Making Room for the Human Element in Food Safety Auditing


In today’s world of food safety requirements, food producers large and small and at all levels of the supply chain are subject to increasingly rigorous industry-driven food safety standards and audits. Third party audit standards have been revitalized by the all too apparent ineffectiveness of the way external parties verify food safety programs as brought to light in several foodborne illness outbreaks. Following the Jensen Farms incident, auditing firms have tightened the process for certification, for example, by raising the minimum score required for certification from 85% to 90%. In addition, the administration bodies at the major third party audit firms are intensely scrutinizing audit results and the performance of auditors. The anticipation of the implementation of FDA’s FSMA, turns the pressure up even higher, and it is likely that the third party standards will incorporate large sections of the new federal rules.

Change is good, and there is a need for better evaluations. The goal of course is to provide the industry with auditors that are qualified and capable of identifying unsafe operations so that operators can address them. It is also essential that buyers are made aware of potential problems and so they can make more informed choices about qualifying suppliers.

Auditors now spend about 90% of their time in an audit looking at paperwork. The management systems documentation evaluation portion of the audit can take an entire day. Auditors require documentation to verify that an operator is carrying out a total quality management system based on a continuous improvement model. Even small companies must now dedicate personnel strictly to keep up with the increasing demands of more and more detailed documentation.

Outbreaks of foodborne illness are caused by the contamination of foods by pathogens. Investigations of these events very often reveal major lapses in sanitation. It is therefore of great concern when a food safety auditor is spending 90% of their time looking at paperwork, when the real risks are in the plant or operating environments.

There is also a risk that the industry will become so focused on record keeping that basic sanitation, and other key elements of a food safety program, such as employee hygiene, training and supervision will begin to falter.

Another troubling aspect of the increasing demand for documentation is the effect this is having on smaller or family owned and operated food businesses. The premise for the food safety management system is a good one, but the practical aspects of applying the literally hundreds of management protocols, and all the while keeping up with the fundamental aspects of sanitation and hygiene, has become a major burden for small firms. While we say the third party system is a “voluntary system”, that is really not correct. There is simply no market for suppliers without a food safety system. Producers at all levels must implement elaborate managements systems and keep them constantly updated and verified, regardless of the nurture of the company, its size or complexity.

To expect a firm operated by a husband and wife, for example, to document every conversation about food safety or have detailed job descriptions, is an unrealistic expectation and adds nothing to the safety of the products produced.

In our zeal to perfect our auditing methods we can loose sight of reality.

A tiered system is probably not possible given the way our third party standards are developed, but placing small operations- a major portion of the food industry- in an unfair situation is not acceptable.

The inability of an auditor to deal with human elements in the audit process makes a fair determination of conformance with the standard impossible. Rigid, inflexible rules, when they exist just for the sake of rules are distasteful to everyone concerned and cheapen the value of our service to the industry.


Is the Food Industry Doing Enough to Control Allergen's?

Widespread allergen exposures and the extent of the problem

A recent spat of food product recalls due to undeclared allergenic agents illustrates the problem the food industry has in preventing allergen exposures.

While food manufacturers usually have allergen controls in place, protecting those in the population with food allergies can be particularly challenging. Undeclared allergens are considered a significant chemical hazard in food and thus a critical control in many processes, yet most product recalls are due to undeclared allergens.

The US Food and Drug Administration (FDA), requires manufacturers to list on the food label the eight most common ingredients that trigger food allergies. At-risk consumers rely on the labels on foods to guide them in making healthy choices, and to protect themselves from allergens. Therefore, the failure to properly label foods when they contain allergenic ingredients, or when they have the potential to contain an allergenic compound is a massive failure of company’s food safety system.

Allergens are proteins and other substances known to react with a susceptible person’s immune system to precipitate an allergic reaction; there are approximately 15 million at- risk consumers in the US population. Persons with allergies may develop sometimes-serious medical consequences, such as breathing difficulties or go into anaphylactic shock after exposure to a host of allergens in food.

There are eight major allergens that cause 90% of allergic reactions:

  • Milk
  • Eggs
  • Peanuts
  • Tree nuts (such as almonds, cashews, walnuts)
  • Fish (such as bass, cod, flounder)
  • Shellfish (such as crab, lobster, shrimp)
  • Soy
  • Wheat

Food labeling laws require food allergens to be identified even in very small amounts — but only when they're contained as an ingredient. Manufacturers aren't required to include warnings about food allergens accidentally introduced during manufacturing or packaging (cross-contamination). The label lists the type of allergen — for example, the type of tree nut (almond, walnut) or the type of crustacean shellfish (crab, shrimp) — as well as any ingredient that contains a protein from the eight major food allergens. The labels also include any allergens found in flavorings, colorings or other additives.

Many manufacturers voluntarily include warnings, but these advisory labels aren't always clear. Manufacturers have different ways of saying a food allergen may be present. For example, labels may say, "manufactured in a factory that also processes wheat" or "may contain soy." Work is needed to make the format of these advisory labels more consistent so that it's easier to identify which products contain allergens. Medical authorities advise consumers in doubt about whether a product contains something they are allergic to, to avoid it until and they check with their doctor.

When foods contain an undeclared allergen, or when allowable levels of a food additive, such as sulfites, used as a preservative are exceeded, such foods are deemed adulterated and a recall is initiated.

A product recall is a crisis for a company; it results in serious economic loss and legal entanglements, and can be a major challenge to the viability of a brand.

Hazard Analysis Critical Control Point (HACCP) controls during manufacturing

Product contamination and adulteration can take several forms; we classify substances as foodborne hazards if they are reasonably likely to cause illness or injury when out of control. We can classify them into 4 broad categories, such as chemical, physical, biological and radiological (thanks Fukashima). We develop controls for the particular hazards that are expected to occur, and critical controls for the likely ones with the most potential for harm. Food safety plans built on the principles of Hazard Analysis Critical Control Point (HACCP) must consider the likelihood of occurrence of these chemical hazards in most food manufacturing processes. While producers of commodities such as eggs, fresh meat or fresh produce do need to list allergens, most other foods require some type of allergen control and/or label.

Control starts with identifying the specific allergenic ingredients. Then, an operator must determine how they are handled and how they flow through a production system. Such studies often reveal points where cross contamination with allergens may occur. Controlling cross contamination between allergenic and non-allergenic ingredients on production lines is necessary when the line runs both allergenic and non-allergenic food, or when a variety of allergens are run. However, cross contamination controls begin at the time a firm receives an allergen-containing ingredient and continue during its storage, internal transport and during packing.

Proper cleaning between product runs is the most fundamental control. Visual inspection of the equipment to detect particles remaining post-cleaning is a useful effort, but unseen residues of allergens may linger and cross contaminate the next product run, as even the best cleaning may not result in 100% removal of particles. The cleaning process must also consider the forms, i.e., pastes or films, encountered and match that with the appropriate cleaner. Some plants must use dry cleaning methods when water in a production environment is detrimental, such as when manufacturing confectionaries, or in bakery environments. Such dry methods can be ineffective and can lead to cross contamination. Even when detergents and water can be applied to equipment, applications may be uneven, leaving traces behind. As better laboratory methods of detection have increased the specificity of tests, investigators looking for allergens can detect smaller and smaller amounts of them.

In-plant allergen testing of equipment, however, can provide verification that allergens are not present on a surface after cleaning. Some tests used in a plant environment are not allergen-specific, and utilize quick colorimetric tests for proteins, sugars or other markers of allergen contamination. Operators instead should use ELISA kits (enzyme-linked immunosorbent assay); while much more sophisticated and expensive they can be validated and possibly validate the protein or sugar swab methods. ELISA tests may be a better choice for in plant testing. Such testing can be qualitative as well as quantitative (a 5 ppm Level of Detection typically). Operators should also develop protocols to establish the baseline information needed to interpret results. Establishing baseline acceptance criteria requires establishing the levels of allergens in products when various levels of allergens are detected on surfaces of equipment. Off-site labs having more sophisticated methods usually conduct such validation studies. Such validation data may allow operators to accept some trace levels and avoid the pitfall of chasing molecules around a plant, when such levels are shown not to affect the final product.

Operators must designate cleaning tools for specific areas to avoid the tool as a form of cross contamination and Sanitation Standard Operating Procedures must be developed. Such SSOP should contain the designation of a cleaning crew and sanitation employees need ongoing training. The SSOP should contain the items requiring cleaning, the types of cleaners used, dilution values for detergents and degreasers, how to maintain effective levels, water temperature, tools used, how often the cleaning is carried out, and the timing of visual inspections and verification. As in all HACCP based-systems the results of the testing program are recorded and verified.

Cross contamination may occur during storage and internal transport

Storage of allergen containing materials together in the same area can also lead to cross contamination when the operation has not effectively designated the proper storage areas. Storage of allergenic foods above non-allergenic, or a mix up of ingredients or finished products can lead to cross contamination through the environment. Ideally a facility should store sensitive items in separate enclosed areas, but not all plants have the capacity for separate storage. In these situations, careful monitoring and a visual marking or signage is helpful.

Even forklifts and pallet jacks could play a role along with totes and other containers.

Labeling Failures

Because we have risks in allergen control, and our controls may not always be successful, the label should provide the at-risk consumer with enough information for making a decision. As mentioned earlier however, the use of language such as “may contain…” or “made in a plant that also processes…” make food choices more difficult and impacts the quality of life for such consumers.

Labels are applied to final unit packages by hand, or by a label machine, typically. Rolls of labels have to be run for each batch of product. The timing and staging often lead to the packing of several products at once and different label sets on the plant floor. When the products differ as to allergens it is easy to make an error in the application of labels. Errors can also occur in the printing of labels, and allergenic ingredients may be inadvertently left out if the operator has not done his due diligence and did not realize the product or ingredient contained an allergen. Highly refined oils are hidden ingredients in many products and may contain trace amounts of proteins, for example.

Foodservice allergen control

Patrons of restaurants are often highly at risk to be exposed to allergens. No such menu labeling requirements are required in the USFDA Food Code. Restaurants handle a complex variety of foods and it is nearly impossible to know for every recipe and every product, what allergens may or may not be there or to separate them. Furthermore, the operating conditions of restaurants are very different then processing plants and there is very little that can be done about preparing and storing various allergen sensitive foods together.

The last line of defense is the waiter or waitress who is often the only person except for the cook who can answer a question about whether a food contains a certain ingredient or not. Even then, it may be impossible to know in every case, every allergenic ingredient.

The effectiveness of industry allergen control programs

As illustrated by the recent spate of recalls, the food industry’s response to allergen control has been less than completely successful and more needs to be done. The industry needs better testing regimens and adherence to properly developed cleaning protocols. As in the case with preventing microbial contamination, a company must provide the resources necessary, and have the experience and technical ability to monitor and control a sometimes-complex array of policies, procedures and validation methods.

And for a variety of reasons, some unknown, the situation is getting worse:

  • According to a study released in 2013 by the Centers for Disease Control and Prevention, food allergies among children increased approximately 50% between 1997 and 2011.
  • Researchers are trying to discover why food allergies are on the rise in developed countries worldwide, and to learn more about the impact of the disease in developing nations. More than 17 million Europeans have a food allergy, and hospital admissions for severe reactions in children have risen seven-fold over the past decade, according to the European Academy of Allergy and Clinical Immunology (EAACI).

As with all things food, the hopeful implementation of FDA’s FSMA will strengthen the backbone of allergen control efforts in the future, but the industry should recognize more is needed now.

