To better understand my piece on Rose Acre Farms, let me further clarify a few things. I am a sanitarian by training, I am not per se an expert in all aspects of poultry or egg production. I have a bias toward sanitation (the maintenance of healthful conditions) as a primary, or even the most fundamental disease control practice. As an environmental health professional, I am focused on preventing routes of disease transmission through the environment. To do this, we must understand that the routes are complex and involve three fundamental interactive epidemiological principles; Agent-Host -Environment.

In my foodborne-communicable disease investigation work over the last 40 years, its notable that in almost all cases, gross contamination involving the food is evident. Most often, the disease agent is passed either directly from an infected source (human or animal) or indirectly via cross contamination through an environmental exposure to contaminated air, water, human, surface or food.

The nature of the 2018 Rose Acre Farms outbreak and recall is not typical in that we have vertical transmission of Salmonella from the ovary of the chicken to the egg. In this case the factors of Agent and Host are working somewhat independently from the Environmental source, but there must always be an environmental source somewhere in the chain of infection. Recognizing the potential sources of contamination is problematic of course, as the environmental conditions in poultry operations are highly conducive to the propagation of bacteria.

We know from the FDA investigations of both the 2018 Rose Acre and the Quality Egg outbreak 10 years ago that there were poor environmental sanitation conditions, especially the rodent vector problem that cannot be ignored. Some industry experts at Egg-News have publicly claimed that no matter how many rodents or flies are breeding in the manure beneath the cages, that if the chickens are not infected to begin with, they will not become infected. However, it cannot be denied that transmission to the layer-hens happened through some exposure of the chicken to salmonella in the layer-house. The potential sources there are water and chicken feed. Depending on the situation, rodents could spread the bacteria around an entire operation and contaminate storage areas and water sources, especially when the infestation is severe, as it was at Rose Acres. Flies are also capable of becoming vectors. There is also processing happening at both operations where eggs were washed and further handled, so we might have a situation where the shell is contaminated, leading to problems in further handling. The sanitation at Rose Acres is suspect based on FDA finding poor cleaning methods of the equipment, and I personally observed the same or similar problems at Quality Egg. I don’t believe all of this is coincidence.

Salmonella Braenderup is not a typical egg-associated Salmonellae strain, the same industry experts have also publicly claimed that a possible environmental route might exist through the environment, such as a structural defect in this case; I agree with that based on FDA findings.

Why I believe there is a bigger problem in the egg industry is that Quality Egg and Rose Acre farms, the bad actors I am referring to, are some of the biggest producers in the US, so it cannot be said that the issues are isolated to a small segment of the industry. It is simply not enough for industry spokespersons to claim most egg producers are safe when we have massive contamination of the food supply through eggs. If you look at some of the data from foodborne illness surveillance systems like CDC’s Foodnet, you will see Salmonella infections in the population are still almost at baseline after almost 20 years of hard work by the food industry as whole to put into place best management practices. So, its aggravating when we see major food operators flaunt the rules. I know Rose Acre said, “we have to do better”. That is a healthy response and a good starting place- if they mean it. The Netherlands eliminated salmonella from their egg supply many years ago; they accomplished this through meticulous hygiene in the entire operation.

The deeper problem I am alluding to is that while these egg industry bad actors are known to the buying community, the supply chain seems unwilling to make buying decision based on food safety. That is also egregious, since we now have laws in place through FSMA that are supposed to curb that mentality.

And what about FDA and USDA in all of this? They seem to be just standing by until something bad happens then they go into reactive mode. This should not be. In fact, egg-borne disease transmission is preventable…so why are we not doing it?

Listeria monocytogenes bacteria are very hardy infectious bacteria and widely distributed in nature, and very difficult to control. Listeria monocytogenes previously known to veterinary science as a pathogen of sheep, first came to light as a major foodborne agent when the largest and most deadly outbreaks in US history occurred in queso fresco cheese manufactured in Los Angeles, California. http://en.wikipedia.org/wiki/List_of_foodborne_illness_outbreaks_by_death_toll

Continue Reading Listeria monocytogenes Current Epidemic and Public Health Response

As the result of numerous national and international outbreaks of foodborne illness, food industries worldwide have come under increasing pressure to ensure that their products are safe, wholesome, and meet government standards. FDA and USDA have the primary authority for our food supply nationally, while individual states typically regulate local food operations through state and county departments of agriculture and health.

