Tag Archives: FSMA

Emily Kaufman, Emport, Allergens
Allergen Alley

Matrix Matters: Why Allergen Test Kits Are Only Half the Story

By Emily Kaufman
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Emily Kaufman, Emport, Allergens

On-site rapid tests for allergens are an important part of any manufacturing facility’s allergen control plan. Several companies offer allergen test kits for day-to-day use, and it can be hard to tell the differences between them or determine which is the best fit for a given facility. What’s a busy QA professional to do?

One of the most overlooked factors when choosing an allergen test kit actually has almost nothing to do with the test kit itself. Instead, it’s much closer to home: The matrices being tested are just as—if not more—important to consider than the test kit itself.

Before you commit to any allergen test kit, you should talk to someone extensively about the types of products you plan to test. There are a variety of surprising and counterintuitive ways that your matrices can impact the functionality of a test, and you’ll save time and money by understanding information BEFORE you start testing. Below, we’ll review some of the most common matrix challenges.

High Fat Matrices

fruit pops, allergensLet’s imagine a facility that makes ice cream and sorbet. Let’s assume they make a gourmet strawberry ice cream and a fat-free strawberry sorbet, both of which ought to be peanut-free—but since some of the ingredients come from a supplier who also works with peanuts, the QA team decides to run a rapid peanut test on the strawberry products.

Much to the team’s surprise, the sorbet tests positive for peanut but the ice cream does not. What could be happening? Of course, the simplest explanation is possible: The sorbet has peanut residue in it and the ice cream does not. However, there’s another, trickier possibility: They could have the same amount of peanut residue, but the full-fat ice cream could inhibit the test kit’s ability to detect the allergen.

In general, the higher the fat content of your matrices, the higher the detection limit on your test kit. It’s an imprecise spectrum: Using rapid tests to find traces of allergenic protein on an oil is nearly impossible, on fat-rich items like ice cream or cream-based soups it’s a challenge, on items with little or no fat it shouldn’t be an issue. That isn’t to say there couldn’t be other issues with low-fat items, as we’ll review below.

Matrices Processed with High Heat

peanuts, allergensLet’s say our ice cream facility starts making a peanut-butter-swirl flavor. Perhaps they will begin testing their rinsewater for peanut residue after running that flavor, to ensure satisfactory cleaning. The kit they use says it can detect peanut allergen to 5 ppm, and rinsewater is not a high-fat matrix, so they should be good, right?

In this exact example, it’s probably just fine. However, it’s important for the QA team to consider the temperature at which peanuts were roasted. While raw peanut might be detectable at 5 ppm, roasted peanuts could have a detection limit that is much higher. In fact, very strongly roasted peanuts could only be detectable at levels of 500 ppm or more. This doesn’t mean there is no reason to test—but it’s important to know that many antibody-based tests will respond differently to an allergen processed with high heat than one that is raw. The same detection challenge can sometimes be seen with canned or tinned items that are subjected to high heat in processing.

Fermented or Hydrolyzed Matrices

Two of the trickiest items when it comes to allergen detection are soy sauce and fish sauce. In both of these condiments—and many other common ingredients subjected to these types of processing—the allergenic material is subjected to heavy modification. As proteins get folded and broken in unpredictable ways, they become more challenging for antibody-based test kits to detect. In fact, soy sauce and fish sauce are nearly undetectable by most kits.

When validating a cleaning process after using one of these ingredients, often the safest thing to do is to test for a different allergen—formulated in a simpler way—that is also present. Sufficient cleaning after a product made with fish sauce and breadcrumbs, for example, could be proven with a gluten kit; that second allergen will be unaffected by the fermented allergens in the recipe.

Matrices without Multiple Proteins

Some kits look for a variety of proteins commonly found within one allergen. Other times, though, each test kit will be looking for one specific protein. It’s important to confirm that the allergenic protein your facility works with is in fact an allergenic protein that your test kit is trained to recognize.

Perhaps the most common FALCPA allergen where this plays a role is milk. While there are a number of proteins in milk, casein is the most common and accounts for approximately 80% of the protein in milk, making it a common target for allergen test kits (both rapid and ELISA). The remaining 20% of protein is comprised of various whey proteins, most commonly beta-lactoglobulin.

In the case of our ice cream and sorbet facility mentioned above, a kit that detects casein OR beta-lactoglobulin OR both proteins together could be suitable for confirming that the sorbet is truly milk-free. However, there are other types of product that contain only whey proteins, which are a popular way to increase protein content in a variety of foods and beverages. If a facility that works exclusively with whey proteins uses a kit that only detects casein, they will never have a true understanding of their allergen contamination risk.

Another challenging FALCPA allergen is fish, as there are many different species of fish with quite divergent protein structures. If you are testing for fish contamination, it’s important to understand which species of fish the test you are considering can detect, and which species may pose a problem. If there is a mismatch between kit and matrix, then you’ll need to find a different way to ensure safety.

