SEPA
March 2007
Evaluation of the U.S.
EPA Pesticide Product
Reregistration
Process: Opportunities
for Efficiency and
Innovation
Promoting Environmental Results
•« •
Through Evaluation
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Table of Contents
Acronyms iv
Acknowledgments v
Preface v
Executive Summary vi
1. Introduction 1-1
1.1 Purpose and Evaluation Questions 1-1
1.2 Evaluation Audience 1-2
1.3 Program Description 1-2
1.3.1 Statutory Framework 1-2
1.3.2 Product Reregistration Process 1-4
1.3.3 Roles in the Product Reregistration Process 1-6
1.3.4 Product Reregistration Program Logic Model 1-7
1.4 Review of Related Evaluations 1-9
1.4.1 Funding and Accountability 1-9
1.4.2 Reregistration Policy 1-9
1.4.3 Information Management 1-10
1.4.4 Performance Management 1-11
1.5 Organization of Report 1-12
2. Methods 2-1
2.1 Data Collection Methods 2-1
2.2 Data Collection Approach 2-5
2.3 Data Analysis 2-7
3. Progress on Product Reregistration 3-1
3.1 Status of Product Reregistration 3-1
3.2 Duration of the Product Reregistration Process 3-4
4. Reregistration Eligibility Decisions 4-1
4.1 Issues with REDs 4-1
4.2 Case Studies 4-2
4.2.1 Rodenticide Cluster 4-2
4.2.2 Captan 4-4
4.2.3 Dicofol 4-5
4.3 Alternative Strategies for Implementing Mitigation 4-6
4.3.1 Memoranda of Agreement- Chlorpyrifos and Phosmet 4-6
4.3.2 Propanil Pilot Project 4-8
5. DCI Justifications and Preparation 5-1
5.1 Preparation of DCI Justification Package 5-1
5.1.1 Template for DCI Justification Package 5-1
5.1.2 Supporting Data 5-2
5.1.3 Tracking 5-2
5.2 Resources and Staff Time 5-3
5.3 Approval of the DCI Justification Package 5-3
6. Data Requirements and Review 6-1
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6.1 Data Management of Registrant Responses 6-1
6.2 Acute Toxicity and Product Chemistry Analysis 6-4
6.2.1 Background on Acute Toxicity and Product Chemistry Guidelines 6-4
6.2.2 Design of Analysis 6-5
6.2.3 Audit Conclusions 6-5
6.3 2,4-D Streamlined Data Requirements 6-6
6.3.1 2,4-D Batching Approach 6-7
6.3.2 2,4-D Storage Stability Requirements 6-7
6.3.3 Pros and Cons of this Approach 6-7
6.4 Communication 6-8
6.5 Management and Staffing 6-9
7. Label Assessments and Reviews 7-1
7.1 Label Assessment-Special Review and Reregistration Division 7-1
7.2 Label Review- Registration Division 7-2
7.3 Ziram Pilot Project 7-3
7.4 Workload Management and Other Issues 7-3
7.5 Current Strategy to Expedite Product Reregistration 7-4
8. Suggested Changes to Process Design and Other Recommendations 8-1
8.1 RED Development 8-1
8.1.1 Improve Transition of Cases from Reregistration Branches to PRB 8-1
8.1.2 Require More Participation by RD in the Development of Label Tables 8-2
8.2 Implementation of RED-Specified Mitigation 8-2
8.2.1 Implement Mitigation in an Expedited Manner When Cost-Effective 8-2
8.2.2 Pursue Additional Regulatory Action When Warranted 8-3
8.2.3 Further Explore Self-Certified or Electronic Labels 8-4
8.3 DCI Justifications and Preparation 8-4
8.3.1 Ensure that DCIs Are Prepared According to the Package Template 8-4
8.3.2 Modify Format of Supporting Data in Risk Assessments 8-4
8.4 Streamlined Data Requirements 8-5
8.4.1 Conduct Additional Analyses to Determine Value of Product-Specific Data 8-5
8.4.2 Leverage Related Efforts for Process Improvements 8-5
8.4.3 Expand Batching Approaches to Reduce Number of Requested Studies 8-5
8.4.4 Encourage Use of Self-Certified Product Chemistry Data 8-6
8.5 Registrant Responses 8-6
8.5.1 Create Incentives for Registrants to Provide Expedited Responses 8-6
8.5.2 Establish Procedures and Pursue Suspensions 8-7
8.5.3 Retain Data Review Functions within PRB 8-7
8.6 Label Reviews and the Role of the Registration Division 8-7
8.6.1 Discontinue Label Assessments within SRRD 8-8
8.6.2 Improve Transition of Cases from SRRD to RD 8-8
8.7 Management, Resources, and Staffing 8-8
8.7.1 Reevaluate Allocation of SRRD Resources 8-9
8.7.2 Maintain Emphasis on Product Reregistration 8-9
8.7.3 Pursue SWAT Teams and Other Strategies to Reduce Backlog 8-9
8.7.4 Obtain Support for DCI Preparation 8-10
8.8 Communication 8-10
8.9 Performance Management 8-11
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8.9.1 Improve Performance Measures and Strategic Targets 8-11
8.9.2 Incorporate Product Reregistration into PARS 8-11
8.10 Information Management 8-11
8.10.1 Continue to Prioritize an Integrated Tracking System 8-12
8.10.2 Maintain Web Site as a Repository of Reregistration Decisions 8-12
Appendix A Interview Guide 1
Appendix B Individuals Interviewed or Consulted 6
List of Exhibits
Figure 1-1. Overview of Product Reregistration Process
Figure 1-2. Logic Model: U.S. EPA Office of Pesticide Programs Product Reregistration
Figure 3-1. Universe of Pesticide Products at End of FY2006
Figure 3-2. Distribution of Completed Actions through the End of FY2006
Figure 3-3. Actions Completed from FY2002 through FY2006
Figure 3-4. Actions Completed in FY2006 Compared to Target
Figure 3-5. Duration of Product Reregistration Process for All Products (Reregistered and
Conditional or Unconditional Reregistered Products)
Figure 3-6. Duration of Period from RED Signature to Product Sent to PM (Panel A),
Duration of Period from Sent to PM to Decision (Panel B)
Figure 3-7. Duration of Period from RED Signature to Product Sent to PM for Products that
are Not Yet Completed
Table 2-1. Summary of Data Collection Methods
Table 3-1. Cumulative Completed Reregistration Actions through FY2006
Table 3-2. Products with Actions Pending at the End of FY2006
Table 3-3. Mean Duration of Process for All Products and by RED Case
Table 3-4. Mean Duration of Process for RED Case by the Number of Products
Table 3-5. Median Duration of Process for All Products and by RED Case
Table 3-6. Median Duration of Process for RED Case by the Number of Products
Table 3-7. Product Reregistration Completion Status by Fiscal Year
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Acronyms
AD Antimicrobials Division
Al Active Ingredient
BEAD Biological and Economic Analysis
Division
BPPD Biopesticides and Pollution
Prevention Division
CBI Confidential Business Information
CFR Code of Federal Regulations
CRM Chemical Review Manager
CRS Congressional Research Service
CSF Confidential Statement of Formula
DCI Data Call-In
EPA U.S. Environmental Protection
Agency
FEAD Field and External Affairs Division
FFDCA Federal Food, Drug, and Cosmetic
Act
FIFRA Federal Insecticide, Fungicide,
and Rodenticide Act
FQPA Food Quality Protection Act
FR Federal Register
FTE Full-Time Equivalent
GAO General Accountability Office
GPRA Government Performance and
Results Act
HED Health Effects Division
HHDA Hazard to Humans and Domestic
Animals
IRED Interim Reregistration Eligibility
Decision
ISB Information Services Branch
IMC Information Management Council
ITRMD Information Technology and
Resource Management Division
MOA Memorandum of Agreement
MRID Master Record Identification
Number
NRDC Natural Resources Defense
Council
OGC Office of General Counsel
OIG Office of Inspector General
OMB Office of Management and Budget
OPP Office of Pesticide Programs
OPPIN Office of Pesticide Programs
Information Network
OPPTS Office of Prevention, Pesticides,
and Toxic Substances
PARS Performance Appraisal and
Recognition System
PART Program Assessment Rating Tool
PDCI Product-Specific Data Call-in
PM Product Manager
PPDC Pesticide Program Dialogue
Committee
PPE Personal Protective Equipment
PPLS Pesticide Product Label System
PRA Paperwork Reduction Act
PRB Product Reregistration Branch
PRIA Pesticide Registration
Improvement Act of 2003
PRN Pesticide Registration Notice
PSB Program Support Branch
RCS Regulatory Coordination Staff
RD Registration Division
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RUP Restricted Use Pesticide
SEE Senior Environmental
Employment
SOP Standard Operating Procedure
SRRD Special Review and Reregistration
Division
TRED Tolerance Reassessment
Eligibility Decision
USDA U.S. Department of Agriculture
WPS Worker Protection Standard
IV
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Acknowledgments
In Fall 2005 the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs
(OPP) entered the EPA Program Evaluation Competition and was selected for an evaluation of
its product reregistration process. This competition, jointly sponsored by the Office of Policy,
Economics and Innovation and the Office of the Chief Financial Officer, encourages the
effective use of program evaluation throughout EPA. As a subcontractor to Industrial
Economics, Abt Associates conducted this evaluation under EPA contract EP-W-04-023.
The Abt Associates evaluation team gratefully acknowledges the input and guidance provided
by Peter Caulkins, OPP Special Review and Reregistration Division, and Yvonne Watson, EPA
Office of Policy, Economics, and Innovation, throughout the design and implementation of the
evaluation. We also appreciate the time made available by OPP staff members to meet with the
evaluation team, which provided us with critical information on their roles, responsibilities, and
perspectives on product reregistration that would not have otherwise been available.
Preface
As a subcontractor to Industrial Economics, Abt Associates conducted this evaluation under
EPA contract EP-W-04-023. This report reflects the information made available to Abt
Associates either by EPA or through published sources. A substantial amount of the
information is qualitative in nature and was collected through a series of interviews with EPA
staff. The findings presented in this report are based on the information made available to the
evaluation team. Further, the conclusions and recommendations presented in this report are
those of the evaluation team and are not necessarily reflective of EPA's position.
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Executive Summary
The U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) conducts
a comprehensive review of pesticides initially registered before November 1, 1984, to ensure
that they meet contemporary health and safety standards and labeling requirements. After the
registrant signals its intent to reregister an active ingredient, EPA conducts science reviews,
develops a risk assessment and publishes it for public comment, and issues a Reregistration
Eligibility Decision (RED). EPA then must reregister each of the individual pesticide products
that contains the active ingredient. This final step in the process - pesticide product
reregistration - is the focus of this evaluation.
Product reregistration consists of three basic steps, which are completed by either the OPP
Special Review and Reregistration Division (SRRD) or the Registration Division (RD): (1) SRRD
sends registrants a Data Call-In (DCI) notice requesting the needed product-specific data. (2)
SRRD receives and evaluates the requested studies from the registrants and conducts a
preliminary label assessment. (3) RD reregisters a product if it was found to meet its standards
by issuing a reregistration notice and stamping a revised label that includes the necessary
mitigation.
Evaluation Purpose and Approach
There is considerable interest within EPA to streamline and expedite the product reregistration
process. The purpose of this evaluation is to identify potential opportunities for innovation and
streamlining of the product reregistration process in order to (1) ensure timelier implementation
of the mitigation measures specified in the RED, and (2) make the process as efficient as
possible in order to decrease the amount of time needed for product reregistration and use
resources in the most effective manner. The evaluation was designed to answer the following
questions:
• What components of REDs have caused delays in product reregistration?
• What problems, bottlenecks, or unnecessary duplication of efforts occur in the product
reregistration process that are under the control of OPP?
• What innovations or streamlining in process could result in more timely implementation
of mitigation specified in the RED and/or more efficient production of outputs?
• What are the pros and cons of each of the proposed innovations or streamlining
measures?
• What is the optimal allocation of tasks between the Special Review and Reregistration
Division and the Registration Division?
• Are any external entities or considerations impeding the product reregistration process?
The methodology employed several data collection methods, including interviews, document
review, reregistration program data, case studies, and subject matter experts.
Product Reregistration Progress
Since beginning reregistration in the late 1980s, EPA has completed reregistration actions for
7,358 products. Reregistration actions for 11,948 products (conventional and antimicrobial)
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were pending as of October 2006. Of the pending reregistration actions, the products are
distributed through all phases of the pesticide reregistration process. Most of the products
(9,088 or 76%) have not yet had the Data Call-in (DCI) approved by the Office of Management
and Budget (OMB). The FY2006 REDs resulted in 6,722 products that will require DCIs.
On average, it took more than 54 months to reregister a product. On average, approximately 41
months were needed to transmit the reregistration package to the Product Manager (PM) in RD,
and after the reregistration package had been sent to the PM, it took approximately 14 months
to complete the reregistration process. The distribution of these data indicated that they are
skewed such that the mean (average) is not adequate to represent the average duration of the
process; the median time is more informative in this instance. The median time to complete
product the product reregistration process was 30 months.
Product Reregistration Delays Associated with REDs
The Registration Eligibility Decisions (REDs) and subsequent activities were found to be a
source of delay in product reregistration. REDs were often published before they are complete
or before all outstanding issues were properly addressed. These documents represented a
"snapshot in time" of the data made available to EPA, and registrants often provided additional
data that warrant amending the RED. Some registrants were inclined to challenge the contents
of a RED as a way to delay implementing mitigation. Also, some REDs did not represent
decisions or included provisions for additional studies, such that product reregistration could not
be effectively implemented after the RED was published. REDs sometimes contained small
errors, most of which were straightforward and easy to address. The label tables often
contained language that RD or SRRD Product Reregistration Branch (PRB) believe could been
improved or that is not consistent with labeling for other products. Many of these issues only
became apparent at implementation, which was during the product reregistration process.
Post-RED issues were not given high priority in work plans and adequate resources within the
four SRRD reregistration branches, as statutory deadlines required continued focus on REDs.
Staff from the reregistration branches were often unavailable to assist with post-RED issues.
Given the length of time from when a RED was published, to when post-RED issues were
addressed, to when product reregistration was conducted, the Chemical Review Manager
(CRM) who wrote the RED was often no longer in that position.
Problems, Bottlenecks, and Unnecessary Duplications of Effort
Because of the length of the product reregistration process, as well as the delays that often
occur, the mitigation identified in the RED is often not implemented for several years. This delay
is particularly troublesome given that the universe of pesticides includes those that were
registered prior to November 1, 1984. EPA has made several attempts to implement RED-
specified mitigation as soon as possible, including through memoranda of agreement and
requests to registrants. Even with regulatory action as a possible consequence of non-
response, registrants did not submit amended labels for a substantial number of products.
There is substantial backlog in the number of DCIs that need to be approved by the Office of
Management and Budget (OMB) and sent out by OPP so that product reregistration can begin.
The review by OMB also results in substantial delay because the approval process takes an
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average of nine to ten months. In addition, the format for the justification package has been and
continues to be an issue, the needed information is not readily available in a suitable format,
and OPP lacks an adequate tracking system for the DCI process.
One of the sources of delay in the product re registration process are the registrant responses,
which require a lot of time for the registrants to prepare and submit, as well as for EPA to
receive, track, review, and respond to (if required). During the course of its reregistration
program, EPA has initiated several efforts to increase the quality of data it receives from
registrants so that data are not deficient, which requires additional time for the registrant to
prepare and submit studies and for EPA to review them.
As currently designed, the Special Review and Reregistration Division (SRRD) conducts
preliminary label assessments, and the Registration Division (RD) conducts full label reviews.
The review by SRRD was intended to focus on mitigation required by the reregistration process,
whereas RD focused on label amendments and content more generally. Despite this division of
labor, the two reviews are duplicative and RD has not used many of SRRD's label assessments.
Efficient information management is an issue for all aspects of the product reregistration
process. In 2000, EPA launched the Office of Pesticide Programs Information Network
(OPPIN), which was intended to be an integrated, office-wide system. This system, which
replaced existing systems to track reregistration on the product and active ingredient levels,
failed to meet the needs of OPP with respect to product reregistration. In response, many staff
have created one-off tracking systems in order to get their jobs done, making comprehensive,
reliable status updates very difficult to retrieve. OPP again requested improvements to OPPIN
in November 2006, but requests to modify OPPIN are often not granted due to competing
demands and because OPPIN will be retired in September 2008. It is unclear the extent to
which the new information management system, PRISM, will address the needs of product
reregistration.
In its FY2007 reregistration work plan, SRRD allocates eight percent of its resources (full-time
equivalent (FTE)) to product reregistration. This allocation is roughly equivalent to past staffing
levels and SRRD expects the staffing level to remain fairly constant in the short term. SRRD
intends to allocate funds to product reregistration at roughly the same level through FY2013.
SRRD has predicted that it will complete product reregistration by the end of the 2012 calendar
year.
Based on data provided by EPA, Abt Associates developed a conservative estimate as to when
it believes OPP might complete product reregistration, assuming that the current level of activity
and resource allocation continue. We estimate that product reregistration may not be
completed for more than twelve years, or the end of FY2018. This is six years longer than
EPA's current prediction, and five years longer than the period for which EPA has budgeted.
External Entities or Considerations
Two divisions of the Office of Pesticide Programs (SRRD and RD) are generally responsible for
reregistering conventional pesticide products. However, other divisions participate in the effort,
including the Field and External Affairs Division (FEAD) and the Information Technology and
Resource Management Division (ITRMD). Both FEAD and the Office of Prevention, Pesticides,
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and Toxic Substances Regulatory Coordination Staff participate in the preparation of DCI
justification packages and facilitate communication with OMB. FEAD recently developed a
streamlined template for the package to improve the process. FEAD also provides scientific
and technical staff support to SRRD. ITRMD is responsible for information technology and
management. ITRMD receives and responds to requests for data systems improvement, such
as those to OPPIN. The science divisions also provide some support for product reregistration,
as needed.
The Office of Management and Budget (OMB) reviews and approves DCI justification packages.
This review period varies in length and often results in EPA responding to several rounds of
questions and issues raised by OMB. A new OMB desk officer was recently assigned to
pesticide DCI approvals, so the timeline and procedures for the review of DCI justification
packages may change. As needed, the U.S. Department of Agriculture and other federal
agencies consult on product reregistration issues.
Finally, the pesticide registrants play a key role in product reregistration and are also a
significant source of delay. In response to a DCI, registrants provide both ninety-day and eight-
month responses, which include amended labels, waiver requests, and requested studies. In
addition to the time provided for response, additional time is required when registrants submit
deficient studies that have to be repeated/upgraded. Also, the review of this material and the
communication with the registrant consume a significant portion of OPP's time as well.
Recommendations to Streamline or Modify Product Reregistration
The reregistration program has evolved over time and in response to significant policy changes,
including the Food Quality Protection Act, Pesticide Registration Improvement Act, and the
public participation program. The pesticide reregistration program is required under the Federal
Insecticide, Fungicide, Rodenticide Act, but the process is not codified in regulation. Although
this arguably has its down sides, for purposes of this evaluation it means that EPA has the
flexibility to modify and improve the process to better meet its desired outcomes.
Internally, OPP initiated a dialogue to improve the product reregistration program, including
developing a "SWAT Team" approach to expedite product reregistration. In addition, recent
management attention has raised the visibility of product reregistration in both RD and SRRD.
Based on the results of the evaluation, the following recommendations are presented to further
expedite product reregistration and/or implement RED-specified mitigation more quickly:
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Recommendations of the Evaluation Team
RED Development
Improve the Transition of Chemical Cases from Reregistration Branches to PRB
Require More Participation by RD in the Development of Label Tables
Implementation of RED-Specified Mitigation
Implement Mitigation in an Expedited Manner When Cost-Effective
Pursue Additional Regulatory Action When Warranted
Further Explore Self-Certified or Electronic Labels
DCI Justifications and Preparation
Ensure that DCIs Are Prepared According to the Package Template
Modify Format of Supporting Data in Risk Assessments
Streamlined Data Requirements
Conduct Additional Analyses to Determine Value of Product-Specific Data
Leverage Related Efforts for Process Improvements
Expand Scope of Batching Approaches to Reduce Number of Requested Studies
Encourage Use of Self-Certified Product Chemistry Data
Registrant Responses
Create Incentives for Registrants to Provide Expedited Responses
Establish Procedures and Pursue Suspensions
Retain Data Review Functions within PRB
Label Reviews and the Role of the Registration Division
Discontinue Label Assessments within SRRD
Improve Transition of Chemical Cases from SRRD to RD
Management, Resources, and Staffing
Reevaluate Allocation of SRRD Resources
Maintain Emphasis on Product Reregistration
Pursue SWAT Teams and Other Strategies to Reduce Backlog
Obtain Support for DCI Preparation
Communication
Improve Internal and External Communication about Product Reregistration
Performance Management
Improve Performance Measures and Strategic Targets
Incorporate Product Reregistration into PARS
Information Management
Continue to Prioritize an Integrated Tracking System
Maintain Web Site as a Repository of Reregistration Decisions
These recommendations are discussed in detail in the body of the report, including applicable
pros and cons for each.
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1. Introduction
To ensure the safety of older pesticides, the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) amendments of 1988 required the U.S. Environmental Protection Agency (EPA) to
conduct a comprehensive review of pesticides initially registered before November 1, 1984.
Through its pesticide reregistration process, the EPA Office of Pesticide Programs (OPP)
ensures that older pesticides meet contemporary health and safety standards and labeling
requirements. Reregistration includes approximately 600 active ingredient cases and more than
20,000 pesticide products that contain these active ingredients.
The reregistration process is composed of several steps. After the registrant signals its intent to
reregister a pesticide, OPP conducts science reviews, develops a risk assessment and
publishes it for public comment, and issues a Reregistration Eligibility Decision RED). After
OPP publishes a RED, it then must reregister each of the individual pesticide products that
contain the active ingredient. This final step in the process - pesticide product reregistration -
is the focus of this evaluation.
1.1 Purpose and Evaluation Questions
Risk assessments and mitigation requirements are incorporated in Reregistration Eligibility
Decision documents (REDs) for each active ingredient; however, the mitigation for that active
ingredient is not implemented in the field until the individual product labels have been changed.
This is accomplished through the product reregistration process that follows the completion of
the RED, a process that often spans several years and thus prolongs the implementation of
environmentally protective measures specified in REDs. In addition, the recent signature of the
REDs for food-use pesticides will next require OPP to reregister thousands of individual
products. For these and other reasons, there is considerable interest within EPA to streamline
and expedite the product reregistration process.
