G/TBT/N/USA/992  
 
19 May 2015  
(15-2607)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1009] 
Name and address (including telephon e 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 : Please submit 
comments to: USA WTO TBT Enquiry Point, Email:  ncsci@nist.gov  
3. Notified under Article 2. 9.2 [ ], 2.10.1 [ ], 5.6. 2 [ ], 5.7.1 [ ], other: For the purposes 
of transparency, we are notifying this measure as 'other' because it amends a previously 
notified measure. We note that this amendmen t does not appear to qualify for notification 
under Articles 2.9.2, 2.10.1, 5.6.2, or 5.7.1  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Food facilities. 
Processes in the food industry (ICS: 67.020), Plants and equipment for the food industry 
(ICS: 67.260) 
5. Title, number of pages and langua ge(s) of the notified document: Amendments to 
Registration of Food Facilities (30 pages, in English).  
6. Description of content: The Food and Drug Administration (FDA or we) is proposing to 
amend its regulation for registration of food facilities that requires domestic and foreign 
facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This  proposed rule would amend and update FDA's 
registration regulations and is part of our implementation of the FDA Food Safety 
Modernization Act (FSMA), which added new provisions for the registration of food 
facilities. Moreover, a number of provisions in FSMA apply only to facilities required to register, including hazard analysis and risk-based preventive controls and mandatory recall 
authority. The proposed amendments will further enhance FDA's capabilities with respect 
to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human health or Safety 
8. Relevant documents:  80 Federal Register (FR) 19159, 9 April 2015; Title 21 Code of 
Federal Regulations (CFR) Part 1. Will appear in the Federal Register when adopted. 
G/TBT/N/USA/32 (13 February 2003) Registration  of Food Facilities Under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 –
http://www.gpo.gov/fdsys/pkg/FR-2003-02-03/html/03-2443.htm  and all related 
addenda/corrigenda. G/TBT/N/USA/992 
 
- 2 - 
 
  9. Proposed date of adoption: To be determined 
Proposed date of entry into force: To be determined   
10. Final date for comments: 8 June 2015 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
https://members.wto.org/crnattachm ents/2015/TBT/USA/15_2011_00_e.pdf