United States
Environmental Protection
Agency
Office of July 1985
Pesticides and Toxic Substances
Washington DC 20460 7^01 QRS 1
Pesticides
National Pesticides
Monitoring Plan
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National Pesticides
Monitoring Plan
U.S. Environmental Protection Agency
Region 5, Library (PL-12j)
77 West Jackson Boulevard, 12th Floor
Cfticago.il 60604-3590
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Table Of Contents
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TABLE OF CONTENTS
l- IJlTJ^DJJ_CT_I_p_N - page 1.
A. Wh d t is Monitoring Within the Context of Pesticide
Regulation?
B. Why is Monitoring Important to Pesticide Regulation?
C. Who has Responsibility for Collecting Monitoring
Data?
D. What Areas of Data Gathering are Important?
E. What Does This Plan Do?
II. iOAL_AND___0_BJJ_C_TI_V_ES - page 6.
A. Objective I: Assist in Determining the Impact of Old
(Existing) Chemicals on Health and the Environment
page 9.
1. Subobjective A: Determine the Extent of Use of
Pesticides Currently Being Applied - page 12.
2. Subobjective B: Determine the Extent of Exposure
to Workers from Pesticide Application - page 19.
3. Subobjective C: Monitor for Pesticides in Ground
Water and Surface Water - page 23.
4. Subobjective D: Determine the Extent of Pesticide
Residues in Food and Feed - page 28.
5. Subobjective E: Determine Exposure from Indoor
and Domestic Outdoor Applications of Pesticides
page 32.
B. Objective II: Assist in Determining the Impact of
Regulatory Decisions to Permit New Chemicals and/or
Uses - page 36.
1. Subobjective A: Require Monitoring of Specific
Chemicals on an As-Needed Basis - page 37.
2. Subobjective B: Biotechnology ~ page 40.
C. Objective III: Measure User and Industry Compliance
with Regulatory Decisions in the Field - page 43.
1. Subobjective A: Determine Extent to which Pesticide
Users are in Compliance with FIFRA Requirements ^s
Reflected on Product. Labeling - page 44.
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III.
2. Subobjective B: Determine Extent to which Pesticide
Registrants, Producers and Distributors are in
Compliance with Pesticide Regulatory Decisions and
Policies - page 46.
3. Subobjective C: Determine Quality and Validity
of Data Submitted in Support of Pesticide
Registrations - page 48.
4. Subobjective D: Determine Effectivenenss of the
Pesticide Applicator Certification and Training
Program in Protecting the Public from Potential
Hazards of Restricted Use Pesticides - page 51.
D. Objective IV: Determine Trends of Pesticides in the
Environment to Evaluate Overall Program Effectiveness
(Environmental Results) and to Identify Unanticipated
or Emerging Problems. page 53.
1. Subobjective A: Establish Information Indicating
Trends in Use of Chemicals or Non-Chemical Approaches
page 55.
2. Subobjective B: Further General Understanding of
Exposures to Agricultural and Other Workers - page 57.
3. Subobjective C: Identify Trends in General or Ambient
Environmental Contamination - page 60.
4. Subobjective D: Document the Occurrence of
Pesticide-Induced Illness and Other Incidents of Harm
page 64.
Implementation page 67.
A. Establish and Maintain Data Systems page 67.
1. Electronic Bulletin Board
2. Data Management Systems
3. Inventory of Registrant-Imposed Studies
B. Provide Quality Assurance page 68.
C. Provide Federal/State Guidance, Coordination page 69
1. Interagency Coordination
?.. Priority List of Chemicals
3. Technical Assistance
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0. Provide Registrants Guidance page 71.
1. Data Requi rements
2. Protocols, Guidelines, GLP's
3. Technical Assistance
E. Provide Public Access to Information page 12.
1. Electronic Bulletin Board
2. Annual Report
3. Publication in AOAC Journals
4. Update Monitoring Plan
Appendix - Brief Summary of Resource Commitments
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ACKNOWLEDGMENTS
The Office of De5ticide Programs (OPP) would like to
tiank the many people both in our own program and other EPA
offices, who participated in work groups and provided
information contained in this plan. They are too numerous to
identify individually, but their contributions and cooperation
are appreci ated.
It is appropriate to acknowledge those individuals who
contributed so much of their time and effort to the difficult
task of editing and producing this report in final form.
They are:
Carol P. Stangel, Policy and Special Projects Office, OPP
Ann E. Carey, Exposure Assessment Branch, Hazard Evaluation
Oivi sion , OPP
Thomas E. Dixon, Exposure Assessment Branch, Hazard Evaluation
Division, OPP
James V. Roelofs, Policy and Special Projects Office, OPP
Rose M. Jackson, Policy and Special Projects Office, OPP
Christine Gi11is-Terry, Policy and Special Projects Office,
OPP
Special thanks to Mr. Robert Barles, of the Office of
Management Systems and Evaluation for his valuable editorial
suggestions and generous assistance.
We also wish to thank Mr. Robert J. Flanagan of the
Office of Public Affairs for his assistance with graphics and
pri nti ng.
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Introduction
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Goal & Objectives
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11 • GOAL AND OBJECTIVES
The primary goal of monitoring for pesticides is to
provide information on exposure and effects to enhance
the accuracy of pesticide risk assessments and thereby,
improve the soundness of FIFRA risk/benefit regulatory
decisions. Monitoriny should also provide information
that supports determinations of compliance with the
Agency's pesticide regulatory decisions. Finally, EPA's
pesticide monitoring efforts need to provide information
to evaluate the ultimate effectiveness of its FIFRA
programs in controlling unreasonable risks posed by
pesticides.
Risk assessments are performed on any given chemical
by calculating what is known about the inherent toxicity
of the chemical in conjunction with the degree to which
humans or other species are exposed to that chemical
(see Figure III). Knowledge of the actual levels and
duration of exposures and the subsequent effects resulting
from the use of a pesticide can significantly enhance
the accuracy of an assessment of the risks posed by
that chemi cal 's use.
In a world of limited resources, the Agency must make
decisions carefully about where its monitoring dollars
will be invested. The Agency must identify the kinds of
regulatory decisions which can benefit most from increased
exposure data, and among those regulatory decisions,
which should receive highest priority attention.
As a first step, the Agency must decide if its
information needs for a regulatory decision require a
monitoring investment or whether these needs can be be
fulfilled adequately by less expensive surrogate data or
predictive modeling capabilities. As indicated in
Figure III, predictive exposure modeling and effects (i.e.
toxicity) determinations, based on laboratory testing,
have come to play a key role in EPA's efforts to develop
timely and cost-effective assessments. EPA has developed
these predictive capabilities based upon years of scientific
research and monitoring of pesticide environmental
behavior and toxic effects. Today cost-effective estimate.,
of exposures and effects can be predicted from laboratory
data (e.g., animal toxicity testing and measures of a
pesticide's chemical/physical properties) or surroga'.e
data (e.g., use or application patterns similar to
well-known pesticides). Monitoring continues to play an
often crucial role in developing or validating these
predictive capabilities. Also where confidence in
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these capabilities is limited, monitoring information
may provide the only evidence of exposure (e.g., ground-
water contamination) or effects (e.g., declines in
wildlife populations). With limited resources, the
Agency must weigh the often increased confidence provided
by monitoring data against the usually more cost-effective
estimates provided by predictive models or surrogate
data. The choice depends on the confidence in the
available predictive tools and the significance of the
decision to be made. In a number of cases, the costs of
implementing a monitoring design capable of providing
the needed information may be extremely prohibitive. In
other cases, monitoring may be unethical (i.e., some
human effects monitoring) or beyond our scientific
capabi 1 i ti es.
Once the Agency has decided to obtain information on
actual exposures or effects through pesticide monitoring,
it must then decide if monies need to be expended by EPA
or whether the data should be acquired by cooperating
with other Federal agencies and the States or by imposing
monitoring requirements on pesticide registrants. While
EPA has a leadership role, it is clear that responsibilities
for pesticide monitoring have been, and will continue to
be, shared among various government and private entities.
This plan organizes EPA's monitoring information needs
into four basic objectives (see Figure I). The first
two objectives are derived from the primary pesticides
monitoring goal of improving risk assessments and the
FIFRA. risk/benefit decisions based upon them. The third
objective is to monitor for compliance with EPA's
pesticide regulatory decisions. The final objective is
to provide monitoring information that can be used to
evaluate the ultimate effectiveness of the Agency's
overall pesticide regulatory program and alert EPA to
any unanticipated or emerging risks. These objectives
are summarized below.
OBJECTIVE 1: ASSIST IN DETERMINING THE IMPACT
ON~ITEALTH
AND THE ENVIRONMENT FOR SPECIFIC
REGULATORY DECISION-MAKING
One of the Agency's priorities is to complete the job of
reassessing the health and environmental impact of
pesticides registered before today's registration
requirements were put into place. Monitoring can
contribute to that reassessment process by providing
information on the actual exposure or effects resulting
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Vc ?', DETFRMINE THE IMPACT OF REGULATORY
TO PERMIT NEK' CHEMICALS
AND/OR NEW USES
'» Agency needs to give explicit thought to whether
;'.,.•:-• ing requirements will be imposed as a condition
t,o granting new uses. Part of this process will be to
icc-!;v, \ Ij ho¥, to best monitor for new chemicals in response
to tiie changing trends in types of chemicals themselves
and in response to true innovation such as biologically-
engineered microorganisms. Monitoring for pesticides
permitted by past decisions can provide surrogate data
useful in making decisions on new pesticides.
OBJECTIVE 3: MEASURE USER AND INDUSTRY
COMPLIANCE WITH REGULATORY
DECISIONS IN THE FIELD
One of the fundamental premises of any regulatory program
is that decisions will be complied with in actual practice.
Monitoring of compliance is thus needed to assure that
the Agency's regulatory objectives are being met.
OBJECTIVE 4: DETERMINE TRENDS OF PESTICIDES IN THE
ENVIRONMENT FOR OVERALL PROGRAM EVALUATION
AND IDENTIFYING UNANTICIPATED OR EMERGING
EXPOSURE PROBLEMS
In addition to reassessing the impact of specific
chemicals in the environment, monitoring helps to analyze
and understand the overall status of pesticides in the
environment (e.g., use, exposures, and effects). These
trends can assist the Agency in accomplishing one of its
primary goals, which is to determine the real-world,
environmental results of regulatory decisions. Trends
analysis can also detect unanticipated emerging problems
so that appropriate regulatory action can be taken to
respond to the situation before a crisis develops.
These four objectives are explored in depth below. For
each oMective, the need for monitoring will be explored,
the regulatory utility will be articulated, the entities
responsible for monitoring will be identified, and a
summary of planned monitoring activities will be presented
In other words, this document will address the questions
WHY monitor, WHO will monitor, and WHAT monitoring will
be undertaken. Monitoring of the environment necessarily
reflects the environment's extremely complex interlinkages
Thus, any organization of monitoring information needs and
its special uses will always be somewhat arbitrary. It is
hoped that this presentation, organized in terms of basic
regulatory program responsibilities, is an effective and
logical structure for communicating EPA's pesticide
monitoring plans.
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Objective 1
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A. OBJECTIVE 1: A S_S_I_ST_IN D_E_T E RMi.NI_N_6__T_H E_I_M P_A C TJ3F JDLJ)
TEXISTINGT CHEMICALS ON HEALTH AND"
~~~~~ ~
One of the top priorities of the Office of Pesticide
Programs (OPP) is to re-examine the decisions made on
pesticides registered over the past 30 years to ensure
that they continue to meet the statutory requirement that
no pesticide should be marketed which imposes unreasonable
adverse effects on hunans or the environment. The FIFRA
requires the reregistration of previously registered
pesticides. This entails the review of the data bases
for all chemicals registered prior to 1977 when modern
data requirements were imposed to (a) ensure that basic
health and safety data have been developed and are of
satisfactory quality to meet today's standards, (b) recon-
sider the current regulatory requirements and registration
status of each chemical in light of modern data, and
(c) set forth the standards and conditions under which
that chemical will be registered in the future. There
are approximately 600 active ingredients representing
45,000 products undergoing reregistrati on review. The
outcome of the review is a registration standard which
explains EPA's regulatory position on the use of a
pesticide active ingredient and documents the information
available to the Agency about the chemical. Registration
standards include a chemical description and use profile,
the Agency's regulatory position and rationale, the
criteria for registration under the standard, acceptable
product composition ranges and limits, tolerance reassess-
ment information, what additional data need to be developed
and when, and what restrictions and labeling changes will
be imposed. The Program had completed 94 registration
standards as of December 31, 1984, and is developing
additional standards at a planned rate of 25 chemicals a
year.
In some cases, the rereview of old data or the review
of newly generated data will indicate that the pesticide,
as currently marketed and used, may be posing unreasonable
adverse effects to humans or the environment, that is,
its risks may outweigh its benefits to society. In these
cases, a special review may be initiated. A special
review is an intensive review of the pesticide's risks and
benefits. It is a public process in which the Agency first
identifies and quantifies to the extent possible the human
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10
health or environmental problems being posed and the
benefits being derived from agricultural or other sectors'
use of the chemical; second, proposes a regulatory position;
and finally, issues a final position which may be to continue
current uses, restrict some or all uses, or cancel some or
al1 u ses .
Monitoring data can assist the Agency in making both
registration standards and special review decisions. Data
indicating the extent to which existing pesticides are occur-
ring in the environment can provide information on which to
base realistic exposure assessments which in turn will lead
to better assessments of the potential risk of a pesticide to
hunans and other nontarget life. Such exposure information
is especially critical in making decisions on special review
chemicals where the inherent toxicity has raised serious
concerns about potential health impacts.
Monitoring data in the form of use and usage information is
important not only in performing exposure assessments, but
also in developing benefits analyses which are a critical
part of special review decisions. In addition, monitoring
data can assist the Agency in establishing priorities for
special review. For example, if the Program is considering
initiating special reviews for several chemicals because of
potential toxicological concerns, and monitoring data indicate
that one of these chemicals is more prevalent or persistent
in the environment or in a certain key medium, such as ground
water, that chemical will have higher priority for review in
order to to determine if regulatory action is needed.
In general, then, monitoring data can contribute in
several ways to assessing impact of existing pesticides in the
environment, including:
0 development of exposure profiles for pesticides
undergoing registration standards;
0 development of labeling restrictions for pesticides
undergoing registration standards;
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0 reassessment of permissible residue levels
(tolerances) for pesticides undergoing registration
standards or special reviews;
0 setting priorities for chemicals which are candidates
for special revi ew;
0 development of exposure and risk assessment for
chemicals undergoing special review; and
0 development of benefits analysis for chemicals
undergoing special review.