The purpose of this evaluation is to identify potential opportunities for innovation and
streamlining of the product reregistration process in order to:
• Ensure timelier implementation of the mitigation measures specified in the RED, and
• Make the process as efficient as possible in order to decrease the amount of time
needed for product reregistration and use resources in the most effective manner.
In order to focus the evaluation and establish a clear goal, Abt Associates and EPA identified
several specific questions regarding the product reregistration process that were of particular
interest. This evaluation was designed to provide the answers to the following questions:
1. What components of REDs have caused delays in product reregistration?
2. What problems, bottlenecks, or unnecessary duplication of efforts occur in the
product reregistration process that are under the control of OPP?
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3. What innovations or streamlining in process could result in more timely
implementation of mitigation specified in the RED and/or more efficient production of
outputs?
4. What are the pros and cons of each of the proposed innovations or streamlining
measures?
5. What is the optimal allocation of tasks between the Special Review and
Reregistration Division and the Registration Division?
6. Are any external entities or considerations impeding the product reregistration
process?
1.2 Evaluation Audience
The findings, conclusions, and recommendations of this process evaluation will be of interest
largely to the individuals responsible for or who participate in the pesticide product reregistration
process. Thus, the primary audiences for this report are EPA managers and staff who will use
the results of the evaluation as a management tool to identify issues related to the current
process, including the extent/nature of the problems and possible modifications to the product
reregistration process. The findings may further serve as a catalyst for innovation within the
program, which will increase efficiency and reduce the product reregistration backlog, beyond
the scope of what is recommended in this report.
Please note that due to the nature of the evaluation and the information contained within this
report, this report and its supporting documentation is considered internal, EPA deliberative
material, and therefore should not be cited, quoted, or distributed outside the Office of Pesticide
Programs or the Office of Policy, Economics and Innovation unless otherwise approved by both
the management of the Office of Pesticide Programs and the EPA Work Assignment Manager,
Yvonne Watson.
1.3 Program Description
Product Reregistration for conventional pesticides is largely the responsibility of the EPA Office
of Pesticide Programs (OPP) Special Review and Reregistration Division (SRRD), although the
final end products - reregistration notices and stamped labels - are dependent upon the
Registration Division (RD). In addition to product reregistration, SRRD is also responsible for
reregistration eligibility decisions, tolerance reassessments, and special reviews. Reregistration
of antimicrobial pesticides or biopesticides is the responsibility of the Antimicrobials Division
(AD) and Biopesticides and Pollution Prevention Division (BPPD), respectively. This evaluation
focuses only on conventional pesticide products because of the limited time and resources
available and because conventional products are most common.
1.3.1 Statutory Framework
The Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as amended in 1988,
authorized EPA to conduct a comprehensive pesticide reregistration program. Reregistration
involves a complete review of the human health and environmental effects of older pesticides
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originally registered before November 1, 1984. The re registration process is finite and will
conclude when all pesticides registered prior to November 1, 1984, have been reregistered (or
cancelled). The reregistration requirements of FIFRA are not codified by rulemaking.
FIFRA specified five stages of reregistration and included provisions for collection of
reregistration fees. Product reregistration is considered part of phase five, data review and
reregistration (FIFRA section 4(b)). According to FIFRA section 4(g)(2)(b):
• Before reregistering a pesticide, EPA shall obtain any needed product-specific data
regarding the pesticide and shall review such data within ninety days after its
submission.
• EPA shall require that the data be submitted not later than eight months after a
determination of eligibility has been made for each active ingredient of the pesticide,
unless a longer period is required for the generation of the data (no more than two
additional years).
• After reviewing its active ingredient(s) and product-specific data, EPA shall determine
whether to reregister a pesticide. If eligible to be reregistered, EPA shall reregister such
pesticide within six months after the submission of the product-specific data.
The Pesticide Registration Improvement Act (PRIA) of 2003 established pesticide registration
service fees for registration actions. It also included specific deadlines for completion of specific
aspects of the reregistration process:
• Complete all REDs for food-use pesticides by August 3, 2006
• Complete all REDs for non-food-use pesticides by October 3, 2008
EPA met its deadline to complete the 231 REDs for food-use pesticides, with the exception of
aldicarb.1 PRIA did not provide deadlines for completion of product reregistration.
Pesticides with food uses must meet the safety standards of the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996. EPA
must determine that pesticide residues remaining in or on food are safe. As amended by
FQPA, FFDCA requires the reassessment of all existing tolerances (pesticide residue limits in or
on food).
FQPA also amended FIFRA to require periodic review of pesticide registrations to ensure that
all pesticides continue to meet statutory and policy standards over time. FIFRA section 3(g)
specifies that EPA establish procedural regulations for conducting registration review on a
fifteen-year cycle. This regulatory scheme, called registration review, was proposed for public
comment in July 20052 and the EPA Administrator signed the final action on August 1, 2006.3
1 EPA Press Release, "U.S. Pesticide Safety Highest in the World," August 1, 2006,
http://www.epa.gov/newsroom/
2 40 CFR part 155, Procedural Regulations for Registration Review, Proposed Rule, 70 FR 40251, July
13,2005
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EPA designed the program to address lessons learned from reregistration, including predictable
schedules, sound science, transparency and public participation, flexibility, early stakeholder
involvement, and using a docket system.4
1.3.2 Product Reregistration Process
Pesticides that meet current scientific and regulatory standards may be declared "eligible" for
reregistration. To be eligible, an older pesticide must have a substantially complete database,
and must not cause unreasonable adverse effects to human health or the environment when
used according to EPA-approved label directions and precautions. EPA publishes its
reregistration eligibility decision in one of two document types:
• REDs, or Reregistration Eligibility Decisions, for pesticides that have sufficient
supporting data and whose risks can be successfully mitigated.
• IREDs, or Interim Reregistration Eligibility Decisions, for pesticides that are undergoing
reregistration, require a reregistration eligibility decision, and also must be included in a
cumulative assessment under the Food Quality Protection Act (FQPA) of 1996 because
they are part of a group of pesticides that share a common mechanism of toxicity.
For pesticides that require tolerance reassessment decisions under FFDCA, but do not require
a reregistration eligibility decision, or where the RED was completed prior to the passage of
FQPA (1996), EPA publishes a Report on FQPA Tolerance Reassessment Eligibility Decision
(TRED).
After EPA declares a pesticide reregistration case conditionally eligible for reregistration (the
condition being that RED-specified mitigation is incorporated on the label), the individual end-
use products that contain the active ingredient must be reregistered. This concluding part of the
reregistration process is called "product reregistration." Product reregistration consists of three
basic steps (Figure 1-1):
1. After issuing a RED for an active ingredient, SRRD sends registrants a Data Call-In
(DCI) notice requesting any product-specific data needed to complete reregistration for
each of the individual pesticide products covered by the RED.
2. SRRD receives and evaluates the requested studies from the registrants. It requests
additional information, as needed, and conducts a preliminary label assessment.
3. Based on its review of the data and labeling, RD reregisters a product if it was found to
meet FIFRA and FFDCA standards. The primary output of this step is a reregistration
notice (issued to the registrant) and the stamped pesticide label, which includes any
revised mitigation specified in the RED or during the product reregistration process.
3 40 CFR part 155, Procedural Regulations for Registration Review, Final Rule, 71 FR 45719, August 9,
2006
4 "Compare Registration Review to Reregistration," Presentation by Susan Lewis, Special Review and
Reregistration Division
1-4
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Signed
RED(s)
Issue Data
Call In
CDDn/DCD
Evaluate
Registrant
Data
CDDn/DDD
Reregister
Product
on
Stamped
Label
i
Figure 1-1. Overview of Product Reregistration Process. (Source: OPP Enterprise Architecture
Process Description: Special Review and Registration Division Product Registration, SRA)
Issue Data Call-in
After a RED is signed, EPA collects both product-specific data and confirmatory data on the
active ingredient as identified in the RED. EPA requests this information through Data Call-ins
(DCIs) that are approved by the Office of Management and Budget (OMB) and then issued by
EPA to the pesticide registrants. DCIs may either be generic (for confirmatory data) or product-
specific (PDCIs). The Program Support Branch in SRRD is responsible for preparing the DCIs.
Evaluate Registrant Data
Registrants must respond to a DCI to indicate whether or not they intend to support a product
within ninety days of issuance. If the product will not be supported, EPA publishes a
cancellation notice in the Federal Register. If a registrant does not respond to the DCI, EPA has
the option to initiate a suspension of the registration. Registrants continuing to support a
product must submit study data to EPA within eight months of the DCI being issued. The
Information Technology and Resource Management Division/Information Services Branch
(ITRMD/ISB) reviews the study format, assigns a record number, and sends the studies to the
Chemical Review Manager (CRM) in SRRD Product Reregistration Branch (PRB).
The SRRD CRM coordinates and tracks all activities and communication with the registrant.
Product chemistry and acute toxicology studies are evaluated within PRB. If a study contains
efficacy data, RD conducts the evaluation since PRB does not have in-house expertise in that
area. If a study contains deficiencies, the CRM notifies the registrant and requests a corrected
study. After all data have been reviewed, PRB conducts a label assessment and then sends
the required documentation to RD for a label review and reregistration decision.
Reregister Product
Once RD receives the product reregistration package, the Product Manager (PM) reviews it for
completeness and requests any missing data from PRB. In most cases, the label submitted by
the registrant with the original reregistration submission is no longer current, so RD requests an
updated label from the registrant. Any package inaccuracies are corrected at this time.
Once the amended label has been provided and is acceptable, RD develops a reregistration
notice. If a product contains multiple active ingredients, EPA instead issues an amendment to
the product's registration; a product with multiple active ingredients is not reregistered until the
last active ingredient in its formulation is eligible for reregistration and its label has been
1-5
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amended. The registrant receives a reregistration notice and a copy of the stamped label. The
label is recorded in Pesticide Product Label System (PPLS), which is available on the OPP Web
site. This concludes the product reregistration process.
For more information on the product reregistration process, please refer to "OPP Enterprise
Architecture Process Description: Special Review and Reregistration Division Product
Reregistration," SRA International, September 29, 2005.
1.3.3 Roles in the Product Reregistration Process
This section provides a brief overview of the key OPP divisions that play a role in product
reregistration. Other OPP divisions sometimes contribute to product reregistration, as needed
and/or requested.
Special Review and Reregistration Division (SRRD) is responsible for pesticide
reregistration, tolerance reassessment, and registration review for conventional chemical
pesticides.
• Reregistration Branches write the REDs, process confirmatory data on an active
ingredient that are submitted in response to a DCI, and address post-RED issues.
• Program Support Branch (PSB) is responsible for preparing DCI justification packages
and issuing DCIs.
• Product Reregistration Branch (PRB) tracks ninety-day and eight-month responses to
product-specific data call-ins, processes product guidelines and identifies deficiencies,
communicates with the registrant, conducts label assessments, and processes
packages for RD.
Registration Division (RD) is responsible for product registrations, amendments, registrations,
tolerances, experimental use permits, and emergency exemptions for conventional chemical
pesticides. With respect to product reregistration, RD conducts label reviews, requests
additional label changes (as needed), sends reregistration notices, and stamps (approves)
labels.
Information Technology and Resources Management Division (ITRMD) is responsible for
information support, dockets, the OPP Web site, computer support, budget, and personnel.
Wth respect to product reregistration, ITRMD receives and processes the ninety-day and eight-
month submissions and supports some of the information management databases (e.g.,
OPPIN).
Field and External Affairs Division (FEAD) is responsible for program policies and
regulations; legislation and congressional interaction; regional, state, and tribal coordination and
assistance; international and field programs; and communication and outreach activities. Wth
respect to product reregistration, FEAD reviews the DCI justification package and facilitates
communication with OMB and other federal agencies.
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1.3.4 Product Reregistration Program Logic Model
The evaluation questions (see Section 1.1) were considered relative to the logic model for the
pesticide product reregistration program (Figure 1-2). A logic model is a visual, systematic way
to represent how a program works by illustrating the relationships between a program's
resources, activities, outputs, and short-term, intermediate, and long-term outcomes. The
model highlights the key connections between program components and outcomes, as well as
providing some context in which the program operates.
The program's logic model illustrates several key considerations regarding the product
reregistration process:
• Issuing the RED does not directly result in mitigations appearing on the label. That
is, the program cannot achieve its short-term outcome (updated mitigation practices
specified on label of products sold to growers/applicators) until the completion of the
entire product reregistration process.
• Product reregistration relies upon registrant-submitted data and receiving that data in
a timely manner.
• OPP often has to request additional information from the registrant as it evaluates
product-specific data, which results in delays as OPP requests data, the registrant
develops the data, and OPP tracks and reviews (or re-reviews) additional
submissions.
• Seven entities consult or participate in the product reregistration process, which
removes aspects from the direct control of OPP. These organizations include other
parts of EPA, other federal agencies, and the pesticide registrants (see "Partners
that Consult or Participate").
• Several external factors affect program effectiveness, which influence resources,
activities, outputs, and outcomes. These factors affect OPP's regulatory
responsibilities, its priorities, the timeliness of information provided, and the
resources available to complete product reregistration.
• Product reregistration has a variety of customers with different interests, concerns,
and incentives.
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Figure 1-2. Logic Model: U.S. EPA Office of Pesticide Programs Product Reregistration
Mission
To improve human and environmental health by ensuring older pesticide products are safe and to effectively manage and mitigate risk based on the best available
science. The product reregistration program fulfills this mission by reviewing older pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) to ensure they meet current scientific and regulatory standards.
Resources
Activities
Outputs
Short-term
Intermediate
Long-term
Special Review and
Reregistration Div.
• Program Support
Branch (1 FTE)
• Product Reregistration
Branch (16.5 FTE)
Registration Div.
(6 FTE)
OGC
OW
OAR
Chemical databases
Contracts ($25 - 40k)
v
Issue Reregis
Eligibility Dec
Interim Rerec
Decision (IRE
.(ration
ision (RED) or
ist ration
D) documents
Some of the required
mitigations identified
Public and
environmental groups
more aware of risks of
active ingredients
1
Issue data ca
or IRED to re
(OMB approv
ll-insfor RED
gist rants
ed)
Evaluate product-specific
data submitted
Conduct preliminary
label assessment and
label review
Reregister
product
pesticide
\
^
Voluntary cancellation
requests
DCI receipts and
responses
Requests for additional
information from
registrants, as needed
Reregistration notice
Stamped pesticide label
with updated mitigations
Some products
voluntarily cancelled by
registrants and
unavailable to growers/
applicators and
consumers (residential
use products)
Updated mitigation
practices specified on
label of products sold to
growers/applicators
Product labels more
enforceable by state
agencies
Consumers can better
compare pesticide
options
Growers/applicators/
consumers may
choose safer pesticide
product alternatives
Applicators use existing
pesticide products used in
a safer manner based on
updated label
Consumers have
more confidence in
safety of food supply
and production
Reduce
exposure to
applicators,
workers, critical
habitats, and the
environment
Preserve critical
beneficial uses
of pesticide
products
1
Improve human
health and the
environment
Partners that Consult or Participate
Office of Management and Budget
U.S. Department of Agriculture
Regulatory Coordination Staff (EPA OPPTS)
Field and External Affairs Division (EPA OPP)
Information Technology and Resource Management
Division /Information Services Branch
Other Federal Agencies (FWS, NMFS, FDA)
Pesticide Registrants
External Factors Affecting Program Effectiveness
Oversight of Office of Management and Budget
Responsiveness of Pesticide Registrants
Level of budget allocation
Implications of new legislation and regulations
FIFRA Scientific Advisory Panel recommendations
North American Free Trade Agreement requirements
European Commission regulatory decisions
Customers
Pesticide Registrants develop and produce products
Growers/Applicators purchase, apply, and use products
Agricultural Workers work in areas where products are
applied
Environmental Groups advocate a position and raise
awareness of environmental issues to the public
General Public use residential products and consume food
and other commodities that are treated with pesticides
State Agencies enforce pesticide labels
-------
1.4 Review of Related Evaluations
Numerous entities have commented on reregistration and its shortcomings, though none have
focused exclusively on product reregistration. Nonetheless, reviews conducted by the
Government Accounting Office (now called the Government Accountability Office), the EPA
Office of Inspector General, the Office of Management and Budget, and other entities illustrate
the depth of the issues explored later in this report, as well as the striking similarities and
marked differences between product reregistration and reregistration generally. In addition,
OPP itself has also commented publicly on product reregistration, including in the recent
rulemaking for its registration review program.
1.4.1 Funding and Accountability
In 1996, the Congressional Research Service (CRS) reviewed the Food Quality Protection Act,
including reregistration and its related funding issues.5 Reregistration is financed through a
combination of appropriated funds and registration "maintenance" fees paid by pesticide
registrants. EPA maintains that fee collections have been lower and costs higher than originally
anticipated, and as a result maintenance fees have been extended. Pesticide registrants
contend that historical funding levels had been adequate, and they questioned whether EPA
had managed funds efficiently. One reason for higher than expected costs and reregistration
delays has been late and deficient reregistration package submissions, according to EPA, and
these problems are being addressed.
EPA requires manufacturers applying to register or reregister a pesticide to submit reports of
scientific studies on pesticide toxicity and behavior in the environment. EPA requires that
studies conducted by industry conform to EPA standards of scientific quality. Studies that do
not meet EPA standards are rejected and must be repeated/upgraded and then reevaluated.
Rejected studies contribute to the high cost of registration. While pesticide registrants have
argued that EPA's scientific standards are excessive, EPA has insisted that registration
decisions should be based on the best available science. Historically, EPA rejected
approximately 30 percent of studies submitted. A 1991 analysis of factors contributing to late
and deficient study submissions prompted a joint EPA-industry project to improve performance.
Because of workshops, guidance, and registrant efforts, the study rejection rate in 1996 was
half of what it was in 1993 and many submissions are timelier, according to EPA.
Some have argued that industries have little incentive to submit timely and adequate
applications to maintain registrations of older pesticides; while a decision is pending about the
safety of the older pesticides, manufacturers may continue to market them.
1.4.2 Reregistration Policy
In 1986, the Natural Resources Defense Council (NRDC) evaluated the reregistration program
and related policies.6 The reregistration process has its roots in the 1972 FIFRA amendments
5 CRS Report to Congress: Pesticide Legislation: Food Quality Protection Act of 1996
(P.L. 104-170), 96-759 ENR, September 11,1996, Linda Jo Schierow, available at
http://ncseonline.org/nle/crsreports/pesticides/
6 "Pesticide Reregistration: An Evaluation of EPA's Progress," Lawrie Mott, Natural Resources Defense
Council, San Francisco, California, April 3, 1986
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and in its 1986 report NRDC noted, "until recently reregistration was not even a high priority
within EPA's pesticide program." Of NRDC's three key findings, one is particularly relevant to
the premise of this evaluation: reregistration has not been expeditious. Two of the
corresponding recommendations include:
• EPA should immediately issue final regulations establishing procedures for
reregistration. Further, NRDC noted, "Without final regulations, EPA's reregistration
program is operating on an ad hoc basis. Furthermore, absent a regulatory framework,
the public cannot readily follow EPA's process."
• EPA should institute biannual public reports that identify which pesticides have been
reregistered, etc. The public has no simple way to determine which pesticides have
been reregistered.
Similarly, the Administrative Conference of the United States recommended that EPA adopt,
whenever possible, rules setting clear standards for pesticide reregistration data and should
communicate those standards to registrants.7 In 2000, the EPA Office of Inspector General
(OIG) concluded that EPA did not consider regulation development a high priority since the
pesticide statutes are very prescriptive and the program is highly centralized.8
As it developed its registration review program, EPA and industry considered the shortcomings
of its reregistration program.9 In response to its proposal, industry commented that EPA should
not implement registration review of end-use products until it fixes the problems with the review
of end-use products in reregistration. Registration review and reregistration are likely to be
similar and registration review might duplicate the effort of reregistration, especially when a
product may undergo product-specific review several times. The commenters were concerned
that if EPA does not achieve efficiencies in the review of end-use products, the fifteen-year
registration review will extend to forty years.
In response, EPA stated that it expects reregistration to satisfy most product-specific data
requirements and achieve many label improvements for end-use products. Although EPA does
not expect it will routinely require product-specific data during registration review, it expects that
registration review will be an important vehicle for the continuing update of labels. EPA agreed
that the review of end-use product labels could benefit from process improvements, and that
registrants and other stakeholders can help develop approaches to make this process more
efficient.
1.4.3 Information Management
As early as 1980, GAO auditors determined that EPA was behind schedule, lacked a tracking
system to identify problems, did not have a formal operating procedure for reregistration, and
had not adequately monitored its overall progress in the reregistration program.10 In 1991, GAO
reported on the lengthy delays associated with reregistering pesticides and that such delays
7 Recommendations of the Administrative Conference of the United States, 1 CFR part 305,
Recommendation 93-5, Procedures for Regulation of Pesticides
8 Pesticides: Follow-up Report on EPA's Pesticide Program, Report No. OOP00011, March 27,2000, EPA
Office of Inspector General
9 Pesticides; Procedural Regulations for Registration Review, Final Rule, 71 FR 45719, August 9, 2006
10 Delays and Unresolved Issues Plague New Pesticide Protection Programs, GAO, 1980
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stem, in part, from the inadequate support provided by EPA's information systems for
reregistering pesticides.11
In 1992, GAO reported that after having invested $14 million over three years in data systems
development, EPA could not easily assemble accurate, reliable, and complete information on
chemicals in its reregistration process.12 GAO concluded that these information management
problems resulted from inadequate systems planning and poor data management. In addition,
OPP employed nine separate data base systems to track or manage information about
chemicals pending reregistration. Each of these data systems was designed and developed
separately without taking into account a way of using them jointly. EPA staff entered
information about pesticide studies numerous times into different systems, and data compilation
is labor intensive and time consuming.
In 2000, the EPA Office of Inspector General (OIG) published a follow-up report to its 1994
evaluation of the pesticide program.13 OIG found that the OPP Information Network (OPPIN)
had been designed to address most of its information management concerns, but some of the
original concerns still exist. OIG noted that OPP had not completed actions to improve
information systems that contain inaccurate, incomplete, and duplicate data or that are not
integrated.
1.4.4 Performance Management
In FY2005, the Office of Management and Budget (OMB) evaluated the reregistration program
using its Program Assessment Rating Tool (PART).14 The FY2005 Program Assessment
indicated that the program was "adequate," and included the following conclusions:
• There is no evidence to indicate that a different program design would be more effective
or efficient than what is currently used. The 1996 FQPA changes added clarity to
science reviews and introduced higher visibility deadlines, which forced increase
effectiveness.
• To help ensure the program is effectively targeted, statues establish criteria for
prioritizing reregistration activities and sets specific deadlines and timelines for
completion.
