As has been widely reported, Jensen Farms facility was audited by Primus Labs’[1] agent Bio Food Safety on July 25, 2011, mere days before the first illness was reported.  Auditor James Dilorio gave the facility a “superior” rating, and a score of 96%, noting that many of the pieces of equipment, and many of the packing procedures in place that the FDA found so problematic, were in “total compliance.”  Undoubtedly, auditing companies will respond, and have in fact done so, that they only conduct the type of audit they are asked to do, but this argument goes only so far when juxtaposed against the egregious safety, processing, and equipment failures that lead to this outbreak.

Mr. Dilorio did identify several deficiencies in his facility audit, which lasted just over four hours, including three “major deficiencies”:  (1) wood, which is a material universally known for its propensity to act as a reservoir for contamination, was used in the construction of 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.  Dilorio also identified multiple “minor deficiencies” and non-compliances, including:  (1) the storage area was left open during operating hours; (2) there were no records of corrective actions taken based on previous audits; and (3) stickers on pest control devices were in the wrong location.

These violations certainly were properly noted, regardless of the type and style of audit that Frontera required.[2]  But the truth, however, is that Mr. Dilorio failed to deduct points for several other non-compliances that may have caused Jensen Farms to automatically fail.  All of the following must be considered alongside what is not only the obvious, but also the stated, primary concern for Primus audits:  “Auditors should interpret the questions and conformance criteria in different situations, with food safety and risk minimization being the key concerns.”[3]

Pest Control:  GMP section 1.2.1 clearly states that all product must be free of pests, and that any down score in this section requires an automatic failure.  Mr. Dilorio noted that, on this issue, Jensen’s facility was in total compliance, and that “all products are free from pests or any evidence of them.”  At section 2.5.10, however, Mr. Dilorio noted that inbound packaging loads “arrive[] in open bulk wagons.”  Leaving aside the issue of the condition of the wagons, it was not possible for Jensen to assure pest-free product at its facility using open wagons for transport when any number of birds, rodents, or other pests had open and free access.  Moreover, section 2.5.13 indicates that there was no effective check for pests on incoming loads, but stated as justification for no down score on this issue that “[p]roduct arrives to the facility in open bulk wagons to be packed.”  This is not merely a failure of Primus’s standards regarding the control of pests, it is a clear violation of good manufacturing and agricultural practices and industry standards due to the uncontrolled potential that the system created for product to become contaminated.  When coupled with the lack of an effective system for ridding incoming product of pests and other contamination prior to packaging, this failure should have been noted, and should have constituted an automatic failure under Primus’s standards.  Again, in Primus’s own words, “each question and conformance have to be looked at individually and scored according to the severity of the deficiency, the number of deficiencies and the associated risks.”

Packing Machinery:  As is detailed below, Pepper Equipment Company sold Jensen packing equipment that was not in adequate repair, and was not properly designed for the safe processing of cantaloupe.  The equipment was made for processing potatoes, a different agricultural commodity requiring different packing equipment.  The equipment could have been updated to include new brushes designed for cantaloupes[4] (clearly a different size and shape than potatoes, requiring different equipment to clean them), an injections system designed for microbiological chemicals, dryers to eliminate microbiological contamination, and the addition of stainless steel parts in place of wood, which would have allowed this machine to be effectively and regularly sterilized.  This equipment implicated section 1.6.3, which asked whether “equipment design and condition (e.g. smooth surfaces, smooth weld seams, non-toxic materials, and no wood) facilitate effective cleaning and maintenance?”  Clearly, as the FDA’s environmental assessment showed, the design of Jensen’s equipment in place at the time of Primus’s audit did not allow for this—a critical failure that was, admittedly, exacerbated by Jensen’s inattention to the condition of its facility.  Nevertheless, Mr. Dilorio noted that, with regard to section 1.6.3, Jensen’s facility was in total compliance.

The Further Control of Pests:  Jensen’s facility was not secure, as is evidenced by Mr. Dilorio’s four point deduction at section 1.9.8.  Further, raw product was stored both inside and outside the packing facility, without adequate control anywhere for pests.  Although Mr. Dilorio deducted points for the several doors that were left open during hours of operation, this non-compliance must be viewed in the broader context of whether Jensen’s facility and operations were properly controlling for pests and likely routes of contamination.  Clearly it was not, and Primus cannot be allowed to divorce itself completely from the obligations that it undertook in auditing Jensen Farms by thinly asserting that there was not a category broad or comprehensive enough to require failure for Jensen’s obvious food safety deficiencies.

