Most industries face issues with breaking down silos and promoting cross-functional collaboration. For the next class of leaders to be well equipped to promote and practice a strong food safety culture, more work needs to be done on alignment within organizations and across industry. In part II of Food Safety Tech’s series on food safety culture, Brian Bedard, executive director of the GMA Science and Education Foundation and Lone Jespersen weigh in on leadership.
Food Safety Tech: Food Safety Culture requires strong professional leaders. How can industry work together to develop the leadership that is needed?
The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MORELone Jespersen: We start by acknowledging that we have an abundance of strong leaders in the food industry. We don’t need to build from the ground up or something new. We need to look at what makes [these leaders] strong. Why are some leaders more successful than others? Identify the companies that have strong food safety leaders that are not within food safety—those that come from finance, HR, procurement, and the CEO—and formally acknowledge their technical and leadership competencies.
I’m aware of three organizations that are actively looking at what constitutes a food safety professional and its competencies—IFPTI (International Food Protection Training Institute) in the United States, Safe Food Canada, and the International Union of Food Science and Technology. Alignment between the work conducted by each of these organizations is important to shorten the time between development and business impact. It’s really important to get this alignment. The more we keep working in small subgroups while not comparing notes and agreeing on those competencies, the more we’re going to see the cost of developing leaders going up. And we’ll have fewer strong leaders, because it will be hard for individuals to move on in their career if it is not clear what it means to be a competent, strong food safety leader.
There’s a very large group of food safety leaders, the ‘Malcolms-in-the-Middle’ who are excellent leaders and are one or two steps down from the head of food safety in an organization. Sometimes we forget that we have strong leaders at this level, and they have a much stronger handle on food safety culture because they’re the ones who have to make sure programs work for frontline associates, supervisors, and managers. Letting that level become more visible to what their competencies are or should be and making sure that they contribute and are heard in the conversations [is important].
Brian Bedard: We need to collaborate and get some alignment around what we think leaders need. Unfortunately, this is creating a competitive space among service providers and training entities that can work with leaders.
There are a couple of fundamental principles that need to be addressed:
The leaders at the top need to recognize and drive it down through their entire system so that everyone is responsible in terms of their annual work and development plans, including metrics and the deliverables in their annual evaluations
The ‘Malcolms-in-the-Middle’ who, in most cases, manage the budget. It’s critical to get them on board to ensure that, when making investments, they’re spending money on driving food safety culture throughout an organization
Several specific opportunities now exist to promote food safety culture leadership, including the Food Safety Leadership Workshop being offered by the GMA Science and Education Foundation at the upcoming GMA Science Forum (April 18, Washington, DC).
While the United States has no legal definition of food fraud, current thinking tends to be focused primarily on companies and products involved in the illegal substitution of one ingredient for another in a product. Such substitution generally involves substituting a cheap filler in the place of the labeled ingredient. In recent news, Parmesan and Romano cheeses have captured news headlines because of illegal “misbranding” of foods meaning that the label on shredded cheeses from companies like the Castle Cheese, Inc. company in Slippery Rock, PA include ingredients found through FDA testing that are included in percentages beyond allowable levels. In the case of shredded cheeses, so called “imitation” cheese better is known as wood pulp. The labels stated that the ingredients were 100% cheese.
Perhaps Slippery Rock is an apt name for the Castle Cheese operation where the inclusion of wood pulp was cheaper than the inclusion of real parmesan cheese. Such activities are becoming increasingly known as “economically motivated” and the practice is one of economically motivated adulteration. The FSMA final rule, Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, will make these practices illegal.
Such intentional cheating has a long record in the history of food. No one really knows the extent of such food fraud activities, when they started (perhaps at the beginning of time?), or who could claim to be the first person to win an international award for creativity.
There are so many ways to commit food fraud that it boggles the mind and creates an almost complete inability on the part of governments, testing laboratories, food processors, retailers and the public to identify, let alone fully prevent and capture the guilty every single time.
Think about a few things. Is it fraudulent to leave the identification of GMO ingredients off of labels? If a packer knowingly packs a product in dirty packaging, is that practice fraudulent? If the food safety part of the government knows how high the levels of fecal coliform are on most of the produce we eat but does not acknowledge the problems or inform the public, is this practice fraudulent? How about the idea that a retail outlet replaces an “expired” label on hamburger with a new unexpired label? Or how about the time Sysco was shipping perishable foods in refrigerated trucks and storing eggs, milk, meat, chicken and other products in the same storage sheds where you might keep leftover junk from your garage? Do “Good Things Come From Sysco”?