• The annual goals are output measures but are acceptable because it is a process-
oriented licensing program that results in "products" (i.e., reregistrations).
• The annual output goals reflect activity required to meet statutorily required completion
dates. The program did have difficulty meeting annual targets in the past, leading to
changes in the statutorily required dates. The targets and baselines for the output
measures are adequate.
11 Pesticides: EPA's Information Systems Provide Inadequate Support for Reregistration, GAO/T-IMTEC-
92-3, October 30, 1991
12 Pesticides: EPA's Information Systems Provide Inadequate Support for Reregistration, GAO/IMTEC-
92-3, October 30, 1991. Pesticides: Information Systems Improvements Essential for EPA's
Reregistration Efforts, GAO/IMTEC-93-5, November 23, 1992.
13 Pesticides: Follow-up Report on EPA's Pesticide Program, Report No. OOP00011, March 27,2000, EPA
Office of Inspector General
14 "Program Assessment: Pesticide Reregistration," expectmore.gov, accessed on July 11, 2006.
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• The program uses multiple electronic methods to track information on the progress of
reregistration actions and reports on the progress of activities are provided to program
management weekly. OPPIN is a central database used to track activity, and it stores
history that is easily retrievable.
A performance measure for pesticide product reregistrations was not included in PART, nor was
product reregistration considered explicitly when evaluating the reregistration program.
In August 2006, the EPA Office of Inspector General (OIG) issued a critique of the Food Quality
Protection Act.15 OIG commented that although EPA has made progress in implementing the
requirements of the FQPA, OPP has primarily measured its success and the impact of FQPA by
adherence to its reregistration schedule rather than by reductions in risk to children's health.
For FY2005, OPP used the following output measures to assess programs:
• Cumulative percentage of REDs completed
• Number of product reregistrations
OIG commented that the measures used by OPP generally indicate actions taken, instead of
environmental or human health outcomes achieved. It concluded that OPP lacks outcome
measures to assess the specific impact of those actions on the health of children and others.
1.5 Organization of Report
This report is composed of eight main chapters:
Chapter 1, Introduction, identifies the purpose of the evaluation and its audience, as well as
key questions that will be answered. This section also includes a description of the program
and a review of related evaluations.
Chapter 2, Methods, summarizes the approach for conducting the evaluation, and is based on
the EPA-approved methodology.
Chapter 3, Progress on Product Reregistration, assesses the status of product reregistration
and summarizes the duration of the processes.
Chapter 4, Reregistration Eligibility Decisions, discusses the issues associated with this part
of the reregistration process that impact product reregistration. This section also discusses
three case studies and alternative strategies used by EPA to implement mitigation.
Chapter 5, DCI Justifications and Preparation, addresses the current process for preparation
and mail out of the generic and product-specific data call-ins by EPA and approval by the Office
of Management and Budget, as well as associated issues and recent changes.
Chapter 6, Data Requirements and Review, summarizes some of the issues associated with
registrant responses to the DCI, discusses an analysis of product-specific acute toxicity and
product chemistry data, identifies strategies for batching data requirements, and discusses
communication and management issues.
15 Measuring the Impact of the Food Quality Protection Act: Challenges and Opportunities
EPA Office of the Inspector General, Report No. 2006-P-00028, August 1, 2006,
http://www.epa.gov/oig/reports/2006/20060801-2006-P-00028.pdf
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Chapter 7, Label Assessments and Reviews, addresses the division of labor between SRRD
and RD to revise pesticide product labels, discusses workload and other issues, and
summarizes the current strategy to expedite product reregistration.
Chapter 8, Suggested Changes to Process Design and Other Recommendations,
discusses the project team's recommendations for modifying specific aspects of the product
reregistration process based on its findings presented in Chapters 3 through 8. This chapter
also identifies specific areas where EPA may wish to modify its current program to better
address product reregistration.
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2. Methods
The evaluation of the product reregistration program is a process evaluation, which is defined by
the Government Accountability Office (GAO) as one that "assesses the extent to which a
program is operating as it was intended. It typically assesses program activities' conformance to
statutory and regulatory requirements, program design, and professional standards or customer
expectations."16 Therefore, by design, this evaluation does not seek to determine the extent to
which OPP achieves its intended outcomes (for instance, reduced exposure to pesticides) but
only the activities that contribute to the outcomes.
In preliminary discussions, OPP identified a number of issues and concerns regarding product
reregistration, including information management, the division of labor between SRRD and RD,
issues in REDs, and information management. Abt Associates sought to examine these
concerns and determine the extent of issues, as applicable, as well as identify other issues.
This chapter summarizes the data collection methods, data collection approach, and analysis
plan.
For more information on the approach taken for this analysis, please see "Identifying
Innovations and Streamlining OPP's Product Reregistration Program: Program Evaluation
Methodology," July 24, 2006.
2.1 Data Collection Methods
Abt Associates used a variety of methods to collect the information to answer the six evaluation
questions. The data collection largely resulted in qualitative data, which we supplemented with
quantitative data as needed and as available. Each data collection method used is described
below along with the evaluation question(s) it helped answer. Limitations to each approach are
identified. The following table summarizes each of the collection methods and the evaluation
questions to which they will be applied (Table 2-1).
Table 2-1. Summary of Data Collection Methods
Evaluation Question
What components of REDs have caused
delays in product reregistration?
What problems, bottlenecks, or unnecessary
duplication of efforts occur in the product
reregistration process that are under the
control of OPP?
What innovations or streamlining in process
could result in more timely implementation of
mitigation specified in the RED and/or more
efficient production of outputs?
Data Collection Method
Interviews
•
•
•
Document
Review
•
•
•
Program
Data
•
Case
Studies
•
•
Subject
Expert
•
•
•
16
U.S. Government Accountability Office, "Performance Measurement and Evaluation: Definitions and
Relationships," GAO-05-739SP, May 2005.
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Evaluation Question
What are the pros and cons of each of the
proposed innovations or streamlining
measures?
What is the optimal allocation of tasks
between the Special Review and
Reregistration Division and the Registration
Division?
Are any external entities or considerations
impeding the product reregistration process?
Data Collection Method
Interviews
•
•
Document
Review
Program
Data
•
Case
Studies
Subject
Expert
•
•
•
The information collection activities above are governed by requirements under the Paperwork
Reduction Act (PRA). Under PRA, EPA's information collection is limited to nine or fewer non-
federal individuals or entities. Requests for similar information and/or similar questions must be
limited to nine or fewer non-federal respondents. This evaluation was conducted in compliance
with the PRA and other OMB rules on information collection requests.
Interviews
Abt Associates conducted a series of open-ended interviews (i.e., with no pre-determined
response options) with numerous EPA staff. These individuals were accessible, have an
interest in the results of the evaluation, and have a thorough understanding of the product
reregistration process and its issues. In each interview, we characterized an individual's role in
the reregistration process and solicited his/her perspective on the process in its entirety.
Interviews with management focused more on the overall process, as well as the information
flow between OPP divisions. Specific questions were prepared in advance of the interviews to
ensure coverage of issues and to manage time (Appendix A).
Interview responses and comments are not referenced/attributed to specific individuals in this
report or related discussions and presentations. A list of individuals interviewed or consulted is
appended to this report (Appendix B). We believe that this approach increased the honesty of
the answers and opinions provided in the interviews. All interviews were audio-recorded (with
the permission of the interviewee), and the tapes were used to clarify issues and confirm the
evaluator's notes.
This method of data collection was consistent with the statement of work, and also provided the
opportunity to identify issues, solicit explanatory information, and understand the general
functioning of the product reregistration program. This was appropriate given the process-
improvement focus of the evaluation. Abt Associates sought to supplement the information
gained in interviews with reregistration status, performance, and tracking data (where available),
published documents, and additional information from OPP staff.
Although the perspectives of the registrants and the Office of Management and Budget (OMB)
would be a helpful addition to this data collection, we limited our contact to EPA staff because of
the limited time and resources available to complete this evaluation. However, in the document
review and reregistration program data sections that follow, we identify sources from which we
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obtained both published information on the roles of these two groups and their perspectives on
product reregistration.
Document Review
Published documents available from EPA, the Government Accountability Office (GAO), the
Office of Management and Budget (OMB), industry associations, and environmental groups
served as another data source. Abt Associates reviewed these documents to determine the
documented issues of reregistration, how reregistration is presented to the registrants and the
general public, and how other external auditors perceive the program. These data sources
were reviewed and cited, as appropriate, in Chapter 1 to summarize how reregistration has
been characterized and/or criticized in the past.
Other documents informed this evaluation, including program descriptions and procedures.
Under contract to EPA, SRA International developed a process flow diagram and accompanying
report, which details the product reregistration process and its information management
practices.17 These materials summarize the process and its use, identify data sources and
applications, describe execution of the process, estimate its duration, and identify potential
improvements. The information management issues identified by SRA International were
considered relative to other information collected during the evaluation. Abt Associates also
reviewed additional documentation provided by EPA, including management briefings, fact
sheets, and example tracking reports. These sources provided a further understanding of the
process and areas of improvement.
Reregistration Program Data
Abt Associates used existing program data to characterize progress to date on the number of
pesticide products reregistered, to establish the length of time it generally takes to reregister a
pesticide product, and to consider the value of proposed data streamlining options.
To better define the problem, Abt Associates reviewed available data to determine progress
made to date on product reregistration. The background materials developed by SRA
International represent educated guesses and ideal conditions of the product reregistration
process. For this evaluation, we sought to document in a verifiable manner the timeframe
associated with product reregistration. Because of the estimated burden associated with this
collection and the lack of a central data source, Abt Associates relied on information available
from (1) the quarterly product reregistration briefing for Jim Jones, Director, Office of Pesticide
Programs; (2) data pulls from OPP SRRD staff; and (3) Pesticide Reregistration Performance
Measures and Goals for FY2005.18
As part of the evaluation, Abt Associates reviewed the draft findings of OPP regarding the
added value of acute toxicity and product chemistry reviews on mitigation. EPA initiated this
review to determine what mitigation is generally added to a product label during these two
reviews compared to that specified in the RED. One possible way to streamline product
reregistration would be to eliminate or streamline these two aspects of the process; however,
17 SRA International, Inc., Support Documentation, "OPP Enterprise Architecture Process Description
Special Review and Reregistration Division (SRRD) Product Reregistration: Support Documentation,"
Task 4: Baseline & Target Architecture Refinement, Task Order Number 5: OPPT Target Architecture
Support, September 29, 2005, Contract Number EP-W-05-024
18 Pesticide Reregistration Performance Measures and Goals for FY2005, 71 FR 36075, June 23, 2006
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OPP had no analysis upon which to base this decision. For the draft analysis, EPA selected a
random sample of pesticide products and determined the changes made to the mitigation
statements as a result of the two review procedures. Because the original data are considered
Confidential Business Information (CBI) and because of the time required to collect the data,
OPP initiated this portion of the evaluation internally. Abt Associates reviewed the sampling
technique and data collection and commented on the adequacy of the sample size. Abt
Associates then audited a subset of acute toxicity data to confirm EPA's results. Because
product chemistry data is considered CBI, Abt Associates did not audit those results.
Case Studies
EPA requested two types of case studies for evaluation - pesticides for which problems with the
RED caused delays in reregistration and pesticides for which re registration was expedited
through Memoranda of Agreement (MOAs). These cases allowed Abt Associates to consider
selected pesticides in a more in-depth manner to identify issues and possible solutions. This
approach would have been far too resource intensive to complete for all active ingredients.
However, this data collection method allowed us to highlight and/or validate perceived
successes and failures of the product reregistration program. In order to complete the case
studies, we relied on other data collection methods identified in this section, including interviews
and document reviews.
By completing the RED case studies, we determined what problems in the REDs caused delays
in product reregistration. With this information, OPP may be better informed and could change
its procedures to avoid future issues. For the case studies of active ingredients for which an
MOA was signed, these case studies illustrated one way that EPA tried to implement mitigation
on the label in a timelier manner. The purpose of these studies was to inform recommendations
on streamlining the product reregistration process, if possible, but without going to the effort of
completing an MOA for each active ingredient. In addition, we considered products for which
reregistration was streamlined, such as 2,4-D, by batching data requirements, to determine if
this case could be used as a model.
Subject Matter Expert
As Abt Associates planned for the evaluation and developed the methodology, SRRD
management provided assistance. Management identified background information and
materials, answered questions, and clarified issues or concerns. This feedback allowed Abt
Associates to understand issues regarding the product reregistration program prior to collecting
information, and helped shape the evaluation questions and the development of the logic model.
This data source is particularly useful when the individual has a unique skill or professional
background related to the issue being evaluated that helps the evaluator to better understand
the issue and project participants. It is also useful given the internal, process-related orientation
of the program evaluation. To ensure that the biases and opinions of a subject matter expert do
not influence the data obtained or the conclusions made, Abt Associates challenged
assumptions, collected supporting evidence, and/or identified counter-opinions or views.
Similarly, staff from the EPA Office of Policy, Economics, and Innovation served as a resource
on evaluation design and implementation, in addition to administering the project.
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2.2 Data Collection Approach
This section summarizes how Abt Associates applied each of the above data sources/collection
methods to answer the evaluation questions. The data collection largely relied on interviews
with OPP staff and managers, which allowed us to gain a full understanding of the product
reregistration process and ways in which it could be improved or streamlined. We identified
specific areas on which to focus, based on the evaluation questions, a review of background
documents, and preliminary conversations with EPA staff.
Problems in REDs (Evaluation Questions 1 and 2)
Abt Associates collected and reviewed information for three case studies on REDs that caused
delays in product reregistration: dicofol, captan, and the rodenticide cluster. These cases were
selected because EPA is aware of issues with the RED that caused delays in product
reregistration. Abt Associates could not make this selection independently, as it requires
internal program knowledge and judgment. As the step immediately preceding product
reregistration, the RED plays an important role in the information available for product
reregistration. In the course of the evaluation, Abt Associates determined how often REDs
cause issues in product reregistration by interviewing OPP management and chemical review
managers. This review provided perspective for the sample selected for the evaluation.
Abt Associates reviewed RED documentation to become familiar with its contents and
conclusions prior to meeting with OPP staff. Because REDs for food-use active ingredients
were completed in August 2006, the extent to which RED-associated issues may be addressed
in the future is limited. Thus, this part of the evaluation largely documents historical issues that
may influence upcoming project work.
Implementation of RED-specified Mitigation (Evaluation Question 3)
Abt Associates reviewed information for two Memoranda of Agreement (MOAs) that allowed
mitigation specified in the RED to appear on the label prior to the completion of product
reregistration: chlorpyrifos and phosmet. These cases were selected because they are two of
approximately ten instances in which EPA signed an MOA to expedite revising labels with
mitigation. These set the precedent for implementing RED-specified mitigation prior to the
completion of product reregistration and may serve as a model for a voluntary program in the
future. Further, these two cases were selected because information is available both in the
record and by interviewing staff who participated in the process. Both are organophosphate
pesticides. Chlorpyrifos posed serious health risks and revised mitigation was placed on the
label within a quick timeframe. Phosmet reregistration is ongoing and highlights the complexity
of the issues and the considerations of the product reregistration program.
Abt Associates reviewed the MOA documentation to become familiar with its contents and
conclusions prior to meeting with OPP staff. Abt Associates also considered the profile of each
of the cases, the level of mitigation specified by the RED, and the number of products impacted.
Similarly, OPP initiated a pilot project that uses the MOA as a model for implementing mitigation
(propanil). The goal was to have registrants revise the label with the RED-specified mitigation
prior to the completion of product reregistration. Abt Associates reviewed available information
on propanil and interviewed staff about the success of the approach.
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Data Requirements: Batching (Evaluation Questions 2, 3, and 4)
Abt Associates considered the case of 2,4-D as a model for how products may be further
batched. Batching is one potential way to reduce the number of data requirements that the
registrant needs to fulfill while still making the information available to EPA, as well as reducing
the number of studies that OPP needs to review. We interviewed OPP staff to learn their
experience with streamlining acute toxicity data requirements by batching products and using
existing information about the products for storage stability.
Data Requirements: Acute Toxicity/Product Chemistry (Evaluation Questions 2, 3, and 4)
In order to determine the impact of product-specific acute toxicity reviews and product chemistry
reviews conducted during product reregistration on the product label and confidential statement
of formula (CSF), OPP analyzed the changes in product labels that resulted from these reviews
over the period of its product reregistration activities. OPP initiated this review to determine
what mitigation is generally added to a product label during these two reviews. Abt Associates
verified the sampling procedure, assisted in data analysis, and audited a subset of OPP's
results.
For more information on the approach for the audit, please see "Results of Audit - Evaluation of
Acute Toxicity and Product Chemistry Review Findings," Memorandum to Yvonne Watson and
Pete Caulkins, U.S. EPA, from Debra Kemp, Albert Acquaye, and Jason Sacks, Abt Associates
Inc., January 30, 2007.
Label Reviews (Evaluation Questions 2, 3, 4, and 5)
As currently designed, the product reregistration process often includes label
assessments/reviews by both SRRD and RD, which is perceived as a duplication of effort by
some staff members. We determined why RD often conducts an extensive second review and
identified possible alternatives through interviews of relevant staff.
In addition, a pilot project was designed to determine if the product reregistration process would
be more efficient if SRRD conducted only product chemistry and acute toxicity reviews and if
RD alone conducted label reviews. To determine this, both SRRD and RD conducted a label
review independently of ziram products and determined if the two were consistent. Ziram was
selected for this exercise because its products were in the appropriate stage of product
reregistration for this pilot.
Relationship between SRRD and RD (Evaluation Question 5)
Although the responsibility of SRRD, RD contributes significantly to the product reregistration
process by reviewing labels, issuing reregistration notices, and stamping revised labels.
However, the two groups use different systems and have different management and unique
cultures. Thus, through interviews we identified issues with the current division of labor and
existing issues and proposed alternative means to divide the work, allocate resources, and
communicate process information. Abt Associates first reviewed the product reregistration
process flow diagram and relevant standard operating procedures (SOPs). We then
interviewed staff and managers in both divisions to determine the current division of labor and
any associated issues.
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DCI Preparation and OMB Approval Process (Evaluation Question 6)
The preparation of the DCI is the first step in the product reregistration process. Despite
approved SOPs, the SRRD contended that the DCI process is time-consuming and often
evaluated by OMB against varying standards. OMB's approval of a DCI package was believed
to be a source of delay in the product reregistration program. Thus, in this evaluation, Abt
Associates explored the DCI preparation process and any associated issues.
Information Management (Evaluation Questions 2, 3, and 4)
One of the conclusions of SRA International was that, "EPA and participants of the product
reregistration process could very much use an automated method of tracking the numerous
products throughout the process. Currently, all tracking is done manually in PRB and only the
CRM has direct access to the tracking data." To further support this conclusion, we considered
shortcomings in information management, opportunities for improvement, and historical barriers
to these improvements. Abt Associates interviewed SRRD, RD, and other OPP staff regarding
product-level tracking for reregistration.
Management/Budget (Evaluation Questions 2, 3, and 4)
Although mandated by statute, OPP historically viewed reregistration (and particularly product
reregistration) as less important than registration activities. The need to create SRRD in 1989
to focus specifically on reregistration in part reflects this problem. In addition, pesticide
reregistration is a politically sensitive and high profile issue with both industry and environmental
groups. Abt Associates interviewed OPP management and staff to identify management
priorities, budget issues, and external influences.
Timeline for Product Reregistration (Evaluation Question 2)
The premise of this program evaluation was that product reregistration is a time-intensive and
lengthy process. Abt Associates validated this assumption with the data available from OPP
management briefings, annual reports, and internal databases.
2.3 Data Analysis
Abt Associates compiled and assessed a variety of information, both qualitative and quantitative
in nature. For qualitative information obtained from interviews, Abt Associates referred to its
notes and interview tapes to summarize the information provided. When and if a discrepancy
was identified, we confirmed the information with a third source or with OPP management. As
noted in the preface to this report, the findings are reflective of the information provided to the
project team.
For quantitative information, Abt Associates used a standard software package and data
analysis and presentation techniques to summarize the progress on product reregistration. To
the extent that these data sources are limited in utility, we have identified these issues in this
report. If data were missing or seemed inconsistent, we confirmed potential data issues with
OPP staff.
Abt Associates documented its quality assurance procedures in its Quality Assurance Project
Plan, which was approved by Abt Associates, Industrial Economics, and EPA in July 2006.
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3. Progress on Product Reregistration
EPA originally estimated that re registration would include approximately 600 active ingredient
cases (consisting of more than 1,100 active ingredients) and approximately 20,000 pesticide
products. The exact universe changes as REDs are published and estimates are refined. EPA
projects that product re registration will not likely be completed before the end of calendar year
2012.
19
3.1 Status of Product Reregistration
Since beginning reregistration in the late 1980s, EPA has completed reregistration actions for
7,358 pesticide products. Reregistration actions for 11,948 products (conventional and
antimicrobial) were pending as of October 2006. The overall product reregistration universe,
both completed and pending, is presented in Figure 3-1. SRRD will also be responsible for
product reregistrations that will follow completion of the 54 remaining, non-food use REDs
October 2008.
20
by
Pending (11,948)
62%
Completed (7,358)
38%
Figure 3-1. Universe of Pesticide Products at End of FY2006
Of the reregistration actions completed through the end of FY2006, the majority of the actions
were cancellations (Table 3-1 and Figure 3-2).
19
20
Pesticide Reregistration Performance Measures and Goals, Notice, 71 FR 36075, June 23, 2006
http://www.epa.gov/oppsrrd1/reregistration/rereg istration_facts.htm
3-1
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Table 3-1. Cumulative Completed Reregistration Actions through FY2006
Action
Reregistered
Amended
Cancelled
Suspended
Total
Number of Products
2,070
563
4,695
30
7,358
Suspended (30)
0%
Cancelled (4,695)
64%
Reregistered (2,070)
28%
Amended (563)
8%
Figure 3-2. Distribution of Completed Actions through the End of FY2006.
Figure 3-3 shows actions (reregistrations, amendments, cancellations) completed from FY2002
through FY2006. (The EPA database was limited to actions completed since 2002, and older
data were not readily available.) Note that summing annual actions would result in a greater
number of completed actions than reported above since each individual product is potentially
subject to multiple actions over time. Figure 3-4 shows actions completed in FY2006.
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600
500
400
-*- Products Reregistered
-•- Products Amended
-•-Products Cancelled
-•-Total
2002
2003
2004
Fiscal Year
2005
2006
Figure 3-3. Actions Completed from FY2002 through FY2006
500
Reregistered
Amended
Cancelled
Total
Target
Dec-05
Mar-06
Jun-06
Sep-06
Month
Figure 3-4. Actions Completed in FY2006 Compared to Target
3-3
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Of the reregistration actions that were pending at the end of FY2006, the products are
distributed through all phases of the pesticide reregistration process (Table 3-2). Most of the
products (9,088 or 76%) have not yet had the data call-in prepared and/or approved by OMB.
