Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2018

Fifteenth Annual Report

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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) of FIFRA requires EPA to report on the progress made on these enhancements.

Electronic Submission Portal for PRIA Electronic Submissions

EPA's Office of Pesticide Programs (OPP) continued to improve the Pesticide Submission Portal (PSP)
during FY' 18. 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' 18 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.

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'18, incremental improvements were made to the Endangered Species
Knowledge Base system to refine our ability to catalog and retrieve information.

Electronic Submission of the Confidential Statement of Formula (eCSF)

During FY'18, OPP continued to refine the Electronic Confidential Statement of Formula (eCSF)
Builder and initiated beta testing with nine registrants. This web-based tool will be housed in the larger
Pesticide Submission Portal (PSP) and provide the ability for registrants to enter and submit
information from the CSF 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 provide greater
accuracy in the CSF review process than the current paper-based form. Deployment of the eCSF
Builder into the PSP is being coordinated with the development and deployment of the OPP Electronic
Pesticide Label Builder anticipated in FY' 19.

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Electronic Submission of Product Labels

During FY' 18, OPP finalized software development of the OPP Electronic Pesticide Label (OPPEL,
formerly named SmartLabel) builder. The OPPEL system provides a tool for building electronic
pesticide labels that are then managed in electronic format within OPP. The electronic pesticide label,
submitted as an .xml file, is validated in the portal; if any errors are detected, an error message is
generated informing the submitter of the portion of the label that is incorrect. Once the label passes
validation, it will be in-processed via the PSP. In addition to completing the builder and validator, OPP
completed development of the tools needed to open the .xml pesticide label files and automatically load
them into a database. OPP will then review the labels using an electronic review tool. OPP is launching
a test of the OPPEL system to ensure the it works as intended prior to making the system available for
submission of all pesticide labels.

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 online. The
system tracks the frequency of electronic submissions by stakeholders. A summary of this information
for FY' 18 is presented below:

Stakeholder Submissions by Type of Product

Type of
Product

Total# of
Submissions

# Paper
Submissions

# CD/DVD
Submissions

# of Portal
Submissions

% Paper
Submission

%
CD/DVD
Submission

% Portal
Submission

Conventional

7,845

4,011

14

3,820

51%

<1%

49%

Antimicrobial

2,420

750

5

1,665

31%

<1%

69%

Biopesticide

1,110

481

44

585

43%

4%

53%

Total

11,374

5,241

63

6,070

46%

<1%

53%

Antimicrobial pesticides had the highest percentage of electronic submissions while conventional
pesticides had the lowest. All three types of products have shown increases in electronic submissions
since the electronic portal opened and FY' 18 was the first fiscal year in which the percentage of
submissions submitted electronically through the portal exceeded 50%.

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) of FIFRA, to report the progress made toward implementing the capability to
electronically submit and review labels submitted with registration actions.

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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'18 Electronic Label Reviews

% of labels reviewed electronically in the Registration Division

88% - 93%

% of labels reviewed electronically in the Antimicrobials Division

90% - 95%

% of labels reviewed electronically in the Biopesticide and Pollution Prevention
Division

61% - 92%

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