STOP Foodborne Illness receives many requests to speak at conferences, trainings and meetings. I recently spoke at the Harris County Food Safety Summit in Houston, along with David, one of our Texas volunteers. David became ill from Salmonella after eating at a hospital. The event’s audience consisted of health inspectors, and restaurant owners and managers. It was a great crowd.
At this year’s Food Safety Consortium, STOP Foodborne Illness is holding a fundraiser and honoring heroes in food safety. LEARN MOREAt the United Fresh meeting, I participated on a panel with Rylee, a STOP Nevada volunteer, who spoke about her experiences as a victim of a foodborne illness. Also include on the panel were folks from The California Leafy Green Marketing Agreement to talk about our collaborative training video project. STOP Board Member Jorge Hernandez, also the Chief Food Safety Officer for Wholesome International, moderated the discussion. The video was played (available on STOP’s website). I was asked what I thought about competitive marketing advantage as it relates to food safety. To be honest, I don’t really think about that: STOP Foodborne Illness has an obligation to do what we can to prevent illness and death that stems from foodborne illness. We know that sharing personal stories makes a difference in training.
Now that I’m back in the office, our team has three requests, one for speaking and two requests from media to talk about food safety. We hear a lot about food safety culture these days, but actually taking the steps to facilitate, implement and monitor that change can be more of a challenge. We are reading about so many new technologies and practices related to food safety, which is great, but they must be accompanied by a company’s knowledge and commitment in order to be successful.
We will continue to contribute to the conversation. We are most interested in prevention and in solutions and like you, want to make a difference. We want to have fewer and fewer conversations with devastated family members about their experience with foodborne illness. Thanks again for all you do to create a strong food safety culture. How is your organization instilling a strong culture? Let us know how we can help.
Being audit-ready at any moment can be a daunting task, but pest management is one aspect of your audit that you can ace if you’re doing the right things. Pest control can account for up to 20% of your score, so taking it seriously can give you a huge boost the next time an auditor comes to your facility.
There are two components needed to help ease the stress of a third-party audit: An Integrated Pest Management (IPM) program and proper documentation.
IPM programs focus on incorporating green prevention and exclusion tactics into your facility’s ongoing sanitation and facility maintenance strategies, only using chemical solutions as a last resort. FSMA established that these tactics should be used when dealing with food safety issues and that thorough records should be kept to document the risk-based prevention efforts. This gives food manufacturing facilities even more of a reason to employ an IPM program.
A strong IPM program already has documentation built into it, as tracking pest activity and monitoring results over time are crucial steps to implementing the most effective pest prevention techniques for your business. Every IPM plan is tailored to your facility’s needs, so it needs to be dynamic and adaptable over time as new technologies emerge and your business needs change. Having the ability to show documentation of these changes and their positive effects will get you off to a great start on your next audit in showing your risk-based prevention food safety plan. If you do not already have an IPM program in place, speak with your pest management provider about establishing one.
Auditors like to see IPM programs in place because it means your business is taking a proactive approach and keeping detailed records.
Think about it like this: If the auditor is the judge and there’s no jury, would you ever walk into a court case without any evidence to prove your innocence? Of course not! So you wouldn’t want to walk into an audit without any documentation either.
In other words, document everything. Facilities must prepare and implement written food safety plans that identify potential risks to food safety, enumerate the steps and processes that will be executed to minimize or prevent those dangers, identify and implement monitoring procedures, keep detailed records of the food safety program, and list actions that will be taken to correct problems that do arise. If you’re doing all of this, you’ll make an auditor’s life that much simpler and improve the chances of receiving a high score.
When working to get audit-ready, you’ll want to have the following forms of documentation ready to go:
Proof of Training and Certification
Even though you know that your pest management professional is properly trained and certified, your auditor does not. Keep documentation on hand at your facility, as auditors may want to see one or more of the following documents:
A copy of the valid registration or certification document
hysical, written evidence that your pest management provider has been properly trained to use the materials necessary for your IPM program
Evidence of training on IPM and Good Manufacturing Practices (GMPs)
Proof of Service and Material Changes
A strong IPM program changes as new technologies emerge and your business’s needs shift over time, so be sure to have detailed documentation of these changes as they occur. It’s also important to note the reasons for making changes. Auditors will be looking for written documentation for even the smallest of changes to your IPM program, so take careful notes as your program adapts along with your business.
It can also help to assign specific roles to your employees. This not only will give employees clear direction on how they can contribute to your IPM program, but it can also help your case with an auditor by showing that your facility is maintained by an entire team rather than just a few people. Teamwork is a key part of any IPM program, so be prepared to show how your team runs effectively.
Pest Sighting Reports That Correspond with Corrective and Preventive Actions
When there is a pest sighting in your facility, record it immediately. Keeping records of sightings will help ensure that steps are taken to improve and show accountability to an auditor. Once action is taken, record exactly what was done and the results of the counteractive efforts. That way, you’ll have a paper trail that shows an auditor that for every pest problem, your pest management provider came up with a proactive pest solution that resolved—or is working to resolve—the issue.