In Response to Michael Taylor


In Response to: "Blue Bell and the Very Real Impact of the Food Safety Modernization Act" at Food Safety news

I appreciate Michael Taylor's comments in the above article posted on Food Safety News and also believe that FSMA is a step in the right direction. The fact, however, is that companies around the globe have already adopted food safety systems! This article makes it sound like preventative controls are something new and that such programs will be brought about by new federal law. The fact is in most major operations the preventative controls are in place right now. There are firms that have not adopted such in their operations, and FSMA may help to address this, but by and large, the large food borne illness outbreaks we have seen are not the result not having a prevention program, but the failure of the program to prevent the hazard from occurring.

Breaking a law, however, comes with a high cost for non-compliance, and that hammer is needed for some. But for most operators, this is not the answer to the microbial contamination control problem in their facilities. Our overarching goal in industry should be to be in compliance with FDA's new laws, however, we need effective food safety management systems and we do not always have them. This is illustrated by the findings of serious sanitation issues, after the fact, in the investigation of the Blue Bell ice cream plant outbreak and many others.

As a regulator, consultant, auditor and investigator for almost 40 years, I am painfully aware of the difficulties in the implementation of complicated quality assurance and safety programs. In light of this, I feel simply more or different "preventative controls" are not likely to improve the situation much, by themselves.

Still, we look to FDA to help us, and I am still wondering if we will get what we need from the agency. We need consistent application and enforcement of the rules, and FDA has to get agents into the field, but most importantly, firms must organize their companies around food safety. This means establishing active and effective committees, appointing dedicated food safety staff, and a planned approach to assuring the safety of products. Companies must also effectively train and educate everyone in the organization, and maybe most importantly, apply the available science and technology to the food safety problem.

A lack of commitment within companies is a root cause of much of the failures of the existing programs, along with a lack of resources. We waste tons of money on audits, manuals, record keeping etc, etc, when we should be investing in educating our employees, improving our  infrastructures and applying technology. These applications should include onsite laboratory capability, remote monitoring of critical processes, and sophisticated traceability and recall programs.

I totally support what FDA is doing with FSMA, but we should recognize that a new system of preventative controls is only a solution if our food safety management systems are working effectively.











Environ Health Associates, Inc.







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The HACCP Alliance Certification seal on the “Applying HACCP Principles™” course means it is the most recognized HACCP certified course offered to the food industry.

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FSMA Progresses but Confusion and Apprehension Build in the Produce Industry

I suppose anytime one enacts a sweeping new law that affects an entire industry we can expect an outcry from the newly regulated. When it comes to the US Food and Drug Administration’s Food Safety Modernization Act, this is no exception.

FSMA has been plodding along to its final conclusion in 2015, with FDA laying the ground work for what will be a long and difficult process of implementation of the rules.

See also:

While there has been progress in rulemaking with the release of two critical rules, preventive controls for human food, and produce safety, and five more, we have still have only a murky idea of the impact this legislation will have..

The produce rule is difficult to interpret. For example, the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption contains provisions that apply to farms, but also exempts farms based on a number of factors, such as type of crop, size, ownership of growing areas and production facilities, as well as commercial vs noncommercial operations. With all the exemptions, it is a roll of the dice whether a farmer will need to comply with any, all, or part of the proposed rules.

Naturally, with the present uncertainty there is concern. Publically, the produce industry seems to begrudgingly accept FDA’s powers, but in private, produce industry professionals express doubt about FDA’s abilities to effectively carry out the regulation in such a vast industry, and few operators have actually read the rules, even though two key ones have been out for comments since Jan. 2013.

Some of the apathy is due to the major produce operators in large part having already applied most of the required food safety initiatives outlined in the rule. The larger firms in the industry adopted the main tenants of Good Agricultural Practices and Good Manufacturing Practices in the form of industry guidance and third party audit standards years ago. The problem now seems to be, as it was from the beginning, the so called small farmers and producers. Most of these minor suppliers have not been brought under the same requirements as those imposed upon major suppliers to the large retail stores. These are the produce suppliers who grow and handle products at the end of the supply chain. It includes facilities that store, re work and deliver products weeks after harvest directly to food service and small groceries. Currently, our third party system of food safety controls has not affected these operators, and thus the fear.

Some amount of fear may not be bad thing, however. In my experience, many of these operations are in poor condition and lack hygienic standards. I recently visited a wholesale distribution and cold storage facility in Miami. The operation handled flowers, plants and produce, commingling them! Re-packing was going on throughout this poorly kept operation on the tops of old boxes and wooden pallets. The dirty hands of the cloth gloved workers touching previously washed products while they graded out decayed and non conforming product, with no hand wash sinks available.

This is the kind of operation I occasionally find in the backwater of the produce industry. It’s not my role to fix these issues, I was there to bid on a consulting project, which I did, and I was glad when I walked away from this mess. But I am left with the question of whose responsibility is this?

With that thought in mind, it was with some annoyance that I read the comments of the State of Georgia Commissioner of Agriculture, Gary Black on FSMA.

Black said in late December “new food safety rules proposed by the federal government could prove cumbersome and costly for Georgia farmers”. That cost is probably not as high as Mr. Black might make out, but I agree it can be expensive to hire a consultant to develop a program of food safety controls in operations where they never existed before, perhaps $2,500.00 to $5,000.00 or more for the consultant in a business doing $500,000. Add to this, the costs to upgrade operations such as refrigeration, acquire equipment, and make structural improvements to meet inspection requirements.  FDA suggests that about $30,000 might be needed in large operations. My own experience is that currently, a medium sized produce packing facility can spend up to $250,000 a year to comply with the third party food safety standards already imposed by the major buyers.

One could argue, however, that such expenditures for safe facilities and hygienic operations are simply the cost of doing business and it is unfair for only parts of the industry to shoulder the obligation.

Dr. Michael Doyle, director of the University of Georgia's Center For Food Safety gave some balance to the discussion. “From my perspective, it's all about public health," Doyle said. "We've had so many of these outbreaks." According to FDA there have been 131 outbreaks attributed to produce between 1996 and 2010, and that list has obviously grown.

Read more here:

Read more here:

Negativity comes not only from the ranks of government, but from so called “food freedom” groups.

Read more here:

Due to the push back from all sides, the end of the year saw FDA express reservations about some of its new FSMA requirements, especially those proposed for agricultural water testing, and is reevaluating the impacts of the regulation on farms, generally.

Read more here:

What this means is a setback for consumers who will wait even longer for the safety of produce, and in the meantime, the produce industry is still very vulnerable to large outbreaks of foodborne illness, as we saw in 2013 with Hepatitis A in imported pomegranate seeds,

and the parasite Cyclospora in imported greens used in salad mix.

Another Jenson Farms type of outbreak is not out of the question, either.

See here:

The Produce Industry Still has a Long Way to Go to Ensure Food Safety

The Produce Industry Still has a Long Way to Go to Ensure Food Safety

While there is quite a bit of controversy concerning what happened at Jenson Farms, there is no denying that the fresh produce industry has been forced to reevaluate its food safety efforts.

The Buyer Driven Food Safety Model

Third party food safety audits are still what they have always been, an industry led method to determine conformance with a set of voluntary standards.  As third party auditors, we have no control over the operations we audit. The only real control lies with the customers of the operation. The customer can choose not to purchase from a supplier, work with the supplier to correct problems uncovered in the audit processes, or ignore the audit findings. Increasingly however, customers are becoming more selective and looking much more closely at audits before making buying decisions. Unfortunately, the dictates of supply and demand still apply, and if a customer needs product and the price is right, buyers will purchase from suppliers with questionable records, or even those without any oversight at all. In the end, audit findings are still just one of the criteria that a prospective customer uses to make a buying decision.

Traceability and Recall

Traceability is improving, with some firms investing considerable resources in advanced electronic record keeping and coding of unit packaging. Still, recent outbreaks show that traceability is a difficult matter. The recent outbreak of cyclosporiasis in leafy greens this year illustrates the difficulty with traceability. Even with over 600 cases of illness affecting numerous states, investigators did not conclusively link the outbreak cases to a supplier. The final report by CDC indicated that both cilantro and bagged salad items were involved, without pointing to a single source of the contamination of both products. Products might be coded when they are packaged, but processors do not always maintain the needed batch coding records to tie inputs to outputs, and there is plenty of comingling going on throughout the supply chain. While traceability systems such as PTI, Harvest Mark and ScoringAg are available, the industry has not come to a consensus as to what it wants, leaving suppliers with uncertainty as to what system to choose.

Antimicrobial Treatments

Packers and processors are using a variety of antimicrobial treatments such as ozone, chlorine dioxide, chlorine and peracetic acid; however, we lack clear scientific evidence for the sanitizing effect of these treatments on fresh produce. Treating the water used to wash produce is a wise idea, especially if the wash water is reused (recycled), and we can reliably determine the effectiveness of that type of treatment. The problem with sanitizing produce is that each product has its own world of microbial issues, such as surface area characteristics and vulnerability to microbial colonization, and each antimicrobial treatment process has its own set of variables, e.g., concentration, contact time, and coverage. Determining the precise methods needed to inactivate a wide range of microbes in such diverse products and processes remains elusive. Currently, the USDA does not recognize any microbial treatment for whole fruits and vegetables as capable of sanitizing and therefore no antimicrobial product has a registration for reduction of human pathogens on whole fruits and vegetables. Much more research is needed in this particular area of produce safety.

The Food Safety Knowledge Gap

The produce industry is moving forward with the education and training of its personnel, but currently there is no approved or recognized program of instruction in food safety in the produce industry. Unlike training programs at the restaurant level, very little has been done to identify the core curriculum needs of the produce industry. For example, operators of complicated antimicrobial addition systems are usually recruited from existing production staff having no training in chemistry or microbiology. Such operators often do not fully appreciate the complexities of sanitizing processes and concepts such as free chlorine, oxidation-reduction-potential (ORP), and pH. While microbial treatment of process water and surfaces are becoming standard operating procedures, the industry lacks the expertise to perform tests or interpret results. Findings often get filed without an evaluation by a knowledgeable person.  The use of ATP as a verification tool is required by most third party standards (and FSMA), yet few firms have the skills needed to effectively establish such programs and/or benefit from this type of monitoring.

While a HACCP program is often required (by buyers) the understanding of the concept by the produce industry is marginal. Without a grasp of epidemiology, microbiology and science in general, this concept is nothing more than window dressing in many firms.

Equipment Design and Construction Standards

There is no formal registration process for equipment used in the produce industry. Unlike the dairy industry where processors have very successfully applied the 3-A standards, there is no set of criteria for the finish of surfaces, or even the types of equipment used to pack or process fruits and vegetables. We see everything from cast iron to stainless steel construction of various grades, with rubber, plastics and even cloth and wood used as food contact surfaces.

Control of Wastewater

There are several commodities that are not typically washed before packing, such as berries and watermelons, but many produce items are washed, generating a substantial amount of wastewater. The systems for collection and discharge of wastewater from washing- flumes dump tanks and spray bars are often poorly designed, resulting in water flooding production areas. Wherever there is water collecting, these is a substantial risk of microbial contamination; workers splash through wastewater pooling on floors, and forklifts splash such water onto packaging and products . Poorly designed and located floor drains and floors that are not properly sloped to drain are common problems throughout the industry.

Facility Construction and Design

Just as there are no recognized industry standards for equipment, there is no national industry standard for design of produce facilities. Facilities can be open sheds with no walls and bare concrete floors while other are enclosed production facilities with a variety of layouts and construction types. Facilities in the produce industry are often viewed as part of farming operations and resemble farm buildings (pole barns), as opposed to the processing facilities one might find in fisheries or meatpacking. Attempting to control contamination, (physical, chemical and microbiological) in such facilities can be frustrating to those tasked with sanitation.

