i
SSSZ
^ Strategy of the
| Environmental Protection Agency
r for
Controlling the Adverse Effects of Pesticides
May, 1974
Office of Pesticide Programs
Office of Water and Hazardous Materials
Environmental Protection Agency
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STRATEGY OF THE
ENVIRONMENTAL PROTECTION AGENCY FOR
CONTROLLING THE ADVERSE EFFECTS OF PESTICIDES
May, 1974
Office of Pesticide Programs
Office of Water and Hazardous Materials
Environmental Protection Agency
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io Sr 41
____ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
THE ADMINISTRATOR
The enactment of the Federal Insecticide, Fungicide, and Rodenticide
Act Amendments of 1972 has imposed new responsibilities and authorities
on Federal and State governments for controlling the adverse effects of
chemical pesticides. The new legislation provides for several significant
departures from previous mechanisms for dealing with pesticides and
presents real challenges to the ingenuity, commitment, and foresight
of all concerned - - regulators, the industry, and users.
This strategy presents EPA 1 s policies and operational plans for
implementing the new legislation. Pesticides do not recognize media
boundaries, so the strategy also addresses the need for close coordination
with other legislation concerning air, water, solid waste, and food,
among others. I hope the fundamental need for cooperation among several
Federal agencies, Regional Offices, and the States is clearly
evident throughout this document. Successful balancing of the
adverse impacts of pesticides against their real benefits depends
heavily on uniform action and effective communications among us, industry,
pesticide users, and concerned environmental spokesmen.
The strategy is part of a management system conceived to implement
the pesticides legislation. It should guide EPA Headquarters, EPA
Regional Offices, and the States in setting annual objectives,
allocating resources in support of these objectives, and regularly
reporting on their achievement. It is meant to ensure that the many
activities conducted under the 1972 Amendments, by conforming to a
cohesive strategy, will complement each other. The strategy will
be revised as necessary to reflect the changing circumstances of the
national pesticides program.
This document relates what EPA intends to do in balancing pesticide
costs and benefits. I urge each reader to carefully consider its
implications for you - - the importance of your role in the achievement
of objectives set forth herein and your contribution to the evolution
of an even more effective pesticides strategy.
/Russe1l E. Train
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COI TEflTS
SLI 1hu\RY • 11
J NERODLILTION . . . . . . . . . . . . . ........... 1.
PROBLEM SIATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
STRATECY OVERViEW . . . . . . . . . . • • • • • • • • , . . . . . . 9
PL 19
1.
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StTh?IMARY
With the 1972 passage of an atnendrient to the Federal Insecticide,
Fungicide, and Rodenticide Act of 1947 (FIFRA), the Environmental Pro-
tection Agency was given broad new responsibilities -— and powers —— to
protect man and his environment from the adverse effects of chemical
pesticides. This new FIFRA Amendment, the Federal Environmental
Pesticide Control Act, comes at a time when pesticide benefits and
costs require thorough reexamination. At the same time, the need
for immediate controls Is evident. Accordingly, until October of
1976, the date for full implementation of the amended Act, the
Environmental Protection Agency will pursue a course highlighted by
four major thrusts.
1. By October, 1976, EPA must register and classify over 40,000
products in addition to its normal workload. This increase
is a direct result of the amended Act: all new registration
and classification actions must be based on an assessment of
the unreasonable adverse effects of pesticides. This requires
a comparison of the benefits of using pesticides with their
costs. Accomplishing this huge task with available resources
requires registration procedures fundamentally different from
current ones. EPA will automatically re—register, on appli-
cation, those products whose formulation ingredients and
previous use records raise no significant questions of safety
to human health or the environment. For those compounds that
raise questions on the basis of accident history or chen ica1
composition, however, applicants will be required to submit
full test and supporting data. These products will be subject to
normal registration review. This screening process will focus
EPA’s attention on those products which present the greatest
potential hazard, will permit EPA to meet its peak workload
at only modest resource increases, and, most important, will
allow for the development of other important program activities.
EPA will assure that products registered will continue to meet
conditions of registration and classification through surveillance
and testing of samples from producing establishments and the
marketplace.
2. FIFRA, as amended, gives to EPA significant tools for the control
of local health and environmental problems arising from misuse
of pesticides. By requiring that applicators of potentially
hazardous products be properly certified, by Improved labeling
and packaging of pesticide products, by Th’.posing other regulatory
restrictions as warranted, by timely enforcement against instances
of misuse, and through public education programs emphasizing
proper uses and dangers of pesticides, EPA anticipates a
significant reduction in health and environmental effects.
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3. A comprehensive hazard evaluation system is needed to better
understand the nature and extent of adverse effects of pesticides
on man and the environment and to provide a basis for program
and regulatory decisions. EPA will significantly alter current
prograirs —— pesticide monitoring, human health studies, laboratory
experimentation, and special projects —— to more systematically
acquire the inforration necessary for review of current and future
pesticides.
4. An effective strategy for regulating the use of pesticides
must take into account the technological, economic, organiza-
tional, social, and physical environment of pesticide use and
the changes occurring in that operating environment. Mindful
of this, EPA is conducting and supporting basic scientific studies
in ecological and human health effects of pesticides to support
hazard evaluation and in the development of alternative pest
control techniques. Principal near—term research emphasis
will be placed on:
• generating data to suppcrt current and anticipated litigation,
• devising standardized laboratory test methodologies,
• developing model ecosystems, and
• identifying safer substitute chemical pesticides.
Concurrently, policy studies will be undertaken, including:
• collection of data and refinement of methodologies for
cost—benefit analysis,
• investigation of barriers and incentives for the adoption of
improved pest control techniques, including integrated pest
management programs, and
• development of loni—term alternative EPA pesticide program
strategies.
While these four principal thrusts are being impletrented, EPA will
develop a long—term pesticides strategy for the period coirinencing in 1977.
The new strategy viii be designed on the basis of experience gained in
administering pesticide supply and use control prograirs and in improving
evaluation of pesticide hazards and from new knowledge gained in research
and policy studies.
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1
INTRODUCT ION
BACKGROUND
The benefits to man’s health, welfare, and comfort from the use of
chemical compounds to control certain animals, plants, or micro—organisms
are frequently offset by the deleterious effects of these compounds on
the environment and on man himself. In the United States, enormous
strides have been made in increasing and protecting food, fiber, and
forestry products and ;Ln checking disease since the beginning of
largescale pesticide use in the middle 1940’s. Domestic consumption
of pesticides now amounts to almost one billion pounds of active
ingredients —— more than half of that is used in agriculture. At
the same time, the public has been increasingly concerned about the
nature and extent of adverse pesticide effects.
The need for Federal government involvement in the control of
pesticides was perceived early and is principally addressed by the
Federal Insecticide, Fungicide, and Rodenticide Act of 1947. Since
1970, the responsibility for administering this Act has rested with
EPA. In October 1972, the Act was amended to give broad new pesticide
control authority to the Agency. Fully implementing the Act, as amended,
between now and late 1976 is an essential responsibility of the Environ-
mental Protection Agency and strongly influences strategic planning for
the period. Further, the new pesticide legislation must be coordinated
with provisions of air, water, and labor legislation and the Food, Drug,
and Cosmetic Act.
PURPOSE
The pesticide program strategy presented in this paper has been
developed to clarify Agency policy with respect to lessening pesticide
problems, balancing controls against the real benefits pesticides offer,
and guiding EPA and other Federal and State agencies in implementing
the control measures implied by the new law. This strategy is an
operational plan. It describes what EPA will do in the period through
1976 in light of existing capabilities, legislation, and resource and other
constraints. Actual resource needs will be specified in annual issue
papers and detailed plans. However, this strategy has been predicated on
a realistic estimation of future resource availability.
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Despite almost 30 years of intense use in this country, many
facets of pesticides benefits and undesirable effects are only partially
understood. Thus, a substantial part of this operational strategy
is also devoted to uncovering the relationships between pesticides
and man and the environment. To be updated as circumstances dictate,
the modified strategy will reflect our growing knowledge, the success
of past program actions, and changes in priorities brought about by
Agency programs and external events involving pesticides. Thus, while
this plan does not state EPA’s long—range pesticide strategy, it does
provide the basis and mechanisms for determining that strategy. It
also serves as the starting point from which detailed sub—strategies
and program activities will be specified in the coming months.
