Pesticide Registration Improvement Renewal Act 21 Day Initial Content Screen

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Pesticide Registration Improvement Renewal Act21
Day Initial Content Screen

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

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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.

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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.''.

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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.

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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 FDAs example, retention of a portion
  of the fee for an incomplete application will
  provide an incentive to improve applications
• FDA observed improved application

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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

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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

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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

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BPPD Short Term Procedure

• BPPDs 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.

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RD Short Term Procedure

• After fee category assigned, RDs 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/studie
  s 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

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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

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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

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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. Formulators Exemption Statement (EPA Form
  8570-27) or 5.

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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?

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Deficiencies

• If deficiencies in the data or forms are
  identified during the Agencys 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

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40 CFR 152.105

• If the Agency determines that an application is
  incomplete or that further information is needed
  in order to complete the Agencys 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.

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Guidance for Complete Applications

• EPAs 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

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Guidance for Complete Applications

• Label Review Manual
• http//www.epa.gov/oppfead1/labeling/lrm/
• Labeling web page
• http//www.epa.gov/pesticides/regulating/labels/la
  bel_review.htm
• Pre-registration meetings with registering
  Divisions encouraged

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Guidance for Complete Applications

• Registering Divisions Ombudsman
• Antimicrobial Division
• Michael Hardy703-308-6432 (hardy.michael_at_epa.gov)
  
• Biopesticides and Pollution Prevention Division
• Rob Forrest 703 308-9376(forrest.robert_at_epa.gov)
• Brian Steinwand 703-305-7973
• (steinwand.brian_at_epa.gov)
• Registration Division (Conventional Pesticides)
• Linda Arrington 703-305-6249 (arrington.linda_at_epa
  .gov)
• Rachel Holloman 703-305-7193
• (holloman.rachel_at_epa.gov)