Commodity Inert Ingredients- Guidance for PRIA Category 1018 EPA has established a list of inert ingredients that have been designated as commodity inert ingredients (https://www.epa.gov/pesticide-registration/commodity-inert-ingredients). This designation will help streamline and reduce the volume of paperwork associated with the Confidential Statement of Formula (CSF) Form (EPA Form 8570-4). As part of PRIA 5, a new category (1018; decision review time 3 months) was created for a submission requesting the addition of a single inert ingredient (to the Commodity Inert Ingredient List. This document provides guidance for 1018 submissions. For those inert ingredients designated as commodity inert ingredients, applicants for pesticide registration or registration amendments will be afforded the ability to obtain these inert ingredients from various commercial sources without having to provide the Agency with specific supplier name and address information for each such source on the CSF Form. This approach will reduce the amount of information required on the CSF, as well as the need for frequent revisions of the CSF to account for new sources of these inert ingredients. Only those inert ingredients designated as "commodity inert ingredients" would be eligible for this reduced source reporting. The following definitional criteria should be addressed in any PRIA 1018 submission requesting addition of a chemical to the list of commodity inert ingredients: 1. The substance must be on EPA's list of approved non-food inert ingredients and/or have an established tolerance or exemption from tolerance published in 40 CFR §§180.910 through 180.960. 2. The substance must not be registered by EPA as a pesticide active ingredient. 3. EPA's approval of the inert ingredient and/or the establishment of a tolerance or the exemption from tolerance must not be supported by any data that are eligible for compensation under FIFRA§§3(c)(l)(F) and 10, and/or FFDCA §408(i). • A screenshot of the chemical of interest on InertFinder can be provided as verification of points 1 and 3 (https://ordspub.epa.gov/ords/pesticides/f?p=INERTFINDER:l::::l::). 4. The substance must not be a mixture or proprietary blend and must be identified by a single Chemical Abstracts Service Registry Number (CAS Reg. No.) if one has been assigned. • The CAS Reg. No. must be provided, if available, as well as the full chemical name, as approved for inert ingredient use. If the chemical is a polymer, the minimum number average molecular weight should be provided. 5. The substance must be available from multiple commercial sources (a minimum of three sources). • A list of suppliers should be provided, including the name and address for each supplier Page 1 of 2 ------- • The physical form (e.g., powder, liquid, etc.) and the purity of the chemical as given by each supplier should also be provided. Based on the review of submitted information, EPA will make a determination of whether the chemical submitted is appropriate for inclusion in the Commodity Inert ingredient List and will add the chemical to the Commodity Inert Ingredients website (https://www.epa.gov/pesticide-registration/commoditV" inert-ingredients) as well as designating the inert ingredient as a commodity inert ingredient in the InertFinder database (https://0rdspub.epa.g0v/0rds/pesticides/f?p=INERTFINDER: 1:0::NQ:1). Note: Once a chemical has been designated as a commodity inert ingredient, subsequent CSF submissions should reflect this designation. However, previously submitted, and accepted CSFs do not need to be revised and resubmitted to the Agency solely to include the commodity inert ingredient designation as registrants are permitted to obtain such inert ingredients from various sources via non- notification. Page 2 of 2 ------- |