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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
March 11, 1994
OFFICE OF
THE WSPECTOR GENERAL
MEMORANDUM
SUBJECT: Audit Report No. E1EPE2-05-0015-4100205
"0 EPA's Pesticide Program
0^ FROM: Michael Simmons
Qs Associate Assistant Inspector General for
Cy Internal and Performance Audits
Cvj TO: Lynn R. Goldman, M.D.
£i Assistant Administrator for Prevention,
v Pesticides and Toxic Substances
During 1991, we began a series of audits of the pesticide
program with the goal of addressing how effectively and
efficiently the program is protecting the public and the
environment from pesticide hazards. This report is the result of
substantial efforts on the part of both our staffs. The
cooperative spirit and open lines of communication from your
office throughout this effort have enabled us to identify key
management actions which can be taken to improve the
implementation of the pesticide program.
We are pleased with your plans to consider this report in
your streamlining efforts. As you pointed out in your response
to the draft report, this is a time of budget cuts and resource
constraints. We hope that our report will be useful to.you as
you make the hard decisions ahead. We remain ready to assist you
in any manner you deem necessary.
This audit report represents the opinion of the OIG. Final
determinations on matters in the audit report will be made by EPA
managers in accordance with established EPA audit resolution
procedures. Accordingly, the findings described in the audit
report do not necessarily represent the final EPA position.
Action Required
In response to the draft report, your office provided
responsive action plans and milestone dates for correcting the
findings. As a result, and in accordance with our longstanding
agreement outlined in EPA Order 2750, we find your response to
OCT 2 1995
US EPA Headquarters Library
Room 2904, Mailcode 3404
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the report acceptable. Therefore, we are closing this report in
our tracking system as of this date. Please track all action
plans and milestone dates in the Management Audit Tracking
System.
We have no objections to the further release of this report
to the public. Should you or your staff have any questions
regarding this report, please contact Kimberly O'Lone, Audit
Manager, Northern Audit Division, at (312) 886-3186.
cc: Douglas D. Campt, Director
Office of Pesticide Programs (7501C)
Michael M. Stahl, Director
Office of Compliance Monitoring (7201)
Joyce Hay, Audit Liaisoij (7101)
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EPA'e Pesticide Program
EXECUTIVE SUMMARY
PURPOSE •
In 1991, the Office of Inspector General (OIG) initiated a
new approach to .performing audits in order to provide more
comprehensive audit coverage of key program areas in the
Environmental Protection Agency (EPA)-. These comprehensive
assessments provide extensive coverage of a program area,
thus allowing for a better picture of the program, function,
or activity. One of the areas the OIG selected for a
comprehensive assessment was the pesticide program.
In preparing this assessment, the OIG performed a series of
audits of specific activities in the pesticide program. We
also considered reports the General Accounting Office (GAO)
issued. (See Chapter 1, Scope and Methodology section for
further details.) The objective of our review was to
evaluate the efficiency and effectiveness of the management
of the pesticide program.
BACKGROUND
Pesticides are chemicals or biological substances used to
control unwanted plants, insects, fungi, rodents, or
bacteria. Pesticide use has contributed to increased
agricultural production and improved public health through
control of disease-carrying pests. However, acute and
chronic human health and environmental risks also can be
associated with the use of many pesticides. In determining
whether to permit the marketing of a pesticide and how to
regulate its use, EPA balances potential risks against the
benefits that may be derived from the pesticide's use. The
goal of the pesticide program is to provide health and
environmental protection while permitting a steady supply of
pesticide products.
EPA .regulates the use of pesticides under the authority of
two laws, the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug and Cosmetic Act
(FFDCA). EPA is responsible under FIFRA for registering
pesticides to ensure that, when used according to the label
directions, they will not pose unreasonable risks to human
health or the environment. FIFRA requires EPA to balance the
risks of pesticide exposure to human health and the
environment against the benefits of pesticide use to society
and the economy. Under FFDCA, EPA regulates the safety of
the food supply by setting tolerance levels, or maximum legal
»
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limits, for pesticide residues on food commodities. The
purpose of a tolerance is to ensure that consumers are not
exposed to unsafe levels of pesticide residues in food.1
The pesticide program has developed a variety of regulatory
and educational programs to protect human health and the
environment from the harmful effects of pesticides. These
include registering pesticides for specific uses, setting
tolerances for pesticide residues on food, setting standards
to protect workers who are exposed to pesticides, certifying
and training pesticide applicators, and educating consumers
about pesticide use and exposure. The three largest
activities in the pesticide program are registration,
reregistration and special review.
RESULTS-IN-BRIEF
For many years, the pesticide program experienced significant
problems that needed to be corrected if the program was to
(!) efficiently use its resources, and (2) effectively
carryout its mandates. Pesticide program personnel are very
dedicated to protecting the environment. However, years of
criticism about program operations and completing activities
resulted in an organizational culture that did not
proactively attempt to correct problems. Management
improvements are needed to correct the causes for problems
which continue to occur, and to make the programs more cost
effective in the future.
Budget decreases during the 1980's resulted in the pesticide
program focusing on short-term results .and solutions to
problems. During the 1980's, the pesticide program's budget
decreased both in resources and staffing. Faced with
declining resources, the program focused on activities that
absolutely needed to be done and how it could get the
quickest results. As a result, basic program activities,
such as integrating information systems and updating
regulations, did not get done. Left undone, these activities
have made it more difficult and costly to manage the
pesticide program.
Neither regulating pesticides nor managing this program is an
easy task. The complex scientific decisions the program must
make every day regularly embroil the program in controversy.
1 As discussed in Chapter 1, Scope and Methodology section,
food safety issues were not included in the scope of this review.
ii
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Only a well-managed program, that uses every resource to its
fullest extent, meets its deadlines, and corrects its
problems before others point them out will merit public and
Congressional confidence.
The pesticide program needs to focus on improving its
management processes. The goal of these improvements should
be to prioritize what needs to be done and direct resources
to the highest priority items, and take steps to free-up
resources in the future. To do this will often require long-
term commitments from managers and staff. This report
contains recommendations for improving the management of the
pesticide program. Some recommendations, such as improving
the management processes and information management, will
result in cost savings to the program. Other
recommendations, such as up-dating regulations and ensuring
the integrity of scientific data, will result in increased
public confidence in the program.
Just as important as changing management processes is
changing the organizational culture. The pesticide program
was often aware of deficiencies before they were identified
in audit reports, but did not always take action to correct
the deficiencies. The pesticide program also often missed
target dates that Congress and it established. Over the
years target dates in such areas as reregistration,
registration and development of regulations have often been
missed. The result is an organizational culture where
uncorrected deficiencies and missed target dates were
accepted. This organizational culture needs to change and
management must be accountable for correcting deficiencies
and meeting target dates. • •
PRINCIPAL FINDINGS
1. Continued Management Improvements Needed In The
Pesticide Program
Pesticide program managers made diligent efforts during 1993
to improve how they manage the program. These improvements
must not only be continued, but expanded, if the-program is
to efficiently protect humans and the environment from
pesticide hazards. For many years, audits have reported
uncorrected problems in the pesticide program. Pesticide
program management was often aware of problems before they
were identified in audit reports, but, because of competing
priorities, did not correct them. Long-standing problems had
not only impaired the program's ability to protect humans and
iii
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EPA'a Pesticide Program
the environment from pesticides hazards, but has also
affected the credibility of the program. The pesticide
program made improving program management a high priority in
fiscal years 1993 and 1994. These efforts need to be both
commended and expanded. In particular, changes are needed to
the program's organizational culture.
Pesticide program officials repeatedly told auditors that
problems were not corrected because they were not a priority
or there were not enough resources. While the lack of
resources contributed to some of the problems, it cannot
account for the full extent of what was reported. The
continuing problems in the pesticide program are, in part,
the result of how the program was managed. The issues
discussed in other chapters also had an impact on ~he
program's ability to manage pesticides efficiently and
effectively. Years of criticism about program operations and
completing activities resulted in an organizational culture
that did not proactively attempt to correct problems. When
resources are scarce, more management attention is needed to
ensure that the scarce resources are used efficiently.
2. Pesticide Information Management Systems Need To Be
Improved
The pesticide program had many computerized information
systems that often contained inaccurate and incomplete data,
and duplicated each other and were not integrated. This
happened for two main reasons. One was the approach the
program took to information system development. The second
was that the program did not develop quality assurance
procedures to support its systems. Because of the extent of
the information management problems, we believe the program
may have a material weakness in internal controls related to
information management. In August 1992, the pesticide
program developed an information management strategy that
discussed several of our concerns. Funding of this strategy
needs to be an important priority for the pesticide program.
Information management problems affected the program in many
ways. Staff members relied upon inaccurate, incomplete data
when making decisions. In addition, the pesticide program's
divisions had difficulty coordinating work on the same
chemicals, because the different systems were not integrated.
We realize that the pesticide program has stated that it has
limited resources; however, we believe that wisely investing
resources in information management now can make the systems
operate more efficiently and effectively. This will free up
IV
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other resources in the future that the program can use in
other areas.
3, Regulations. Policies. And Procedures Need To Be
Developed And Improved
The pesticide program often operated (1) with regulations
that were not up-to-date or finalized, (2) and without
policies and procedures for numerous program activities.
This happened because the program did not consider
development and revision of regulations, policies, and
procedures to be a priority. Without these documents to
serve as internal controls, the pesticide program cannot be
sure that it is effectively controlling operations, and may
have difficulty enforcing its regulations. Because the
regulations were not up-to-date or finalized, the registrants
were not always clear as to what the pesticide program
expected from them. In 1992, the pesticide program proposed
to create a new division to handle policy issues. The
division's role was still being defined at the time of our
review. If this division's responsibilities include
activities related to developing and updating regulations,
policies, and procedures, many of our concerns will be
addressed.
We identified several instances where the pesticide program's
regulations no longer reflected what the program was actually
doing. For instance, product managers used a combination of
current regulations, proposed revisions to those regulations,
and pesticide regulation notices, when evaluating pesticide
labels. Using this combination.of rules in evaluating labels
created uncertainty for the registrants, and made it difficult
for them to know what information was needed on a pesticide
label.
GAO and OIG reports also identified problems with policies
and procedures in numerous program areas. For example, the
absence of policies and procedures contributed to the release
for sale in the United States of unregistered pesticide
imports. To a large extent, staff members responsible for
the import program used their own judgement for admitting or
rejecting pesticide products since they did not have uniform
policies and procedures to follow. The pesticide program
generally took action to develop policies and procedures in
the areas mentioned in GAO and OIG reports. However, the
pesticide program needs to ensure that these documents exist
in all areas where they are needed.
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4. Pesticide Program Budget History
The pesticide program experienced significant decreases in
resources and staff during the 1980's. During the same time,
the program's responsibilities grew. The pesticide program
has repeatedly attributed the reasons for delays in
activities to lack of funds. In order to determine whether
the pesticide program has sufficient resources, the pesticide
program needs to perform a study of its resource usage and
needs. Depending on the results of the study, the program
could use the study to reallocate existing resources and
request additional resources as needed.
5. Actions Taken To Improve Data Integrity
Ensuring the integrity of data registrants submit is
essential to the pesticide program. In recent years,
weaknesses have been identified in the (1) Good Laboratory
Practices (GLP) program, (2) quality of disinfectant
effectiveness studies, and (3) pesticide program's review of
information concerning adverse effects of pesticides. Each
of these areas were designed to ensure the integrity of data
supporting pesticide registrations. The pesticide program is
taking action to improve each of these areas. (See Chapter 6
pgs. 43 through 46) These actions need to.continue in order
for the program to ensure the integrity of scientific data.
6. Changes In FIJFRA Could Benefit The Pesticide Program
Revisions to the pesticide law would enhance enforcement and
streamline the cancellation process. The pesticide program
has identified sections of the pesticide laws that inhibit
performance of the program's activities. OIG audit reports
have confirmed some of these problems.2 For instance, OIG
reviews have found that (1) the law has limited the pesticide
program's enforcement authority in several program areas, and
(2) the cancellation process, as outlined in the law, can
take four to eight years to complete. As a result of these
problems, the program was unable to effectively carry out
some activities. The Agency has requested that Congress make
these changes to FIFRA. We support the Agency's efforts to
bring about the changes and encourage them to continue.
2 In this report we discuss the problems with the law that
our audit reports have confirmed. Because we have not reviewed
any problems under FFDCA, we are unable to comment on the effects
those problems have had on the pesticide program.
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AGENCY COMMENTS AND ACTIONS
In responding to the draft report on March 4, 1994, the
Assistant Administrator stated that the report's findings and
recommendations were particularly useful in this time of
budget and resource constraints and will help the Office of
Prevention, Pesticides and Toxic Substances (OPPTS) meet the
goals and objectives of the National Performance Review and
streamlining efforts now underway. The Assistant
Administrator was pleased to see that the report highlighted
the many improvements and changes in the pesticide program
over the past several years.
The Assistant Administrator further stated that the report's
emphasis on the infrastructure of the program was proper and
timely in a long-term evaluation of the program, and viewed
the report as a means of fine tuning the rough edges of an
essentially sound core program of pesticide regulation.
Actions the Assistant Administrator agreed to take included:
o a continuing emphasis on management accountability and
evaluating the program to recommend changes in the
management structure;
o reviewing information management as part of the FMFIA
process; and
o reviewing the pesticide program's regulations, policies,
and procedures to identify and prioritize those needing
revision.
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TABLE OF CONTENTS
EXECUTIVE SUMMARY i
CHAPTERS
1 INTRODUCTION ...... 1
PURPOSE 1
BACKGROUND 1
SCOPE AND METHODOLOGY 4
PRIOR AUDIT COVERAGE 6
2 CONTINUED MANAGEMENT IMPROVEMENTS NEEDED IN THE
PESTICIDE PROGRAM 7
HISTORY OF UNCORRECTED PROBLEMS 7
MANAGEMENT ATTENTION NEEDED TO CORRECT PROBLEMS . 12
CONCLUSION 15
AGENCY COMMENTS AND ACTIONS 15
DIG EVALUATION 16
3 PESTICIDE INFORMATION MANAGEMENT SYSTEMS NEED TO
BE IMPROVED 17
PESTICIDE PROGRAM HAD MANY INFORMATION SYSTEMS . . 17
INFORMATION SYSTEM DEVELOPMENT FOCUSED ON
QUICK SOLUTIONS 18
DATA IN SYSTEMS WERE INACCURATE AND INCOMPLETE . . 19
INFORMATION SYSTEMS DUPLICATIVE AND
NOT INTEGRATED 22
THE PESTICIDE PROGRAM DEVELOPED AN INFORMATION
MANAGEMENT STRATEGY ..... 24
INTERNAL CONTROLS FOR INFORMATION MANAGEMENT
ARE INADEQUATE 24
ix
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TABLE OF CONTENTS fcontinued)
CONCLUSION 25
AGENCY COMMENTS AND ACTIONS 25
OIG EVALUATION . 26
4 REGULATIONS, POLICIES AND PROCEDURES NEED TO BE
DEVELOPED AND IMPROVED 27
POLICIES, PROCEDURES AND REGULATIONS ARE
IMPORTANT INTERNAL CONTROLS 28
REGULATIONS NOT UP-TO-DATE OR FINALIZED 28
PESTICIDE PROGRAM LACKED POLICIES
AND PROCEDURES 31
NEW DIVISION MAY ADDRESS OUR CONCERNS 33
CONCLUSION 33
AGENCY COMMENTS AND ACTIONS 34
OIG EVALUATION .34
5 PESTICIDE PROGRAM BUDGET HISTORY 35
SOURCES OF FUNDING 35
RESOURCE AND STAFFING LEVELS . 37
CONCLUSION 41
AGENCY COMMENTS AND ACTIONS 41
OIG EVALUATION 42
6 ACTIONS TAKEN TO IMPROVE DATA INTEGRITY 43
IMPORTANCE OF DATA INTEGRITY 43
ACTIONS TAKEN TO IMPROVE DATA INTEGRITY 44
CONCLUSION 46
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TABLE OF CONTENTS fcontinued)
7 CHANGES IN FIFRA COULD BENEFIT THE
PESTICIDE PROGRAM 47
FIFRA LIMITED THE PESTICIDE PROGRAM'S
ENFORCEMENT AUTHORITY . 47
FIFRA'S PROCESS FOR PESTICIDE CANCELLATION IS
CUMBERSOME AND RESOURCE INTENSIVE 49
CONCLUSION 51
EXHIBITS
EXHIBIT 1 AUDIT REPORTS AND TESTIMONIES INCLUDED
IN THE SCOPE OF THE REVIEW 53
EXHIBIT 2 GAO REPORTS REFERRED TO BUT NOT INCLUDED
IN THE SCOPE OF THE REVIEW 55
EXHIBIT 3 COMPUTER SYSTEMS SUPPORTING PESTICIDE
PROGRAMS 57
APPENDICES
APPENDIX 1 ASSISTANT ADMINISTRATOR FOR PREVENTION,
PESTICIDES AND TOXIC SUBSTANCES' RESPONSE
TO THE DRAFT REPORT 61
APPENDIX 2 ABBREVIATIONS 89
APPENDIX 3 DISTRIBUTION 90
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CHAPTER 1
INTRODUCTION
PURPOSE
In 1991, the Office of Inspector General (OIG) initiated a
new approach to performing audits in order to provide more
comprehensive audit coverage of key program areas in the
Environmental Protection Agency (EPA). These comprehensive
assessments provide extensive coverage of a program area,
thus allowing for a better picture of the program, function,
or activity. One of the areas the OIG selected for a
comprehensive assessment was the pesticide program.
In preparing this assessment, the'OIG performed a series of
audits of specific activities in the pesticide program. We
also considered reports the General Accounting Office (GAO)
issued. (See Chapter 1, Scope and Methodology section for'
further details.) The objective of our review was to
evaluate the efficiency and effectiveness of the management
of the pesticide program.
