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Data management, food manufacturing

FSMA and the Importance of Data Visibility and Management in Food Manufacturing

By Jeff Budge
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Data management, food manufacturing

Implementation of FSMA has prompted many organizations to take a closer look at sanitation practices, documentation of food safety plans and the traceability of materials and ingredients used to create food products.

Meanwhile, shifts in technology, such as cloud migration as well as the rise of big data and analytics platforms, present both opportunities and challenges in food manufacturing.

In many cases, digital transformation, including the adoption of a multi-cloud strategy, occurs as part of a roadmap set forth by a food company’s software vendors. Tech giants, including Microsoft, Oracle and SAP, are driving digital transformation through the modernization of ERP systems and dictating how food companies should utilize applications, data and software.

In those situations, digital transformation is not a choice, it’s a requirement. CIOs and IT professionals are seeking help. They are looking to understand the dynamics and characteristics of these new environments because they are compelled to change.

Yet, there are also organizations that would rather do more than simply follow the lead of their software vendors. Instead, they choose their own destiny in terms of IT modernization. They’re looking for opportunities by leveraging data to make better business decisions.

Before a food manufacturer can get to that point, however, there must be a strategy for gathering, storing, connecting and presenting different types of data across an organization as well as to external customers and business partners.

Managing the data required for FSMA compliance is an ideal example of the importance of pursuing digital transformation.

Food Safety Data and FSMA Compliance

A major component of FSMA involves having detailed documentation of a food safety plan and the ability to produce data proving adherence to that plan when the FDA shows up for a plant inspection. Food manufacturers need to show best practices are being followed, and that corrections are being made when concerns emerge. Otherwise, the FDA may impose fines or temporarily shut down production, which cuts into the bottom line.

Because of FSMA mandates such as the Sanitary Transportation Rule, your documented food safety plan needs to be communicated to key participants throughout the supply chain as responsibility for food safety problems typically falls back to the manufacturer.

For that reason, food processors need solutions allowing them to track and trace their product from the farm field to store shelves, or to any other final customer.

Imagine being a food manufacturer trying to document sanitation in a basic spreadsheet or even on paper. The extra work involved with specifying food safety tests, collecting and archiving results, and validating sanitation procedures would be overwhelming. Yet, just as perplexing of an issue is being a digitized food manufacturer with poor visibility and management of all the information that various IT systems and platforms provide.

Most companies acknowledge that the cloud is a necessity in today’s world. Organizations often need multiple cloud solutions to accomplish business objectives, from regulatory compliance to finances, inventory control and distribution.

CIOs, technology professionals and food safety/sanitation leaders should work with existing IT solutions partners or find consultants and experts who can ensure the following questions can be answered:

1. Is the location of your data known?

Data visibility in the cloud is the first step in the process, and it is a challenge for many organizations. You need to know where your data lives, that the right people have access to it and that it is secure. When you know where your data lives, you’ll better understand how to use and protect it.

2. Is your data in a location that allows for integration?

Can the different applications your company uses talk with each other, or is all the information siloed across different cloud providers and departments in the organization? Is it integrated? Can certain information, such as food safety plans, be communicated with partners including suppliers, distributors and your carrier network?

3. Can your data be put into a framework allowing it to be extracted, visualized and leveraged?

Data doesn’t help anyone if you’re unable to take that information and use it to make better business decisions. Whether it’s food safety, operational efficiency, forecasting needs or developing new ideas, the most successful food manufacturers will leverage integrated data to move the organization forward.

Data management, food manufacturing
Managing the data required for FSMA compliance is an ideal example of the importance of pursuing digital transformation in food manufacturing facilities. (Image courtesy of One Neck IT Solutions, LLC

The Advantages of Pursuing Digital Transformation

If you were to go back about a decade and observed a small- to mid-sized food manufacturer using Microsoft as its data platform, that manufacturer would likely have been running applications for the business that created data while receiving little guidance pertaining to how the information should be interpreted and used. Fortunately, that has changed.

Today, companies like Microsoft, Oracle and SAP actively focus on the use of data rather than only data collection. The right IT solution, coupled with expert partners, allows you to eliminate the guesswork and leverage data to your advantage.

FSMA mandates are complicated, and compliance is crucial, but the pursuit of digital transformation supports the efforts of food manufacturers who are prepared to improve transparency and responsibility surrounding food safety.

Digital transformation represents change, which is never easy, but it will be worth the effort. Start by evaluating your organization’s technology needs as they relate to FSMA compliance as well as additional business objectives. Then, identify areas of internal strength and areas where improvements are needed.

Some food manufacturers partner with an IT solutions provider for support developing a cloud migration plan and a subsequent strategy for operating in multi-cloud environments. Others need managed services, helping them handle day-to-day IT needs through outsourcing so in-house resources can develop high-value solutions. Still, others are looking for consultative guidance to help them understand what changes in technology truly mean to their organization.

You want your people to focus on what they do best. Many food manufacturers are in locations where there’s a lack of technical resources for hire. That’s why they turn to IT consultants and service providers who understand their business, can provide expertise that fills the talent gap and are able to interpret business needs into technology solutions.

Digital transformation isn’t one big project, it’s an ongoing journey, a series of waves of new technologies and new ways to use applications and data. Make sure you find trustworthy allies to give you the guidance and solutions you need, not only for regulatory compliance but for growth and continued success.