Microbial Testing

Probably the best deterrent to an outbreak in high risk commodities is a robust microbial sampling program for products and surfaces. There is some controversy as what constitutes a high risk commodity, but those fresh produce commodities with an edible peel and those that are in a ready to eat form (no cooking required) might be targeted, along with those produce items with a history of causing outbreaks. It is reasonable that since outbreak investigations can often isolate the pathogen on incriminated produce that such contamination could be spotted ahead of time before such products cause harm. The problems remain as to what to sample, what analysis methods to use, what microbial indicator organism to use, or pathogen to look for, and how much and how often to sample; and then there are the problems of how to interpret the results, and when to initiate a recall. The produce industry is by and large poorly prepared to employ microbial testing to its advantage.


FDA rules under FSMA are still not clear. After years of waiting, the produce industry is still uncertain as to what the impact of the new requirements will be, and FDA itself appears to be groping for answers. It will be years before the FDA can effectively enforce its rules, and the industry must move forward on its own, now.

While the produce industry is frightened by what happened to the Jensen brothers, the industry remains perplexed as to what to do, and the reality is this same scenario could play itself out again at any number of firms. What is clear is that in spite of the progress that has been made in food safety, the fresh produce industry has a long way to go to prevent another Jensen Farms type of incident.

Today Show's Rehash of the Auditor Bash

Despite that all of this has been said before, Bloomberg and the Today Show still think there is something to say about third party food safety audits, but they say nothing new. Of course, there are going to be outbreaks in facilities that have third party inspections. Just like there are outbreaks in facilities regulated by USDA, FDA and every county health department across the US. Why is that a surprise? Third party auditors are in almost every facility that should be inspected by FDA. Where is FDA? Do the agency and its inability to police the food industry share the blame for the situation? What about the thousands of facilities that do not have outbreaks THAT ARE AUDITED? It’s impossible to measure prevention…let’s see…show me the data on how many outbreaks didn’t happen? Hmmm.

All of these stories expose the weakness in the third party system, which I admit there is. As an auditor, I do not carry a badge, cannot stop production, and cannot close an establishment. I can even be constrained from taking pictures, samples and can be denied access to records and documents at the discretion of management.  I can only evaluate the questions on the audit template and only those that are in the so called scope of the audit.

Doug Powell asks for the data, and well he should, but he is not likely to get it since this data is proprietary. Audit companies are not going to publish the scores of auditees, and why should they? These audits are simply tools for the buying community to make purchasing decisions, not public health protection documents. If there is weakness in the system, it is that retailers will buy from anyone, and simply hide behind a smoke screen of due diligence, putting the burden of food safety on the supplier, while the buyers themselves are free to scour the markets for the best price and ignore food safety.

And forget the scores, there are so many questions that the points do not always indicate the real level of risk, but buyers and retailers do not read the reports, they simply go by scores. In my opinion, the buyers need to be educated because few if any of them really know how to interpret the findings from third party audits.

Left to its own devices, due to the inability of our public health agencies to afford us food protection, the food industry has created a system it can live with. Such is the case with third party audits. No retailer is going to make the system so strict that it constricts the supply, or God forbid causes a shortage and prices rise. And there is the profit motive, as this article brings out, and not just at AIB. Remember, FMI the billion dollar voice of the food industry owns the most recognized GFSI scheme called SQF, and they are not alone- all auditing companies work for the industry and adjust themselves to the prevailing powers that be- to make money, that is business and just what you would expect from an industry driven concept. It is so naïve to think any other way.

If you want independent auditors who are not beholden to someone, then we better fund a righteous FDA and keep the political honchos in Washington away from the inspectors. It can’t be done either-so there.

So now what?

More outbreaks, more tragic deaths and more of the blame game; this nightmare is not going away just because the Today Show runs a story. The problem is that the microbes have become firmly entrenched in our environment and attack our food supply at will, and we seem to lack the ability to detect them or eradicate them. Our best hope is a huge infusion of scientists, science and technology into the food industry, but we are a generation away from seeing the beneficial effects, even if we start now.

So on we go with incompetent people running our food safety programs, basic hourly workers with no knowledge of chemistry or microbiology in charge of food safety in too many plants, coopted auditors, and poor little old FDA limping to the scene after some tragic event to tell us what went wrong. Pathetic.

Read on and try not to barf.

Show us the data, forget the faith; food sickens millions as company-paid checks find it safe



Doug Powell

William Beach loved cantaloupe -- so much so that starting in June last year he ate it almost every day. By August, the 87-year-old retired tractor mechanic from Mustang, Oklahoma, was complaining to his family that he was fatigued, with pain everywhere in his body.

On Sept. 1, 2011, Beach got out of bed in the middle of the night, put his clothes on and walked into the living room. His wife, Monette, found him collapsed on the floor in the morning. At the hospital, blood poured from his mouth and nose, splattering sheets, bed rails and physicians.

He died that night, a victim of Listeria monocytogenes. Beach was one of 33 people killed by listeria that was later traced by the U.S. Food and Drug Administration and state officials to contaminated cantaloupes from one Colorado farm. It was the deadliest outbreak of foodborne disease in the U.S. in almost 100 years.

“He died in terror and pain,” says his daughter Debbie Frederick.

That’s how Stephanie Armour, John Lippert and Michael Smith begin their food safety and aduits and inspections opus for Bloomberg. The Today Show may run a version this morning, because I taped a bit for it at Brisbane’s Channel 7 studios last week.

About seven weeks after Beach started eating cantaloupes, a private, for-profit inspection company awarded a top safety rating to Jensen Farms, the Granada, Colorado, grower of his toxic fruit. The approval meant retailers such as Wal-Mart Stores Inc. (WMT) and Wegmans Food Markets Inc. could sell Jensen melons.

The FDA, a federal agency nominally responsible for overseeing most food safety, had never inspected Jensen.

During the past two decades, the food industry has taken over much of the FDA’s role in ensuring that what Americans eat is safe. The agency can’t come close to vetting its jurisdiction of $1.2 trillion in annual food sales.

In 2011, the FDA inspected 6 percent of domestic food producers and just 0.4 percent of importers. The FDA has had no rules for how often food producers must be inspected.

The food industry hires for-profit inspection companies -- known as third-party auditors -- who aren’t required by law to meet any federal standards and have no government supervision. Some of these monitors choose to follow guidelines from trade groups that include ConAgra Foods Inc. (CAG), Kraft Foods Inc. and Wal-Mart.

The private inspectors that companies select often check only those areas their clients ask them to review. That means they can miss deadly pathogens lurking in places they never examined.

What for-hire auditors do is cloaked in secrecy; they don’t have to make their findings public. Bloomberg Markets obtained four audit reports and three audit certificates through court cases, congressional investigations and company websites.

Six audits gave sterling marks to the cantaloupe farm, an egg producer, a peanut processor and a ground-turkey plant -- either before or right after they supplied toxic food.

Collectively, these growers and processors were responsible for tainted food that sickened 2,936 people and killed 43 in 50 states.

“The outbreaks we’re seeing are endless,” says Doug Powell, lead author of an Aug. 30, 2012, study on third-party monitors called “Audits and Inspections Are Never Enough.” Powell, a professor of food safety at Kansas State University, says Americans are at risk whenever they go to a supermarket.

“You need to be in a culture that takes food safety seriously,” Powell says. “Right now, what we have is hidden. The third-party auditor stickers and certificates are meaningless.”

In some cases, for-hire auditors have financial ties to executives at companies they’re reviewing. AIB International Inc., a Manhattan, Kansas, auditor that awarded top marks to producers that sold toxic food, has had board members who are top managers at companies that are clients.

Executives of Flowers Foods Inc. (FLO), which makes Tastykake, and Grupo Bimbo SAB in Mexico City, which makes Entenmann’s pastries, Sara Lee baked goods and Wonder Bread, serve or have served on AIB’s board.

“There’s a fundamental conflict,” says David Kessler, a lawyer and physician who was FDA commissioner from 1990 to 1997. “We all know about third-party audit conflicts. We’ve seen it play out in the financial world. You can’t be tied to your auditors. There has to be independence.”

As flawed as the inspection system is in the U.S., it’s more problematic with imported food, especially coming from countries with lower sanitary standards, says Michael Doyle, director of the University of Georgia’s Center for Food Safety. In some emerging markets, farms growing food for export to the U.S. aren’t inspected at all.

The U.S. will import half of its food by 2030, up from 20 percent today, Doyle says. Bloomberg Markets visited growers in China, Mexico and Vietnam and found unsanitary conditions for produce, fruit and fish exported to the U.S.

Auditors evaluate their clients using standards selected by the companies that pay them, says Mansour Samadpour, owner of IEH Laboratories & Consulting Group in Lake Forest Park, Washington, which does testing for the FDA. The auditors sometimes follow a checklist that the company they’re inspecting has helped write.

“If you have a program for adding rat poison to a food, the auditor will ask, ‘Did you add as much as you intended?”’ Samadpour says. “Most won’t ask, ‘Why the hell are we adding poison?”’

Not only has the government outsourced auditing to the food industry; the auditors themselves often outsource their vetting to independent contractors -- people over whom they don’t have direct management control.

While Primus Labs declined to comment directly for this story, it did supply a response from its law firm, Kaufman Borgeest & Ryan LLP in New York. Auditors, the statement says, serve at the pleasure of their clients and cannot go beyond what they are asked to do.

“Third-party auditing will continue to be as effective as those requiring the audits (buyers/suppliers) and the audited suppliers make them,” the law firm writes. James Markus, a lawyer representing Jensen, didn’t return calls seeking comment.

From the outset, the FDA lacked the resources to inspect all of the country’s food producers.

The food industry moved to fill that vacuum with private auditors in the 1990s. Danone SA (BN), Kraft, Wal-Mart and other companies created the Paris-based Global Food Safety Initiative in 2000 to write guidelines for third-party auditors.

The program, whose vice chairman is Frank Yiannas, Wal- Mart’s vice president for safety, requires companies to be audited once a year. It doesn’t mandate testing for pathogens. In 60 manufacturing plants, Wal-Mart suppliers reported a third fewer recalls in the two years after adopting GFSI standards, Yiannas says.

In some cases, companies use their own auditors to check suppliers. In 2002 and 2006, Nestle USA, a subsidiary of Vevey, Switzerland-based Nestle SA (NESN), refused to use Peanut Corp. of America as a supplier. Nestle inspectors found rodent carcasses and pigeons in Peanut Corp.’s Plainview, Texas, plant.

Nestle’s rejection didn’t stop Lynchburg, Virginia-based Peanut Corp. from doing business with other customers or seeking approval from third-party auditors. In 2008, AIB International auditor Eugene Hatfield gave Peanut Corp.’s Blakely, Georgia, plant a “superior” rating.

And there’s a whole lot more. Our take on all this is below:

Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman


Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

Fear Mongering or Facts, Plaintiff Attorneys and Social Media in Food Safety

Fear Mongering or Facts, Plaintiff Attorneys and Social Media in Food Safety

The tort system has become the fulcrum for food safety in the absence of a credible public health response to foodborne illness. Nobody goes to jail in the US for even the worst food safety breaches, even those that result from gross negligence, but they do get sued, big time. FDA especially, has lacked the power to levy any meaningful penalties against offending firms, even ones that have released contaminated foods knowingly into commerce. The Parnells and De Costers rest in their immunity from prosecution after they poison thousands and killed innocent consumers with their tainted products, but they cannot escape the long arm of the plaintiff attorney. The complacency that has developed due to the liaise-fare attitude of government, turned to fear of lawsuits, has now hardened into an attack on plaintiff lawyers, the last recourse for injured parties.


