Process and Substance in Third Party Food Safety Audits

 
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.

The public health burden of foodborne illness in the US is significant, with many thousands hospitalized. The Centers for Disease Control and Prevention reports these agents are responsible for 5,000 deaths a year.

Outbreaks of foodborne illness cost the US food industry untold millions in claims and legal fees yearly, as well as cause crises and business disruptions. (One law firm alone has recovered over 500 million dollars in damages for clients affected by foodborne illness).

In response, the world’s major retailers now require that their suppliers, growers, packers, processors, and manufactures of food prove their adherence to their standards for safety and quality. Auditing companies, hired by the suppliers themselves, now inspect many thousands of food operations a year, globally. Such inspection numbers may actually rival or even surpass what government is able to do, making the private regulation of food safety both big business and an important public health issue.

Auditors follow a set of standards and guidelines developed by the auditing firms who employ them. The process for creating a “third party standard” is in itself regulated by the International Standards Organization, better known as ISO. Certification bodies use these private standards and pay a percentage of the proceeds from auditing back to the standard holder or owner. The standard is developed through an open and transparent consensus process that involves the buyers and sellers of products, government, the scientific community, and other interested parties. Many standards can be found on the websites of the organizations providing such services. In addition, there are guidelines produced that help to guide the auditing process and set policies and procedures in place for the execution of the audit.

Ultimately, audits provide the buyer with assurance that suppliers meet the standards they adopt. The expectation is that of limiting liability by demonstrating due diligence in sourcing raw materials. However, such findings do not necessarily protect the exposure of a seller or buyer if there is an outbreak or if a consumer is made ill or injured. Even when firms have satisfactory audit findings, they may be sued under the doctrine of “strict liability”. In such legal cases, the plaintiff does not have to prove negligence, only that “they were injured by a product”, and the product was in some way “defective”, i.e., was adulterated.

The goal of any food safety program then should be to prevent food borne illness or injury. The independent third party food safety audit can be a tool to further this goal, but such audits are not currently particularly capable of protecting public health, as they are more focused on limiting the buyer’s legal liability. However, when third party standards are followed, they undoubtedly reduce the potential for illnesses to occur. Adherence to them is likely leading to better food safety, but recent events have revealed significant flaws in the third party audit model.

Much has been written about the 2011 Listeria monocytogenes outbreak in cantaloupe that claimed the lives of 33 victims in one of the most devastating foodborne illness outbreaks of recent years. In the trial of the grower/packer, Eric Jensen, FDA opined that the auditor employed by Mr. Jensen was seriously deficient in his findings. The basis for FDA’s criticism is that the audit firm found the operation to be at a 96% conformance rate with the standard (Superior) just days before the outbreak was identified, and allegedly did not find many of the violations later reported by FDA. While FDA takes the position the audit was flawed, the audit firm publicly supports the findings of the auditor. The auditing company in spite of this criticism stands behind the auditor and states, “he did his job with great care”.

This was not the first serious outbreak of foodborne illness where an auditor was criticized for giving a superior rating to a facility that was later shown to be unsanitary. In 2007, the Peanut Corporation of America knowingly distributed salmonella contaminated peanut products and caused a recall of over 4000 different foods, as well as taking the lives of 7 persons and injuring many more. Although the facility was very poorly maintained and had a serious rodent problem, the auditor had several months before given the firm a superior rating.

Third party audits clearly suffer from some serious drawbacks as regards public health protection. Private auditors have no authority to stop production or to embargo or condemn food products; this can only be done by regulatory agencies that have legal authority. In fact, auditors have no legal authority, at all. Under the contract, the “auditee” can restrict the scope of the audit, stop an audit, or simply cancel it. The true power in the third party model is the buyer. If the buyer is unhappy with the audit results, the buyer can cancel orders or put the supplier on some provisional status. The buyer can also chose not to do business with a supplier that opts out of being audited. Buyers however, rarely exercise these powers, as typically, buyers need to have products and need to have as many sources of products as possible. Limiting competition over time puts the buyer in a poor position; therefore price, availability, and quality issues may outrank safety scores. It is well known in the industry that produce buyers especially can and do go outside the approved supply chain whenever they feel they need to.

If an auditor finds the potential for product adulteration, the best he/she can do to protect public health is down-score the item in the audit question, reducing the audit score (for example, failure to properly validate the sanitary quality of re-circulated water in a produce washing operation would result in a 10 point loss out of more than 1000 available points). Less frequently, an auditor may actually see an actual contamination issue, such as broken glass in contact with food or fecal contamination. In these cases, the auditor can strike against the relevant question and if that question results in the failure of the audit (and very few questions do), the audit can stop, but only at the auditee’s request; the auditor has no ability to stop the audit.

Although an auditor may advise the auditing firm immediately of such hazardous findings, the findings may take several days to get to the buyer requesting the report. In the meantime, although it would be illegal to do so, the auditee might ignore the findings and continue selling and distributing contaminated products.

To summarize, auditors have no authority to stop production and very limited power to protect public health when they find adulterated products or the conditions that lead to that.

As an alternative, auditors cannot report such findings to authorities. Whistleblower rules under FDA do not afford protection to auditors who are under contract to keep audit findings confidential. Such contractual agreements preclude an auditor from reporting adulterated food or grossly insanitary conditions to local public health officials, FDA or USDA, although this may change under proposed FDA rules (FSMA).

Currently, auditors announce their visits, sometimes months in advance. The conditions an auditor might find on the day of the audit may be very different from the conditions otherwise maintained, making the audit findings highly biased. Experienced auditors will find telltale signs of neglect in a facility, but other gross problems may be temporarily covered up. The provision for unannounced audits is in the protocols of some certification bodies, but unannounced audits rarely occur.

Especially in the auditing of fresh produce operations, much more scientific information is needed to strengthen the audit criteria. In the Jensen Farms case for example, the court found that chlorine should have been used to sanitize the cantaloupe. However, the scientific literature does not support a significant reduction in Listeria with a chlorine wash, once the organism has attached to a fruit. The FDA guidance at the time of this outbreak did not specifically require the use of chlorine in single-use potable water used to wash and cool the cantaloupe. The audit template used by the audit firm also did not specifically require the use of a sanitizer like chlorine to sanitize single use water. Uncertainty in the scientific basis for critical sanitation rules and changing perspectives in this very volatile industry is counter-productive to an effective audit.

Equipment used in most food processing environments (operations that cut produce, or otherwise alter the form of raw products) must meet well-understood design standards for cleanliness and sanitation. Independent standard setting bodies such as UL and NSF typically set design criteria for food processing equipment in regulated industries, but such certifications are lacking in operations packing whole fresh fruits and vegetables. At Jensen Farms; the packing equipment used did not have to meet pre-approval by any recognized body, yet FDA found that the condition of the packing line conveyor was a substantial contributing factor to the outbreak. An auditor is in a difficult position to make a determination about the acceptability of a variety of equipment under a wide variety of usage conditions without the aid of such certifications or agency pre-approvals.

Produce facilities currently do not need to meet a pre-approval process for their physical construction, either. In the Jensen Farms outbreak, the failure to properly discharge and control wastewater was found to be significant by FDA, as were the condition of the floors, yet we have no published guidelines for construction of the facility itself. Given the wide variation in locations and variety of produce operations in general, the lack of a formal building code is a major hindrance to an effective audit.

The review of laboratory findings greatly strengthens the validity of audits, but only when the findings are verifiable and accurate and the sampling methods and results are free of bias. Unfortunately, the way the standard that was used by the Jensen Farms auditor was written, microbial tests of environment and equipment were optional. One of the hallmarks of outbreaks is that identification of that outbreak usually involved the detection of the causative agent in products. If investigators can find the agent after the fact in food, it only makes sense that product and environmental testing results are critical to an evaluation of a firm’s true level of safety. This is another area that needs significant strengthening.