Recall

Meat Recall Roundup: Listeria, Salmonella and Allergens the Culprits

By Food Safety Tech Staff
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Recall

The meat industry has been on alert over the past few days, much of which has been due to Salmonella and Listeria concerns. The following are the Class I recalls that have hit:

  • JBS Tolleson, Inc. recalls 6,937,195 pounds of raw non-intact beef products over concerns of Salmonella Newport contamination. According to the CDC, there are currently 57 reported cases across 16 states. No deaths have been reported. A traceback investigation involving store receipts and shopper card numbers enabled FSIS to trace the reported illnesses to JBS “as the common supplier of the ground beef products”.
  • Johnston County Hams recalls more than 89,000 pounds of RTE deli loaf ham products over concerns of adulteration with Listeria monocytogenes. The CDC and other health agencies are monitoring the outbreak, which has thus far infected four people, and one death has been reported. Recalled products were produced between April 3, 2017 and October 2, 2018. Also connected to this event is the recall of Callie’s Charleston Biscuits, which may contain ham from Johnston County Ham.
  • Canteen/Convenco recalled more than 1700 pounds of RTE breaded chicken tenders with BBQ sauce and hot sauce. The products were misbranded, as they may contain milk, and this was not declared on the finished product label. Thus far there have been no reported cases of adverse reactions due to consuming the products.
  • Ukrop’s Homestyle Foods has recalled more than 18,200 pounds of RTE meat and poultry deli-sliced products over concerns of product adulteration with Listeria monocytogenes. The products were produced and packaged from September 14–October 3, 2018. No confirmed illnesses have been reported to date.
Stephanie Pollard, ClearLabs
In the Food Lab

The Power of Advanced NGS Technology in Routine Pathogen Testing

By Stephanie Pollard
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Stephanie Pollard, ClearLabs

The food industry is beginning to transition into an era of big data and analytics unlike anything the industry has ever experienced. However, while the evolution of big data brings excitement and the buzz of new possibilities, it also comes coupled with an element of confusion due to the lack of tools for interpretation and lack of practical applications of the newly available information.

As we step into this new era and begin to embrace these changes, we need to invest time to educate ourselves on the possibilities before us, then make informed and action-oriented decisions on how to best use big data to move food safety and quality into the next generation.

Stephanie Pollard will be presenting “The Power of Advanced NGS Technology in Routine Pathogen Testing” at the 2018 Food Safety Consortium | November 13–15One of the big questions for big data and analytics in the food safety industry is the exact origins of this new data. Next Generation Sequencing (NGS) is one new and disruptive technology that will contribute significantly to a data explosion in our industry.

NGS-based platforms offer the ability to see what was previously impossible with PCR and other technologies. These technologies generate millions of sequences simultaneously, enabling greater resolution into the microbial ecology of food and environmental surfaces.

This represents a seismic shift in the food safety world. It changes the age-old food microbiology question from: “Is this specific microbe in my sample?” to “what is the microbial makeup of my sample?”

Traditionally, microbiologists have relied on culture-based technologies to measure the microbial composition of foods and inform risk management decisions. While these techniques have been well studied and are standard practices in food safety and quality measures, they only address a small piece of a much bigger microbial puzzle. NGS-based systems allow more complete visibility into this puzzle, enabling more informed risk management decisions.

With these advances, one practical application of NGS in existing food safety management systems is in routine pathogen testing. Routine pathogen testing is a form of risk assessment that typically gives a binary presence/absence result for a target pathogen.

NGS-based platforms can enhance this output by generating more than the standard binary result through a tunable resolution approach. NGS-based platforms can be designed to be as broad, or as specific, as desired to best fit the needs of the end user.

Imagine using an NGS-based platform for your routine pathogen testing needs, but instead of limiting the information you gather to yes/no answers for a target pathogen, you also obtain additional pertinent information, including: Serotype and/or strain identification, resident/transient designation, predictive shelf-life analysis, microbiome analysis, or predictive risk assessment.

By integrating an NGS-based platform into routine pathogen testing, one can begin to build a microbial database of the production facility, which can be used to distinguish resident pathogens and/or spoilage microbes from transient ones. This information can be used to monitor and improve existing or new sanitation practices as well as provide valuable information on ingredient quality and safety.

This data can also feed directly into supplier quality assurance programs and enable more informed decisions regarding building partnerships with suppliers who offer superior products.

Similarly, by analyzing the microbiome of a food matrix, food producers can identify the presence of food spoilage microbes to inform more accurate shelf-life predictions as well as evaluate the efficacy of interventions designed to reduce those microbes from proliferating in your product (e.g. modified packaging strategies, storage conditions, or processing parameters).

Envision a technology that enables all of the aforementioned possibilities while requiring minimal disruption to integrate into existing food safety management systems. NGS-based platforms offer answers to traditional pathogen testing needs for presence/absence information, all the while providing a vast amount of additional information. Envision a future in which we step outside of our age-old approach of assessing the safety of the food that we eat via testing for the presence of a specific pathogen. Envision a future in which we raise our standards for safety and focus on finding whatever is there, without having to know in advance what to look for.

Every year we learn of new advancements that challenge the previously limited view on the different pathogens that survive and proliferate on certain food products and have been overlooked (e.g., Listeria in melons). Advanced NGS technologies allow us to break free of those associations and focus more on truly assessing the safety and quality of our products by providing a deeper understanding of the molecular makeup of our food.

Megan Nichols
FST Soapbox

Sustainability Strategies for the Food Industry

By Megan Ray Nichols
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Megan Nichols

Sustainability is a word that you’ll hear a lot these days, especially as industries try to become more eco-friendly. The food industry has been lagging behind in the world of sustainability, and in order to keep up with national and international food demands, it is difficult to implement the kind of change that is necessary to make the world a little greener. However, that doesn’t mean that food companies shouldn’t try. The following are some sustainability strategies that might be easier to implement in the food industry.

Water Conservation

field irrigation
Field irrigation (Wikipedia commons image)

While the majority of the Earth’s surface is covered in water, only about 3% of that water is drinkable—and 2 of that 3% is frozen in the planet’s glaciers and ice caps. This is why water conservation is so important. According to the United States Geological Survey (USGS), roughly 39% of fresh water used in the United States is used to irrigate crops.

Switching from flood irrigation with sprinklers to drip irrigation can reduce water usage.

Wastewater reuse is also a new technique that is gaining traction in the food industry. While it isn‘t practical in all situations due to the technology needed to remove chemicals and impurities from the wastewater, it can help reduce water waste and water use in the food industry. Simply reviewing water usage and switching to procedures that are less water-intensive can save a company money and reduce its overall water usage.

