The FDA has now published the results of its assessment into the Jensen Farms situation. The results generally buttress the points we made in pieces such as these:
CANTALOUPE CRISIS ANALYSIS: Key Performance Indicators and Food Safety… Shall The Twain Ever Meet?
The report, titled Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh whole Cantaloupe Implicated in a Multi-State outbreak of Listeriosis, provides much insight into the situation. We noted six simple steps to explain what likely happened:
1) There is no evidence the contamination came from the field, though this cannot be ruled out:
Because the samples collected in the growing fields were negative for Listeria monocytogenes whereas the environmental samples collected in the packing facility and cantaloupe collected in cold storage (discussed further below) were positive for Listeria monocytogenes,the growing fields are not a likely means of contamination. However, FDA has determined that the growing environment cannot be eliminated as a potential contributor in the introduction of Listeria monocytogenescontamination.
2) The design of the facility allowed for the pooling of water near the cantaloupes:
Certain aspects of the packing facility, including the location of a refrigeration unit drain line, allowed for water to pool on the packing facility floor in areas adjacent to packing facility equipment. Wet environments are known to be potential reservoirs for Listeria monocytogenes and the pooling of water in close proximity to packing equipment, including conveyors, may have extended and spread the pathogen to food contact surfaces. Samples collected from areas where pooled water had gathered tested positive for an outbreak strain of Listeria monocytogenes.
3) The design of the facility made it difficult to clean thoroughly:
Further, the packing facility floor where water pooled was directly under the packing facility equipment from which FDA collected environmental samples that tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from outbreak strains. The packing facility floor was constructed in a manner that was not easily cleanable. Specifically, the trench drain was not accessible for adequate cleaning.
4) A truck and driver shuttled back and forth bringing culled cantaloupes to a cattle operation which created an opportunity for contamination:
Another potential means for introduction of Listeria monocytogenes contamination into the packing facility was a truck used to haul culled cantaloupe to a cattle operation. This truck traveled to and from a cattle operation and was parked adjacent to the packing facility where contamination may have been tracked via personnel or equipment, or through other means into the packing facility.
5) Jensen Farms purchased used equipment for the packinghouse that was of a kind that could not be easily or routinely cleaned. The equipment was used previously to pack a different commodity. Trade sources indicate this was potatoes – though the FDA report does not identify the commodity. Pathogens that are not problematic for potatoes could have been introduced on used equipment:
In July 2011, the firm purchased and installed equipment for its packing facility that had been previously used at a firm producing a different raw agricultural commodity.
The design of the packing facility equipment, including equipment used to wash and dry the cantaloupe, did not lend itself to be easily or routinely cleaned and sanitized. Several areas on both the washing and drying equipment appeared to be un-cleanable, and dirt and product buildup was visible on some areas of the equipment, even after it had been disassembled, cleaned, and sanitized. Corrosion was also visible on some parts of the equipment. Further, because the equipment is not easily cleanable and was previously used for handling another raw agricultural commodity with different washing and drying requirements, Listeria monocytogenes could have been introduced as a result of past use of the equipment.
Environmental samples collected from the packing facility equipment tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from three of the four outbreak strains. After the firm discarded portions of the packing facility equipment and cleaned and sanitized the remaining packing equipment, environmental samples tested negative for Listeria monocytogenes.
The design of the packing facility equipment, especially that it was not easily amenable to cleaning and sanitizing and that it contained visible product buildup, is a factor that likely contributed to the introduction, growth, or spread of Listeria monocytogenes. Cantaloupe that is washed, dried, and packed on unsanitary food contact surfaces could be contaminated with Listeria monocytogenes or could collect nutrients for Listeria monocytogenes growth on the cantaloupe rind.
6) The failure to pre-cool the melons before refrigerating them created the environment that would lead to condensation, which created ideal conditions for pathogens to grow:
In addition, free moisture or increased water activity of the cantaloupe rind from postharvest washing procedures may have facilitated Listeria monocytogenes survival and growth. After harvest, the cantaloupes were placed in cold storage. The cantaloupes were not pre-cooled to remove field heat before cold storage. Warm fruit with field heat potentially created conditions that would allow the formation of condensation, which is an environment ideal for Listeria monocytogenes growth.
The combined factors of the availability of nutrients on the cantaloupe rind, increased rind water activity, and lack of pre-cooling before cold storage may have provided ideal conditions for Listeria monocytogenes to grow and outcompete background microflora during cold storage. Samples of cantaloupe collected from refrigerated cold storage tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from two of the four outbreak strains.
FDA also issued a Warning Letter to Jensen Farms, and CDC continues to update the situation.