OUTLINE OF REMAINDER OF THE REPORT
Chapter 2, PROELEM STATEMENT, briefly describes problems caused
by pesticides —— including a summary of the important problem unknowns
and trends. Chapter 3, STRATEGY OVERVIEW, describes policy decisions
that directly affect the way the new law is implemented. Chapter 4,
OPERATIONAL PLAN, details the important steps to be taken over the
next three years in regulating and better understanding pesticides.
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2
PROBLEM STATEMENT
NATURE OF THE PESTICIDES PROBLEM
Pesticides manufacturing, formulating, and sales are big business.
In recent years, 1.3 billion pounds of pesticide active ingredients
have been produced annually in the United States. About one billion
pounds of pesticide active ingredients are consumed each year in the
U.S.: 55 percent by the agriculture sector; 30 percent by industrial,
institutional, and government users; and 15 percent by home and garden
users. Therefore, any action regulating pesticide use must be based
on a careful assessment of its effect on those activities to which
pesticides represent an important, beneficial input——for pest control
in agriculture, homes and gardens, industry, institutions, and government.
Pesticides, unlike most air and water pollutants, are intentionally
released into the environment —— where their acknowledged benefits are
expected to take place. In fact, largely because of those benefits,
pesticides now have become increasingly important to agricultural
production, to public health and sanitation, to protection of capital
investments and natural resources, and to improvement of human comfort
and well—being.
However, since pesticides are biological poisons that are seldom
specific as to the time, place, or target of their chemical activity,
their proliferation in the environment has caused serious health and
environmental problems and may be causing others not now well under-
stood.
ADVERSE PESTICIDE IMPACTS
Human Health Effects
Ultimately, the most important of harmful pesticide impacts are
those which occur in humans. Approximately 200 deaths each year
(including a small number of suicides and homicides) are caused by
pesticide poisoning —— a sizable fraction of all poisoning deaths in
the United States. As many as 14,000 individuals may be non—fatally
poisoned by pesticides in a given year, 6,000 seriously enough to
require hospitalization. *
*1972 Poison Control Center data imply ratios of 70 to 1 and 30 to 1
for non—fatal to fatal pesticide poisonings for cases with symptoms
only and cases serious enough for hospitalization, respectively. The
numbers shown in the text reflect these estimates, using 200 annual
fatalities as a base.
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In general, more is known about exposure to pesticides than about
effects, although some revealing data are available. For example, it
is apparent that some population groups suffer higher risks of adverse
effects than others.
Householders
The largest single group of individuals exposed to pesticides are
those exposed to home and garden products. Children under the age of
five are most often affected; they appear to have from two to five
times higher incidence of fatal and non—fatal poisoning than the
general population. Ingestion, the leading cause of children’s
pesticide poisoning, frequently results from improper home storage
of chemicals, packaging by manufacturers in breakable containers and
containers without childproof closures, and application of products
such as powders and baits in places where children can retrieve them.
While many adult fatalities are the result of suicide and homicide,
continued or repeated low—level exposure to certain home chemicals
is nevertheless feared to cause long—term harm.
Manufacturing and Formulating Workers
Individuals occupationally exposed to pesticides, including
manufacturing and formulating workers, applicators and their helpers,
and agricultural field workers, constitute a second group at high risk
to local pesticide exposure. No reliable national figures are
available on acute pesticide poisoning in this group; even less is
known about chronic effects. In general, recognition of the hazards
has led to protection of pesticide workers through protective clothing
and devices such as respirators, ambient air treatment, work station
rotation, and health monitoring.
Pesticide Applicators
Some 40,000 commercial and up to 2,000,000 private applicators
and associated workers are exposed to hazards from chemical pesticides
in some of their most dangerous forms——unmixed, undiluted, and often
in large, bulky containers. As their occupations require frequent
handling of pesticides, applicators and helpers could be expected to
be wary of acute poisoning dangers, and indeed there seems to be a
relatively low incidence of poisonings. Systemic changes, the significance
of which has not been fully established, have been measured among this
group, however.
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The principal causes of these human effects are poor application
techniques and equipment, failure to use protective clothing and devices,
inadequate sanitation, and overall lack of knowledge about hazards —— largely
from a simple failure to read, understand, or heed labels or from labels
that are not sufficiently informative.
Farm Field Workers
Other than householders, farm field workers constitute the largest
group at risk to pesticide poisoning——several million in the U.S. The
principal route of exposure is dermal contact with pesticide residues
on plant surfaces; of less frequency is direct exposure during chemical
applications. Lack of protective clothing and equipment, lack of know-
ledge of pesticide dangers, and, most important, premature reentry
to treated fields seem to cause most field worker poisonings. Although
few data are available on field worker pesticide exposure, a 1969
study conducted in California showed a thirteen—times higher incidence
of individual field workers making doctor visits because of systemic
pesticide effects than in a low—exposure control group.
General Population
Human health effects resulting from diffuse pesticides exposure
are poorly understood. Arising both from food residues and from media
contamination, diffuse exposure occurs principally from persistent and
mobile pesticides. In addition, other compounds with lower persistence
may be adding toxic metabolites and breakdown products to the environment.
It is known that the body stores several pesticides and that systemic
changes may result. Diffuse exposure causes particular concern because
of the potential for long—term effects among large numbers of people.
Environmental Effects
It is not possible to summarize the total extent of environmental
effects of pesticides across all ecosystem components. Locally, overuse,
misapplication, improper storage, runoff, and improper disposal of
pesticides have resulted in many wildlife and domestic animal poisonings,
unintentional plant destruction, killing of beneficial insects, develop-
ment of pest species resistance, and contamination of soil and water.
Neither the short—term loss nor the prognosis for reversibility can
currently be evaluated in most cases of local environmental damage.
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however, an ecosystem more diverse and numerous in species is a
stronger and more stable system; it is clear, therefore, that serious
damage can be caused and may have been caused already. Diffuse environ-
mental effects appear to be largely an extension of local effects to
a global scale. A great deal more study of the mechanisms that spread
local problems is necessary —— including the modes of pesticide transport
through soil, air, water, and biological routes and the effects of
chemical properties such as persistence and bioaccumulation.
UNKNOWNS
The things we do not know about pesticide impacts——both positive
and negative——may turn out to be more important than those things we
do know. As a result, our strategy must be based on current under-
standing while remaining flexible to information improvements. The
most important areas of unknowns can be grouped into three broad
classes.
Problem Definition and Extent
While the important types of pesticide problems have been identified,
there are substantial gaps in both the qualitative and quantitative
description of these problems. This information is necessary both
to evaluate pesticide problems relative to other environmental problems
and, more particularly, to be prepared to assess fully the costs and
benefits of alternative pesticide control actions. A vital element of
such an assessment is a clearer picture of what pesticides enter the
environment, in what amounts, and in what locations.
Further, more knowledge is required of the connecting links:
What practices (e.g., failure to read labels, lack of protective
measures, inadequate packaging, improper storage and disposal) allow
man and his environment to be harmfully exposed to pesticides? Finally,
it must be asked how such underlying mechanisms can best be controlled.
Structural Uncertainties
The most fundamentally difficult and in many ways most important
unknowns, and the ones for which solutions can be predicted with least
assurance, are those concerning the types and bases of physical/chemical/
toxicological interactions between pesticides and living organisms,
particularly those resulting from low—dosage exposure over extended
time periods. Still, this knowledge is germane to any understanding
of both why pesticides work as intended and how they cause human
health and environmental impacts.
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Differences in Interpretation of minimum thresholds and the
significance of low—level, long—term exposures on a population at
large make assessments difficult. Tumorigenic, carcinogenic,
mutagenic, and teratogenic effects of certain pesticidal compounds
have been observed in laboratory situations, but their implication
for man Is inconclusive. The grave nature of these potential effects,
however, dictates the need for prudence in allowing present use, for
further directed research, and for imposition of restrictive control
measures once significant risk is established.
Beneficial Effects
To have the capability for adequate cost—benefit analysis of
pesticide control alternatives, the beneficial effects of pesticide
chemicals must be better defined. As with pesticide problems, benefits
of pesticides have been broadly categorized (e.g., agricultural production,
disease control, structur s protection) but require considerably more
systematic qualification and quantification.
