Analytical Studies
for the U.S.
Environmental Protection Agency
*-
IIPORIUTKNI
VOLUME VII
Pesticide
Decision Making
flu
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The
National
Researc
Cound
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Committee on Pesticide Decision Making
Commission on Natural Resources
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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
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
Commission on Natural Resources
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"
Environmental Studies Board
Assembly of Behavioral and
Social Sciences*
Ocean Affairs Board
Commission on Natural Resources
*In cooperation with the Building Research Advisory Board.
b\n cooperation with the Building Research Advisory Board and the Transportation
Research Board.
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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. 1977
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NOTICE
The project that is the subject of this report was
approved by the Governing Board of the National Research
Council, whose members are drawn from the Councils of the
National Academy of Sciences, the National Academy of
Engineering, and the Institute of Medicine. The members of
the committee responsible for the report were chosen for
their special competences and with regard for appropriate
balance.
This report has been reviewed by a group other than the
authors according to procedures approved by a Report Review
Committee consisting of members of the National Academy of
Sciences, the National Academy of Engineering, and the
Institute of Medicine.
This study was requested and funded by the U.S.
Environmental Protection Agency.
Contract No. 68-01-2U30
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COMMITTEE ON PESTICIDE DECISION MAKING
William G. Eden, (Chairman), Lawson state College,
Birmingham, Alabama
Perry L. Adkisson, Texas ARM 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 8 Consumer
Services, Tallahassee, Florida
Robert E. Hamraan, 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 R. Shea, U.S. Department of Agriculture,
Washington, D.C.
Philip J. spear. National Pest Control Association, Inc.,
Vienna, Virginia
Lucille F. Stickel, U.S. Fish & Wildlife Service, Laurel.
Maryland '
A. Dan Tarlock, Indiana University, Bloomington, Indiana
Gerald T. Weekman, North Carolina State University, Raleigh.
North Carolina
Staff
Fred w. Clayton, staff Officer
Mary Lou Button, Secretary
James E. Tavares, staff Officer
Lawrence c. Wallace, staff Officer
iii
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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
Administrat ion
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 ARM University
Ellis B. Cowling, North Carolina State University
William P. Flatt, Agricultural Experiment stations.
University of Georgia
Robert P. 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 Thome and Associates
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CONTENTS
FOREWORD Viii
PREFACE ix
ACKNOWLEDGMENTS xi
SUMMARY 1
CHAPTER 1 PESTICIDE REGULATION 12
Introduction 12
Statement of the Problem 12
EPA Pesticide Activities 14
CHAPTER 2 THE ROLE OF DATA IN EPA DECISIONS
ON PESTICIDES 18
Registration and Reregistration 18
Classification 21
Cancellation/Suspension 22
Risk/Benefit Assessment 32
Tolerances 43
Exemptions for Federal and State Agencies 46
Permits for Experimental Uses 48
Minor Uses of Pesticides 48
Research 53
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Monitoring 53
CHAPTER 3 COORDINATION AND COMMUNICATION OF
INFORMATION ON PESTICIDES 64
Information Requirements 6U
Sources and Distributors of Pesticide Information 71
CHAPTER 4 PERSONNEL FOR PESTICIDE REGULATION 78
CHAPTER 5 INTERNATIONAL IMPACT OF EPA PESTICIDE
DECISIONS 85
Introduction 85
Summary of Responses 86
International Cooperation 90
APPENDIX OUTLINE OF WORKSHOP ON IMPACT OF PESTICIDE
REGULATIONS AND DECISIONS 92
GLOSSARY 95
REFERENCES 96
vii
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FOREWORD
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, B.C. 20418.
viii
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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 leaking in
the regulation of pesticides, and (21 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 (NRC
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
Fodenticide 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 did a limited
investigation of the impact of EPA's pesticide decisions on
other countries.
ix
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Three Committee panels gathered and evaluated
information for certain phases of the study. These were a
Federal Panel, which was concerned with EPAfs 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, Pood 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. Ruhr, 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 Riss, 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.