The FDA investigation is thorough and sensible, but there is not one thing new in the investigation. That is to say that every single thing mentioned as possibly contributing to this problem was a known hazard before this season began.
So how did this happen? How is it that the produce industry — and we better face up to this — has killed 25 people and caused a miscarriage? How did the regulatory environment create conditions that allowed this tragedy?
On the trade side, there are two specific questions that exemplify the problem:
A) Wal-Mart, in many ways a great leader in food safety and certainly a company with almost unparalleled resources to make sure food safety is done right, bought these cantaloupes. How did this happen?
B) Wegmans, widely recognized as a smaller chain anxious to do the right thing on food safety, wound up having to do a recall on fresh-cut cantaloupes sold at its Buffalo area stores. How did this happen?
It is actually quite clear how this happened, and there are very specific issues that must be addressed, issues that may require us to blow up the distribution chain for produce in America.
The common link between Wal-Mart and Wegmans is that neither bought Jensen Farms cantaloupes directly. In both cases, it was an intermediary that made the purchases.
We have no way of knowing for sure but it is very possible, indeed likely, that Jensen Farms didn’t have a vendor number for either chain. And it is very likely that neither chain had vetted its facilities and operations. Both chains were relying on intermediaries to do so.
Yet, interestingly enough, almost every single time we have spoken to intermediaries over the past five years after a food safety outbreak, the intermediaries themselves get squeezed out as the farms stop all sharing of information as they plot their legal strategies. The fact that this can happen is itself an indication that the supply chain is not aligned sufficiently to produce food safety.
In the aftermath of the Spinach Crisis, in a response to a buyer-led food safety initiative we received a letter from a grower-shipper that we published as part of a larger piece titled, Pundit’s Mailbag – Grower/Shipper Calls Buyer-Led Food Safety Initiative Hollow Call For Action. In that piece the letter made the key point:
Food safety is like flavor; to successfully deliver it you must have commitment and control in an aligned supply chain. The commitment required is to hold food safety (or flavor) as a core value. The control can only be asset-based. The parties involved must have control over the assets necessary to execute daily. These assets are obvious from the shipper standpoint, and from the buyer side it is control over the PO’s.
Yet neither the retail chains nor the intermediaries typically have any control over the “assets necessary to execute daily.” If given a choice, would the well-respected Frank Yiannas, Vice President — Food Safety at Wal-Mart, have endorsed buying a used potato dump tank rather than a new piece of cantaloupe specific equipment? Almost certainly not. For that matter, would Frontera, which was the intermediary on much of this produce that found its way to Wal-Mart, do the same? We doubt it. Would Bill Pool, the Manager of Agricultural Production and Research over at Wegmans, think this a great idea? Forget about it. But — it is highly unlikely that any of these people — or for that matter Wegmans’ fresh-cut supplier — were asked.
And if you are not going to be asked, how can you control food safety?
Well, as our spinach crisis letter-writer indicated, the way you control food safety when you can’t personally be at the farm is that you need a supply chain aligned by common values.
This is where our critique of Wal-mart’s food safety policies becomes uncomfortable for Wal-mart. When we say that Wal-mart is not doing all it can on food safety, we are not saying that Frank Yiannis is remiss. We are saying that the core of food safety is completely out of his control. Because he is not authorized to assure Jensen Farms that it is in a deep partnership with Wal-Mart and that it can count on Wal-Mart POs flowing as long as it does the right thing on food safety.
Frank Yiannis is not even authorized to make that promise to Frontera, so that Frontera can pass on the promise to its suppliers.
Properly understood, the food safety question raised by this issue is why did Jensen Farms buy a used potato washer rather than a brand new piece of equipment specific for the cantaloupe industry? The answer there is pretty clear: It wanted to save money. But, of course, if it knew that Wal-Mart would gladly pay more for product produced in superlative facilities, it wouldn’t save money by buying cheap equipment. So Wal-Mart has created the economic environment driving these food safety decisions.
We’ve never met a packer that wouldn’t love a nice pre-cooling facility. So why didn’t Jensen Farms have one? Because it is expensive to build such a facility and is difficult to amortize the cost over a six-week season. Once again, though, the issue is clear: It is not the cost of these things that are problematic; it is the doubt that Wal-Mart is aligned with Jensen Farms and will happily pay more for cantaloupes to have them pre-cooled in modern facilities. Our thought: If Jensen Farms built a world class pre-cooling facility and tried to raise cantaloupe prices sufficiently to earn a reasonable return on that investment, the cantaloupes would be then cheaper in California, and Wal-Mart would drop this deal like a hot, well, like a hot cantaloupe. So it is Wal-Mart’s procurement decisions that drive food safety decisions on a day-to-day basis — maybe more so than anything the food safety or quality assurance department might do.
