Food Safety and Environmental Health Blog : Disease Prevention, Public Health, Sanitation Information & Analysis : Environ Health Associates

Looks like 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.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm174171.htm

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 thier 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 DC 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 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.

http://leavittpartnersblog.com/2012/01/investigation-of-cantaloupe-listeria-outbreak-has-congress-asking-serious-questions-around-third-party-audits/?

The controversy continues over the value of third party audits in food safety at the fresh produce level, as pointed out by Professor Doug Powell at Kansas State University in his BITES blog.

Jim Prevor, produce industry analyst, says changes are needed, while the law firm Marler-Clark is suing a food safety auditor and a third party auditing firm.

The lingering question remains, "how can we improve this system"?

Third party audits are best implemented when there are regulatory controls over the audited operations, thus underpinning them.

In their absence, third party audits are flawed by a lack of standard government requirements such as the preapproval of equipment, structures, layout and design, waste disposal methods and potable water sources.

Third party food safety audits are currently conducted as part of a firm’s overall quality assurance program. The audits are simultaneously  environmental risk assessments, regulatory compliance assessments, evaluations of production processes and analyses of management controls.

Food safety auditors, auditing companies, standard setting and certification bodies, and all players in the produce supply chain share a common interest. These partners should work together through a logical and cooperative approach guided by the best available science, to protect public health, and in so doing, their own interests.

Suggestions for improving the third party food safety auditing processes include:

Changing the roles of the Audit Company, Buyer, and Customer:

Currently, buyers (retailers, middlemen, brokers, marketing groups) require that suppliers schedule and pay for an audit with an auditor or auditing company. Since the auditee makes such arrangements, they are the customers of the audit firm. The auditor is beholden to the “customer” to establish the time and location of the audit in advance. The auditee also negotiates the price, and can even request a particular auditor, although the final decision as to which auditor to assign in generally left to the auditing firm.

If roles are reversed, and the “buyer” becomes the “customer”, then the buyer would schedule the audit, and the buyer would pay for the auditing firm for the audit. The buyer would then receive the audit report directly and have control over its dissemination.  Most importantly, this process would allow for an unannounced audit to occur. Auditing firms know that scores of announced audits are often much lower that announced ones, suggesting observational bias that this method might filter out.

The Buyer, as the Customer, would become the driving force behind audits, their timing, stringency, frequency and interpretation.

Fee arrangements and the practical aspects of doing business may pose hurdles to this approach, but the resulting value to buyers may make this method attractive enough to induce changes in the current business models.

Roles of government and auditing firm:

The Food Safety Modernization Act (FSMA) currently addresses the need for auditor competency when working in post-harvest operations under federal jurisdiction and as part of FDA’s “Foreign Supplier Verification Program”. Auditing companies should require that auditors become fully familiar with existing FDA produce safety guidance and the new requirements of the FSMA, especially the requirements for a hazard analysis and science-based controls.

The FDA should begin an effort to meet with buyers and auditing company executives to discuss partnerships, and establish liaison with them to coordinate their activities around meeting the goals of the FSMA.

The FDA should protect auditors under whistle blower protection provisions and require that the Buyers (as the drivers of the model) provide to them all third party documents related to food safety within 10 days. The third party risk assessment findings should drive the need for FDA to conduct its own rapid response risk assessment within 30 days, if and when necessary to protect public health.

Auditing companies should report “automatic failures” resulting from adulteration to FDA  within 24 hours.

Transparent communications should happen between the FDA, auditing firms and buyers. FDA should make known its own compliance records in a timely fashion. Third parties should not audit any facility operating under FDA sanctions until such firms are in substantial compliance.

When third party audit criteria are less stringent than federal rules, their value as a risk assessment tool is negated.  Risk assessments, especially newly adopted ones such as Global GAP- should be scrutinized. Currently, the failure to have toilets available to field workers in Global GAP would not trigger an automatic failure, this standard also allows hand gel to replace hand washing, such unsanitary practices are not acceptable under the FSMA.

Reassessments by buyers and auditing firms

A buyer should be required to perform a reassessment either through a third party auditing firm or through its own (2nd party) audit, in any operation where corrective actions must be verified.

The following should trigger a reassessment audit;

1. A Critical Control Point failure in a Hazard Analysis Critical Control Point (HACCP) based system.
2. An automatic failure of the audit. 
3. Laboratory or others test indicating a microbial, chemical or physical hazard exists in a facility, product or process. 
4. Significant noncompliance with FDA rules (when published).
5. Significant repeated failures of the food safety management system.