TRENDS
Further worsening the difficult task of controlling Imprecisely
defined problems are the effects of trends In the economic, technological,
organizational, social, and physical environment; to these, the pesticide
program strategy must be responsive, able to shift emphasis and change
direction to most efficiently protect human health and the environment.
Four trend areas are particularly important to the pesticide strategy.
Resources: Various shortages could affect pesticide use in uncertain
but possibly dramatic ways. On the one hand, increased world—wide
demand for U.S. farm products would increase the pressures for more
production through all available means, including pesticides. On
the other hand, shortages of petroleum, a basic ingredient of many
synthetic pesticide chemicals, could raise pesticide prices and reduce
availability of pesticide products, forcing the use of more labor or
acreage to achieve the same agricultural output.
Changes in Types of Chemical Pesticides: Several factors, Including
development of pest resistance, more effective chemicals, and regulatory
actions, can cause old pesticides, often of known characteristics, to
be replaced with new chemicals, frequently with substantially unknown
effects. This process may be counteracted to some extent by rising
costs of chemical research and development.
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Development of Non—chemical Control Measures: Biological, cultural,
and other technological pest—control techniques may some day obviate
the need for much chen ical pest control. However, effective control
programs using both chemical and non—chemical controls are not now
widely available or used.
Agriscience Developments: In part a result of the above trends, changes
in agricultural technology and economics give rise to new growing methods,
improved crop varieties, and shifts among the production inputs. Each
of these can affect the need for chemical pesticides.
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3
STRATEGY OVERVIEW
The goal of the pesticide program —— balancing the benefits of
pesticides against their costs —— will be met through the achievement
of four objectives:
• assuring that products are acceptably safe and effective
when used as intended;
• assuring that products are properly used;
• developing sufficient data and appropriate methodologies
for assessing the hazards of pesticides; and
• conducting scientific research and policy studies to support
current and new programs of control.
The first two objectives —— here called Supply Control and Use
Control —— are intended to meet the statutory requirements of the new
legislation. They are at the core of the EPA ’s near—term regulatory
program. The third objective —— Hazard Evaluation —— is also rooted
in the new Act. Its implications extend, however, beyond the immediate
program. It represents an attempt to provide a firm scientific basis
for both a near— and long—term regulatory program. The fourth objective——
Research and Policy Studies —— is aimed at both meeting current
and new control objectives and also at supporting the development
of the hazard evaluation system.
SUPPLY CONTROL
The backbone of the pesticide regulatory program is the registra-
tion process. It serves to keep highly hazardous chemicals off the
market and, through labeling, classification, and other regulatory
restrictions, to control the use of others. It must also assure
adequate availability of desirable pesticides whose benefits exceed
their adverse impacts in use. The new Act requires re—registration
and classification of currently registered pesticides by October
1976. A similar requirement applies to those pesticides currently
registered by States for use in intrastate commerce. It is estimated
that these statutory mandates will add over 40,000 registrations to
the normally submitted registration petitions. The choice of a scheme
to accomplish this enormous workload greatly influences the resources
that can be allocated to other activities.
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All pesticides that have neither exhibited nor are suspected
of causing significant adverse .npacts will be re—registered upon
manufacturer application and without requiring further testing data.
This determination will be based on groupings by chemical ingredients
and safety—in—usc history for’ those pesticides long in use. Corres—
ponclingly, full tesLin data, including results of animal toxicological
studies, will he required to support re—registration petitions for
those pesticides suspect because of ingredients or use history. This
group of chen’ic ls t ay be subject to a complete review, comparing their
benefits and costs, bc-fore registration. The review will include
chemicals currently under administrative review in addition to others
that have already been identified as having the potential to cause problems.
Emphasis will be placed upon persistent and bio—accuniulative pesticides
and those pesticides which potentially present long—term health risks
or special d ngcrs to household users.
Tho simple expedient of requiring manufacturer application before
re—re ’istratior. will serve the further purpose of clearing out currently
registered products that are no longer being produced. This, in addition
to automatic registration of specified groupings of pesticides, will
substantia]ly reduce the workload compared with product—by—product
review process. There arc also other registration procedural
efficiencies which must be considered in detail; these will be addressed
by an EPA--wide task force.
t number cf other policy issues have been raised concerning supply
control. The registration process was long chiefly concerned with
product elf .Lcaty since the time the original pesticide law as enacted
in 1910. (tv r the years, the concern for hur’an and environmental
safety I as been transformed into a requirement for industry to submit
more hazard evaluation data to support their petiticris. Although
this trend may well continue, EPA is still concerned with the need
for proof of efficacy, since worthless pesticides that enter the
environt”cnt create the possibility of risk with no off-setting benefit.
however, lower priority will be given to efficacy evaluation in those
areas where parties in addition to industry arc- involved in product
development. This applies especially to agricultural pesticides
whose development has involved land grant universities or other third
parties. For those pesticides aimed at the Iior.e market or with direct
public—health application, efficacy evaluation will continue to be
an important part of thc registration process.
As for the test data, no set of criteria can preempt expert
judgment. however, standarized review rianuals, procedures, and methods
will be developed for registration and tolerance—setting activities.
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Standardized criteria and procedures will lessen the possibility of
contradictory and uneven reviews and also reduce the amount of time
needed to review each application. The possibility of requiring
industry to use government certified laboratories to perform testing
will be investigated as a further means of ensuring objectivity and
standardization in data submissions.
While the amended Act carries no specific provisions relating
to the contamination of food, EPA will continue setting tolerances
for maximum residual amounts of pesticides on food and feed crops
under the mandate of the Food, Drug and Cosmetic Act. Tolerance
setting remains as an important method for protecting the safety of
the consumer. Ways of increasing the efficiency of the process will
be explored, notably in reducing the time from manufacturer submission
of a tolerance petition to EPA approval or disapproval.
Although a regulatory agency, EPA recognizes the importance of
ensuring that new and effective pest controls are developed. It is
especially important to encourage innovative research and development
from private sources. As one element of this program, regulations
governing experimental use permits will be developed that fulfill the
manufacturer’s need for new data as well as protect the environment
during the testing period. Related to this is the minor use problem
—— the unavailability of pesticides for uses which account for a
relatively small percentage of pesticide sales. Manufacturers are
often reluctant to submit such pesticides for minor use registration
because the expense of additional testing and liability from damage
claims are not economically justified. EPA will investigate methods
of facilitating this process for second—party registrants.
The continuing review of generic chemical classes Is another
major element of supply control which will be given emphasis. In it,
suspect products already in use are investigated to determine if their
use raises substantial questions of safety. This process has tradi-
tionally been an expensive and time—consuming one for all involved
parties. Efforts will be intensified in speeding up this process.
The first step In this direction Is a two—month mini—review of any
suspect compound to determine whether a full review is necessary.
This mini—review will be made on the basis of all available dara,
including research and hazard data obtained during the re—registration
process. Major effort will also be devoted to assessing the relative
safety of potential alternatives to products under review.
Supply control as underwritten by product registration must be
enforced to be effective. A concerted program over the last few
years of labeling and quality—control enforcement has reduced
the number of gross violations of FIFRA registration requirements.
The new Act gives additional enforcement authority in these
areas through mandatory registration of establishments, through
books and records requirements, and through surveillance at
the point of manufacturing rather than in the marketplace. During
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the next two years the major effort will be directed toward the registra-
tion and inspection of manufacturer and formulator establishments; reduced
emphasis will be placed on market surveillance.
USE CONTROL
In addition to controlling the supply of pesticides, EPA will, in
close cooperation with States, attack environmental and health problems
that arise from poor use practices. Powerful tools to combat them
are available in the new legislation.
Labeling is a crucial step in assuring proper pesticide use.
Labeling is approved at the time of registration if it provides
adequate instructions and precautions to prevent unreasonable adverse
effects. However, four factors bear recognition——the label is limited in
the amount of information it can contain; it has been shown that
users often do not read printed instructions; there is some question
about how well any user understands labeling instructions even if he
does read the label; and a user may choose not to follow the label.
These factors suggest the nature of the use control strategy.
A major thrust will be to restrict to competent applicators
the use of certain compounds with a potential for causing localized damage.
