Tag Archives: risk

Angelica Grindle, DEKRA

Four Steps for Utilizing Behavioral Science to Control Exposure to COVID-19

By Angelica Grindle, Ph.D.
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Angelica Grindle, DEKRA

Safety is defined as controlling exposure for self and others. Going into 2020, the food industry battled safety concerns such as slips and falls, knife cuts, soft-tissue injuries, etc. As an “essential industry”, food-related organizations now face a unique challenge in controlling exposure to COVID-19. Not only must they keep their facilities clean and employees safe, they must also ensure they do not create additional exposures for their suppliers or customers.

These challenges increase at a time when employees may be distracted by stress, financial uncertainties, job insecurity, and worry for themselves and their families. Additionally, facilities may be understaffed, employees may be doing tasks they do not normally do, and we have swelling populations working from home.

While there is much we cannot control with COVID-19, there are specific behaviors that will reduce the risk of viral exposure for ourselves, our co-workers, and our communities. Decades of research show the power of behavioral science in increasing the consistency of safe behaviors. The spread of COVID-19 serves as an important reminder of what food-related organizations can gain by incorporating a behavioral component into a comprehensive exposure-reduction process.

Whether you have an existing behavior based safety process or not, follow these four steps.

Step 1: Pinpoint Critical COVID-19 Exposure Reduction Behaviors

It is critical to clearly pinpoint the behaviors you want to see occurring at a high rate. In the food industry, an organization must control exposure both within their facilities as well as during interactions with suppliers and customers. Controlling exposure within facilities will typically include those behaviors recommended by the CDC such as:

  1. Maintain six feet of separation at all times possible.
  2. Avoid touching your eyes, nose and mouth with unwashed hands.
  3. Minimize personal interactions to reduce exposure to transmit or receive pathogens.
  4. Frequent 20-second hand washing with soap and warm water.
  5. Make hand disinfectant available.
  6. Use alternatives to shaking hands.
  7. Frequently clean and disinfect common areas, such as meeting rooms, bathrooms, doorknobs, countertops, railings, and light switches.
  8. Sneeze and/or cough into elbow or use a tissue and immediately discard.
  9. Conduct meetings via conferencing rather than in person.
  10.  If you are sick, stay home.
  11. If exposed to COVID-19, self-quarantine for precaution and protection of others.

Supplier/Customer exposure-reduction behaviors will vary depending upon your specific industry and may include pinpointing the critical behaviors for food preparation, loading dock delivery, customer home delivery, and customer pick up. When creating checklists to meet your unique exposures, be sure the behaviors you pinpoint are:

  • Measurable: The behavior can be counted or quantified.
  • Observable: The behavior can be seen or heard by an observer.
  • Reliable: Two or more people agree that they observed the same thing.
  • Active: If a dead man can do it, it is not behavior.
  • Influenceable: Under the control of the performer.

Once you have drafted your checklists, ask yourself, “If everyone in my facility did all of these behaviors all the time, would we be certain that we were controlling exposure for each other, our suppliers, and our customers?” If yes, test your checklists for ease of use and clarity.

Step 2: Develop Your Observation Process

To do this, you will want to ask yourself:

  • Who? Who will do observations? Can we leverage observer expertise from an existing process and have them focus on COVID-19 exposure reduction behaviors or should we create a new observer team?
  • Where? Which specific locations, job types, and/or tasks should be monitored?
  • When? When will observers conduct observations?
  • Data: How will you manage the data obtained during the observations so that it can be used to identify obstacles to safe performance? Can the checklist items be entered into an existing database or will we need to create something new?
  • Communication: What information needs to be communicated before we begin our COVID-19 Exposure Reduction process and over time? How will we communicate it?

Step 3: Conduct Your Observations and Provide Feedback

Starting the Observation
Your observers should explain that they are there to help reduce exposure to COVID-19 by providing feedback on performance.

Recording the Observation
Observers should note on the checklist which behaviors are occurring in a safe manner (protected) and which are increasing exposure to COVID-19 (exposed).

Provide Feedback
Feedback is given in the spirit of reducing exposure. It should be given as soon as possible after the observation to reinforce protected behaviors and give the person to opportunity to modify exposed behaviors.