But none of those examples have anything to do with intentionally substituting a cheaper ingredient for an ingredient on the label. Honey, olive oil, coffee, juices, fish, alcohol, milk and dairy products, fish, vitamins, meat, spices, organic foods, maple syrup, peanut product, flavorings, preserves, cereals, colorings, wines, vinegar, purees, sweeteners ,and other ingredients are involved. And food fraud occurs in manufacturing, processing, packing and food holding operations. Such large opportunities for all foods in all operations means the entire food chain is—at one time or another, in one place or another—suspect.
The Grocery Manufacturers Association (GMA) estimates that food fraud may cost the global food industry between $10 billion and $15 billion annually with lost sales between 2% and 15%. They estimate that approximately 10% of all commercial food products are impacted.
Considering the fact that the food industry claims their profit margins are only a few percent, it would seem that if they wanted to reduce food costs, food fraud would surely be a prime business improvement target. And GMA, unfortunately, is also focused on economically motivated adulteration such as unapproved additives, mislabeling, counterfeit ingredients, transshipment (shipping from one country to another to repackage and relabel in order to avoid taxes), and dilution.
When a consumer enters a supermarket in search of fresh meat, poultry or fish to cook for dinner, he or she knows little about how those products were packaged. Adding water to the pad that is often inserted under the meat to soak up blood, adds weight to the scale and money to the price. Packing the meat using carbon monoxide is common in order to “preserve” the product color. Red meat should look red, right? While the FDA considers this practice generally recognized as safe (GRAS), studies regarding how carbon monoxide interacts with the foam packaging and the clear plastic wrap covering the package are nonexistent. What makes the practice deceptive is the lack of information on the label that tells consumers carbon monoxide is used to preserve color. Of equal importance are recent studies that clearly show that many of the plastics used in today’s food packaging operations contain toxic chemicals shown to be dangerous to humans.
‘Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product for economic gain’.
After the monster European horsemeat scandal (remember that one?) in which horse meat was substituted for beef to the embarrassment of many companies, such as Burger King and Ikea, the United Kingdom promised proactive solutions from food laboratories and improving supply chain audits in an effort to slow and diminish the number of incidents reported annually.
In the United States, we frequently point to the melamine (milk substitution) in baby formula or the pet food problems that came out of China as evidence that foreign companies are primarily to blame for food fraud. Coupled with governmental trade agreements and the attitude that other countries are dumping substandard product on American consumers, it seems easy to blame others for food fraud –except for the fact that we in America are dealing with so many incidents.
The problem with our inability to tackle food fraud in part comes from the gap between our ability to identify and develop appropriate and targeted food ingredient testing capabilities. So many types of food, so many types of tests, so many types of ingredients, and so many types of ways to intentionally or accidentally cheat the system all combine to confuse and confound our efforts to quickly and economically establish detection systems.
In most food distribution arenas, food traceability systems are slowly being agreed upon and implemented. However, the FDA does not seem to be able to help with establishing data and other standards that would help establish traceability requirements designed to quickly and accurately get to the source suppliers in food fraud events. Other industries under FDA medical device and drug laws have worked to establish solid chain of custody systems. Chain of custody implies that the suppliers and handlers are legally responsible and clearly identified. Leadership in this area is clearly needed.
While there are many good resources evolving both within and outside of the United States, those resources are scarce and relatively immature. It seems that without some basics, such as legal definitions, standardized testing practices, and an agreement that food fraud is much more than substitution of one ingredient for another, we have a very long way to go if we expect to get the food fraud system under control.
From measurement tools to a shift in mindset and leadership, a recent debate at the Food Safety Consortium brought to light the varying levels of opinion and understanding about food safety culture. In a four-part series with Food Safety Tech, Brian Bedard, executive director of the GMA Science and Education Foundation and Lone Jespersen, director of food safety at Maple Leaf Foods continue the conversation about food safety culture and where it’s headed in 2016.
Food Safety Tech: What is the most controversial aspect to the concept of Food Safety Culture?
Lone Jespersen debates food safety culture at the Food Safety Consortium in November.
