Transcript Slide 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
Statutory Provision
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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.
Statutory Provision
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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.
Notification of Deficiency
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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.
Why is A Preliminary Technical
Screen Needed?
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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:
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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.
Preliminary Technical Screen – con’t
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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.
Preliminary Technical Screen – con’t
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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.
Pilot of Checklists for Technical
Screen in AD and RD
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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.
RD’s Results from Checklist Pilot
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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.
AD’s Checklist Implementation Plan
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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.
Experience with Preliminary Technical Screen as of
March 1, 2013
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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:
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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.