Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2018
Fifteenth Annual Report


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Process Improvements in the Pesticide Program
Pesticide Reevaluation Programs
Registration Review
Office-Wide Improvements
EPA's Office of Pesticide Programs (OPP) continues to find opportunities to be more efficient in
the registration review process and has implemented several changes during FY' 18. Some
examples included streamlining Draft Risk Assessments and Proposed Interim Decisions into one
deliverable, combining multiple chemical risk assessments into one assessment by class, and
continuously improving program coordination and implementation.
OPP continued to improve the Pesticide Submission Portal (PSP) during FY' 18. In FY' 18,
features were added to allow registrants to 1) submit Registration Review label amendments
through PSP, 2) submit data on behalf of a consortium composed of multiple registrants, and 3)
establish a passphrase hint. In addition, various bug fixes and user experience improvements were
released in FY' 18. These features will save a significant amount of registrant time and paper by
eliminating the need to print and mail the submissions, as well as reducing the response burden on
registrants that belong to a consortium.
Furthermore, in 2018, to improve transparency and communication of risk assessment results and
registration review decisions, OPP completed the technical development of a pesticide registration
review decision capture database. OPP's Chemical Review Managers are currently being trained
on how to use the database to track mitigation measures required through registration review. OPP
expects that this database will improve consistency of risk mitigation decisions across the
program.
Pesticide Reevaluation Division Improvements
In November 2014, OPP management convened a "Lean Team" comprised of 10 staff from across
OPP to participate in a 5-day Kaizen Event to improve the pesticide registration review process.
The overarching goal of the Event was to optimize chemical team interactions in a manner that
creates more consistent, defensible, protective, and enforceable pesticide risk management
decisions that are timely and efficient. The Lean Team identified pesticide registration review as
one topic and finalized the Registration Review Process Map and Leaning Registration Review for
Conventional Pesticides. The report outlines potential registration review process improvements
intended to guide a more efficient and effective registration review process.
Between 2015 and 2017, the Pesticide Re-evaluation Division (PRD) has been implementing the
improvements identified in the report. Examples of major outcomes in 2015 from the Lean process
included the development of aggregate pesticide use information tables to streamline incorporation
of such information in the risk assessment process. In 2016, the program added more time between
risk assessment and Preliminary Interim Decision (PID) publication to provide for the development
and consideration of the benefit and impact of risk mitigation decisions. Additionally, PRD also
developed a standard operating procedure (SOP) that defines the milestones and needed team
engagement for risk mitigation decision development. The objective was to improve
communication across the impacted divisions and ultimately improve the decisions documents that
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PRD develops. In 2017, the program continued to implement the risk mitigation SOP as the
registration review shifts into the risk-management phase.
In 2018, PRD made significant strides in continuously identifying potential hurdles and finding
solutions in meeting the 2022 registration review deadline. In March 2018, the PRD management
team, along with the Division's senior staff, held an all-day retreat. The Division revisited the
2014 Lean report action items and identified two additional areas for better coordination and
planning. One area is for PRD's Chemical Review Managers to work more explicitly with their
team members to clearly identify the risk management goals, especially for cases with ecological
and worker risks, early on. Another area of impediments is the delay in receiving necessary data
for the Agency to conduct risk assessments. To address the risk management goal and the data
delay challenges, PRD is actively developing a weight of evidence approach for defining risk
management goals and a framework to address data delays. In 2019, PRD will coordinate with the
science divisions and the Biological and Economic Analysis Division to finalize a path forward on
both issues for the Program. In terms of additional areas for efficiency, in 2018, PRD piloted
"streamlined Interim Decision" for several cases where no significant comments or major changes
were made on the Proposed Interim Decisions.
PRD continued to work with registrants to receive and review amended labels per registration
review interim decisions. PRD completed review of nearly 300 labels in 2018 and will continue to
provide updates on the number of product labels that have been approved with the required
mitigation in future reports.
Antimicrobials Division Improvements
In FY' 18, the Antimicrobials Division (AD) launched a series of weekly meetings with AD
regulatory and science leadership to strategize options for meeting the 2022 registration review
deadline. This improved the process for developing the annual registration review deliverable
goals leading up to 2022.
Also, in FY' 18, AD improved efforts to receive outstanding data that are necessary to complete
registration review cases. AD implemented an Access Database to facilitate the tracking of Data
Call-in (DCI) responses. This improved the process for identifying which registrants AD should
contact regarding overdue data. Additionally, AD finalized a Product Suspension SOP to
streamline the process for following up with delinquent registrants.
Finally, in FY' 18, AD started receiving amended labels per registration review interim decisions.
AD will provide updates on the number of product labels that have been approved with the
required mitigation in future reports.
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