Lone Jespersen: I don’t think there are a lot of controversial aspects. I think the debate in Chicago [at the Food Safety Consortium] showed exactly that—companies understand the importance of food safety culture. The challenges that we collectively face lies in what food safety culture is and how we can best measure improvements within our organization to sustain a strong and effective food safety culture. That, by definition, requires that we know what food safety culture is and what we are going to measure. That is where the lack of clarity, understanding, and alignment is.
Over the last few months, I’ve done a lot of comparisons between the measurement tools, and they’re actually not terribly different, but as usual, we get confused by words. As long as we have a clear understanding of how tools are different and what they actually measure, it will be possible for each of us to select the best method for our organization. It’s more confusion than controversy. If we speak of controversy, I think it is with manufacturers and processors who are increasingly worried about what FDA is going to do when they talk about the food safety culture—will investigators come and look for food safety culture without a clear understanding of what it is? Again, it requires that we have a common understanding, which we don’t have today.
Brian Bedard of the GMA SEF at the Food Safety Consortium
Brian Bedard: I agree. It’s not really controversy; it’s more of confusion and misunderstanding. We’re seeing some alignment and a better understanding that food safety culture is not something totally different and out in left field; it’s a new way of looking at food safety that is all-encompassing and gets around what was happening in the past, which was an ad-hoc, disjointed approach to dealing with food safety issues. It gives companies a more refined process to drive food safety that everyone can understand, from senior managers right on down.
Regulators around the world are looking at food safety culture as one way to help them do their work better. Our concern is that food safety culture shouldn’t become a regulatory tool per se but should be awareness and [an] appreciation that food safety culture at a company can help regulators better understand the risks they are supposed to be evaluating in a preventive manner.
The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MOREJespersen: It’s also about looking at food safety culture and the discussion today, which largely takes place in the forum of food scientists, food safety leaders, heads of food safety at large organizations—in other words, between individuals who are educated and experienced food safety professionals. Their experience is in developing microbiological environmental testing programs, full-scale food safety management systems that go across manufacturing facilities—very complex and technical issues, all of which couldn’t be more different than that required of a professional within an organizational where it’s about behaviors and consequences. The same goes for investigators and auditors [and their roles]—they’re good at assessing written systems, etc. What about behavioural observations and assessments? This stakeholder assessment hasn’t been a part of the debate, and we need to bring it in.
Monitoring for veterinary drug residues is conducted to ensure food safety and compliance with approved veterinary medicine practices. Veterinary drugs are used in animal husbandry for a variety of reasons, including as a curative/preventive of disease in herd and flock, to improve meat quality, and to promote growth. The chemical classes of drugs that may be used are broad, but major classes include antibiotics, anti-parasitics, and hormones. While risk-modifiers are used to minimize risk for consumption, residues from these drugs, their breakdown metabolites, or associated impurities of the drug may persist in animal tissue, necessitating the requirement that contaminant testing be undertaken.
In the United States, trace analysis of contaminants in food products began in the early 1970s following amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1968. Worldwide, the regulatory requirements for contaminants in food have seen significant tightening due to a number of high-profile contamination crises and increased trade of food across country borders. From the technology standpoint, lower detection limits have been made possible by improvement of the detection capabilities of the analytical methods and instruments. Some of the most stringent requirements for contaminants in food are found in the European Union, where the levels of contamination should be below Minimum Residue Limits (MRLs), whereas in the United States, such limits are called U.S. tolerances.
Image courtesy of MilliporeSigma
When analyzing for drug residues, the choice of tissue has historically been the liver and kidney tissues, as these organs serve to remove the contaminants from the body and, as a result, the concentration of contaminants there is higher and easier to detect. Muscle tissue now often is added to the target list, as its contamination would have a direct impact on consumers.
With regards to veterinary drugs testing, one can distinguish between screening methods and confirmatory methods. The former should be fast and high-throughput and used to detect the presence of an analyte. The confirmatory methods should be able to provide confirmation of an analyte’s identity and quantitation at the levels of interest. Microbiological methods were popular for screening of antimicrobial drugs since these drugs inhibit growth of microorganisms, but suffer from a lack of specificity since not all microorganisms are equally sensitive to all antibiotics. Rapid screening methods include immunoassay-based testing kits, which are specific, fast, and can include multiple antibiotic classes in one test. Confirmatory methods typically include chemical analysis techniques with LC-MS detection, which provides the best ionization for most classes of veterinary drugs, along with better selectivity for focused analysis and lower detection limits. LC-MS can provide specific analysis of compounds from multiple classes in the same run through either targeted MS/MS or non-targeted analysis of unknowns through high mass resolution methods. The speed of LC-MS analysis has improved with the introduction of ultra-high pressure liquid chromatography-MS (UHPLC-MS) instruments. In the last few years, UHPLC-MS methods simultaneously serve as screening and confirmation methods for multiple classes, so called “multi-residue methods”. Some of these methods use MS/MS detectors and some use high-resolution mass spectrometers utilizing time-of-flight and ion trap detectors. These methods now can provide fast turn-around time and better accuracy in comparison to microbiological methods. They may be preferentially used by testing laboratories that are equipped and capable of utilizing the latest MS instrument technologies.
