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The Importance of a Well-structured HACCP Team in Combating Food Safety Problems

The Science and Witchcraft of Food Microbiology

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Product Recall Management Recommendations Unveiled in New Joint Industry Report

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The Importance of a Well-structured HACCP Team in Combating Food Safety Problems

Abdulwahed Kassim Mohammed

Both the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) of the United Nations (UN) support the continual development of national policies to improve food safety and quality with the overall objective of protecting consumer health and furthering economic development.[1]
 
Although foodborne illnesses are a common occurrence, there is no effective surveillance mechanism in place. Thus, in the absence of such data, realistic risk assessment is difficult to carry out; additionally, consumer perception of foodborne illness risk is very low indeed. Unless this is corrected, there will never be complete acceptance of any food safety management system. 
 
The industry has been trying to develop systems that could assure practical assurance for food to be safe enough for human consumption. In the early days of the Hazard Analysis and Critical Control Points (HACCP) concept, NASA and Pillsbury came together in the late 1960s to work out a safety system to protect astronauts from food poisoning and foodborne infections. HACCP was initially developed as a means to obtain increased confidence over the microbiological safety of foods used in the space program.
 
In the 1970s, except for the low-acid canned foods industry and large corporations, HACCP was not widely adopted into daily food operations. The HACCP system as we know it today took form at the 1971 National Conference on Food Protection. The first comprehensive treatise on HACCP was published in 1973 by the Pillsbury Company. During the 1980s, the concept evolved and gained acceptance throughout the world.
 
The HACCP concept was endorsed by the WHO/FAO as an effective way of controlling foodborne disease in 1983 when the Joint FAO/WHO Expert Committee on Food Safety advised that HACCP should replace the traditional end-product testing approach to food safety assurance. In 1985, the HACCP system was recommended by the National Academy of Sciences (NAS).
 
On November 28, 1989, the National Advisory Committee on Microbiological Criteria for Food (NACMCF) gave final approval to its first major document, “Hazard Analysis and Critical Control System,” which was forwarded to the cabinet secretaries of the Department of Agriculture, Health and Human Services, Commerce, and Defense.
 
In the 1990s, HACCP re-emerged as the primary approach to assure the safety of the food supply. Since then, there have been considerable efforts to harmonize the use of HACCP from national and international institutions to manage food safety hazards in the food industry worldwide.
 
In early 1992, the NACMCF updated the original 1989 HACCP system document, which evolved as the standard for HACCP development in the United States. The NACMCF completed its revision of the 1992 system and approved the new version on August 14, 1997,[2] which is similar to the recently adopted UN/FAO Codex Alimentarius HACCP system, which was adopted in June 1997.
 
There is a consensus among the world’s food organizations that HACCP can be the best approach to manage significant food safety hazards; however, what is most important is to have an effective HACCP team. This is one of the major factors that needs to be addressed very carefully; that’s why assembling the HACCP team is the first recommended step in the logical sequence for application of the HACCP format recommended by Codex AlimentariusCommission (CAC)
 
Teamwork
Since it is the responsibility of the food industry to develop and implement HACCP plans and for regulatory agencies to facilitate this process according to the NACMCF, food processors have to be wary when selecting or making up their team.
 
In general, there are many models/theories for teamwork, and this is just one of the models that have set some rules for teamwork in order to be effective:
 
            Identify a leader.
            Meet regularly.
            Respect others: agree to disagree.
            Listen to one another.
            Be open to constructive criticism.
            Be honest.
            Know respective abilities and limitations.
            Understand respective roles and responsibilities.
 
A team is a small number of people with complementary skills who are committed to a common purpose, performance goals and approach for which they are mutually accountable.
 
Recognizing that teams often serve a variety of constituents, many models in the organizational literature propose a multifaceted approach to team effectiveness, capturing features of healthy internal functioning, such as team process, conflict, communication or motivation and indicators of team effectiveness gathered from sources external to the team including customer satisfaction, innovation, market share or external reputation.
 
The data gleaned from the research, which was designed to explore the interrelationship between team diversity and task complexity in terms of its impact on performance, support the hypotheses that the diversity is beneficial in teams with high complex tasks and detrimental in teams with less complex tasks.  
 
Bringing a cross-functional perspective to organizational problems helps build understanding, problem-solving capabilities, coordination, communication and, ultimately, improved quality and productivity.
 
HACCP and Teamwork
Complexity of the Production Process
Food production processes differ in many ways, for example, the number of process steps, specificity of production processes and the heterogeneity of raw materials due to seasonal harvesting and natural variation. This diversity is called the complexity of the production process. This complexity causes variation during manufacturing, which makes demands on quality management to control food production quality.
 
