Attachment F: Electronic Submission Interim Guidance Documents

Electronic Submission for Registering Pesticide Products | Pesticides | US EPA

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Current as of April 14, 2009
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Before manufacturers can sell
pesticides in the United States, EPA
must evaluate the pesticides

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Data Requirements for Pesticide
Registration
Templates for Use in Developing
Pesticide Study Documents
Web-distributed labeling

thoroughly to ensure that they meet federal safety standards to protect
human health and the environment. EPA grants a "registration" or license

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that permits a pesticide's distribution, sale, and use only after the company

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meets the scientific and regulatory requirements.

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Applications for a new or amended pesticide registration must include the
appropriate EPA forms. These forms are available for download from the
Pesticide Registration Kit Web page. This page also contains information on
preparing a application submission and points of contact for additional
assistance.

Registration
Information Sources
Depending on the nature of the application, supporting data may be
required as part of the submission. These scientific (or "data") requirements
are set out in 40 Code of Federal Regulations (CFR) FR 158. The documents
that are submitted to fulfill the data requirements are commonly called
"studies."
Applications for new or amended registration must also be accompanied by
draft labeling that meets the regulatory requirements set out in 40 CFR
152.50. Further information on labeling requirements is available in the
"Label Review Manual, Chapter VI. Label Submission Requirements".

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Electronic Submission for Registering Pesticide Products | Pesticides | US EPA

The entire contents of a submission supporting an application for new or
amended registration, experimental use permits, tolerance petitions, and
supplemental distributor applications may be submitted in electronic format
as described below. At this time submissions that support reregistration or
registration review are not eligible for electronic submission. Also not
currently eligible for electronic submission are supplemental information
submitted at Agency request, FIFRA 6(a)(2) submissions, submissions of
data as a condition of registration, and notifications.
The Office of Pesticide Programs now has a new Electronic Confidential
Statement of Formula (e-CSF) application. This application has been
designed as a stand alone application to support the implementation of
Pesticide Registration Information SysteM (PRISM) and is available from the
website. Read more about the e-CSF application.
On this page:

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e-CSF Application
New XML format for e-submissions
Studies
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Guidance on Study Formatting
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Guidance on Supplemental Files/Review Aids
Current Guidance - Labels
Contacts For More Information

For questions or assistance with the PRISM e-Submission or e-CSF
application, please refer to the contact information below.

PRISM e-Submission and e-CSF
Application Help
Support Hours: 8:00 am 4:00 pm Eastern Time, Monday
through Friday
Phone Number:
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Robert Schultz - 703-3088186

E-mail Address: OPP_eSubmission_Help_Desk @epa.
gov

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e-CSF Application
Getting Started
To get started with the e-CSF process, download the application to your
computer's desktop, open the application, and begin entering information
about a CSF. Each section of the application corresponds to a section in the
EPA Form 8570-4. Once the e-CSF form has been completed, it may be
saved as PDF and XML documents. The e-CSF process requires an ink
signature - electronic signatures are not acceptable. Please be sure
to sign the e-CSF form where appropriate and incorporate the
signed page into the PDF document to be submitted electronically.

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Download the e-CSF application (30 MB, ZIP file)
e-CSF User Guide (57 pp, 2.1 MB, About PDF)

About the e-CSF
The Confidential Statement of Formula (CSF) form (EPA Form 8570-4) is
used to identify the complete chemical composition of each pesticide so it
can be evaluated for registration under the Federal Insecticide, Fungicide,
and Rodenticide Act. This form is designed for reporting the ingredients used
in the formulation of a pesticide product and must be completed and
submitted with each application for new registration of a pesticide and
application for amended registration if the revision involves a formula
change.
To progress towards the e-Gov Initiatives, the Office of Pesticide Programs
has designed an application that allows for the ability to submit data
currently available on the CSF form in an electronic file format to reduce the
reliance on paper as part of the Paperwork Reduction Act. Data entry
requirements associated with the current paper-based process will also be
reduced. This new capability will be referred to as electronic CSF (e-CSF).
The e-CSF application allows for a streamlined paperless-like process,
improved access to critical decision documents, as well as enhancing
availability of information to both internal and external stakeholders. It
supports the following functional areas:

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Electronic Submission for Registering Pesticide Products | Pesticides | US EPA
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CSF Form Generation; and
Data Entry.