There are five particular areas of monitoring activities
which will assist in the review of existing chemicals.
These are: developing use and usage data, monitoring to
determine exposure to workers, monitoring ground and surface
water, monitoring for residues in food and feed, and deter-
mining exposure from indoor and domestic outdoor application.
Each of these areas is discussed below (see Figure IV).
As noted in Figure IV, several types of monitoring
information are not specifically addressed under this
objective. In some cases, these other information types
can be of equal or more importance to existing chemical
regulation decision making. They have been omitted from
this section for several reasons. Compliance monitoring is
completely addressed under a separate section, Objective 3.
The Agency is increasingly looking at the likelihood of
compliance or enforceabi1ity of its regulatory decision-
making and the activities under Objective 3 will certainly
provide information useful to meeting Objective 1. Environ-
mental dispersion and contamination, other than for ground
water and surface water, is primarily limited to aerial
drift, volatilization and particle reentrainment. Aerial
drift, while not discussed here, continues to be an important
data requirement of registrants; it is also part of the work
described under this objective for determining field worker
exposures. Finally, monitoring information on body burdens
and effects is certainly a very important consideration in
the assessment of existing chemicals, particularly for special
reviews. The general discussion of this type of monitoring
information is found under Objective 4. However, much of the
work discussed under Objective 1 on worker exposures is aimed
at identifying body burdens and health impacts.
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12
V A R X N F USE° F 1 DS
Pesticides are applied in virtually all geographic areas of
the United States to some degree. About 10 percent of the
total land area of the U.S. receives some type of pesticide
application in any one year. These applications include
agricultural pesticide use on hundreds of crops as well as
applications of pesticides in urban and suburban settings for
household, lawn and garden pest control. Given the great
variety of pesticide use situations and the multitude of
pesticide chemicals registered for use, the benefits and
potential risks afforded to different segments of our
population and environment vary widely. EPA needs information
on the kinds, amounts and circumstances of pesticide use in
order to better understand both the benefits provided and the
extent of exposure, and ultimately risks, presented. Monitor-
ing efforts to provide current pesticide use and usage data
for both agricultural and nonag ri cul tural sites are, therefore
an important component of the National Monitoring Plan.
WHAT DATA SHOULD BE COLLECTED: Qualitative data on how,
when, where and why particular pesticides are used on given
sites in given geographical areas, and quantitative data on
pesticide usage, should be collected for both agricultural
and non-agricultural pesticides and use sites. Currently,
EPA has a reasonable amount of use and usage data, particular-
ly for major agricultural crops, primarily from proprietary
data bases available to the Agency on a subscription basis.
In general, more usage data in the public domain would be
useful to formally support program actions. Additional data
are needed regarding:
0 non-agricultural pesticide use and usage;
0 "minor" or specialty agricultural crops;
0 detailed (e.g., county- 1 evel ) geographical breakdowns
of agricultural pesticide use and;
0 pesticide use patterns and product performance.
WHY : These data will permit EPA to better understand both
pesticide benefits and exposures, and thus make better regula-
tory decisions on continued registration of pesticides now in
use .
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_RE_GUL_A.IOR_Y__1L1LI--LLY: Pesticide use and usage data can
"pr6"vTde a viiTal link between the Agency's initial regulatory
assumptions made during the registration process, as reflected
in product labeling, and the consequences of use (residues
in environmental media, any observed adverse effects, etc.).
Use/usage data help to elucidate the relationship between
registration/conditions of registration and resulting conse-
quences, in terms of both risks and benefits to society. By
showing how benefits and exposures are occurring as a conse-
quence of registered pesticide use, these data can permit the
Agency to validate or invalidate its regulatory assumptions
about use and use patterns. The data gathered are thus es-
sential to the Agency's reevaluation of existing pesticide
regi strati ons.
Use and usage data support other monitoring activities in two
ways. First, such data are needed to establish priorities and
identify locations and media from which samples should be
collected. Second, these data are required to properly interpret
the significance of results from other types of monitoring
acti vi ti es.
In summary, then, use and usage data are needed by EPA to:
0 help establish residue and effects monitoring priorities
and design monitoring studies;
0 help interpret the results of other types of monitoring
activities;
0 determine efficacy of pesticides in the field;
0 perform routine exposure assessments; and
0 perform benefits assessments.
VJHO SHOULD COLLECT: EPA, several other Federal agencies,
the States, pesticide registrants, private companies, user
groups and trade associations all have various roles in
developing and collecting pesticide use and usage data.
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EPA - has the Federal lead role- In collecting pesticide
use/usage data but relies on a wide variety of sources,
as detailed below. EPA participates with USDA, FDA, the
Bureau of the Census, State officials through the American
Association of Pesticide Control Officials (AAPCO) and the
State FIFRA Issues Research and Evaluation Group (SFIREG)
and State land grant universities in an interagency plan-
ning group on pesticide use and usage data needs. That
group has designated EPA responsible for conducting usage
surveys on urban and non-farm sites.
USDA - historically, has surveyed agricultural pesticide
users and has been designated as responsible for continu-
ing this function by the interagency group.
Other Federal Agencies - are generating certain use/usage
data consistent with their respective goals and responsi-
bilities. EPA has formed interagency agreements with
USD I, the Department of Defense (DOD) and others so that
information of use to the Agency may be generated coopera-
ti vely.
States - independently generate use/usage data, some of
which are useful to EPA in decision-making.
Pesticide Registrants - have a continuing responsibility
to provide data as needed by EPA regarding their products'
risks and benefits. EPA has recently requested detailed
geographical use/usage data on a number of pesticides to
defend existing registrations, and may do so for other
pesticides.
Private Subscription Data Bases - several companies collect
data on pesticide usage that is used largely by pesticide
producers in their marketing studies. EPA purchases such
data bases, which provide wide crop coverage data at very
reasonable cost. These data are useful to EPA as a back-up
and for cros s-checki rig purposes. However, these data are
not a full substitute for data in the public domain which
can be quoted and referenced in support of Agency actions.
User Groups and Trade Associations - have cooperated
with EPA in conducting usage surveys, and express an
interest in working further on future surveys.
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0 EPA Regions - collect production and distribution
data that are used as a proxy for usage data.
ONGOING/PLANNED ACT I V_I_TJ_E_S AND PJOJJ C TS_ j_ EPA's strategy is
to co n't in u e t cT~cTe~veTo p p e sTfci de u s e"7~u sage data for major
agricultrual commodities. At the same time, however, increasing
attention will be given to acquiring more information on minor
crop use, household and domestic use, and other non-agricultural
uses. Key activities designed to gather pesticide use and usage
data include:
Pesticide User Network
EPA is currently devoting resources to establishing and
maintaining pesticide user networks representing major
agricultural, public health and other non-agricultural
uses. These national networks involve the pesticide user
community in the development and analysis of OPP program
activities, and provide a mechanism for obtaining pesticide
benefits, exposure and product performance information
directly from users. Timely and accurate benefits and
exposure-related use information is essential to imple-
mentation of OPP's special review procedures. Information
on product performance in the field is also potentially
significant for evaluating the balance of risks and benefits
involved in decisions for registration actions and emergency
exemptions, as well as special reviews. The Agency is
reevaluating the current policy of waiving the submission
of product efficacy data for non-health related pesticide
uses.
Production and Import Data System Enhancement
EPA is continuing to devote resouces in FY 85 to a FIFRA
section 7 data enhancement effort. Data on pesticide
production and distribution are reported to EPA by each
producer under section 7 of FIFRA. These data are vital
to the Agency as they provide a proxy for usage data, and
are often the only data available for certain minor agri-
cultural and non-agricultural use sites. As such, they are
used to prioritize problem chemicals, to identify chemicals
of immediate regulatory concern, to provide a starting
point for economic analyses used in the registration
standards and special review programs, and to assist in
planning monitoring projects.
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16
This project will provide a needed overhaul of the existing
section 7 and import data system so that it may be used
more efficiently by Agency analysts.
° EPA Surveys on prbany Non-Farm Sites
Consistent with our responsibilities as designated by
the interagency planning group on pesticide usage
surveys, OPP has conducted surveys of golf courses,
nurseries and commercial applicator activities and has
selected several additional categories of usage sites
that would be feasible to study with appropriate
funding (including usage by households, mosquito
control districts and hospitals). As data from these
surveys become available, EPA will begin to develop a
comprehensive profile of pesticide usage in non-agri-
cultural areas.
° USDA Surveys of Agricultural Sites
To increase the usefulness of the USDA surveys, EPA
will negotiate an agreement with USDA to expand its
efforts. (More frequent data collection, coverage of
significant minor crops, and geographical detail down
to county rather than regional levels are needed.)
The trend in recent years has been toward more
limited funding of USDA pesticide usage surveys.
However, EPA will continue to try to work with USDA
to enhance this important source of usage data.
° USDA's NAPIAP
The National Agricultural Pesticide Impact Assessment
Program (NAPIAP) under USDA, was created in the
late 1970's to contribute to benefits assessments for
use by EPA in the RPAR or special review process, and
will continue to serve as a liaison with EPA on
pesticide use, exposure, and other regulatory matters.
For example, the NAPIAP has been asked to provide use
and exposure information for several special reviews
this year. NAPIAP is partially funding a cooperative
study with Oregon State University to examine benefits
of forest vegetation management. NAPIAP may also
continue to provide Pesticide Assessments by commodity
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17
At present, there are two working agreements with the
USDI: (1) an agreement with the Fish and Wildlife
Service Labs in Denver, Colorado, to evaluate the
effectiveness of vertebrate pest control agents, and
(2) an agreement to develop programs for control of
selected pests utilizing integrated pest management
(I PM) systems.
D_0_D_ Ag reement
An agreement is currently in effect with the DOD
Armed Forces Pest Management Board for the generation
of certain non-agricultural use site information and
specific information on public health pests.
U.S. Forest Service (USFS) MOD
A Memorandum of Understanding (MOD) is currently
in effect with the Forest Service to provide OPP
with current as well as historical pesticide use
information on Forest Service lands. The Forest
Service will develop and provide: (1) yearly
pesticide use reports, (2) project reports on efficacy
trials of pesticides of current interest, (3) yearly
listings of NAPIAP projects and project reports on
exposure, and (4) current assessments of alternatives
to specific pesticides of current regulatory interest
to EPA.
The States
Through SFIREG, EPA will continue to exchange infor-
mation informally with the States on product perform-
ance. Also, we will continue to use certain pesticide
usage surveys conducted by the States.
National Pest Control Association (NPCA)
An agreement is currently in effect between OPP and
the NPCA to obtain product performance and use data
from field testing programs which include screening
of currently registered devices, pesticides, or biora-
tional agents intended for use in the professional
urban pest control fields.
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18
American Mosquito Control Association (AHCA)
A Looperative Agreement is being negotiated between
EPA and the AMCA to provide: (1) data on use and
effectiveness of pesticides used in vector mosquito
control activities, (2) information on common vector
control practice and integrated pest management
practice, and (3) a forum of users on label improve-
ment and similar items of interest.
University of North Carol i na_ ( UNC)
OPP has a Cooperative Agreement with the UNC to
assess the precision of the AOAC Use Dilution
Test. This test is used as the efficacy test to
register all hospital disinfectants and is used by
Florida, North Carolina, Virginia, Mississippi,
Canada, New Zealand, and Brazil for enforcement
purposes. Additional microbiological tests to assess
product performance are also being investigated under
this cooperative agreement.
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19
SUBOBJECTIVE B: DEJE_RMJM^IE_JQiLJAILliLAF_E^P^U_RJ. T0_JdO_RK_E_R_S
FROM PESTICIDE APPLICATION
Certain individuals are exposed to pesticides more than
the general population. In particular, there are thousands
of individuals who are exposed to pesticides through their
work; mixers, loaders, farmers, pest control operators, and
farmworkers. Some of these individuals are exposed when they
reenter a field sprayed with pesticides to harvest crops.
Determining the risks to those occupationally exposed to
pesticides is an important component to regulating existing
and new chemi cals.
Monitoring occupational exposures is therefore a critical
part of performing accurate risk assessments. In this
sense, monitoring can encompass actual exposure studies,
overall health effects studies, and personal risk mitigation
measures.
WHAT DATA SHOULD BE COLLECTED: Field and personal impact
resfdue studies, dermal absorpti on studies, epidemiological
studies, and protective clothing research should be pursued.
WHY: These data will permit the Agency to understand actual
exposures of more highy exposed populations, determine
the health impact of pesticides to those who work with these
chemicals on a regular basis, and identify practical risk
reduction techniques for pesticide users.
REGULATORY UTILITY: Based upon the data gathered in this
category,the Agency may:
0 initiate a special review, cancellation or suspension
based on potential unreasonable adverse effects to
workers;
0 restrict uses to certified applicators, or impose other
restrictions, such as the requirement for applicators
to wear protective clothing; set re-entry intervals for
pesticides which specify the time required between the
application of a pesticide before workers can reenter the
field without special protective measures;
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20
0 develop protective standards Lhrough rulemaking, e.g.,
to reduce risks and/or ensure worker understanding of
potential risks.
0 develop special protections for children in field
situations, e. g., longer reentry intervals, special
clothing requirements.
In addition to assisting OPP in making direct regulatory
decisions under FIFRA, worker-related monitoring data can
assist the States and DSDA in tailoring applicator training
materials to educate applicators about potential risks and
how to guard against them, and assist EPA, HHS, USDA, and the
private sector in developing educational materials for
agricultural field workers, or professional applicators.
WHO SHOULD COLLECT:
0 OPP (EPA) - maintains a capability through the National
Pesticide Hazard Assessment Program to perform a range
of worker-rel ated studies from residue studies to epi-
demiological studies. This Program operates through
cooperative agreements with seven universities in various
regions throughout the U.S.
0 USDA - has a responsibility to assist in determining
benefits of pesticides and, through the National
Agricultural Pesticide Impact Assessment Program
(NAPIAP), performs exposure studies for pesticides,
especially those undergoing special review.
0 National Institute of Occupational Safety and Health
(NIOSH) - as the research arm of OSHA, performs studies
relating to exposure to pesticides in a manufacturing
setting, which may have applicability to understanding
pesticide exposures.
0 Department of Health and Human Services (HHS) - through
the migrant labor clinics, is also in a position to collect
and disseminate information on pesticide risks to the
field worker labor force.
0 Registrants - may also be required to collect applicator
exposure data to support product registrations. The
Agency is now exploring development of generic data re-
quirements for this type of exposure data.
