FSMA Fridays: FDA Access To Records Under FSMA (Part Four Of Four)

On the last Friday of every month, Barbara Levin of SafetyChain, a leading provider of food safety and quality assurance automation, and compliance solutions, hosts FSMA Fridays™, the leading online forum for the food and beverage community to learn the latest information about the FDA’s Food Safety Modernization Act (FSMA). Featuring Dr. David Acheson, the popular monthly interactive pod/webcast is sponsored by SafetyChain Software and The Acheson Group.

In part three of FSMA Fridays: FDA Access To Records Under FSMA, Jill Bender and the Acheson Group panel answered questions from the pod/webcast’s live audience regarding the FDA’s procedures of requesting records through on-site inspections and other means, individual state authority’s power versus the FDA’s power of attaining records, and guidelines for the FDA to attain records under the Freedom of Information Act. Here, in part four of the series, the group continues to answer questions from the live audience.

Jill: Sarah’s asking if the FDA is utilizing the third-party auditing, will they have a safe access, as FDA?

David: That's a really good question. Well, we have to remember that the third-party audit process, under FSMA, is designed exclusively for the issuance of certificates around either high-risk foods or voluntary-qualified importer program. Those are the only two areas where a third-party audit certificate is relevant.

Third-party audits can be used as part of supplier verification program. It's not a requirement, and this is a different animal than an inspection, based on the reasonable probability that your food has caused a serious adverse health event. I do not see any situation where, if the agency things somebody's food has been associated with a serious adverse health event, that they will be sending in a third-party auditor to do any of this. I say no, it's a different animal, and I'm just trying to differentiate apples from oranges here, because the role of the third-party auditor is a very different one than the role we're talking about here, which is records access as a result of an event.

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