Insight alert: listeria-in-cantaloupe outbreak that killed 32 was preventable

As ratings for broadcaster CNN continue a free-fall to nowhere, they’ve come out with a new insight: the 2011 listeria-in-cantaloupe outbreak that killed 32 was preventable.

So are 99 per cent of all outbreaks.

CNN Presents on Sunday will feature an in-depth look into the outbreak which, based on a text version appearing on the Intertubes today, is a cut-and-paste job with no new analysis or insight.

“After a months-long investigation surrounding the outbreak, CNN has found serious gaps in the federal food safety net meant to protect American consumers of fresh produce, a system that results in few or no government inspections of farms and with only voluntary guidelines of how fresh produce can be kept safe.”

Those gaps have always been there and are still there.

Dr. James Gorny, the FDA chief investigator who led a team to Jensen Farms in Colorado said, "We had melons from the grocery stores which were positive for Listeria, with the exact same genetic fingerprint as we found in all of the ill individuals. We had ill individuals with that same genetic strain of Listeria. We had food contact surfaces at the packing house of Jensen Farms with the exact same, genetically matched strain of Listeria. So we had lots and lots of evidence that this was … as definitively as possible, a smoking gun, that this was the source of the contamination. … The evidence is very, very strong in this case. Some of strongest I’ve ever seen.

"What turned the operation upside-down was some significant changes they made. It was a very tragic alignment of poor facility design, poor design of equipment and very unique post-harvest handling practices of those melons. If any one of those things would have been prevented, this tragedy probably wouldn’t have occurred."

But the story of what happened at Jensen Farms, and why no one stopped the sale and shipments of the cantaloupes, also sheds light on serious problems in the nation’s fresh produce food safety net, and a voluntary system created by businesses to ensure a quality product, known as third-party audits.

No kidding.

Just days before the Listeria outbreak, Jensen Farms paid a private food inspection company called Primus Labs to audit their operation. Primus Labs subcontracted the job to another company, Bio Food Safety, which sent a 26-year-old with relatively little experience to inspect Jensen Farms.

The auditor was James DiIorio, and he gave Jensen Farms a 96% score, and a "superior" grade. On the front page of his audit at the farm, DiIorio wrote a note saying "no anti-microbial solution" was being used to clean the melons.

Dr. Trevor Suslow, one of the nation’s top experts on growing and harvesting melons safely, 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.’"

But why just blame the auditors. Who bought these cantaloupes, and where was their internal expertise to assess the audit reports arriving on their desks before, presumably, the melons arrived on their retail shelves.

"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,"

Samadpour said 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."

So how best to improve the system? Legislation will do little or nothing, the auditing route has regular problems, and food safety is an afterthought in much of the commercial market in the absence of an outbreak. Suggestions? That’s a show I might be interested in watching.

A preview is below.

Learning from strawberries, spinach and melons: promote safe food practice before the next outbreak

In 1996, California strawberry growers were wrongly fingered as the source of a cyclospora outbreak that sickened over 1,000 people across North America; the culprit was Guatemalan raspberries.

After losing $15-20 million in reduced strawberry sales, the California strawberry growers decided the best way to minimize the effects of an outbreak – real or alleged – was to make sure all their growers knew some food safety basics and there was some verification mechanism. The next time someone said, “I got sick and it was your strawberries,” the growers could at least say, “We don’t think it was us, and here’s everything we do to produce the safest product we can.”

In Sept. 2006, an outbreak of E. coli O157:H7 killed four and sickened at least 200 across the U.S. This was documented outbreak 29 linked to leafy greens, but apparently the tipping point for growers to finally get religion about commodity-wide food safety, following the way of their farmer friends in California, 10 years later.

In 2011, Jensen Farms, an eastern Colorado cantaloupe grower produced melons that killed 32 and sickened at least 146 with listeria in 28 states. One grower trashed the reputation of the revered Rocky Ford Melon: plantings this year are expected to be down 75 per cent.

Now the Rocky Ford Growers Association has turned to government-delivered food safety audits rather than third-party audits, and committed to emboss a QR code on every melon it slates for retail sale. This QR code will tell consumers where the melon was grown, harvested, and prepared.

Location doesn’t mean safety. Include the production details.

In Aug. 2011, Oregon health officials confirmed that deer droppings caused an E. coli O157:H7 outbreak traced to strawberries, many sold at roadsides, that sickened 14 people and killed one.

So when NPR asks, Are local salad greens safer than packaged salad greens, it’s the wrong question.

