Pesticide News Story: EPA Approves Streamlined Confidential Statement of Formula Process for End-Use Products and Manufacturing Use Products
For Release: December 14, 2011
On July 29, 2011, the agency announced the availability of a guidance memo on a streamlined process for Confidential Statements of Formula, Form 8570-4, for technical grade active ingredients. The agency is announcing today that it is releasing a similar, new guidance memo specific to end-use products and manufacturing use products and that it has updated the July 29, 2011, guidance memo for technical grade active ingredients.
As part of the registration process for pesticides, registrants must submit a Confidential Statement of Formula, Form 8570-4, that lists all the components and their percentage by weight in a pesticide product, and other information about the formulation. The CSF is a crucial element of submissions related to new pesticide products.
In the past, registrants may have submitted separate Confidential Statements of Formula to reflect different inert ingredient suppliers and each country in which the product is produced. New guidance to EPA reviewers allows EPA to instead accept from registrants an attachment to the Confidential Statement of Formula for end-use and manufacturing use products that lists additional inert ingredient suppliers and additional countries in which the pesticide may be produced, provided the criteria in the guidance are met. In addition, the guidance to EPA reviewers clarifies that it is acceptable for companies to list the name and address of the appropriate company contact for production-related questions in lieu of each production location.
This streamlined process for end-use and manufacturing use products, along with the streamlined process for CSFs for technical grade active ingredients, will not only reduce paper and registrant burden, but it will also provide useful information to EPA staff and reduce handling and tracking of many unnecessary pages. All of the guidance memos addressing end-use products, manufacturing-use products and technical grade active ingredients are available on the Pesticide Registration Manual Web-page at: http://www.epa.gov/opprd001/registrationmanual/appendix-a.html.