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

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.