PRIA 3 Quarterly Stakeholder Meeting

EPA held its PRIA 3 Quarterly Stakeholder Meeting on July 11, 2018. Rick Keigwin, Director of the Office of Pesticide Programs (OPP), informed attendees that the Agency is experiencing resource challenges (which includes a decrease in OPP staff to below 600 employees) and indicated this is affecting productivity.

Steve Schaible, OPP’s PRIA Coordinator, provided an informative presentation on the following topics:

• PRIA 4 update
• Follow-up from previous Stakeholder Quarterly Meeting
• PRIA 3 summary for Fiscal Year 2018
• PRIA renegotiation rates
• On-time completion rates for Fiscal Year 2018
• Pending non-PRIA fast tracks and notifications
• Fees collected
• Two-day label approval
• Electronic label reviews
• Electronic submissions
• 45/90 preliminary technical screens

Mr. Schaible’s presentation is available here: PRIA 3 Presentation

Guidance on placement of first aid statements on pesticide labels

On March 8, 2018, EPA released final guidance clarifying where first aid statements should appear on the label of pesticide products. The guidance responds to input from states and pesticide registrants.  EPA will continue to require Toxicity Category I products to have first aid statements on the front panel of the label, while Toxicity Category II and III products can have these statements on any panel.

To view the guidance document, please click here: Document Summary

EPA publishes revised antimicrobial efficacy test guidelines

In a February 28, 2018 Federal Register notice, EPA announced the availability of the revised antimicrobial test guidelines (OCSPP Product Performance Test Guidelines 810.2000, 810.2100, and 810.2200). The revised procedures incorporate comments received on the draft guidelines issued by EPA in 2015.

A number of significant changes have been made to the guidelines with regard to confirmatory data, repeat testing, wetness determination testing for towelettes, testing at lower certified limits, internal toilet testing, performance standards, and other topics. Click on the following link for more detailed information provided via EPA’s website: Final OCSPP Product Performance Test Guidelines for Antimicrobial Pesticides Series 810.2000-2200

PRIA 3 status and PRIEA (PRIA 4) progress

The U.S. Congress has passed another continuing resolution extending the Pesticide Registration Improvement Act (PRIA 3) until December 22, 2017.  Congress has been working on a replacement for PRIA 3.  The new bill, the Pesticide Registration Improvement Extension Act (PRIEA or PRIA 4) remains on hold by Senator Udall (D-NM) due to concerns about EPA’s delay of certain new rules (Worker Protection Standard changes and restricted use pesticide certification/training). Because the bill cannot come to a vote, the new continuing resolution gives additional time to pass PRIEA, or a longer-term continuing resolution for PRIA 3.

Final guidance clarifying FDA and EPA jurisdiction over mosquito-related products

On October 5, 2017, the U.S. Food and Drug Administration (FDA) issued final Guidance for Industry which clarifies that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes, including those products produced by biotechnology, such as genetically engineered mosquitoes, will be regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  FDA will continue to regulate (as drugs), under the Federal Food, Drug, and Cosmetic Act (FFDCA), mosquito-related products that are intended to prevent, treat, mitigate, or cure a disease.

Click here to view the final Guidance for Industry #236 – Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products.

U.S. government extends PRIA 3

On September 8, 2017, a bill was signed that extends the third iteration of the Pesticide Registration Improvement Act (PRIA) until December 8, 2017.  PRIA was due to expire on September 30, 2017.  Originally implemented in 2004, PRIA created a registration service fee system for various applications submitted to EPA, including for pesticide registrations, amended registrations, and tolerance petitions.  Government, industry, and environmental stakeholders have been working on, and continue to work on, the Pesticide Registration Enhancement Act, a replacement for PRIA.

EPA downsizing

The Washington Post recently reported that, within the last couple of weeks, nearly 400 employees had left EPA. These employees chose to accept buyouts and early retirement. The administration reported earlier this year that it plans to offer the deals to 1200 EPA employees. This will bring the agency to its smallest employment status since the Reagan administration.

Proposed updates to PR Notice 98-10

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) announced proposed updates to the long-standing Pesticide Registration (PR) Notice 98-10, “Notifications, Non-notifications and Minor Formulation Amendments.”  The PR Notice provides guidance to registrants submitting minor modification that do not require extensive EPA review.

The EPA is accepting comments from all affected parties regarding the proposed updates until December 5, 2017 (originally October 6, 2017).  Click here to view and submit comments on the draft proposed PR Notice.