After taking corrective action, continue monitoring the issue over time and note any developments in order to help prevent the issue from reoccurring. Creating a trend report that keeps track of which pests your facility is dealing with over time can help, too, as it will help you determine which pests are the most problematic. Your provider can help build such a report.
Records of Pest Monitoring Devices and Traps with Corrective Actions
Pest monitoring devices and traps are great for giving insight into areas around your facilities that are most susceptible to pests. Along with these devices, however, you’ll need to show the following information to an auditor:
When and how often the monitoring devices and traps were checked
The type and quantity of each pest found
Corrective actions taken to reduce pest activity and prevent further issues
Work with your pest management provider to gather all of this information, as it is usually the technician who works on these devices regularly. Being able to give an auditor the full picture can certainly help you on your inspection as it demonstrates attention to detail throughout your entire facility.
Annual Pest Management Assessments and Resulting Actions Taken
With most IPM programs, your pest management provider will thoroughly inspect your facility annually to identify areas that can be improved. Many auditors require these annual check-ups, and they will be looking for proof that these facility assessments occurred and that action was taken as a result that led to positive changes. Year-over-year improvement is important, so measure your success against the areas of improvement specified in these annual inspection reports. That way, you can meet the objectives prior to an audit.
These annual inspections give you a chance to look back and see the progression over the years. If there are any pest issues that pop up year after year, make them a priority in order to show that your program is trending in the right direction.
This proactive approach to pest management will help protect your business from pests and the inherent risks, as well as help give you a better chance of receiving an excellent score on your next audit.
So don’t be afraid of an audit the next time one comes around. With a strong IPM program in place and detailed documentation over the course of the year, there won’t be an exorbitant amount of preparation needed. Stay organized and keep all of the above-mentioned documents together and on-site to keep things simple for both you and your auditor. All of these elements will help your facility receive a strong score and be audit-ready at a moment’s notice.
Judging the nature and suitability of items we put in our mouths is a task we perform daily, whether it’s due to different taste preferences, being on a diet, or from particular foods not agreeing with our metabolisms. Some foods can trigger mild reactions such as an upset stomach, or more serious skin rashes and outbreaks, from shortness of breath to even death.
Many of us have been somewhere where someone with a peanut allergy has been brought to everyone’s attention. The situation may have been publicized before boarding a plane, at a school where parents are asked to refrain from giving their children any food containing peanut products, or restaurants that clearly indicate which dishes are peanut-free on their menu, or that the kitchen is absent of the legume.
The number of people with food allergies continues to rise, and although many theories have been provided for the increase, the exact cause is unknown. Many foods are documented as being able to produce an allergic reaction—milk, eggs, soy and shellfish, to name a few—but peanuts and gluten are highlighted as major offenders. Canadian government regulations require that manufacturers label products that contain certain allergens, even if they are made in a facility where allergens are in another product.
The Threat of Gluten and Peanuts
Gluten contained in wheat has become a widely avoided food substance, although the reason for this might has more to do with health concerns than allergies. The American College of Allergy, Asthma and Immunology (ACAAI) estimates that 400,000 U.S. school children have a peanut allergy, with many of those also having other food allergies. According to the ACAAI, many children will eventually outgrow most food allergies, but only 20% of those who have a peanut tolerance will outgrow it.
The charity organization Food Allergy Canada states that 2.5 million people suffer from a food allergy in Canada, while 2 in 100 children are susceptible to peanuts causing a reaction. There isn’t a cure for food allergies, so governments and food inspectors have the weighty task of ensuring that commercially produced products are packaged or served with proper labeling and information to protect consumers. This requires constant checking and testing of products that may have come in contact with peanuts or gluten.
New Tool for Food Inspectors
To provide regular analysis, the procedure has been lengthy and expensive, but scientific researchers at Canada’s University of Guelph have developed an apparatus that can identify allergens in a much shorter time span while being considerably more cost effective. The new allergen detector could expedite allergen reporting and possibly reduce the number of allergic reactions through more timely results.
Schematic of the biosensor for the rapid detection of food allergens. Image courtesy of BioNanoLab, University of Guelph.
Based on the ELISA (enzyme-linked immunosorbent assay) platform that is widely used in diagnostic labs to identify allergens, the new apparatus provides comparable accuracy. The technology has been miniaturized so that equipment is portable, about the size of an audiocassette case, and tests can be conducted on location instead of relying on a lab that may be far away.
An Allergen that Glows
In the case of peanuts, the scientists focused on a prominent allergen named Ara h 1, because it can be identified through non-radioactive fluorescence. Although there are other allergens in peanuts, they don’t share the same property by which they can be identified, as does Ara h 1.
