EPA’s Office of Pesticide Programs held a workshop on the Pesticide Registration Improvement Renewal Act of 2007 (PRIA 2).  Topics included changes to PRIA, decision tree for identifying PRIA categories, payment timing and process, waiver process, content/application completeness review, interpretations of new categories, and other implementation issues. PRIA or fee for service is undergoing changes. For some that might not have had the chance to participate, the following are a few points from the PRIA II meeting. The entire slide presentation is attached. Slide Presentation

1. Small businesses will no longer have a 100% fee waiver.. If a business has less than 60 million dollars in global income they still have to pay 50% of fees. If less than 10 million income then still have to pay 25% of fees. IR4, federal and state government are still exempt from fees. Minor uses may be waived or reduced. The financial information needs to be signed by the registrant management rather than their agent.

2. Fees are paid upfront. If a package fails 86-5 or 21 day screening (to be conducted within 21 days of receiving payment) then 25% of total fees due are NOT refunded. The need for a pre-registration meeting was emphasized.

3. Check lists for the 21 day screening are still being developed but include such things as passing 86-5, forms(present, filled and signed), labels, data needed, inerts cleared, tolerance petition, notice of filing. Forms include such things as the Application forms, CSF, Certification respect data, formulators exemption, data matrix. An unsigned form can result in a forfeiture of the 25% fee. BPPD will attempt to contact registrants within the 21 day screening period. It is a screen for scientific and administrative completeness.

4. The 21 day screening is a completeness/format check, not a deficiency check. After the 86-5 check and 21 day screening, actual deficiencies would be handled through a 75 day letter. So you could pass the 21 day screen, then immediately get a 75 day deficiency letter.

Linda Hollis is the person in BPPD that is developing the screening procedure. Robert Forrest will be setting fee categories.

BPPD Short Term Procedure BPPD Short Term Procedure

•     BPPD BPPD’s current screening contractor conducts the screen using checklist       after fee category is assigned

•     If contents all present and no 86-5 issues, forwarded 5 issues, forwarded for       review for review

•     If missing contents and/or formatting issues, contractor drafts preliminary       rejection letter which is forwarded to Branch Chief/Team Leader forwarded to       Branch Chief/Team Leader

•     BPPD contacts applicant to obtain missing BPPD contacts applicant to obtain       missing forms/information/studies and resolve formatting forms / information /       studies and resolve formatting issues

•     BPPD finalizes rejection letter and forwards for BPPD finalizes rejection letter and       forwards for management concurrence

•    BPPD management presents to the Office Director or BPPD management presents       to the Office Director or the Deputy Director for signature.

5. NEW PRIA fee categories

The number of PRIA fee categories has increased from 32 to 54 and include 17 microbial and biochemical definitions, 8 for straight chain lep pheromones and 29 for Plant Incorporated Protectants (PIP). These are still under OGC review. There are also new categories and new fees for reviewing protocols ($2,000 for biochemical and microbials and $5,350 for PIP). PIP categories are now all subdivided into requiring or not requiring an SAP meeting. SAP meetings are usually needed for new active ingredients, new crops or new IPM systems.

Other item....When there is a New source of active ingredients or inerts (substitution of sources)will now require a 5 batch analysis.

Michael Braverman, Ph.D.
Manager, Biopesticide Program
IR-4 Project, Rutgers University
500 College Road East, Suite 201W
Princeton, New Jersey 08540
Tel (732) 932-9575 ext 4610
Fax 609.514.2612

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