While audit companies are rightly focused on the process their auditors follow in executing an audit, it is clear that audit results, however true to the standard and inspection protocol they might be, often lack substance. It is also clear that auditors are not entirely capable of detecting unsafe operations, and totally ineffective at stopping such operations, even when they observe gross contamination of products.

Because the court in the Jensen Farms case has found that auditors have a legal and moral responsibility to protect public health, auditing companies and the food industry as a whole must address these basic weaknesses and solve the problem of auditors being responsible to protect public health without the authority to do so.

 

Airline Food Safety and Industry Denial

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...

Who Was the Peanut Auditor?

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

 

FDA and Industry-Stop Fighting and Start Cooperating

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.

 

Improving the effectiveness of third party food safety 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 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

Listeria and Cantaloupes; a Marriage Made in Hell

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.
 

Mid Year 2011 Food Safety Insights

Its good to refelct on where we are every once in a while, this way we can benchmark the face of food safety which is changing all the time. So at mid year 2011, here are my thoughts.

I continue to be surprised by the way the microbes seem to outwit us.

We seem to be making progress in reducing the incidence of some specific pathogens, but others we cannot seem to get a hold on.

Traceability has two sides, it makes industry vulnerable when regulatory feels it needs to act, but it does reduce exposures.

The global transfer of pathogens is really astounding, countries around the globe were somehow invloved in the chain of EHEC O104:H4, but we don't have all the facts. What we know is wherever the reservoir is of EHEC, the bug seems to be able to exploit a pathway and they do not respect borders at all. As we see this spring and summer in the Mystery in the South, this ability applies to states, counties, etc. within borders. And we have done a less than good job of identifying the vectors, vehicles and reservoirs, and controlling them. I don't think we have the capacity to completely stop EHEC at this point in time.

Food safety, probably more so than any other public health problem, must be solved in and by the global food safety community, and the resources to do this work are shrinking.

I am still waiting to see any credible goverment-led food safety initiatives in the mainstream media. We have a lot of insightful writers going at the subject now from a variety of angles, and so there is education at some level, but not the type that has the answer for consumers. More and more, I don't think we have the answer for the consumer. I think we need to tell consumers that and wake them up.

There is a serious backlash to regulation, we still hear about how backyard farmers are going to impacted by the FSMA when all those concerns are simply bogus. Some writers just want to exploit fear to sell copy. Writers continue to say that the local movement is the safe route, its so misleading, yet there may be a grain of truth in some of the argument, and it's a definite trend to watch; a trend that will likely have good and bad effects. Riding the coatails of this movement are the so called "good for you but dangerous foods" like sprouts and raw milk. With advocates again appealing to the anti-regulatory backlash people.

Consumers continue to sue the food industry, which is expected after so many injuries. Litigation is becoming a real thorn for companies and we seem not to be able to prevent the hits. 

Well publicized outbreaks can taint an entire industry, sector, commodity and not just the brand, it's all too clear.

The anti-regulatory climate is getting uglier with legislatures and industry teaming up to dismantle monitoring and control orf the food supply by government. We hear industry saying recalling products when pathogens are found, but no outbreak is occurring, is unnecessary.

Yet, the "voluntary" private sector food safety initiates push on and we may be making some headway with suppliers. Third party auditors can carry almost the same clout as regulators, and our ranks are growing. But we don't have the police powers needed to truly protect and we only go when we are invited. In addition, we make recommendations, not requirements.

We are making some progress with primary production, maybe. Based on no major outbreaks in a while with produce, but after the fiasco in the EU, and several recalls in the last few months of produce, I can only say that I am "cautiously optomistic."

I could go on, but this is probably enough complaining, gloom and doom.

I have not had a GI infection in about 10 years now, so maybe things are getting a little better, who can say?

FDA Funding Uncertian-Industry Steps Forward

As the result of political and economic pressures, FDA will likely not have the resources it needs to carry out its responsibilities under the FSMA. What this means is that more responsibility will be placed on the food industry to self-govern. The various industry initiatives will need to expand to make up the difference.

Some of the things industry can do in cooperation with FDA include:

 

 

  • Expand education
  • Create transparency of food safety systems and risk assessments to the consumer level
  • Continue the research, development and application of food safety technology
  • Expand testing of products
  • Foster a Watchdog/Sentinel role
  • Outreach and assistance to the mid sized and small operations
  • Expand and apply traceability systems

Former ranking Republican Jack Kingston has called the U.S. food supply “99.99 percent” safe. He goes on to say “We challenge anyone to find a function of government that has a success rate better than 99.99% which the food supply, based on the Obama Administration’s own estimates, currently maintains,” said Kingston spokesman Chris Crawford.

In contrast, The Centers for Disease Control and Prevention said last month that about one in six Americans gets sick, and 3,000 die, from foodborne diseases each year.

if .01 % of the food supply is unsafe, as Mr. Crawford explains, this would mean about 1 million meals a day eaten in the US are unsafe.

The impact to public health aside, the food industry suffers anytime there is a food recall or an outbreak, and there are political and economic outcomes, as we see today in Europe.

Regardless, industry must step forward in an even greater way than currently. I believe we are up to the challenge, but we need coordination and strengthening of the scientific basis for risk assessments and a better way to measure risk-reductions.

If FDA cannot fully apply its powers, it makes sense for industry and FDA to work together in new ways. Lets spend the money that is available in ways that will have a beneficial effect. Creating more bureaucracy is not the answer. We need a leader that both industry and FDA can trust, that can forge the type of cooperative spirit needed. That person has not emerged, yet.

Inspecting a Food Safety Reporter's Kitchen

 

Join me here as I go deep inside a food safety reporter's home and kitchen and uncover the lurking, ever present microbes. Wendy Ryan and Tampa Bay's Channel 9 really made this entertaining and educational, tough to do, we can take a few tips from these media/communication masters.

See a former health inspector test Wendy Ryan's kitchen

Tips on food safety

http://www.abcactionnews.com/dpp/money/consumer/dirty_dining/former-health-inspector-offers-tips-to-keep-your-kitchen-clean

 

Food Safety in a Nutshell

What we are seeing now in the latest peanut butter recall and the problem with hazelnuts is this continued change in illness patterns from animal derived foods, to plant derived foods.  See Bill Marler's blog on the topic.

http://www.marlerblog.com/lawyer-oped/defranco-e-coli-hazelnut-and-skippy-salmonella-peanut-butter-recall-announcement---a-side-by-side-co/

The situation is fueled by increased consumption, scrutiny, better detection methods and more industry testing. Small outbreaks and recalls ( small-if numbers remain low) remind us that the pathogens are poised to contaminate foods wherever they can. We seem to be catching the problem earlier but the reservoirs of infection persist.

Of  chief concern to me is whether our preventive techniques are working and how well.

De Franco was certified, I would be surprised if the Skippy plant was not licensed and inspected.

So where does this leave us in prevention, what do we have to do to reduce the potential for outbreaks further so that intermittent sporadic episodes like this do not occur, or occur so infrequently that we can consider it acceptable? We are far from there, but I would like to be sure we are going in the right direction and so am interested in what further issues might be revealed by these incidents.

 

The Food Safety Inspection Party

Food safety auditing and inspection is a complex world thanks to the prevalence of food hazards and the repeated nature of outbreaks where some type of inspection or audit was a feature. As I spend about 40% of my time doing this type of work, I would like to spell out what I see as the food safety inspection system roles.