Natural Pest Control

Pesticides and fertilizers are among some of the most dangerous chemicals in the food industry. For largescale operations, however, they are necessary to ensure a large and healthy harvest. Some companies, such as Kemin Industries, are shunning these typical processes in favor of more sustainable options.

“Our mission at Kemin is to improve the quality of life for more than half the world’s population, and we believe sustainability plays an important role in our work,” said Dr. Chris Nelson, president and CEO of Kemin Industries. “Our FORTIUM line of rosemary-extract-based ingredients uses Kemin-grown rosemary for maximum effectiveness against color and flavor degradation. Kemin is the only rosemary supplier that is certified SCS Sustainably Grown, and we’re one of the world’s largest growers of vertically integrated rosemary.”

Vertical integration doesn’t have anything to do with how the rosemary is grown. In the agriculture industry, it means Kemin owns the entire supply chain for its rosemary, from field to processing to distribution.

“We use botanicals—spearmint, oregano, marigold and potato, in addition to rosemary—in our other products as well,” continued Nelson. “As an ingredient manufacturer, we understand the value of good suppliers. When the planet is supplying us with the ingredients we use in our products, it’s important to us that we are responsible in our growing practices.”

Sustainable Distribution

Distribution is one of the biggest problems when it comes to creating eco-friendly and sustainable supply chains. Upwards of 70% of the products in the United States are transported by truck, and each of those trucks generates CO2 and greenhouse gases.

There are two plans of attack for sustainability in food distribution: Reducing the distance food needs to travel, and upgrading trucks to use greener fuel options like biodiesel or electricity, such as the ones Tesla is offering.

Reducing the emissions created by tractor-trailers could help make the entire process a bit more sustainable, although it would require a large investment to upgrade the distribution process.

Back to Their Roots

It’s only in recent decades that agriculture has started being sustainable in an effort to keep up with the demands of the consumer. By going back to our roots and focusing on farming techniques that promote things like soil health—by rotating crops instead of using artificial fertilizers—and lowering water use and pollution, agriculture can become sustainable once again.

Farming, sustainability
Creative Commons image

Modern agricultural techniques are detrimental, both to the environment and to the people who work there. These methods ensure we have enough food to supply consumers, but they lead to soil depletion and groundwater contamination. In addition to this, it can also lead to the degradation of rural communities that would normally be centered on farm work. That’s because corporate farms focus on quotas and large harvests without the community angle.

These commercial farms also cost more to run, and many have poor conditions for farmworkers because of the harsh chemicals used to kill pests and fertilize depleted topsoil.

Farm numbers have dropped since the end of World War II, with corporate farms taking the place of smaller family farms. While the number of farms has dropped, the remaining farms have increased in size. The average farm in 1875 was roughly 150 acres, and there were more than 4 million of them. Today, less than half that number remains, but the average size of the farms has increased to more than 450 acres.

Sustainability is a popular buzzword right now, but it’s a lot more important than most people believe. Switching to sustainable practices, whether that means changing production, distribution or anything in between, will help ensure the food industry can keep fresh, healthy food on our table for decades to come without damaging the environment. Sustainability is something that should be adopted by every industry, especially agriculture.

Risk, food safety

Food Defense and Intentional Adulteration: How Prepared Is Industry?

By Maria Fontanazza
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Risk, food safety

The FSMA Intentional Adulteration rule (Mitigation Strategies To Protect Food Against Intentional Adulteration) requires companies that fall under the rule to implement a written food defense plan, identity vulnerabilities and establish mitigation strategies based on those vulnerabilities. This is new territory for FDA as well as for many companies in the industry—and for this reason, the agency has established a longer compliance timeline. However, that doesn’t mean companies should wait—the time to prepare is now.

Christopher Snabes, senior manager, food safety at the The Acheson Group (TAG) and Jennifer van de Ligt, Ph.D., associate director at the Food Protection & Defense Institute (FPDI) sat down with Food Safety Tech to discuss some of the challenges they see industry facing related to intentional adulteration and food defense.

In addition, TAG and FPDI are interested in gauging the industry’s level of readiness in this area and have put together the survey, Intentional Adulteration & Food Defense Industry Preparedness. We encourage you to take the survey. And don’t miss subject matter experts from TAG and FPDI at this year’s Food Safety Consortium as they discuss Food Defense: Lessons Learned from Recent Incidents + Key Steps to Mitigating Risks.

Food Safety Tech: Given the subject matter of the survey, what do you feel is the current preparedness level regarding compliance with the FSMA Intentional Adulteration rule?

Christopher Snabes, The Acheson Group
Christopher Snabes, The Acheson Group

Christopher Snabes: I see this from a variety of fronts. Some companies established food defense solely on the events of 9/11, putting initial food defense plans in place [that involved] fences, installing security guards and gates, and locking the outside doors. Some companies we’ve worked with feel this is sufficient enough to meet the IA rule, and that’s not correct.

TAG has assessed several companies that are in the process of conducting food defense assessments, and they’re doing them based on best industry practices, and preparing for the inside attacker and/or a terrorist getting into key production areas.

TAG has worked with some companies that are fully waiting for the second and third guidance documents from FDA to come out before they do the full food defense plan. We’ve worked with some companies doing a mix of the above—they’re not waiting for the guidance but are actively testing their plans and having an outsider test their vulnerability, and then they’re rewriting plans based on the findings. They’ll also update their food defense plans, once the second and third FDA guidances are released to the public.

We feel these are the most prepared facilities; there are not a lot of companies at this point, but they’re starting to pick up steam. At this point, I would say most companies are actively pursuing a food defense plan as well as beginning to test their vulnerability.

