Scores on Doors was too direct for the Brits, but now they’ve come out with a Cause for Concern scheme to name and shame meat plants that have lousy audits.

It’s part of the UK Food Standards Agency ongoing commitment to openness and transparency to regularly publish audit reports of approved meat plants in England, Scotland and Wales (audit here means those done by government inspectors, rather than third-parties; but I could be wrong, it’s not clear).

Cause for concern is a process developed in response to Professor Pennington's report on the 2005 E. coli outbreak in Wales, which recommended that there needed to be improved management oversight of poorer performing meat plants. The process makes it clear which plants need to improve their standards to ensure risks to public health are kept to a minimum.

There are currently eight premises on the list. This will be updated, initially on a weekly basis, to reflect changes as meat plants move on or off the list.

Tim Smith, Chief Executive of the FSA, said, “If our inspectors decided that hygiene standards in a plant are so poor that public health could be at imminent risk, we would immediately stop that plant from operating. However, for those businesses that could improve quickly by following our advice, we hope that publication of this list will push them to raise their game and get off the list.”

There’s plenty of swarminess to go around in a new report by the U.S. House of Representatives Energy and Commerce Committee on the listeria-in-cantaloupe outbreak of 2011.

That’s what happens when 30 (or 31) people are killed, 1 suffers a miscarriage and at least 146 are sickened from eating some fruit.

The report concludes the outbreak could have been avoided if Jensen Farms of Colorado had maintained its facilities in accordance with existing guidance from the U.S. Food and Drug Administration (FDA), which is not mandatory.

This is nothing new. FDA has been issuing guidance on how to produce safe produce since 1998 and, like spinach and leafy greens and tomatoes, cantaloupe growers now have to act like, oh, we didn’t know.

Fortunately, the vast majority of cantaloupe growers do know how to produce safe product. But any commodity is only as good as its worst performer. Which is why verification matters, and once again, audits, as currently designed, aren’t up to the task.

Not mentioned in the report is the devastating effect the outbreak had on individuals, families, other growers and the flaws in relying on others – in food safety they’re called auditors -- to check things out.

Here’s what the various players told the Congressional investigators:

FDA officials cited several deficiencies in Jensen Farms’ facility, which reflected a general lack of awareness of food safety principles and may have contributed to the outbreak, including:

• condensation from cooling systems draining directly onto the floor;
• poor drainage resulting in water pooling around the food processing equipment;
• inappropriate food processing equipment which was difficult to clean (i.e., Listeria found on the felt roller brushes);
• no antimicrobial solution, such as chlorine, in the water used to wash the cantaloupes; and,
• no equipment to remove field heat from the cantaloupes before they were placed into cold storage.

FDA emphasized to Committee staff that the processing equipment and the decision not to chlorinate the water used to wash the cantaloupes were two probable causes of the contamination.

Primus Labs has audited Jensen Farms during the course of Jensen Farms’ relationship with Frontera Produce, beginning in 2003. Primus Labs hired a subcontractor, Bio Food Safety, Inc., to conduct its recent audits of Jensen Farms. On August 5, 2010, Jerry Walzel, the President of Bio Food Safety, audited the Jensen Farms packing facility and gave it a 95% grade - a “superior” rating, despite finding several major and minor deficiencies.

One precaution that Jensen Farms took in 2010, which it dropped in 2011, was to use an antimicrobial solution, such as chlorine, in the cantaloupe wash water. The front page of the August 2010 audit stated, “[t]his facility packs fresh cantaloupes from their own fields into cartons. The melons are washed and then run through a hydro cooler which has chlorine added to the water. Once the product is dried and packed into cartons it is placed into coolers.” After the August 2010 audit was completed, one of the Jensen brothers informed Mr. Walzel that they were interested in improving their processes. According to Jensen Farms, in response to this inquiry, Mr. Walzel indicated that they should consider new equipment to replace the hydrocooler the farm used to process cantaloupe. Mr. Walzel stated that the hydrocooler, with its recirculating water, was a potential food safety “hotspot,” and advised them to consider alternate equipment. Based on his comments, and input from a local equipment broker, Jensen Farms purchased and retrofitted equipment previously used to process potatoes.

