This document notifies the public that the Administrator of EPA has forwarded to the Secretaries of Agriculture and Health and Human Services a draft proposed rule under sections 21 and 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The draft rule proposes to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion product”) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain EPA approval before it can be distributed or sold in the United States. This draft proposed rule would codify the Agency’s current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in EPA’s regulations. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion products under FIFRA. Regulating prion products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective.


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