BACKGROUND
Pesticides are chemicals or biological substances used to
control unwanted plants, insects, fungi, rodents, or
bacteria. Pesticide use has contributed to increased
agricultural production and improved public health through
control of disease-carrying pests. However,' acute and
chronic human health and environmental risks also can be
associated with the use of many pesticides. In determining
whether to permit the marketing of a pesticide and how to
regulate its use, EPA balances potential risks against the
benefits that may be derived from the pesticide's use. The
goal of the pesticide program is to provide health and
environmental protection while permitting a steady supply of
pesticide products.
EPA regulates the use of pesticides under the - authority of
two laws, the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug and Cosmetic Act
(FFDCA). EPA is responsible under FIFRA' for registering
pesticides to ensure that, when used according to the label
directions, they will not pose unreasonable risks to human
health or the environment. FIFRA requires EPA to balance the
risks of pesticide exposure to human health and the
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EPA'a Pesticide Program
environment against the benefits of pesticide use to society
and the economy. Under FFDCA, EPA regulates the safety of
the food supply by setting tolerance levels, or maximum legal
limits, for pesticide residues on food commodities. The
purpose of a tolerance is to ensure that consumers are not
exposed to unsafe levels of pesticide residues in food.
The Office of, Pesticide Programs, within OPPTS is responsible
for carrying out EPA's responsibilities for regulating
pesticides. The Office of Compliance Monitoring (OCM), also
within OPPTS, is responsible for enforcing pesticide laws and
administering the Good Laboratory Practices program (GLP).
The pesticide program has developed a variety of regulatory
and educational activities to protect human health and the
environment from the harmful effects of pesticides. These
include registering pesticides for specific uses, setting
tolerances for pesticide residues on food, setting standards
to protect workers who are exposed to pesticides, certifying
and training pesticide applicators, and educating consumers
about pesticide use and exposure. The three largest
pesticide program activities, in terms of personnel and
funding, are registration, reregistration and special review.
Registration
Companies must register all pesticides with EPA before they
can market them. Pesticide registration decisions are based
primarily on the program's evaluation of test data companies
provide. Depending upon the type of pesticide, EPA can
require 70 different kinds of tests, which can cost a company
up to $10 million. These tests are needed to determine
whether a pesticide has the potential to cause adverse
effects on humans or the environment. Potential human risks
include acute toxic reactions, such as poisoning and skin and
eye irritation. The pesticide program requires tests to
determine if there are possible long-term effects like
cancer, birth defects, or reproductive system disorders.
Tests are also performed to determine what effect the
pesticide may have on ground or surface water.
Before registering a pesticide, the pesticide program reviews
the (1) test data or studies, and (2) labeling. The purpose
of these reviews is to determine that, when used according to
label directions, the pesticide does not pose unreasonable
risks of adverse effects to human health and the environment.
For new pesticides, the pesticide program's review can take
two to three years.
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Reregistration
Federal efforts to reassess pesticide safety began in 1972.
At that time, Congress amended FIFRA to require EPA to
reregister, or reevaluate, all pesticide products that were
registered under older, less stringent standards. Primarily
because of insufficient resources, EPA's early attempts to
develop a reregistration program were unsuccessful. The
Congress amended FIFRA several times since 1972, reaffirming
the need for expeditious reregistration.
Growing public concern about how long it would take to
reassess existing pesticides spurred Congress to act in 1988
to substantially change EPA's approach. Congress amended
FIFRA in 1988, directing EPA to establish a five-phase
reregistration program to be completed within about nine
years. The aim of this phased approach was to generate a
substantially complete base of scientific information for
each pesticide before the program reassesses it for
reregistration. The 1988 amendments also required the
registrants to fund part of the cost of reregistration by
paying fees and compiling information the pesticide program
needed.
Special Review
Congress gave EPA authority not only to register pesticides,
but also to cancel the registration if a pesticide were found
to cause unreasonable risks.. However, before the pesticide
program can cancel a registration, it is required to weigh
the risks of adverse effects and the benefits of a
pesticide's use. The program usually accomplishes this
through a special review. As a result of the special review,
the program can reduce pesticide risk through:
o changing the label to require additional precautions for
users, limiting the amount of the pesticide that can be
used, or eliminating specific uses of the pesticide;
o restricting the use of the pesticide to certified
applicators; or
o suspending or canceling all or some uses.
During the special review, the pesticide remains on the
market with no additional restrictions. In some cases, the
pesticide program may believe that allowing the pesticide to
stay on the market would pose an unacceptably high risk. In
such cases, EPA may issue a suspension order that bans the
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sale or use of the pesticide while the program is considering
whether the pesticide should continue to be used. In order
to suspend a pesticide, EPA must find that use of the
pesticide poses an imminent hazard and offer the registrant
an expedited hearing. However, if EPA finds that an
emergency exists, it can ban the use of a pesticide effective
immediately.
Other Responsibilities
In addition to registration, reregistration, and special
review, the pesticide program has responsibilities in many
different areas. The pesticide program carries out some
responsibilities itself, while states and regions assist the
program in other areas. These additional responsibilities
included:
o
o
e
o
o
o
o
o
o
o
o
e
o
groundwater protection,
worker protection,
outreach and education,
integrated pest management,
biological pesticides,
storage and disposal of pesticides,
endangered species,
inert ingredient s,
emergency exemptions,
imports and exports of pesticides,
certification and training of applicators,
experimental use permits, and
special local needs permits.
SCOPE AND METHODOLOGY
In developing our findings and recommendations, we used 23
OIG and GAO reports and testimonies issued between September
1988 and July 1993. (See Exhibit 1 for listing.) While
these reports do not include every activity of the pesticide
program, they provided sufficient coverage of program
activities to reach a conclusion on the management of the
program. Throughout this report we also refer to audits
issued before 1988. (See Exhibit 2 for listing.) These
reports are presented for historical purposes, and are not
used to develop the findings in this report.
The scope of our review included all areas of the pesticide
program, except enforcement and food safety. Enforcement was
not included because states and regions are responsible for
enforcement, and the focus of our review was activities of
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the Office of Pesticide Programs located in Washington, DC.
Food safety was not included because these activities are
carried out in conjunction with the U.S. Department of
Agriculture, and OIG audits are generally-limited to EPA
activities.
In conducting this audit, we reviewed and identified
recurring issues in audit reports issued during the last five
years. We discussed these issues with program management.
As needed, we updated the information included in previous
audit reports. We also met with state officials and
registrants to discuss the operations of the pesticide
program.
We performed our audit in accordance with the Government
Auditing Standards issued by the Comptroller General of the
United States (1988 revision). The reports we used for this
audit were also performed in accordance with Government
Auditing Standards with the following exceptions:
OIG Special Reviews3
Follow-up to Pesticide Imports
Follow-up to Emergency Suspended and Canceled
Pesticides
EPA Procedures to Ensure Quality Data Under the Good
Laboratory Practices Program
Alternative for Ensuring Accurate Laboratory Data
EDP Internal Controls for Selected Pesticide Revolving
Funds' Information Systems
OIG Survey . •
Survey of the Office of Pesticide Program's Registration
- Process
GAP Testimonies
EPA's Repeat Emergency Exemptions May Provide Potential
for Abuse
EPA Lacks Assurance That All Adverse Effects Data Have
Been Reviewed
EPA's Information Systems Provide Inadequate Support for
Reregistration
3 These reports were special reviews. Special reviews are
more limited in scope than audits and are conducted in accordance
with OIG Manual Chapter 150.
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For those reviews conducted in accordance with Government
Auditing Standards and OIG Manual Chapter 150, we relied upon
the information in the reports without additional testing or
review. For the one survey, we reviewed the auditor's
workpapers to verify the information used in this report.
While not taking full responsibility for the information
contained in the reviews and testimonies, the standards
followed by the OIG and GAO gave us reasonable assurance of
the quality and accuracy of the information. We relied on
the information in the reviews and testimonies to reach
conclusions on how the pesticide program was managed and have
cited examples from the reviews and testimonies throughout
this report.
As part of our audit we reviewed the 1990, 1991, and 1992
Agency Federal Managers' Financial Integrity Act (FMFIA)
reports. These reports identified three areas of weaknesses
in internal controls relating to the pesticide program: the
antimicrobial program (disinfectants), the pesticide disposal
process, and data integrity. Other weaknesses in internal
controls are described throughout the report.
We briefed pesticide program management about our findings on
June 30, 1993. We provided position papers to the pesticide
program during September 1993. We met with pesticide program
management on October 7, 1993. Comments to the position
papers were included in the draft report.
On December 16, 1993, we issued our draft report. We held an
exit conference with the Assistant Administrator for
Prevention, Pesticides and Toxic Substances on February 17,
1994. The Assistant Administrator responded to the draft
report on March 4, 1994. After reviewing the response and
conducting the exit conference, we made appropriate changes
and finalized the report. The Assistant Administrator's
response is included as Appendix 1.
PRIOR AUDIT COVERAGE
As discussed in the Scope and Methodology section, the OIG
and GAO have performed many audits on various activities of
the pesticide program. However, none of these audits
addressed the general management issues that are discussed in
this report.
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CHAPTER 2
CONTINUED MANAGEMENT IMPROVEMENTS NEEDED
IN THE PESTICIDE PROGRAM
Pesticide program managers made diligent efforts during 1993
to improve how they manage the program. These improvements
must not only be continued, but expanded, if the program is
to efficiently protect humans and the environment from
pesticide hazards. For many years, audits have reported
uncorrected problems in the pesticide program. Pesticide
program management was well aware of problems before they
were identified in audit reports, but, because of competing
priorities, did not correct them. Long-standing problems had
not only impaired the program's ability to protect humans and
the environment from pesticides hazards, but has also
affected the credibility of the program. The pesticide
program made improving program management a high priority in
fiscals 1993 and 1994. These efforts need to be both
commended and expanded. In particular, changes are needed to
the program's organizational culture.
Pesticide program officials repeatedly told auditors that
problems were not corrected because they were not a priority
or there were not enough resources. While the lack of
resources contributed to some of the problems, it cannot
account for the full extent of what was reported. The
continuing problems in the pesticide program are, in part,
the result of how the program was managed. The issues
discussed in other chapters also impacted on the program's
ability to manage pesticides efficiently and effectively.
Years of criticism about program operations and completing
activities resulted in an organizational culture that did not
proactively attempt to correct problems. When resources are
scarce, more management attention is needed to ensure that
the scarce resources are used efficiently.
HISTORY OF UNCORRECTED PROBLEMS
OIG and GAO reports repeatedly highlighted deficiencies in
the pesticide program's administration of (1) core program
activities, and (2) other necessary activities. Pesticide
program management was well aware of the many problems
included in the reports, but, based on priorities, did not
correct them. Uncorrected, some problems have become so
large that it is difficult to see how they can be corrected.
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Deficiencies In Core Program Activities
Reviews have found continuing deficiencies in core program
activities. These activities include registration,
reregistration, and special reviews of pesticides, as well as
assuring the quality and integrity of scientific data.4
Registration activities were not adequately carried out.
Reregistration and special review activities were not timely
completed. Uncorrected deficiencies in core program
activities hampered management's ability to carry out the
program's mission effectively.
Registration is the heart of the Federal program for
regulating pesticides. Before registering a pesticide, the
program reviews (1) test data or studies, and (2) labeling.
Audits of the pesticide program found deficiencies related to
the registration process. For example,
o Review of studies: In 1990, GAO reported that doctors'
and consumers' reliance on the pesticide program's
review of registrant-submitted data for assurance that
disinfectants worked as claimed was unfounded (Report
No. GAO/RCED-90-232). This occurred because a
scientific consensus was lacking on the validity of test
methods and standards the pesticide program recommends
to registrants for substantiating disinfectant claims.
Although the program had known about the scientific
controversies surrounding its recommended test methods
and standards for almost a decade, it had made little
progress in resolving the controversies. GAO concluded
that the test methods and standards had been disputed to
such an extent that their credibility to substantiate
efficacy claims was impaired. Subsequent to the review,
the program identified the disinfectant program as
containing material weaknesses in internal controls and
was taking action to correct the deficiencies.
o Labeling; A 1992 OIG review found that the pesticide
program was missing toxicity studies to support the
precautionary statements on many pesticide labels
(Report No. 2100613). According to pesticide program
officials, many of the older studies had become
obsolete. Others were in pesticide program files, but
not organized so that they could easily be located. If
program staff wanted to find the studies, they faced an
intensive search.
4 See Chapter 6 for discussion of data integrity.
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o Congressional deadlines; FIFRA includes timefraraes for
the program's processing of certain types of
registrations. The pesticide program is required to
process registrations of products identical or
substantially similar to other registered products in 90
days. In fiscal 1992, the pesticide program averaged
120. days to process these registrations, with some
taking as long as six months. The program is also
required to process experimental use permits within 120
days. These reviews averaged 167 days.
As highlighted below, the OIG, GAO, and Congress have been
concerned for many years about delays in other core program
activities, such as reregistration and special review.
o Rereaistration; GAO issued reports in 1975, 1980, 1986,
and 1993 about the program's inability to complete the
reevaluation or reregistration of older pesticides.5
Under the 1972 amendments to FIFRA, Congress required
EPA to reregister all pesticide products that were
registered with less information on their long-term
health and environmental effects than was currently
required. In 1986, GAO reported that the program had
not completed a final reassessment on any pesticide
, active ingredient. Congress amended FIFRA in 1988 and
- directed EPA to accelerate the reregistration process so
that it would be completed by 1997. Despite progress,
the program does not expect to complete reregistration
until 2006, 34 years after Congress originally directed
EPA to start.
o ~Special review: For many years, Congress, GAO and the
OIG have been concerned about the amount of time the
pesticide program took to complete special reviews of
pesticides. In 1984, the U.S. House of Representatives
Committee on Government Operations found that the
special review process was not achieving its intended
function of providing expedited decisions when new
information showed a potential for pesticide hazards.6
Before and after the Committee report, GAO found similar
problems with special review. GAO issued reports in
5 Report Nos. RED-76-42 (1975), CED-8-32 (1980), GAO/RCED-
86-125 (1986), and GAO/RCED-93-94 (1993).
6 The Committee on Government Operations, September 25,
1984, PROBLEMS PLAGUETHE ENVIRONMENTAL PROTECTION AGENCY'S
PESTICIDE REGISTRATION ACTIVITIES
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1980 and 1986 that found that the program was not
meeting its goal of quickly making regulatory decisions
on potentially hazardous pesticides in special review.7
A 1993 OIG report on the special review process found
that program management had recognized a need to reduce
the amount of time it took to complete reviews of
hazardous pesticides (Report No. 3100256). The report
found that the pesticide program used negotiations with
registrants, instead of the special review process, to
achieve risk reductions. However, this change to
negotiations had been at the expense of public
involvement in the decision-making process.
Other Important Responsibilities Not Timely Addressed
Reviews have found that the pesticide program did not timely
correct deficiencies in its administration of other
responsibilities. While not considered part of the core
program activities, these responsibilities were still
important to protecting humans and the environment from
pesticide hazards. The pesticide program often did not
address deficiencies in these areas for many years after it
was aware of the problems.
0 Inert ingredients: During the 1970's, pesticide program
officials recognized that inert ingredients had not been
evaluated for their potential risks to humans and the
environment. In 1975, GAO recommended that the
pesticide program develop appropriate guidelines for
testing inert ingredients that may present a health or
environmental hazard (Report No. RED-76-42). It was
twelve years before the pesticide .program published its
Inerts Strategy. The pesticide program found that it
knew little or nothing about the adverse effects for
most (over 1300) inert ingredients. According to
program officials, a complete review of these inerts
could now rival the reregistration program in size and
scope. The pesticide program planned to request data on
these inerts during 1993, but funding for this activity
was dropped during budget cuts.
o Emergency exemptions: GAO testified before the U.S.
House of Representatives Subcommittee on Environment in
1991 concerning long-standing problems with the
program's granting of emergency exemptions (Report No.
7 Report No. CED-80-32 (1980) and GAO/RCED-86-125 (1986) .
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GAO/T-RCED-91-83).B GAO testified that the pesticide
program had issued a large number of exemptions, at
times for the same uses for several years. In one case,
emergency exemptions had been granted for 12 years.
GAO's current work illustrated that problems described
in its 1978 and 1981 reports continued to exist more
than ten years later. Subsequent to GAO's testimony,
the.pesticide program developed criteria to (l)
differentiate between chronic and emergency situations,
and (2) measure a pesticide's progress towards
registration.
o Banned pesticides; In 1986, the U.S. House of
Representatives Government Operations Committee
recommended that the pesticide program develop a.
coherent storage policy to ensure that emergency
suspended and canceled (banned) pesticides were properly
stored. In addition, timely information was to be
provided to all regional offices regarding the banned
pesticide locations. The pesticide program took some
action, but its initial strategy for one banned
pesticide, dinoseb, did not include all the steps
necessary to accomplish the Committee's recommendations.
As a result, we found, during our 1990 review of the
banned pesticide program, several locations where
dinoseb containers were leaking and corroding (Report
No.-0100486).
ProblemsAttributed to Lack of Priority or Resources
When asked why activities were delayed or not performed,
pesticide program officials consistently told auditors that
either it was not a priority, or there was a lack of
resources. Eleven of 23 reports stated that program managers
cited one or both of the reasons for the problems identified.
The pesticide program has been giving these reasons for
almost 20 years.
For example:
"The Environmental Protection Agency said it would
not require the full range of data to support
registration under the 1972-act because of limited
8 EPA is allowed to grant Federal and State agencies
exemptions to use unregistered pesticides in emergency
situations.
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staff and time." (Source: 1975 GAO report on the
.pesticide program, Report No. RED 76-42)
"Reasons for slow review include a shortage-of
staff and a policy that did not give priority to
such studies." {Source: 1991 GAO report on
groundwater, Report No. GAO/RCED-91-75)
"The imbalance of resources versus workload
(competing priorities) was viewed by management as
a major cause for their untimely completion of
registrations." (Source: 1993 DIG survey of the
registration process, assignment no. E1EPF2-11-
0036)
The program agreed that guidelines for initiating
special reviews would be desirable, but stated that
"The Agency can not commit to allocating resources
to this goal." (Source: 1993 OIG report on
pesticide special review process, Report No.
