Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 111/2/19
29 July 2015
Dear Sirs,
Commercial Information Circular No. 737/2015
US : User Fee Programme to Provide for Accreditation of Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
The US Food and Drug Administration (FDA) has published a proposed rule to support a new programme under the FDA Food Safety Modernization Act (FSMA). Under the new programme, certifications issued by accredited certification bodies (CBs) will be used by importers applying for expedited review through the Voluntary Qualified Importer Programme and may also be required by the FDA as a condition of granting admission into the US when certain food safety risks have been identified. FDA will receive comments on the proposed rule by 7 October 2015.
BACKGROUND
2.FSMA, enacted on 4 January 2011, gives the FDA important new tools to better ensure the safety of imported food and one of these tools is a new programme authorised by section 307 of FSMA for third-party auditing and certification of eligible foreign entities, including registered foreign food facilities that meet the US' applicable requirements.
3.On 29 July 2013, the FDA published for public comment in the Federal Register (FR) a proposed rule that the FDA would recognise accreditation bodies (ABs) to accredit CBs, except for limited circumstances in which the agency may directly accredit CBs. Among other things, the proposal includes eligibility requirements for ABs to qualify for recognition and requirements that ABs participating in the FDA programme much meet as well as eligibility requirements for CBs to qualify for accreditation and requirements that CBs choosing to participate in the FDA programme must meet.
DETAILS
4.The FDA is now proposing to (1) amend the 23 July proposed rule on the accreditation of third-party auditors and certification bodies to conduct food safety audits of eligible foreign entities (including registered foreign food facilities) and issue food and facility certifications, and (2) establish a reimbursement (user fee) programme to assess fees and require reimbursement for the work performed to establish and administer the system for the accreditation of third-party auditors. The user fee proposal includes provisions on parties subject to a user fee, computation of the user fee, FDA notification to the public of annual fee rates, collection of the user fee, and consequences derived from the failure to pay a user fee.
5.The comment period on the July 2013 proposed rule closed on 27 January 2014, and the FDA is currently working on the final rule. Since the new user fee proposed rule is based on the accreditation of third-party auditors proposed rule, it will be aligned with the accreditation of third-party auditors final rule when it is finalized.
6.Electronic comments can be submitted to Federal eRulemaking Portal at http://www.regulations.gov. For further details of the user fee programme, please refer to the FR notice at http://www.gpo.gov/fdsys/pkg/FR-2015-07-24/pdf/2015-18141.pdf.
ENQUIRIES
7.For enquiries concerning this circular, please contact Mr Lewis LAU at telephone number 2398 5405.
Yours faithfully,
(Miss Janice LAU)
for Director-General of Trade and Industry