BPIA participated in a Pesticide Registration Improvement Act (PRIA) 3 Stakeholder meeting at the U.S. Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention Office of Pesticides Program (Agency). View slides from the meeting here.
The meeting was led by PRIA Coordinator, Pete Caulkins, who indicated that he would retire after 38 years of service at the end of January 2017. Steve Schaible who has been the PRIA Ombudsman will take Coordinator Caulkins’ place.
Of particular interest are the reasons why “not-grants” letters are issued. See slides 13-14. Once such a letter is issued, the submission will be taken out of the PRIA process and enters PRIA purgatory. While the Agency can still work on that submission, there are no longer any applicable statutory review times, and there are some such submissions that have been at the Agency since PRIA 2.
Also of note, a draft Pesticide Registration Notice (PRN) 98-10 regarding notifications is going through review at the Office of Management and Budget (OMB) and will eventually be available for public comment through the Federal Register.
Additionally, the Biologicals and Pollution Prevention Division (BPPD) technical screen statistics show a disproportionate amount of 45/90 day letters with 25% compared to less than 7% for RD and AD.
Lastly, PRIA 4 legislation is expected to pass sometime before the start of the Agency’s 2018 Fiscal Year. Of note in PRIA 4 is BPPD’s inclusion in the two-day label review process requirements that label review for any PRIA action which includes label amendments be performed within a two-week window between the pre-decisional determination date and the PRIA due date.