With that as a backdrop, the story below reeks of a reactionary mentality. The suggestions that social media be used to spin food safety information and deter consumers from getting the facts they need during an outbreak will not get very far. The public is not so easily fooled.


I believe that firms that practice food safety and are committed to the principles of public health protection should tout their message.

But to play games with the access to factual information especially during an outbreak just reveals the shocking and desperate state the food industry is in.


Instead of manipulating social media, the food industry should be redoubling their efforts to stop the foodborne epidemic in this country and come clean with the American public.


US: Four ways plaintiffs’ lawyers leverage Google to stir food-safety fears
Fast Company
Richard S. Levick
Despite the fact that America’s food safety infrastructure is the most efficient and effective in the world, the International Food Information Council Foundation’s 2012 Food and Health Survey found that only 20 percent of Americans are “very confident” in food supply safety. At the same time, one in six U.S. consumers has stopped buying a particular food or beverage brand because of safety concerns in the last twelve months.
Given the rash of high-profile food recalls we’ve seen since 2007, the figure is understandable, even if it isn’t backed up by hard facts. Spinach, tomatoes, peanuts, lettuce, ground beef, and a host of other kitchen table staples all experienced significant incidence of contamination in the last five years. The resulting consumer anxiety got so bad in 2009 that Americans actually put their food safety fears on par with worries about the War on Terror.
That’s a compelling statistic--and it ought to make farmers and food manufacturers wonder if there’s something else that is contributing to Americans’ fear of food. Even at the 2010 height of salmonella, listeria, and E. coli outbreaks, the U.S. Centers for Disease Control and Prevention released data showing that only one in every 125 million meals served in the U.S. had the potential to make a consumer fatally ill. Science supports a conclusion that the food we eat every day is, indeed, safe. So why don’t Americans feel that way?
The answer lies in the fact that statistics can’t compete with emotion when it comes to assuaging anxiety. Numbers don’t move people the way that human drama does--and there are no more dramatic events in the food industry than when a person dies after eating something she believed was safe.
This facet of human nature explains a large part of the equation; but not all of it. There is another factor at play, and it manifests itself in the efforts of those with skin in the food-fear game. Food industry adversaries--the plaintiffs’ bar chief among them--understand how emotion impacts the marketplace. Even more troubling for the food industry, they understand how to manipulate digital and social media strategies to ensure their emotional appeals ring out in the marketplace.
By way of example, when we look at the circumstances surrounding the recent salmonella outbreak that killed two people, sickened 150, and originated at an Indiana cantaloupe farm, we see just how effective their efforts are at controlling the flow of information on food safety issues. In other words, we see just how good they’ve gotten at controlling search results on Google, the venue more people turn to for information than any other (digital or otherwise).
1.Plaintiffs control the keywords. As of this writing, a Google search for the term “cantaloupe outbreak” lists a law firm as the top sponsored link. A search for “cantaloupe lawsuit” returns six plaintiffs’ firm sites on the first page. Industry messaging on safety issues is nowhere to be found on the first page of either of these searches. Bottom line--on virtually every food outbreak issue, the plaintiff’s bar is masterfully controlling the dialogue on Google.
2.Plaintiffs dominate the blogosphere. When users click those links mentioned above, they are most often directed to blog posts that outline how the industry failed to keep cantaloupe consumers safe. While the posts provide plaintiffs with an important messaging venue, the blogs themselves ensure high search rank for the posts because they are sources of the frequently-updated content that attracts the Google spiders.
3.Plaintiffs use online video. A Google Video search for “cantaloupe listeria lawsuit” features two plaintiff-produced videos in the top three results. Just like the blog posts mentioned above, these videos don’t paint the industry as a responsible steward of public health. And as Google increasingly emphasizes the spoken word over the written one, these videos further optimize plaintiffs’ messaging.
4.Plaintiffs geo-target. As mentioned above, a Google search for “cantaloupe lawsuit” returns one plaintiff-maintained link. At the same time, a Google search for “cantaloupe lawsuit Kentucky” (one of the hardest hit states during the outbreak) returns two sponsored links. That tells us that at least one firm is targeting its efforts to the geographic areas where its messages will resonate most.
What all of this means is that the plaintiffs’ bar is operating in a virtual information vacuum when contamination strikes the food and beverage industry. “Within the legal community, they are simply outworking and outsmarting the other side when it comes to online communication,” says Bob Hibbert, a partner at Morgan Lewis & Bockius who has worked on number of high-profile food safety issues. “It’s clearly in the best interest of the food industry, and of the people who represent it, to mount a more effective response to this challenge.”
Fortunately, leveling the playing field doesn’t require any great strategic leap. Food manufacturers need to understand that the same tactics driving high levels of consumer anxiety can be employed to diminish it as well. Specifically, food companies should:
1.Own their risk terms and keywords. Plaintiffs’ keyword dominance exists because food manufacturers don’t own the risk terms that their consumers use to find information on the latest safety crises. While they likely optimize their Web properties for terms related to their products (“tomato,” “spinach,” ”cantaloupe,” etc.), they don’t do the same for terms such as “foodborne illness,” “recall,” “lawsuit,” or “outbreak”--and that enables the plaintiffs’ bar and other adversarial voices to dominate the conversation. At the moment an instance of contamination is discovered, food companies need to engage in Search Engine Optimization (SEO) and Marketing (SEM) campaigns that rank their response messages at the top of the list when their risk terms are queried. Even better, food manufacturers that do the same in peacetime not only eliminate the need to scramble when trouble arises; they create a compelling safety narrative that plaintiffs will have to overcome.
2.Address the blogosphere. Plaintiffs’ attorneys maintain blogs as a means to provide a steady stream of optimized content that keeps their messages front and center on search engines. They know that if they are active all the time, the Google spiders will elevate their sites when a food recall hits and it comes time to troll for class action clients. By blogging about all the ways they work to diminish the possibility of contamination, food manufacturers can also create the salient, frequently-updated content that ranks on Google when consumers seek information on food safety.
3.Engage via video. Food manufacturers that reach out to consumers with engaging video content not only provide themselves a leg up on the SEO front; they establish the emotional connections needed to bridge the safety perception gap. Articulating food safety statistics such as those cited above merely tells people their food is safe. Video shows them why they should consume with confidence. With video content that highlights safety procedures and the men and women charged with carrying them out, food manufacturers can powerfully articulate a commitment to safety that sticks with their audience. By going a step further with how-to videos that outline healthy food preparation steps, they can themselves take on the identity of true consumer advocates.
4.Be where the fear is. When an outbreak does occur, the companies at the center the problem--as well as those whose brands may be tarnished by mere association--need to target their messages to affected populations. Not only does geo-targeting streamline their optimization efforts by focusing resources where they are need most; it enables companies to directly reach the very consumers most likely to change their buying and eating habits as a result of a contamination incident.
Google is the portal by which consumers gain or lose confidence in products and services. As such, it is too important a venue for food manufacturers to cede to their adversaries. At a time when more than half of Americans are concerned about the foodborne illness, the industry has a compelling safety story to share. With strategies that enhance Web optimization, they can help ensure that a captive audience is there to hear it.
Follow Richard Levick on Twitter and circle him on Google+, where he comments daily on the issues impacting corporate brands.
Richard Levick, Esq., President and CEO of LEVICK, represents countries and companies in the highest-stakes global communications matters--from the Wall Street crisis and the Gulf oil spill to Guantanamo Bay and the Catholic Church. Mr. Levick was honored for the past three years on NACD Directorship’s list of “The 100 Most Influential People in the Boardroom,” and has been named to multiple professional Halls of Fame for lifetime achievement. He is the co-author of three books, including The Communicators: Leadership in the Age of Crisis, and is a regular commentator on television, in print, and on the web.


Subway's Sick FSMS

The verification of supplier food safety has emerged as a critical component of a retail operation’s Food Safety Management System (FSMS), but we continue to see Subway stress supplier safety while poor management of its own operations results in outbreaks of foodborne illness.

See Bill Marler's Food Safety News to learn how a Subway contributed to a community wide outbreak of norovirus gastroenteritis.

In light of the costs borne by the supply chain to satisfy retail industries’ high standards for prevention, it is unfair for a firm as influential as Subway to have lax control over its own operations.  

It’s critical to have safe lettuce coming in the backdoor, but if an infected employee handles it, it negates all the costly prevention done upstream by suppliers. The revelation that this was allowed to happen creates animosity on the part of suppliers and undermines Subway’s own efforts at supplier control.

Subways’ food safety management system failed as the result of poor decision making; what we see here is the failure of food safety culture. Subway has an obligation to consumers who expect the company to be a supplier of safe wholesome food. Subway has an obligation to its suppliers to maintain the same vigilance over food safety they expect from them. By failing its obligations, Subway risks the reputation it has built, and the value of its brand.

As consumers, we should expect MUCH more of Subway. As food safety professionals, we should ask “what is the root cause of this failure” and “how best can Subway’s management solve the problem”.

Food Service Industry Push Back on Letter Grades

I am for a more fair system when it comes to inspections and grading. The grading numbers may not mean much, and this is because inspections are snap shots of events and there are all sorts of bias and human elements. However, when the facility maintains its records of food safety efforts, its more like seeing a moving picture. When inspections or audits make an evaluation based on what they see, and what they determine to be required in the firm's food safety program, now you have something that has the ability to be meaningful. Its the firm's daily practices that will make or break a sanitation program. Lets start evaluating that. 

But wait, that means a food service operation has to have an internal food safety program to evaluate! 

Too bad restaurants don't have to do have one, its not required, they "just follow the code". 

That mentality doesn't work and all this controversy about grading being a poor measure is true; but it is just a subterfuge for the fact that the FS industry as a whole will not agree to a mandatory self-control program that would allow checks and balances. Fortunately, most of the rest of the supply chain has. 

Here is what the FRA has to say about grading in 2005,

and thier stance has not changed, in aspite of the fact that reports from agencies with letter grading support risk reduction has occurred. 

If this is to catch on we have to overcome some of the problems that are rightly recognized. Its just we have not understood what food safety management is and applied it to Food Service and this means we have no real measurement we can rely on. 

The latest pushback from NYC. 

NEW YORK: City Council throws rotten tomatoes at restaurant grades
New York Daily News
It is but a slight exaggeration to say that everyone who eats in a restaurant in New York City — which means essentially everyone who lives, works or visits — loves the A, B and C placards posted in eatery windows.
Those grades, based on Health Department inspections, have had powerful effects. They have improved restaurant sanitation, reduced food-borne illnesses like salmonella and boosted business at restaurants that have earned the top mark.
What’s not to like?
Ask the City Council and Speaker Christine Quinn.
The industry has fought letter grading from the moment the Bloomberg administration floated the idea. Restaurateurs have griped repeatedly that inspections are too tough, fines are too high and the marks are based on poorly chosen criteria.
Now, Quinn & Co. have produced a survey purporting to find that the program desperately needs reform. A questionnaire asked restaurateurs their opinions about the grading. Of the city’s 24,000 restaurants, 1,297 responded.
Based on the survey, Quinn is calling for a reevaluation of the violation system, an ombudsman to adjust inspection results before hearings are held and an “early warning system” to weed out supposed inconsistencies in inspections.
She needs to get specific and prove her proposals will not undermine the most important consumer protection in recent New York memory.


Environmental Health Down on the Farm

As an environmental health professional, I have enjoyed a successful career in hands-on food protection from farm to table. My success in this wide array of conditions has come through the effective application of environmental health principles.