In the food supply, we have provisions for self assessment, regulatory inspection and second and third party assessment Recently, we have seen media reports on the so called failures of assessment methods used by third party auditors to determine food safety risk. But the scope of recent criticism has also involved regulatory inspections. To date, much of the arguments are simplistic.

barfblog.foodsafety.ksu.edu/barfblog/tag/washington-post

The Washington Post article below, the basis for the above blog by Doug Powell did not take into account the limitations in these models, nor did it recognize the full breadth of what this field entails.

http://www.washingtonpost.com/wp-dyn/content/article/2010/10/21/AR2010102106900.html

While flaws exist in this model, there is a basic need for an accurate determination of risk that only an an accurate assessment and inspection of controls by people both in and out of the organization will provide.

As the food safety inspection science and practice has evolved, we rely upon internal reviews of food safety systems and outside entities, private and public, to provide some type of oversight, control and guidance.

Inspection by regulatory agencies are assessments of compliance with codes. Such rules are developed to protect the public and are laws. Only the inspection agency has the authority to take legal actions to protect the public. Powers include inspection without notice, closing an operation, seeking fines, and seek other administrative penalties. The inspection agency in most instances has the duty to embargo, destroy and or withhold from sale any contaminated or adulterated commodity. They may take immediate action to protect the public when an imminent health hazard is present. Licenses are issued and the privilege to maintain the license is based on compliance with the law. These roles are very different from the roles of other assessors. Protecting public health is the first, and most important public health capability of an inspection agency.

Self audits are performed by operators themselves. Th requirement for a self audit is often missing at the retail level and at the various levels of the food supply that have little or no regulatory or third party oversight. In order to perform an adequate self audit the operator must have specific training in risk assessment. While some believe that “walking around” a kitchen a few times is sufficient to make a food safety risk assessment, the findings mean little or nothing if there is no risk based method. Typically the risk based methods used by anyone performing a food safety assessment are found in codes and in third party standards.

Second party inspection is performed by buyers of products. These may be random. The second party inspector may or may not have specific food safety skills. The buyers may visit an establishment for several reasons other than inspection. While some have argued that the direct assessment of risk by buyers is the best answer to the oversight problem this method of risk assessment is also problematic when the buyer is unfamiliar with actual risks and how they develop in an operation.

Third parties are hired by firms to prove to buyers that the buyers rules are in place through a pre arranged audit of the facility and records. The voluntary third party rules or standards are complex, have many over lapping areas with laws and rules, blending diverse codes and buyer requirements that may be outside the cope of laws to provide controls for chemical, physical and biological contamination. They go further than inspection and also provide an insight into management controls and supervision; they are at once an evaluation of an organization as well as compliance with laws and rules or codes of practice. Instead of relying solely on law the third parties use a standard devloped in cooperation with the industry.

Third party auditing is also complex because the auditor often has duties of assessing risk in a wide number of arenas. Some auditors or companies have risk assessment capacity specific to a commodity, but many auditors and firms are generalists.

These roles are continuing to evolve, as the standards and laws guidance documents and rules evolve.

Do not be surprised to see more apparent dysfunction of the audit or inspection process to prevent illness. Preventing illness and injury through food is not simply a matter of inspection and involves much more than what audit company went where and who got what score.

The complicity of the auditor with the auditee and audit bias that might result from business relationships is a human problem that will not be solved by re arranging "who pays who" for an audit. The third party audit is buyer driven, meant to be educational in nature, and voluntary (in that the firm should be able to seek whatever assessment company it desires to satisfy an audit). Of course third party auditing is a competitive business and operates like one, lets be clear about those limitations.

The inspection by regulatory agencies on the other hand has the capacity to prevent illness much more readily than a third party audit. We cannot at this point, due to the limitations in the  industry driven roles and models, expect the third party auditor to prevent outbreaks or act as a go between for the regulatory agency. We can strengthen these models in some important ways but there will be a limit to how close non-regulatory frameworks will come to a regulatory audit and true public health protection.

In reality, the self audit has the most capacity to thwart risk, but only if the operational controls are well grounded on science. This is where the important strengthening must be made and this is what ideally the third party systems should focus on.

I believe that the self inspection, and second and third party models must be based upon a solid requirement that no unsafe operations are allowed to be licensed in the first place. Once we have this fundamental, the other parts of the system can function. The other parts of the food safety inspection system cannot and do not stand in the gap for laws and rules and their enforcement.

While critics are accurate in saying the third party audits at Quality Egg and PCA failed to prevent an outbreak, and thus were ineffective risk assessments, these same firms had very poor regulatory oversight.

Neither of these firms should have been open for business, and where this is the case, you will see the other parts of the model flounder badly.

 
 

Florida's Food Safety Morass

Florida presses on its reckless path of destroying public health and continues its sinking spiral of deregulation. Here is another story about how political pressure by industry and lack of public outrage whittles away our safety net. All of this is occurring at a point in time where federal efforts are strengthening public health agencies to protect the food supply. Florida's Restaurant and Health Care lobbies dictate public health policy and the apathy in Florida is truly remarkable. Transfer of public health protection to untrained licensure officials coupled with less inspection will mean more hazards and illnesses. This is exactly what we saw in the restaurant industry when the health authorities were removed from restaurant inspection.

Are we saving money? Nobody seems to think so. So what is the real motive? Its simple, here in Florida our legislature listens to industry, and whatever they want they get, what is best for the consumer is not even considered in these decisions. Not once has anyone said "this is in the best interests of the people of the state of Florida". Our political machine is off the hook here, what a SHAME.

Read more about it in Florida Today

www.google.com/url

Open Letter to Carol B. Dover at The Florida Restaurant Association

 

 

 

 

8-4-10

An Open Letter to Carol B. Dover of the Florida Restaurant Association.

Dear Ms Dover:

In reply to your recent Tampa Tribune article

,http://www2.tbo.com/content/2010/aug/04/na-food-inspections-strong/
 

you failed to mention several important facts about your involvement in food safety and inspections in Florida. From an historical perspective, I have personally seen and experienced what you and FRA have done in regards the Division of Hotels and Restaurants (the Division), inspection. and food safety training. As you are a former Director of the Division, you should recall the following facts.

Prior to 1990, the Division, within the Florida Department of Business Regulation (DBR) shared the statutory responsibility for regulating restaurants with the Florida Department of Health and Rehabilitative Services (HRS) who contracted with the county health departments to perform the inspections. While there was duplication in this relationship, the county had the authority to bring legal action through DBR and DBR ultimately controlled the license, the county had only permitting authority.

In 1990, the Office of Restaurant Programs (ORP), a state level organization, was formed under HRS to regulate restaurants, taking the food safety program from the individual counties, but leaving the DBR licensing structure in place. ORP operated for 2 years and in that time completed all requirements for inspections. Additionally, the focus under the state brought uniformity to DBR enforcement and compliance was moving forward very rapidly. In 1992, Florida had few reported foodborne illness outbreaks, and this was also the last year all inspections were performed as required in Florida.

In 1992, you successfully prevailed upon the legislature to move the new and effective health program- ORP, to the licensing agency- DBR, your former agency. Your argument at that time was that 67 counties were performing inspection 67 ways which was a facetious argument because command was already centralized in Tallahassee . But those of us in the organization saw the real reason behind this move. That reason had to do with controlling the inspection process.

DBR’s takeover of the health department’s food program was disastrous. The first cycle produced only 50% of the required establishment inspections. The transferred inspectors from ORP had to receive additional training in lodging laws and rules as well as fire safety. Conditions in Florida’s restaurants deteriorated and in 1997 we had recorded over 350 outbreaks, 10 times as many outbreaks in just 3 years.