This is the next generation of food safety in the produce industry — moving food safety out of dedicated departments and into the procurement function.
The only way this can be done is to drop day-to-day trading and replace that with alignment with key vendors where both parties work together on driving costs out of the system while achieving shared goals such as food safety or sustainability.
PROFOUND IMPLICATIONS
The implication of this for many industry firms is profound. In the first of our cantaloupe pieces, we referenced a piece we did regarding a problem that Costco once had with some carrots up in Canada. Costco was buying these Mexican carrots through an intermediary in Los Angeles, and we asked why it was doing this. To us, it seemed that such a large company as Costco, as committed to food safety as Costco was and is, would buy from the big mainstream carrot producers.
The thing to understand, though, is that there is no option for the Los Angeles intermediary to sell Costco carrots from Grimmway or Bolthouse. If Costco decides to create an aligned supply chain with the top people in the field – that Los Angeles intermediary is out of the supply loop altogether.
The reason so many of the trade’s food safety efforts — from the Leafy Greens Marketing Agreement to the trade association’s initial endorsement of the Food Safety Modernization Act — have revolved around standard-raising is that only generally raised standards allow the industry to exist as it has. If the Wal-Mart policy becomes simply to always buy from the top three shippers in the game, does Wal-Mart need intermediaries at all?
The food safety lesson for the trade is clear to see, but problematic to implement:
There must be an aligned supply chain built around food safety and other key values. Producers must feel confident that they will have the business so they can feel free to invest in the best equipment, facilities and dedicated food safety personnel and protocols. Intermediaries must know that they have the business so they know what values they are being paid to promote.
Despite the thoroughness of its investigation, the FDA, disregarding all its talk about prevention, continues to pull its punches and be less than helpful in communicating with the trade. It remains a politically hobbled agency. For example, the FDA made a pretty specific finding regarding pre-cooling:
After harvest, the cantaloupes were placed in cold storage. The cantaloupes were not pre-cooled to remove field heat before cold storage. Warm fruit with field heat potentially created conditions that would allow the formation of condensation, which is an environment ideal for Listeria monocytogenes growth.
The combined factors of the availability of nutrients on the cantaloupe rind, increased rind water activity, and lack of pre-cooling before cold storage may have provided ideal conditions for Listeria monocytogenes to grow and outcompete background microflora during cold storage.
So, one would think the FDA would in some way make it clear that cantaloupes should not be sold that have not been pre-cooled. Perhaps there would be a regulation to prohibit this. Perhaps the FDA would issue a “recommendation not to consume” cantaloupes that have not been pre-cooled. Surely in FDA’s draft guidance for industry, Guide to Minimize Microbial Food Safety Hazards of Melons, it would update the milquetoast recommendation contained therein:
Cooling and cold storing melons as soon as possible after harvest because delays in cooling when melons with netted rinds (such as cantaloupe) are wet from washing operations may allow for multiplication of human pathogens on the rind surface.
This guidance says nothing about pre-cooling, although that is the specific problem the FDA identified with Jensen Farms.
The FDA’s vague guidance is the bane of the industry. Food safety is not a “yes” or “no” situation. It is in many ways a public good and thus a policy choice by the country regarding how much it would like to spend on food safety.
Instead, one gets bizarre recommendations such as this one:
FDA recommends:
Employing methods to reduce flying insect access to animal feces and other likely sources of human pathogens.
Think of a poor farmer trying to follow FDA guidance. What methods should he employ? How much should “access to animal feces” be reduced? From what baseline? What are the “other likely sources” with which he should be concerned? How would a farmer know when he had adequately addressed this recommendation from the FDA?
As best as we have been able to ascertain, the FDA insists on such vague language as a self-protection method for the agency. It may recommend “monitoring for signs of animal intrusion,” but it will never say run patrols once a week to check for animal intrusion because if it turns out animals intrude in between its selected monitoring regimen, the FDA does not want to take the blame. It prefers to issue vague recommendations then; if there is a food safety outbreak, declare ipso facto that obviously the farm was not adequately monitoring for animal intrusion.
The other problem is politics. It is clear that the FDA believes all cantaloupes should be pre-cooled, but small local growers, even regional growers, typically don’t have pre-coolers. FDA executives don’t want the hassle of being dragged in front of congressional committees and asked why they are depriving Farmer Jones of his livelihood.
So instead of speaking bluntly, the FDA makes oblique references in its reports and hopes the mainstream industry will pick up on it. Of course, this is not promoting food safety; it is promoting the bifurcation of the American food system, where local and small scale operations will sell sub-standard product into an alternative distribution network, while conventional retailers sell safer product but lose market share to those selling lower priced and less safe product. Is this really the world the FDA wishes to build?
