun in 1975, and the assignment of its administration
to a newly-formed Office of Special Pesticide Reviews
(OSPR) in the Office of Pesticide Programs, the Suspect
Chemical Review Program was terminated and the
pesticides on its list were placed on a list of
possible RPAR candidates. Additional RPAR candidates
now come from reregistration reviews, applications for
new pesticide registrations, and from public complaints
and other outside sources.
When the OPP Registration Division determines, in
its review of a pesticide for registration or
reregistration, that the product meets or exceeds any
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of the EPA criteria of risk to humans or the
environment, and that a rebuttable presumption against
its registration exists, the pesticide enters the RPAR
process and comes under the purview of the OPP Office
of Special Pesticide Reviews. An advantage of the RPAR
process is that it allows EPA to gather extensive
scientific information on the effects of a chemical
before the Agency determines whether prolonged,
courtroom-type hearings are necessary. The following
steps are taken in the RPAR process:
1. The applicant is initially given 45 days to
submit evidence in rebuttal of the "presumption of
risk" (this period may be extended for an additional 60
days).
2. At the end of this period, EPA determines
whether the allegations of risk have been rebutted
successfully.
3. If the rebuttal was successful, EPA permits
registration or reregistration of the pesticide; if the
applicant has not made a successful rebuttal, the
Administrator issues a notice to cancel, deny
registration, or change the classification of the
pesticide, or a notice of intent to hold a hearing.
When OSPR was established in OPP in 1975, it was to
be a temporary organizational unit that was
specifically set up to handle the RPAR workload.
Because the handling of RPAR cases for registration and
reregistration was expected to require a concerted and
continuous effort for the next two years, it was not
considered feasible to add this task to the ongoing
work being done by the existing divisions in OPP.
OSPR was established on the project manager concept
(not to be confused with the product manager system in
the OPP Registration Division, which was mentioned
earlier in the Registration and Reregistration section
of this chapter). Originally, five to ten OPP staff
members were to be assigned, as needed, to OSPR to work
as project managers. Each one was to be responsible
for managing specific pesticide cases in the RPAR
process from beginning to end, i.e., from the
determination that a rebuttable presumption appears to
exist through any hearings that might be held on a
pesticide. Since that time, OSPR has achieved
permanent status and consideration is now being given
to making it a division, rather than an office, within
OPP. When OSPR is fully staffed, it is expected to
consist of a director and a deputy director, branch
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chiefs (each one responsible for at least five project
managers), and clerical support. The fact that OSPR
has now been set up as a permanent unit composed of at
least 20 project managers suggests that a minimum of 20
pesticides will be under RPAR review at all times.
This is in contrast to the original concept of a
temporary organization made up of five to ten GPP staff
members that were to be assigned as necessary to work
in the unit as project managers.
A Pesticide Chemical Review Committee (PCRC) has
been established to provide policy review within EPA
for the OSPP. operation. PCRC is chaired by the
Director of OSPR and is composed of representatives of
other areas in EPA; i.e., the Office of General
Counsel, the Carcinogen Assessment Group, the Office of
Enforcement, the Office of Research and Development,
the Office of Toxic Substances, and the Office of
Planning and Management.
For each pesticide in the RPAR process assigned to
a project manager, a working group is named and made up
of people from the units represented on PCRC. Each
working group member continues to serve in this role
throughout the entire period that a compound is in the
RPAR process. The working groups assist project
managers in these functions:
• the preparation of all decision documents and
related materials (PCRC reviews these documents);
• keeping PCRC members informed of the issues
and progress of the RPAR process in each case;
• establishing contact with all available
technical and scientific sources within and outside the
Agency who may be called upon to assist or to
contribute to the RPAP. review; and
• working with the EPA Office of General
Counsel, if hearings are held on a pesticide, in
planning and preparing EPA's presentations and
recommendations to the hearing officer.
PCRC and the working groups are made up of people
who, for the most part, come froir, units other than OPP.
These units are not directly involved with pesticides
on a day-to-day basis. It is the opinion of this
Committee that the RPAR process is an important step in
the cancellation and suspension procedure and that the
staff appointed to carry out this procedure should be
composed of scientists and policymakers who are
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knowledgeable about pesticides. If the OSPR function
is to be successful, it must be flexible so that it can
meet the variety of tasks which are required and it
must represent the highest level of scientific
expertise.
Extensive Analyses of Risks and Benefits
Information on the risks and benefits resulting
from the use of a pesticide may be developed and
analyzed by EPA during much of the decision-making
process. These factors must be weighed and balanced in
the RPAR process and must enter into Agency decisions
to hold a hearing, or to deny, cancel, or reclassify a
pesticide registration.
Furthermore, EPA is required by FIFRA, as amended,
to take into account the impact of a proposed action
against a pesticide on the production and prices of
agricultural commodities, on other aspects of the
agricultural economy, and on retail food prices. The
Agency must notify the U.S. Department of Agriculture
of an intended action of this kind and provide USDA
with a copy of its analyses of the agricultural impact.
The EPA Administrator must also submit a notice of
intent to cancel or change the use of a pesticide to an
independent Scientific Advisory Panel, whose members
are chosen according to provisions of FIFRA, as
amended. The panel comments on the impact that a
proposed decision is likely to have on human health and
the environment.
Depending upon the complexity of the issues,
cancellation hearings may last for a year or more.
During these hearings, the EPA Administrator may allow
a pesticide to continue to be sold and used, or may
suspend the sale and use of the pesticide if there is
evidence that the pesticide poses an imminent hazard to
human beings or the environment.
EPA Hearings on Pesticides
FIFRA, as amended, specifies that when a hearing is
held by EPA, either on its own initiative or in
response to the request of an applicant, it must be
presided over by a hearing examiner. In most cases,
this examiner has been an administrative law judge.
The examiner, under the law, has the power to issue a
subpoena to compel testimony or production of documents
from any person.
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Some scientists and other people concerned about
the efficiency and equity of EPA decision making have
pointed out the limitations of a trial-type hearing
(NRC 1977a), which is the format used in hearings on
pesticides. In these proceedings, the applicant and
the Agency take adversary roles. The applicant submits
information to support registration or reregistration;
EPA submits information to support its contention that
a pesticide meets or exceeds the Agency's criteria of
risk to humans or the environment. This format can
limit and distort the role of scientific information
and judgment in decision making on pesticides. It is
also time consuming and costly.
Although the statutory requirements for hearings on
pesticides contain some specifications on how the
hearings shall be held—that is, with a hearing
examiner as presiding officer, and in accordance with
certain provisions of the U.S. Code and guided by the
principles of the Federal Pules of Civil Procedure—the
Committee on Pesticide Decision Making believes that
some modification in the format of the hearings should
be made so that they are less adversary and more like
the usual public hearing or rule-making procedure.
(For a more complete discussion of the advantages and
disadvantages of trial-type proceedings in EPA decision
making, see Chapter 4 in NRC 1977a.) The recommended
modification would better serve the interests of the
Agency, the applicant, and society because, by
lessening the adversary character of the hearings, it
would open up the hearings to a full consideration of
scientific information and judgment about the use of a
pesticide. This should help to resolve issues that are
often extremely complex and should permit the best
possible evaluations of the quality of both positive
and negative data, the expected exposures to a
pesticide, the relative risks to various sectors of the
population and to the environment, the oncogenic risks
posed by a pesticide, and the trade-off between risks
and benefits that must be considered in the final EPA
decision.
Disposal of Cancelled Pesticides
The recent suspension of most uses of heptachlor
and chlordane offers insight into one problem that may
be created by a cancellation and suspension notice. On
December 24, 1975, the EPA Administrator issued an
order suspending further production of heptachlor and
chlordane except for limited minor uses. However, the
impact of the order was tempered by delaying until
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August 1, 1976 the date that the prohibition on
production became effective for the use of these
compounds on corn pests. The Administrator also
permitted the sale and use of existing stocks of the
compounds if they had been manufactured before July 29,
1975.
The Environmental Defense Fund (EOF) charged that
the EPA order did not offer adequate protection against
hazards resulting from the use of heptachlor and
chlordane, and the group sought an injunction against
the continued production and use of the pesticides on
corn pests. EDF also challenged the Administrator's
decision to allow continued use of existing stocks on
the basis that EPA should have provided for the
retrieval and controlled disposal of these stocks.
Judge Leventhal of the U.S. Court of Appeals of the
District of Columbia Circuit affirmed the Agency's
suspension order, but noted that, "Although we have no
doubt that the Administrator has the power under FIFRA
to exempt from a suspension order the use of existing
stocks ...the Administrator acted arbitrarily when he
failed to even inquire into the amount of stocks left,
and the problem of returning and disposing of them"
(Bureau of National Affairs 1976).
Recommendation
• EPA should,make a detailed review of
potential problems involved in the safe
disposal of a pesticide before it issues a
cancellation order.
RISK/BENEFIT ASSESSMENT
Risk and Benefit Information Used by EPA
Amended FIFPA, the statutory basis for EPA's
regulation of pesticides, specifically requires the
Agency to consider the risks and benefits associated
with pesticide regulatory activities. In its
definition of "unreasonable adverse effects on the
environment," the Act says this is "any unreasonable
risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits
of the use of any pesticide" (PL 92-516, Sec. 2 [bb]).
Consequently, these risks, costs, and benefits must be
considered when EPA approves, denies, cancels, or
restricts the use of a pesticide, and when it finds
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that a pesticide poses an imminent hazard to human
health or to the environment.
In the EPA regulations for amended FIFRA (HO CFR
162.11), the decision-making process which leads to the
possible cancellation, denial, or change in the
registration of a pesticide appears to be a two-step
procedure. In the first step, EPA evaluates the health
and environmental risks that may result from use of a
pesticide on the basis of the Agency's criteria for
toxicity or other risk. (The criteria, which are
identified in the RPAR procedure, are discussed in the
Cancellation/Suspension section of this chapter.) Use
patterns, the potential number of toxic events,
economic data, or data on benefits are not considered
during the initial evaluation of a pesticide.
A second step in the EPA decision-making process
occurs when, on the basis of the initial evaluation, a
pesticide is thought to meet or exceed the criteria of
risk and a "rebuttable presumption" of risk is found to
exist. To rebut this presumption successfully, the
applicant must prove that use of the pesticide will not
result in significant acute or chronic toxic effects,
or that the Agency was in error in finding that the
criteria for risk were met or exceeded by the
pesticide. The applicant may, however, include
information on benefits resulting from use of the
pesticide with the evidence that is submitted to EPA.
EPA regulations further state that, in deciding
upon a course of action, "...the Administrator may, in
his discretion, take into account staff recommendations
resulting from preliminary analysis, if any, concerning
the balancing of risks against benefits" (40 CFR 162.11
Cal [5] [iii]). The EPA staff is not specifically
required by the regulations to conduct a risk/benefit
analysis at this time and, if such an analysis is made,
the Administrator may choose to ignore it. Even if a
staff analysis is made which shows that benefits exceed
risks, the regulations limit the Administrator's
options on the course of action that may be taken when
a decision has been made on the basis of the
preliminary evaluation that the pesticide meets or
exceeds EPA's criteria of risk. The Administrator may
issue a notice that registration is denied or cancelled
or a notice of intent to hold a hearing (UO CFR 162.11
[a] [5] [iii]), but cannot, at this stage, decide to
register a pesticide product.
Thus, despite the fact that FIFRA, as amended,
requires determinations about the unreasonable adverse
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effects of a pesticide to take into account not only
criteria of risk, but also any economic, social, and
environmental costs and benefits resulting from the use
of a pesticide, it is not until the last stages of
EPA's decision making that Agency regulations require
consideration of benefits as against risks. During a
hearing before a final order of denial or cancellation
of a registration, EPA regulations permit an applicant
to sustain the burden of proof that the pesticide
should be registered—even when it meets or exceeds the
criteria of risk—by showing that the risks are
outweighed by the economic, social, and environmental
benefits of use (i»0 CFR 162.11 [b] [1] [i] [C]).
The Committee on Pesticide Decision Making believes
that EPA regulations should be changed to require
consideration of the relative risks and benefits of a
pesticide's use at an earlier stage in the Agency's
decision-making process. This would enable EPA to
determine whether a particular pesticide clearly has
benefits which far outweigh the risks of a proposed use
without the need to hold a hearing that may be costly
to the applicant and to the government and that may
produce the same result as a careful risk/benefit
analysis.
Recommendation
• EPA regulations (40 CFR 162.11 Tal f5J
riiil) should require, and not simply permit,
the consideration of benefits in
determinations of whether to issue a notice of
intent to deny or to cancel a registration.
This would conform with Section 2 Fbbl of
FIFRA. as amended.
Responsibility for Risk/Benefit Analysis in EPA
The OPP Criteria and Evaluation Division (CED) is
responsible for preparing documents on the risks and
benefits resulting from the use of pesticides that are
being reviewed for registration or reregistration.
Analysis of risks is done by the Metabolic Effects
Branch and by the Ecological Effects Branch of CED,
while the analysis of benefits is done by the Economic
Analysis Branch.
The only guidelines for the assessment of benefits
that the Agency has published are contained in its
administrative procedures, "Health Risk and Economic
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Impact Assessments of Suspected Carcinogens" (O.S. EPA
1976). These procedures represent an interim
administrative tool for the Rebuttable Presumption
Against Pegistration process and were not intended to
serve as a complete or final method for determining the
economic benefits and risks resulting from the use of a
pesticide. The procedures were critized, however, by
the Moss Subcommittee on Oversight and Investigations
for limiting the cost factors to be considered to such
immediate factors in pesticide use as costs to the
user, productivity changes, and the effect on retail
food prices (U.S. Congress, House 1976). The
guidelines did not include such cost factors as death,
suffering, or environmental degradation, which the
subcommittee thought should also be assessed in
risk/benefit analyses.
While the Committee on Pesticide Decision Making
recognizes the purpose of EPA's interim guidelines, it
believes that the Agency should develop more complete
procedures for evaluating the risks and benefits of
pesticide use and should then publish the proposed
procedures for review and comment. Several recent
reports (Kennedy et al. 1975, NRC 1975a, Edwards and
Langham 1976) would be helpful to EPA in developing
this document.
Cost/Benefit, Risk/Benefit, and
Trade-off Analyses
Much of the controversy over the regulation of
pesticides results from the difficulty of finding
acceptable methods for quantifying the beneficial and
adverse effects of these chemicals. If questions
concerning pesticide use and regulation are to be
resolved on a factual rather than an emotional basis,
however, substantive factors of this kind must be
carefully delineated and assessed.
Economic data are vital in any cost/benefit or
risk/benefit analysis in the pesticide decision-making
process. The need for such data was recognized, for
example, in a report of the National Academy of
Sciences which recommended that Congress give high
priority to funding large-scale experiments to measure
the economic consequences of alternative pest control
methods, including pesticides, biological controls,
cropping methods, use of pest-resistant varieties of
plants, and the like (NRC 1975b).
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The argument for considering the economic effects
of pesticide regulation is one of relatively long
standing (Headley and Lewis 1967). When pesticides
effectively control pests, economic benefits may result
from increased agricultural productivity, the
protection of forests and building structures from the
ravages of pests, and the control of disease vectors.
On the other hand, society must expend finite resources
when it makes use of pesticides. There also may be
indirect costs in terms of deleterious effects on the
environment, people, farm animals, pets, nontarget
insects, wild mammals, birds, fish, and plants,
including any chronic problems resulting from long-term
exposures to pesticides.