This is likely a function of the deadline to complete the REDs for the food-use pesticides by
August 3, 2006, which increases the product reregistration backlog. The FY2006 decisions
resulted in 6,722 products that will require PDCIs, in addition to remaining decisions from
FY2004 and FY2005 that also require PDCIs.
Table 3-2. Products with Actions Pending at the End of FY2006
Location of Products in Process
Awaiting OMB approval -Antimicrobial pesticides
Awaiting OMB approval - Conventional pesticides
Awaiting issuance of PDCI -Antimicrobial pesticides
Awaiting issuance of PDCI - Conventional pesticides
Awaiting resolution of post-RED issues (in PRB)
Awaiting registrant response to PDCI
In PRB process
In AD process
In BPPD process
In RD for reregistration
Total
Number of Products
2,229
6,859
17
1,096
143a
318
437
24
53
772
11,948
Includes eight products that are also included under "In PRB Process"
The 143 products awaiting resolution of post-RED issues are those for azinphos-methyl and the
rodenticide cluster. There are 116 products in PRB and 446 in RD that were awaiting
completion of the cumulative risk assessments for the organophosphates and the carbamates.
The organophosphate cumulative risk assessment was completed in July 2006.
The FY2006 data source for this section was an internal EPA briefing.21 These data will be
further refined and audited by the EPA Office of Inspector General before being published in the
Federal Register in 2007. By law, EPA must establish and publish in the Federal Register its
annual performance measures and goals for pesticide reregistration, tolerance reassessment,
and expedited registration. Performance measures and goals were published for FY2005 in the
Federal Register on June 23, 2006.22 Data on trends were obtained from OPP Chemical
Review Managers.
3.2 Duration of the Product Reregistration Process
SRRD maintains a database, referred to as "STATUS," that includes basic tracking data for
products in each of the reregistration cases. Although more detailed information is provided in
individual "charts and tables" (in Microsoft Word format), these data are not centralized and
21 Product Reregistration Quarterly Review, Briefing for Jim Jones, Associate Director of the EPA Office of
Pesticide Programs, October 2006
22 Pesticide Reregistration Performance Measures and Goals, Notice, 71 FR 36075, June 23, 2006
3-4
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therefore not available for purposes of this analysis. Using the tracking data available, we
determined the duration of the product re registration process. From these data, we can
distinguish three points in the reregistration process: (1) when the RED or IRED is issued; (2)
when the reregistration package is sent to the product manager (PM) in RD; and (3) when the
product is reregistered (decision date). Other milestones, including the date the DCI was sent
to OMB, DCI was issued, data were reviewed, etc., are not available in this data source.
In the following tables and figures, we consider 124 REDs covering 1,639 products that were
designated in the STATUS database as reregistered (reregistration code 22) and
unconditionally reregistered with amendment or conditionally reregistered with amendment
(reregistration code 17). Tables 3-3 and 3-4 and Figure 3-5 present the results for a
combination of these two reregistration codes.
Table 3-3 shows that, on average, it took 54 months to reregister a product. An average of 41
months was needed to get the reregistration package to the Product Manager (PM) in RD, and
after the reregistration package had been sent to the PM, it took an average of 14 months to
complete the reregistration process.
With regard to a RED, on average, it took about 47 months to reregister all products covered by
a RED. The average maximum time needed for reregistering all products covered by a RED
was about 76 months. The average maximum time needed to get the reregistration package to
the PM was about 53 months, and on average, once the reregistration package got to the PM,
the maximum time to complete the reregistration process was about 33 months.
Table 3-3. Mean Duration of Process for All Products and by RED Case
Group
All Products
By RED (case mean)
By RED (case maximum)
Mean Duration (months)
RED Signed to
Sent to PM
41
34
53
Sent to PM to
Reregistration Decision
14
13
33
RED Signed to
Reregistration Decision
54a
47a
76b
a Total process duration may not be the sum of the two phases because of rounding.
b Total process duration is not the sum of the two phases because we calculated the mean of the
maximum length of time in each specific phase and for the entire process.
Table 3-4 presents the mean duration to complete all products for REDs by the number of
products. On average, it took 36 months to reregister REDs that covered only one product, and
47 months to reregister all products under REDs that covered more than 70 products. REDs
that covered between 14 and 26 products took the longest time (57 months) to complete the
product reregistration process. Complete reregistration of the products in these cases also took
the longest periods during both phases of the process.
3-5
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Table 3-4. Mean Duration of Process for RED Case by the Number of Products
Number of Products
per RED
1
2-5
6-13
14-26
27-35
36-70
More than 70
Mean Duration (months)
RED Signed to
Sent to PM
25
32
36
38
41
39
40
Sent to PM to
Reregistration Decision
12
12
17
18
14
9
7
RED Signed to
Reregistration Decision a
36
44
52
57
55
48
47
Total process duration may not be the sum of the two phases because of rounding.
A closer examination of the distribution of the duration of re registration of all products shows
that the mean does not represent the true picture of the duration of registration. Figure 3-5
depicts the distribution of products by the duration to complete the reregistration process.
Figure 3-6 shows the distribution of products by reregistration phase.
1000
3
O
14-
o
I
800
600
400
200
Signed RED to Decision Date
•Mean
7
Years
10
11
12
Figure 3-5. Duration of Product Reregistration Process for All Products (Reregistered and
Conditional or Unconditional Reregistered Products)
3-6
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1000
800
600
HI
.Q
= 400
200
Panel A: RED to Sent to PM
•Mean
7
Years
10
11
12
1000
Panel B: Sent to PM to Decision
7
Years
10
11
12
Figure 3-6. Duration of Period from RED Signature to Product Sent to PM (Panel A). Duration
of Period from Sent to PM to Decision (Panel B). These graphs include all products
(reregistered and conditional or unconditional reregistered products)
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Figure 3-5 and 3-6 show that the average (mean statistic) is skewed by a small number of
products. More often than not, the duration of the process was less than the mean. This is
most obvious for the time needed to reregister a product after it has been sent to the PM. Of
the 1,639 products covered in this analysis, 1,155 products, or 70 percent, were reregistered in
less than 14 months (the mean time it took to reregister products) after the registration package
was sent to the PM (Figure 3-6, Panel B). As such, we present the median time for each of the
phases for all the reregistered products in Table 3-5 and the median time by the number of
products per RED in Table 3-6 below.
Table 3-5. Median Duration of Process for All Reregistered Products and by RED Case
Group
All Products
By RED (case mean)
By RED (case maximum)
Median Duration (months)
RED Signed to
Sent to PM
30
29
46
Sent to PM to
Reregistration Decision
7
9
17
RED Signed to
Reregistration Decision
41
41
69
a Total process duration may not be the sum of the two phases because of rounding.
b Total process duration is not the sum of the two phases because we calculated the mean of the
maximum length of time in each specific phase and for the entire process.
Table 3-6. Median Duration of Process for RED Case by the Number of Products
Number of Products
per RED
1
2-5
6-13
14-26
27-35
36-70
More than 70
Median Duration (months)
RED Signed to
Sent to PM
30
28
30
30
38
30
38
Sent to PM to
Reregistration Decision
6
6
10
13
10
8
5
RED Signed to
Reregistration Decision
35
39
37
57
55
36
46
For the universe of products that have not yet completed product reregistration, but that have
been sent to the PM in RD, the distribution of the time it took to reach this milestone is
presented in Figure 3-7. Since being sent to the PM, the products have remained in RD
anywhere from less than one month to more than 11 years. RD staff commented in interviews
that many products are sent to them when there are still outstanding issues that need to be
addressed.
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300
250
« 200
•S 150
01
100
50
Mean
RED to Sent to PM
678
Years
10 11 12 >12
Figure 3-7. Duration of Period from RED Signature to Product Sent to PM for Products that
are Not Yet Reregistered
The duration of the period from when the RED is signed to when the product is sent to the PM
for reregistration includes several steps, not all of which are the responsibility of SRRD or even
EPA. Part of this time includes the preparation and approval of the DCI justification package
and the DCIs themselves (see Chapter 5). In addition, this period also includes the time for
registrant responses (both ninety-day and eight-month), EPA review of the data submitted, and
additional communication with the registrant. Thus, the estimates from the time the RED is
signed to when the product reregistration package is sent to the Registration Division (RD) is
not indicative of the time that SRRD Product Reregistration Branch (PRB) spends working on
product reregistration (i.e., the time from the PDCI issued until the product reregistration
package is sent to RD).
For the 755 products pending in PRB at the end of FY2006, SRRD data indicate that:
• 42 percent have been in PRB less than 12 months
• 36 percent have been in PRB between 12 and 24 months
• 20 percent have been in RPB between 24 and 36 months
• 2 percent have been in PRB more than 36 months
Table 3-7 presents the number and percentage of products completed for each fiscal year.
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Table 3-7. Product Reregistration Completion Status by Fiscal Year
Fiscal
Year
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005 a
2006
Total
REDs/
IREDs
Issued
8
20
10
22
34
42
28
13
14
13
9
15
16
17
29
41
331
Associated
Products
442
969
853
729
809
1,050
1,360
707
238
195
578
736
1,016
713
1,184
8,693
20,272
Products
Completed
422
954
824
717
772
970
1,117
560
188
164
270
516
505
126
0
1
8,106
Products Pending
Number
20
15
29
12
37
80
243
147
50
31
308
220
511
587
1,184
8,692
12,166
Percent
5
2
3
2
5
8
18
21
21
16
53
30
50
82
100
100
60
Location
RD
RD, AD, BPPD
AD, RD
AD, RD
AD, RD
AD, RD
AD, RD, BPPD, PRB
RD
RD
RD
RD
RD
SRRD PRB
SRRD PSB
SRRD PSB
SRRD PSB
-
Pollution Prevention Division, PRB = Product
= Registration Division, SRRD = Special
a The Fluazifop-p-butyl TRED required a PDCI.
Key: AD = Antimicrobials Division, BPPD: Biopesticides and
Reregistration Branch, PSB = Program Support Branch, RD
Review and Reregistration Division
Source: "Status of Product Reregistration: Pending Products," December 12, 2006.
For purposes of implementing mitigation specified in the RED to reduce risks to human health
and the environment, the overall length of the process - from the time EPA signs the RED to the
time it stamps the label - is a key metric. However, for purposes of a process evaluation,
determining the duration of each individual step becomes critical. Unfortunately, as currently
managed, EPA data are of limited value for analyzing the time associated with each step in
product reregistration. As explained in later sections, EPA does not track product reregistration
data in a centralized database because the main OPP information management system
(OPPIN) is not adequate.
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4. Reregistration Eligibility Decisions
Reregistration Eligibility Decision (RED) documents include EPA's evaluation of the database
for a chemical, its conclusions about the potential human health and environmental risks of the
current product uses, and its decisions and conditions under which these uses and products will
be eligible for reregistration. A RED also identifies the data and labeling requirements for
products eligible for reregistration, as well as any additional confirmatory data needed on the
active ingredient. Almost every RED includes some measures or modifications to reduce risks,
e.g., declaring certain uses ineligible for reregistration; restricting use of products to certified
applicators; limiting the amount or frequency of use; improving use directions and precautions;
adding more protective clothing and equipment requirements; employing ground water, surface
water, or other environmental and ecological safeguards; and other measures.
The "generic" chemical review managers (CRMs) in the reregistration branches of SRRD
develop REDs based on available data and analyses conducted by the OPP science divisions.
After a RED is signed, the Program Support Branch (PSB) and the Product Reregistration
Branch (PRB) of SRRD initiate product reregistration. The "product" CRMs in PRB provide
oversight for product reregistration. As needed, the reregistration branches are responsible for
post-RED activities that arise after the RED is published and/or EPA receives product-specific
and confirmatory studies.
4.1 Issues with REDs
This evaluation included three case studies where issues in the RED were believed to delay
product reregistration. In addition to specific issues, several more general issues regarding the
RED-development process became apparent. These include workload management, staffing,
and division of labor, all of which are discussed in this section.
The generic CRMs in the four SRRD reregistration branches are responsible for writing a RED
for an active ingredient. This part of the reregistration program faces public scrutiny, has
ambitious deadlines, and demands a heavy workload. Over the years, this part of the
reregistration program has evolved, particularly with respect to the FQPA requirements,
scheduling, public participation, and transparency. However, the goal of this part of the process
is to publish a RED by the given deadline. As a result, some REDs were published without
addressing some outstanding issues. OPP also commented that virtually every RED likely has
an issue or a hole because these may not be apparent until the RED is implemented (i.e.,
during product reregistration). Thus, REDs are sometimes amended to address outstanding
issues or to include data that are submitted after the RED is signed. Sometimes EPA still
initiates the data call-ins after the RED is signed, even if there are known outstanding issues. In
these cases, the registrants are often contacted by both the reregistration branch and PRB.
For those REDs that did not have post-RED issues, generic CRMs indicated that they assumed
that product reregistration happened as planned and were unaware of some of the delays and
challenges. This is a source of frustration, as years of work to write a RED do not always result
in environmental and human health protection as quickly as expected.
Post-RED issues were historically not given high priority in work plans and adequate resources
within the four reregistration branches, as statutory deadlines required continued focus on
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completing REDs. SRRD often looks to the science divisions for support with post-RED issues.
Because there are no deadlines associated with post-RED activities, writing new REDs remain
the priority. However, now that the August 2006 deadline to complete food-use REDs has
passed, SRRD management has indicated a commitment to addressing post-RED issues
(including product reregistration) in FY2007 and beyond.
REDs are not considered legally enforceable; EPA can only enforce DCIs and labels. Some
registrants are inclined to challenge the contents of a RED to delay implementation of RED-
specified mitigation. As EPA developed a more robust public participation process, registrants
are more likely to be aware of upcoming eligibility decisions, which might reduce post-RED
issues in the future and speed the product reregistration process.
Given the length of time from when a RED is published, to when post-RED issues are
addressed, to when product reregistration is conducted, the CRM who wrote the RED is often
no longer in that position. Typically, after about five years CRMs either are promoted or change
positions. As staff leave, REDs that are in process need to be transitioned to other staff. As a
result, institutional knowledge is often lost and new staff require additional time to become
familiar with the issues.
Generic CRMs are responsible for identifying mitigation that needs to be included in revised
labels as part of the RED development. Although the CRMs are knowledgeable of the issues of
the case, some noted that they are not in the best position to draft label language. CRMs,
although trained in writing labeling language, do not perform the task regularly enough to
become extremely proficient at it, which sometimes results in problems when developing the
label table. Generic CRMs commented that staff members in PRB and/or RD are better suited
to determine how the language should read on the RED. Some within OPP believe the most
efficient approach to drafting labeling language would consist of the decision-makers - PRB and
RD - playing a more active role in the process.
4.2 Case Studies
To better understand how Reregistration Eligibility Decisions (REDs) sometimes cause delays in
product reregistration, Abt Associates examined three REDs that were believed to delay product
reregistration: the rodenticide cluster, captan, and dicofol. Each case study identified issues
and challenges that arise throughout the reregistration process and, in particular, as a result of
the contents of a RED.
4.2.1 Rodenticide Cluster
In July 1998, EPA published the RED for the rodenticide cluster, which included six active
ingredients.23 Rodenticides represent EPA's first attempt to cluster active ingredients, an
approach that is also being used for fumigants. Since most of the rodenticides share similar use
patterns, issuing reregistration decisions for one chemical at a time could shift the rodenticide
market, perhaps to chemicals that pose greater risk but may be addressed later in the queue.
EPA also intended this approach to maintain a level playing field. Levels of exposure to the
varying rodenticides are generally similar, but they differ in toxicities. Thus, EPA expects to
23 Reregistration Eligibility Decision: Rodenticide Cluster, U.S. EPA Office of Prevention, Pesticides, and
Toxic Substances, EPA 738-R-98-007, July 1998
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differentiate mitigation measures based on individual toxicities of the chemicals. Although
clustering chemicals is more efficient for purposes of analysis, the number of issues and
registrants involved complicates actual decisionmaking. In retrospect, EPA commented that it
could have published concurrent but separate REDs for each chemical in the cluster and then
made decisions for all the cases at the same time. By maintaining separate documents, EPA
may have simplified the decision.
The rodenticide RED was incomplete and did not represent final regulatory decisions such that
EPA could not implement much of what it included. Outstanding issues included human health
(particularly accidental exposure to children) and ecological risks, and the RED included a two-
phase approach for mitigating risk. The first phase would put into place short-term measures to
identify, decrease, and monitor exposures largely through the use of bittering agents, dyes, and
other measures. The second phase sought to reduce exposures in the long term by convening
a stakeholder workgroup. EPA commented that the program has matured considerably since
the rodenticide RED was published, and it is unclear why the RED was published in its final
form. Under today's standards, EPA likely would not publish a document that did not provide
actual reregistration eligibility decisions.
After convening a stakeholder workgroup, EPA changed its position on the requirements for
bittering agents and dyes in 2004, which was subsequently challenged in a lawsuit. EPA was
asked to reconsider this decision and develop a better record. Also, the rodenticide RED
predated EPA's formal public participation process for reregistration. EPA is currently
addressing the ecological risks of the rodenticide cluster. In January 2003, EPA released a
preliminary ecological risk assessment for public comment; a revised assessment was
published in September 2004.24 EPA is formulating a mitigation plan to address these risks that
it published for public comment in January 2007.25
Because of these outstanding issues, EPA has not yet completed pesticide reregistration for
rodenticide products. After the RED was signed in 1998, EPA sent out DCIs, but they were put
on hold in light of the outstanding issues. If EPA were to require bittering agents, this would
require new product chemistry and acute toxicity studies, which makes it impractical to submit
these data until the issue is resolved.
Because of these delays in reregistration, PRB encouraged registrants to voluntarily amend
labels to incorporate some of the mitigation specified in the RED in advance of product
reregistration. EPA also considered allowing registrants to have a master label that could be
used on several different packages. This effort was largely unsuccessful and registrants would
not voluntarily amend labels, although some voluntarily added bittering agents. For other
reregistration cases, EPA has been successful in having registrants voluntarily amend labels.
Once the ecological risks are addressed through the forthcoming mitigation plan, SRRD expects
to issue an amendment to the RED for public comment. EPA will then address any outstanding
policy issues or regulatory activities. In the meantime, more than eight years have elapsed
since the RED was signed without significant changes to the labels for the rodenticide cluster.
24 Rodenticides: Availability of Revised Comparative Ecological Risk Assessment, 69 FR 56756,
September 22, 2004
25 Proposed Risk Mitigation Decision for Nine Rodenticides, January 17, 2007, available at
http://www.epa.gov/oppsrrd1/reregistration/rodenticides/rodenticid es_mitigation_decision.pdf
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This case study illustrates the challenge of clustering active ingredients that might have similar
use patterns, but differ in toxicity and other characteristics. EPA staff noted that publishing
separate documents concurrently could be a good alternative. This case cautions against
publishing a RED without addressing all outstanding issues and not developing a solid record.
Lastly, rodenticides shows that registrants are not always amendable to voluntary label
changes.
4.2.2 Captan
In November 1999, EPA published the RED for captan, which included a determination that it
was a probable human carcinogen based on the properties of a highly reactive but short-lived
metabolite.26 The risk assessment, however, indicated that this classification did not warrant
additional mitigation. After EPA published the RED, additional data were submitted during the
public comment period that led EPA to amend the RED in November 2004.
The RED pre-dated the formal reregistration public participation process that is in place now,
which meant that early opportunities for public comment were more limited. EPA received
additional data after the RED was signed that led EPA to recalculate certain re-entry intervals
and margins of exposure for specific uses and applications. These new values were included in
the RED amendment. The amendment also addressed a few minor inconsistencies that
needed to be clarified (e.g., definition of a berry and seed treatment).
Also, after the RED was published in 1999, registrants requested that EPA consider a cancer
reclassification for captan, presumably for marketing and other reasons. Because its current
cancer classification did not warrant additional mitigation, EPA did not feel it was appropriate to
use its limited resources on the analysis. The Captan Task Force, which is composed of captan
registrants, voluntarily contracted with an independent body of scientists to review the data to
support a mode of action determination for captan. The OPP Health Effects Division (HED)
then reviewed this work. Based on the third-party review and subsequent HED review, EPA
determined that captan acts through a non-genotoxic threshold mode of action. This
determination, however, did not change the risk management conclusions or amend the RED.
Overall, it took approximately two years to complete the cancer reclassification.
The cancer reclassification and the amendment to the RED were published for public comment
in November 2004.27 EPA received a modest number of comments, mostly on the cancer
reclassification or issues un-related to the RED amendment. The captan amendment was less
complex compared to other cases that have been amended. However, the process took
considerable effort and was also not given top priority when compared to writing new REDs.
Because of the length of time between completing and subsequently amending the RED, EPA
worked with the registrants and the Captan Task Force to amend product labels with RED-
specified mitigation as soon as possible. The technical registrants, who were most interested in
the cancer reclassification, were able to encourage the product registrants, who were most
26 Reregistration Eligibility Decision: Captan, U.S. EPA Office of Prevention, Pesticides, and Toxic
Substances, EPA 738-R-99-015, November 1999
27 Captan; Cancer Reclassification; Amendment of Reregistration Eligibility Decision; Notice of
Availability, 69 FR 68357, November 24, 2004
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interested in the RED amendment, to revise their labels in an expedited manner. Registrants
were also motivated by good environmental stewardship. The SRRD reregistration branch
collected the labels in early 2005, which were then sent to the Product Reregistration Branch
(PRB) for assessment. However, this approach resulted in confusion because two branches
were in contact with registrants, and communication could have been better coordinated. EPA
has since completed the product reregistration process for captan products. Reregistration for
captan products took seven years from the time the RED was signed.
This case study reiterates that REDs represent the best data and analysis available at the time,
and the need to engage registrants in the submission of new data. This case also included a
creative solution for a third-party cancer assessment, which saved EPA resources. Lastly, the
case illustrates that voluntary label changes can sometimes be successful.
