Faith-based food safety has to go after audit deception in China: McDonald’s CEO can do better

Not surprisingly, the China meat scandal has widened.

audit.checklist-241x300McDonald’s Corp feels “a bit deceived” by the audit it received for Shanghai Husi Food Co Ltd, a China supplier that was shut down this week after a TV report showed workers mishandling meat, Chief Executive Don Thompson said on Tuesday.

“We are no longer serving product from the primary facility there that has the challenges and the issues,” Thompson said on a conference call after McDonald’s reported lower-than-expected quarterly earnings.

But why would a huge brand rely an audit?

The Shanghai Food and Drug Administration on Sunday halted operations of Shanghai Husi following a Dragon TV report that showed workers picking up meat from a factory floor, as well as mixing fresh meat with meat beyond its expiration date.

The scandal also has ensnared other Shanghai Husi customers, including KFC parent Yum Brands Inc and Burger King Worldwide Inc.

Many U.S. restaurant operators and retailers rely on third-party auditors to check whether their suppliers comply with food safety rules and other regulations. It is not uncommon for suppliers at the center of food safety scandals to have received high marks on their audits.

 We wrote, and repeated here, it’s time to change the discussion and the approach to safe food. Time to lose the religion: audits and inspections are never enough.

• Food safety audits and inspections are a key component of the nation’s food safety system and their use will expand in the future, for both domestic and imported foodstuffs, but recent failures can be emotionally, physically and financially devastating to the victims and the businesses involved;

• many outbreaks involve firms that have had their food production systems verified and received acceptable ratings from food safety auditors or government inspectors;

• while inspectors and auditors play an active role in overseeing compliance, the burden for food safety lies primarily with food producers;

• there are lots of limitations with audits and inspections, just like with restaurants inspections, but with an estimated 48 million sick each year in the U.S., the question should be, how best to improve food safety?

• audit reports are only useful if the purchaser or  food producer reviews the results, understands the risks addressed by the standards and makes risk-reduction decisions based on the results;

• there appears to be a disconnect between what auditors provide (a snapshot) and what buyers believe they are doing (a full verification or certification of product and process);

• third-party audits are only one performance indicator and need to be supplemented with microbial testing, second-party audits of suppliers and the in-house capacity to meaningfully assess the results of audits and inspections;

• companies who blame the auditor or inspector for outbreaks of foodborne illness should also blame themselves;

• assessing food-handling practices of staff through internal observations, externally-led evaluations, and audit and inspection results can provide indicators of a food safety culture; and,

• the use of audits to help create, improve, and maintain a genuine food safety culture holds the most promise in preventing foodborne illness and safeguarding public health.

Audits and inspections are never enough: A critique to enhance food safety

30.aug.12

Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

 

Open letter to the FSA on the publication of Campylobacter survey results

Richard Lloyd of Which? a UK consumer organization, writes to the UK Food Standards Agency to say:

chicken.thermI am writing to express our grave concern about the proposal being put to the FSA Board to withhold information about the levels of the deadly food poisoning bacteria Campylobacter in supermarket chickens. Campylobacter is a major public health issue. 72,000 people were reported to have suffered Campylobacter food poisoning last year and it kills an estimated 100 people every year.

As you know, the main source for the bacteria is in raw chicken which is why the FSA decided to undertake testing across supermarkets, butchers and convenience stores and publish the results on a quarterly basis with information by retailer and processor.

The publication of the performance of each retailer is in the public interest. The FSA should not sit on this survey data which it initially intended to publish in full.

The FSA was set up because of concerns about commercial and political interference in decisions about food safety. It is with great regret that it has become necessary to remind you of your role to put consumers first, be independent and operate transparently.

At your board meeting today, I urge you to reject the proposal to withhold this information and instead to publish the results in full on a quarterly basis in order to provide consumers with this important information and help to drive up standards.

PR before peer review, incomplete advice, damaging food safety reputation

My grade 7 teacher in Canada, Mrs. Patrick, was the grammar police and instilled a strong value in getting things right (write?). My wife has now taken over that role.

powell_soliI explain to students and my kids that grammar is like traffic signals: maybe it’s not efficient but it’s some rules we can agree on so that I can get to the idea of what you’re trying to express.

Science or evidence-based, has its own rules.

Whether it’s a grasp for headlines, funding or ego, press releases before publication continue, and continue to be a bad idea.

Food safety types can do better.

In Sept. 2000, I called Procter & Gamble to substantiate claims their consumer-oriented Fit Fruit and Vegetable Wash removed 99.9 per cent more residue and dirt than water alone.

The PR-thingies hooked me up with some scientists at P&G in Cincinnati, who verbally told me that sample cucumbers, tomatoes and the like were grown on the same farm in California, sprayed with chemicals that would be used in conventional production, and then harvested immediately and washed with Fit or water. The Fit removed 99.9 per cent more, or so the company claimed.

One problem. Many of the chemicals used had harvest-after dates, such as the one tomato chemical that was supposed to be applied at least 20 days before harvest.

That tidbit wasn’t revealed in the company PR accompanying Fit.

Back in 2000 I asked why the results hadn’t been published in a peer-reviewed journal, and the P&G types said it was an important advance that had to be made available to consumers as soon as possible, without the delays and messiness of peer-review.

sorenne.hockeyThings haven’t changed much. What I still don’t quite comprehend is why researchers who do go to the effort of getting published in peer-reviewed journals – which isn’t easy – feel the need to share results publicly before peer review or publication. It lessens their effort.

