. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/691/Add.11 
4 January 2013  
 (13-0022) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 21 December 2012, is being circulated at the 
request of the Delegation of the United States of America. 
 
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Guidance for Industry:  Questions and Answ ers Regarding Food Facility Registration  
 The US Food and Drug Administration (FDA) is  announcing the availability of a guidance for 
industry entitled "Questions and Answers Regarding Food Facility Registration (Fifth Edition)", 
which replaces the fourth edition of a guidan ce entitled "Questions and Answers Regarding 
Registration of Food Facilities (Edition 4)" issued  in August 2004.  The guidance provides updated 
information pertaining to the registration of food facilities that manufacture, process, pack, or hold 
food for human or animal consumption in the United States. 
 On 10 October 2003, FDA issued an interi m final rule (68 FR 58894) to implement 
amendments to the FD&C Act made by the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) ( P ublic Law 107-188).  Section 415 of the FD&C Act 
(21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold 
food for human or animal consumption in the Unite d States to register with FDA by 12 December 
2003.  This guidance was developed to answer freque ntly asked questions relating to the registration 
requirements of section 415. 
 Section 102 of Food Safety Modernization Act (FSMA) ( Public Law 111-353), enacted on 
4 January 2011, amended section 415 of the FD&C Act,  in relevant part, to require facilities engaged 
in manufacturing, processing, packing, or holding food for consumption in the United States to submit 
additional registration information to FDA.  Th is revised edition of the guidance includes new 
information relating to the FSMA amendments to section 415.  
 The Federal Register Notice notice 77 FR 74571 published on 17 December 2012 and can be 
found at:  http://www.gpo.gov/fdsys/pkg/FR-2012-12-17/pdf/2012-30328.pdf  
 The guidance can be found at: 
 " http://www.fda.gov/Food/GuidanceComplianceRe gulatoryInformation/GuidanceDocuments/
FoodDefenseandEmergencyResponse/ucm331957.htm  " G/SPS/N/USA/691/Add.11 
Page 2  
 
  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 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 Agency guidances at 
any time.   
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 guidance to http://www.regulations.gov .  Submit written 
comments on the guidance to the Division of Do ckets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Please indicate Docket 
No. FDA-2012-D-1002 when submitting comments.  Subm it written requests for single copies of the 
guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. 
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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