Such compounds will be available only to private applicators (farmers)
and commercial applicators who have demonstrated competence in their
use. This restriction should significantly reduce accidents by
keeping hazardous substances out of the home and out of the hands
of the untrained. Certified applicators* must know how to follow
label Instructions, must know how to augment them when necessary
(consistent with label intent), must know safety principles, must
demonstrate competence in using application equipment, and must know
how to dispose of unused pesticides. Also, since the first decision
in pesticide use Is the Identification of a pest problem, certified
applicators must be able to identify major classes of pests in their
region. Applicators will be certified by States according to Federal
standards. Enforcement of restricted—use regulations will be a joint
Federal/State responsibility.
P6S Lc information programs, including media advertising, will be
investigated as a means of complementing the restricted—use program.
Rather than emphasizing specific practices, these programs will be
*The certified applicator program strongly interacts with the registration/
classification program described above. In fact, denying the registration
of potentially toxic products is a clear alternative to restricting their
use to certified applicators. During registration/classification,
it will be determined whether a pesticide product will cause unreasonable
adverse effects and, if so, whether further restrictions will diminish
those effects. Certification programs are directed at guaranteeing that
applicators of restricted—use pesticides are properly qualified.
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directed toward motivating the user to read and adhere to label
instructions. Similar educational efforts have been attempted in
the past but have suffered from a lack of message specificity and
audience direction. The lessons learned from past efforts will be
the basis for further development.
In addition to restricting certain pesticides to certified
applicators, the Act gives the Administrator authority to impose other
restrictions on pesticides by regulation. This authority provides
a powerful tool to be applied for both supply and use control of
those chemicals capable of providing significant benefit but also
substantial Costs to society. These other regulatory restrictions
will be designed to achieve a satisfactory balance between benefits
and risks associated with particular chemicals. Such other restrictions
may include seasonal and/or geographic pound limitations on applications,
annual permit requirements, control over distribution (including sale
and purchase), allowing use of a pesticide only in conjunction with
an integrated pest management system, and many others. EPA will develop
a structured framework to specify what other regulatory restrictions
will be applied under what conditions and to what extent.
While these programs are expected to have major impact, certain
other clearly needed programs will be instituted to deal with adverse
health and environmental effects. These will include specific require-
ments for childproof packaging for home—use products, disposal and
storage regulation and enforcement, development of dissolvable packaging,
and modified formulations of hazardous compounds. The development of
dissolvable packaging promises a control of problems arising from
direct inhalation and skin contact during mixing and blending operations.
Current technology is adequate to meet this problem but details must
be worked out. Spillage and food or clothing contamination during
transportation will be controlled through promulgation of transportation
and storage regulations. Protective clothing —— lack or nonuse of
which has been implicated in large numbers of accidents to applicators
and farm workers —— will be promoted. Today’s technology appears
to be adequate to produce light—weight and comfortable clothing.
However, Federal encouragement may be needed to bring about production
and use of this clothing. Labeling may be employed to require the use
of protective clothing and devices as necessary.
Effort will also be directed toward mitigating adverse health
effects among farm workers —— a sizeable group. State controls over
reentry intervals (time between pesticide application and when workers
return to the fields) will be reviewed by EPA. Preferably, enforcement
at the Federal level will be a joint venture between the Department
of Labor Occupational Safety and Health Administration (OSHA) and EPA
enforcement personnel. Further misuse enforcement will be reinforced
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by evidence from crop residue reports (FDA), accident Investigations,
and media monitoring. Enforcement against misuse relies in part on
the provision that makes illegal the use of a registered pesticide
in a manner inconsistent with its labeling. Consequently, a major
effort will be undertaken to encourage the development and use of
labels that are both Instructive to the user and enforceable in a
court of law and to place in effect cost—effective compliance
programs.
HAZARD EVALUATION
Under FIFRA as amended, pesticide registration and use may be
approved only if unreasonable adverse effects on the environment will
not result. Two types of dangers are associated with use of pesticides:
foreseen dangers inherent in the pesticides even when properly used,
and those either unforeseen or associated with misuse. Initial decisions
on allowing these potentially toxic materials into the environment are
made during the registration process largely on the basis of tests per-
formed by the manufacturer under laboratory and controlled field situations.
Unfortunately, such testing systems are Incapable of guaranteeing the
extent to which toxic or other adverse effects In man and the environment
can be expected when pesticides are put to practical use.
On the contrary, the value of toxicological assessment of hazards
using animals in the laboratory is fundamentally limited. First, the
determination of an effect is a difficult and at times uncertain process.
Second, large numbers of test animals are required to obtain confidence
in dose—response calculations for a specified effect. Third, extrapolating
such results from animals to man is as yet a very Inexact art. Fourth,
the manner in which the product is used and moves in the environment may
bear little relationship to the laboratory experience upon which hazard
has been predicted. Finally, the test process cannot anticipate all
possible serious effects.
Through cancellation and suspension provisions, however, the amended
FIFRA does authorize removal from the market of registered products whose
use causes unreasonable adverse effects. Human effects monitoring,
ambient residue monitoring, and accident surveillance systems now serve
to alert EPA and provide supporting data for such actions as well as
for periodic reconsideration of products and uses.
A comprehensive, effective hazard evaluation system can thus serve
EPA in a variety of ways. It can feed information into the registration
process by identifying possible harmful effects of pesticides and their
by—products. Decisions in the registration process are made many times
over a long span of years as uses expand, as registrations expire and
must be renewed, and when cancellation/suspension actions and reclassif i—
cation actions are under consideration. Hazard evaluation provides a
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major input to these decisions. It can also identify chemicals re-
quiring non—routine, in—depth review, and supply data which may either
clear them for continued registration or support cancellation actions
for specific classes or uses of pesticides. It can provide a basis
for the design of control programs and information for use in making
research and other non—regulatory decisions.
Ultimate regulatory decisions must be based upon factors in addition
to the hazards presented by pesticides. The hazard evaluation system is
concerned only with the latter. Socio—econoinic data and other information
will complement hazard data to permit an evaluation comparing risks and
benefits and leading to the crucial decision as to whether a pesticide
as used will produce unreasonable adverse effects.
Under amended FIFRA, EPA will design and implement a hazard
evaluation system which integrates toxicological testing with programs
that provide data on the presence and effects of pesticides and their
by—products in man and his environment. Using this design, EPA will
consider to what extent existing hazard data programs will be continued
and what new ones will be required. This major commitment constitutes
the third thrust of the pesticide strategy. Extensive testing, monitor-
ing, and surveillance programs have been in operation for a number of
years. Performance has suffered, however, from a failure to properly
structure and integrate the programs and the data outputs from the
various components.
The first step in the development of the hazard evaluation system,
both conceptually and chronologically, will be the development of overall
system design consistent with resource availability and technical
feasibility. Second, the individual components will be developed, implemented,
and integrated into an operating system. EPA must still meet its regula-
tory responsibilities while this process is underway. Certain on-
going programs involving field studies, monitoring, accident surveillance,
and toxicological testing will continue while system design and program
development and integration are underway.
As noted above, data to support a hazard evaluation system can be
generated both under carefully controlled circumstances, such as
laboratory and experimental testing, and under essentially uncontrolled,
in—use conditions, as through accident surveillance and monitoring programs.
The former class is most useful in making early registration/classification
decisions while the latter is most concerned with subsequent decisions
including those associated with reclassification, suspension, and cancellation
actions. This useful distinction masks the fact, however, that an effective
system should integrate all information available at the time of any
decision into a unified decision—facilitating apparatus. For this purpose,
one primary activity will be the development of one or more model ecosystems
as discussed in the next chapter.
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A very ambitious program has been outlined above. Fundamental
scientific and policy problems must be addressed——problems not unique
to the pesticides program but conmion to all attempts to control
hazardous materials entering the environment. Even given the possi-
bility of technological breakthroughs, the resource requirements to
implement the program may be exceedingly high. However, a truly
effective hazard evaluation system would be of extraordinary usefulness
and significance.
RESEARCH AND POLICY STUDIES
The final thrust of the pesticides stra gy is toward a vigorous
investigation both to support current regulatory actions and, more
important, to develop data and analytical techniques and program options
to meet future control program needs. The research program will have
two major components: scientific research and model development; and
studies to evaluate specific questions of policy and strategic planning.
