1 / 11

The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3)

The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3). 45/90 Preliminary Technical Screen and Status on the Pilot of Checklists EPA OPP PRIA 3 Workshop April 10, 2013 By Keith A. Matthews, Director BPPD. Statutory Provision.

cole
Télécharger la présentation

The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) 45/90 Preliminary Technical Screen and Status on the Pilot of Checklists EPA OPP PRIA 3 Workshop April 10, 2013 By Keith A. Matthews, Director BPPD

  2. Statutory Provision • PRIA 3 requires a preliminary technical screen to determine if pesticide registration applications and accompanying data and information are: • accurate and complete; • consistent with proposed labeling; • consistent with the proposed tolerance or tolerance exemption; and • likely to result in granting of the application.

  3. Statutory Provision • The Preliminary Technical Screen must be completed not later than 45 days after the PRIA start date for applications with decision review times ≤ 6 months and not later than 90 days after the PRIA start date for applications with decision review times > 6 months.

  4. Notification of Deficiency • If the application fails the Preliminary Technical Screen, EPA will notify the applicant of such failure either by certified mail or by email. • Applicants have up to 10 business days after receipt of such notification to cure the identified deficiencies. • Failure to cure the identified deficiencies within 10 business days of receipt of EPA’s notification of deficiency may result in rejection of the application by EPA.

  5. Why is A Preliminary Technical Screen Needed? • PRIA has succeeded in providing greater predictability for the timing of registration decisions. Nonetheless, a not insignificant proportion of PRIA actions have required renegotiated due dates: • 2009 – 19.3% of completed actions required due date extensions; • 2010 – 31.0% of completed actions required due date extensions; • 2011 – 23.7% of completed actions required due date extensions; • 2012 – 19.4% of completed actions required due date extensions.

  6. Preliminary Technical Screen – con’t • The 45/90 day Preliminary Technical Screen is designed to enable EPA to cull significantly deficient application packages; • The 45/90 Preliminary Technical Screen is more thorough than the existing 21- day content screen, - but it is NOT the equivalent of a full, comprehensive review; • Expected benefits of the Preliminary Technical Screen include: -- identification of significantly deficient applications that divert Agency resources from non-deficient applications; -- more efficient utilisation of staff resources; -- reduced % of re-negotiated due dates.

  7. Preliminary Technical Screen – con’t • Significant deficiencies can include: -- missing data; -- inaccurate information on forms or absent forms; -- inerts that are not approved for proposed uses (and not pending before the Agency); -- insufficient bridging or waiver arguments; -- failure to propound an adequate substantial similarity claim; -- data compensation issues.

  8. Pilot of Checklists for Technical Screen in AD and RD • In 2012 under PRIA 2, BPPD implemented a comprehensive checklist approach for biopesticides applications and has screened all incoming PRIA submissions using the checklist; • In a PRIA 3 Coalition meeting (January 17, 2013), AD and RD agreed to pilot a checklist approach for antimicrobials and conventionals; • RD has conducted a pilot of the checklist approach. AD intends to initiate implementation of a pilot by mid-May.

  9. RD’s Results from Checklist Pilot • RD considers the piloted checklist to contain redundant items that are covered by the 21 day content screen (e.g., signed and dated CSF form, approved inerts for food or non-food use, CAS Nos. and chemical names for inerts); • RD is developing its process for conducting the 45/90 day technical screen. RD considers the piloted checklist approach as more akin to a comprehensive review; • RD will discuss the 45/90 day preliminary technical screen process in greater detail in the breakout session this afternoon.

  10. AD’s Checklist Implementation Plan • Post the Preliminary Technical Screen Checklists on EPA’s website; • Modify the checklists as appropriate; • Train staff on implementing the pilot; • AD will discuss its proposed 45/90 day preliminary technical screen process in greater detail in the breakout session this afternoon.

  11. Experience with Preliminary Technical Screen as of March 1, 2013 • We have conducted PRIA 3 Preliminary Technical Screens on 310 submissions; • 32 10-day letters have been issued • 1 rejection • Reasons listed in the 10-day deficiency letters include: • Failure to support a substantial similarity determination after 2 attempts; • CSF lists an unapproved inert that is not pending with the Agency; • Missing data – acute eye study, lack of residue data supporting tolerance petition, lack of non-target plant data, lack of manufacturing process information, description of method not provided; • Inadequate bridging argument; • New product not a 100% repack as claimed.

More Related