Success Feedback
Success feedback helps reinforce the behaviors you want occurring consistently. Effective success feedback includes:

  • Context: The situation in which the behavior occurred.
  • Action: The specific behaviors observed which reduce exposure to COVID-19.
  • Result: The impact of those behaviors on themselves or others—in this case, reduced COVID-19 exposure for themselves, their families and community.

“I care about your safety and do not want to see you exposed to COVID-19. I saw you use hand sanitizer prior to putting on eye protection. By doing that, you reduced the likelihood of transferring anything that might have been on your hands to your face which keeps you safe from contracting COVID-19.”

Guidance Feedback

Guidance feedback is given for exposed behaviors to transform that behavior into a protected one. Effective guidance feedback includes Context, Action, Result, but also:

  • Alternative Action: The behavior that would have reduced their exposure to COVID-19.
  • Alternative Result: The impact of that alternative behavior, such as reduced COVID-19 exposure for themselves, their families, and community.

“I care about your safety and do not want to see you exposed to COVID-19. I saw that you touched your face while putting on eye protection. By doing that, you increased the likelihood of transferring anything on your hand to your face which increases your risk of exposure to COVID-19. What could you have done to reduce that exposure?”

When giving guidance feedback, it is important to have a meaningful conversation about what prevented them from doing the safe alternative. Note these obstacles on the checklist.

Step 4: Use Your Data to Remove Obstacles to Safe Practices.

Create a COVID-19 exposure reduction team to analyze observation data. This team will identify systemic or organizational obstacles to safe behavior and develop plans to remove those obstacles. This is critical! When an organization knows that many people are doing the same exposed behavior, it is imperative that they not blame the employees but instead analyze what is going on in the organization that may inadvertently be encouraging these at-risk behaviors.

For example, we know handwashing and/or sanitizing is an important COVID-19 exposure reduction behavior. However, if your employees do not have access to sinks or hand sanitizer, it is not possible for them to reduce their exposure.
Similarly, the CDC recommends that people who are sick not come to work. However, if your organization does not have an adequate sick leave policy, people will come to work sick and expose their co-workers, customers and suppliers to their illness.

Your COVID-19 exposure reduction team should develop plans to remove obstacles to safe behavior using the hierarchy of controls.

Conclusion

Consistently executing critical behaviors is key to reducing exposure to COVID-19 as flattening the curve is imperative in the worldwide fight against this pandemic. Regardless of the type of behavior or the outcome that the behavior impacts, Behavior based safety systems work by providing feedback during the observations and then using the information obtained during the feedback conversation to remove obstacles to safe practices.

By using these tips, you can add a proven and powerful tool to your arsenal in the fight against COVID-19 and help keep your employees, their families, and your community safe.

Maria Fontanazza, Food Safety Tech
From the Editor’s Desk

COVID-19 in the Food Industry: So Many Questions

By Maria Fontanazza
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Maria Fontanazza, Food Safety Tech

Industries across the global are reeling from the COVID-19 crisis. Although we are clearly not in a state of “business as usual”, the food industry is essential. And as this entire industry must continue to move forward in its duty to provide safe, quality food products, so many questions remain. These questions include: Should I test my employees for fever before allowing them into the manufacturing facility? What do we do if an employee tests positive for COVID-19? How can the company continue safe production? Should we sanitize between shifts on the production line? Should employees on the production floor wear face masks and shields? At what temperature can the virus be killed? The list truly goes on. We saw it ourselves during the first Food Safety Tech webinar last week, “COVID-19 in the Food Industry: Protecting Your Employees and Consumers” (you can register and listen to the recording here). Amidst their incredibly busy schedules, we were lucky to be graced with the presence and expertise of Shawn Stevens (food safety lawyer, Food Industry Counsel, LLC), April Bishop (senior director of food safety, TreeHouse Foods, Inc. and Jennifer McEntire, Ph.D. (vice president of food safety, United Fresh Produce Association) for this virtual event.

From a manufacturing point of view, we learned about the important ways companies can protect their employees—via thorough cleaning of high-touch areas, vigilance with CDC-recommended sanitizers, conducting risk assessments related to social distancing and employees in the production environment—along with the “what if’s” related to employees who test positive for COVID-19. Although FDA has made it clear that there is currently no indication of human transmission of the SARS-CoV-2 virus through food or food packaging, some folks are concerned about this issue as well.