It is extremely difficult to calculate all of these
costs involved in the use of pesticides, particularly
those that are indirect costs. For example, it is
difficult to quantify the degree of risk, if any, for
each species or individual in a species. It is hard to
arrive at a monetary amount or even a range of figures
that would be universally accepted as the cost of a
possible increased incidence of cancer or of other
risks to human health, because calculations of this
kind involve many complex factors such as earnings lost
(one way to measure the economic value of human life).
A report by the National Academy of Sciences has
explored in some detail the problems encountered in
using a mathematical approach to decision making in the
regulation of chemicals in the environment (NEC 1975a).
The report noted that:
Decisions about regulating chemicals in the
environment always involve values about which
the affected parties disagree; thus the values
of the decision maker will play a crucial role
in the outcome. There is no satisfactory way
to summarize all the costs or benefits of
regulatory options in dollars or other terms
which can be mathematically added, subtracted,
or compared. In short, there is no substitute
for an experienced decision maker exercising
good judgment. However, the techniques
developed by decision theory and benefit-cost
analysis can provide the decision maker with a
useful framework and language describing and
discussing trade-offs, noncommensurability,
and uncertainty. They can also help to
clarify the existence of alternatives,
decision points, gaps in information, and
value judgments concerning trade-offs.
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A trade-off analysis has been suggested as the best
method to evaluate the costs and benefits resulting
from the use of chemicals (NRC 1975a, Abel 1976). This
approach is adapted from the traditional cost/benefit
analysis, which makes use of dollars or some other
common unit; however, the trade-off analysis also
permits the use of descriptive information for factors
that are difficult to measure and, as suggested by its
proponents, it "preserves more detail for the decision
maker11.1 The Committee on Pesticide Decision Making
believes that an explicit analysis of the benefits and
risks of pesticide use should become part of EPA's
decision-making procedures. As has been suggested in
another National Academy of Sciences report, a
"systematic and well documented analysis could
substantially improve the quality of EPA decisions by
providing a framework for discussion and for public
understanding of the factors that enter the decision
process" (NRC 1977a) .
The use of a matrix is a way to summarize all the
information that has been derived from such a trade-off
analysis. While most of the decisions involved in such
an analysis are complex and include a myriad of detail,
the matrix permits the preservation only of those
factors that have the highest priority in decision
making. An example of a trade-off matrix for
pesticides, which is adapted from one devised by Abel,*
is shown in Figure 2.1. Before this detailed analysis
is done for regulatory decision making on pesticides,
it may be advantageous to do a mini-study as a
screening step early in the decision-making process. A
more complete analysis then might be done only when a
major or complex trade-off decision is needed. The
Administrator should also be aware of the fact that
trade-offs for different uses of a pesticide may vary
greatly, depending on the availability of alternative
pest control methods, resistant varieties of a crop,
and other factors.
Because the trade-off matrix for pesticides shows
all the decision maker's alternatives in columns, the
shift in effects among the available options and the
impact of a particular decision can be readily seen for
each effect that is analyzed. This facilitates the
comparison of all administrative alternatives that have
a common denominator and that are directly comparable.
The different categories of effects, however, are
likely to be expressed in terms that cannot be related
to a common denominator and, therefore, the various
categories cannot be objectively and quantitatively
compared. One alternative that should be part of every
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EFFECTS
I Risks
A. Health
1. Lost person years
2. Lost activity days
3. Population exposed
B. Environment
1. Nontarget species
2. Vegetation damaged
3. Animal losses
4. Endangered species
5. Aesthetics
6. Recreation
II. Economic
A. Consumer surplus
B. Producer surplus
C. Costs of production
1. Capital
2. Operating
D. Other costs
1. Training applicators
2. Enforcement expense
3. Government adminis-
trative expense
E. Plants closed
f. Jobs lost
III. Distribution
A. Population group benefited
B- Population group adversely
affected
C. National
IV. International
V Agricultural
A Production
B. Commodity prices
C Retail food prices
D. Agricultural economy
VI. Pesticides Used
A. Amount of pesticide
B. Amount of substitute A
C- Amount of substitute B
COMMENTS
(Uncertain-
ties about
quality and
extent of
data, other
No action
ALTERNATIVES
Ban
Restricted
Additional
label
Substitutes0
Pest
Pest
c. Substitutes can be anothei
restrictions on the label.
SOURCE: Adapted from Abel, F. H. (1 976) The Use of Econo:
Committee on Pesticide Decision Making.
ri Registering Pesticides; an unpublished paper
FIGURE 2.1 Trade-off matrix for pesticide decision making.
141
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analysis is a case in which no action is taken and the
pesticide is not subjected to any regulatory
constraints. When applicable, another component, shown
in the last column of Figure 2.1, should be an analysis
of trade-offs under alternative pest control methods,
which may or may not involve the use of a pesticide. A
comparison of the columns in Figure 2.1 will show the
net change in effects, whether adverse or beneficial,
between the case of no regulation and the use of a
selected option or options. A special column in the
trade-off matrix is provided for comments, so that
major items or issues that cannot be captured by other
components of the matrix can be displayed.
Health effects, the first category on the suggested
trade-off matrix, are calculated in terms of years of
life that may be lost as a result of premature death,
days of activity that may be lost as a result of ill
health (this could be subdivided into days lost to mild
and to serious illness), and the size of the population
that will probably be exposed to the pesticide. All
health effects would not necessarily be negative; for
example, a pesticide might prevent death or illness by
control of mosquitoes that transmit malaria.
Currently, EPA limits its consideration of health
hazards in pesticide use to a determination of whether
the toxicity of a pesticide meets or exceeds the
Agency's criteria for unreasonable adverse effects to
humans or to the environment. This is an acceptable
first step in the decision process, and the fact that a
pesticide does or does not trigger one or more of these
criteria should be reported in the column for comments.
There is still not adequate information, however, for a
risk/benefit trade-off decision on health effects.
Information on the manner and extent of the pesticide's
use and the cumulative exposures likely to occur are
also needed by the decision maker to determine the
number of adverse health effects (i.e., illnesses and
deaths) that can be expected to become "costs" or
"risks" to society. While a determination of the
effects that a pesticide may have on health is a
scientific judgment, the question of whether these
effects are acceptable, as compared to the benefits
resulting from a pesticide's use, is a subjective value
judgment to be made by the decision maker. The
distinction between the scientific basis for
determining the level of risk and the judgmental basis
for determining the acceptable level of risk is
discussed in greater detail in Lowrance (1976).
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The health category on the matrix also includes the
effects of a pesticide on the environment.
Environmental effects include the effects on nontarget
vegetation and animals, on endangered species, and on
the aesthetic and recreational environment of humans.
Of the many different kinds of possible environmental
effects resulting from the use of a pesticide, only a
few are likely to be important in any one decision.
Economic effects, the next category on the matrix,
are important in the risk/benefit analysis only if
conversion of the number of effects into dollar values
is useful to the decision maker. Edwards and langham
(1976) present a theoretical discussion and a case
study of quantifying effects in economic terms and
conducting a cost/benefit analysis, and the limits and
possible problems resulting from such an approach are
discussed in a National Academy of Sciences report (NRC
1975a). Direct economic effects on the trade-off
matrix might include a lower cost to consumers for food
produced with the aid of pesticides and any increased
cost to farmers in producing the food. The measurement
of direct economic effects is discussed in detail in
Kennedy et al. (1975), Edwards and Langham (1976), and
Headley and Lewis (1967). The indirect economic
effects of a pesticide's use may include changes in
employment, training programs, equipment purchases, and
capital costs.
The next matrix category is distribution effects,
which are shown in terms of the groups of people—age
groups, worker groups, etc.—and the total number of
people who are expected to benefit or to be adversely
affected by a decision on a pesticide.
The use of a category on international effects in
this matrix is in recognition of the fact that
pesticides are a component of international trade.
While EPA cannot, of course, make decisions about what
other countries should do in relation to their pest
control needs, the Agency does have a responsibility to
consider the effect of its decisions on other peoples
in the world. The Committee on Pesticide Decision
Making has no specific suggestions for the kinds of
data that should be considered in this category and
suggests that the Agency seek comments from the U. S.
Agency for International Development (AID) and
appropriate international organizations, such as the
Food and Agriculture Organization and the World Health
Organization. (See Chapter 5 for a discussion of the
international impacts of EPA pesticide regulations.)
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The agricultural portion of the matrix calls for
gross measures of the economic effects on agriculture
of a decision that is made on a pesticide. The four
measures used in this category meet the requirement of
the 1975 amendments to FIFRA that, in proposing action
on a pesticide, EPA must take into account the impact
of that action "on production and prices of
agricultural commodities, retail food prices, and
otherwise on the agricultural economy" (Sec. 6 [b]
[2]). The legislation does not specify how the impacts
on agriculture are to be measured or traded off. Among
the issues involved are a decrease in agricultural
production that may occur when pesticides are not used,
and the increase likely to occur in consumer costs if
production falls.
The final section of the trade-off matrix calls for
an accounting of the quantities of pesticides that will
be used under alternative options for action.
The detailed procedures that EPA uses to gather and
evaluate data for the trade-off analysis of risks and
other costs compared to the benefits resulting from
pesticide use should be developed after consultation
with scientists in other government agencies at both
state and federal levels, scientists in universities
and colleges, and other people who are knowledgeable
about the risks and benefits that may occur when
specific chemicals are employed by agriculture,
industry, or in home uses. Consultation and review
outside the Agency will help to gain public
understanding and acceptance of the complex trade-off
process.
Recommendation
• EPA should develop detailed procedures
for assessing the risks and benefits resulting
from the use of a pesticide and for analyzing
trade-offs between the risks and benefits. In
doing so. EPA should seek outside review and
comment from the scientific community-
Adequacy of Data on Economic Losses
Unfortunately, adequate economic data usually do
not exist to make accurate estimates for a trade-off
matrix of the savings that can be realized through the
use of pesticides on crops, forests, or structures or
to estimate losses that would be sustained if a
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pesticide were not available. While this shortcoming
does not destroy the usefulness of a trade-off matrix
as a decision-making tool, it must be taken into
account when the matrix is used. In order to determine
the effects of using a pesticide for cutworm in corn,
for example, it is important to know how likely it is
that a cutworm infestation will occur, how many acres
might be infested, and the potential extent of crop
losses.
There are a number of reasons why adequate economic
data for risk/benefit analyses are not available.
First, there is the fact that registrants of pesticides
are required to submit data relative to the risk
categories established by EPA and on the efficacy of a
candidate compound against target pests, but they are
not required to provide data showing the impact of a
pesticide compound on agricultural productivity.
Consequently, high quality data on the historical or
potential ability of a pesticide to prevent losses,
gauged in terms of monetary value, are not available
for use in EPA's cancellation or suspension hearings.
Moreover, data showing the impact on productivity are
difficult to obtain. The development of such data
requires estimating the acreages that have been treated
or that will be treated, the crop yields and, perhaps,
the prices of agricultural commodities if a pest is not
controlled. Estimates that are based on the use of a
pesticide in test plots may not be adequate to meet
these data requirements because the plots may not
provide the same results as would be obtained under
field conditions. When a pesticide has more than one
use, it may be particularly difficult to analyze its
potential economic benefits because it will be
necessary to determine how much money should be
assigned to the prevention of losses in each use of the
pesticide.
Benefit determinations are also complicated by the
economics of pesticide use. A determination of
economic benefits resulting from the use of a pesticide
cannot always be made simply by comparing data on crop
yields with and without the pesticide. There is a
difference between striving for the maximum biological
yield obtainable and the most favorable economic return
possible. It might not be economically desirable to
strive for the highest biological yield.
In making risk/benefit determinations, EPA needs
full access to all available information on pesticide
use. In the past, there has not been a full exchange
of information between EPA and USDA for this purpose.
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in part because of the adversary nature of the EPA
cancellation and suspension proceedings, in which the
USDA role tended to be one of opposition to the
cancellation of pesticide compounds. A memorandum of
understanding between EPA and USDA, which was signed in
December 1976, should bring about greater cooperation
between the two agencies in developing the objective
and accurate data that EPA requires for the regulation
of pesticides. The memorandum establishes the
principles and mechanisms whereby the two agencies will
gather the information for risk/benefit assessments
when a pesticide enters the RPAR process because it is
presumed to create an unreasonable adverse effect on
humans or the environment. The EPA/USDA memorandum
states:
It is agreed that this [cooperative effort ]
will be done in a manner which recognizes and
utilizes the capabilities of each agency to
the greatest feasible extent in either making
resources available to the other agency or for
the joint planning and execution of
activities. Consistent with its broad
agricultural responsibilities, USDA and
State/universities are recognized as major
sources of information on pesticide uses,
relative effectiveness of pesticides and the
importance of specific pesticide uses for
agricultural and forestry purposes...EPA is
recognized as a basic source of information on
pesticide registration and environmental and
health hazards associated with pesticide use.
Both agencies have important contributions to
provide on environmental aspects of pesticide
use.
As long as little or no regulatory pressure was
exerted on the use of pesticides and as long as
pesticides were cheap, the profitability of using.
pesticides seemed self-evident. Their effectiveness
was well-known or accepted in terms of the costs of
pest control for such important crops as cotton,
tobacco, apples, vegetables, and certain cereals. As a
result, there was not a compelling need for farmers and
agricultural researchers to give a high priority to
studies of the monetary effects of pesticide use. The
U.S. Department of Agriculture has not had an ongoing
program to evaluate the economic feasibility of pest
control, for example, primarily because other matters
were more urgent in the period before the public became
aware of the hazards resulting from pesticide use and
before more stringent regulatory provisions were
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enacted in FIFRA, as amended. in 1976, in accordance
with the memorandum of understanding between USDA and
EPA, USDA organized a pesticide impact assessment
program that draws on information and expertise from
State Agricultural Experiment Stations (SAES). This
program has two weaknesses: it is concerned
principally with pesticide compounds that are being
challenged by the RPAR process of EPA and it is,
therefore, a reactive program; and the SAES data on
pest damage are derived in many instances from efficacy
tests in small plots rather than from field situations.
However, the impact assessment program does have a
research component, which indicates that the USDA
recognizes a need for additional data.
TOLERANCES
Pesticides that are used to control pests during
the production and storage of agricultural commodities
may result in residues of chemicals on or in
agricultural food or feed. To protect the safety of
our food supply. Congress has provided for the
regulation of such residues in the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended. Section 108 of
the Act (21 OSC 346a) pertains to the establishment of
tolerances (the allowable residue level) for pesticide
chemicals in or on raw agricultural commodities;
Section 409 of the Act (21 USC 318) deals with food
additives, which include pesticides.
A pesticide that is to be used on a human food or
animal feed crop cannot be registered until EPA
establishes a tolerance or an exemption from the
requirement for a tolerance (see the section on
Exemptions in this chapter) for that pesticide use.
Because it would be impractical for FDA to enforce
tolerance levels on foods at the point of consumption,
the tolerances are established by EPA on raw
agricultural commodities.
Under EPA regulations governing the establishment
of tolerances (40 CFR 180.7), it is the responsibility
of the registrant of a pesticide to petition the Agency
for a proposed tolerance level or an exemption from a
tolerance. The petitioner must include these data on
the pesticide•s toxicology, residues, and analysis, as
specified in Section 408 of FFDCA:
• the name, chemical identity, and composition
of the pesticide;
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• the amount, frequency, and time of application
of the pesticide;
• full reports of investigations made with
respect to the safety of the pesticide;
• the results of tests on the amount of
residues, including a description of the analytical
methods used;
• practical methods for removing residues that
exceed a proposed tolerance;
• proposed tolerances for the pesticide; and
• reasonable grounds in support of the petition.