The Jenson brothers stated that they changed from the hydrocooler to the new food processing equipment in an attempt to strengthen their food safety efforts.
Jensen Farms stated that they contracted with Primus Labs to perform an audit in July 2011. Again, Primus Labs subcontracted with Bio Food Safety to conduct the audit. Mr. Walzel did not conduct this audit; a new auditor from Bio Food Safety, James Dilorio, conducted the audit on July 25, 2011, and, after spending approximately four hours inspecting the facility, gave Jensen Farms a 96% grade - again a “superior” rating. Despite this high rating, Mr. Dilorio identified several deficiencies, including three “major deficiencies”: (1) wood (which can house bacteria and cause splinters) covered the unloading and packing tables, (2) lack of hot water at hand washing stations, and (3) doors left open during operating hours, potentially allowing pests to enter the facility.

Jensen Farms noted that it received a visit from a representative of Frontera Produce, its distributor, shortly before the 2011 audit. According to the Jensen brothers, this representative provided them with advice about preparing for the audit, but did not note any problems. Jensen Farms informed Committee staff that quality control representatives from various retailers have visited the farm as well. The Jensen brothers stated that based on these inspections and their prior food safety record, they had no concerns about their operations prior to the recent outbreak.

Will Steele and Amy Gates, the CEO and executive vice president of Frontera Produce, told Committee staff that they had visited Jensen Farms to inspect its facilities and provide business advice and both were critical of the current standards for third-party audits and had concerns about inadequate standards.
Ms. Gates indicated that there is “no industry standard for validation points” after an audit, while Mr. Steele stated that “this is the industry standard. I’ve always believed there’s got to be more validation points. This case clearly demonstrates that.”

Robert Stovicek, president of Primus Labs told Committee staff that his company’s role is to conduct an impartial assessment of a client’s operations and provide its findings to the client. He stated that the audits are intended to assess whether the client’s operations are in compliance with current baseline industry standards—not to improve those standards or push a client towards best practices. Mr. Stovicek said that Primus Labs would “be a rogue element if they tried to pick winners and losers” by holding industry to higher standards. He also said that Primus Labs did not have the “expertise to determine which best practices should be pushed by the industry.”

Jerry Walzel, the president of Bio Food Safety, told the Committee that – consistent with Primus Labs policy – the audits only deducted from the score if a method or technique was inconsistent with FDA regulations; they did not deduct from the score if FDA guidance was not being followed. … He stated that Bio Food Safety auditors were “roped in by regulation and Primus training,” and that “guidelines are opinions…. regulations are law.”

Additionally, he noted, “we are not supposed to be opinionated on this, we are supposed to go by FDA’s regulations… FDA should have mandated that you cannot sell cantaloupes that have not been sanitized.”

According to Frontera Produce, in response to the outbreak, many major retailers have already instituted end-product testing of cantaloupe to identify Listeria, Salmonella and other pathogens. Frontera Produce officials also informed Committee staff that retailers and industry groups are studying the possible implementation of additional checks at different critical control points in the supply chain, including risk-based assessments and sample testing. Primus Labs noted, and FDA confirmed, that buyers will immediately start requiring auditors to take environmental swabs while auditing food facilities.

Democrats on the House Energy and Commerce Committee, including Rep. Diana DeGette of Denver, also asked the FDA to step up regulation of outside auditors, who they say bring numerous "conflicts of interest" to the food safety system. Excerpts from their letter are below:

The investigation identified significant problems with the third-party inspection system used by growers and distributors to ensure the safety of fresh produce, This auditing system is often the first and only line of defense against a deadly foodborne disease outbreak. …

Our investigation reveals some of the reasons why: the auditors' findings were not based on the practices of the best farms and failed to ensure that the producer met FDA guidance; the auditors missed or failed to prioritize important food safety deficiencies; the auditors lacked any regulatory authority and did not report identified problems to the FDA or other state or federal authorities; the auditors did not ensure that identified problems were resolved; and the auditors provided advance notice of site visits and spent only a short period of time on-site. It also became apparent in the investigation that the auditors had multiple conflicts of interest.

