WASHINGTON — A congressional report released Jan. 10 summarizing an investigation into the recent Listeria outbreak traced to cantaloupes grown on a Colorado farm raised concerns about the integrity of third-party safety audits of food facilities, especially given the frequent role of a third-party auditor as the first line of defense in assuring food manufactured under unsafe conditions is prevented from entering the market.

The late-summer outbreak of Listeria monocytogenes, whose source was cantaloupes grown and processed at Jensen Farms, a family-owned operation in Granada, Colo., infected 146 persons in 28 states. Thirty persons died, and one woman miscarried as a result of the outbreak. Yet the Jensen Farms cantaloupe processing facility was inspected by a third-party auditor as recently as July 2011, and that auditor gave Jensen Farms a “superior” rating of 96 on a scale of 100. A year earlier, an auditor from the same firm also gave the facility a superior rating.

Staff of the House Committee on Energy and Commerce in the past few months interviewed the principals involved, including the owners of Jensen Farms; executives of Frontera Produce, which distributed Jen-
sen Farms cantaloupes to re-tailers across the country; the president of Primus Labs, which was selected to conduct audits of the Jensen Farms facility; and the president of Bio Food Safety, whose firm was selected by Primus to provide auditors who actually inspected the facility. Staff also interviewed officials of the Food and Drug Administration, who discussed what the agency found when it inspected the Jensen Farms’ facility in September and October, when it tied the facility to the outbreak.

The FDA investigation revealed several safety deficiencies in the Jensen Farms facility and pointed to two probable causes of Listeria contamination. First was inappropriate cantaloupe processing equipment that itself was difficult to clean. Listeria was found on the felt roller brushes of the unit. And second, no antimicrobial solution, such as chlorine, was added to the water used to wash the cantaloupes. The installation of new equipment, actually used equipment form-erly used to process potatoes and reconfigured to process cantaloupes, and discontinuing the use of an antimicrobial solution in water used to wash cantaloupes both occurred after the 2010 audit and before the 2011 audit.

The FDA officials emphasized to the committee staff that the outbreak likely would not have occurred if Jensen Farms had maintained its facilities in accordance with the existing agency guidance on handling cantaloupe issued in July 2009. They indicated “everything that was found wrong was addressed in the FDA guidance.”

The auditor who inspected the facility in July 2011 indeed noted that no antimicrobial solution was used in cleaning the cantaloupes, but he made no deductions in rating the facility with regard to safety on that account. Staff interviews with Primus Labs and Bio Safety indicated why this was the case.

The report indicated Robert Stovicek, president of Primus, said audits were intended to assess whether the client’s operations were in compliance with current baseline industry standards, not to improve those standards or push a client toward best practices. The report stated Stovicek added Primus Labs would be “a rogue element if they tried to pick winners and losers” by holding industry to higher standards. He also said Primus Labs did not have the expertise to deter-mine which “best practices” should be adopted by the industry.

The report indicated Jerry Walzel, president, Bio Food Safety, said consistent with Primus Labs policy, the Bio Food Safety auditors only deducted from the food safety score if a method or technique used was inconsistent with FDA regulations. Auditors did not deduct from the score if an FDA guidance was not being followed. 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 FDA regulations… FDA 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, FDA 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 FDA 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 FSMA requires that with respect to imported foods, the FDA 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 FDA standards will influence the actions of auditors inspecting domestically grown produce as well. We hope that FDA will consider our findings when drafting these rules, and we suggest the FDA 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,” Acheson said. “The issue of what to do about FDA 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 FDA guidance is, quite frankly, looking for trouble.”