Lack of an Antimicrobial Cleaner for Equipment:  Not only was Jensen not using an antimicrobial in its wash system, but also it was not using one to clean critical pieces of processing equipment.  Instead, it favored “Simple Green Pro 5,” which does not contain an antimicrobial.  Mr. Dilorio made the right observation, but stated that the failure was of no consequence (“N/A”), and that Jensen’s score therefore was “not affected.”  Mr. Dilorio clearly considered and appreciated the threat that this practice posed, however, as he noted specifically in his comments to section 1.4.8 that “product is washed with water only at this facility and there is no anti-microbial solution injected.”

Lack of Any Hot Water at Handwashing Stations:  There is no more basic food safety requirement than the effective cleaning of hands.  Any standard, including both the fresh produce industry’s and Primus’s, must include the use of hot water.  Mr. Dilorio noted that this was a major deficiency, deducting 10 points from Jensen’s score, but failed to recognize that this very elementary deficiency, by itself or in combination with Jensen’s other major deficiencies, constituted an unsatisfactory condition that required automatic failure, not a superior rating.

Standing Water:  Jensen’s facility may not have had standing water at the time of Mr. Dilorio’s audit.  Certainly, the facility was as sparkling as it could possibly have been, given that the audit was pre-scheduled and well-prepared for by both Jensen and Frontera.  But the facility was designed such that water had a propensity to pool, which created a contamination reservoir.  Coupled with the lack of an effective barrier for pests, both in the facility and outside, this floor design presented a contamination risk for everything in the facility.  Mr. Dilorio should have downscored Jensen as a result, if not failed Jensen for creating an unsatisfactory condition under USDA audit guidelines.

No Routine Environmental or Water Microbiological Testing:  Jensen did not routinely conduct microbiological testing of environmental, water, or finished product samples.  This is in violation of section 1.4.8 of Primus’s audit manual at page 26, where the “major deficiency” categories all assume that an antimicrobial is being used in the first place.  The tests contemplated in that section are to ensure that antimicrobial concentration is correct.  Clearly, the lack of an antimicrobial anywhere in the facility, and the corresponding lack of microbiological testing to ensure that the equipment and water are not a source, or potential source, of contamination, must also be a major violation.  Again, Primus auditors are cautioned in their audit manual to have “food safety and risk minimization” as their “key concerns.”

Failure to Precool Melons:  Jensen did not pre-cool its melons at all, whether by forced air, water, or any other method.  This is a violation of all good agricultural and manufacturing practices for melons, and is inconsistent with standard industry practice, which may vary with respect to the practice used, but does not simply ignore cooling altogether.

Backflow Prevention Deficiency:  This non-compliance, for which Mr. Dilorio gave Jensen zero out of three points, must be judged, like everything else in his audit, against the backdrop of a facility washing a raw agricultural product without the use of an antimicrobial.  Just as it should have suggested to Mr. Dilorio, the lack of an antimicrobial heightened the risks to consumers presented by Jensen Farms’ many other safety failures.  More specifically, backflow prevention is critical to ensuring that contaminated water is not recirculated.  Mr. Dilorio issued zero points on this item, thus establishing that there was a problem.  Whether that meant that the check valve was missing entirely, or that the system simply had not been checked or monitored regularly, this is an item that, viewed in a vacuum, may seem innocuous, but viewed with the backdrop of food safety and risk minimization as “key concerns” achieved far greater significance.

[1]           Primus Labs is one of the nation’s largest third-party food safety auditors.  Primus Labs conducts approximately 15,000 audits per year, primarily involving fresh produce facilities, for over 3,000 clients worldwide.  A typical facility is audited once per year, and a Primus Labs audit results in a pass/fail determination, a score from 0-100%, and a report that lists any violations.  Passing scores can differ greatly:  a company can pass with comment, pass without comment, or pass with either major or minor compliance issues.  A company fails if it has one “egregious” non-compliance or if it scores less than 80% overall.  According to Primus Labs, the vast majority of the thousands of audits it conducts each year receive passing grades:  98.7% in 2010, 97.5% in 2009, and 98.1% in 2008.

[2]           In fact, the “type and style” of the Jensen Farms audit required by Frontera, no doubt at the insistence of major retailers like Walmart, was a checklist style audit to ensure compliance with industry standards for the safe production of cantaloupes.

[3]           This quotation is from Primus’s audits manual, revised in November 2011, after it was sued in the Wilcox matter.  The manual goes on to state, “[w]here laws, commodity specific guidelines and/or best practice recommendations exist and are derived from a reputable source these practices and parameters should be followed if they present a higher level of conformance than those included in the audit scheme system.”

[4]           Pepper did sell Jensen “1/2 share of brushes for washer,” so the exact configuration of this equipment is not yet fully known.