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# 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 stan dards 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 scien tific 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 prep aring a application subm ission 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 mu st 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 II I. General Labeling Requirements" (17 pp, 997k, About PDF )

. Electronic-Submissions (or "e-Submissions) are av ailable 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 res p onse to Orders ” , MRIDs , g uidance Resources EDSP Data Requirements for Pesticide Registration Templates for Use in Developing Pesticide Study Documents Web-distributed labelin g 

## Pesticides: Regulating Pesticides htt p : // www.e p a. g ov / o pp 00001 / re g ulatin g/ re g isterin g/ submissions / Last u p dated on Wednesda y, Ma y 09 , 2012 

### Page 1 of 7 Electronic Submission for Registering Pest icide Products | Pesticides | US EPA

8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /and other resources
Note : At this time submissions that support re-r egistration or registration review are not eligible for electronic submission. Also not curre ntly eligible for electronic submission are: supplemental information submitted at Agen cy request, FIFRA 6(a)(2) submissions, submissions of data as a condition of registration, and notifications.



### Methods for assembling el ectronic 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 “zippe d” 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 meth od 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 produc ed by the e-Dossier Builder are unique and not related to the XML guidance provided below. Please do no t 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 ha s been adapted by EPA. This harmonization assures industry that a documentation packag e submitted to one participating regulatory agency can likewise be submitted to the ot her 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 

### Page 2 of 7 Electronic Submission for Registering Pest icide Products | Pesticides | US EPA

8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /e
- Submission XML Guidance Document for Pesticide Re g istration Packa g es
- 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 pr ocess, download the application to your computer's desktop, open the application, and begin entering in formation 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 incorp orate 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 Rodentic ide 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 regi stration of a pesticide and application for amended registration if the revi sion 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 th e 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 avai lability 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 comput er 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 ne eded 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, an d will focus on additional form ula information, inert chemical, weight, density, viscosity, etc. The user will have the ability, to update and/or edit CSF information. 

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8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /One of the primary objectives of the e-CSF applic ation is to be able to provide the first step to a paperless process. The a pplication 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 standa rds 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 wi ll 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-digi t 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 purp ose 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 transmitta l document in MRID order without any breaks in sequence. Do not use MRIDs fr om the same root MRID for different submissions. Print the MRID ending in '00" on the up per 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 Fo rmat (PDF) as the stan dard 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 te xt 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 instructio ns 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 book marking and hypertext linking. The document is modeled after si milar 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 th e appropriate settings of various software products used in the creation of PDF file s. Included are instructions for Adobe® Acrobat® Distiller, Microsoft® Wo rd, and Corel® Wordperfect®.
Adobe Acrobat Distiller Job Options for electronic studies (3k) This file supplies a ready-to-use Job Opti ons 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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8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /Guidance on Study Formatting Suggested Format for Acute Toxicity Studies (5 pp, 155k, about PDF ) This document suggests the format for stud y reports for acute toxicity studies. One format is appropriate for oral, dermal, pr imary eye irritation, and skin irritation studies. Slightly different formats are appr opriate 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-ch ronic 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 repo rt 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. Book marks to individual tables are not needed. Links should be included only when the submitted document is a full study report , and most useful when referenc ing 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 Supporti ng Chronic Toxicology Studies
Chronic/Subchronic Toxicit y Studies ( PDF ) ( 20 pp , 347k, about PDF ) 

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8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /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 increa se 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 an y required label revisions.
The submission of electronic labels by registrants is voluntary but strongly encouraged. For basic guidance on the pape rwork and procedure used to re gister 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 integr ity (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 Produc t 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 gu idance 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 te xt .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 elec tronic label on a CDROM accompanying a paper applicatio n (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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8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /identical. Download, fill out, print, and sign the form. Adobe Acrobat Distiller Job Options

- for electronic labels (3k) This file presets the EPA recommended Adob e Acrobat settings to create text .pdf labels using Adobe® Acrobat® Distiller® . Save this file under " C:\Program Files\Adobe\Acrobat 7.0\Distillr\Settings" (o r 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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8/27/2012 htt p ://www.e p a. g ov/o pp 00001/re g ulatin g /re g isterin g /submissions /