Maybe it’s a culture thing.

Culture encompasses the shared values, morals, customary practices, inherited traditions, and prevailing habits of communities. It’s when one food service or farm or retail employee says to another, dude, wash your hands, without being told by the boss or the inspector.

Or one when PhD tells another PhD, press release before peer-review sorta sucks. And that’s the culture of science.

Or should be.

In July, 2014, the U.S. Centers for Disease Control took some bi-partisan hits for poor tracking of dangerous pathogens, to which director Tom Frieden responded the agency had corrected the specific defects cited in previous investigations, but had not realized there was a deeper problem with the culture of safety at CDC which he will now address.

For me it’s a hockey-coaching thing: try to do better than last week, have fun, and pay attention – before a 10-year-old runs over the 5-year-old. Keep your stick on the ice and don’t take wooden nickels.

And don’t produce food that makes people barf.

Press release before publication is always a bad idea – cold fusion?

 Dr. Douglas Powell is a former professor of food safety who shops, cooks, ferments and coaches hockey from his home in Brisbane, Australia.

Just market food safety at retail, government is hopeless: FSA plan to name and shame supermarkets selling Campylobacter chicken ditched after pressure from retailers

Maybe there’s something lost in translation; I’m barely starting to understand Australian.

chickenBut if I read this right, the piping hot UK Food Standards Agency has put retail over public health after scrapping plans to regularly name and shame supermarkets selling chicken contaminated with Campylobacter.

Lots of chuckles next time FSA proclaims they are a science-based agency.

According to the Daily Mail, FSA had promised to carry out regular surveys of chicken sold on the high street and publish the results, including the names of the stores, every three months.

The idea was that the public naming and shaming exercise would put pressure on the stores to clean up their chicken and reduce the food poisoning risk to customers.

However, the officials at the watchdog now want to scrap this idea and instead only publish data on the number of birds that are contaminated without identifying the stores involved.

The move has been condemned by a leading academic, who suggested it was driven by pressure from the industry and Government departments, who are keen support supermarkets, farmers and processors.

chicken.thermThe changes represent a major victory for the commercial interests of the big retailers, putting concerns for their sales and profits ahead of consumer safety and their right to know what they are eating.

The fact that the supermarkets have managed to water down the scheme is just the latest evidence as to how lobbying by big business has driven a change in official policy on food and health issues.

Similar lobbying killed off a plan for a blanket ban on junk food snacks and drinks from displays around supermarket check-outs.

The FSA recently revealed that more than one million people are falling victim to food poisoning every year with supermarket chicken named as the greatest threat.

Campylobacter, which is most often found on raw chicken, is the biggest cause of food poisoning in the country.

An official study published in 2009 revealed that two in three of all fresh chicken on shelves was contaminated with campylobacter. More than one in four – 27 per cent – were classed as being highly contaminated.

Despite the fact the FSA has asked supermarkets and farmers to make combatting campylobacter a top priority, the situation appears to have shown no improvement since then.

An FSA paper on the food poisoning caused by campylobacter warned: ‘In addition to the attendant economic costs, cases cause inconvenience, discomfort and misery to those who become infected and a small proportion of cases result in death or long-term consequences, such as reactive arthritis, irritable bowel syndrome and Guillain-Barré syndrome, the latter of which affects the peripheral nervous system.’

Despite the clear threat, the FSA’s executives are now asking its board to redraw the rules for its surveys to ensure the stores selling contaminated chicken are not identified in its quarterly results.

A paper prepared by officials states this is in response to ‘legitimate concerns expressed by the industry and other government departments’. The references to other departments relates to the food and farming department, DEFRA, which sees itself as a champion of British farmers, including those producing chicken.

The FSA paper states: ‘In the last update to the Board in March 2014 it was stated that the FSA intended to release the full results, including the names of the retailers and processors, of testing of around 1,000 samples every 3 months during the survey, with the first results published around June/July 2014.’

However, it says it has now decided to change this approach because there is a risk the results will be incomplete and misleading and it would – in some way – be unfair to the stores.

The FSA said: ‘One of the drawbacks of this approach is that no interpretation can properly be placed on interim raw data until the full year’s sampling is complete and fully analysed.

The watchdog’s board is being asked to approve this new approach at a meeting tomorrow.

Erik Millstone, the Professor of Science Policy at the University of Sussex, condemned the move to let the supermarkets off the hook.

Auditor’s role? Three years since people died from cantaloupe

Attorney Bill Marler writes:

cantaloupe.salmonellaIt has been almost three long years since dusty Holly, Colorado, became the epicenter of a Listeria monocytogenes human tragedy. Many are painfully aware that litigation has been ongoing since the fall of 2011. The litigation stems from one of the deadliest foodborne illness outbreaks in United States history. At least 147 people were sickened and more than 33 people died[1]. Since 2011, some of those sickened who survived have died — as have several family members (including spouses) — as they have waited for justice. Several have been left with brain injuries and/or the risk of future complications.

The Outbreak and the Audit

This outbreak began with Primus’ audit on July 25, 2011, at Jensen Farms, continued to stores that enticed customer loyalty (some now refusing to be responsible for what they sold), and ended in hospitals, morgues and rehab centers across much of the western U.S.