Establishing "Safe" Residue Levels
The evaluation of pesticide residues in food in
order to establish tolerance levels for these residues
is a complex undertaking from a regulatory standpoint.
There are some inherent difficulties in the use of
laboratory procedures, such as tests on experimental
animals, to determine with mathematical precision the
hazards that a pesticide may present to human beings.
There are also limitations in the ability of assay
methods to measure residues of pesticides or other
additives in foods when they are present at low levels.
The Food and Drug Administration, which has the
regulatory responsibility under Section 409 for
nonpesticide additives in food, has commented on these
limitations in its Criteria and Procedures for
Evaluating Assays for Carcinogenic Residues (U.S. DHEW
1977) :
...any introduction of a compound (whether or
not carcinogenic) is likely to leave minute
residues in edible tissues that are below the
level of detection of any known or likely to
be developed method of analysis...Thus, when a
tissue is examined with an assay having a
lowest limit of measurement of 1 ppb [part per
billion] and no interpretable response is
observed, the analyst can only conclude that
the compound under analysis is not present at
levels of 1 ppb and above. It can never be
concluded that the compound is "not present"
in the absolute sense.
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Faced with such complications, a government agency
that regulates the use of chemicals is forced to seek
an administratively tenable position between the
unknowns of science and the mandates of regulatory
legislation. For example, although Section 409 of
FFDCA specifies that the government shall establish
regulations "prescribing the conditions under which
such additive may be safely used," the government
agencies that carry out this mandate must make the
determination of safety on the basis of the best
knowledge that is available; of necessity, the agencies
must perceive the levels that they permit for the use
of chemicals as "acceptable," or toxicologically
insignificant, rather than as demonstrably "safe." The
language of Section 408 of FFDCA, which is somewhat
broader than Section 409 in its safety requirements,
calls for "experts qualified by scientific training and
experience to evaluate the safety of pesticide
chemicals, as safe for use, to the extent necessary to
protect the public health." This section also says
that appropriate consideration should be given to other
relevant factors, such as the need for an adequate,
wholesome, and economical food supply.
In its evaluation of proposed tolerances or
exemptions from tolerances, EPA requires petitioners to
provide a minimum amount of data on toxicological
studies, which can be summarized as follows:
• studies of acute toxic effects to establish
the lethal dose for various kinds of exposure to a
pesticide, such as oral and dermal;
• 90-day animal feeding studies to determine the
subacute toxic effects of a pesticide;
• lifetime feeding studies in animals to
determine the chronic effects of a pesticide (primarily
the oncogenic effects) ;
• metabolism studies to determine the metabolic
fate of the pesticide chemical and its possible
concentration in tissues;
• reproduction studies in animals to determine
whether the pesticide causes any physical,
physiological, or behavioral abnormalities;
• studies of teratogenic effects of a pesticide;
and
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• studies of the mutagenic effects of a
pesticide.
Other factors that enter into EPA decisions on
establishing tolerance levels for the residues of a
pesticide in various foods, or in permitting an
exemption, are scientific judgment of the -data that
have been submitted to the Agency; the chemical
properties of the pesticide, including the potentiating
effect that the chemical may have through interaction
with other substances; the pattern of use for the
pesticide; the probable exposure of humans to similar
chemicals; and the cumulative contribution to the human
diet by commodities that bear similar residues.
EPA regulations for the establishment of tolerances
contain a definition of "negligible residue" which
appears to permit a less rigorous procedure in some
instances (40 CFR 180.1 [1]). This definition is:
The term "negligible residue" means any amount
of a pesticide chemical remaining in or on a
raw agricultural commodity or group of raw
agricultural commodities that would result in
a daily intake regarded as toxicologically
insignificant on the basis of scientific
judgment of adequate safety data. Ordinarily
this will add to the diet an amount which will
be less than 1/2,000th of the amount that has
been demonstrated to have no effect from
feeding studies on the most sensitive animal
species tested. Such toxicity studies shall
usually include at least 90-day feeding
studies in two species of mammals.
This definition in EPA regulations does not agree with
the present data requirements of EPA, which include
data based on investigations of the chronic toxicity of
a pesticide in lifetime feeding studies on aninr.als.
While chronic toxicity is a major concern in the
use of pesticide chemicals, this Committee questions
whether such studies should be required in all
instances. In some cases, scientific review by the
Agency of the level of risk posed by a chemical may
permit the determination of a tolerance level without
requiring 2- to 3-year studies, depending on such
factors as the limited proposed use of the pesticide,
the family of compounds to which it is related, and
test data showing that few or no residues of the
chemical are likely to be present in food.
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The Committee does not imply that the Agency should
discontinue its vigilance in the regulation of
pesticides or its concern for the oncogenic effects of
certain pesticides, but only that expensive and
extensive chronic feeding studies should not be
required where there is clear scientific evidence that
they are not necessary.
Recommendation
• By emphasizing scientific data and
-judgment, EPA should in some instances permit
use of a concept similar to that of negligible
residues, as defined in HO CFR 180.1 (1) .
EXEMPTIONS FOR FEDERAL AND STATE AGENCIES
Congress recognized that the inherent constraints
in the pesticide registration process might impede the
timely response by EPA to critical situations of pest
infestation and damage. Section 18 of FlFRA, as
amended, provides a mechanism to make it possible for
federal and state agencies to react expeditiously to
emergency conditions of this kind. Section 18 says:
The Administrator may, at his discretion,
exempt any Federal or State agency from any
provision of this Act if he determines that
emergency conditions exist which require such
exemption.
The Administrator, in determining whether or
not such emergency conditions exist, shall
consult with the Secretary of Agriculture and
the Governor of any State concerned if they
request such determination.
EPA regulations for exemptions under Section 18 (i»0
CFR 166) state that consideration will be given to
three types of exemptions: specific (for pest
outbreaks of an emergency nature); quarantine-public
health (to prevent the introduction or spread of a
foreign pest); and crisis (for critical situations in
which there is not enough time to get a specific
exemption) .
The legislative provision for exemptions offers
regulatory flexibility when there are critical
outbreaks of pests and no pesticides have been
registered for the uses that are needed to control or
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eradicate them. The successful use of this provision,
however, depends upon the attitudes, intentions, and
prudent judgment of the parties involved; an
unsupported proclamation of an emergency should not be
enough to set this provision in motion. On the other
hand, EPA must be flexible and reasonable in its
evaluation of a request for an exemption. If the
Agency is overly restrictive, the intent of Congress to
provide measures for meeting emergency pest control
situations will not be carried out.
Timeliness is important in processing requests for
exemptions because of the emergency nature of these
actions. Apparently, there have been occasions when
EPA failed to respond promptly to requests for an
exemption. In 1976, the Florida Department of
Agriculture and Consumer Services applied to EPA for a
specific exemption to use Vydate L on tomatoes to
control leaf miners. Vydate L is a registered
pesticide, but this compound is not registered for use
on tomatoes. After 10 weeks, EPA denied the request
and asked for more information (personal communication
from Vincent Giglio, Director, Inspection Division,
Florida Department of Agriculture and Consumer
Services). Currently, the EPA handling of exemptions
is being reviewed by the U.S. General Accounting Office
(GAO) as part of a review of EPA's special registration
programs (the other programs under review are
experimental use permits. Section 5 of FIFRA, as
amended; and state registration of pesticides to meet
special local needs. Section 24 [c]). GAO has
uncovered some problems with respect to the time it has
taken EPA to approve or deny requests for exemptions,
although there has been some recent improvement in this
area.
Recommendation
• EPA should respond expeditiously to
requests for exemptions under Section 18 of
FIFRA. as amended, for the emergency control
of pests.
PFJRMITS FOR EXPERIMENTAL USES
Before a chemical is registered as a pesticide, it
is subjected to a multistage testing process. The
substance is first screened in the laboratory for its
efficacy against a pest species and its effect on other
species. If this efficacy is exhibited, the substance
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is put through laboratory or greenhouse tests, if the
researcher decides that the substance appears to have
value as a pesticide and should be tested in field
plots in order to collect the information needed for
registration with EPA, an EPA experimental use permit
is required.
EPA supervises the use of pesticides under these
experimental permits. If the Agency determines that an
experimental use may result in any residue on or in
food or feed, it may establish a temporary tolerance
level for the residues before issuing a permit or
require that the food or feed be disposed of in a
manner which will not endanger humans or the
environment. In general, EPA regulations for
experimental use permits provide reasonable protection
against hazards that might result from the testing of
new pesticides or the testing of registered pesticides
for new uses.
EPA regulations for experimental use permits do
not, however, specify a period of time within which the
Administrator must rule on a request for these permits.
It is important that the Agency act expeditiously on
the requests so that researchers can plan a field
program and commit research facilities well in advance
of a growing season.
Recommendation
• EPA should rule on applications for
experimental use permits within 90 days after
an application is received.
MINOB USES OF PESTICIDES
A special problem exists in the registration of
pesticides for minor uses. These uses for pesticides
may involve major pests on minor crops or minor pests
on major crops, but in either case the total volume of
the pesticide that is used is small compared to the
amount used for the control of major pests on livestock
and on such crops as cotton, grains, and soybeans.
Manufacturers of pesticides are reluctant to seek
registration of their products for minor uses because
the market potential for these uses is not great enough
to justify the costs of developing data required for
registration. Manufacturers are also concerned with
their potential liability for crop damage because their
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costs for legal defense might be large in relation to
the revenues that are obtained from a pesticide that is
sold for minor uses.
A number of pesticide uses of a minor nature occur
in agriculture. Many fruit and vegetable crops that
are grown in relatively small quantities, but that make
up a significant part of our diet, are an example of
the kinds of crops on which pesticides find an
essential or important, but minor, use. Pesticides
also have minor uses in public health, structural,
institutional, vertebrate, aquatic, ornamental, and
veterinary pest control programs. As an example of the
magnitude of the problem that exists when pesticides
for minor uses are not available, Cornell University
has compiled a list of more than 2000 minor uses for
which there are no federally-registered pesticides.
Interim registrations were obtained for approximately
30 food and 870 nonfood uses in October, 1975. .About
200 of these uses are to control pests on food, feed,
forage, and livestock and about 1800 of the uses are
for trees, shrubs, and ornamental plants (personal
communication from James E. Dewey, entomologist,
Cornell University).
Before FIFRA was amended in 1972, the federal
government did not explicitly prohibit uses of
pesticides that were not included on a pesticide label
as long as these uses did not result in residues
exceeding tolerances established under the Federal
Food, Drug, and Cosmetic Act. Even this requirement
did not have to be met if pesticides were not
distributed and sold in interstate commerce, except for
those cases where state registration may have imposed
limitations. Pesticides in intrastate commerce were
not affected because they were not subject to federal
regulation.
Although the amendments to FIFRA do not mention
minor uses of pesticides, these uses are affected by
the more stringent requirements of this legislation; by
EPA's strict interpretation of Section 12 (a) (2) (G),
which deals with labeling; and by the requirements of
the Federal Food, Drug, and Cosmetic Act, as amended,
for the establishment of tolerances for pesticide
residues in food and feed. The pertinent provisions of
FIFRA, as amended, are:
Sec. 3 (a^ requires federal registration of all
pesticides sold in intrastate and interstate commerce.
State registrations are preempted.
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Sec. 3(c)(2) gives EPA authority to specify the
kinds of data which are required to support
applications for the registration of pesticides. EPA
has determined that any application for registration or
reregistration, or for the amendment of an existing
registration, must be accompanied by supporting data
for each specific use that is sought for the pesticide.
The Agency does not, for example, permit extrapolation
of data from tests that have been made to support the
registration of a pesticide for a particular target
pest to the use of the same pesticide on another pest,
even when these pests are closely related and the rates
of application and other conditions of use are the
same.
Sec. 12 (a) (2) (G) makes it unlawful to use any
registered pesticide in a manner inconsistent with its
labeling. As noted above, EPA has interpreted this
section to mean that each specific use of a pesticide
must be registered. This use then appears on the
product's label, and in most cases other uses are
unlawful. (Exceptions have been made by EPA for a few
pesticides; see the discussion below of Pesticide
Enforcement Policy Statements.)
Sec. 24 (c) permits states to register pesticides
for special local needs, which include many minor uses.
State registrations are subject to cancellation by EPA
within 90 days if disapproved by the Administrator
within that period.
The report of the Senate Committee on Agriculture
and Forestry (U.S. Congress, Senate 1972) indicates the
intent of Congress in Section 24 (c) to permit
flexibility in the registration of pesticides by states
to enable them to deal with local problems:
The purpose of this subsection is to give a
State the opportunity to meet expeditiously
and with less cost and administrative burden
on the registrant the problem of registering
for local use a pesticide needed to treat a
pest infestation which is a problem in such
State but is not sufficiently widespread to
warrant the expense and difficulties of
Federal registration.
It has been difficult for states to make use of Section
24 (c), however, because EPA cannot permit a state to
register pesticides under this Section unless a
tolerance has been established for residues of the
pesticide in or on the particular food or feeds for
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which the Section 24 (c) registration is being sought
(U.S. EPA 1977b).
Most pests on minor crops, and minor pests on major
crops, can be adequately controlled with registered
pesticides that are already on the market. In such
cases, data on the hazards that a pesticide may present
to humans or to the environment have already been
developed. The principal obstacle to registration of
these pesticides for minor uses is the fact that data
on the efficacy and residues of each pesticide must be
developed for every use. The data on efficacy must
demonstrate that a pesticide will effectively control a
target pest without harm to the host plant under
agricultural and environmental conditions that are
representative of areas where the pesticide will be
used. The data on residues, which are required to set
residue tolerances, must also be representative of
geographic areas where the pesticide will be used (U.S.
EPA 1977b).
EPA has tried to remove some of the barriers to the
registration of pesticides for minor uses by
encouraging applicants for registration to broaden
label directions, e.g., by using such phrases as "and
similar corn root pests" and "similar broadleaf weeds
in the home lawn." As a result of this policy, EPA has
permitted the broadening of label directions for a few
pesticides when there were no indications that problems
would occur if these pesticides are used on related
pests. To assuage the fears of manufacturers and users
that EPA enforcement actions might be taken on the
grounds of "use inconsistent with the label" for these
pesticides, the EPA Pesticides and Toxic Substances
Enforcement Division has issued Pesticide Enforcement
Policy Statements (PEPS), each defining the kinds of
label deviations that are permitted for a particular
pesticide and against which enforcement action will not
be taken.
It is the opinion of the Committee on Pesticide
Decision Making that a reliance upon prosecutorial
discretion, which in effect is what the PEPS do, is a
poor way to regulate the use of pesticides. The PEPS
concept of conditionally grouping similar target
species on a label, however, might be useful if it were
to be applied across the board to pesticides that have
minor uses and that do not present a hazard to humans
or to the environment. On this basis, the thrust would
be positive rather than negative; furthermore, the
grouping would represent basic EPA policy rather than a
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prosecutorial arrangement in which exceptions are made
to Agency policy.
EPA might also consider grouping similar crops for
the purpose of estimating pesticide residues on the
crops and to establish tolerances. The crop groupings
might be made in accordance with proposals that various
researchers have made for grouping foods to estimate
residue levels.2) it will be necessary, however, for
EPA to determine whether the provisions on pesticide
residues in the Federal Food, Drug, and Cosmetic Act
will permit this use of the grouping concept.
Recommendation
• EPA should investigate the scientific and
regulatory feasibility of adopting the concept
of grouping similar pests and similar crops
when the data on these pests and crops are
related and demonstrate the safety and
efficacy of pesticides.
