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

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.