the pesticide registration improvement extension act of 2012 (pria 3) what’s new in pria 3...
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THE PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 2012
(PRIA 3)
WHAT’S NEW IN PRIA 3Presented at:
PRIA 3 WorkshopApril 10, 2013
ByPeter Caulkins
OPP PRIA Coordinator, EPA
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Summary of PRIA 3 Provisions 2nd 5-year extension of the original PRIA passed in
2004; extends fee-for-service system with specified fees and decision review times for each covered registration category through FY2017;
The result of widespread support and collaboration of a coalition of industry, growers, environmentalists and farm worker advocates;
Expands the number of covered registration categories to 189 [from 140 under PRIA 2];
Includes footnotes that impact registrant submissions and Agency handling of submissions;
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Summary of PRIA 3 Provisions (con’t.)
Preserves the existing PRIA 2 set-asides for worker protection activities, applicator training programs and partnership grants;
Provides new authority to conduct a preliminary technical screen to weed out significantly incomplete applications;
Provides new authority for label issue resolution period/clean labels
Extends for 5 years maintenance fees and increases to $27.8 M/yr;
Creates new set-aside for IT enhancements @ $0.8 M/yr [from maintenance fees];
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New PRIA 3 Registration Categories
14 new conventional categories [1new AI, 2 new use, 3 tolerance, 4 new product, 3 amendment, 1 other];
14 new antimicrobial categories [5 new use, 1 new product/amendment, 8 EUP];
20 new biopesticide categories [3 microbial & biochemical new AI, 3 microbial & biochemical new use, 6 microbial & biochemical new product, 3 microbial & biochemical amendment, 3 PIP new AI, 2 other];
10 new inert ingredient approval categories;
8 new miscellaneous categories [Human Studies Review Board, SAP review, Gold Seal Letters, exclusive use extension petitions, combination product];
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New PRIA 3 Registration Categories (con’t.)
Most frequently used new PRIA 3 categories
M006 Gold Seal Letter requests -- >220 submissions R351 Amendment, unregistered source – 13 submissions R314 New product, new AI combination – 11 R333 New product, unregistered source – 7 I003 Amend inert tolerance, no new data – 4 I001 New inert food use – 3 I002 Amend inert tolerance, new data –3 B673 New product, unregistered source – 2
Some PRIA 2 categories deleted based on lack of use or included in a new category
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PRIA 3 Set-Asides
Existing set asides in PRIA 2 for worker protection activities, applicator training programs, partnership grants and inerts & fast track applications continue in PRIA 3
-- worker protection/applicator - ≥ $1.0 m/yr (from Registration Fund)-- partnership grants - $0.5 m/yr (from Registration Fund)-- inerts/fast tracks - $3.09 - $3.48 m/yr
(from maintenance fees)
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PRIA 3 Maintenance Fees
Maintenance fees increased from $22.0 - $27.8 m/yr;
Maintenance fee caps were adjusted to result in a more equitable distribution of fees across registrants
-- caps for larger companies increased 50% – 63%;
-- caps for small businesses increased 41% - 42%-- 25% discount for 1st product of “qualified small business” (≤ 500 employees, ≤ $10 m in avg
global gross sales; ≤ 5 products)
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Footnotes in PRIA 3
PRIA Due Dates which fall on weekend or holiday now extended to next business day; [footnote Tables 1-10]
Limitation on number of new product applications (5) with new active ingredient or first food use application; each additional new product application is subject to its own registration service fee, as is a new inert approval submitted with the new a.i. or first food use package; [footnote Tables 1,2,3,7,8,11,12,15]
Applicant-initiated information submitted after the technical deficiency screen is subject to 25% of the related fee for new a.i. and first food use category; [footnote Tables 1,2,3,7,8,11,12,15]
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Footnotes (con’t.)
If an application is associated with and dependent upon a pending inert ingredient approval, the decision time line for the associated application will be extended to match the PRIA due date of the pending inert action, unless the due date for the associated action is further out, in which case it will be subject to its own decision review time line; [footnote Table 18]
Involves awkward transactions: Registrant for the dependent application must include in their application proper
identification of the inert ingredient currently pending before the Agency including – name of inert ingredient, name of inert ingredient applicant and the inert ingredient approval request tracking number “IN_ _ _ _ _” which is included in the Agency’s Receipt of Application letter to the inert applicant;
CBI concerns prevent EPA staff from giving out information on another company’s submission; dependent applicant must get this information from the inert applicant, not EPA;
Initial due date for the dependent application will be administratively modified to reflect the anticipated completion date of the inert ingredient approval;
Subsequent changes to the dependent application’s due date caused by time extensions needed for the inert application will be renegotiated;
