Commercial Information Circulars

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

Ref : EIC 111/2/19

2 August 2011

Dear Sirs,

Commercial Information Circular No. 462/2011

US : Domestic and Foreign Food Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012

The US Food and Drug Administration (FDA) issued in the Federal Register (FR) of 1 August 2011 a notice to announce the fiscal year (FY) 2012 fee rates for certain domestic and foreign food facility reinspections, failure to comply with a recall order, and importer reinspections that are mandated in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective from 1 October 2011 to 30 September 2012. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19331.pdf.

DETAILS

2.The FSMA provides the FDA with authority under Section 743 of the FD&C Act to assess and collect from users three different kinds of fees to fully capture the costs incurred by the following activities: (i) certain domestic and foreign food facility reinspections, (ii) failure to comply with a recall order, and (iii) certain importer reinspections. Taking into account the staff costs incurred in FY 2010 and the inflationary factors, the FDA announces the fee rates for the above activities for FY 2012 at an hourly rate of US$224 if no foreign travel is required and at an hourly rate of US$335 if foreign travel is required. These fees are effective from 1 October 2011 and will remain in effect through 30 September 2012. In respect of foreign food facility reinspections, the FDA will send the invoice for the fees to the US agent for the foreign food facility who is responsible for paying the fee. Please refer to the above mentioned FR notice for the assessment and other details of the fees. The FDA is accepting comments to these user fees and intends to consider such comments in implementing the user fees in FY 2013. Interested parties may submit comments to the FDA by 31 October 2011.

3.Separately, the US Congress has directed the FDA to publish, within 180 days of enactment of the FSMA, a proposed set of guidelines in consideration of the burden of fee amounts on small business. In this regard, the FDA issued an FR notice on the same day to seek public comment on whether a reduction of fees or other consideration for small business is appropriate, and if so, what factors the FDA should consider for each. The FDA is also seeking public comment on how small business should be defined and recognized. Interested parties may submit comments and relevant data to the FDA by 17 October 2011. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19333.pdf.

4.The FDA has recently updated the FAQs posted in its designated FSMA website in relation to the FY 2012 user fees. The FAQs are available at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247559.htm#fees. 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