Additionally, operation and design of production processes differ. For example, the ratio between batch and continuous processes affect quality management activities. Also, the number of closed and open processes differs, affecting risks and actions during production. Automatic and manual operations also influence risks, speed and actions of the production process. Therefore, the complexity of the production process is expected to affect performance of quality management and/or production quality. The diversity of food production processes may explain why food quality systems differ in the realized production quality.
 
HACCP is focused on the primary process and aims to assure the production of safe food products by identifying and controlling the critical production steps.
 
The team-based approach to problem solving, with involvement across the whole organization, is an explicit part of the HACCP system irrespective of company size. This approach, of utilizing fully the human resources across the company to develop solutions through teams, can offer a powerful guide to future action in other areas of the business operation.
 
A HACCP team is the group of people who are responsible for developing, implementing and maintaining the HACCP system.[2] A HACCP team should include operations supervisors and line operators, quality control staff and persons from departments, such as purchasing, receiving and distribution. Further, HACCP is a team approach that involves all members of the staff in food safety.
 
However, based on all guidance, we conclude that to have a successful HACCP plan, you need to have a multidisciplinary and inter-hierarchical team.
 
There have been a few studies conducted in this context about HACCP teams across food factories that recommended that the HACCP team should be multidisciplinary and consist of individuals with the appropriate technical skills and expertise about the products and processes.[e.g., 3, 4]
 
HACCP Team as Inter-hierarchical
As the HACCP team should be multidisciplinary, it also needs to be inter-hierarchical. Multidisciplinary represents the breadth/horizontal aspect of the organization, which mainly refers to differing knowledge and expertise, while inter-hierarchical refers to the length/vertical side of the organization represented by differing positions.
 
Study Results
From the results obtained, current research has revealed the most positive experiences of the HACCP team and the difficulties encountered by the teams are as follows:
 
1. Positive experiences gained, related specifically to teams
            Members’ knowledge improved
            Members’ awareness and commitment increased
            Employees performance improved
 
2. Other positive findings gained from HACCP in general
            Business improved
            Business secured
            Management improved
            Compliance with the legislation 
            Healthy working environment emerged
 
3. Negative experiences that relate specifically to teams
            The starting steps were a challenge
            Lack of time 
            Lack of space was an obstacle for conducting HACCP
 
4. Negative experiences that relate to HACCP in general
            Financial difficulties
            HACCP as distortion
            HACCP as a controversy 
 
Conclusion
The primary purpose of this article was to explore the composition of HACCP teams and to what extent they have been built up as multidisciplinary and inter-hierarchical entities, taking into consideration the ultimate goal of beneficial and invaluable HACCP implementation to produce safe food.
 
The above findings clearly illustrate the advantages of assembling a team that is beneficial to the team individuals themselves, which in turn has a positive influence on the HACCP system in general.
 
Multidisciplinary as well as inter-hierarchical approaches appear to be invaluable for an effective HACCP team to implement and maintain HACCP to produce safe products.

Abdulwahed Kassim Mohammed is the Food Inspection Health Officer and HACCP Auditor, Dubai Municipality, Dubai, United Arab Emirates. He has a M.Sc. in HACCP from The University of Salford, Greater Manchester, UK and a B.Sc. in Food Science and Technology from Baghdad University, Iraq. Questions about the studies alluded to in the article can be addressed to the author at foodinprogress@gmail.com.

References 1. www.who.int/foodsafety/publications/fs_management/HACCP_SLDB.pdf.
2. NACMCF. 1997. Hazard Analysis and Critical Control Point Principles and Application Guidelines. National Advisory Committee on Microbiological Criteria for Foods.
3. Azanza, M.P.V. and M.B.V. Zamora-Luna. 2005. Barriers of HACCP team members to guideline adherence. Food Control 16:15-22.
4. Kassim, A. 2008. Exploring HACCP teams across the Dubai Food Industry. Thesis, Salford University, UK.

 

 

The Science and Witchcraft of Food Microbiology

By Cliff Coles

We have certainly had our fill of the headlines reporting on the dangers in our food supply; about the recall of 143 million pounds of beef, reports questioning the safety of the food supply and the need for more regulatory oversight in the food industry. I want to take a minute and go back to look at the headlines from almost 30 years ago. Ironically, these headlines have not changed very much with respect to the food industry.
 
