. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1933/Add.3 
1 June 2010  
 (10-3025) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum
 
  
The following communication, received on 26 May 2 010, is being circulated at the request of 
the Delegation of the United States
. 
 
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Guidance for Industry:  Questions and Answer s Regarding the Reportable Food Registry as 
Established by the Food and Drug Administ ration Amendments Act of 2007 (Edition 2)  
 The Food and Drug Administration (FDA) is a nnouncing the availability of a draft guidance 
entitled "Questions and Answers Re garding the Reportable Food Registry as Established by the Food 
and Drug Administration Amendments Act of 2007 (Edition 2)".  The draft guidance provides 
information to the industry in complying with the Reportable Food Registry requirements prescribed 
by the Food and Drug Administration Amendmen ts Act of 2007 (FDAAA).  Further, the draft 
guidance addresses inquiries that the agency has rece ived through its Reportable Food Registry help 
desk and/or by other means since the implem entation of the Reportable Food Registry on 
8 September 2009, and provides information on the new Safety Reporting Portal.  The agency is also 
seeking comments from industry on the Reportable F ood Registry requirements, and specifically on 
the issue of "transfer" as discussed in the cu rrent Edition 1, and dr aft Edition 2 guidance. 
 The notice of availability and request for co mments for Edition 2 published in the Federal 
Register on 25 May 2010 (75 FR 29350) can be found at: http://edocket.access.gpo.g ov/2010/pdf/2010-12456.pdf
 
 The draft guidance for Edition 2 can be found at:  http://www.fda.gov/Foodguidances , 
http://www.fda.gov/Food/GuidanceComplianceRegul atoryInformation/GuidanceDocuments/FoodSaf
ety/ucm212793.htm  
 The notice of availability for the Edition 1 pu blished in the Federal Register, 74 FR 46434-
46435 on 9 September 2009 can be found at http://edocket.access.gpo.gov/2009/pdf/E9-21713.pdf  
 The Reportable Food Registry can be found at: 
 http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm  
This addendum concerns a: 
[ ] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of previously notified draft regulation G/SPS/N/USA/1933/Add.3 
Page 2  
 
  [ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[X] Other:  See description above. 
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) :  Although comments can be sent at any time, to ensure that the agency 
considers your comments before it begins wo rk on the final version, submit electronic 
or written comments by 26 July 2010. 
Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[X] National Enquiry Point.  Address, fax number and e-mail address (if available) of other 
body: 
Written or electronic comments can be submitted on the guidance to the Division of Dockets 
Management (HFA–305), Food and Drug Administrati on, 5630 Fishers Lane, Room 1061, Rockville, 
MD 20852. Submit electronic comments on the guidance to http://www.regulations.gov
, please note 
Docket No. FDA–2009–D–0260 in submission. 
For further information contact:  Faye Feldstein,  Center for Food Safety and Applied Nutrition (HFS–
005), Food and Drug Administration, 5100 Paint Br anch Pkwy., College Park, MD 20740, 1–888–
SAFEFOOD.  
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 27, 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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