The 4th Annual Food Labs conference provides practical solutions and best practices on running, managing and equipping a food lab. | March 7–8, 2016, Atlanta, GA | LEARN MOREAll mass spectrometry methods that strive to perform simultaneous analysis of multiple veterinary drug classes are prone to the same drawbacks. Due to the differences in the analytes’ polarity, acidity and hydrophobicity, the quantitative extraction of analytes from tissue samples could be difficult. Ideally, the sample preparation methods should be compatible for compounds with varying physico-chemical properties but still provide selective separation from the matrix components to avoid occurrence of matrix effects during quantitation. The co-extracted matrix impurities are undesirable since they can affect the ionization of targeted analytes and result in under- or over-estimation of their concentration (ion suppression or enhancement). Due to the difficulty in designing a method that works for a wide variety of analytes, cleanup is often omitted for multi-class multi-analytes methods, and the stable isotope internal standards are used to correct for ionization effects during quantitation. However, omitting the sample cleanup could lead to other methodology problems.
As noted in the veterinary drug analysis session during the 2015 AOAC Annual meeting, sample cleanliness can result not only in matrix effects and impact quantitation, but it can also have an effect on the mass accuracy when high-resolution mass spectrometry is used and, therefore, can affect the identification of the analytes and lead to false negatives.
The most often used methodologies for sample cleanup during analysis of veterinary drugs in tissues is solid-phase extraction (SPE), both in cartridge and dispersive formats. C18 SPE proved to be a very versatile sorbent that often resulted in the best cleanup and best precision of analysis, closely followed by polymeric sorbents when applied to multi-class LC-MS analysis.
Aminoglycosides Antibiotics
Aminoglycosides is one class of veterinary antibiotics that is hard to include into multi-class methods. The aminoglycoside structures include connected modified sugars with different number of substituents including hydroxy- and amino-groups. The higher degree of polarity for aminoglycosides contributes to their solubility properties: these compounds are freely soluble in water and to some extent are soluble in lower alcohols, but are not soluble in common organic solvents and have solubility issues in solvent-water mixtures with high organic contents. Therefore, the normal extraction conditions that include organic solvents and are frequently applied to most other classes of veterinary drugs do not work well for aminoglycosides. A separate method is often used to extract and analyze these antibiotics.
Most often aminoglycosides are detected by mass spectrometry through the formation of positive ions during electrospray ionization. The LC separation of aminoglycosides could be done by either a reversed-phase (RP) method with ion-pair mobile phase additive to insure the retention of compounds or by HILIC chromatography. We have investigated both methods and looked at the sensitivity for detection of these compounds. The use of ion-pair is most often presented as a disadvantage, as it can reduce the analyte signal through the decrease of ionization efficiency and fouling the LC-MS instrument. While the use of ion-pair in our study decreased the ionization for some of the lighter compounds in this class (streptomycin, puromycin), ionization efficiency increased for the heavier mass compounds (gentamycin, neomycin). RP chromatography resulted in improved separation of the analytes compared to HILIC. LC-MS fouling from the use of HFBA was not observed in our investigation that spanned the course of a couple of years. In the HILIC mode with use of formic acid as a mobile phase additive, the detection of neomycin was problematic due to very low sensitivity. It was as low as one seventh of the sensitivity obtained by RP method.
