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

On August 17, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is now accepting official Foreign Purchaser Acknowledgement Statements (FPAS) and FPAS annual summaries through the Central Data Exchange Pesticide Submission Portal (CDX PSP). EPA states this improved process allows for pesticide exporters to submit an FPAS electronically rather than physically mailing them, providing a key flexibility during the COVID-19 public health emergency. According to the Federal Register notice, an FPAS may be submitted using CDX PSP as of August 18, 2021.  86 Fed. Reg. 46246.

Pesticides intended solely for export from the U.S. to a foreign country are not required to be registered in the U.S., but exporters must submit an FPAS to EPA to comply with requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 17(a)(2). An FPAS includes critical information about the pesticide intended for export, which EPA uses to notify the Designated National Authority of the importing country.

Exporters have two options for complying with FIFRA Section 17(a) and 40 C.F.R. Section 168.75 through submission of an FPAS to EPA: per-shipment reporting and annual reporting.

Per-Shipment Reporting: To comply with requirements for per-shipment reporting, the exporter must provide EPA with the signed purchaser acknowledgement statement and the accompanying certification for each export within seven working days of the exporter’s receipt of the signed statement or by the date of export (whichever occurs first). The exporter must continue to submit this documentation prior to each shipment.

Annual Reporting: The exporter must submit a signed per-shipment purchaser acknowledgement statement for the first shipment each calendar year of an unregistered pesticide product to a particular purchaser and an annual summary of shipments to that purchaser. This FPAS should indicate that the exporter is choosing to provide an annual summary and certifying that the shipment in the FPAS was the first of the calendar year.  When using the annual reporting option, the exporter is required to submit an annual report for each unregistered pesticide exported within the preceding calendar year. The exporter must submit the annual summary no later than March 1 of the following calendar year.

The annual summary report must be in writing, signed by the exporter, and include the following information:

• The dates of each shipment of the pesticide exported to the foreign purchaser during that calendar year; and
• If known, or reasonably ascertainable, the country or countries of final destination of the export shipments.

Information on the required contents of FPAS about submitting statements electronically is available here.

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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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