While the country was caught up in the Tylenol extortion poisonings in 1982, the San Francisco Chronicle reported that a “new disease” had been linked to McDonald’s hamburgers. In fact, this report caused McDonalds to cease trading on the stock exchange for 1 day. Forty-seven cases of the disease were traced to outlets in Oregon and Michigan. Twenty-one additional cases were traced to other fast food restaurants and meat cooked at home. Gina Kolata of the Contra Costa Times reported on the history and epidemiology of the new disease. The outbreaks actually began in White City, a town on the border with California and Oregon, where a dozen people were stricken 1 week in December 1981. Patients described symptoms that lasted for days as pains that were like having hot metal placed in their abdomens and described as worse than labor pains by the women affected by the illness. Medical professionals could not isolate the cause from the ‘then’ list of suspected pathogens. In fact, it was not clear whether the outbreak was chemically induced or caused by a virus. Epidemiological work conducted by Dr. Lee Riley of the Centers for Disease Control and Prevention (CDC) suggested that the common link was McDonalds, but he also surmised that he was dealing with something new. The association with McDonalds might have been purely coincidental, but if there was a connection, the question remained as to the vehicle that caused the illnesses. While Dr. Riley worked on the cases in Oregon, another outbreak occurred in Michigan in May 1982, and again the common link appeared to be food served at McDonalds. Dr. Joy Wells, working simultaneously on the disease outbreaks, noticed that stool samples from nine of the 12 patients that were obtained at the onset of the illness contained a type of E. coli designated as O157:H7. The investigators were leery about any E. coli being able to cause that kind of reaction, let alone a variant that could survive the heating that the hamburgers were supposed to be subjected to at McDonalds’ outlets.
 
As it would turn out in July 1982, the meat grinding facility that supplied McDonalds in Michigan had retain samples of beef from the suspect lot. Researchers found the same strain of E. coli O157:H7 in the meat as that isolated from the patients’ stool specimens. This finding provided a direct link between the raw material used by McDonalds and the other outlets that were linked to the outbreaks. Fortunately, there were no deaths in any of these outbreaks.
 
A Great Mystery
It was initially thought that this particular strain was very common and it was only a coincidence that it was in the patients’ stools and retained meat samples. After a search of the available database of 3,000 E. coli cultures maintained at the CDC in 1982, only one E. coli O157:H7 had been isolated in 1975 from a 50-year old California woman. The woman was a naval officer based in Oakland, CA whose job description included international travel. From her medical records, the researchers established that she also had bloody diarrhea and the same strain of E. coli in her stool specimens. To the researchers, this finding confirmed that there was a new strain of E. coli that could not only get into food but could make people seriously ill. But how and why these bacteria act so virulently was left for other outbreaks to establish.
 
As other outbreaks occurred, the ferocity and overall resistance of the new E. coli O157:H7 organism became clearer. Outbreaks continued to plague the fast food industry with the Jack in the Box outbreak in 1993, fermented dry salami made with pork and beef in December 1994 and Odwalla Apple Juice in November 1996. The Odwalla and salami outbreaks established that the danger was no longer limited to hamburger. In fact, unpasteurized milk, cantaloupe, lettuce and vegetables grown in manure have all been linked to other outbreaks of O157:H7. Outbreaks occurred in public swimming pools where human fecal material contaminated the pool water system and at petting zoos. According to Dr. Janet Mohle-Boetani of the Infectious Diseases Branch of the California Department of Public Health, there have been 19 outbreaks of E. coli 0157:H7 linked to leafy greens since 1995 traced to contaminated irrigation water, improperly composted manure and direct contact with feces of cattle and other livestock.
 
As the research continued into the origins of E. coli O157:H7 and of how the rogue organism acquired a toxicity normally found in Shigella, Dr. Alison O’Brien from the Health Sciences University in Bethesda, MD reasoned that the normally benign E. coli had somehow picked up the gene that causes the bacteria to make the Shigella toxin. If this were the case, Dr. O’Brien believed that the new E. coli was now armed with likely the third most dangerous bacterial toxin known, right after tetanus and botulism. While her suspicions did confirm the presence of the Shigella gene, it was genetically altered so that it was now even more deadly than the Shigella toxin.
 