It’s not whether large is safer than local, conventional safer than organic: it’s about the poop, and what any grower is doing to manage the poop. Or risks.

Any farm, processor, retailer or restaurant can be held accountable for food production – and increasingly so with smartphones, facebook and new toys down the road. Whether it’s a real or imaginary outbreak of foodborne illness, consumers will rightly react based on the information available.

Rather than adopt a defensive tone, any food provider should proudly proclaim – brag – about everything they do to enhance food safety. Explanations after the discovery of some mystery ingredient, some nasty sanitation, sorta suck.

Microbial food safety should be marketed at retail so consumers actually have a choice and hold producers and processors – conventional, organic or otherwise – to a standard of honesty. Be honest with consumers and disclose what’s in any food; if restaurant inspection results can be displayed on a placard via a QR code read by smartphones when someone goes out for a meal, why not at the grocery store? Or the school lunch? For any food, link to web sites detailing how the food was produced, processed and safely handled. Manage the poop, manage the risk, brag about the brand.

How to wash produce and what consumers say they do

Surveys still suck.

But at least researchers from the U.S. Food and Drug Administration recognize the limitations of self-reported food safety behavior, in this case applied to produce washing practices in the kitchen. From a recent paper in Food Protection Trends:

“Although washing does not guarantee removal of pathogens if the item has become contaminated, it increases the likelihood that pathogens will be removed, compared with not washing or using washing methods that are not recommended. Soaking and use of any type of cleaner are not recommended washing methods. Soaking does not remove contami¬nants as effectively as rubbing or rinsing produce under running water. Cleaners not meant for produce can introduce chemical contaminants, and produce washes are considered no more effective than water. Unlike other types of produce, almost all bagged, pre-cut let¬tuce in the market place is pre-washed. For bagged, pre-cut lettuce that is labeled as pre-washed, additional washing is not recommended as it is not likely to en¬hance safety and introduces the op¬portunity for cross-contamination of the product with pathogens that may be in the home kitchen. …

“This study has some strengths and limitations. One of the limitations is that the data are self-reported. We rely on consumers’ ability to both remember what they do and convey it accurately. Self-reporting is also subject to the de¬sire to give socially desirable responses; an observational study of consumer produce washing showed that far fewer consumers actually wash produce than report doing so in surveys. Also, the findings would have been more use¬ful if we had asked consumers why they washed cantaloupes and bagged, pre-cut lettuce. Finally, our survey suffered from the increasingly common problem of low response rates for household sur¬veys, although this does not necessarily bias the survey results. Some of the main strengths of this study are the sampling method, large sample size and weighting strategy, which allows our findings to be representative of the population. This allows us to make comparisons at the population level.

“Food Safety practices should be¬gin on the farm and be rigorously ap¬plied along the entire chain so that food products are safe for human consump¬tion without the need for extraordinary measures. Consumers, however, are the critical endpoint along the food supply chain. Educational efforts with respect to product washing should focus on explaining why it is important to wash hard rind produce such as cantaloupe be¬fore cutting, but not rewashing produce that is ready to be eaten.”

The abstract is below:

Consumer vegetable and fruit washing practices in the United States, 2006 and 2010
Food Protection Trends, Vol. 32, No. 4, Pages 164–172
Linda Verrill, Amy M. Lando 1 and Kellie M. O’Connell
Vegetables and fruits may become contaminated with pathogens anywhere along the farm-to-plate continuum. Therefore, the FDA recommends that vegetables and fruits that have not already been washed be washed by the consumer before slicing or consuming them. The FDA included in its 2006 and 2010 Food Safety Survey a series of questions about purchasing and washing of strawberries, tomatoes, cantaloupes, and bagged, pre-cut lettuce. The Food Safety Survey is a telephone survey tracking consumers’ knowledge, attitudes and behaviors related to food safety. In 2006, of those who buy these products, 98% wash strawberries, 97% wash tomatoes, 57% wash cantaloupes and 54% wash bagged pre-cut lettuce. Overall, for both years, more women than men wash cantaloupes, and more men than women wash bagged pre-cut lettuce. Cantaloupe washing declined from 2006 to 2010 for men, while lettuce washing increased for women in the same period. Targeted education campaigns should emphasize the importance of washing produce, especially fruits with hard rinds.

Safest food in world; US seed type testifies

“We have the safest food supply in the world. Despite the listeria outbreak, the sheer volume of produce, fresh or processed, that is consumed by the American public with little or no incidence is testimony to that fact.”