The problems identified in the audits of Jensen Farms are similar to those that the Committee identified in food safety investigations in 2009 and 2010. In 2009, following the Salmonella outbreak in peanut butter products sold by the Peanut Corporation of America (PCA), a Committee investigation revealed that a private, for-profit auditing firm gave the company glowing reviews (step forward American Institute of Baking). The auditor, AlB, was selected by PCA, it was paid by PCA, and it reported to PCA. The auditor awarded a "superior" rating to the company’s plant. Six months after the audit, PCA's products killed nine people and sickened 691 people .

In 2010, the Committee's investigation into an outbreak of Salmonella in eggs produced by Wright County Egg revealed the same problems with third-party audits. Following the outbreak, federal officials inspected Wright County Egg facilities and found serious violations of food safety standards, including barns infested with mice, chicken manure piled eight feet high, and uncaged hens tracking through excrement. There were very different results when Wright County Egg farms were inspected by AlB. AlB gave Wright County Egg an award two months before the outbreak, rating them "superior" and awarding the company a "recognition of achievement.”

Weaknesses in third-party auditors represent a significant gap in the food safety system because the auditors are often the only entities to inspect a farm or facility. … Like it or not.our food safety system relies heavily on third party auditors to identify dangerous practices and prevent contaminated foods from reaching the market.

 Woe is the California lettuce and spinach grower.

"It was just more regulations. More inspections. More paperwork. More filings. More fees," said Chris Bunn, part of a four-generation Salinas Valley farming family. Now in his 60s, he quit two years after the 2006 outbreak. "I miss it terribly," Bunn said. "It was a wonderful business."

Deborah Schoch, a senior writer at the California HealthCare Foundation Center for Health Reporting, writes in the Mercury News today that five years after their healthy-looking green fields became the epicenter of a national food disaster, farmers in the Salinas Valley are still working to regain something even the most bountiful harvest can't ensure: the public's trust.

They are doing their best to rebound after investigators linked spinach grown and bagged here to a deadly E. coli strain that would kill three people, sicken 206 more and shake the nation's faith in California leafy greens. So far, they have succeeded in avoiding another major outbreak.

Last year, Monterey County produced spinach worth $127.5 million, down from $188.2 million in 2005, according to reports from the county agricultural commissioner's office.

Salinas Valley growers and processors have retooled nearly every step in their industry -- from planting seedlings to harvesting and washing greens. They have rallied to create a state-industry pact on how to protect 14 types of leafy greens that is being held up as a national model.

"It was the watershed moment for the produce industry," said Joe Pezzini, chief operating officer of Ocean Mist Farms in Castroville.

Too bad it didn’t happen 10 years earlier.

In October, 1996, a 16-month-old Denver girl drank Smoothie juice manufactured by Odwalla Inc. of Half Moon Bay, California. She died several weeks later; 64 others became ill in several western U.S. states and British Columbia after drinking the same juices, which contained unpasteurized apple cider -- and E. coli O157:H7. Investigators believed that some of the apples used to make the cider might have been insufficiently washed after falling to the ground and coming into contact with deer feces.

Almost 10 years later, on Sept. 14, 2006, the U.S. Food and Drug Administration announced that an outbreak of E. coli O157: H7 had killed a 77-year-old woman and sickened 49 others (United States Food and Drug Administration, 2006). The FDA learned from the Centers for Disease Control and Wisconsin health officials that the outbreak may have been linked to the consumption of produce and identified bagged fresh spinach as a possible cause.