“The U.S. food supply remains safe for both people and animals. There is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19,” said Frank Yiannas, FDA deputy commissioner for food policy and response in the agency’s blog last week. “Unlike foodborne gastrointestinal viruses like norovirus and hepatitis A that make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness. This virus is thought to spread mainly from person to person. Foodborne exposure to this virus is not known to be a route of transmission.”

As the industry continues to adjust to this new and uncertain environment, we at Food Safety Tech are working to keep you in touch with experts who can share best practices and answer your questions. I encourage you to join us on Thursday, April 2 for our second webinar in this series that I referenced earlier, COVID-19 in the Food Industry: Enterprise Risk Management and the Supply Chain. We will be joined by Melanie Neumann, executive vice president & general counsel for Matrix Sciences International, Inc. and Martin Wiedmann, Ph.D., Gellert Family Professor in Food Safety at Cornell University, and the event promises to reveal more important information about how we can work through this crisis together.

We hear it often in our industry: “Food safety is not a competitive advantage.” This phrase has never been more true.

Stay safe, stay well, and thank you for all that you do.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Fraudulent Dinner Is Served

By Susanne Kuehne
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Susanne Kuehne, Decernis
Olive Oil, Food Fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database.
Image credit: Susanne Kuehne

Due to extensive opportunities for fraud, the lack of an adequate monitoring system, cost pressures in the industry, and lack of transparency in the food supply chain, amongst other factors, fraudulent food products still pose a significant risk within the hospitality industry. A recent study discusses the food service food fraud vulnerability assessment (FS-FFCA), showing as an example that one-third of extra virgin olive oil samples at restaurants and catering facilities were adulterated. More tools are urgently needed to protect consumers and legitimate operations from illicit activities.

Resource

  1. van Ruth, S.M., et al. (March 9, 2020): “Feeding fiction: Fraud vulnerability in the food service industry”. Food Research International, Volume 133, July 2020, 109158

 

Eddie Hall, Vital Vio
FST Soapbox

How Automated Technology is Transforming Sanitation in Plant Operations

By Eddie Hall
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Eddie Hall, Vital Vio

Food safety remains a top-of-mind concern for food manufacturers, especially considering some of the top recalls in 2019 were caused by bacteria contamination—including Listeria and E. coli. Every aspect of the plant operation, from maintenance to executives, to junior staff and quality control, holds both responsibility and concern in producing safe food. Unfortunately, there’s a lot at stake when plant operations’ sanitation programs run into issues, which can cause health threats.

While the rapid explosion of new innovations complements our daily lives in efficiency and convenience, plant operations may find difficulty in keeping up-to-speed with new technology such as robotics, drones and automated applications. When facilities’ equipment becomes more and more outdated, it poses food safety challenges around cleaning, maintenance and upgrades.

Luckily, in some cases, innovation is becoming much easier to deploy. Opportunities abound for food processing plants to integrate new technologies into their operations to deliver significant returns on investment while simultaneously enhancing sanitation, safety and production efficiency on the plant floor.

The Dangers with Today’s Practices

There are many pitfalls with older, more traditional cleaning techniques. In a place where cleanliness is critical to food safety and public health around the world, the industry understands sanitation means more than just scrubbing, mopping and wiping. While these are important daily practices to be done around the processing plant, there are still concerns on whether this kind of intermittent cleaning is truly enough to keep surfaces completely sanitized—knowing that continuous cleaning around the clock seems impractical in any facilities.

Unfortunately, there are many areas, some very hard to reach, for bacteria and other pathogens to live and spread around a processing plant. Zone 1, which holds the conveyor belt and other common high-touch points, consistently comes into contact with food, chemicals and humans. However, for processors to reduce the likelihood of contaminated food, they must consider areas outside of Zone 1 as well—including employee break rooms, hallways and bathrooms—to implement automated sanitation technologies. Additionally, the most common food contaminants, such as Listeria, Salmonella and E. coli, are usually invisible to the naked eye. Therefore, plants need to employ automated technology to continuously kill microscopic bacteria, mold and fungi to prevent regrowth and ensure clean food and equipment.

