Auditors getting their due? Kroger sues Primus in Jensen cantaloupe listeria case

Coral Beach of The Packer writes that in a cross claim filed June 2 in a Colorado state court, the country’s second largest retailer names Primus and distributor Frontera Produce Ltd. as defendants in the death of a Colorado man who contracted a Listeria monocytogenes infection after eating cantaloupe from the Holly, Colo.

cantaloupe.salmonella“Primus misrepresented the conditions and practices at Jensen Farms ranchlands and packinghouse by giving it a superior rating and high score despite the existence of conditions and practices that should have caused a failure of the facility,” according to Kroger’s claim.

Primus has 30 days to respond, but the food safety auditing company has maintained its lack of liability in dozens of cases filed by victims and relatives and in a federal case filed by brothers Eric and Ryan Jensen, owners of the bankrupt cantaloupe operation.

The 2011 listeria monocytogenes outbreak traced to the Jensens’ cantaloupe resulted in 33 deaths and another 147 illnesses across 28 states, according to the Centers for Disease control and Prevention.

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.

jensen.cantaloupe.2Audits and inspections are never enough: A critique to enhance food safety


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.


Food executives holding board positions at auditor AIB ‘could be a conflict’

One of the sidebars to the Bloomberg Markets Magazine piece about auditors and food safety led by Stephanie Armour, focuses on AIB International, the auditor involved in some big-time screw-ups, like the Peanut Corp of America outbreak that killed nine and sickened 700 and the Wright egg Salmonella outbreak that sickened almost 2,000.

Turns out, AIB Chairman David Murphy is president of Mother Murphy’s Laboratories Inc., a Greensboro, North Carolina, flavoring company that uses AIB to vet its factories. AIB Vice Chairman Donald Thriffiley Jr. is a senior vice president of Flowers Foods in Thomasville, Georgia. Flowers, which makes Tastykake desserts, uses AIB audits.

AIB’s previous chairman, Daniel Babin, is vice president of supply chain strategy at Bimbo Bakeries USA Inc. in Horsham, Pennsylvania. Its parent, Mexico City-based Grupo Bimbo SAB, the world’s largest breadmaker, with brands such as Arnold bread and Thomas’ English Muffins, is audited by AIB.

Spokespeople for Bimbo and Mother Murphy’s said there was no conflict and these relationships didn’t affect audits of their operations. Flowers Foods says Thriffiley works to ensure that audits are independent and impartial.

“We do not believe that serving on the AIB board would in any way influence the outcome or quality of the inspections,” says David Marguiles, a Bimbo spokesman.

The American National Standards Institute, a group that oversees private auditors on behalf of the Global Food Safety Initiative, hasn’t cited AIB for any conflicts, says Maureen Olewnik, AIB’s vice president for auditing.

ANSI’s vice president for accreditation, Lane Hallenbeck, says he didn’t know that executives at food companies held posts at AIB; he plans to investigate.

“It sounds likes this could potentially be a conflict,” Hallenbeck says.

’No enforced laws in produce safety;’ listeria-in-cantaloupe cantaloupe hot potato passed to the auditor

Roy Costa of Environ Health Associates, Inc. writes:

We will not see then end of the Jensen/Frontera/ Primus Auditor issue for some time. While there is plenty of room for criticism of Jensen, Fonterra, and Primus there are also problems with FDA, and this tragic incident has become a hot potato being passed to and fro by Congress.

I keep reading FDA’s take on this as if they had an actual law in place that people had to follow, and actual inspectors in the field for enforcement, and an educational arm. FDA still has no muscle on the farm, just a law now on the books that is lagging behind. Until they get their act together, it’s not fair to blame the industry for not getting it together when they themselves cannot.

I am not defending anyone, but if I were, I could look at the 2009 FDA Guidance for melon and wonder where it says that Jensen should have used a chlorinated hydro cooler to cool melons. FDA says it’s safe to use flowing water of satisfactory quality without an antimicrobial to cool melons. Nowhere does it say melons had to be pre-cooled, anywhere. In fact according to FDA, melons can be field packed and placed directly into a cooler. A hydro cooler (this is a refrigerated, circulated water bath, tank or drench that may also contain ice) is recommended, but the flowing water method is allowable, according to the guidance. Any auditor who would read the Melon Guidance of 2009 would have said FDA has no requirement to use an antimicrobial in single pass wash water.