In the decade between these two watershed outbreaks, almost 500 outbreaks of foodborne illness involving fresh produce were documented, publicized and led to some changes within the industry, yet what author Malcolm Gladwell would call a tipping point -- "a point at which a slow gradual change becomes irreversible and then proceeds with gathering pace"(http://en.wikipedia.org/wiki/Tipping_Point) -- in public awareness about produce-associated risks did not happen until the spinach E. coli O157:H7 outbreak in the fall of 2006. At what point did sufficient evidence exist to compel the fresh produce industry to embrace the kind of change the sector has heralded since 2007? And at what point will future evidence be deemed sufficient to initiate change within an industry?

In 1996, following extensive public and political discussions about microbial food safety in meat, the focus shifted to fresh fruits and vegetables, following an outbreak of Cyclospora cayetanesis ultimately linked to Guatemalan raspberries that sickened 1,465 in 21 U.S. states and two Canadian provinces (U.S. Centers for Disease Control and Prevention, 1997), and subsequently Odwalla. That same year, Beuchat (1996) published a review on pathogenic microorganisms in fresh fruits and vegetables and identified numerous pathways of contamination.

By 1997, researchers at CDC were stating that pathogens could contaminate at any point along the fresh produce food chain -- at the farm, processing plant, transportation vehicle, retail store or foodservice operation and the home -- and that by understanding where potential problems existed, it was possible to develop strategies to reduce risks of contamination. Researchers also reported that the use of pathogen-free water for washing would minimize risk of contamination.

Yet it would take a decade and some 29 leafy green-related outbreaks before spinach in 2006 became a tipping point.

What was absent in this decade of outbreaks, letters from regulators, plans from industry associations and media accounts, was verification that farmers and others in the farm-to-fork food safety system were seriously internalizing the messages about risk, the numbers of sick people, and translating such information into front-line food safety behavioral change.

Today, according to  Schoch, major food and retail chains, from McDonald's to Walmart, want proof that their lettuce is as clean as any natural product can be.

That means no cattle grazing uphill from a spinach farm, no roaming wild pigs, no farm crews without hairnets or gloves, no missing reports.

Some food chains even send inspectors unannounced.

"They'll be the Toyota Camry with the Hertz sticker on the edge of the field, looking with binoculars," said Mike Dobler, 50, a third-generation grower who works with his family on a large-scale vegetable farm based in Watsonville.

"They're looking to see if you're doing what you say you're doing," Dobler said.

Before September 2006, he said, "we were taken at our word, and nobody asked."

Actually, lots of people asked, including FDA, state public health types, journalists, lawyers and academics. Growers apparently just didn’t pay attention.

A table of leafy green related outbreaks is available at http://bites.ksu.edu/leafy-greens-related-outbreaks (they didn’t all originate with California produce, but lots did).

Melvin N. Kramer, president, EHA Consulting Group, Inc., writes that over the past several years, and clearly over the past several weeks, there has been increased interest, criticism, and a general sense of a conundrum in reference to the reliability, reproducibility, validity, and general worthiness of a third-party audit.

Many people with varying interests have weighed in with a lot of facts, few figures, and a fair amount of speculation. We believe, and have even published, that the key to an appropriate assessment from a third-party audit starts with the qualification and experience of the auditor. As long as there are firms that are recruiting and sending out on third-party audits individuals with minimum credentials, such as the one we found on one company’s website, “high school diploma, or equivalent, plus ten (10) years food processing experience (food plant experience in a responsible food safety position),” then these audits are doomed to be a potentially harmful and indeed can be worthless.

However, if the third-party auditor is properly trained, schooled, and credentialed in food safety and microbiology (a bachelor’s degree, with a minimum of thirty credits in the biological/environmental sciences), then third-party audits can be an extraordinary good tool to be used by industry in assessing, to assure that the health and well-being of the consumer is not going to be compromised.

When conflicts of interest arise, anywhere, there is always cause for concern. Some of these conflicts of interest are present in the auditing firm, when companies sell laboratory services, pest control services, chemicals, or other services, and the third-party audit becomes a lost leader, just like a can of peas in a supermarket, selling for far under the fair market value.

In 2009, we posted a blog on our website, which is as true today as it was then, and we clearly welcome others to revisit it and continue this important dialog.

A good working definition of public health is preventative medicine in action.