Looking to New Tech to Fight Germs

When looking to upgrade a plant operation facility, automated technology should be top-of-mind. Automated food production technologies solve two main problems: Food safety and sanitation efficiency. Wash-down robotic systems work to prevent food contamination, while other automated robots complete tasks on the production floor such as packaging, transporting and lifting. With the CDC estimating that roughly one in six Americans suffer from foodborne illnesses, the need for improved sanitation design is integral.

In today’s age, there are several ways to achieve heightened cleanliness by incorporating automation and robotics into production lines. Slicers, dicers and cutters are manufactured with hygienic design in mind. Smart cleaning equipment can automatically store various cleaning steps. Data tracking applications can monitor sanitation steps and ensure all boxes are checked throughout the cleaning program.

Incorporating antimicrobial LED lighting ensures sanitation is truly integrated into the facility’s design—working continually 24/7 to kill and prevent bacteria, and its growth while also serving a dual purpose of both antimicrobial protection and a proper source of illumination. As is the case with this type of technology, once these lights are installed, it becomes an easy, hands-free way of reducing labor, chemicals and, in many cases, work stoppages.

According to Meticulous Research, the global food automation market is expected to be worth $14.3 billion by 2025. With automation set to explode, it’s important for leaders in the food and beverage industry to take advantage of safety tech innovations to advance sanitation around the processing plant. Facility upgrades to improve, enhance and automate sanitation could impact food manufacturers in the long-term by decreasing costs, preventing recalls, improving brand value, gaining consumer trust, minimizing risk and impacting the bottom line.

Megan Nichols
FST Soapbox

Four Ways To Improve Your Food Safety Management System

By Megan Ray Nichols
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Megan Nichols

Foodborne illnesses cost billions of dollars each year in the United States. A lack of standards can lead to severe consequences, including loss of customers, negative impact on brand reputation and employees missing work due to illness. As a result, safety is vital for any brand that is committed to high-quality food and maintaining a positive brand image.

Food safety management systems—the processes and procedures that companies set up to prevent contamination—are essential in reducing the risk of foodborne illness and ensuring the safest products possible.

By FDA regulation, most food processors must have HACCP as well as corrective actions/preventive action (CAPAs) plans in place. Even with the right safety guidelines, however, contamination or exposure to food hazards can still occur. The following are four ways to improve the quality of your food safety management system.

1. Conduct Regular Audits

Even if your business’s HACCP is highly effective in theory, it won’t prevent contamination unless actual practice lines up with documentation. Regular audits can ensure employee practice complies.

HACCPs are structured around identifying both potential food hazards and critical control points (CCPs) where your system has the opportunity to prevent, mitigate or eliminate a potential issue. Usually, this means storing food items or performing some biological, physical or chemical action to a target limit— like a specific temperature—to prevent or mitigate contamination.

For example, in the manufacturing of chicken products, cooking and hot-holding are critical control points at which the product needs to be heated to a certain temperature to eliminate or prevent potential hazards. Here, an audit would be a chance to ensure employees cooked and hot-held foods at the proper temperatures. If they aren’t, the food safety management team can make policy changes that ensure practice lines up with planning.

The audit process should be consistent and occur regularly. It should also cover every aspect of your HACCP strategy and place a particular focus on potential hazards and CCPs. These audits can be a way to uncover the strengths and weaknesses of your current HACCP strategy. Companies can use this information to build upon existing practices or demonstrate how procedures could be more effective.

Stainless steel
Stainless steel is popular in food handling due to impermeable surface and resistance to corrosion, two characteristics that help reduce the risk of food contamination. (free image from Splash)

2. Consider a CCP Monitoring System

You can use automated or digital systems to ensure that CCPs aren’t deviating from control limits. With the right sensors, it’s possible to ensure that food remains between target limits at each CCP. For example, automated sensors can quickly alert plant staff if the temperature of food in cold storage rises above a certain threshold, or if there is a deviation from a given CCP.

These alerts can help staff quickly respond to deviations, ensuring compliance, and reducing the risk of contamination by food hazards.