The process requires a small amount of the suspected food to be liquefied in a suspension so that it can be injected using a filter syringe into a silicon-based plate, or chip, of microcapillaries. As the sample passes through tiny tubes of the microfluidic chip using capillary action, it travels through a beam of light from a LED source that is monitored by a specialized camera, which is also a product of the scientists’ work.
The image captures Ara h 1 protein particles that fluoresce when they come in contact with the chemical properties of the suspension. Currently, the camera records the data and sends it to a computer to be analyzed and deciphered with a result being provided within 20 minutes, compared to a conventional lab test that takes up to four hours after a sample has been received.
In a modification to provide an extremely portable system, research is underway to develop an app to enable results via a smartphone. Testing foods in the near future will be as convenient and prompt as holding the detector in one hand and a smartphone in the other so that a restaurant owner, for example, will be assured that dishes are allergen-free before being served to customers.
Imitating the Human System for Detection
To enable the allergen to fluoresce, the compound graphene oxide (GO) was utilized in combination with a bio-sensing component, known as an aptamer. The aptamer acts similarly to antibodies that identify and attach themselves to foreign and hostile elements that enter our blood system. Once a GO-aptamer mixture is attached to the allergen, the light source allows the protein particle to be detected and its image captured electronically.
By altering an aptamer’s composition to identify other allergens, such as gluten, the detector is a versatile piece of scientific equipment for identifying potentially hazardous food ingredients. The developers of the technology are confident that their discovery will change the future of identifying potentially hazardous food components. The final step in the allergen detector’s development seems to be fine tuning the detection process for certain processed foods, such as roasted peanuts, that can alter the composition of Ara H 1 making it less obvious to be identified.
Confusion reigns in many organizations and especially with our food safety and quality professionals, as we debate and attempt to decide how best to address the requirements of FSMA. With the first compliance date of September 2016 drawing near, companies are feeling increased pressure to take action. As many are already accredited to a GFSI-approved food safety scheme such as SQF Level 3, BRC, Primas, IFS or FSSC 22000, often the question is, how does my current system fit into FSMA, and where do I need to make changes? The undercurrent to this question is the implication that changing the system to fit FSMA will cause it to no longer be tailored for the desired GFSI food safety scheme, and that a change could cause issues with those audits (which are crucial for purchasing, marketing and sales).
The Food Safety Consortium will discuss critical industry issues, including FSMA compliance. The event takes place in Schaumburg, IL | December 5–9, 2016 | LEARN MOREAs with so many of our industry challenges, there is no easy and prescriptive answer to these questions. Each organization has to make the decision for their own system based on their individual hazard analysis, risk tolerance and resources. Some over-arching themes begin to emerge, which may be analyzed to assist the decision makers in the creation of a road map to FSMA compliance.
During our FSMA Preventive Control Qualified Individual (PCQI) training courses we are repeatedly asked, “What qualifies as a preventive control? Are our critical control points (CCPs) automatically a preventive control? How about our operational prerequisite programs (OPRPs)—are these PCs also?” While there is no easy answer (yes or no), there are some important things to keep in mind that can help in the decision.
The official answer is that a preventive control should be any point in the process where, with a loss of control, it is reasonably foreseeable that a significant food safety hazard either will occur or has an increased likelihood of occurrence. Remember this is intended to be a single point in the process, not the entire process. For example, the sanitation program may be managed as a prerequisite program; however, there may be a point in the process that requires special sanitation attention and without it, there is a reasonably foreseeable likelihood of a hazard.
Thinking about the concept, a logical conclusion is that a loss of control leads to a significant food safety hazard or, at the very least, increases the likelihood of said hazard. It follows that a loss of control would beget the need for a withdrawal if the product had already left the organization’s control. Therefore, one should only designate a point as a preventive control if the implications of conducting a recall in the event of failure have been analyzed as part of the risk assessment. The organization must be fully prepared to conduct such a recall in the event of failure.
The FSMA Preventive Control regulation (§21CFR117.135 – Preventive Controls) requires a recall program only if there is a preventive control identified in the process. Of course, any food processing organization would be remiss if they did not have an effective recall program defined and tested by regular mock recalls. Waiting for a true recall is no time to find out that your program has issues. Even without a preventive control, what happens if a supplier contacts the processor with an issue that requires a recall?
Through the evolution of compliant and mature food safety management systems, it is common for an organization to initially identify multiple CCPs and then, through data collection and process improvements, slowly reduce the CCPs to control points managed through OPRPs or PRPs over time. So, should an OPRP (Operational Prerequisite Program – ISO 22000:2005 Section 7.5) also be designated preventive control? This is perhaps one of the grayest of gray areas in this arena. A deviation in a preventive control, if the product has left the organization’s control, requires a recall. A recall for a deviation in an OPRP is not absolute, and it is actually handled by the food safety team and management on a case-by-case basis, depending on the risk. In addition, although identified when possible, a critical limit is not required for an OPRP (ISO 22000:2015 Section 7.5). Parameters are required for a preventive control.