Jennifer van de Ligt, Food Protection and Defense Institute, University of Minnesota
Jennifer van de Ligt, Food Protection and Defense Institute

Jennifer van de Ligt: I agree with Chris and would add that in the past two years or so, there’s also been a shift in how the industry is viewing the Intentional Adulteration rule. Many companies currently have food defense plans based on the events of 9/11 and, for the first couple of years, as the new Intentional Adulteration rule was being written, there was still a heavy emphasis on “that should be enough.” I very rarely hear that now when discussing the Intentional Adulteration rule with our industry partners. I think companies are more prepared from an understanding perspective to move beyond perimeter security and guards to really think about the risks in the facilities that would come from people with legitimate access— what the rule defines as “insider attackers”. Although understanding is increasing, Chris is correct that different parts of industry are on different paths. Some just now understand that they have to do more, while others are well on the way on to looking at how they need to structure themselves internally and are already moving towards vulnerability assessments.

FST: Are you seeing company size play a role in the readiness level?

Join the Food Protection and Defense Institute and The Acheson Group (TAG) at the 2018 Food Safety Consortium for an interactive discussion as they explore recent food defense events, highlighting key components of the incidents relative to government interactions, FSMA regulations, brand reputation, financial interests, and public health response. van de Ligt: The larger companies thinking about a multi-international approach seem to be further along in the process. I think they started thinking about the vulnerability assessment, how they’re going to structure it in their company, and how they’re going to come to compliance because of the breadth and the scope that impacts them. But we’re also seeing, at least in our training, some of the mid-sized companies beginning to take action. I think again, they realize that even though they’re smaller, they’re going to need additional resources, and they might not have those resources in house, so it might take them a bit longer.

Snabes: In general I would agree with Jennifer. I think a lot of it is because they have additional resources, and they can leverage them across many facilities as needed. I don’t see as much action being taken outside the United States on the facilities that are importing into the United States. I think that’s just starting to ramp up. I’m also seeing very small businesses that aren’t required to follow the IA rule implementing this because they want to protect their brand.

FST: What challenges are you seeing companies experience in understanding food defense, IA, and the appropriate preventive actions they should be taking?

FSMA Checklist: Intentional Adulteration rule Snabes: Just understanding how the rules can apply to the business. For some companies, that’s still a challenge. Other companies, like the large ones, get it. Other small- and mid-sized companies are still trying to figure out how it applies to them. After that, the challenge is realizing there are expenses involved. For example, they have to install key fobs, cameras in critical areas, etc. They also have to realize they can meet the IA rule by not spending an exorbitant amount of money. For example, within a budget there are things companies can do without having to spend a lot of money, such as food defense awareness training.

Another challenge is educating all workers in food defense; enforcing the food safety culture within the facility and the idea that their job can be at risk. They have to realize that if they don’t recognize an individual inside the premises, or if something is out of place in a critical area, they need to inform their supervisor. If they see something, they need to say something—and ensure that the intentional adulteration is not taking place.

Educating employees is the least expensive way to invest in food defense, and it is the most effective. However, this can be a challenge for the companies that, for example, have a high turnover rate—if you have a lot of employees coming in and out, that means constant training, enforcement and re-educating. We see quite a bit of companies with a large turnover rate.

van de Ligt: I agree with those points. In our training, we also talk about food defense culture and how it needs to be supported across the business, similar to the way food safety culture is already in many of our businesses, and how to incorporate food defense awareness training, and on-boarding and refresher training.

The other challenges I see is that once you get to the understanding of what needs to be done and you get the buy in, there are some logistical issues at some of the companies—from big to small. Some companies are struggling with understanding which part of the business should be responsible for this (the food safety group, the security group, etc). Because we are talking about legitimate access and who is responsible for putting the plan together: How do these groups that may not have worked closely within the bigger companies now create that shared collaborative environment?

At the smaller companies, where they may not have that breadth or resources, now you’re asking a specialist in one area to pick up a completely different expertise and discipline. With a food safety and quality person, part of their job may be supply chain and sourcing, and now they also have to learn food defense. How are they managing and balancing all the different FSMA rules in their portfolio—because you have one person actually thinking about the breadth of them all. This presents a challenge to the logistics of implementation.

The other challenge I see is that FDA has done a really good job in providing input, guidance and listening sessions, and has been open and available to answer questions—more so for this rule than any of the other rules that I’ve watched go through industry. However, with the guidance being published so close to the compliance date it presents a challenge—companies that are waiting on the guidance will have to comply very quickly without the best understanding on what FDA’s thoughts are—because they’re waiting on the pending guidance.

FST: What steps should companies take to mitigate the IA risk?

van de Ligt: I have three action items for every company to take.

  1. Read the IA rule, including the preamble if they haven’t. There’s a lot of information there that will help them understand the mindset and how the IA rule came about.
  2.  Read the guidance document when it comes out. The first guidance contains many clarifying examples that will help understanding and implementation.
  3. Train the key people who are going to be responsible for writing the food defense plan and all employees on food defense awareness.

There are resources out there, whether it’s talking with FDA or coming to a sponsored training, for folks to get assistance in understanding and interpretation, and it would be great for them to take advantage of it.

Snabes: I agree with those three points. In general—do an FDA food defense assessment of your facility. Look for and concentrate on the key activity types that are critical. At least get a list of what areas are going to be the ones you have to mitigate. For example: The offloading of liquids, open vats, hand applied additives, etc. The most important thing I suggest doing right away is food defense awareness training for not just the supervisors, but all the employees—everyone from receiving to shipping to supply chain, etc. Everyone should be aware of the importance of food defense training and how their job depends on it.

In general, with food defense or IA—the rule is a brand new concept to FDA. It’s something they never tackled before. Because of that, there is going to be a longer time of educating before regulating. FDA is going to bend over backwards to work with companies so they understand how this rule is going to be implemented.

Any company out there can have a “strong employee” who wants to cause intentional adulteration, so the time to plan for that is now. Don’t wait for the rule to come into effect before you start planning.

