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Registration Service Fees
Overview of Fee Reduction Formula for Applications Received by EPA from March 23, 2004 to September 30, 2007
Resources
Current as of October 2007
This fee reduction formula applies to pesticide registration applications received by EPA from March 23, 2004 to September 30, 2007 under the Pesticide Registration Improvement Act (PRIA 1).Some of these applications have due dates in 2009.The formula has to be revised for applications received under the Pesticide Registration Improvement Renewal Act of 2007 (PRIA 2) effective October 1, 2007. Refunds and fee reductions under PRIA 2 can not exceed 75% of the registration service fee. It will be posted when available. Applicants with questions about fee reduction formulas for PRIA 2 applications should contact a registration ombudsman.
Under Section 33(b)(8)(C) of the Pesticide Registration Improvement Act, the Agency has discretionary authority to issue refunds of registration service fees on the basis that the Agency completed portions of the review of the application before March 23, 2004 (the effective date of PRIA). The Agency has decided to utilize this discretionary authority for all applications for which a mandatory registration service fee is required (as described in section 33(b)(2)) and for which a voluntary registration service fee is submitted under section 33(b)(4).
Rather than refund part of the registration service fee for the portion of the review completed prior to March 23, 2004, the Agency developed formulas for determining the reductions in the registration service fee for actions which are partially completed. What follows are the formulas, developed based upon the unique review processes within the Antimicrobials Division, the Biopesticides and Pollution Prevention Division, and the Registration Division. The net amount due will be calculated by determining the fee associated with the action (from the March 17, 2004 Federal Register Notice or the June 2, 2005 Federal Register Notice). Any previously submitted tolerance fees will be subtracted from this amount. This total will be further reduced in proportion to the amount of work that was completed on the action prior to March 23, 2004.
Guide to Reading the Tables
The Agency has developed three different tables, reflecting the three registering divisions within the Office of Pesticide Programs: the Antimicrobials Division, the Biopesticides and Pollution Prevention Division, and the Registration Division, which is responsible for conventional pesticides. These formula were developed in collaboration with the three registering divisions and differ only in ways that reflect the unique review processes within these divisions.
The tasks listed in the tables are the sequential steps in the Agency's review process. Column 1 reflects the task or activity involved in the review process. Column 2 reflects the percentage of work that particular task entails for the entire Agency review process. Column 3 reflects the total percentage of work that the Agency has completed if all tasks through that stage in the process have been completed. Column 4 reflects the percentage of work remaining to be completed in the review process task once a particular stage is completed.
For example, if a pending application has completed front end screening and is awaiting primary review, the Agency has completed 10% of the review and will reduce the applicable registration service fee by 10%. According to the formula, the Agency must still complete 90% of the review for the particular application.
Antimicrobials Division
| Tasks to Be Completed | Percent of Work by Task | Percent of Work Completed | Percentage Remaining if Item is Completed |
|---|---|---|---|
| Front End, Completeness Screen, Dockets, Tracking, OPPIN, Distribution | 10% | 10% | 90% |
| Primary Review | 35% | 45% | 55% |
| Secondary Review | 15% | 60% | 40% |
| Risk Assessment - End point Selection | 20% | 80% | 20% |
| FR Notice, Registration Decision | 20% | 100% | 0 |
Antimicrobials Division Fee Categories (Printer Version): Federal Register, March 17, 2004 (172 KB, 10 pgs, PDF)
Biopesticides and Pollution Prevention Division
| Tasks to Be Completed | Percent of Work by Task | Percent of Work Completed | Percentage Remaining if Item is Completed |
|---|---|---|---|
| Front End, Completeness Screen, Dockets, Tracking, OPPIN, Distribution | 10% | 10% | 90% |
| Primary Review | 30% | 40% | 60% |
| Secondary Review | 20% | 60% | 40% |
| Risk Assessment | 15% | 75% | 25% |
| BRAD, FR Notice, Registration Decision | 25% | 100% | 0 |
Biopesticides and Pollution Prevention Division Fee Categories (Printer Version): Federal Register, March 17, 2004 (172 KB, 10 pgs, PDF)
NOTE: If a data gap or significant deficiency is identified during review of the data/studies which require resubmission of data that need to be reviewed before the risk assessment can be conducted, then it is determined that only 50 percent of the work is completed. It is anticipated that in such cases renegotiations of time lines are likely to be needed.
Registration Division (conventional pesticides)
Whereas the Antimicrobials Division and the Biopesticides and Pollution Prevention Division are interdisciplinary divisions where both the regulatory review and science assessment occur within self-contained units, the Registration Division utilizes the services of the Environmental Fate and Effects Division (EFED) and the Health Effects Division (HED) to complete science reviews for the majority of registration actions. Therefore, the Registration Division has developed formula for two scenarios: A) where the Registration Division relies upon support from OPP's science divisions and B) where the Registration Division completes both science review and regulatory review within the Registration Division (e.g., New ProductÂ-Fast Track, and some Non-Fast-Track Actions).
A) New Active Ingredients, New Uses, and Other Actions Required Review by EFED and HED
Tasks to Be Completed Percent of Work by Task Percent of Work Completed Percentage Remaining if Item is Completed Front End, Completeness Screen, Dockets, Tracking, OPPIN, Distribution 10% 10% 90% Primary Review 25% 35% 65% Secondary Review 20% 55% 45% Risk Assessment 25% 80% 20% FR Notice, Registration Decision 20% 100% 0 Registration Division Fee Categories (Printer Version): Federal Register, March 17, 2004 (172 KB, 10 pgs, PDF)NOTE: The science review reflects 70 percent of the Agency's review work for a particular registration action for a conventional chemical. The Agency has divided this 70 percentage in half - 35% for review by EFED and 35% for review by HED. In calculating the progress in completing the registration action, the Agency will multiply the percentage of work completed in each division using the table below by 35% in order to document the total percentage of work completed for a particular registration action.
B) Science and Regulatory Reviews Completed Solely within the Registration Division.
Tasks Completed EFED HED Primary Review 50% 40% Secondary Review 15% 20% Drinking Water Assessment 15% ---- Risk Assessment 20% 40%
C) Actions For Which RD Completes Both Science and Regulatory Reviews Within the Division (For example, Fast Tracks and Certain Non-Fast Track Actions)
Tasks to Be Completed Percent of Work by Task Percent of Work Completed Percentage Remaining if Item is Completed Front End, Completeness Screen, Dockets, Tracking, OPPIN, Distribution 10% 10% 90% Science Reviews 80% 90% 10% Registration Decision 10% 100% 0