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EPA/OCSPP RIN: 2070-AJ26 Publication ID: Fall 2011 
Title: Prions; Amendment of EPA’s Regulatory Definition of Pests to Include Prion 
Abstract: 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. 
Agency: Environmental Protection Agency(EPA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 152.5(d)   
Legal Authority: 7 USC 136    7 USC 136(w)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
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    
Additional Information: 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
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: http://www.epa.gov/pesticides/  
Sectors Affected: 32532 Pesticide and Other Agricultural Chemical Manufacturing; 32561 Soap and Cleaning Compound Manufacturing; 541940 Veterinary Services 
RIN Data Printed in the FR: No 
Agency Contact:
Carlton Kempter
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
7510P,
Washington, DC 20460
Phone:703 305-5448
Fax:703 308-6467
Email: kempter.carlton@epa.gov

Tajah Blackburn
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
7510P,
Washington, DC 20460
Phone:703 308-0372
Email: Blackburn.Tajah@epa.gov