THE PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 2012

(PRIA 3)

Label Issue Resolution Period/Clean Labels

Presented at:

PRIA 3 WorkshopApril 10, 2013

ByLois Rossi

Director, Registration Division

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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.

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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:

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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;

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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.

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Questions

Lois RossiDirector, Registration Division

Rossi.lois@epa.gov(703) 305-5447