After spending the day before production fully started[2] inspecting Jensen Farms, Primus gave Jensen Farms a “96% score” and a “superior rating[3].” Had Jensen Farms failed the audit, the cantaloupes would never have been shipped to consumers across the country. But, Primus sees it differently:

“I understand 96 seems incongruous,” the legal counsel for Primus, attorney Jeffrey Whittington of Kaufman Borgeest & Ryan LLC, has said. “People in the food industry know what that means[4].”

Do we? Others see these audits for what they really have become:

“These so-called food safety audits are not worth anything,” said Dr. Mansour Samadpour, president and CEO of IEH Laboratories, one of the nation’s largest food safety consulting labs for industry. “They are not food safety audits. They have nothing to do with food safety.” Consumers should have no faith in the current system of farm audits because farms pay for their own inspections. “If this industry is sincere and they want to have their products be of any use to anyone, they should be printing their audit reports on toilet paper,” Samadpour said. “People who are commissioning these audits don’t seem to understand that they are … not worth the paper that they’re written on[5].”

The Litigation

There are a total of 66 victim claims in litigation in more than a dozen states. Marler Clark has the honor of directly representing 46 and indirectly several more[6]. Of the 66 claims, 61 of them were valued by the claims administrator in the Jensen Farms bankruptcy, for a total value of $45,595,000. The additional five claims will clearly put a conservative claim value on this litigation of well over $50,000,000.

jensen.cantaloupe.2Primus has expended in excess of $2,500,000 so far on motion practice that will be fully discussed below. Primus’ insurance policy requires it to first consent to any settlement, for which it has shown no interest to date. There is approximately $2,500,000 left on the insurance policy.

As I have told counsel for Primus, in 20 years of litigating every major foodborne illness outbreak in the U.S., my firm has never sued an auditor. The reasons that we did so in this case are well set out in the FDA report, House subcommittee correspondence and our amended complaints[7]. We certainly knew the legal arguments that we faced. There was a long history insulating auditors/inspectors from liability. I never expected to win all those arguments. However, even winning some has created new law and significant exposure to Primus and the industry despite Primus’ alternative view of the world[8].

Although some retailers — namely Walmart[9] — have resolved claims on behalf of customers, resolution of victims’ claims against Primus is still likely one of the keys to extinguishing this litigation in a manner satisfactory, and fair, to all parties,  even Primus. In short, if Primus does not resolve these claims immediately, then it will be bankrupted, whether by jury verdict or its attorneys’ billing, or, more likely, a combination of the two.

Primus’ position, from day one of this litigation, has been to spare no expense in spending down its burning limits policy in total defense of its reputation[10]. To Primus, this case is not about making good business decisions, or about the facts and the law. If it were, then the repeated successes in defeating Primus’ Rule 12(b)(6) motions to dismiss, which are discussed in detail below, would be reason enough to resolve these claims. After all, by the time of trial in any of these cases, Primus is likely to have little left on its $5,000,000 policy, and all it will take is one jury to end Primus forever.

The score on Primus motions to dismiss, as of today’s date, is nine to three[11] — nine courts nationally have agreed that Primus owed duties of reasonable care to consumers and that victims’ complaints sufficiently alleged breach of that duty and causation as well.

The Audit and the Investigation

You may have some sense for Primus’ role in the sequence of events leading to the cantaloupe Listeria monocytogenes outbreak, and I will endeavor to give you the facts as we see them. We have no idea whether the facts as they have developed even matter to Primus, but, ultimately, as the lawyers for people severely injured or killed, they are all that matter to us.

Before getting to that, however, it is worth observing that all victims nationally have been assigned the rights of Jensen Farms against Primus[12]. Clearly, Primus will have significantly more difficulty getting Jensen Farms’ claims for economic injury dismissed because those claims are premised, in part, on the existence of contractual privity between it and Jensen Farms. Thus, Primus’ arguments, addressed below, on the lack of duty owing to consumers of Jensen Farms may ultimately be beside the point. Even if all consumer claims against Primus were dismissed — which will not happen since nine of 12 courts nationally have already ruled in victims’ favor — Primus will still face the certain claims against it by Jensen Farms for breach of contractual and related duties owed during the conduct of the July 25, 2011, audit[13]. Primus will not escape responsibility.

On Sept. 10, 2011, after Jensen Farms cantaloupes had been identified as the source of this outbreak, FDA and Colorado state health officials conducted an inspection at Jensen Farms. They collected multiple samples, both product and environmental, for laboratory testing. Of the 39 environmental swabs collected from within the Jensen Farms packing facility, 13 were confirmed positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from three of the six outbreak strains. Of the 13 positive environmental swabs, 12 were collected at the processing line and one was collected from the packing area. Cantaloupe collected from the firm’s cold storage during the inspection also tested positive for Listeria — in fact, five of the 10 samples collected were positive for Listeria — with PFGE pattern combinations that were indistinguishable from two of the six outbreak strains.

