. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/691/Add.10 
30 October 2012  
 (12-5919) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 29 Octo ber 2012, is being circulated at the request 
of the Delegation of the United States of America. 
 
_______________ 
  
Updated Guidance for Industry: Necessity of th e Use of Food Product Categories in Food Facility 
Registrations and Updates to Food Product Categories; Availability. 
 The US Food and Drug Administration (FDA) is  announcing the availa bility of an updated 
guidance document for industry entitled "Necessity of the Use of Food Product Categories in Food 
Facility Registrations and Updates to Food Product Categories".  FDA has revised this guidance in 
response to amendments made by the FDA Food Sa fety Modernization Act (FSMA) to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act).  This  guidance contains FDA's determination that 
information about food product categories in food facility registrations is necessary for a quick, 
accurate, and focused response to a food safety rela ted issue or incident, an actual or potential 
bioterrorist incident, or other food-related emerge ncy.  The guidance also identifies the additional 
food product categories included as mandatory fields  in food facility registrations, as determined 
appropriate by FDA.  This guidance document can be found in the US Federal Register, Volume 77 
Number  206, page 64999 (77 CF 64999) or on the Internet at:  " http://www.gpo.gov/fdsys/pkg/FR-
2012-10-24/pdf/2012-26239.pdf ". 
 Biennial Registration Renewal for Food F acilities began at 12:01 a.m. on 22 October 2012.  
The updated food facility registration system is  accepting food facility registration renewals. 
Registration of Food Facilities:  
"http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/
default.htm " 
Registration Under the Food Safety Modernization Act: 
http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm  
On-line registration:  
"http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/
OnlineRegistration/default.htm " 
Registration/Cancellation by Pape r (Mail or FAX) or CD-ROM: 
"http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/
ucm073728.htm " G/SPS/N/USA/691/Add.10 
Page 2  
 
  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 th e previously notified measure in terms 
of products and/or potentially affected Members, a new deadline for receipt of comments should be 
provided, normally of at least 60 calendar days.  Under other circumstances, such as extension of 
originally announced final date for comments, th e 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) :  Submit either electronic or written comments on FDA guidances at any 
time.   
Agency or authority designated to handle commen ts:  [ ] National Notification Authority, [ ] 
National Enquiry Point.  Address, fax number and e-mail address (if available) of other body: 
Submit electronic comments on the guidance to http://www.regulations.gov .  Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.  Pl ease refer comments to Docket No. FDA-2012-D-
0585. 
FOR FURTHER INFORMATION CONTACT:  Amy Barri nger, Center for Food Safety and Applied 
Nutrition (HFS-615), Food and Drug Administration,  5100 Paint Branch Pkwy., College Park, MD 
20740, USA;  Tel:  1-240-402-1988;   E-mail:  Amy.Barringer@fda.hhs.gov 
Text available from:  [X] National Notification Au thority, [ ] National Enquiry Point.  Address, 
fax number and e-mail address (if available) of other body: 
United States SPS National Notification Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 14, Washington D.C. 20250;  Tel:  +(1 202) 720 
1301;  Fax:  +(1 202) 720 0433;  E-mail :  us.spsenquirypoint@fas.usda.gov 
 
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