G/SPS/N/USA/691/Add.13
24 November 2014 
(14-6822)  Page: 1/2
Committee on Sanitary and Phytosanitary Measures  Original: English
 
  NOTIFICATION 
Addendum 
The following communication, received on 21 November 2014, is being circulated at the request of 
the Delegation of the United States of America. 
 
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 Questions and Answers Regarding Food Facility Regi stration (Sixth Edition); Guidance for Industry; 
Availability 
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 
entitled ''Questions and Answers Regarding Food Facility Registration (Sixth Edition)". The guidance includes one additional question and answer regarding FDA's policy regarding food facility 
registration for farms that also pack or hold raw agricultural commodities grown on a farm under 
different ownership in light of other ongoin g FDA Food Safety Modernization Act (FSMA) 
rulemakings. 
On 10 October 2003, FDA issued an interim 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) ( Public Law 107-188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities th at manufacture, process, pack, or hold food for 
human or animal consumption in the United States to register with FDA by 12 December 2003. 
This guidance was developed to answer frequently  asked questions relating to the registration 
requirements of Section 415. 
FDA recognizes that there is significant international interest in how we are implementing the Food 
Safety Modernization Act of 2010 and as a result has elected to notify this action even though this 
notification is not an obligation under Article 7 and Annex B. 
Text is available at: http://www.gpo.gov/fdsys/pkg /FR-2014-11-19/pd f/2014-27290.pdf . 
The guidance can be found at: http://www.fda.gov/Food /GuidanceRegulation/ GuidanceDocuments
RegulatoryInformation/ucm331959.htm . 
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 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.)  G/SPS/N/USA/691/Add.13 
 
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  [ ] 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 co mments: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber 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. Submit 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 an d Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.  
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 
The notice is available in the Federal Register at Vol. 79, No. 223, Page 68810 published on 
19 November 2014 and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2014-11-
19/pdf/2014-27290.pdf .  
The guidance can be found at: http://www.fda.gov/Food /GuidanceRegulation/ GuidanceDocuments
RegulatoryInformation/ucm331959.htm .  
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