Nowhere in food safety today is environmental health needed more than down on the farm, where the environmental health risks factors are becoming better understood. As a sanitarian and independent food safety auditor, there are some key areas of environmental health in my work on the farm; water quality, animal control, and worker hygienic standards. Private food safety auditors have started calling these the "Three W’s" for Workers-Water-and Wildlife.

Typical Tomato Reusable Harvesting Container Rinse Typical tomato wash water used to rinse picking buckets 

Downstream effects of the environmental health problems originating on produce farms are huge. The  problems reverberate through the the rest of the controls we have in place. Because the risks are not well controlled, we need more and more robust surveillance, traceability and product recall ability, testing; and of course, redress for victims in court. These unfortunate individuals and their families hold the bag at the end of the system without much control.  The cost burden on the food industry due to outbreaks is remarkable. The Listeria problem in cantaloupe may cost industry $150 million in legal fees, alone. All of this has happened because we have not effectively established in the produce industry a relatively few environmental health protections that should have been there years ago.

Thinking optimistically, we can fix most of the produce contamination problem during growing and harvesting of produce by effective controls over workers; water supplies and usage in all its forms; and wildlife. We can ease the pressure on the supply chain, and minimize the downstream effects on consumers and society at large.

Agriculture has been side by side with animal husbandry and wild animal populations forever, so we cannot expect to remove the zoonotic reservoirs for pathogens completely in farm environments. Therefore, there will always be some risk in fresh produce; but the residual risks passed on in the supply chain will be better managed during packing, processing and handling downstream, if the microbial burden is low.

Vaccination maybe an option to protect against E coli infection in cattle, since we have one with efficacy; but granted, this protection has had poor discussion and vaccines have not been applied. If we had an effective vaccine and farmers would use it, one would start there. Ideally, we would reduce the incidence of pathogenic E coli in cattle (the reservoir) through vaccination, and then move on to exclude the wild animal populations and clean up water sources.

It is likely that adequate fences and other animal barriers, adequate setbacks (still don’t know what this means in every case), water treatment (when needed), strict adherence to personal hygiene, self-inspection and maintenance will solve most of the E. coli and Salmonella problem in growing areas.

We can do this, but a coordinated national efforts is not so simple, and everything has a cost. Somebody must pay, then somebody must make sure it gets done, and financial resources are not necessarily there.

The farms I see would need about $10,000 to $50,000 (could be higher for some) of initial investment, and probably at least 10% of that for yearly maintenance, to implement effective wild animal exclusion measures. The cost would be borne by the farmer in addition to the many other costs of Good Agricultural Practices(GAP), like personal hygiene, training, use of antimicrobials and water treatment, liquid and solid waste controls, that he currently pays for.

Not all farms need the same intensity of controls; I see irrigation water coming out of deep wells as clean as tap water (Total Coliform < 1 cfu), and often the crops see no foliar applications. I see other situations where the foliar application of water is sourced from the surface, and must be treated.

Animal intrusion risks vary widely also; there are some farms in the Southeast where I see only isolated dogs, cats, or bird exposures with an occasional rodent or ground animal.

On some other occasions, I see systematic deer, pig and other wildlife intrusion and extensive droppings. Sometimes we find feces to the extent where harvesting must be halted, and/or production stopped.

In the western US, I see the cattle operations butted right up to produce production; the Salinas Valley in California has much different space requirements, resource needs, and land use issues then Immokalee in the Florida Everglades. As an aside, during our private investigation of the 2006 spinach E coli matter, I sampled one cow patty from a Salinas area hillside pasture and recovered an E. coli: O157:H7 isolate (but not the outbreak strain). One lucky random sample? Or is this bug seriously rampant in this area?

In addition, there are areas with water diversion and flooding problems (due to drought conditions we have not seen much of this factor in outbreaks) and several other environmental health risks we can point out across the board in agriculture.

This is all manageable, and makes it more manageable for us to put into place all of the other safeguards we now need.

On the farm we have “in your face" environmental health problems similar to those that are already addressed by the existing environmental health profession.

We need environmental health professionals to fix environmental health down on the farm, and they can do it, its as simple as that.

Jensen's hot potato passed to the auditor

Looks like we will not see then end of the Jensen/Frontera/ Primus Auditor issue for some time. While there is plenty of room for criticism of Jensen, Fonterra, and Primus there are also problems with FDA, and this tragic incident has become a hot potato being passed to and fro by congress.

I keep reading FDA's take on this as if they had an actual law in place that people had to follow, and actual inspectors in the field for enforcement, and an educational arm. FDA still has no muscle on the farm, just a law now on the books that is lagging behind. Until they get thier ACT together, it’s not fair to blame the industry for not getting it together when they themselves cannot.

I am not defending anyone, but if I were, I could look at the 2009 FDA Guidance for melon and wonder where it says that Jensen should have used a chlorinated hydro cooler to cool melons. FDA says it’s safe to use flowing water of satisfactory quality without an antimicrobial to cool melons. Nowhere does it say melons had to be pre-cooled, anywhere. In fact according to FDA, melons can be field packed and placed directly into a cooler. A hydro cooler (this is a refrigerated, circulated water bath, tank or drench that may also contain ice) is recommended, but the flowing water method is allowable, according to the guidance. Any auditor who would read the Melon Guidance of 2009 would have said FDA has no requirement to use an antimicrobial IN SINGLE PASS WASH WATER.

And here we have more from Leavitt and Partners, a DC consulting firm, taking shots at the auditing company from left field and just repeating the double talk while not really understanding what they are saying. But of course, this is business.

This whole discussion is beginning to smell and is turning into a witch hunt and a diversion for the fact that we have next to no currently enforced laws in produce safety. As result, we see systematic failure of the food safety protection they would afford us. And so industry has taken on itself this huge challenge of agricultural food safety and failures are occurring, and will continue. Third party audits are not designed for public health protection, and even if strengthened they will not their place.

And when and how does FDA propose to notify the industry about the minimum requirements under the FSMA? Most folks I speak to don't have a clue what to do.

This sad scene points not just to failure of audits, but reveals food safety at the primary production level of our food supply has been neglected. It’s going to take decades to educate farmers and to fix the problems spread over millions of acres of land and thousands of farming operations. The failures include FDA not being able to enforce rules or educate the industry, and if I sound like I am repeating myself, I am.

The third party food safety audit system was never intended to stand in the place of regulation. If we as auditors were supposed to enforce FDA Guidance, and now Laws, just how is that supposed to work? There is no mechanism for that.

Where are the thousands of competent people to do this job, the army who understand agriculture and how to do a produce risk assessment, commodity by commodity? How are small producers like the Jensen brothers supposed to cope with the detailed scientific risk assessment he and now thousands like him must by law perform?

This situation has got to be solved by industry and FDA working together, and proper funding and research.

Fix the mess first with regulations and guidance, then maybe there is some justification that Jensen and the rest of us should have known better.

Passing the hot potato is only going to burn more consumers.

Toilet Paper Audits and the Writing on the Wall

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

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


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


I think we need to clarify how the buyers can best use these reports, and how to improve the reporting process rather than throwing stones at one one is shatterproof.


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


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


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


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


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


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


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

  • Audits are routinely announced, meaning that the time of the audit is known ahead of time by all parties. An auditing firm that conducts both announced and unannounced audits reports that the differences in the score between the two measures can be 10 percentage points or more. Risk based inspections do not necessarily require unannounced visits as the risk in a process can usually be determined from operations, but at least some announced audits are a good idea. 
  • Buyers currently are empowered by their customers to go outside the recognized certified sellers if product is needed. The pool of unregulated and unsupervised facilities is still large. It is not uncommon to have an audited, certified and even inspected produce operation, operating beside an unregulated unaudited firm. Inconsistencies like that cause animosity and dysfunction.  

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

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

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

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

The US Cannot Afford Food Safety Says AMI

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

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

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

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

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

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

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

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

The Role of the Third Party Food Safety Auditor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This is not the role of the third party auditor.



Making Believe Sprouts are Safe

In Bill Marler's blog below, he quotes Bill Bagby of Tiny Greens, who sickened scores of people for 4 months with his contaminated sprouts.

Mr. Bagby says,

"Sprouts are kind of a magical thing," says Bagby, owner of Tiny Greens, a sprout farm in Urbana, Ill. "In terms of vitamins they're just off the charts compared to normal produce."

If this is magic, it is Black Magic of the worst kind. It is not really magic though...its make-believe. And the motive is as always… money. I wonder if Mr. Bagby believes his own statements about the health benefits vs. risk of sprouts? Does he feel eating raw sprouts is worth the risk of losing one’s kidneys?


This is the same ploy we hear from the raw milk industry. If Mr. Bagby was doing all he could to make a safe product, I might have some sympathy for him, but he operated an unsafe and unsanitary operation according to FDA. There is no excuse for the use of unsafe compost.


No responsible grower of any produce item I have ever met would do such a thing.

Mr. Bagby continues to mislead the public, he gives no evidence that his products are safer today than they were yesterday; having an "audit" once a year is not a food safety program. The changes he should have made were likely obvious and likely were put off, that is until he sickened consumers.


FDA’s public stand on sprouts is saddening. These officials know full well that this commodity is too risky to consume, they do not eat them, themselves. Yet, they avoid confronting the issues. After the terrible tragedy in Europe, it is now time for a shot across the bow to the entire sprout industry. We need FDA to say "get rid of the unsafe operations in your industry, make your product safely or we will put you out of business" and not, "it’s an individual decision ". When unsafe cars or tires kill people, we don't hear Washington folks saying "buying these unsafe cars and tires is an individual decision". Its not a matter of "tastes good", or "good for you", these products are too difficult to make safely, even under the best of conditions, and they pose a continuing public health threat.


No respectable, conscientious retailer should ever offer sprouts for sale. A firm like Jimmy Johns seems to me, totally reckless. Even after several illnesses from their sandwiches, they continue to offer sprouts. So I must conclude it’s a popular item and thus the firm is willing to take the risk.


Tiny Greens constituted a public health hazard for at least 4 months when it caused the last outbreak and so my feeling is the operator cannot be relied on in the future. Does he expect his auditor to stop him the next time he takes a short cut with food safety? The next time it could be devastating, knowing what we know now about the ability of the most severe strains of E. coli to contaminate these products.


I am sure FDA is hoping that the sprout industry will "kill itself off", which I believe will eventually happen, but how many consumers will have to die before our public health folks will tell the American public the plain truth, "raw sprouts are too dangerous to eat".

Lets stop all the make-believe.

Hemorrhaging to death is not worth the nutritional benefits of anything...period.

The Chicago Tribune asks, What should Consumers Do About Sprouts?

The answer is easy, "don;t eat them".,0,4296792.story


The Chicago Tribune tried to portray Mr. Bagby and company in a balanced way, but I do not think he deserves a favorable spotlight for his "magical" views.

Food Safety Auditing in Produce- is it Working?

Third party audits of produce are relatively new phenomena. Fueled primarily by the retail sector’s demands for safe year-round supplies of fresh fruits and vegetables, there is a serious industry-led effort underway to evaluate primary production and the resulting supply chain.

While the third party audit model has some similarities with regulatory inspections, there are major differences; Third party audits are buyer driven and may contain some unscientific provisions (one insect in a package, even an intermittent mosquito or ant) fails the audit. Another automatic failure often found in third party assessments is the provision for a blood and body fluid policy. It is universally agreed that the risk of HIV transmission is zero through food, and other bloodborne risks are very remote. Yet, the failure to have a policy on bloodborne pathogens is totally unacceptable to buyers.


There is no sound scientific reasoning behind provisions like these, yet since it is a buyer-driven risk assessment, these “hazards” to the retailer and his “business” are very real.


