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.

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.

Fall 2008 was a crappy time in Canada. While the Maple Leaf listeria-in-deli-meats outbreak would kill 23 and sicken 56, a listeria-in-cheese outbreak plagued Quebec (that’s in Canada, according to some), sickening lots, especially expectant mothers.

Amy was pregnant, heightening sensitivities.

At the time, public attention and concern in Quebec was far more focused on the plight of cheesemongers than the sick and several dead. Regulators took some tough steps to limit the outbreak but in a culture that values tradition, the Quebec Minister of Agriculture was forced to capitulate and change his tune from, "The province is not there to compensate. We aren't an insurance company," to offering a three-year, $8.4-million aid package, along with $11.3-million in interest-free loans to Quebec's small cheese producers and retailers less than three weeks later.

Government health-types in Quebec have now offered their version of events in the current issue of the Journal of Food Protection.

Although numbers of sick people were all over the place at the time, the researchers conclude there were 38 confirmed sick with the same strain of Listeria monocytogenes (LM P93) across Quebec from June through Dec. 2008, including 14 pregnant women and two babies born to asymptomatic mothers. There were two elderly deaths and three neonatal deaths.

The traceback of many brands of cheese that tested positive for LM P93 collected from retailers identified two cheese plants contaminated by L. monocytogenes strains on 3 and 4 September. PFGE profiles became available for both plants on 8 September, and confirmed that a single plant was associated with the outbreak. Products from these two plants were distributed to more than 300 retailers in the province, leading to extensive cross-contamination of retail stock.

So where is that local cheesemonger you know, trust and can look in the eye, getting their cheese from?

The abstract is below:

Widespread Listeriosis outbreak attributable to pasteurized cheese, which led to extensive cross-contamination affecting cheese retailers, Quebec, Canada, 2008
01.jan.12
Journal of Food Protection®, Volume 75, Number 1, January 2012 , pp. 71-78(8)
Gaulin, Colette; Ramsay, Danielle; Bekal, Sadjia
http://www.ingentaconnect.com/content/iafp/jfp/2012/00000075/00000001/art00011
Abstract:
A major Listeria monocytogenes outbreak occurred in the province of Quebec, Canada, in 2008, involving a strain of L. monocytogenes (LM P93) characterized by pulsed-field gel electrophoresis (PFGE) and associated with the consumption of pasteurized milk cheese. This report describes the results of the ensuing investigation. All individuals affected with LM P93 across the province were interviewed with a standardized questionnaire. Microbiological and environmental investigations were conducted by the Quebec's Food Inspection Branch of Ministère de l'Agriculture, des Pêcheries et de l'Alimentation du Québec among retailers and cheese plants involved in the outbreak. Between 8 June and 31 December 2008, 38 confirmed cases of LM P93 were reported to public health authorities, including 16 maternal-neonatal cases (14 pregnant women, and two babies born to asymptomatic mothers). The traceback of many brands of cheese that tested positive for LM P93 collected from retailers identified two cheese plants contaminated by L. monocytogenes strains on 3 and 4 September. PFGE profiles became available for both plants on 8 September, and confirmed that a single plant was associated with the outbreak. Products from these two plants were distributed to more than 300 retailers in the province, leading to extensive cross-contamination of retail stock. L. monocytogenes is ubiquitous, and contamination can occur subsequent to heat treatment, which usually precedes cheese production. Contaminated soft-textured cheese is particularly prone to bacterial growth. Ongoing regulatory and industry efforts are needed to decrease the presence of Listeria in foods, including pasteurized products. Retailers should be instructed about the risk of cross-contamination, even with soft pasteurized cheese and apply methods to avoid it.

Anyone can clean up for a day. I’m proof.

But the U.S. Department of Agriculture's Food Safety and Inspection Service is warning meat and poultry processing plants to cut it out: how else will the government-types know what goes on – listeria-wise -- the rest of the year, or every four years?

"By altering routine practices, establishments may make changes that are not consistent with their documented food-safety system and that impede FSIS’s ability to assess the safety of the product," FSIS said in a notice signed by Daniel Engeljohn, assistant administrator for the Office of Policy and Program Development.

The notice warns processing plants to avoid making changes in their procedures in food manufacturing during testing and says that a Noncompliance Report (NR) could be issued to a plant that changes its practices without good reasons during LM testing. Permission to use the equipment involved in making the product could also be denied, the notice says.

Every four years, FSIS conducts a Food Safety Assessment (FSA) and routine sampling for listeria (RLM) at any plant that produces ready-to-eat meat and poultry products, such a frankfurters or chicken nuggets. Intensified Verification Testing (IVT) is conducted anytime LM is found in the product or on a food contact surface, the notice said.

"A recent analysis of data from FSIS LM verification programs showed that some establishments have altered routine production, sanitation, or food safety practices during RLM or IVT sampling," Engeljohn wrote. "These changes typically are temporary, in that they are applied only during FSIS RLM or IVT sampling, and normal production processes are resumed at the completion of the RLM or IVT sampling," he wrote.

The changes have included increasing the use of sanitizer during testing; "drastically" reducing the length of the production shift, the lot size, or the number of employees handling the product; skipping production of product with a higher level of risk, such as sliced product; and failing to use equipment that had previously been shown to be contaminated.

"Such practices can interfere with FSIS’s assessment of routine conditions or corrective actions at the establishment and may limit FSIS’s ability to determine whether post-lethality exposed RTE meat and poultry products are not adulterated as required by the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA)," Engeljohn wrote.

If the plant cannot provide a "supportable rationale" for making changes in its processes during the scheduled testing period, the test should be rescheduled and FSIS enforcement personnel should inform their district offices, the notice said.

Does zero tolerance promote such practices?