FDA Issues Draft Guidance for Industry on Third-Party Certification Programs

Richard Sellers

The FDA published a notice in the Federal Register July 10 that solicits public comments on a draft Guidance for Industry: Voluntary Third-Party Certification Programs for Food and Feeds. AFIA expected such a guidance based on comments in FDA’s Food Protection Plan published late last year. Comments on the draft guidance are due by Sept. 8, 2008.

The draft guidance lays out FDA’s current thinking on certification programs, and AFIA is evaluating the guidance in relation to the way it operates the Safe Feed/Safe Food (SF/SF) Certification Program. This program could qualify for FDA recognition, provided it meets the recommendations in the draft guidance for industry.

In the near future, AFIA will hold a forum for interested members to provide comments to AFIA, while preparing comments on the guidance to FDA. AFIA strongly encourages those firms that have SF/SF-certified facilities and those either involved in obtaining certification or considering obtaining certification to participate in the program.

The draft guidance details a number of requirements for inspectors in certification organizations, requirements for those certified and conflicts of interest requirements for operating organizations. Moreover, FDA would require the certification entity to notify FDA immediately of any finding that a product produced by a certified facility would have the potential to cause serious adverse health consequences or death in humans or animals.

A forum is planned within a month to develop comments for this draft guidance.

For a copy of the guidance, click here.