. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/691/Add.9 
10 September 2012  
 (12-4793) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 29 Augus t 2012, is being circulated at the request 
of the Delegation of the United States of America. 
 
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Draft Guidance for Industry:  Necessity of the Use of  Food Categories in Food Facility Registrations 
and Updates to Food Categories 
 The Food and Drug Administration (FDA) is a nnouncing the availability of a draft guidance 
for industry entitled "Necessity of the Use of F ood Categories in Food Facility Registrations and 
Updates to Food Categories".  The draft guidance id entifies additional food categories to be included 
in food facility registrations as de termined appropriate by FDA.  The notice published in the Federal 
Register on 15 August 2012 (77 FR 48990). 
 This guidance contains findings that serve as the predicates for binding requirements on 
industry.  As stated in "Guidance for Industry on  Necessity of the Use of Food Product Categories in 
Registration of Food Facilities" (2003), which im plemented, in part, section 415, as added by 
section 305 of the Public Health Security and Biot errorism Preparedness and Response Act of 2002, it 
contains FDA's finding that inclusion of the food cat egories in §170.3 in food facility registrations is 
necessary for a quick, accurate, and fo cused response to an actual or potential bioterrorist incident or 
other food-related emergency.  
 The notice can be found on " http://www.gpo.gov/fdsys/pkg/FR-2012-08-15/pdf/2012-
20038.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:    G/SPS/N/USA/691/Add.9 
Page 2  
 
  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) :  14 September 2012.  Although one can comment on any guidance at any 
time (see 21 CFR 10.115(g)(5)), to ensure th at the Agency considers your comment 
on the draft guidance before FDA begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by 14 September 
2012. 
Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax num ber and e-mail address (if available) of other 
body: 
Submit electronic comments on the draft guidance to http://www.regulations.gov .  Submit written 
comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  
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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