EPA Provides Flexibility to Pesticide Manufacturers Using “Commodity Inert Ingredients”
Citing a nationwide shortage of disinfectant products during the Novel Coronavirus Disease 2019 (COVID-19) pandemic, the U.S. Environmental Protection Agency (EPA) announced on March 26, 2020 that it will now allow pesticide manufacturers to obtain certain “commodity” inert ingredients from different suppliers without notifying EPA. EPA’s announcement also came on the same day that it separately expressed its expectation to specifically focus on ensuring compliance with Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requirements applicable to pesticide products that claim to address COVID-19 impacts. It also follows the Agency’s ongoing efforts to expedite approval of anti-coronavirus claims for registered disinfectants.
An inert ingredient is any substance or group of similar substances other than an active ingredient that is intentionally included in a pesticide product by its manufacturer. Such ingredients may include emulsifiers, solvents, carriers, aerosol propellants, fragrances, and dyes. EPA lists all known inert ingredients online in its InertFinder database.
FIFRA requires that a pesticide manufacturer submit to EPA information on a product’s composition, including all inert ingredients, when seeking to register a new pesticide or applying for an amended registration if the revision involves a change in formula. Manufacturers submit this information using the Confidential Statement of Formula (CSF) form (EPA Form 8570-4), which until this latest change required manufacturers to identify the supplier name and address for each ingredient. Manufacturers are required to notify EPA before changing the source of any inert ingredient for which the registrant must identify the supplier name and address; in the case of disinfectants and other antimicrobial products, EPA requires submission of this notification at least 60 days before distribution or sale of the affected product begins.
B. “Commodity Inert Ingredients”
With this announcement, EPA has identified approximately 280 “commodity inert ingredients” that can be obtained from various commercial suppliers with no significant differences in the ingredient. These commodity inert ingredients include sodium chloride, glucose, acetic acid, and other common ingredients. Manufacturers will no longer need to list the names or addresses of their suppliers for each commodity inert ingredient on the CSF form, and so may source such ingredients from different suppliers without first notifying EPA. However, manufacturers must continue to submit supplier information for any inert ingredients not included on EPA’s list.
According to EPA, this change will provide pesticide manufacturers with significant new flexibility to source these necessary and commonly available product components, and should facilitate production of disinfectant products when regular supply chains are disrupted.
Visit Beveridge & Diamond’s COVID-19 Resources Page for more information on navigating the global pandemic. Beveridge & Diamond’s Pesticides practice has worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use pesticidal products and devices. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides practice helps clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. If you have any questions, please contact the authors.