The standards set by retailers are mostly reasonable, but are often defined in minutia. There may be numerous questions that are so closely related that details become burdensome. For example, there are often a half dozen questions or more on rodent traps alone that must be evaluated independently, such as; are they positioned correctly, numbered, secured, clean, marked as monitored, kept on a schematic, with wall markings, in sufficient number, in sound condition, etc., etc. The intention is to cover every possible threat that a rodent will enter a building without being trapped or poisoned.


The detailed nature of audits sometimes lasting several days, with up to 500 individual questions, and often occurring multiple times in a year can be vexing, counterproductive and exhausting to all involved. Add to this that third parties often demand scientific programs and science-based risk assessments from operators unprepared through education or experience to provide such reasoning, and you have a problematic and sometimes dysfunctional system.


A huge gap emerges between the food safety expert-auditor and his “bible of standards”, and those just now becoming familiar with basic food safety concepts.


Auditors are often the first and primary source of scientific information for produce-facility operators unfamiliar with concepts such as Free Chlorine, Oxidation-Reduction Potential, microbial sampling plans, and interpretation of microbial testing results, ATP bioluminescence technology and other sanitation assessments and controls. Auditors often find themselves as much educating the operator as evaluating their performance. The auditor on the other hand often finds the produce-production manager assigned to food safety educating him on what things really work.


There is a notable lack of food safety knowledge at the primary producer level but there may also be a lack of traditional agricultural knowledge on the part of the auditor. Few auditors have the wide range of experience in public health protection, food safety, environmental health, water, chemistry, vector control, and the life sciences to truly provide an expert evaluation of safety in the agricultural world. Furthermore, it takes years of experience in the field for even qualified auditors to begin to understand the wide range agricultural and facility environments they must work in.


While food safety experts, production managers, and business owners struggle with these issues in produce safety, we should keep in mind that the findings of audits will not necessarily always be indicative of risks, and food safety programs no matter how well intentioned will not always prove effective given the robust exposures often encountered in farming environments. We are yet to stop the harvesting of foods where migratory birds have zeroed in, controlled floods, shot every wild pig, or figured out how to keep deer from jumping 8 foot fences to get to crops.


In light of all the obstacles, it’s encouraging to see contamination events caught quickly, and exposures kept small. More and more the contaminated produce that comes to light is recalled and/or production is stopped before a wide-scale outbreak occurs. This speaks to the food safety efforts of industry as we try to limit the inevitable exposures through testing and intensive traceability systems. Re-call systems are developed with computerized tracking of lot code information, and they recently have proven effective at preventing grand exposures through contaminated produce common just 2 or 3 years ago.


The produce sector is unique perhaps in its willingness to accept strict third party oversight, government regulation, and also to adopt and embrace food safety systems. Given enough time, the safety of produce will be assured. In the meantime, many of us have a lot of work to do.

Jack DeCoster's Sad Legacy

As a  person ages, one tends to think about how their life's work will be evaluated by future generations. Most people would want to be remembered for some accomplishment and hope that in the future, mistakes they made along the way will be forgotten.

For some, however, whatever they may have accomplished in life will be overshadowed by some spectacular moral failure. This is the unfortunate legacy of Jack DeCoster, self-made multi-billionaire farmer and US egg baron, par excellence .

By most accounts, Mr. DeCoster is the person behind the bulk of the eggs produced in this country. Through his subsidiaries and deals too entangled to entwine, Mr DeCoster and his cohorts control your egg supply, and have for many years.

Monopolies are not a good thing in any industry, but what makes this situation so incredibly bad for consumers is that the egg supply in this country is so seriously contaminated with Salmonella.

One only has to look at recent events and the history of DeCoster's fiasco's,  environmental, occupational, and public health to see that he is personally responsible for what has happened to the egg supply. It appears that most of the contaminated (and non contaminated) eggs in the US pass through him and his assorted businesses.

It didn't have to be this way, but this is the way DeCoster apparently wants it.  So will he be remembered- not as the self-made successful business man- but: "The Notorious Egg Man Who Made America Ill".

For DeCoster's latest assault on America's public health, see:



The Brown Stuff is Manure

A site discusses a recent effort to make raw milk more available.

Bad idea. Its not that raw milk sanitation cannot be improved but to make it perfectly safe is probably not possible without pasteurization.

See Why to Pasteurize Pastuerize.pdf

Creating a Monster Agency

I do not agree that one food safety agency is better. Such a behemoth will be bound by a morass of red tape. The agencies have evolved over the last 100 years, They have their own culture and hierarchy. The turbulence caused by any drastic change will hurt the public health mission of all the agencies involved and will take 20 years to sort out, This is a dangerous move and must not happen.

What is needed is better funding, more focus on the consumer and enlisting the private sector in a true partnership with public health.

GAO report supports single food safety agency

By Tom Karst Published on 03/04/2011 03:03PM

Consolidating food safety oversight into one agency could save the federal government money and improve performance, the U.S. Government Accountability Office reports.

The report, called “Opportunities to Reduce Potential Duplication in Government Programs, Save Tax Dollars, and Enhance Revenue,” concludes the current oversight of food safety is inconsistent, inefficient and ineffective.

Although reducing fragmentation in federal food safety oversight may not result in significant cost savings, new costs may be avoided by preventing further fragmentation, the report said.

The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration are the primary food safety agencies, but the report said 15 agencies have some degree of oversight on 30 food-related laws.

The increasing popularity of raw foods, rising imports and the vulnerability of some of the population to foodborne illness make efficient federal oversight of food safety more important than ever, the GAO said.

The FDA is the agency for federal oversight of produce safety so consolidation is not a huge industry priority, said Kathy Means, vice president of government relations and public relations for the Newark, Del.-based Produce Marketing Association.

She said the recently passed Food Safety Modernization Act made some improvements in how the FDA approaches risk-based oversight.

“There are ways to gain efficiency without monster reform,” she said.

Even if consolidation does occur, it would take several years and require existing agencies to operate well in the meantime, she said.

While not agreeing with all of the GAO report recommendations, Rep. Rosa DeLauro, D-Conn., said in a statement that the study provides additional evidence for the need to consolidate food safety oversight into one independent agency.

“I have introduced legislation that would establish such an agency since 1999 and believe that this is a critical step toward preventing foodborne illnesses and protecting public health,” DeLauro said in a statement.

Audit Creep

Beth Bland of the Goegia Fruit and Vegetable Growers Association makes some interesting points in her comments to the FDA. See:

The association voices the opinion of many that third party audit schemes have taken a life of their own and now constitute a greater burden for the primary producer than is necessary to ensure food safety. Please see my letter to the associaition in response

Dear Ms Bland:

I read your good comments circulating now and your thoughts on third party audit schemes. The issues you brought up are real and need to be addressed.

The third party audit model should not take the place of government inspection. Only government inspectors have legal authority to protect the public. Third party schemes have developed to protect the buyer in the absence of government regulation, as you have correctly opined. Third party audits do in fact also protect the public, but a third party auditor cannot stop an unsafe operation, embargo a product or enforce a recall. These powers to protect the public are clearly the governments' job. Additionally, some buyers might go around the system when they need product.

As a third party auditor, consultant and former regulatory official, I have seen both sides of the picture. The business of food safety has many problems. I believe that if FDA eventually has the manpower and the authority to enforce GAP standards, the buyers will accept a satisfactory FDA inspection as an indication that the firm has food safety programs in place. The third party scheme will eventually become a best practices model that the buyers can use to separate the good, from the best. Third party audits will not go away because buyers want assurance that the infrastructure of the organization is soundly built around food safety. Government inspectors do not go that far, looking only at the facts about sanitation they see during the inspection, and this snapshot does not tell the whole story.

The two systems together will deliver both the assurance that bad operations do not continue to operate, and will satisfy the buyer that the integrity of the food safety management system is in place for the good and best operations. I believe a scaling back of third party audits will generally take place and my role will change to more consulting and less auditing

I commend you and you organization for supporting food safety, and your sincerety. I was in Tifton Ga., with Kiley Harper (RC Hatton), for the meeting with FDA this spring and your industry was well represented and very well informed. Both Kiley and I were on the water safety panel and we addressed many of your concerns about water quality and how to measure it, but we certainly do not have all the answers. Most irrigation water systems I see have no problems meeting the LGMA standard, but we do not see a lot of foliar application of surface water here in Florida, either.

We do not have a definitive answer as you know, on what constitutes a good irrigation water test result; or at what level of bacterial indicator we should expect a pathogen, or more fundamentally, the best indicator. Only applied research over a long period can establish this in produce irrigation water, if at all.

On the up side, we are seeing a big improvement in produce borne outbreaks, not having a large scale domestic incident for quite some time (since peppers/tpmatoes).

Positive actions by you and your group are accomplishing much and food safety folks like myself appreciate what you are doing.

Thanks very much.


In Florida Health Inspectors Just Walk Around Kitchens

So now we have an idea what eliminating health inspections is all about in Florida. The republican congressman from Florida who chairs the House Health Care Appropriations Committee (vice chair), a Mr. Frishe, says he has gone through a kitchen before and thus is a qualified health inspector.
Further, Frishe sees no reason DCF and AHCA workers can't inspect kitchens and questions the need for a bachelor of science degree for food-service inspectors. "I've gone through kitchens before and I know what to look for," said Frishe.
Frishe also says, harshly, "A group (of legislators) would just love to dismantle the DOH," said Rep. James Frishe, R-St. Petersburg, vice chairman of the House Health Care Appropriations Committee. "That vote was to send a message." 
Thanks for your message. We get it, congressman, loud and clear. 
What an incredibly bad understanding about what it takes to ensure food safety and an arrogant and freaky demonstration of total ignorance.  Not to mention a complete disregard for public health and safety.
Whether you are a regulator or not, all food safety folks should monitor this ugly situation in Florida.
Again, a link to a good overview of the situation.

Political Pressure on Public Health Agencies‏

Please see the article from Bites, below, thanks again to Doug Powell at Kansas State.
Where are our US public health scientists when food safety/public health regulatory agencies get in a corner? They just do not show up on the scene to take a stand against the political pressure from industry. The US public health science community appears co-opted, fractured, isolated in thier institutions and totally oblivious to these challenges. US Public health scientists when they are interested in food get their grants and quietly do their research in less controversial areas such as diet, nutrition, and security and are basically not heard when it comes to food safety. They rarely provide credibility to the need for public health protection.
We saw this in Florida last month when the state legislature abolished public health protection programs for our most vulnerable populations, we saw no support for public health, not the media, the medical community, not the universities and its scientists, and not the consumer. It seems nobody is outraged when Florida nursing homes, childcare centers and hospitals lose public health protection programs. Our agencies over here are sitting ducks for the industry who uses their political fire power through lobbies to shoot them down, because food safety rules require effort and expense and interfere with business. 
Here in the UK, amazingly, we have a food industry trade group correcting the Guardian for supporting the de-regulation of the food industry and standing up for food safety! And a respected sceintist speaking out! 
Congratulations, at least they are putting up a fight.
UK: We will all be losers if the FSA is abolished
The Guardian
Melanie Leech, Director general, Food and Drink Federation, writes that contrary to your article (Victory for food firms as safety watchdog axed, 12 July), we understand that no decision has been made about the future of the Food Standards Agency. Your story claimed that food manufacturers had been lobbying to close down the FSA. However, as the voice of UK food and drink manufacturing, the Food and Drink Federation has consistently supported the need for an independent, well-funded food safety regulator. The FSA has been highly effective in this role in the 10 years since its creation, not least in ensuring that consumer confidence in the food we eat has grown significantly. Were its independent role to be abolished, neither the industry nor the consumers would be the winners.