There really isn’t one answer that fits every situation, but it is important to remember that the requirements for FSMA Preventive Controls regulation (§21CFR117.135) are designed for those operations that in the past have not had the opportunity to define, implement and maintain a food safety program—one that includes a hazard analysis based on HACCP guidelines (Codex Alimentarius Commission [Annex to CAC/RCP 1-1969, Rev. 3 (2003)]) and/or a GFSI-approved food safety scheme. Personally, we feel that if an organization has evaluated their process in compliance with a GFSI-approved food safety scheme, then any reasonably foreseeable hazards have been identified and addressed through a control point such as a CCP, OPRP or PRP. However, that said, upwards of 90% of recalls are linked to either ineffective or nonexistent PRPs such as allergen mislabeling, which accounted for 53% of all recalls last year. Thus, it is imperative that we evaluate all aspects of our processes with the same scrutiny that we do our microbial pathogen and metal control programs, which are common CCPs in today’s world of food safety.
Risks must be evaluated through an effective risk assessment based on science and facts. We start almost all of our workshops with the great American Society for Quality (ASQ) video: Cost of Poor Quality. This highlights the lack of an effective risk assessment performed on January 28, 1986, related to the launch of the Challenger. Unfortunately, emphasis was not on the fact that the engineers presented about the lack of cold temperature stability of critical O-rings, but rather on the fact that the launch had already been postponed for two days, and there was intense media and political hype surrounding the event. An effective risk assessment must be based on facts and objectivity, not on our feelings about what we want or need the decision to be.
FSMA PCQI training stresses the use of reliable and credible resources such as academia, trade organizations and process authorities. The internet itself can also be a valuable resource. Jon Porter stated in 2004, “HACCP, as we know it, would not exist without the internet.” (If Jon could only see us now.) However, again, we must be sure we are choosing credible information from the internet. We all know that we can usually find any answer we desire on the internet, but is it credible and accurate?
Competent industry sector-experienced consultants may also be good options if the organization ensures their credibility. Sometimes, a set of independent eyes can be just what the doctor ordered. Even in cases where the organization has a fully qualified team that is perfectly capable of managing the food safety program on their own, the right external resource (i.e., consultant) may provide an additional, independent viewpoint to your process. A friendly debate with an external resource can oftentimes open a whole new vista of previously unconsidered possibilities for the team.
The FSMA Preventive Controls regulation (§21CFR117.135) states that “each organization is required to have a PCQI that has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system”. What qualifies an individual to be qualified through job experience is not specifically defined but is judged by the effectiveness of their food safety program. However, if FDA visits the facility and asks for the PCQI and no one has taken an FDA-recognized course—but there is someone that the organization has identified as qualified—this has the potential to start the visit off with a negative focus. We urge each organization to send two food safety associates to an FDA-recognized FSMA PCQI training course regardless of their background (this provides a back-up person in case the primary representative is ill, traveling for business or pleasure, wins the lottery, or otherwise leaves the company, etc.). This provides a strong foundation for the future, as ownership of the system is always crucial to not just surviving an inspection, but excelling—and as food safety professionals that is an idea we can all support.
Did you know there are more than 250 different types of foodborne illnesses? And while that number may seem daunting, especially when one in six Americans become ill from consuming contaminated foods or beverages each year, there are a few foodborne germs that are responsible for the majority of illness outbreaks, according to the CDC.1 What are these illnesses? What are their symptoms? What can you do to help reduce the risk of an outbreak happening at your restaurant?
The CDC estimates that approximately 48 million people get sick from a foodborne illness each year, with 128,000 hospitalizations and 3,000 deaths. And of these numbers, there are two common illnesses that stand out—norovirus and Salmonella. In fact, these two pathogens account for nearly 70% of all foodborne illness outbreaks in the United States.
Norovirus
Norovirus is responsible for 58% of domestically acquired foodborne illnesses and nearly half of all foodborne disease outbreaks due to known agents.2 Of these instances, most norovirus outbreaks occur in a food service setting, particularly restaurants.
Oftentimes, infected employees are the cause of these types of outbreaks. For example, individuals who are exhibiting symptoms come to work and contaminate food by touching either ready-to-eat foods or food-contact surfaces with their bare hands, which can lead to cross contamination.
Norovirus spreads easily and quickly, so people can contract it by not only by consuming contaminated foods or beverages, but also from having direct contact with individuals who are infected with the virus or touching surfaces or objects that have norovirus on them as well. In addition, norovirus outbreaks can also occur from foods that are contaminated at their source.2
In this video about Norovirus, I discuss the actions you can take, which includes practicing good hand hygiene, to reduce the risk of a norovirus outbreak negatively impacting your restaurant.
