G/SPS/N/USA/2502/Add.6  
 
15 September 2015  
(15-4687)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 14 Septem ber 2015, is being circulated at the request 
of the Delegation of the United States of America. 
 
_______________ 
 
 Current Good Manufacturing Practice, Hazard Anal ysis, and Risk-Based Preventive Controls for 
Human Food; Final Rule 
The Food and Drug Administration (FDA) is amending its regulation for Current Good 
Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, it is modernizing the long-standing current good manufacturing practice requirements. 
Second, it is adding requirements for domestic and foreign facilities that are subject to its 
regulation for Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food. It is also revising certain definitions in its regulation for 
registration of Food Facilities to clarify the scope of the exemption from registration requirements 
provided for "farms" and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. It is taking this action as part of its announced initiative to revisit the current good manufacturing 
practice requirements since they were last revised in 1986 and to implement new statutory 
provisions in the FDA Food Safety Modernization Act. 
Text can also be found on the US Federal Register website at: https://federalregister.gov/a/2015-
21920 . 
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] 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 
[ ] 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.6 
 
- 2 - 
 
  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 on the US Federal Register website at: https://federalregister.gov/a/2015-
21920 .  
__________