Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2017

Fourteenth Annual Report

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March 1, 2018

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2017

Process Improvements in the Pesticide Program
Improvements in Information Management and Labeling

Progress in Implementing PRIA 3 IT Set-Asides

PRIA 3 provided for $800,000/year in Maintenance Fee funds to be set aside (beginning in
FY' 13) to support enhancements of information technology systems to improve the review of
pesticide applications. Included in these IT improvements over the course of the PRIA 3
statutory timeframes are (1) enhancing the information systems capabilities to improve the
tracking of pesticide registration decisions by December 31, 2013; (2) implementing a system for
tracking conditional registrations by December 31, 2013; (3) establishing the capability to
electronically review labels submitted with registration actions; (4) enhancing the database for
information regarding endangered species assessments for Registration Review; and (5)
establishing the capability for electronic submission of Confidential Statements of Formula with
registration actions by December 31, 2014. Section 33(k)(2)(G) requires EPA to report on the
progress made on these enhancements.

Electronic Submission Portal for PRIA Electronic Submissions

OPP continued to improve the Pesticide Submission Portal (PSP) during FY' 17. The Pesticide
Submission Portal replaces the CD/DVD-based process by which pesticide registrants can
submit applications electronically to EPA. In addition to electronic submission capability, the
PSP introduces functionality to provide submission status information back to the submitter.
While much of the PSP enhancement activity in FY' 17 supports electronic submissions in
response to Registration Review data call-ins, some enhancements were made to the overall
user experience and to provide additional capability for registration actions. An example of the
latter is the expansion of PSP to allow electronic submission of Gold Seal letter requests.

Enhancing the Database for Information Regarding Endangered Species Assessments
for Registration Review

The Endangered Species Knowledge Base was developed to assist in our endangered species
assessments by providing a single location for information on each of the designated endangered
species - information that is typically reused for multiple assessments. We expect the
availability of this information in a single location will allow staff to realize gains in efficiency
when performing these assessments. For FY' 17, incremental improvements were made to the
Endangered Species Knowledge Base system to refine our ability to catalog and retrieve
information and to allow users to add newly listed species to the database and to track when and
by whom changes to the database were made.

Electronic Submission of the Confidential Statement of Formula (eCSF)

During FY' 17, OPP continued software development of the Electronic Confidential Statement of
Formula (eCSF) Builder. This web-based tool will be located in the larger Pesticide Submission
Portal (PSP) and provide the ability for registrants to enter information from the CSF and submit
this information to OPP via the PSP as part of their application package. The information
received will allow OPP to better support queries on product formulation data and to provide
greater accuracy in the CSF review process than the current paper-based form. Deployment of
the eCSF Builder into the Pesticide Submission Portal is being coordinated with the

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2017
development and deployment of the Smartlabel Builder expected in FY' 18.

Electronic Submission of Product Labels

During FY' 17, OPP began development of the Smartlabel/Use Index Builder. Similar to the
eCSF Builder, the SmartLabel/Use Index Builder will be a web-based tool located in the larger
Pesticide Submission Portal (PSP) and provide the ability for registrants to enter information
contained on the product labels and to then, via the PSP, submit this information to OPP as part
of their application package. The information received by OPP will be the same content as the
current paper-based label. This will allow OPP to better support queries on product use data and
to provide greater accuracy in the label review process. Deployment of the Smartlabel/Use Index
Builder into the Pesticide Submission Portal is being coordinated with the deployment of the
eCSF Builder to provide a unified experience for both registrants and OPP staff.

Electronic Submission and Document Retention

The agency's electronic submission portal allows for submission of all PRIA covered actions
electronically. The agency's specifications and procedures for electronic submissions (including
electronic labels) can be found at: https://www.epa.gov/pesticide-registration/electronic-submissions-
pesticide-applications.

FY' 16 was the first full year that the agency's new PRIA submissions tracking report came on
line. The system tracks the frequency of electronic submissions by stakeholders. A summary of
this information for FY' 17 is presented below:

Stakeholder Submissions by Type of Product

Type of

Total # of

# Paper

# CD/DVD

# of Portal

% Paper

%

% portal

Product

Submissions

Submissions

Submissions

Submissions

Submission

CD/DVD
Submission

Submission

Conventional

8,683

4,878

57

3,748

56%

1%

43%

Antimicrobial

2,589

1,046

32

1,511

40%

1%

59%

Biopesticide

1,105

633

26

446

57%

2%

41%

total

12,371

6,551

115

5,705

53%

1%

46%

Antimicrobial pesticide submissions had the highest percentage of electronic submissions while
biopesticide submissions had the lowest. All three types of products have shown increases in
electronic submissions since the electronic portal opened.

Electronic Review of Labels

Label reviews can be very labor intensive especially when the label is quite long. Electronic
label reviews have been recognized in OPP as having critical efficiency gain potential.

Recognizing how critical the agency's efforts are in this area, Congress required the EPA [under
Section 33(k)(2)], to report the number of labels reviewed using electronic means.

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2017

The percentage of labels reviewed electronically in each regulatory division continues to increase.
The following table shows the current percentage of labels reviewed electronically in each
division.

FY'17 Electronic Label Reviews

% of labels reviewed electronically in RD

86% - 91%

% of labels reviewed electronically in AD

83% - 92%

% of labels reviewed electronically in BPPD

69% - 82%

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