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0 Office of Research and Development (EPA) - has a
major role "in developing research on protective
clothing, and may initiate health-related studies
in special circumstances.
MG_^G/PLANN^_^CTIVJ_mj_A^_PRqjJ_C_T_S: There are several
special proJects relating to worTer exposure planned or
underway:
° Fi e 1 d Worke r Exposui re St udi es
OPP has a several field worker exposure studies planned
for FY 85, including:
studies to determine adult and juvenile worker
exposures in selected crops;
studies to determine whether the use of vegetable
oils as diluents in applying pesticides increases
the persistence of residues and thus increases
exposures to field workers.
Results of these studies will permit the Agency to refine
the methodology for establishing reentry intervals, determine
if there are greater impacts of pesticides on children
working in fields than adults, and determine if new policies
are needed to address use of diluents, as well as provide more
information on how pesticides behave in the environment which
will assist in reassessing the risks of all outdoor use
pesticides undergoing registration standards review.
° Protective Clothing and Devices
OPP is initiating additional field studies through
the National Pesticide Hazard Assessment Projects
(NPHAP) this fiscal year (and will continue these
studies during FY 86 and 87) to monitor applicators
wearing different types of garments during different
types of spray operations. These studies will address
performance of the garments in reducing exposure, as
well as thermal comfort levels of the workers. ORD will
begin testing the permeability of various types of
glove materials to pesticides, and will fund garment
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22
material testing at the University of Tennessee through
a cooperative agreement beginr'n--; this fiscal year.
ORD is coordinating this w»rr, for OPP with other personal
protection research b e i n i, conducted on behalf of EPA's
Office of Toxic Substances (OTS) and the Office of -Solid
Waste and Emergency Response (OSWER).
""he d a c •' developed through these field and lab studies
will be used by OPP to develop protective clothing
performance standards for purposes of risk reduction.
A protective clothing and equipment guide for users
will be completed by FY 88. The data will also be used to
establish a consistent internal OPP policy on protective
clothing and equipment that will be applied to every aspect
of" the regulatory process including registration and
labeling, special reviews, registration standards, and
farmworker protection standards.
S t u d i e s of Applicator Exposure During Various Application
Te~chn fques
Through the NPHAP, OPP is conducting field and lab studies
to formulate an applicator exposure data base for hand
held, power train, chemigation, aerial and ULV techniques.
These data will be used to fill significant data gaps and
permit human exposure assessments and evaluations.
Health Effects and Special Studies
OPP also has a variety of studies planned for FY 85 which
involve determining the extent of human exposure to
pesticides. These projects are also described in Objective
IV. D , and they include:
> a study in Hawaii to monitor levels of heptachlor epoxide
i n mothers'milk;
> development of a technique to detect exposures to an
organophosphate insecticide (parathion);
> a study of animal skin permeability to investigate dermal
exposure potential; and
> statistical surveys of pesticide poisoning incidents.
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SUBOBJEC T nC : MOTO R E RU DWTE R A ND
Protection of ground water and surface water is a
significant goal of the Agency and a major social and policy
issue of the 1980's. The general public, as well as nontarget
plant and wildlife species may be exposed to pesticide residues
inadvertently through drinking and tap water, irrigation
systems, etc. Ground and surface water can thus be seen as
a significant potential route of hunan and environmental
exposure to pesticides. Monitoring ground and surface water
for pesticide residues is essential to understanding and
limiting the risks of exposure presented to people and
their environment. Such monitoring is therefore a
significant component of the National Monitoring Plan.
WHAT DATA SHOULD BE COLLECTED: Ground water and surface
water samples for pesticide residue analysis should be collected
from a variety of sources around the country.
WHY : The resulting data will permit the Agency to assess
the extent of contamination of water by pesticides, to better
understand the relationship between use directions and residues
in the environment, to understand which areas of the country
may be more vulnerable than others to contamination, and to
better determine the level of pesticide exposure to humans
and wildlife through water sources.
REGULATORY UTILITY: Such data can provide the basis for:
0 initiation of Special Reviews when chemicals of
toxicological significance are found at levels of
concern;
0 Registration Standards and Special Review regulatory
decisions including label restrictions or other
modifications to existing registrations (including
cancellation of certain pesticides, across the board or
in key geographical areas);
0 determination of extent of risk and need for treatment
or clean-up;
0 drinking water standards and health advisories;
0 confirming and/or improving the models and methods used
to predict the environmental fate of pesticides, and
suggesting new directions for research;
0 determination of the impact of recently introduced
agricultural practices including no-till farming,
and pesticide application through irrigation
systems (chemigation) on the environment, which
can lead to modifications on labels.
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24
WHO__SHO_UL_D__CO_LL_ECT: There are a variety of agencies and
prira'f"e ~eri'l 'rc fes~ who have a role in collecting data on pesticides
in ground and surface water:
0 IISGS - has an overall mission in mapping and deter-
mining quality of surface and ground water; has expertise
end ci joing activities in sampling water sources for
i var-iety of contaminants.
" USDI - has a mission in protecting aquatic and endangered
species which may be impacted by water quality and
use of pesticides.
0 States - have mission to both protect water quality
and share with the Federal government the regulation
of pesticides; State water, health and agricultural
agencies involved in monitoring for pesticides.
0 Office of Pesticde Programs (F.PA) - has the lead
responsibility for evaluating pesticide exposure infor-
mation; OPP works cooperatively with other EPA Offices
and other agencies to acquire data through specific water
monitoring projects.
0 Office of Drinking Water (EPA) - has a mandate to set
standards for contaminants, including pesticides, in
public water supplies, from either ground or surface
wate r.
o
Office of Water Regulations and Standards (EPA) - has a
mandate to set standards for effluents, including
pesticide chemicals, in surface waters from point
sources. OWRS also provides guidance to States on Best
Management Practices for controlling non-point sources
of water contaminants.
o
Office of Ground Water Protection ( F p A) - has mandate
to coordinate implementation of National Ground
Water Protection Policy, including a Monitoring Plan.
Office of Research and Development (EPA) - can collect
monitoring data if mandated for special projects,
and has a larger role in developing quality assurance
measures and technologies to predict movement of
chemicals to ground water.
Pesticide Registrants - have a continuing responsi-
bility to provide data to the Agency to demonstrate
that their products do not pose unreasonable adverse
effects to humans or the environment. For chemicals
with a potential to leach to ground water or run off
to surface waters, actual monitoring nay be a key
factor in determining whether the product poses un-
reasonable adverse effects.
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LN_G.°_LflGj/ZLANAED ACinnjIES AND_LRO_iLcH: OPP's strategy is to
acquire inTbrmaTion on s p e cf i f Tc cTTemfcals of concern through
several EPA-sponsored studies and by requiring monitoring by
registrants. OPP will also undertake jointly with other -EPA
programs, Federal agencies, and the States, several ground-
water monitoring surveys to identify general pesticide
contamination and to develop predictive exposure modeling
capabilities for this critical medium. Specific activities
include:
0 QPP/ODVI Survey
The Office of Pesticide Programs and the Office of
Drinking Water are jointly planning a national
survey of drinking water from ground water sources
to measure the presence of selected pesticides. The
survey will be planned in FY 85 and executed, assuming
that funding is forthcoming, in FY 86. The results
of the study will provide information on the potential
extent of contamination of drinking water in various
parts of the country, which will allow the Agency to
better assess the impact of certain pesticides on
human health and may lead to label restrictions or
possible cancellation of some products on the market.
Call-In on Potential Leachers
OPP issued special data call-in letters in FY 84 requiring
manufacturers of registered products to conduct and submit
environmental fate data on over 100 pesticides known or
suspected to leach to ground water. The data from this
call-in will be submitted to EPA in FY 85 and FY 86.
Pesticide registrants will develop these data. The results
of these data will permit the Agency to determine what
further field monitoring will be required of the registrant,
and assist in developing exposure assessments for registration
standards.
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R e •,! i s t r a n t Field Monitor:
GPP is requiring, as part of the registration standards
process, registrants of at least four chemicals to -conduct
field monitoring of ground water as a condition of con-
V r; u 5 d registration in FY 85. Pesticide registrants will
i e r a s i. G n 3 i b 1 e for developing these data. The results of
*;h;j pisot projects will permit OPP to refine its recently
developed draft policy on imposing monitoring requirements
during the registration standards process, help complete
exposure assessments of the four chemicals in question,
and permit the Agency to decide what labeling and/or
restrictions need to be imposed on these registered
products.
ORD Aldicarb Survey
As a result of a special Congressional appropriation,
ORO has been conducting monitoring for the pesticide
aldicarb in Florida. This was a federally funded project
conducted through a State university. Data from this
project will assist OPP in reaching a conclusion on the
future labeling or other restrictions of aldicarb during
the already ongoing special review of the chemical. The
registrant and several States are also continuing to
monitor areas that may be vulnerable to leaching for
aldicarb.
Oougherty Plains Field Validation Study
ORD, with OPP support, has a 5-year study underway in
Georgia to validate environmental fate models. The
study, which is federally funded, is measuring pesti-
cides in soil and water and comparing the actual
presence with predictions of computer models. The
results of the survey will permit the Agency to refine
current models and to predict with more accuracy and
confidence the potential for pesticides to move to ground
water. This will in the long run lead to less expensive
and more efficient decision-making to the extent that
modeling can be used in lieu of field testing.
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U . S x Geol 091' cal _ Su
OPP is planning to work extensively with USGS in FY 85
to ensure that ongoing USGS ground water programs are
designed to collect data in ways which will assist OPP
decision making. A particular project funded by OPP in
FY 85 is designed to create an Interagency Agreement with
USGS to help OPP collect data, and to identify areas of
the country where pesticides are more prone than others
to leach. This effort will assist the Agency in target-
ing label restrictions and further monitoring efforts.
OPP will also work with USGS to investigate the possi-
bility of a cooperative surface water monitoring program.
States Moni tori ng
Many States are monitoring ground water sources for
pesticides. States will continue to monitor for pesti-
cides and other toxic substances as their resources pern it.
EPA and the States are working on ways to identify priorities
and mechanisms for capturing the findings of State activities
(see also Part III, Inpl ementati on) .
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D r r R [ E HE E x T"" - Oi- PESTICIDE RESIDUES IN
and feed commodities commercially available in the
!j . S today have been treated with pesticides at some time
OUT i; i!iei! ;.roauction, harvest, storage or processing. The
FeJ T'. ! government is responsible for ensuring that potentially
h a i.- ; 'i o u $ pesticide residues do not result in food and feed
commodities travelling through the channels of interstate
commerce. EPA, establishes tolerances, or legally enforceable
residue limits, for all pesticide food and feed uses, while FDA
an,i uS)A enforce those tolerances. While effective food and
feed residue monitoring is essential to compliance programs
(Objective 3), it is also directly relevant to EPA's pesticide
risk assessment responsibilities.
mftJ_OATA_SHOULD BE COLLECTED: Residue data for pesticides
in raw agricultriTal cfommodi ties and in foods ready for
consumption should be collected from different geographical
a reas.
W HY: Residue data on raw agricultural commodities determine
whether pesticide tolerances are being exceeded, and permit
EPA to determine whether tolerances are set at appropriate
levels. Data on the extent of food contamination permit EPA
to better evaluate human exposure to pesticides through food,
and thus perform sound dietary risk assessments.
REGULATORY UTILITY: Dietary residue data are vital to EPA,
FDA and USDA reguTatory programs. Such data provide the basis
f o r:
0 Reassessment of tolerances in the registration
standards process;
0 Performing dietary risk assessments of chemicals
undergoing special review or registration standards;
0 Determining overall trends in dietary pesticide residue
levels over time which contributes to the exposure
profile in regi'tration standards.
0 Establishment of action levels in lieu of tolerances
for pesticides whose registrations have been can-
celled and tolerances revoked because of health-related
concerns.
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WJ1° _MQ^L[LJIP_LI-ECT: EPA' FDA' IJSDA> the States and pesticide
"FegTsTrant"s eacftfTave a role in collecting and developing
dietary residue data.
0 EPA - cooperates with and supports to some extent the
FDA and USDA dietary residue data monitoring programs
so that the data developed by those agencies will
also serve our regulatory needs. EPA also conducts
special food monitoring projects as needed to support
special reviews, reregistration or cancellation
proceedings (for example, several EDB cooking/baking
studies were performed in FY 84).
o
o
FDA - has the Federal lead in developing dietary residue
data since it has enforcement responsibility for all
food and feed (including milk and shell eggs) except
for meat, poultry tissue and liquid eggs.
USDA - shares the Federal lead for residue data development
with FDA, as USDA is responsible for enforcing pesticide
tolerances for meat, poultry tissue and liquid eggs.
The States - often develop data on pesticide residues in
food/feed produced and/or marketed within their boundaries,
consistent with their pesticide regulatory and health
protection responsibilities, and often have contracts with
FDA and USDA to perform federal programs or portions
thereof within their boundaries.
Pesticide Registrants - have a continuing responsibility
to provide data demonstrating that their products do
not pose unreasonable adverse effects. For products
used on food or feed crops, actual dietary residue
and exposure data may be a key factor in determining
whether the product poses unreasonable adverse effects.
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0_N'-iplNG_/PL_A_N_NE_p _A_C TI VITIES_ AND PROJECT'S: EPA's strategy is to
1o •/;'•" Tue "to -.rjVk wf'fli TTTT a"ncT US"lTr" I T'ncrease the utility and
t, / .1 -. '"• a'' i -i vy of ..formation. ""A will also be seeking more
a:-I <..!-> residue data from registrants, and from State monitoring
programs. Specifically, EPA is working on the following
activities:
,_• .:; _'lGni t_prj_ng/Survei 11 ance
FDA, USDA and the States are continuing to carry out
routine pesticide surveillance/compliance monitoring
programs. FDA has made improvements in its monitoring
program during the past four years which have made the
data gathered particularly useful to EPA in asessing
pesticide risks. USDA1s National Residue Program is also
being expanded, but closer cooperation with USDA is needed
to increase the number of pesticides included and the
tissue types analyzed for pesticides, so that USDA's data
may be equally useful to EPA in developing dietary exposure
and risk asses sments.
FDA Su_rvei 11 ance Index Project
OPP will continue to provide quantitative usage analyses
and chemistry, toxicology and environmental fate summaries
to FDA to support that agency's preparation of the Sur-
veillance Index. That document presents FDA's method of
ranking pesticides in order of monitoring priority based
on potential health risk and potential for occurrence in
the food supply. Currently about 140 pesticides/pesticide
groups are included; another 50 should be added by the end
of FY 85. OPP's data contributions to the Surveillance
Index help to influence which pesticides are included in
FDA's monitoring programs.
