Jan 11, 2012 (CIDRAP News) – A private food-safety auditor gave Jensen Farms in Colorado a "superior" rating a few weeks before cantaloupes from the farm were linked to a deadly Listeria outbreak, according to a report from a US House committee.
The auditor graded the Jensen Farms operation only on compliance with basic industry standards, not the Food and Drug Administration's (FDA's) produce safety guidance, says the report from the House Energy and Commerce Committee.
Also, the panel found that the operators' decision to buy a piece of used equipment that was later cited by the FDA as a probable factor in the outbreak was based in part on the advice of the private auditor.
Democrats on the committee, in a letter to the FDA, said the report renews concerns about the role of third-party food safety auditors. They noted that similar episodes happened in two other recent disease outbreaks (in 2009 and 2010), in which a peanut processor and an egg producer received high ratings from private auditors shortly before their products were tied to major outbreaks.
Outbreak led to 30 deaths
The Listeria outbreak linked to Jensen Farms cantaloupes in the late summer of 2011 involved 146 cases in 28 states, with 30 deaths, according to official numbers from the Centers for Disease Control and Prevention, making it the deadliest foodborne outbreak in decades.
In its investigation, the House committee's staff interviewed officials from the FDA, Jensen Farms, auditing businesses, and the distributor of the cantaloupes.
The report reviews the FDA's previously reported findings from inspections and environmental sampling at Jensen farms. The FDA found that 13 of 39 samples gathered at the facility on Sept 10 tested positive for Listeria.
In a later inspection the agency identified several safety problems, including the lack of a pre-cooling step before moving cantaloupes into cold storage, design flaws that allowed water to pool near equipment and walkways, washing and drying equipment that had been used earlier on potatoes and was difficult to clean, and the lack of an antimicrobial, such as chlorine, in the water used to wash cantaloupes.
"FDA emphasized to Committee staff that the processing equipment and the decision not to chlorinate the water used to wash the cantaloupes were two probable causes of the contamination," the report states.
The report says food safety audits of Jensen Farms were conducted in 2010 and 2011 by Bio Food Safety Inc., a subcontractor working under Primus Labs. After an audit in August 2010, Jerry Walzel, president of Bio Food Safety, gave the firm a 95% grade, worth a "superior" rating, despite several major and minor deficiencies. At that time the facility was using chlorine in its wash water.
In response to questions from the farm owners about how to make their operation safer, Walzel advised them to replace their hydrocooler with other equipment on grounds that the recirculating water could be a problem, the report states. On the basis of this advice and input from an equipment broker, Jensen Farms bought and retrofitted the equipment previously used to process potatoes.
Facility won grade of 96%
Bio Food Safety audited the Jensen facility again in July 2011, and this time the auditor, James Dilorio, gave the firm a 96% rating, despite noting some "major deficiencies," such as no hot water at hand washing stations, the committee said. Dilorio noted that the company was not using an antimicrobial in its cantaloupe wash water at that time.
The president of Primus Labs, Robert Stovicek, told the panel that his firm's audits aim to "assess whether the client's operations are in compliance with current baseline industry standards—not to improve those standards or push a client towards best practices." Doing the latter would make the company "a rogue element," he said.
Similarly, Walzel of Bio Food Safety told the committee that audited firms lose points if they don't follow FDA regulations, but not if they fail to follow FDA guidance. "Guidelines are opinions . . . regulations are law," he said.
The report observes that the FDA has no specific regulations on cantaloupe processing, only draft guidance that was released in July 2009. "The guidance which Bio Food Safety did not consider in its audit represents the agency's best and most timely advice on how processing should be handled," it adds.
Frontera Produce, distributor of Jensen Farms cantaloupe, said that in response to the outbreak, many major retailers have already begun testing cantaloupe for Salmonella, Listeria, and other pathogens, according to the report. Also, Primus Labs and the FDA said retail stores will now require auditors to take environmental samples when auditing food facilities.
The committee also noted that the FDA does not regulate domestic third-party auditors. But the new FDA Food Safety Modernization Act requires the FDA to set up an accreditation system and standards for auditors of imported foods, and industry observers think this will influence domestic auditing standards as well.
The findings from the Listeria outbreak investigation will be discussed at a conference scheduled tomorrow at the University of California, Davis, the report says.
Jan 10 House committee press release
Jan 10 press release from Democrats on House committee
Letter to FDA from Democrats on House committee
Oct 19, 2011, CIDRAP News story on FDA findings concerning Jensen Farms packing facility