Hot Topics in Intentional Adulteration, Food Fraud and Food Crime

Jessia Burke, Allergen Control Group
Allergen Alley

Allergen Detection & Control: Challenges & Strategies

By Jessica Burke
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Jessia Burke, Allergen Control Group

While global market demand for “free-from” food products is increasing, undeclared and mislabelled allergens, sulphites and gluten, throughout the supply chain, continue to be the number one cause of consumer product recalls. This is of major concern since the number of individuals affected by life-threatening allergies is on the rise, especially in children. Unfortunately, there is no cure for a food allergy; avoidance of allergenic food(s) is the only way to prevent an allergic reaction.

It is clear that allergen recalls negatively affect the consumer, however, they also result in huge financial implications and loss of brand credibility to all organizations involved. Businesses and brands may take a significant hit to their reputation since consumer perception plays a key role in the success of a business. With the increased use of the internet and social media, it is even more important to stay out of the spotlight and avoid recalls.

Among the reasons allergens hold the #1 position for product recalls may be lack of knowledge, insufficient supplier and raw material information, packaging errors, and accidental cross-contact. Cross-contact may be the result of poor cleaning practices, inadequate handling and storage procedures, employee traffic, and improper identification and assessments of risks. In addition, from a regulatory perspective, priority allergen lists and ingredient labeling laws vary from country to country, causing confusion for both manufacturers and consumers.

The good news is, implementing a strong allergen control plan can help to prevent recalls, protecting consumers and your business.

It starts with conducting a thorough risk assessment of each step in your process to determine where procedures and controls need to be implemented. A process flow diagram is very useful in understanding where allergenic ingredients and foods exist in the plant and where they are introduced into the process.

Control measures must be implemented even before raw materials enter the facility. The importance of understanding the incoming ingredients, inputs and suppliers cannot be overstated. The allergen status of every raw material handled or present in a food business needs to be identified and effective risk assessment tools applied. This involves identifying and documenting the food allergens present in each raw material, including non-food items like maintenance and cleaning chemicals. It’s imperative to recognize suppliers and backup suppliers’ vulnerabilities to ensure the success of the program. This should include identifying all allergens handled in the facility, as this might not be obvious based on ingredient declarations or product specification documents. Ensure supplier ingredient specification documents are current and routinely reviewed so accurate assessments can be made about the level of allergen risk.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. It is important to review labels at receiving to confirm the allergen status of raw materials. This serves as verification that ingredients have not been modified and the allergen status is still accurate. It also provides the basis upon which to determine storage and handling requirements. Visual tools are great for displaying the allergen status of each raw material. This can be done through applying color coded stickers or tape, unique tags or some other method, and should be done immediately at receiving. To avoid the potential for cross contamination from one ingredient to another, each allergen and/or group of allergens should have its own designated storage area or space. In addition, never store allergenic ingredients above ingredients that do not contain the same allergen.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. (Shutterstock image)

Controlling allergen risk throughout processing can be a major challenge since there are so many opportunities for cross contact. Ideally, physically segregate production of foods containing allergens from the production of non-allergenic foods. When physical segregation is not possible, dedicated production lines and equipment is best practice. Barring this, scheduling production runs appropriately can reduce the risk of cross contact and minimize sanitation and changeover activities. Where possible, schedule non-allergenic production before processing allergen-containing products. In addition, dedicate and identify tools and utensils for allergenic ingredients and products. Providing a visual aide can help ensure appropriate practices, and one way to do this is through color coding. Similarly, use dedicated employees on non-allergenic production lines and/or allergenic production lines. Make the employees easy to identify by implementing colored uniforms, hairnets or smocks. Identify allergenic materials by labelling or color coding throughout the manufacturing process. This should include rework, which should only be added to work in progress containing the same allergens.

Control of allergens does not stop at processing; the Maintenance department also plays a big role. Sanitary design needs to be considered when purchasing any piece of equipment. The equipment must be easily and fully washable to ensure proper sanitation. Positioning of equipment is also important in terms of cleanability and the potential of cross contact from an allergenic production line to a non-allergenic production line. Airflow and the potential for contamination of air borne allergenic dust to non-allergenic ingredients, products and equipment also should to be considered. Lastly, maintenance procedures must be put in place to prevent cross contact. This includes processes for repairing or maintaining equipment, cleaning tools and changing work apparel between repairs, as appropriate.

Consumers rely heavily on ingredient declarations and allergen statements on packaging to make purchasing decisions. “For those living with the medical condition of food allergy, the simple act of eating is complicated; avoiding their allergen is the only tool they have to manage the risk of a potential allergic reaction. These consumers require accurate labeling information to help them stay safe while still having sufficient food choices,” states Jennifer Gerdts, executive director at Food Allergy Canada. As such, it is imperative that the information on finished product labels and packaging is accurate. A solid allergen control program includes processes for reviewing labels for new and modified products to ensure they are reflective of the ingredients in the product. Labels and packaging should also be verified for accuracy prior to receipt, and at the beginning of a production run or at changeover. Outdated labels and packaging should be discarded immediately to prevent the chance of accidental usage. Inventory control procedures and label/packaging reconciliation is imperative to ensure the correct labels/packaging have been applied to the appropriate finished product.

It is crucial to develop and implement robust procedures for effectively cleaning equipment, utensils, food contact surfaces and non-food contact surfaces. This must include cleaning between batches of allergenic and non-allergenic production and responding to allergen spills. Carefully consider the tools and cleaning chemicals used for each the task, as this can make a significant difference in the success of the sanitation program. Verification and validation of cleaning practices must be undertaken to confirm that cleaning activities are effective in removing the allergens in the facility. This can be done through visual inspections, swabbing after sanitation and trending results.

One of the most important tools for ensuring the success of any allergen control program is educated employees. All foods handlers, regardless of their position, should undertake training in food allergens. Employees are the eyes and ears of the plant floor, the more knowledgeable they are, the more likely proper procedures will be followed, and potential risks identified.