Another approach to the problems of pesticides that
are used for minor purposes is to provide federal
support for the development of data in cases where
industry is unable to justify the costs of research in
terms of the economic return from sales. The
Interregional Research Project Number H (IR-4), which
is located at the New Jersey State Agricultural
Experiment Station, was begun in 1961 to obtain the
data required for establishing residue tolerances in
food crops as part of the registration of pesticide
products. IR-4 has been expanded to include the
gathering of data on residues for the registration of
pesticides for minor uses and also has begun to move
into the area of nonfood crops (U.S. EPA 1977b) . The
program is federally funded through the Cooperative
State Research Service of the U.S. Department of
Agriculture.
Although some relief from the problems involving
the minor uses of pesticides may be obtained through
measures of this kind, this Committee believes that
these problems also require changes in FIFRA, as
amended, so that there is an improved statutory basis
for dealing with the question of pesticides that have
minor uses. The changes that this Committee proposes
would be to specify the interpretation of the present
statutory expression, "it shall be unlawful to use
any registered pesticide in a manner inconsistent with
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its labeling." The legal interpretation of this phrase
should be clearly defined to allow the application of a
pesticide in a concentration less than that specified
on the label, and to allow for the use of the pesticide
against a pest that is not specified on the label, as
long as the application is made to a crop or site that
the label does specify. These changes are incorporated
in Senate proposals for the further amendment of FIFRA.
This Committee endorses the changes contemplated by the
recent Senate Bill, S1678, which agree in principle
with the following Committee recommendation:
Recommendation
• EPA should define the phrase "it shall be
unlawful...to use any registered pesticide in
a manner inconsistent with its labeling" as
follows:
— application to a crop, animal, or
site not included in the labeling claims.
or
— application of an amount of active
ingredient, product per unit area, or
space exceeding those on the labeling, or
— failure to follow restrictions or
limitations on the labeling.
RESEARCH
The legal authority for EPA's research on
pesticides is stated in Section 20 of FIFRA, as
amended:
The Administrator shall undertake research,
including research by grant or contract with
other Federal agencies, universities, or
others as may be necessary to carry out the
purposes of this Act, and he shall give
priority to research to develop biologically
integrated alternatives for pest control. The
Administrator shall also take care to insure
that such research does not duplicate research
being undertaken by any other Federal agency.
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Current Status
Research on pesticides conducted by EPA scientists
is strongly oriented toward the Agency's regulatory and
decision-making functions. OPP investigations of
pesticide products, for example, have a practical and
specific orientation and primarily consist of checking
the test results, efficacy claims, labels, and other
information that have been submitted to OPP for the
registration, reregistration, or setting of tolerance
levels for pesticides (personal communication from Jean
Pulliam, Chief Research Coordinator, OPP). Because OPP
considers its laboratory investigations to be
informational in character rather than as research in
an academic sense, the functions of these laboratories
are described in Chapter 3 of this report, which
describes the scientific and technical information used
by EPA in its regulation of pesticide chemicals. In
addition, OPP has also conducted and supported special
studies in a number of broad categories: effects of
pesticides, alternative pest control methods,
laboratory methods and quality control, recovery and
conversion of pesticide wastes, cost/benefit assessment
methods, and assessments of unreasonable adverse
effects resulting from the use of pesticides (Grosse
1976).
The pesticides research program of the EPA Office
of Research and Development (ORD) is also directed
toward support of the Agency's regulatory
responsibilities, but the program has a somewhat wider
focus than the information and research related
activities of OPP. The ORD operating plan for the 1978
fiscal year in the area of research on pesticides
includes these activities (U.S. EPA 1977c):
Health effects research—evaluation of in vivo and
in vitro testing for potential carcinogenicity of
pesticides; research on the health implications of
"new generation" pest control agents such as insect
viruses, pathogenic bacteria, hormones,
attractants, etc.; the development of analytical
analyses and measurement methodologies to meet
requirements for detecting sirall quantities of
pesticide residues in environmental samples and in
human tissue; evaluations of human exposures to
pesticides in various living and working
situations; and the development of predictive
models for assaying human dose/response
relationships to pesticides.
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Ecological effects research—studies of the effects
of pesticides on sensitive organisms; effects of
pesticides on ecosystems; routes and rates of
pesticide movement through ecosystems; fate of
pesticides in the ecosystem; and the frequency and
significance of carcinogens and viruses in the
environment.
The budget submission for pesticides research in
the ORD Operating Plan for the 1978 fiscal year was
$8.3 million, of which $1.1 million was to fund
contracts, $1.1 million was for grants, and $75,000 was
for interagency agreements, with the balance to be used
by the Agency for its own research and administrative
expenses (U.S. EPA !977c). This budget submission was
somewhat smaller than the $10.8 million for ORD
research on pesticides for the 1977 fiscal year and was
about the same as the $8.8 million that was spent for
this purpose in the 1976 fiscal year (U.S. EPA 1977a).
Coordination of Research
Research relating to pesticide chemicals done by
EPA, other federal agencies. State Agricultural
Experiment Stations, universities, and other groups is
not coordinated in any formal or effective way,
although attempts to coordinate some of the information
produced in this research have been made (see Chapter 3
of this report for a discussion of this problem). A
recent study by the National Research Council
emphasized the importance of coordinating the many
research programs relating to environmental protection
(NRC 1977c):
It is not likely that EPA will ever have the
financial resources to perform or sponsor all
the research needed to support its
responsibilities, in which hundreds of
billions of dollars are at stake. Indeed, we
doubt that it would be wise public policy to
spend the enormous sums required through a
single agency, however central its role. Our
doubts arise from a recognition of the
legitimate substantive interests of other
agencies, of the great range of scientific
disciplines involved in this research, and of
the difficulties a regulatory agency
inevitably faces in maintaining capabilities
in basic scientific research...it appears to
us necessary to marshal for environmental
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protection more of the national research and
development effort than can or should be
handled by EPA alone.
The need to coordinate environmental research to
prevent duplication and to enable EPA to get maximum
benefits from the limited funding available for this
purpose is one of the major problems facing the Agency.
It is difficult to accomplish this goal, however, for a
subject area as large and as complex as environmental
protection. In this field, research is scattered among
many agencies and other institutions, each with its own
compelling needs or mandates and with its own budgetary
constraints and requirements for the timeliness of
research information. Among the mechanisms that are
available to coordinate the planning and conduct of
research under such diverse conditions are interagency
groups and coordinating committees, formal interagency
agreements, and memoranda of understanding between
agencies or between agencies and the private sector
(U.S. Congress, Senate 1962).
To obtain coordination of research on pesticides
within EPA, and to facilitate coordination with
pertinent research elsewhere, the Committee on
Pesticide Decision Making believes that all EPA
research contracts and grants relating to pesticides
should be cleared through OPD. Although this might
present some problems for administrative and technical
personnel in the Office of Pesticide Programs, these
problems are likely to be outweighed by the benefits to
be gained in time, cost, and the coordination of
information.
Recommendation
• EPA should clear all contracts and grants
for research on pesticides through its Office
of Research and Development (ORD) to gain
better coordination and centralized technical
review of the research.
Quality Control
Proposals that originate inside the Agency or in
other federal agencies for research funded by EPA are
not usually subjected to external technical review (NRC
1977c). Review of proposals originating both inside
and outside the Agency for research on pesticides by
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scientists and other people knowledgeable about the
proposed areas of investigation might ensure better
project design. Such review would also help prevent
duplication of effort by various federal agencies and
institutions. The review process might be carried out
in a manner similar to the peer review methods used by
the National Science Foundation or the National
Institutes of Health.
Publication of Research
Prepublication review of final reports of EPA
research on pesticides is also largely done within the
Agency. The project officer in the division that
issued the research contract is responsible for
reviewing the reports for quality control and final
acceptance, when the subject matter relates to the
development of patent rights for a new chemical
product, the research results are sent to the
appropriate company or industrial representative before
they are released for publication; the results are not
published if publication would involve disclosure of
trade secrets or infringement of patent rights.
Publication of the results of EPA research on
pesticides is an important part of the research
process. It opens up access to the research findings
to policymakers and to regulatory personnel in federal,
regional, and state agencies, to other research
scientists, and to users of pesticides, chemical
companies, trade associations. State Cooperative
Extension Services, and the general public.
Nevertheless, EPA largely disseminates the results of
its research in internal reports and usually does not
publish the results or subject them to external peer
review. ORD issues a quarterly bibliographic summary
of all its published reports, however, which is widely
distributed (NRC 1977c).
Research sponsored by ORD that is conducted by
private contractors may be published by the Agency in
the form of reports on completed contracts.
Presumably, scientists working under contract for EPA
at universities and at other research sites also seek
publication in scientific journals, for the usual
academic reasons, of the results of their research.
The publication in scientific and technical
journals of research on pesticides usually involves
some type of peer review by scientists on the journal's
staff or its advisory board or by specialists to whom
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articles are sent for comment before publication.
Although it may take more than a year for publication
in these journals, whereas the publication of reports
by EPA only takes about three months, publication in
scientific journals has the advantages of peer review
and distribution within the scientific and technical
community. Unfortunately, it may not be possible to
publish the results of research both in EPA reports and
in scientific and technical journals because journal
editors often take the position that Agency reports
constitute prior publication and they may not be
willing to publish the results again. In the opinion
of this Committee, the advantages of publication in
scientific and technical journals outweigh the
disadvantage that this form of publication is likely to
take longer than does the publication of reports by
EPA.
Recommendation
• EPA should seek publication of the
results of its research contracts and grants
in scientific and technical journals rather
than in Agency reports.
Use of Research Results in
Decision Making
Information on the results of EPA research is
channeled through a formal decision-making sequence.
Key components of this sequence include a working group
that has been appointed to examine a regulatory action
or standard under consideration, the EPA Steering
Committee, and, finally, the EPA Administrator. (For a
description of the use of scientific and technical
information in the EPA decision-making process, see the
report to EPA by the Environmental Research Assessment
Committee of the National Academy of Sciences [NRC
1977c].)
The use that the Office of Pesticide Programs makes
of research reports and other scientific and technical
information is described in Chapter 3 of the present
report. This Committee believes that the OPP staff
should become more involved in the transfer of relevant
information to administrative decision makers who are
charged with interpreting and implementing-the Agency's
programs. As has been pointed out by the Environmental
Research Assessment Committee (NRC 1977c):
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Even if the decision makers involved were all
trained scientists—which they neither are nor
are likely to be—they would almost certainly
lack the breadth of technical experience
needed to judge the validity and applicability
of such diverse scientific and technical
information. We therefore conclude that
scientists, informed and up-to-date in their
respective fields, should be responsible for
gathering, analyzing, transforming, and
transferring the [scientific and technical]
information in a form that can be used by
nonexperts.
Much of the advice that the Office of Pesticide
Programs receives from advisory committees is oriented
toward policy needs rather than toward the technical
aspects of decision making on pesticides. The OPP
should make more extensive use of roultidisciplinary
groups, both outside and inside the Agency, to provide
better channels of communication with the scientific
community on the technical aspects of its pending
decisions on pesticides. This would also give the
interested public a better insight into the EPA
decision-making processes as they relate to pesticides.
MONITORING
The National Pesticide Monitoring Program
The importance of adequate environmental monitoring
programs has been constantly reiterated by various
studies, beginning with one in the early sixties by a
Presidential science advisory committee (President's
Science Advisory Committee 1963). This Presidential
committee recommended that the federal government
should develop a continuing network to monitor the
levels of chemical residues in the environment. The
result was the establishment of the National Pesticide
Monitoring Program (NPMP) as a cooperative effort by
several federal agencies. With the enactment of FIFRA,
as amended, the NPMP achieved statutory status.
Sections 20(b) and (c) of the law, which delegate the
authority to EPA to develop and carry out a plan for
monitoring pesticides in all components of the
environment, state:
Sec. 20(b) NATIONAL MONITORING PLAN.—The
Administrator shall formulate and periodically
revise, in cooperation with other Federal,
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State, or local agencies, a national plan for
monitoring pesticides.
Sec. 20(c) MONITORING.—The Administrator
shall undertake such monitoring activities,
including but not limited to monitoring in
air, soil, water, man, plants, and animals, as
may be necessary for the implementation of
this Act and of the national pesticide
monitoring plan. Such activities shall be
carried out in cooperation with other Federal,
State, and local agencies.
Historically, the NPMP monitoring of pesticide
residues has been scattered among federal agencies.
This situation still exists and, according to an
evaluation by the Battelle Columbus Laboratories
(Carroll et al. 1975), the dispersion of responsibility
for monitoring residues has limited the program's
effectiveness.
The NPMP is made up of these subprograms:
• Food and feed monitoring. This effort has
three components—a "market basket" study which is made
by the Food and Drug Administration (FDA) to determine
the amount of pesticide residues in a well-balanced
diet; an FDA nationwide surveillance of domestic and
imported raw agricultural commodities, processed foods,
and animal feeds; and surveillance by the USDA Animal
Plant Health Inspection Service of residues in meats
and poultry.
• Human monitoring. This program is operated by
EPA in cooperation with the National Center for Health
Statistics of the U.S. Department of Health, Education,
and welfare. Its purpose is to determine, on the basis
of tissue samples, the incidence and level of exposure
to pesticides in the general population.
• Soils monitoring. EPA monitors the presence
of pesticides in cropland, noncropland, and urban soils
in this program.
• Water monitoring. EPA and the Geological
Survey of the U.S. Department of the Interior jointly
operate this program to estimate ambient levels of
pesticide residues in water and in the sediments of
major drainage basins of the continental United States.
• Estuarine monitoring. EPA monitors residues
in estuarine fish and fauna in this program.
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• Ocean monitoring. EPA and the National Marine
Fisheries Service of the National Oceanic and
Atmospheric Administration in the 0.S. Department of
Commerce monitor pesticide residues in ocean fish.
• Bird monitoring. The U.S. Fish and Wildlife
Service in the U.S. Department of the Interior monitors
residues in ducks and starlings in this program.
• Freshwater fish monitoring. Pesticide
residues in lake and river fish are monitored by the
U.S. Fish and Wildlife Service.
• Air monitoring. Two pilot studies were
conducted by EPA in this area, but there is no regular
NPMP program now in operation to monitor pesticides in
air.
The Battelle study of the NPMP concluded that the
program organization is essentially that of an
association of subprogram directors and that overall
NPMP management does not exist:
Key project findings...indicate lack of
management accountability and lack of
operational continuity in the current NPMP.
At present, each subprogram manager is
responsible for...structuring monitoring
designs, maintaining analytical quality, and
reporting the collected data for his portion
of the program. Since each subprogram manager
is responsible to the particular agency by
which he is employed, and since there is no
coordinating group with overall NPMP
management responsibilities and authority,
program continuity and accountability do not—
and, indeed, cannot be expected to—exist.
The Battelle report also criticized the time lags,
which sometimes have been as long as three to four
years, between the collection of monitoring data and
the compilation, evaluation, and publication of these
data. A report by the National Agricultural Chemicals
Association on the first 10 years of NPMP operation
(Spencer 1974) makes a similar criticism of the NPMP.
The effort to develop or maintain an effective
interagency organization concerned with pest control
has a long and uneven history (see Chapter 3 of this
report). If monitoring of pesticide residues is to be
done in an orderly and systematic way, it is clearly
necessary for EPA to assume the central responsibility
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that it was given under FIFRA, as amended, to implement
a national pesticide monitoring plan. It is
unrealistic, however, to expect that EPA can or should
take over all monitoring activities that are now being
carried on by federal agencies. These agencies are
certain to continue addressing their individually
mandated responsibilities for monitoring pesticide
residues, and they are unlikely to yield to any
displacement in such activities by EPA. EPA's goals
should be the reasonable ones of coordination in
program planning, identification of data requirements,
establishment of quality control for analytical
techniques, and the establishment of a formal reporting
mechanism for the data that are drawn from monitoring
programs.
