2070-AJ26 201110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 2070 Office of Chemical Safety and Pollution Prevention OCSPP 2000 Environmental Protection Agency EPA Prions; Amendment of EPA’s Regulatory Definition of Pests to Include Prion In 2003, the Agency decided that a prion (proteinaceous infectious particles) is a "pest" under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and that a product intended to reduce the infectivity of prions on inanimate surfaces (i.e., “prion product”) is considered to be a pesticide. Any company seeking to distribute or sell such a product is required to register the product with EPA unless the product is exempt from registration requirements before it can be distributed or sold in the United States. Through this action, EPA proposed to formally declare prions to be a pest and to amend its regulations to add prions to the list of pests (40 CFR part 152). A supplemental notice will propose product performance data requirements (i.e., efficacy data) for prion-related products and announce the availability of draft efficacy testing guidance for comment. EPA believes that regulating prion products protects human health and the environment against unreasonable adverse effects and ensures that such products are effective. Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 40 CFR 152.5(d) 7 USC 136 7 USC 136(w) No NPRM 01/26/2011 76 FR 4602 Supplemental NPRM 11/17/2011 76 FR 71294 Supplemental NPRM Comment Period End 01/17/2012 Final Action 11/00/2012 EPA publication information: NPRM - http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2010-0427-0002; Supplemental NPRM - http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2010-0427-0020; EPA Docket information: EPA-HQ-OPP-2010-0427 No Businesses Federal State No http://www.epa.gov/pesticides/ 32532 Pesticide and Other Agricultural Chemical Manufacturing 32561 Soap and Cleaning Compound Manufacturing 541940 Veterinary Services No No Carlton Kempter 2070 Office of Chemical Safety and Pollution Prevention OCSPP 703 305-5448 703 308-6467 kempter.carlton@epa.gov 7510P, Washington DC 20460 Tajah Blackburn 2070 Office of Chemical Safety and Pollution Prevention OCSPP 703 308-0372 Blackburn.Tajah@epa.gov 7510P, Washington DC 20460