Food Business News - January 31, 2012 - 23

F.D.A. regulations. Auditors did not deduct from the score if an F.D.A. guidance was not being followed. Mr. Walzel was said to have observed “guidelines are opinions … regulations are law” and added, “We are not supposed to be opinionated about this, we are supposed to go by F.D.A. regulations… F.D.A. should have mandated that you cannot sell cantaloupes that have not been sanitized.” Democratic members of the Energy and Commerce Committee sent a letter to Margaret Hamburg, F.D.A. commissioner, on the release of the report. The letter stated, in part, “Weaknesses in third-party auditors represent a signiﬁcant gap in the food safety system because the auditors are often the only entities to inspect a farm or facility. Although the Food Safety Modernization Act has increased the frequency with which F.D.A. inspects facilities like Jensen Farms, the agency is unlikely to inspect these facilities more than once every three to ﬁve years. Like it or not, our food safety system relies heavily on third-party auditors to identify dangerous practices and prevent contaminated foods from reaching the market.” The letter made note that the F.S.M.A. requires that with respect to imported foods, the F.D.A. is required to establish an accreditation system and model auditing standards for third-party audits. “While the law requires these steps only for imported foods, industry ofﬁcials told the committee that the F.D.A. standards will inﬂuence the actions of auditors inspecting domestically grown produce as well. We hope that F.D.A. will consider our ﬁndings when drafting these rules, and we suggest the F.D.A. consider developing a voluntary model program for domestic auditors that could become the standard

of care for third-party auditing programs in the United States.” David Acheson, a partner at the law ﬁrm of Leavitt Partners with expertise in food and import safety, said he didn’t believe the statement that “guidelines are opinions … regulations are law” was indicative of the perception and practices followed by the industry and/or its auditors. “But if that is a view, the consequence will

herald the end of self-policing and ensure that all good manufacturing practices and guidance documents become regulation,” Mr. Acheson said. “The issue of what to do about F.D.A. guidance versus regulations is not new. The fact that one does not have to follow guidance is true in a literal sense. But from a practical perspective, any company that does not follow F.D.A. guidance is, quite frankly, looking for trouble.” FBN

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January 31, 2012

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Food Business News - January 31, 2012

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