. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/703/Add.3 
8 March 2012  
 (12-1298) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 7 March 2012, is being circulated at the request of 
the Delegation of the United States. 
 
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Interim Final Rule: Request for Comments;  Establis hment, Maintenance and Availability of Records: 
Amendment to Record Availability Requirements 
  The Food and Drug Administration (FDA) is  amending its regulations on establishment, 
maintenance, and availability of reco rds.  FDA is issuing this interim final rule (IFR) to amend FDAs 
regulation on the record availability requirements to  implement the amendments  to the Federal Food, 
Drug, and Cosmetic Act (the FD&C  Act) made by the FDA Food Safety Modernization Act (FSMA).  
The FSMA amendment expands FDAs former records access authority beyond records relating to the 
specific suspect article of food to records relating to any other article of food that the Secretary of 
Health and Human Services (the Secretary) reasonabl y believes is likely to be affected in a similar 
manner.  In addition, the FSMA amendment permits FDA to access records relati ng to articles of food 
for which the Secretary believes that there is a reasonable probability that the use of or exposure to the 
article of food, and any other article of food that  the Secretary reasonably believes is likely to be 
affected in a similar manner, will cause serious a dverse health consequences or death to humans or 
animals.  This expanded records access authority wi ll further help improve FDAs ability to respond 
to, and further contain threats of serious adverse heal th consequences or death to humans or animals.   
 The interim final rule was published in Fede ral Register of 23 February 2012 (77 FR 10658) 
and can be found at:  http://www.gpo.gov/fdsys/pkg/FR -2012-02-23/pdf /2012-4165.pdf .  This interim 
final rule is effective 1 March 2012. 
 For more information, please see FDAs webs ite on the Establishment and Maintenance of 
Records at:  http://www.fda.gov/Food/FoodDefense/Bioterrorism/Recordkeeping/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 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[X] Other:  Modification to Maintenance and Inspection of Records final rule 
G/SPS/N/USA/703/Add.1. G/SPS/N/USA/703/Add.3 
Page 2  
 
  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) :  23 May 2012.  The requirements in this interim final rule will be in 
effect 1 March 2012.  FDA invites public co mment on this interim final rule and will 
consider modifications to it based on comments made during the comment period. 
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: 
Comments on this interim final rule can be submitte d either electronically or written by 23 May 2012.  
You may submit comments, identified by Docket No. FDA-2002-N-0153 (formerly Docket No. 2002N-0277) and/or RIN number 0910-AG73, by any of the following methods: 
I. ELECTRONIC SUBMISSIONS 
Submit electronic comments in the following way: 
 Federal eRulemaking Portal:  http://www.regulations.gov . Follow the instructions for 
submitting comments. 
II. WRITTEN SUBMISSIONS 
Submit written submissions in the following ways: 
 Fax:  301-827-6870 
 Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions):  Division of Dockets 
Management (HFA-305), Food and Drug Admi nistration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD  20852. 
Instructions:  All submissions received must include the Agency name and docket number and 
Regulatory Information Number (RIN) for this ru lemaking.  All comments received may be posted 
without change to http://www.regulations.gov , including any personal information provided. For 
additional information on submitting comment s, see the "Comments" heading of the 
SUPPLEMENTARY INFORMATION section of this document. 
Docket:  For access to the docket to read b ackground documents or comments received, go to 
http://www.regulations.gov  and insert the docket number, found in brackets in the heading of this 
document, into the "Search" box and follow the prompts and/or go to the Division of Dockets 
Management, 5630 Fishers Lane, rm . 1061, Rockville, MD  20852.  
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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