G/SPS/N/USA/2645  
 
31 March 2014  
(14-1974)  Page: 1/3  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved:   
2. Agency responsible: US Food and Drug Administration 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Food and food products, including animal feed and pet 
food under FDA's jurisdiction, except that infant formula and dietary supplements are exempt. Also, meat, poultry and egg products that are exclusively regulated by the 
US Department of Agriculture are exempt. HS Codes: 03, 04, 05, 07, 08, 09, 10, 11, 12, 
15, 16, 17, 18, 19, 20, 21, 22. 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Implementation of the Food and Drug Administration 
Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act  Language(s): English  Number of 
pages: 7 
http://www.gpo.gov/fdsys/pkg/FR- 2014-03-26/pdf/ 2014-06614.pdf  
6. Description of content: The Food and Drug Administration (FDA) is issuing this 
advance notice of proposed rulemaking (ANPRM) to solicit comments, data, and information to assist the Agency in implementing the FDA Food Safety Modernization Act 
(FSMA), which added new provisions to the Reportable Food Registry (RFR) 
requirements of the Federal Food, Drug, an d Cosmetic Act (the FD&C Act). Under the 
new provisions, FDA may require a responsible party to also submit to FDA ''consumer-oriented'' information regarding certain reportable foods, including information 
necessary to enable a consumer to accurately identify whether the consumer is in 
possession of a reportable food. FDA must prepare and publish on FDA's Internet Web site a one-page summary of the consumer-oriented information that can be easily 
printed by a grocery store for the purposes of consumer notification. FDA is seeking 
input on topics including consumer-oriented information submissions, consumer notifications, posting consumer notifications in grocery stores, and grocery stores 
subject to the new requirements. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text)   G/SPS/N/USA/2645 
 
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  [ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available:  
FDA's Reportable Food Registry for Industry Webpage: 
http://www.fda.gov/Food/Complianc eEnforcement/RFR/default.htm  
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food 
Registry as Established by the Food and Dr ug Administration Amendments Act of 2007 
(Edition 2): http://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformatio
n/RFR/ucm212793.htm  (available in English) 
10. Proposed date of adoption (dd/mm/yy) : Not applicable 
Proposed date of publication (dd/mm/yy) : 26 March 2014 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : Not applicable 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 9 June 2014 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
You may submit comments, identified by Docket No. FDA-2013-N-0590 or Regulatory 
Information Number (RIN) number 0910-AG97, by any of the following methods: 
Electronic Submissions 
Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for 
submitting comments. 
Written Submissions 
Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. 
Instructions: All submissions received must include the Agency name and Docket No. 
FDA-2013-N-0590 and RIN 0910-AG97 for this advance notice of proposed rulemaking. 
All comments received may be posted without change to http://www.regulations.gov , 
including any personal information provided. For additional information on submitting 
comments, see the ''Comments'' heading of the SUPPLEMENTARY INFORMATION section 
of the document. G/SPS/N/USA/2645 
 
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  13. Texts available from: [X] National Notification Authority, [ ] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
United States SPS National Notification Auth ority, 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  
Text available in the Federal Register, Vol. 79, No. 58, at page 16698 or at 
http://www.gpo.gov/fdsys/pkg/FR- 2014-03-26/pdf/ 2014-06614.pdf