By Heather F. Collins, M.S. and Barbara A. Christianson

On May 10, 2021, the U.S. Environmental Protection Agency (EPA) announced the launch of an electronic Confidential Statement of Formula application (eCSF builder) to support pesticide registration applications. The new electronic tool is part of EPA’s interest in improving and modernizing the internal processes and digital workflows for pesticide registration submissions.

As part of the registration process for new pesticide products, EPA requires the submission of a Confidential Statement of Formula (CSF). The form lists all the product’s components and percent by weight, along with various additional information.

Currently, CSF applications must be submitted to EPA in hard copy. The new eCSF builder will automatically validate certain data in a CSF application prior to submission to EPA. EPA states this functionality, along with real-time validation of chemical ingredients through EPA’s Substance Registry Services, will make the pesticide registration process more efficient, saving EPA and registrants time and resources. While paper CSF forms remain available, EPA encourages submitting applications electronically, as the review of paper applications could be a longer process.

Users can access the eCSF builder on the Central Data Exchange (CDX) under Pre-Submission Tools, Form Builders, by clicking the Create eCSF button. Users can provide feedback to EPA through the CDX.

Additional information is available on our blog.

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By Heather F. Collins, M.S. and Barbara A. Christianson

On May 2, 2018, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, EPA announced the progress of its electronic pesticide label data submission project, SmartLabel, and its electronic Confidential Statement of Formula (eCSF) submission project.  The SmartLabel and eCSF will be submitted through EPA’s Pesticide Submission Portal (PSP) on the Central Data Exchange (CDX).

EPA is developing the SmartLabel program to improve efficiencies in the submission, review, and approval of pesticide label information.  EPA believes creation of electronic master labels as structured data will improve the accuracy and clarity of pesticide label information and will allow it to be revised easily and efficiently. 

EPA indicated that the SmartLabel program will use CDX for the creation of labels in XML format.  Once uploaded through CDX’s PSP, the label will undergo an internal validation and move through an internal workflow.  EPA anticipates this will aid in faster approvals of labels.

The eCSF is an electronic version of EPA’s current paper CSF (EPA Form 8570-4).  This eCSF submission option will allow applicants to electronically submit product specification data and will:

• Pre-populate information such as product properties and manufacturing/formulating site addresses from the PSP log in;
• Link the eCSF to previous electronically submitted product information; and
• Link chemical names to EPA information sources.

The electronic form is anticipated to result in significant time savings for the applicant and the EPA reviewer.  EPA stated that most submitted CSF actions are modifications to current formulations and not all fields will need to be re-entered when submitting a modification using eCSF.  Additional benefits that EPA believes will result are a reduction in time and effort needed for error corrections, electronic data validation, and less reliance on paper-based processes.

The SmartLabel and eCSF teams are continuing to work with Office of Pesticide Programs (OPP) Divisions to harmonize OPP-wide vocabularies and data validation rules.  The SmartLabel team and eCSF team are also working to harmonize overlapping vocabulary.  Nine registrants are conducting testing on software development and most likely will participate in additional testing of the software.   

EPA anticipates that the SmartLabel and eCSF programs will move EPA from a paper-based workplace to a paperless workplace.  The SmartLabel and eCSF builders are anticipated to be released for voluntary submissions in Summer 2018, and EPA encourages registrants to submit labels and CSFs using the new builders.

EPA stated that any questions or comments on SmartLabel should be sent to Patricia Parrott at .(JavaScript must be enabled to view this email address) and questions or comments on eCSF should be sent to Diane Isbell at .(JavaScript must be enabled to view this email address) or Jimmy Davis at .(JavaScript must be enabled to view this email address).  Registrants should monitor these initiatives closely, as they may result in significant changes to their own internal processes relating to registration submissions and recordkeeping. 

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