In identifying its data requirements in relation to
pesticide residues, EPA should include not only
monitoring data but also other relevant data, such as
reports (for instance. National Cancer Institute
[1975]) on the geographical and occupational
frequencies of cancer in the United States that might
indicate the possibility of some linkages with the
presence of a pesticide chemical in a particular region
or work site.
Recommendation
• EPA should accept and act upon its
statutory responsibility for the ~
implementation of a National Pesticide
Monitoring Plan by determining the data that
are needed for the regulation of pesticides
and by exerting leadership among the federal
agencies with monitoring programs to assure
that the NPMP adequately addresses these
needs.
Some steps have been taken in this direction. In
1975, the EPA Office of Pesticide Programs prepared a
national pesticide mointoring plan that calls for the
development of monitoring "networks" and of a
centralized system for handling data. The proposed
networks include existing federal monitoring programs,
any new programs that may be required, and the
integration of regional and state monitoring programs
when their designs and analytical methodologies are
compatible with those of the national programs. EPA
has revised its draft of the plan a number of times in
response to comments from other federal agencies. The
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latest version of the plan was submitted to these
agencies in March 1977.
The Pesticides Monitoring Journal
The Pesticides Monitoring Journal has served as a
vehicle for distributing scientific and technical
information gathered from pesticide monitoring
programs. It is published quarterly under the auspices
of the Federal Working Group on Pest Management
(FWGPM), which is responsible to the Council on
Environmental Quality. When the FWGPM become inactive
after the dissolution of its secretariat (see Chapter 3
of this report), EPA took over the editorial
responsibilities for the Journal.
The Journal has not only published the NPMP
findings but has been an outlet for the results of
other studies of pesticide residues. During the period
when the FWGPM had the editorial responsibility for the
Journal, there was extensive scientific peer review of
the contents before their publication and there were
rigorous requirements for the validity of the chemical
analytical methodologies used in the studies for which
data were reported. As a result of funding
limitations, EPA has been unable to continue the
prepublication peer review, although some technical
opinions are still obtained from outside the OPP
Technical Services Division, where the Journal is now
produced.
To maintain its credibility and value, the Journal
should reestablish rigorous requirements for the
presentation of data on residue sampling. A board made
up of analytical chemists whose work is concerned with
pesticides should be responsible for reviewing the
chemical methodology in each study that is reported.
This board should include chemists who are experienced
in the analysis of different substrates because
analytical procedures differ widely, particularly in
sample preparation. Additional reviewers, including
biological scientists and other persons drawn from the
scientific community in the manner usually employed by
technical journals, should review the sampling plan,
statistical validity, interpretation, and other
technical aspects of each study that is reported in the
Journal.
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Recommendation
• EPA should adopt an editorial policy for
the "Pesticides Monitoring Journal" that
represents the highest scientific standards_gf
data reporting and analysis and should make
rigorous requirements for the explicit
description of analytical methodologies in
"Journal" articles.
NOTES
Abel, F.H. (1976) The Use of Economic Information
in Registering Pesticides. An analysis of the role
of economics and economic data in pesticide
decision making from the perspective of the law,
the regulations, and EPA procedures. (Unpublished
paper prepared for the Committee on Pesticide
Decision Making.)
Duggan, E.E. and M.B. Duggan (1976) Definition and
Classification of Food and Food Groups for the
Purpose of Codex Tolerances for Pesticide Residues.
A report prepared for the Food and Agriculture
Organization of the United Nations. ESN 0107-75-
06. (Working document only.)
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CHAPTER,3
COORDINATION AND COMMUNICATION OF
INFORMATION ON PESTICIDES
INFORMATION REQUIREMENTS
The information needed by EPA for the regulation of
pesticides originates in a number of disciplines and
comes from a broad spectrum of agricultural, forestry,
industrial, environmental, and health interests. It
must cover not only the toxic effects that may occur in
humans, wildlife, or farm animals as a result of
pesticide use but also the economic and agricultural
effects of a pesticide and of substitute chemicals or
alternative pest control methods. The sources of these
data are varied and include field experience in the use
of various pest control measures on crops, surveys to
obtain quantitative information on the use of pesticide
chemicals, and laboratory tests.
To ensure consumer protection and environmental
quality, EPA requires extensive testing of pesticides
before they can be registered and marketed. Although
the Agency independently tests certain kinds of
products and validates testing systems, it lacks
adequate resources to test all of the products for
which toxicological studies are required. In the case
of pesticides, the responsibility for such testing is
assigned by law to the manufacturer. Under FIFRA, as
amended, the adequacy and validity of laboratory and
field tests essentially remain the responsibility of
the product sponsor as part of the process of
establishing the marketability of a pesticide. EPA
guidelines outline the type and extent of testing that
is required to determine the safety and utility of a
product, and the results of these studies must be
submitted to EPA before a product can be registered and
sold.
Because the manufacturer or processor of a
pesticide bears the burden of proof for establishing
the pesticide's efficacy and safety, the EPA function
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is primarily one of review and response to information
submitted by an interested party. This is a complex
and difficult assignment because it must mesh with the
Agency's responsibility to protect humans and the
environment from unreasonable adverse effects stemming
from the use of pesticides. To make appropriate
judgments about a pesticide, EPA must have both the
scientific capability to assess the data submitted by
industry and a ready access to independent data and
other information that are relevant to each pesticide
that is under review.
The importance of data and other information from
independent sources was made evident by John R.
Quarles, Jr. , then Deputy Administrator of EPA, in
testimony on pesticide safety testing before a joint
hearing on January 20, 1976 of the Subcommittee on
Administrative Practice and Procedure of the Senate
Judiciary Committee and the Subcommittee on Health of
the Senate Committee on Labor and Public Welfare. Mr.
Quarles said that, although private laboratories which
do research on pesticide chemicals for industry
"generally provide competent and honest services, there
are indications that serious problems may exist." He
said that four improper situations are possible:
... a laboratory could be technically
incompetent to perform the test, due to an
inadequacy of personnel, essential equipment
or management experience. Second, valid test
results indicating dangerous pesticide
characteristics may be withheld from EPA.
Third, a laboratory might be so dependent upon
a pesticide producer for contract work that
its independent scientific judgment could be
impaired by the close economic relationship.
And fourth, a laboratory might intentionally
misrepresent test results at the request of
the manufacturer.
Mr. Quarles also described a specific situation of
this kind that had occurred:
For example, in recent EPA administrative
hearings on Heptachlor/Chlordane and
Aldrin/Dieldrin, we found that many of the
laboratories which had completed chronic
toxicity studies performed extremely
conservative histologic examinations. In
virtually every instance, independent
pathologists diagnosed many more cancerous and
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precancerous tumors in the test animals than
did the original laboratory pathologists.
The integrity of independent laboratories is
essential. If objective judgment is impaired by the
dependence on future contracts, then the test results
would be in question whether the funding came from
pesticide manufacturers or from EPA.
EPA's needs for adequate data have been
considerably enlarged by the Congressional requirement
that, in addition to acting on new applications for
pesticide registration, EPA must review about 33,000
registered pesticide products which were approved
before the enactment of the FIFRA amendments. EPA is
also reviewing some 4000 tolerances for pesticide
residues. The reviews of older pesticide products have
shown that, in many cases, the testing that was done in
order to obtain registration of those products in past
years is now inadequate in terms of present scientific
testing standards and statutory requirements. Agency
problems in reevaluating such data, particularly in
areas where there are indications that a pesticide
chemical may have oncogenic effects, have resulted in
EPA halting its registration and reregistration of
pesticides. (See Chapter 2 for a more detailed account
of the problem.)
Credibility of Information
The testing required for pesticides is established
by EPA's basic legislation, by its regulations, and by
the available technology to fulfill these requirements.
The laboratory data required by EPA in the pesticide
program are primarily intended to assess the acute,
subchronic, and chronic toxicity of a pesticide product
to humans or to animals, including any reproductive,
teratogenic, carcinogenic, mutagenic, or degenerative
effects, based upon the appearance of these effects in
laboratory animals. Data may be derived from in vivo
or JQ vitro tests, and these laboratory investigations
may involve biochemistry, nutrition, immunology,
microbiology, and other disciplines. The importance of
toxicological and other test data in EPA decisions on
the safety and efficacy of pesticide products demands
protocols and procedures in these studies that are
scientifically sound and that will ensure the quality
and integrity of the data.
Although the laboratories of pesticide
manufacturers and those of research or testing firms
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that are under contract to applicants for pesticide
registration or reregistration do most of the data
development relating to the safety and efficacy of
pesticides, some data submitted to EPA in support of
pesticide products are derived from studies made by
veterinary and medical clinics, hospitals,
universities. State Agricultural Experiment Stations,
and the research laboratories of government agencies or
their contractors. The facilities where these studies
are done range from those of large corporations to
laboratories in which a few people study a pesticide
chemical for a sponsoring firm or institution. The EPA
Office of Pesticide Programs also maintains
laboratories, which provide support for Agency reviews
and other regulatory functions relating to pesticides.
Six of the laboratories are located in EPA facilities
in Beltsville, Maryland and three are in Corvallis,
Oregon. These laboratories, which are administered by
the OPP Technical Services Division, specialize in the
following areas: (in Beltsville) microbiology,
entomology, plant biology, animal biology,
pharmacology, and chemistry; (in Corvallis) plant
biology, anti-fouling (the control of organisms that
foul boat hulls and marine structures and equipment),
and entomology (personal communication from Dr. William
S. Murray, Director, OPP Technical services Division).
Because EPA must place great reliance in its
decision making on data that have been submitted by
applicants, there must be confidence in the Agency's
ability to determine that these data have quality and
integrity. To meet this objective, it is important for
EPA to have a quality assurance program. A basic
method for obtaining data that have scientific validity
is to establish standards for testing pesticide
products which define the required reliability and
precision of the analytical systems used in the tests
of pesticide products. OPP publishes two procedural
manuals, one on chemical and the other on biological
methods, that are updated regularly and are available
to laboratories that do pesticide analyses. In effect,
these manuals serve as standards and they are used in
the Agency's legal proceedings for pesticide products.
OPP also tries to improve the quality of data on
pesticides by providing some technical advice, covering
a wide range of disciplines, to regional, state, and
university laboratories that analyze pesticide
products.
It is also necessary to incorporate quality
standards for data in the Agency's published guidelines
that specify the kinds of information that must be
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submitted for the registration or reregistration of a
pesticide. EPA has published in the Federal Register
(U.S. EPA 1975) its proposed guidelines on Agency
requirements in the following areas: test procedures
to establish the effectiveness and usefulness of the
different categories of proposed pesticides; the
development of claims for a pesticide label;
information on the chemistry of a pesticide product,
and the fate and movement of the pesticide in the
environment; and the collection and reporting of data
on the toxicity of the pesticide. The proposed
guidelines are being reviewed by the EPA Scientific
Advisory Panel and revisions in the procedures will
incorporate the recommendations of this group. EPA
stated, in publishing its proposals, that the
guidelines are not intended to be static and will be
modified or expanded as new scientific information
becomes available. The Agency has not yet published
its guidelines for a number of other important areas in
pesticide regulation: registration procedures;
experimental use permits; petitions for tolerances; and
packaging, storage, and disposal methods.
To help in determining the quality of data that
have been submitted in support of pesticide products,
it is important for EPA to contract for independent
research that covers all pertinent categories of
toxicological testing, such as long-term feeding tests
for chronic effects, short-term feeding tests for acute
effects, short-term screening tests, reproduction and
teratology tests, and tests for mutagenicity. In
addition, the Agency should accelerate its efforts to
collect valid data in a computerized system that would
make data readily available for all regulatory needs in
the control of pesticides.i This data system should
include information on alternative pest control
measures and on the economics and benefits of various
pest control technologies. This information is needed
by the Agency for risk/benefit assessments. A high
level of support within EPA will be necessary to
establish a dependable system for the retrieval of
current* relevant, and reliable data on pesticide
chemicals because building such a system will be a
difficult and costly undertaking.
Recommendation
• OPP should take the lead in developing a
modern data system to identify important
sources of scientific and technical
information on pesticides and to provide a
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reliable method for collecting, evaluating.
validating, indexing, and computerizing data
on pesticides.
Intra-agency Considerations
To learn more about EPA's needs for data and the
Agency's use of scientific and technical information in
its decision making, this Committee explored two areas
in some detail. One was the Rebuttable Presumption
Against Registration (RPAR) process described in the
Cancellation/Suspension section of Chapter 2 in this
report. Another was EPA's use of information in
setting tolerance levels for pesticide residues. The
latter, which is described briefly here, indicates that
better coordination and communication of information on
pesticides is vital to the Agency if it is to lessen
its dependence on information from its applicants and
petitioners.
The Federal Food, Drug, and Cosmetic Act specifies
the information that must be submitted with a petition
for the establishment of a tolerance for residues of a
pesticide chemical. This information must include the
chemical identity and composition of the pesticide;
information on its use; full reports of investigations
of the pesticide's safety; the results of tests on the
amount of residue and a description of the analytical
methods used; the proposed tolerance; and practicable
methods for removing residues that exceed this
tolerance. Data provided by the petitioner are then
reviewed by the Chemistry, the Toxicology, and the
Efficacy and Ecological Effects Branches of the OPP
Registration Division.
The Chemistry Branch has been using a set of
informal guidelines that were first developed when the
Food and Drug Administration was responsible for
setting tolerances for pesticide residues and that are
periodically updated by EPA. These guidelines offer
petitioners for tolerances a detailed description of
the information that is required to support a proposed
tolerance. The reviewing chemists in the OPP Chemistry
Branch also use the guidelines to determine whether the
kinds of data that are submitted are appropriate. The
ability of reviewers to evaluate the data can often be
limited by a lack of current and relevant information
in the scientific literature. This problem is
accentuated in the case of new candidates for
pesticides because there is no field experience to draw
upon in evaluating these products. Furthermore, it is
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likely that the only studies of the metabolic routes of
a new pesticide in crops and animals were made by the
petitioner or by the petitioner's contractor. Because
these studies are held in confidence until presented to
EPA, the data are not available in scientific
literature, where they might be assessed and commented
on by the larger scientific community. However, in
cases where a petitioner seeks to establish tolerances
for an approved pesticide on additional crops, or when
a pesticide is related in some other way to pesticides
for which tolerance levels have been established, a
reviewer can compare the data for the registered and
the proposed uses. There may also be pertinent
information in the scientific literature which will be
useful to reviewers in such instances.
In addition to assessing the petitioner's data,
reviewers must determine whether the assay method used
by the petitioner to identify and quantify the
estimates of chemical residues is an adequate one.
This judgment is aided by the results of residue
recovery studies done in the laboratory section of the
Chemistry Branch. These recovery studies are somewhat
limited, however, by a lack of equipment and trained
personnel to determine the extraction efficiency of an
assay method for aged and weathered residues that are
present on crops when they are harvested.
The Toxicology Branch of the OPP Registration
Division also uses an informal set of guidelines that
were developed by the Food and Drug Administration and
that have been updated to take account of changes in
standards for toxicological testing. Like their co-
workers in the Chemistry Branch, the Toxicology Branch
reviewers are handicapped by the fact that most of the
data available to them on the toxic effects of a
pesticide are provided by an interested party.