3100256)
MANAGEMENT ATTENTION NEEDED TO CORRECT PROBLEMS
The deficiencies auditors have found in the pesticide program
in the last several years have not been limited to one
specific part of the program. The widespread nature of the
deficiencies indicates that management improvements are
needed across the entire program. While lack of resources
may have contributed to the deficiencies, it did not justify
program managers allowing the deficiencies to remain
uncorrected for many years. During 1993, program management
began changing how it manages the program. Additional
improvements will require a change in the organizational
culture to one that proactively corrects problems.
Ongoing Improvements In The Management Process
The pesticide program managers made diligent efforts during
1993 to improve how they manage the program. On an office-
wide basis, the managers established long and short-term
priorities, allocated resources based on the priorities, and
monitored progress toward meeting the priorities. At the
division level, the managers also worked to improve the
coordination and scheduling of various work. Efforts such as
these are important to controlling the pesticide program, and
improvements need to continue in the years to come.
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For a government program, management can be defined as the
process of directing and controlling its resources, including
people. On an office-wide basis, this is done through
budgets and long and short-term plans and commitments. At
the division or branch level, directing and controlling
resources involves prioritizing, scheduling and monitoring of
work to meet the budgets, plans and commitments.
For 1993, the pesticide program managers used a new approach
to setting priorities. The managers divided the program into
eight areas, and identified long and short-term objectives
for the areas. .The long-term objectives became part of the
four year strategic plan, which identified program goals and
objectives. The short-term objectives became part of the
1993 resource management plan. Pesticide program managers
then allocated resources based on the objectives and
priorities. During the year, the managers monitored progress
toward meeting the objectives and whether resources were
being used according to the plan. In past years, there had
been major deviations between how the resources were planned
to be used, and how they were actually used. In 1993, the
pesticide program used their resources according to the
allocation plan.
During 1993, each of the divisions worked-on improving the
scheduling and coordination of work. Coordination is very
important to the pesticide program because the efforts of
several divisions are needed before a-decision can be made
concerning a product's registration. In order for a decision
to be made, each of the divisions need to be working on the
same chemicals. The office-wide planning process helped .to
coordinate each division's work. During 199-3, the
Registration Division (RD) and. Special Review and
Reregistration Division (SRRD), who register and reregister
products, coordinated review schedules with the science
divisions (HED and EFED), who review the data that support
the registration or reregistration. The divisions identified
when the program would receive the studies from registrants,
prioritized the studies for review, and negotiated due dates
for the science reviews. One division director stated that
the scheduling process worked well with SRRD and they are
still working to improve the process with RD. The result of
the improvements in scheduling and coordination has been that
time schedules are being met, science division staff
understand what is expected of them, and there are fewer
complaints from RD and SRRD.
In 1993 the pesticide program made important progress in
improving the management process. Even when budgets were
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EPA'e Pesticide Program
cut, improving the management process remained a high
priority. In a June 1993 briefing for the EPA Administrator,
the program identified strengthening management as one of its
challenges for fiscal 1994. Improving the management process
should continue to be a high priority for the pesticide
program.
Changes Needed In The Organizational Culture
Years of criticism about program operations and completing
activities resulted in an organizational culture that did not
proactively attempt to correct problems. The pesticide
program was often aware of problems before they were
identified in audit reports, but did not always take action
to correct the problems. Management must be held accountable
for forthrightly addressing problems.
As shown by the examples in this report, the OIG and GAO have
reported problems in the pesticide program for many years.
In 1975, GAO issued a report entitled Federal Pesticide
Registration Program; Is It Protecting The Public And The
Environment Adequately From Pesticide Hazards? The overall
conclusion of the report was that consumers were not
adequately protected. The report described deficiencies in
areas such as inert ingredients, pesticide labeling, and
registration. Since 1975, many other reports have been
issued detailing deficiencies in almost all areas of the
pesticide program. Criticism became routine in the pesticide
program. According to pesticide program officials, the
criticism, combined with budget and staffing decreases during
the 1980's, made it difficult for the program to correct the
deficiencies it found, as well as those included in OIG and
GAO reports. This resulted in an organization culture that
did not proactively correct problems.
Over the past several years, there has been an emphasis on
changing the organizational culture in EPA. In 1991, the
then Administrator stated that he wanted to "encourage a
culture in which potential problems are forthrightly
identified and corrected." This emphasis continued under the
current Administrator. One of the Administrator's goals is
to make EPA a model of accountability in which there is a
balance of mission and management.
Changing organizational culture will take time, but is
necessary if management improvements are to be successful.
In the past several years, management of the pesticide
program has worked at improving how it directs and controls
its resources. These improvements will significantly affect
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EPA* s Pesticide Program
the pesticide program only after managers recognize that they
are accountable for how they manage the program.
CONCLUSION
Management improvements need to continue if EPA is to protect
human health and the environment from pesticide hazards.
Auditors have reported many uncorrected problems in the
pesticide program. The continuing problems are related to
how the program was managed. In 1993, the pesticide program
began to make improvements in the management process. These
improvements are important to directing and controlling
resources in the pesticide program, and need to continue in
the years to come. The pesticide program also needs to work
at changing its organizational culture and making management
accountable for forthrightly addressing problems. These
efforts will not only improve how the pesticide program is
managed, but can improve the credibility of the program.
AGENCY COMMENTS AND ACTIONS
The Assistant Administrator stated that she will continue to
emphasize management accountability. The pesticide program
found that its improved priority planning process had already
reaped valuable benefits in program management. The
Assistant Administrator recognized that, in times of budget
cutbacks and streamlining, a systematic approach to program
management, with improved follow-up to management decisions,
will enable the program to continue a high level of service
without sacrificing or compromising essential regulatory
initiatives.
The Assistant Administrator had established a Streamlining
Task Force, which has forwarded recommendations to the
Administrator. Included in the Task Force's report is a
commitment to retain an outside consultant to evaluate and
make recommendations for changes in the management structure
of the pesticide program. The Assistant Administrator will
make this audit report available to the consultant.
At the time of the Assistant Administrator's response, the
Agency was in the process of reorganizing its enforcement
activities, and the Office of Compliance Monitoring was to be
transferred to a new Office of Enforcement. The Assistant
Administrator stated that her office would ensure that it
continues to coordinate activities with enforcement
personnel.
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PIG EVALUATION
The Agency's actions will address our findings.
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CHAPTER 3
PESTICIDE INFORMATION MANAGEMENT SYSTEMS
NEED TO BE IMPROVED
The pesticide program had many computerized information
systems that often (!) contained inaccurate and incomplete
data, and (2) duplicated each other and were not integrated.
This happened for two main reasons.. One was the approach the
program took to information system development. The second
was that the program did not develop quality assurance
procedures to support its systems. Because of the extent of
the information management problems, we believe the program
may have a material weakness in internal controls related to
information management. In August 1992, the pesticide
program developed an information management strategy that
discussed several of our concerns. Funding of this strategy
needs to be an important priority.
Information management problems affected the program in many
ways. Staff members relied on inaccurate and incomplete data
when making decisions. In addition, the pesticide program's
divisions had difficulty coordinating work on the same
chemicals, because the different systems were not integrated.
We realize that pesticide program officials have stated that
the program has limited resources; however, we believe that
wisely investing resources in information management now can
make the systems operate more efficiently and effectively.
This will free up other resources in the future that the
program can use in other areas.
Information management systems were, critical to the pesticide
program's activities. The program relied on information
systems to make a variety of program management, budgetary,
enforcement, and regulatory decisions about pesticides. The
program also used the systems to provide information about
pesticides to Congress, industry and the public. In the
pesticide program, information management was critical,
because so much of the program's work was information
dependent and so many of its resources were devoted to
information management.
PESTICIDE PROGRAM HAD MANY INFORMATION SYSTEMS
As part of its 1992 information management strategy, the
pesticide program identified 23 computer systems that it used
to support its programs (see Exhibit 3). Many of these
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systems were on a Local Area Network (LAN), but were not
integrated with other systems. Some other systems were
"stand-alone" systems, for use on only one computer or by one
branch office. The list of 23 systems does not include all
of the systems in use for the pesticide programs.
INFORMATION SYSTEM DEVELOPMENT FOCUSED ON QUICK SOLUTIONS
When FIFRA was amended in 1988, the pesticide program quickly
began to build new systems to support the amended
legislation. Because of the short timeframes for meeting the
1988 FIFRA requirements, the pesticide program decided to
stress the quick development of office-wide systems. The
program made a conscious choice that quick systems
development would take priority over resolving data accuracy
and integration problems.
GAO found that the program developed a strategy based on
three premises (Report No. GAO/IMTEC-93-5). They were:
° speed of system delivery was more important than data
quality and reliability;
o systems would be built and modified while new or revised
work processes were being developed; and
o data integration efforts would be undertaken only after
the individual systems were developed and refined.
When a division needed a system to track information, the
pesticide program quickly developed a system to meet that
need. The program did not take time to consider all the
information that might be needed or what other divisions in
the pesticide program might need that would be related to the
system under development.
As a result of this approach, many of the systems did not
meet the needs of the program's different divisions. The
program found that, after systems were developed, other
divisions needed related information that could not be
included in the current system. Some divisions developed
their own systems, while others still lacked the systems they
needed. For example:
o The Environmental Fate and Effects Division (EFED)
developed its own system for tracking pesticide
incidents because the program's main system for this did
not include all the information EFED needed for its
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work. EFED's system was separate from the program's
main tracking system, but did duplicate some of the same
data. Also, EFED's system was not included in the 23
systems the pesticide program identified in its 1992
information management strategy.
The pesticide program's science divisions (EFED and the
Health Effects Division) did not have the information
systems they needed to assist in scheduling science
reviews. The science divisions' work supports the RD
and SRRD in regulating pesticides. One science division
director stated that a good management tool would be an
information system that would enable her to see what
work assignments were waiting from both RD and SRRD. RD
had a system that could help her division keep track of
the RD work assignments. However, there were several
problems with RD's system. First, the system was
developed for RD, without the science division's needs
in mind. Second, the system only covered RD and did not
include work from the SRRD. SRRD had its own separate
system. Another science division director agreed that
she found RD and SRRD's systems useless, because they
did not contain the information she needed. The
pesticide program now plans to integrate these systems.
DATA IN SYSTEMS WERE INACCURATE AND INCOMPLETE
The data contained in the many pesticide information systems
were often inaccurate and incomplete. The pesticide program
had not developed quality assurance procedures for checking
the accuracy of data that was input into its systems. The
pesticide program was aware of the need for quality assurance
procedures, but had not developed them. Consequently, the
pesticide -program had numerous data consistency, accuracy,
and completeness problems in its information systems. Having
inaccurate information systems caused the pesticide program
to use some of its scarce resources inefficiently. In
addition, when related systems were developed using already
existing information systems, data accuracy problems were
compounded. In fiscal 1993, according to pesticide program
officials, they made significant progress in improving the
accuracy and completeness of their primary databases.
Quality Assurance Problems Were Not Corrected
Both the OIG and GAO have reported concerns over the
integrity of pesticide databases. To address these concerns,
the OIG and GAO recommended that the pesticide program
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develop quality assurance procedures for the specific
databases reviewed. In its 1990 report on disinfectants, GAO
went further, recommending that the pesticide program
determine the extent to which data integrity problems applied
to other data on pesticides and take corrective actions
{Report No. GAO/RCED-90-139). The pesticide program still
has not developed written quality assurance procedures for
its databases.
In recent months, the Office of Information Resources
Management has been enhancing the Agencywide quality
assurance program. In conjunction with this effort, the
pesticide program needs to develop quality assurance
procedures for all of its databases. These procedures are
needed to maintain the integrity of all data in the
information systems. The procedures also help to ensure that
decisions are made based on data that are as accurate as
possible. Until the data in the current pesticide databases
are accurate and complete, the pesticide program cannot rely
on the data. As part of its information management strategy,
the pesticide program identified two critical areas for which
it plans to prepare quality assurance procedures (see page 22
for further details on the information management strategy).
Inaccurate Data Used To Build New Systems
The pesticide program used data, which it knew to be
inaccurate, to build files in some of its new information
systems. In 1990, GAO reported that the data in the
disinfectants databases were inaccurate, incomplete or
missing (Report No. GAO/RCED-90-139). According to GAO's
report, data quality problems existed because the program
lacked adequate procedures for ensuring that data were
accurately coded and entered into the systems. The program
also lacked procedures for ensuring that the data remained
up-to-date once entered. As a result, much of the data in
the systems may have been inaccurate or incomplete. In 1992,
GAO reported that the program then used this data to build
some of its new reregistration systems. Building new systems
on data known to be inaccurate compounds data integrity
problems and makes the new systems unreliable as well.
The information on disinfectants was included in the systems
that formed the central core of information for the pesticide
program. Three systems that contained disinfectants data
were the Pesticide Product Information System (PPIS), the
Pesticide Document Management System (PDMS) and the Federal
Insecticide, Fungicide, and Rodenticide Act and Toxic
Substances Control Act Enforcement System (FATES). PPIS
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served as the central storage place of basic data on
pesticide product registrations, such as product labels,
active ingredients, and uses. PDMS served as a central
archive of the documents or studies that registrants
submitted to the pesticide program to support pesticide
registrations. FATES contained data on, among other things,
the types and amounts of pesticides produced during the
current year and the amounts sold or distributed during the
previous year.
Scarce Resources Were UsedInefficiently
The inaccurate and incomplete1 databases caused the pesticide
program to use its resources inefficiently. For example, the
program manually reviewed registration files because the
information systems did not contain accurate data on inert
ingredients in pesticides. The pesticide program did correct
the two examples discussed below. However similar problems
exist in other information systems. As discussed later in
this chapter, in 1993, because of resource constraints, 'the
pesticide program was able to make only limited improvements
to the information systems. At the same time, the program
used its resources inefficiently because the information
systems were inaccurate and incomplete.
The 1991 DIG report on inert ingredients in pesticides
(Report No. 1100378) stated that the pesticide program
manually reviewed 20,000 registration files because its
computer database did not contain accurate or sufficient
information.9 Since at least 1984, the pesticide program
had been aware of, and not corrected, the inaccuracies in the
inert ingredient information in its database. Internal
documents from 1984 and 1987 indicated that information on
specific inert ingredients was difficult to retrieve and did
not accurately reflect the registrants' confidential
statements of formula (CSF). According to the OIG report,
for the 50 current registrations reviewed, almost half (22)
of the statements were not accurately reflected in the
database. Besides the database being outdated, this resulted
from a lack of quality assurance procedures. As of October
1993, the pesticide program was working to improve the
information on inert ingredients in its databases.
In October 1991, GAO testified that it was difficult for the
program to provide Congress with information on the number of
Section 6(a)(2), or adverse effects, studies registrants had
9Inert ingredients also were tracked as part of PPIS.
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submitted {Report No. GAO/T-RCED-92-16). Even though the
program had four systems capable of tracking this data, the
information the program provided to Congress was not
generated by any of the systems. The pesticide program was
unable to quickly obtain the status of the studies for
several reasons. First, the program's information systems
were not designed to distinguish Section 6(a)(2) studies from
other studies. Second, non-integrated systems required
individual systems to be accessed, queried, and cross-checked
for data reliability against other systems containing
duplicate information. Third, information pertinent to the
study's review status and actions remained in paper files or
was maintained by individual review managers in their own
word processing files. Cross-checking information in several
systems to ensure data reliability, and searching manual
files and individual computer files for information on
studies is an inefficient use of resources. Since the 1991
testimony, the pesticide program changed how it handles
Section 6(a)(2) studies, which, according to program
officials, will improve the accuracy of the information.
INFORMATION SYSTEMS PUPLICATIVE AND NOT INTEGRATED
The pesticide program developed many information systems that
often duplicated each other without integrating the systems.
The original strategy of the program was to develop and
refine the systems, then integrate the data. However, the
program had not invested the time and resources needed-to
integrate the many systems. Without integrated systems, the
different divisions within the program were often unable to
coordinate work. Also, since some of the duplicate systems
did not contain consistent data, the quality of the program's
decisions based on that data may have been impaired. The
pesticide program has recognized the importance of data
integration and is making progress in integrating systems.
Different Divisions Unable To Coordinate Work
An effect of having many information systems that were not
integrated was that different divisions within the pesticide
program could not always coordinate their work on the same
chemicals or products. If the pesticide program had better
designed and integrated its systems, pesticide program staffs
could more easily access each other's work. The program
could stop using its resources for following up on issues
where one division had information the other division needed
to perform its duties. Pesticide program officials stated
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EPA's Pesticide Program
that they are committed to developing a single, office-wide
tracking, scheduling and planning system.
Pesticide program staff and registrants have discussed with
us situations that occurred because information systems were
not integrated. A registrant told us that there appeared to
be a "hole" between RD and SRRD, as if they did not
communicate with each other. The registrant stated that it
sometimes sent studies to both divisions just to ensure that
everyone who needed the study received it. Other examples
included:
o A division director told us that he had found cases
where SRRD identified concerns with a chemical, while RD
was registering a new product with the same chemical.
He stated that merging the RD and SRRD's systems would
help the program more readily identify these situations.
o Another registrant we spoke with said it canceled a
product with RD and assumed SRRD was aware of the
cancellation. However, SRRD kept notifying the
registrant it had to submit data to support the
product's reregistration. Eventually, SRRD canceled the
product because the registrant never.submitted the data.
If SRRD and RD's systems were integrated, both divisions
would be aware of the status of all products. Resources
would not be wasted canceling a product that a
registrant had already voluntarily canceled.
DataDid Not Always Match In All Pesticide Systems
GAO identified several instances where data -that was
duplicated in several different information systems did not
always match. Having many information systems that duplicate
each other can result in inconsistencies between databases,
if the systems are not integrated. For example, GAO found
that separate reregistration systems often duplicated each
other. Tn order for the program to ensure that all
information in the systems remained accurate and up-to-date,
all data changes made in one system needed to be synchronized
across every other system with the same data.. However, at
the time of GAO's review in 1992, there were no procedures in
place to ensure that this synchronization occurred (Report
No. GAO/IMTEC-93-5). Subsequent to the report, these systems
were integrated.