Pesticide Analytical Manual (PAM), Volume II
OPP is providing updated analytical methods for use
by FDA and USDA in dietary residue surveillance
compliance monitoring programs through preparation
of PAM Volum., II. Availability of this updated
manual will minimize conflicts in enforcement
methods at the State and national level.
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On-line Access to FDA and USDAMoni tori
If future resources permit, OPP will explore with
FDA and USDA the possibility of establishing
on-line access to those agencies' monitoring data
bases, to speed up data access and make EPA's
analyses of the data for exposure assessment more
efficient. These data bases include Feedcon and Foodcon
which enter data on contamination findings in food and
feed sampling programs.
Residue Data Call-in _f^_r___Gf_a_i_n_ F_umi gants
Out of concern with the ethylene dibromide situation, OPP
has initiated a special Data Call-In for grain fumigants
through which residue and other exposure data will be
gathered. Letters requiring the data were sent in FY 84,
and OPP expects to receive the data in FY 85. These data
will allow OPP to make better informed re regi st rat i on
and other regulatory decisions about the grain fumigants.
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SUBOBJEC 7 I V E E : D E_T_E _R_M_I N_E_E X_PO _S_U R E FRO M_ I ND 0 0_R_ _A_ND _D 0_M E_S T I C
O'lJTDOOR" APP"LICATTr'NS 0"F ~PTsf I CIDES
+ ;a
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33
REGULATORY UIT IL I_T_Y : Monitoring data on domestic and indoor
peTticide exposures nay be used by EPA:
0 to define baselines;
0 to prioritize future data call-in activities;
0 to detect unforeseen problems which require special
regualtory consideration;
0 to develop monitoring data requirements and guidelines
for future registrant-sponsored studies;
0 possibly, to set standards similar to tolerances for indoor
air pesticide residue levels; and
0 ultimately, to develop better risk assessments of existing
chemi cals.
These data will be useful to OPP in making registration,
reregistrati on and special review decisions. They may also be
useful to ORD and other Federal agencies interested currently
in indoor air quality. OTS may find the data useful as that
program shares OPP's interest in human exposure in the home and
other indoor environments. EPA's Air Office may be able to use
the data in its toxic air pollutant program (under section 112
of the Clean Ai r Act).
WHO SHOULD COLLECT: Several public and private parties have an
actual or pote~nti al role in developing indoor and domestic
outdoor exposure data.
0 OPP - has the primary C9ordination function for indoor and
domestic outdoor pesticide exposure data, and is planning
to support some multi-residue, survey-type studies with
ORD. This work will assist in developing monitoring guide-
lines for registrant sponsored studies.
0 Other Federal Agencies - EPA participates with 14 other
agencies in the Interagency Research Group on Indoor
Air Quality. Some of the other participating agencies
may develop data or methods that will be useful to OPP's
monitoring and evaluation efforts.
0 States - may develop useful indoor monitoring data consistent
with their pesticide regulatory and public health protection
responsi bi1i ti es.
0 Pesticide Registrants - have a continuing responsibility
to provide data demonstrating that their products do not
pose unreasonable adverse effects. For domestic or "home
and garden" use products, actual indoor and domestic
outdoor residue and exposure data may be vital in determining
whether unreasonable adverse effects are posed.
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34
ifi'.!i_NJ/°, • ,'^NFi) ACTIVITIES '•", •,: .-J_t_CTS : EPA's strategy is
c'onTi"• ni'
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35
Monito_ring S_tud_y with_OJU)
OPP and OR.n are working closely together to design a
study of indoor human exposure to pesticides. ORD is
managing in cooperation with OPP a Total Exposure Assess-
ment Methodology (TEAM) study of exposure to pesticides
used in and around the home. This study is supported by
a $ 1 million Congressional appropriation in FY 85. The
objective of the study is to estimate the frequency and
distribution of exposures of an urban or suburban population
to selected pesticides. The study will produce data on
personal exposure which will be extremely useful to OPP in
developing future exposure/risk estimates.
The monitoring, exposure and use habit data generated by
this research project will be useful to OPP in defining
baselines, prioritizing future data call-ins and further
research activities, and detecting unforeseen problems
which require special regulatory consideration.
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SUMMARY OF OBJECTIVE I
Assist in Determining Impact of
Old (Existing) Chemicals on Health and
the Envi ronment
DATA COLLECTION/GENERATION PROJECTS FOR IMPLEMENTATION UNDER
THE NATIONAL MONITORING PLAN
Project
Regulatory
Responsible Objectives
Party Supported
Survey of Urban/
Non-Farm Sites
Pest Control
Efficacy
EPA (OPP)
USD I
Registration (including
Standards development)
Special Reviews.
Determine efficacy of
vertebrate pest control
determine effectiveness
of IPM.
Current
_S_t_atus_
Ongoi ng
Ongoi ny
Use of Pesticides
in Forests
DOD
U.S. Forest
Service
Non-agric. use: Site
information.
Efficacy feedback; usage
data which can be used in
Registration and Special
Reviews.
Ongoi rig
Pesticide User
Networks
Private Sector
Groups (Users)
Enhancement of
Production Data
Reporting
Professional Pest
Control Practices
in Urban Areas
Use of Pesticides
in Mosquito Control
National Agri-
cultural Pesticide
Impact Assessment
Program (NAPIAP)
Field Worker
Exposure Studies
EPA (OPP)
Private Sector
(National Pest
Control Assoc.)
Private Sector
(Amer. Mosquito
Control Assoc.)
USDA
EPA (OPP-
National Pesti-
cide Hazard
Assessment
Projects)
Determine impact of
efficacy waiver policy;
info on minor uses;
comparative efficacy
for Special Review
process.
Prioritize Special Review
and Registration Stand-
ards; target ground water
monitoring
Efficacy Feedback
Efficacy feedback; usage
information which can be
used in Registration and
Special Review.
Use and benefits data for
Special Reviews
Registration (label
restrictions, re-entry
intervals) and Special
Reviews
Funded for
FY85 and
to be con-
tinued in
FY86
Funded for
FY85; to
he expai:
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SUMMARY OF OBJECTIVE I:
Assist in Determining Impact of Old (Existing)
Chemicals on Health and the Environment
DATA COLLECTION/GENERATION PROJECTS (CONTINUED)
Project
Descri ption
Applicator
Exposure
Studi es
Responsible
Party
EPA (OPP)
Regulatory
Objectives
Supported
Registration and Special
Review-provide dermal
and inhalation exposure
for risk assessment
Current
Status
Ongoing:
funded for
FY85
Health Effects
and Special
Studi es
Protective
Clothing &
Devices
Dougherty Plains
Field Validation
Study
Ground Water
Vulnerability
Assessment
Ground Water Con-
tami nation Studi es
OPP/ODW Drinking
Water Survey
Data Call-In on
Potential Leachers
EPA (OPP-through
National Pesticide
Hazard Assessment
Projects)
EPA (ORD w/OPP
Support)
EPA (ORD w/OPP
Support)
IJSGS/EPA (OPP)
USGS/EPA (OPP)
EPA (OPP & ODW)
Registrants
Registration, Special
Review, assist in risk
assessments
Registration & Special
Review-determine risk
reduction protective
measures.
Will permit model vali-
dation; useful in deter-
mining likelihood of
groundwater conmination
for Regi stration and
Special Review purposes.
Target monitoring to vul-
nerable areas; assist
label development in
Registration and Special
Revi ews.
Assist in Evaluation of
Results of OPP/ODW Survey;
Registration - to develop
label restrictions for
ground water protection.
Registration Standards,
Special Reviews
Drinking Water Standards
Registration, Special
Revi ews
Ongoing:
Funded in
FY85; to
completed
in FY86
Ongoing;
funded for
FY85
In 3rd
year of
5-year
project
Funded
FY85
for
To be planned
in FY85
Planning
funded for
FY85; Imple-
mentation
S for FY86
pursued.
Call-in
letters
complete;
data arriving
in FY85
and FY86.
-------
SUMMARY OF OBJECTIVE I
Assist in Determining Impact of Old (Existing
Chenicals on Health and the Environment
DATA COLLECTION/GENERATION
Project
Description
Pilot Project:
Reyistrant
Monitoring for
Ground K Surface
Water
ORD Aldicarb
Study
Food Monitori ng
and Surveillance
Surveil1ance
Index Project
Pesticide
Analytical
Manual
Termi ticide
Studies
Responsible
Party
Registrants
ION PROJECTS (CONTINUED)
Regulatory
Objecti ves
Supported
Current
Status
EPA (ORD)
Ai r Monitori ng
Studies
FDA and USDA
EPA (OPP)
EPA (OPP)
Regi strants
OPP (through
Mississippi
State Univ.)
EPA (ORD)
Registration Standards
Special Reviews
Drinking Water Standards
Contribute to Special
Review on Aldicarb
Registration (tolerance
reassessment) and Special
Review (dietary risk
assessment)
Assists FDA in targeting
food monitoring activities
Assists FDA and USDA in
food surveillance
activities
Registration - develop
appropriate labels
Special Review-whether
further restrictions or
cancellation is re-
qui red.
Registration, Special
Review. Will provide
exposure data and models.
Pilot initi-
ating in FYH.5;
Results in
FY86/37
Draft reports
avai1able;
completion date
April 85
Ongoing
Ongoing
funded for FY35;
150 chenicals
done so far.
Ongoing; funded
for FY85
3(c) {?)(•<>
letters i' sued ;
protocols under
consideration.
Ongoi ng; to he
conpletPd i"
FY85
Ir -Srn
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35
OBJECTIVE II
DETERMINE THE
TCTTFR11TT ¥FW
IMPACT OF
REGULATORY
TND/W NE'lf
DECISIONS
WET
Although reexami nation of existing pesticide uses for
registration is certainly a top priority of E^A at present,
the ongoing regular pesticide registration process and other
related new chemical/new use approvals are also of vital
importance to the Agency. The Office of Pesticide Programs
makes about 300 decisions involving new pesticide chemicals,
about 75 decisions concerning new biorationals, and 14,500
decisions on new or amended uses of existing pesticides each
year. In addition, about 400 experimental use permit reviews
and 500 emergency exemption reviews are completed.
The availability of recently revised registration regulations,
data requirements and guidelines helps to ensure that new
chemical/ use approvals by EPA are based on complete, up-to-date,
scientifically sound data. However, while adequate amounts of
good quality toxicity data generally are available to EPA in
making pesticide registration decisions, data on exposure --
the other side of the risk assessment equation -- are not always
required or available for pre-market pesticide decision nakiny.
Monitoring activities can provide the
that can assist EPA's decision-making
i n :
data on exposure
for new chemical/new
uses
0 Development of exposure profiles for chemicals undergoing
registration;
0 Development of labeling restrictions; and
0 Development of permissible residue levels (tolerances'.
To fulfill this objective, EPA is pursuing two general subob
jectives. The first is to further develop existing guidelines
for human exposure monitoring by registrants and to
other possible monitoring requirements of registrar
pesticides. The second subobjective is to develop
for registrantrequired monitoring of new pesiticide
biotechnology. The Agency may also perform some d.
monitoring efforts to cross-check results obtained
and to improve EPA's expertise in this area.
e x p1 ore
; for r\;
• i d e ; i n •
ci c " 1 v e .
i i ate
r e g i s t
f
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III
-------
SUBOBJECTIVE A: REQUIRE MONITORING OF APJJL1LLL_<11EJ1LCAL S
While toxicology data generally are required and available
to support new pesticide/new use registration decisions, a
full complement of exposure data is not always available in
advance of registration. Historically, EPA has relied on
surrogate studies to estimate exposure to applicators, mixers,
loaders, and other workers involved in pesticide applications
where such information is important to assessing risks. However,
actual exposure data are needed to make informed risk assessments
for new pesticides and uses, in some cases.
As a data requirement for registration, or as a condition of
approving a new pesticide or new use, OPP may require that the
registrant conduct certain monitoring studies needed to fully
determine the exposure potential, and therefore the risk, of the
new pesticide or use. OPP has begun requiring monitoring data in
advance of new registrations in some cases (i.e., for pesticide
uses that have the potential for contaminating ground water).
Through the Pesticide Assessment Guidelines, which inform
registrants of acceptable testing methods to use in meeting Agency
data requirements, EPA is developing additional guidance on exposure
monitoring by registrants. For example, Subdivision K of the
Guidelines, concerning field worker reentry, contains exposure
monitoring components (i.e., protocols and requirements). For
Subdivision U on applicator exposure, OPP is also developing
comprehensive monitoring guidelines which will assist registrants
in developing useful applicator and other types of worker exposure
monitoring data. Aside from directly supporting registrations,
monitoring data may also be needed by OPP to support requests for
experimental use permits and emergency exemptions.
In addition to human exposure monitoring data, information
on new pesticide use and usage would also be useful to OPP.
We are considering the possibility of requiring these types
of monitoring as part of the terms and conditions of our
approval of new pesticide/new use registrations. Such a
reporting requirement could help shift the burden of producing
use/usage data to pesticide registrants. Figure V indicates
those types of monitoring information where registrant-required
efforts are currently in effect or being considered,
-------
38
Data on applicator and other
Tfunan a iTd en v f~ronm e nifaT exposures presented by the new
pesticide or use should be developed. Follow-up use and
usage data may also be requested/required.
W_H_Y: These data will permit EPA to better evaluate the
"p~c"t a n t i a 1 risk of proposed new pesticide products and uses, and
to evaluate our decisions on new products/uses in later years.
REGULATORY UTILITY: Exposure/risk data and use/usage data on
new pestTlfides and new uses can:
0 (when requested prior to registration) assist EPA in
evaluating registration proposals, experimental use
permit requests, and emergency exemption requests;
0 (when requested as a condition of approving a proposed
new registration) permit EPA later to verify exposure/
risk assumptions, and make changes in labeling or
registration of a product as needed.
WHO SHOULD COLLECT: Since these data are product-specific
and wouid be used to support or maintain new pesticides and
uses, registrants will be primarily responsible for generating
and submitting them to EPA as needed. EPA will be responsible
for providing guidance in the form of monitoring data
requirements, test protocols, guidelines, etc.
ONGOING/PLANNED ACTIVITIES AND PROJECTS: Related activities
include the foilowi ng:
° Pesticide Assessment Guidelines, Subdivision U-
Pesti cide Appl i cator Exposure^
OPP is developing guidelines for use by pesticide
registrants in conducting applicator exposure monitoring
studies for both indoor and outdoor uses. In developing
these guidelines EPA will determine when studies are to be
required, and will develop protocols for field studies.