4.2.3 Dicofol
In September 1998, EPA signed the dicofol RED and determined that products containing
dicofol may be eligible for reregistration (as specified in the RED) contingent upon results of a
dermal toxicity study that was due to EPA in December 1998.28 In 2005, EPA published an
addendum to the RED to establish re-entry intervals (which were not included in the RED) and
solicited public comment.29
OPP maintains a strict, annual schedule for RED development and signature to meet the
statutory deadlines in FQPA, and the deadlines are rarely (if ever) postponed or missed. In
order to meet OPP's annual goals, these deadlines often correspond to the end of a fiscal year,
which explains why a majority of REDs are signed in September. The dicofol RED was signed,
although it lacked information on worker exposure, so that EPA could count dicofol tolerances
toward the number of tolerances that were reassessed in FY1998. Staff commented, however,
that given the significant data gaps, it would be unlikely that the dicofol RED would be published
in that form according to current standards. Despite incomplete information on re-entry
intervals, EPA mailed out DCIs in 1998 and received responses and amended labels from the
registrant, but label review is pending the resolution of outstanding issues.
To address EPA's concerns with occupational exposure following the signature of the RED, the
registrant submitted a dermal toxicity study and a chemical-specific dislodgeable foliar residue
study approximately one year after the RED was signed. Given the use of the pesticide and the
nature of the study, these data were submitted in a timely manner. However, the data indicate
that a substantially longer restricted entry interval (REI) was warranted compared to the REI on
the label at the time (more than 3 months compared to 24 hours). These data triggered the
involvement of the OPP Biological and Economic Analysis Division (BEAD), who conducted an
impact analysis to examine the current market and viable alternatives and met with the
registrant. Other more minor issues in the RED, such as updating calculations to be consistent
with a revised definition of "short-term exposure" from the OPP Health Effects Division (HED)
were also addressed after the RED was signed.
98
Reregistration Eligibility Decision: Dicofol, U.S. EPA Office of Prevention, Pesticides, and Toxic
Substances, EPA 738-R-98-018, November 1998
29 Dicofol; Addendum and Closure of Reregistration Eligibility Decision; Notice of Availability, 70 FR
51794, August 30, 2005
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Over time, interest in the dicofol case diminished, as other activities within OPP were given a
higher priority and staff responsibilities were shifted (several generic CRMs have worked on the
dicofol case). When dicofol again became a priority, EPA drafted and published the addendum
to the RED for public comment. The growers indicated to EPA that the proposed REIs were
unacceptable and maintained that dicofol was a much-needed miticide in the industry. EPA
planned to release a second addendum to the dicofol RED after the August 3, 2006, FQPA
deadline. This was pushed back further when staff became involved in registration review
activities. However, in Summer 2006, the registrant announced that it intends to discontinue
dicofol because it does not have sufficient market share.
Given the discrepancy over REI and the registrant's plans to discontinue the product, the
registrant did not voluntarily revise its label to include any of the RED-specified mitigation and
the labels remain unchanged. More than eight years have elapsed since the RED was signed
without significant changes to the labels for dicofol.
The dicofol case study illustrates the issues that result from publishing a RED before it is
complete, and that sending DCIs in such situations might not be appropriate. The case also
highlights that new data sometimes delay product reregistration and require additional review
and consideration.
4.3 Alternative Strategies for Implementing Mitigation
This section reviews two cases where EPA pursued implementation of RED-specified mitigation
through signing a memorandum of agreement with registrants, as well as a current pilot project
to achieving this same objective without the formal agreement.
4.3.1 Memoranda of Agreement - Chlorpyrifos and Phosmet
EPA uses Memoranda of Agreement (MOAs) as a mechanism by which registrants amend
product labels to include RED-specified mitigation in advance of the product reregistration
process and may also agree to provide data or take other action. Although used infrequently,
EPA has used MOAs in approximately six to twelve instances, including the chlorpyrifos and
phosmet cases. The following two cases highlight some of the successes and shortcomings of
MOAs. These case studies provide support to the recommendations made later in this report.
In addition to MOAs, EPA has made efforts to amend terms and conditions of registrations to
include RED-specified mitigation in a timelier manner. This approach requires fewer resources
and does not commit EPA to anything. However, MOAs also provide a mechanism to get data,
which is not possible only through amending the terms of conditions of a registration.
Chlorpyrifos
In June 2000, EPA signed an MOA with the chlorpyrifos registrants after several months of
negotiation.30 Under the MOA, registrants requested voluntary cancellation of their existing
products and submitted applications for replacement registrations excluding those uses that
were canceled (e.g., termite control, residential use). In return, EPA stated that it had no
30 Memorandum of Agreement between the Environmental Protection Agency and Signatory Registrants
Regarding the Registration of Pesticide Products Containing Chlorpyrifos, June 2000
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intention to initiate cancellation or suspension proceedings and would act on replacement
registrations within ten working days.
EPA was particularly concerned about exposures from residential uses of chlorpyrifos, and
estimates that a chlorpyrifos product was in one in four households in the United States. As an
organophosphate, chlorpyrifos posed acute risks and exposure and incident data indicated
regulatory action was appropriate. In addition, a number of environmental groups published
reports on risks of pesticides in food and in the home. This level of concern provided some
leverage to convince registrants to take action.
In negotiations, registrants agreed to cancel residential uses. Both EPA and the registrants
agreed that a recall of residential-use products was not necessary. There were approximately
10 million pounds of chlorpyrifos in homes, and a recall would pose logistical and disposal
problems, including additional environmental and public health concerns. EPA's key objective
was to develop an agreement that ensured that mitigation was placed on the label as soon as
possible.
Chlorpyrifos is an interesting case because there were originally more than 900 products and
extensive mitigation was required. EPA cancelled more than 300 products and amended
approximately 100 labels. There are currently about 300 chlorpyrifos products. Because of the
complexity of the agreement and the number of labels, EPA developed guidance and
communications materials for the regulated community. In order to meet its obligations, EPA
assembled a staff of six to eight people from the reregistration branches, PRB, and RD who
worked full-time for five to six months on the case to process labels and voluntary cancellations.
This work was mostly complete by January 2001, approximately eight months after the MOA
was signed.
After having dealt with the residential uses, EPA focused its attention on agricultural uses and
remaining regulatory issues, such as the Interim Reregistration Eligibility Decision (IRED) that
was published in September 2001. Based on product-specific data, labels had to be reviewed
and amended for formal product reregistration, but the product universe was considerably
smaller because residential uses had been cancelled.
Several key aspects of the chlorpyrifos case made an MOA a particularly appropriate and
successful tool: the registrant was a willing participant in negotiation, EPA was also committed
to activities and deadlines, chlorpyrifos received public attention and required swift action, there
were numerous products, and residential uses were of concern.
Phosmet
In 2001, EPA signed an MOA with Gowan Company, the only registrant of phosmet.31 In 2001,
EPA also published the IRED for phosmet. Although it is an organophosphate, phosmet does
not exhibit the same risk profile of some of the others. There were some residential uses and
some incident reports, and Gowan initiated voluntary cancellations for residential uses.
31 Memorandum of Agreement between the Environmental Protection Agency and Gowan Company
Regarding the Registration of Pesticide Products Containing Phosmet, October 2001
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Growers expressed to EPA the necessity of phosmet, so EPA pursued an MOA to ensure that
mitigation was put in place and worker protection issues were addressed as soon as possible.
The agreement required Gowan to amend all of its phosmet product labels based on the IRED
and any modifications EPA considers necessary based on comments received during a sixty-
day comment period. After June 30, 2002, products were required to bear labeling approved by
EPA in accordance with the agreement. The agreement also required that all registrations of
phosmet products labeled for specific crops would include the following terms and conditions:
• After October 30, 2006, products shall bear restricted entry intervals (REIs) specified in
the MOA unless prior to that date EPA decided that another REI is appropriate.
• By October 30, 2005, the registrant would submit biomonitoring data, a feasibility study
of gloves suitable for field workers, and data reflecting benefits and use patterns of
phosmet.
EPA expected to receive revised labels from Gowan in May 2002 so that they could be
reviewed and approved in advance of the June 30, 2002, deadline. Because of errors in the
submissions, there were several rounds of label reviews and EPA did not approve amended
labels until 2005. There were a number of issues that contributed to the delay: SRRD and RD
disagreed whether or not the amended labels needed to be complete updates in light of relevant
PR notices or if the labels only needed to have the mitigation specified in the IRED included.
Note that the MOA stated that "each phosmet product must include on its product label in the
Direction for Use section all of the labeling statements identified in the IRED..." SRRD
maintained that a complete amendment conflicted with its intent to implement RED-specified
mitigation as soon as possible and was beyond the scope of the exercise. Also, due to the
substantial number of iterations of labels between OPP and the registrant, it took a long time to
finalize the label amendments. There were only a limited number of phosmet labels that were
affected by the MOA (ten to twelve) and EPA attempted to prioritize them.
Gowan completed the studies per the agreement and EPA reviewed the data. In 2004,
phosmet was the subject of a lawsuit by farmworker organizations that challenged occupational
exposure risks. EPA expected that the REIs would need to be lengthened, as was proposed in
June 2006, which would require additional label amendments. In January 2007, EPA issued its
final decision on nine uses of phosmet that will lengthen most REIs and impose additional
mitigation measures. Generic and product-specific DCIs were issued on April 9, 2003. As of
October 2006, the majority of phosmet products had not been reregistered.
Several key aspects of the phosmet case made an MOA a particularly appropriate and
successful tool: there was only one registrant and there were additional issues beyond label
mitigation to be addressed. This case also illustrates that an MOA does not necessarily
guarantee timely implementation of all label changes.
4.3.2 Propanil Pilot Project
In an effort to implement the mitigation specified in the RED on the labels in a timelier manner,
EPA initiated a pilot project for propanil. EPA published the propanil RED in September 2003
and mailed out DCIs in Spring 2006. SRRD provided the label table to RD at the same time that
it issued the PDCI. RD sent a letter to the registrants in May 2006 to request that they
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incorporate RED-specified mitigation while SRRD continues with the product reregistration
process. This is similar to the approaches for chlorpyrifos and phosmet (above) but without the
negotiation and signature of an MOA.
The Propanil Task Force responded to RD's request by questioning why EPA requested the
amended label before the registrants responded to the DCI. The Office of General Counsel
(OGC) prepared both a specific response to the Propanil Task Force and a generic letter for
future use. The letters explained that EPA is working to reduce the amount of time between
issuance of the RED and implementation of mitigation required in the RED. Registrants were
given ninety days to provide a revised label. In the absence of the required label changes in the
RED, EPA stated that the pesticide label does not have sufficient directions for use and/or a
precautionary statement to adequately protect health and the environment (and could therefore
be considered "misbranded" under Section 2(q) of FIFRA).
As of January 2007, of the 43 products: amended labels for 23 products were submitted to EPA
and accepted with comments; 3 were pending in label review; 3 provided no response; and 14
products were voluntarily canceled. On average it took 6 months to receive and accept (with
comments) amended labels, not including those that did not respond.
This pilot project illustrates that it is possible to implement RED-specified mitigation, although it
will likely require a change in registrant culture as they become familiar with the new process.
Given that half of the labels were not submitted, EPA will need to address the consequences of
such actions moving forward. In addition, this approach does increase the burden on SRRD, so
EPA will need to focus its activities appropriately.
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5. DCI Justifications and Preparation
After a RED is signed, the preparation of the generic Data Call-In (DCI) or product-specific Data
Call-In (PDCI) notice is the first step in the product reregistration process. Before the DCI can
be issued to the registrant, EPA must prepare and receive approval of a DCI justification
package from Office of Management and Budget (OMB). This DCI justification package lists all
of the product-specific studies, as well as any confirmatory data, that the registrant must submit
in order to complete reregistration for each of the individual pesticide products covered by the
RED.
Several EPA offices and other agencies are involved in the preparation of a DCI justification
package. The Program Support Branch (PSB) is responsible for preparing the DCI justification
package and, once approved by OMB, for sending the DCI to the registrant. Several entities
assist PSB in the development and review of the DCI justification package, including:
• OPP Field and External Affairs Division (FEAD),
• OPP Science Divisions: Environmental Fate and Effects Division (EFED) and Health Effects
Division (HED),
• Office of Prevention, Pesticides, and Toxic Substances (OPPTS) Regulatory Coordination
Staff (RCS), and
• SRRD Product Reregistration Branch (PRB).
The U.S. Department of Agriculture (USDA) also assists with DCI justification packages,
particularly when high-profile chemicals and/or high-cost studies are involved. To ensure the
DCI justification package complies with OMB standards, FEAD and RCS review it before
submitting it to OMB.
5.1 Preparation of DCI Justification Package
Despite approved standard operating procedures (SOPs) for developing the DCI justification
package, the process is time-consuming and often evaluated by OMB against varying
standards. OPP believed that approval of a DCI justification package was a source of delay in
the product reregistration program, and we explore this issue in this section.
5.1.1 Template for DCI Justification Package
In an effort to streamline and standardize the DCI justification package based on feedback from
OMB on a DCI for the toxics program, RCS initiated changes to the format of the DCI
justification packages. Through an iterative process, PSB and RCS re-formulated the template
to include "boilerplate" responses for study rationale and intended data use. Despite the intent
of streamlining the process, the first package PSB prepared using the template (submitted on
May 22, 2006) was much lengthier than previous DCI packages because PSB included both the
boilerplate language and standard elements from the old format. The lengths for the most
recent packages are:
One year ago: 30 pages long for 26 chemicals
Most recent package: 80 pages long for 21 chemicals
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In August 2006, OMB presented EPA with ten questions, which were mostly about process and
therefore relatively easy to address (e.g., why is OPP requesting acute toxicity data from the
registrant?). OMB approved that particular DCI package in October 2006, five months after it
was submitted. It is unclear at this time whether the template changes will help expedite the
review and approval of DCI justification packages by OMB.
5.1.2 Supporting Data
A lack of supporting data can lead to several delays in assembling the DCI justification package.
First, the manner in which the OPP science divisions write the risk assessments (RAs) is viewed
as problematic by several PSB staff. Currently, neither the RAs nor the REDs summarize or
clearly identify upfront the rationale for new studies. Often, PSB staff need to review the entire
RA to locate necessary information or contact the science divisions to help develop the
rationale, both of which can be time consuming.
Second, in conducting the RA, the science divisions may conclude that the registrant needs to
conduct "special studies" in order to generate sufficient confirmatory data for product
reregistration. In practice, the science divisions delineate the basic parameters of these special
studies but do not provide PSB with cost burden estimates. Since special studies fall outside of
standard test cost estimates, PSB is responsible for estimating the cost burden for the DCI
justification package, despite not being as familiar or knowledgeable as the science divisions
about study components.
5.1.3 Tracking
Tracking, as it relates to the DCI preparation process, has several shortcomings. Due to the
lack of an integrated tracking system and the multiple players involved in the DCI process, there
are at least four tracking systems used by staff to meet different needs: the Office of Pesticide
Programs Information Network (OPPIN), a Microsoft Excel-based tracking system, and several
Microsoft Word-based tracking systems.
As one of the first steps in the DCI-related tracking process, the generic CRM or product-
specific reregistration CRM generates the DCI or PDCI, respectively, in OPPIN. (In practice,
PSB, not the generic CRM, typically generates the DCI.) OPPIN is not well suited, however, for
detailed tracking of the DCI process because it does not include the needed data fields and
reporting functions. Consequently, PSB uses a Word-based system to track the review periods
of DCI justification packages by different EPA divisions (i.e., FEAD and RCS) and OMB. It then
uses another system to track the return of green cards from registrants. Once PSB processes
the product-specific green cards, it forwards them to the product reregistration CRM in PRB who
tracks the ninety-day response for the PDCI in Charts and Tables. If the DCI also required
generic, confirmatory data, PRB forwards a copy of the green cards to the generic CRM for
tracking. The tracking system used for ninety-day and eight-month responses varies among
CRMs on the active ingredient level - some use OPPIN; others use separate systems.
OPPIN, which is about five years old, was an attempt at creating a centralized, integrated
information management system that would meet the needs of and be accessible to all OPP
divisions. Multiple staff expressed dissatisfaction with OPPIN, citing it is not user-friendly, data
are not current or complete, and lack of a "report-card" function (guideline status report) to
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easily check the status of any given chemical in the post-RED process. CRMS, the
predecessor of OPPIN for tracking re registration of active ingredients, had this functionality,
allowing the user to determine where an active ingredient is in the process (e.g., to check the
status of submitted studies from a given registrant). Due to its design, CRMS also provided a
level of staff accountability that OPPIN does not offer. A new system called PRISM is currently
under development and intended to take over the functionality of OPPIN to address currently
unmet needs. It is unclear at this time whether PRISM will have the "report card" function or
something similar to it.
5.2 Resources and Staff Time
At this time, inadequate staffing in PSB contributes to bottlenecks and delays in the preparation
of the DCI justification package. Currently, there are no senior scientists or senior science
writers on PSB's staff roster. PSB currently relies on FEAD staff for preliminary reviews of
supporting data and documentation. It is not uncommon for FEAD staff members to spend
approximately ten percent to twenty percent of their time on DCI preparation and review.
Due to the statutory deadlines for reregistration, generic CRMs begin work on new chemical(s)
after the RED is signed. By the time PSB commences the development of the DCI justification
package, the CRMs are likely focusing on new chemicals. Consequently, answers to product-
specific questions may be difficult to obtain due to the lapse of time between the RED signature
and DCI preparation, as well as competing priorities among the CRMs. Moreover, since there
are twenty-one CRMs at this time, PSB often must track down the right people to get
information.
5.3 Approval of the DCI Justification Package
Since 2003, the total length of time for preparing a DCI (including OMB's review approval) has
decreased from an average of 18 to 24 months to an average of 9 to 10 months; the shortest
length of time being four months as OPP improved its procedures and developed its relationship
with the previous OMB desk officer. A consistent source of delay in the DCI preparation
process is OMB's review and approval, which can often span several months. Staff expressed
the importance of building a relationship with the OMB officer, so both parties have a mutual
understanding of the process. However, the turnover in OMB officers is relatively high: many
officers serve for only two to three years.
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6. Data Requirements and Review
Key aspects of the product reregistration process are the ninety-day and eight-month responses
by the registrant, as well as the review of these data by EPA. Several issues are important to
consider relative to the delays and issues with product reregistration, including data
management, communication, management priorities, and staffing.
6.1 Data Management of Registrant Responses
Given the number of data guidelines, communications, and other pieces of information that
correspond to each product, information management is key to the product reregistration
process. Tracking of information is critical for DCI preparation and mail out, ninety-day
responses, eight-month responses, data review, label assessment and review, and
reregistration decisions. Overall, there are approximately forty-four discrete data elements that
must be tracked for each product (i.e., six toxicity studies, twenty-eight product chemistry
studies, efficacy studies (if required), waiver requests, study deficiencies, time extensions, and
suspensions). Products that are combinations of active ingredients, which may or may not be
conducted at the same time, further complicate tracking.
In 2005, SRA International developed a report that described and illustrated the product
reregistration process and commented on the adequacy of its tracking systems.32 SRA
concluded, "EPA and participants of the product reregistration process could very much use an
automated method of tracking the numerous products throughout the process. Currently, all
tracking is done manually in PRB and only the CRM has direct access to the tracking data."
Thus, for this evaluation, Abt Associates interviewed several OPP staff members to identify
information management issues.
The Office of Pesticide Programs Information Network (OPPIN) was intended to be a
centralized system to address the needs of all OPP programs. However, OPPIN is inadequate
for purposes of product reregistration because it does not provide the required data fields or
reporting functions. It also does not provide PRB the necessary reports to verify the data
contained within OPPIN against other data sources, which is critical given the number of
tracking systems used for product reregistration. Staff also noted that the concerns with OPPIN
extend beyond those of reregistration. SRRD staff have requested modifications to OPPIN to
address its shortcomings in tracking reregistration for both active ingredients and end-use
products. Generally, requests related to the reregistration of active ingredients have been made
more frequently, as many staff believed that those requests were more likely to be granted than
those on the product level. OPP staff noted that information management needs for registration
review are being addressed to their satisfaction. In addition, staff commented that PRIA actions
accounted for most of the OPPIN maintenance budget.
In November 2006, SRRD management again requested several revisions from ITRMD, which
reiterated SRRD's priorities from June 2004.33 These revisions follow in priority order:
32 OPP Enterprise Architecture Process Description: Special Review and Reregistration Division Product
Reregistration," SRA International, September 29, 2005.
33 Based on an e-mail message from Pete Caulkins, Associate Director, SRRD, to ITRMD, "Product
Reregistration IT Development Projects," Septembers, 2006
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• RED Outcome Report at the Product Level, which would track by case name and
chemical each product, the PDCI issuance date, ninety-day response date, eight-month
response date, data review status, date sent to RD, and fields that track RD's interaction
with the registrant.
• RED Outcome Summary Report that tracks the total number of products cancelled,
reregistered, and amended. A key aspect to this report would be the ability to aggregate
these data by chemical, branch, PM, etc.
• Guideline Status Report to track generic studies required by the RED.
These three features were promised to SRRD by ITRMD as part of the next revision to OPPIN.
The first report, RED Outcome Report at the Product Level, was available in the precursor
system to OPPIN, which was called PRATS. PRATS was disabled in 2003 after OPPIN was
launched. PRATS data are available in read-only format, but PRATS is no longer available for
data entry. PRATS included specific fields for tracking product-specific studies (receipt,
acceptability, review status, etc.), which is not available in OPPIN.
As a result, EPA has been forced to track outside the centralized system, which is counter to the
intent of developing OPPIN. To track product-specific reregistration information, SRRD
developed "charts and tables." Charts and tables are a Microsoft Word template that CRMs use
to record product reregistration information. They include background information, such as RED
date, case, code, PM contact, and number of products, as well as the status of responses in
review, products suspended, products canceled, products in label review, products sent to RD,
and letters out.34 For each product, the document includes blowback requested/received,
product chemistry data status, toxicity data status, due date for data, date sent to label review,
and date sent to RD. It also summarizes contact with the registrant by product and identifies
action items. Each CRM has some flexibility to modify the template according to his/her own
style, and each file is not available to other CRMs or management because CRMs generally
save these files on his/her personal drive. In addition, some CRMs are timelier than others in
maintaining their charts and tables.
To provide tracking information to management, SRRD maintains two external databases in
either Microsoft Access or Word: (1) STATUS includes information from the "bean sheet," which
is a summary report submitted to RD with each reregistration package, and (2) REDS includes
the chemical, CRM assignment, number of products, and how many products are reregistered,
amended, or cancelled. These databases are only accessible to one SRRD PRB staff member,
and serve as the data source for management reports and SRRD's annual performance report.
Despite its disadvantages, OPPIN allows SRRD to track RD activities with respect to product
reregistration. This helps SRRD maintain its STATUS database. Although there are some
similarities between OPPIN and STATUS, OPPIN does not provide the proper reporting
features such that PRB can access the needed information in a usable manner.
The third report that was requested, the Guideline Status Report (often referred to as a "report
card") has been requested several times by SRRD.35 This revision would largely benefit the
34 Based on charts and tables forTrifluralin, September 15, 2005, provided by Pete Caulkins, Associate
Director, SRRD.
