Behind the label: An inside look at the US EPA approval process

It takes 10 to 12 years and around $300 million to bring a new pesticide, including herbicides, fungicides or insecticides, to market. While much of that time and money is spent in a lab and on in-field testing, U.S. EPA and other governmental agency reviews have started to take a bigger piece of that pie.

In addition, products have to re-register every 15 or so years with updated data. Dicamba, for example, is undergoing the re-registration process as part of the earlier conditional registration.

Here’s a quick look at what EPA requires for registration review:

- Docket opening-EPA creates a public document with a preliminary work plan that summarizes the information EPA already has on the pesticide, and the anticipated path forward. This plan includes facts about the pesticide’s current use and usage, anticipated risk assessment and data needs and an estimated timeline for review. When this is published, EPA provides public comment periods for at least 60 days.

- Focus meetings-this typically involves registrants and others in an open meeting to address areas of uncertainty such as unclear labels or missing studies that could impact EPA’s pesticide risk assessments and risk management decisions. These focus meetings are publicly available.

- Case development-the agency reviews available data and information and assesses changes since the pesticide’s last review, conducts new assessments as needed, include the public in a public comment period on a draft risk assessment and finally, consult with regulatory partners such as the National Marine Fisheries Service and the U.S. Fish and Wildlife Service.

- Registration review decision-EPA determines whether the pesticide meets the standard for registration and issues a proposed decision. The proposed decision allows for a 60-day comment period. After considering comments, EPA issues a final registration decision that is published to the Federal Register.