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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city
MY COLOUR

Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

24 November 2008

Dear Sirs,

Commercial Information Circular No. 587/2008

US : FDA Announced Final Rule on Prior Notice of Imported Food under the Bioterrorism Act

The US Food and Drug Administration (FDA) announced in the Federal Register (FR) notice of 7 November 2008 the final rule making changes to the interim final rule (IFR) on prior notice of imported food under the US Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). The final rule will be effective on 6 May 2009. 

DETAILS

  1. The trade was informed via Commercial Information Circular No. 258/2003 that the FDA issued an IFR requiring the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the US beginning on 12 December 2003.
     
  2. The final rule requires that the prior notice be submitted to FDA electronically via either the US Customs and Border Protection (CBP) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. The final rule made certain changes to the IFR including definitions, period and method of submitting the prior notice to FDA and information required in a prior notice. Details of the changes are set out in the FR notice.
     
  3. FDA has also made available a draft Compliance Policy Guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002". The draft CPG provides written guidance to FDA's and CBP's staff on enforcement of Section 307 of the Bioterrorism Act and the agency's implementing regulations, which require prior notice for food imported or offered for import into the US. This guide is available at http://www.cfsan.fda.gov/~pn/cpgpn7.html. Interested parties may submit comments on this document by 8 December 2008.
     
  4. Due to bulkiness of the final rule, it is not appended to this circular for reference. A copy of the FR notice can be downloaded from: http://edocket.access.gpo.gov/2008/pdf/E8-26282.pdf. Traders are advised to visit FDA's website at http://www.cfsan.fda.gov/~pn/pnoview.html for the latest information about the implementation of the final rule on prior notice of imported food.

ENQUIRIES

  1. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.

Yours faithfully,




(Miss Bonny CHAO)

for Director-General of Trade and Industry