Continue Reading Process and Substance in Third Party Food Safety Audits

http://abcnews.go.com/US/mice-roaches-fda-inspecting-airline-food/story?id=17739284&page=4

I had the opportunity to help develop the above report, and review the findings of FDA inspections over the last few years at the nation’s top air carrier caterers. The findings, as reported by ABC 20-20 are clearly indicative of lack of control over production environments, people and production processes, the very things food safety management systems are supposed to address.

The comments by industry are predictable. The "we didn’t do it" philosophy, "head in the sand" approach is apparent, in spite of spin doctor statements. When you get caught with these types of issues, the public is not going to listen to the rhetoric about how great your food safety programs are, quite the contrary. Not one of these spokespersons would admit that their company had a problem or offer solutions, its all about denial. We see this again and again, especially after outbreaks.

The heads of these companies apparently are so disconnected from reality that they feel they can boast about how great their food safety programs are, even in the face of 1,500 FDA violations and many instances of gross sanitation conditions. Again, this is the same mantra we hear after an outbreak in FDA regulated facilities.

I lay much of the blame at the feet of FDA. This agency has the authority to stop such conditions and they opt time and again to walk away from problems and not take the tough stand that as consumers we expect, except in the most egregious of cases.

All we have to do is look at the poor record on FDA in the pharmaceutical compounding business or at Sunland (peanuts), or in the myriad of other outbreaks where the agency had performed inspections. No one is accepting responsibility, we get the same pathetic answers from FDA as from industry.

Taking a tough stand by inspectors is personally costly, it means confrontation, its perilous to careers and even to ones personal safety. I know this only too well, so I am very grateful to have an opportunity to again stand some ground against the food industry representatives who want to claim all is well in the face of mounting sanitation and health code violations and deceive themselves and the public.

This type of public confrontation is what we need to dispel the false sense of security the food industry and FDA has created for itself.

I applaud ABC 20-20 and all the other media who go to bat for the nation’s consumers. This type of work is actually a preventive approach, as it pushes the issues in a way that compels both FDA and industry to respond, unlike third party audits and FDA inspections that occur behind closed doors.

I hope I have more opportunity to tell it like it is, and I hope the airline food industry is listening. I know they are hearing, but are they listening? Time will tell, but from the sound of their statements, I don’t think so.

Continue Reading Airline Food Safety and Industry Denial

Whilst I value the commentary of my friend and colleague, Doug Powell and agree almost 99% with his theory and thought, I have to question this aside at the conclusion of the story below.

Do we ask "who was the inspector" every time we have an outbreak in a regulated restaurant or meat plant? How is that relevant? 

The auditor or inspector is not in charge of food safety. As a profession, we are there to evaluate either conformance with a prescribed set of rules written by a buyer (in the case of an auditor) or compliance with laws written and enacted by government.

The findings are useful for improving an operation, and the findings may point to risks inherent in a process or product or facility, but the inspection or audit process may not necessarily uncover every defect, hidden hazards or those of such a nature that they cannot be readily discerned through visual observation or records review. In any case, breakthrough events do not invalidate either inspections or audits, nor do they undermine their value or negate the need to continue such.

On the other hand, we have seen obvious defects and unsafe conditions left unchecked by an auditor or an inspector, and then a subsequent outbreak occur. We have to ask why that happens, and I believe that reporting and observational biases are a challenge for both inspectors and auditors. The biggest prejudices that such an expert has are lack of knowledge, time constraints, failure to see the entire operation, pressure from the operator, invalid audit or inspection protocol, faulty inspection report or method used to evaluate risks, politics, business concerns and self interest.

These flaws potentially exists in every inspection or audit process and the extent of which they manifest will invalidate the outcome.

Therefore, it is important to ask more than just who an inspector was; it is much more important to look at the whole auditing and inspection process. I believe these failures are not so much the result of "who was the auditor" but how well the audit process was able to uncover issues, and of course how well the operation cooperated with the auditor and responded to concerns.

 29 sick with Salmonella linked to Trader Joe’s peanut butter; why is Penn. going public and others aren’t?
21.sep.12
barfblog
Doug Powell
http://barfblog.com/29-sick-with-salmonella-linked-to-trader-joes-peanut-butter-why-is-penn-going-public-and-others-arent/
Now would be the usual time for some consumer education group to issue yet another jackass advisory, this time about how consumers should cook their peanut butter, or choose it with care, or something else they have no control over.
It is food safety education month, don’t ya know.
The Pennsylvania Department of Health today advised consumers that Trader Joe’s Valencia Creamy Salted Peanut Butter made with sea salt may be related to a multi-state outbreak of salmonella.
The department is working with the Centers for Disease Control and Prevention and public health officials in several states to investigate the outbreak. Nationally, there have been 29 cases of illness with two cases reported in Pennsylvania.
Trader Joe’s has voluntarily removed the product for sale from its stores; however, consumers who have the product in their homes should discard it and should also be aware that this product is sold online through other retail outlets.
Additionally, the department advises anyone who recently consumed Trader Joe’s Valencia Creamy Salted Peanut Butter made with sea salt and then became ill to consult their healthcare provider, local health department, or call the Department of Health at 1-877-PA-HEALTH.
Where did this peanut butter originate? Does hipster fave Trader Joe’s audit their suppliers? Who was the auditor?
Nothing yet on the Trader Joe’s website.
http://news.yahoo.com/pennsylvania-department-health-warns-consumers-discard-trader-joes-220200445.html
http://www.traderjoes.com
 

