When setting standards for electronic submission and review, the challenge
is to set standards that strike a good balance between registrants/applicants
and OPP staff requirements. Standards must be inexpensive and easy for
the wide range of U.S. registrants to implement while providing OPP
reviewers with easily learned functionality that improves the efficiency
and effectiveness of the review process. Additionally, technology standards
selected by OPP should be non-proprietary, open standards to the extent
possible in keeping with implementation guidance related to the Government
Paperwork Elimination Act and e-government.
While following the same basic strategy, OPP has had seperate pilot
efforts focused on developing standards for electronic studies data
and for electronic product labels. This allows the specific standards
to be tailored to the unique aspects of how these two types of documents
are created, tracked, and used. Current pilot efforts for electronic
product labels are described later in this document. The following describes
the strategy used by OPP to develop electronic standards in the context
of electronic studies.
In 1999, OPP created an office-wide work group to coordinate a series
of pilots with registrants that were designed to set standards for electronic
data submission and review efforts. The chair of the work group is Kate
Bouvé, Chief, Information Services Branch (ISB), Information
Resources and Services Division, OPP. The work group provides a forum
to discuss technical issues, promote staff communication and training
needs, and to identify pilot opportunities.
The strategy to select a type of submission as the object of a pilot
is generally based on a combination of factors: the volume of the submissions,
the intensity of the staff effort to process the submission, OPP's technological
readiness to handle the submission, and the interest and willingness
of registrants/submitters. After consultation with a small number of
OPP staff and registrants/submitters, interim guidance and technical
specifications are quickly developed and posted on the Web. ISB and
other OPP staff invite submitters to participate in the pilot and guide
them through the submission process. OPP staff are identified who will
process the electronic submission and are trained in use of the electronic
tools. Reviewers' feedback is sought using a pilot evaluation form.
The guidance is adjusted according to the feedback received from submitters
and staff. When OPP is satisfied that the approach is technically sound
and meets the ‘balance' criteria, the standard is set for that
type of submission. The standard is then posted on the Web to inform
registrants/applicants, and the electronic review process is fully implemented
internally. OPP continues to seek both internal and external feedback
so the standard and related guidance are likely to evolve with time
and advances in technology. Additional pilot opportunities are identified
and pursued, standards set, and so on.
As of Summer 2002, OPP has set a standard for electronic submission
and review of study reports. Meanwhile, pilot efforts currently focus
on electronic submission of supplemental data files associated with
chronic toxicology studies and label text. In the future, as OPP completes
its data systems migration and integration efforts and the Agency resolves
data transmission and storage security issues, OPP anticipates additional
pilots involving Web-based, forms-based submissions. Full consultation
with registrants and OPP program and technical staff will continue to
be essential and will guide the pilot selection process.
OPP's strategy for setting standards for electronic submission and
review efforts has included extensive communication and coordination
with other parties. OPP has built upon the U.S. Food & Drug Administration's
submission standards for new drug applications which include use of
Adobe PDF for studies and SAS Transport protocol for submitting supplemental
data files. OPP is working closely with Canada's Pest Management Regulatory
Agency (PMRA) through a joint North America Free Trade Agreement (NAFTA)
project to share experiences and to ensure compatible systems. OPP will
be co-hosting with Canada's PMRA an Organization for Economic Cooperation
and Development (OECD) Information Technology workshop on electronic
submission and review technologies to be held in Ottawa, Canada in October
2002. The purpose of the workshop is to demonstrate electronic submission
and review technologies to pesticide regulatory agencies in other countries.
The pesticide industry has been very supportive of electronic data
submission and review efforts and OPP is grateful for the efforts of
submitters who participate in pilots. The new processes have the potential
to transform companies' document management practices and to speed the
review of applications by EPA. OPP joined the American Crop Protection
Association (now Crop Life America (CLA)) to present a workshop in March
2000. Another joint workshop is planned for November 2002. CLA and individual
registrants have worked closely with OPP in developing the electronic
submission standards and processes.
OPP has established Adobe Portable Document Format (PDF)
as the standard file format for the electronic submission of required
studies, using compact disks as the transport medium. Electronic submission
of studies is encouraged, but not required. Submitters may submit complete
submissions or just a few studies electronically.
OPP has developed a number of guidance documents
to inform data submitters how to best prepare electronic submissions
of studies. The collection of guidance documents will grow and be refined
as more experience is gained.
Adobe Acrobat with related tools is the standard for OPP reviewers
to evaluate PDF versions of study reports and prepare review documents.
Adobe Acrobat provides the functionality needed by OPP reviewers including
the ability to easily navigate within and among studies and related
supplemental files, perform full text searches, annotate text and tables,
export data to other software for analysis, extract and edit text or
tables, and view and print text and tables in a variety of ways.
The decision on the standards for electronic submission and review
of studies was based on the experience gained during a series
of pilots (149 KB, PDF). A list of companies participating in the
pilots as well as a summary of OPP reviewers' comments is available.
OPP's Registration Division announced in a January 11, 2002 letter
to conventional pesticide registrants that OPP encourages electronic
submission of data packages where practicable.
Supplemental Data Files Supporting Chronic
Toxicology Studies
OPP is working to establish standards for submission of supplemental
data used by reviewers to perform additional analysis of chronic toxicology
studies and to improve the reviewers' understanding the data. These
include data sets defined within study protocols that cannot be readily
extracted from a PDF version of the study report. Tumor data generated
in a chronic toxicology study is one example. With the assistance of
the Bayer Corporation, OPP is piloting a format for submission of supplemental
data for chronic and sub-chronic toxicology studies using SAS Transport
protocol. Submitted data are being assessed using JMP software to determine
the utility of the specified format. Participation by additional data
submitters in pilot efforts is encouraged. Interim
guidance on the format of these data has been developed.
Product Label Text
OPP's Registration Division formed an Electronic Label Submission
sub-work group in January 2000 to develop a better process to review
product labels. In this effort, product label reviewers use computers
to compare proposed label text to the current EPA accepted label text
that is submitted electronically by applicants. The goals of the pilot
are to increase reviewer efficiency, improve the quality of label reviews,
and reduce overall turnaround time on registration decisions. The work
builds on earlier pilots conducted in 1997. Adobe PDF was selected as
the submission standard for the pilots. Participation by product registration
applicants is encouraged. Interim
guidance on the creation and submission of label text information
has been developed.