We also wish to acknowledge our appreciation for the
very helpful editorial assistance of Patricia Marshall and
xi
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to Mary Lou Sutton for her able and tireless secretarial
support. Appreciation is also due to Robert C. Eooney,
Philippa Shepherd, Estelle Miller, and Claire Chow of the
editorial staff who generously provided assistance in
preparing this report.
xii
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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
EPA1 s regulation of pesticides is provided by Sections U08
and «»09 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
(OPP) 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 CFR 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," 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
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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 more
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 FIFRA, as amended. The proposal met with
objections in 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
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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.
MAJOR 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. FIFRA, 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 multiagency 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 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.
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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
multiacrency 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 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 analysing trade-offa
between the risks and benefits- In doing so- EPA
should seek outside review and comment from the
scientific community.
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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 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 USDA 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 ^
nation's use of pesticides.
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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,
soilr water, plants, and in humans and other nontarget
species. FIFRA, 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 regulationkof pesticides
and by exerting leadership among the federal
agencies with monitoring programs to assure that
the NPMP adequately addresses these needs.
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 regulationsi should require, and not
simply permit, the consideration of benefits in
determinations of whether +•«-. issue a notice of
intent to deny or to cancel a registration. This
would conform with Section 7 f *M2 of FIFRA, as
amended.
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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 anv pesticide
that exceeds EPA criteria for chronic toxicity
(oncogenesisl 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 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 FIFRA, 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
reregjstration 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
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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 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 iwfc
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
8
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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 {OPDl 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
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 U).
• Each major 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.
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.
• m 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.
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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 EPAr
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
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: "UNREASONABLE
ADVERSE EFFECTS ON THE ENVIRONMENT. —» The term
'unreasonable adverse effects on the environment* 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 1
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 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
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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 roust 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 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
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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 91-140). 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 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
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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.
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 (OSPP) 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
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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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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 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 POLE OF DATA
IN 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 requires 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 bv
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, 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).
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The range 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 (10 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 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
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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 OPP
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).
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
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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 FIFRA 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
FIFRA.
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 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 roost 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
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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 FIFFA,
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.
Recommendation
• QPP 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. '
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
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Administrator may hold a hearing to determine whether action
should be taken. A hearing roust 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 (40 CFR 162.11):
• when there is a hazard of acute toxicity in humans,
domestic animals, or wildlife (measured by formulas for
lethal doses);
• when there is a hazard of chronic toxicity—
oncogenic effects (i.e., any tumor) are induced in humans or
in experimental animals as a result of 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.
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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 rereaistration problems whenever
possible before resorting to the RPAP process if a
pesticide will have a restricted use or when its
pattern of use will not create unreasonable adverse
effects. ' r
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 197U, 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
RPAR process,.
A major controversy over the EPA regulations for the
RPAR 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
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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"
(NPC 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 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.
Recommendation
• The carcinogenic potential of any pesticide
that exceeds EPA criteria for chronic toxicitv
{oncoaenesisl 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
25
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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 j.n 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.
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. Fed 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
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." ""~~
26
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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 viyo systems with correlations over a wide
range of doses and, preferentially, of 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 FIFRA was transferred
from OSDA 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.
HEW 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.
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When the OPP Registration Division determines, in its
review of a pesticide for registration or reregistration,
that the product meets or exceeds any 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 PPAR process:
1. The applicant is initially given U5 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 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
28
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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 OPP 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 OSPR
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 RPAR
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 from 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 knowledgeable about pesticides. If the
OSPR function is to be successful, it roust be flexible so
that it can meet the variety of tasks which are required and
it must represent the highest level of scientific expertise.
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Extensive Analyses of Bisks 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 EPAR 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.
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 huroans or the
environment. .This format can limit and distort the role of
30
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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 NBC 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 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 (EDF) 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.
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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 FIFPA 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).
Recommendat ion
• 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 FIFRA, 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 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
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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 [a] [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
Administrators 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 (40 CFP 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 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
(40 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.
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Recommendation
• EPA regulations (HO CFR 162.11 Tal f51 riiil)
should require, and not simply permit, the
consideration of benefits in determinations of
whether to issue atnotice of intent to deny or to
cancel a registration. This would conform with
Section^ 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 Impact Assessments of
Suspected carcinogens" (U.S. EPA 1976), These procedures
represent an interim administrative tool for the Rebuttable
Presumption Against Registration 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.
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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 (NEC
1975b) .
