. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/615 
4 February 2011  
 (11-0573) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  UNITED STATES
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Environmental Protection Agency (EPA) (632) 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :    
3. Notified under Article 2.9.2 [X], 2.10. 1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Pesticides (HS 3808; ICS 
13.020, 65.100) 
5. Title, number of pages and language(s) of the notified document:  Declaration of Prion as 
a Pest under FIFRA and Amendment of EPA's Regulatory Definition of Pests to Include 
Prion (7 pages, in English) 
6. Description of content:  EPA proposes to declare a prion (i .e., proteinaceous infectious 
particle) a "pest" under the Federal Insecticid e, Fungicide, and Rodenticide Act (FIFRA), and 
to amend its regulations to expr essly include prion within the regulatory definition of pest.  
EPA currently considers a prion to be a pest unde r FIFRA, so a product intended to reduce the 
infectivity of any prion on inan imate surfaces (i.e., a "prion-related product" ) is considered to 
be a pesticide and regulated as such.  Any comp any seeking to distribut e or sell a pesticide 
product regulated under FIFRA must obtain a section 3 re gistration, section 24(c) registration, 
or a section 18 emergency exemption before it ca n be distributed or sold  in the United States. 
This 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 the regulatory definition of pest.  This amendm ent, together with the formal declaration that 
a prion is a pest, will eliminate any confusion about the status of pri on-related products under 
FIFRA.  Codifying the Agency's current interp retation of FIFRA will not change the manner 
in which EPA currently regulates prion-related products under FIFRA sections 3, 24(c) and 
18. Regulating prion-related produc ts under FIFRA is appropriate  for protecting human health 
and the environment against unreasonable advers e effects and ensuring that such products are 
effective. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of environment,  human health and safety  
8. Relevant documents:   76 Federal Register (FR) 4602,  26 January 2011;  40 CFR Part 152 G/TBT/N/USA/615 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   28 March 2011 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:   
http://edocket.access.gpo.gov/2011/2011-1636.htm  and  
http://edocket.access.gpo.gov/2011/pdf/2011-1636.pdf