It remains a question as to how the genetic transference was made, but there has been a very sound educated guess. As it turns out, bacteria themselves can be infected with viruses (phages), which sometimes pick up the genes of their previous host and carry it into their new host. However, the strains of Shigella normally found in the U.S. did not have the same potent toxin found in E. coli O157:H7. However, the Shigella normally isolated in Central America did! In 1970, Central America experienced a pandemic of Shigella dysentery. It is theorized that as the toxic Shigella from this outbreak mixed with the harmless E. coli in the victims’ intestines or with harmless E. coli that inhabited animal manure, a virus may have carried the Shigella toxin genes into the E. coli. This new E. coli variant was now able to cause catastrophic illness in susceptible persons with an infectious dose of fewer than 10 organisms. In addition, it was able to withstand acidic environments, such as found in apple cider, commercial mayonnaise and the gastrointestinal tract of humans and rumen animals. It was also suspected that the navel officer from Oakland had been to Central America just after the outbreaks began there.
 
More Intrigue
Moving forward, a Situation Report in 1998 authored by the National Food Processors Association and Campden & Chorleywood Food Research Association would turn out to be extremely prophetic. The report indicated that verocytotoxin-producing E. coli (VTEC) in the United Kingdom accounted for a 5% mortality rate in patients with VTEC-hemolytic-urenic syndrome (HUS). The report went onto identify June through August as the peak months of sporadic E. coli O157:H7 cases in the U.S. The report reiterated that ready-to eat products containing the O157:H7 organism would be considered adulterated by regulatory authorities. The report did not receive the attention it deserved.
 
Let me be clear that recalls are not limited to E. coli O157:H7 by any means, and the outbreaks are not just occurring in the U.S. TheNew Era Canning Company was forced to recall products manufactured over the past 5 years due to the potential for Clostridium botulinum contamination in canned foods produced in a crateless retort system, even though there were no reports of illness. Parmesan & Asiago Dip with Garlic and Basil made in California was recently recalled for the potential of C. botulinum in the products. Outbreaks for Salmonella and every other pathogen have shared the headlines for various products at various times. In August 1996, E. coli O157:H7 was linked to 9,000 illness and eight deaths caused by radish sprouts in Japan. One Japanese city alone had 6,500 citizens affected by the outbreak. As we are well aware, our own spinach outbreak occurred 10 years later in August 2006. 
 
Are there commonalities to each of the recalls? How does the connection between the food and an outbreak take place? What impact does the recall have on consumers and the industry overall and what does it mean to the management of the company?
 
The U.S. Food and Drug Administration (FDA) held a Webinar on February 11, 2008 that identified the Agency’s concerns and issues related to the canning industry. The FDA outlined their top 10 reasons for 483 citations across all categories associated with CFR121. Granted the issues were directed more to the canning industry, there were commonalities that apply to the entire food industry. Sixteen percent of the citations were due to the failure of the reviewer to sign/date production records. Fifteen percent of the citations were due to the failure of a review of the process records by a qualified member of the plant management, and 6.7% were due to the forms being used failing to identify the critical factors of what was being recorded. When the FDA examined the reasons for 483 citations for process deviations, 41% of the issues were due to the failure to identify the critical factors when they were out of control, 12% were due to no documented corrective actions, and 9% were due to the failure to evaluate the deviation for public health significance. In other words, the companies were failing to follow regulations and their own food safety plans. I can personally attest that these issues are very common in our industry, and I have personally been in meetings where top management has casually dismissed them.
 
What Can Be Done?
Where do you start? Its overwhelming to have a microbiological testing program, a Hazard Analysis and Critical Control Points (HACCP) program, a crisis management program and a recall program, let alone worrying about improperly filled out paperwork.
 
I believe that the common link to the recalls is the failure on behalf of management to have a committed, cohesive, documented set of basic programs in place. These programs must not only be documented and implemented, management must make sure that they are maintained and evaluated on a regular basis. The programs that need to be in place can only be implemented after a sound risk assessment of the products, processes and controls have been conducted at the appropriate management level. The need to identify where hazards could be introduced at each step of the process cannot be over-emphasized. This is a three-part operation: (a) what are the risks, (b) what is the assessment of the severity of the risk(s) and (c) how do we analyze the risk control measures. Risk is the probability and severity of loss from exposure to the hazard. Assessment is the application of quantitative or qualitative measures to determine the level of risk associated with a specific hazard. The process defines the probability and severity of an event. Severity can range from catastrophic to negligible, and probabilities can range from frequent to unlikely. Industry should never take a risk if the overall costs of the risk exceed its benefits to food safety.
 