The instrument response for aminoglycosides also depends on sample extraction and cleanup and the accompanying matrix ionization effects. The extraction from animal tissues has been traditionally done using the McIlvaine buffer that includes 2% Tricloroacetic acid (TCA) to precipitate proteins and release any bound analytes and 0.4 mM EDTA to prevent the binding of the analytes to cations and/or glass. Then the extract undergoes cleanup steps using SPE. The SPE sorbent most often used is a cation exchange phase, as the aminoglycosides have ionizable amino-groups and can be retained from the extract through ion-exchange interactions. Another option for the SPE cleanup became recently available—molecularly imprinted polymeric (MIP) SPE. MIPs, which are sometimes called “chemical antibodies”, mimic the performance of immunoaffinity sorbents. MIPs have binding sites that conform to the shape and functionality of a specific compound or a compound class. Strong binding of the analyte to the MIP makes it possible to perform intensive SPE washes that lead to very clean samples. Unlike immunoaffinity sorbents, MIPs are compatible with organic solvents and strong acids and bases.
We have tested the MIP SPE versus the traditional weak cation exchange (WCX) SPE cleanup for aminoglycosides spiked into pork tissue. The resulting ionization effects were compared as an indication of samples cleanliness. The quantitation in both cases was done using matrix-matched calibration curves and in both cases the recoveries for most of the ten tested aminoglycosides were above 70% (with exception of spectinomycin at 33% in case of WCX cleanup and tobramycin at 55% in case of MIP cleanup). For the two cleanup methods, there was a significant difference in matrix effects. In Figure 1, matrix factors close to 1.0 indicate little to no matrix influence for analyte detection: the ionization of the analyte in mass spectrometer is not influenced by co-extracted matrix impurities and quantitation values are not skewed. Values for matrix factors that are significantly greater than 1.0 suggest matrix enhancement for the analyte and values less than 1.0 are considered to be the result of matrix suppression. Significant matrix suppression was observed for all analytes when WCX SPE was used for cleanup. The ion suppression effect was significantly less for samples cleaned using MIP SPE. In addition, we observed significant time savings when using the MIP SPE cleanup method, as it did not require sample evaporation after using water-containing elution solvent.
Figure 1. Matrix factors close to 1.0 indicate little to no matrix influence for analyte detection
Conclusions
While improvement in the laboratory instrumentation allows the simultaneous and fast analysis of multiple contaminants, sample preparation remains important for reliable identification of contaminants in screening methods and error-free quantitation in confirmatory methods. Both the extraction and sample cleanup methods can contribute to accurate multi-class methods analyzing wide variety of veterinary drugs. New and upcoming technologies such as molecularly-imprinted polymers could be used for more targeted analysis of specific classes of analytes via instrumental methods.
Increased media attention and consumer awareness of verifying ingredients, detecting allergens and effectively tracing the source of outbreaks has placed much higher scrutiny on food processors and manufacturers. With the anticipated FSMA final rule on intention adulteration (Focused Mitigation Strategies to Product Food Against Intentional Adulteration) expected in late spring, having the ability to effectively detect and address product contamination and adulteration will be of significant importance to manufacturers. In preparation for the upcoming Food Labs Conference March 7–8, Food Safety Tech sat down with Craig Schwandt, Ph.D., director of industrial services at McCrone Associates, to learn how contamination is currently affecting food companies and what they should be doing to protect their products and ensure consumer safety.
Craig Schwandt will be presenting “Contaminant Particle Identification: Establishing Provenance and Complying with FSMA” at this year’s Food Labs Conference | March 7–8 | LEARN MOREFood Safety Tech: What are the big issues facing the food industry related to product contamination?
Craig Schwandt: I think the biggest issue facing the food safety industry is realizing that FSMA, in its final ruling, comes with requirements to ensure food safety from farm to table. In the past, many [ingredients] were GRAs, or generally recognized as safe, so when there was a contaminant, [food companies] had a lot of liberty in disposing of the batch and weren’t too concerned about where it came from.
FSMA is going to require that [food companies] keep records of what contaminants are found, how they address it and whether it’s a recurring problem, and [that they] have a procedure in place to track back and [conduct] forensic analysis. In the analytical services industry we call it investigational analysis, which is a description of what actually takes place for ascertaining what the contaminant is and how it got there. That information is provided to clients so they can track back in their production process—all the way to the raw materials and then ascertain where the contaminants came from in that production chain.
The big challenge will be in recognizing that they have to start keeping records and then actually doing the investigation to determine what contaminants are there and determine where they’re coming in.
Craig Schwandt, Ph.D., McCrone Associates
FST: Are companies taking the right steps to detect and identify contaminants in food?
