WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/704/Add.2 
12 May 2011  
 (11-2420) 
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
. 
 
_______________ 
 Criteria Used to Order Administrative Detention of  Food for Human or Animal Consumption, Interim 
final rule; request for comments  
 The US Food and Drug Administration (FDA) is  amending its regulations on administrative 
detention of food for human or animal consum ption.  As required by the FDA Food Safety 
Modernization Act (FSMA), FDA is issuing this inte rim final rule to change the criteria for ordering 
administrative detention of human or animal food.  Under the new criteria, FDA can order 
administrative detention if there is reason to beli eve that an article of food is adulterated or 
misbranded.  This will further help FDA prev ent potentially harmful food from reaching U.S. 
consumers and thereby improve the safety of the US food supply.  The interim final rule was 
published in Federal Register of 5 May 20 11 (76 FR 25538) and can be found at:  
http://www.gpo.gov/fdsys/pkg/FR -2011-05-05/pdf/2011-10953.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) (Public Law 107-188), was signed into law on 12 June 2002.  Among 
other things, the Bioterrorism Act amended the FD &C Act by adding subsection (h) to section 304.  
This provision provided FDA the authority to order th e detention of any article of food if during an 
inspection, examination, or investigation an FDA of ficer or qualified employee finds there is credible 
evidence or information indicating that the article of  food presents a threat of serious adverse health 
consequences or death to humans or animals.  Th e Bioterrorism Act also amended the FD&C Act by 
adding subsection (bb) to section 301 (21 U.S.C. 331), making it a prohibited act to move an article of 
food in violation of a detention order or to remove or alter any mark or label required by a detention 
order that identifies an article of food as detained   In accordance with the Bioterrorism Act, FDA 
issued a notice of proposed rulemaking (proposed rule ) in the Federal Register  of May 9, 2003 (68 FR 
25242) http://www.fda.gov/OHRMS/DOCKETS/98fr/03-11459.pdf , proposing procedures for the 
administrative detention of an article of food.  In  the Federal Register of 4 June 2004 (69 FR 31660) 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-12366.pdf , the Agency issued the final rule 
establishing the procedures for administrative deten tion, including among other provisions the criteria 
for ordering administrative detention.  The administ rative detention regulations have been codified at 
Title 21, Code of Federal Regulations (CFR) Part 1, Subpart K (21 CFR part 1, subpart K).  This 
interim final rule amends those regulations.  Speci fically, the interim final rule is amending §§ 1.378 
and 1.393(a) by replacing the existing criteria used  to order administrative detention with the new 
criteria required by section 207 of FSMA. G/SPS/N/USA/704/Add.2 
Page 2  
 
  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 Administrative Detention of Food for Human or Animal 
Consumption final rule G/SPS/N/USA/704/Add.1 
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: 
 Comments on this interim final rule can be submitted either electronically or written by 
3 August 2011.  You may submit comments, iden tified by Docket No. FDA-2011-N-0197 and/or RIN 
number 0910-AG67, 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  rulemaking.  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. 
 
  G/SPS/N/USA/704/Add.2 
 Page 3 
 
 
   Docket :  For access to the docket to read backgrou nd 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. 
 For Further Information Contact
:  William A. Correll, Jr., Office of Compliance, Center for 
Food Safety and Applied Nutrition, Food and Drug  Administration,  5100 Paint Branch Pkwy.,  
College Park, MD 20740, 301-436-1611  
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-ma il:  us.spsenquirypoint@fas.usda.gov 
Text available on the internet at:  http://www.gpo.gov/fdsys/pkg/FR -2011-05-05/pdf/2011-10953.pdf   
 
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