Research
Currently, EPA is conducting and supporting scientific research
in several areas of Importance to the pesticide program. First, in
support of hazard evaluation, a better knowledge of harmful impacts
of pesticides is being reached through a number of environmental
and human health effects studies. Second, EPA is supporting research in
integrated pest management, as i& the Department of Agriculture,
through both cooperative and independent investigations. Third, improved
techniques, equipment, and laboratory methods are being sought for
monitoring pesticide levels in man and the environment. Finally,
problems involved in safe disposal of waste materials are also being
addressed.
In addition, new emphasis will be placed upon certain areas of
scientific research. Research will be intensified toward supporting
current and anticipated litigation on chemicals suspected to present
unreasonable hazards to health and the environment in direct support
of the hazard evaluation system. Of particular concern are chemicals
which bioaccumulate or present special toxicities. Although the
EPA research burden will be eased by requiring manufacturers to
submit extensive data to support their petitions for re—registration,
there still remains a significant short—term research need to support
review of suspect chemicals. Many of the chemical families currently
in use may be expected to continue in use for the next decade or more.
Furthermore, because of their extensive use in the past and continuing
existence in the environment, they provide an excellent subject for
health and environmental effects research.
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A second new emphasis of the scientific research program will
be the development of improved laboratory test methodology for current
compounds and development of standards for testing protocols and
registration requirements for anticipated pesticides, including biological
controls. Standards for test methods are needed for three pesticide
regulatory functions: (1) determination of the efficacy of products as
a basis for registration; (2) as a basis for enforcement actions, hearings,
or other proceedings; and (3) determination of specialized toxic
reactions. Actual testing will continue to be an industry responsibility.
A third emphasis of the scientific research strategy will be the
development of model ecosystems, proceeding from the current state of the
art. The models will predict human and environmental hazards on the basis
of chemical properties and expected use patterns and serve as a basis
for well—founded design of more efficient and effective hazard evalua-
tion programs.
An EPA research program will also be carried out to systematically
identify safer alternative chemicals for pesticides in common use,
accounting for relative efficacy, impacts, and costs. This is particularly
important so that possible future cancellation or restriction actions
do not result in unacceptable user hardships or food shortages.
Policy Studies
Policy studies will complement scientific research. Through
socioeconomic and system investigations they will better define the
nature and scope of pesticides problems and thus lead to improved
long—run programs. Five major areas have thus far been identified
in which studies will be performed. First, methodologies will be
developed to give quantitative support to the notion of “unreasonable
adverse effects.” Since, according to the new Act, registration and
cancellation/suspension actions must take into account the economic,
social, and environmental costs and benefits of the use of any pesticides,
this concept underlies a major part of the entire regulatory program.
Studies will be undertaken to improve the quantitative determination
of the costs and benefits resulting from pesticides use.
Second, studies will be performed to develop viable options
that stimulate the development and use of improved pest control techniques.
These will be directed at determining the extent to which regulatory
actions affect industrial innovation; the need for incentives in
encouraging private research; and the potential impact of government
testing, regulation, and—other--mechanisms for directing research
activities. The Act directs that research priority be given to biological
alternatives and integrated pest management. While the actual develop-
ment of specific alternative pest control techniques will largely be
the responsibility of other Federal agencies, studies will be
made of institutional factors in their development and use. Under
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its authority to provide special restrictions when necessary to
prevent unreasonable adverse effects on the environment, EPA may,
for example, allow the use of a particular product only if it is
part of an integrated program of pest management.
Third, program strategies that differ significantly from the
current one of controlling the supply of pesticides and of preventing
their misuse will be investigated. Such options as demand control
through crop insurance programs; taxes on products related to social
costs of their use; and more refined controls, such as prescription
systems or licensed pest—control advisors, will be explored.
Fourth, studies of how to increase the operating efficiency
and effectiveness of EPA’s supply and use control activities will
also be made, including evaluation of how the authorities of legislation
other than FIFRA —— air, water, labor, and food and drug acts —— can
best be utilized to both complement and supplement pesticide legislation.
Fifth, a major study of the future (the years 1985 — 2000) will
be initiated. Since agricultural policies, population trends, food
demand, resource depletions, and other economic factors are the context
in which regulation takes place, a forecast of alternative future
conditions is important to any longer—term strategy.
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4
OPERATIONAL PLAN
The previous chapter has outlined the major elements of the
EPA pesticides strategy to be pursued over the next three years.
This chapter presents specific program plans. Although there are
numerous activities necessary to meet objectives, these will be
presented in detailed operating plans for each fiscal year.
However, detailed implementation plans for important segments of this
strategy will be initiated immediately.
SUPPLY CONTROL
The program activities primarily related to control of the
supply of pesticides reaching the market place are incorporated in:
(1) registration and classification of pesticides; (2) review of suspect
chemicals and then suspension/cancellation/reclassification actions
as appropriate; (3) distribution and sales control; and (4) enforcement
and compliance control. The former two of these areas are principally
headquarters responsibilities, while the latter two will progressively
be the responsibility of Regional Offices and States.
Actions of EPA Headquarters
Principal EPA headquarters activities will be to:
• issue regulations for experimental—use permits;
• accomplish the registration and classification of over
40,000 pesticides;
• develop restrictions applicable to pesticide products;
• develop and improve registration and enforcement data
handling systems;
• conduct review of suspect chemicals;
• issue regulations defining book— and recordkeeping
requirements for pesticide producers; and
• assure full compliance with regulations under the
amended FIFRA.
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SUPPLY CONTROL SUMMARY
Major Actions and Milestones FY 74 FY 75 FY 76 FY 77
Experimental Use Permit Regulations XX
Experimental Use Permit Monitoring — _______ _______ _______
New Registration Regulations
Re—registration/Intrastate Registration —
Product Guidelines for Re—registration XX
State Registration Analysis and Guidance
Improved Registration Data System
Chemical Reviews
Review/Improvement of Registration
Enforcement — ________ ________ ________
Establishment Registration and Records
Regulations XX
Coordination of Regions/States Registra-
tion Enforcement
Regions Restricted Use Surveillance
Plans XX
Structure Other Regulatory Restrictions ________ ________ _______
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Experimental use permit regulations, which provide the first
opportunity for EPA to apply controls to a particular product, will
be issued for public comment in March 1974 and in final form within
an estimated three months; until that time, procedures under the 1947
FIFRA remain in effect. Following regulations, specific guidelines
wi1l be issued establishing data requirements for permits, safeguards
to protect experimental users, and reporting requirements.
The registration process must cope with re—registration and
classification of some 32,000 previously Federally registered products...
It must also review, register, and classify an estimated 12,000 products
now registered by the States only, from October 1974 to October 1976,
in addition to nortrai annual workloads of some 35,000 actions.
Special procedures uill be required to assure efficient, effective
handling of registration during this transitional period. However,
through improvements and changes in the system as outlined below,
it is anticipated that a 100 — 200 percent increase in workload can
be handled by a moderate increase in resources. After the major
-transition, these process improvements will allow a resource
decrease of up to 50 percent to handle the future workload projected
for FY 77 (last three quarters) and beyond.
E r1y guidance to industry on both registration and classification
aspects of currently registered products is important. It will provide
a smooth transition for EPA and an opportunity for industry to pre-
pare additional data in an orderly fashion. EPA will issue final
regulitions for registration and classification by October 1974.
During past years a considerable body of knowledge and independent
data have been gathered by EPA. On that basis, guidelines will be
provided which will identify those product types that EPA would
propose to re—register on the basis of: (1) simple application of
the manufacturer; (2) minimal basic data; and (3) complete test
data consistent with standards. Similarly, guidance will be issued
on product types which EPA would propose to subject to a case—by—
case review for classification to restricted or general use and those
which would be considered initially for the general—use category with
only minor label amendments. Procedures for processing new registrations,
as well as for re—registration of currently registered products, will
be contained in registration regulations to be promulgated in October 1974.
Federal registration of products previously registered only
intrastate will depend upon the quality of the original State review
procedures and upon the extent of review which would be applied to a
similar Federal registration. Analysis of State registration processes
will be completed by September 1974, and guidance will be Issued within
the next quarter.