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THE PESTICIDE PROGRAM DEVELOPED AN INFORMATION MANAGEMENT
STRATEGY
In August 1992, the pesticide program developed a 5-year
pesticide information management strategy. According to the
strategy, the fiscal 1993 priorities were to locus on:
o further identifying the needs of the program,
e establishing and maintaining both scientific and
regulatory precedents,
o improving data accuracy and reliability,
o increasing productivity, and
o pursuing universal information management literacy.
We were very encouraged by the program's actions in
developing the information management strategy. The strategy
listed as its priorities several issues addressed in this
report. However, because the program was only able to
provide limited funding in fiscal 1993, little progress was
made. Unless the program places a higher priority on
information management and funds it, the program will not
make much progress in this area.
We recognize that the program does not have unlimited
resources to solve its information management problems.
However, wisely investing resources in information management
can result in future cost savings for the pesticide program.
We have identified in this report several areas where
resources, both time and money, could be saved if the
problems with the information systems were corrected. By
investing resources in the systems now, the program can make
its systems operate more efficiently and effectively. This
will free up other resources in the future that the program
can use in its other operations.
INTERNAL CONTROLS FOR INFORMATION MANAGEMENT ARE INADEQUATE
The program's inability to ensure the accuracy and
completeness of the information it bases its decisions upon
may be a material weakness in internal controls under FMFIA.
A material weakness exists when the office lacks reasonable
assurance that its objectives are being accomplished.
Everything the pesticide program does and all the decisions
it makes are based on information. As a result, managing
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that information is very important to the program's success.
The program must place a higher priority on information
management issues to ensure that it is accomplishing its goal
of protecting humans and the environment from the harmful
effects of pesticides. Therefore, the pesticide program
should consider information management as a weakness in its
annual assessment of internal controls.
CONCLUSION
The pesticide program relies upon its many information
systems to make critical decisions affecting human health and
the environment. The data in the information systems were
often inaccurate and incomplete. The systems were also
duplicative and not integrated. During fiscal 1993, the
pesticide program made steady, but limited, progress in
improving its information systems. The pesticide program
needs to place a higher priority on managing its information
systems. It needs to wisely invest resources into the
information systems now so that future cost savings can be
realized. This will increase public and Congressional
confidence in the program's ability to protect human health
and the environment.
AGENCY COMMENTS AND ACTIONS
In responding to the draft report, the Assistant
Administrator stated that the pesticide program had
instituted internal "Alternative Management Control" reviews
in which it identifies areas in need of. special attention.
Semi-annual reports are submitted to the Office Director for
each of the areas identified. The Information Management
Strategy was identified in this system during the fiscal 1994
FMFIA process, and reports are due in April and September.
As the pesticide program goes through the FMFIA process for
fiscal 1995, it will reassess progress on the strategy and
incorporate the results into 1994 annual assurance letter.
During 1994, the pesticide program funded key elements of the
information management strategy. In 1994, the program
devoted $445,000 and 4.3 full-time equivalent (FTE) to two
projects, each to integrate several major tracking systems.
In the future, the program expects to focus on integrating
inventory and tracking systems in order to determine not only
basic information about chemicals and uses, but the program
will also be able to find out the current status of
regulatory activities.
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PIG EVALUATION
The Agency's actions, when completed, will address the
findings in this chapter.
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CHAPTER 4
REGULATIONS, POLICIES. AND PROCEDURES NEED
TO BE DEVELOPED AND IMPROVED
The pesticide program often operated (1) with regulations
that were not up-to-date or finalized, and (2) without
policies and procedures for numerous program activities.
This happened because the program did not consider
development and revision of regulations, policies, and
procedures to be a priority. Without this guidance 'to serve
as internal controls, the pesticide program (1) cannot be
sure that it is effectively controlling operations, and (2)
may have difficulty enforcing its regulations. Because the
regulations were not up-to-date or finalized, the registrants
were not always clear what the pesticide program expected
from them. In 1992, the pesticide program set up a new
division to handle policy issues. The division's role was
still being defined at the time of our review. If this
divisions responsibilities include activities related to
developing and updating regulations, policies, and
procedures, many of our concerns will be addressed.
We identified several instances where the pesticide program's
regulations no longer reflected what the program was actually
doing. For instance, product managers used a combination of
current regulations, proposed revisions to those regulations,
and pesticide regulation notices, when evaluating pesticide
labels. Using such a combination of rules in evaluating
labels created uncertainty for the registrants and made it
difficult for them to know what information -was required on a
pesticide label.
GAO and OIG reports also identified problems with policies
and procedures in numerous program areas. For example, the
absence of policies and procedures contributed to the release
for sale in the United States of unregistered pesticide
imports. Staff members responsible for the import program
used their own judgement for admitting or rejecting pesticide
products since they did not have uniform policies and
procedures to follow. The pesticide program generally took
action to develop policies and procedures in the areas
mentioned in GAO and OIG reports. However, the pesticide
program needs to ensure that these documents exist in all
areas where they are needed.
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POLICIES. PROCEDURES AND REGULATIONS ARE IMPORTANT INTERNAL
CONTROLS
Policies and procedures are an important part of internal
control documentation. The Office of Management and Budget's
Circular A-123 requires policies and procedures to be
maintained. They also provide the foundation for an
effective program or activity. In addition, policies and
procedures provide management with objective criteria for
monitoring and evaluating an office's performance. To a
certain extent, the success or failure of a program or
activity can be directly related to the policies and
procedures that guide the personnel responsible for the
activities. Because of this, the OIG and GAO have often
pointed out to the pesticide program the importance of
developing and following policies and procedures.
Up-to-date and finalized regulations also serve to
effectively control operations. Regulations are important
for two main reasons. First, they tell registrants what they
need to do to register a pesticide. Second, up-to-date
regulations make enforcement easier. When something other
than what is in the regulations is followed, those affected
by the regulations (in this instance, primarily the
registrants) are frustrated. They are not sure what
regulations will be enforced.
REGULATIONS NOT UP-TO-DATE OR FINALIZED
Several audit reports have described instances where the
pesticide program's regulations were not up--to-date or
finalized. The regulations did not always reflect the
program's activities. The pesticide program also had been
slow to complete its regulations. Unclear regulations or
regulations that are not being followed cannot be easily
enforced and, therefore, program activities may not be
carried out the way they were intended. Also, registrants do
not know what to expect from the pesticide program or how to
meet the requirements for pesticide registration.
Regulations Did Not Always Reflect Program's Activities
We identified several instances where the pesticide program's
regulations no longer reflected what the program was actually
doing. In some cases, the program had developed revisions to
the regulations, but had not finalized the revisions. In
other .instances, the program had not even developed official
revisions, although it had changed its processes. When the
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program no longer follows its standing regulations, its new
requirements are not enforceable. Furthermore, unofficially
making such changes confuses the registrants and the public,
who may not know what the Agency expects or plans to
implement.
Product Managers Used A Combination Of Rules
To Evaluate Labels
A 1992 DIG report (Report No. 2100613) found that product
managers used a combination of current regulations, proposed
revisions to those regulations, and pesticide regulation
notices when evaluating pesticide labels. In 1984, the
pesticide program proposed to revise and expand its labeling
regulations. However, according to pesticide program
officials, they did not finalize the revisions because of
other priorities. Even though the program did not finalize
the proposed revisions to the regulations, product managers
used them, along with other rules, when reviewing and
accepting pesticide labels. According to pesticide program
officials, if there is conflict between existing regulations
and the 1984 proposed changes, and a registrant challenges
EPA decision, then the current regulation would be enforced.
However, not finalizing the regulations created uncertainty
for the registrants and made it difficult for them to
understand the wording needed on a pesticide label.
In response to the 1992 OIG audit report, the program agreed
to review the current labeling practices to determine if and
when the regulations should be revised. In February 1993,
the pesticide program withdrew the proposed revisions from
the regulatory process. According to program personnel, they
withdrew the regulations because they were-proposed so long
ago (nine years) that the regulations will need to be
reproposed.
Regulations For Special Reviews Of Pesticides Did Not
Reflect Current Agency Practice
To reduce the time it took to conduct a special review under
its regulations, the pesticide program began to frequently
use alternative processes. A 1993 OIG audit found that this
was a significant change from the regulations (Report No.
3100256). The regulations for special review do not reflect
the pesticide program's current approach of using
negotiations to achieve risk reductions. The regulations
need to be revised to more accurately reflect the program's
approach to risk reductions.
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Pesticide Program Slow To Complete Regulations
The pesticide program had been slow to complete its
regulations. Without completed regulations, the pesticide
program was left with no enforceable guidelines to implement
its activities. During the years that pass without
regulations, human health and the environment continue to be
threatened.
Many of the regulations that were within one year of
completion in 1990 still had not been completed by 1993. We
compared the October 1993 Agency semiannual regulatory agenda
with the agenda from April 1990. The semiannual regulatory
agenda included regulations in proposed and final stages.
Only 7 out of the 20 rules (35 percent) in the 1990 agenda
had been completed or withdrawn from the regulatory process.
Almost half (9) of the 1990 rules had not even changed
categories to become closer to completion (see Table 1).
Table 1
Changes in Regulatory Agenda Status
Between April 1990 and October 1993
Kind of Change
None - in same category
Moved from proposed to final stage '
Withdrawn before completed
Completed - final action taken
Number
of Rules
9
4
4
3
We identified several specific cases where the pesticide
program had been slow to develop and revise its regulations.
As discussed earlier in this chapter, since 1991, the program
had been planning to revise the regulations that established
what data registrants were to submit to support their
registrations. The notice of proposed rulemaking for this
regulation is now scheduled for April 1994. Another instance
of the slow progress is that it has been almost five years
since Congress amended FIFRA and called for a new regulation
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for pesticide management and disposal. The program still has
not completed this regulation. The program has separated the
regulation into three different parts. In May 1993, it
published one of the three parts for public comment. A
second part was ready for Office of Management and Budget '
review in March 1993, while the program just started working
on the third part in February 1993.10 Pesticide program
officials stated that the regulations were late because of
the complicated rulemaking process and the complex and unique
issues that had to be addressed. It has already taken almost
five years to get this far, with no part of the regulation
finalized. It may take several more years before all of this
regulation is completed.
PESTICIDE PROGRAM LACKED POLICIES AND PROCEDURES
Numerous audit reports have cited a lack of policies and
procedures as causing problems in the pesticide program.
Without policies and procedures in place to guide program
personnel, management cannot be sure that staff are
consistently implementing the pesticide program's activities.
Leaving employees to rely on their own judgment or experience
can result in great variances between how they handle similar
activities. This creates problems for registrants who may
have to deal with several different staff members.
Both the OIG and GAO have identified instances where staff
members were left to rely on their own judgement rather than
policies and procedures. Because the lack of policies and
procedures is so wide-spread, the pesticide program has
little control over how the program's activities are
implemented. As a result, the program's activities may not
have been carried out fairly and consistently. Several
examples are given below.
No Procedures To Ensure Consistent Label Reviews
Precautionary labeling statements for many pesticide products
did not meet regulatory requirements. A 1992 OIG report on
pesticide labeling stated that this occurred because the
program did not have procedures to be sure product managers
were consistent in their reviews of pesticide labels (Report
No. 2100613). As a result, the labeling statements on
pesticides may not adequately protect humans and the
10 The third part of the regulations, while related, was not
required in FIFRA.
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environment from unnecessary risks. Also, registrants were
often confused about what wording was needed on a label,
because of differences between product managers. After the
OIG report was issued, the pesticide program formed several
workgroups to address labeling issues, including developing a
guide for reviewing labels.
No Guidelines For Determining Whether Pesticides Are
Substantially Similar
A 1992 OIG survey of the pesticide registration process found
that there were no guidelines for determining when products
are substantially similar (Assignment No. E1EPF2-11-0036).
As part of the 1988 FIFRA amendments, Congress created a
"fast track," or expedited registration, of applications that
the program determined to be substantially similar or
identical to products already registered. The opinion of
when products are substantially similar varied within the
pesticide program. For instance, there were different
criteria for determining similarity from a product chemistry
and a precautionary labeling point of view. In the absence
of established guidelines, the pesticide program cannot be
sure that consistent and fair decisions were made when
determining whether products were substantially similar.
No Policies AndProcedures For Pesticide Import
Activities
The absence of policies and procedures contributed to
problems in the pesticide import program. The regional staff
members who conducted the import program were using their own
judgment for admitting or rejecting pesticide products that
did not match the known registration data. According to the
1988 OIG report, the lack of policies and procedures
contributed to the release for sale in the United States of
unregistered pesticide imports (Report No. 81660). In
response to the OIG report, the Office of Compliance
Monitoring provided more guidance to the regional staff and,
as of October 1993, is working with U.S. Customs Service to
develop a memorandum of understanding to define roles and
responsibilities for monitoring imports.
No Guidance For Conducting Lab Inspections And Data
Audits
The pesticide program had not developed guidance for
conducting inspections and data audits at labs that had
performed studies on the effectiveness of disinfectants.
a result, the staff auditing the .data relied on their
As
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professional judgment rather than program guidance. In
addition, GAO's 1990 report (Report No. GAO/RCED-90-139)
stated that the pesticide program had not published
guidelines specifying what types of inspection or audit
findings would prompt registration or enforcement action.
The program also had not specified the type of action it
should take in each case, without guidelines on;what types
of findings will result in Agency actions or what those
actions should be, the program cannot be sure that similar
violations are treated consistently and fairly.
NEW DIVISION MAY ADDRESS OUR CONCERNS
In 1992, the pesticide program proposed to create the Policy
and International Affairs Division {PIAD) to handle policy
issues. While the program has not determined the division's
specific .responsibilities, they may include some activities
related to developing and updating regulations, policies, and
procedures. In organizing PIAD, the pesticide program showed
that it was placing a higher priority on regulations,
policies, and procedures. We strongly support this step.
Centralizing responsibility for ensuring that regulations,
policies, and procedures are up-to-date, adequate and
finalized may help address many of our concerns. According
to pesticide program officials, until the new division is
completed, the functions of regulatory oversight and
coordination have been focussed to a greater extent in the
current Policy and Special Projects Staff.
CONCLUSION
Regulations, policies, and procedures are an important part
of any program's internal control system. In many instances
in the pesticide program, these documents were out-of-date,
non-existent or not being followed. The pesticide program
corrected areas which were mentioned in audit reports, but
there is still an overall issue that needs to be addressed.
Without regulations, policies and procedures to serve as
internal controls, the program's management cannot be sure
that the program activities and objectives are being met.
The pesticide program needs to focus on developing,
completing and implementing the necessary regulations,
policies, and procedures. This will help to ensure that the
program's activities are being carried out consistently and
fairly when protecting human health and the environment. It
will also help the program to improve its reputation with the
public and Congress.
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AGENCY COMMENTS AND ACTIONS
In responding to the draft report, the Assistant
Administrator stated that, as part of its priority planning
process, the pesticide program has surveyed the list of
regulations and policies needing work, compared them to
competing projects, and determined which regulatory efforts
are the greatest priority. The pesticide program has funded
areas of greatest priority, including Part 158 regulations,
issuance of the proposed rule on container design and residue
removal regulations11.
The Assistant Administrator also stated that, as part of
Executive Order 12866, each agency must submit to the Office
of Management and Budget a plan for periodically reviewing
its regulations, with a view to modifying or updating them.
The pesticide program's effort during 1993 was on Part 158
regulations, FIFRA Section 6(a)(2) reporting requirements,
and review of regulations and policies affected by the
Delaney clause of FFDCA.
PIG EVALUATION
The Agency's actions will address the findings in this
chapter.
11 40 Code of Federal Regulations Part 185 addresses data
requirements for registration.
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CHAPTER 5
PESTICIDE PROGRAM BUDGET HISTORY
The pesticide program experienced significant decreases in
resources and staff during the 1980's. During the same time,
the program's responsibilities grew. The pesticide program
has repeatedly attributed the reasons for delays in
activities to lack of funds. In order to determine whether
the pesticide program has sufficient resources, the pesticide
program needs to perform a study of it resource usage and
needs. Depending on the results of the study, the program
could use the study to request the needed resources.
SOURCES OF FUNDING
The pesticide program receives funding from three sources:
the Congress, the Tolerance Fund, and the FIFRA Fund.
Tolerance Fund •
FFDCA allows EPA to collect fees from companies to cover the
cost of establishing tolerances for raw agriculture
commodities. A tolerance is the maximum legal limit of a
pesticide residue allowed on food commodities and animal
feed. EPA establishes tolerances to prevent consumer
exposure to unsafe levels of pesticide residues. FFDCA
authorized EPA to promulgate regulations to require payment
of fees that will be sufficient to provide, equip and
maintain an adequate service for establishing raw
agricultural tolerances. EPA does not have the authority to
collect the cost of food additive tolerances.
Even though the law allows the pesticide program to collect
fees to cover the cost of establishing the tolerances, it has
not been doing so. A recent audit of the tolerance fund
(Report No. 3100265) found that for 1992, the pesticide
program collected about $1.2 million in fees, while total
cost for processing the tolerances was about $3.5 million.
The audit found that, according to program officials, after
fees were revised in 1986, the pesticide program made a
conscious decision to consider only increases in personnel
compensation and benefit costs when tolerance fees were
revised. However, the law allowed the pesticide program to
collect fees to cover the cost for establishing the
tolerances. In response to the report, the Acting Chief
Financial Officer agreed to have the pesticide program
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conduct a review of the cost associated with processing
tolerance petitions to determine if the fees should be
raised. Raising fees should provide much needed revenue.
FIFRA Fund
The 1988 amendments to FIFRA mandated an accelerated
reevaluation of pesticide products registered prior to
November 1984, commonly known as reregistration. To pay for
reregistration, Congress authorized EPA to collect two types
of fees: a one time reregistration fee for each active
ingredient and an annual registration maintenance fee to be
paid for each registered product. The fees collected are
deposited to the FIFRA Fund.
The pesticide program did not collect as much maintenance
fees as Congress expected. FIFRA instructed EPA to, as close
as practicable, collect $14 million per year in maintenance
fees. As shown in the table below, it was not until 1992
that the pesticide program collected $14 million in one year.
If the program had collected the $14 million each year, the
program would have had about an additional $12 million to use
for reregistration.