However, they do have access to some independent
studies of chemical toxicity, including studies by the
National Cancer Institute, of the oncogenic effects of
a number of pesticides for which residue tolerances
have been set. These studies, which take two to three
years, may be helpful to reviewers in the Toxicology
Branch when they have been made of chemicals that are
closely related to a candidate for a tolerance. For
short-term studies of the acute toxic effects of a
pesticide, reviewers in the Toxicology Branch are able
to use laboratories operated by the OPP Technical
Services Division.
The Efficacy and Ecological Effects Branch of the
OPP Registration Division is concerned with any adverse
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effects of pesticides on humans or the environment and
with the efficacy of new pesticide products. Reviewers
proceed on the basis of their own background and
experience, consultation with their associates in other
OPP units, the EPA regulations, and the Interim EPA
Guidelines for Suspected Carcinogens.
In addition to the problem of relying almost solely
upon data from petitioners for residue tolerances,
personnel in the three branches of the OPP Registration
Division commented, in remarks to the Committee on
Pesticide Decision Making and its staff, that there
were problems of poor communications with personnel in
the OPP Criteria and Evaluation Division and that they
did not receive much cooperation from the EPA Office of
Research and Development (ORD). There also seems to be
limited coordination between the OPP branches that
review pesticide applications and the Pesticides and
Toxic Substances Enforcement Division of the EPA Office
of General Enforcement. There is somewhat better
coordination between the OPP branches and the Pesticide
Misuse Review Committee (PMRC) in that office. The
PMRC provides information to EPA headquarters on
concurrence with regional enforcement actions, develops
guidelines for handling cases in which pesticides have
been misused, studies patterns of misuse, and
determines whether the labeling and packaging of
pesticides are adequate. As a result of its reviews of
cases in which pesticides have been misused, the PMRC
has made 17 recommendations on labeling to the
Registration Division which will be incorporated in the
reregistration process for those products.
Recommendation
• OPP should develop and utilize an
internal communications system which will give
all OPP divisions an effective role in the
decision-making process.
SOURCES AND DISTRIBUTORS OF PESTICIDE INFORMATION
Information about pesticide chemicals is dispersed
among regulators, producers, and users of pesticides,
medical scientists and researchers, fish and game
commissions, agricultural research stations, state
extension services, and other agencies and groups.
These form a loosely constructed information network
that can be a valuable resource for EPA to draw upon in
the regulation of pesticides and can serve as a
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mechanism for the dispersion of information on EPA
decisions. If this network is to be effective in these
roles, however, it must be able to communicate rapidly
with EPA on such matters as the availability of
pesticides, the cancellation of pesticide
registrations, changes in pesticide labeling, emergency
pest control needs, requirements, and problems that
arise in the use of specific pesticides.
U.S. Department of Agriculture
EPA is required by FIFRA, as amended, to notify the
Secretary of Agriculture at least 60 days before
issuing a notice of intent to cancel a registration, to
change its classification, or to hold a hearing on a
pesticide. Except for this relationship that has been
established by Congress, EPA and USDA did not develop a
formal arrangement for the exchange of information
until recently, although there have been continuing
communications on a personal level between employees of
the two agencies. A good beginning toward the
establishment of closer relationships was made in the
memorandum of understanding that was signed by the
agencies in December 1976. This document establishes
an administrative mechanism for gathering and assessing
information to be used in making benefit/risk
assessments in the EPA Rebuttable Presumption Against
Registration (RPAR) process and it represents an effort
to implement the legislative mandate regarding changes
in classification or cancellations of pesticides (see
Chapter 2 of this report for more detail on the
memorandum).
USDA has extensive scientific and technical
information on the use of pesticides and is a major
resource for much of the data that EPA needs to carry
out its regulatory functions in this area. The USDA
Current Research Information System (CRIS), for
example, could be used by EPA to obtain detailed data
on the pest control needs and practices of farmers, the
use of pesticides in forestry, and other pertinent
statistical information.
Recommendation
• The cooperative action undertaken by EPA
and USDA on benefit/risk assessments should be
broadened so that EPA has ready and regular
access to the extensive data resources of USDA
on all aspects of pest management. For
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example. EPA should work with USDA to develop
and conduct a survey, preferably on an annual
basis, of the nation's use of pesticides.
Other Federal Agencies
The U.S. Department of Health, Education, and
Welfare has been important to EPA as a source of
scientific and technical information on the health
aspects of pesticide use and regulation. The
Toxicology Branch of the OPP Registration Division, for
example, has used oncological studies by the National
Cancer Institute of several registered pesticides and
has benefited from communications with the Food and
Drug Administration and the Public Health Service of
HEW.
Interagency Relationships
Since 1940, attempts have been made to establish
regular communications among federal agencies on the
safe and effective use of pesticides, on research in
this area, and on federal pest control programs.
Various formal interdepartmental groups were set up for
this purpose, each displacing an earlier group in an
attempt to develop effective working relationships in
the pest control sector. The sequence of groups
established for this purpose was: the
Interdepartmental Committee on Pest Control, the
Federal Pest Control Review Board, the Federal
Committee on Pest Control, and a subcommittee on
pesticides of the Committee on the Environment.
Finally, the Federal Working Group on Pest Management
(FWGPM) was set up in 1970 under the Council on
Environmental Quality with the responsibility of
reviewing and coordinating the proposed pest control
programs of its member federal agencies. A secretariat
of seven persons, the functioning arm of the FWGPM, was
supported by EPA until the secretariat was dissolved in
June 1976 as the result of a recommendation by the
Office of Management and Budget; the FWGPM has been
inactive since that time. The lack of a formal
communications network on pest control at the federal
level could inhibit the flow of information between EPA
and other federal agencies whose research or other
functions relate to EPA concerns.
One formal interagency organization that was
recently established is the National Center for
Toxicological Research in Jefferson, Arkansas, which is
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funded jointly by EPA and the Food and Drug
Administration. The center has begun doing research on
carcinogenicity and teratogenicity at the low levels
corresponding to most human exposures to pesticide
chemicals and is beginning to be a valuable source of
this information for EPA decision making.
State Agencies
A number of state agencies are directly involved
with pesticides in their regulatory, research,
educational, or administrative functions. Many states
have passed enabling legislation for state regulation
of pesticides and for the implementation of programs
consistent with the state's particular needs. In
states that have effective regulatory programs, the
knowledge of personnel in the regulatory agency—in
most cases this is the state department of
agriculture—can be a valuable asset that should be
used by EPA in its decision making on pesticides.
Program capabilities of the regulatory agency still
need to be developed or strengthened, however, in a
number of states that have enacted legislation for
pesticide regulation. Other states have not assumed
responsibility for the regulation of pesticides because
of limited resources, a lack of critical need, or
lobbying by affected groups.
Recommendation
• State agencies regulating the
registration, distribution, and use of
pesticides should have a formal liaison.
either through a state advisory board for
pesticide regulation or through a memorandum
of agreement, with these groups; the State
Agricultural Experiment Stations; State
Cooperative Extension Services; other state
agencies; industry and trade associations; and
public health, environmental, and user groups.
It is difficult to quantify the knowledge of
pesticides in state agencies such as the State
Agricultural Experiment Stations, which do research in
agriculture; the State Cooperative Extension Services,
whose functions are primarily educational; and public
health agencies; departments of natural resources; and
fish and wildlife commissions. One measure that might
be used is the amount of money spent for research on
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pest control by some of the agencies at the state
level. A study by the National Academy of Sciences
(NEC 1975b) reported that in 1972 more than $130
million were spent for this purpose by USDA's
Agricultural Research Service and Forest Service, the
State Agricultural Experiment Stations, forestry
schools, and cooperating institutions. Other state
agencies, such as the State Cooperative Extension
Services, have had considerable field experience in the
use of pesticides. These agencies are particularly
important to EPA because they constitute part of the
network for information on pesticide regulatory
decisions that is in direct communication with the
users of pesticides, local farm and labor
organizations, and trade associations.
The importance and effectiveness of state agencies
in pesticide decision making was demonstrated in 1970
when growers in the northwest United States noticed the
appearance of a new insect pest in forage grasses,
which were being destroyed by insect larvae. The State
Agricultural Extension Service quickly identified the
troublesome insect as the crane fly, a recognized
problem in Canada, but not in the United States. There
was no pesticide registered in the United States for
control of the crane fly at that time, but with
information from its counterpart in Canada, the
Extension service did field tests of a number of
pesticides and helped to obtain registration for the
use of methyl parathion to control this pest on forage
grasses.
State agencies may also be more aware than a
federal regulatory agency of the possible risks in the
use of a pesticide because they are closer to these
problems. This is illustrated by another example of
action that was taken by a state agency. In the late
1960s, there were many complaints that ornamental trees
were showing signs of damage. Upon investigation, a
state agency determined that these injuries resulted
from applications of "weed and feed" herbicide products
containing dicamba. The label for these products,
which were being applied to lawns, did not contain a
warning against applications within the dripline or
root zones of trees and shrubs. After research
confirmed the fact that applications of the chemical
were injuring these plants, the registrants of the
pesticides were notified of the problem and the
necessary warnings were then placed on the products.
Despite the knowledge of pesticides at the state
level, and the needs at this level for information on
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EPA's decisions relating to pesticides, communications
between EPA and state agencies seem to be poor. In
comments made to the Committee on Pesticide Decision
Making, officials of the State Agricultural Experiment
Stations and State Cooperative Extension Services said
that EPA does not seem to be aware of the expertise and
the scientific and technical information that are
available in the states. They also said that the flow
of information from EPA to the states is seriously
inadequate. It sometimes takes months before
information about EPA decisions for specific pesticides
reaches the State Cooperative Extension Services and,
in many cases, an Extension Service pest management
specialist first learns from a source in industry about
an EPA action that affects what the specialist is
demonstrating to farmers for the control of a
particular pest. Agency officials reported that
frequent EPA changes in its regulations and the
inability of users to get current information have
caused so much delay in the public information programs
carried on by State Cooperative Extension Services that
these programs have lost some of their impact and
credibility with the users of pesticides.
People who use pesticides need precise and timely
information about these chemicals. The directions for
pesticide use and the educational materials prepared by
State Cooperative Extension Services and other agencies
must be specific, accurate, and up-to-date.
Furthermore, users of pesticides need to be kept
informed of current and potential problems associated
with pesticides and their options for solving these
problems. For these reasons, it is imperative that
regulatory officials, researchers. State Cooperative
Extension Service specialists, and other concerned
people at the state level should have ready access to
current EPA actions in regard to pesticide
registration, reregistration, and setting of residue
tolerances.
Some communication between EPA and state groups is
provided by the EPA State-Federal FIFRA Implementation
Advisory Committee and, to a lesser degree, by the EPA
Administrator's Pesticide Policy Advisory Committee and
the formal commentary mechanism that accompanies
federal rule-making. Participation by EPA scientists
and other professionals in state, regional, and
national meetings of professional organizations would
also facilitate state-federal communications on the
regulation of pesticides.
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The microfiche system now being developed by EPA
should provide much of the information on a product-by-
product basis that is required to satisfy the needs of
user groups. This system is too complex and cumbersome
for general use, however, and it will be necessary for
states or regions to develop guides that are based on
the microfiche information for use by the public.
Recommendation
• In cooperation with the State-Federal
FIFRA Implementation Advisory Committee. EPA
should develop and implement a reference
system that would give State Agricultural
Extension Services, state regulatory agencies.
pesticide users, and other concerned groups
immediate access to information on current EPA
registrations.
Surveys of Pesticide Use
Under earlier legislation on pesticides, it was not
necessary to identify and quantify the benefits to be
derived from the use of a pesticide or to develop data
to measure potential losses that might result from
cancellation of an effective pesticide product. These
data are required by provisions of FIFRA, as amended,
and they must enter into decisions made by the EPA
Administrator to cancel or change the use of a
pesticide.
Good published data on the use of pesticides that
would help in assessing benefits, or the potential
losses when a pesticide is cancelled, are relatively
scarce. To obtain information of this type, the USDA
Economic Research Service has done some sample surveys
on farmers• use of pesticides in different regions of
the United States and for different crops and classes
of livestock. The most recent survey, in which 8600
farmers in 49 states were interviewed, was made of
farmers' use of pesticides in 1971. Three reports on
the survey cover the quantities of pesticides used,
identified by the type of active ingredient; the extent
of use, in terms of acreage and specific crops; and
expenditures for pesticides, by type of crop and by
level of gross farm sales (USDA 1975). A similar USDA
survey that has not yet been published was made in
1976.
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Four midwestern states did detailed studies in 1969
and 1970 of the use of pesticides on farms. Minnesota
is the only one of these states that has continued to
fund and conduct such surveys. The most recent
Minnesota survey, which was made by the Minnesota
Department of Agriculture in cooperation with the USDA
Statistical Reporting Service, gathered information for
1974 on acreage treated with pesticides by major crop
and chemical; acreage harvested; category of applicant
(farmer or custom applicator); method of application;
relative effectiveness of the pesticide; rates of
pesticide application; the use of pesticides on
specialty crops; and estimated costs of losses due to
insects on untreated acreage (Minnesota Department of
Agr icuIture 1975).
The value of surveys of this kind is that they are
based on experience with the use of pesticides rather
than on estimates or other information of a more
general nature. Good data on field experience with
pesticides can be used for the following purposes:
• to help analyze the benefits and risks
involved in the use of pesticides;
• to determine the long-term distribution of
pesticides and the chemical load in the environment;
• to correlate the application rate and
frequency of pesticide use with the monitoring of
pesticide residues;
• to evaluate integrated pest management
procedures;
• to enable State Cooperative Extension Services
to direct their educational programs to specific needs;
• to assess needs for training and certifying
pesticide applicators;
• to assess the total economic and energy costs
of pest control;
• to plan research priorities and needs; and
• to project the annual demand for chemicals and
spray equipment.
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Monitoring Programs
The National Pesticide Monitoring Program (NPMP),
described in Chapter 2, has the potential for providing
valuable data on residues of pesticide chemicals in
humans, in wildlife, and in the environment. The
limited funding and the diverse interests and
responsibilities in this program, have inhibited its
development and its use as a major source of data for
the regulation of pesticides.
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CHAPTER 4
PERSONNEL FOR PESTICIDE REGULATION
The implementation of pesticide legislation by the
EPA Office of Pesticide Programs depends in large
measure upon the skills, quality, distribution, size,
and flexibility of its professional staff. The
Committee found it difficult to assess these personnel
factors in the OPP, however, because that office was
considering various proposals for realignment of job
functions while this study was underway.
It was also difficult for the Committee to
determine the exact relationship between specific
occupational functions in the Agency and the iirpact of
these functions on final decisions that are made about
pesticides. Throughout the entire Committee study,
however, it was apparent that decision making on
pesticides is a complex process that is highly
dependent upon a variety of scientific, technical, and
administrative skills. Public opinion often assigns to
lawyers a primary role in the decisions that are made
by regulatory agencies, possibly as a result of
newspaper stories about the adjudicatory proceedings in
these agencies. Furthermore, tenable evidence to
support the actions of a regulatory agency is,
appropriately, a matter of legal concern once this
evidence has been developed by other personnel. It was
evident during the course of this study, however, that
EPA relies heavily upon the information and knowledge
of scientists and technicians to determine whether the
use of a particular pesticide is safe or if it appears
to meet or exceed the criteria that the Agency has
established to determine the presence of hazards to
humans or to the environment. It seems reasonable to
assume that decisions to issue notices of intent to
cancel, suspend, or to change the use of a pesticide,
and other major decisions of the Agency are shaped by
the information that has been developed by scientists,
technicians, and administrators at every stage of
pesticide regulation.