35 "OPPIN Generic Data Management Functionality Assessment," Patrick Dobak, May 2, 2005
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reregistration branches that are responsible for tracking confirmatory data for active ingredients,
as well as tracking DCI responses. Whereas PRB worked outside the system to develop charts
and tables, the effort on the active ingredient side was not as coordinated. As a result, SRRD
reregistration branches do not know where confirmatory data are in review nor if the guideline
has been satisfied. RD also pursued the development of a database external to OPPIN to track
generic data for registration.
Also, on the active ingredient level, staff noted that OPPIN was not well suited for tracking
"special studies," which are those that are not included as standard guidelines. Similarly, PRB
noted that it does not have a way to track voluntary letters, and Certitrack might be useful for
this purpose. Certitrack is a database to track correspondence that was used by some PRB
CRMs, but it is a DOS-based program that requires a dedicated printer. OPPIN also does not
provide the proper capabilities for data management, as many of the corrections need to be
made by a database administrator.
SRRD staff noted that improvements to OPPIN do not seem to be a priority given that OPP is
developing PRISM, which will replace OPPIN in September 2008. PRISM, while still in the
planning and acquisition phase, intends to use the basic table structures of OPPIN. PRISM,
however, will supplement those tables with new and redesigned data structures as it is
developed. The primary intention of PRISM is to provide OPP staff and management with an
improved presentation layer, integrate currently missing applications and other improved
software features, and provide new functional applications. Ultimately PRISM is intended to
provide a more stable environment for the entire pesticide industry and, coupled with new
technologies (Documentum, CDX, and J2EE driven applications), will enhance EPA's ability to
meet its strategic goals.36 Staff noted that OPP has not directly addressed how product
reregistration will be addressed in PRISM.
Several staff members expressed that the ultimate success of PRISM hinges upon improved
communication between management and staff. In particular, they currently play a mostly
responsive role in maintaining and improving OPP tracking needs, e.g., they attend meetings
when asked, or provide management with information when requested. These staff members
expressed that they would be better able to anticipate and respond to tracking issues if open
lines of communication between all staff are maintained. Several staff commented that
ITRMD's visibility and involvement in programmatic activities is limited. Because ITRMD has
taken a compartmentalized approach when developing both OPPIN and PRISM, staff noted a
need to bridge communication within the office. One potential avenue is through the Information
Management Council, which is comprised of all OPP division directors and provides a forum to
advance IT needs.
As a result of the shortcomings of OPPIN and the current approach to data management, EPA
unintentionally created a window of time for which data are not properly tracked because they
are not available electronically or not available in a centralized format. The current approach
means that PRB is unable to monitor progress in an effective and efficient manner, which
wastes a lot of time and things are more likely to fall through the cracks.
36 http://www.epa.gov/oamhpod1/admin_placement/06101137qa1.doc
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6.2 Acute Toxicity and Product Chemistry Analysis
SRRD conducted an assessment of the impact of product-specific acute toxicity and product
chemistry reviews on label mitigation. The SRRD assessment sought to determine the impact
of these reviews on revisions made to the product label during reregistration beyond what would
be required by the Reregistration Eligibility Decision (RED). SRRD's preliminary analysis
indicated that product-specific data had a significant impact on label mitigation. To confirm their
findings, Abt Associates conducted an audit of the acute toxicity portion and assessed its utility
for the evaluation of the product reregistration program. This section provides background on
the data and guidelines and discusses the design of EPA's analysis and our conclusions
regarding SRRD's analysis.
For more information on the approach and specific results of the audit, please see "Results of
Audit- Evaluation of Acute Toxicity and Product Chemistry Review Findings," Memorandum to
Yvonne Watson and Caulkins, U.S. EPA from Debra Kemp, Albert Acquaye, and Jason Sacks,
Abt Associates Inc., January 30, 2007.
6.2.1 Background on Acute Toxicity and Product Chemistry Guidelines
The acute toxicity data required on end-use products for product reregistration include the acute
oral, acute dermal, and acute inhalation studies, which evaluate systemic toxicity resulting from
short-term exposure via the designated route. The remaining acute studies are the primary eye
irritation, primary skin irritation, and the dermal sensitization studies. The eye and skin irritation
studies assess potential irritation or corrosion from a single exposure, while the dermal
sensitization study evaluates allergic contact dermatitis resulting from multiple exposures.
These acute studies identify routes of concern, as each study is categorized based on degree of
effect (categories 1 through 4), with Category 1 indicating the most severe effect and Category
4 representing the least severe effect. In addition, each category corresponds with specific
label statements or requirements necessary to reduce exposure and protect against acute
health effects. The resulting label statements/requirements vary significantly based on product-
specific factors such as the formulation type and whether the use pattern is agricultural,
occupational/industrial, or residential. Furthermore, label statements for agricultural and
occupational use products may vary based on whether the product is subject to the Worker-
Protection Standard (WPS).
Acute studies result in hazard communication directly to the user and/or medical professionals
through the label sections and/or product classifications listed below.
1. Restricted-Use Pesticide (RUP) Classification
2. Signal Word/Skull and Crossbones Symbol
3. First Aid Statements
4. Note to Physician
5. Hazards to Humans and Domestic Animals (HHDA)
6. Personal Protective Equipment
7. Child-resistant Packaging
The product chemistry data required for product reregistration can be grouped into two
categories: (1) product identity, composition, and analysis, and (2) physical and chemical
properties. Product identity, composition, and analysis allow EPA to clearly define the product
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formulation and identify any inert components of concern. The physical and chemical properties
assess potential hazards posed by the formulation (e.g., flammability, corrosivity, and storage
stability). Identification of these hazards allows the implementation of preventative measures.
Some of the more basic physical and chemical properties evaluated allow EPA to respond to
emergency requests for identification of unlabeled pesticides.
6.2.2 Design of Analysis
At the completion of FY2005, SRRD randomly selected a sample of 120 products (7 percent of
reregistered products) of the 1,730 products had been reregistered. The sample size of 120
results in one product per RED listed on the OPP Web site with available batching tables at the
time this assessment was performed. Abt Associates believes that a larger sample size would
be better suited for this analysis, but understands the limited time and resources available to
SRRD. SRRD noted that crosschecking labels with the results of the acute toxicity and product
chemistry reviews was a lengthy process. Based on its description of how it identified a specific
product from each of the 120 REDs, Abt Associates believes that the selection procedure SRRD
described was objective and unbiased.
Although Abt Associates confirmed its sampling procedure, we believe that SRRD could have
better designed its study and in turn provided a better answer to the issues at hand. For
example, we would have suggested that EPA select randomly from among the entire universe
of products for which product reregistration was completed or for which labels had been
amended. This would have allowed SRRD to confirm that recommendations based on acute
toxicity reviews were indeed placed on the final label. In addition, we would have suggested
that EPA not constrain itself from sampling one product from each RED given how the number
of products vary.
Also, Abt Associates did not believe that EPA's results were presented in a detailed enough
manner such that the reader was left with a clear idea of what a "revised statement" means. By
establishing criteria for each category or at least providing examples, the reader might have had
a clearer idea of how substantive the revisions could be. Similarly, EPA could have made its
categories more specific, including multiple categories for signal words (e.g., added, increased,
decreased), first aid statements (skin/clothing, eyes, swallowed, inhaled), and individual
categories for mitigation statements that appear most frequently and may therefore skew the
results (e.g., having container available when calling poison control center, notes about
cholinesterase inhibition, etc.).
Finally, the analysis did not provide a comparison of extent of mitigation identified by product-
specific data as compared to extent of mitigation identified in the RED. We understand that
RED-specified mitigation is generally more substantial. That said, some OPP staff members
commented that the product-specific mitigation was negligible. Abt Associates believes that an
analysis that identifies the mitigation required by the RED, as well as that specified by product-
specific data would be informative.
6.2.3 Audit Conclusions
Although Abt Associates was generally able to confirm the majority of EPA's findings for each of
the twelve products included in the audit, the audit revealed several discrepancies and other
issues of concern. These discrepancies were identified in the above-referenced memorandum
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to EPA. In addition, EPA seemed to be inconsistent in how it characterized Personal Protective
Equipment (PPE) in its results. Generally, EPA included the discussion of PPE requirements in
the Hazard to Humans and Domestic Animals (HHDA) section of its acute toxicity review memo;
however, for purposes of its results sometimes these changes were considered revisions to
PPE and sometimes revisions to HHDA.
Often, mitigation specified by the acute toxicity review did not appear on an amended product
label. Note, however, that not all products have been reregistered. Similarly, amended labels
often included additional mitigation beyond that recommended in the review memo or the label
table from the RED. The source (e.g., registrant or RD) of such mitigation is unclear, as well as
if mitigation specified by acute toxicity reviews may have otherwise been included on the label
(e.g., updates to first aid statements based on current label review standards).
For these reasons as well as the shortcomings identified in the study design, Abt Associates did
not feel it was appropriate to include EPA's analysis in its report.
6.3 2,4-D Streamlined Data Requirements
Through batching and citing existing data, OPP can substantially reduce the number of sets of
product-specific acute toxicity data to be reviewed for each active ingredient, thus reducing the
time required to re-register products. It may be possible to reduce the time required for acute
toxicity reviews even further, if the batching process is streamlined. One such example of
streamlining may be found in the case of 2,4-D. 2,4-D is an ingredient in more than 600
agricultural and home use products. It comes in multiple chemical forms, and is found in
numerous products intended for use in a wide range of uses. The Industry Task Force II on 2,4-
D Research Data worked with OPP to reduce product-specific acute toxicity data requirements
by using existing data and streamlining the batching process. The Task Force included almost
all registrants affected by the 2,4-D reregistration, including every company that had technical
registrations for 2,4-D.
Batching allows registrants to use or cite acute toxicity data from a group of similar products to
satisfy data requirements. Batching tables are included in the RED and group product
formulations that, from an acute toxicity perspective, allow one set of acute data to be used to
support the reviews of all products within the batch. Once batching tables are published in the
RED, it is the responsibility of registrants to act upon them and submit data to OPP. For
instance, after product A submits the required data to EPA, registrants of products B, C, and D
that belong to the same batch as product A and want to use (cite) data for product A in support
of their products, may pay or offer to pay the registrant of product A to cite its data.
Depending on the chemical and the formulations, OPP may not be able to batch all the acute
toxicity data, instead requiring all registrants to submit individual acute toxicity data. This is
usually the case for fertilizer products, which may result in individual eye irritation data being
required and other acute toxicity data being batched. In many instances, registrants choose not
to take advantage of the batches and rather chose to submit their own data, which EPA is
obliged to review. Many registrants do not take advantage of the batching because the data
already exist, they would prefer to submit their own data, or they do not want to pay data
compensation fees. OPP estimates that typically between 20 and 30 percent of registrants take
advantage of batching.
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6.3.1 2,4-D Batching Approach
The level of success of batching varies from chemical to chemical, since formulations may be
quite different. In the case of 2,4-D, a preliminary attempt at batching one of the formulations
with the majority of 2,4-D products yielded about 50 to 60 batches. The Industry Task Force II
on 2,4-D Research Data submitted a proposed batching scheme, although it was of limited
value because it did not include information on inert ingredients, which is confidential business
information. The acute data provided by the Task Force, however, were very useful in satisfying
the data requirements for individual products and product batches, even though organizing and
evaluating such a large volume of data was very time consuming.
This approach did, however, allow PRB to use the existing acute data provided by the Task
Force to satisfy some or all data requirements for most of the product batches. This negated
the need for a registrant to submit a waiver to cite what was already submitted to EPA. The
formation of a task force specifically to address product-specific data requirements will likely
result in greater participation in the batching groups by registrants. Also, because Task Force
data were available during the batching process, they were used to determine product grouping.
In some cases, this allowed for products with a larger range of active ingredient to be grouped
together. As a result, EPA asked for only 1,027 acute toxicity studies out of a possible 3,618
studies, which will decrease the burden on the registrants, EPA, and OMB.
6.3.2 2,4-D Storage Stability Requirements
The Industry Task Force II on 2,4-D Research Data approached EPA with information and data
to show that different formulations using the chemical are extremely stable under various
conditions. For this reason, it was possible to eliminate the storage stability data requirements
that are the most expensive ones for registrants and the longest for OPP staff to review.
Registrants had over time submitted almost ninety storage stability studies to support
registrations or in enforcement cases, all of which indicated that regardless of time, the product
remains stable with up to five to seven years of shelf life. As a result, OPP waived the need for
any more storage stability studies.
6.3.3 Pros and Cons of this Approach
In general, this approach will save time in reviewing data by identifying good studies that have
been conducted properly to support the registration of large groups of products. This batching
approach resulted in a 72 percent reduction in the amount of data required compared to getting
a six-pack for each of the 603 products.37 A six-pack for each of these products would have
resulted in 3,618 individual studies required, while EPA is asking for 1,027 studies through the
current approach. Typically with batching, however, many products use existing data (either
from another company within the same batch, or previously generated product-specific data) to
support product reregistration. Even if one-third of the 603 products used existing data, this
approach would have resulted in a 57 percent reduction in the amount of acute data required.
This approach required registrant participation to determine the studies that may be used to
support the reregistration of various product groups. The larger the number of registrants
involved in a task force, the greater the degree of participation in batching since the formation of
the task force provides an organizational structure to facilitate data sharing and minimize
37 2,4-D Batching Project Briefing, provided by Pete Caulkins, February 13, 2007.
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registrant costs. Because all 2,4-D registrants were members of the Task Force, they were
likely to participate.
Typically OPP would issue the data requirements and shift the responsibility to the registrant.
By working with the Task Force, they were able to determine what they needed. OPP has
learned from its 2,4-D experience. PRB developed a revised process for working with task
forces that does not place as great a burden on its staff. OPP has targeted permethrin (1,185
products), MGK-264 (706 products), and PBO (1,704 products) as candidates for a revised,
streamlined approach. This approach appears to be best suited for situations where a task
force exists, which can provide the necessary infrastructure to coordinate responses among the
various end-use product registrants, ensure their participation, and address data compensation
issues.
6.4 Communication
Several entities are involved in product reregistration, including the SRRD reregistration
branches following the publication of the RED and the Registration Division after data review is
complete. Data collected through interviews indicate that there is a breakdown in
communication at the transition of products to and from PRB.
Staff in the reregistration branches often operated on the assumption that the signature of the
RED essentially concludes reregistration and that mitigation is implemented in a timely manner.
Staff noted that the public and environmental and public health organizations often share this
perception. Staff of the SRRD reregistration branches and the Registration Division admitted
that they are not as familiar with the process or issues associated with product reregistration as
perhaps is warranted.
Further, they recognize that communication with the registrant is not always productive because
the registrants lack an incentive for product reregistration. Recently, SRRD has pursued
avenues to prevent delays in registrant submissions, which often resulted from submitting
comments or inadequate data later in the process. OPP staff also noted that the "stick"
associated with product reregistration - suspension - has not been applied recently. SRRD is
currently in discussion to reestablish the procedures for that process now that the EPA Office of
Compliance is no longer involved in suspension actions.
At the end of each month, SRRD sends a status report to RD that identifies which products are
currently with RD for reregistration. This is based on the STATUS tracking database that SRRD
maintains external to OPPIN. Several RD staff noted that these reports could provide additional
information to make them more useful, and some noted that they did not actively use the report
for management purposes.
Whereas reregistration of conventional pesticide products is the responsibility of SRRD, other
OPP divisions are responsible for reregistering products under their area of focus. SRRD staff
noted the Biopesticides and Pollution Prevention Division (BPPD) has also commented on the
inadequacy of OPPIN for product reregistration. However, SRRD staff noted that they were not
familiar with the product-specific data tracking procedures within other OPP divisions (BPPD
and AD).
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6.5 Management and Staffing
As part of the overall reregistration process, product reregistration is only one of the priorities
within either SRRD or RD. Historically, writing and publishing REDs was the priority for SRRD
and registrations (particularly PRIA actions) were the priority for RD. Recent attention, however,
is being focused on product reregistration through pilot projects, quarterly briefings for OPP
Director Jim Jones, and regular SRRD/RD meetings on product reregistration. Most recently,
the RD Director designed an approach for product reregistration moving forward (see Section
7.5 of this report). OPP management and staff are dedicated to seeing the RED-specified
mitigation implemented on product labels, as well as addressing the vulnerability associated
with the delays in product reregistration.
Despite attempts within FIFRA to establish deadlines for product reregistration (see Section
1.3.1 of this report), product reregistration has never been pushed and management focused on
the front-end of the process. In addition to the impacts on OPP's backlog, a registrant also does
not know when it will receive a reregistration decision after submitting an eight-month response.
OPP has improved the process by which registrants submit data, including standard formats.
OPP staff and management noted that product reregistration is one of the most inefficient
processes in OPP, though that is not a result of the people, but the design of the system. To
help address performance, SRRD sets goals for product reregistration annually, and these
goals are met (see Figure 3-4). SRRD staff noted that because of end of fiscal year deadlines
for REDs and other activities, product reregistration gets the most attention in October to
January.
In its FY2007 reregistration work plan, SRRD allocates its FTE resources as follows:38
• 40 percent to completing non-food-use REDs
• 41 percent to post-RED issues
• 8 percent to product reregistration, which covers both SRRD PRB and RD
• 11 percent to registration review
Over time, a greater percentage of resources will be allocated to registration review. After
FY2008, SRRD expects that funds will no longer be allocated for completing REDs, though it
will continue to budget for post-RED issues. Funds are allocated for product reregistration
through FY2013. The eight percent FTE allocation is roughly equivalent to past staffing levels
and SRRD expects the staffing level to remain fairly constant in the short term.
Some staff members commented on the decrease in PRB staffing over time as a result of
attrition and retirement. They maintain that it is a challenge for PRB to keep up in light of the
workload and reductions in staff. PRB did recently hire a new product chemistry reviewer and a
new CRM. Training for new staff is conducted on an ad hoc basis, and written procedures for
product reregistration are not available.
on
Personal communication with Pete Caulkins, January 2007
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7. Label Assessments and Reviews
SRRD PRB and RD conduct label assessments and label reviews, respectively. SRRD's
preliminary label assessment focuses on comparing the amended label to the label table in the
RED to ensure that the label adequately captures the required mitigation. After SRRD's
preliminary label assessment, RD reviews the label in its entirety and is responsible for
stamping the final, approved version.
A brief overview of the reregistration process as it relates to the label review process is provided
below:
• Registrants send OPP a revised label as part of the 90-day response to the DCI to
incorporate mitigation on the RED;
• Registrants send OPP product-specific data and/or confirmatory (generic) data over the
eight-month response period;
• SRRD evaluates the product-specific data, requests additional information as needed,
and determines if additional mitigation is needed;
• After all study reviews are complete, the CRM assembles a label review package for the
PRB Label Review Team;
• PRB Label Review Team develops a preliminary label assessment (see Section 7.1);
• The CRM assembles final review package ("bean sheet," all applicable science reviews,
the preliminary label assessment, and the draft amended product label) and delivers to
Product Manager (PM) in RD; and
• The PM in RD conducts final review of label (see Section 7.2) and requests additional
revisions from the registrant, if required. Once approved, the PM stamps the final label
and issues a reregistration notice.
7.1 Label Assessment - Special Review and Reregistration Division
The primary purpose of SRRD's preliminary label assessment is to determine whether the draft
labels submitted in connection with product reregistration comply with amended labeling
language specified in the RED/IRED.39 To avoid duplication of effort between SRRD's and
RD's label reviews, the preliminary label assessment does not comment on other aspects of the
label, such as labeling requirements specified in 40 CFR part 156.10, Pesticide Regulation
Notices (PRNs), and Criteria and Policy Notices. To assemble the preliminary label assessment
and to maintain consistency, SRRD uses a template with the following sections: a scope
statement, background, summary of findings (including recommended label changes), and an
appendix with a checklist of whether the label changes made by registrants are acceptable or
unacceptable.
The preliminary label assessment occurs once the CRM submits the label review package to
the SRRD PRB Label Review Team. The label review package consists of the draft label
39 PRB Preliminary Label Assessment. Memorandum provided to Abt Associates by Larry Schnaubelt,
PRB.
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submitted by the registrant, SRRD's review of the product-specific data, and the label table,
which assists SRRD in comparing the label to the mitigation specified in the RED. The label
included in the label review package is the most recent, hardcopy version submitted by the
registrant as part of the eight-month response to the DCI. Over this same time period, however,
the same registrant may have submitted drafts of amended labels to RD (e.g., to add a new
use), and SRRD may be unaware of these label changes. Consequently, the label reviewed by
SRRD as part of its preliminary label assessment may not be the most recent version. This
problem is magnified by the long timeframes in which label reviews occur, as documented in
Chapter 3 of this report. Once completed, the preliminary label assessment is submitted back
to the CRM, who then assembles the final review package and delivers it to the appropriate PM
in RD.
7.2 Label Review - Registration Division
After receiving the final review package from SRRD, the PM conducts the final label review and
stamps the label. It is the responsibility of the PM to identify and address any outstanding
labeling issues, including any remaining RED-specific issues, and to obtain the necessary label
changes required for final product registration. To do so, the PM typically composes a letter to
the registrant specifying necessary labeling revisions.
RD commonly finds issues with the labels that require additional revisions by the registrant (e.g.,
labels are not compliant with acute toxicity data) or prompt RD to re-conduct the label
assessment performed by SRRD. For example, the preliminary label assessments commonly
identify labeling issues but do not contain recommended solutions, requiring the PM to duplicate
the part of the review related to RED mitigation. Another contributing factor is poor version
control of labels between SRRD and RD. As mentioned previously, it is common for PMs to
receive old labels as part of the final review package from SRRD, due to the fact that the PRB
Label Review Team assesses the amended label submitted by registrants as part of the eight-
month response. In these instances, PMs often conduct an entire label review from scratch,
since the preliminary label assessment is based on an outdated label.
The OPP Label Review Manual was created as a way to help maintain consistency in RD's
label reviews. Despite these guidelines, RD's label reviews are not always conducted in a
consistent manner. For example, in instances where a registrant requests the addition of a new
use to the label, and the product is still somewhere in the re registration process, some (but not
all) PMs will require that the registrant implement the mitigation stated in the RED at the same
time as adding the new use to the label. These PMs will not stamp the new label until the
mitigation stated in the RED is incorporated on the label.
Similarly, PMs vary in the way they use SRRD's preliminary label assessment. Several RD
Branch Chiefs noted that the label assessments are especially beneficial to new PMs who are
not experienced in conducting label reviews or who do not have an extensive knowledge of the
product and its regulatory history. The majority of PMs, however, noted that they either entirely
disregard the label assessments or only use them as a way to ground-truth their own label
reviews.