Expanded role of microanalysis

Because auditors have access to a supplier's micro-testing results, they can base risk assessments on the findings. Expanded micro-testing will allow auditors to make better judgments concerning the microbiological quality of products, equipment, and water used in a wide variety of processes and environments.

The government and science community, including researchers, academicians, and practitioners should work together to enable a more accurate microbial risk assessment.

The future of third party audits

In the short-term, there is no viable substitute for third party risk assessments in fresh produce operations. Buyers are not prepared to audit the many suppliers they have by themsleves, and government bodies are not adequately funded to begin the process of regulating the full multitude of suppliers, domestic and international.

In the long-term, an effective FDA would reduce the need for constant oversight by third parties, but this does not appear to be a certainty given the political and economic picture as it appears today.

Self-audits (internal audits or 1^st party audits) are much underutilized. Supplier “self-reporting” directly to buyers could provide data so that audit frequencies could be adjusted using a risk-based approach.

The best alternatives to improve produce safety through third party audits may include:

• ·         Buyer financing and coordination of the audit
•        Unannounced audits
• ·         FDA involvement in the third party audit process including determining auditor competency, training  and oversight
•        Risk based frequencies for audits based on self-reporting
• ·         Transparency of all audit and inspection findings by all concerned
• ·         Validated physical, chemical and microbial standards
• ·         Expanded use of 1^st and 2^nd party audits

The noted microbiologist Mansour Samadpour has recently suggested to Bloomberg’s Stephanie Armour that (See Bill Marler's blog) 

“You can make these audits useful by writing them on toilet paper. Then someone would at least use them,” said Mansour Samadpour, president of Lake Forest Park, Washington-based IEH Laboratories and Consulting Group, a food-safety consulting firm, in an interview. “They’re worthless. They give a false sense of security.”

http://www.marlerblog.com/legal-cases/the-best-quote-ever/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+MarlerBlog+(Marler+Blog

Are third party audits currently useless to buyers and to the supplier who pays for them?

I think we need to clarify how the buyers can best use these reports, and how to improve the reporting process rather than throwing stones at one another...no one is shatterproof.

Understand that assuring food safety in the fresh produce supply chain is very different in many ways from assuring the safety of the meat, poultry, dairy or other food industries, most of which are highly regulated.

Currently, there are some alternatives to the independent third party risk assessment on farms, but those solutions are a ways off. Some state regulators are focusing in on the agricultural sector, but today the regulation and enforcement of food safety standards is left to the industry.

The “food safety industry” is quite competitive and diverse; private labs compete for market share against auditing firms with labs, auditing firms compete with other auditing firms, standard setting and certification bodies compete, pest control services also compete with chemical suppliers who also own auditing firms.

Therefore, understanding what is being said by firms like IEH Laboratories and Consulting Group about its competitors requires some retrospection.

The testing of agricultural products for safety by labs today is not routine. However, as this trend grows we may eventually see a produce firm that "has passed a Lab test" involved in an outbreak just as we have seen raw meat facilities that have passed government inspection and laboratory analysis involved.

I would like to ask Mr. Mansour if he would be just as critical of labs for giving a "false sense of security" when the products they test cause outbreaks? Is USDA inspection worthless if inspected products cause outbreaks?

It is clear to me that third party audits are needed in the absence of any other outside controls of primary producers at this time. The produce industry, together with the food safety industry that supports it, should consider the following soft spots in this process: 

• Audits are routinely announced, meaning that the time of the audit is known ahead of time by all parties. An auditing firm that conducts both announced and unannounced audits reports that the differences in the score between the two measures can be 10 percentage points or more. Risk based inspections do not necessarily require unannounced visits as the risk in a process can usually be determined from operations, but at least some announced audits are a good idea. 

• Buyers currently are empowered by their customers to go outside the recognized certified sellers if product is needed. The pool of unregulated and unsupervised facilities is still large. It is not uncommon to have an audited, certified and even inspected produce operation, operating beside an unregulated unaudited firm. Inconsistencies like that cause animosity and dysfunction.  

·         The pressure on buyers, especially brokers and other middlemen to buy from anyone, results in placing some operations in a competitive disadvantage. There is no clear answer to this as some operations just simply ignore the requirements that others must follow and can still sell their products. 

• The standards the third parties use are written by the buyers. These are also the entities that evaluate the findings, and make buying decisions supposedly based on conformance to their standard. Buyers cannot raise the bar so high as to eliminate a large share of the supply chain and thus develop those standards so as to be inclusive of the current levels of sanitation and safety in the industry- which can be less than perfect. I have not seen yet where a low score on an audit has caused an operation to go out of business. An outbreak will do this, but not a low or even failing score. In today's market, if the supplier has needed product, the volume and the physical quality, he will be able to sell it to a customer somewhere with our without a passing grade, even with or without an audit of any type. 