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Registration guidelines, to be issued by June 1974, will appear
in a looseleaf updatable format and will initially specify registration
submission requirements applicable to 50 to 60 percent of all products.
By the end of FY 75, EPA expects to issue specifications for test
methods. By the end of FY 76, further expansion and detailing of the
guidelines will be accomplished to objectively define requirements
covering 80 to 90 percent of all products submitted for registration.
This will leave only the most difficult registrations for review
outside the guidelines. Requirements for efficacy review when supported
by third party testing (except for public health uses) will be
deeniphasized in favor of human and environmental effects.
As Federal registration begins to incorporate intrastate products,
provisions for special circumstances and minor uses of a local nature
will be critical. flegulations and guidelines for State certification
under a special local need program will be issued in October 1974.
Regulations governing exemptions from the provisions of the Act for
Federal and State agencies under emergency conditions are now in effect.
Other regulatory restrictions, as provided for in the registration
authority of amended FIFRA, will play an increasing role in supply control,
particularly in those cases where: (1) total poundage released to
the environment is critical; (2) hazards are presented to non—target
organisms, including man, which can be limited more efficiently than
by restriction to use by certified applicators; (3) benefit/risk
relations may be improved by simply confining use to within a total
pest management program; (4) specificity and care in the decision to
use are particularly important to avoid potentially serious effects
remote in time or distance from the application site; and (5) other special
cases which may arise from time to time. EPA will structure during
FY 74 a plan to determine when, where, and to what extent these special
restrictions should be applied. The intent is to establish consistency
of control where environmental protection requires restrictions other
than or in addition to those available through certified applicator
regulations.
Key elements of a supply control program consistent with an
efficient, effective internal operation will be put in play by
October 1974 and will include:
• computerized data and information—handling facilities for
registration, chemical reviews, and regional support;
• internal review criteria and guidelines for registration
personnel to apply existing data in a consistent way in
making registration decisions; and
• improved access to monitoring and enforcement data.
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Initial registration cannot anticipate the potential consequence
o cvery registration or classification action. EPA must therefore
conduct a review program. Generic reviews of chemicals will continue
to deternine the benefits and risks of continued use——clearing some
compounds and restricting others to varying degrees. Over 100 suspect
chemical substances have been identified to date. Even though the
more efficient new procedures of mini—reviews followed as necessary
by full reviews are employed, this process could take well past the
year 2000 at the current rate of 6 to 8 compounds per year. Additional
major resource emphasis must therefore be devoted to this area.
Priority emphasis is planned for: (1) “genetic” effect home and garden
compounds and (2) large—volume/use compounds with potential for
persistence and bioaccuirulaticn. Safer alternatives for suspect
chemicals will be sought through a formal review and research program.
A systematic effort is now being mounted to identify and evaluate
the relative merits of possible substitutes for potentially hazardous
chemicals.
Compliance with the registration requirement of FIFRA is monitored
through a random sampling scheme determined by the EPA Office of
Enforcement. Enforcement intelligence gained from this program —— as
carried cut through Regional Offices —— as well as from the selective
sampling of products and firms with known violation histories, will
be reviewed at the end of FY 74 to determine if program modifications
are necessary. The change in surveillance emphasis from the market-
place to establishments, which was begun in FY 74, will continue to
more efficiently ensure that unsafe products do not reach users.
Regulations for establishment registration, requirements for books
and records, and inspection schedules are now being developed and
will be operational by late FY 74. These regulations will be important
to EPA’s ability to track product dIstribution and to structure an
effective sampling scheme.
Actions of Regional Offices
In controlling supply of pesticides, Regional Offices will:
• survey compliance with experimental use permits;
• help develop “special local need” registration programs with
States;
register all pesticide producing establishments; and
play the primary role In enforcing Federal registration provisions.
Regions will continue to monitor performance of experimental use
permits to assure that permit conditions are being met and that
unforeseen events of a significant nature are immediately made known
to Headquarters. Enforcement actions to prevent or prosecute violations
are e Regional responsibility.
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Regions will also play a key role in working with States to develop
and monitor State performance under certified plans and enforcement
agreements in the areas of: (1) experimental use permits, which a
State may issue (if approved) and (2) a program of registration of
pesticides for special local needs. Although EPA Headquarters will
review and approve State plans and specific State local need regis-
trations, regions will be expected to (1) monitor the extent of use
of local need registrations, (2) provide necessary Federal enforcement,
(3) comment on State plans before approval, and (4) comment on specific
State registrations with respect to nature of local use, expected
extent of use, and environmental impacts.
Regions will continue as the primary EPA element in registration
compliance surveillance and enforcement and will continue to sample
products under Headquarters guidance, carry out chemical laboratory
analyses, and take enforcement actions. During FY 75 coordinated
programs will be developed by Regional Offices with States to avoid
duplication of efforts. Compliance surveillance by Regions of sale of
restricted—use pesticides should be programmed for FY 77.
State Responsibilities
States desiring to register pesticides for special local needs
or to exercise other authorities delegated by FIFRA must submit plans
to the Administrator after the Federal regulations are issued. Plans
must provide assurance of: (1) adequate technical review capability;
(2) surveillance of experimental uses; (3) appropriate authorities
to take remedial actions to revoke permits or registration; and
(4) procedures and authorities to assure consistency with Federal
registration and classification policy.
A Federal/State cooperative enforcement program is being developed
to involve States in programs of product supply surveillance and
enforcement and to avoid duplication. Although resource constraints
are significant, it is evident that an increasing State partnership
will be required.
Other Federal agencies, particularly USDA, must contribute to
the fund of knowledge available for supply control, including:
(1) sponsorship of pest control research that must be publicly provided
in minor use areas; and (2) identification of ttessentialte uses,
benefits, and alternatives during chemical reviews.
USE CONTROL
The current major regulatory thrust in use control is provided by
classification and applicator certification. The new enforcement and
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USE CONTROL SUNNARY
Major Actions and Milestones FY 74 FY 75 FY 76 FY 77
Applicator Certification Standards XX
State Certification Program Guidelines XX
Product Classification Standards XX
Applicator Certification
Training Demonstration Projects
Improved Labeling Regulations XX
Public Education Programs
Product Packaging Requirements
Agricultural Worker Protection Standards XX
Food Tolerance Improvements XX
Cocperative Regions/States Use Enforce-
ment Plans XX
Product Storage, Transport, and Disposal
Procedures and Regulations
State Certification Program Plans
Submitted
Cooperative EPA/OSHA Reentry
Surveillar ce Plans ________ _______
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penalty provisions are expected to enhance both these control measures.
Classification and certification can provide control over significant
problems of applicator, farm worker, and local environmental hazards
while alleviating diffuse problems stemming from misuse and overuse.
Regional Offices and States will play key roles in implementing and
enforcing all use controls. Other regulatory restrictions, discussed
under supply control, will also be investigated as a means of improving
use control.
Actions of EPA Headquarters
EPA headquarters will issue;
• Standards of competency for certified February 1974 (Proposed)
applicators June 1974 (Final)
• Regulations for State Certification September 1974
Programs
• Regulations for Classification October 1974
(Effective date applicator certification October 1976)
Technical assistance for applicator training and development of
State plans will be provided xd.th.in available resources. Demonstration
contracts are currently being developed to test alternative methods
of training applicators and to assess innovative methods of training.
These will be completed by mid FY 75; results will be made available
to the States beginning in September 1974.
Labeling is a key tool in both user information and enforcement.
Significant improvements will be required to improve clarity and
coinprehensibility of labels. Studies carried out over the past three
years have provided insights into needed improvements; these will be
implemented durinp the 197^-76 re-registration period. A labeling
symposium will be held in FY 1974.
Public education through a media-oriented program will be
instituted in FY 75 on an experimental basis to enhance the potential
benefit of improving labeling. Studies have shown that the majority
of users do not now read labels. Media spots directed at the potential
hazard of improperly handled pesticides and the value of label infor-
mation have beer, shown effective in some cases.
Use-control programs will depend upon a mix of regulation,
education, and training directed toward voluntary compliance and
enforcement. Enforcement strategies in such a broad new field are
difficult at best and are irade irore difficult by resource constraints.