The application will reside on the users computer and will contain all
necessary logic and data fields for the CSF form. The form will be saved as
an XML file and can also be saved as a PDF if the user chooses. The XML file
will later be parsed for import into PRISM. The application will collect and
store specific information needed to facilitate the e-CSF process. This
information will primarily consist of chemical formulation information for the
CSF. The CSF will be entered by the user, and will focus on additional
formula information, inert chemical, weight, density, viscosity, etc. The user
will have the ability, to update and/or edit CSF information.
One of the primary objectives of the e-CSF application is to be able to
provide the first step to a paperless process. The application incorporates
design considerations that allow for future interfaces to the e-PRISM
interface. The future of e-CSF is the integration into the e-Submission
portal. By leveraging open standards like XML, e-CSF can provide the means
for transferring and importing data, in a more efficient manner.

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New XML format for e-submissions
The e-Submission initiative is helping EPA move toward a more paperless
environment. The information exchange from industry to EPA is based on a
harmonized XML schema used by Canada's PMRA, which has been adapted
by EPA. This harmonization assures industry that a documentation package
submitted to one participating regulatory agency can likewise be submitted
to the other participating agency, thus increasing standardization and
decreasing the burden on industry.
Information submitted to EPA in the XML schema format will improve data
quality and allow for a more efficient pesticide registration process.

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Electronic Submission for Registering Pesticide Products | Pesticides | US EPA

Instructions for e-submissions using the XML schema
The e-Submission XML Guidance Document provides instructions to create
and submit files containing digitized versions of their submission documents
(i.e., studies, labels, and forms) using Pest Management Regulatory Agency
(PMRA) e-Index Builder or by using a XML file creation application (i.e.,
Notepad,, Microsoft Word, etc.)

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e-Submission XML Guidance Document for Pesticide Registration
Packages (PDF) (51 pp, 451k, About PDF)
Sample XML schema ( 36k, ascii txt - RTF)

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Studies
Before sending an electronic submission that will include one or more
studies, contact Teresa Downs ([email protected]), 703-305-5363 to
request a set of 'root' MRIDs (Master Record Identifiers). A MRID is unique
eight-digit number assigned to each study submitted to EPA. The first six
digits are referred to as the 'root' MRID. In the case of non-electronic data
submissions, MRIDs are assigned by EPA upon receipt. In the case of
electronic data submissions, the MRIDs are assigned to each study by the
registrant using the root MRID provided by EPA. The first MRID always ends
in '00' and must be assigned to the transmittal document that describes the
purpose of the submission and lists all of the included studies by title and
MRID. MRIDs ending in '01' through '99' are available for assignment to
supporting studies. If a submission includes more than 99 studies EPA will
provide two or more root MRIDs as needed. List studies on the transmittal
document in MRID order without any breaks in sequence. Do not use MRIDs
from the same root MRID for different submissions. Print the MRID ending in
'00" on the upper right corner of page one of the transmittal document.
Print each study's MRID on the upper right corner of the title page (page
one).
EPA has established Adobe Portable Document Format (PDF) as the

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standard file format for the electronic submission of required studies, using
compact disks as the transport medium. Adobe Acrobat allows OPP
reviewers 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 and tables,
and view and print text and tables in a variety of ways.
Specifications for Creating a PDF Version of Study Reports (PDF)

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(10 pp, 291k, about PDF)

This document provides detailed instructions on how to convert
study reports to PDF for electronic submission. It includes
information about file formats, naming conventions, fonts,
conversion options, and guidance on bookmarking and hypertext
linking. The document is modeled after similar guidance developed
by the Food and Drug Administration (FDA).
Software Settings for the Creation of PDF Files for Electronic Study
Submission (PDF) (16 pp, 352k, about PDF)

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This document provides details regarding the appropriate settings
of various software products used in the creation of PDF files.
Included are instructions for Adobe® Acrobat® Distiller,
Microsoft® Word, and Corel® Wordperfect®.
Adobe Acrobat Distiller Job Options for electronic studies (3k)

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This file supplies a ready-to-use Job Options file for use with
Adobe® Acrobat® Distiller. Save this file in the "Acrobat 5.0\Distillr
\Settings" folder under the Adobe folder on your local hard drive.

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Guidance on Study Formatting
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Suggested Format for Acute Toxicity Studies (PDF) (5 pp, 155k, about
PDF)

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This document suggests the format for study reports for acute
toxicity studies. One format is appropriate for oral, dermal,
primary eye irritation, and skin irritation studies. Slightly different
formats are appropriate for acute toxicity - inhalation and skin
sensitization study reports. It also indicates where PDF Bookmarks
and links should be used.