Year
1989
1990
1991
1992
Maintenance Fees
Collected
$ 7,377,000
11,520,000
10,821,000
15,171,000
The reasons for the shortfall were that (1) there were limits
on how much a company would have to pay, and (2) the number
of registrations supported by payments of the maintenance fee
turned out to be much lower than anticipated. The maximum
fee, as defined in FIFRA, a company would have to pay was
$20,000 if it had less than 50 registrations, and $35,000 if
it had more than 50 registrations. In 1991, Congress raised
the limits, which increased the fees paid by larger
registrants. A decrease in the number of registrations also
contributed to the shortfall in maintenance fees. In 1989
alone, the number of registrations went from about 44,000
down to about 25,000 because companies did not pay their
maintenance fees. Many of the products for which companies
did not pay fees were no longer being produced.
As of 1992, the pesticide program collected the authorized
amount of fees. However, FIFRA only allows the pesticide
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EPA's Pesticide Program
program to collect maintenance fees through 1997, which was
when reregistration was to be completed.. Since
reregistration is not expected to be completed until 2006,
the pesticide program will lose this critical source of funds
unless the Congress reauthorizes the collection of
maintenance fees through the completion of reregistration.
EPA is working with Congress to extend the fees.
1992 Audit Of The Tolerance and FIFRA Funds
The Chief Financial Officer Act of 1990 required EPA to
prepare financial statements for its revolving funds,
including the Tolerance and FIFRA Funds. The Inspector
General is required to audit the financial statements.
Fiscal 1992 was the first year these statements were prepared
and audited. The objective of the audit was to express an
opinion on whether the financial statements were fairly
presented. The audit found weaknesses in key internal
accounting controls for both funds (Report No. 3100265).
These weaknesses contributed to the DIG not being able to
determine if the financial statements were fairly presented.
RESOURCE AND STAFFING LEVELS
During the 1980's, the pesticide program's budget decreased
both in resources and staffing. (See page 38 for charts on
resources and staffing.) With the additional fees to fund
reregistration, the program's budget returned to, and then
exceeded, the level it was in 1979. When viewed from the
perspective of constant dollars, it was not until 1990 that
the pesticide program attained the same, level of resources it
had in 1980. The same conclusion can be drawn from staffing;
in 1991, the pesticide program reached the same staffing
level it had in 1980.
Increases in funding during the late 1980's came from fees
registrants paid for reregistration. Without these fees, the
program's budget level (staffing and resources in constant
dollars) would still be lower than it was in 1979 and 1980.
While fees have helped EPA make reregistration decisions, the
fees, as discussed above, will run out before reregistration
is completed. EPA is working with Congress to extend the
fees past 1997.
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Chart 1. Pesticide Program Resources 1979 - 1993 J
100
10 -
1979 I 1981 J 1983 I 1985 | 1987 | 19B9 | 19'91 | 1993
19BO 1982 1984 1985 19BB 1990 1992
Chart 2. Pesticide Program Resources 1979 - 1993 1<2
(1979 Dollars)
10 -
1979 I 19B1 | 1983 | 1985 | 1987 | 1989 | 1991 | 1993
1980 1982 1904 1986 1988 1990 1992
>:-3 Appropr i at i or- g\^ Tolerance Puna V///>(,
Pund
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Chart 3. Pesticide Program Staffing 1979 - 1993
100 -
1979 | 1981 | 19B3 | 1985 | 19B7 | 1989 ] 1991 | 1993
19SO 1982 198-4 1986 19B8 1990 1932
Appropriation
Tolerance Fund
f I FBA Fund
Chart Notes
The pesticide program provided the information used to
prepare the charts. With the exception of 1992, the amounts
for the Tolerance and FIFRA funds have not been audited.
Also, the OIG was not able to render an opinion on the 1992
financial statements for the Tolerance and FIFRA funds.. As a
result, we cannot•attest to the accuracy of the information
presented. However, we believe the charts provide a general
indication of the resources available to the program.
The figures in charts 1 and 2 are in millions of dollars.
The charts do not include resources and staffing for
enforcement and research'and development since these areas
were not included in the scope of our review. Also, the
charts do not include resources and staffing associated with
the disposal of banned pesticides. Prior to 1988, EPA was
required to accept -banned pesticides and dispose of them at. :
Government expense. Yearly costs for disposal ranged from $2
million to $41 million.
In chart 2, the resource levels are adjusted to 1979 constant
dollars. Adjustments were made using the yearly Gross
National Product Implicit Price Deflators.
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Delays In Program Activities Frequently Attributed To
Resource Constraints
For many years, audits have reported uncorrected problems in
the pesticide program. (See Chapter 2 for further details.)
Lack of resources was one reason pesticide program officials
gave for not correcting problems. To ascertain whether the
program does have enough resources to carry-out its
responsibilities, it needs to perform a study of its resource
use.
During the 1980's, the pesticide program was criticized for
not completing activities timely. At the same time the
program was taking on new responsibilities. In 1980, the
pesticide program was criticized for the pace of decisions in
the registration standards and rebuttable presumption against
registration programs, predecessors of the reregistration and
special review programs. The new or increased
responsibilities included product specific reregistration,
groundwater protection, worker protection, biotechnology,
disposal of pesticides and endangered species. As a result,
the pesticide program's budget decreased as responsibilities
and pressure to achieve results increased.
Budget levels is one reason program officials have given for
not implementing audit report recommendations. For example,
a 1991 DIG report (Report No. 1100378) found that the
pesticide program was not reviewing the potential effects of
inert ingredients in pesticides. The program agreed that
corrective action was needed, but the Acting Assistant
Administrator stated that action was delayed because of
budget cuts. Also, in a 1993 report on the -special review
process, the pesticide program agreed that guidelines for
initiating special reviews were needed (Report No. 3100256).
However, the Agency stated that funding was not available for
preparing the guidelines.
To answer the question of whether the pesticide program has
sufficient resources to carryout its responsibilities, the
program needs to conduct a study of how it uses its
resources. The study should look at:
o whether the program is using its current resources most
efficiently, and
o what resources are needed to carryout responsibilities
not currently being completed.
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Only after the program conducts a study will it be able to
determine whether it has sufficient resources.
CONCLUSION
According to pesticide program officials, budget cuts during
the 1980's significantly affected its ability to carry out
its growing responsibilities. To increase its resources, the
pesticide program can collect tolerance fees to cover the
cost of processing tolerances. The pesticide program needs
to-conduct a review, in conjunction with the Chief Financial
'Officer, of the cost associated with processing tolerance
requests in order to recover those costs.12 The pesticide
program also needs to continue to work with Congress to
extend the authority to collect reregistration fees past
1997. Finally, the pesticide program needs to perform a
study of its resource usage and needs to determine if
additional funding is needed.
AGENCY COMMENTS AND ACTIONS
In responding to the draft report, the Assistant
Administrator stated that the pesticide program's new
priority planning process adequately assesses current
resource .and funding needs within the context of long-range
goals. The pesticide program was confident that a study of
resource usage and needs would show that the program cannot
possibly accomplish all that is expected with its existing
resources. In the current environment of budget cuts, the
pesticide program did not believe an additional study would
be an efficient use of resources. Resources could more
profitably be devoted to core improvements in the program
that could alleviate other problems identified in this
report.
The program was working with Congress in amending FIFRA and
FFDCA. Included as part of the legislative package was
provisions for tolerance and registration fees. In
developing the legislative package, the pesticide program is
also preparing a costing package.
12 The OIG recommended that this review be performed in its
1992 audit of FIFRA and Tolerance Fund Financial Statements
{Report No. 3100265).
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EPA'B Pesticide Program
PIG EVALUATION
The DIG accepts the pesticide program's decision not to
perform a detailed study of resource usage and needs. We ask
that the Assistant Administrator provide a copy of the
legislative costing package to our office when it is
completed.
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EPA's Pesticide Program
CHAPTER 6
ACTIONS TAKEN TO IMPROVE DATA INTEGRITY
Ensuring the integrity of data registrants submit is
essential to the pesticide program. In recent years,
weaknesses have been identified in the (1) Good Laboratory
Practices (GLP) program, (2) quality of disinfectant
effectiveness studies, .and (3) pesticide program's review of
information concerning adverse effects of pesticides. Each
of these areas were designed to ensure the integrity of data
supporting pesticide registrations. The pesticide program is
taking action to improve each of these areas. These actions
need to continue in order for the program to ensure the
integrity of scientific data.
IMPORTANCE OF DATA INTEGRITY
Important decisions on the safety and effectiveness of
pesticides must be based on adequate and reliable data. To
produce such data, studies need to be conducted with
qualified personnel, according to.scientifically sound
protocols with a detailed attention to quality controls. The
reliability of data submitted in support of product
registrations is essential if EPA is to regulate pesticides
to protect human health and the environment.
FIFRA requires registrants to demonstrate that their products
meet safety and health requirements. Registrants either
perform studies in-house or contract with a laboratory. In
the late 1970's problems began to surface in laboratories
generating study data. As a result, EPA established the GLP
program. The pesticide program established standards to
specify the minimum practices and procedures which
laboratories and registrants must follow to ensure the
integrity of the pesticide data they submit.
To be sure that the pesticide program had up-to-date
information on the effects of registered pesticides, in 1972,
Congress added section 6(a)(2) to FIFRA. The section reads:
If at any time after the registration of a
pesticide the registrant has additional factual
information regarding unreasonable adverse effects
on the environment of the pesticide, he shall
submit such information to the Administrator.
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According to EPA, section 6(a)(2) was enacted to ensure EPA
promptly receives any data possibly leading it to conclude
that the use of a pesticide may pose unreasonable health and
environmental risks. This is especially important because
most pesticides used today were initially registered before
current scientific standards were imposed. Until
reregistration is complete, EPA's position is that section
6(a)(2) will act as a safety net for identifying and removing
potentially dangerous pesticides from the marketplace.
ACTIONS TAKEN TO IMPROVE DATA INTEGRITY
In recent years the pesticide program has improved its
ability to ensure the integrity of the data registrants
submit. These improvements came as a result of several
reports and a pesticide spill which called into question the
quality of the GLP program, disinfectant effectiveness data,
and the review of adverse effect reports. Based on the DIG
reports and an OCM review, the Agency reported data integrity
as a material weakness in internal controls in 1991 and 1992.
Good Laboratory Practices Program
In 1991 and 1992, the OIG issued two reports concerning
weaknesses in the GLP program (Report Nos. 1400064 and
2100661). One report found that the OCM was not inspecting
all laboratories which conducted pesticide testing. OCM was
inspecting about 200 laboratories, when the actual universe
was around 800 laboratories. The second report found that
when selecting laboratories for inspections, OCM did not
adequately consider products the pesticide program was
currently reviewing. As a result, inspection reports were
not available to the science divisions when they were
reviewing scientific data. In response to the reports, OCM
began inspecting many of the laboratories which had not been
previously inspected. OCM also expanded its computer system
that it used to target inspections so that inspections would
focus on studies with registration and reregistration
decisions pending.
The GLP reports also found that EPA had no standards for
determining if a specific GLP deficiency would compromise the
validity of a study and result in study rejection. The
pesticide program had never rejected a study because of GLP
deficiencies. Acceptance or rejection standards would enable
a reviewer to reject a study based on a significant GLP
violation. OCM and the pesticide program are working to
develop a list of violations that would likely lead to study
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EPA*B Pesticide Program
rejection. The list was expected to be completed by November
1993.
In recent years the pesticide program has also been
considering how it can improve its GLP program. At the
request of the program, the DIG conducted a study of what
other organizations, both public and private, were doing to
ensure the accuracy and reliability of laboratory data
(Report- No. 2400032). The report concluded that a national
laboratory accreditation system would benefit the pesticide
program and the individual laboratories and provide greater
assurance of the integrity oflaboratory data. The pesticide
program is reviewing the feasibility of a laboratory
accreditation program.
Integrity of Disinfectant Efficacy Data
A 1990 GAO report found that EPA lacked sufficient control
over the quality and integrity of registrant submitted data
on the effectiveness of disinfectants (Report No. GAO/RCED-
90-139) . GAO found a number of weaknesses, including that
EPA had not:
o identified all labs to be audited,
o observed tests while they were in process,
o prepared and processed "inspection reports timely, and
o issued guidelines for inspectors to use during
.inspections.
In its report, GAO stated that the only way for EPA to
determine whether a registrant had submitted only selective
data or had deliberately submitted invalid data was by
testing the product. GAO recommended that EPA look into
alternatives for operating a laboratory to test the
effectiveness of disinfectants.
In response to the report, EPA reported the disinfectant
program, including the data integrity assurance process, as a
material weakness in internal controls for 1990, 1991, and
1992. As part of the corrective action, EPA signed an
Interagency Agreement with the Food and Drug Administration
(FDA). FDA will test products prior to registration to
determine if the study data supporting the registration is
questionable. The pesticide program also entered into a
contract with one of EPA's Cincinnati laboratories for
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EPA's Pesticide Program
additional product testing for tuberculocides and hospital
disinfectants.
Review Of Data On Adverse Effects
After a spill of the pesticide metatn sodium into the
Sacramento River in 1991, the pesticide program discovered
that it had not reviewed information that indicated the
pesticide could cause birth defects. Subsequent to the
incident, GAO testified that the pesticide program did not
require registrants to specifically identify information on
adverse effects. As a result, the information may not
receive the program's immediate attention. The studies on
adverse effects of metam sodium were unreviewed for over four
years.
The pesticide program changed the way it reviews submissions
relating to adverse effects of registered pesticides. The
program set up a special team of reviewers who are
responsible for tracking submissions on adverse effects.- The
program was also finalizing its regulations on submitting
adverse effect data.
CONCLUSION
Because the pesticide program relies upon data registrants
submit, ensuring the integrity of the data is essential. The
pesticide program has recognized the importance of ensuring
(1) the accuracy and reliability of the data submitted, and
(2) that it reviews all data on adverse effects of registered
pesticides. In 1991 and 1992, EPA reported -data integrity as
a material weakness in its internal controls. The program
has a corrective action plan for improving data integrity
which will address many of the issues included in OIG and GAO
reports. The pesticide program, in conjunction with OCM,
needs to continue to implement its corrective action plan.
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CHAPTER 7
CHANGES IN FIFRA COULD BENEFIT THE PESTICIDE PROGRAM
Revisions to the pesticide law would enhance enforcement and
streamline the cancellation process. The pesticide program
has identified sections of the pesticide laws that inhibit
performance of the program's activities. OIG audit reports
have confirmed some of these problems.13 For instance, OIG
reviews have found that (1) the law has limited the pesticide
program's enforcement authority in several program areas, and
(2) the cancellation process, as outlined in the law, can
take four to eight years to complete. As a result of these
problems, the program was unable to effectively carry out
some activities. The Agency has requested that Congress make
these changes to FIFRA. We support the Agency's efforts to
bring about the changes and encourage them to continue.
FIFRA LIMITED THE .PESTICIDE PROGRAM'S ENFORCEMENT AUTHORITY
OIG reviews have found that FIFRA's enforcement provisions
have limited the pesticide program's enforcement authority in
several program areas. First, the maximum civil penalty
under FIFRA was $5,000, as opposed to $25,000 under other
environmental statutes. Second, an OIG review of the GLP
program found that stronger enforcement authority was needed
for the GLP program {Report No. 1400046). Finally, the
program did not enforce its .toxic inert ingredient
requirements, because FIFRA prohibited the release of inert
ingredient information to the states. The low level of
penalties provided for under FIFRA and the lack of
enforcement activities (1) gives the wrong message to
industry, and (2) implies that FIFRA violations are not a
high priority and no penalty, or a very small penalty, will
result from not complying.
Higher Civil Penalties Needed For- FIFRA Violations
The relatively small civil penalties under FIFRA hindered
strong enforcement. The current FIFRA is one of the weakest
environmental protection statutes in terms of the penalties
13 In this chapter we discuss the problems with the law that
our audit reports have confirmed. Because we have not reviewed
any problems under FFDCA, we are unable to comment on the effects
those problems have had on the pesticide program.
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EPA's Pesticide Program
that can be assessed for significant violations. The maximum
civil penalty is $5,000 per violation for persons who sell,
distribute, or commercially use, pestiiides. Other persons
who violate FIFRA may be assessed a penalty of not more than
$1,000 for each offense, after they have received a written
warning or citation for a prior violation. Other
environmental laws, such as the Clean Air Act, the Toxic
Substances Control Act and the Comprehensive Environmental
Response, Compensation, and Liability Act, all have a maximum
penalty of $25,000. In.1972, when the penalty provisions
were first added to FIFRA, a $5,000 penalty would have been
considered significant. However, no major changes have been
made to the penalty provisions in over twenty years.
Stronger Enforcement Authority Needed For GLP Program
The GLP program currently lacks a strong enforcement
authority under FIFRA. FIFRA does not specifically mention
the GLP program. In addition, if a company does not follow
GLP regulations, it has not violated FIFRA. The program
enforced violations identified during laboratory inspections
as violations of the FIFRA maintenance of records
requirement. Under the maintenance of records provision of
FIFRA, the Agency cannot assess a civil penalty against a
laboratory for a first time violation,- the Agency may only
issue a written warning. Subsequently, if the same violation
occurs during the next inspection, the laboratory can be
assessed a maximum penalty of $1,000, or if the laboratory is
also the registrant, a maximum penalty of $5,000. Partly
because of these limitations in FIFRA, the Agency did not
assess a civil or criminal penalty for a GLP deficiency from
1984 to 1991. .
Confidentiality Of Inert Ingredients Delayed Development Of
An Enforcement Strategy
During our 1991 audit of inert ingredients in pesticides, we
found that, although the pesticide program took steps to
develop a compliance monitoring strategy for inert
ingredients, it did not complete those steps (Report No.
1100378). One of the reasons for not completing the strategy
was that the program could not release information on inert
ingredients to the states for enforcement purposes. Under
FIFRA, the identity of inert ingredients and the percentages
contained in pesticide products are considered confidential
and, therefore, not releasable to state regulatory officials.
Without a compliance monitoring strategy for enforcing toxic
inert requirements, the program had little assurance that
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EPA's Pesticide Program
registrants were properly complying with toxic inert
requirements.
