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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

12 December 2003

Dear Sirs,

 

Commercial Information Circular No. 303/2003

US : Announcement of Transitional Compliance Policy
on Food Imports Under the Bioterrorism Act

Further to Commercial Information Circular No. 299/2003 dated 8 December 2003, the US Food and Drug Administration (FDA) and the US Bureau of Customs and Border Protection (CBP) issued on 11 December 2003 a compliance policy guide that describes their strategy for maintaining an uninterrupted flow of food imports while improving their safety in accordance with the Bioterrorism Act. A copy of the policy guide is at Annex A and is also available at http://www.cfsan.fda.gov/~pn/cpgpn.html.

2. In addition, the FDA has posted to its website a list of questions and answers (Q&A) regarding registration of food facilities. A copy is at Annex B and can also be found at 
http://www.cfsan.fda.gov/~dms/ffreguid.html#fn1 .

DETAILS

Compliance Guidance Document

3. Whilst the interim final rules on registration of food facilities and prior notice becomes effective on 12 December 2003 (US time), FDA and CBP expect a "good faith" effort at compliance. As stated in the compliance guidance document, the two agencies will primarily rely on educating the affected firms and individuals during the next eight months following the effective date:-

  1. For shipments of food other than those mentioned in (b) below, the two agencies will utilize communication and education initiatives, escalating imposition of civil monetary penalties, and ultimately refusal of shipments to achieve compliance with the prior notice requirements. This phase-in period will end on 12 August 2004. During this period, FDA and CBP will generally use civil monetary penalties and refusals only in response to repetitive, flagrant and other serious violations. For more details, please refer to Table 1 of Annex A.
     
  2. Regarding food mailed, brought or accompanied to the US by individuals for non-personal use, the guidance document makes clear that FDA and CBP generally will continue their education efforts and will not refuse its admission before 12 August 2004 because of inadequate or lacking prior notice. Please refer to Tables 2 & 3 of Annex A for more details.

Q & A Document

4. The document sets out a list of questions and answers regarding the registration of food facilities. Worth noting is Q.13-14 and 21 which provides clarification on the definition of facilities that hold food as well as the liability of the US agent for foreign facilities.

ENQUIRIES


5. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5403.

Yours faithfully,


(Ms. Shirley TSE)
for Director-General of Trade and Industry



Note : While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.