Under the leadership of the Divisions’ head staff, a revamping of the inspection process took place and the state’s Hospitality Education Program operating from only a $6.00 fee per establishment per year trained nearly all of the state’s food service managers. Regrettably, this year the Hospitality Education Program (HEP) was decommissioned. In recent years, the HEP program had been reduced to a minor role at the Division in spite of its outstanding record, and one can only speculate the reasons behind this

In 2000, your organization successfully passed legislation requiring all Florida food workers to be trained in food safety. While training is a good idea, your organization through its political power won the right to “preferred” training provider status and the industry narrowly escaped having all other current training programs in place at that time made illegal There is no coincidence here. The new requirements for training launched a very successful FRA SafeStaff program which generates millions of dollars a year for your organizations’ lobbying efforts.

Because of your record in Florida, it is difficult for me to see your statements in the Tribune about Florida’s food safety inspection program as anything but mere political posturing. The lack of credibility at the FRA is made even more acute as your organization has the capacity to do much good for the citizens and visitors of this state.

I understand you had for many years a sign in your office in Tallahassee that read “the only good regulation is no regulation”. I might add that the only good regulation is one that benefit’s the people, and where public health and safety is concerned, those decisions traditionally have been in the hands of qualified public health scientists and medical personnel. Many believe they should remain there..

While responsible representation from industry is vital to the legislative process, public health decision making should be open, and public health laws and rule making should be as free from political pressure as our current system can make it. Right now, I am afraid recent news reports show Florida again as a bad example of how to go about food safety.

Respectfully,

Roy E Costa RS MS(MBA)

Catering to Foodborne Illness

The following MSNBC story about caterers having the highest risk is right on.

http://www.msnbc.msn.com/id/38420815/ns/health-food_safety/
 

This has also been my experience as an investigator. The reasons for this include time and temperature abuse due to large batch cooking in advance of service sometimes 48 hours in advance, excessive handling of ready to eat foods (NoV), and facilities that are either unlicensed or woefully inadequate (cross contamination, etc, etc.). In Florida we had a campaign to get the caterers licensed.back in the 90's. We required that catering trucks for example report daily to a commissary under inspection. We also got a state law passed (back in good old days before all food safety legislation came from industry lobbies) requiring that they put their license number up on the  delivery truck and anywhere they advertised.

Unfortunately, we estimated there were hundreds if not thousands of unlicensed caterers in Florida. They stretched all the way from neighborhood ladies baking wedding cakes (for sale) to those providing full meal service in catering halls, to vehicles delivering food to work sites, and even some preparing food for large conventions.

Too bad ignorant people are willing to hire a caterer without checking to see they are licensed and inspected. We gave up on running them down as it took so much time to ferret them out, catch them, and prosecute them (and fine them a few hundred dollars). I personally uncovered dozens of unlicensed caterers in the Central Florida area just going through phone books and ads in penny-savers and newspapers. Just another hole in the safety net that few seem to care about.

Glad this data is coming to light, but fixing this will not be easy.

Also see 30.jul.10, barfblog, Doug Powell


http://www.barfblog.com/blog/143437/10/07/30/are-catered-meals-biggest-source-foodborne-illness-americahttp://www.msnbc.msn.com/id/38420815/ns/health-food_safety/

http://barfblog.foodsafety.ksu.edu/blog/141211/10/03/08/anyone-can-prepare-food-and-make-people-barf-north-dakota


http://barfblog.foodsafety.ksu.edu/blog/143413/10/07/29/57-people-barfing-after-weddings-illinois-banquet-hall


http://barfblog.foodsafety.ksu.edu/blog/138935/09/10/12/consumer-groups-industry-lots-others-misuse-food-safety-data-political-gain



 

At Risk Populations Under Attack in Florida

Food safety has risen to a mainstream issue in the last few years. The reasons behind the rising interest of the public have to do with increasing risks. These risks have resulted in numerous contaminated products, hunderds of large recalls, billions in losses, hunderds of millions in lawsuits and thousands of illness and deaths. How is it possible that our fourth largest state, Florida, would remove public health protection from some of its most vulnerable populations at a time like this? Our public health agencies and the protections they offer to "at risk populations" are without political support and governmental decisions can be easily influenced by money and political power; those are the only logical answers.

Florida has a long history of attacking public health protections. In 1992, the last year health inspectors completed the required inspections in food service operations, the powerful Florida Restaurant Association successfully moved the restaurant inspection program from the then HRS Office of Restaurant Programs to the then Department of Business Regulation, a licensing agency- not a public health agency. This shift also triggered massive realignments of agency responsibilities, transfers of hundreds of positions, and the disorganizing of what was at that time a well run and efficient  inspection operation. The problems continued to plague DBR from thence forth, and the situation was made worse through another reorganization that created the Department of Business and Professional Regulation and yet another reorganization that took place saw Florida's Division of Hotels and Restaurants lose 20 key field positions.

Now we see a similar effort by lobbies to remove public health inspectors from institutions such as childcare centers, hospitals and nursing homes and give the licensing authority the responsibility for public health protection. History is repeating itself and the consequences will come. The situation with foodborne illness outbreaks in Institutions has been remarkably lower than in restaurants. Only about 10% of the food borne illness outbreaks investigated by the health department (yes they would still be responsible for that) are attributed to institutional food service.

Florida holds the number one ranking in foodborne illness reported in the nation. Some of this has to be looked at in terms of the remaining Department of Health DOH environmental epidemiologists in the field and their excellent work uncovering outbreaks, but the fact is the numbers are too high. We do not want to repeat these mistakes, but we here in Florida are all too familiar with Tallahassee's good ol' boy backroom politics and the tactics of industry lobbies.

Its a shame our government lets the people down time and again in favor of special business interests, but this latest attack on public health protection and the safety of food for kids, old folks and those already ill is a new low for Florida.

Please see the following article for more information.

FLORIDA: New law removes health inspectors
25.jul.10
Tampa Bay Online
Carl Orth
www2.tbo.com/content/2010/jul/25/pa-new-law-removes-health-inspectors/

The Value of Third Party Audits

Recent statements by several experts about the legitimacy of third party audits are missing the point. Third party audits are far from Ponzi schemes. They act to protect the buyer when they are realistically representative of the safety of foods and the buyer uses then as a basis for buying decisions. If there is a major shortcoming, it is that buyers do not always adhere to the audit findings, and choose their suppliers on some other basis. Buyers on the other hand are obligated to get the products needed to sell at the retail level. We all need food, and the retail industry cannot stop supplying consumers every time there is a potential problem revealed in an audit. Buyers of food are not police officers empowered to cut off suppliers with questionable sanitation. On the other hand, reputable firms are blind when they purchase unsafe products that would have been very apparent if tested or a visit to the facility made.

As I have argued, apparently in vain, the lack of a foundation of food safety throughout the food supply is the real culprit, not the weaknesses of the third party model. There should be no one, not one firm operating without the oversight of a government agency enforcing minimum standards. As some have written, minimum standards are all we can expect from government, but that is a lot. Without them, its naïve thinking that the industry will “police” itself. That is not what industries do; they expect government to do this. One of the paradigms that must be broken is that getting rid of government inspectors and turning all food safety totally over to industry is the wave of the future. Industry associations have argued this and to an extent have short-circuited the food safety system, but they have been pretty quiet of late and these same associations are now calling for intensive oversight.

I believe very strongly in industry self control, but we need to realize that the way business works, that self-control will be stronger or weaker depending on the entities involved. Therefore I argue that we need both; we need a validated industry self control model and an effective governmental oversight model working in tandem.

