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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
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Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 111/2

14 December 2004

Dear Sirs,

Commercial Information Circular No. 323/2004

US : FDA Announced Final Rule on Establishment and Maintenance of Records and Draft Guidance for Records Access Authority

Further to Commercial Information Circular (CIC) No.141/2003 dated 15 May 2003 and CIC No. 152/2004 dated 4 June 2004, the US Food and Drug Administration (FDA) has recently published a fact sheet and a Federal Register (FR) notice of 9 December 2004 announcing the final rule on the establishment and maintenance of records under the Bioterrorism Act. The FDA has also announced in another FR notice of the same date to seek public comments on the draft Guidance for Records Access Authority.

Details

(a) Final Rule on Establishment and Maintenance of Records under the Bioterrorism Act

  1. According to the fact sheet at Annex A (pdf format), the final rule applies to US' domestic persons (excluding farms, restaurants and certain others) that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the US; and persons who place food directly in contact with its finished container. For these regulations, the term "persons" includes individuals, partnerships, corporations, and associations.
     
  2. In gist, the rule requires records to be created when food is received, released or transported. The period for which the records must be retained ranges from six months to two years, depending on the perishability of the food. When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences for death to humans or animals, records or information must be available for inspection by FDA as soon as possible, not to exceed 24 hours from time of receipt of the official request.
     
  3. All businesses covered by this rule must comply within 12 months from 9 December 2004 (i.e. the date of the FR notice), except small and very small businesses. Small businesses (employing fewer than 500, but more than 10 full-time equivalent employees) must comply within 18 months from the date of FR notice, and very small businesses (employing 10 or fewer full-time equivalent employees) have to comply within 24 months from the date of the FR notice.
     
  4. In view of its bulkiness, the relevant FR notice is not annexed to this circular. Interested parties may wish to download the FR notice from the US Government's website at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26929.pdf. Hard copies are also available at the Information Counter on G/F of the Department.
     
  5. For further information on the final rule, please contact Nega Beru, Center for Food Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1400.

(b) Draft Guidance for Records Access Authority

  1. The FDA announced in an FR notice of 9 December 2004 (Annex B (pdf format)) the availability of a document entitled "Draft Guidance for Records Access Authority". The draft guidance (Annex C (pdf format)) is intended to clarify the circumstances under which FDA may access and copy records under the Bioterrorism Act and establish procedures to exercise its authority. Interested parties may send their written comments on the draft guidance by 24 January 2005 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or by e-mail: http://www.fda.gov/dockets/ecomments.
     
  2. For further information on the above draft guidance, please contact Rudaina Alrefai, Division of Compliance Information and Quality Assurance (HFC-240), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-632-6815, e-mail: rudaina.alrefai@fda.hhs.gov.

ENQUIRIES

  1. For enquiries about the content of this circular, please contact the undersigned at telephone number 2398 5403.

     

Yours faithfully,



(Ms Charmaine LO)

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.