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Electronic Submission for Registering Pesticide Products 

Electronic Submissions (via formatted CD/DVD) 

to the Pesticide Program 

Current as of March 2012 

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 

Resources 

EDSP 

Data Requirements for 

Pesticide Registration 

Templates for Use in 

Developing Pesticide Study 

Documents 

Web-distributed labeling

Pesticides: Regulating Pesticides 

http://www.epa.gov/opp00001/regulating/registering/submissions/

Last updated on Wednesday, May 09, 2012

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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 (downs.teresa@epa.gov), 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 (downs.teresa@epa.gov), 703-305-5363 

Labels - Tom Harris (harris.thomas@epa.gov), 703-308-9423 

EDSP - Jane Smith (smith.jane-scott@epa.gov), 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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