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The distribution of scientific and technical
personnel at various levels is also of interest in
assessing the relative importance the Agency gives to
different types of knowledge and skills. Although this
study focuses on the Office of Pesticide Programs and
not on EPA as a whole, it seems likely that the
distribution of personnel is somewhat similar
throughout EPA. Data compiled by the NRC Committee for
Study of Environmental Manpower (NEC 1977b) indicate
that:
• EPA employs 43 percent of its 10,000 full-
time, white-collar personnel in scientific and
engineering categories, a higher proportion than in
most government agencies.
• Scientists and engineers make up a large
proportion of EPA personnel at top and middle levels of
the Agency (scientists represent 65 percent and
engineers represent 5 percent of the Civil Service
"supergrade" employees of EPA in grade levels 16 to 18
and earn $39,629 to $54,410; at the middle management
level, scientists have 32 percent of the positions in
grades 12 to 15, and earn $20,442 to $43,923, while
engineers have 27 percent of the jobs at this level).
• The educational level of EPA personnel is
high, with 6 percent having Ph.D. degrees and 19
percent having master's degrees.
A detailed analysis of the professional employment
in the various OPP divisions (excluding OSPR) as of
February 1976 provides information on the distribution
of professional personnel in these divisions.» Table
4.1 shows the distribution of scientific and tehnical
positions in OPP by broad position categories, and
Table 4.2 shows the distribution of these jobs by
specific position description.
In its examination of the distribution of OPP
personnel, the Committee concluded that there are not
enough top-level positions for scientists in the OPP
divisions. It is the opinion of this Committee that
each major OPP division should add at least one senior
scientist with responsibility for organizing and
evaluating the work of these divisions. Additional
scientists also are needed in a number of other
occupational categories.
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TABLE 4.1 Distribution of Scientific and Technical Positions in Office of
Pesticide Programs, by Position Category, February 19761
Position Category
Administrative
Biological Sciences
Physical Sciences
Information
Social Sciences
Computer Sciences
Environmental Sciences
Medical Sciences
Mathematical & Statistical Sciences
Legal
Other
Total
Number of
Positions
94
125
79
28
14
13
12
9
6
2
53
435
Percent
22
29
18
6
3
3
3
2
1
1
12
100
1 Excludes positions in the Office of Special Pesticide Reviews, which was being restruc-
tured when this study was underway.
SOURCE: U.S. EPA (1976) Organization and Staff, Office of Water and Hazardous
Materials. Unpublished document.
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TABLE 4.2 Distribution of Scientific and Technical Positions in Office of
Pesticide Programs, by Position Description, February 19761
Position Description
Number of
Positions
Administrative
Biological Sciences
Zoologist
Pharmacologist
Biologist
Physiologist
Entomologist
Fisheries biologist
Agronomist
Microbiologist
Plant pathologist
Plant physiologist
Biological technician
Botanist
Toxicologist
Human genetics specialist
Wildlife biologist
Animal biologist
Coordinator, biological methods
Agricultural research technician
Physical Sciences
Chemist
Physical science technician
Physical science aide
Information
Writer-editor
Technical information specialist
Management information specialist
Editorial assistant
Science writer
Technical information assistant
Library technician
Social Sciences
Economist
Sociologist
94
2
10
24
3
21
6
7
15
8
10
11
1
1
1
1
1
1
2
68
8
3
12
9
1
1
1
3
1
12
2
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TABLE 4.2 Continued
Number of
Position Descriptions Positions
Computer Sciences
Computer systems analyst 4
Computer programer 4
Computer technician 3
Computer systems operator 1
Computer aide 1
Environmental Sciences
Environmentalist 2
Ecologist 6
Environmental specialist 3
Systems ecologist 1
Medical Sciences
Health effects analyst 2
Veterinary medical officer 1
Pathologist 1
Entomologist 1
Coordinator, field studies 3
Public health educator 1
Mathematical & Statistical Sciences
Operations research analyst 4
Biostatistician 1
Statistical assistant 1
Legal
Legal assistant 2
Other
Product manager 12
Pesticide product specialist 31
Pesticide technician 5
Standards and labeling officer 1
Special registrations officer 1
Research analyst 1
Chemical engineer 1
Research assistant 1
Total 435
Excludes positions in the Office of Special Pesticide Reviews, which was being restruc-
tured when this study was underway.
SOURCE: U.S. EPA (1976) Organization and Staff, Office of Water and Hazardous
Materials. Unpublished document.
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Recommendation
• Each ma-jor OPP division should add at
least one senior scientist to its staff;
additional scientists also are needed to
increase OPP effectiveness in several
occupational categories, including toxicology.
pathology, and the mathematical, statistical,
environmental, agricultural, social, and
computer sciences.
The fact that federal pay levels for scientists and
technicians are competitive with the salaries these
persons can obtain elsewhere may not be enough to
attract additional scientists of high caliber. It is
also important for EPA to improve the status of its
scientists among their peers in the greater scientific
community and to expand the opportunities for its
scientists to keep up with developments in their
specialized fields.
Recommendation
• EPA should expand the opportunities for
its scientists to communicate with their peers
in the greater scientific community by
encouraging participation in scientific
meetings and by increasing the opportunities
for an exchange of scientists between EPA and
universities and other institutions and
agencies.
The coordination of scientific expertise within OPP
also can help to give scientists an effective role in
the regulation of pesticides. At present, both the OPP
Registration Division and the Criteria and Evaluation
Division perform major scientific analyses of a related
nature that might be better coordinated if they were
centralized within OPP. This might also help to
improve communications between scientists who are doing
research on pesticide chemicals and the staff who are
involved in the RPAR process.
Recommendation
• In order to achieve greater coordination
of scientific effort in the regulation of
pesticides. OPP should consider combining the
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scientific personnel now located in its
Registration and its Criteria and Evaluation
Divisions into a single group. OPP should
also assign a highly qualified scientist in
each OPP division to coordinate the scientific
effort of that division with the work of
scientists in other OPP divisions.
This coordination would enable scientists to work as a
team, to plan and coordinate their work across the
divisions of OPP, and to provide the EPA Deputy
Assistant Administrator and the EPA Administrator with
balanced scientific judgments for the regulation of
pesticides.
NOTE
U.S. Environmental Protection Agency (1976)
Organization and Staff, Office of Water and
Hazardous Materials. Unpublished document.
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INTERNATIONAL_IMPACT OF EPA
PESTICIDE DECISIONS
INTRODUCTION
Section 17 (d) of FIFRA, as amended, provides that
the EPA Administrator shall participate and cooperate
in international efforts to develop improved research
and regulations on pesticides. This Committee thought
it appropriate to investigate, within its limited time
and resources, the impact of EPA pesticide decisions on
other countries.
The attitudes and actions of many countries toward
the regulation of pesticides are heavily influenced by
legislation and regulations of the United States that
govern the use of pesticides. This influence stems
from the position of the United States as a country
with a highly developed science and technology to serve
as a base for pest control; an importer of large
quantities of agricultural commodities; an exporter of
large quantities of pesticides; and a country with
great agricultural and other uses for pesticides and
extensive federal experience in pesticide regulation.
These factors tend to influence the attitude and
actions toward pesticides in countries with less
experience in this field and with fewer scientists and
technicians to provide expertise for the regulation of
pesticides.
EPA decisions to ban or restrict the use of a
particular pesticide on the basis that it is hazardous
to humans and to the environment are of great concern
in other countries where the pesticide is still being
used. People in those countries often fear that they
are in imminent danger from the pesticide even when it
is carefully used by an appropriate government agency
to cope with a problem, such as an outbreak of vector-
borne disease, that does pose an imminent danger to
human beings. In many of these countries, it is
assumed that the United States possesses preeminent
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knowledge and judgment in the regulation and use of
pesticides because we have extensive experience with
pest control techniques; however, only certain portions
of this knowledge are applicable to the situation in
other countries. Although the fundamental principles
of the chemistry and toxicology of compounds are
universal, the environmental behavior of a chemical and
its residues may vary from country to country,
depending on climate, soils, and other conditions.
Public health considerations and economic capabilities
also differ among countries and must enter into the
value judgments that are made about the optimum methods
for pest control.
SUMMARY OF RESPONSES
To learn about the impact of EPA decisions on other
countries, the Committee on Pesticide Decision Making
made inquiries to the appropriate agency in each of 23
countries. These countries were selected on the basis
of varying stages of economic development and their
different environmental, agricultural, and public
health concerns. Responses to the Committee's question
on the impact of EPA regulatory actions were received
from the following countries: Australia, Canada,
Federal Republic of Germany, France, India, Mexico, the
Netherlands, New Zealand, Pakistan, South Africa,
Sweden, and the United Kingdom. The responses from
these countries are on file at the Board on Agriculture
and Renewable Resources, National Research Council,
where they may be inspected by the public. The
following section of this chapter summarizes the
responses to the question: "What is the impact in your
country of decisions made by the Office of Pesticide
Programs of the U.S. Environmental Protection Agency?"
Australia
Residues of pesticides in meat and other food
products that Australia ships to the United States must
conform to tolerance levels for residues established by
EPA. As a result, EPA decisions on tolerances strongly
influence the use of pesticides in Australia.
The response to the Committee's question indicated
that Australia would prefer to see the EPA adhere more
closely to the residue limits that have been
recommended by the Codex Committee on Pesticide
Residues because these limits recognize the differing
needs of participating nations. The Codex Committee, a
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subsidiary body of the Food and Agriculture
Organization of the United Nations/World Health
Organization (FAO/WHO), proposes international
tolerances for pesticide residues in specific foods.
Australia also said that it requires some chemicals
in its agricultural production for which EPA has not
set tolerances because these pesticides are not needed
in the United States. The response indicated that
Australian authorities were uncertain whether EPA would
recognize the tolerances that Australia has set for
these products in the absence of tolerances set by EPA.
Strong regulatory actions taken in the United
States and in other developed nations spur public
action groups in Australia to put pressure on the
government, and this has sometimes made it difficult
for Australian authorities to pursue what they believe
to be a reasonable and appropriate course of action for
their nation. Despite these pressures, Australia is
phasing out the use of DDT rather than abruptly banning
this chemical. Australia was one of the first
countries in the world, however, to impose restrictions
on the use of DDT.
U.S. actions on the cyclodiene compounds have had
minimal impact. Aldrin and dieldrin are used to
control pests that attack sugar cane and to control
termites, but have few other uses. Chlordane is
considered essential for control of ants at urban and
industrial sites, but it has never had significant uses
in agriculture. Heptachlor also is used mainly against
termites and has limited use in agriculture.
Canada
Canadian authorities said in their response to the
Committee that any action by the United States to
restrict or ban a pesticide is immediately reported by
the Canadian press and this elicits.a prompt government
response. In the case of EPA actions on DDT, aldrin,
and dieldrin, Canada was forced to react on a crash
basis rather than in a more organized way. The
Canadian government has made a special effort since
that time to anticipate EPA regulatory actions in order
to minimize the economic impact in Canada from the loss
of a useful pesticide. The Canadian authorities said
that there is now excellent liaison between Canada and
the United States in the area of pesticides.
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Federal Republic of Germany
The German Federal Biological Institute closely
monitors EPA decisions. Pesticides that are restricted
or banned in the United States are frequently subject
to similar actions in Germany, but it was not clear in
the response to the Committee's question whether this
occurred as a result of decisions that were made by EPA
or because German authorities made the same decisions
at about the same time.
The German authorities indicated that the EPA
tolerances for pesticide residues affect German exports
to the United States and that the maximum tolerance
levels that are established for pesticide residues in
Germany are based primarily upon the EPA levels.
France
When French authorities respond to requests for
approval of pesticides that are manufactured in another
country, they take EPA decisions on the pesticide into
consideration. In addition, toxicological studies for
these products are examined, additional information may
be sought, records of biological effectiveness are
considered, and tests are conducted in various regions
to assess the use of a pesticide under different
agronomical situations.
India
India's response to the Committee indicated that
EPA decisions probably have little or no effect on the
regulatory practices or availability of pesticides in
India. For example, DDT and aldrin (but not dieldrin)
are approved for use in that country. Pesticide
residue levels, however, cannot exceed the limits set
by EPA in the agricultural commodities that are shipped
to the United States.
Mexico
Tolerance levels and safety periods for the time
between application of insecticides and a harvest are
regulated by the Mexican government's Department of
Plant Health. The tolerance levels are in accordance
with those established by EPA.
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The Netherlands
The government of the Netherlands limited the use
of DDT, aldrin, and dieldrin before it was aware of EPA
actions on these compounds.
EPA's establishment of limits for pesticide
residues in some instances has had an important
economic effect in the Netherlands. Some of that
country's exports have been denied entry to the United
States because of their levels of pesticide residues,
and the resulting need in the Netherlands to intensify
control of these residues has resulted in higher prices
for certain food products. The Netherlands authorities
said that their two programs to monitor these
pesticides are a direct consequence of EPA regulatory
actions. One of the programs monitors these compounds
in beef, veal, pork, and eggs; the other monitors the
compounds in biological systems.
New Zealand
Because New Zealand depends primarily upon the sale
of farm produce in its foreign exchange, EPA decisions
on pesticides have great impact in that country. New
Zealand authorities appear to disagree with the United
States on the need to restrict the use of DDT, but they
must observe the decisions we have made on this
pesticide for products that are exported to this the
United States. Other organochlorine insecticides are
not used in agriculture, except for the use of BHC
under permit.
New Zealand, like Australia, strongly supports the
acceptance of international standards for tolerance
levels as established by the FAO/WHO Codex Committee on
Pesticide Residues.
Pakistan
BHC and DDT are the only pesticides that are
manufactured in Pakistan, although other pesticides are
imported by the government. These and other
organochlorine compounds are now being used in
Pakistan, although BHC and DDT were practically banned
after EPA actions on these pesticides.
Some concern was expressed in the response from
Pakistan about the effect of EPA decisions on countries
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in Asia and Africa which now insist that the fruits and
vegetables they import from Pakistan be "residue free."
South Africa
South Africa said that its agriculture depends upon
export markets and that it must adhere to the tolerance
levels for pesticide residues that are set by importing
nations. The Embassy of South Africa also said in its
response to the Committee:
Action taken by the EPA has been followed with
keen interest - on occasion with dismay and
concern. So for instance DDT has been
entirely withdrawn to protect our export
market though there was no justification for
withdrawal from an environmental or human body
burden point of view. The same applies to a
lesser extent to aldrin, dieldrin, heptachlor,
and chlordane.
Sweden
EPA decisions on DDT, aldrin, and dieldrin had no
effect upon Sweden's regulation of these pesticides
because Sweden took similar actions at an earlier date.
No information regarding other effects of EPA decisions
on Sweden was available.
The United Kingdom
The United Kingdom controls the use of pesticides
through the Pesticides Safety Precaution Scheme (PSPS).
a nonstatutory arrangement that is formally agreed to
by the government and by three industrial associations
that represent pesticide manufacturers. Under the PSPS
arrangement, manufacturers notify the government before
marketing a new pesticide or before they suggest new
uses for existing pesticides. In addition, several
Acts of Parliament relate to the use and disposal of
pesticides.
Apparently, the EPA decision to cancel uses of DDT,
aldrin, and dieldrin had little effect on pesticide
practices in the United Kingdom. Before EPA made its
decisions on these pesticides, the United Kingdom had
decided to keep these chemicals under review and to
replace them with less persistent chemicals whenever
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possible. Other effects of EPA actions in the United
Kingdom were not learned.