Jon Poole, Chief executive, Institute of Food Science & Technology, writes the demise of the FSA would be regarded by many as a loss – including the food industry itself. The Institute of Food Science & Technology, an independent professional body, has seen the FSA working closely with the industry over the past few years. The adversarial style of relationship suggested in your reports is neither accurate nor helpful. During its existence, the FSA has provided coherent strategy and direction on issues such as reductions in saturated fat and salt and in food-borne diseases such as campylobacter in chicken, as well as regulating food business operators. These are all still live issues and the functions of the FSA, in whatever form, will continue to be needed in the future. Very few in the sector would see its break-up as a positive step.

Pig to Human H1N1

There has been speculation about the transmission of the swine flu virus, better known as H1N1 virus, from pigs to humans during animal raising or processing and the feeling now is NO according to WHO. USDA has not issued any kind of advisory about this potential when working with pigs and this novel strain is unlikely to be transmitted this way. With that said, with pigs in Canada recently identified as infected with H1N1 it would be a possibility that if pigs were infected the virus could contaminate the meat and thus provide a means of human infection. Handling could expose workers in that event, but normal cooking would make the meat safe for the consumer. Also, this Canada event seems to be an anomaly as the pig was likely infected by a human carrying H1N1 and not the other way.
At this moment it does not appear that H1N1 is moving at all through the pig population. Person to person spread is the real threat at this time. Culling herds such as in Egypt was not well-advised given that we have very scanty info that pig to human infection poses much of a risk, or any risk at all. Of course we do not know for sure what the future holds, but for now the risk is very low or non- existent for workers to become infected when in contact with pigs or from the pork supply in general. It does need close watching, however.


Anonymous Sanitation Complaint

I referred this “anonymous sanitation complainant” to the proper authorities in the jurisdiction in question. This message brings up some very interesting points:

1. Working conditions and health of employees and the duty of the employer

2. Attitudes about cleanliness

3. Motivation

4. Self esteem

5. Communications

6. Duty to the public

7. Duty to the firm


I don’t think the health department can fix all of these problems. 


REGARDING: My Compliant

PROBLEM: Everything is falling apart. Roaches are EVERYWHERE. The place has a very unclean atmosphere.

I have problems keeping myself in the mood to continue my employment there. But if anything, maybe this letter will find the right ears and maybe something can be done.

I'm not sure how much I've eaten from that restaurant, but now that I work there and have seen 1st hand the environment in which the food is subject to (roaches crawling on walls, floors, equipment; finding roaches in drink mixes) - the place is NASTY and I cannot find another job at the moment to get out of blank.


I request to be ANONYMOUS - If I can be entitled to some claim\suit after seeing how the food has been prepared and served in such an environment, food that I have eaten most recently, I feel I've been violated, my trust misplaced, my money wasted on food that is not of high quality.


Please let me know my options or what you or anyone else can do.

Produce Is Ripe for Regulation

Abstract: The safety of produce and its production has come under scrutiny as the results of repeated and serious outbreaks of foodborne illness. Environmental health standards for sanitation, personal hygiene, water, and soil quality during farming operations are now recognized as critical for the safety of produce. Public health and rregulatory initiatives targeting produce are underway in Florida, California, and other jurisdictions as a result of numerous outbreaks of E. coli O157:H7 and Salmonella. The California Senate last year approved three bills designed to implement tougher food safety rules for growers and handlers of spinach and other leafy greens. In addition, the California Department of Food and Agriculture (CDFA) is administering a voluntary California Leafy Greens Marketing Agreement (Marketing Agreement) requiring Good Agricultural Practices (GAP). Florida is regulating tomato safety through the Department of Agriculture and Consumer Services (DACS). Environmental health practitioners have many of the skills needed to address the challenge of regulating on-farm food safety. State public health agencies are applying public health protection programs to farms and  the role of the sanitarian/environmental health specialist is essential. 

Environmental Health on the Farm


The safety of produce depends on many environmental health factors from the farm to the consumer’s plate. For example, intensive farming of leafy green vegetables occurs in the Salinas Valley on the central coast of California. In this location, farms are subject to flooding from the polluted Salinas River and its tributaries. One major source of pollution in the basin is the surface water run off from the valley’s extensive cattle operations. In addition to polluted water, reservoirs of pathogens include workers, cattle, manure, and wildlife. Once produce is contaminated, pathogens are difficult to remove. Modern distribution and processing systems contribute to the rapid and wide dispersion of contamination if it occurs. There is also a high demand for fresh-cut (processed) produce at the retail level. High demand has increased the amount of processed produce in the marketplace and the numbers of people potentially exposed to farm pathogens. These factors, mostly related to the environment crops are grown in, are causing large and numerous outbreaks of foodborne illness. Experts now recognize the farm as a critical link in the safety of the nation’s food supply and environmental health professionals are now at work in this area.


Following environmental health standards in farming is a new concept. Traditionally, environmental health programs have not focused on produce safety on the farm, but legislatures are now  considering laws and rules to stop the spread of disease through produce, as they have done in the past with milk, seafood and meat. Environmental health programs at all levels must expand to confront the risks to public health posed by human health hazards originating in the farming environment.


Recent Produce Outbreaks


In 2006, produce-borne E coli O157:H7 in spinach and lettuce, and Salmonella in tomatoes, caused several well-publicized and serious outbreaks. In the spinach outbreak, contaminated produce eventually reached 26 states and caused over 200 cases and at least 3 deaths. California leafy greens caused a total of 22 reported outbreaks in the last 12 years, and the Salinas Valley was the source of produce in nine of them. The “Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Prepackaged Spinach”, released March 21, 2007, may be the first investigation to link a produce-borne pathogen to a specific US farm[1]. Close on the heels of the spinach outbreak, investigators traced California grown lettuce to 2 outbreaks E coli O157:H7 at two national taco chains. In 2008 the US experienced one of its worst outbreaks of salmonella through contaminated produce with both peppers and tomatoes associated with illnesses.


California’s Proposed Regulations and Voluntary Programs


California legislatures are seeking to make the California Department of Health the regulator of mandatory on-farm food safety under a series of bills sponsored by state Sen. Dean Florez[2]  A competing industry level program is already in place, and it is questionable whether the bills have strong industry support. The voluntary program is an industry effort supported by the California Department of Food and Agriculture (CDFA). Most of the largest produce growers in California this March signed on to the “California Leafy Greens Marketing Agreement” (Marketing Agreement) allowing the CDFA to conduct GAP (Good Agricultural Practices) inspections on farms, packinghouses and processing plants[3],[4]. With 99% of produce grown in California under the Marketing Agreement, and inspections and audits occurring, farms will more consistently apply Good Agricultural Practices. However, there is skepticism about the sufficiency of voluntary controls alone. If we experience another large outbreak with leafy greens, calls will undoubtedly arise again for public health agencies to intervene.


Weakness in the Buyer Driven Food Safety Model


FDA first published a “Draft Guidance for Industry; Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” in 1998, and in March of 2007 issued a “Final Draft” form[5]. The Guide met with general approval by agriculture, but compliance still remains “non-binding”. Industry at some level has adopted the guidance, but compliance is not uniform and we continue to see significant outbreaks involving fruits and vegetables. The FDA also published the “Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain.-1st Edition” in 2006[6]and a second edition in February of 2007. This guidance also lacks the force of regulations, and how well the supply chain follows FDA guidance is unknown. For these reasons, many feel there is a need for a specific body of rules that all must follow.


Because industry with or without mandatory rules must still supply a safe product, the produce industry has been operating a self-regulating “buyer-driven” food safety system. Although buyers value the safety of products, economic realities may limit the strength of this voluntary approach. There is no requirement for buyers to be so food safety conscious that they  constrict the supply of produce that they rely on, and price must always be a major factor in a buying decision.


Strengthening the Buyer Driven Food Safety Model through Regulation


In the absence of a regulatory presence, third party auditing firms together with management and the buyers themselves provide the oversight in the buyer-driven model. Third party auditors unlike their regulatory counterparts “inspectors”, do not approve suppliers, enforce standards or decide what products enter commerce. Third party audits provide an assessment of compliance with one of several voluntary food safety standards generally based on FDA guidance documents. While there is much interplay and coordination between the two sectors, third parties act independently of government.


The current trend is for  the major wholesale buyers, Albertsons, Wal-Mart, McDonalds, Publix Markets, and other large food retailers to request a third party audit of a produce supplier as a condition of approval. The model needs strengthening because while audits may be thorough and the audit findings comprehensive, as previously explained, buyers make decisions based on factors other than audit results. In the end, the final decision to select or reject a produce supplier rests with the buyer and his needs at the time. Buyers evaluate audit criteria, but also base decisions partly on quality, quantity, and the economics of supply and demand. A complimentary regulatory program would strengthen this model.


While it seems logical that the federal government should administer the program, the State Departments of Health or Agriculture are in a better position than federal agencies to regulate produce. FDA reports it cannot move swiftly enough to meet the current challenges in regulating the nation’s produce supply and questions whether its own regulations will work (7). USDA currently does not have any jurisdiction over on-farm food safety, and experts agree that federal laws would take years to put into place.


Proposed Mandatory State Rules-“The California Produce Safety Action Plan”


In February, 2007, California Senator Dean Florez, introduced “The California Produce Safety Action Plan”, a package of senate bills designed to bring mandatory rules to California produce growing operations for the first time. These bills are in response to the deadly E. coli O157:H7 outbreaks that have hurt the leafy green industry in California. “After 22 E. coli outbreaks associated with leafy greens, we know that market forces have not been strong enough to bring reform to the leafy green industry”, Florez said, during his remarks to the California senate. “For years” he explained, “the federal government through the FDA has been left to writing open letters practically begging the industry to act. None of it has worked” he added, “it’s time that government does its job.”  While these bills met with opposition and are struggling to move forward, the structure of the bills provides valuable insight into how environmental health regulations can be structured.


Bills introduced by Sen. Flores in California

SB 200

The first bill, SB 200, allows the California Department of Health Services (DHS) the authority to effectively manage and protect the public safety in the event of an E. coli outbreak. It includes the authority to-

• Quarantine
• Recall, and
• Destroy infected produce

SB 200 also creates the Leafy Green Inspection Program at DHS. Inspectors will inspect farms under this program. DHS inspectors will have the authority to conduct their own investigations and take action to protect public health, including the quarantine of produce.

SB 201

SB 201 mandates the application of GAP. DHS will act as the gatekeeper and create regulations for the industry to follow.

SB 201 also requires DHS to develop Hazard Analysis and Critical Control Point Plans (HACCP) systems for leafy greens and requires growers to develop a plan for each growing location and to keep records.

SB 202

SB 202 requires the creation of a trace-back system. This system will require product coding to identify the source of the product all the way to the specific farm where it was grown.


Produce Inspection Duties


If such rules come into practice the regulator tasked with seeking compliance must acquire a high level skill specific to farming operations. The regulator must validate the management controls in place, verify the effectiveness of GAP application, and  be able to identify or estimate levels of contamination.


The roles of the inspector would include auditing records, making visual inspections, ensuring farmers meet GAP standards, and performing tests. Specific duties might include:


·           Testing of water

·           Testing of soil

·           Testing of produce

·           Prohibiting use of raw manure

·           Prohibiting the use of creek water for irrigation

·           Prohibiting the use of portable toilets in the fields themselves

·           Maintaining buffer zones around various hazards

·           Overseeing composting operations

·           Approving grazing land set backs

·           Septic tank installation approval

·           Evaluating Concentrated Animal Feeding Operations (CAFO) set backs

·           Testing water sources (ponds / creeks / lakes / rivers, etc.)