Its evident that the FDA regulated food industry does not want to pay user fees. With the political climate being what it is, FDA may not get sufficient funding to carry out its mandates.

 

If this is the way government and industry decides on what is best for the public health, then the consequences need to be assessed and some sort of alternative developed. See:

http://www.foodengineeringmag.com/articles/print/88970

 

The problem is that there is no united opinion on on how best to develop an industry led government-private sector initiative that is universally adopted. The the current system of competing private standards has shown its limitations and we need more than this.

 

The FSMA should become the universal standard for industry compliance and conformance, a radically new approach, but totally common sense.

 

Much of what the FDA says needs to be done can be done through cooperation, allowing FDA to take a less aggressive position in regulation, This can happen only if voluntary compliance will work and industry will accept FDA standards as the bible, and FDA as the leader.

 

The potential savings for everyone could be maximized by developing the key programs and criteria that could be used by industry to support the FDA mission. If industry wishes to keep the current model of self inspection and provate standards, in line with the new model of mandatory reporting of FDA compliance, all the better.

 

Furthermore, FDA should start discussions about interagency agreements and contracts with state and local health departments to provide manpower to see how much can be saved through this approach.

 

Beyond the current FDA guidance documents, I propose a system that relies on mandatory reporting by the private sector to government.

 

This measure is not as perfect as an FDA inspector in the field. but competent industry personnel, working under strict management and oversight of FDA is a good half way point.

 

The electronic reporting requirements can easily be developed. FDA manpower and technology could better be used in this approach.

 

As a minimum I would suggest:

 

  1. Establish the food safety criteria to be used by FDA regulated segments, starting with the highest risk operations and develop reporting formats, this should move ahead if the funding issues can be dealt with
  2. Establish the qualification for third party second party and first party inspection for each of the critical sectors newly under FDA, this has to be done anyway
  3. Develop the oversight standards of the agency, not limited to frequency of reporting, criteria for determining risk, and interventions
  4. Establish the reporting database and security measures for the data entry

The application of technology is a key benefit in moving forward, especially if funding is minimal as predicted. Industry already has the experience in electronic reporting, and government should work with industry to further develop the methods already in use to collect and disseminate food safety data and manage risk in the food supply.

 

Instead of fighting over money, I would suggest a new spirit of can do and a frank discussion of how we can help one another.

 

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 1st 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 1st and 2nd party audits

Media types looking for a sound bite on Listeria in cantaloupes are pulling their hair out tonight.

You couldn’t ask for a more complicated scenario. Advice like “wash your hands” or “cook your foods” or “don’t cross contaminate” is nearly worthless. Here are some troubling facts

Listeria monocytogenes:

  • Psychrophilic, multiplication possible all the way to 29 degrees
  • Ubiquitous, found in almost all environments, terrestrial and aquatic
  • Found in feces of animals
  • Most problematic in ready to eat foods
  • Forms bio films on food prep surfaces that resist sanitizers, nearly impossible to remove once adhesion occurs
  • Incubation period can be days to months
  • Huge dose response curve, from 100 or less cells, to 1,000,000 or more
  • High morbidity and mortality up to 50% of cases
  • Some strains are pathogenic some are not
  • Highly virulent strains may be emerging
  • Targets immune-suppressed victims, fetuses, neonates, pregnant, those on immunosuppressive drugs, those with disorders of the liver, gut, blood
  • Attaches to nervous tissues, systemic infections 

Cantaloupes:

  • Rough netted exterior traps contaminants
  • The rind surfaces of these melons likely can support adhesion as well as colonization by many pathogenic bacteria
  • Melon meat is highly conducive to bacterial multiplication, rich in nutrients and moisture just below the rind
  • Keeps well under refrigeration
  • When cut, surface pathogens are transferred into the meat
     

Combine the two and you have a marriage made in hell.