And here we have more from Leavitt and Partners, a consulting firm, taking shots at the auditing company from left field and just repeating the double talk while not really understanding what they are saying. But of course, this is business.

This whole discussion is beginning to smell and is turning into a witch hunt and a diversion for the fact that we have next to no currently enforced laws in produce safety. As result, we see systematic failure of the food safety protection they would afford us. And so industry has taken on itself this huge challenge of agricultural food safety and failures are occurring, and will continue. Third party audits are not designed for public health protection, and even if strengthened they will not take their place.

And when and how does FDA propose to notify the industry about the minimum requirements under the FSMA? Most folks I speak to don’t have a clue what to do.

This sad scene points not just to failure of audits, but reveals food safety at the primary production level of our food supply has been neglected. It’s going to take decades to educate farmers and to fix the problems spread over millions of acres of land and thousands of farming operations. The failures include FDA not being able to enforce rules or educate the industry, and if I sound like I am repeating myself, I am.

The third party food safety audit system was never intended to stand in the place of regulation. If we as auditors were supposed to enforce FDA Guidance, and now Laws, just how is that supposed to work? There is no mechanism for that.
Where are the thousands of competent people to do this job, the army who understand agriculture and how to do a produce risk assessment, commodity by commodity? How are small producers like the Jensen brothers supposed to cope with the detailed scientific risk assessment he and now thousands like him must by law perform?

This situation has got to be solved by industry and FDA working together, and proper funding and research.

Fix the mess first with regulations and guidance, then maybe there is some justification that Jensen and the rest of us should have known better.

Passing the hot potato is only going to burn more consumers.

Food safety sucks in Australian capital: auditor

Canberra’s food safety inspection regime is being undermined by poor record keeping, staff shortages and a “reactive” approach to enforcing hygiene standards in the city’s restaurants, according to an Auditor General’s report.

The Canberra Times reports the auditor also found that ACT Health had no policies or procedures in place to respond to foodborne illness outbreaks, despite having to cope with four outbreaks, on average, annually between 2004 and 2009.

Auditor General Maxine Cooper found that there had been a “sharp” 30 per cent decline in scheduled inspections for food businesses and that the Health Protection Service had been unable to achieve its own targeted for the number or frequency of inspections.

At one point early in 2011, the agency was forced to hire contractors to cover gaps in the ranks of its inspectors so it could carry on checking the compliance of the city’s restaurants.

In some cases, the audit found, the records kept by the Health Protection Service were not even good enough for auditors to form a view on the agency’s performance.

“There are shortcomings in the regulation and administration of food safety that need to be addressed to provide the community with assurance that the food they buy and eat is safe,” the Auditor General concluded.

Listeria outbreak victims go beyond farm to target grocers, auditors

The three prime targets of lawsuits in the cantaloupe listeria outbreak have just $17 million in liability coverage for more than 130 illness cases that could easily cost more than $100 million, say experts in liability law.

The Denver Post reports the wide gap could make new legal targets out of grocery stores, distributors and auditing labs as victims seek richer funds for compensation, according to product-law experts.

"If they can get the deep pockets in, they’re going to get them in," said Denver lawyer Justin Prochnow.

"I think the case as a whole has the potential to make new law in Colorado," said lawyer Scott Eldredge, a malpractice and liability specialist who also teaches at the University of Denver’s Sturm College of Law.

Seattle lawyer Bill Marler said a third-party auditor that certified Jensen’s safety practices before the outbreak has also been threatened with lawsuits. PrimusLabs of California has $5 million in insurance.

Bob Stovicek, president of PrimusLabs, stands behind his company’s audit as in line with cantaloupe-industry practices.

"Primus has never been sued, nor are we aware of any third-party auditing firms being sued under similar circumstances," Stovicek said in an e-mail. "That being said this is an almost unprecedented tragedy," adding that he is aware lawyers are trying to pull auditors into cases.

With deaths and serious illnesses often producing $1 million to $3 million each in bills and other compensation, the 139 cantaloupe illnesses will produce massive claims, attorneys say.

Attorneys’ fees vary widely but generally are in the range of 15 percent to 30 percent of settlements.