How to Troubleshoot Your Matrices

If you are beginning an allergen testing program, find time to talk with the manufacturers of any allergen kits you are considering. You may also want to talk with the representatives of any labs that are doing third party testing for you. Some questions to ask include:

  • What matrices have you validated your tests for?
  • Do you anticipate any issues with my matrices?
  • How should I validate your tests for my products?
  • What factors impact the sensitivity of this kit?
  • Does the detection limit change based on the matrix?

Your kit manufacturer (or third-party testing lab) should make you feel confident that they understand the quirks of your specific matrices—and they should have ideas for how to troubleshoot any challenges that they foresee. If a supplier tells you that their kit will work equally well across all matrices and declines to offer proof that corresponds to your needs, beware (or at least be prepared to conduct rigorous validation on your own). Allergen detection is complicated, and as with so much of life: If it sounds too good to be true, it probably is.

Laura Lombard, IMEPIK
FST Soapbox

The Business Case for PCQI Training

By Laura Lombard
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Laura Lombard, IMEPIK

Beyond reducing liability or checking a regulatory box, investing in robust training can reap measurable business impact. The FSMA regulation requires that Preventive Control Qualified Individuals (PCQIs) “have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system,” as per Subpart C Section 117.180 (c) (1). Even if the person serving in the role of PCQI is qualified through job experience, FDA investigators will expect adherence to development and application of risk-based controls as contained in the standardized PCQI curriculum material or the alternative training allowed in the regulation.

Let’s face it: Our employees serving in the role of PCQI come from a spectrum of food safety plan experience. In addition, many are mentoring new members as Qualified Individuals on the food safety team. Others are building a whole new team from scratch. Team members may be specialized department heads or hold several titles and job duties within a manufacturing facility. Your PCQI is charged with overseeing the development and analysis of the food safety plan. The PCQI needs a team that has had consistent training in the language of the new rules and how to comply to support the PCQI’s charge.

Beyond meeting the regulation, companies should train at the PCQI level to safeguard a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more you save in costly recalls, loss of current or potential customers, and your brand’s reputation. A company with a robust safety culture has a competitive advantage over competitors who are more lax in their food safety and may suffer financially and reputationally from recalls and customer quality assurance complaints. In an era when customers are seeking more information about the food they consume, being a trusted food safety brand can make your company stand above the crowd.

In addition, consistent training can help with internal culture change and worker productivity. Working on hazard analysis and defining preventive controls requires that employees show critical thinking and problem-solving skills. Team members taking a curriculum with standardized material and consistent learning objectives can reflect together to identify and document gaps and corrections to practices or processes. They can quickly apply their learning for more accurate analysis of the components of the food safety plan. This is the true impact from investment in high quality instruction—motivating employees to learn updated food safety practices, change their behavior, and make more efficient and effective decisions to keep the quality and safety of your products. Well-trained food safety employees are a key factor in the protection of your customers, your company’s brand and the prevention of costly food recalls. The investment in training at the PCQI level is strategic on all fronts.

Erika Miller
FST Soapbox

Does the Sanitary Transportation Regulation Require Seals for LTL Shipments?

By Erika Miller
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Erika Miller

This question has come up frequently in our FSMA Sanitary Transportation workshop. Just as with all the parts of FSMA, the focus of the Sanitary Transportation of Human and Animal Food regulation is on addressing hazards that may be present throughout the food chain and assigning responsibility (liability) for preventing those hazards. There are very few specific requirements—most of it is couched in very general language, for flexibility on both sides (FDA’s and industry’s).

While the regulation does not specifically address locks or seals on trailers, the FDA has stated publicly that they intend to enforce the adherence of industry to generally accepted best practices. Sometimes, as in the case of certain animal food applications, the FDA has stated they will accept mild steel transports instead of stainless (as would typically be required for hauling food) because it’s all about the risk, and mild steel is not a risk in those applications. What is the risk of an unlocked load to the food being hauled, and to the business being conducted? Maybe a seal or lock on an LTL can protect a significant investment from an identified hazard.

Generally, in most food hauling operations, seals or locks are required on trailers by businesses in order to protect their investments. They are also expected under GFSI-approved food safety management systems, used by most food manufacturers (which are private, voluntary standards, not regulatory). They are definitely required if you want to haul 100% juice under Juice HACCP and the JPA guidelines.

There are so few straightforward answers with FSMA. You must always look at your operation, your risks, and decide if controls are necessary. Document the basis for your decision, ensuring it is based on facts. If the FDA inquires, you must make your case for your decision. Do you feel comfortable defending it, all the way to a court of law if need be? If so, then stand by it.

If there are potential risks to food that is being hauled (don’t forget about defense-type risks as well, like the truck being stolen or misrepresented) then you must take reasonable, industry-standard precautions to prevent those hazards from occurring.

Of course, you want to do this anyway because it is smart business.