• Retailers and their own culture effect food safety audit systems in produce.

I was in a well-known market the other day and saw next to the open bin of cracked and otherwise damaged mixed tree nuts (with no traceability), bags of packed nuts, clean and unbroken with source codes. The bagged nuts were about 50% more expensive.

Rather than using audit reports for toilet paper, buyers should instead be using them to make decisions and all involved in the private assurance of produce food safety systems should read the writing on their own wall.

As we trudge along in food safety at the farm level, the sense of desperation is obvious, but there is hope and movement forward. 

Not only is the produce industry reeling from the recent food safety disasters in its products, the pressure is on in the labor market and on the economic front. Growers and packers of fresh fruits and vegetables seem just as isolated as any group in their problem. They are seeking help, and this is positive, and the answer may be a more cooperative approach. 

We in food safety must realize we are superimposing a self-regulatory and soon to be regulatory framework on an industry that has not had this to deal with.  FDA is supporting industry efforts to self-regulate, and the two together can accomplish much, but we still need produce industry specifications for suppliers based on sound science.

The article below makes a point of the need for cooperative efforts amongst industry and government. Part of that is for FDA to ensure that the standards industry uses to assure safety are effective in very diverse crops.

Some of the audio is a bit garbled, but Tony Piedimonte of Florida's Wm P Hearne company makes some salient points about the industry stance. 

Thanks to the Packer for covering the following story. 

http://www.thepacker.com/fruit-vegetable-news/Food-safety-labor-issues-discussed-at-Florida-Ag-Expo-133632553.html

While the Environmental Health professional’s role in food safety is marginalized in some places (such as in Florida, where the Environmental Health staff conduct less than 10% of the food safety inspections) there is a growing need for their involvement directed toward the safety of fresh produce.

With experience in the safety of water, land use, plans review, wastewater disposal and treatment, soils, vector control, the use of sanitizers, pesticides and the like, I believe the environmental health profession holds one of the best, tangible responses to today’s produce dilemma.

Unless adequate funds become available, the Food Safety Modernization Act, the federal response to the current public health crises affecting our nation’s primary producers, will not provide the solution.

The impact of the repeated outbreaks of foodborne illness should be a stern warning to our nation’s legislators, but they seem oblivious to the problem. When 30 people die from tainted cantaloupe, bells and whistles should be sounding in Washington; instead, its dead air in D.C.

If a terrorist attack killed 30 Americans, would our nation’s leaders say, ”We cannot afford a response...?"

If FDA cannot do this job alone (and why should they?), then we have an untapped resource in our County Public Health Units. There are over 3,000 health departments in the US, with more than enough infrastructures to support the produce food safety regulation/enforcement task, both in facilities and on farms. If properly trained, managed and funded, environmental health professionals could expand the roles they now play in protecting public health, into agriculture.

Rules must be developed and the inspection workforce needs to be trained in a somewhat new discipline, but the qualified Environmental Health Specialist has the capabilities needed now. With proper guidance and support, they can be effective in produce facilities and on farms.

In addition to our local public health professionals, there should also be an expanded role for state Departments of Agriculture and even USDA to help fill in the gaps in produce safety regulation and enforcement.

While we search for ways to prevent the next food safety disaster, consider properly funding and supporting local environmental health protection efforts. Give our county public health units what they need for the effective enforcement of laws and rules and we will see a reduction in foodborne illness.
 

Lessons Learned From Foodborne Illness Outbreaks

Part 2.  

Listeria Outbreak in Cantaloupes

 “They probably look at themselves as victims too, but as between the person who bought the cantaloupe in the grocery store, who is more of the victim? And does a grocery store have an obligation to its consumer to not sell them products that are contaminated and from entities that have limited assets and insurance. That’s why it is 100% likely that this cantaloupe outbreak is going to bring in everybody in this outbreak, including the retailers and the auditor and Frontera and Jensen Farms because that’s the only way that the victims - whom we all would agree have far less culpability than the other side of the equation - that’s the only way that these people are going to be fairly treated. But it’s going to be a battle”.  Bill Marler.

The Listeria outbreak in cantaloupe is still producing cases. Much has been written about the responsibilities of all involved and what needs to happen to correct deficiencies in our approach to food safety in produce, along with much sadness and much controversy.

As attorney Bill Marler has said in this exceptional interview in the Packer, the legal associations of the packinghouse, retailer, distributor, auditor and consumer are clear, and it is sobering.

