# Presentation: 660831

## Pesticide Registration Improvement Renewal Act21 Day Initial Content Screen

- Elizabeth Leovey	OPP Immediate Office
- Linda Arrington	Registration Division
- Michael Hardy	Antimicrobial Division
- Linda Hollis	Biopesticides and Pollution 			Prevention Division

## Statutory Provision

- Section 33(f)(4)(B)
-  Completeness of application.--
- (i) In general.--Not later than 21 days after receiving an application and the required registration service fee, the Administrator shall conduct an initial screening of the contents of the application in accordance with clause (iii).
- (ii) Rejection.--If the Administrator determines under clause (i) that the application does not pass the initial screening and cannot be corrected within the 21-day period, the Administrator shall reject the application not later than 10 days after making the determination.

## Statutory Provision

- (iii) Requirements of screening.
- In conducting an initial screening of an application, the Administrator shall determine whether--
- (I)(aa) the applicable registration service fee has been      paid; or
- (bb) at least 25 percent of the applicable registration      service fee has been paid and the application contains a      waiver or refund request for the outstanding amount and      documentation establishing the basis for the waiver request;      and
- (II) the application contains all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.''.

## Statutory Provision

- Section 33(b)(2)(G)
- Non-refundable portion of fees.—
- (i) In general.--The Administrator shall retain 25 percent of the applicable registration service fee.

## Why a content screen?

- PRIA Coalition observed increases in due date extensions (negotiated due dates)
- Currently approx. 14% of completed actions have a negotiated due date
- Many extensions due to missing data, incomplete forms, 86-5 failures, etc. – items that can be caught during a content screen
- Missing contents result in additional EPA resources spent on applications
- Following FDA’s example, retention of a portion of the fee for an incomplete application will provide an incentive to improve applications
- FDA observed improved application

## Status of 21 Day Content Review

- Interim two step procedure tested and Divisions developed Short Term procedures
- Checklists tested and revised
- Proposed Long Term procedure developed
- No applications rejected thus far for incomplete contents – working on the process

## Procedures

- Short Term
- Divisional staff or Divisional contractor
- 86-5 review as conducted under PRIA 1
- Long Term
- ITRMD contractor as part of  86-5 screen
- All rejections (both short term and long term procedures) approved by Office Director or Deputy Office Director after a review of the rejection letter and documentation of attempts to contact applicant for missing contents and resolve formatting issues

## Antimicrobial Division – Short Term Procedure

- Product Manager conducts the 21 day screen using checklist
- Results of screen discussed with AD management during one of its weekly meetings
- PM contacts the applicant on missing contents and formatting issues
- If needed, PM drafts rejection letter for concurrence by AD Management
- AD management presents the rejection letter to Marty Monell for signature

## BPPD Short Term Procedure

- BPPD’s current screening contractor conducts the screen using checklist after fee category is assigned
- If contents all present and no 86-5 issues, forwarded for review
- If missing contents and/or formatting issues, contractor drafts preliminary rejection letter which is forwarded to Branch Chief/Team Leader
- BPPD contacts applicant to obtain missing forms/information/studies and resolve formatting issues
- BPPD finalizes rejection letter and forwards for management concurrence
- BPPD management presents to the Office Director or the Deputy Director for signature on day 22 to 31.

## RD Short Term Procedure

- After fee category assigned, RD’s 21 day content review team reviews application using the checklist
- If contents complete and no 86-5 issues, application is forwarded to PM for review
- If issues, 21 day content review team contacts applicant for any missing forms/information/studies and formatting
- If issues unresolved, 21 day content review team drafts rejection letter for RD management concurrence
- RD management presents rejection letter to Marty Monell for signature

