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. 738/2015
US : FDA's Draft Guidance for Industry and Food and Drug Administration Staff : Third-Party Auditor/ Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
The US Food and Drug Administration (FDA) announced in the Federal Register (FR) of 24 July 2015 the availability of a draft guidance for industry and FDA staff entitled "Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards." The draft guidance, when finalized, will contain FDA recommendations on third-party auditor/certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA programme required by the FDA Food Safety Modernization Act (FSMA). The relevant FR notice is available at http://www.gpo.gov/fdsys/pkg/FR-2015-07-24/pdf/2015-18142.pdf. FDA will receive comments on the draft guidance by 7 October 2015.
DETAILS
2.In developing the draft guidance, the FDA considered several voluntary consensus standards for their relevance to the qualifications of third-party auditors/certification bodies that would certify foreign food facilities and/or their foods for conformance with the requirements of the Federal Food, Drug, and Cosmetic Act. The agency also sought to identify the standards most commonly used by stakeholders (e.g., other governments, public and private accreditation bodies, the food industry and the international standards community) in qualifying third-party auditors/certification bodies for conducting food safety audits.
3.The draft guidance document is issued as a companion to the proposed rule "Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications" that was published in the Federal Register of 29 July 2013 (http://www.gpo.gov/fdsys/pkg/FR-2013-07-29/pdf/2013-17994.pdf). When this guidance is finalized, it will serve as a companion guidance document to the final rule. The draft guidance is available at FDA's website: http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM455331.pdf. Electronic comments can be submitted to http://www.regulations.gov.
ENQUIRIES
4.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