Salmonella
Each year in the United States, Salmonella is responsible for 1 million foodborne illnesses, 19,000 hospitalizations and 380 deaths.3 In fact, the pathogen accounts for 11% of all foodborne illnesses in the United States.
People become infected with Salmonella by either eating contaminated food that has not been properly cooked or has been contaminated after preparation.4Salmonella is often found in raw food products that come from animals such as eggs, meat, and unpasteurized milk and dairy products.
While Salmonella is fairly common, measures can be taken to help reduce the risk of infection, such as through proper cooking and holding temperatures. In addition, proper disinfection and sanitization of food contact surfaces (i.e., countertops and cutting boards) helps reduce the risk of cross contamination. Practicing good hand hygiene before eating, and before and after preparing food can also help prevent the spread of this bacterium.
No one ever thinks their restaurant will fall victim to a foodborne illness outbreak, but it can happen and these outbreaks are more common than you may think. It is critical for you to share information about foodborne pathogens and prevention with your staff. This type of education and training can have a significant benefit to your restaurant.
In recent years, several food products typically considered safe by consumers have fallen victim to recalls as a result of Listeria monocytogenes (Lm). Caramel apples, ice cream, packaged salads and frozen vegetables were responsible for sickening dozens of people and killing more than 10. These products are part of an alarming group of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes and raw cookie dough. And the broad range of pathogens causing these outbreaks is just as diverse, and they continue to find creep into food processing facilities, finished food products and consumer homes.
At the 2016 Food Safety Consortium, Shawn Stevens will moderate the workshop session, Bringing the final FMSA pieces together: You have a basic preventative control program, what’s left? | Friday, December 9 | LEARN MORERegardless of sophistication or expertise in pathogen control, there isn’t a single company out there that is immune to the risk of contamination. Why? Well much of the foods (or ingredients) that we consume are grown and harvested in environments that are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Lm, Salmonella or E. coli in the fields where they are grown, in transit or in the processing facilities.
Once pathogens are introduced into the processing environment, they can quickly spread and contaminate food products. Recent studies reveal that Listeria is a significant concern in these environments. For example, out of 5,000 samples from the food preparation areas of 30 retail grocery establishments, approximately 10% tested positive for Lm. These are scary numbers considering almost 16% of those who become infected with Lm will die.
In today’s new environment, FDA will be seeking justification to bring criminal charges whenever a contaminated product causes human illness. You should be nervous about this: If your company sells finished goods into commerce, those products may be selected for sampling and testing, and your company runs the risk that the results will come back positive for a pathogen of concern. And what’s more troubling is the fact that many companies do not conduct environmental testing in their food processing facilities, and so they have no idea whether pathogens (whether transient or resident) are lurking within their facilities. Thus, a microbiological profiling study conducted under the veil of the attorney-client privilege should be conducted to determine the presence of any microbiological persistence issues within a facility. Upon completion of the study, a company should invest in pathogen-reduction technologies to decrease the chances that FDA will uncover pathogens in the environment during an inspection. Finally perform a criminal protection audit to help strengthen company programs and develop protocols that will further protect against criminal exposure.
The bottom line is that if food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products.
Microbiological Profiling Studies
Lesson number one from the Blue Bell Lm outbreak is that pathogens can be extremely elusive and, as a result, a simple environmental monitoring program will never save your company from being involved in an outbreak or being the focus of criminal sanctions. All food companies should be aggressively testing for Lm (or other pathogens, depending upon the product risk profile) in their facilities and must take strong action against sporadic or intermittent positive findings. Although many food companies view a single operational failure as the culprit of an outbreak, the reality is that in most cases, the cause is something far more subtle, far more persistent, and far more dangerous. In recent years, a large number of outbreaks have involved Lm and antibiotic-resistant Salmonella that was linked to products that had been processed over multiple months.
Food companies should conduct a comprehensive one-time microbiological profile for pathogens in their processing facilities. Be sure to coordinate your profiling study with a lawyer experienced in food safety to make sure that the study is designed correctly and that the results will be protected under the attorney-client privilege. Once the results are reported, the company can take care of any positive findings, identify the contamination source, implement technologies to reduce and control the contamination, and develop a microbiological control and monitoring program to ensure that the pathogen remains controlled moving forward.
Pathogen Reduction Technologies
The second lesson learned from the Blue Bell case is that, when Lm or any resistant pathogen is found sporadically in the environment, what was once regarded as effective corrective actions (i.e., re-cleaning, re-sanitizing and re-testing) are no longer enough. In addition to existing cleaning and sanitizing procedures, companies should use new pathogen reduction technologies to help control the environment.
Inexpensive air and surface treatment technology that sanitizes the food processing environment is now available. The treatment is approved for use in occupied spaces and provides 24-hour treatment of the environment. By using active air and surface treatment, food processing companies can gain a level of control and decrease the possibility that any pathogen, if introduced, will persist or establish a niche.