## Proposed Long Term Procedure

- After Divisional experts assign the fee category, the application will be forwarded to a contractor
- Contractor will conduct both the 86-5 review and following a checklist, the 21 day content screen
- Contractor informs applicant of missing contents and 86-5 failures
- ISB/ITRMD develops draft rejection letter forwards to designated AD, BPPD or RD contact for review and revision
- Divisional contact obtains their management concurrence on any proposed rejection
- Division presents rejection letter to Marty Monell for signature

## Completeness Screen

- Completeness – Initial content screen
- Necessary forms are present and filled out
- “Necessary” – item needed for the Agency to grant the application.
- “Filled out”, all of the boxes completed, signatures
- Labels submitted with the application
- Required data in application
- Required per Part 158,
- Pass 86-5
- 86-5 workgroup evaluating current requirements considering global harmonization

## Content Screen Items

**Preliminary Checklist developed** – Y, N or N/A
**	****Has full fee been paid?**
**	****1. Application Form** (EPA Form 8570-1) – signed & complete?
**	****2.  Confidential Statement of Formula** (EPA Form 8570-29)  Completed, add to 100%?
**	****3. Certification with Respect to Citation of Data** (EPA Form 8570-34)?    [Applicable, if submission is not a 100% repack]
**	****4. Formulator’s Exemption Statement** (EPA Form 8570-27)** **or #**5**.
**	**

## Content Screen Items

**	****5. Data Matrix** provided ?(EPA Form 8570-35) [Applicable, if submission is not a 100% repack] -  Public copy of Matrix provided per PR Notice 98-5, Offers to pay being discussed
**	****6. Is Label Included?**
**	****7. If Data Required, has it been submitted? **
**	****8. CRP Certification Statement** (if applicable) included?
**	****9. Passed 86-5?**
**  ****10. After inerts list is available, is inert cleared (does not apply to R311 or R312)?**
**  ****11. If includes tolerance petition, draft Notice of Filing provided?**

## Deficiencies

- If deficiencies in the data or forms are identified during the Agency’s review of the application, 75 day deficiency notices will be issued per 40 CFR Part 152.105
- Notice issued after the 21 day content review

## 40 CFR 152.105

- If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency’s review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application.  If the applicant believes that the deficiencies cannot be corrected with 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application.  If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application and will treat the application as if it has been withdrawn by the applicant.  Any subsequent submission relating to the same product must be submitted as a new application.

## Guidance for Complete Applications

- EPA’s web site
- Regulating Pesticides on OPP home page on epa.gov
- Conventional, Antimicrobial and Biopesticide web pages
- PRIA 2 on http://www.epa.gov/pesticides/fees/
- Blue Book - *General Information on Applying for Registration of Pesticides in the United States*
- Individual chapters, examples of completed forms and appendices on a draft web site
- Web site currently going through EPA review
- Will be updated for PRIA 2

## Guidance for Complete Applications

- Label Review Manual
- _[http://www.epa.gov/oppfead1/labeling/lrm/](http://www.epa.gov/oppfead1/labeling/lrm/)_
- Labeling web page
- _[http://www.epa.gov/pesticides/regulating/labels/label_review.htm](http://www.epa.gov/pesticides/regulating/labels/label_review.htm)_
- Pre-registration meetings with registering Divisions encouraged

## Guidance for Complete Applications

- Registering Division’s  Ombudsman
- Antimicrobial Division:
- Michael Hardy703-308-6432 (_[hardy.michael@epa.gov](mailto:hardy.michael@epa.gov)_)
- Biopesticides and Pollution Prevention Division:
- Rob Forrest 703 308-9376(_[forrest.robert@epa.gov](mailto:forrest.robert@epa.gov)_)
- Brian Steinwand 703-305-7973
-     (steinwand.brian@epa.gov)
- Registration Division (Conventional Pesticides):
- Linda Arrington 703-305-6249 (_[arrington.linda@epa.gov](mailto:arrington.linda@epa.gov)_)
- Rachel Holloman 703-305-7193
-    (_[holloman.rachel@epa.gov](mailto:holloman.rachel@epa.gov)_)