Complete regular reviews of the allergen management program to ensure that it remains current, effective, and continues to assist in the production of a safe and legal food product. The program should be reviewed, at a minimum, whenever a customer complaint is received regarding allergic reactions, there is a change to raw materials or suppliers, there is a change in manufacturing processes, there has been an introduction of new machinery, or there is a change to cleaning practices and procedures.

An important aspect of an allergen control program is allergen testing. Testing can be used to confirm the allergen status of raw materials at receipt, to verify cleaning processes, and to evaluate finished products. An array of test methods exist for this purpose, including but not limited to, immunochemical methods such as ELISA or lateral flow devices, DNA-based methods, such as Polymerase Chain Reaction (PCR), Mass spectrometry (MS), and other non-specific methods such as Protein tests, ATP and visual inspection to verify cleaning. The choice of test method is very important and depends on the purpose of the test, the type of sample, food matrix, processing effects, desired turn-around time, availability of equipment, skill level of person doing the analysis and cost. ELISA and lateral flow devices are often used on-site at the production facility because results can be obtained quickly, costs are relatively low, and personnel can be easily trained to use these tests. In some circumstances of highly processed samples, PCR may be a better choice. However, PCR testing requires specialized equipment and skilled technicians so is usually performed in a third-party testing lab. Mass spectrometry is yet another option but can be costly and like PCR, this method requires specialized equipment and skilled personnel to perform the analysis.

As you can see, there are many factors to consider when developing an effective allergen control program. While it may seem daunting, it is critical understand how to identify and assess all allergen risks and develop a plan to control, verify and validate each one. The upfront work may be challenging, however once implemented, an effective allergen control program will protect allergenic consumers from the potentially life-threatening effects of inadvertently consuming and allergenic product, and will protect your business from financial loss and a tainted brand reputation.

Karen Everstine, Decernis
Food Fraud Quick Bites

A Look at Fraudulent Labeling Practices

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Food fraud happens in many ways, and it can be challenging to categorize the various methods of fraud. Dilution and/or substitution involves the intentional addition of an alternate product with the intent to replace weight or volume (olive oil, juices and fish are prone to this type of fraud). Artificial enhancement is the addition of a substance that is not intended to replace weight or volume, but to have a functional effect (such as the use of industrial dyes in spices). Certain forms of food fraud, such as theft/resale, counterfeit packaging, or overruns may not involve the addition of alternate ingredients. However, as customers and consumers, we would be taking a risk to trust the safety of any foods that are intentionally misrepresented.

Food Fraud
Categories of methods by which food fraud happens (as defined in the Food Fraud Database1). Graphic courtesy of Decernis

While all forms of fraud can be considered “mislabeling” in one way or another, we consider fraudulent labeling claims to be defined as misrepresentation of a label attribute that implies a particular production technique. Examples include representing non-organic products as organically produced, the sale of foods as halal that do not meet the appropriate standards, changing poultry expiration dates, and labeling products such as eggs and Iberian ham as “free range.” In 2017, a company in Canada was fined for selling falsely labeled kosher cheese. More recently, in Malaysia, millions of products were seized based on the use of fraudulent halal labels.

We have compiled more than 300 records of food fraud involving the use of fraudulent labeling claims. The most common fraudulent claims identified in our records are shown in the chart below.

Fraudulent labeling claims
Fraudulent labeling claims based on records reported in the Food Fraud Database.1

Consumer interest in organic foods is increasing and NSF cites “added value claims” such as organic and free range as one of the important factors driving food fraud risk.2 There continues to be a need for robust analytical tools for the authentication of organic foods. However, recent research has indicated it may be unlikely that authentication of these food products can be can be achieved by a single analytical method or the measurement of a single marker.3,4 Given the technical complexity and cost of ensuring the authenticity of organic label claims through analytical testing, preventing this type of food fraud also requires strong supply chain management and trustworthy supplier relationships along with effective auditing programs.

References

  1. The Decernis Food Fraud Database is a continuously updated collection of food fraud records curated specifically to support vulnerability assessments. Information is gathered from the scientific literature, regulatory reports, media publications, judicial records, and trade associations from around the world and is searchable by ingredient, adulterant, country, and hazard classification.
  2. NSF, “Risk Modelling Of Food Fraud Motivation – ‘NSF Fraud Protection Model’ Intelligent Risk Model Scoping Project FS 246004.” (2014). Retrieved from https://www.food.gov.uk/sites/default/files/media/document/NSF%20Final%20report.pdf.
  3. Inacio, CT and Chalk, PM. (January 2017) Principles and limitations of stable isotopes in differentiating organic and conventional foodstuffs: 2. Animal products. Crit Rev Food Sci Nutr.. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25849871
  4. Capuano, E., et al. (September 11, 2012). Analytical authentication of organic products: an overview of markers. Journal of the Science of Food and Agriculture. (Vol. 93) No. 1. https://doi.org/10.1002/jsfa.5914
Laura Bush, Mike Taylor
Food Safety Culture Club

Is FSMA Driving Food Safety Culture?

By Lauren Bush, Michael Taylor
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Laura Bush, Mike Taylor

We were asked if we think FSMA is driving strong food safety cultures. Our answer is: Yes, but there’s more to the story.

For the dozens of impacted families that advocated for years on behalf of the thousands of individuals who are sickened and die each year from foodborne illness, FSMA marked a sea change in accountability for preventing foodborne illness. And it demonstrated that the consumer voice can impact a Washington legislative process often perceived as impenetrable to the everyday citizen. It’s also true, however, that even before FSMA, leading companies had been implementing modern preventive measures in response to unacceptable illness outbreaks and consumer demands. And food safety thought leaders were writing about food safety culture and working to drive it. We thus see FSMA reinforcing the movement to strengthen food safety cultures rather than being the primary driver.

After all, a genuine food safety culture is as much about people and motivation as regulation. The people in food companies driving strong cultures are motivated at a personal level by knowing the severe harm deadly pathogens in food can inflict on illness victims and their families. And they are motivated at a business level by the realization that the success of a food company hinges on continuously meeting high consumer expectations for food safety. These personal and business motivations are the original and continuing drivers of strong food safety cultures.