2018

The Future of Food Safety: A Year in Review

By Mahni Ghorashi
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2018

We started this Q&A series earlier this year with a clear vision—to gather the success stories, best practices, hurdles and achievements from the best in our industry. Our hope is that as the series expands and evolves, food safety professionals everywhere will be informed and inspired by what the future holds.

Over the course of the year, I had the pleasure of interviewing three such experts: Bob Baker, corporate food safety science and capability director at Mars, Inc, Frank Yiannas, vice president of food safety at Walmart, and Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill.

I encourage you to read the interviews for their unique perspectives, but here are a few of the biggest insights that we can all take with us into 2019.

The Continued Rise of New Technologies

Mike Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace.

Frank Yiannas: The emergence of blockchain technology has also enabled food system stakeholders to imagine being able to have full end-to-end traceability at the speed of thought. The ongoing U.S.-wide romaine lettuce E.coli outbreak showed us, once again, that our traditional paper-based food tracking system is no longer adequate for the 21st century. An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.

Blockchain has the potential to shine a light on all actors in the food system. This enhanced transparency will result in greater accountability, and greater accountability will cause the food system to self-regulate and comply with the safe and sustainable practices that we all desire.

The Most Exciting Shifts

Baker: What’s encouraging is we’re seeing is a willingness to share information. At Mars we often bring together world experts from across the globe to focus on food safety challenges. We continue to see great levels of knowledge sharing and collaboration.

There are also new tools and new technologies being developed and applied. Something we’re excited about is a trial of portable ‘in-field’ DNA sequencing technology on one of our production lines in China. This is an approach that could, with automated sampling, reduce test times.

Yiannas: While there is no doubt that there are numerous new and emerging challenges in food safety, the many advancements being made should give us hope that we can create a safer, more efficient and sustainable food system.

There is progress being made on many fronts: Whole genome sequencing is becoming more accessible; new tools are being developed for fraud detection; and FSMA is introducing stringent public-health surveillance measures that have dramatic implications for U.S. retailers and suppliers and our import partners.

Most importantly, consumers are now overwhelmingly interested in transparency. People today are further removed from how food is grown, produced and transported than at any other time in human history. Plus, they increasingly mistrust food and food companies due to the food outbreaks and scares we have faced in recent years.

Recalls and the Role of Regulation

Robach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Baker: At Mars, quality is our first principle and we take it seriously—if we believe that a recall needs to be made in order to ensure the safety of our consumers, then we will do it. We also share lessons from recalls across our business to ensure that we learn from every experience.

Unfortunately, there does not seem to be a safe place for businesses to share such insights with each other. So although we are seeing more collaboration in the field of food safety generally, critical knowledge and experience from recalls is not being shared more broadly, which may be having an impact.

Looking Ahead

Baker: The food safety challenges facing us all are complex and evolving. Water and environmental contaminants are areas that industry and regulators are also looking at, but all of these challenges will take time to address. It’s about capturing and ensuring visibility to the right insights and prioritizing key challenges that we can tackle together through collaboration and knowledge sharing.

…

We’re looking forward to continuing our quest in the new year and already have a few exciting experts lined up. Stay tuned!

Food Safety Tech

Call for Abstracts: Be a Part of the 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Tech

The supply chain is a potentially weak and vulnerable part of a company’s food safety plan. The annual Food Safety Supply Chain Conference is months away and we are accepting abstracts for presentations. The conference takes place May 29–30, 2019 in Rockville, MD.

If you have expertise in the following areas, we invite you to submit an abstract to present at the conference:

  • Food Safety Supply Chain Vulnerabilities & Solutions
  • Audits & Inspections
  • How to Write Supplier Specifications
  • Blockchain Technology
  • FSMA’s Sanitary Transportation Compliance Tools & Techniques
  • Supply Chain Traceability
  • FSMA’s FSVP Compliance Tools & Best Practices
  • Data, Predictive Analysis
  • Recalls: barcode labeling, case histories and lessons learned
  • Testing Strategies of the Supply Chain
  • Supplier Verification Best Practices
  • Supply Chain Risk Management
  • Food Safety Transportation, Distribution and Logistics
  • Food Authenticity
  • Food Safety/Quality Culture measurement in supplier management
  • Supplier Management Case Histories

Each abstract will be judged based on educational merit. The submission deadline is February 8, 2019.

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
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Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements

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.

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

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.

FDA

FDA Issues Guidance Document for Qualified Facilities Under FSMA Rules

By Food Safety Tech Staff
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FDA

Last week FDA released a guidance document to help facilities understand whether they are subject to the “qualified facility” definition under the FSMA preventive controls rules for human and animal food. Titled “Determination of Status as a Qualified Facility”, the guidance offers frequently asked questions about the requirements for facilities that manufacture, process, pack or hold human as well as animal food (defined separately—Part 117 for human food and Part 507 for animal food).

“Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.” – FDA

Facilities that fall under the PC Human Food rule must submit the first required attestation forms by December 17, 2018, and those subject to the PC Animal Food role must submit the first required attestation forms by December 16, 2019.

More information about the new guidance for industry is available on FDA’s website.