That is a key underpinning to Whitaker’s call to use audits and other tools to determine the next actions to take, to focus on the steps required to keep the food supply safe.
It also underpins the arguments Jim Gorny, vice president for food safety and technology for PMA, said later that morning while laying out PMA’s concerns about proposed rules for implementing the Food Safety Modernization Act.
Gorny talked about regulatory and consulting audits in connection with the third-party accreditation rule for importers, one of the proposed rules for implementing the food safety act.
A regulatory audit is done to determine if the facility meets FDA requirements. Those results must be reported to FDA.
A consulting audit is for a business to look at how it complies with FDA rules and takes a wider view. FDA isn’t notified unless there is a major problem. That sounds reasonable, and it has the pleasing feel of putting the hammer down.
However, what constitutes a major problem? Also, this rule could stifle an importing company doing the right thing and using an audit to improve its system.
After all, we know things go wrong and science is messy.
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