July 25, 2014

Congress Finds Third-Party Audits Ignore FDA Guidance

A report released today by the House Energy and Commerce Committee found that third-party auditors, which the FDA relies upon to oversee produce growing and processing facilities, often don’t do their jobs according to FDA guidelines. The report was prompted by the deadly Jensen Farms cantaloupe Listeria outbreak that happened late in the summer of 2011.

The report includes interviews with officials at the FDA, Jensen Farms, the cantaloupe distributor Frontera Produce, and the third-party auditors, Primus Labs and their subcontractor, Bio Food Safety, Inc. All involved parties also provided documentation of the outbreak.

The FDA doesn’t have regulations for cantaloupe processing; it only offers guidance to processors and auditors. At the present time, the government can’t close a processing facility if it violates guidelines and it does not regulate the auditors the farms use to confirm they are abiding by good safety practices, even though some kinds of produce are considered “high risk” products that are easily contaminated.

The FDA has guidance documents that have been released over the years about produce, eggs, seafood, dietary supplements, contaminants, additives, and canned foods.

History of the Audits

On August 25, 2010, Bio Food Safety Inc. gave Jensen Farms a 95% grade, which is a “superior” rating, although it found “several major and minor deficiencies.” (A failing score is less than 80%.) This report said that the melons were pre-cooled in chlorinated water before being put into cold storage.

In 2011, the owners of Jensen Farms wanted to improve their food safety processes; Bio Food Safety told them that they should make changes to their system, which the FDA says is an “inherent conflict of interest”, especially since those changes may have caused the outbreak. Jensen Farms bought and retrofitted old equipment that had been used to process potatoes. That was a problem because potatoes are not eaten raw, unlike cantaloupe.

On July 25, 2011, another audit was conducted by Bio Food Safety Inc, and the company was given a 96% grade, even though three major deficiencies were found:

  • The unloading and packing tables were made of wood, which can harbor bacteria
  • Hand washing stations did not have hot water
  • Doors were left open so animals could get into the processing facility

That report also mentioned that pre-cooling was no longer taking place, and the water used to wash the melons was not chlorinated, two major changes from 2010.

One month later, the outbreak began. The cantaloupes had been shipped to 28 states; it sickened people in all of those states. More than 100 people became ill and 30 people died. The outbreak was finally declared over on December 21, 2011.

After the outbreak, in September 2011, the FDA listed several problems they observed during an environment assessment. Those problems, including others observed at later assessments, included:

  • Lack of a pre-cooling step before the cantaloupes were put in cold storage. Coming straight from the fields, the cantaloupes are hot and are usually pre-cooled before being stored.
  • The packing floor and equipment at the facility wasn’t easily cleaned, since it included equipment such as felt roller brushes.
  • Washing and drying equipment had been used on another product.
  • Cooling system condensation was pooling on the floor because of poor drainage.
  • No chlorine in the water that was used to clean the cantaloupes.

Those issues were listed in a warning letter to Jensen Farms from the FDA on October 18, 2011. The FDA stressed that the unchlorinated water and the new processing equipment were the two main probable causes of contamination.

Primus Labs has a history of giving excellent scores on its audits. Most companies pass its audits; in the last three years, more than 97% of facilities passed a Primus audit.

And third party auditors do not have to report their findings to the FDA or any state or federal agency, even when a facility fails the audit. Frontera Produce has said they have never notified any authority about audit results.

Congressional Reaction

Democrats on the House Committee said that, “weaknesses in third-party auditors represent a significant gap in the food safety system.” The Democrats, Henry Waxman, Diana DeGette, Frank Pallone, Jr. and John Dingell, also asked the FDA to enact stricter oversight in a separate letter.

The Democrats said that the auditors had conflicts of interest, they missed some key issues and problems, and they did not report problems the audit uncovered. The letter ends with these words:

The results of the investigation released today reveal numerous problems with the third party auditing system used to inspect the Jensen Farms cantaloupes. These problems are unlikely to be limited to Jensen Farms, however. The officials the Committee interviewed indicated that the practices used at Jensen Farms are similar to those used in thousands of other food safety inspections.

Indeed, the problems identified in the audits of Jensen Farms are similar to those that the Committee identified in food safety investigations in 2009 and 2010. In 2009, following the Sallmonella outbreak in peanut butter products sold by the Peanut Corporation of America (PCA), a Committee investigation revealed that a private, for-profit auditing firm gave the company glowing reviews. The auditor, AlB, was selected by PCA, was paid by PCA, and it reported to PCA. The auditor awarded a “superior” rating to the company’s plant.

Six months after the audit, PCA’s products killed nine people and sickened 691 people.

In 2010, the Committee’s investigation into an outbreak of Salmonella in eggs produced by Wright County Egg revealed the same problems with third-party audits.

Following the outbreak, federal officials inspected Wright County Egg facilities and found serious violations of food safety standards, including barns infested with mice, chicken manure piled eight feet high, and uncaged hens tracking through excrement.

There were very different results when Wright County Egg farms were inspected by AlB. AlB gave Wright County Egg an award two months before the outbreak, rating them “superior” and awarding the company a “recognition of achievement.”

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 have resources available 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.

We believe reforms in third-party audits are essential. We call on you to address the problems identified in this investigation in regulation and guidance. Thank you for your attention to these concerns.

Republicans on the Committee signed the report but did not add their voices to the call for stricter regulations and did not sign the letter. Republicans also did not want to hold a hearing on the report, but simply released it to the public without comment.

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