FIFRA 30/30 - February 7, 2018

February 7, 2018 Topic – Strategies for Dealing with “Regulatory Strong-Arming” (Registration Changes Required by EPA OPP Product Managers that are Unrelated to a Pending Amendment)  

Our second edition of FIFRA 30/30™ addresses how to respond to OPP product managers who, as part of the approval of a pending amendment, require label or registration changes that are unrelated to the pending amendment.  For example, a registrant submits an amendment to revise use directions.  During EPA’s review, it determines that several approved marketing claims must be deleted before it approves the revised use directions.  EPA also requests deletion of a non-public health use claim because “efficacy data are not on file.”  Does EPA have the authority to require these actions under FIFRA?  How should the registrant respond and what are its options?  We discuss and answer these and related questions during the next FIFRA 30/30™.      

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