What happened at PCA was deplorable but it is not the standard for the third party audit industry. Most auditors understand and report risks, they do not allow relationships that develop on the job to sway them.  Many just go about their business politely and professionally, but still record the errors they see, there is a knack to doing this that we learn. The best auditing firms are very aggressive about not allowing inappropriate relationships to happen, sure, it does, but the best of us discourage it. Auditors are not just vendors that show up at a plant; that is something that industry must also come to realize.

As I have also written, I have faith that this is all working for the best, because basically I have faith in this country and its ability to rise above the obstacles, especially now that we have reached a “Jungle” experience again after 100 years.

Now with consumers, legislatures, media and government appalled by what happened in Plainview and Blakely I predict we will see a real partnership between industry and government. I also believe third party auditing firms will play an important role in bringing order out of the chaos.

In conclusion, once our government enforces basic sanitation throughout the food chain, third parties will be able to do what they do best, and that is separate the Good, from the Excellent from the Superior. It is ridiculous that there is even one firm operating in “Poor” or less capacity such as I observed at PCA. Third parties in reality should never see this. This is lax government oversight. Do not expect third parties to fix the poorest operating facilities, it is not their role, that role belongs to the public health community and fixing that problem will fix most others.

Investigation Techniques in Foodborne Illness Outbreaks

Inspections during Foodborne Illness Outbreaks

When a public health agency becomes aware of an outbreak of foodborne illness, they put into place interventions to stop the transmission. Central to that effort is an environmental assessment referred to as an inspection. Companies may also employ third party inspectors during outbreaks to determine the strength of prevention efforts. Legal firms and private investigators interested in understanding how these outbreaks occur, and why, increasingly conduct inspections during or after foodborne illness outbreaks (See WALB Article on PCA).

www.safefoodsblog.com/uploads/file/WALB Article.pdf 

The Causes of Foodborne Illness

The key principle guiding the inspector is the understanding of the causes of outbreaks. Pathogens cause disease when they are present in sufficient numbers in food to produce an infection or intoxication. How they get into food and survive to the consumer depends on a series of related factors that the inspector must develop as the basis for his inspection techniques.

The Agent, the Host and the Environment

It is fundamental to understand the relationships between the host, the environment and the agent. The characteristics of the host or victim such as age and health status play a role in disease transmission. In addition to the vulnerability of the host, the victim must consume the food so there are logistic considerations about the host and his exposures. The location of the victim, the amount or form of the food consumed, and other facts about consumption and handling relate to whether the person will come in contact with the pathogen. Onset of illnesses and types of symptoms are particular to pathogens and help to provide confirmation of the agent at work.

The Environmental Route of Exposure

The environment plays an essential role in supporting the disease transmission pathway. Disease transmission through the environment occurs when a reservoir of the agent is present and exploits a means of spread. Since the organism in most cases is not motile, it needs a vehicle to get from its reservoir to the food. There it must survive and/or proliferate in the food product. Environmental conditions significantly affect contamination, growth of bacteria, and survival of any pathogen in the food.

Contamination, Growth and Survival

The act of contamination can occur through people, water, vectors such as pests, surfaces, and potentially through the air. Growth of the pathogen occurs when sufficient moisture and temperature are available to the organism for a sufficient time. Facts about the food itself and its ability to support microbial growth include its nutrient content, water content and level of acidity, as well as any processing aids used that influence growth. Survival of the organisms in the food or environment is dependent upon the surface available for colonization, cleaning and sanitary practices, and treatments used on the product such as cooking or pasteurization.

Etiologic Agents

Foodborne agents include over 200 known pathogens; bacterial pathogens that exist in a spore or vegetative cell, viruses, parasites, and toxins. The ability of the organism to survive environmental conditions depends on a number of factors, but Salmonella, Listeria, E coli O157:H7and several other pathogens appear to be hardy enough to survive for long periods, possibly months in ideal conditions. Some spore forming organisms such as Clostridium botulinum need anaerobic conditions to grow, and anaerobic conditions in product and packaging favor other pathogens as well. The reservoir of the pathogen is often difficult to discern. The value of environmental-microbial testing to inspection is that it can identify locations where the organisms have been harboring. Suspicious areas always include moist areas as well as surfaces receiving repeated exposure to dirt and environmental contamination such as floors and drains. There is always a possibility that incoming raw products continually seed the production environment with contamination. It is also possible that multiple reservoirs of the organism in the environment or in people lead to cross contamination throughout the production system.

The Inspection and Analysis

With the understanding of the pathway of infection and the complex relationships between the agent, host and environment, investigators apply an analysis of the food production process. Inspection is a process of observation and the inspector analyzes his observations to determine the likely exposures of the final product to contamination and to identify the process steps that allow proliferation and survival.

Analysis of Production

Food production processes start with the receipt of raw materials but the process at any one step in the food supply are interconnected with all other points right up to consumption. The inspector conducts a visual inspection of the structure, environment, equipment, layout and other factors while focusing on the production process.

Raw materials can contain the pathogen, and include packaging as well as the other ingredients ultimately used in the finished product. While visual observations may reveal potential problems, microbiological and other analysis may be necessary to determine the safety of incoming materials. It is safe to say the opportunity for contamination is significant in raw agricultural commodities grown in the soil and raw meat and other raw, animal foods.

Receiving is usually followed by storage although there may be some immediate use of products as they arrive Stored products may be subjected to hazardous environmental conditions such as pests, dirt, chemicals and foreign of objects Any moisture or signs of vermin where food or packaging is stored increases the risk for contamination.

Foods may be staged into production and be in various forms during processing. Since handling of products occur during production (or preparation), the human element becomes important as does machinery and equipment used, utensils, and the flow of foods through the process itself. Any point can lead to contamination or growth of bacteria if the process is not controlled. Cross contamination can occur when there is poor maintenance of food contact surfaces or under poor storage conditions.

Packaging occurs in food processing while service occurs at the retail level as the final step in the production process. Transportation is an intermediate step in the supply chain and can lead to contamination of finished products. Servers in food service environments can also contaminate foods that were otherwise safe to consume. The key is to analyze the entire food production process and avoid missing hazardous steps.

Evidence Gathering

Photographs, samples and other techniques such as interviewing provide additional evidence in the development of theories of causation and bolster the data obtained through the inspection process. The inspection findings may also benefit from a statistical approach and ranking of factors in terms of their significance and severity. A final report captures the data from all findings and often leads to a conclusion about how foods became contaminated.

Inspection during Foodborne Illness Outbreaks is an Essential Tool

Inspection as a tool in foodborne disease investigation is a critical part of preventing the further spread of pathogens. Inspections also lead to an understanding of the complex associations that influence the probability that a foodborne agent reached a product by a specific pathway. Inspections form a central piece in determining what went wrong and how to prevent similar outbreaks it in the future.

Inspectors should make it clear to operators that they must apply the outbreak inspection findings to the process under study as a matter of urgency and take corrective actions to improve it and other similar processes.

Whether or not an inspection is routine or occurs during or after an outbreak, the ultimate value of inspection in general is to improve the food supply. When applied in a very systematic fashion, inspections during foodborne illness outbreaks can move food safety efforts forward very effectively and dramatically protect the public in the future.

Third Party Audits-Passing the Buck or Coming Full Circle?

In the absence of food safety regulations in many commodities or the lack of oversight in general, companies have turned to the private regulation of the food supply. On an individual and voluntary basis, dozens of auditing firms and hundreds of private parties are looking closely at the safety of thousands of suppliers. The supplier-food safety scheme is pushing all the way back from the retailer to the primary producer or farmer. As each link in the supply chain tightens standards, there will be a corresponding improvement in the safety of final products.