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 (NFC 1975a). The
report noted that:
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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
addedr 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. *
A trade-off analysis has been suggested as the best
method to evaluate the costs and benefits resulting from the
use of chemicals (NPC 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 maker".* 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" (NPC 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
^i^S the Preservation only of those factors that
*?igneft Priority in decision making. An example of
"Jj^rix.for pesticides, which is adapted from one
by Abel,i is shown in Figure 2.1. Before this
Jj818 Lt d°2e f°r re?ulat<>ry decision making on
, it may be advantageous to do a mini-study as a
™ Step earl£ 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
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EFFECTS
I. Risks
A. Health
1. Lost person years
2. Lost activity days
3. Population exposed
B. Environment
1. Non target species
2. Vegetation damaged
3. Animal losses
4. Endangered species
5. Aesthetics
6. Recreation
H. 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
concerns)
ALTERNATIVES
No action
taken
Ban
immediately
Phase out
Restricted
use8
Additional
label
restrictions"
Substitutes0
Pest
control A
Pest
control B
a. Reclassify the pesticide from general use to the restricted-use category, which requires that it be used only by certified applicators.
b. Place conditions on the use of the pesticide by changing or adding to the restrictions on the label.
c. Substitutes can be another pesticide or other pest control methods.
SOURCE: Adapted from Abel, F. H. (1976) The Use of Economic Information in Registering Pesticides; an unpublished paper prepared for the
Committee on Pesticide Decision Making.
FIGURE 2.1 Trade-off matrix for pesticide decision making.
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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 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
38
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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).
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 (NEC 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
39
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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.)
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
c°sts compared to the ^^its 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 risk* *™y benefits resulting fr^i th«»
use of a pesticide and for analyzing t^j-offg
between the risks and benefits. Ingoing soTlipA
shQuld_seek outside review and comment from the
scientific community. J
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
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losses that would be sustained if a 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, 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
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signed in December 1976r 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 RPAP process because it is presumed to
create an unreasonable adverse effect on humans or the
environment. The EPA/OSDA 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 enacted in FIFRAr 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
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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 U08 of the Act (21 USC 3«6a) 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 348) 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 (UO 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;
• 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.
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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. HEW 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.
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,
f?« 5 as demonstrably "safe." The language of Section
a08 of FFDCA, which is somewhat broader than Section a09 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.
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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
• 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 (10
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
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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 mammaIs.
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 animals.
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.
The Committee does not imply that the Agency should
discontinue its vigilance in the regulation of pesticides or
its concern for the pncogenic 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 qp CFR 180.1 fl). " ' r~^ '
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 FIFRA, 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 i.f he determines that emergency conditions
exist which require such exemption.
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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 (40 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 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 FIFBA, 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.
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Recommendation
• EPA should respond expeditiouslv to requests
for exemptions under section 18 of FIFRA. as
amended, for the emergency control of pests.
PERMITS FOR EXPERIMENTAL USES
Before a chemical is registered as a pesticider 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 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.
MINOR 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
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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
cottonf 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 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 Pood, 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 FIFBA 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
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tolerances for pesticide residues in food and feed. The
pertinent provisions of FIFRA, as amended, are:
Sec. 3ja)^ requires federal registration of all
pesticides sold in intrastate and interstate commerce.
State registrations are preempted.
sec. 3(c)12} 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 fa)(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. 2<*(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 2U(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
2Mc), however, because EPA cannot permit a state to
register pesticides under this Section unless a tolerance
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has been established for residues of the pesticide in or on
the particular food or feeds for which the Section 2U(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
prosecutorial arrangement in which exceptions are mada to
Agency policy.
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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 (Duggan and
DugganZ). 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 1 (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
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
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the changes contemplated by the recent Senate Bill, S1678,
which agree in principle with the following committee
recommendation:
Recornmendat ion
• 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 cropt 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.
PESEARCH
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.
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
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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 OED 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 small
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.
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 1977c), 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).
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Coordination of Research
Research relating to pesticide chemicals done by EPA,
other federal agencies, State Agricultural Experiment
Stations, universities, and othe± 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 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
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to pesticides should be cleared through ORD. 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^gf
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 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.
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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 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-
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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):
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 multidisciplinary 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
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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, 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 OSDA 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
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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.