These guidelines will provide a useful data-gathering
mechanism for the Agency and will assist registrants
in performing useful studies. The data developed will
be used in exposure assessments for pesticide registra-
tion and review decisions.
-------
39
Pesticide Assessment Guidelines, Subdivision JK -
Fleid Wo rk e r R ee nt ry
These final guidelines contain a model for calculating
reentry intervals and exposure levels. Availability of
this model will serve pesticide registrants and Agency
reviewers in developing and evaluating worker exposure
data submitted in support of registration decisions.
Other Monitoring Requirements for Specific Pesticides
In several cases, OPP has already imposed monitoring
data requirements in connection with the registration of
particular new pesticides. For example, the registration
of Ridomil was accompanied by a monitoring requirement,
related to ground water contamination potential.
Similarly, OPP has informed registrants of aldicarb,
carbofuran, oxamyl , aldoxycarb, carbosulfan and other
pesticides that new registrations will not be issued
in the absence of additional monitoring data indicating
the leaching potential/environmental fate of these
pesti ci des.
-------
40
S'JfiCfiJECT •'•, E 8: RJ OJ~E_CHNOl.r "}
A category of potential new pesticides that are of particular
concern to FPA are the products of biotechnology, that is,
i r"^!3? pesticides which have been genetically altered or
•., ni DU ; -•• . O'J hy hunans. These products potentially offer both
•• i < y s d"C benefits to society. By altering mi croorgani sns to
overcome limitations such as sensitivity to environmental
factors, lack of virulence or potency and limited host range,
biotechnology (e.g., RDNA technology) provides the opportunity
to develop more efficacious and economically attractive pesticides
as an alternative to chemical pesticides. However, these kinds of
manipulation may also warrant concerns with respect to safety.
Subtle changes in host range or virulence could have deleterious
ecological or human health effects. On the other hand, biotech-
nology may also offer the possibility of developing biologically
contained microbial pesticides by incorporating features such as
lethal mutants, antibiotic susceptibility or temperature or sub-
strate dependencies that limit their survival.
No engineered pesticide products have been registered by EPA to
date and no applications for registration have been received.
However, notifications of several planned experimental small scale
field programs have recently been received. The Agency does
not at this time have reason to believe that significant adverse
effects will necessarily occur as a result of small scale field
testing of genetically engineered pesticides. However, The Agency
is taking a conservative approach and screening each notification
received against our adopted interim policy on small scale field
testing of these products. Based on information contained in the
notifications, we will determine whether experimental use permits
(EUP's) are required.
WHAT DATA SHOULD BE COLLECTED: Monitoring Data on the movement,
and fate of the microorganism during field testing should be
developed.
W_H_Y: These monitoring data will enable EPA to better understand
th~e characteristics and potential risks of engineered micro-
organisms, and serve in developing the appropriate data require-
ments for such p;oducts.
-------
0 The description of the monitoring program to accompany
small scale field testing, which is to be submitted to
EPA as part of the initial notification, will help.the
Agency determine whether an experimental use permit
(E'JP) is needed.
0 Monitoring the microorganism during the field testing
program would yield environmental fate and exposure
data vital to the Agency's decision on any subsequent
application for registration.
0 Follow-up monitoring requirements may be developed in the
future and attached to any approvals of registrations for
genetically engineered products, in order to produce data
that would allow the Agency to review and re-evaluate its
registration decisions, and make any needed modifications.
HHO SHOULD COLLECT: Potential registrants of engineered
pesti cides sTi o u 1 d generate the required monitoring data for
their products. EPA should assist in this effort by providing
guidance on acceptable test protocols. The Agency also may
perform some duplicate field monitoring, at least
initially, to cross-check results obtained by potential
regi strants.
ONGOING/PLANNED ACTIVITIES AND PROJECTS
° Interim Policy on Small Scale Field Testing
OPP's interim policy published in the Federal Register
on October 17, 1984, requires a notification procedure which
includes a description of the program for monitoring the
microorganism during small scale field tests. As potential
registrants contact EPA about performing any small scale
field testing, they will be expected to meet this infernal
requirement. Monitoring descriptions provided will help us
to make decisions on proposed small scale field testing.
-------
42
Q. 11A.J3r_P_P^§ASLJL°Li.c_y_ 3e- a rci^ n.9 AerAaJ n.._Ni cr°ki a 1 Product s
The proposed policy published in the Federal Register on
Oecember 31, 1984, reflects OPP's interim policy on ELJP
notification. Concerning data requirements for registration,
c-it proposed policy notes that additional data beyond those
normally required for conventional microbial products may be
required for nonindigenous and engineered microbials on a
case-by-case basis. These additional data could include
environmental fate data, and potentially monitoring
studies, to elucidate the fate of engineered pesticides
in the environment.
Special Studies by EPA
Some cross-check monitoring studies on engineered pesticides
may be conducted by EPA. These would help validate or in-
validate the (potential) registrant's test results and would
thus strengthen regulatory decisions on the products of
bi otechnology.
-------
SUMMARY OF OBJECTIVE II
Determine the Impact of Regulatory Decisions to
Permit New Chemicals and/or New Uses
DATA COLLECTION/GENERATION PROJECTS FOR IMPLEMENTATION UNDER THE
NATIONAL MONITORING PLAN FOR_PESTICJOES
Regulatory
Project Responsible Objectives Current
Description Party __ Supported Status
Pesticide Applicator OPP
Exposure Guidelines
Field Uorker OPP
Re-entry
Guidelines
Monitoring for
Specific New
Pesticides and
Uses
Biotechnology
Interim Policy
on Field Testi ng
OPTS Proposed
Biotechnology
Policy
Pesticide
registrants
Pesticide
regi strants
Pesticide
regi strants
Special OPP
Biotechnology
Studies
Guidelines will permit
uniform data develop-
ment to support regis-
tration and Special
Reviews
Guidelines will permit
uniform data to support
registration decisions
and Special Reviews
Data developed help
determi ne envi ron-
mental fate and ex-
posure from pesticides
uses.
Required monitoring
protocols will permit
OPP to make decisions
on proposed field
testing.
Additional monitoring
data may be requi red
case-by-case; will
permit registration
decisions.
May undertake to con-
firm registrant data,
increase institution-
al knowledge.
Initiated
in FY84;
Draft March
1985.
completed
Requi rements
imposed by
OPP case-by-
case as data
are needed.
In effect
10/17/84
Notice
per
Proposed per
12/31/84 FR
Notice
Antic','.
but n,(-
pi anriPM
JTSd
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Objective 3
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43
D. OBJECTIVE III: MEASURE USER AND INDUSTRY COM P U_A_NCJE
WITH REGULATORY DECISIONS IN'T'HE FIELD
FIFRA is a statute that requires both user and product
compliance. Compliance is measured through marketplace,
producing establishment, use observation, experimental use
permit, emergency exemption, special local need and applicator
compliance inspections. Such inspections develop evidence of
violations through the collection of samples, labeling and
records which can result in civil, administrative and/or criminal
enforcement actions.
Currently, enforcement of FIFRA is delegated to participating
States through cooperative agreements. The States conduct
inspections, take enforcement actions, and certify pesticide
applicators under such cooperative agreements. These cooperative
agreements resulted in over 76,000 inspections in FY 84 conducted
by participating States.
Generally, States do not conduct laboratory inspections/
data audits, import/export, and monitoring of 6(a)(2) adverse
effects reporting. Such inspections are usually conducted by EPA
because States may not have the legislative authority. Also,
States may not be able to receive confidential data submitted by
registrants in support of their registrations.
The Office of Compliance Monitoring operates an information
collection system authorized under FIFRA Section 7. This
section requires manufacturers of pesticides to annually
submit reports regarding the amounts of pesticide products
produced by their registration number. This data is used by
OPP to develop impact and risk/benefit analyses for pesticides.
-------
44
SUBOBJECT1VE A: DETERMINE EXTENT TO WHICH PESTICIDE
USERS ARE IN c0MPLIANCE WITH FIFRA "
'REQUIREMENTS" AT REFLECTED UN PRODUCT
LTB " "
Pesticides are in use constantly by private and commercial
applicators in a wide variety of settings. By law, all such
use must be in accordance with approved product labeling.
EPA relies heavily on labeling as a means of conmunicating
vital precautionary information to users, to ensure safe use.
Information on user compliance with labeling is important to
EPA both fron the standpoint of supporting enforcement actions
and in reflecting the effectiveness of the labeling itself.
States conduct pesticide applicator record inspections to
ensure that certified applicators or individuals under their
direct supervision are using restricted use pesticides in
accordance with their labeling. Also, States conduct inspections
at pesticide dealers to ensure that only certified applicators
are purchasing restricted use pesticides. For Fiscal Year
1984, States through the cooperative agreements conducted
approximately 20,000 applicator recordkeeping and license
inspections as well as approximately 16,000 dealer record
i nspecti ons.
WHAT DATA SHOULD BE COLLECTED: Environmental samples and
documentarysamplesoTapplicator/dealer records regarding the
use and sale of restricted use pesticides.
WHY: To detect and substantiate violations.
REGULATORY UTILITY: These data may provide the basis for:
0 FIFRA enforcement actions under section 12 of
the 1 aw;
0 modifications to existing label statements where
these are unclear or unenforceable;
0 imposition of additional regulatory requirements
such as restricted use classification, CRP,
closed systems, protective clothing, etc.;
0 Modifications to applicator C&T programs;
0 special user advisory or guidance pronouncements.
-------
45
c
0 The States , for EPA.
0 FDA, USDA and DOL have MOU's with EPA for exchange
of information on pesticide use/misuse.
ONGOING/PLANNED ACTIVITIES AND PROJECTS:
° State FIFRA Programs
The FIFRA Cooperative Enforcement Program has some
49 States participating as well as the District of
Columbia, Puerto Rico, the Virgin Islands, Guam,
the Mariana Islands and the Pacific Trust Territories
as well as a number of Indian Tribes.
The States, through priority setting detailed in the
cooperative agreement guidance, establish priorities
for specific problem areas within the State. This
priority setting process enables States to focus
their training, compliance monitoring and enforcement
personnel and resources on specific pesticide manu-
facturing, distribution and use activities which pose
a risk to health and the environment. Any adverse data
generated from such inspections are referred to OPP for
the appropriate regulatory use.
The States may also use such information to further
restrict pesticide use, e.g., ground water restrictions
in Wisconsin. Such information may also be used to
revise Pesticide Applicator Training and Certification
materials developed by the U.S. Department of
Agriculture, Cooperative Extension Service.
° FDA & USDA Tolerance Com pi i a nee Programs
Tolerances for pesticide residues on food and feed
commodities are established by EPA, but enforced by
FDA for most commodities, except meat, poultry and
some egg products, which are inspected by USDA A
commodity with residues in excess of established
tolerance levels, or for which no tolerance is
established, is adulterated and subject to enforce-
ment action, which may include seizure of a shipment.
FDA and USDA sampling programs help ensure co^ ''iance
with tolerances by both domestic and foreign p . Moid-:
users, since tolerances apply to all comnocM
regardless of origin. Information on the ann
results of these compliance sampling program
shared with EPA.
-------
46
EXT: • • ^Jilil^_^Ejjj_cjj)_E
"'^ V/ODUCERS AND DISTRIBUTORS
~~~
B E-G [ LLAl°Al EL0 Li IONS AND POLICIES
• c h> •-} - c i L! d s used in the U.S. and exported to other
1 ". -irf--' from the U.S. are produced by some 8788 pesticide
, --uJijcing establishments. By law, pesticides made avail-
able for use in this country must be registered, as must all
pesticide producing establishments. EPA monitors the pesticide
producing industry to ensure that their practices and products
cc'nply wit.i the requirements of FIFRA.
r : i e States monitor registrant and pesticide producing
establishment compliance by conducting establishment and
marketplace inspections. Pesticide producing establishment
inspections provide EPA with data regarding compliance with
the accepted label and verification of the ingredients in the
pesticide product. Marketplace inspections discover unregistered
products which will either result in the registration of the
product or its removal from the retail channels of trade. For
Fiscal Year 1984 States through the cooperative agreements
conducted 17,456 market place inspections.
States also conduct marketplace inspections to verify
registrant/distributor compliance with State annual registration/
licensing fee requirements. Registrant noncompl i ance with
State regulations can result in stop sale orders being issued
against their products.
MAT_J)ATA SHOUU) JM^COJ-L^CTtD: Pesticide samples from stocks
reTeased for sVrpment .
To detect and substantiate violations.
LL_ILY: These data may provide the
__
b a s i s f o r":
State regulatory actions for non- r egi st rat i on such as
stop sale orders issued against products whose
reg i st ran t/ ,1 i st r i bu tor did not pay the State registration/
licensing fee.
FIFRA enforcement actions under sections 12.
Registration decision-making as described under Objective
I of this plan.
-------
47
0 The States , for EPA
ONGOING/PLANNED ACTIVITIES AND PROJECTS :
° State Programs
The States monitor industry compliance with FIFRA
through marketplace and pesticide producing establish-
ment inspections. Such inspections result in the
collection of samples of pesticide products and their
labeling. Labels are compared to the most recent
accepted versions to assure that products bear the
most up-to-date directions and precautions.
The States also analyze samples to verify that the
active ingredients claimed on the label are actually
in the product at the percentage stated, and that no
other ingredients are contaminating the product.
Cross-contamination of a pesticide product can indicate
manufacturing or formulation problems that may trigger
other regulatory actions by OPP.
Discrepancies between accepted and actual pesticide
labeling or active ingredients can result in civil,
administrative and/or criminal enforcement actions.
° Federal Programs
EPA conducts the Compliance Monitoring program in
Nebraska. This program is essentially the same as
the State Cooperative Enforcement discussed previously.
-------
JilC'i iVe C: H i TERM I NE QUAi. I A Hi) VALIDITY OF DATA
" iUBfflTTElT I? " ;i'P' "
s pe-jiici'ie regulatory decisions are only as good as
'•'':• b.. • i" t. • v' by industry concerning the properties
hese c Mfi-ri ca l s , To insure a sound regulatory program, it
s ?* .:• i •' '• "• 1 th..i, pesticide laboratories follow good practices
produce data of high quality to support pesticide registra-
>- States Jo not conduct Laboratory Inspection/ Data Audits,
EPA does. The Office of Compliance Monitoring coordinates
v;ith OPP, 0 T S, and certain other agencies in conducting
Laboratory Inspection/Data Audits. For FY 84 EPA conducted
approximately 90 Laboratory Inspection/ Data Audits.