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A 10 to 20 percent shift in product surveillance resources is planned
for FY 75 to initiate misuse enforcement programs. Short—term emphasis
will be on design, testing, and development of cooperative Federal/State
strategies. A substantial degree of compliance by certified applicators
can be expected since loss of certification could result from violation
of FIFRA.
Packaging requirements for home—use products to prevent child
poisonings will be prepared in cooperation with the Consumer Products
Safety Commission and will be incorporated in re—registration review
of all such products.
A variety of other Headquarters activities impacting on effects
of pesticide use include:
• Standards for agricultural worker protection are now in
preparation and are scheduled for publication before the
1974 growing season.
• Plans for the surveillance of field reentry conditions
will be developed cooperatively with the Occupational
Safety and Health Administration (OSHA).
• Food residue tolerances established under the Food, Drug,
and Cosmetic Act will continue to be a strong motivation
to proper use of chemical pesticides on food and feed to
avoid confiscation and loss of crops under FDA enforcement
programs. To simplify the numerous tolerances now in effect,
EPA will seek to develop crop groupings and codify existing
tolerances in 1975. These crop groupings will also be helpful
in allowing pesticides cleared for one crop to be used on
similar crops produced on a much smaller scale——the so—called
“minor crops.”
• International tolerances established by the Codex Alimentarius
Commission have a direct impact on international trade positions
and on domestic tolerances. Increased attention will be paid
to this area.
• In cooperation with the Office of Solid Waste Management,
recommendations dealing with safe storage and disposal techniques
for pesticides and containers are being developed; prel1n inary
guidelines have already been published.
• The Office of Water Programs will be designing regulations
dealing with water pollution from pesticide runoff, including non—
point—source control.
• Pesticide transportation regulations, where now incomplete
or inadequate, will be developed through cooperation with
the Department of Transportation.
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Actions of Regional Offices
Regions will gradually assume a major EPA role in use control.
Resources devoted to use control should be increased significantly
by F? 76.
Regions will help the States develop their certified—applicator
programs and will provide final review and approval of State plans.
They will also monitor performance under approved plans. Regions
must become familiar with applicator training techniques and provide
technical assistance to States. Regions will also work with media
organizations in promoting public service materials for safety—in—use
programs.
The groundwork for cooperative—use compliance programs with
States should start in FY 74 in coordination with Regional activities
related to applicator certification. States will be encouraged to
obtain adequate legislative bases for misuse enforcement if they do
not currently exist. Regions will also cooperate with the
Occupational Safety and Nealth Administration (OSFJA) in a
sharing of information concerning field reentry and factory
worker surveillance.
Regions will extend national interagency agreements with USDA
Extension Service into States where they currently do not exist and
assure that States, in developing applicator training programs, make
maximum use of existing capabilities.
Monitoring of program performance and environmental impacts arising
from emergency condition exemptions for State and Federal agencies will
be carried out by Regions with reporting to Headquarters.
Regions will also coordinate with States in assuring compliance
with pesticide storage and disposal regulations and implementing
local disposal plans and systems.
State Responsibilities
States must play a primary role in use control through training a
necessary and certifying applicators and executing appropriate post—
certification control. States must submit plans for certification
programs by October 1975. Although States will need specific legislati e
authority, to be detailed by March 1974, conditional approval may have
to be given to plans which identify such authority as pending.
State cooperative enforcement programs are essential to adequate
FIFRA implementation. Existing state enforcement programs are uniquely.
qualified to fill certain deficiencies in Federal enforcement capabili-
ties. Cooperative efforts with other agencies will form a major basis
of use control due to the magnitude of the task and the diversity
of use control needs and potentials; duplication must be avoided and
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expertise of agencies outside EPA fully utilized. Enforcement of
worker protection standards is expected to be carried out cooperatively
with OSHA in the Department of Labor through cooperative State programs
for worker protection.
HAZARD EVALUATION
Hazard evaluation programs have traditionally been directed by
Headquarters. This orientation will continue through FY 1976. The
hazard evaluation programs conducted up to the present time have
included human and environmental monitoring and accident and incident
reporting, as well as the traditional toxicological testing programs
and experimental use programs conducted by applicants for registration.
Major emphasis through FY 1976 will be on design of an overall system
—— review and restructure of existing component programs, development
of new programs, and the integration of program outputs. The objective
is a comprehensive, operational system responsive to EPA’s decision—
making needs. Neither the difficulty of designing nor the resources
to operate the system should be underestimated. Allowance must be
made for the fact that many crucial aspects of the relationships between
pesticide use and human and environmental effects will not be clearly
known in the near future.
System conceptualization and overall design will be the primary
focus through FY 75. An essential element will be the integration of
hazard data of varying types and quality, made available from multiple
sources. Integration implies a way to relate and compare data on
different aspects of a pesticide use situation so as to display the
relative significance of the various hazard aspects of the pesticide use
and to help in evaluating total hazard. Integration of data should
help in posing useful hypotheses about kinds of hazards for which
there are no direct data; such hypotheses might be drawn from data
available on other hazards and from analagous pesticide use situations.
An important component of the integration effort will be the development
of one or more model ecosystems. A model eco ystem should provide
a means for interrelating laboratory toxicological data, environmental
levels and effects data, human levels and effects data, and use and
other•data. Design of the model ecosystem iil1 require an understanding
of interactions among ecological subsystems; the model itself will in
turn facilitate additional understanding of these relationships. Such
a model would prove a framework for field testing, and would lead to the
identification of organisms and subecosystems in which to monitor for
ambient pesticide alert levels. Modeling of such biological systems
is now primitive. However, the availability of a better framework
for understanding the relationships and impacts of pesticides in the
real environment would justify the effort needed to construct improved
mode1’ ecosystems.
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Monitoring systems will be designed to acquire data on human
effects both immediate and remote in time and place from the application
site and also both acute and chronic in nature. Review of programs
conducted up to the present, especially the epidemiological studies,
and their redesign, or the design of completely new programs, will
be a major activity in FY 1974 and 1975. A basic question is whether
such programs can be designed and carried out with the resources likely
to be available and still promise output justifying the investment.
Design studies must consider: (1) rules for deciding which study populations
and which pesticides to observe; (2) statistical integrity and design
of samples from populations to be studied; (3) other aspects of study
design including long term followup of the observed population; (4) ease
of integrating results with those from other data acquisition activities
into the hazard evaluation system; and (5).managerial and organizational
arrangements insuring quality in performance over the life of the studies.
To accomplish this, the most capable experts available, in or out of
government, will be retained. Completion of this effort is projected
for inid—FY 1975.
Monitoring of pesticides and their effects in parts of the
environment other than man also involves the acquisition of data on
both immediate and remote phenomena. The ambient environmental monitoring
programs carried out by EPA and others under the general design (1967) of
the Federal Working Group on Pest Management are being reviewed in connection
with development by EPA of a National Pesticides Monitoring Plan as
required by the amended FIFRA. The Plan and its components must be
completely integrated into the hazard evaluation system. Review, re-
design and development of environmental monitoring programs will entail
development of a rationale for selecting the pesticides to study; for
selecting the environmental media, organisms, and ecosystems on which
to acquire data; and for decisions on sample selection and other aspects
of integrity and usefulness of the programs. In addition to long term,
ongoing environmental monitoring programs, short term projects will
be designed and conducted to acquire information on the environmental’
behavior of pesticides or uses of special significance, because of
highly suspected hazard or for other reasons. These special studies
must also provide results that can be integrated into the hazard evafuation
system as well as serve their more immediate purposes. Some resource
will be reserved and kept in readiness to carry out such high prioritfy,
largely unforeseeable projects.
Another major program contributing to the hazard evaluation system
will report data on accidents and other incidents Involving pesticidel.
Existing EPA activities are being reviewed, and a program will be (‘
designed to provide coverage and accurate and useful data consistent
with resources. The extent and method of investigation of Incidents,
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comparability of data, statistical validity and other design and
managerial issues must be addressed. The Regions, together with State
and local agencies, will play a major role in the acquisition and sub-
mittal of such data.
