G/SPS/N/USA/691/Add.14  
 
15 April 2015  
(15-2029)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 13 April 2015, is being circulated at the request of the 
Delegation of the United States of America. 
 
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 Amendments to Registration of Food Facilities; Notice of Proposed Rulemaking 
The Food and Drug Administration 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 regulati ons 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. 
http://members.wto.org/crnattachments/2015/SPS/USA/15_1587_00_e.pdf  
This addendum concerns a: 
[ ] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[X] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:   
Comment period: (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days. Under 
other circumstances, such as extension of or iginally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : 8 June 2015 G/SPS/N/USA/691/Add.14 
 
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  Agency or authority designated to handle co mments: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
You may submit comments by any of the following methods: 
Electronic Submissions 
Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting 
comments. 
Written Submissions 
Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper submission s): Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Instructions: All submissions received must include the Docket No. FDA-2002-N-0323 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , 
including any personal information provided. For additional information on submitting comments, 
see the ''Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.  
Text(s) available from: [X] National Notificati on Authority, [ ] National Enquiry Point. 
Address, fax number and e-mail addre ss (if available) of other body: 
United States SPS National Notification Auth ority, USDA Foreign Agricultural Service,  
International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; 
Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: us.spsenquirypoint@fas.usda.gov 
The notice is available in the Federal Register at Vol. 80, No. 68, Page 19160 published on 
9 April 2015 and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2015-04-09/pdf/2015-
08018.pdf   
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