Declaration of Prion as a Pest under FIFRA and Amendment of EPA’s Regulatory Definition of Pests to Include Prion; Notification to the Secretaries of Agriculture and Health and Human Services

Docket ID: EPA-HQ-OPP-2010-0427
Agency: Environmental Protection Agency (EPA)
In 2003, the Agency decided that a prion (proteinaceous infectious particles) is a "pest" under the 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. In 2011, EPA proposed to formally declare a prion to be a pest and to amend its regulations to add prion to the list of pests (40 CFR part 152). A supplemental notice also proposed to amend the product performance data requirements (i.e., efficacy data) to specifically list prion-related products and announced the availability of draft efficacy testing guidance for comment. EPA believes that regulating prion-related products protects human health and the environment against unreasonable adverse effects and ensures that such products are effective.
RIN: 2070-AJ26
Impacts and Effects: None
CFR Citation: 40 CFR 152.5(d)
Priority: Substantive, Nonsignificant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2013
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 7 USC 136; 7 USC 136(w)
Legal Deadlines: None
Government Levels Affected: Federal, State
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: No
Small Entities Affected: No
International Impacts: No
Energy Effects: No
Included in Regulatory Plan: No
ActionDateFR Citation
NPRM01/26/201176 FR 4602
Supplemental NPRM11/17/201176 FR 71294
Final Rule02/28/201378 FR 13501
Final Rule Effective04/29/2013
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Type: Rulemaking
Location: HQ-OPP

Primary Documents

View All  (5)
Comment Period Closed
Jan 17, 2012 11:59 PM ET
Proposed Rule
Posted: 11/17/2011
ID: EPA-HQ-OPP-2010-0427-0020
Comment Period Closed
Mar 28, 2011 11:59 PM ET
Proposed Rule
Posted: 01/26/2011
ID: EPA-HQ-OPP-2010-0427-0002
Comment Period Closed
Posted: 02/28/2013
ID: EPA-HQ-OPP-2010-0427-0029
Comment Period Closed
Proposed Rule
Posted: 08/08/2012
ID: EPA-HQ-OPP-2010-0427-0025
Comment Period Closed
Proposed Rule
Posted: 07/07/2010
ID: EPA-HQ-OPP-2010-0427-0001

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 02/28/2013
ID: EPA-HQ-OPP-2010-0427-0032
Comments Not Accepted
Supporting & Related Material
Posted: 02/28/2013
ID: EPA-HQ-OPP-2010-0427-0030
Comments Not Accepted
Supporting & Related Material
Posted: 02/28/2013
ID: EPA-HQ-OPP-2010-0427-0031


View All  (8)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Melba Morrow
703 308-2716
703 308-8481 (Fax)
7510C, Washington, DC 20460
Washington, DC 20460
Tajah Blackburn
7510P, Washington, DC 20460
Washington, DC 20460
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.