Schwandt: Some of them do and some don’t. At last year’s Institute of Food Technologist’s conference in Chicago, there was a session on FSMA in which there were representatives from FDA, the Grocery Manufacturers Association and a major food company. I was a little bit shocked by the food company’s position. They felt they didn’t need to take all of the steps required by FSMA because they dealt directly with producers from all over the world. They felt removing intermediaries from their supply chain sufficiently protected their products from adulteration. This seems to be oversimplifying the production and supply chain process. Even though they may directly deal with farmers, there’s still opportunity from the time food stuff is harvested to being dried, placed in containers, and shipped from overseas to the U.S.—there are several steps where unintentional contaminants can arise. So to say they didn’t need to look at the potential for contamination because they dealt directly [with farmers] is a bit oversimplified. I think this perspective typifies some of the industry’s viewpoint at the moment.
The Foreign Supplier Verification Program specifically addresses this concern. Even companies that deal directly with producers and supplies in the country of the product’s origin will be required to demonstrate that they tested it and verified it as uncontaminated.
The understanding and recognition by suppliers of these new regulations is the biggest issue facing the food industry right now—especially now that the final rulings have been issued and we’re in the grace period before compliance with the regulation is required.
FST: What technologies are helping in the effort to fight product adulteration, especially as it relates to FSMA compliance?
Schwandt: Handheld instrumentation is making headway at identifying, at a gross scale, screening capabilities—handheld x-ray fluorescence instrumentation and handheld infrared spectroscopy, to identify things at the bulk level. Mass spectrometry methods and chromatography are exceptional at their ability to do really fast general screening for chemical adulterants. I think many of the food laboratories and food companies have in-house laboratories and screen in that general way.
In terms of some of the solid phase contaminants, I think there’s a lack of in-house capability at the moment where one can use simpler [methods] like optical microscopy and another microscopy-based methods to identify the physical solid phase contaminants.
A good example is the use of magnetometers. Many companies use large-scale process line magnetometers to highlight the presence of metal pieces in their product. A magnetometer tells you that there are metal contaminants in your product, it does not provide a specific alloy identification. Whether one needs to go further to use additional methods and actually ascertain the composition of the alloy, is the question. That’s a new requirement—to identify what it is and then to try and assess where in the process it may have occurred. Using a microscopy-based method is advantageous because metal pieces are easily isolated and identified. Once food industry clients have an idea of what the alloy is, they can compare it to the metal alloys that make up their machinery along the way, whether it’s packaging or sorting machinery, [and] essentially establish where the particles enter into the food process.
Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.
Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.
Food Safety Tech: How has FSMA changed the landscape of employee training?
Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.
Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.
FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?
Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.
Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.
Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.
The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.
FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?
Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.
“When a flower doesn’t bloom you fix the environment in which it grows, not the flower.” A quote, by Alexander Den Heijer, trainer, speaker, purposologist, that rings true in food safety. When there is a contamination issue in food processing, one must fix the environment in which food is being processed. Safe food is a product of a clean environment.
We have better environmental sampling programs in our food manufacturing plants and processing facilities, and we have sanitation standard operating procedures, so why are we seeing a prevalence of Listeria, and in rising numbers? I recently sat down with Jeff Mitchell, vice president of food safety at Chemstar, about the recent increase in Listeria outbreaks and how you can rid your facility of the dangerous pathogen.
We’re seeing Listeria—in product recalls and outbreaks—over the last couple of years, and in multiple numbers. Why do you think this is happening?
My interview with Jeff Mitchell about the increase in Listeria recalls. Watch the video
Jeff Mitchell: The distribution of Listeria in the environment has not changed, and the processes that we use for processing food really haven’t changed. What’s changed is the way that we collect data. We have PulseNet now, which gathers information. If someone goes to a medical treatment facility with a foodborne illness, they’re going to investigate that and they’re going to get the whole genome sequencing on the pathogen.
There’s a difference between understanding what transient Listeria is and resident Listeria. I think there are a lot of sanitation efforts being put forth to eliminate the resident populations—those are the populations we’re most concerned about, and they’re the ones that are being related back to a lot of these recalls.
If I have resident Listeria in my facility, why can’t I find it?
Food Safety Tech is organizing a Listeria Detection & Control Workshop, May 31 – June 1, 2016 in St. Paul, MN. LEARN MOREMitchell: Resident populations of Listeria are found in a biofilm—most bacteria aggregate within a biofilm. A biofilm is a survival mode for the bacteria; it protects it from sanitizer penetration. That layer actually masks it from sampling. You could swab a surface or an area and not pick it up, because the biofilm is masking it.