Let us start with microbiological testing. First and foremost, what are you testing for, what are we going to test and how much of that something we are going to test? Once we figure out from our risk assessments what microorganisms are of concern, we need to design a statistically sound testing program. One of the reasons that HACCP came about was that the developers of the program, NASA, Natick and Pillsbury, determined that they simply had to test too much product to ensure safety. For example, the International Commission of Microbiological Specifications for Foods (ICMSF) has published a series of sampling plans for pathogen testing. However, we are still faced with what we will define as ‘a lot’ of product. Classically, it can be defined by an arbitrary time period, a number of inbound pounds, containers, pallets, etc. In any case, the definition of ‘a lot’ must be statistically sound. Criteria using the presence or absence testing of products for specific organisms, such as Salmonella or E. coli O157:H7, are based on a two-class sampling plan, and, in general, the plans require that no target organism can be detected in a given quantity of each of several sample units. While legal counsel and the FDA will never want to hear or even care what the testing costs you, make no mistake that cost is a factor in all testing; however, return on investment must be considered also. The sense of having a safe product on the market and, more importantly, having the markers in place to provide an early alert to a possible serious situation before it goes into the market are invaluable. If the methodology being used can be shown not to lose sensitivity by composite sampling, the cost of testing can be significantly reduced. The sampling plan must consider the amount of samples in a lot for analysis. Two primary considerations must be understood before sample compositing is to be considered.[1] First, any result that can be classified based on the presence or absence of something will be governed by the binomial distribution, and no matter how many samples are tested with negative results, the samples can never be unequivocally stated that the lot from which they were drawn is totally free of contamination with the target organism. Secondly, the typical application of the binomial distribution is predicated on the assumption that the target organisms will be distributed homogeneously throughout the sample and that there is equal opportunity for any sample unit to contain the target organism. However, in the real world, such even distributions of low numbers of pathogenic organisms in food products are a rare occurrence. If the sample fails to contain the target microorganism, the test will always be negative. Also, be aware that by compositing, a now positive sample involves more product that needed. This is especially true for products such as ground beef. Studies have clearly shown that pathogens, such as E. coli O157:H7 are not uniformly distributed. If one is dealing with fluid products, such as milk or juice, distribution is much more uniform.
 
Enter Witchcraft: The Unknown
So now we ask, “If the testing I just spent money on cannot reliably detect organisms without a horrendous amount of samples, what is the use in running the tests?” That is where witchcraft enters into the equation. The microbiological test methods we use for analysis must match the organism for which we are testing, meet the needs of production, provide reliable results in a timely manner to allow ample time left on the product’s shelf life and fulfill the needs of our risk assessment. For example, 20 years ago, Listeria monocytogenes was not considered to be a significant pathogen, in part because the pre-enrichment process was done at cold temperatures over a 2-week period. With fresh or ready-to-eat products, they would be off the shelves by the time results were obtained. There are reliable rapid tests that can provide 12–24 hour turn around on samples, provided they are negative.
 
For any of you over 40, please keep in mind that the microbiology that you studied in school is NOT the microbiology being used today. Rapid, finite genetic testing is being conducted in laboratories. Now, a laboratory can obtain a genetic fingerprint of the bacteria isolated from your sample to compare against known pathogens in hours. Positive results will usually require more time to confirm the organism if necessary. Many companies will simply chose to dump the product based on presumptive positive results. The program that tests finished product as the only means of assuring safety is contrary to the philosophy of HACCP; a sound program will address raw materials as well as finished goods. Having a microbiological hold-and-release program in place is a consideration that needs to be discussed. Hold and release is becoming inevitable due to regulatory pressures, consumer expectations and customer requirements. Strong consideration needs to be given to a test-and-hold program for both inbound raw material and the outbound finished product. Test and hold is common throughout the food industry, and while it definitely presents challenges to the produce industry, it is being successfully implemented, even if it runs contrary to HACCP principles.
 
In the absence of any microbiological test-and-hold program, the producer has no choice but to conduct a recall when faced with contamination issues. By not defining a sound lot designation, all product that has been produced is now subject to the recall order. This is one reason why many companies define lots based on a set time period (1 to 2 hours) rather than on a full 8-hour shift or a day’s pack. One or 2 hours of suspect product are much easier to deal with than a full day’s worth or longer of product.
 
And then HACCP
A company that neither has a sound HACCP program nor a program that identifies everything in the process as a CCP is doomed to failure. The HACCP program must be a functioning document, not one that is put together to satisfy the customer. I have seen HACCP programs that have been well developed and those that have had no idea of the concept of HACCP. If you go into a plant and find that the HACCP plan is sitting on the manager’s shelf and covered with dust, you can assume that the latter is the case with that plant. For historical purposes, HACCP was developed to allow space missions to go forward by reducing the risk of foodborne illness. We needed a plan to reliably test the food and drink (a) to feed the astronauts and (b) without testing every package. By assessing the risk at every step in the process from the raw material received to the packaging material used to the finished product distributed, a well-designed HACCP plan will identify the ‘red flags’ that every process has in place.
 