3. Review and Maintain Equipment

An thorough equipment program can be highly effective in reducing the risk of food contamination. To minimize risk, your plan should look at the equipment needed in your plant, as well as how it’s constructed and maintained. For example, choosing industry-standard or food-safe materials can help prevent contamination. Investing in the right kind of stainless steel can both improve operating costs and help reduce the risk of food exposed to hazards.

Preventive maintenance plans for food safety equipment can also reduce the risk of contamination by ensuring the proper functioning of site equipment.

4. Provide Employee Support and Encourage Buy-In

Training programs are an essential component of any HACCP. If your employees don’t know how to handle food properly or aren’t aware of HACCP documentation or the CCPs in the food processing pipeline, they won’t be able to execute the plan and prevent contamination.

While training programs are crucial, they don’t necessarily guarantee compliance. Common pitfalls exist that can discourage employees from following the plan. To encourage employee buy-in, training should begin by discussing the importance of food safety and the potential risks of contamination.

The training should also be robust enough that employees feel confident when executing the HACCP. Training staff should be sure to provide visual demonstrations and opportunities for employees to practice before they become responsible for food safety. Tests or evaluations both during and after training can be useful tools in determining how well your employees understand your business’s HACCP strategy. Regular follow-ups on training can also ensure compliance and reduce the risk of contamination.

Improving Food Safety Management Systems

For any business that works with food, safety programs are essential in ensuring the safest and highest quality product possible. Existing food safety management systems can often improve with the right methods. For example, automated monitoring systems can reduce the risk of deviating from CCP limits. Employee training and regular audits can also ensure that a plant’s food safety practices line up with the documented plan.

food safety tech

Next Week: Attend the ‘Drivers in Food Safety Testing’ Webinar

By Food Safety Tech Staff
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food safety tech
Angela Anandappa, Alliance for Advanced Sanitation
Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation and member of the FST Advisory Board

Join Food Safety Tech next week for the first in a series of complimentary webinars, called Drivers in Food Safety Testing, about the important components and issues that encompass food safety testing. Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation and member of the FST Advisory Board, will lead the discussion with a presentation about Technologies Leading the Way. The complimentary webinar is aimed at food safety professionals within quality assurance and control, compliance, food lab and contract lab management, and risk management. A technology spotlight given by Lyssa Sakaley, senior global product manager for molecular pathogen testing at MilliporeSigma will follow Anandappa’s presentation. The event will conclude with an interactive Q&A with attendees.

Drivers in Food Safety Testing: Technologies Leading the Way
Wednesday, March 18 at 1 pm ET
Register now!

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part III)

By Frank Pisciotta, Spence Lane
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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. Part II reviewed access, subject matter experts, mitigation strategies and community drinking water. This final article reviews broad mitigation strategies, feasibility assessments, food defense plans, partial ingredient security and the “Three Element” approach through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities, but which can also be applied to the smaller facilities that are currently in the process of readying for the next deadline of July 26.

Lesson 14: When the final rule was released, the concept of using broad mitigation strategies was eliminated. That notwithstanding and realizing that many companies seek to operate at a stricter standard for food defense with a clear focus on brand protection, versus only those process steps that potentially could result in a “wide scale public health impact.” Broad or facility-wide mitigation strategies should not be abandoned, but are less likely to get you a lot of credit for IA compliance. Including existing food safety prerequisite programs (PRP), programs and practices that are put in place to maintain a sanitary environment and minimize the risk of introducing a food safety hazard, can, in some cases, also be included as security mitigation. PRP’s with slight modifications can also contribute to a good “food defense” posture. For example, one PRP addresses hazardous chemicals and toxic substances. In some cases, non-food grade substances that could result in product contamination (not necessarily wide-scale public health impact) might be available to a disgruntled insider. It is obvious companies are concerned about contaminants being brought into the plants, but please do not overlook contaminants that are already there and ensure that they are properly secured when not in use.

Other facility-wide programs (broad mitigation) that contribute to effective food defense might include site perimeter or building security, visitor and contractor management, pre-employment background checks, employee security awareness and food defense training and sanitation chemical management.