INTERNATIONAL COOPERATION
Because the actions taken by the United States in
the regulation of pesticides may have a great impact on
other nations, it is important that EPA fully implement
Section 17(d) of FIFRA, as amended, and cooperate in
international efforts to control pests and to regulate
the use of pesticides.
In this effort, EPA should bear in mind that
conditions and needs for pest management may vary
considerably from country to country. Crop and
climatic differences, variations in soils and other
geographic characteristics, health conditions, economic
considerations, and many other factors must be taken
into consideration.
A recent draft statement by the U.S. Agency for
International Development on the environmental impact
of proposals for pest management recognizes this need
for international cooperation and the fact that needs
and conditions may differ considerably from country to
country.1 The statement says:
While AID and the U.S. Government are
responsible for their programs in the pest
management area, it must be recognized that
the decisions regarding development policies
and practices in the less developed countries
(LDC's) lie with the sovereign governments of
those nations. U.S. influence in these
decisions varies from case to case, but in all
instances must be exercised in a collaborative
and sensitive style if we are to continue to
be a welcome force for development.
Except in emergencies, AID will discourage
requests for pesticides and the use of
pesticides unless they are to be used in
integrated pest management-crop production
systems. If and where pesticides are
supplied, regardless of whether purchased in
the United States for export or purchased
locally in less developed countries, their
selection should not be governed entirely by
domestic U.S. regulations, registrations, or
restrictions, but by the needs of the
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recipient country and the specific conditions
in the country.
Recommendation
• EPA should ascertain the potential impact
that its major regulatory actions may have on
other countries through prior consultation
with the Food and Agriculture Organization.
the World Health Organization, and other
appropriate international bodies. EPA also
should work with the U.S. Department of State
and other federal agencies to engage in
cooperative activities with other nations for
the development of effective programs for pest
management and pesticide regulation.
NOTE
U.S. Agency for International Development (1976)
Draft Environmental Impact Statement on the AID
Pest Management Program. Volume 1 - Summary.
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APPENDIX
The Committee on Pesticide Decision Making convened
a workshop on August 18 and 19, 1976 on The Impact of
EPA Pesticide Regulations and Decisions. The purpose
of the workshop was to provide a public forum for the
discussion of the impacts of recent pesticide
regulations and decisions. Edward Glass was chairman
of the organizing committee, which consisted of Perry
Adkisson, Morris Cranmer, Joseph Headley, Lucille
Stickel, and Dan Tarlock. Individual papers, authors,
and discussants are listed below. Copies of the papers
and the discussant remarks may be reviewed at the Board
on Agriculture and Renewable Resources, National
Academy of Sciences, Washington, D.C.
The Committee workshop covered these topics:
Purpose and Philosophy of Pesticide Laws and
Regulations
John Osmun, Purdue University, West Lafayette,
Indiana
Impact on Nontarget Areas—Residues in Soil, Water, and
Air
Ronald J. Kuhr, New York State Agricultural
Experiment Station, Geneva, New York
Discussant - Virgil H. Freed, Oregon State
University, Corvallis, Oregon
Impact on Nontarget Areas—Biosystems
Eugene E. Kenaga, Dow Chemical Company, Midland,
Michigan
Discussant - Tony J. Peterle, Ohio State
University, Columbus, Ohio
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Impact on Research and Development of Pesticides
K. Ross Fitzsimmons and Richard R. Whetstone, Shell
Chemical Company, San Pamon, California
Discussant - Ely Swisher, Rohn & Haas Company,
Philadelphia, Pennsylvania
Impact on the Use of Pesticides
Boysie Day, University of California, Berkeley,
California
Discussant - Alexander C. Davis, New York State
Agricultural Experiment Station, Geneva, New York
Impact on the Development of Integrated Pest Management
Robert P. Upchurch, University of Arizona, Tucson,
Arizona
Discussant - L. Dale Newsom, Louisiana State
University, Baton Rouge, Louisiana
Impact on Food and Fiber Production in the United
States
J. Edward Swift and James Kendrick, University of
California, Berkeley, California
Discussant - Fred H. Tschirley, Michigan State
University, East Lansing, Michigan
Impact on FAO and on Food and Fiber Production in
Developing Countries
William Furtick, Food 6 Agriculture Organization,
Rome, Italy
Discussant - Ahmad S.K. Ghouri, Pest Management
Research Council, Pakistan
Impact on European Plant Protection Organization and on
Food Production in Industrialized Countries
Gus Mathys, European Plant Protection Organization,
Paris, France
Discussant - Lucas Brader, Food & Agriculture
Organization, Rome, Italy
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Impact on Public Health in the United States
Maurice W. Provost, Florida State Board of Health,
Vero Beach, Florida
Discussant - Morris F. Cranmer, National Center for
Toxicological Research, Jefferson, Arkansas
Impact on International Health Organizations and Public
Health in Foreign Countries
John F. Copplestone, World Health Organization,
Geneva, Switzerland
Discussant - John E. Davies, University of Miami
Medical School, Miami, Florida
Impact on Educational Institutions
Edward H. Smith and Charles E. Palm, Cornell
University, Ithaca, New York
Discussant - Donald C. Peters, Oklahoma State
University, Stillwater, Oklahoma
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GLOSSARY
AID U.S. Agency for International Development
CAG Carcinogen Assessment Group of EPA
CRIS Current Research Information System of USDA
CED Criteria and Evaluation Division of OPP/EPA
EOF Environmental Defense Fund
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization of the
United
Nations/World Health Organization
FDA Food and Drug Administration of HEW
FEPCA Federal Environmental Pesticide Control Act of
1972
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and
Rodenticide Act
FWGPM Federal Working Group on Pest Management
GAO U.S. General Accounting Office
HEW U.S. Department of Health, Education, and
Welfare
NPMP National Pesticide Monitoring Program
NEC National Research Council
OPP Office of Pesticide Programs of EPA
ORD Office of Research and Development of EPA
OSPR Office of Special Pesticide Reviews of OPP/EPA
PCRC Pesticide Chemical Review Committee of OPP/EPA
PEPS Pesticide Enforcement Policy Statements
PMRC Pesticide Misuse Review Committee of EPA
RPAR Rebuttable Presumption Against Registration
SAES State Agricultural Experiment Stations
SCES State Cooperative Extension Services
USDA U.S. Department of Agriculture
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REFERENCES
Abel, F.H. (1976) Determining acceptable levels of
health and environmental damages. Pages 107-116,
Proceedings of the First US/USSR Symposium on
Comprehensive Analysis of the Environment, March
25-29, 1974, Tbilisi, Georgia, USSR. EPA-600/9-75-
004. Washington, D.C.: U.S. Environmental
Protection Agency; PB-259 600. Springfield, Va.:
National Technical Information Service.
Ames, B.N., W.E. Durston, E. Yamasaki, and F.D. Lee
(1973) Carcinogens are Mutagens: A simple test
system combining liver homogenates for activation
and bacteria for detection. Proceedings of the
National Academy of Sciences 70:2281-2285.
Bureau of National Affairs (1976) FIFRA—Chlordane and
Heptachlor—Suspension of Registration.
Environment Reporter Decisions 9(14)1433-1443.
Carroll, T.E., W.T. Lawhon, D.A. Holzworth, and R.S.
Reimers (1975) Evaluation of the National Pesticide
Monitoring Program (NPMP). Prepared for Office of
Pesticide Programs by Battelle Columbus
Laboratories. Washington, D.C.: U.S. Environmental
Protection Agency; PB-261 514/4BE. Springfield,
Va.: National Technical Information Service.
40 CFR 162.11 (1976) EPA Criteria for Determination of
Unreasonable Adverse Effects under the Federal
Insecticide, Fungicide, and Rodenticide Act, as
amended.
40 CFR 162.46 (1976) EPA Registration Review under the
Federal Insecticide, Fungicide, and Rodenticide
Act, as amended.
40 CFR 166 (1976) EPA Exemptions for Federal and State
Agencies under the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended.
105
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40 CFR 180.1 (1976) EPA Definitions and Interpretations
of Tolerances and Exemptions from Tolerances under
the Federal Food, Drug, and Cosmetic Act, as
amended.
HO CFR 180.7 (1976) EPA Procedure for Filing Petitions
Proposing Tolerances or Exemptions for Pesticide
Residues in or on Raw Agricultural Commodities
under the Federal Food, Drug, and Cosmetic Act, as
amended.
Edwards, W.F. and M.R. Langham (1976) Public welfare in
relation to alternative pesticide policies.
Journal of Environmental Economics and Management
2(4) :295-308.
Grosse, W.C. (1976) Information activities in support
of the EPA pesticide program. Journal of Chemical
Information and Computer Sciences 16(1): 10-14.
Headley, J.C. and J.N. Lewis (1967) The Pesticide
Problem: An Economic Approach to Public Policy.
Baltimore, Md.: Johns Hopkins Press.
Kennedy, P., P. Lowrey, A. Berstein, and F. Rueter
(1975) A Benefit-Cost System for Chemical
Pesticides. Prepared for the U.S. Environmental
Protection Agency by CONSAD Research Corp.
EPA/540/9-76/001. Washington, D.C.: U.S.
Environmental Protection Agency; PB-250 988/3BE.
Springfield, Va.: National Technical Information
Service.
Lowrance, W.W. (1976) Of Acceptable Risk: Science and
the Determination of Safety. Los Angeles, Calif.:
William Kaufman, Inc.
McCann, J., E. Choi, E. Yamasaki, and B.N. Ames (1975)
Detection of carcinogens as mutagens in the
Salmonella/microsome test: Assay of 300 chemicals.
Proceedings of the National Academy of Sciences
72(12):5135-5139.
Minnesota Department of Agriculture (1975) General Farm
Use of Minnesota Pesticides, 1974. St. Paul,
Minn.: Minnesota Department of Agriculture.
National Cancer Institute (1975) Atlas of Cancer
Mortality for U.S. Counties, 1950-1969.
Epidemiology Branch, National Institutes of Health,
DHEW Publication No. (NIH) 75-780. Bethesda, Md.:
U.S. Department of Health, Education, and Welfare.
106
-------
National Research Council (1975a) Decision Making for
Regulating Chemicals in the Environment. A report
of the Committee on Principles of Decision Making
for Regulating Chemicals in the Environment,
Environmental Studies Board, Commission on Natural
Resources. Washington, D.C.: National Academy of
Sciences.
National Research Council (1975b) Pest Control: An
Assessment of Present and Alternative Technologies.
Volumes I-V. Study on Problems of Pest Control,
Environmental Studies Board, Commission on Natural
Resources. Washington, D.C.: National Academy of
Sciences.
National Research Council (1975c) Principles for
Evaluating Chemicals in the Environment. A report
of the Committee for the Working Conference on
Principles of Protocols for Evaluating Chemicals in
the Environment, Environmental Studies Board,
Commission on Natural Resources, and the Committee
on Toxicology. Washington, D.C.: National Academy
of Sciences.
National Research Council (1977a) Decision Making in
the Environmental Protection Agency. Volume II.
Analytical Studies for the U.S. Environmental
Protection Agency. Report of the Committee on
Environmental Decision Making, Environmental
Studies Board, and the Committee on Public
Engineering Policy, Commission on Natural
Resources. Washington, D.C.: National Academy of
Sciences.
National Research Council (1977b) Manpower for
Environmental Pollution Control. Volume V.
Analytical Studies for the U.S. Environmental
Protection Agency. Report of the Committee for
Study of Environmental Manpower, Board on Human-
Resource Data and Analyses, Commission on Human
Resources. Washington, D.C.: National Academy of
Sciences.
National Reseach Council (1977c) Research and
Development in the Environmental Protection Agency.
Volume III. Analytical Studies for the U.S.
Environmental Protection Agency. Report of the
Environmental Research Assessment Committee,
Environmental Studies Board, Commission on Natural
Resources. Washington, D.C.: National Academy of
Sciences.
107
-------
President's Science Advisory Committee (1963) Use of
Pesticides. Washington, D.C.: U.S. Government
Printing Office.
Public Law 92-516 (1972) Federal Environmental
Pesticide Control Act. 86 Stat. 973-999. (Amended
Insecticide, Fungicide, and Rodenticide Act).
Public Law 93-135 (1973) Agriculture, Environmental and
Consumer Protection Appropriation Act, 1974. 87
Stat. 468.
Public Law 94-140 (1975) Amended Federal Insecticide,
Fungicide, and Rodenticide Act. 89 Stat. 751.
Quarles, J.R., Jr. (1975) Testimony. Pages 1-105,
Federal Insecticide, Fungicide, and Podenticide Act
Extension. U.S. Congress, House, Committee on
Agriculture, Committee Serial 94-0. 94th Congress,
1st Session.
Spencer, D.A. (1974) National Pesticide Monitoring
Program - An Overview of the First Ten Years of the
Program's Operation. Washington, D.C.: National
Agricultural Chemicals Association.
21 USC 346 (a) (1970) Section 408 of the Federal Food,
Drug, and Cosmetic Act (Tolerances for Pesticide
Chemicals in or on Raw Agricultural Commodities).
21 USC 348 (1970) Section 409 of the Federal Food,
Drug, and Cosmetic Act (Food Additives).
U.S. Congress, House (1973) Agriculture, Environmental
and Consumer Protection Appropriation Bill, 1974.
Committee on Appropriations, House Report 93-275.
93rd Congress, 1st Session.
U.S. Congress, House (1976) Federal Regulation and
Regulatory Reform. Report of the Subcommittee on
Oversight and Investigations, Committee on
Interstate and Foreign Commerce. 94th Congress,
2nd Session.
U.S. Congress, Senate (1962) Report to the President on
Government Contracting for Research and
Development. Senate Document No. 94, Committee on
Government Operations. 87th Congress, 2nd Session.
U.S. Congress, Senate (1972) Federal Environmental
Pesticide Control Act of 1972; Report to accompany
108
-------
PL 92-516. Committee on Agriculture and Forestry,
Senate Report 92-838. 92nd Congress, 2nd Session.
U.S. Department of Agriculture (1975) Farmers1 Use of
Pesticides in 1971...Quantities. Agricultural
Economic Report No. 252; Farmers' Use of Pesticides
in 1971...Extent of Crop Use. Agricultural
Economic Report No. 268. Farmers' Use of
Pesticides in 1971...Expenditures. Agricultural
Economic Report No. 296. Washington, D.C.: U.S.
Department of Agriculture.
U.S. Department of Health, Education, and Welfare
(1969) Report of the Secretary's Commission on
Pesticides and Their Relationship to Environmental
Health (Parts I and II). Washington, D.C.: U.S.
Government Printing Office.
U.S. Department of Health, Education, and Welfare
(1977) Food and Drug Administration, food producing
animals: Criteria and procedures for evaluating
assays for carcinogenic residues. 42 FR 10412.
U.S. Environmental Protection Agency (1975) Pesticide
program: Guidelines for registering pesticides in
the United States. 40 FR 26802.
U.S. Environmental Protection Agency (1976) Health risk
and economic impact assessments of suspected
carcinogens: Interim procedures G guidelines. 41
FR 21402.
U.S. Environmental Protection Agency (1977a)
Justification of Appropriation Estimates for
Committee on Appropriations, Fiscal Year 1978.
Washington, D.C.: U.S. Environmental Protection
Agency.
U.S. Environmental Protection Agency (1977b) Office of
Pesticide Programs National List of Priority Needs
for Minor Use Registration of Pesticide Products.
42 FR 13448.
U.S. Environmental Protection Agency (1977c) Office of
Research and Development 1978 Operating Plan
Overview. Washington, D.C.: U.S. Environmental
Protection Agency.
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