WHAT DATA SHOULD BE COLLECTED: Results of Good Laboratory
Practice (GLP) inspections and data audits that validate or
invalidate studies submitted to the Agency in support of pesticide
regi strations.
WHY : To determine compliance with the EPA GLP
regul at i ons published in the F_R on November 29, 1983,
and to insure that study reports submitted by labs/
registrants to EPA can be supported by the raw data.
REGULATORY UTILITY: These data may provide the
"bTsTs ToTl
0 enforcement actions against labs and/or registrants;
0 reconsideration by OPP of previous registration/regulatory
decisions on particular pesticides, including potentially
requests for additional or replacement studies,
registration/tolerance reassessment, and imposition of
additional use restrictions or cancellation of product
registrations/revocation of tolerances.
0 validation of studies which will be submitted (ongoing
studies are audited/inspected);
0 assurance that data which the Agency is requiring to
be developed is being developed on schedule.
-------
49
WHO SHOULD COLLECT: In December 1983, the Office of Pesticides
and Toxic Substances (OPTS) established the Office of Compliance
Monitoring (OCM) as the management focus for laboratory
inspection/data audit activities under both FIFRA and TSCA.
Thus, OCM plans annual inspection/audit activities in coordin-
ation with OPP (and OTS for chemicals not used as pesticides) and
also coordinates with FDA and the National Toxicology Program
(NTP) through interagency agreements in order to utilize
federal resources effectively.
0 OCM conducts laboratory inspections to verify compliance
with the Agency's Good Laboratory Practices (GLP)
regulations under FIFRA and TSCA.
0 OPP and OCM conduct audits of specific studies to
determine validity of data submitted to the Agency in
support of pesticide registrations.
0 FDA also inspects laboratories to determine compliance
with their GLP regulations, which are substantially
similar to FIFRA GLP requirements. FDA's reports are
available to EPA. FDA, on request, reviews actual
pesticide studies during inspections.
0 NTP is available on an as-needed basis to provide scientific
expertise in conducting data audits.
ONGOING/PLANNED ACTIVITIES AND PROGRAMS: Since the reorgani-
zati on mentfoned abovelTFTe 1 a b inspection/data audit program
for pesticides has significantly increased over previous
years. For example, the target of 60 pesticide inspections/
audits for FY 84 was an increase over 45 the previous year,
and the target was actually exceeded, with over 90 inspections
and audits accomplished. For FY 85, 76 pesticide inspections
and audits are planned. This is believed to be a realistic
figure in terms of resources available. This level of in-
spections and data audits appears to be adequate to ensure
periodic inspection of major testing facilities, and there is
leeway in the system to provide for targeting a specific
laboratory and/or study on a "for cause" basis if the need
arises. The Agency is not planning to revise the current
inspection/audit program, but rather to gain experience with
the present, relatively new system.
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50
It should be noted that Laboratory Inspections/Data Audits
are conducted by EPA personnel at both foreign and domestic
laboratories. All data submitted to EPA must adhere to -the
Agency's Good Laboratory Practice procedures (GLP's). All
"t-'jdy data submitted to OPP must have a certification signed
by the registrant, the sponsor, and the study director in-
dicating that the study:
1. was conducted according to the GLPs; or
2. was not conducted according to the SLPs and outlines
those areas that differ and why they differ; or
3. may or may not have been conducted according to the
GLPs because the submitter was not the sponsor of the
study (for example, the submitter is a subsequent
registrant relying on a study sponsored by a previous
regi strant) .
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51
SUBOBJECTIVE D: DETERM I NE EFFECT I VENESS OF THE _P_E!ST I_C I_D_E
APPLICATOR CERTIFICATION' AND TRAINING'
TTT& T)
FROM POTENTIAL HAZARDS" OF RESTRICTED USE
Since the 1970's, EPA has been restricting by regulation
certain pesticide product uses to certified applicators or
persons under their direct supervision, under the authority
of FIFRA Section 3. The Agency has also implemented an
extensive applicator certification and training program,
largely through the States, under FIFRA section 4. More
recently, OPP has begun classifying certain pesticide uses
for "restricted use" through the registration standards/
reregi strati on process. Products are being restricted based
on chronic as well as acute toxicity hazards. Thus, there is
an increasing need to determine the effectiveness of the
certification and training program in educating applicators
about safe use of the more highly toxic, restricted use
pesticides.
WHAT DATA SHOULD BE COLLECTED : Data on the incidence of use
versus ~TfTe m i s u s"e cff rest net e d use pesticides.
WHY : To determine the extent to which restricted use pesticides
are misused as compared to unrestricted pesticides to determine
if the training of pesticide applicators results in fewer
pesticide misuse incidents. Such data will assist the States
in assessing and possibly revising their current C&T Programs.
REGULATORY UTILITY: This information may provide the
Fa si s for:
0 modifications in the State certification and
training programs;
0 modifications in pesticide label language to
increase its clarity, effectiveness, enf orceabi 1 i ty ;
0 further regulatory actions for some pesticides, if
restricted use classification is not effective
in protecting users and/or the public.
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52
EPA through the Regions, States, or a university
or private contractor.
ACTIVITIES AND PROGRAMS :
The FIFRA cooperative agreement program for Pesticide
Applicator Certification and Training has essentially
the sane participants as the enforcement program.
The annual cooperative agreement guidance requires the
States to establish priorities for the certification and
training program. These priorities could result in the
addition of new categories for pesticide applicators
as well as new or revised training to address problems
relating to the use of restricted use pesticides.
Any changes in the classification of pesticides will
require close cooperation and coordination between
States and the Agency to assure that pesticides which
are chronically or acutely toxic are applied by
applicators who have received adequate training under
the C & T program.
For FY 85 the Agency, in cooperation with the States,
will review the C & T program as it relates to training
applicators who have been trained to apply acutely
toxic pesticides but now may apply chronically or
environmentally toxic pesticides. This review will
provide data needed to assess current C & T programs
and suggest modifications if necessary.
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SUMMARY OF OBJECTIVE III: Measure User and Industry Compliance with Regulatory
Decisions in the Field
OATA COLLECTION/GENERATION PROJECTS FOR IMPLEMENTATION UNDER THE
NATIONAL MONITORING PLAN FOR PESTICIDES
Project
Description
Responsible
Party
User Compliance
Programs
Food Tolerance
Compli ance Program
Manufacture ng/Formu-
lating Compliance
Programs
Lab Inspection and
Data Audit Program
Applicator
Certification and
Training (C&T)
Programs
States
FDA and USDA
States
(EPA for
Nebraska)
EPA, FDA,
Assistance from
NTP
EPA with States
ReguTatory
Objectives
Supported
Determine extent of user
compliance with product
labeling; need for
additional regulation.
Determine compliance
with tolerance require-
ments; need for additional
regulation.
Ensure producer/dis-
tributor compliance
with FIFRA regulations
Ensure submission of
valid data by registrants
Determi ne extent of mi suse
of restricted pesticides
for possible modifications
of C&T programs, labeling
or regulatory status (i.e.,
continue registration or
cancellation).
Current
Status
Ongoi ng
Ongoing
Ongoing
Continued
expansion
in 1986
Ongoi ng
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Objective 4
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53
OBJECTIVE IV: DETERMINE TRENDS OF PESTICIDES IN THE
'ENVIRONMENT TO TVALUATE PROGRAM E'FFE C T I V E N ESS
(ENVIRONMENTAL RITU1TS)
PROBLEMS
Although monitoring activities are often related to specific
pesticides, one of the basic objectives served by a multifaceted
monitoring program is to provide a broad picture of human and
environmental exposure to pesticide chemicals. Monitoring for
trends in different environmental media serves two general
purposes for regulatory decision making. First, gathering in-
formation about pesticide exposure in a variety of human and
environmental media can help to identify an emerging, and perhaps
unanticipated mode or magnitude of exposure to pesticides, and
thus, alert decision makers to the need for action. In addition
to "flagging" potential problems, monitoring of a variety of media
is important to measuring the actual environmental results of past
regulatory decisions. The environmental results of some actions
may not be fully played out for years after a decision, and may
involve unexpected consequences that could be important to planning
future regulatory strategies.
There are several significant limitations on the Agency's ability
to pursue a broad approach to monitoring the ambient environment.
One obvious constraint is cost. The Agency can not realistically
expect resources to be available for every type of monitoring
activity that could generate information ideally desirable to have.
Therefore, EPA must exercise responsibility to allocate monitoring
resources to give the most cost-effective support to regulatory
deci si ons.
The cost problem is particularly acute for ambient (or general
trend) monitoring because the strategy of shifting the burden to
the private sector is not always available as an option. As noted
throughout this plan, registrants have an obligation under the
FIFRA to provide EPA with data adequate to show their products
do not pose unreasonable adverse effects. Thus, EPA can use
the legal authority of FIFRA to require some chemical-specific
monitoring. However, this approach is not always available
in relation to ambient monitoring of air, soil, water, or animal
and human tissues. For example, the occurence of residues can
not always be associated directly with specific uses of pesticide
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54
product1;, and residues in the anblent environment may include a
variety of pesticides simultaneously, including cancelled
peLsticides for which there is no responsible registrant. Thus,
identifying other governmental or private organizations-involved
in monitoring activities is particularly important to gathering a
• "•ft-| ^ :" ? c *.. c u m of ambient monitoring data.
Another fact to recognize about the Agency's monitoring needs in
general is that pesticide use has evolved over time, so that new
techniques and strategies for monitoring are needed in order to
evaluate new generations of pesticide products. Historically,
concern about pesticide residues in the environment was directly
linked to the extreme persistence of chlorinated hydrocarbon
insecticides, such as DDT, aldrin, dieldrin, chlordane, and
heptachlor, and monitoring activities were directed at these
compounds. These compounds are relatively easy to detect, and
trends for the environmental burden of this group of pesticides
are generally well understood. However, these chemicals have
been largely taken off the market in the past decade, and have
been replaced by different classes of chemicals. Today, we need
to assess the impact of newer types of chemicals, such as bio-
rat i o n a 1s and synthetic pyrethroids, many of which are not as
persistent or simple to detect. A whole new generation of genetic-
ally engineered pesticides may also be entering the market in the
near future. Thus, in approaching the objective of monitoring for
trends in various environmental media, the Agency faces the
challenge of developing innovative methods and strategies for
choosing what and how to monitor in order to get an accurate
picture of the impact of pesticides as currently used.
As indicated by Figure VI, this objective involves nearly all
types of monitoring information. These have been organized into
four subobjectives: identify trends in the use of chemical or
non-chemical approaches to pest control; advance general under-
standing of worker exposures to pesticides; track trends in
general pesticide contamination (including human body burdens);
and document pesticide related illness and other incidences of
harm.
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SUBOBJECTIVE A: iTBiy_SH_IJNF1ATI_^ N^NDJ^T I_N G_T_R_E_N D_S_I_N
PP° AC H
As a result of pesticide regulatory decisions by EPA and
other market factors, patterns of pesticide chemical and non-
chemical use have changed over a period of years. For example,
while chlorinated hydrocarbon pesticides were widely used
during the 1950's and 1960's, Federal regulatory actions and
the availability of newer organophosphate pesticides and IPM
techniques effected a shift in use to those newer compounds
and strategies during the 1970's. OPP believes it is valuable to
monitor pesticide use and usage in order to determine broad trends
in the use of pesticides and other pest controls over time. Such
data would be useful in illustrating the social and environmental
results of Agency actions, in indicating trends in EPA's regulatory
influence, and in predicting the effects of emerging new pest
control technology and agricultural practices.
WHAT DATA SHOULD BE COLLECTED: Use and usage data, focusing
on individual chemicals, clusters of pesticides by use patterns
(for example, fumigants or nematocides) , or particular
agricultural comnodities/crops or other use sites. These
data should be collected and evaluated during a five to ten
ye a r period.
_ These monitoring data nay be analyzed to determine trends
iri~the amount and frequency of use of particular pesticides
and other pest controls.
!LG_ULAL!liY UTILITY: These time-related use/usage trends data
may be used by U'P'P" to:
0 provide a basis for requiring or conducting additional
monitoring or health effects studies to determine the
consequences of use of substituted pesticides/pest controls;
0 evaluate and if necessary adjust previous pesticide
regulatory decisions;
0 identify situations in which further regulatory action
on a previously regulated chemical, or entirely new
regulatory action is needed;
0 guide future regulatory decisions.
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56
__ COLLECT: EPA, in cooperation with USDA and/or other
agencies, fhrougTi "agreements with private groups or through a
contractor, should collect these data.
ONGOING/PLANNED ACTIVITIES AND PROJECTS: Although EPA collects
pesticide usage data" from a variety of sources including other
agoncies, private subscription data bases, and registrants (as
listed in Objective I. A), there is no project at this time to
compare and evaluate broad pesticide use/usage patterns over time
OPP will develop such a project in the near future.
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SIJBOBJECTIVF. B: A DV_A N C E _SE_NE_R_AL_ JJ NO_E_R_SJ A_ND I N G J3_F A G_R_I_CJJJ-_TU R A L
AND _0_T H\R_ _WO_R_K ER JE X PO S_tf R_E__S" TO _P_ETn_C I D E_S
There are thousands of individuals who are exposed to
pesticides through their work, particularly in agriculture.
These include mixers, loaders, fanners, pest control operators,
and farmworkers. Some of these invidivuals are exposed when they
reenter a field sprayed with pesticides to harvest, crops. Deter-
'Mining the risks to those occupation ally exposed to pesticides
is an important component to regulating existing and new chemicals
Monitoring general trends in worker exposures to pesticides is
therefore a critical part of this objective.
KH AJ_ _DAT_A A!IQ1LL_P_ A*L cAk LE_CJJLP : Baseline data on exposures to
pesticides by applicators and farm workers should be expanded
to include a wider variety of field situations, groups at risk,
and application technologies.
W_H_Y_: Such data will help the Agency identify problem exposure
situations and assist in learning of the actual consequences of
EPA registration and regulatory decisions.
iLLLLII1 Based upon the data gathered in this
category, the Agency may:
0 reexamine existing pesticide registrations and product
1 abel ing;
0 act to restrict or otherwise modify existing registrations,
or to amend product labeling;
0 explore broader remedies such as child resistant packaging,
closed systems, or protective clothing requirements;
0 improve labeling, use restrictions, conditions of use
for new products and uses "up front," that is, during
the registration process preceeding market entry.
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58
0 OPP - has the lead responsibility for collecting and
developing data on pesticide applicator and farm worker
exposures.
0 ORD - as EPA's research lead, it plays a key role in
performing needed exposure- rel ated studies, developing
needed test methods, etc.
