. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/690/Add.8 
11 November 2008  
 (08-5487) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
NOTIFICATION  
 
Addendum
 
 
 
The following communication, received on 10 November 2008, is being circulated at the 
request of the Delegation of the United States . 
 
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 Final Rule; Regulation Implementing Title III of th e Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002; Section 30 7:  Prior Notice of Imported Food (Docket No. 
FDA-2002-N-233) (formerly Docket No. 2002N-0278)  
 
Prior Notice Final Rule Draft Compliance Policy Guide Sec. 110.310—“Prior Notice of Imported 
Food Under the Public Health Security and Biote rrorism Preparedness and  Response Act of 2002” 
(Docket No. FDA-2007-D-0487) (formerly Docket No. 20070-0260)  
 
On 7 November 2008, the US Food and Drug Ad ministration (FDA) published in the Federal 
Register a final rule implementing Section 307 of  the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Bioterr orism Act):  Prior Notice of Imported Food 
Shipments (Docket No. FDA-2002-N-233) (formerly Do cket No. 2002N-0278).  As with the interim 
final rule (10 October 2003; 68 FR 58974), the final rule requires the submission to FDA of prior notice of food, including animal feed, that is impor ted or offered for import into the United States.  
The final rule requires that the prior notice be submitted to FDA electronically via either the US 
Customs or Border Protection (CBP) Automate d Broker Interface of the Automated Commercial 
System (ABI/ACS) or the FDA Prior Notice System Interface (PNSI).  The final rule retains the 
timeframes from the interim final rule:  information must be subm itted and confirmed electronically 
as facially complete by FDA for review no less than eight hours (for food arriving by water), four hours (for food arriving by air or land/rail), and tw o hours (for food arriving by land/road) before the 
food arrives at the port of arrival.  The final rule  permits prior notice submissions to be submitted no 
more than 15 calendar days before the anticipated date of arrival for submissions made through PNSI 
and no more than 30-calendar days before the anticip ated date of arrival for submission made through 
ABI/ACS, instead of the five-calendar days requi red in the interim final rule.  Food imported or 
offered for import without adequate prior notice is su bject to refusal and, if refused, must be held. 
 
The complete text of the Final Rule contai ned in the Federal Register (FR), 73 FR 66294 
(available in English) can be found on the Internet at:   http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-26282.pdf
.  
 
Further information can be found on the FDA web site at 
http://www.fda.gov/oc/bioterrorism/bioact.html .   
 G/SPS/N/USA/690/Add.8 
Page 2  
 
  FDA also published on 7 November, 2008, the Prior Notice Final Rule Draft Compliance 
Policy Guide (CPG) that describes our enforcement st rategy for the final rule.  Although comments on 
the CPG may be submitted at any time, to ensure  that FDA considers comment on the draft CPG 
before it begins work on the final version of the CPG, comments should be submitted by 
8 December 2008.  Submit written comments on the draft CPG to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fish ers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.regulations.gov
.  The guidance document can 
be found at http://www.fda.gov/ora  under "Compliance References." 
  
The complete text of the Notice contained in the Federal Register (FR), 73 FR 66411 
(available in English) can be found in the Internet at 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-26281.pdf .  
 
For further information contact:  Laura Draski, Office of Regulatory Affairs (HFC-100), Food 
and Drug Administration, 5600 Fishers La ne, Rockville, MD 20857, 866-521-2297 
 
 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) 690 0677;  E-ma il:  us.spsenquirypoint@fas.usda.gov 
 
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