Reflecting on Mr. Marler’s perspective, we will look at the chain of legal liability and see how it intersects with the chain of causation to see if we can learn something from these monumental, tragic and frightening events.

One must look at the disease pathway to see the intersections clearly, and it is a complex scenario with Listeria monocytogenes due to this pathogens ubiquitous presence in the environment, its likely ability to create bio-films on the surfaces of plants and inanimate objects and its propensity to cause serious illness in the immune deficient.

In terms of the infection pathway, we do not know whether the causative agent spread to the packinghouse and colonized the equipment, or the equipment was already contaminated by another farming operation due to previous use and spread to the packinghouse as pointed out by FoodSafetyNews.

What we have learned is that conditions at the packinghouse allowed propagation of Listeria monocytogenes at this site, and subsequent conditions eventually affected the entire supply chain. Additionally, contaminated products continued to be sold for an extended period, revealing our failed traceability systems .

On the packinghouse level, once the environment is contaminated, Listeria monocytogenes can spread throughout production and create niches for growth. That conditions were ripe for this at Jensen Farns is now clear, but unfortunately in hindsight.

On the product level, we know from FDA that cantaloupe is potentially hazardous, but this hazard was believed to occur only after cutting the melon.We did not understand the clear probability of the pathogen to not just colonize a melon surface, but also proliferate on it.  I believe this chain of causation probably involves growth conditions for the pathogen on the surface of the melon, probably post washing. This phenomena should have been realized, but it was not.

The temperature controls at Jensen would not have been sufficient to control LM after colonization of the melon. Growth would begin at the packinghouse cooler and continue through to the cold-supply chain. Any increase in temperatures in the supply chain would result in accelerated growth, thus amplifying the problem for the next user.

At the level of the buyer, the buyer is obliged to ensure conditions at its supplier do not render a product adulterated. The buyer should maintain controls over the supplier. These can include test of water, tests of products, independent audits, self-audits and second party audits along with letters of indemnity and guarantees. Given that the buyer receives products that may be contaminated, controls should be in place in further distribution to reduce the likelihood of any dangerous product reaching the consumer, pointing to the need for more testing nearest to the consumer level and traceability.  It’s interesting that industry has vigorously opposed the random testing of products and has effectively killed some of these programs.

That all involved in this distribution chain now bear responsibility is clear. This is not the first outbreak of a pathogen in cantaloupes. That our standards for handling cantaloupes were too low is painfully clear.

At the level of supplier control, the retail industry must start getting smarter about how to qualify its suppliers, currently the industry-required tests of finished products may be driven by a poorly defined risk assessment, or simply rely on industry practices, The bar is now raised extremely high for quality assurance in the produce industry and we should see a move to integrate technology into the food safety effort at a very high level, especially traceability and end products testing. We should see a major emphasis on water quality, in in-process tests and final tests for products, whether they be directly from a farm, from a packinghouse or from a processor. If there is a gaping hole in the producer-buyer-retailer food safety net, it’s the failure to adopt the best microbial standards and best quality assurance standards and traceability for producers.

At the level of the consumer, an acute problem arises with controlling Listeria. Refrigerator temperatures would not be able to prevent the slow the growth of LM; there have been no consumer advisories on how long or at what temperature to keep whole cantaloupes, making this a unique challenge for the consumer.

This melon’s netted surface hinders removal of LM (especially in a bio film) making washing by the consumer of little effect.  Before, during and after preparation, it is common for consumers to leave food before serving without temperature controls and to put the leftover items away at some latter time, potentially allowing proliferation in the cantaloupe meat.

Unfortunately, we have not properly educated the consumer about the intricacies of food safety and they simply do not know in every case of contaminated product hitting them, what to do.

But as food safety professionals, we should know what to do.

Events like this can trigger a bit of fear. In a twist of fate and circumstances, I was auditing a firm less than 100 miles away from the site of the Jensen Farms outbreak about a week before the fateful Jensen Farms audit. I met with farmers just like Mr. Jensen.

I have to ask myself, if I was the auditor, would I have spotted the inconsistencies in production?

Would I have understood the critical environmental factors I was seeing and understood the entire process and its role in the growth of LM?

Would I have appreciated the relationship of the factors I was looking at and reacted to the risk of the survival and growth of Listeria monocytogenes on the surface of Jensen Farms' melons?

The answer could be frightening. No, I may not have realized the conditions were ripe for a Listeria outbreak the has killed 28 people to date.

This is a gut wrenching realization and one that has been with me since the day this outbreak began; if we are going to truly perform a valid risk assessment, we need to be carrying a very big bag of tools.