In the listeria cases, attorneys may try to show retailers contributed by not demanding tougher farm audits, by failing to test for pathogens themselves, or by failing to wash the fruit one more time before sale.

The role of food safety auditors?

Any time I write anything marginally critical of food safety auditors, my in-box is flooded with comments about how auditors aren’t inspectors, they’re just doing a job, I’m a propeller-head, and how unfair it all is.

If those audits are really worth something, market them at retail so consumers can choose.

Here are some other voices:

Tom Karst of The Packer writes that given the failure of third-party audits to pinpoint potential food safety problems in recent cases involving German sprouts, Georgia peanuts and Colorado cantaloupe, some primary handlers of produce might be considering sending in their own teams to inspect suppliers.

“I am hearing from a few of the larger produce organizations (first handlers) is that is what they are going back to,” said Dave Gombas, senior vice president for food safety and technology for the Washington, D.C.-based United Fresh Produce Association. “They are not trusting the third-party audits and they are going out and doing their own inspections as well to verify if the third-party (inspectors) are doing a good job.”

My group has been saying that since about 1998.

In light of recent outbreaks, some growers question the value of audits, said Chris Schlect, president of the of the Northwest Horticultural Council, Yakima, Wash.Gombas said the services auditors offer vary greatly — one of the biggest issues to resolve in the industry.

While the FDA is charged with developing a process to accredit third-party auditors in foreign countries under the new Food Safety Modernizaton Act, Gombas predicts FDA will find it hard to rely on third-party audits.

“Everyone is looking for FDA to come up with a solution, but I don’t know if they have any better answers than we do,” he said.

He noted the United Fresh effort to harmonize Good Agricultural Practices did not address third-party auditor certification.

“We knew that the harmonzied standard was a tough enough goal to achieve.”
The Global Food Safety Initiative which begin in 2000 and was designed to harmonize audit standards in Europe — still hasn’t solved that issue.

Ed Beckman, president of California Tomato Farmers and Scott Horsfall president and CEO of the California Leafy Greens Marketing Agreement, wrote to the Packer to say it has become very clear that a truly effective food safety program is about much more than the score you receive from your food safety inspector and that the true measure of success does not come from an audit score but is achieved when an entire commodity group or industry adopts a culture of food safety that is designed to identify risks, strives for continual improvement and always seeks to learn more.

Jim Crawford wrote to the Denver Post to say that the private-sector food safety auditor who gave a near-perfect score to Jensen Farms’ listeria-contaminated cantaloupe-packing process is subject to no Food and Drug Administration oversight, or to any other regulatory accountability. The article notes that this is the case with the entire third-party food-safety auditing industry.

Ontario egg inspections lack surprise

My colleague Jim Romahn has started his own blog, Agri 007, and in his latest entry, writes:

There appear to be lots of warnings for egg farmers and grading stations that the enforcers are coming, so few are caught and disciplined.

Take egg quota violations, for example. Egg Farmers of Ontario checks hen numbers when the birds are 23 weeks old. Farmers know when an inspector is coming. If they’re over the limit, they naturally cull their flock to get under the wire. But until then, they could be housing more hens to make more profit.

Take egg grading stations. The Canadian Food Inspection Agency sends advisories that it is coming to check compliance, often a couple of weeks in advance. There may be some merit to advance warning so the company can have its HACCP records ready for inspection, but there is certainly no merit when it comes to checking day-to-day sanitation practices and automated egg grading.

Some retail chains have hired the Guelph Food Technology Centre to conduct audits for them. In these cases, too, there has been advance warning. I am told that signs have gone up in at least one plant to advise staff to practice “zero tolerance” on those days.

The federal and provincial governments have granted egg farmers extraordinary powers over production and pricing, but in return have asked them to provide the public with a steady supply of safe and wholesome eggs. Egg farmers who value supply management and want to retain public trust surely realize that discipline is crucial, especially related to food safety.
The management at Egg Farmers of Ontario is surely aware of the possibility that some members cheat on production limits, so why not have some more surprise inspections? The management is obviously aware now of allegations that cracks have made it into the Grade A table market, posing a risk to food safety, so what has it done?