0 Department of Labor (DDL) - has worker protection
responsibilities which are similar to and sometimes overlap
with EPA's user protection responsibilities under FIFRA.
DDL shares our concern with health impacts on workers who
comes into contact with pesticides.
0 Universities - seven are part of the National Pesticide
Hazard Assessment Program (NPHAP) which is conducting special
exposure/health effects studies under cooperative agreements
with EPA; a number of these studies concern worker exposure.
The NPHAP is more fully described in Subobjective D: Docu-
menting Pesticide-Induced Illnesses and Other Impacts.
ONGOING/PLANNED ACTIVITIES AND PROJECTS: Several key activities
are in progress To monitor trends in agricultural worker exposures
to pesticides.
° Exposure for Crops Other Than Tree Fruit
The Agency has developed a model for Subdivision K of the
Pesticide Assessment Guidelines (see also Objective II. A)
which correlates dislodged residues with field worker
exposure based on data obtained during the picking of tree
fruit, since this is generally perceived to be the highest
exposure situation. The Agency does not currently have a
method for setting reentry intervals in less hazardous
situations. Data are being developed on other crops/tasks
so that worker exposure may be predicted for situations
other than the "worst case."
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Compl eti on
Final reports from this project, which was conducted
under an E P A / D 0 L interagency agreenent, are being review-
ed. This review will determine what work must be done to
produce a summation of pesticide exposure of juvenile
workers during agricultural operations. From the summation,,
recommendations will be made as to measures that
should be taken to protect children in agriculture.
ULV A p p 1 i cat i o n F i e 1 d^w_o r k e r E_x_P_p_s_u_r_e St_u d_y_
Use of ultra low volume (ULV) pesticide formulations/
applications is increasing. The greater efficacy
and longer duration of effective pest control
attributed to ULV applications suggest that fieldworker
exposure may also be greater than after use of other
formulations. Reentry intervals established with
other pesticide formulations nay not be effective for
ULV formulations. OPP is developing a method to
quantify dislodgeable pesticide residues after ULV
application and will apply that methodology for
monitoring fieldworker exposure to residues from ULV
application.
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60
S 'J 4 0 8 J E C T I V E C : TRACK TRENDS _IN GENERAL 0 R _AHB IJN_T
ENVIRONMENTAL CONTAMI NATIO~N
TK« i.erni "ambient monitoring" should be clarified in
?".m's context. In general, this term is meant to distinguish
'Between monitoring aimed at evaluating the occurrence of
pesticides in a particular medium (e.g., human tissues),
as contrasted with monitoring for a particular chemical.
In practice, these are not wholly separate types of
activities. Monitoring for a specific chemical is generally
conducted in a selection of media; for example, EQB residues
are monitored in stored grain and ground water, where they
are likely to occur, but not in wildlife species where there
is virtually no possibility of exposure. Similarly, a project
aimed at ambient monitoring in purpose, such as ground water
monitoring, must usually select for analysis specific pesti-
cides with some recognizable potential as contaminants,
because there is no "all purpose" analytical method for
chemical detection. Thus, "ambient monitoring" is not a
rigid category, and some of the projects listed under Ob-
jective I, pertaining to existing pesticides in ground water,
food and feed commodities, and indoor air are ambient monitor-
ing as well as chemical-specific evaluations.
In conducting ambient pesticide monitoring activities
and in documenting the occurrence of general pesticide exposure
problems, OPP will focus in part on those pesticides for
which some regulatory action has already been taken (that is,
pesticide uses which have been restricted or cancelled).
Specifically, we will record trends in the residue levels of
those pesticides in humans and environmental media, and in
the incidence of related accidents and illnesses. These
trend data will illustrate the environmental results of OPP's
past regulatory actions, and nay provide the basis for further
evaluation of the pesticides in question.
OPP will also initiate appropriate follow-up monitoring
activities as decisions to restrict, cancel or continue
pesticide uses a^e reached, through special reviews or other
risk/benefit evaluations. Pesticide registrants will be
responsible for conducting such monitoring for proprietary
chemicals, while EPA and/or cooperating agencies or organizations
will conduct needed environmental results monitoring in other
cases.
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61
W_H_AT__Dj\JA SHOULD BE COLLECTED: Data on pesticide residues
o c c u r r i rTg fh appropriate environmental media (such as human
tissue, soil, water, air, wildlife, etc.)
___ These mentoring data will enable EPA to chart trends in
"Fe~s~idue levels and in other health-related parameters, and
determine whether intended health and environmental results
of regulatory decisions are being achieved. The Agency also
needs such data to "flag" unanticipated or emerging health or
environmental problems involving pesticide exposure.
R E GUL ATO R Y U T I LI TV : These trend data on ambient env i ronnent a •
occurrence of pesficides will provide the basis for:
0 regulatory decisions or modifications of previous decisions
as necessary to achieve desired risk reduction/health and
environmental results (including potentially additional use/
label restrictions, tolerance revocations, cancellations
suspensions, or enforcement follow-up investigations);
0 identification of successful cases where trend data show
that desired environmental results, e.g., reduced exposure,
are being achieved. This information will be useful in
tailoring future regulatory decisions where similar conditions
are presented and similar results are desired;
0 identification of unanticipated or emerging problems to ale ft
the Agency to the need for closer evaluation of a s i t u a * i o n .
or regulatory action to deal with a new pesticide expos.-1"'"
situation.
MHO SHOULD COLLECT: EPA, in cooperation with other Fed era!
a n d STaTe agencies, universities, contractors, etc., will
collect most of ambient data for past regulatory de : i c i ons ,
However, as decisions on proprietary chemicals are r.aoe in c
future, pesticide registrants will be required to L o n d j c t f o
t rends /envi ronme ntal results monitoring activities,
ONGOING/PLANNED ACTIVITIES AND PROJECTS: The following
moni to~r i ng act vvTtTes a r e uTufe r w ay t o "" f 1 1 u s t r a t e environment1
results, or could be undertaken/adopted to pic-.d- . rv
data on regulated pesticides.
° Develop inventory of all __ p e s_tj_c i_c_e_jr^ej_a_t_e_..._ _ji o n : i -• i_n g
The Agency should inventory all potentially i
monitoring activities be'irg pursued in otne-
E P A , the States, and other F e d f •• , ! age , ',
assist efforts to "piggyback" p-:.ticice o--> . .
needs onto existing projects through c c o n e '.-.-/
agreements or other means, and to influence :=
being conducted already. This importer'. ; n • t M -.
to establishing coordinated e s f :• r t s w :, ': h o t •• e •. p .
and agencies should !. •: '-."^ > •--.*;*• • " " "• r-«"
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62
Residues^ in__H_un_an_ A_d_i pose Tissue
OPP has participated with OTS's National Hunan Adipose
Tissue Survey (NHATS), which maintains collections
of tissue speciments. Over a period of 10 years this
project has provided data on residues of a number of
pesticides, primarily cancelled chlorinated insect-
icides, OPP can arrange for analyses of old or new
pesticides of concern with OTS to further utilize this
data resource on human exposure.
Blood Sample Network
In FY 1985, OTS is designing a program to collect blood
samples from existing sources such as Red Cross blood
banks. Samples will be analyzed for various industrial
chemicals. OPP will evaluate this approach, to see whether
pesticides can be included in the analyses of samples.
Blood may be a useful medium to test in addition to
adipose tissue, since different pesticides or effects
may be detected.
Hispanic HANES
The Department of Health and Human Services conducts
this ongoing Health and Nutrition Evaluation Survey
(HANES) of the Hispanic population. OPP is generating
pesticide exposure data by analyzing blood serum and urine
samples collected in this survey. These data provide general
exposure information about the Hispanic population's
exposure to pesticides of past and present regulatory
i nterest .
NHANES III
A National HANES project is scheduled for 1988 by the
Department of Health and Hunan Services. OPP is investiga-
ting the utility of this survey to provide additional data
on human exposure, through access to human samples which
EPA woul d analyze .
Special studies by FDA to show EDB food residue levels
are being completed this fiscal year.
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63
T e r m1 tic ides Studies -
The field monitoring data gathered by OPP and pesticide
registrants will help define the current human exposure t;;
selected termiticides and provide information on environmen-
tal results of EPA's past decisions on termiticides.
S e 1 e c t e d R e s i d u e s i n F o o d -
FDA conducts prepared food residue studies developed through
the Total Diet/Market Basket Surveys (described nore in sub-
objective 1-D above). OPP is analyzing these data to chart
trends in levels of regulated pesticides in foods, so that
environmental results in terms of dietary exposure may be
k nown.
Residues in Birds and Freshwater Fish -
At OPP's request, USDI (FWS) is providing the results
of their on-going studies on residues of pesticides of
interest to OPP in migratory and non-migratory birds an-J
freshwater fish. OPP is analyzing these data to determine
environmental results of past regulatory decisions on
selected pesticides.
Oj;_h_e_rjs -
As OPP piggybacks onto other existing ambient monitoring
programs, develops partnerships with other offices and
agencies to cooperatively develop trends data, or initiate<
relevant monitoring activities of its own, analyses for
specific pesticides of interest can be included. To cite
one example, OPP will be exploring the possibility of
utilizing the existing Environmental Radiation Anbient
Monitoring System (ERAMS) to collect environmental sample; to:
pesticide analysis.
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64
SU808JECTIVE D: DOCUMENT THF OCCURRENCE OF PESTICIDE-INDUCED
"ILLNESS A~N\)~
Trends in the health status of the U.S. population are
j;i important indicator of the impacts of past regulatory
decisions on pesticides. Similarly, trends on other organisms,
particularly fish and wildlife, are also important in evaluating
the effectiveness of EPA's pesticide regulatory actions. Data
documenting the occurrence of pesticide-related illnesses and
other impacts can also help EPA identify emerging pesticide use
and exposure problems. Thus, monitoring activities to determine
the extent of pesticide exposure problems as evidenced by
related illness and other harmful effects are an important aspect
of the National Monitoring Plan.
HHAT DATA SHOULD BE COLLECTED: Baseline data on accidents
and illnesses, health effects, and exposures among the general
public and certain segments of the U.S. population (i.e., farm
workers or communities with likely high exposures) should be
developed. Data on environmental impacts particularly to fish
and wildlife also need to be developed.
WHY: These data will permit the Agency to identify trends in
pesticide-related health impacts among the U.S. population,
impacts on the environment, particularly wildlife, identify
problem exposure situations, and in general, clarify the actual
health and environmental consequences of EPA's registration and
regulatory decisions.
REGULATORY UTILITY: Data on pesticide-rel ated human illness and
environmental impacts may provide the basis for:
0 reexamination of existing pesticide registrations and
product labeling;
0 actions to restrict or otherwise modify existing
registrations, or to amend product labeling;
0 broader remedies such as child resistant packaging,
closed systems, or protective clothing requirements;
0 improved labeling, use restrictions, conditions of use
for new products and uses "up front."
In general, data on illnesses and incidents are of primary
use to OPP for developing registration standards and conducting
special reviews because they contribute hard evidence to the risk
side of the risk/benefit equation. These data may also be of use
to other programs and agencies concerned with chemical-related
health impacts and trends.
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0
65
OPP has the lead responsibility for collecting and
developing data on human illness and impacts relating
to pesticides.
Department of Interior has prinary responsibility for
the protection of fish and wildlife.
National Ocean and Atmospheric Administration has
responsibilities for the health of n a r i n e fisheries, and
certain aquatic endangered species.
Universities - seven are part of the (NPHAP) described
below, and are conducting special exposure/health effects
studies under cooperative agreements with EPA.
QM9JL.NG/JLLA-ME1 A£LLV_LLIL5.J^D_JL^1EJ±LS: EPA wi11 continue to
collect data on pesticide illness incidents throughout the
country as well as conduct more specific studies of localized
pesticide health problems. EPA will also be exploring possibil-
ities for tracking harmful effects to wildlife. Specific
efforts include:
° P_esti ci de E x p o s u r e I n c i d e n t s - Current _Ac_tJ_v i_t_i_e_s_ -
OPP's NPHAP project at Texas Tech University includes
the National pesticide Telecommunications Network. This
is a twenty-four hour hot-line which provides an emergency
response mechanism to address inquiries concerning the
diagnosis, nanagernent and treatment of pesticide related
po i soni ngs .
OPP headquarters staff includes a Pesticide Incident
Response Officer who can be contacted to utilize the medical
and laboratory capabilities of the various NPHAP projects
and cooperators to provide medical and analytical consulta-
tive support in relation to pesticide incidents.
OPP continues to work with States through AAPCO to promote
the collection of pesticide incident information by the
States.
° P_esticide Exposure Incidents - Fut_ure Acti vi t. i es
Collecting good statistical information on the occurrence of
pesticide-related incidents nationally has proven difficult
in the past, but continues to be a matter of interest and
concern for EPA, Congress and the public. The Agency's
former Pesticide Incident Monitoring System (°IMS), which
relied primarily on voluntary reporting of incidents was
unsatisfactory in many ways. OPP is now evaluating the
utility of two existing statistical surveys which are receiv-
ing some EPA support now. These are Colorado State University
Hospital Study of Acute Pesticide Poisonings, and the 0 o n s u r. • i
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66
Product Safety Commission's 'CPSC's) Emergency Room
Survey. GPP will det r^nne whether these two surveys
should be modified or a new statistical design be
developed to satisfy the need for better data on pesticide
i ncidents.
tlJd es
Operating through the National Pesticide Hazard Assessment
Program (NPHAP), with projects located at seven univer-
sities throughout the U.S., OPP has the unique capability
of planning, conducting and evaluating national and local
exposure/health effects studies at minimal cost. Examples
of studies that may be funded in FY 85 include Heptachlor
in Mother's Milk (Hawaii), Monoclonal Antibodies (Texas),
and Immunoassay for Field Exposure to Paraquat (Cal.).
The data produced through these special studies will
enable OPP to study exposure trends and the impacts of
pesticide regulatory decisions and Programs on health and
safety, and may provide the basis for regulatory modifi-
cations where necessary.
SJUuJ_y_ t h_e f easi bi_1 i_ty of d eve loping a new approach
To~m~o n i tTo r in g for envi ronmenfa 1 irrrp~a~cts
The Agency needs better information on the effects of
current pesticide use, particularly in reference to fish
and wildlife effects. Current monitoring data on wildlife
is generally limited to reporting trends in residue levels
in tissues, which is of very limited utility; residue
levels in themselves do not demonstrate the occurrence or
absence of adverse effects. There is no regular source
of information on actual environmental effects such as
changes in populations, survivability or behavior. Such
data are clearly relevant to risk/benefit decisions on
pesticide uses. The Agency needs to consider possible
avenues for obtaining such data. A feasibility study
should be undertaken during FY 1986, and if appropriate,
a pilot program be undertaken or planned for the following
year. This work could lead to the development of protocols
for registrant required monitoring of pesticide impact on
non-target species.