After finding evidence of extensive contamination at Jensen Farms, FDA again, with the assistance of Colorado state officials, conducted an environmental assessment at the facility in an effort to identify the practices and conditions that led to such widespread contamination. The results of the assessment, which occurred on Sept. 22 and 23, 2011, were disclosed in a report dated Oct. 19, 2011. Among other things, the report found faults with Jensen Farms’ facility design, equipment design and post-harvest practices[14].

cantaloupeAfter conducting this environmental assessment, FDA issued a warning letter to Jensen Farms, indicating, “We may take further action to seize your product(s) and/or enjoin your firm from operating. Additionally, the receipt of this warning letter and any action taken to correct the violations cited in it do not preclude a subsequent criminal prosecution by the United States Department of Justice[15].” The Jensen brothers were later prosecuted and pleaded guilty to manufacturing and shipping adulterated cantaloupe[16].

But the FDA did not close its file on this outbreak after issuing its very clear warning. Officials from the agency also participated in much-publicized briefings with the House Committee on Energy and Commerce in October and December 2011. At those meetings, FDA officials cited multiple failures at Jensen Farms, which, according to the committee report, “reflected a general lack of awareness of food safety principles.” Those failures, several of which draw from the FDA’s Environmental Assessment Report, included:

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 (e.g., 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.

In particular, FDA heavily criticized the decision not to chlorinate the water used to wash cantaloupes, despite the fact that the wash was not re-circulated, as well as the use of improper processing equipment in the packinghouse. As is discussed below, both of these factors not only contributed to the cause of the outbreak, but also were the subject of discussion and recommendation by Primus and its agent, Bio Food Safety, during the July 25, 2011, audit at Jensen Farms.

Dr. Trevor Suslow, one of the nation’s top experts on safetly growing and harvesting melons, was shocked to see that on the audit at Jensen Farms:

“Having antimicrobials in any wash water, particular the primary or the very first step, is absolutely essential, and therefore as soon as one hears that that’s not present, that’s an instant red flag,” Suslow said. The removal of an antimicrobial would be cause for an auditor or inspector to shut down an entire operation, he said.

“What I would expect from an auditor,” Suslow said, “is that they would walk into the facility, look at the wash and dry lines, know that they weren’t using an antimicrobial, and just say: ‘The audit’s done. You have to stop your operation. We can’t continue.’”[17]

In short, the general conditions, personnel and facility at Jensen Farms in the summer of 2011 did not just fall well short of good manufacturing practices and industry standards; they also violated FDA guidance on the safe production of cantaloupes. In fact, this is specifically the opinion held by FDA officials who spoke with the committee in October and December: “FDA officials stated that the outbreak could have likely been prevented if Jensen Farms had maintained its facilities in accordance with existing FDA guidance[18].”

The juxtaposition of the condition of Jensen Farms’ facilities at the FDA investigation in September 2011 and the stated condition of Jensen Farms’ facilities and practices (e.g., “96%/Superior” rating) during the July 25, 2011, audit is central to this case.

Perhaps members of the House of Representatives Committee on Energy and Commerce have the audit problem correct:

There are inherent conflict of interest concerns with the third party auditor relationship. Although large purchasers must approve auditors (and in the case of Jensen Farms (sic, Frontera), provided a list of pre-approved auditors that were to be used), Jensen Farms made the final decisions about which of these specific auditors to hire. This creates a conflict for the auditor: a failing audit has significant economic implications for the producer, to the extent an auditor applies more demanding food safety standards, and it may be less likely to be hired by a given producer. This inherent conflict may account for the extraordinarily high pass rates — above 97% — for Primus Labs audits[19].

In the wake of this monumental outbreak, the prevailing system for third-party audits has come under intense scrutiny. Time and again, this firm has represented injured people, or the families of those who have died, in outbreaks where a negligent processor was given glowing reviews only for investigating agencies later to find during unbiased, competent investigations done without the veneer of conflicting interests that the facility in which the food was produced was not suitable for the production of CAFO[20]-destined animal feed, much less food for human consumption. And, clearly, Jensen Farms’ packing facility was no exception.

Will Steele (president of Frontera):

“In the wake of this experience, we are examining, among other things, the role of audits. Third-party audits are an important and useful tool, but they are obviously not fail-safe. Audits provide baseline information on conditions at the time they are conducted. So we are looking at possible changes that might further enhance food safety. One area of focus is whether additional steps are needed to validate the audit findings regarding food safety protocols that are in place. Validation could be in the form of a follow-up audit, or perhaps other measures that will help provide additional assurance of food safety compliance.”

As has been widely reported, Jensen Farms’ facility was audited by Primus[21] agent Bio Food Safety on July 25, 2011, mere days before the first illness was reported. Auditor James DiIorio gave the facility a “superior” rating and a score of 96 percent, noting that many of the pieces of equipment, and many of the packing procedures in place that 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 led to this outbreak.

Mr. DiIorio 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.  Mr. DiIorio 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.[22] But the truth, however, is that Mr. DiIorio failed to deduct points for several other non-compliances that should 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.”[23]

Again, the condition of Jensen Farms’ facility on review by FDA and Colorado state officials simply cannot be reconciled with the glowing review that Mr. DiIorio gave the facility and farms on July 25, 2011.[24] Auditors cannot be as hamstrung as public comments since publication of Mr. DiIorio’s audits have suggested; otherwise, the entire system is a farce, which may well be the point after all.

