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 Barbara A. Christianson

On June 4, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will host a webinar for pesticide registrants to provide registrants an overview on how to request Certificates of Registration, commonly known as Gold Seal letters, using the Pesticide Submission Portal. Gold Seal letters serve as proof for pesticide exporters that the product is registered with EPA and meets all necessary registration requirements.

According to EPA, since launching the digital platform in 2020 in response to the COVID-19 public health emergency, the electronic process has resulted in quicker processing of Gold Seal letters and thorough and complete internal tracking. Due to continuing safety precautions within EPA, it is still unable to produce traditional, paper-based Gold Seal letters. Accordingly, registrants must continue to submit requests through the Pesticide Submission Portal.

Stakeholders interested in attending the presentation can click here to join the online meeting (registration is not required). The webinar will be held on June 14, 2021, at 1:00 p.m. (EDT).

Information on how to request a Gold Seal certificate letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here.

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By Heather F. Collins

On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year.  The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically.  The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration. 

This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases.  Users can submit study citations, data matrices (Form 8570-35), cover letters and studies (protocols, study profiles, supplemental study data) using the new "Voluntary Submission" link on the PSP home page.  This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported.  EPA states:  “This action is another step in a phased approach that will ultimately lead to EPA’s ability to accept all pesticide applications electronically, a move that will help modernize the pesticide registration process, increase operational efficiencies and reduce paper waste.”  EPA indicates that in addition to these changes, this update introduces enhancements and bug fixes.

EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4 which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission.

Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration Notice 2011-3 is applicable only to paper submissions.  Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA.

More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.

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By Lisa M. Campbell, Sheryl L. Dolan, and Margaret R. Graham                                            

On September 1, 2015, the U.S. Environmental Protection Agency (EPA) announced the debut of a new electronic system for pesticide applications, the Pesticide Submission Portal.  According to EPA, this debut is the first step in a phased approach that ultimately will allow EPA to accept all pesticide applications electronically -- a move that will help modernize the pesticide registration process, increase operational efficiencies, and reduce paper waste.  EPA will continue to accept paper, CD and DVD applications, but encourages applicants to take advantage of what EPA states is the new, more efficient option.

The following types of applications will now be accepted through the Pesticide Submission Portal:

• New pesticide active ingredients;
• New pesticide products containing already-registered pesticide active ingredients;
• Amendments to registered pesticide products;
• Experimental use permits;
• Inert ingredient requests;
• Pre-application;
• Petitions for food or feed tolerance, and
• Distributor products.

The Portal is accessed through EPA’s Central Data Exchange (CDX) Network and requires user registration.  For registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools using EPA’s XML guidance, they may use the Portal and forego the courier costs to send to EPA. 

For electronic submissions, applicants do not need to submit multiple copies of any pieces of their application, as the requirement for multiple copies of data and five copies of draft labeling only applies to paper submissions.  Additional benefits of using the Portal include a status indicator that allows registrants to track the movement of their submissions and automatically generated MRID numbers.

Additional information on the Portal, including a user guide and updated XML guidance, is available on EPA’s Electronic Submission for Pesticide Applications page.

Applicants will need to invest some time and resources up-front to register with CDX and become familiar with the electronic submission requirements.  With that investment, however, EPA’s secure portal should make the submission process more efficient for applicants.  Additionally, as EPA now scans all paper submissions upon receipt, electronic submissions should increase efficiencies and reduce the opportunity for error during EPA’s front-end processing -- always a good thing.

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