Electronic Submissions to EPA

EPA's Office of Pesticide Programs (OPP) Registration Division encourages electronic submission of data packages where practicable. Electronic submissions may include full data submissions, study reports, and supplemental data files. A number of guidance documents are posted on the EPA website to help applicants best prepare electronic submissions of studies.

Compact disks with files in Adobe Portable Document Format (pdf) are standard for electronic submission of required studies. The PDF files must include searchable text rather than be image-only PDF files. Most common word processing software can support creation of searchable text PDF renditions identical to the original reports. Adobe Acrobat then allows OPP reviewers to navigate within and among studies and related supplemental files, perform text searches, add annotations, export data for analysis, edit text or tables, and prepare review documents. Frequently asked questions about formatting specifics for electronic submission of studies can be found at the EPA website. 

EPA recommends the use of bookmarks and links to help reviewers move efficiently through a document as well as across documents. Bookmarks are a type of link that appears in the navigation pane on the left side of the user’s Acrobat screen. Links appear within the body of a document and are commonly identified by blue text. They permit the reader to jump to other locations with related information in the same document or other electronic documents.  The EPA provides instructions on the use of bookmarks and links. Suggestions from the EPA on how to format electronic full data submissions are also available.

The Organization for Economic Cooperation and Development (OECD) has developed a standardized dossier format for full electronic data submissions for registration of agrochemicals in the European Union (EU). The dossier includes application forms, summaries of submitted studies and proposed use patterns, assessments of science disciplines, and an overall risk assessment and proposed risk mitigation measures, as well as the individual study reports. Guidance for preparing an application in OECD dossier format is available on the Web. Canadian regulatory agencies also accept submissions in dossier format. EPA will accept submissions in the dossier format as long as formatting requirements in PR Notice 86-5 are included.

Study Templates

To support improved efficiency of the submission registration process and harmonization efforts, regulatory agencies are encouraging the use of electronic submissions rather than paper submissions. As part of harmonization efforts, Canada’s PMRA (Pest Management Regulatory Agency), the U.S. EPA Office of Pesticide Programs (OPP), and industry have worked together to develop electronic standard data evaluation forms or templates for studies required to support pesticide registrations. These templates have been in use by the agency reviewers since 2002 to prepare Data Evaluation Records (DERs) and identify key components used by OPP and PMRA to evaluate the suitability of a study for regulatory purposes. The templates include an executive summary and formatted data tables. They also specify basic study information necessary for a suitable submission such as materials, methods, results, and the applicant’s conclusions. While the level of detail remains the same as would normally be included in a study report, the templates describe the layout and scope of information that should be contained in the submission.

Applicants’ use of the templates to report study results should improve consistency of both content and format, as well as the quality of submitted studies. Use of the same templates by regulatory reviewers will facilitate the evaluation process, increase efficiency, and ultimately improve time-to-market for products.  

The EPA website provides additional information on the use of these templates. The PMRA website includes evaluation templates arranged according to study area, such as CES (Chemistry Evaluation Section) and EAD (Environmental Assessment Division).

The above websites also outline information necessary for an efficient agency review, and illustrate that use of the templates improves the likelihood of a successful submission.

CADDY Submissions

Our experienced electronic publishers have handled dozens of submissions including CADDY supplements with a variety of software tools. From that experience, we have created our own system designed to handle submissions. Our system, CEPS, is not available for purchase at the current time as a stand-alone. Instead, our experienced staff works with your documents to obtain the submission-ready dossier and prepare the CADDY ready to be delivered into the regulator’s hands.

• Files can be sent electronically and/or CDs can be burned and shipped from our Wilmington, Delaware office in the US.

• CADDY files and CDs are quality checked for conformity and retrievability prior to shipment.

• CPS is actively in touch with the CADDY Group keeping CPS aware of current bugs and also up-to-date on planned upgrades.

• CPS is pro-active in regards to CADDY requirement updates and submit as soon as practical in the advanced version.

• CPS knows all the current requirements and is up-to-date on development of new CADDY guidelines.

• CPS is experienced with “imperfect” source documents, so our electronic publishers know how to work through them.

• CPS is flexible and can incorporate last minute chances efficiently.

• CPS can handle “unusual”, specialized, multi-company submissions.