Lesson 15: If you are using the three elements approach (Guidance Chapter 2 Section G) or the hybrid approach (Guidance Chapter 2 Section H), you will be required to make an assessment on feasibility. In the early VA’s conducted, prior to the second installment of the guidance in March of 2019, feasibility was essentially an all or nothing proposition. One could argue that a judgment call was required as to whether an intentional adulteration incident could be accomplished given the inherent conditions. Those conditions might include a lot of coworkers who might be able to observe and serve as witnesses to deter the act. With the release of the second installment of the guidance from the FDA, a new tool was made available which would allow food and beverage companies to run a calculation and make a more accurate prediction of how much of an unnamed “representative contaminant” which is assumed to be highly lethal and heat stable it might take to contaminate a product batch. Typically, the larger the batch size, the higher the quantity of the “representative contaminant” would be required to achieve a lethal dose (LD) in a serving size. So, to provide an additional level of validation with identified actionable process steps, the use of the LD calculation might be considered to provide more realistic insight into the feasibility element. For instance, if it would require one hundred pounds of the “representative contaminant,” you might feel justified in concluding that it is not realistic to get that amount of contaminant into the batch at the process step and rule out the point, step or procedure as an APS. This can save money and ensure limited food defense resources can be channeled to the areas where legitimate risk can be reduced.

Lesson 16: After an APS is identified, sites will need to determine, as the rule states, whether the existing “mitigation strategies can be applied…to significantly minimize or prevent the significant vulnerability.” Simply stated, what is in place today for food safety, and the broad-based security measures in use, may or may not be enough when you consider an insider motivated to contaminate the product. The FDA’s mitigation strategies database may offer some insights into additional food defense measures to consider. Where additional mitigation strategies are identified, from the time of completion of the VA until a site’s regulatory compliance deadline arrives (next one is July 26, 2020), that change must be incorporated into the food defense plan and fully implemented. We recommend that a site make a list of new mitigation strategies after the VA is complete for tracking purposes during the implementation phase. No mitigation strategies should be included in the food defense plan that are not fully implemented and where records cannot be adequately produced.

Lesson 17: In the second installment of the guidance, the concept of partial ingredients was introduced. The key activity types (KAT) of secondary ingredients is now considered to include the storage of partially used, open containers of secondary ingredients where the tamper-evident packaging has been breached. Tamper evident tape looked to have promising benefits, but several of our clients have abandoned the use of this mitigation strategy, which has been proven repeatedly to be defeated without detection. It appears that using containers that can be secured with numbered seals might be a better option and even better if the seals would be metal detectable in the event one went astray in a product stream.

Lesson 18: Food defense plan unification. Facilities regulated under the IA rule are likely to already have a food defense plan for other initiates such as SQF or BRC. The IA Rule is not unlike other counter-terrorism regulations in potential to create challenges to meet voluntary and regulatory requirements without having multiple food defense plans. The IA Rule based on its modeling after HACCP creates some very specific requirements in terms of how data needs to be presented and records maintained. Sites may be doing other things to support food defense, and one strategy that might keep auditors in their lane would be to include any non-IA Rule food defense content (e.g., for SQF or BRC) in an appendix to the IA Rule Food Defense Plan.

Lesson 19: Under the VA method the FDA refers to as “the “Three Element” approach, suggestion is made in the guidance released in March 2019 that regulated facilities might consider creating stratified categories for each element of public health impact, degree of physical access and ability of the attacker to successfully contaminate product. This is asking regulated facilities to engineer their own vulnerability assessment methodology. It is our opinion that this is asking a lot from a food and beverage facility and that creating categories for each element (e.g., refer to Table 3 on page 54) will extend the time it takes to complete a vulnerability assessment, create a lot more uncertainty in the process and does not necessarily help companies to identify the areas where intentional adulteration risk is highest.

Conclusion

Organizations who have yet to execute vulnerability assessments (due July 26) or those who have already completed vulnerability assessments who may wish to reflect back on their existing VAs in an effort to eliminate unnecessary APS’s should find these strategies helpful in focusing limited resources to the areas where they can have the greatest effect. Since the initiation of this article series, the FDA has released its third installment of the guidance. Once we reflect on this new installment, we will address our thoughts in a future article.

