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

The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3). Label Issue Resolution Period/Clean Labels Presented at: PRIA 3 Workshop April 10, 2013 By Lois Rossi Director, Registration Division. New PRIA 3 Provision.

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

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  1. The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) Label Issue Resolution Period/Clean Labels Presented at: PRIA 3 Workshop April 10, 2013 By Lois Rossi Director, Registration Division

  2. New PRIA 3 Provision • Where a new AI, new use, new product or amended product application involves the Agency’s approval of a new or amended product label, new provisions in PRIA [Footnote in Tables 1-5, 7-10] require that: • Before the end of the action’s decision review time period, the Agency will communicate to the registrant any label changes that are required for approval of that action; • The registrant can (a) agree to all of the changes, (b) request up to 30 days to resolve label differences, or (c) withdraw the application without prejudice; • The Agency has 2-business days to review and approve a revised label submitted by the registrant.

  3. New PRIA 3 Provision – con’t • These new provisions only apply to conventional and antimicrobial pesticide actions submitted after October 1, 2012; • The Agency’s implementation process for these new provisions are depicted in the following flow-chart:

  4. Resulting Process Improvements • Under PRIA 2 often not adequate time to discuss and resolve label issues before expiration of the PRIA Due Date leaving the applicant with a “take it or leave it” dilemma; • The Agency’s creation of the “Predecisional Determination Due Date” 2-4 weeks before the PRIA Due Date provides time to resolve label issues or negotiate a time extension to allow for the submission and review of additional data to address the label issues; • After the expiration of the PRIA Due Date, the applicant can also request up to 30 days to reach agreement on the label issues;

  5. Resulting Process Improvements – con’t • Approving only clean labels relieves our state partners from the burden of reviewing each label to ensure that all of the Agency’s required changes have been incorporated; • Applicants also benefit from clean labels which reduces their uncertainty from differing state interpretations of EPA’s intended changes.

  6. Questions Lois Rossi Director, Registration Division Rossi.lois@epa.gov (703) 305-5447

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