Finally, with all the talk of recalls, the company that fails to have an adequate documented recall program in place may ultimately learn the hard way, the hard way being an actual recall. The recall program needs to address the management expectations, the responsibilities of each member of the recall team and sense of urgency that must be communicated to everyone involved. I have seen many recall programs in place that have never been tested by conducting internal mock recoveries. I have seen mock recoveries where ‘inventory adjustments’ were made to show that 100% of the product was traced through the system, when, in fact, anywhere from 1 to 100 cases of product were not accounted for. When questioned as to what an ‘inventory adjustment’ was, I heard excuses that ran from items that were dumped without Certificates of Destruction to inventories that were lost in the warehouse system BUT will eventually surface once the front boxes are moved. That is not a program.
 
I will also add that I have yet to see a recall that happened on a weekday during the hours of 8-5. The recalls I have been involved with seem to occur on the Friday before a long weekend or during the week of Christmas. A well-defined recall program will have the ability to ensure that the identified raw materials, all finished products, all packaging materials and any work-in-process product is removed from distribution and from the manufacturing environment as efficiently and completely as possible and that the program can be put into operation at any time. The program must be able to trace product forward and backward through the entire growing, harvesting, manufacturing and distribution cycle. The program needs to be continually tested with internal mock recoveries that include exercises conducted occasionally after normal business hours. If such recoveries reveal holes in the system, the company must continue to conduct mock recoveries at specific short intervals until it is right and can be executed convincingly. Mock recalls must be more than paper exercises conducted whenever there is an audit. They need to involve all persons who would be involved in a real exercise. Companies must take into account that key people may not be around when the real thing happens. All the programs require the buy-in and commitment of top management.  
 
The Recall
So, despite your best efforts or, worse, your lack of effort, a problem occurs that results in the initiation of a recall. First, let us understand that the majority of recall demands are made by the regulatory agencies and that their demands are not negotiable. By the time you are brought into the recall process, the investigation has most likely already started, and it is more than likely in its advance stages. There appear to be at least six characteristics common to most recalls:
 
•            There is often a time crunch. Some immediate decisions are requires and some decisions should have been made yesterday.
•            You never have complete information.
•            Facts change rapidly, with different levels of factual understanding among key officials.
•            What information you do have is not available to all key people or, worse, has been available to only a few for a long time.
•            There is often pressure from the media for a public statement.
•            Chaos is a given.
 
I would add that you should be expected to be questioned as to (a) what did you know, (b) when did you know it and (c), as importantly, what did you do about it?These questions were asked when Odwalla had their E. coli O157:H7 problems. What the investigators found clearly demonstrated that management knew there were problems but failed to act.
 
So how does the finger end up pointing at you and your product? I have actually had the President of a company involved in a Salmonella outbreak involving airline meals ask me how they could prove it was his product and not the ice served with the drinks on the plane? For definition purposes, a foodborne disease outbreak is two or more cases of similar illness resulting from the ingestion of food. Foodborne epidemiological cohort studies are used to determine the food associated with illness in which the attack rate of persons who ate a food item are compared to the attack rate of persons who did not eat the food. The attack rate is the proportion of people who became ill versus the relative risk. Once your product has been implicated by either an unopened package that has tested positive for the pathogen or implicated by an opened package of product that has tested positive for the pathogen, the world you know changes rapidly. Positive testing may have occurred at the FDA laboratory, U.S. Department of Agriculture laboratory, the CDC, a state department of agriculture laboratory or in a state health department laboratory. Testing may have been initiated by a market survey, research project or as part of a consumer complaint investigation. Testing may have been initiated because your competitor is harvesting from the same field and their product is positive. This creates the ‘guilt by association’ condition.
 
Recall Tools
PulseNet, a national network of public health laboratories, allows labs around the country to compare and share microbial DNA fingerprints. Remember that in 1982, there were only 3, 000 E. coli culturesat CDC; there are now over 200,000 pulsed-field gel electrophoresis (PFGE) or DNA fingerprints on file that are shared with every state. This network linked multiple state outbreaks to the PFGE of the spinach isolates. Pathogen specific surveillance is increasingly more important in foodborne disease surveillance with clinical and public health labs. Public health officials look at PulseNet USA and PulseNet International as invaluable tools for the rapid identification and dissemination of outbreak information. It is obvious that this rapid information transfer will require all manufacturers to have their records in order, the recall procedures in place and their crisis management team on the ready. PulseNet was the tool that allowed epidemiologists to link seemingly unrelated reports of Salmonella back to a toasted oat breakfast cereal, a product not normally associated with food pathogens.
 