FDA

FDA Releases Supplemental Draft Guidance for Intentional Adulteration Rule

By Food Safety Tech Staff
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FDA

Read the series: Lessons Learned from Intentional Adulteration Vulnerability AssessmentsThis week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule. The draft, “Mitigation Strategies to Protect Food Against Intentional Adulteration”, includes chapters that address food defense corrective actions and verification, reanalysis and recordkeeping. It also includes appendices on FDA’s Mitigation Strategies Database, along with how business can assess their status as a small or very small business.

This is the third and final installment of the draft guidance for the IA rule.

The FDA is still on schedule to begin routine intentional adulteration inspections next month.

Ben Schreiber, ActiveSense
Bug Bytes

How ERM Can Simplify Pest Management

By Benjamin Schreiber
2 Comments
Ben Schreiber, ActiveSense

Whether you work in food manufacturing, distribution or retail, pests are both a fact of life as well as a regulatory disruption. At the same time, pest management solutions aren’t always clear-cut: While there are a variety of effective strategies employed by pest management professionals (PMPs) servicing the food industry, industry challenges—shifting regulatory standards, a lack of proper documentation and more—can complicate the process. For these reasons, short-term rodent problems can become long-term logistical nightmares, leaving food manufacturers in an undesirable situation when a third-party food plant auditor arrives.

Fortunately, emerging technologies in pest management practices are helping facility managers streamline their food and beverage quality assurance processes, reducing the risk of product loss, regulatory action, improper brand management and more. Specifically, electronic remote monitoring (ERM) allows PMPs to detect and monitor rodents in real time, providing you with important information to help reduce risk and increase audit compliance. As such, the value of food safety pest management strategies that incorporate ERM systems is only growing. Seeking out PMPs who use ERM allows you to invest in technologies that protect your margins, ensure the quality of your product and, ultimately, safeguard your most important asset—your reputation.

Modernizing Pest Management With ERM

At first glance, it might seem like pest management practices haven’t drastically changed since they were first implemented in the food manufacturing industry. Many rodent trapping systems remain similar to their original design: Devices designed to trap or kill that must be individually inspected and serviced by professional technicians. Technicians must then relay any risks to facility managers, who have to determine if additional resources are needed to avoid product loss or audit-based infractions.

Upon closer examination, it’s clear that while pests themselves have not significantly changed, both the pest management industry and the modern food supply chain have become increasingly complex. Food facility managers must contend with increasingly stringent food safety standards, and PMPs must rise to meet these needs with evolving pest management strategies.

In many ways, ERM technologies are the structural pest control industry’s response to these challenges, providing technicians with real-time notifications about rodent behavior and allowing them to make risk-based assessments that identify and treat problems before infestations occur. Unlike pest control strategies that rely on periodic service visits from technicians, PMPs who utilize ERM technology can monitor pest activity around the clock, 24/7/365, in virtually any environment. Instead of monitoring individual traps, PMPs can use ERM technology to know exactly when and where pest activity occurs, including in hard-to-monitor areas such as drop ceilings, crawlspaces, shelving undersides and other traditionally overlooked spaces. Technicians then receive valuable analytics from each trap they install, as well as documentation and reporting, that help managers achieve audit and regulatory compliance.

FSMA and ERM

In 2015, the FDA issued the final component of preventative control for human food under FSMA, officially enacting legislation that requires food safety plants to focus on risk-based pest prevention instead of reactive pest control strategies. As a result, quality assurance professionals and facility managers are often tasked with reallocating personnel toward proactive pest control activities in addition to their day-to-day responsibilities.

In many ways, ERM systems go hand-in-hand with FSMA and GFSI regulations. While preparing for a situation that hasn’t yet occurred can be a costly and time-consuming process, ERM has helped PMPs develop custom pest management strategies that assess and control situations in accordance with FSMA and other auditing firm guidelines. In many ways, ERM can provide all parties—PMPs, in-house auditors and third-party regulators—with a track record of pest history that all parties can cross-reference when assessing a facility.

From Risk-Averse to Risk-Based

When it comes to food safety rules and regulations, the only constant is change. In the structural pest control industry, auditors have historically implemented strict guidelines about trap placement that are frequently changing: For instance, traps should be placed every 10, 15, or 20 feet, regardless of facility susceptibility to various pest conditions. Failure to comply with regulations can result in point deductions on audits, even if the conditions that might lead to an infestation are not present. As such, food processing plants often choose to abide by the most stringent audit guidelines imposed upon them by other parties, such as retailers. By utilizing ERM technologies, food safety and quality assurance professionals can use additional pest monitoring analytics to focus on specific compliance issues, rather than spending additional time and money on other strategies.