Of course, this is clearly not Primus’ view, at least not according to public comments since the date that Mr. DiIorio’s audit was first exposed. Robert Stovicek, president of Primus, has repeatedly defended the audit. “Even though it looks as horrendous as it does,” he stated in an interview with the Denver Post,[25] Stovicek indicated that he would continue using Bio Food Safety as its auditing agent, that he had full confidence in Mr. DiIorio,[26] and even that Mr. DiIorio did a “good job,”[27] despite not knowing whether Mr. DiIorio had ever even audited a cantaloupe operation before.[28]

One issue not noted in the foregoing list, instead being reserved for discussion here, is Jensen Farms’ failure to use an antimicrobial in the wash system. Mr. DiIorio prominently noted on the front page of his facility audit report that this is “a packing facility for cantaloupes which are washed by a spray bar 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.”[29]

This was not just a simple violation, or something that Mr. DiIorio should have down-scored Jensen Farms’ 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 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. DiIorio’s observation at section 1.4.8 that no antimicrobial was being used during cleaning of Jensen Farms’ 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 Farms’ cantaloupes, what could Mr. DiIorio 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 Farms’ operations generally.

We would, of course, be remiss to fail to point out that, in this case, Mr. DiIorio 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. DiIorio’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[30]. More specifically, in interviews with the House Committee on Energy and Commerce, Eric and Ryan Jensen stated that Mr. DiIorio 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. “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[31].”

Does an Auditor have a Duty to Consumers?

In short, the directive from Primus to its lawyers has been to conduct this litigation in a scorched-earth fashion, leaving no argument unmade, even frivolous ones[32]. In keeping with this, Primus has filed a Rule 12(b)(6) motion to dismiss in every case except those filed in Texas. In each motion, Primus has challenged every element of the case against it, from duty to breach to causation to damages. As set forth previously, 12 courts have ruled on the motions, with nine rulings favorable to victims and three to Primus.

There are 26 cases venued in Colorado. One Colorado trial court has already ruled on Primus’ motion to dismiss before the cases were recently consolidated. That ruling occurred in the Hauser matter, where the trial judge at first granted Primus’ motion based on Colorado’s observance of the misfeasance/nonfeasance distinction, but reconsidered his ruling on the motion for reconsideration. Ultimately, the court in the Hauser matter reinstated the case against Primus based on the theory of liability arising from Restatement 2d of Torts § 324A.[33]

An understanding of the § 324A claim is essential to any review of victims’ claims nationally against Primus. To date, the courts in Colorado (e.g., the Hauser court), Louisiana, Nebraska, Oklahoma and others have relied heavily on § 324A in denying Primus’ motions to dismiss. The theory is simple and straightforward, and, as the language of § 324A below would suggest, its application to the facts of this case is clear:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to protect [perform] his undertaking, if:

(a)       His failure to exercise reasonable care increases the risk of harm, or

(b)       He has undertaken to perform a duty owed by the other to the third person, or

(c)       The harm is suffered because of reliance of the other or the third person upon the undertaking.

Applied against Primus, the sequential evidentiary analysis is as follows: (1) Primus undertook to render services for Jensen Farms by conducting the July 25, 2011, audit; (2) the purpose of Primus’ audit was to ensure that the Jensen Farms facility and practices were in keeping with Good Agricultural Practices and industry standards (the relevant standards of care); (3) the reason for the audit was, ultimately, to ensure that Jensen Farms’ one commodity was safe for consumption by human beings; therefore, Primus should have recognized that the audit was necessary for the protection of a certain group of “third person[s]”; (4) Primus failed to conduct the audit using reasonable care, and (5) consumers of Jensen Farms cantaloupes were injured because Jensen Farms relied on Primus’ audit.

Primus’ arguments on breach, causation, and damages are fact-intensive and are therefore really only relevant in assessing what a jury will ultimately say. With respect to breach, we do not believe that many juries will be able to reconcile the glowing review issued to Jensen Farms by Primus (e.g., “96%/Superior” rating) with the condition of the facility on a more objective assessment by FDA and Colorado state health officials approximately one-and-a-half months later.

Further, with respect to breach, it is important to note that Primus failed to follow its own guidelines in the conduct of the July 25, 2011, audit. Primus has long contended that the parameters for its audit of Jensen Farms were very narrow and did not require any assessment or action beyond the questions/issues identified in its audit report. However, our investigation has revealed internal audit guidelines that Primus is required to follow during an audit but did not.

Primus’ arguments on causation and damages are even less compelling. We recognize that the primary argument against victims’ claims concerns Primus’ duties to consumers of Jensen Farms cantaloupes.

Condensed as far as reasonably possible, Primus has consistently made two arguments as to why it owed no duty of care to consumers of Jensen Farms cantaloupes. First, consumers were not foreseeably affected by its negligence, and second, consumers were not in privity of contract with Primus.

With respect to foreseeability, most courts that have ruled on Primus’ motions have not struggled with this issue. The victims’ case, very simply, is that they were the known and intended users of the single commodity produced by the entity that Primus audited, and the utility of a “food safety audit” by a “food safety auditor” such as Primus is nonexistent if it is not to make products safe (e.g., not contaminated by harmful pathogens) for human consumption. Victims, as consumers of Jensen Farms cantaloupes, were eminently foreseeable to Primus.