The 2011 enactment of FSMA was made possible by the coming together of consumers, food safety experts, and industry leaders who agreed that application of the best available science to prevent problems is the responsibility of everyone. This agreement and the enactment of FSMA powerfully demonstrated how far our food safety culture had come since the uphill battles of 25 years ago over accountability for keeping E. coli O157H:7 out of ground beef and mandating HACCP for meat, poultry and seafood. There is now consensus that adoption of modern preventive controls is a basic responsibility of everyone producing food.

Food safety culture is about much more, however, than simply doing the basics of preventive controls. It’s about staying on top of change in the hazards that occur in our food system and in the means available to minimize them, and being committed to continuous improvement in response to these changes. FSMA took the breakthrough step of making continuous improvement a regulatory requirement by tying the definition of preventive controls to current expert knowledge about how to control hazards and requiring controls to be updated regularly as new knowledge emerges. In this way, FSMA reinforces the movement to strengthen food safety culture and makes it everyone’s responsibility.

But it all still comes back to motivation. Stop Foodborne Illness has long contributed to that motivation by sharing the stories of individuals and families who have experienced devastating loss and lasting harm from foodborne illness. Companies seeking to strengthen their cultures invite Stop constituents to tell their stories in employee training sessions and meetings with senior executives. In this new era of food safety, we see great opportunity to expand collaboration with food companies to help drive the widest possible implementation of best practices, continuous improvement and strong food safety cultures. In this effort, FSMA is our important ally.

Bush and Taylor co-chair the Board of Directors of Stop Foodborne Illness, a non-profit consumer organization that represents victim of foodborne illness and their families.

HPP, high-pressure processing

HPP Keeps Food Safe, While Extending Shelf Life

By Mark Duffy
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HPP, high-pressure processing

Research shows the global high pressure processing (HPP) food market to be worth $14 billion in 2018. By 2023, the market will reach an estimated $27.4 billion and will grow to $51.1 billion by 2027, according to Visiongain, a UK-based business intelligence company. This growth is a result of many factors, including consumer trends, food safety and food industry demand.

One of the biggest consumer food trends is the clean label movement. Consumers are more attentive to what they eat and drink than ever before, requesting more information about the products they buy and consume. For instance, 73% of U.S. consumers agree it is important that ingredients on a food label are familiar and would be used at home, according to Innova Market Insights, a market research firm for the food and beverage industry.

Consumers want fresh, convenient and less processed foods and beverages. Shoppers, especially millennials, are willing to spend more money to receive better-for-you products, and they are also more willing to research production methods before making purchases.

HPP, high-pressure processing
An employee loads meat, sealed in its package, into the HPP canister where it will be subjected to isostatic water pressure (300 to 600 Mpa or 43,500 to 87,000 psi – five times stronger than that found at the bottom of the ocean – for typically one to six minutes. Pressures above 400 MPa / 58,000 psi at cold (+ 4ºC to 10ºC) or ambient temperature inactivate the vegetative flora (bacteria, virus, yeasts, molds and parasites) present in food, extending shelf life and ensuring food safety. All images courtesy of Universal Pure

On the industry side, due to an increasing concern over food safety and the rise in foodborne illness, food producers and retailers are seeking reliable food safety and preservation methods that will help ensure the best product quality. Not only do they want to keep their customers safe, they also want to ensure their brand is protected.

Food waste and sustainability is also important to consumers and industry. In the 2017 Nielsen Global Sustainability Survey, 68% of Americans said that it is important that companies implement programs to improve the environment; 67% will be prioritizing healthy or socially-conscious food purchases in 2018; and 48% will change their consumption habits to reduce their environmental impact.

Companies want to be responsible and make sure good food does not go to waste. Longer shelf life decreases a product’s chance of ending up in a landfill. Additionally, the longer a product lasts, the further it can be safely distributed and sold.

What is HPP?

High pressure processing (HPP) ironically isn’t really processing at all. HPP is a unique food preservation method that utilizes cold water and extreme pressure (up to 87,000 psi) to inactivate foodborne pathogens and spoilage organisms.

The effectiveness of the HPP process depends on the amount of pressure applied, vessel holding time, temperature, product type and targeted pathogens and spoilage organisms.

Unlike chemical and thermal treatments that can compromise flavor, vitamins and nutrients, HPP is a non-thermal, non-chemical process. Without the use of heat, the product’s original qualities remain intact. Also, because water pressure is applied uniformly in all directions, HPP foods retain their original shape.

HPP, high pressure processing
HPP equipment on a plant floor. Food, already sealed in its package, is loaded into these gray and yellow canisters and sent through the HPP vessel behind them where water and high pressure are applied to inactivate foodborne pathogens.

Current and New Applications for HPP

One of the most popular uses for HPP is for proteins, including roast beef, chicken, pork and ground meats like turkey, chicken and beef. Other uses include premium juices, dips, wet salads, dairy and seafood, as well as pet food.
Some of its newer applications are in the preservation of baby food, premium juices, plant-based protein drinks, cocktail mixers, nutrient dense shots, coffee and tea selections and bone broth. HPP is widely used for ready-to-eat meats, dips, guacamole, salsa and hummus. Raw pet food, which has been affected by Salmonella and other pathogenic outbreaks in recent months, is also a growing market for HPP. Just like for their own food, pet owners are demanding fresh, non-processed foods for their pets. HPP is a proven means of creating a safe, clean-label raw pet food.

While food safety is still the number one reason for HPP, many manufacturers and retailers also cite shelf-life extension as a major benefit. Table I is a breakdown on the type of food, shelf-life extension and key benefits of HPP.