That according to Pete Suddarth, product development and field director of customer relations for Abbott & Cobb Inc., Feasterville, Pa.

Testify. Fact. Sounds a little spiritual (appropriate since so much of food safety is faith-based).

The Packer reports that food safety has become a major focus of seed companies and they work to adapt their products to a changing environment and increased market demands.

The rest of the story was about disease resistance, quality and yield, although Art Abbott, president of Abbott & Cobb, said the firm is working on reducing the heavy netting on cantaloupes to make them less susceptible to moisture absorption. This trait would help to reduce possible pathogen infections.

May reduce. May.

Can you seed types do anything about sprout seeds?

Going public: Del Monte drops lawsuit against Oregon public health over cantaloupe

Fresh Del Monte is ending its lawsuit against Oregon health officials who linked a salmonella outbreak to its Guatemalan cantaloupe.

In August, Coral Gables, Fla.-based Del Monte Fresh Produce NA Inc. said it would sue the Oregon Health Authority’s Public Health Division and the agency’s top scientist over how it handled the investigation of the February and March 2011 outbreak that sickened 20 people in the western U.S. and Pennsylvania and Maryland.

Lynne Terry of The Oregonian reported yesterday that Del Monte Fresh Produce said in a letter e-mailed to the state earlier this month that it would not act on its notice to sue William Keene and Oregon Public Health.

"Obviously, it’s a relief for us that that’s withdrawn so now we can focus on the job we’re supposed to do which is to protect the public’s health," said Dr. Katrina Hedberg, state epidemiologist. The tort claim filed last August had gobbled up time of state scientists and lawyers dealing with it, she said.

The claim was unprecedented. State epidemiologists investigate dozens of foodborne illness outbreaks every year and name the culprits to prevent more people from getting sick. No other company has ever filed a suit or threatened to sue Oregon over one of those investigations.

"There have been lots of outbreaks," Hedberg said. "Why some companies choose to work with public health and others want to fight it — I can’t answer that."

Del Monte Fresh Produce wouldn’t either. A spokesman said the company "does not comment on ongoing or closed investigations."

The company’s letter said the withdrawal marked "a show of good faith" in its discussions with Oregon Public Health over food safety. It asked for another meeting with Oregon’s top food safety detectives.

The state agreed to a meeting in Portland.

"I’m not sure why they want it," Hedberg said. "We work with businesses and companies but that does not preclude us from notifying the general public if we find a food item that’s been responsible for an outbreak or cluster of illnesses."

The saga dates to January 2011 when people started getting sick. In March, the company recalled nearly 60,000 whole cantaloupes imported from its facility in Guatemala. The recall notice, published on the Food and Drug Administration website, said the melons could be contaminated with Salmonella Panama, the strain involved in the outbreak.

In July, the FDA imposed an import alert, effectively banning the sale of the Guatemalan melons until the company demonstrated they were safe. Located in Coral Gables, Fla., Del Monte Fresh Produce is a major importer of cantaloupe. A third of its supply comes from Guatemala.

The company, which is not part of the Del Monte Foods conglomerate, responded to the alert by filing suit against the FDA. Then in August, it filed the tort claim against Keene and Oregon Public Health along with a separate ethics complaint against Keene.

The documents said Keene conducted a shoddy investigation. They said he never found salmonella in its cantaloupes but named the company anyway. Del Monte Fresh Produce also blamed Keene for the recall, saying he pushed the FDA to take action.

But Keene was not the only epidemiologist who concluded that Del Monte Fresh Produce was to blame in that outbreak. His peers in Washington state reached the same conclusion.

In September, the FDA lifted its import alert and Oregon’s Government Ethics Commission dismissed the ethics claim against Keene.

At the time, Kirk Smith, epidemiology supervisor for the Minnesota Department of Health, told the Washington Post it’s rare for scientists investigating foodborne illness outbreaks to test the exact food suspected of carrying pathogens. By the time symptoms occur and a foodborne illness is reported and confirmed, the product in question has likely been consumed or has exceeded its shelf-life and been thrown away.

Instead, scientists, like detectives, interview victims, collect data, analyze patterns and match food “fingerprints” to determine the likely source of an outbreak.

“The majority of outbreaks, we don’t have the food to test,” Smith said. “Laboratory confirmation of the food should never be a requisite to implicating a food item as the vehicle of an outbreak.

Epidemiology is actually a much faster and more powerful tool than is laboratory confirmation.”