Primus itself has made party admissions establishing that consumers were foreseeable. On Oct. 21, 2011, as the full scope of the cantaloupe outbreak was becoming apparent, Primus stated as follows in a press release entitled, “At least 25 People have died and 123 sickened by the Cantaloupe Crisis—How PrimusLabs Works to Minimize These Disasters:”

PrimusLabs cannot count the lives saved through the decades of servicing the fresh produce industry. Unfortunately, we can only pray and mourn for the lives that have been lost due to the unfortunate circumstances that were beyond our control. Every Life is precious. For over 20 years our passionate commitment at PrimusLabs is food safety and minimizing illness and death from fresh produce.

To succeed on its claim that consumers were not foreseeable, whether at trial or on a motion, Primus will have to establish that it could not reasonably have expected consumers of Jensen Farms cantaloupes to be imperiled by a negligently done food safety audit. To make that claim in the face of both common sense and the Oct. 21, 2011, press release will only make juries mad. Primus knows that it is a food safety audit, it knows that it audits companies that produce food for human consumption, and it knows that the primary risk associated with not doing its job properly is people getting sick.

For its privity argument, Primus has inappropriately tried to bootstrap in a privity requirement that arose in a line of cases dealing with negligently done accounting audits.

The Restatement section that Primus bases its privity argument on is Restatement 2d of Torts § 552. The several states have all either adopted § 552, or created rules requiring some level of privity in relevant factual scenarios. By its own terms, however, § 552 is confined to business transaction resulting in “pecuniary loss” and has been applied exclusively in cases dealing with negligently done accounting audits where the injury was only pecuniary in nature. § 552 simply does not apply in situations involving negligent misrepresentations (e.g., audit reports) causing physical injury. If the words of § 552 leave any room for doubt, Comment (a) to § 552 does not:

Although liability under the rule stated in this Section is based upon negligence of the actor in failing to exercise reasonable care or competence in supplying correct information, the scope of his liability is not determined by the rules that govern liability for the negligent supplying of chattels that imperil the security of the person, land or chattels of those to whom they are supplied (see §§ 388-402), or other negligent misrepresentation that results in physical harm. (See § 311). When the harm that is caused is only pecuniary loss, the courts have found it necessary to adopt a more restricted rule of liability, because of the extent to which misinformation may be, and may be expected to be, circulated, and the magnitude of the losses which may follow from reliance upon it.

There is simply no requirement in the law of any relevant state that a victim in a personal injury case asserting claims of negligent misrepresentation must have specifically relied on the misrepresentations for the misrepresentations to be actionable.

Perhaps some of the “new law” that Primus has helped create in the Beach case, both by its bad audit and litigation approach, serves as a proper conclusion:

While the degree of certainty of harm to Mr. Beach is not decisively in favor of imposing a duty in this instance, there is certainly moral blame that can be attached to Primus Group’s conduct due to the alleged large oversights committed during the July 25, 2011 audit. Additionally, there is clearly a need to prevent future harm in situations like this, where innocent consumers eat what they think to be healthy food, which turns out to be contaminated with a potentially lethal pathogen. Further, imposing such a duty neither places an inordinately heavy burden on food safety auditors, nor causes great consequences to the community. In fact, the burden placed on food safety auditors remains unchanged — had the audit not reflected that the packing facility was in total compliance with food safety standards when it allegedly was not, Primus Group presumably would not have been named as a party in this case, if this case had filed. Finally, although not briefed on the issue, it certainly stands to reason that there is insurance available for food safety auditors in conducting food safety audits, just as there is malpractice insurance for doctors or lawyers.

Whether victims succeed in the injury lawsuits against Primus verges on irrelevance at this point. Primus will cease to exist by its own attorneys’ billings or by jury verdicts against it. Most likely, it will be a combination of the two.

One thing has become increasingly clear over the past three years — this litigation[34] will force the third-party audit industry to change, and perhaps my clients will find some small solace in that. Yes, the audit industry and their masters at major retailers should have changed this farce long ago, and, yes, our government should have enacted legislation to more adequately assure the public that someone you love is not killed by a cantaloupe. However, this is why the civil justice system exists — there are times when consumers must take responsibility when those who should have did not, and that is exactly what we are doing.

Thanks to Drew Falkenstein, Andy Weisbecker and Debbie Carr.

[1]  Website:  http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/index.html

[2]   “Pursuant to (Primus’) own guidelines, the audit was to be immediately terminated” if the packinghouse was not operating in a normal fashion.  See Jensen Farms v. Primus Complaint, Attachment No. 1.

[3]  See Jensen Farms Audit, Attachment No. 2. Frontera has not disputed Plaintiffs’ allegation that it would not have marketed the cantaloupe if the Primus audit had failed the JFP (See, Frontera’s Answer and Cross Claims, ¶¶ 15, 17). Moreover, this undisputed fact must be taken as true for purposes of Primus’ Motion to Dismiss.

[4]  Website:  http://www.thepacker.com/fruit-vegetable-news/Jensens-seek-probation-as-PrimusLabs-denies-liability-240645421.html?view=all

[5]  Website:  http://www.cnn.com/2012/05/03/health/listeria-outbreak-investigation/

[6]  Website:  http://www.marlerclark.com/case_news/view/jensen-farms-rocky-ford-cantaloupe-listeria-outbreak-colorado-new-mexico

[7]  See Amended Complaint, Attachment No. 3.

[8]  See Primus’, The Outbreak:  The Untold Story of Listeria Monocytogenes At Jensen Farms, Attachment No. 4.