The audit instrument is best used like a surgeon’s scalpel. The scalpel is best for delicately separating the good, from the excellent, from the superior. Sometimes we need a hatchet for the ones that need it, and all we have in our tool kit is a small knife.

We should ask about FDA's prevention role, and the role a strong FDA might have played in preventing this outbreak; and ask about the regulatory scenarios moving forward. Certainly, these events point to the urgent need for FDA to come in and level the food safety playing field.  But unfortunately, no one wants to pay for the FDA to do its best work, so now the auditor, the consumer, the packinghouse, the farm the processor, the retailer and the consumer must pay.

Thanks to the strength of our legal process and the skill of our legal firms, that there will be justice in the end. This would bring closure for me, except for the fact that our public health structure is letting us down and my efforts without that crucial element will be forever flawed.

I predict we are going to see more sad stories, failures and more finger pointing, and maybe rightly so.

Lessons Learned-

If there are more hazardous facilities out there, they need to be identified, repaired, or closed.  

All produce facilities should be reviewed to make sure they have the correct infrastructure, ideally, before they are allowed to operate.

Buyers must insist on the application of the best quality assurance methods and traceability systems.

Food safety efforts from farm to table need proper financial support.

There needs to be less politics played with food safety and a cooperative effort byindustry and government to protect the consumer.

The education of the American consumer about food safety is woefully lacking.

We are now seeing huge gaps in the food safety net.  We also see the effect of the serious pathogens like E coli that have become entrenched in our food animals, thus in our food supply, and in our environment. The failure of agriculture to control E. coli has contaminated the entire food supply, our water and soil.

These events will continue and escalate due to our inability to create a nationwide food safety system form farm to fork and the propensity of these pathogens to proliferate. Glaring deficiencies exist; most notably, flaws in basic sanitation and related practices found at the farm, in restaurants, and in the transportation sector are going without effective controls. These correctable conditions if left uncorrected allow for the persistence of deadly infectious agents in food.

While we  as an industry concentrate our prevention efforts in the supply chain, remember that not addressing the starting and ending points of this chain thwarts all other purposes.

A comprehensive approach to the problem must involve a strong response by FDA to both on farm and consumer safety.  Without adequate resources, FDA cannot do this job. Without industry support for proper funding the Food Safety Modernization Act will fail. This Act crafted by industry working alongside government addresses concerns in the food supply in the most comprehensive approach yet attempted,

A double standard is evident in the lack of industry support for FDA and FSMA. This is clearly seen in a letter to congress from the American Meat Institute and its signatories.

As long as powerful political interests put political power and influence over public health, food safety in this country will continue to deteriorate. The effect on industry has already been devastating for certain groups, especially for growers of tomatoes, spinach, peanuts; and now the entire melon industry is tainted with the problem of Listeria monocytogenes in cantaloupes.

The many millions of dollars defending lawsuits and untold millions lost in sales, as well as the loss of confidence of the American consumer, and the huge burden for those with resulting health care costs are compelling reasons for industry to support FDA.

Industry paying its fair share is something we should expect. Just "not wanting to pay" to ensure that there is a strong regulatory framework for food safety is not acceptable.

As the result of the release of the FDA environmental assessment at Jensen Farms, the roles of all food safety persons involved at Jensen Farms-Frontera have rightfully come under fire.  Once again the the nature of industry led food safety regulation itself (food safety auditing) is in question. 

That all involved maintain some degree of responsibility for this disaster is without question. When a disaster like this occurs, one must ask who is responsible, but also why did it occur and how can it be prevented in the future.

The produce industry is unregulated and has been since the founding of this country, and this is the primary problem. In the recent past, we have become painfully aware of the inadequacies of our industry led prevention efforts at the farm level. In defense of the effort, while much has been done, it has been a short time to change the nature of agriculture This is what we are doing by implementing food safety strategies in open air and on- farm environments. We must also change the culture; animals on farms, for example, have been a given for centuries.

Food safety auditors executing a buyer driven auditing model rely upon the certification body to develop and manage the standard that guides their work in the field. The standard is not a public health law and it is not developed like one. The auditor has no legal authority to demand records, embargo products, or close an operation, for example.

Enforcement, if you will, has been in the hands of the "buyers". They rely on third party audits, their own second party audits, letters of guarantee and the like, before make buying decisions. Buying decisions should take into account food safety, but supply and demand pressures might induce buyers to purchase from sources without a clear safety margin. However wrong this is, there is nothing illegal about this practice.

Auditors currently are not required to inform FDA of violations, but auditors are currently required to know what regulatory violations have been cited in the records of the firm, and if they were corrected. Auditors are also expected to follow the guidelines of the audit and make an accurate assessment of findings. When this is not done we must ask why.

