WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/690/Add.11 
12 May 2011  
 (11-2419) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum
 
  
The following communication, received on 10 May 2 011, is being circulated at the request of 
the Delegation of the United States
. 
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Information Required in Prior Notice of Imported Food, Interim final rule; request for comments  
 The Food and Drug Administration (FDA) is amending its regulations on prior notice of 
imported food.  As required by the FDA Food Safety Modernization Act, FDA is issuing this interim 
final rule to require an additional element of info rmation in a prior notice of imported food.  This 
change requires a person submitting prior notice of imported food, including food for animals, to 
report the name of any country to which the article has been refused entry.  The new information can 
help FDA make better informed decisions in mana ging the potential risks of imported food into the 
United States.  The interim final rule was published in Federal Regi ster of 5 May 2011 (76 FR 25542) 
and can be found at:  http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10955.pdf .  This 
interim final rule is effective 3 July 2011. 
 Background :  The Public Health Security and Biot errorism Preparedness and Response Act of 
2002 (the Bioterrorism Act) was signed into la w on 12 June 2002.  Among other things, the 
Bioterrorism Act amended the FD&C Act by a dding section 801(m).  This provision created the 
requirement that FDA receive certa in information about imported foods  before arrival in the United 
States.  It also provided that an article of food im ported or offered for import is subject to refusal of 
admission into the United States if adequate prio r notice has not been provided to FDA.  In 
accordance with the Bioterrorism Ac t, the Department of Health and Human Services (HHS) and the 
Department of the Treasury jointly published a no tice of proposed rulemaking (proposed rule) in the 
Federal Register of 3 February 2003 (68 FR 5428) " http://www.fda.gov/OHRMS/DOCKETS/98fr/03-
2444.pdf ", proposing requirements for submission of prior notice for human and animal food that is 
imported or offered for import into the United Stat es.   On 10 October 2003, HHS and the Department 
of Homeland Security (DHS) issued the prior noti ce interim final rule (2003 IFR) (68 FR 58974) 
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-25877.pdf  (corrected by a technical amendment on 
2 February 2004; 69 FR 4851) http://www.fda.gov/OHRMS/DOCKETS/98fr/04-1592.pdf .  The 2003 
IFR required that prior notice be submitted to F DA electronically using either the US Customs and 
Border Protection (CBP) Automated Broker Interfa ce (ABI) of the Automated Commercial System 
(ACS) or the FDA Prior Notice System Interface (PNS I).  The 2003 IFR also set forth the timeframes 
within which prior notice must be submitted. In the Federal Register of 7 November 2008 (73 FR 
66294) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-26282.pdf , HHS and DHS published a final 
rule that made a number of changes to the 2003 IFR, including changes to certain provisions 
containing definitions, submission timeframes, and th e information that must be submitted in a prior 
notice.  The final rule went into effect on 6 May 2009.  In calendar year 2010, 10,116,018 prior notices were submitted. G/SPS/N/USA/690/Add.11 
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   The prior notice regulations are codified at Title 21, Code of Fede ral Regulations (CFR) 
part 1, subpart I (21 CFR 1.276 to 1.285).  Secti on 1.281 of the regulations describes the information 
that must be submitted in a prior notice.  This in terim final rule amends those regulations as required 
by section 304 of FSMA.  Specifically, the interim fina l rule is amending paragr aphs (a), (b), and (c) 
of § 1.281 to require that the prior notice include th e identity of any country to which an article of 
food has been refused entry. 
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 of Prior Notice of Imported Food rule 
(G/SPS/N/USA/690/Add.8) 
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) :  3 August 2011 .  The requirements in this interim final rule will be in 
effect 3 July 2011.  FDA invites public comme nt 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 number and e-mail address (if available) of other body: 
Interested persons may submit either electronic or written comments on this interim final rule by by 
3 August 2011.  Comments can be submitted on this interim final rule, identified by Docket No. FDA-
2011-N-0179 and/or RIN number 0910-AG65 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. 
  G/SPS/N/USA/690/Add.11 
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   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 access to the docket to read background documents or comments received, go to 
http://www.regulations.gov  and insert the docket number FDA-2011-N-0179, into the "Search" box 
and follow the prompts.   
 For further information contact :  Anthony C. Taube, Office of Regulatory Affairs, Office of 
Regional Operations, Food and Drug Administra tion, 12420 Parklawn Dr., ELEM-4051, Rockville, 
MD 20857, 866-521-2297  
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  
Text can be found on the internet at:  " http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-
10955.pdf " 
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