[9]  To date Kroger, like Primus, has taken the position that it has no responsibility for the product/services that it sells to consumers. Kroger, like many large retailers today, takes the position that it contracts away its liability to consumers to broker/shipper/manufacturers like Frontera that supplied it the Jensen Farms’ cantaloupe. Despite requiring inadequate insurance, and having little concern with the supplying company’s assets, Kroger essentially claims it is the victim.  The problem for real victims is that Frontera, like Jensen Farms, is woefully underinsured and will be unable to compensate the sick, or the families of the dead, for their legitimate injuries caused by purchasing a cantaloupe from their local Kroger.  Kroger’s position will likely push Frontera into bankruptcy. See Attachment 5. See also, “Why Food Retailers Really Don’t Care” – http://www.marlerblog.com/lawyer-oped/why-food-retailers-really-dont-care/#.U8wI91a4lSU.  Think about this the next time you walk into a grocery store.

[10]  Primus’ litigation strategy has done nothing to remedy its reputation, and, in fact, has created a road map for future litigation against all auditors, not just Primus.

[11]  The nine wins are in: Rutherford, Beach, Hauser, Onsager, Pumphrey, Underwood, Gilbert, Drinkwalter and Braddock. The three losses are in: Corsi, Babcock and Lopez Order.

[12]  Website:  http://producenews.com/news-dep-menu/test-featured/11791-marler-jensen-case-sending-shockwaves-through-the-produce-industry

[13]  See Jensen Farms v. Primus Complaint, Attachment No. 1.

[14]  See FDA Environmental Assessment Report, Attachment No. 6.

[15]  See FDA Warning Letter to Jensen Farms, Attachment No. 7.

[16]  See Jensen Plea Agreement, Attachment No. 8.

[17]  Website:  http://www.cnn.com/2012/05/03/health/listeria-outbreak-investigation/

[18]  See Energy and Commerce Committee Report, Attachment No. 9.

[19]  See Committee on Energy and Commerce January 10, 2012 Letter to FDA Commissioner Margaret Hamburg, Attachment No. 10.

[20]  “CAFO” stands for Concentrated Animal Feeding Operation.

[21]  Primus is one of the nation’s largest third-party food safety auditors. Primus conducts approximately 15,000 audits per year, primarily involving fresh produce facilities, for more than 3,000 clients worldwide. A typical facility is audited once per year, and a Primus audit results in a pass/fail determination, a score from 0-100 percent, 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 percent overall. According to Primus, the vast majority of the thousands of audits it conducts each year receive grades: 98.7 percent in 2010, 97.5 percent in 2009, and 98.1 percent in 2008.

[22]  In fact, the “type and style” of the Jensen Farms audit required by Frontera Produce, 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.

[23]  This quotation is from Primus 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.”

[24]  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.

[25]  Website:  http://www.denverpost.com/search/ci_19159245.

[26]  Website:  http://www.denverpost.com/search/ci_19159245.

[27]  Website:  http://www.thepacker.com/fruit-vegetable-news/jensen-farms-earned-hight-third-party-audit-marks-132272688.

[28]  Website:  http://www.denverpost.com/search/ci_19159245.

[29]  The July 2011 audit, however, did not mark the beginning of the relationship between Jensen Farms and Primus/Bio Food Safety. On Aug. 5, 2010, Jerry Walzel, the president of Bio Food Safety, audited the Jensen Farms packing facility and gave it a score of 95 percent 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 Jensen 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.

[30]  See The Primus Audit Failures and Victims’ Allegations, Attachment No. 11.

[31]  See Committee on Energy and Commerce January 10, 2012 Letter to FDA Commissioner Margaret Hamburg, Attachment No. 10.

[32]  “Because Primus Group’s arguments concerning its common law duty can be boiled down to a mischaracterization of what is required of the pleadings at this stage, the Court will not reconsider its prior finding concerning Primus Group’s common law duty. Moreover, in arguing that Plaintiffs neither alleged any of Mr. Dilorio’s findings after he conducted the audit, nor alleged any action taken by Jensen Farms based upon Mr. Dilorio’s findings, Primus Group is mistaken. Primus Group’s arguments concerning § 324A(c) suffer from similar inadequacies. Finally, in an attempt that can be described as frivolous at best, Primus Group argues that Plaintiffs’ Complaint failed to establish a duty under Oklahoma’s third-party beneficiary theory due to a lack of supporting evidence.” See Beach Order.

[33]  Primus attempted to take an interlocutory appeal of this ruling to the Colorado Court of Appeals. The Court of Appeals rejected the effort and declined to consider the appeal. What weight or effect the Hauser Court’s ruling will have on the Colorado Courts ultimate ruling on Primus’ motion to dismiss is not known, but plaintiffs nonetheless believe that application of 324A to plaintiffs’ claims in Colorado is clear.

[34]  Website: “Civil litigation is a really blunt instrument for social change,” he said. “There are other ways to deal with things that are appropriate, but sometimes it’s a last resort.” http://www.foodsafetynews.com/2012/06/food-safety-attorney-bill-marler-delivers-food-bank-safety-keynote/#.U8wxDVa4lSU

Chinese meat supplier of McDonald’s and KFC gets the ax

The Chinese outlets of McDonald’s and KFC have stopped using meat from a Shanghai company after a local television news program accused the supplier of using chicken and beef past their expiration date, triggering an investigation by local food safety officials.

