There’s plenty of swarminess to go around in a new report by the U.S. House of Representatives Energy and Commerce Committee on the listeria-in-cantaloupe outbreak of 2011.
That’s what happens when 30 (or 31) people are killed, 1 suffers a miscarriage and at least 146 are sickened from eating some fruit.
The report concludes the outbreak could have been avoided if Jensen Farms of Colorado had maintained its facilities in accordance with existing guidance from the U.S. Food and Drug Administration (FDA), which is not mandatory.
This is nothing new. FDA has been issuing guidance on how to produce safe produce since 1998 and, like spinach and leafy greens and tomatoes, cantaloupe growers now have to act like, oh, we didn’t know.
Fortunately, the vast majority of cantaloupe growers do know how to produce safe product. But any commodity is only as good as its worst performer. Which is why verification matters, and once again, audits, as currently designed, aren’t up to the task.
Not mentioned in the report is the devastating effect the outbreak had on individuals, families, other growers and the flaws in relying on others – in food safety they’re called auditors — to check things out.
Here’s what the various players told the Congressional investigators:
FDA officials cited several deficiencies in Jensen Farms’ facility, which reflected a general lack of awareness of food safety principles and may have contributed to the outbreak, including:
• condensation from cooling systems draining directly onto the floor;
• poor drainage resulting in water pooling around the food processing equipment;
• inappropriate food processing equipment which was difficult to clean (i.e., Listeria found on the felt roller brushes);
• no antimicrobial solution, such as chlorine, in the water used to wash the cantaloupes; and,
• no equipment to remove field heat from the cantaloupes before they were placed into cold storage.
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.
Primus Labs has audited Jensen Farms during the course of Jensen Farms’ relationship with Frontera Produce, beginning in 2003. Primus Labs hired a subcontractor, Bio Food Safety, Inc., to conduct its recent audits of Jensen Farms. On August 5, 2010, Jerry Walzel, the President of Bio Food Safety, audited the Jensen Farms packing facility and gave it a 95% grade – a “superior” rating, despite finding several major and minor deficiencies.
One precaution that Jensen Farms took in 2010, which it dropped in 2011, was to use an antimicrobial solution, such as chlorine, in the cantaloupe wash water. The front page of the August 2010 audit stated, “[t]his facility packs fresh cantaloupes from their own fields into cartons. The melons are washed and then run through a hydro cooler which has chlorine added to the water. Once the product is dried and packed into cartons it is placed into coolers.” After the August 2010 audit was completed, one of the Jensen brothers informed Mr. Walzel that they were interested in improving their processes. According to Jensen Farms, in response to this inquiry, Mr. Walzel indicated that they should consider new equipment to replace the hydrocooler the farm used to process cantaloupe. Mr. Walzel stated that the hydrocooler, with its recirculating water, was a potential food safety “hotspot,” and advised them to consider alternate equipment. Based on his comments, and input from a local equipment broker, Jensen Farms purchased and retrofitted equipment previously used to process potatoes.
The Jenson brothers stated that they changed from the hydrocooler to the new food processing equipment in an attempt to strengthen their food safety efforts.
Jensen Farms stated that they contracted with Primus Labs to perform an audit in July 2011. Again, Primus Labs subcontracted with Bio Food Safety to conduct the audit. Mr. Walzel did not conduct this audit; a new auditor from Bio Food Safety, James Dilorio, conducted the audit on July 25, 2011, and, after spending approximately four hours inspecting the facility, gave Jensen Farms a 96% grade – again a “superior” rating. Despite this high rating, Mr. Dilorio identified several deficiencies, including three “major deficiencies”: (1) wood (which can house bacteria and cause splinters) covered the unloading and packing tables, (2) lack of hot water at hand washing stations, and (3) doors left open during operating hours, potentially allowing pests to enter the facility.
Jensen Farms noted that it received a visit from a representative of Frontera Produce, its distributor, shortly before the 2011 audit. According to the Jensen brothers, this representative provided them with advice about preparing for the audit, but did not note any problems. Jensen Farms informed Committee staff that quality control representatives from various retailers have visited the farm as well. The Jensen brothers stated that based on these inspections and their prior food safety record, they had no concerns about their operations prior to the recent outbreak.
Will Steele and Amy Gates, the CEO and executive vice president of Frontera Produce, told Committee staff that they had visited Jensen Farms to inspect its facilities and provide business advice and both were critical of the current standards for third-party audits and had concerns about inadequate standards.
Ms. Gates indicated that there is “no industry standard for validation points” after an audit, while Mr. Steele stated that “this is the industry standard. I’ve always believed there’s got to be more validation points. This case clearly demonstrates that.”
Robert Stovicek, president of Primus Labs told Committee staff that his company’s role is to conduct an impartial assessment of a client’s operations and provide its findings to the client. He stated that the audits are intended 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. Mr. Stovicek said that Primus Labs would “be a rogue element if they tried to pick winners and losers” by holding industry to higher standards. He also said that Primus Labs did not have the “expertise to determine which best practices should be pushed by the industry.”
Jerry Walzel, the president of Bio Food Safety, told the Committee that – consistent with Primus Labs policy – the audits only deducted from the score if a method or technique was inconsistent with FDA regulations; they did not deduct from the score if FDA guidance was not being followed. … He stated that Bio Food Safety auditors were “roped in by regulation and Primus training,” and that “guidelines are opinions…. regulations are law.”
Additionally, he noted, “we are not supposed to be opinionated on this, we are supposed to go by FDA’s regulations… FDA should have mandated that you cannot sell cantaloupes that have not been sanitized.”
According to Frontera Produce, in response to the outbreak, many major retailers have already instituted end-product testing of cantaloupe to identify Listeria, Salmonella and other pathogens. Frontera Produce officials also informed Committee staff that retailers and industry groups are studying the possible implementation of additional checks at different critical control points in the supply chain, including risk-based assessments and sample testing. Primus Labs noted, and FDA confirmed, that buyers will immediately start requiring auditors to take environmental swabs while auditing food facilities.
Democrats on the House Energy and Commerce Committee, including Rep. Diana DeGette of Denver, also asked the FDA to step up regulation of outside auditors, who they say bring numerous "conflicts of interest" to the food safety system. Excerpts from their letter are below:
The investigation identified significant problems with the third-party inspection system used by growers and distributors to ensure the safety of fresh produce, This auditing system is often the first and only line of defense against a deadly foodborne disease outbreak. …
Our investigation reveals some of the reasons why: the auditors’ findings were not based on the practices of the best farms and failed to ensure that the producer met FDA guidance; the auditors missed or failed to prioritize important food safety deficiencies; the auditors lacked any regulatory authority and did not report identified problems to the FDA or other state or federal authorities; the auditors did not ensure that identified problems were resolved; and the auditors provided advance notice of site visits and spent only a short period of time on-site. It also became apparent in the investigation that the auditors had multiple conflicts of interest.
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 Salmonella 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 (step forward American Institute of Baking). The auditor, AlB, was selected by PCA, it 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. … 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.