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7.3 Ziram Pilot Project
In Spring 2006, EPA initiated a pilot project using the ziram case where RD and SRRD
conducted concurrent, independent label reviews for each of the products to determine how the
two divisions assessed label changes. In March 2006, reviews were conducted for three
products. There were no differences in the label reviews conducted by the divisions, except that
RD had two, minor non-substantive additions that were a result of pesticide notices.40 Note that
two of the products were manufacturing-use products that typically do not require many label
changes as a result of the RED.
Also in Spring 2006, SRRD and RD conducted label reviews for sodium acifluorfen using its
standard process (i.e., a label assessment in SRRD and a label review in RD). Reviews
indicated that the registrant had included a new use on the label, which was caught by both
SRRD and RD reviewers.
Although these two reviews indicate the similarities in reviews between the two divisions, our
preliminary conclusion is that two pilots are not an adequate sample from which to draw a
conclusion. Further, we would have recommended that the reviewers not be told of the pilot
project to better represent typical review conditions.
7.4 Workload Management and Other Issues
In some RD branches, products are assigned to PMs and their staffs based on chemical
ownership. In other branches, one or two staff members are designated to conduct label
reviews on a full-time basis. Many PMs and their staffs are currently juggling label reviews for
product reregistration with PRIA and other registration work. Other personnel issues include
frequent staff turnover and the likelihood of several PMs retiring in the near future.
With regard to managing workload, the number of review packages delivered by SRRD to RD is
highly variable. Branch Chiefs and PMs in RD often do not receive a "heads-up" from SRRD
about when to expect review packages. PMs may receive one hundred review packages at a
time, or as few as one or two review package every few weeks to a month. The product
reregistration backlog is also highly variably among the RD branches. For example, two
branches have no backlog while the remaining branches have backlogs of one hundred or more
products.
Several PMs expressed preference for receiving all product labels pertaining to one chemical at
one time. This is advantageous because it allows the review teams to meet and discuss any
issues, thus leading to greater consistency in the label reviews. The downside of batching is
that SRRD may hold back a large number of completed packages while completing the
remaining products, which delays implementation of mitigation and potentially results in
outdated assessments for a significant number of products.
Several staff noted that there is very little collaboration or communication between SRRD and
RD on the label assessments and reviews. For example, the PRB Label Review Team rarely
40 Product Reregistration Quarterly Review, Briefing for Jim Jones, Associate Director of the EPA Office of
Pesticide Programs, July 2006
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receives feedback nor is asked questions by RD on the preliminary label assessment. Similarly,
it is common for there to be little to no interaction between the SRRD CRM and the PM when
the final review package is delivered to RD.
To facilitate the handoff of packages between SRRD and RD, OPP recently developed new
standard operating procedures (SOPs) to provide RD with streamlined label review packages
from PRB.41 By providing only the critical documents used in PRB's label assessment, OPP
expects that RD staff will be able to proceed with reregistering the product with less effort and in
a shorter time period. A streamlined package would entail sending RD only the final acceptable
review from each discipline (e.g., acute toxicity, product chemistry with acceptable confidential
statement of formula, and efficacy), the label assessment, and one copy of the latest draft label
(used in the label assessment). Previously, each CRM assembled packages differently and
often provided more information than RD required. Both of these issues required RD to spend a
significant amount of time reviewing and sorting materials in the package before conducting its
label review.
7.5 Current Strategy to Expedite Product Reregistration
Recognizing the backlog in product reregistration, upper management in RD has placed an
increased emphasis on product reregistration recently. In Fall 2006, the RD Director developed
a plan to expedite product reregistration by forming "SWAT teams," which would include staff
from both RD and SRRD and would focus on reducing product reregistration backlog. This is a
promising approach because it bridges the divide between RD and SRRD, which will help to
facilitate communication between the divisions.
Four categories of products were identified: (1) Products in RD for which the PM has
communicated with the registrant but has not yet received a label that is in compliance with the
RED, (2) Products in RD for which the PM has not yet taken any action, (3) Products in SRRD
PRB for which the DCIs have been issued, and (4) Products in SRRD PRB for which the DCI
has not yet been mailed.42
Products in Categories 1 and 2 will be addressed by RD staff exclusively. During our
interviews, we found that some RD branches had taken the initiative to reduce its product
reregistration backlog (as of September 2006), whereas others had not yet addressed products
in their branch. Categories 3 and 4 will be addressed by SWAT teams (SRRD and RD).
To address Category 1 products, the PM will send a letter that outlines a registrant's obligations
and allow a given amount of time to incorporate these changes before EPA takes action. To
address Category 2 products, the PM will send a letter to the registrant requesting label
changes as stated in the RED. The registrant must also send a letter that certifies that the only
changes on the label were those required by the REDs.
In early October, SWAT teams were established to expedite product registration for Categories
3 and 4. Each team consists of about five SRRD and RD staff, each dedicating full-time, or
close to full-time, to product reregistration over the next few months. The SWAT teams will
41 SOP for Reregistration Packages sent to RD, provided to Abt Associates by Venus Eagle, September
2006
42 Categories for Products in the SRRD-RD Pipeline, August 2, 2006
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conduct label reviews, send letters to registrants about required label revisions, and initiate
regulatory action when a registrant does not comply. Each SWAT team will be assigned about
one to three active ingredient cases, covering about 100 products in total.43 RD predicted that
the SWAT teams would work for a period of two months.
The SWAT team approach is unique for several reasons:
• It includes ambitious internal deadlines for completing product reregistration
• Product reregistration was made a priority within RD (particularly with respect to
products in Categories 1 and 2)
• RD will provide support to SRRD with products that have not yet completed the SRRD
portion of the reregistration process.
• It includes strict deadlines for registrant responses, including 30 days for registrants to
submit amended labels (Categories 1 and 2). OPP is also considering requiring
registrants to amend labels with RED-specified mitigation in advance of product
reregistration (Categories 3 and 4).
Preliminary information on the SWAT team approach indicates that each of the RD branches is
implementing the approach differently. In any event, the management attention placed on
product reregistration will ensure that product reregistration happens in a timelier manner. As
the approach is further implemented, EPA will need to assess if the 30-day deadlines are being
met, what the role for either division was, and compare number of actions completed in FY2007
to previous years.
43 Details of Reregistration Process Categories (Draft), provided to Abt Associates by Pete Caulkins,
SRRD, September 8, 2006
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8. Suggested Changes to Process Design and Other
Recommendations
Based on the findings and analysis presented in Chapters 3 through 7 of this report, this chapter
presents our recommendations for improving the product reregistration process. As
appropriate, we also present pros and cons for each recommendation.
8.1 RED Development
In August 2006, EPA completed the REDs for food-use pesticides as required by the Pesticide
Registration Improvement Act. At that time, EPA only had 54 REDs to complete (9 percent).
Thus, there are still opportunities to improve non-food-use REDs and to direct more attention to
post-RED activities. Based on the case studies discussed in Chapter 4, Abt Associates
identified the following issues or problems with REDs that contribute to delays in product
reregistration:
• REDs were often published before they are completed or before all outstanding issues
were properly addressed.
• The documents represent a "snapshot in time" of the data available to EPA, and
registrants often provide additional data that warrant amending the RED.
• Some REDs did not represent reregistration decisions or included provisions for
additional studies, such that product reregistration could not be effectively implemented
after the RED was published.
• REDs sometimes contained small errors, most of which were straightforward and easy
to address.
• The label tables often contained language that RD or PRB felt could be improved or that
was not consistent with labeling for other products.
• Staff from the reregistration branches were often unavailable to assist with post-RED
issues.
• When a case is transitioned to PRB, staff are often unfamiliar with the RED contents and
issues.
• The implementation of REDs was often influenced by other issues, which may not have
been directly related to the RED itself (e.g., the cancer reclassification for captan, the
registrant's decision to discontinue dicofol, legal challenges, etc.).
With these findings in mind, Abt Associates provides the following recommendations regarding
RED development.
8.1.1 Improve Transition of Cases from Reregistration Branches to PRB
The transition of a chemical case from the SRRD reregistration branches to PRB could be
improved. One potential way to accomplish this would be to have a "hand-off" meeting that
would be attended by the generic CRM, his/her branch chief, the PRB branch chief, and the
product CRM. This would be an opportunity for the reregistration branches to brief PRB on the
issues, particularly those that are outstanding, and improve the relationship and coordination
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within SRRD. This would address the concerns of PRB that reregistration branches do not
actively participate in many post-RED issues and also the concerns of the reregistration
branches that product reregistration lacks visibility. A meeting would also help delineate roles
and responsibilities, and signal a clear transition from one branch to another. Until this meeting
occurs, the chemical case would remain the responsibility of the reregistration branches and
help encourage them to address post-RED issues.
8.1.2 Require More Participation by RD in the Development of Label Tables
Based on our conversations with both RD and SRRD (reregistration branches and PRB), we
believe that the development of the label table in the RED should be improved. This
recommendation is based on comments from the reregistration branches that they do not have
adequate expertise in labeling. Similarly, both the PRB Label Review Team and the RD PMs
noted that label tables often include language that is written in a way that is not suitable for a
label or that is inconsistent with other products containing the active ingredient. RD noted that
PMs are invited to attend the meetings, but RD does not generally play an active role in the
development of the label table. RD Branch Chiefs should ensure that PMs are invited to and
attend these meetings. The involvement of both the PM and the RD Team Leader in the RED
process will help ensure the quality and thoroughness of the label review as it relates to RED-
specified mitigation. In addition, RD should be required to review and approve label tables
before they are published to ensure consistency and appropriateness. Note that because of
our recommendation to eliminate label assessments within PRB (below), the development and
review of the label table would not be a role for PRB.
8.2 Implementation of RED-Specified Mitigation
Based on its review of Memoranda of Agreement (MOAs), pilot projects, and RD's SWAT team
approach, Abt Associates identified the following issues or problems related to implementation
of RED-specified mitigation:
• Because of the length of the product reregistration process, as well as the delays that
often occur, the mitigation identified in the RED is often not implemented for several
years. This delay is particularly troublesome given that the universe of pesticides
products to be reregistered includes those that were registered prior to November 1,
1984.
• Even with regulatory action as a possible consequence of non-response, several
registrants did not submit amended propanil labels to include RED-specified mitigation.
• In the case of phosmet, amended labels were not submitted in an expedited manner as
specified in the MOA.
With these findings in mind, Abt Associates provides the following recommendations regarding
the implementation of RED-specified mitigation.
8.2.1 Implement Mitigation in an Expedited Manner When Cost-Effective
With the goal of implementing RED-specified mitigation as soon as possible, OPP is considering
requiring registrants to amend product labels after a RED is signed to include the required
labeling changes. OPP is considering using this approach for all products because OPP
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believes that identifying a subset of products would not maintain a level playing field among the
registrants. By potentially adding an additional step into the product reregistration process,
OPP needs to consider the additional staff time and resources this would require. Not only
would OPP need to conduct an additional round of label review, but it would also need to track
responses and maintain communication with the registrant.
Although we understand EPA's rationale for applying this policy to the entire universe of end-
use products, OPP would have several options available to it if adequate staff and resources
were unavailable:
• Identify subset based on risk characteristics based on the attributes of the product (e.g.,
market share, use patterns) or the level of mitigation required by the RED
• Select REDs that are likely to have issues that might delay product reregistration,
including related regulatory activities, etc.
Any rationale for differentiating policies would have to be defensible and be consistent with
applicable laws and regulations.
In addition, during the course of product reregistration, both RD and SRRD would be in contact
with the registrant. RD would request a label amended with RED-specified mitigation, whereas
SRRD would request ninety-day and eight-month responses. OPP would need to ensure that
these efforts are consistent and coordinated to reduce confusion on the part of the registrant.
Members of the regulated community, particularly smaller companies, are likely to miss the
distinction between the two divisions and only focus on the Agency level. Note that this issue
arose during the captan reregistration, where both the SRRD reregistration branch and PRB
were in contact with the registrants at the same time. Moving forward with the proposed
approach, OPP would need to establish better communication and coordination between the RD
PM and the SRRD PRB CRM.
Alternatively, although it prolongs implementation of RED-specified mitigation, EPA could
require the amended label with the ninety-day response, but instead of holding onto it until the
product is ready for label review, PRB could immediately send the label to RD for review. This
assumes, however, that the DCI is sent out in a timely manner because RD is considering
having a PM send letters to the registrants independently of the DCI. As a benefit, issuing the
letters prior to the DCI may allow OPP to identify products that would be cancelled before it
goes to the effort of preparing and mailing a DCI.
8.2.2 Pursue Additional Regulatory Action When Warranted
As demonstrated in the cases of propanil and phosmet, several registrants did not submit
amended labels despite the consequence of regulatory action or the conditions of the MOA. To
ensure that mitigation is consistently implemented and that registrants are aware of the
implications of noncompliance, EPA needs to be prepared to pursue the "additional regulatory
action" to which it refers in its letters to the registrant. Without this aspect, the success of
implementing RED-specified mitigation is limited.
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8.2.3 Further Explore Self-Certified or Electronic Labels
As part of its approach to implement RED-specified mitigation sooner, EPA would require
registrants to submit a letter that certifies that the only changes that were made to the label
were those specified by the RED. Although this issue is outside the scope of this evaluation,
Abt Associates suggests that EPA consider requiring a registrant to identify and certify the
nature of label changes for all label amendments. This step would increase the transparency,
and also reduce the burden on the PM for identifying label changes that may or may not be
appropriate. Similarly, several staff noted that OPP has discussed but is not yet actively
pursuing an electronic labeling system that would allow EPA to compare label amendments
electronically (i.e., in a manner similar to document comparison features in word-processing
programs). These two changes to program design would decrease label review burden
generally and provide RD with significantly more time to address other issues, including product
reregistration.
8.3 DCI Justifications and Preparation
Based on our findings in Chapter 5, Abt Associates identified the following issues or problems
associated with developing Data Call-in (DCI) justification packages and mailing out DCIs that
contribute to delays in product reregistration:
• The format for the DCI justification package has been and continues to be an issue.
Based on the direction provided by the Field and External Affairs Division (FEAD),
SRRD used a new streamlined template for the justification package, but it also
supplemented the template with a substantial amount of information.
• Risk assessments and REDs often do not provide the necessary information to create
the DCI justification package, which requires PSB to spend a significant amount of time
collecting additional information.
• As with other parts of the product reregistration process, SRRD does not have the
adequate tracking systems available to them and has been forced to develop external
systems on an ad hoc basis.
With these findings in mind, Abt Associates provides the following recommendations regarding
the preparation of DCI justification packages and DCIs generally.
8.3.1 Ensure that DCIs Are Prepared According to the Package Template
PSB should use the template for the DCI justification package to prepare the DCI package more
effectively and efficiently. While it is important to anticipate the needs and questions of OMB,
PSB should ensure that the DCI packages provide the essential information, not try to anticipate
all of the information that OMB could (but may never) require at a later time. In turn, the DCI
justification package template should be revised according to the comments and lessons
learned from OMB on an ongoing basis.
8.3.2 Modify Format of Supporting Data in Risk Assessments
The RAs should contain an up-front description of the data gaps and the rationale for new
studies so that PSB staff do not have to search for or re-create this information. As part of the
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description, the science divisions should include cost burden estimates for "special studies,"
since they are in the best position to project the requirements and costs of special studies. As a
next step, PSB and the science divisions should work together to identify what PSB routinely
needs from RAs or REDs in order to construct the DCI justification package, and then how that
information can best be presented and summarized going forward.
8.4 Streamlined Data Requirements
Based on EPA's analysis discussed in Section 6.2 of this report, Abt Associates expected to
make recommendations for streamlining acute toxicity or product chemistry data requirements
based on characteristics of end-use products. However, as described in that section of this
report, Abt Associates concluded that the analysis was not designed in a manner that yielded
results appropriate for this purpose. Without adequate data on which to base
recommendations, Abt Associates is unable to make recommendations for streamlined data
requirements. However, based on its research, Abt Associates provides the following
recommendations regarding the product-specific data requirements.
8.4.1 Conduct Additional Analyses to Determine Value of Product-Specific Data
In order to provide data to inform an approach for streamlined data requirements, OPP could
consider undertaking additional analyses that would be more informative and detailed than the
one provided to support this evaluation. Such an analysis would involve randomly selecting
from the entire universe of products for which product reregistration was completed or for which
labels had been amended. This analysis would also not be limited to sampling one product
from each RED. To increase the utility of the results, EPA should identify mitigation resulting
from product-specific data in a more detailed manner and record these results in either
Microsoft Excel or Access to facilitate analysis. We also believe that a comparison of RED-
specified mitigation to that warranted by product-specific data would be informative.
8.4.2 Leverage Related Efforts for Process Improvements
In June 2006, the Pesticide Program Dialogue Committee (PPDC) PRIA Process Improvement
Workgroup met to discuss issues with product chemistry studies.44 The workgroup was formed
in reaction to a provision in PRIA on process improvement. The workgroup includes members
from EPA and industry, including the director of the Registration Division. Both EPA and
registrants have noted that product chemistry studies are often provided as the rationale for
extending decisions on registration actions under PRIA. Staff from SRRD participated in the
workgroup discussion of product chemistry. Given the common interest in product chemistry
studies, Abt Associates recommends that SRRD maintain its participation is these discussions
and take full advantage of any procedures, guidance, or calculations that result from this related
improvement process. This is also an opportunity for RD and SRRD management to leverage
ideas and approaches that are applicable to product reregistration.
8.4.3 Expand Batching Approaches to Reduce Number of Requested Studies
For the case of 2,4-D, EPA worked with the Industry Task Force to identify storage stability
studies and to further batch acute toxicity data based on existing studies. For this approach to
44 http://www.epa.gov/oppfead1/cb/ppdc/pria/june06/june06-minutes.pdf
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succeed, all (or almost all) registrants need to be involved. In addition, the number of 2,4-D
products also justified the approach.
Due to the unwieldy amount of data received from the Task Force, OPP has decided that future
efforts to reduce acute toxicity data requirements will not consider existing data during the
batching process. Rather, PRB will provide the Task Force with the batching and allow them to
identify acute data that support product batches, after which PRB will evaluate the data for
acceptability. The acute toxicity profile and MRIDs for the studies available to support each
batch will be identified in the final batching document. EPA should explore ways to engage the
registrants early on in the batching process, perhaps by identifying windows of opportunity in the
public participation process. This may help to address batching issues in a timelier manner.
EPA is currently considering ways in which product-specific acute toxicity and product chemistry
data requirements could be further batched or streamlined for other cases, including PBO
(1,704 products), pyrethrins (1,490 products), MGK-264 (706 products), and permethrin (1,185
products).
8.4.4 Encourage Use of Self-Certified Product Chemistry Data
In 1998 OPP issued Pesticide Registration (PR) Notice 98-1, Notice to Manufacturers,
Producers, Formulators, and Registrants of Pesticide Products, which allows a "self-
certification" program for certain product chemistry data for manufacturing-use products and
end-use products. Applicants are allowed to submit a one-page summary of the products
physical and chemical properties, but are no longer required to submit the studies upon which
the summary is based. Registrants must submit the studies if requested by OPP. Based on our
conversations with OPP staff, few registrants take advantage of this option for the purposes of
product reregistration. If they did, OPP would likely request the supporting studies, particularly
for storage stability. Thus, the benefit of this policy to registrants is not clear because they still
need to complete the studies, prepare a summary (that imposes additional burden), and then
respond to OPP inquiries. As such, this attempt at streamlining data requirements and
submissions does not appear to be an effective one, and EPA should consider if it can provide
an incentive for registrants to submit self-certified data or provide guidance that would yield
storage stability studies that would not require OPP review.
8.5 Registrant Responses
One of the sources of delay in the product reregistration process is the registrant responses,
which require a lot of time for the registrants to prepare and submit, as well as for EPA to
receive, track, review, and respond to (if required). During the course of its reregistration
program, EPA has initiated several efforts to increase the quality of data it receives from
registrants. To ensure that registrants submit responses in a timely manner, or perhaps
encourage registrants to submit responses more quickly than required, Abt Associates provides
the following recommendations.
8.5.1 Create Incentives for Registrants to Provide Expedited Responses
As appropriate and permissible under applicable laws and regulations, EPA should consider if it
could create incentives for registrants to submit data early or signal their intent to cancel a
product. One potential approach would be to reduce registration maintenance fees or allow
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additional flexibility. EPA would need to consider if these approaches would provide an
adequate benefit to OPP relative to the cost (either in dollars or effort). This recommendation is
based on the finding that registrants are often unwilling to voluntarily provide data and amend
labels. This finding runs counter to the situation in RD where registrants want OPP to process
registrations as soon as possible and registrants willingly submit information in a timely manner.
8.5.2 Establish Procedures and Pursue Suspensions
Recently, OPP has not initiated suspensions of product registrations because the procedures
are under review. OPP also noted that suspensions require a significant amount of paperwork
such that EPA often enters into negotiations instead. It is also difficult to lift a suspension.
Because registrants lack an incentive for product reregistration to occur, as they often lose uses
or must add additional mitigation to the label, EPA must make an aggressive effort to receive
registrant responses. EPA is currently reviewing its procedures and signature authority for
suspensions, and should consider suspending registrations of products for which the registrant
is not submitting the required information. Despite the effort, this practice will send a clear
message to the regulated community.
8.5.3 Retain Data Review Functions within PRB
Until 1989, product reregistration was the responsibility of the Registration Division. SRRD, and
PRB specifically, was created specifically to address reregistration because it was not a priority
within RD. Some have suggested that given the similarities between the two programs that
product reregistration should again be the purview of RD. Although Abt Associates suggests in
the next section that the label assessment in PRB should be discontinued, we believe that
requesting, managing, and reviewing registrant submissions should remain the responsibility of
PRB and be organizationally separate from registration. If these functions were moved to RD,
they could be lost when combined with the competing priorities of registration. We believe there
is a significant benefit to having dedicated product reregistration reviewers in PRB.
8.6 Label Reviews and the Role of the Registration Division
Based on our findings in Chapter 7, Abt Associates identified the following issues or problems
associated with label reviews and assessments that contribute to delays in product
reregistration:
• The label assessments are used by some of the registration branches, whereas others
do not even consult the documents. Some product mangers commented that PRB
information was out of date or inconsistent with related products containing that active
ingredient.
• The goal of the PRB label assessment was to consistently implement product
reregistration on product labels, but the consistency goal was subsumed by a broader
effort for labeling consistency (e.g., Label Review Manual).
• The ziram pilot project did not provide enough information from which to draw
conclusions.
• The procedures for the transition between SRRD PRB and RD have helped to
streamline the package.
