WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1933 
6 July 2009  
 (09-3294) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Notifying Member:  UNITED STATES
 
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; ICS 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 exclusiv ely regulated by the US Department of 
Agriculture are exempt. 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ X ] All trading partners, or 
[   ] Specific regions or countries:    
5. Title of the notified document:  Draft Guidance for Industry:   Questions and Answers 
Regarding the Reportable Food Registry as Established by the Food and Drug 
Administration Amendments Act of 2007;  Ava ilability;  Announcement of Further Delay 
in Implementation of the Food and Drug Administration Amendments Act of 2007 
[FR Doc. E9-13614] Public Notice Pages 27803-27804  Language:  English  Number of 
pages:  2 
6. Description of content:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled "Guida nce for Industry:  Questions and Answers 
Regarding the Reportable Food Registry as Established by the Food and Drug 
Administration Amendments Act of 2007".  The draft guidance, when finalized, will assist the industry in complying with the Reportable Food Registry requirements prescribed by 
the Food and Drug Administration Amendments Act of 2007 (FDAAA).  FDA is also 
announcing a further delay in the implementa tion of the Reportable Food Registry (the 
Registry) of FDAAA until 8 September 2009, to  consider any comments received on the 
draft guidance and through the agency's pl anned outreach initiatives, and to allow for 
further testing of the electronic portal for reportable foods.  The draft guidance, when 
finalized, will represent the agency's current thinking on this topic.  It does not create or 
confer any rights for or on any person and does not operate to bind FDA or the public.  An alternate approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations. G/SPS/N/USA/1933 
Page 2  
 
   On 27 September 2007, the President signed FDAAA into law (Public Law 110–85). 
Section 1005 of FDAAA amends the Federal Food, Drug, and Cosmetic Act (the act) by 
creating a new section 417 (21 U.S.C. 350f), among other things.  Section 417 of the act requires the Secretary of Health and Human Services to establish within FDA a Reportable Food Registry (the Registry);  the Registry is to be established not later than one year after 
the date of enactment (i.e., by 27 Septembe r 2008).  To further the development of the 
Registry, section 417 of the act requires FDA to establish, also within one year after the date of enactment (i.e., by 27 September 2008) , an electronic portal (the Reportable Food 
electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be s ubmitted by public health officials.  
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 stan dard?  If so, identify the standard:  
[   ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)    
[   ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)     
[   ] International Plant Protection Convention (e.g.  ISPM N°)     
[ 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:  The public 
notice can be found at 27803 Federal Register / Vol. 74, No. 111 / Thursday, 11 June 2009  at http://edocket.access.gpo.gov/2009/pdf/E9-13614.pdf
.  The Guidance for Industry: 
Questions and Answers Regarding the Reporta ble Food Registry as Established by the 
Food and Drug Administration Amendments Ac t of 2007;  Draft Guidance  can be found 
at:  
http://www.fda.gov/Food/GuidanceComplianceR egulatoryInformation/GuidanceDocument
s/FoodSafety/ucm165626.htm  
10. Proposed date of adoption (dd/mm/yy) :  8 September 2009 
Propose date of publication ( dd/mm/yy) :  11 June 2009 
11. Proposed date of entry into force:  [   ] Six months from date of publication , and/or  
(dd/mm/yy) :  8 September 2009 
[   ] Trade facilitating measure   G/SPS/N/USA/1933 
 Page 3 
 
 
  12. Final date for comments: [   ] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ):  27 July 2009 
Agency or authority designated to handle comments:  [   ] National Notification 
Authority, [   ] National Enquiry Point.  Address, fax number and E-mail address (if available) of other body:    
Submit written comments on the draft guidance to the Division of Dockets Management 
(HFA–305), Food and Drug Administration, 563 0 Fishers Lane, rm. 1061, Rockville, MD 
20852.  Submit electronic comments on the draft guidance to http://www.regulations.gov
. 
Submit written requests for single copies of the draft guidance to the Office of Food Defense, Communication and Em ergency Response, Center fo r Food Safety and Applied 
Nutrition (HFS–005), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740 
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 Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  
us.spsenquirypoint@fas.usda.gov