So there is a connection between the two independent systems of food safety "regulation", but a relationship that is way underutilized.

Auditors conduct prearranged audits to evaluate the conditions of the environment, equipment, water supply, personnel, waste removal, use of chemicals, vector control, general sanitation, equipment hygiene, and structure maintenance, within a sometimes narrow scope of the audit. Regulators should be approving plants and operations in advance, then making frequent unannounced visits to determine compliance with laws and rules. They also have free range to demand any required document and inspect any licensed area. While both touch on the same items, the perspectives and powers are vastly different. The legal process should occur in cases where violations are not corrected or immediate threat to the public is found, and buyers should not purchase from unsafe sources. Auditors cannot perform these vital public health functions, nor can they the directly affect buying decisions.

Generally, FDA guidance and the available research form the basis for the audit criteria. However, issues like severity can be difficult to interpret. For example, in cantaloupes the commodity has not had the type of industry oversight we have in leafy greens or tomatoes (under market orders).  But FDA has provided guidance to the melon industry. We should mention this reference below: 

• Using single pass (or one use) cooling water of sufficient quality for this intended purpose also may be used to cool product.

This is the source of info that indicates single pass water of sufficient quality may be used for washing melons. There is no mention of antimicrobial in this application. For dump tank or flume water, or where direct melon to melon contact occurs in common water, then treatment is indicated. Standards vary greatly as to disinfection of water, and for sanitizing various fruits and vegetables.

The risk assessments are still developing (and so are the politics involved with any industry led effort.) It is telling that according to "commodity thinking" cantaloupes fall into the class of fruits and vegetables with "inedible peels". This narrow definition ignores the other routes of disease transmission with this product. Microbial testing of products and the production environments is not a given. This is telling because in other Listeria susceptible products FDA and USDA demand stringent testing programs for the environment.

Water used in packing operations is required by the third parties to be potable. FDA has not published specifics about how to determine potability in a packinghouse environment, the references simply being for the use of potable water at the start of a washing process. Potability has come to mean that coliform bacteria are not present in a 100 ml sample. There are no guidelines for chemical parameters for safety in the potable supply and no requirements for the wells themselves to be treated or permitted before construction. No FDA requirement I know of demands that the local health departments permit, inspect, and require a certified operator to maintain the water quality.

At Jensen Farms, washwater for cantaloupes was apparently not reused, being simply a single pass wash of cantaloupe without treatment. There is nothing prohibiting washing cantaloupes or any produce in this fashion in the standard as long as the source is potable. This is room for improvement in the third party standard, but until the industry as a whole agrees on water treatment standards for these melons it is unclear how to develop them. This is now apparently a glaring deficiency, and just one amongst a myriad of things not addressed in food safety at the packinghouse level by FDA. 

In light of these problems in our food safety systems, auditors and auditing companies have stood in the gap for regulators. I appreciate FDA and its remarks concerning the training of auditors and any classes they could offer would be much appreciated. To date, however, I know of know such training program for industry auditors sponsored by the FDA that is available today. One day that might change.

We also have to thank the FDA for such a well developed theory on causation and it is perfectly clear that the focus should be on the packing environment.

Problems that existed in this plant in this situation are accurately described by FDA in its report. The evidence is clear for the propagation and spread of Listeria monocytogenes through water and surfaces, and "improper cooling" of cantaloupe. Pre cooling to remove field heat as a route of causation makes perfect sense, but pre-cooling is by no means a standard practice on farms or packinghouses in general as pointed out by FDA in its guidance.

The nature of equipment in packinghouses is subject to contamination and often hard to clean; moving heavy crates of products will deteriorate floors; draining is often a problem especially where washing flumes and spray systems are used. Some structures and waste disposal systems are better developed than others for this type of "dirty" packing work; however, there are no standards for construction of a packinghouse.

Currently, there are no regulations for the construction and maintenance of packing equipment; its design, layout or even fundamental function have no legal basis. Regulatory agencies normally have the functions of approving the designs, equipment and plumbing schedules, lighting, finish of walls and floors in a plant. Auditors rate these items according to the dictates of the standard within the scope of the audit. Of course FDA has the authority over such, and it would be best to have regulations of these items, but FDA has not exercised that authority and has only written guidance for general requirements. I appreciate what FDA has done in ferreting out the causation at Jensen/ Frontera, but it would have been much better for them to have published packinghouse rules, and been there before the outbreak to enforce the requirements they address as violations now.

Therefore, in light of these ongoing and serious gaps in food safety, the industry itself has required what it finds to be the best practices to protect itself to the extent it can. That these industry requirements are suited to the needs of the buyer is self-evident and expected. More importantly, things need to change as we understand risks better; but what a tragic way to learn.