·           Validating recall procedures

·           Verifying trace back and trace forward systems


Florida Tomato Initiative


In Florida, enforceable standards are required in the tomato industry. Florida tomato growers successfully asked our state legislature for regulation. Under Florida Administrative Rule 5Q-6 these measures and inspections will begin this fall. "We want mandatory inspections to bring everybody that handles tomatoes in the state in the loop to comply with food safety," said Tony DiMare, vice president of Homestead-based DiMare companies, one of the state's largest tomato growers in a story published recently in the Palm Beach Post[7]. "We wanted to take a proactive approach and stay ahead of the curve". The importance of this initiative is underscored by the fact that although Florida was not shipping tomatoes during the early outbreak of this year, the Florida tomato industry lost millions due to fears of  potential contamination


The law takes effect before the fall planting season and is under the auspices of inspectors with the State of Florida Department of Agriculture and Consumer Services.. While the largest tomato operations in the state see the advantage of regulation, many of the small and mid-sized growers will feel a serious impact due to new rules covering mandatory washing and temperature controls for products.


Environmental Professionals and Produce Regulations


Environmental health professionals have experience in most key areas important to produce safety. New regulations will require regulators to quickly assimilate knowledge about GAP and apply the principles of GAP to their inspection duties. The FDA guidance documents are a good place to start assimilating knowledge but understanding how the industry applies GAP will take some experience. Determining a grower’s compliance with GAP requires familiarity with Hazard Analysis Critical Control Point (HACCP), especially the process of validating and verifying HACCP systems at all levels of the produce supply chain. The produce industry is actively applying HACCP to growing, harvesting, packing and processing.


Regulators will evaluate and interpret microbial data. To assess the effectiveness of on-farm food safety programs regulators need working knowledge of basic microbiological sampling methods and testing procedures for products, water and soil. Sanitarians will also need to stay aware of current research and emerging scientific findings. They will take on the job of assisting in mitigation of microbiological hazards and need an understanding of how pathogens contaminate produce and how to assess risks. To ensure their own efforts are successful, regulators must base regulatory decisions on sound scientific evidence.


Throughout the history of public health, sanitarians have played an important part in food protection. With experience in so many key areas, environmental health professionals will undoubtedly make a valuable contribution to on-farm-food-safety through regulation. Public health regulation will enhance what the produce industry is doing now, improve its food safety record, and restore consumer confidence in a healthful and safe produce supply.



[1] “Investigation of an Escherichia coli O157:H7 Associated with Dole Prepackaged Spinach” California Department of Food and Agriculture. US Food and Drug Administration.

[2] “Food Safety Bills Face First Legislative Test“. Dean Florez. California State Senate.

[3] “California Leafy Greens Marketing Agreement“. California Department of Food and Agriculture.

[4] “Assessments Begin for Leafy Greens Marketing Agreement“ News Release. California Department of Food and Agriculture.. April 2, 2007.

[5] “Guidance for Industry; Guide to Minimize Microbial Food Safety Hazards of
Fresh-cut Fruits and Vegetables“: US Food and Drug Administration. Draft Final Guidance. March 2007.

[6] “Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain.-1st Edition“. Produce Industry Publication. April 26, 2006.

[7] “FDAConsiders Safety Guidelines for Produce” CNBNC report

8-Tomato Growers Push for Regulation“. The Palm Beach Post. April 2, 2007.


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Who Owns Food Safety?

Who Owns Public Health Protection?

In an ideal world, the government would have the capacity, resources and determination to ensure public health and safety and government would essentially own food safety as one of its key initiatives, controlling the food industry through laws administered by public health agents of the government. This is the way it was for many years. In the very recent past, when the US food supply seemed “the safest in the world” there was little private sector involvement in food safety and the private practice of food safety served mainly as reinforcement for the strong position held by government. Such industry level efforts did not compete with government for “market share” or a piece of government food safety programs.

Today, our governmental agencies entrusted with public health, FDA and USDA, often lack the authority and political strength needed to address new problems of many types related to the health and safety of the populace. While Americans seem to take their public health protection for granted, when it comes to food safety, our governmental agencies have backed away from their responsibility and have relinquished some of their “ownership” over food safety and public health protection to the private sector. There are consequences , some good and some not that we must understand.

Government Disengagement Creates a Vacuum

There are many reasons for apathy on the part of government, but the fact remains that government’s ineffectiveness to protect the public has created a vacuum, and other stakeholders have come forward to fill in the vacuum. This vacuum is being filled by a variety of food safety stakeholders with a profit motive, including private companies of all types (e.g., Environ Health Associates), academia, and research groups and others. This has given rise to a new sector of the food industry the  “for profit food safety products and services industry”. In this relatively new arena, we have various players competing with government for ownership of some part of food safety. Competitors include many types of food service providers (pest control companies, chemical suppliers, lab services, auditing firms, training agencies and programs), professional associations, certification bodies, consulting firms, law firms, and others. All would  would like to lay claim to a share of the lucrative food safety market.

While the unmet needs of the industry and the demand for food safety are the basis for the demand for products and services, the inevitable market forces inherent in any industry model are shaping the field of food safety in subtle yet significant ways. While government attempts to hang on to a leadership position, there are many who claim ownership of parts of the food safety model reserved in the very recent past to government and who approach food safety from a business standpoint.

Who are the Owners of Food Safety Training?

Currently, there are several groups who claim a market share in food safety training. For example, The National Restaurant Association-NRA is a dominant player in the restaurant, food-safety-training market. As a case in point, the Florida Restaurant and Lodging Association-FRLA has over the last ten years fostered strong political connections to Florida’s regulatory agencies and now enjoys a close relationship with the Florida Department of Business Regulation-DBPR, a state agency. 

Influenced by the FRLA lobby, DBPR chose FRLA as the preferred provider of restaurant, employee-food-safety training materials in the state. This is has been a windfall for FRLA and its sales figures are in the millions every year. FRLA now controls easily 90% of the food-safety training market in Florida where there are at least 50,000 mangers and 500,000 employees needing training.. NRA fosters similar relationships in many states, making NRA’s particular brand of training “ServSafe” virtual law in many locations. Such sales provide a sizeable cash flow to NRA and its state affiliates. NRA ands its affiliates use these funds primarily to lobby legislatures on behalf of the industry, not consumers.

Who Owns Food Safety Training in Seafood? 

We see professional associations such as The Seafood HACCP Alliance, with another approach to food-safety training-market "ownership". The Seafood HACCP Alliance through its relationship with the Association of Food and Drug Officials (AFDO) has influenced the required training of all seafood processors. Now, only those trainers sanctioned by AFDO and taking and approved AFDO accredited course (the only approved one, being owned by the Seafood HACCP Alliance, and rarely offered) are FDA approved to give courses. These required courses provide a significant source of revenue to private, AFDO trainers. It is not clear exactly if or how AFDO benefits, but one can see a potential problem for governmental officials who belong to AFDO advocating AFDO as the sole approved source of training.

Who Owns Food Safety Training in the Meat Industry?

At the level of the manufacturing of meat, food safety training must meet the requirements of the International HACCP Alliance at Texas A&M in order to have validity with USDA. Any training considered “valid” training must now pass through the HACCP Alliance, and is subject to fees and review. We can see a similar sort of problem here for USDA in terms of creating a monopoly for the HACCP Alliance. 

Who Owns Food Safety Auditing?

A similar example exists in auditing for compliance with so-called voluntary standards. The Food Marketing Institute FMI, the self-proclaimed voice of the multi-billion dollar food industry, recently entered the food safety-auditing sector in the US. Through its influence over buyers and the retail distribution chain, FMI’s brand of food safety auditing is trying to become the standard by which the entire food production chain self -regulates its own sanitation programs. While the program may have ultimate benefits for consumers, there is a lucrative monopoly position developing for FMI similar to that owned by NRA in restaurants. While there are many competing standards, FMI’s SQF (Safe Quality Foods) standard was recently endorsed by Wal-Mart, the worlds largest retailer. Suppliers to Wal-Mart are feeling pressure to adopt this standard while FMI is driving significant income to itself. FMI is a powerful political lobbying/marketing group that has the best interests of its members, and not necessarily consumers as its core mission. 

Who Owns International Food Safety?

There are examples of ownership at the international level of food safety, where groups like ISO, the International Standards Organization have put pressure on international regulators to adopt standards based on the work of this group; ISO standards are proprietary and owned by this non-governmental organization. While ISO has a very strong consumer focus, the effort is a business proposition as well as a food safety concept.

Who Owns Food Safety Research? 

In the background are the researchers at the National Institutes of Health and their counterparts; academicians who receive extensive research grants, and who claim ownership to the scientific basis for food safety. The budget for food safety research through NIH grants is in the millions each year. Their ownership of food safety research is ownership over a key segment of the market because it is this body of research that drives legislation and the validity of food safety systems across all segments. While our government spends billions on research, the food industry is very slow to adopt new technology. NIH research has produced a great deal of theoretical knowledge but the public has seen very little added protection from foodborne pathogens from new innovations developed and knowledge gained through research.

Who Really Owns Food Safety?

The reality is that a forgotten group of stakeholders actually owns food safety-and it is we… consumers collectively. The consumer through his buying power and voting power is truly the rightful owner of food safety. Several groups such as the Partnership for Food Safety Education, and Centers for Science in the Public Interest-CSPI have recognized this, yet no consumer level group has been able to unite consumers to affect the changes needed in the current food safety model for the exclusive benefit of consumers. While we as consumers hold the real power in food safety, we are often misinformed and remain mostly disengaged from food safety policies. We do not see the advantage we actually have. There is nothing wrong with educational messages from the Partnership teaching consumers how to safely cook or clean, but ultimately, the real power consumers have to protect themselves is at the voting booth and at the supermarket and not in the kitchen. 

The reality is that there is no “market”, no “profit motive” to motivate stakeholders to organize consumers and properly mobilize them. We have a few creditable grassroots activists and consumer groups whose voices the public hears faintly over the din of industry propaganda and government messages. We can find worlds of information from government agencies on their websites, but our government currently has no plans for any organized consumer education scheme. As in everything governmental these days, there is not enough resources, and a serious lack of leadership preventing government from maintaining an effective consumer protection effort or even attempting a meaningful campaign to educate consumers. 

Law firms are now leaders in the food industry, thanks to the failures of public health protection. The hundreds of millions of dollars in lawsuit settlements and judgments paid to consumers who have been injured provide law firms specializing in this area with leverage to influence industry food safety policies and practices in a positive way. Yet, it is really the consumers the attorneys represent that have the most power for meaningful change, not the law firms themselves. 

If trends hold, eventually we may have a very serious mass foodborne illness outbreak affecting consumer in a way not seen before. Thousands of cases of serious infections have occurred over the last few years, some with life threatening hemorrhagic colitis associated with contaminated produce and meat.  Some far more serious illnesses related to food wait patently in the wings to emerge, or re-emerge as serious threats. 

Eventually, the voting/buying public will awaken to the fact that the industry acting in its own best interest will not provide them the protection they expect. Consumers must demand that their government first does whatever is necessary to protect them as a bottom-line responsibility.

Consumers rightly own food safety because we pay for all the interventions government and industry invoke when we purchase food or pay our taxes. Therefore as owners, consumers need to have an influence in the way industry goes about public health protection. If government elects to essentially delegate some of its public health protection responsibilities to industry, than consumers have a right to know what industry is doing to protect them and to have a much greater say in the matter.

As consumers and owners of food safety we have the power to demand that our government effectively protects our health and welfare, to demand that our elected and appointed officials exert real power over those who produce our food, and to require the food industry to maintain transparency.