Newfoundland fish inspection disorganized, ineffective

Of the 3,575 inspections recorded in 2010 in Newfoundland (that’s in Canada), 42 per cent of them were situations in which inspectors travelled to a processing facility or landing site, but no inspection was done because there was no fish there.

Provincial auditor John Noseworthy noted, “Given that 42 per cent of the inspections were situations where there was no fish to inspect, they probably might want to go back and revisit that, and determine if that’s the best way to go about it. There doesn’t seem to be any sort of plan."

Noseworthy also found enforcement officers did more inspections of cod than they did for shrimp, despite the fact that harvesters land five times more shrimp every year than they do cod.

Another major gap in the system is at Port aux Basques, from where 90 per cent of the province’s exported seafood leaves.

Inspections there were only done seven hours per day, five days per week; of the 437 inspections conducted between January and November 2010 none were recorded in the provincial database.

The government responded the province’s fishery is "intense and erratic," which makes it difficult to do the sort of planning Noseworthy is calling for.

Fisheries Minister Clyde Jackman pointed out that all the province’s shrimp is landed in such a short period of time that it’s tough to carry out a lot of inspections.
Because the season for cod is much longer, more inspections are done.

Derek Butler, executive director of the Association of Seafood Producers, said Noseworthy’s report "reflect lack of a complete understanding of the industry."
Instead of more inspections and better scheduling, Butler said there should be less inspection.

He said meaningful quality control is done by the Canadian Food Inspection Agency, as well as European Union and American quality certification.

FDA approach to food safety ‘wander around and hope to bump into something’

"’I refuse to buy shrimp in the U.S. We’ve inspected plants in Vietnam. Those plants are state-of-the-art. They’re certainly better than shrimp-handling in the US."

So says Roger Berkowitz, CEO of the Boston-based Legal Sea Foods restaurant chain, who insists Asian shrimp is gaining in the U.S., not because it’s cheaper but because it’s safer.

That food safety nugget was delivered in an otherwise mundane series of articles published this week by the Christian Science Monitor.

There’s also some sharp words for the two primary U.S. inspection agencies, the Food and Drug Administration and the U.S. Department of Agriculture. USDA is inspection-focused. US law requires it to inspect every carcass of meat and poultry that it’s responsible for, even though numerous scientific reports have questioned the effectiveness of those rapid conveyor-belt inspections.

"There is an awful lot of money being spent on guys standing around watching the chickens fly by," says Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida, Gainesville, and a former official at the Food Safety and Inspection Service at the USDA. "It’s hard to tell what you are getting for your money."

The USDA’s costly carcass-by-carcass inspection soaks up about 60 percent of US food-safety funding, even though it covers only about 20 percent of the food Americans eat (mostly meat). That leaves the FDA with only around 40 percent of the funding, even though it’s responsible for ensuring the safety of 80 percent of the food supply. With less funding, it’s difficult for the FDA to inspect food facilities on a regular basis.

"In my mind, [the FDA] doesn’t have an inspection system," says Scott Hurd, a veterinary professor at Iowa State University and former deputy undersecretary of agriculture for food safety at the USDA. "It has a ‘wander around and hope you bump into something’ " approach.

Numerous outbreaks linked to Mexican produce earlier this decade spurred the Mexican industry to clean up its image by developing various voluntary standards. For example, México Calidad Suprema is a generic brand that growers and packers commit to operate by high food-safety standards.

"Nobody ensures that" quality, says Frank Pope, who exports carrots produced in Queretaro, in central Mexico, to the US. "The market takes care of it."

Such faith in the market and voluntary efforts by the Mexican growers and packers have won over some U.S. wholesalers. "They’re working very hard to counteract that" taint, says Peter John Condakes, whose New England produce wholesale and distributing company buys more than half of its Roma tomatoes from Mexican companies. "Truthfully, in a lot of cases, the packing sheds are as strict or more strict than in the United States."

Lousy food safety auditors put public and brands at risk

The voluntary quality control system widely used in the nation’s $1 trillion domestic food industry is rife with conflicts of interest, inexperienced auditors and cursory inspections that produce inflated ratings, according to food retail executives and other industry experts.