Agency Actions
The pesticide program has recognized the need for stronger
enforcement authority and higher penalties. In 1989, 'the
proposed Food Safety Amendments to FIFRA contained provisions
to enhance the program's ability to enforce its regulations.
The proposed legislation contained language specifically
covering "pesticide testing facilities" and increased civil
penalties to a maximum of $25,000 per violation per day.
However, the proposed amendments did not become law.
In 1993, the Agency developed another legislative package to
strengthen pesticide laws. One goal of the package was to
provide the Agency with tools necessary to ensure pesticide
laws are adequately and appropriately enforced. At the time
of this report, Congress had not considered the new package.
In response to our Inert Ingredients report, the pesticide
program stated that it was determining whether it could
release information on toxic inert ingredients -to the states
(Report No. 1100378). The program was planning to issue a
list of reformulated products to the states by December 31,
1994. Although the program did not have to change FIFRA in
this instance, it has spent several years trying to work its
way around the requirement of inert ingredient
confidentiality in FIFRA. It has already been six years
since the inert strategy was first published. In the
meantime, the strategy has not been enforced because the
pesticide program has been determining its position on the
confidentiality issue.
FIFRA'S PROCESS FOR PESTICIDE CANCELLATION IS CUMBERSOME AND
RESOURCE INTENSIVE
As currently practiced,
four to eight years to
registration. Products
cancellation process is
cancellation for years
meanwhile continuing to
unreasonable risks. As
considered negotiations
attractive alternatives
product's registration.
it can take the pesticide program
cancel a pesticide product's
remain on the market while the
pending. Registrants can delay the
through the process outlined in FIFRA,
sell a product that may pose
a result, the pesticide program
and voluntary compliance more
rather than trying to cancel a
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TheCancellation Process Under FIFRA
Under FIFRA, the pesticide program can cancel the
registration of a pesticide if it determines that use of the
pesticide causes unreasonable risks to the environment. If
the pesticide program decides to cancel one or more uses of a
pesticide, it will issue a notice of intent to cancel^ A
registrant, or any person adversely affected by the decision
to cancel a product, can challenge the decision in a formal
adjudicatory hearing before an Administrative Law Judge (with
review by the Administrator). During the hearing process,
the pesticide generally remains on the market. If the
registrant is dissatisfied with the outcome of the
administrative hearing, it gets another chance to challenge
the program's decision by appealing the decision to a federal
court.
Administrative Hearings Delav Implementation Of Special
Review
During our 1993 audit of the special review process, we found
that the administrative hearing process can delay
implementation of special reviews (Report No. 3100256).
Since the special review process began in 1976, the pesticide
program has held administrative hearings on 22 percent (11 of
50) of all special reviews completed. The length of the
hearing can range from six months to six years, with the
average being 30 months. Over the years, the hearing process
has become shorter. Hearings during the 1970's averaged 50
months, as opposed to only 20 months during the 1980's.
While the hearings are ongoing, the registrants can continue
selling the products. . •
The very potential of a hearing also affects the decisions
the pesticide program makes during special reviews. Program
management told us that it tends to be more willing to
negotiate a conclusion to a special review if it knows that
the registrant will request a hearing and can continue to use
the pesticide until the hearing is completed.
Pesticide Program .Finds It Difficult To Cancel A Product For
Labeling Violations
Canceling a pesticide product that does not meet labeling
requirements was difficult. The program can cancel the
registration of products when registrants do not make label
changes. However, to do this, the program must prove that
not making label changes will cause unreasonable adverse
effects. The extended cancellation process, as discussed
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EPA's Pesticide Program
above, allows the registrant to continue selling the product
during the hearings, without the required labeling.
According to program officials, the cancellation process can
be cumbersome and resource intensive. As a result, the
program generally relied on a voluntary compliance strategy
rather than a cancellation-based strategy.
Aaencv Actions
As part of the 1989 Food Safety Amendments to FIFRA, the
pesticide program suggested streamlining the cancellation
process to make it faster and less cumbersome. As mentioned
before, these amendments were not made into law. In 1993,
the program developed a new package that included a goal of
eliminating cumbersome procedures for removing pesticides
which pose unreasonable risks. Another goal of the package
was to provide new regulatory options to reduce risk in a
timely manner without resulting in costly or disruptive
cancellation proceedings.
CONCLUSION
In several instances, sections of FIFRA kept the pesticide
program from carrying out its activities in the best way
possible. The pesticide program is working with Congress to
amend FIFRA. Among the changes they plan to request are
stronger enforcement authority and revisions to the
cancellation process. In our opinion, changes to these
sections of FIFRA would be beneficial to the pesticide
program and would help the program in its goal of protecting
human health and the environment. We strongly support
amendments to FIFRA that would improve the pesticide
program's enforcement and cancellation activities.
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Exhibit 1
Page 1 of 2
EPA PIG REPORTS
INCLUDED IN THE SCOPE OF THE REVIEW
Report Name
EPA's Pesticide Import Program
Follow-up Review Of EPA's Pesticide
Import Program
EPA Emergency Suspended And Canceled
Pesticide Program
Follow-up Review Of EPA's Emergency
Suspended And Canceled Pesticide
Program
Inert Ingredients In Pesticides
EPA Procedures To Ensure Quality Data
Under The Good Laboratory Practices
Program
Alternatives For Ensuring Accurate
Laboratory Data
Cooperation And Coordination Problems
Limit Effectiveness Of The Good
Laboratory Practices Program
Labeling Of Pesticides
Special Review Of EDP Internal
Controls For Selected' Pesticide
Revolving Funds' Information Systems
Survey Of The Office Of Pesticide
Program's Registration Process
Fiscal 1992 Financial Statement Audit
Of The FIFRA and Tolerance Funds
Pesticide Special Review Process
Date
08/16/88
02/10/93
09/28/90
03/26/93
09/30/91
09/30/91
03/31/92
09/30/92
09/30/92
03/31/93
04/02/93
06/30/93
07/22/93
Number
81660
3100097
0100486
3400030
1100378
1400046
2400032
2100661
2100613
3400043
14
3100265
3100256
14 The assignment (E1EPF2-11-0036) was closed after the
survey and no audit report was issued.
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Exhibit 1
Page 2 of 2
GENERAL ACCOUNTING OFFICE REPORTS AND TESTIMONIES
INCLUDED IN THE SCOPE OF THE REVIEW
Report Name
Export of Unregistered Pesticides
Is Not Adequately Monitored By
EPA
Disinfectants: EPA Lacks
Assurance They Work
Disinfectants: Concerns Over The
Integrity Of EPA's Data Bases
Pesticides In Groundwater
EPA's Repeat Emergency Exemptions
May Provide Potential For Abuse
EPA Lacks Assurance That All
Adverse Effects Data Have Been
Reviewed
EPA's Information Systems Provide
Inadequate Support For
Reregistration
Better Data Can Improve The
Usefulness of EPA's Benefit
Assessments
Information System Improvements
Essential For EPA's
Reregistration Efforts
Pesticide Reregistration May Not
Be Completed Until 2006
Date
04/89
08/90
09/90
04/91
07/91
10/91
10/91
12/91
11/92
05/93
Number
GAO/RCED-89-128
GAO/RCED-90-139
GAO/RCED-90-232
GAO/RCED-91-75
GAO/T-RCED-91-83
GAO/T-RCED-92-16
GAO/T-IMTEC-92-3
GAO/RCED-92-32
GAO/IMTEC-93-5
GAO/RCED-93-94
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Exhibit 2
Page 1 of 1
GENERAL ACCOUNTING OFFICE
REPORTS REFERRED TO BUT NOT
INCLUDED IN THE SCOPE OF THE REVIEW15
Report Name
Federal Pesticide Registration
Program: Is It Protecting The
Public And The Environment
Adequately From Pesticide
Hazards?
Delays And Unresolved Issues
Plague New Pesticide Protection
Programs
Pesticides: EPA's Formidable
Task To Assess And Regulate Their
Risks
Date
12/75
02/80
04/86
Number
RED-76-42
CED-80-32
GAO/RCED-86-125
IS Reports were used to provide historical or background
information.
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Exhibit 3
Page l of 3
COMPUTER SYSTEMS SUPPORTING PESTICIDE PROGRAMS16
System Name
A-List Inventory Support
System (ALISS)
Accelerated Reregistration
Tracking System (ARTS)/
Simple Maintenance of ARTS
(SMARTS)
Confidential Statement of
Formula (CSF)
Data Call In/ Case Review
Manager System (DCI/CRMS)
Dietary Risk Evaluation
System (DRES)
Fee Systems
FIFRA 6(g)
Foreign Purchase
Acknowledgement System
(FPAS)
System Functions
Identified data gaps, overdue
studies; tracked study dates,
receipts; captured science
decisions
Captured and analyzed
Reregistration Phase II /III
responses; managed waivers, time
extensions; captured science
decisions on Phase III/IV
Captured and analyzed all CSF
information
Identified data requirements,
companies and products for each
active ingredient; tracked waivers
and time extensions; tracked data
packages to/ from science divisions
Combined food consumption and
residue information into an
estimate of exposure through diet;
compared exposure to toxicity
values
Analyzed market share; generated
bills; tracked payments
Automated the information
submitted under FIFRA 6 (g)
requirements (notice of stored
pesticides with canceled or
suspended registrations)
To track submittal of FPAs (system
still under development)
16 List of systems was obtained from the pesticide program's
August 1992 information management strategy.
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Exhibit 3
Page 2 of 3
COMPUTER SYSTEMS SUPPORTING PESTICIDE PROGRAMS
System Name
FIFRA/TSCA Tracking System
(FTTS)
BED Tox 1-liner
Incident Data System (IDS)
Lab Inspection study Audit
(LISA)
Label Use Information
System (LUIS)
National Compliance Data
Base (NCDB)
Pesticide Document
Management System (PDMS)
Pesticide Handlers
Exposure Database (PHED)
System Functions
Captured and managed pesticide
compliance/enforcement activities;
maintained inspection, case,
enforcement action, and settlement
information; generated STARS
reports
Served as a quick reference tool
to access information about
toxicology studies submitted to
the program
Captured and managed incident
information
To target labs/ studies for
inspections and audits; capture
and manage results of inspections
and audits (system still under
development)
Captured labeling information;
aggregated analysis by active
ingredient; captured science
decisions
Served as national repository for
regional/Headquarter FTTS data
(see FTTS) ; generated STARS
reports
Managed information on all
studies, summaries and reformats
Contained generic data which could
be used to estimate pesticide
exposure to mixers, loaders, and
applicators
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Exhibit 3
Page 3 of 3
COMPUTER SYSTEMS SUPPORT PESTICIDE PROGRAMS
System Name
System Functions
Pesticide Information
Network (PIN)
Served as database for
environmental fate data,
ecological effects data,
genetically engineered plants and
microbes data, and pesticides in
groundwater
Pesticide Product Info.
System/Reference Files
System (PPIS/REFS)
Captured labeling information;
captured and maintained general
product information (registration
status, etc.)
Pesticide Regulatory
Action Tracking System
(PRATS)
Managed information on all types
of regulatory actions and
submissions
Pesticide Reference Dose
Tracking System (PRDTS)
Served as quick guide for
reference dose values; included
chemical identification and
critical study information for
each entry
Pesticide Registration
Enforcement System (PRES)
Managed suspension information;
generated Notices-of-Intent-To-
Suspend
Section Seven Tracking
System (SSTS)
Captured and managed information
on pesticide production (Regions
maintained this information)
Tolerance Index System
(TIS)
Served as index to tolerance
regulations; captured tolerances
after published in the Federal
Register
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EPA's Pesticide Program
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Appendix 1
Pacre 1 of 28
WR A 1994
OFFCEOF
PREVENTION. PESTIODESWD
TOMC SUBSTANCES
MEMORANDUM
SUBJECT: Office of the Inspector General (DIG)
Draft Theme Report on EPA's Pesticide Programs
(E1EPE2-05-0015)
PROM: Lynn R. Goldman, M.D.
Assistant Administrator
TO: Michael Simmons
Associate Assistant Inspector General
i.
Thank you for the opportunity to review and comment on your office's draft
Theme Report entitled "EPA's Pesticide Program." I appreciate your efforts to meet
with me and my staff to discuss the results of your audit. I am only sorry I was
not able to spend more time with you. The Inspector General's new approach to
audits, introduced in 1991, studying an entire program in some depth over an
extended time period has allowed the audit team a better opportunity to understand
the program and has provided me, as a new Assistant Administrator, with an
invaluable tool.
This report represents a consolidation of a number of earlier audits into a
comprehensive evaluation of our pesticide program and makes broad
recommendations in a number of significant areas related to management and
internal procedures. This report is particularly useful in this time of budget and
resource constraints and will help OPPTS meet the goals and objectives of the
National Performance Review and the streamlining effort now underway. I plan to
provide the final report to our Streamlining Task Force for consideration as they
evaluate the overall management of all our programs.
I am pleased to see that the report highlights the many improvements and
changes in our pesticide program over the past few years. I believe that the
program has benefitted from the IG's assessments, and that we have already
successfully integrated many of the recommended changes into the program.
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The draft report focusses primarily on the infrastructure of the program-the
integrity of its management and information systems, the completeness of its
regulatory,policy, and procedural framework, the shortfalls in its resources and
budget, the legislative constraints of FIFRA that hinder the optimal administration
of the program, and the difficulties in maintaining a high quality scientific database
to support our decision-making. We believe that this emphasis is proper and timely
in a long-term evaluation of the program, and view the draft report as a means of
fine-tuning the rough edges of an essentially sound core program of pesticide
regulation. Legislative initiatives now underway, if enacted, will allow OPPTS to
continue to improve in those areas highlighted in the report.
Attached is our more detailed response to the specific recommendations
contained in the draft report.
Attachments
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QIC THEME REPORT: EPA's PESTICIDE PROGRAM
SUMMARY OF CONCLUSIONS AND RECOMMENDATIONS AND OPPTS RESPONSE
MANAGEMENT IMPROVEMENTS
CONCLUSION: The report cites a number of core regulatory activities which have not
been conducted in the timeframes required by the law, as well as problems with other
important supporting activities which are not being remedied in a timely fashion. The
report concludes that these activities need increased management attention. The report
continues, however, by acknowledging the significant changes in management tracking,
prioritization, and resource planning that have occurred in the last two years, leading to a
strengthened approach to management that has already demonstrated a greater
responsiveness to and accountability for problem areas. It urges management to
continue these improvements and suggests that the Administrator needs to make efforts
to change the organizational culture of OPP to one of management accountability for
correcting deficiencies.
RECOMMENDATION: The report recommends that the program continue to improve
how it directs and controls its resources, focusing on establishing long and short-term
priorities, allocating resources based on priorities, allocating resources based on those
priorities, and monitoring progress toward them and improving the scheduling and
coordination of work between divisions.
RESPONSE: OPP has found that its improved Priority Planning process has already
reaped valuable benefits in program management, and will continue to use this approach.
We recognize that, in times of budget cutbacks and streamlining, a systematic approach
to program management, with improved follow-up to management decisions, will enable
us to continue a high level of service without sacrificing or compromising essential
regulatory initiatives. Our continuing plans include an emphasis in management
accountability.
In addition, in response to the call of the National Performance Review, OPPTS has
established a Streamlining Task Force whose recommendations have just been forwarded
to Administrator Browner. Included in our report is a commitment to retain an outside
consultant to evaluate and make recommendations for changes in the management
structure of the Office of Pesticide Programs. This report will be made available to our
consultant. .
Attached is a copy of my report on OPPTS's streamlining plans and our schedule for
implementation. Planned activities will be monitored as we go through streamlining
effort. As you know, the Agency is in the process of reorganizing its enforcement
activities, so that our Office of Compliance Monitoring will be transferred to a new Office
of Enforcement. As we undertake our own reorganization, we will ensure that we
maintain.coordination of activities with enforcement personnel.
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INFORMATION MANAGEMENT SYSTEMS
CONCLUSION: The report notes that information management systems critical to the
efficient functioning of the program have been both duplicative and not we!; integrated
and lacking in quality control. The report calls OPP's development of an Information
Management Strategy an encouraging response and notes that during 1993 OPP made
steady but limited progress in improving its information systems, but notes as well the
lack of funding to implement many of the Strategy's activities. It concludes that OPP
needs to place a higher priority on managing information systems and to wisely invest
resources in the systems to realize future cost savings.
RECOMMENDATION 1: OPPTS should report information management as a material
weakness under FMFIA until corrected.
RESPONSE: OPPTS does not believe that reporting information management as a
material weakness would be cost effective. The effort would entail considerable
resources in reporting on a problem on which we are already making considerable
headway. We believe those same resources should be focussed on the systems
improvement and integration that the report recommends rather than detailed elaboration
on the problem. The 1994 planning process funded significant steps toward the systems
integration recommended in the report, for example, the PRATS system was improved
to increase its speed and user friendliness, significantly enhancing its utility.
In addition, the Program has instituted internal "Alternate Management Control" reviews
in which we identify areas in need of special attention and which require semi-annual
reports to the Office Director. The Information Management Strategy was identified in
this system during pur FY 1994 FMFIA process, and reports are due in April and
September. As we go through the FMFIA process for FY 1995, we will reassess
progress on the strategy and incorporate the results in our fall 1994 assurance totter.
RECOMMENDATION 2: OPPTS should provide adequate resources to implement its
pesticide Information Management Strategy.
RESPONSE: OPP is funding key elements of the Information Management Strategy in FY
1994, but it cannot, of course, be implemented all at once. In FY 1994, we are devoting
$445K and 4.3 FTE to two projects-one to integrate two major inventory systems (PPIS
and LUIS) and the other to integrate two tracking systems (CRMS and PRATS). Ukely
future efforts will focus on integrating the two classes of systems-inventory and
tracking-so that the program will ultimately be able to ascertain not only basic
information about chemicals and uses, but also be able to find out the status of the
current regulatory activities on those chemicals and uses.
We also hope to be able to make use of the Inspector General's agency-wide assessment
of information management. We are hopeful that the report will help us to identify
management approaches which will make our systems more efficient without costing
more resources.
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REGULATIONS. POLICIES. AND PROCEDURES .