The third party food safety business model is that buyers ”accredit” or approve the third party food-safety firms they will accept audits from, and suppliers are free to hire whatever firm they wish to satisfy the buyer. The supplier pays the auditing firm directly and the auditing firm sends the audit findings to the buyer. The buyer does not pay for the audit and the findings do not bind his purchasing decision.

Third party audits have the capacity to improve food safety and provide another means of protection in the wake of government inaction or even failure. Third parties use private food safety standards developed either in partnership with prospective buyers or in formal expert groups at the national and international levels. They provide the basis for determining “conformance” whereas regulations provide the basis or scope of the regulatory inspection, which is “compliance”. Third party audits cannot take the place of regulatory inspection in protecting the consumer for the simple fact that only government has the legal power to enforce compliance. Third party audits since they are voluntary often take on a collaborative air. A buyer maintaining good working relationships with his auditing companies makes good business sense and adversarial relationships are not productive. Bias can easily slip in when the audit customer and the auditing firm grow too close. Bias can enter from the supplier side as well. When choosing an auditing firm a supplier may decide to select a firm based on price, personal knowledge of the company and its personnel, as well as the strength of the auditing system and its recognition.

The premise for any company to hire an auditing firm is the needs of the buyer who is more than likely requesting the audit. The consumer benefits from the third party scheme in more consistently safe products but protection is weak when the most hazardous facilities continue to operate. Disqualification of a supplier is the responsibility of the buyer, but the audit findings in no way bind the buyer. Third parties can rate a firm but they cannot dictate to the buyer who to use. In such an unregulated system, unsafe operations continue to operate and distribute unsafe food to consumers who continue to become ill and die. Unsafe operations continue even when audits reveal clear significant problems and more troubling, sometimes auditors do not clearly report unsafe conditions.

Bias can work in another way. Since the auditing firm really wants the suppliers business, relationships between suppliers, auditors and firms may develop. If those personal relationships cloud the findings and discretion of the auditor, the system becomes very weak.

Shifting the weight for protecting the consumer to third parties alone is not a good system and is simply “passing the buck”. There must be at the basis for the model, a comprehensive and competent authority with enforcement powers and consistent presence. We cannot rely upon independent third parties for this. Government authority backing up the system greatly improves the third party model and gives it credibility especially when efforts are coordinated with industry. Government acting in tandem with industry third parties and thus the industry itself brings us full circle in the evolution of food protection efforts. Such an effort would pave the way for a significant improvement in the safety of foods and the protection of consumers.

External Audits are not Public Health Inspections

With both the New York Times and the Atlanta Journal Constitution reporting on inspections and audits, audit company auditors and the third party food safety scheme are coming under fire. There is ample evidence that both the third party audit model and regulatory inspection model have deficiencies, as brought out by the most recent PCA incident and other  food safety crises. There appears to be some confusion however about the root causes of these deficiencies, and we should differentiate third party audits from regulatory inspection. The scopes and purposes of these audits are different in important ways while sharing many similarities.

Third party audits seek to evaluate and examine conformance with a private food safety standard, while of course regulatory audits seek compliance with public health rules and laws. Private companies own and develop the third party audit standards, and although FDA has begun looking at a certification process for such firms, they act independently from regulatory agencies and are not bound to evaluate all laws and rules relative to a firm. 

The scope of the audit limits the third party auditor in determining conformance while the government inspector is bound to determine compliance with the code and seek enforcement. An auditor may find himself narrowly looking at criteria as specified by the standard, and the policies of the auditing company. For example, in a manufacturing environment, the auditor may be interested in one or two lines or one or two processes for a particular labeled good, and find that the scope of the audit does not cover some otherwise important areas of the whole operation and its products.

The strength of the audit from a public health perspective is basically that the audit goes deeper into management systems that support the compliance with laws than most regulatory inspections. The strengthens of the regulatory inspection is that violations of a food safety nature trigger enforcement at some level, re inspection, condemnation and embargo of product and other interventions not available to the third party auditor. Regulatory agencies also have (or should have) the power to compel compliance and the release of vital food safety information such as microbiological tests data, and demand a recall.

The two systems are therefore complimentary and both together have the capacity to bring about public health protection. We can improve the two systems and bring them closer together in a number of ways. The third party auditing company should have the ability to withhold certification based on its own criteria. This means that even a firm who might achieve a Superior Rating could have their certifications withdrawn if they fail to stay in substantial compliance with laws and rules, withhold information about the safety of the product or process, or engage in fraudulent activities. This is currently not the case in many audit schemes, the decision to do business with a supplier is left totally to the buyer who can opt to make a buying decision, based solely on the audit criteria.

We can strengthen the regulatory model in a number of ways. Currently, many food safety agencies are under staffed, poorly funded, and ineffective at regulation. The fragmentation of public health is something the food industry has brought upon itself. Industry must seek to obtain proper funding for food safety agencies or must agree to fee increases to keep these very necessary functions going . Industry must support agencies to expand their jurisdiction.

Third party audits alone will not protect public health, and public health is greatly improved by the independent review of food safety management systems by an outside expert. However, the owners of private standards do not intended to be public health protection agencies and their standards should not take the place of a farm to fork regulatory framework for food safety. The shakiness in this framework is the underlying cause of our food safety dilemma and industry is finding that its third party, buyer driven standards alone will not properly protect their own interests or public health.
 

Food Safety After Peanuts

The food safety net just showed us another huge tear as the result of contaminated peanut butter products. The problem will be felt for years in the peanut industry and will likely change the food safety landscape in many ways.

 

The government reaction has been harsh and focused in this latest deadly outbreak. More government action means more regulation, and as yet, we have not seen any sweeping changes, but they are likely to come. For the first time we have the highest level of government showing concern, namely the White House. The One Big Agency concept keeps emerging and it is good to examine why proponents believe it is necessary, namely reducing duplication and closing gaps. There is also the idea that policy on food safety could come from one office. We now also have possible criminal behavior on the part of one of the food industry, and the legal consequences of causing an outbreak are becoming clearer and deeper. On the positive side, in this latest crisis there is a real sense of openness for change.

 

The foodborne outbreaks caused by once thought harmless items such as peanut butter has been the icing on the cake for a very mean period in the history of food safety. It is ironic that at the time the food safety concept is rapidly growing, the hazards keep building against controls.

 

The question is what we are going to do about it; what do we do before something like this happens again? We have had in the past a vacuum as far as any true leadership to get us out of the problem. Its been a long time since there were any definitive changes in the way we do food safety and there is real room for improvement. So what are we going to do prevent the next outbreak? Do we call for more reforms? Is this the same pattern of business as usual or do we expect something a little bit more decisive from government after peanuts?

 

Obama joins calls for improving US food safety regime:

http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/feb0209fda.html

 

Peanut butter may get 'high risk' designation as government tightens oversight of food makers

http://www.startribune.com/politics/national/congress/39465507.html?elr=KArks8c7PaP3E77K_3c::D3aDhU6:_0c:QyDiiUiacyKUnciaec8O7EyUr

The "One Big Food Safety Agency" Movement

No one disputes the fact that our food safety net has several gaping holes. Like clockwork, one can seemingly depend on a major foodborne illness outbreak to occur every few weeks. This month it is peanut butter, again, a few months back it was peppers and tomatoes, before that potpies, veggie snacks, canned chili, etc, etc.

Proponents for a massive reorganization of our regulatory agencies continue to make their voices heard. However, few if any of these proponents really appreciate what has caused the dysfunction in our food safety systems. A reorganization of our federal agencies is a dangerous idea that simply will not work and political motives are behind much of the "One Big Food Safety Agency" movement.