In addition to the acquisition of data bearing directly on hazard,
alerting (alarm level) programs will be designed and implemented, if
possible by adding them to other data acquisition programs, to provide
indicators of potential hazard. At the present time, knowledge as
to the relationship between the presence of pesticides or their break-
down products in environmental media or organisms and adverse effects
is not sufficient to define danger levels. Under these circumstances,
the “trigger” level in the alerting system may initially be set at
levels presumed to be below those at which control action would other-
wise be appropriate. Data showing the presence of a pesticide at the
trigger level should thus not foreclose the opportunity to conduct
special research and data acquisition before occurrence of wide—ranging,
significant health or environmental effects. The usefulness of the
alarm mechanisms should be enhanced by improvements in model ecosystems.
Studies will (1) develop rules for deciding which compounds, ecosystems
and indicators to use; (2) develop the rationale for determining the
trigger level; (3) develop the course of action to follow after alert -
levels have been triggered; and (4) design the operating system for
acquiring the data.
Design of the hazard evaluation system and design of its coitponents
will not be completed until sometime in FY 1975. In the meantime,
decisions must be made as to whether to continue current programs, with
appropriate adjustments in resources and emphasis. Considerable attention
has already been given to the development of a program strategy for this
interim period. Under consideration are: (1) a trial experimental—use
surveillance program; (2) a compilation of data gathered during previous
efforts; and (3) special short term projects, particularly in the area
of acute effects on agricultural workers. A decision on the short term
program strategy will be made in the near future.
T he Regions can contribute significantly to hazard evaluation
system design efforts overall during FY 1974 and early FY 1975 by
cata]. oging and reporting on ongoing pesticide monitoring and accident
reporting activities within the areas for which they are responsible.
Other Federal agencies currently play major roles in monitoring and
data acquisition, and will be expected to continue to do so. Their
cooperation is essential both to the redesign and implementation of a
national monitoring plan.
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RESEARCH AND POLICY STUDIES
The fourth strategic thrust consists of a flexible program of
directed research and policy studies. While important elements of
this program can now be identified, a capability to quickly redirect
certain elements must be maintained so that the program ca i fully
support an evolving strategy. Primarily a Headquarters effort,
Regions will be asked to support research and policy studies on the
basis of their experience and specialized expertise.
Research Program
EPA is now conducting and supporting a scientific research program
directed both at providing support for pesticide regulatory actions
and toward establishing a firmer understanding of pest control methods
as they impact on man and the environment. The current research
program is composed of a variety of both short and long term inves-
tigations. The amended FIFRA, and this strategy, impose new requirements
for changes in emphasis among some of the research efforts.
Currently, scientific research is being carried out in three
broad pest control areas.
Effects
Development of an operational hazard evaluation system requires
that many unknowns concerning pesticide effects be addressed. Several
longer term investigations (3 years or more) of both ecological and human
health effects are now underway or planned:
• baseline studies of a relatively uncontaminated ecosystem
to allow measurement of net chemical effects;
• development of methodologies for assessing pesticide effects
in particular environmental systems;
• studies of synergistic effects of pesticides in combination
with other pollutants;
• studies to quantify transport, transformations, degradation,
and fate of pesticides in the natural environment;
• development of pesticide/fertilizer runoff models;
• expanded and improved laboratory studies of pesticide
toxicities to man.
Alternative Pest Control Methods
The Department of Agriculture has a large program devoted to
developing alternatives to chemical pest control. EPA ’s research
here is directed at supplementing this program, filling in gaps that
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may occur and involving segments of the research community not
traditionally involved with agriculture. Two principal studies being
supported in part by EPA are:
• a study of the potential for alternate pest control methods
for seven major crop types;
• a study of control alternatives for soil insects.
Both studies are concerned with pest populations dynamics and inter-
actions, damage thresholds, natural enemies and resistance, and new
control possibilities. The objective of both USDA and EPA programs
in integrated pest management is the availability and use of pest
control methods, including selective chemicals use, which permit
adequate control with reduced unwanted effects on man and the total
environment.
Other Research
Current research efforts are directed at filling several other
important needs:
• development of new methods, techniques, and equipment for
monitoring pesticides in the environment;
• provision of standard reference materials, analytical techniques,
and samples for residue laboratory work;
• assurance of inter—laboratory quality control in analysis
of monitoring samples;
• development and evaluation of technology for recovery and
conversion of pesticide waste materials;
• attention to the problems of field worker exposure and
means of establishing safe reentry conditions.
The pesticides strategy has several implications for the relative
emphasis among research topics. Higher near—term priority will be
given principally to four areas.
• Research in support of chemical reviews and litigation will
be of high priority between now and 1980. In many cases,
basic groundwork must be accomplished to quantify specific
chemical effects and interactions as described above. In
most anticipated review/litigation cases, the capability for
rapidly acquiring quality research results will also be required.
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• Also of high importance will be research projects to develop
product test methods and protocols. For eventual use by
both industry and government, two particular needs are
evident: (1) tests for new generations of pesticides such
as viruses and hormones to assess potential for hazard; and
(2) tests to establish the efficacy of public health products,
including disinfectants.
• The linkages among subsystems of the environment for use in
models to support the hazard evaluation system will also be
developed. Model development must proceed carefully yet
rapidly from a generally primitive base. In this regard,
relationships must also be developed for relating laboratory
experimentation to real world effects.
• A large effort to systematically identify safer chemical
alternatives to currently used pesticides is being initiated.
This substitutability among chemicals must take into account
the relative efficacy, impacts, and economics of alternate
chemicals. EPA must be in a position to recommend the best
available pest control methods in the event of cancellation
or use restriction of pesticides now in common use so that
unacceptable economic impacts or food shortages do not result.
Policy Studies
A major focus of the next two years will be a series of policy—
oriet ted studies to explore direct and indirect determinants of
pest’icide demand, pesticide benefits, alternative pest control options,
and institutional mechanisms and constraints. Some of these studies
are currently underway or about to be contracted while others will be
initiated during FY 75. First round studies will be completed by the
end of FY 75 and the remainder in FY 76 to form the basis for pesticide
strategy in the period following full implementation of the amended
FIFRA in October 1976. The following five study areas will he pursued:
1. The foundations will be set for the assessment of pesticide
costs and benefits, including an operational definition of “unreasonable
adverse effects” of pesticides as referred to in the amended FIFRA.
Several specific EPA studies include:
• a review of applicability of cost—effectiveness methodologies
from other fields;
• assessments of the magnitude, Impacts, and control of pesticide
pollution from urban usage and agricultural non—point sources;
• a study of the factors underlying crop yield increases;
• an evaluation of the effect of food quality and appearance
standards on pesticide use.
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2. The EPA role in and alternatives for influencing Integrated
pest management will be assessed. A preliminary report is to be
cor.:pleted by the end of FY 74. Additional efforts in this area are:
• evaluation of pesticide user decision—making criteria and
sources of information;
• evaluation of the institutional mechanisms and incentives
for modifying the decision process;
• study of private sector research decision—making criteria
in terms of prospects for innovations and need for direct
Federal research or incentive programs;
• determination of desirable directions for research in
integrated pest management.
3. flew approaches to pesticide control will be Investigated to
either cor:’plement or supplement current programs. Planned studies
include:
• evaluation of crop insurance as a means of reducing pesticides
use;
• study of the feasibility of using licensed pest control advisors
to prescribe pesticides.
4. P. set of studies will be initiated to Improve the efficiency
and effectiveness of supply and use control aspects of pesticide re-
gulation. These will include:
• design of information nanagement and decision—making processes
that will serve to focus results of human and environmental
monitoring, enforcement, research results, and economic
analysis in the regulatory process;
• evaluation of risks of less stringent registration requirements
to determine a minimum set of data consistent with an acceptable
risk level;
• evaluation of an industry self—testing program similar to that
employed by FDA;
• coordination and evaluation of air, water, and other legislation
as they relate to program objectives.
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5. Alternative futures in which the pesticide programs may be
operating over the long run will be studied. The pesticide programs
at all levels of government do not operate independently of other
aspects of society and the economy. Significant recent changes in
food supply and energy availability bring home the fact that a long—
term program cannot be designed on the basis of current conditions.
As assessment of the potential worlds in which a regulatory program
may find itself 10 — 25 years from now is essential to planning a
flexible yet meaningful strategy for the future. This study will
be initiated for completion by January 1976.
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