UnknownThe program, aired on Shanghai-based Dragon TV on Sunday evening, showed hidden camera footage of workers at a meat-processing facility operated by Shanghai Husi Food using out-of-date chicken and beef to make burger patties and chicken products for McDonald’s and KFC, in some cases scooping up meat that had fallen onto the assembly line floor and throwing it back into a processing machine.

In response, the Chinese units of McDonald’s and KFC both said in news releases posted from their official Sina Weibo social messaging accounts that they had halted use of all products from Shanghai Husi, which is owned by the OSI Group, based in Aurora, Ill.

20% of all food items sold found to be substandard in India

Over 20 per cent of food items served in restaurants and fast food outlets across the country have been found to be substandard or adulterated, according to government data.

UnknownOut of 46,283 food samples including milk, milk products, edible vegetable oil and spices tested at various government laboratories during 2013-14, as many as 9,265 samples were found to be adulterated and misbranded.

Uttar Pradesh reported the highest number of such cases in 2013-14, with a total of 2,930 vendors being prosecuted and as many as 1,919 of them convicted. A total penalty of more than Rs 4.47 crore was imposed on offenders in the state.

In 2012-13, a total of 2,551 cases were registered and there was conviction in 1,010 cases. Penalty amount of over Rs 3.70 crore was imposed on offenders.

Label rules take effect next month for mechanically tenderized beef in Canada

Canadian shoppers will be able to see next month if the beef they’re buying has been mechanically tenderized.

Labelling regulations to take effect Aug. 21 are designed to protect consumers after the largest meat recall in the country’s history two years ago.

needle.tenderize.crHealth Canada says beef that has been mechanically tenderized must have a sticker saying that.

Packaged steaks must also have cooking instructions that the meat must reach an internal temperature of 63 C and must be turned at least twice.

Health Canada says the rules are meant to ensure that tenderized meat is labelled from the processor to the consumer, since it’s hard to tell just by looking at it.

But Bruce Cran, president of the Consumers’ Association of Canada, said the cooking requirements are too complicated for most people and he wants mechanical tenderizing banned outright.

“What average Canadian having a beer and a steak is going to measure the temperature of the meat?” Cran asked.

Cran says irradiation of all meats is the best way to ensure meat is safe.

Health Canada received an application to irradiate ground beef, poultry, shrimp and prawns a decade ago, but a spokesman says the public was worried about the process.

Another application from the industry is under consideration.

Mark Klassen, director of technical services with the Canadian Cattlemen’s Association, supports irradiation but says mechanically tenderized beef is safe as long as it’s cooked properly.

Klassen said the association was involved in the research that supported the new labelling, including the cooking instructions. He says it also tested the labels with a sample of Canadians to make sure they were understandable and practical.

He said the research determined that earlier Health Canada instructions to bring the meat to the same internal temperature as ground beef, 71 C, made the beef tougher. He said 63 C is safe as long as the meat is turned at least twice.

No such thing as no risk, managed risk is better; research clears bulb onions of E. coli risk

Research conducted at Oregon State University’s Malheur County experiment station has shown that E. coli contamination is not a risk in furrow- or drip-irrigated bulb onions.

UnknownThe research began last year after the U.S. Food and Drug Administration released a proposed produce safety rule that would limit the amount of generic E. coli bacteria that can be present in irrigation water.

This year’s trial is much larger and researchers expect it will confirm last year’s findings, which showed bulb onions pose no risk of E. coli contamination, regardless of how they are irrigated and regardless of the water quality.

Researchers even enriched some of the water with extremely high levels of generic E. coli by using runoff water from a pasture. Still, there was no trace of bacteria when the onions were ready for packing.

“By the time we packed them out, the numbers were all zero,” said Clint Shock, director of the Malheur experiment station.

There were traces of E. coli present on the outside of some onion bulbs when they were pulled out of the soil and left on the ground to dry. But after they were cured in the field — all bulb onions in this area go through that process — and ready for packing, no E. coli was present on any of the onions.

“The results of last year showed that the bacteria died off really rapidly after they were lifted, and cured in the field,” Shock said. “And we didn’t have any generic E. coli at all on any of the onions when we packed them out.”

E. coli levels for soils and onions were recorded during growing, harvesting and processing conditions. At no time was E. coli ever detected inside of any of the onions.

Metal tip found in Calgary boy’s burger may be meat tenderizing needle: expert

Needle or mechanically tenderized beef can introduce shiga-toxin producing E. coli like O157 into the center of a steak, rendering it not safe if undercooked, but what about the actual needle?

needle.tenderize.crJames Deane, who is six, was eating a hamburger made from meat purchased from Costco on Wednesday night in Calgary when he bit into a piece of metal which looks like the tip of a needle.

Domenic Pedulla, president of Canadian Food Safety Group, says meat is injected with brine or flavouring a lot of times because they’re using a lower quality or tough cut.

James’ father, Mike Deane, contacted Costco and the Canadian Food Inspection Agency after finding the needle.

Costco confirms the meat was purchased at its south Calgary store, and has started an investigation with the supplier, JBS Food Canada, Inc., which has a plant in Brooks, Alta.

JBS says it is aware of the allegations and is co-operating with the investigation.

Pedulla says processors run their products through metal detectors to avoid such situations.

He says foreign objects in food are becoming less common “because processors are tightening up their procedures and the technology is getting better.”