While our agencies do seem overwhelmed, actually the solutions are relatively simple; more industry self-control and more oversight by a properly funded and managed government would make a world of difference.

First, industry self-controls should be mandatory, not voluntary! Regardless of the industry, process or commodity, it is the producer that holds the key to food safety. Yet, except for red meat, juice, poultry, seafood and the dairy industry, most of the food industry, including the entire food service industry operates with no formal requirements for a food safety system. Industry self-control does not necessarily mean government should back away from its authority. In fact, mandatory self-regulation would bolster governmental efforts if government were in true partnership with industry and not simply shifting the cost and burdens of public health protection, as seems to be the case.

When operators properly develop and implement food safety systems, they work. Health authorities are no longer reporting juice outbreaks. Statistics show some progress in reducing outbreaks of E. coli O157:H7 in red meat, especially at the retail level and there are very few reports of large-scale outbreaks of salmonella from poultry. This is probably the result of government-mandated self-regulation, although it is somewhat uncertain why we see declines in outbreaks in some pathogens.

The record of the highly regulated seafood industry is remarkably good. We do not have nationwide outbreaks associated with seafood. While groups such as the Centers for Science in the Public interest have misunderstood the statistics related to seafood outbreaks, the seafood industry is undoubtedly one of the safest in spite of the fragility and propensity for bacterial growth of its products.

Government, especially the FDA, is terribly underfinanced, poorly managed and lacks political support. Its counterpart, USDA, seems to fare a little better in its budget, but politics at the highest levels in USDA ensures less effectiveness as a public health agency. These two facts are the major reasons we have a weakened food safety system. Opponents of self-regulation should consider that a mandatory self-imposed food safety system with a strong government oversight is a very different model from voluntary self-regulation where government has no jurisdiction, or abdicates its authority.

An example for how things are improving exists today in the produce industry, probably the most hazardous of all food industries. The California leafy greens industry and the Florida tomato industry have adopted self-regulation, and in the absence of federal oversight, state government has stepped in to provide the needed regulatory oversight. We have an excellent developing model where strict governmental regulations of producers are coupled with demands from buyers for validated self-control systems. We need across the board what is happening in Florida and California, and not just in the produce industry. If we had mandatory industry self-control, coupled with strict government oversight, large-scale foodborne illness outbreaks would stop, and sporadic incidence would dramatically drop.

The panacea of creating One Big Food Safety Agency will not solve our food safety problems. It will however make it much worse. As a government manager who has been through government reorganization, I will tell you it takes years for the agency to recover. Generally, the politics that occur are so damaging to morale and the mission of the agency that any meaningful efforts come to a standstill. It is incredibly naive to think that two massive agencies with 100 years of protocols and independence can be merged into a single agency successfully just by an edict in Washington. While the problem of “who inspects what pizza” makes good fodder for those with an anti-regulatory agenda, this archaic problem can be easily solved by an interagency agreement, or memo of understanding between the two agencies.

If Mr. Obama is smart, he will look to make USDA and FDA efficient and accountable and give them the support they need. These agencies have served us very well up until recently when politics and politicians gutted FDA. USDA is a separate problem. USDA has suffered by being an advocate for industry while simultaneously shouldering a serious public healthy responsibility.

Food safety is a critical public health issue, so what are the leaders in public health concentrating on? Take a look at the American Public Health Association, or the Association of Colleges of Public Health. They are bellwethers for what is on the mind of the public health scientists in this country. Few in these groups are seriously interested in food safety. Colleges of public health do not teach food safety as a public health specialty although there may be a lecture or two in the environmental health track. A long-term solution to strengthening the food safety system is for the public health academic community to attract and train more qualified food safety experts and deploy them into both regulatory and industry food safety positions. It is time for the public health scientists to get out their ivory academic towers and embrace contamination of the food supply as a major public health concern.

We should not waste precious resources in a useless and dangerous reorganization of the federal bureaucracy. It is time for public health scientists, industry leaders and government officials to develop an initiative similar to the “President’s Food Safety Initiative” of 1998. The result of the 1998 effort yielded tremendous progress on many fronts, very cost-effectively.

Providing leadership in Washington, sensible tweaking and funding of our existing regulatory systems, and requiring industry to shoulder more weight to protect the public are what we need. Advocating for “One Big Food Safety Agency” is a colossal mistake in thinking and such an effort will guarantee that we fall further behind the microbes in their incessant attack on people through food. Thankfully, President Obama is probably going to be too busy to make this happen anytime soon.

Public Health and Food Safety Policy in the Obama Administration

 

Public health policy and food protection are issues that we expect the new Obama administration to address eagerly. Financial problems, wars in Afghanistan and Iraq, and Home Land Security have shifted focus away from our core public health agenda, and now is the time to return our focus. Everyone agrees that public health programs have suffered in the last eight years. Keep in mind, however, that public health protection is possible in the US more so than in many places around the world. We have public health infrastructure, a little decrepit, but still there.

The new administration should take an accounting of what is on the ground now, what is working and what is not, and develop a comprehensive plan of action similar to the "President's Food Safety Initiative" of 1998.. Safety-net type programs that were instituted like PulseNet www.cdc.gov/pulsenet/ and FoodNet www.cdc.gov/FoodNet/  are now very valuable. If the new administration is wise, it will invest in these and other types of surveillance programs and set meaningful public health goals. Most importantly, the new administration must implement strategies to achieve its goals based on science and a risk assessment.

The Obama team should develop true partnerships where government and industry equally share the burdens of food protection. One possible way to do this is to strengthen the existing industry-driven, self-regulation model. The Obama administration can accomplish this through better federal agency oversight and verification of the entire food supply chain. Presently, there are major gaps in federal regulation of the US food supply that weaken industry efforts.  

Applying technology is a quick way to move forward rapidly. For example, the food industry is applying sophisticated food safety data capture devices in their food safety management systems. Programs are built into common platforms that run on the I Phone and PDA of a wide assortment. Data is also transmitted through the Internet to database management systems that track and analyze data-see http://www.scbs.net.au/index.htm. Tapping into the resources of industry food-safety professionals and the available technology can definitely strengthen public health protection.

“One big agency” to bring all regulation for the food supply under one umbrella is a compelling thought that the Obama team must evaluate. The new administration should consider first, however, how to enhance what is already functioning. There may be some advantages in combining some functions of the USDA Food Safety and Inspection Service-see www.fsis.usda.gov/and the FDA Center for Food Safety and Applied Nutrition-see www.foodsafety.gov/list.html.

Without question, the new administration should call for more coordination and better allocation of resources in both USDA and FDA, and then properly fund these agencies to meet the administration’s public health goals. The last administration failed to recognize that our agencies have been less than capable in managing the risks in the US food supply. This administration should first honestly evaluate the successes and failures of current public health policies as regards food safety and other pressing matters and then lead us forward.

We recommend that the administration seriously look at the Office of the Surgeon General- see www.surgeongeneral.gov and strengthen the role of the nation’s "Chief Health Officer". The Surgeon General has not voiced any support for food safety efforts since he last spoke out publically on the issue, back in 1999. This vastly underutilized post should come to the fore under President Obama. We should expect the Surgeon General's Office to take initiatives in the interest of public health to elicit more support and involvement in food safety from the medical and public health communities, and to speak to the American people about food protection.