CONCLUSION; The report concludes that the pesticide program's regulations, policies
and procedures are not up-to-date and in some cases do not accurately reflect current
program practices. The report cites in particular labeling regulations, special review
regulations, data requirement regulations, statutorily mandated container design and
residue removal regulations, and policies relating to import procedures, laboratory
inspections, and data audits. Without regulations, policies, and procedures to serve as
internal controls, the program's management cannot be sure that the program activities
and objectives are being met. OPP needs to focus on developing, completing, and
implementing the necessary regulations, policies, and procedures.
RECOMMENDATION: Develop schedule for (1) systematically revising pesticide program
regulations, in particular those mentioned, and (2) preparing and updating the policies
and procedures needed.
RESPONSE: We agree that many regulations and policies need updating and revision.
As part of its Priority Planning process, OPP has surveyed the list of regulations and
policies needing work, compared them to competing projects, determined which
regulatory efforts are of greatest priority, and has funded continued work in those areas,
including progress on Part 158 regulations and issuance of the proposed Phase II rule on
container design and residue removal regulations. In addition, the Administration's
legislative proposal provides for periodic revision of guidelines.
Even though we do not plan to invest the resources necessary for adoption of Special
Review regulations, we are currently working on a Federal Register Notice which would
tell the public how we seek public input in Special Reviews and soliciting ideas on ways
to improve the process.
Although no activity is currently scheduled on the Labeling regulations; OPP has
established a Labeling unit within the Registration Division to address labeling policies
and procedures. The unit, currently being staffed, will focus on critical labeling needs,
including whether and when to revise and update labeling regulations.
Finally, it should be noted that Executive Order 12866 will impose a level of
systematicrty upon the review and revision of regulations. Under the Executive Order,
each agency must submit to OMB a plan for periodically reviewing its existing
regulations, with a view to modifying or updating them. OPP's effort this fiscal year is
threefold: Part 158 data requirements, FIFRA section 6(a)(2> reporting requirements (Part
153), and review of regulations and policies affected by the Delaney clause of the
Federal Food, Drug and Cosmetic Act (Part 180). And although the new Division
mentioned in the report has not become a reality as yet, the functions of regulatory
oversight and coordination have been focussed to a greater extent in the current Policy
and Special Projects Staff.
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PESTICIDE PROGRAM BUDGET HISTORY
CONCLUSIONS: The report cites OPP's continued claim of underfunding and lack of
resources as a reason for many of the deficiencies and delays noted over the years. The
report concludes that OPP should review, with the Chief financial Officer, the costs
associated with tolerances in order to recover those costs, that OPP should work with
Congress to extend authority to collect reregtstration fees past 1997, and that it should
perform a study of resource usage and needs to determine if it is adequately funded for
needed activities.
RECOMMENDATIONS: OPP should conduct a study of its resource needs and usage to
determine whether it is adequately funded to meet its statutory obligations and program
responsibilities, and, if indicated, should take action to obtain additional funding through
all available means.
RESPONSE: OPP's new priority planning process adequately assesses current resource
and funding needs within the context of long-range goals. While we are confident that
such a study would show that the program cannot possibly accomplish all that is
expected of it with existing resources, we believe that, in the current environment of
budget cuts, an additional study would not be useful to the program, but would only
consume resources that could more profitably be devoted to core improvements in the
program that could alleviate other problems identified by the OIG in its report.
The Administration's legislative package includes provisions for tolerance and registration
fees. Also, in conjunction with the development of our legislative package, the Program
prepared a costing package. We would be happy to share it with you as soon as the
Administration's legislative position is finalized.
IMPROVEMENTS TO DATA INTEGRITY
CONCLUSION: The report concludes that OPP has recognized the importance of
accuracy and reliability of data and prompt reviews of all data on adverse effects.
Having recognized an internal weakness, OPP has begun corrective action to improve
data integrity as a critical element in its program and to ensure appropriate handling of
adverse effects data. The report encourages the program to continue to implement the
corrective action plan.
RECOMMENDATION: NONE
RESPONSE: OPPTS agrees with these conclusions.
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FIFRA LEGISLATIVE CHANGES
CONCLUSION: The report confirms the need for statutory changes in FIFRA to improve
the Agency's underlying authority. In particular the Agency's enforcement authority
under FIFRA is weak; The inerts program is hampered by Confidential Business
Information limitations, and cancellation processes are cumbersome and time-consuming.
These problems have kept OPP from carrying out its activities in the best way possible.
OIG supports proposed legislative changes for stronger enforcement authority and
revisions to the cancellation provisions.
RECOMMENDATION: NONE
RESPONSE: OPPTS appreciates the support of OIG for legislative changes. The
Administration is currently preparing legislation that would strengthen its enforcement
authority (including increased penalty provisions), provide that CBI could be provided to
States with comparable CBI protection, and streamline the suspension and cancellation
provisions to mitigate the effects of the lengthy procedures now required.
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ATTACHMENT I
OPPTS STREAMLINING ACTION PLAN
Elements Lead Due Date
1. Organization Proposals:
OPPTS Immediate Office Organization AA 2/28/94
OPP and OPPT to draft organizational ODs/OPP completed
proposals, circulate to staff and and OPPT by 3/31/94
unions, and submit to AA.
OPP interim plan to AA will address: OD/OPP 3/31/94
+ initiating outside management
review of OPP
+ pilot interdisciplinary division
for reduced use, safer pesticides,
and new biologicals
+ Impacts on ability to get work done,
especially on contract management
«
OPPT interim plan to AA will address: OD/OPPT 3/31/94
+ procedures and criteria to evaluate
effectiveness of recent OPPT
reorganization
+ impacts on ability to get work done,
especially on contract management
Human Resources
Plan for formal rotational OPPTS/IO > 2/28/94
assignment program, including rota-
tions across office lines
Plan for enhanced training will include: OPPTS/IO . 2/28/94
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+ Improved needs assessment
+ Increased availability
+ More equitable allocation of
training resources
Plan for program to pilot OPPTS/IO 2/28/94
manager evaluations from peers
and subordinates
Strategy for outlining new career OPPTS/IO 2/28/94
tracks and developing dual
track options (team Idrs. technical
experts, senior scientist, etc.)
Define statements of roles of new ' OPPTS/IO 3/31/94
supervisors and supervisory
training curriculum
3. Diversity
Form OPPTS Diversity Task Force to OD/OPP 3/31/94
develop:
+ proposals for enhanced recruitment.
mentoring, training, development
and promotion of women and minori-
ties in OPPTS
+ plan for offering training for all OPPTS
workforce on the value of diversity
4. Delegation, Empowerment, Accountability
OPP Implement recommendations of OD/OPP 3/31/94
Delegations Task Force
OPPT Commence analysis of OD/OPPT 3/31/94
opportunities for delegation
5. Process Improvements
OD's Prepare List of Activities
w/Little or No Risk Reduction
Benefit for possible elimination
ODs
3/31/94
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Reconvene Streamlining Task Force
and identify opportunities for
improvements to core processes
Task Force to Review Progress of
QATs, make recommendations on
which QATs to continue and new
QATs needed
All OPPTS QATs Complete Work,
Submit Reports to Task Force
Task Force Reviews QAT Reports
Makes Recommendations
OPPTS/10 3/31/94
OPPTS/IO 3/31/94
OPPTS/10 6/30/94
OPPTS/IO 8/1/94
6. Customer Survey of OPPTS customers to
gather ideas and suggestions on how to
improve OPPTS effectiveness
Phase 1:
DODs
3/31/94
identify sample customers
develop appropriate survey
instrument
field-test draft survey with
sample customers to ensure
usefulness
Phase 2:
To be determined after
make necessary changes to survey
and finalize
develop full list of customers and
conduct survey
compile survey results and make
recommendations for improvements
develop measures for customer
satisfaction
establish system to track measures
completion of Phase 1
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DRAFT -- 2/2/94
STREAMLINING PLAN
OFFICE OF PREVENTION, PESTICIDES & TOXIC SUBSTANCES
Submitted By:
Lynn R. Goldman
Assistant Administrator
February?, 1994
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I. PURPOSE
This report outlines the plan by which the Office of
Prevention, Pesticides and Toxic Substances will meet the Agency's
streamlining objectives. The principle constraints on the
streamlining plan are the government-wide targets of reducing the
number of employees in senior grades IGS-14, GS-15, and SES) and
increasing the ratio of non-supervisory staff to supervisors. The
first task we have been given is to determine how we will meet
these numerical goals.
For OPPTS, these constraints work out to reducing by 27 the
number of staff in senior grades by the end of FY 1995, and
increasing the supervisory ratio from the current 1:4.4 to the
target of 1:11 by the end of FY 1998.
In addition, this plan lays out how OPPTS will address the
other objectives of the streamlining effort-increasing delegation,
employee empowerment, and accountability at all levels; reducing
the number of supervisors and management layers; increasing career
opportunities for all employees; and increasing the diversity of
the management team. These are the most important goals of
reinventing government and also require a multi-year plan.
There are three attachments to this document: 1) an Action
Plan for OPPTS' Streamlining Effort, 2) OPPTS's Mission Statement
Committee's Report, and 3) the OPPTS Organizational and Career
Design Committee Report.
II. PROCESS FOR DEVELOPING THE PLAN
General Process
In developing this plan OPPTS sought to involve all members of
the staff in a highly participatory, open, and interactive process.
In mid-November a call went out to alt OPPTS employees
soliciting volunteers to serve on a Streamlining Task Force to
advise senior management in the streamlining process. Over 100
employees responded, and 37 were selected, representing the full
range of grades, disciplines, and levels of experience in OPPTS.
The Task Force was then subdivided into three committees. One
group was tasked with crafting a proposed OPPTS vision statement,
a mission statement, and a set of principles to guide daily
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operations. A second group was asked to prepare analysis of
streamlining options and their impacts in the areas of
organization, processes, and work force management and diversity.
The third committee was responsible for communicating with the
entire staff about the work of the Task Force and ensuring the
openness of the overall process.
In a mini-retreat on November 23, 1993, the OPPTS senior
management team met to clarify the objectives of the streamlining
process and to develop a clear charge for the Task Force. The
first meeting of the Task Force took place on December 2.
After five weeks of essentially full-time work, on January 10,
the Task Force met with the senior management team to deliver their
reports, copies of which are attached to this plan. On January 12- .
13, the OPPTS senior management team met again to review and
discuss the Task Force reports. During and after this two-day
retreat the Office and Division Directors of OPPTS developed a set
of streamlining recommendations for the Assistant Administrator.
Based on these recommendations and follow-up meetings with the
union and the Streamlining Task Force, this plan was prepared.
Communications
From the outset, a concerted effort was made to encourage and
collect ideas and comments from OPPTS employees, and to keep them
informed regularly of the progress of the Streamlining Task Force.
An employee survey was distributed, suggestion boxes were placed at
key locations in Waterside Mall and Crystal City, and the OPP Local
Area Network was set up to collect comments and suggestions .
electronically. Copies of all draft reports and briefing materials
were distributed to all employees as they were developed, as were
weekly progress reports. To date, 119 responses to the survey and
80 general comments have been received by the Task Force and were
considered by the Assistant Administrator.
Several meetings with employees were held to inform managers
and staff of progress and provide an opportunity for staff
feedback. Additional meetings with supervisors and all hands have
been scheduled for mid-February to explain this plan. The
communications group of the Streamlining Task Force will continue
to ensure the timely and free flow of relevant information in both
directions between management and staff.
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Region III served as the lead region, participating fully in
the senior management retreat. All regions received the draft
reports and survey. A conference call with Regional
Pesticide/Toxics Division Directors was held January 5, and written
comments were provided by the regions to OPPTS. Regions will
continue to receive updates and copies of all documents developed
during the streamlining process.
Stakeholders outside the Agency who are interested in and
affected by OPPTS activities have also contributed. OPPTS met with
environmental and public interest groups, industry associations,
and former OPPTS Assistant Administrators. A meeting with
congressional staff is being planned for early February. Letters
requesting comments were sent to all States and tribal
organizations, other Federal agencies (FDA, USDA, OSHA, NIEHS), and
other EPA programs (ORD, OGC, OPPE). Written comments have been
received from several States (Alaska, California. South Dakota,
Idaho and Georgia) and from industry (the National Agricultural
Chemicals Association, and Ciba-Geigy Corp.) External comments
have been placed in a special streamlining docket in the OPP Field
Operations Division.
OPPTS will continue internal and external communication
efforts as the OPPTS and Agency Streamlining Plans are developed,
refined, and implemented. The following specific activities are
anticipated at this time:
*G Develop additional sets of Questions/Answers for issues of
concern to OPPTS employees;
*G Continue to provide regular updates to OPPTS employees, have
open meetings of staff with senior managers and the AA, and
meet with outside groups as needed to ensure there is good
communication on how the plan will affect programs and people;
*G Conduct a customer survey to identify and question our
customers about program delivery; and
*G Use the extensive file of employee comments on the OPPTS
streamlining effort to guide future efforts. An early example
of this was a recent compilation of all employee comments
about training, provided to the OPPT Human Resources Team.
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III. MISSION/VISION
Background
The Mission Group of the Streamlining Task Force was charged
with drafting a mission statement, a vision statement, operating
principles, and a strategy for OPPTS. In the short term, these
documents were to provide the context for streamlining and setting
future program directions. Once completed, these documents will
also guide each of us in day-to-day decisions, and provide the
basic structure for assessing proposed streamlining changes.
Process
The Mission Group started from the statutory mandates of OPP
and OPPT, considering as well previous statements and current
operations in both offices. Emphasis was placed on identifying
points of similarity between the offices, and on developing a
common language for considering these issues.
Once draft statements were in hand, members of the team met in
many small groups with managers and staff to get comment. As a
result of the groups discussions and of feedback from other staff, •
it became clear that sharp definitions were needed for critical
terms. The following were developed to meet this need:
Mission: The purpose or primary function of the
organization.
Vision: What the organization should look like in the
future, where we want to be and what we want to be
doing.
Principles: The basic values, operating principles, and
foundation of the organization.
Strategy: How the organization will fulfill the mission and
work towards the vision. This serves as an outline
pointing us in the basic direction that we must go.
with the actual details of these activities
discussed and prioritized in strategic and
operating plans.
Attachment II contains the report of the Mission Group's
effort, and reflects staff and management comments. For the
statements of mission, vision, principles, and strategy to be
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effective, they must be thoroughly understood and subscribed to by
all OPPTS staff. Toward this end the Mission Group will be
available over the next several months to educate the entire staff
about our mission, vision, principles and strategies.
IV. REDUCING STAFF IN SENIOR GRADES
The FY 1995 target calls for the reduction in the number of
OPPTS staff in GS-14, GS-15, and SES positions by 27 by the end of
FY 1995. This will reduce staff in these senior grades from the
level of 412 as of December 1, 1993 to a target level of 385.
(These figures are adjusted from the original OPPTS values to
reflect the transfer of 15 senior employees in the Office of
Compliance Monitoring to the Office of Enforcement and Compliance
Assurance.)
OPPTS believes that we can probably meet this target through
attrition. Historical attrition rates in OPPTS have ranged from 9-
15% a year. Although the rate was only 6% in FY 1993, we believe
that as the economy improves our attrition rate will return to the
normal range.
In addition to general economic considerations, Congress may
provide incentives for more to retire. Cash buy-outs or the
reduction of penalties for early retirement may accelerate
attrition. Forty-seven GS-14, GS-15, and SES employees in OPPTS
will become eligible for retirement by the end of FY 1995. The
Agency and OPPTS should work with employees to provide
opportunities for discontinued service retirements. Through a
combination of these kinds of actions. OPPTS believes it likely
that the target for reducing senior staff can be met through
attrition. We will monitor actual experience closely, however, and
will consider other mechanisms to achieve the target if they prove
necessary.
The somewhat haphazard nature of attrition may cause problems
that will require attention to ensure continuity of program
operations. Critical vacancies will have to be filled, but we will
attempt to use the long range plan to shift senior staff into
critical vacancies. Hiring at senior levels will be strictly
limited and monitored by the Assistant Administrator's office.
V. ORGANIZATIONAL/STRUCTURAL STREAMLINING
The OPPTS work force today includes about 1320 employees, of
whom 245 are supervisors. Thus the initial ratio of supervisors to
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non-supervisory staff is 245 to 1075, (1075 = 1320-245), or about
1:4.4. To achieve a ratio of 1:11 in a population of 1320, the
number of supervisors must be reduced to 110, a reduction of 135
supervisors from current strength, or about 55%.
The Organization/Career Design Committee of the Streamlining
Task Force defined and evaluated a broad range of options for
organizational restructuring of OPPTS, all of which are can be
configured to meet the 1998 target for reduction in supervisors.
These options are discussed in detail in Attachment III. They all
represent significant challenges for the organization, as the two-
and-a-half-fold increase in the supervisory ratio would profoundly
affect the jobs of everyone. They differ significantly in their
potential impacts on other objectives of streamlining, including
staff mobility and diversity in management, and some raise
significant problems in ensuring consistent high quality products
and decisions across the organization.- Some of the organization
options involving combining functions now performed independently
in OPP and OPPT are not practical so long as the offices are spread
across three locations in the District of Columbia and Virginia.
OPPTS's plans to devise a structure in 1994 which can attain
the 1:11 ratio by the end of FY98. This will enable the Office to
identify supervisory positions which will need to be phased out so
that we may begin voluntary reassignments using all available
opportunities in order to avoid adverse actions and protect our
existing work force. Our goal is to implement these changes and
conduct careful monitoring over time, with an opportunity for mid-
course correction in FY1996. Therefore, it is critical that
Agency-wide decisions are made regarding the allocation and
accounting for senior positions. Further, we must agree to common
Agency-wide checkpoints for monitoring attrition and progress
toward reduction targets in order to ensure equity across all
offices.
OPPTS's Approach to Increasing Supervisory Ratio: an "Interim" Plan
The OPPTS senior management team agrees that it is too soon to
commit to reorganization, although as the streamlining effort
proceeds this may prove necessary. OPPT has reorganized recently.
Options for either Office involve changes of major significance.
which should be tested thoroughly before a commitment is made.