• Ocean monitoring. EPA and the National Marine
Fisheries Service of the National Oceanic and Atmospheric
Administration in the U.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 1971) 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
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and systematic way, it is clearly necessary for EPA to
assume the central responsibility 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 latest version of the plan was submitted to these
agencies in March 1977.
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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 cbntents 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.
Recommendation
• EPA should adopt an editorial policy for the
"Pesticides Monitoring Journal" that represents the
highest scientific standards of data reporting and
analysis and should make rigorous^requirements for
the explicit description of analytical
methodologies in "Journal" articles.
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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; an unpublished paper prepared for the
Committee on Pesticide Decision Making.
Duggan, R.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).
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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 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 Agencyfs
responsibility to protect humans and the environment from
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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 B, 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 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.
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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 UOOO 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
Devaluating 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 in 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 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
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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)r 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 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
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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. 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 reliable method for collectingP
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
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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 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
petitioners 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 petitioners 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
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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 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.
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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 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 FIPRA, 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
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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 example, ^PA
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 19UO, 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
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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 funded jointly by
EPA and the Food and Drug Administration. The center has
begun doing research on carcihogenicity 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;
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departments of natural resources; and fish and wildlife
commissions. One measure that might be used is the amount
of money spent for research on pest control by some of the
agencies at the state level. A study by the National
Academy of Sciences (NRC 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 EPA's
^fi0?3 relat}n9 to Pesticides, communications between EPA
and state agencies seem to be poor, in comments made to the
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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 FIFPA 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.
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.
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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
regulatdry 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
xn different regions of the United States and for different
crops and classes of livestock. The most recent survey, in
which 8600 farmers in H9 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.
^,« midweste*n 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 197M 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
Agriculture 1975) .
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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.
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
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 impact 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.
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
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seems likely that the distribution of personnel is somewhat
similar throughout EPA. Data compiled by the NRC Committee
for Study of Environmental Manpower (NRC 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.
Recommendation
• Each ma-lor 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.
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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
Number of
Positions
94
125
79
28
14
13
12
9
6
2
53
Percent
22
29
18
6
3
3
3
2
1
1
12
Total 435 100
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
Computei systems analyst 4
Computer piogramer 4
Computer technician 3
Computer systems operator 1
Computer aide I
Environmental Sciences
Environmentalist 2
Ecologist 6
Environmental specialist 3
Systems ecoiogist 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
Special registrations officer
Research analyst
Chemical engineer
Research assistant
Total . 435
Excludes position* 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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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 jtheir peers in
the greater scientific community and to expand the
opportunities for its scientists to keep up with
developments in their specialized fields.
Recommendat ion
• 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.
Recommendat ion
• In order to achieve greater coordination of
scientific effort in the regulation of pesticides,
OPP should consider combining the scientific
personnel now located ip its Registration and its
Criteria and Evaluation Divisions into a single
group.OPP should also assign a highly qualified
scientist in each OiPP 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.
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NOTE
U.S. Environmental Protection Agency (1976) Organization
and Staff, office of Water and Hazardous Materials.
Unpublished document.
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CHAPTER 5
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 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
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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,
va~ad,aZuFederal 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
+K *esidue?.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
srs-pStSg^StSssr""1 Stron91y influence the
fc° the Committee's question indicated that
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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.
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 siirilar 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.
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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.
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
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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 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
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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 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.
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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.*
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 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 Osraun, Purdue University, west Lafayette, Indiana
Impact on Nontarget Areas—Residues in Soil, Water, and Air
Ronald J. Ruhr, 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
Impact on Research and Development of Pesticides
K. Ross Fitzsimmons and Richard R. Whetstone, Shell
Chemical Company, San Ramon, California
Discussant - Ely Swisher, Rohn 6 Haas Company,
Philadelphia, Pennsylvania
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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 8 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 S Agriculture
Organization, Pome, Italy
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
lexicological Research, Jefferson, Arkansas
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Impact on International Health Organizations and Public
Health in Foreign Countries
John F. Copplestoner 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 O.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
EDF Environmental Defense Fund
EPA O.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
NRC 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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40 CFR 180.7 (1976) EPA Procedure for Filing Petitions
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