Scomboid Poisoning is so Obvious

 

This outbreak is an example of scombroid poisoning. Scombroid enterotoxin is actually a heat stable bi-product of histamine, and results when dark-fleshed fish begin to decompose. Its one of the few illnesses through food that have a correlation directly to spoilage although there may be others (certain strains of C botulinum). Because the symptoms occur rapidly and are easily recognized by the victim as food related, few outbreaks go unreported and uninvestigated. This illness is an example of how reporting artifacts confound epidemiological statistics. A recent study by the Centers for Science in the Public Interest reported that fish and seafood are the vehicles most often identified in foodborne illness outbreaks. Failure to understand the effect of reporting bias in the data related to fish, makes that work and its conclusions flawed. In addition, that study also relied upon data on shellfish infections and intoxications, and ciguatera intoxication. These data also suffer from the same type of reporting bias issues.

However, tuna and other species of Scromboid fishes (jacks, mahi) have a very high risk of this hazard. Its occurrence is quite an important issue as HACCP has been in place in fisheries in the US for many years. Without rigorous supplier controls controlling risks all the way to harvesting, HACCP as an intervention in this illness is weak.

There is a corollary between Scomboid poisoning and other hazards such as those found in fresh produce, that lack a kill step.

UK: Tuna 'link' in sickness outbreak
05.dec.08
BBC News
http://news.bbc.co.uk/2/hi/uk_news/scotland/north_east/7767327.stm
A tuna meal may have been to blame for an illness outbreak at Aberdeen Exhibition and Conference Centre, NHS Grampian has said.
Twelve people needed hospital treatment after the emergency services were called out on Thursday afternoon.
The health board said the common link between the patients was a tuna dish for lunch. Samples are being tested.
One man who fell ill, who did not want to be named, said the symptoms were rashes, headaches and palpitations.

 

Do Not End Food Safety Self Regulation

 

In a recent message to its members, Food and Water Watch says:

 

“Protecting Our Food: End Food Industry Self-Policing”. Consumers need strong standards and strong enforcement by government inspectors. The USDA must abandon attempts to let meat plants do their own inspections. The Food and Drug Administration needs new authority and resources to inspect food processing plants and should be reorganized so it can devote proper attention and inspection resources to imported foods.”

Food and Water Watch describes themselves as:

(Foodandwaterwatch.org is a nonprofit consumer organization that works to ensure clean water and safe food. We challenge the corporate control and abuse of our food and water resources by empowering people to take action and by transforming the public consciousness about what we eat and drink).

As practicing food safety experts, we have seen many improvements in food facility operations as a result of industry self-control procedures. However, a serious deficit exists when government fails to support voluntary, industry food-safety-systems with a public health goal in mind. To enhance industries efforts public health agencies should:

1.      Create mandatory baseline requirements for the entire food chain

2.      Effectively validate and verify industry efforts and coordinate them

3.      Ensure firms create food safety systems primarily to protect public health making this their primary goal

 

While meat, fish, poultry and juice have mandatory food safety systems, not all of the food supply is covered.

 

In the produce sector, we have only buyer driven pressure on producers throughout the supply chain to meet voluntary standards. Many retail firms such as Wal-Mart, Albertson's and Publix require their suppliers to maintain detailed food safety programs based on Hazard Analysis Critical Control Point. However in the absence of regulation (FDA may have primacy but does not exert its power until the fruit is processed), many non-compliant firms still sell to buyers in need of product.

 

There is no mandatory regulation and baseline of safety in the produce industry and many firms operate without a food safety system; while at the opposite extreme, we have exceptional firms with ISO based HACCP models controlling minute aspects of production from growing through distribution.

 

Industry self-policing is critically necessary in produce, however it is same in every food industry. This is the case because all day-to-day operation in any industry are in the hands of the firm. The challenge is for government to use its resources wisely and build upon industry efforts, while at the same time providing a strong safety net for the consumer.

 

Our response to Food and Water Watch and its members is:

 

1. Ending self-policing is not wise; we should strengthen self-policing.

 

2. Public health agencies should be more intelligent about the way they assure food safety for the American consumer and accept their responsibility for protecting the public health while delegating more of the monitoring the safety of the food safety system to industry.

 

3. Ending self-policing will not result in food protection, but just the opposite. Strengthening this model on the other hand holds a great deal of promise

 

Can a Consumer Tell if a Restaurant is Safe?

What a lot of people who travel do, myself included, is just stop at the first restaurant that is convenient. I might make a decision as to what kind of food I feel like having but the venue is kind of arbitrary. I am like most folks; I expect the operator of any establishment to protect my food from contamination. Most QSR's are under some sort of quality system, self imposed of course because most health agencies do not require it. These places are inherently less likely to pass on contaminated foods because they have internal standards they must meet. This is the case for every restaurant; if the there is no continual assurance of safety on a daily then risks are higher. I frequent proprietary restaurants, those without a national "brand", but I also recognize risks are probably higher there.
 
So that is the basic idea. If the facility has a posted score from the regulatory agency, this is even better, because it means whatever internal programs exist they are validated.
 
You cannot tell the risk of contaminated food by observation of the eatery. It is absurd to suggest to consumers that they look around the dining area, closely watch the buss boy, or inspect the bathroom. That is not where contaminated foods come from. You, I and all consumers are basically putting our trust in the hands (literally) of folks we do not know. Doesn't it make sense that the facility operator should be required to properly protect my food? If you can spend the time to learn the system ( they do not make it easy) take a look at the inspection records in Florida. What you will see are repeated cases of critical items out of compliance, and very spotty enforcement.
 
I do not become uninterested in food safety just because I am a consumer. In Florida, I ask to see the last inspection report (except when dining with my wife whom insists I do not do this). It is law that they show it to me. In Palm Beach  County, I look to see that the sign advising consumers that they may "request to see the latest report" is there. If they balk, I will report them.
 
The Florida Restaurant Association fought hard here to keep the restaurant inspection findings from posting, and have temporarily succeeded. They also are very much against any type of posted sanitation rating.
 
With the poor record of compliance in Florida (and most places) consumers need to have complete transparency to make a decision about where to eat
 
That is why my company provides a certification to restaurants that participate in my program, known as "Ten to Win" (see www.safefoods.tv). My perspective is consumers shouldn't have to ask about compliance with the law, or guess about sanitation. 
 

Pros and Cons of Food Industry Self-Regulation

There are those who would debate whether industry should be the leaders or the follower in food safety. Industry has taken a lead over government, going passed the basic food codes. For example, the USFDA Food Code applied at retail does not require food safety systems to be developed, nor does it require certification that employees are training in food safety. The Food Code may infer these tenants of running a safe operation but it does not require it. Thus, industry itself has developed its own food safety protocols for training, food safety systems development and auditing. While this is a very  good thing from a consumer standpoint, letting industry self regulate without oversight is a danger. Industry is motivated by profit as much as it is food safety. While ultimately one could argue that they are both related, food safety requires a serious investment of time, money and workers as well as investments in equipment and the physical plant. Whereas operators do not see a direct economic benefit for these investments, many feel they must protect themselves and most importantly comply with laws. Removing oversight over the efforts of industry in food safety is shortsighted. What is needed is a new approach where government guides industry through the development and application of their own food safety plans and then assesses their own monitoring activities. This is the very approach used by third party auditors. Government efforts would be greatly improved by adopting the industry model and then creating rules, and inducements around them, basically validating and approving the systems in use They would control those operations with clear lines of authority so no unsafe products are released. Self-reporting could be done in a number of ways utilizing technology, allowing constant oversight and rapid intervention.

It is a dangerous thing to allow a vacuum to develop where our sworn public health officials are not involved deeply with food safety protection. The answer is not  a larger role for the government or industry, it is a partnership, but where government maintains its right to protect the public.

To read to differing opinions on this topic, see the links below.

Pro

http://www.csnews.com/csn/news/article_display.jsp?vnu_content_id=1003850433

Con

http://www.cmaj.ca/cgi/rapidpdf/cmaj.081459v2?papetoc