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• SRRD and RD staffs generally do not communicate with each other and are generally
unaware of the issues and procedures in either division.
With these findings in mind, Abt Associates provides the following recommendations regarding
label reviews and the role of RD.
8.6.1 Discontinue Label Assessments within SRRD
While an effort was made to clearly divide roles and responsibilities between RD and SRRD, the
preliminary label assessments and label reviews remain duplicative. As such, we recommend
that that label review responsibility should reside within RD. This recommendation is based in
large part on the finding that many PMs do not consult the preliminary label assessments
because they are outdated (i.e., based on an outdated version of the label) or because the PMs
regard them as unreliable or incomplete. Given their product-specific knowledge and familiarity
with the label review process, PMs are arguably the best-qualified individuals to conduct the
label reviews. While a label assessment in SRRD and a full label review in RD ensures that at
least two individuals have reviewed the label, we believe that the efforts are redundant. In
addition, PRB sometimes defers to RD on labeling decisions anyway (e.g., restricted-use
pesticide classifications). Note that this recommendation does not preclude the participation of
SRRD staff in the SWAT team approach developed by RD management.
8.6.2 Improve Transition of Cases from SRRD to RD
Better communication and collaboration are needed when SRRD delivers the final review
packages to RD. Currently, many CRMs deliver final review packages to PMs without notifying
them beforehand or clearly summarizing outstanding issues. We recommend that CRMs and
PMs have "hand-off meetings" at this time so any unresolved issues can be flagged and
discussed. The scheduling of hand-off meetings will also help PMs to better predict and
manage their workloads.
8.7 Management, Resources, and Staffing
Abt Associates drew the following conclusions regarding management, resources, and staffing:
• The resource allocation has remained relatively stable and SRRD expects that will
continue.
• The backlog of product reregistration actions to be completed increased after the
completion of the food-use REDs in August 2006.
• Recent management attention has raised the visibility of product reregistration in both
RD and SRRD.
• The SWAT team approach developed by RD management is a promising approach to
accomplishing product reregistration.
With these findings in mind, Abt Associates provides the following recommendations regarding
management, resources, and staffing.
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8.7.1 Reevaluate Allocation of SRRD Resources
Despite the number of products yet to be completed, particularly following the completion of the
food-use REDs in August 2006, Abt Associates believes OPP should reconsider its allocation of
resources in FY2007 and in the future. In its FY2007 reregistration work plan, SRRD allocates
eight percent of its resource allocation to product reregistration. The eight percent FTE
allocation is roughly equivalent to past staffing levels and SRRD expects the staffing level to
remain fairly constant in the short term. Funds are allocated to product reregistration at roughly
the same level through FY 2013. EPA has predicted that it will complete product reregistration
in 2012.
Based on the data presented in Chapter 3, we considered the work that SRRD has yet to
complete with respect to product reregistration. In FY2006, EPA completed 545 actions, with
11,948 actions pending. Several active ingredients represent a large number of products: PBO
(1,704 products), pyrethrins (1,490 products), MGK-264 (706 products), and permethrin (1,185
products). For purposes of the following calculation, these active ingredients were removed
because we expect that EPA will develop unique approaches for these cases such that they
may not follow the traditional reregistration process. Thus, we expect that approximately 6,903
actions remain exclusive of these chemical cases. We are working on the assumption that EPA
completes 545 actions for FY2007 and beyond, based on stable resource allocation and the
potential increased burden that would be associated with implementing RED-specified
mitigation in advance of product reregistration. When considering 6,903 products and
completing 545 actions per year, we predict that product reregistration may not be completed for
more than twelve years, or the end of FY2018. This is six years longer than EPA's current
prediction, and five years longer than the period for which EPA has budgeted. We understand
that this calculation is rough and that there will also be FTE resources dedicated to the four
major active ingredients identified above; however, given this workload and the necessity to
complete product reregistration in a timely manner, EPA needs to reconsider its resource
allocation.
8.7.2 Maintain Emphasis on Product Reregistration
The attention and emphasis placed on product reregistration by both SRRD and RD
management have been critical to the recent improvements. It is important that this emphasis
and attention be maintained, particularly as the office has competing priorities (e.g., registration
review). In addition, OPP should use all opportunities to elevate issues related to product
reregistration to OPP upper management, particularly when it comes to issues of staffing,
resources, and policy concerns. Because SRRD and RD both share responsibility for product
reregistration, upper management can help align the divisions and establish priorities. This
continued emphasis on product reregistration is also important in the event that senior
management in either division changes before product reregistration is completed.
8.7.3 Pursue SWAT Teams and Other Strategies to Reduce Backlog
As discussed in Chapter 7, the SWAT team approach developed by RD management is a
promising avenue to reduce the product reregistration backlog. After reviewing the materials,
Abt Associates believes that the SWAT team approach will be particularly effective at
addressing products within Categories I and 2 because the approach requires action by both the
PM and the registrant. The changes in process design that correspond to products in
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Categories 3 and 4 are more dramatic and longer term. Moving forward, OPP should be
mindful of the workload that corresponds to the SWAT team approach, the follow-up required,
and the coordination between and roles of SRRD and RD.
Over the long-term, OPP should consider alternative strategies to reduce the product
reregistration backlog over the next several years, including a performance-based contract for
short-term staff support to assist EPA in the completion of product reregistration actions. The
disadvantage of such an approach is that product reregistration requires a lot of internal
communication and relies on institutional knowledge. However, some RD staff noted that newer
staff or Senior Environmental Employment (SEE) employees are often assigned and
successfully complete product reregistration tasks.
8.7.4 Obtain Support for DCI Preparation
The SRRD Program Support Branch (PSB) needs a senior scientist or senior science writer on
staff. Although FEAD is a policy-oriented, not science-oriented group, PSB is relying on FEAD
expertise in this area to assist in the development of the DCI justification package. This new
hire would not only relieve FEAD's time commitment, but would also help expedite the
development of the DCI justification package and provide needed scientific expertise.
Alternatively, SRRD could shift existing staff to provide additional support in this area,
particularly given the number of FY2006 decisions that will require DCIs in the short-term.
8.8 Communication
Based on its research, Abt Associates believes that communication regarding product
reregistration could be improved both internally and externally. Elsewhere in this report, we
note that the reregistration branches, PRB, and RD are unclear on each other's roles. In
addition, PRB used to be physically separated from the rest of SRRD and the new office space
seems to have helped facilitate communication. There are, however, opportunities for additional
improvements by way of trainings, meetings, and brownbag presentations.
With respect to external communication, product reregistration is not mentioned in many OPP
reports, such as the office's annual report.45 In a recent addition to the EPA Pesticides Web
page, "Pesticide Reregistration Facts,"46 EPA highlighted and acknowledged product
reregistration in its summary of the pesticide reregistration process and status. This discussion
does not mention product-specific data and leads the reader to assume that product
reregistration is a check to confirm that RED-specified mitigation appears on a label. It also
notes that EPA "plans to complete the last product reregistration decisions several years after
the last REDs are signed." In contrast, there was very little (if any) discussion on the EPA
Pesticides Web page previously, and this information was included only within the REDs and
Federal Register notices. Abt Associates believes that EPA could increase the transparency of
the program by explicitly mentioning and addressing product reregistration. For example, to be
more explicit and help the regulated community plan better, EPA could add reference to
pesticide product reregistration in the "Status of Pesticide Reregistration" Web page along with
schedules for REDs and registration review.
45 http://www.epa.gov/oppfead1/annual/2005/05annualrpt.pdf
46 www.epa.gov/oppsrrd1/reregistration/rereg istration_facts.htm
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8.9 Performance Management
Based on the measures reported under the Government Performance and Results Act (GPRA),
Abt Associates believes there are opportunities to make these measures more meaningful for
both internal and external stakeholders. Similarly, to address competing priorities within RD, we
suggest that OPP incorporate individual performance goals for product reregistration.
8.9.1 Improve Performance Measures and Strategic Targets
As discussed in Section 1.4 of this report, for purposes of GPRA, EPA reports on the number of
product reregistration actions completed. However, this type of output measure is not
informative because it does not provide a measure of progress relative to the entire universe.
Abt Associates recommends that OPP revise this performance measure to use a percentage,
which would be more informative. We understand that the universe of pesticide products
subject to reregistration is constantly in flux; however, a percentage measure might be more
informative for internal purposes. In addition, Abt Associates would suggest that EPA examine
its targets for the number of pesticide reregistration actions. Although the targets have
increased annually, the targets might not be realistic or ambitious enough to ensure completion
of product reregistration within EPA's desired timeframe.
8.9.2 Incorporate Product Reregistration into PARS
In order for the SWAT team approach and other product reregistration process improvements to
be most effective, RD should place a continued emphasis on product reregistration. Currently,
PMs have to manage their work based on the competing priorities of pesticide registration and
reregistration. Until recently, however, RD management has not placed a high priority on
product reregistration; for example, PMs have concrete job performance goals related to
registration but not to product reregistration. To ensure that RD accomplishes product
registration in an efficient, timely manner going forward, RD management should include
product reregistration-specific goals in each staff member's Performance Appraisal and
Recognition System (PARS). In turn, management should periodically review each PM's
workload to make sure that workload is manageable and appropriately distributed among
individuals.
8.10 Information Management
Abt Associates drew the following conclusions regarding information management with respect
to product reregistration:
• Even though OPPIN was intended to be an integrated system, it has failed to meet the
tracking needs of different components of the product reregistration process.
• Many staff have created one-off tracking systems in order to get their jobs done, making
reliable status updates very difficult to retrieve.
• The current approach to information management not only contributes to inefficient and
inadequate tracking, but also potentially makes EPA vulnerable.
• Information management is an issue in each of the product reregistration sub-processes.
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With these findings in mind, Abt Associates provides the following recommendations regarding
information management.
8.10.1 Continue to Prioritize an Integrated Tracking System
SRRD should continue to prioritize the development of an integrated tracking system that
manages all of the data and information related to the DCI process. For example, the fact that
the current tracking system does not adequately track the status of submitted studies and
confirmatory data from registrants is a potential liability to EPA.
Assuming that PRISM is the predecessor of OPPIN, SRRD should ensure that PRISM has the
necessary data fields and functionality for tracking all components of the DCI process because
future programs (e.g., registration review) will use OPP's DCI authority. As an alternative to
PRISM, it may be more practical and cost effective to develop a relatively simple tracking
system in Access that staff can use for DCI-related tracking. This Access database would track,
at a minimum, the following elements of the DCI process: (1) the submission and approval
dates of the DCI justification by EPA (FEAD and RCS), (2) submission to and approval by OMB,
(3) the outcome of the ninety-day response period whereby registrants specify their intent to
comply, seek a waiver, or cancel their product, and (4) the status of submitted studies over the
eight month response period. (Item #4, for example, would negate the need for the current
"charts and tables" document that is maintained in Word for each PDCI.) Additionally, in
developing the DCI tracking system, OPP should consult other EPA offices (e.g. Office of
Pollution Prevention and Toxics) that issue DCIs to determine what tracking systems they use, if
any, and share lessons learned.
Ideally, OPP would already have in place an integrated, centralized database that would track
all remaining aspects of the registration process. Given that product re registration is a finite
process (anticipated completion being 2012), it may not be an effective use of OPP's time and
resources to build a sophisticated system such as PRISM for the purposes of product
reregistration. Depending on how far along PRISM is in its development phase, we recommend
that OPP revisit its tracking needs to determine whether the potential benefits of PRISM will
outweigh the negatives (e.g., cost, staff time, limited lifespan), and whether the work already
done on PRISM can be transferred towards the creation of a simple, effective Access database.
Although the utility of PRISM from strictly a product reregistration standpoint is questionable,
PRISM will presumably benefit SRRD's upcoming registration review, which will continue past
the complete of product reregistration. The development of any tracking system (whether it be
PRISM or an Access database) should involve all relevant staff. CRMs, FEAD, management,
and PSB (among others) all have different needs for tracking, and in turn, all groups need the
opportunity to provide input on the final system. Since all OPP staff may not be familiar with
Access, the database should be created with a user-friendly interface that makes data entry and
analysis straightforward.
8.10.2 Maintain Web Site as a Repository of Reregistration Decisions
Both SRRD and RD staff rely on the OPP web site (www.epa.gov/pesticides) as a historical
repository of reregistration documentation, including risk assessments, the RED and associated
amendments, label tables, and other Federal Register notices. This reliance on the web site is
an issue because OPP does not use a docket system for reregistration, nor does OPP publish
REDs in hard copy anymore. Because several staff noted that amendments are not often
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posted in a timely manner, it is essential that OPP remain attentive to its web site. This type of
information is not available in OPPIN, but might be available in the Jacket. The Jackets,
however, are not yet available electronically. These records will be critical for registration
review.
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Appendix A Interview Guide
The following interview guide was used for each of the interviews with OPP staff, including
introductions, general questions, issue-specific questions, and conclusions. As appropriate, we
also asked questions that arose during the course of the meeting or that related to comments
made by the interviewer.
Introductions
"Good morning. I am (introduce self).
This interview is being conducted to get your input about the implementation of the product
reregistration program that you have been conducting/involved in. I am especially interested in
any problems you have faced or are aware of and recommendations you have."
"If it is okay with you, I will be tape recording our conversation. The purpose of this is so that I
can get all the details but at the same time be able to carry on an attentive conversation with
you. I assure you that all your comments will remain confidential. I will be compiling a report that
will contain a synthesis of all staff comments without any reference to individuals. If you agree to
this interview and the tape recording, please sign this consent form."
"I'd like to start by having you briefly describe your responsibilities and involvement thus far with
the product reregistration." (Note to interviewer: You may need to probe to gather the
information you need, including length of time individual has worked in the program).
General Questions
"I'm now going to ask you some questions that I would like you to answer to the best of your
ability. If you do not know the answer, please say so."
• In your opinion, what are the biggest challenges faced by product reregistration? How
do these challenges influence your role in the process?
• What do you think are the main factors the influence the length of time that product
reregistration takes? Which parts of the program are affected?
• How has the program changed over the time you have been here?
• Given your role, what would help you do your job better with respect to product
reregistration?
• Which parts of product reregistration do you find the most time consuming? What are
your suggestions for streamlining these portions?
• In what ways do you think product reregistration could be improved?
• What do you estimate would be a reasonable amount of time for reregistering a specific
product after the RED is signed?
Problems in REDs
• We have been told that the RED for caused delays in product
reregistration. Do you agree with this assessment?
• What characteristics of the RED resulted in issues? For example, were parts incomplete,
incorrect?
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• If appropriate, in what ways was the RED incomplete? Incorrect?
• Did the RED contain any contradictory language?
• Were there any circumstances after the publishing of the RED that delayed product
reregistration, for example, data made available, a risk assessment revised?
• How did these factors impact product reregistration? Were all products affected?
• Why do you think that this RED had these issues?
• Is this a high-profile case or of particular interest to the registrant or an environmental
group?
• How did you address each of the issues with the RED?
• Who was responsible? What is the estimate of increased burden?
• What was the impact to the registrant?
• Are there ways that the problems with the RED could have been avoided or decreased?
• What needs to change to eliminate the problem?
• How could these changes be accomplished?
• Have you had (or heard of) similar experiences with other REDs? If so, which ones?
How often?
• When does this occur (close to a statutory deadline, etc.)?
Implementation of RED-specified Mitigation
• How/why were the cases selected for MOAs? How many MOAs have been signed
regarding product reregistration? Do they vary in scope?
• How quickly did mitigation appear on the product label?
• Please characterize communication with the registrant.
• What additional work did this approach require? Can you estimate the additional time?
• How do EPA, environmental groups, and the registrant perceive the case?
• In addition to the MOA, what other factors may be unique to this active ingredient?
• How did this MOA compare to others on which you have worked or about which you
have heard?
• How or do you think that this approach could be modified to streamline product
reregistration generally?
• What type of products (cases) may lend themselves to such an approach?
Propanil Pilot
• Why were the pilot cases selected?
• How did you approach the registrant? What was his/her reaction?
• What are the legal issues? How are they being overcome?
• Please describe the approach for categorizing products and the rationale for the
approach?
• To which categories will EPA apply this option?
• How will these products be considered for product reregistration? Is there any benefit to
the registrant for implementing mitigation on the label sooner?
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• What is the estimated burden to EPA for this pilot? For the approach generally? What
about to the registrant?
• What is the estimate for developing the option? The time required for registrants to
respond? To complete the process?
2,4-D Batching
• Who initiated the batching alternative - EPA or the registrants?
• What role did EPA play in the alternative?
• What characteristics of 2,4-D made this alternative appropriate (number of products,
etc.)?
• What documentation exists on this case?
• What was required of the registrants collectively?
• How were legal concerns or CBI issues addressed?
• How do registrants view the alternative? Would they characterize it as a positive
experience?
• What is the estimated burden savings to EPA or the registrants?
• What are the biggest obstacles to implementing this alternative for other cases?
• In what circumstances would it be appropriate in order to result in the most burden
savings?
Label Reviews
• What is the division of labor between SRRD and RD with respect to label reviews?
• How do SRRD and RD approach the task?
• What is the average time a label review takes? Is there a range?
• Knowing that RD stamps the label, what resources are available to RD that might not be
available to SRRD as they review the label?
• How useful is the information provided by SRRD?
• What do SRRD and RD look for in the label tables? Could these reviews be reconciled?
Ziram Pilot Project
• Why was the pilot case selected? Were all the ziram products completed or just one?
• What information was given to both divisions? Were they aware that is was for a pilot?
• In your opinion, was this label review treated differently than the average case?
• What differences appeared on each label? How significant are they?
• As an individual, are you comfortable with this streamlining option? Why or why not?
• Do you think this option is a valid approach to streamline reregistration?
• How long did the review take? Is that a typical amount of time?
Relationship between SRRD and RD
• How different are the cultures within the two divisions?
• How is workload and communication coordinated?
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• What procedures exist to govern product reregistration?
• What are the priorities for either division? Are they in conflict?
• In what ways could SRRD work better with RD? Vice versa?
• How effective is the SOP for handoff to RD? Pros/Cons?
• What RD resources are available to SRRD - are they coordinated/consistent?
DCI Preparation and OMB Approval Process
• How much time does it take to prepare the DCI? Receive approval?
• Do data exist to support this conclusion?
• Historically, how many DCIs (and DCI packages) are prepared annually? How many
active ingredients? Products?
• What issues arise to slow the process?
• What are the issues with OMB? What efforts have been undertaken to address them?
• What tracking issues arise in this part of the product reregistration process?
• In what ways could this part of the process be streamlined?
• To what extent is OPP constrained by OMB in this part of the process?
• How effective are the SOPs in establishing roles and responsibilities for both EPA and
OMB?
• When were the SOPs written and how current are they?
• Are there any parts of the process that are not covered by SOPs that should be?
Information Management
• On several occasions, GAO commented on the lack of infrastructure to manage
reregistration data. What improvements have been made over the past 10-15 years
generally? For products specifically?
• What tracking systems exist for product reregistration?
• Are there shortcomings in the way SRRD tracks product reregistration?
• What are the obstacles to improving this?
• Which data management needs are most important?
• What is the history of requests to improve tracking?
• How is tracking handled in the registration division?
• What is the functionality of OPPIN for product reregistration versus Als?
• What changes are planned for OPPIN? Will they impact product reregistration?
• On what occasions are data pulls needed? How labor intensive is the process?
• Who needs access to the information?
• What tracking systems are maintained internally? How functional are they? How could it
be improved
• What other information management tools have been developed? For what purpose?
How could they be improved?
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Management/Budget
• How have you seen priorities change within OPP and within the product reregistration
program generally over time? How has funding for both OPP and product reregistration
changed over time?
• From your perspective, how is product reregistration viewed within OPP? Within the
Agency? By the registrants? Environmental and public health groups?
• How and to what extent does political pressure or media attention affect product
reregistration?
• Which types of products receive increased scrutiny? Why?
• Are there aspects of product reregistration that receive less attention?
• What types of project planning exercises are completed for product reregistration (e.g., a
work plan)? Is there a forecast for completing product reregistration?
Conclusion
• Is there anything else today that I have not directly asked that you think is important for
us to consider in our evaluation?
• Is there anyone else that you think we should talk to about these or other issues?
Thank you for your time. We appreciate your thoughts and experiences with product
reregistration. Over the coming weeks, we will be compiling responses. If necessary, would it
be possible to contact you, if needed, for additional information or clarification?
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Appendix B
Individuals Interviewed or Consulted
Peter Caulkins
Pat Dobak
Venus Eagle
Keenan Garvey
Richard Gebken
Cynthia Giles-Parker
Mike Goodis
Katie Hall
John Hebert
Mika Hunter
Marion Johnson
Karen Jones
Dan Kenny
George LaRocca
Meredith Laws
Susan Lewis
Marianne Lewis
Joanne Miller
Tom Myers
Gary Mullins
Cathryn O'Connell
Mark Perry
Maria Piansay
Linda Propst
Margaret Rice
Larry Schnaubelt
Kelly Sherman
Cameo Smoot
Jim Tompkins
Mary Waller
OPP Special Review and Reregistration Division
OPP Special Review and Reregistration Division
OPP Registration Division, Insecticide-Rodenticide Branch (on detail from SRRD)
OPP Special Review and Reregistration Division
OPP Registration Division, Insecticide Branch
OPP Registration Division, Fungicide Branch
OPP Special Review and Reregistration Division, Reregistration Branch 3
OPP Special Review and Reregistration Division, Reregistration Branch
OPP Registration Division, Insecticide-Rodenticide Branch
OPP Biopesticides and Pollution Prevention Division
OPP Registration Division, Insecticide Branch
OPP Special Review and Reregistration Division, Product Reregistration Branch
OPP Registration Division, Herbicide Branch
OPP Registration Division, Insecticide Branch
OPP Registration Division, Insecticide-Rodenticide Branch
OPP Special Review and Reregistration Division, Reregistration Branch 1
OPP Special Review and Reregistration Division, Product Reregistration Branch
OPP Registration Division, Herbicide Branch
OPP Special Review and Reregistration Division, Reregistration Branch 2
OPP Special Review and Reregistration Division, Program Support Branch
OPP Special Review and Reregistration Division, Reregistration Branch 2
OPP Special Review and Reregistration Division, Product Reregistration Branch
OPP Special Review and Reregistration Division, Product Reregistration Branch
OPP Special Review and Reregistration Division, Product Reregistration Branch
OPP Special Review and Reregistration Division, Reregistration Branch 2
OPP Special Review and Reregistration Division, Product Reregistration Branch
OPP Special Review and Reregistration Division, Reregistration Branch 2
OPP Field and External Affairs Division
OPP Registration Division, Herbicide Branch
OPP Registration Division, Fungicide Branch
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