Puradigm, LLC, for instance, utilizes a multi- patented, NASA-based active air and surface sterilization approach to control pathogens in the food processing environment. In studies performed by Kansas State University, the company obtained a 2.9 Log reduction on environmental food contact surfaces in the food processing environment. Similar reductions for other pathogens are displayed in Table I.1
Microbial reductions on stainless steel associated with 24-hour treatment using Puradigm advanced oxidation cell
I make this observation because, given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in their food processing environments. Once these preventative technologies are put into place, companies can perform periodic microbiological monitoring to validate that the controls are effective and working as designed. If such solutions are employed, there is a greater likelihood that when FDA arrives to perform microbiological profiling, the agency will be less likely to find positive test results from the food processing environment, better protecting food companies from additional regulatory or criminal exposure.
Criminal Protection Audits
In addition to commissioning microbiological profiling studies in facilities and employing active air and surface sterilization technologies, food companies should also perform internal criminal protection audits. These audits should be designed to identify gaps in existing company protocols and develop written programs designed to help navigate the challenges posed by any food safety issues uncovered.
If developed correctly, the written program should provide the company with a decision-tree to follow in the event of a positive environmental finding, a series of customer complaints relating to the safety of a product, or a notification from a governmental entity of a potential food safety problem. These protocols and programs, if followed in the event of a food safety issue, can help ensure that the conduct of the company in response to any such issues will in all cases be appropriate, and that there will not be any basis upon which FDA or DOJ could support criminal charges.
Conclusion
The FDA (in cooperation with DOJ) has launched a war on pathogens. The agency is targeting food products at retail and engaging in microbiological profiling of all food companies. Unless companies act now to better quantify and control pathogens in the food processing environment, they are exposing themselves to incredible food safety risk, including significant brand damage (in the event of a recall) and criminal sanctions (if their product is linked to human illness). Companies must carefully consider the emerging risks facing them and take measures to decrease and eliminate their exposure.
Reference
GC/MS Evaluation of Compounds in Air Samples in a Controlled Environmental Chamber Equipped with a Puradigm Advanced Technology Cell, November 5, 2013, Dr. James Marsden, Kansas State University Food Science Institute.
You will hear some new abbreviations being tossed around in questions by executives in food manufacturing and processing these days. “Do I need a PCQI? Who is my PCQI? What is a PCQI?”
Strangely, many of these executives do need a PCQI, and they need one very soon. A PCQI is the “Preventive Controls Qualified Individual” needed to oversee implementation of the HARPC rule under FSMA. Last September FDA published the final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Unless a food manufacturer is specifically exempt, the date for compliance with implementation of the rule’s preventive controls portion is September 19, 2016. A facility’s PCQI is responsible for overseeing the implementation process. For companies that have yet to prepare for compliance, the good news is that several organizations, such as the Food Safety Preventive Controls Alliance, offer training to meet the requirement for having a PCQI.
For large companies (those with more than 500 employees), time is of the essence to meet the September 19 compliance date; for companies with less than 500 full-time-equivalent employees, you have more time to prepare, with September 18, 2017 being the compliance date.
Whether your due date is this year or 2017, your food safety plan is the primary document that guides your preventive controls food safety system. It must be developed using a systematic and risk-based approach that uses scientific principles to identify the hazards that require preventive controls to prevent foodborne illness or injury. It is most effectively prepared not only by a single PCQI but also a cross-functional food safety team that includes individuals with executive support and leadership. In addition to including the hazard analysis in which you must analyze for hazards requiring a preventive control for your product(s), your food safety plan must have preventive controls for your process and for food allergens, sanitation, supply chain and any other appropriate areas where you identified that preventive controls were needed.
Further, your food safety plan must include a recall plan, procedures for monitoring, corrective action and verification when a hazard requiring a preventive control is identified, along with science-based validation for process preventive controls. Of course, Good Manufacturing Practices (GMPs) and other prerequisite programs must be in place to provide a solid foundation for your food safety plan. And there’s more news: FSMA includes significant changes in the GMPs. For example, all formerly non-binding provisions are now binding, including education and training. One of the new GMP requirements is cleaning of non-food contact surfaces “as frequently as necessary” to protect against allergen cross-contact and contamination of food contact surfaces and food packaging.
Back to the possibility that you may qualify for a specific exemption, if you heard that processors subject to the low-acid and acidified canned foods regulation are not subject to the preventive controls rule, the exemption is only for hazards that are microbiological. For physical and chemical hazards, including allergens, a hazard analysis must be conducted to determine whether hazards are an issue and whether preventive controls are needed. This analysis must be documented, even if you determine that no preventive controls are needed. And if preventive controls are needed, they must be developed and documented with verification and possibly validation as previously described. Of course the new GMPs also apply to low-acid and acidified canned food manufacturers.
