Study Formatting and Supplemental Information

Establishing MRIDs

We use MRIDs (Master Record Identifiers) to track and manage information submitted to the pesticide program. Before sending an electronic submission that will include one or more studies request a set of 'root' MRIDs; see the "study contact."  An 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, we assign MRIDs upon receipt.
• For electronic data submissions, the registrant assigns the MRIDs using the root MRID we provided.
  • 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 we 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 our 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.

Resources for Document Creation

• Creating a PDF Version of Study Reports - General Specifications

  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 Creating PDF Files for Electronic Study Submission - 

  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 (3 K, distiller file)

  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.

Guidance on Study Formatting

• Suggested Format for Acute Toxicity Studies

  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
    • 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
  • Developmental Neurotoxicity Studies
  • Prenatal Developmental Toxicity Studies
  • Multi-generation Reproduction Studies