Additionally, ERM allows PMPs to focus their efforts not only on weekly service visits and station checks, but also on important tasks, including assessing facility vulnerabilities, tracking rodent access points, and providing consultation and additional management strategies to their client—you.

Approaching the Audit with ERM

Food plant managers and retailers alike know that auditor approval is everything. Because ERM is a fast-developing technology, many quality assurance managers and facility owners are curious to know if ERM is audit approved. In truth, there are many kinds of audits, each with different goals, assessment techniques and regulatory standards. When it comes to audits, the gold standard is not necessarily the assessment of the facility and production line itself, but rather how well the assessment matches records kept by the food production plant.

To this end, ERM might be the answer to a streamlined audit process. No matter what kind of audit a plant is currently undergoing, ERM allows PMPs to provide records auditors need to verify that all systems are working properly. ERM can mean the difference between a streamlined process and a laborious audit, acting as a documentation system that helps officials conduct a PMP-verified “second-check.” This kind of verification is invaluable in an industry where there are already more than enough regulatory categories to consider without having to further worry about potential pest infestations.

ERM-Oriented Solutions

Thanks to the many advantages they offer, ERM and other remote pest monitoring technologies are growing in popularity. Many facility managers appreciate that ERM allows them to assess pest activity, prevent infestations before they occur, gather data that helps them remain industry-compliant, and acquire and share information with additional parties. If you’re a facility manager, quality assurance professional or other food safety decision-maker interested in the opportunities ERM technologies provide, consider starting the conversation about your pest prevention system with your PMP and how ERM might help improve it.

Trust, But Verify

There is an overwhelming consensus in the pest control industry that technology should be developed to provide end-users with more information. ERM systems are a natural extension of this belief, providing each component of the food production and distribution supply chain—manufacturers, distributors, retailers, quality assurance officials, technicians and others—with more data about how pest control decisions are made. Without data, it can be difficult to ensure technician service visits end in greater transparency about the issues facility owners will face as they prepare for an audit.

Fortunately, ERM can help provide the level of trust and assurance plant managers need to feel confident in their day-to-day operations. ERM is an important step forward for manufacturer-regulator relations, which require a strong combination of data, trust and transparency to ensure that communication systems don’t break down. After all, there are many industries in which miscommunication can lead to catastrophic consequences, and food production is no exception.

While each manufacturing facility, processing plant, distribution center, storage warehouse and retail outlet is different, none are insusceptible to pest infestations, and none can avoid audits required to keep them compliant. Because rigorous oversight is crucial for food producers and consumers alike, working with your PMP to develop pest monitoring strategies that utilize ERM systems and other cutting-edge technologies should be part of your larger pest control consideration process.

In the end, the pest infestation that causes the least damage to your product, profit potential and industry reputation is the infestation that never occurs.

FDA

Drug to Mitigate Peanut Allergies in Kids Gets FDA OK

By Food Safety Tech Staff
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FDA

On Friday FDA announced the approval of a drug to mitigate allergic reactions to accidental peanut exposure in children. Manufactured by Aimmune Therapeutics, Palforzia is intended for use in children who are four years through 17 years old. FDA points out that there is no cure for a peanut allergy and so peanuts must continue to be avoided.

Palforzia is a powder made from peanuts and administered in capsule and sachet form via three phases, the first of which occurs under the supervision of a healthcare professional. This first phase, called “initial dose escalation”, involves administration of a single capsule. The second phase, “up-dosing”, is a phase of 11 increasing dose levels over a period of several months (the first dose of this phase is also administered under watch by a healthcare professional, while the remaining doses can be taken daily at home). Following completion of the second phase, a patient begins the “maintenance” treatment, which is delivered via a sachet (the powder can be mixed with foods such as applesauce and yogurt).

“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in an agency press release.

Palforzia is available through healthcare providers, healthcare settings and pharmacies that receive special certification and are educated on the risk of anaphylaxis in using the drug. Patients interested in receiving the drug must be part of FDA’s risk evaluation and mitigation strategy program.