Just for information and to demonstrate the lengths that investigators need to go during an outbreak, the California Department of Public Health laboratory streaked over 12,000 culture plates during the investigation of the 2006 spinach outbreak. From those plates, over 1,800 isolates were picked for identification and from that, 350 of the isolates confirmed to be E. coli O157:H7. According to Linda Guthertz of the California Department of Public Health Food and Drug Laboratory, 94 isolates were non-O157:H7 E. coli. There was no E. coli O157:H7 isolates from the processing facility or harvesting equipment. E. coli O157:H7 was isolated from four farms and the San Benito River (20 miles upstream of Ranch A). A total of 28 isolates matched the ‘outbreak strain’ at a single ranch obtained from cattle feces, wild pig feces as well as river water and sediment and pasture dirt.  
 
The consuming public has an inalienable right to consume a food product and not become ill. As the owner of a laboratory that investigates consumer complaints for several well-known food manufacturers across the U.S., I can personally tell you that the consumers first ask “How could something like this happen?” quickly followed by “Someone is going to pay for this!”
 
A food safety survey conducted in 1996 revealed that communications with the food industry has become a formidable challenge. That would be a great understatement, considering the events that have transpired since 1996. The survey indicated at that time that 80% of consumers considered food safety as important as crime prevention, safe drinking water and human health and nutrition. Consumers at that time said that they believed that the food safety rules were not tough enough and that there needed to be higher standards. The survey confirmed that the media is the number one source of information for 65% of the consumers regarding food safety issues, and they believed most of what they saw in the media. As a result, companies need to be better prepared to respond to crises when dealing with the media. Even in 1996, the public sited three reasons for the importance of food safety: continued outbreaks of food poisoning, heightened media attention and more public awareness of food safety. Eighty-five percent of the consumers at that time considered bacteria in food the biggest concern and 93% of the participants believed that the food processor was responsible for food safety. These findings point out the need for a good crisis management plan to be in place and the need for companies to be more proactive rather than reactive when a potential crisis looms.
 
Food Safety Responsibility
Food Safety is not the sole responsibility of the quality control group. Food safety is not the sole responsibility of the production personnel. Food Safety is not the sole responsibility of the field management personnel. It is the responsibility of all of management, including the very top of the management chain, plus everyone employed by that company. The total commitment by top management cannot be accomplished without the following:
 
•            Full knowledge of the conditions of the materials, the facility and finished product safety.
•            Full awareness of the consequences caused by failure to deliver a safe product to market
•            Intelligent allocation of the funds to provide safe product, that is, how much time and money will it cost to get a program in place and keep it in place?
•            A bulletproof program with all the tools required for its execution.
•            A clear articulation of management’s commitment and expectations to every echelon and the encouragement of candid feedback from every employee in the organization.
•            A partnership with the growers, harvesters and field personnel, employees and customers.
 
We can test down to the gene level, and we can do the test in a matter of hours rather than the days and weeks it took in the past. Information can be delivered from one lab across the country to another laboratory investigating a suspected outbreak in seconds. But when it comes down to each outbreak or recall, there is a common link. That link is the people…our employees that have not been trained, not well equipped, thought they were doing the right thing or just did not give a damn. How much training is too much training? How sure are you that proper training has been given to your employees? How sure are you that the sanitation crew knows what is expected of them and that the checks and balances are in place at your facility to assure that any sanitation issue is caught and corrected and documented….not just glossed over.
 
Alice in Wonderland questioned the Queen of Hearts as to why the deck of cards was scurrying around the forest. The response by the Queen is as applicable to the food industry today as it was when most of us started our careers….my dear, we have to run this fast just to stay in place.
 
Cliff Coles is at California Microbiological Consulting of Walnut Creek, CA and can be reached at cmlkcoles@aol.com. He wishes to acknowledge IEH laboratories and Dr. Monsour Samadpour, The San Francisco Chronicle, The Contra Costa Times, Dr. Trevor Suslow and The National Laboratory Training Network.
 
Reference
1. Jarvis, B. 2007. On the compositing of samples for qualitative microbiological testing. Lett Appl Microbiol 45:592–598.