Colorado farmers urged to lead in food safety after listeria outbreak

Larry “Larry” Goodridge (right, exactly as shown) got it right when he said farmers bear primary responsibility for food safety and they shouldn’t rely on third-party audits, but should retroactively fail my risk analysis course for saying Colorado’s response to the listeria-in-cantaloupe outbreak that killed 36 people "was as close to perfect as we are going to see" and that "Our food supply is one of the safest in the world, if not the safest."

Goodridge, an associate professor of food microbiology at Colorado State University, did follow up by telling the Governor’s Forum on Colorado Agriculture yesterday, “But if you were to ask that question of family members who had someone die, they would tell you our food supply is not safe." Lots of people would say the food supply is not safe. Maybe about 48 million of them. Best to keep meaningless rankings out of the equation.

He also said the state could improve by creating a team that activated within hours of an outbreak, and that the government should target spending on high-risk produce — in particular, by educating farmers who grow high-risk produce. More focus on food inspectors isn’t likely to significantly improve the system. Larry urged farmers to focus on sanitary practices such as keeping equipment and storage areas clean. He also urged them to educate the public on ways to safely handle produce in the same manner as consumers are advised how to safely handle meat.

As usual, no details were provided on how best to do this so-called education, for farmers or consumers.

Farm Fresh Direct chief executive Jim Knutzon, said he expects the federal government will write more specific regulations for growing cantaloupe and other produce. Then third-party auditors — hired by farms to inspect their operations — will have to check for specific standards called for by the Food and Drug Administration.

’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.

What is the value of government oversight? Lots of rhetoric, little reality

Folks who produce and sell food should not make their customers barf.

And they should not require the government to babysit.

But the California cantaloupe growers have decided to follow the leafy greens types and ask the government to make sure bad producers are kept in check, because apparently they can’t do it themselves.

At the end of a meeting yesterday to figure out what to do to bolster consumer confidence in cantaloupes after 32 died from listeria last fall, the best growers could come up with is government oversight.

Scott Horsfall, President and CEO of the California Leafy Greens Marketing Agreement said, “When our program was formed in 2007, it was very clear to our industry that mandatory government oversight was the best way to verify compliance with food safety standards. Government inspectors are uniquely positioned to provide independent food safety audits because they are a true independent third-party audit with safeguards in place to prevent conflicts of interest.”

Got any references for that? As an outside observer, the LGMA has succeeded in toning down public discussion of lettuce outbreaks; that’s it.

Horsfall added, with the dutiful reference to food safety culture without stating what it means that, “No food safety system is perfect. … The goal is to create a culture of food safety in our operations and this is something we have succeeded in doing. It is the right thing to do.”

Got any references for that? Data? Evidence of any kind?

To build public trust and foster a food safety culture, make inspection data truly transparent, brag about accomplishments with data, not rhetoric, and market all those fabulous food safety efforts at retail using multiple media and multiple messages so consumers actually have a choice.

Don’t bring me down; California cantaloupe growers going government way, want state marketing order

Is government inspection better at ensuring safe produce?

Steve Patricio, Chairman of the California Cantaloupe Advisory Board, provided the following statement today during a Cantaloupe Food Safety press conference:

"The California cantaloupe industry has never been associated with a foodborne illness outbreak. However, in the past 20 years, the California cantaloupe industry has invested in research to ensure our growing, harvesting and packing practices are the safest possible. We were the first commodity group to work with government agencies, scientists and food safety experts to craft Commodity Specific Guidance for Melons and we are 100 percent committed to continuing work to improve the existing guidance and to funding new priority research projects that will lead to a safer product for consumers.

"In keeping with the leadership position we have always taken with respect to food safety, the California Cantaloupe Advisory Board is pledging today to move forward to establish a mandatory state marketing order with government oversight to focus on food safety in the production of California cantaloupe. We are asking for and anticipate participation from other western cantaloupe producing regions and we hope that other cantaloupe producers around the world will follow our lead."

"We are taking this step for two reasons — first because it is the right thing to do. Consumers must be assured that our products are safe. Additionally, it was made clear by the participants at yesterdays Center for Produce Safety working symposium that the trade is demanding nothing less than a program based upon mandatory government inspections. The California cantaloupe industry intends to quickly act and to have such a program in place prior to the coming harvest season."

Can I get that in writing? Listeria outbreak report reeks of swarminess; melon farmers blame auditors/buyers who blame regulators

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.