Jeff goes on to discuss the type of sanitation program that companies should have in place to get rid of resident Listeria. You can learn about the steps you need to take in my video interview.
The FSMA Third Party Accreditation (TPA) final rule was published in the Federal Register in final form on November 27, 2015. Although TPA is not limited to imported food, its primary use will most likely be for food imports. TPA offers foreign food facilities and food importers a way to show FDA that the items coming to the United States meet federal food safety requirements.
An acceptable audit by a certified auditor is the only way an importer can take advantage of another FDA program, the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. If FDA deems it necessary, the agency can also require certified audits for the import of specific foods.
The TPA process requires a number of administrative steps by FDA and non-FDA entities before the first third-party inspection is made. The four major steps are:
FDA is responsible for officially recognizing accreditation bodies.
An officially recognized accreditation body will accredit third-party certification bodies.
The accredited third-party certification body will certify third-party auditors.
The certified auditors will conduct consultative and regulatory audits of food facilities.
If FDA does not find an applicant that it can officially recognize as an accreditation body within two years, it may directly accredit third-party certification bodies.
In order to recognize an accreditation body, FDA must review an applicant’s legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. By using an already existing framework familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) standards, supplemented if necessary, in meeting program requirements under this rule. An official recognition of an accreditation body is granted for up to five years.
FDA is authorized to recognize a foreign government/agency or a private third party as an accreditation body under TPA.
Recognized accreditation bodies under TPA will be required to:
Evaluate potential third-party certification bodies for accreditation, including observing representative samples of the prospective certification body’s work
Monitor performance of the third-party certification bodies it has accredited, including periodical on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted
Self-evaluate and correct any problems in their own performance
Submit monitoring and self-assessment reports and other notifications to the FDA
Maintain and provide the FDA access to records required to be kept under the program
Once accredited, third-party certification bodies under TPA are required to perform unannounced facility audits, and to notify the FDA if a condition is found that could cause or contribute to a serious risk to public health.
The food industry is becoming increasingly fast-paced. Regulations are changing, the supply chain is becoming more transparent, and resources are harder to access. To meet the needs of an ever-changing industry, digital learning is becoming the go-to solution for training managers and frontline food handlers alike, as it can be done quickly and efficiently. Now that most people have smartphones and mobile devices, there are multiple ways to make learning accessible.
Image courtesy of Alchemy Systems
The “Mind of the Food Worker” study conducted by the Center for Research and Public Policy (CRPP) points out that food workers have developed a preference for digital training over traditional classroom or instructor-conducted training. There are many new approaches to learning, including web-based eLearning, kiosk, gamification/competition, social media, digital signage, and coordinated communication programs. Let’s take a closer look at each of these.
eLearning
eLearning is no longer about reading through a PowerPoint presentation or watching a pre-recorded video. The number of companies offering eLearning continues to increase, as do the topics, content and format of the content. In addition, eLearning carries the added benefit of being affordable. For many companies, saving on the cost of travel when an individual attends a workshop provides an attractive incentive.
The ability to learn at one’s own pace at the time and place of one’s choosing has special appeal for today’s learners. The availability of eLearning via mobile devices is meeting that desire. It can be seen everywhere—people glued to their mobile devices while waiting in line, taking a lunch break, or in the evenings on their own time. This is multitasking at its finest.
Kiosks
The ability to take a device to a quiet environment helps with concentration and efficiency in training. Kiosks can be set up in an area that is conducive to learning with no traffic, noise or other distractions and are popping up at workplaces more and more. Learners can come and go at their convenience. A learning lab set up in a manufacturing facility will pay for itself very quickly. Sending workers to the lab one at a time is much more cost effective than shutting down a line or area of the plant for group or classroom training.
Gamification
Gamification, the use of interactive tools in conjunction with learning, is a term being used more often in training industry vocabulary. For example, it can involve the addition of a word and a definition-matching exercise in conjunction with a training module to encourage learners to retain what they have just learned. It also makes the education process more fun—and it seems to be working.
Gone are the days of sitting through hours and hours of dry lectures or reading textbooks that simply do not resonate. This method has always been especially difficult for employees working in a food plant. Sitting in a warm darkened room listening to a droning presentation is an invitation to sleep. Gamification eliminates the droning, and requires attention and participation.