NEWS:

GFSI Successfully Benchmarks Two New Food Safety Schemes

The Global Food Safety Initiative (GFSI), managed by The Consumer Goods Forum, has announced that the Best Aquaculture Practices (BAP) certification scheme developed by the Global Aquaculture Alliance and the On-Farm Food Safety Programme (OFFS) known as the CanadaGAP scheme, managed by The Canadian Horticultural Council (CHC), based in Ottawa, Canada, has been given full recognition by the GFSI Board of Directors.

The Global Aquaculture Alliance is an international, non-profit trade association dedicated to advancing environmentally and socially responsible aquaculture. The food safety module has been developed through its BAP scheme, and the GFSI recognition covers the generic food safety requirements running through the scheme.

The OFFS consists of national food safety standards and a certification system for the safe production, storage and packing of fresh fruits and vegetables. The CanadaGAP scheme has been recognized by GFSI for certification options B & C.

This benchmarking process has been completed using an internationally accepted set of food safety requirements, based on industry best practice and sound science, which are developed through a consensus building process by key stakeholders in the food supply chain. These requirements can be found in the GFSI Guidance Document Version 5, which is freely available for download on www.mygfsi.com.

 Product Recall Management Recommendations Unveiled in New Joint Industry Report

The Grocery Manufacturers Association (GMA), Food Marketing Institute (FMI) and GS1 US today issued a joint industry report that identifies opportunities and methods for improving product recall management practices across multiple dimensions. The report, entitled Recall Execution Effectiveness: Collaborative Approaches to Improving Consumer Safety and Confidence, was conducted by Deloitte Consulting LLP on behalf of GMA, FMI and GS1 US and makes recommendations in three main areas: communication and collaboration; processes, organization and metrics; and technology. The study is part of an ongoing, industry-wide effort to improve product safety and recall programs.

The report findings are based on a thorough evaluation of current and leading recall practices utilized by consumer product manufacturers and retailers, including survey responses from 54 companies representing $152 billion in manufacturer sales and $329 billion in retailer 2008 annual sales, and 29 interviews with industry executives (15 manufacturers, 10 retailers and four service providers).

Among the report’s recommendations is a call for more collaboration among trading partners to enable early identification of possible problems by sharing and investigating consumer complaints, a spike in which could be symptomatic of a problem. The report also suggests investigating the root cause of recalls to further assess prevention measures that can reduce or limit the need for recalls.

When it comes to recall processes, organizations and metrics, using standardized industry tools and processes whenever possible will enhance recall efficiency, according to the report. Investment in employee recall execution training at both the corporate and the store level was also identified as an opportunity for improvement.

Finally, the report identifies technology as the means of supporting its communication and process-oriented recommendations. To read the complete report, visit www.gmaonline.org/publications, www.fmi.org or www.deloitte.com.

USDA Sets New Standards for Ground Beef Purchases

U.S. Agriculture Secretary Tom Vilsack has announced that the U.S. Department of Agriculture (USDA) has completed new food safety standards for ground beef purchased by the Agricultural Marketing Service (AMS) for federal food and nutrition assistance programs including school lunches.

“The health of our school children is a top priority at the USDA, and today we are moving ahead quickly with plans announced earlier this year to ensure that food provided to nutrition programs is as safe and nutritious as possible,” said Vilsack. “The new standards announced today ensure our purchases are in line with major private-sector buyers of ground beef and are part of our continued effort to employ the best scientific knowledge to increase the safety of our nutritional programs.”

This past February, Vilsack announced a series of initiatives to improve the safety of food purchased for school lunch and nutrition assistance programs, and standards announced May 14 marks the completion of one of those initiatives. The standards are the result of a joint review by the USDA’s Food Safety and Inspection Service (FSIS) and Agricultural Research Service that has been ongoing since the February announcement.

The new requirements will be applicable to AMS ground beef contracts awarded on or after July 1, 2010.

In addition to continuing a zero tolerance for E. coli O157:H7 and Salmonella, the new AMS standards will: (1) tighten microbiological testing protocols; (2) tighten the microbiological upper specification and critical limits; (3) increase microbiological sampling frequency for finished products to every 15 min; and (4) institute additional rejection criteria for source trimmings used to manufacture AMS-purchased ground beef. AMS will also consider any vendor classified by FSIS as having a long-term poor safety record as an ineligible vendor until a complete cause-and-effect analysis is completed.


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TISCOR Releases InspectNTrack for Your Integrated Pest Management Needs

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Food Safety Training: ISO 22000 • FSSC 22000 • HACCP

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