Commercial Information Circulars

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

Ref : EIC 111/2/19

6 May 2011

Dear Sirs,

Commercial Information Circular No. 266/2011

US : Criteria used to Order Administrative Detention of Food for Human or Animal Consumption

The US Food and Drug Administration (FDA) issued in the Federal Register (FR) of 5 May 2011 an interim final rule to change the criteria for ordering administrative detention of food for human or animal consumption, as required by the FDA Food Safety Modernization Act (FSMA). Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This interim final rule will be effective as from 3 July 2011. Interested parties may submit comments to the FDA by 3 August 2011. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10953.pdf.

DETAILS

2. FDA's existing regulations on administrative detention of food for human or animal consumption, as codified at Title 21, Code of Federal Regulations Part 1, Subpart K (21 CFR part 1, subpart K), were established after the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). The provisions of the Bioterrorism Act provided FDA the authority to order the detention of any article of food if during an inspection, examination, or investigation an FDA officer or qualified employee finds there is any credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. The detention period can be up to 30 calendar days. The regulations (21 CFR part 1, subpart K) are available at the FDA's website at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1&showFR=1&subpartNode=21:1.0.1.1.1.9.

3. The trade has been informed via Commercial Information Circular No. 29/2011 that the FSMA was enacted on 4 January 2011 to amend the FD&C Act with respect to the safety of the food supply in the US. Section 207 of FSMA amends the criteria for ordering administrative detention of human or animal food in the relevant FDA regulations as follows:

"An officer or qualified employee of FDA may order the detention of any article of food that is found during an inspection, examination, or investigation under the act if the officer or qualified employee has reason to believe that the article of food is adulterated or misbranded."

Decisions regarding whether FDA has a "reason to believe" a food is adulterated or misbranded would be made on a case by case basis because such decisions are fact specific. Please refer to the FR notice for details of the changes.

4. For the latest information regarding the FSMA, traders are advised to visit the website of the FDA at http://www.fda.gov/Food/FoodSafety/FSMA/default.htm. Traders are also strongly advised to seek clarifications with their importers in the US in order to comply with the necessary requirements.

ENQUIRIES

5. For enquiries concerning this circular, please contact the undersigned at telephone number 2398 5682.

Yours faithfully,

(Miss Carmen CHAN)
for Director-General of Trade and Industry