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.