G/SPS/N/USA/2502/Add.7  
 
19 November 2015  
(15-6116)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 19 November 2015, is being circulated at the request of 
the Delegation of the United States of America. 
 
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 Current Good Manufacturing Practice, Hazard Anal ysis, and Risk-Based Preventive Controls for 
Human Food; Clarification of Compliance Date for Certain Food Establishments 
The Food and Drug Administration is clarifying the compliance date provided for certain food 
establishments subject to a final rule that pub lished in the Federal Register of 17 September 2015. 
Among other things, that final rule amended FD A's regulation for current good manufacturing 
practice in manufacturing, packing, or holding human food to modernize it, and to add 
requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-
based preventive controls for human food. FDA is ta king this action in response to requests for 
clarification of the compliance date for facilities that manufacture, process, pack, or hold grade "A" milk or milk products and that are regulated und er the National Conference on Interstate Milk 
Shipments (NCIMS) system. 
The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food rule (published on 17 September 2015 at 80 FR 55908) for grade "A" milk and milk products covered by NCIMS under the Pasteurized Milk Ordinance is 
17 September 2018. 
http://members.wto.org/crnattachments/2015/SPS/USA/15_4627_00_e.pdf  
This addendum concerns a: 
[ ] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[X] 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) : Not applicable. This is a final rule. G/SPS/N/USA/2502/Add.7 
 
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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: 
For further information contact: Jenny Scott, Center for Food Safety and Applied Nutrition 
(HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
240 402 2166  
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 Authority, 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 
Text can also be found in the Federal Register, Vol. 80, No. 222, Page 71934 or on the Internet at: 
http://www.gpo.gov/fdsys/pkg/FR- 2015-11-18/pdf/ 2015-29340.pdf . 
 
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