Its sad that the farmer in this case did not recognize the difference between his potato line and a "cantaloupe line" nor the distinction between a potentially hazardous product like cantaloupes and a non potentially hazardous raw potato. In crops like potatoes, bulb onions, carrots, beets, there is dirt, the distinctions between risks of different crops do not generally drive standards. However, with melons the risks should have been identified, and the best practices possible followed, and they were not.

In a risk assessment we develop such preventive measures for a variety of crop types and information like this often comes out if properly done. But then, HACCP is not "required" in produce; but training in risk assessments should be mandatory for operators of high risk facilities and especially for auditors.

About the future of third party audits, I think we need the FDA to be conducting their own risk assessments and allow us third parties to simply be the eyes and ears of industry, and not the enforcers of public health protection in this nation.

This is not the role of the third party auditor.

Part 1

Outbreaks in fresh produce, while tragic for victims, nevertheless can have a positive outcome if we can learn how to better prevent them, or at least reduce their occurrence. This four part series will discuss the current produce outbreaks in cantaloupes, cucumbers, celery and strawberries and analyze the information that is known, with the intention of improving our food safety systems.

Recent breakthrough events

While the fresh produce industry in the US continues its food safety efforts, pathogens have recently broken through our safety net in diverse products such as cantaloupes, cucumbers, celery, and strawberries. These events have highlighted our immediate need to strengthen food safety systems in the entire fresh produce industry.

The fresh produce industry utilizes Good Agricultural Practices (GAP), Current Good Manufacturing Practices (cGMP), and Hazard Analysis Critical Control Point (HACCP) systems based primarily on guidance from The US Food and Drug Administration (FDA). Some producers of high risk products bolster these efforts with commodity specific guidelines developed by industry. Firms also utilize microbial sampling programs for water, environments and products, and implement traceability programs. Various agencies may have jurisdiction at the produce/processor level of the fresh produce industry, but most of the growing, packing and transportation of produce remains without consistent government oversight. The Food Safety Modernization Act gives FDA broad new authority to tighten regulations in the fresh produce industry, but the agency has not yet effectively exercised these new powers.

Dynamic Industry Based Food Safety Programs

In the absence of mandatory food safety rules in fresh produce, the industry has developed its own voluntary program for produce safety, including its own standards. These programs consist of science-based standards, policies and procedures, training, sampling, and the maintenance of records to support GAP, GMP and HACCP. The major buyers of fresh produce (retailers such as Costco, Wal-Mart, Publix, Kroger, among many others), insist upon the verification of these safety measures using ongoing third party, second party and self-audits. Government agencies, producers and buyers randomly test products for pathogens, and the industry conducts voluntary product recalls when pathogens are found.

These programs should not be static; preventive measures taken by the industry should change and adapt as we learn more about how pathogens contaminate, proliferate and survive in the chain of production from the farm to the consumer.

While it is not possible to know the route of transmission in every situation, we should still analyze foodborne illness outbreaks. What we do know about pathogens can be just as important as what we do not know. Achieving the ideal of a farm to fork food safety net requires a dynamic response from the entire supply chain to the problem of contamination.

Salmonella Outbreak in Cantaloupe

On March 22, 2011 the Del Monte Company issued a limited voluntary recall of cantaloupes from its Asunción Mita, Guatemala farm, saying they have the potential to be contaminated with Salmonella Panama. Over the course of the ensuing outbreak, authorities identified 20 victims in 10 states linked to this farm by epidemiological investigative techniques.

In this outbreak, as in many others, investigators failed to isolate the causative agent from a suspect melon. This prompted two law suits, one against the FDA, and another against a state epidemiologist. Del Monte asserts that the epidemiological approach used to associate cases with vehicles was flawed; while investigators contend that such a rare serotype could not be caused by anything other than exposure to a common vehicle. FDA points out that almost all victims of illness purchased cantaloupe from stores supplied by the Del Monte farm in the relative time period.

Del Monte, as part of its case against FDA, argues that its food safety program would have prevented such occurrences. Third party audit findings from April, 2011 showed a high degree of conformance with industry standards by this facility, but auditors also found that some sanitation controls needed to be improved. Results of third party audits of the packing facility in question suggested two important corrections:

• ·         Covering an exposed sewage ditch
• ·         Incorporation of daily cleaning and sanitation of the dump tank

FDA #22-03 Import Alert

In July of 2011, FDA banned products from the Asunción Mita facility, concluding that they were produced under insanitary conditions and that they likely contain Salmonella. FDA recently lifted this ban.

