. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/32/Add.4 
19 April 2004 
 (04-1750) 
Committee on Technical Barriers to Trade Original:  English 
  
NOTIFICATION 
 
Addendum  
  
 
The following communication, dated 15 April 2004, is being circulated at the request of the 
Delegation of the United States . 
 
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Under Item 10 , the final date for comments should read 14 May 2004.   
 
 
 In addition, the United States has requested th at the following supplementary information be 
circulated:  
Interim Final Rule; Regulation Implementing T itle III of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002;   Section 305:  Registration of Food Facilities 
(Docket. No. 2002N-0276) 
 
The U.S. Food and Drug Administration (FDA) is reopening for 30 days, on a limited range 
of issues, the comment period for FDA's interim fi nal rule (IFR), "Registration of Food Facilities 
Under the Public Health Security and Biote rrorism Preparedness and Response Act of 2002" 
published in the Federal Register of October 10, 2003 (68 FR 58894).  The IFR requires domestic and 
foreign facilities that manufacture/process, pack, or  hold food for human or animal consumption in 
the United States to register with FDA by December 12, 2003.  
FDA is taking this action consistent with its statement in the preamble of the registration IFR 
that it would reopen the comment period for an additi onal 30 days to ensure that those commenting on 
the IFR have had the benefit of FDA's outreach and educational efforts and ha ve had experience with 
the systems, timeframes, and data elements of the registration program.  Accordingly, we are seeking 
comments on the following issues in order to improve FDA's economic analysis:  1. The cost to foreign facilities of hiring and retaining a U.S. agent.  Specifically, FDA invites 
comment, and the submission of data or other information, on the following: 
 
(a) The costs to a foreign facility of hiring a U.S. agent; 
(b) The number of foreign facilities that have hi red a U.S. agent or negotiated additional 
duties from someone with whom they have an existing relationship in response to the 
IFR, instead of relying on an existing relationship with a person who qualifies as a 
U.S. agent; 
(c) The number of foreign facilities that have ceased exporting to the United States 
because they have decided not to hire/retai n a U.S. agent for registration purposes. G/TBT/N/USA/32/Add.4 
Page 2  
 
(d) The distribution of costs between submitting registrations and other services offered 
by the U.S. agent; 
(e) The assumptions underlying FDA's estimates of the costs of hiring and retaining a 
U.S. agent. 
2. The effects on domestic small businesses, if an y, if some foreign facilities cease exporting to 
the United States due to the U.S. agent requireme nt for registration.  Specifically, FDA invites 
comment, and the submission of data or other information, on the following: 
(a) The number of domestic small businesses that have been adversely affected by 
trading partners that have ceased exporting to the United States due to the U.S. agent 
requirement for foreign facility registration;  and 
 
(b) The costs incurred by these domestic small businesses due to the loss of these trading 
partners. 
 
Submit written or electronic comments on the above issues by 14 May 2004.  Submit written 
comments on the document to: 
 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 
U.S.A. 
 
It is possible to submit electronic comments to:    
 http://www.fda.gov/dockets/ecomments
.  
 
Submit comments by indicating DOCKET Number 2002N-0276 and title of document 
"Registration of Food Facilities Under the Public He alth Security and Bioterrorism Preparedness and 
Response Act of 2002."  
The complete text of the Notice contained in the Federal Register (FR), 69 FR 19766 
(available in English) can be found in the Internet at 
 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-8516.htm
 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-8516.pdf  
 
In addition, the document can be obtained from: 
 Ms. Melissa S. Scales,  Center for Food Safety and Applied Nutrition (HFS-24) Food and Drug Administration 5100 Paint Branch Pkwy. 
College Park, MD 20740 
Tel.:  301-436-2378. 
 
Further information can be found on the FDA web site at  
 
http://www.fda.gov/oc/bioterrorism/bioact.html
 
 
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