Food Type Applications Shelf-Life Extension Key Benefits
RTE (Ready-to-Eat) Meats Sliced, cooked meats: chicken, turkey, ham and beef; uncured ham and sausage Greater than 2X Extends shelf life while addressing common vegetative bacterial concerns. Allows manufacturers and retailers to offer reduced sodium products.
RTC (Ready-to-Cook) Meats Ground meats such as turkey, chicken and perhaps beef. 1.5X to 2.5X Increase food safety while extending product shelf life.
Guacamole, Wet Salads, Salsas, Dressings & Dips Guacamole, salsa, chicken salad, seafood salad, dressings 2X–6X Extends product shelf-life and reduces vegetative bacteria issues.
Juices and Smoothies Super premium juices, juice blends & smoothies 20–60 days HPP is a natural way to deal with microorganisms and extend shelf life without the use of heat ,which can negatively affect color and flavor.
Dairy Yogurt & yogurt-based dressings, cream, sour cream, cream cheese and milk. 2X–10X In yogurt-based products and milk, HPP is believed to give a creamier product consistency.
Seafood Oysters, lobster, crab, shrimp, mussels 2X–4X Meat extraction (yield) is better than by hand shucking or steam methods. Labor savings in this manner makes the HPP’ing of shellfish a great application. The shelf-life extension is also significant.
Table I. A breakdown on the type of food, shelf-life extension and key benefits of HPP.

Cost

The cost of HPP varies depending on the size of production runs, fill efficiency of the product within the HPP vessel and the HPP process parameters. The good news is the cost may be offset by other price reductions that HPP enables such as eliminating food additives. While HPP can be performed in-house, many companies outsource their HPP needs so they do not have to allocate significant capital expenses or disrupt production efficiency with an HPP batch process, allowing them to focus on their core competencies.

A Bright Future for HPP

HPP’s future is bright, with new uses on the horizon. These new uses have already resulted in new market opportunities that increase revenue. As its awareness grows among manufacturers, retailers and food service companies, and with additional education about its benefits, more companies will embrace HPP as part of their food safety program and for its shelf-life benefits. With consumer demand for fresh foods and beverages showing no signs of stopping, HPP will lead the way in helping to produce fresh, safe food and beverage products for all to enjoy.

HPP: Achieve High Standards of Food Safety Without Compromising Food Quality

Leonard Steed, AIB International
FST Soapbox

Unannounced Audits: Are You Ready?

By Leonard Steed
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Leonard Steed, AIB International

Many industries are moving toward unannounced third-party certification audits and the food industry is no different. If regulatory audits are unannounced, why is the food industry reluctant to adopt unannounced third-party audits? There are a number of benefits to unannounced audits—most importantly is their positive impact on a company’s food safety culture and how they prepare facilities to face FDA inspections.

Unannounced audits for food are required for many third-party certification audits. Typically, regulatory audits are always unannounced. Unannounced audits help demonstrate compliance and provide confidence to all stakeholders that your manufacturing sites are operating on the same GMP level, day to day, shift to shift, for every day your organization is manufacturing and distributing food products. With announced audits, companies tend to prepare for them before they occur. However, if there is a significant amount of difference between your sanitary operations prior to and during an announced audit versus normal operating conditions, you are sending your employees the wrong message.

Although there are differences between certification schemes, the GFSI third-party unannounced audits usually have a 40- to 60-day window in which the audit must be completed to allow the certification body to complete technical reviews and review corrective actions so that the certificate does not lapse. If it is a surveillance audit, then the audit is more likely to be truly unannounced, but a company still has the option of using blackout dates and the auditor will verify that the request was necessary. The bottom line is most companies have a certain timeframe when they know unannounced audits will occur.

Leonard Steed will present “Unannounced Audits: Are You Ready?” on November 14 at the 2018 Food Safety ConsortiumThe biggest impact on third-party audits is when the audit score is directly related to financial incentives for employees. This situation motivates employees to pursue activities to achieve the maximum score, not directly related to food safety. Activities may include significant audit preparation to eliminate or reduce GMP deficiencies, reduce or control the auditor’s access to records or areas of known plant deficiencies, “auditor shopping”, and to appeal any audit finding that lowers the score. Switching auditors or appealing findings can be legitimate tools to correct a system when auditors make errors in judgement or behavior. The activities to achieve the highest score should be reasonably governed because they could take away from the primary goal to operate in a food safe mode.

The goal of an internal audit program is to be compliant with regulatory inspections and third-party certification requirements and should therefore be risk-based. Determine what factors present the most risk to an organization and then align internal audits with those risks. At this point in time, being able to perform well on a regulatory audit should be a primary concern. Since the FDA and state regulatory agencies usually perform unannounced inspections, it would seem necessary to have your food safety plan, prerequisite programs and operations in a constant state of readiness to mitigate the risk of potentially unsafe food in commerce resulting in a recall.

One way to evaluate your food safety culture is to anonymously survey employees at all levels of the organization to gather information on attitudes and opinions about food safety and institute changes to improve your position. Another way is to initiate change by instituting unannounced audits on all manufacturing shifts and require participation by all departments in the audit function to move away from “QA-centric” food safety verification systems. The significant change is that all departments would be involved as an auditor and responsible for maintaining regulatory compliance. For some companies, the inclusion of all plant departments in the audit function has moved the needle in the goal to improve their food safety culture. To further define food safety culture in other terms, it could mean adhering to GMPs all the time, the importance of accurately completing and verifying food safety records, and fostering consensus between departments on the severity of food safety nonconformances requiring prompt corrective action.

Maintaining GFSI certification is an excellent way to achieve food safety requirements for compliance with FDA inspections. Although not specifically required by GFSI, another application of your internal audit program is to review your regulatory policy by performing a mock FDA inspection to identify any gaps in hazard analysis, identify preventive controls including the supply chain controls, accurately complete food safety records, and provide examples of corrective actions when preventive controls were not completed properly, and environmental corrective actions. If you decide to perform a mock FDA inspection of your facility, do not forget to include the FDA Guidance document criteria, as it is important to understand what the FDA expects to see when they are evaluating your implementation. Your internal audit program is a proactive program to note nonconformances before they become full blown problems, so don’t be afraid to use it to its fullest extent.