This list is not intended to be an exhaustive review of the many failures, violations, and non-compliances that a rigorous audit should have identified. Again, the condition of Jensen’s facility on review by the FDA and Colorado State officials simply cannot be reconciled with the glowing review that Mr. Dilorio gave the facility and farms on July 26, 2011.[1] Auditors cannot be as hamstrung as public comments since publication of Mr. Dilorio’s audits have suggested; otherwise, the entire system is a farce. Given the incredible level of contamination that obviously occurred as a result, we feel that any reasonable jury will agree entirely.
Of course, this is clearly not Primus’s view, at least not according to public comments since the date that Mr. Dilorio’s audit was first exposed. Robert Stovicek, president of Primus Labs, has repeatedly defended the audit. “Even though it looks as horrendous as it does,” he stated in an interview with the Denver Post,[2] Stovicek indicated that that he would continue using Bio Food Safety as its auditing agent, that he had full confidence in Mr. Dilorio,[3] and even that Mr. Dilorio did a “good job,”[4] despite not knowing whether Mr. Dilorio had ever even audited a cantaloupe operation before.[5]
One issue not noted in the foregoing list, instead being reserved for discussion here, is Jensen’s failure to use an antimicrobial in the wash system. Mr. Dilorio prominently noted on the front page of his facility audit report that “[t]his a packing facility for cantaloupes which are washed by a spraybar roller system, graded, sorted by size, packed into cartons and stored in dry coolers. No anti-microbial solution is injected into the water of the wash station.”[6]
This was not just a simple violation, or something that Mr. Dilorio should have downscored Jensen’s facility for in some fashion. It was a clear and present threat to human health, and if third-party audits, regardless of their type, are good for anything other than to rubber stamp the requirements of major retailers, it must be to identify exactly this type of hazard, and act in some fashion—e.g. fail the auditee—to ensure that the risk presented is not merely passed along to consumers.
The lack of an antimicrobial solution has been widely criticized by many experts, from the FDA, academia, and industry, as violating good agricultural and manufacturing practices, as well as baseline industry standards for the production of cantaloupes. Further, the lack of an antimicrobial must be viewed alongside Mr. Dilorio’s observation at section 1.4.8 that no antimicrobial was being used during cleaning of Jensen’s equipment either. Any auditor, just like any food processor, must, in part, assume contamination of product so that he or she can objectively and effectively assess the facility’s ability to remove or eliminate the contamination. Assuming contamination of Jensen’s cantaloupes, what could Mr. Dilorio possibly have thought would be the barrier to contamination of finished product? No antimicrobial in the wash system, and none used during cleaning of the equipment is a recipe for exactly the kind of disaster that unfolded—a risk that was only heightened by the inadequacy of Jensen’s operations generally.
We would of course be remiss to fail to point out that, in this case, Mr. Dilorio was more than just an auditor. Public statements made since the circumstances underlying this outbreak came to light have suggested that an auditor’s role, under the prevailing system, is quite limited. Whether true or not, Mr. Dilorio’s role was more than that, causing him, the company that he worked for, and Primus, for whom he was also acting as agent, to undertake a further duty to those in the foreseeable zone of risk created by their actions or inactions. More specifically, in interviews with the House Committee on Energy and Commerce, Eric and Ryan Jensen stated that Mr. Dilorio actually recommended the faulty production equipment, including the potato washer sold to it by Pepper Equipment, and other practices that Jensen Farms had put in place for the 2011 cantaloupe season. See Committee on Energy and Commerce January 10, 2012 letter to FDA Commissioner Margaret Hamburg, Attachment No. 4. “According to FDA officials, there were ‘serious design flaws’ with the equipment that the auditor recommended, and it did not meet basic standards spelled out in FDA guidance.” Id.
The list of liable parties is as broad as the duties that all owed to consumers of Jensen Farms contaminated cantaloupes. Pepper Equipment Company (Pepper) bills itself as a manufacturer of state-of-the-art washing, sorting, and packaging equipment. Further, Pepper indicates on its website that it has particular expertise in manufacturing custom-built equipment “designed to fit your specific needs.”
On May 23, 2011, Pepper sold Jensen Farms a dual sorting table, a Gillenkirch washer[7] and felt dryer, a conveyor for passing fruit from the dryer to the sorting table, and two “conveyors for stickering.” See Pepper/Jensen Sales Documentation, Attachment No. 5. The total price for the equipment was $106,208.00. Thereafter, Pepper employees Keith, Gage, and Chet drove the equipment to Jensen Farms and spent a total of 179 labor hours preparing and installing the new, or used, equipment at Jensen’s packing facility.
The equipment that Pepper sold, manufactured, and installed at Jensen Farms was neither in adequate repair or appropriate[8] for the job it was intended to do. The FDA—in fact, just about every objective observer of this outbreak—has been highly critical of Jensen’s equipment, and the responsibility for the failure of that equipment falls, in part, to the entity most knowledgeable about the proper use of the equipment. The equipment that Pepper sold to, manufactured, and installed at Jensen’s facility was not appropriate, much less state-of-the-art. Again, like so many things in this outbreak, what was billed, prior to the outbreak, as an unwavering commitment to quality and food safety, in the end proved not to be. Pepper’s equipment should never have been sold to, installed at, or used by Jensen Farms for the processing of cantaloupes.
[1] Unlike the audits performed before the Salmonella outbreaks involving the Peanut Corporation of America and Wright County Egg, the Jensen Farms audit was performed during the outbreak.
[2] http://www.denverpost.com/search/ci_19159245
[3] http://www.denverpost.com/search/ci_19159245
[4] http://www.thepacker.com/fruit-vegetable-news/Jensen-Farms-earned-high-third-party-audit-marks-132272688.html
[5] http://www.denverpost.com/search/ci_19159245
[6] The July 2011 audit, however, did not mark the beginning of the relationship between Jensen Farms and Primus/Bio Food Safety. On August 5, 2010, Jerry Walzel, the President of Bio Food Safety, audited the Jensen Farms packing facility and gave it score of 95% grade—another “superior” rating—despite also 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 hydrocooler 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. When questioned by the Committee about his recommendations to Jensen Farms following the 2010 audit, Mr. Walzel indicated that he could not remember whether he had made these recommendations.
[7] Pepper’s website link to this piece of equipment is currently blocked or disabled.
[8] Interestingly, the Gillenkirch website does not indicate that its equipment is suitable for cantaloupe washing. Potatoes, yes, but not cantaloupes.