Thus OPPTS will rely on the existing structure of Divisions in both
Offices for the time being, reserving until later a decision on
possible reorganization of either or both of them. For this
reason, OPPTS is considering this an "interim* streamlining plan.
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Schedule
The following specific steps will be taken immediately:
1. By February 28, the Assistant Administrator will complete a
plan for achieving the 1:11 ratio within the Immediate Office
of OPPTS.
2. By March 31, 1994, the Directors of OPP and OPPT will each
propose an "interim'' plan containing structures for their
offices consistent with the 1:11 supervisory ratio. These
proposals have been reviewed by staff and labor unions.
A. The OPP plan will incorporate at least the following
elements:
> An independent outside management review of OPP,
> An immediate pilot of a multi-disciplinary division to
promote reduced pesticide use, to encourage development
and use of safer pesticides, and to accelerate
registration of new biological pesticides; and
> An assessment of the impact of proposed changes on the
ability of OPP to get work done, with particular
attention to impacts on contract management and including
any examples of the potential for losses in technical
proficiency or competencies at the 14/15/SES levels.
B. The OPPT plan will incorporate at least the following
elements:
> Procedures and criteria to evaluate the recent OPPT
reorganization, to begin by the end of FY 1994; and
> An assessment of the impact of proposed changes on the
ability of OPP to get work done, with particular
attention to impacts on contract management and including
any examples of the potential for losses in technical
proficiency or competencies at the 14/15/SES levels.
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Additional Organizational Issues:
These additional issues will be further addressed by both
offices, continuing to maximize the participation of staff at all
levels:
1. How overlapping elements of OPP and OPPT programs (such as
pollution prevention and science policy) can be integrated to
ensure consistency while retaining the two-office structure.
2. How first-level work units could be restructured to reduce the
number of management layers, with 12-20 staff reporting to a -
single supervisor, who in turn would report directly to the
Division Director.
3. What functions within the first-level work units, such as
quality control and management of special projects, could be
performed by senior or journeyman staff, working as non-
supervisory team leaders.
4. What criteria (perhaps of organizational size or complexity of
work) would have to be satisfied to justify a supervisory
"deputy" position at or below the Division level, work.
5. What opportunities there may be for regrouping functions at
the Division level, while remaining true to the spirit of
•flattening".
VI. ACTION ON DELEGATIONS, EMPOWERMENT AND WORK PROCESSES
In the spirit of reinventing government, OPPTS its committed
to examining ways to improve the way we do business and make us
more effective and efficient. To succeed in a redesigned
management-to-staff configuration, wholesale changes need to be
implemented to increase delegation, empowerment and
accountability, and make improvements to major production
processes and functions. In the near term, OPPTS's managers and
its Streamlining Task Force will be asked to work to re-examine
our central production processes and to take specific action to
delegate authorities to lower levels. Further, OPPTS hopes to
benefit by conducting its own customer survey to determine where
its customers believe it can become more effective and efficient.
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A. Delegation. Empowerment, and Accountability
OPPTS has made a commitment to the delegation of authority,
general employee empowerment, and accountability for results.
By March 31, 1994 each Office Director wilt take action to
promote the delegation of decision making authorities for actions
no longer requiring prior approval by the Office Director. The
Office of Pesticide Program's Delegation Task Force has already
made recommendations on 40 such actions and that Office will be
considering and taking appropriate action on those
recommendations by the March deadline. The Office of Pollution
Prevention and Toxics will commence a similar exercise in that
time frame and the Office Director will be asked act quickly on
their recommendations. Action will also be taken to redelegate
actions now delegated to the Assistant Administrator.
The Assistant Administrator and Office Directors will
establish mechanisms for accountability for the newly delegated
authorities.
B. Improving Work Processes and Customer Focus
OPPTS Senior Managers have committed to the identification
and elimination of regulations, legal mandates, and review
activities which produce little or no risk reduction. This
effort is highlighted below.
In early February. 1994, The OPPTS Streamlining Task Force
will be reconvened to identify by March 31, 1994 those core
production processes which can be improved, abbreviated, or
eliminated. In so doing, the Task Force will: a) review the
progress of all Quality Action Teams (QATs) which have previously
been established in OPPTS, b) make recommendations for which of
these efforts should be continued, and c) identify areas where
new QATs should be formed to make process improvements.
AH existing QATs whose work continues, and new QATs formed
upon the recommendations of the Streamlining Task Force, will
complete their analysis and submit their reports to the Task
Force by June 30, 1994. At that time, the Task Force will again
be reconvened to review the QAT reports and develop
recommendations for OPPTS senior management on a course of
action.
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By March 31, 1994. the OPP and OPPT Office Directors will
prepare a list of activities with little risk reduction benefits
and determine what actions may be needed to reduce or eliminate
them. Further. OPPTS will continue in its effort to identify
processes and program areas that are currently handled within
OPPTS which could be eliminated or reduced simply by clarifying
jurisdictional responsibility between federal programs.
Simultaneously, the Deputy Office Directors in OPPTS will be
commencing a detailed customer survey exercise in two phases, the
first (to identify customers and commence development of the
survey instrument) to be completed by the end of March 1994.
Finally, OPPTS plans to continue to explore ways to
eliminate redundancies in its own program and support services.
As the likelihood of entering a new EPA facility nears, so does
the possibility for unifying the spaces occupied by OPPTS's two
main program offices (e.g., library, docket, FOIA, etc.). OPPTS
will be planning toward that eventuality as an additional
opportunity to further streamline.
Vli. HUMAN RESOURCES, DIVERSITY & EMPLOYEE DEVELOPMENT
OPPTS has a variety of very complex missions supported by a
highly specialized work force. Its 1320 staff members include
more than 400 senior employees whom reflect the office's
commitment to high quality scientific, administrative, and policy
products. Maintaining and nurturing a healthy and diverse work
force during a period of government reductions is an issue of
critical importance to OPPTS and its senior managers.
A. Actions on Human Resources and Development
The OPPTS Streamlining Task Force examined a host of issues
related to work force management and made more than 50 recommend-
ations for actions which could enhance the quality and training
of our work force. OPPTS Senior Managers have committed the
organization to several priorities: 1) keeping employees
motivated and developing their skills by providing opportunities
for growth and well rounded experiences, 2) improving its systems
for providing timely and constructive feedback to all employees,
upward, downward and laterally throughout the management chain,
and 3) ensuring that its mechanisms for providing formal training
and allocating resources for professional development are
sensible and equitable.
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By March 31, 1994, OPPTS will develop an implementation plan
to help to achieve its priority human resource goals:
1. Dual Career Track: We need to create a new career track
within the offices for senior staff who witl act as team
leaders, technical experts, and special (cross-matrix)
project managers without supervisory responsibilities (such
as performance review and other administrative authorities)
reserved to managers. We will build on existing proposals
for dual track options for scientist and technical staff.
2. Rotational Assignments: We will establish a formal
rotational program within OPPTS (including opportunities for
movement between the Toxics and Pesticides Program Offices)
to encourage cross-training and cultivate a strong cadre of
staff members with experience in a variety of program areas
who can coordinate production and quality assurance
activities at a senior level.
3. Evaluation of Supervisors' Work: We will pilot an enhanced
performance evaluation process for managers to compliment
the current system so that feedback can travel upward and
laterally in the organization rather than simply from a
supervisor to her/his subordinates.
4. Training and Development: We will develop a strategic plan
for staff training and development to ensure that the needs
of the work force in a redesigned OPPTS will be adequately
met. This will involve re-examining how OPPTS
a. assesses its training needs;
b. trains its new employees;
c. trains employees who are candidates for promotion or
reassignment; and
d. allocates its training and professional development
resources.
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B. Actions to Improve Diversity
Where We Are:
Where are we with regard to diversity? Tables 1, 2, and 3
provide some data on the composition of OPPTS's work force. As
the tables indicate, OPPTS, like the rest of EPA, has a
managerial work force that is not representative of our general
work force with respect to inclusion of women and minorities.
What We Have Done:
Since 1988, OPPTS has attempted to address this imbalance.
In the last four years, OPPTS has had only one major hiring
effort, the expansion of FIFRA with the 1988 amendments. To
assist in improving diversity in the program, OPP established a
task force to recruit minorities for the 200 new positions
associated with the FIFRA hiring. This approach increased
diversity within OPP and established cooperative outreach to
minority communities, universities and other groups.
Approximately 2/3 of new recruits in OPP since 1989 are
minorities or women. This mechanism has proven effective and
will continue to be an important pan of our program.
OPPTS has established an Academic Relations Program with
Howard University to advance education and awareness about
protecting the environment and to facilitate recruitment of
minority scientists. We have also participated with the Quality
Education for Minorities (OEM I Network for several years and have
benefited from their science internship program participants.
Our interest also extends beyond the scientific personnel to
the administrative and support staff. OPP has established a
Administrative Support Career Management System (ASCMS) to
improve our ability to attract, develop, and retain high quality
staff. OPPT has an active Human resources council which
provides valuable training and educational opportunities to
staff.
In addition, OPPTS has been an active participant in the
Greater Leadership Opportunities program established by the
Agency. To date we have had 22 mid-level (GS11-13) minority
candidates participate, most of those who completed the program
moved on to expanded roles within the organization including
management positions.
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Where We Are Going:
OPPTS values the diversity of ethnicity, gender, race.
skills, and talents which currently exist in its work force and
is committed to increasing diversity in its management corps. To
achieve these ends, OPPTS's will charter a Diversity Task Force
which will prepare an implementation plan by March 31, 1994 to
carry out the following commitments:
1. Enhancing the OPP and OPPTS programs for minority
recruitment for all vacancies at all levels, to build on our
successes,
2. Conducting diversity training throughout the organization,
stressing the value of a diverse work force to fulfilling
our mission of environmental protection (not simply
numerical goals), and
3. Improving training, mentoring, retention and development of
minority and women employees in order to open new avenues
for increased participation.
< SPECIAL NOTE: >
Tables 1 and 2 are WordPerfect Documents attached to this message
item. You must use WordPerfect to view these tables.
TABLE 1 Diversity Profile: Office of Pesticide Programs
TABLE 2 Diversity Profile: Office of Pollution Prevention and
Toxics
TABLE 3 Minorities and Women by National Program Office can be
obtained in Room 1120, CM2; or 3rd floor reception area next to
SRRD's Director's Office.
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VIII.
NATIONAL PERFORMANCE REVIEW GOALS
The National Performance Review contains three major initiatives which
involve OPPTS directly. They are those relating to: 1) prohibiting the
export of pesticides that are banned for use in the United States, 2)
shifting the Agency toward pollution prevention and away from pollution
control, and 3) promoting quality science for quality products.
A. Stop the export of pesticides banned in the U.S. The Agency, under
OPPTS's lead, is working with Congress, the White House and other federal
Agencies on legislation that would prohibit completely the export of
pesticides banned in the U.S. and place stringent restrictions on the
export of others. OPPTS hopes to see legislation introduced early in
1994. In addition to the legislative changes, OPPTS is working to:
1. Strengthen international agreement on prior informed consent
procedures. The U.S., along with other major pesticide exporting
countries, is extremely supportive of the PIC system. The system's premise
is that importing countries should be able to make informed decisions on
which pesticides they choose to receive, in advance of actual shipment.
EPA has submitted to the United Nations a comprehensive list
pesticides and industrial chemicals that have been banned for ail or
virtually all uses in the United States. Along with the list we have
provided detailed information sheets about the health or environmental
risks of each chemical and the reasons for the regulatory actions taken.
EPA has worked with industry to gain their agreement to participate and
work under the principles established by the PIC system.
EPA is implementing the PIC system and is working with the U.N., other
countries and industry to ensure that decisions taken by countries on PIC
chemicals are honored according to the rules of the PIC system. Further we
have strengthened EPA's own international notification system which
requires that foreign countries be notified about all major regulatory
actions taken on pesticides in the U.S. on the basis of health or
environmental reasons. We have expanded our program to ensure that other
governments have access to information that EPA possesses on the health and
environmental effects of pesticides that we use in the U.S. and may export
elsewhere.
2. Provide interagency technical assistance internationally for
pesticide use. OPP has long been committed to providing technical
assistance to developing countries to help them regulate pesticides and
handle them safely. The EPA has conducted numerous Workshops and Symposia
in developing countries on strengthening pesticide regulation and continue
to conduct such workshops on an "as requested" basis. In 1992, in
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cooperation with the Agency for International Development, we began a more
comprehensive assistance program in Central America with emphasis on
strengthening pesticide regulatory institutions, provision of technical
information, support for pesticide management and safety training programs,
and coordination with assistance efforts conducted by other donor or
international organizations. The program (which is considered a pilot
project) is already providing some assurance that pesticides with be
handled more safely in the Central american Region and that fruits and
vegetables destined for the United States will be free of vioiative
pesticide residues.
The EPA Administrator has also announced plans to ask for
Congressional authorization to spend up to $4,000.000 a year to provide
expanded technical assistance to developing countries. EPA plans to work
with Congress to identify appropriate sources of funding.
B. Shifting the Agency toward pollution prevention and away from pollution
control. OPPT has made significant progress on this NPR goals with these
activities:
1. Partnerships with Industries to Re-engineer Products and Processes.
One of the principle concepts of reinventing government is developing
partnerships with the private sector to achieve government's policy goals
and objectives. OPPT's Design for Environment program was recognized by
the National Performance Review as an excellent example of industry
/government partnerships. The NPR specifically recommended that the Design
for the Environment (DfE) program be expanded to additional industry
sectors. As part of the National Performance Review, OPPTS will work to
assist additional industries make informed, environmentally responsible
design choices by providing standardized analytical tools.
Voluntary industry partnerships will include suppliers and customers
of the target industries and trade associations. DfE will promote
pollution prevention through the use of safer chemicals, processes, and
technologies in the earliest design stages.
2. Develop a Plan to Implement an Executive Order on Pollution
Prevention. In August of 1993. the President signed an executive order to
inculcate the principles of pollution prevention into the planning and
operation of the Federal government. OPPTS will be develop guidance to
help Federal agencies implement the Pollution Prevention Executive Order.
Each Federal agency with facilities that release chemicals (under the
Toxics Release Inventory or TRI) will develop pollution prevention
strategies and later pollution prevention plans for each facility. These
plans will specify pollution prevention activities for the facility and
will include TRI reduction goals.
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3. Encourage Pesticide Use Reduction. OPPTS is actively working with
the U.S. Department of Agriculture (USDA) and the Food and Drug
Administration to promote the reduced use of pesticides. By October 1994,
OPPTS will have prepared commodity-specific goals for use reduction and is
working with USDA toward having 75% of american farm acreage employing
integrated pest management techniques by the year 2000. To further this
goal, OPP coordinated a national workshop on Pesticide Use/Risk Reduction
during the first week of February 1994.
C. Promoting quality science for quality products. As an Office with
responsibility for some very complex environmental missions supported by
technical analysis of data on human health and environmental effects, OPPTS
has a critical role to play in supporting quality science. OPPTS's
streamlining plans will rely heavily on a strategy for creating a new
career track within the offices for senior staff (especially technical
experts) to help us to retain scientist and technical staff who are
responsible for peer review and quality control of science based products.
Additionally, OPPTS will become a leader in developing opportunities for
rotational assignments within OPPTS (including opportunities for movement
between the Toxics and Pesticides Program Offices) to encourage cross-
training and cultivate a strong cadre of staff members with experience in a
variety of program areas who can coordinate production and quality
assurance activities at a senior level.
IX. MEASURES & MILESTONES
OPPTS will institute immediately an integrated monitoring system to
track, on a quarterly basis, data from the individual program offices on
the number of personnel on-board, hiring actions, and departures. This
will involve developing consistent reporting formats and time frames and
collecting new information regarding GS 14, 15, and SES positions. We
will also establish reporting mechanisms within OPPTS so that we can
measure the enhancement of the diversity of our work force in professional,
scientific, managerial, administrative, and support activities.
At the end of each quarter and starting with the close of the second
quarter of FY 1994 (July 1994), OPPTS senior management will meet to review
our progress and chart actions for:
> attrition at the GS 14, 15, and SES levels,
> critical hiring actions at these levels,
> opportunities for enhancing diversity in management,
> hiring actions at the GS 13 level and below, and
> plans for enhancing work force diversity at those levels.
A critical issue for measuring progress in meeting the FY 1995 goals
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will be anticipating incentives for retirement and early-outs. If such
incentives are provided, we would expect attrition at all grade levels to
increase. OPPTS's current attrition rate of 6.5% across all grade levels
must be realized within the pool of 412 GS-14, 15, and SES employees to
enable the office to meet the FY 1995 reduction target. Therefore,
continued improvements in the economy and an incentives program would make
attaining these goals less difficult. It is important, however, that
checkpoints for measuring progress be uniform across the entire Agency, so
that equity across AA-ships can be ensured.
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ABBREVIATIONS
EFED Environmental Fate and Effects Division
EPA Environmental Protectional Agency
FATES Federal Insecticide, Fungicide, and Rodenticide Act
and Toxic Substances Control Act Enforcement System
FFDCA Federal Food, Drug and Cosmetic Act
FIFRA Federal Insecticide, Fungicide and Rodenticide Act
GAO General Accounting Office
GLP Good Laboratory Practices
HED Health Effects Division
OCM Office of Compliance Monitoring
OIG Office of Inspector General
OPPTS . Office of Pesticides, Prevention and Toxic
Substances
PDHS Pesticide Document Management System
PPIS Pesticide Product Information System
RD Registration Division
SRRD Special Review and Reregistration Division
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DISTRIBUTION
Inspector General (2410)
Assistant Administrator for Prevention,
Pesticides and Toxic Substances (7101)
Assistant Administrator for Enforcement (2211)
Agency Followup Official (3101)
Attention: Assistant Administrator for the Office of
Administration and Resources Management
Agency Followup Coordinator (3304)
Attention: Director, Resources Management Division
Audit Followup Coordinator
Office, of Program Management Operations (7104)
Associate Administrator for Regional Operations
and State/Local Relations (1501)
Associate Administrator for Communications, Education and
Public Affairs (1701)
Associate Administrator for Congressional and
Legislative Affairs (1301)
Headquarters Library
Regional Administrators
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