If you heard that warehouses are in the clear due to a specific exemption, there is more to the story. Only facilities such as warehouses that store strictly unexposed packaged materials for which refrigeration is not required are exempt from preventive controls. Facilities that store raw agricultural commodities that are fruits and vegetables are not exempt from hazardous analysis and risk-based preventive controls. All of these facilities, and even those subject to seafood and juice HACCP and not required to do preventive controls, are not exempt from updated GMP requirements.
Take the obvious first or next step for your organization’s compliance with FSMA: Ensure you have a PCQI and start working on your hazard analysis and food safety plan now.
Food safety risk is now a greater concern for retailers and manufacturers than ever before due to the combination of FSMA and increased consumer concerns. Supply chains are more complex, product recalls and foodborne illness outbreaks occur more frequently, and the new normal is prevention rather than inspection. Wrap that all up with advanced technology and the 24-hour news cycle, and consumers are acutely becoming aware of food safety issues as soon as they occur.
What this means for all of the participants in the global food supply chain is that you should review your insurance policies and look for gaps in coverage where you may be exposed. While no two recalls are the same, and foodborne illness outbreaks impact affected companies in different ways, certain trends have emerged to help better understand the claim friction points that frustrate companies after a food safety event.
Two of the most important tools to mitigate food safety risk are contaminated product insurance (CPI) and product recall insurance (PRI). Inventory, cost of refunds and recall expenses are three of the largest recall loss items suffered by companies. Combined, they are the largest percentage of loss (nearly 50%) and represent a substantial portion of uncovered loss for any insured under CPI/PRI. The sole basis for this frustrating friction point is simple—lack of traceability.
CPI/PRI only covers losses that result directly from a covered insured event. If a company is unable to support its claim that costs are directly related to the event and the resulting recall or outbreak, it will not be reimbursed under a CPI/PRI policy. And, as such, loss amounts are generally not covered under general liability and property policies either, so a significant portion of a company’s loss remains uncovered.
Here’s a recent claim example to illustrate the impact on a company that lacked the capability to properly trace its products. An insured purchased a CPI policy with a $2 million Accidental Contamination limit. An event occurred involving a contaminated food product, which triggered that coverage. During the review, the insured provided spreadsheets supporting nearly $1.1 million in customer credits for product shipped and either returned by the customer for disposal or destroyed by the customer. Unfortunately, based on a review of the information provided in support of the spreadsheets, the accountants found that the insured was unable to properly trace and support its claim that the returned or destroyed product was affected by the insured event recall. Under these circumstances, the accountants were only able to confirm $187,000 in losses. The result: The company was unable to recover nearly $1 million in potentially covered losses because it lacked traceability. These outcomes are not uncommon.
The insurance industry understands food safety risks and the need to evolve products to meet the needs of food industry clients. Companies can’t totally mitigate all food safety issues, but understanding the risks is the best way for a business to protect itself. Insurance industry leaders are working in partnership with their food sector clients to ensure that risks are better understood and that the client has appropriate systems in place to help mitigate them.
Insurance companies are tailoring their products to ensure that policies are developed to address the recall risks caused by regulatory changes and help companies ensure compliance as well as an understanding of the regulatory requirements. However, food companies may increasingly find coverage and limits adjusted lower for government recalls in high-risk environments. Insurers are also a key player in the promotion of food safety standards, and some offer favorable rates to food industry clients who are graded top tier for safety.
Some insurers go a step further, allowing clients to allocate a portion of their premium for pre-incident risk-analysis and crisis-response services. Top insurers provide clients access to a network of crisis management specialists as part of their food safety coverage. They should offer risk management guidance in areas such as food safety risk, regulatory compliance, supply chain management and product security.
One of the most critical risk mitigation tactics is developing long-term relationships with trusted, but verified, suppliers, distributors and other key partners. It is also important for companies to undertake regular site visits to their manufacturers or suppliers, and commission third-party audits to maintain reliability and transparency.
Not if, but when a product recall occurs, a company faces a myriad of risks. As with food safety, preventive planning can pay off significantly. By proactively working with insurers, trading partners and technology vendors you can reduce if not eliminate the negative impact of the event.
The vast majority of foodborne illnesses in the United States results from either a management system failure or human error. This supports our belief that all foodborne illnesses are preventable. With the introduction of FSMA, prevention has become a significant focus in the battle to eliminate foodborne illness.
STOP Foodborne Illness is collaborating with Intrinsic Leadership, LLC to offer a Food Safety Leadership program. The primary objective of this program is to equip leaders with the knowledge, skills and abilities to develop and sustain a culture of prevention relative to food safety.
Successful prevention requires more than just the introduction of new knowledge and skills for workers. Success requires the consistent and ongoing application of those skills.