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SUMMARY OF OBJECTIVE IV: Determine Trends of Pesticides in the Environment to
Evaluate Regulatory Decisions (Environmental Results'
and to Identify Unanticipated or Emerging Problems
DATA COLLECTION/GENERATION PROJECTS
Project
Description
Responsibl e
Party
ReguTatory
Objectives
Supported
Current
St atus
Chetni cal/Non-
chemical Use
Trends Study
Fi eldworker
Exposure
Studies
EDB in Grains
Selected Residues
i n Food
Termiticides
Studi es
Selected
Residues in
Birds and Fresh-
water Fi sh
Selected Residues
in Human Adipose
Tissue (NHATS)
Hispanic HANES
NHANES III
Human Illness
Monitori ng
Health Effects
and Special
Studi es
OPP
OPP with DOL
FDA
FOA
OPP, regis-
trants, Missi-
ssippi State
University
USD I (FWS)
OPP and OTS
HHS
HHS
To show use/usage trends
resulting from regulatory
decisions (environmental
results).
To implement and improve
re-entry exposure model
needed for registration
and reregistration
deci sions.
To provide trends, environ-
mental results data on EDR.
To be punned
in FY'-JS
Projects
funded and
underway in
Funded in FY 5>b
To show environmental results Funded .md
of previous decisions. underway in
FY85
To show environmental
results of previous
regulatory decisions.
To show trends, environ-
mental results of previous
regulatory decisions.
To show trends, environ-
mental results of previous
regulatory decisions.
To obtain health trends
data for particular
pesticides.
To obtain additional trends
data on regulated pesticides.
Funded and
underway in F>'8
Funded and
underway i
FY85
-"undo; -rv
underw.'i/ ~
OPP with CPSC To provide accident/incident, -;eii'f: 'runc
and/or Colorado trends data; show results >j.< f~r
(7 universities) trends; show impact of regu-
latory decisions; support
RS/Special Reviews,
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Implementation
Establish And Maintain
Data Systems
Provide Quality
Assurance
Provide Federal/State
Guidance & Coordination
Provide Registrants
With Guidance
Provide Public Access
To Information
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III. I_M_P L_E_ME_NT A T I OJN
In order to implement a comprehensive, effective national
pesticide monitoring program, EPA must undertake certain
basic activities and provide certain support functions. The
areas discussed in this section of the National Monitoring
Plan, while not directly supporting particular regulatory
objectives, together will serve to ensure that a coordinated
Federal pesticide monitoring program is established resulting
in the production of high quality data that are readily
available to EPA and all other parties who need such informatio
A • ESTABLISH AND MAINTAIN DATA SYSTEMS
As the new pesticide monitoring data outlined in this
plan are developed by EPA, registrants and others, it is
essential that the Agency have in place appropriate mechanisms
for managing and using this information and providing access to
it. In order to successfully use the exposure information
generated to enhance EPA decision making on pesticides, OPP
will develop specific mechanisms to receive, store, evaluate,
and disseminate the additional information. These will
include primarily the adaptation of data systems to effectively
handle existing monitoring information and the additional
exposure data to be generated. These data systems will make
the information gathered readily accessible for risk assessment
and regulatory decision making within OPP, and will ensure
timely and appropriate dissemination of monitoring and use
information to other EPA programs, States and other interested
parties outside the Agency.
* • EJ e c t r o n i c Bull eti n Board
The National Monitoring Plan calls for greater use
of externally-generated data in pesticide regulatory
decision-making. To do this successfully, OPP must be
able to track ongoing pesticide monitoring activities
performed externally.
OPP is in the process of establishing an "electronic
bulletin board," which will consist of an automated
listing of ongoing pesticide monitoring activities
sponsored by OPP, other EPA program offices, and other
Federal, regional, and State agencies. The listing will
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be updated twice yearly to share information about
pesticide monitoring activities among the cooperators
and encourage data exchange among the various
organizations with pesticide regulatory responsibilities
An existing data system will be used to ensure early
completion and availability of the bulletin board. This
listing will be available as printed material and in
electronically-accessible form.
OPP has begun to thoroughly investigate use of various
data management systems to handle monitoring data. OPP
hopes to be able to set up several files to store the
additional exposure information to be generated under
this plan. There is a need for mechanisms that will
significantly increase the accessibility to those data
not considered proprietary and provide access to graphics
and statistical package capabilities. These data systems
need to include quality assurance parameters with
each record so that all OPP human and environmental
exposure information will be of a known quality. EPA's
STORET system, as well as microcomputer capabilities are
being considered in the light of these needs.
3 . I n yen t o ry o f Reg i s t r a n t - Imposed Stud ie s
In order to track the development and completion of
pesticide monitoring studies required by OPP of pesticide
registrants, the Program will establish and maintain an
automated inventory or file of registrant- imposed studies,
This system will be similar to and will complement the
electronic bulletin board.
B . PROVIDE QUALITY AsAuJLA_N_Ai
Regulatory decisions in EPA are as good as the data upon
which they are based. To assure high quality data, the Agency
has instituted a mandatory Quality Assurance program which
requires that all data generated by or for the Agency be of
known quality and documented. OPP's Quality Assurance program
as part of the Agency-wide program, encompasses a number of
activities designed to assure that data collected is of known
quality and meets the needs of the data users.
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69
AM OPP-sponsored pesticide monitoring activities will
he conducted in compliance with the OPP Quality Assurance
Plan approved by the Quality Assurance Management Staff of ORD.
Each project will have its own quality assurance project plan
and, once the project is completed, quality assurance parameters
(e.g., confidence levels, conditions of analysis), will become
an integral part of the data base. In cases where monitoring
projects are conducted cooperatively with other FPA offices
and Federal agencies the data quality objectives will be
negotiated. The quality assurance requirements of all partici-
pants must be included in the overall project quality assurance
plan.
It is also important that EPA be able to independently verify
th^ quality of the information being submitted by registrants
and other private data sponsors or cooperators. A number of
field sampling observations and laboratory audits will be
performed annually for a subs am pie of these externally-sponsored
studies. Some short-term monitoring studies may be performed
by QPP if any questions arise concerning the results obtained
in registrant-sponsored studies. The maintenance of such
on-call survey capacity is necessary in order to ensure the
quality of the exposure data used in risk assessments by OPP.
Additional quality assurance procedures will be prepared by
OPP to cover registrant required monitoring. These procedures
will be established as registrant monitoring requirements are
i mpl ement ed .
c • .P_RMI£E_ _FEp_EJ[AL/STAT_E_ .GJHn_A_NCE_,_ _C_(H)_P_E_R_AT I_0_N
As discussed in the Introduction to this Plan, EPA recognizes
its responsibility to assume a leadership role in procuring
pesticide exposure monitoring information. The Agency also
recognizes that collecting monitoring data is a cooperative
effort, shared in part by other Federal and State agencies.
To ensure that the pesticide monitoring activities of the FnA
and other agencies have maximum utility and are of high
quality, EPA will serve as the Federal coordinator and provide
guidance as needed.
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70
a ^
Otner Federal agencies have been actively and
cooperatively pursuing pesticide monitoring activities
that are appropriate within their respective laws and
mandates, during the last twenty years. Under this
monitoring plan, QPP looks to other Federal agencies
to continue and increase their pesticide monitoring
activities in close cooperation with EPA. EPA will
actively work to develop options for coordinating
mechanisms. OpP is investigating with other agencies
the establishment of a pesticide monitoring policy board
to coordinate multi-media pesticide monitoring activities.
2 . Priori ty L i s t o f C h em i c a 1 s
To ensure that the monitoring activites of EPA and
other Federal and State agencies, as well as registrants
and others, are focused and will yield the most useful
information possible, priorities for pesticide monitoring
must be developed. Because OPP's first priority is the
protection of human health, the highest priority for
pesticide monitoring activities is the assessment of
direct human exposure. The second priority is monitoring
direct environmental routes of human exposure, and the
third priority is monitoring indirect eviron mental
routes of human exposure.
EPA plans to develop lists of potential problem
chemicals for monitoring purposes. These lists will
be developed from periodic review of existing exposure,
product chemistry, and environmental fate data including
additional data generated in the implementation of the
monitoring plan. In developing these lists, EPA will
also give priority to pesticides with which the Agency
has health or environmental concerns (i.e., special
review chemicals) and pesticides scheduled for reregistra-
tion or registration standards. The list will provide
guidance for this and other Federal and State agencies
and other organizations in focusing future monitoring
activities. New data generated and received by EPA
will be reviewed and a revised listing compiled annually.
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71
3 . Tech n_i_c a 1 A_s s_i_s_t_a_n_c_e
To ensure the usefulness and quality of pesticide
monitoring information generated by other Federal and
State agencies, OPP will continue to provide (and may
expand its provision of) technical assistance to thes°
and other outside entities. This assistance in planning,
performing and evaluating pesticide monitoring studies "" s
available to other agencies upon request.
While EPA has the lead position in coordinating the development
of and procuring pesticide exposure and monitoring information,
the Agency believes it is appropriate to place the nonitoriny
data generation burden more squarely on pesticide registrants.
For prospective exposure data needs on new pesticide chemicals
as well as retrospective data needs for existing pesticides,
EPA vn' 1 1 require pesticide registrants to generate data on
specific products under existing FIFRA authorities. OPP will
develop monitoring requirements and associated guidance for
registrants to ensure that all monitoring undertaken by
registrants is properly performed and produces usable data of
verifiable quality.
on
OPP will develop monitoring data requirements and
criteria to ensure that adequate exposure informati
needed for the pesticide regulatory process is generated
routinely by pesticide registrants. OPP's current focus
is on developing monitoring requirements for applicator
exposure and potential ground water contamination.
Pro tOJlPjA.'. Jly.Ll^L1 i.n_ls_ '_ JikP ' J5
To ensure that the monitoring data generated externally
is of known and acceptable quality, OPP will develop a
series of protocols for registrant-sponsored monitoring
studies. The protocols will ensure a degree of jniformit,
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72
and specificity by providing guidance for the proper design
and execution of monitoring studies so that the resulting
data can be used by OPP to refine the risk assessnents
for specific products and uses. This project includes
the development of a number of protocols per year,
accomplishment of peer review, and limited field or
laboratory validation of the protocols.
OPP will also develop and publish monitoring guidelines,
and will prepare extensions of existing GLP requirements
to establish an audit function.
3• Technical Assistance
To ensure the usefulness and quality of pesticide
monitoring information developed by registrants, OPP
will provide increased technical assistance to registrants
upon request.
E • PROVIDE PUBLIC ACCESS TO INFORMATION
EPA understands that the pesticide monitoring information
developed under this Plan will also be useful to other agencies,
groups and individuals, and plans to make this information
widely available through a variety of mechanisms.
1 . E1 ec tro n i c B u1 leti n Bo a r d
As described in °art A. above, this automated listing
of ongoing monitoring activities sponsored by Federal
and State agencies will encourage data exchange anong
cooperating organizations and permit easy sharing of
information with outside groups.
2 • Annual Report^
OPP will complete and distribute an annual summary beginning
in 1986, of monitoring information generated by EPA
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73
and its cooperators, including the results of h u p a n a n -1
environmental residue monitoring studies, as well as
information on pesticide use patterns and usage, and
pesticide incidents. This annual report will describe
how the data developed were or will he used to support
the Objectives stated in this Monitoring Plan. The
report will also describe monitoring activities that ar
planned for the coming year.
i c a t i on i n AOAC Journals
Efforts to publish monitoring data through journals
sponsored by the Association of Official Analytical
Chemists (AOAC) have been initiated by OPP recently
and the utilization of this peer- revi ewed publishing
outlet will be expanded.
Updated M o nj t o r i n g Plan
As noted in the Introduction, the present document
is essentially an overview of current pesticide
monitoring activities, rather than a long term plan.
OPP is working now to ensure that monitoring needs
are regularly considered in the process of planning
pesticide program activities. As monitoring consid-
erations are integrated into program planning, the
annual program and budget planning process will offer
the opportunity to identify and plan for longer term
monitoring goals which effectively support OPP's
regulatory responsibilities and objectives. Thus, OPP
expects to develop more long range monitoring plans
over the next several years, and to up-date the National
Monitoring Plan to reflect such developments as appro-
priate, and in no event at greater than five year
i nterval s .
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SUMMARY OF PART III: Implementation
DATA COLLECTION/GENERATION PROJECTS FOR IMPLEMENTATION UNDER THE
NATIONAL MONITORING PLAN FOR PESTICIDES
Project
Description
Electronic
Bui letin Board
Responsibl e
Party
OPP
"Regulatory
Objecti ves
Supported
Will permit data sharing
among Federal/State
agencies; promote partner-
ship and piggyback oppor-
tunities.
Current
Status
PI anni rig
underway
in FY^5
Automated
Data Management
Inventory of
Registrant-Imposed
Studies
Quality Assurance
Program
Federal Coordination
Priority List of
Chemicals
OPP
OPP
OPP with
other ORD
OPP with
Federal
agenci es
OPP
Will increase accessibility
to monitoring data.
Technical Assistance OPP
Monitoring Guidelines OPP
Will
and
«iii permit tracking
followup on imposed moni-
toring data requirements.
To ensure that montitoring
data collected is of known
quality arid meets needs of
EPA and other users.
To ensure coordination,
cooperation in pesticide
monitoring activities.
To help focus efforts of
public and private data
developers.
To ensure quality and
usefulness of data
developed outside EPA;
and to share data and
expertise with parties
outside OPP.
To provide guidance to
registrants and otoer
outside parties in
developing data of
known and acceptable
qua!ity.
Pei ng
explored in
FY85.
PI anning
underway
in FY85
ongoing
FY35
PIanni ng
underway-
Pi anni ng
underway
FY85
Funded ''•!
FY85
I o !>eg i i
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A_PPE_NDIX - Resource Estimates for Current and Planned
Monitoring Activities
Not all of the projects listed under each of tn^ Ob j nc t • .< ••
of this plan can he associated with precise5 resource l- s t i n a ' > • -..
However, estimates can be provided for all the listed proj- ->,'- - '*• -,
with states, territories and Indian tribes is SH,/>)':>, 4 >•
The FY 35 funding for cooperative Applicator Cer t < t j c ;•!.
and Training programs is $1,367,500 «»•,.* a-•»*».-,'<';»?*' -^^
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