The Association for Psychological Science has confirmed that competition engages learners, drives retention, and leads to higher test scores. Got a boring topic for training? Get your game on! A great example of gamified learning that is readily available is Merriam-Webster’s Word of the Day. Sign up for free and receive a daily email with a new word, along with its pronunciation, definition(s), use and history. The email also links to several great games that provide word calisthenics for the brain.
Social Media
Leveraging social media helps to expand and continuously improve training programs. This mode of technology will ensure that every employee in a company has timely, consistent answers to questions. Using private company social media provides a safe environment for posting questions and answers while complementing a training program and filling any knowledge gaps. The CRPP study points out that 80% of workers regularly use public social media platforms such as Facebook and LinkedIn.
Companies can take full advantage of this familiarity with social media by providing an internal forum that encourages open discussion and group learning. This approach enables the workforce to engage in an interactive learning path that is continually up to date. Internal social media also encourages networking, which fosters a sense of camaraderie between individuals, along with company loyalty. One major food company that has used this approach has seen employee questions flourish from 3,000 entries in the first year to more than 15,000 the following year. What an incredible way to keep the workforce updated minute by minute with appropriate, relevant answers to their inquiries.
There is no question that we are in the midst of a unique time period in history. Technology is continuing to innovate at an increasingly rapid rate, which has led to drastic changes that affect nearly every corner of day-to-day life. From the way we find information to our food choices, technology is influencing our lives in new ways.
The Rise of the Internet
Mary Meeker, the venture capitalist who was dubbed the “Queen of the Internet” more than 15 years ago, has described the current Internet age as a period of reimagining. At the heart of this reimagining has been the rapid growth, maturity and adoption of the Internet and Internet-enabled technologies.
In her most recent 2015 research, Meeker published some fascinating statistics. The number of people online has ballooned more 80 times, from a user base of a mere 35 million in 1995 to a staggering 2.8 billion users in less than 20 years. This figure translates into nearly 40% of the total global population.
A breakdown of the 2.8 billion Internet users in 2014. This figure (39% global penetration) exploded from the approximately 35 million users in 1995. Source: Internet Trends 2015 – Code Conference
It hasn’t just been the volume of usage that has evolved radically. The nature by which those billions of users are signing online has also changed. It’s hard to believe that the original iPhone was released in 2007, less than 10 years ago. In that time, the mobile Internet has gone from a novelty to a necessity for many of us in our daily lives. This smartphone adoption has fueled Internet use and has drastically increased the ease with which consumers can get online.
Reimagining Communication and Compliance
The result of our new “always-on,” globally connected world (to borrow Meeker’s term) is a complete reimagining of communication. Consumers expect a velocity and volume of communication that the world has never before experienced. We now take for granted that we can reach friends, family and acquaintances anywhere in the world—at any time—in an instant. This has also drastically changed our expectations of business relationships.
Consumers in an ever-connected world have an expectation of availability and transparency of information from the brands with which they interact and the establishments they frequent. What this means for businesses is that customers expect to have a degree of access to business data that they’ve never asked for previously.
A tangible side effect of this desire for data transparency can be seen within the regulatory environment that organizations operate. Governments and regulatory bodies have increased their expectations of data access and availability over time, resulting in more stringent regulations across the board.
Research from Enhesa shows that the regulatory growth rate is nearly as staggering as Internet growth rates. According to the firm’s research, from 2007–2014 regulatory increases by region were as follows:
North America: +146%
Europe: +206%
Asia: +104%
Impact on Food Safety: Consumer Engagement and Regulatory Growth
One particular area of regulatory growth has occurred within the food and beverage sector. Arguably no product category has a more direct impact on consumers than food, as it literally fuels us each day. It’s no wonder that in an environment of increasing regulations and more empowered consumers that food quality and food safety are under increased scrutiny.
In today’s environment, it becomes much more challenging to brush aside product recalls and food safety incidents or bury these stories in specialized media. The latest news is not just a fleeting negative headline. In a worst-case scenario these incidents are viral, voracious and more shareable than ever before. From Listeria outbreaks to contaminated meat to questionable farming practices—when fueled by the Internet, the negative branding impact of these stories can be staggering. Consumers are paying attention and engaging with these stories—for example, during a Listeria or Salmonella outbreak, online searches for these terms significantly rise.
The rise of hyper-aware consumers has had a measurable impact. As a result, governments have been quick to respond and have beefed up existing regulations for the food and beverage sector via FSMA and GFSI.
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