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EPA: 21-Day Content Screen

Under the Pesticide Registration Improvement Extension Act (PRIA 3), EPA has 21 days after it receives the application and the fee to conduct an initial screen of the application’s contents for completeness and for the applicant to make any necessary corrections. If the contents are not complete at the end of the 21 days, we may reject the application.

EPA staff use two 21-day review worksheets to conduct this screen.


General Checklist
21-Day Initial Content Screen Review Worksheet
Inert Ingredient 21-Day Content Screen Review Worksheet

Checklists for Various Types of Applications Based on PRIA Action Codes

The 21-day content screen is a screen or scan of the application to identify whether certain components or items are present. After the content screen we conduct a technical screen, referred to as the 45/90 preliminary technical screen, to ensure that the application is ready for in depth review. At either of these points, we may determine that other items are missing or that there are deficiencies.

See 45/90 Preliminary Technical Screen Stakeholder Checklists.

21-day Content Screen Checklists

EPA uses the following worksheets in conducting the 21-day content screen and are available to help applicants in developing their pesticide registration applications. (Keep in mind that these were developed and from EPA’s perspective, for use by EPA staff.)

View all data requirements checklists

R300 and R301 Data Requirements Checklist
Application Description – R300
Application Description – R301
R310 Data Requirements Checklist
Application Description – R310
A530 Data Requirements Checklist
Application Description – A530
A531 Data Requirements Checklist
Application Description – A531
A532 Data Requirements Checklist
Application Description – A532
A540 Data Requirements Checklist
Application Description – A540
A550 Data Requirements Checklist
Application Description – A550
A570 Data Requirements Checklist
Application Description – A570
B670 Data Requirements Checklist
Application Description – B670
B672 Data Requirements Checklist
Application Description – B672

In completing the worksheet, we will check boxes for each item in the appropriate column on the far right of the worksheet as to whether it is present (yes) or not (no) or the item is not applicable (N/A). The worksheet also lists other yes or no questions that are related to an item in the application or that we may use to determine the application’s PRIA fee category. Links are provided to forms and other guidance for any questions on specific items and the footnotes contain additional guidance or explanation.

As a practical matter, EPA staff review the application package quickly and notify the applicant by telephone or e-mail of any missing elements. PRIA 3 specifies the scope of this initial content screen, which includes:

whether the appropriate fee has been paid or a portion of the fee paid and request for a fee waiver for the remainder submitted; and
that the application appears to contain all the necessary forms, data, and draft labeling, formatted in accordance with EPA guidance.

The registration ombudsmen are also available to answer questions on the processes we use to conduct these screens and to provide additional information. We encourage applicants to contact the appropriate ombudsman before submission since only the essential forms and data that need to be submitted are the subject of the screen. Depending upon the application, additional information may need to be submitted to enable us to make a regulatory decision.

http://www2.epa.gov/pria-fees/21-day-content-screen

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Checklists for 45/90 Preliminary Technical Screen

We use these checklists to ensure that the application is ready for in depth review. Applicants can use them to help ensure their applications are complete. You may submit the checklist with the application.

FIFRA section 33(f)(4)(B), “Initial Content and Preliminary Technical Screenings” directs the Agency to conduct a preliminary technical screen of the application. This screening is conducted no later than 45 days after the start of the decision review period for actions with decision review time periods equal to or less than 6 months and no later than 90 days after the start of the decision review period for actions with decision review time periods greater than 6 months. In conducting this technical screen, the Agency determines whether:

the application and the data and information submitted with the application are accurate and complete, and
the application, data and information are consistent with the proposed labeling and any proposed tolerance or tolerance exemption, and
the application, data and information are such that subject to full review could result in the granting of the application.

If the application fails the technical screen, and the deficiencies cannot be corrected by the applicant within 10 business days after receipt of the Agency’s notification of the failure, the Agency will reject the application. We use the Fee Reduction Tables to determine what amount of the fee we will retain.

http://www2.epa.gov/pria-fees/checklists-4590-preliminary-technical-screen

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*****FOLLOWING THESE PRELIMINARY REVIEWS, THE EPA CONDUCTS ITS IN-DEPTH REVIEW WITHIN THE STATED PRIA 3 TIME FRAMES*****