In its import alert, FDA recommends that based on previous experience, its food safety personnel should evaluate the following risk factors:

• ·         Safety of water used in irrigation, packing and cooling;
• ·         Manure use and bio-solids, animal management;
• ·         Worker health and hygiene;
• ·         Sanitary facilities in field and packing house, disposal of sewage and silage;
• ·         Maintenance program for cleaning, sanitizing equipment;
• ·         Field and packing facility sanitation;
• ·         Transportation;
• ·         Steps taken to identify and correct insanitary conditions.

 Lessons from this event

At this time FDA has not made public its findings from the inspection of the Asunción Mita packinghouse, but some information about sanitary conditions have been reported by third party auditors. A reference for this can be found in a report by the Florida Center for Investigative Reporting.

Covering an exposed sewage ditch

It is not perfectly clear what the source of this sewage is, whether it is “black water”, meaning waste water from toilets and hand sinks, or “gray water” meaning spent water from other sources (wash flume water, floor drains, drainage from refrigeration, etc.).

Regardless of its source, such wastewater is a potential source of pathogens, and facilities are required to dispose of it safely.

In many regions, we rely upon sewage disposal rules written by health agencies for the collection, transference, treatment and disposal of wastewater. Ideally, there is an enclosed piping system to convey the wastewater to a treatment system before disposal of the effluent, such as into the soil in subsurface septic systems. Such effluent can also be discharged directly into a sanitary sewer if one is available, or treated in an onsite sewage treatment system before discharge into a flowing body of water.

In no case should untreated wastewater, or "sewage" as FDA puts it, from a produce operation be disposed of in a ditch, onto the surface of the ground, or discharged into a body of water.

There may be no rules for wastewater discharge in some agricultural operations, or operations may be loosely regulated. This is often the case in the developing world, or in remote rural locations. In such cases, decisions about what to do with wastewater are left up to plant personnel who may lack knowledge of sanitary wastewater disposal. Unsanitary wastewater discharges and lack of compliance with environmental regulations can unfortunately be found in some produce facilities.

Opponents of government regulation should be aware that the imposition of consistent sanitary waste disposal methods are a hallmark of public health controls. Where these are enforced, environmental exposures to sewage are greatly minimized. Where there is no regulation, such hazards are likely to be forgotten or simply not addressed and create problems.

Incorporation of daily cleaning and sanitation of the dump tank

Not all produce is washed before being packed; in this case the facility did wash its melons. The common practice of field-packing, meaning packing directly into boxes or other containers as the final unit-packaging, is common with several commodities, and has some serious concerns.

In certain cases, makeshift washing in the field occurs, such as in barns using tanks of water. In many farming areas water is a precious commodity and is reused. A tank of water used to rinse produce in a barn may remain for an entire day without changing. Thousands of individual pieces of vegetables may be so exposed to pathogens if even one unit has contaminants. To say that on-farm washing systems like this are antiquated is an understatement.

It is a mistake to assume that water used for field packed product is even potable under the meaning of the law. The US Environmental Protection Agency (EPA) provides the standards for potability of water. Because there is yet no clear government regulations as to the application of potability standards to water used for washing produce, the industry relies on periodic microbial testing of water and the available research and advice of experts. Usually, the produce industry relies on tests for the coliform bacterial indicator group to gauge microbial quality. Where a satisfactory result of < 1 CFU in a 100 ml sample is obtained, the water is considered potable.

However, wash water is rarely tested “in process”, the operator assuming that periodic testing of the water source and treatment is all that is necessary. This is often the case where packinghouse operations use washing systems consisting of sprays or flumes.

The third party audit findings for this operation indicate that the facility in question “dumped” its products into a tank of water (dump tank), and that the frequencies for changing this water and cleaning the tank were questionable.

It is common to see confusion on the part of operators of produce packing facilities as to how to control the safety of process water. What the industry has done in past years to satisfy buyer demand for a product that “looks clean” may cause an exposure if re-circulated water systems are not properly tested, treated, cleaned and maintained.

We must improve our controls for process water, but questions remain: How to do we treat such water? What antimicrobial to use? And how do we test its efficacy? And very importantly, what do we do about improvised washing methods often used in field packing?

Listeria Outbreak in Cantaloupe

On September 14, 2011, FDA issued a press release to announce that Jensen Farms, a Colorado operation, issued a voluntary recall of its Rocky Ford-brand cantaloupes after being linked to a multistate outbreak of Listerosis.

At this time there have been 21 deaths and 109 people have been sickened in the outbreak — including the 21 dead — in 23 states from California to the East Coast

Read more:

(To be continued in Part 2 of this four-part series).