I’ve been saying that for a long time, but this is the Washington Post version, published this morning. I especially like the pictures of the Montgomery Burns Awards for Outstanding Achievement in the Field of Excellence, courtesy of AIB, the Manhattan, Kansas-based audiots that gave a stellar rating to PCA and Wright Eggs just prior to terrible food safety outbreaks and revelations of awful production conditions (see below).

The system has developed primarily because large chain stores and food producers, such as Kellogg’s, want assurances about the products they place on their shelves and the ingredients they use in making food. To get that, they often require that their suppliers undergo regular inspections by independent auditors. This all takes place outside any government involvement and without any signals – stamps of approval, for instance – to consumers. (That’s four-year-old Zoe Warren, right, of Bethesda, who was hospitalized in 2007 after contracting salmonella poisoning after eating a chicken pot pie. The photo is by Susan Biddle for the Washington Post.)

The third-party food safety audit scheme that processors and retailers insisted upon is, in many cases, no better than a financial Ponzi scheme. The vast number of facilities and suppliers means audits are required, but people have been replaced by paper.

In fact, most foodmakers, even those with problems, sail through their inspections, said Mansour Samadpour, who owns a food-testing firm that does not perform audits. "I have not seen a single company that has had an outbreak or recall that didn’t have a series of audits with really high scores.”

Third-party food audits, like restaurant inspection, are a snapshot in time. Given the international sourcing of ingredients, audits are a requirement, but so is internal food safety intelligence to make sense of audits that are useful and audits that are chicken poop.

Industry experts say some "third-party" inspections can be rigorous. Those that audit using internationally recognized private benchmarks "are much more thorough," said Robert Brackett, former senior vice president of the Grocery Manufacturers Association. "But they’re less likely to be used because they are much more expensive."

Audits, inspections, training and systems are no substitute for developing a strong food safety culture, farm-to-fork, and marketing food safety directly to consumers rather than the local/natural/organic hucksterism is a way to further reinforce the food safety culture.

Will Daniels, who oversees food safety for Earthbound Farm, the folks who brought E. coli O157:H7 in bagged spinach in 2006 that sickened 199 and killed four, said, Earthbound regularly received top ratings in third-party audits, including one exactly a month before the tainted spinach was processed, adding,

"No one should rely on third-party audits to insure food safety."

“… if the incentive is to pass with flying colors, it creates a disincentive to air your dirty laundry and get dinged and lose a customer over it.”

After the E. coli outbreak, Earthbound put in place an aggressive testing and safety program that includes outside audits but also requires Earthbound’s own inspectors to show up unannounced to check suppliers. The company tests its greens for pathogens when they arrive from farms and again when they are packaged.

Too bad Earthbound didn’t figure all this out after the 28 other outbreaks involving leafy greens prior to the deadly 2006 outbreak.

Cost is another factor.

Food companies often choose the cheapest auditors to minimize the added expense of inspections, which range from about $1,000 to more than $25,000.

The foodmakers can prepare for audits because they often know when inspectors will show up.

And auditors have a range of experience and qualifications, from recent college graduates to retired food industry veterans. They sometimes walk through a plant, ticking off a checklist to produce a score, Samadpour said. Basic inspections do not typically include microbial sampling for bacteria.

In a written response to questions, Brian Soddy, AIB‘s vice president of marketing and sales, said company audits are intended to give food manufacturers "guidance and education for improvement."

Producers have the ultimate responsibility, he said, adding that the audits are voluntary and not intended to replace any FDA regulatory inspections.
AIB said last week that it is reevaluating its "superior" and "excellent" rating systems because they "have led to confusion in the wake of recent incidents," Soddy wrote.

Some retailers include inspections as just one piece of their safety programs.

Costco, for example, has its own inspectors but also requires its estimated 4,000 food vendors to have their products inspected according to a detailed 10-page list of criteria. Private auditors must X-ray all products for "sticks and stones, bones in seafood – anything you can think of that might be in hot dogs, baked goods, outside of produce," said Craig Wilson, Costco’s assistant vice president for food safety and quality assurance.

Costco maintains an approved list of about nine audit firms. The list does not include AIB.

Wal-Mart requires suppliers of private-label food products sold in its stores and Sam’s Club to be audited using private internationally recognized standards.

In addition to conducting its own product testing, Giant Food requires its vendors to be audited from a list of about a dozen approved firms.