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Suggested Format for Reporting Sub-Chronic and Chronic Toxicity
Studies
This document suggests the format for sub-chronic and chronic
study reports. It also indicates where PDF Bookmarks and links
should be used.

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Study Report Templates
These report templates suggest the format for study reports
submitted to the EPA. These report profiles supercede the study
report templates previously listed on this site. The previously listed
templates were modelled off of the same Agency Data Evaluation
Record (DER) templates as the new study profile templates,
therefore, much of the information is the same except for minor
formatting changes.
PDF document requirements for bookmarks, links, and special
concerns:

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Bookmarks should be included for each level of
heading as seen in the outline structure of the template.
Bookmarks to individual tables are not needed.
Links should be included only when the submitted
document is a full study report, and most useful when
referencing specific data, such as a specific test animal
identified as a concern in the summary.
Before creating the final PDF file -- when creating
tables please use the inherent table features of the source
software. Do not use tabs or other methods to create the
look of a table's columns and rows. Consider including
larger tables as attachments in Lotus 123, Word, or comma
separated ASCII files.

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Guidance on Supplemental Files/Review Aids
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Environmental Fate and Effects Studies
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Avian Reproduction Studies
Terrestrial and Aquatic Plant Studies
Aquatic Toxicity Studies (PDF) (7 pp, 78k, about PDF)
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Oyster Shell Deposition
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Daphnia Life Cycle
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Fish - Early Life Stage
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Fish - Full Life Cycle
Surface Water and Ground Water Field Studies and
Monitoring Data

Supplemental Data Files Supporting Chronic Toxicology
Studies
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Chronic/Subchronic Toxicity Studies (PDF) (20 pp, 347k, about
PDF)

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Developmental Neurotoxicity Studies (PDF) (34 pp, 567k,
about PDF)

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Prenatal Developmental Toxicity Studies (PDF) (18 pp, 329k,
about PDF)

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Multi-generation Reproduction Studies (PDF) (32 pp, 470k,
about PDF)

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Current Guidance - Labels
The use of electronic labels will help to increase EPA review efficiency and
improve the quality of labeling. Electronic labels in text .PDF format will
allow EPA to:

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compare new versus old versions of labels thus quickly identifying
changes and
easily mark-up labels with any required label revisions.

The submission of electronic labels by registrants is voluntary but strongly
encouraged.
For basic guidance on the paperwork and procedure used to register a
pesticide product see "Registering Pesticides" on EPA's website.

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For an initial application (new product or amendment of an existing
product), registrants should submit 1) all the required paperwork, 2) a text .
PDF label on a CD-ROM, and 3) a signed certification with respect to label
integrity (see below). The electronic label must be a text .pdf (not image)
and must be named using the filename syntax in the guidance below.
For a resubmission of a revised label in response to EPA comments, the
text .PDF may be emailed directly to the EPA staffer or Product Manager as
directed in the label review. Alternately, the resubmission may be prepared
as a paper label plus a text .pdf e-label on a CD-ROM plus the certification
form and sent via courier to EPA. However, do not send revised labels by
both email and paper mail.
The documents below provide more detailed guidance regarding submission
of electronic labels:

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Full Specifications for Text .PDF Electronic Labels (PDF) (12 pp,
151k, about PDF)

Detailed specifications on how to compose, create, and submit
text .PDF electronic labels to EPA.

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Condensed (Critical) Specifications for Text .PDF Electronic Labels
Short list of critical specifications for creating text .PDF electronic
labels (extracted from full specifications).

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Frequent Questions - Electronic Labels
Answers to common registrant questions concerning electronic
labels.

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Certification with Respect to Label Integrity (fill and print .RTF) (5k,
RTF)

This certification must be included with the submission of an
electronic label on a CD-ROM accompanying a paper application
(new product or amendment). The certification is not needed when
resubmissions (corrected labels) are sent via email. The
certification states that the paper and electronic versions of the
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Electronic Submission for Registering Pesticide Products | Pesticides | US EPA

label are identical. Download, fill out, print, and sign the form.
Adobe Acrobat Distiller Job Options - for electronic labels (3k)

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This file presets the EPA recommended Adobe Acrobat settings to
create text .PDF labels using Adobe® Acrobat® Distiller®. Save
this file under " C:\Program Files\Adobe\Acrobat 7.0\Distillr
\Settings" (or similar). The file works with Adobe® Acrobat®
Distiller® 5.0 or above.

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Contacts For More Information
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Studies - Teresa Downs ([email protected]), 703-305-5363
Labels - Tom Harris ([email protected]), 703-308-9423

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