We know that training can provide knowledge and skill. However, the most significant predictor of long-term success is the extent to which frontline managers actively support behavioral changes within the employee base. Experience shows that transforming an organization to produce superior results is much more than training programs, process improvement or new technology. While each of these elements are important, sustainable improvement occurs when we are able to shift the way people think about the business in a way that drives them to consistently act different then they did in the past. The role of leadership is to:
Frame the business opportunity in a way that inspires employees to seek a better outcome
Relentlessly pursue management system improvement
Represent, support and encourage a culture that aligns with improvement opportunities
Stories are powerful reminders and provide the “why” behind food safety. Below are two such stories.
Raw Milk – E. coli 0157:H7
It is the stories that create the urgency behind the importance of food safety. Christopher’s story is heart breaking—yet, he was one of the lucky ones, as he recovered from his illness.
Since the publication of the FSMA Preventive Controls Rule for Human Food, the term HARPC has become a common way of describing the type of food safety plan that is needed to comply with the requirements. On first glance its similarities to HACCP could possibly lead one to believe that the requirements for both systems are aligned. But beware, there are a number of fundamental differences and one main contradiction in the requirements, which requires a clarity of understanding when trying to amalgamate the two systems.
With the introduction of the FSMA Preventive Controls Rule, food facilities that have HACCP systems are now faced with the difficult task of trying to adapt their current food safety system to meet the HARPC requirements. These facilities will continue to be required by local law in the countries where they export to, by their customers and by standards such as those recognized by the GFSI to adhere to the HACCP principles. A straight swap from HACCP to HARPC is not going to be an option for many businesses. Therefore, a combined approach is required, one that meets both sets of requirements and has a clear, practical and effective methodology.
Structure of the Controls
One of the consequences of combining the requirements of HACCP and HARPC is that all of the control principles need to come together and work as one. For this reason, the distinctions between pre-requisite controls (PRCs), preventive controls (PCs) and critical control points (CCPs) must be fully understood.
Pre-requisite control: A facility-wide generic control, not specific to one particular process step
Preventive control: A control that prevents or significantly minimizes the hazard
Critical control point: A control that eliminates or reduces the hazard to an acceptable level
There is a hierarchy to the controls, with PRCs being the building blocks for facility-wide general controls; PCs are more specific controls that are typically associated with a particular step in the process; a CCP is one that is above and beyond a PC and is critical to the safety of the food (see Figure 1).
Figure 1.
A PC is one that either prevents the hazard from occurring in the first place, or if the hazard has occurred, it recognizes it and minimizes the impact of the hazard by controlling it and not allowing it to be released as product.
A CCP controls a hazard that is inherently expected in the product by eliminating it or reducing it to a level at which it is safe.
Key Challenges
There are a number of differences between the requirements of HACCP and HARPC. The PC Rule is not as specific or detailed in the way in which the plan should be documented or designed, as the principles laid out in the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) or Codex Alimentarius. However, the FDA may not have directly stated that certain elements such as product description, intended use or intended user must be included, but they do elude to the fact, as the hazards that must be assessed would require this information to be understood and fed into the system. This means that in order to comply with both systems, the principles of HACCP must be adhered to as well as those of HARPC, so elements such as process flow diagram will still be required.
The key difference between the systems related to how significance is determined within the risk assessment. Both systems require a risk assessment that takes into account the severity of the hazard and the likelihood of the hazard occurring. The results of this should determine if the hazard is a significant food safety risk, where it is, and whether a PC is required. Hazards that are not significant would need to be managed through the application of PRCs.
The difficulty enters the picture when assessing the likelihood of the hazard occurring, as the two sets of requirements contradict each other:
The PC Rule asks for the likelihood to be determined in the absence of any controls.
HACCP principle states that the likelihood should be determined, taking the controls into account.
It is acceptable to HACCP principles to follow the requirement for HARPC and carry out the assessment in the absence of any controls, however there are consequences in doing so. The number of significant hazards that will be produced will be substantially higher than in a traditional HACCP plan. Each of these hazards will need to be controlled through a PC, and the CCPs will need to be determined from this set of PCs. Using the typical CCP decision tree is not a practical solution, as the result will likely mean that most of the PCs become CCPs. Nobody wants to go back to the days when facilities had many, many CCPs, as this produces an unmanageable and ineffective food safety system.
A new methodology is required for the determination of CCPs—one that is clear and does not contradict the HACCP principles.
The Benefits of HARPC
Although the introduction of HARPC makes designing and developing a food safety plan more complicated, it does have its benefits. Over time, as pre-requisite programs have developed, the number of hazards that are managed by PRCs have grown—to the point now where most facilities only have a handful, if not one or two, CCPs.
Through a HACCP plan, even very significant food safety hazards can be managed by the PRCs. These significant hazards are therefore managed, just the same as insignificant or low-risk hazards. This may be the reason that the most common recalls and withdrawals today are due to lack of control from pre-requisites.
By introducing the new tier of PCs and assessing significance without taking any controls into account, we mitigate this problem. Ensuring that the key food safety hazards, which perhaps are not critical, are managed through the application of PCs and they thus receive additional focus.
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