21-Day Content Screen
Under the Pesticide Registration Improvement Extension Act (PRIA 4), 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.
- 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.
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.)
- R300 and R301 Data Requirements Checklist
- R310 Data Requirements Checklist
- A530 Data Requirements Checklist
- A531 Data Requirements Checklist
- A532 Data Requirements Checklist
- A540 Data Requirements Checklist
- A550 Data Requirements Checklist
- A570 Data Requirements Checklist
- B670 Data Requirements Checklist
- B672 Data Requirements Checklist
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 4 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.
Applicants must submit the necessary forms and study reports and are strongly encouraged to submit study summaries electronically following the guidance on Study Profiles Templates.
DO NOT submit the checklists with your application.