0597.11_Attachment F

Electronic Submission for Registering Pesticide Products | Pesticides | US EPA

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Last updated on Wednesday, May 09, 2012

Pesticides: Regulating Pesticides

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Pesticides
Regulating Pesticides
Electronic Submission for Registering Pesticide Products

Registering Pesticides

Electronic Submissions (via formatted CD/DVD)
to the Pesticide Program
Resources

Current as of March 2012

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

Before manufacturers can sell pesticides in the United States,
EPA must evaluate the pesticides thoroughly to ensure that
they meet federal safety standards to protect human health
and the environment. The EPA grants a "registration" or
license that permits a pesticide's distribution, sale, and use
only after the company meets the scientific and regulatory requirements.

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.
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 III. General Labeling
Requirements" (17 pp, 997k, About PDF).
Electronic-Submissions (or "e-Submissions) are available for the following regulatory actions:
Endocrine Disruptor Screening Program (EDSP) Orders
Section 3 New Applications
Section 3 Amendments
Experimental Use Permits
Petitions for Tolerance
Distributor Products
On this page are the following tools to build your e-submission:
Methods for assembling electronic packages and creating submission discs (CD/DVD)
e-CSF Application
Studies
Guidance on Study Formatting
Guidance on Supplemental Files/Review Aids
Current Guidance - Labels
Contacts For More Information
EDSP information on “How to submit info in response to Orders”, MRIDs, guidance

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and other resources
Note: At this time submissions that support re-registration 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.

Methods for assembling electronic packages and creating submission
discs (CD/DVD)
There are two methods by which companies can assemble the e-submission discs. In both
methods, the files to be submitted along with an XML data file containing information about
the files and the submission itself are “zipped” into a single file and placed on a disc
(CD/DVD) for submission to the EPA. The first is a new method introducing the use of a
“builder” application described in “A” below. The second, introduced in July 2008, requires
the manual editing of the XML file as described in “B” below.
A. e-Dossier Builder method (All submissions listed above)
The e-Dossier Builder method utilizes a newly developed “builder” software application to
assist the user in the creation of the electronic package. The resulting .zip file produced by
the e-Dossier Builder should be copied onto a disc (CD/DVD) for submission to the EPA.
Unlike the XML method, the e-Dossier Builder method does not require manual editing of XML
and, instead, allows the user to fill in a series of fields and attach the required files. The
Builder does the rest.
e-Dossier Builder
Guidance Document - Version 2.0 (91 pp, 3.2M, About PDF)
Note: The .zip and XML files produced by the e-Dossier Builder are unique and not related to
the XML guidance provided below. Please do not attempt to make any edits to the e-Dossier
Builder output based on the XML guidance from method B. Doing so may result in an
electronic package that is not useable by the EPA ."
B. XML format for e-submissions (All submissions listed above)
The XML method of 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.
Instructions for e-submissions using the XML schema method
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.)
For study files, if possible, please use the file naming convention of study guideline number,
MRID number. For example 850.120.12345600

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e-Submission XML Guidance Document for Pesticide Registration Packages - Version
4.4 (67 pp, 467k, About PDF)
Update to e-Submission Guidance including instructions for Dossier formatted
submissions (3 pp, 95k, About PDF)
Sample XML schema ( 36k, ascii txt - RTF)

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.
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:
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.

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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 eSubmission portal. By leveraging open standards like XML, e-CSF can provide the means for
transferring and importing data, in a more efficient manner.

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 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 (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 (16 pp,
352k, about PDF)

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)
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
Suggested Format for Acute Toxicity Studies (5 pp, 155k, about PDF)
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.
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.
Study Report Templates
These report templates suggest the format for study reports submitted to the EPA.
These report profiles supersede the study report templates previously listed on this
site. The previously listed templates were modeled 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:
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.

Guidance on Supplemental Files/Review Aids
Environmental Fate and Effects Studies
Avian Reproduction Studies
Terrestrial and Aquatic Plant Studies
Aquatic Toxicity Studies (PDF) (7 pp, 78k, about PDF)
Oyster Shell Deposition
Daphnia Life Cycle
Fish - Early Life Stage
Fish - Full Life Cycle
Surface Water and Ground Water Field Studies and Monitoring Data
Supplemental Data Files Supporting Chronic Toxicology Studies
Chronic/Subchronic Toxicity Studies (PDF) (20 pp, 347k, about PDF)

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Developmental Neurotoxicity Studies (PDF) (34 pp, 567k, about PDF)
Prenatal Developmental Toxicity Studies (PDF) (18 pp, 329k, about PDF)
Multi-generation Reproduction Studies (PDF) (32 pp, 470k, about PDF)

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:
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.
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:
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.
Condensed (Critical) Specifications for Text .pdf Electronic Labels
Short list of critical specifications for creating text .pdf electronic labels (extracted
from full specifications).
Frequent Questions - Electronic Labels
Answers to common registrant questions concerning electronic labels.
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 CDROM 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 label are

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

Contacts For More Information
Studies - Teresa Downs ([email protected]), 703-305-5363
Labels - Tom Harris ([email protected]), 703-308-9423
EDSP - Jane Smith ([email protected]), 703-308-0048
PRISM e-Submission and e-CSF
Application Help
Support Hours: 8:00 am - 4:00 pm
Eastern Time, Monday through Friday
Phone Number:
Robert Schultz - 703-308-8186
E-mail Address: OPP_eSubmission_Help_Desk @epa.gov

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