Tag Archives: risk

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FDA Releases Supplemental Draft Guidance for Intentional Adulteration Rule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the series: Lessons Learned from Intentional Adulteration Vulnerability AssessmentsThis week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule.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This is the third and final installment of the draft guidance for the IA rule.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
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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.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part II)

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. To further assist facilities with reviewing old or conducting new VAs, Part II will touch on access, subject matter experts, mitigation strategies and community drinking water through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 6: Utilization of Card Access. The FDA costs of implementing electronic access control, as reported in the Regulatory Impact Analysis document (page 25) are shown in Table 1.

Average Cost Per Covered Facility Initial Recurring Total Annualized
Prohibit after hours key drop deliveries of raw materials $ $1070 $1070
Electronic access controls for employees $1122 $82 $242
Secured storage of finished products $1999 $– $285
Secured storage of raw materials $3571 $– $508
Cameras with video recording in storage rooms $3144 $– $448
Peer monitoring of access to exposed product (not used) $47 $1122 $1129
Physical inspection of cleaned equipment $– $303 $22
Prohibit staff from bringing personal equipment $157 $– $22
Total $9993 $1455 $2878
Table I. Costs of Mitigation

In our opinion, these costs may be underreported by a factor of five or more. A more realistic number for implementing access control at an opening is $5,000 or more depending on whether the wire needs to be run in conduit, which it typically would. While there are wireless devices available, food and beverage organizations should be mindful that the use of wireless devices may in some cases result in the loss of up to 50% of electronic access control benefits. This happens because doors using this approach may not result in monitored-for-alarm conditions, such as when doors are held open too long or are forced open. Some wireless devices may be able to report these conditions, but not always as reliable as hardwired solutions. Using electronic access control without the door position monitoring capability is a mistake. From a cost standpoint, even a wireless access control device would likely be upwards of $2,000 per opening.

Lesson 7: In the interest of time, and in facilities with more complex processes (which increases the work associated with the VA), plan to have quality, food safety and physical security personnel present for the duration of the VA. But also bring in operational specialists to assess each point, step or procedure for the respective operational areas. You may wish to have a quick high-level briefing for each operational group when it’s their turn to deliberate on their portion of the manufacturing operation. Proper planning can get a hybrid style VA done in one-and-a-half to three days maximum for the most complex of operations.

Lesson 8: Conduct a thorough site tour during the assessment process; do not limit your vulnerability activity to a conference room. Both internal and external tours are important in the assessment process by all members of the team. The external tour is needed to evaluate existing measures and identify vulnerabilities by answering questions such as:

  • Is the perimeter maintained?
  • Are cameras pointed correctly?
  • Are doors secure?
  • Are vehicles screened?
  • Are guards and guard tours effective?
  • Internal tours are important to validate documented HACCP points, steps or procedures.A tour also helps to validate process steps that are in multiple parts and may need to be further assessed as a KAT, for public health impact, accessibility and feasibility or to identify issues that have become “invisible” to site employees which might serve a security purpose.
  • Properly conducted tours measure the effectiveness of a variety of potential internal controls such as:
    • Access control
    • Visitor controls
    • Use of identification measures
    • Use of GMP as a security measure (different colors, access to GMP equipment and clean rooms)
    • Effectiveness of buddy systems
    • Employee presence

Lesson 9: Do not forget the use of community drinking water in your processes. This is an easy way to introduce a variety of contaminants either in areas where water is being treated on site (even boiler rooms) or where water may sit in a bulk liquid tank with accessibility through ladders and ports. In our experience, water is listed on about half of the HACCP flow charts we assessed in the VA process.

Lesson 10: Some mitigation strategies may exist but may not be worth taking credit for in your food defense plan. Due to the record keeping requirements being modeled after HACCP, monitoring, corrective action and verification records are required for each mitigation strategy associated with an APS. This can often create more work than it is worth or result in a requirement to create a new form or record. Appropriate mitigation strategies should always be included in your food defense plan, but sometimes it produces diminishing returns if VA facilitators try to get too creative with mitigation strategies. Also, it is usually better to be able to modify an existing process or form than having to create a new one.

Lesson 11: In cases of multi-site assessments, teams at one plant may reach a different conclusion than another plant on whether an identical point, set or procedure is an APS. This is not necessarily a problem, as there may be different inherent conditions from one site to the next. However, we strongly suggest that there be a final overall review from a quality control standpoint to analyze such inconsistencies adjudicate accordingly where there is no basis for varying conclusions.

Lesson 12: If there is no person formally responsible for physical security at your site, you may have a potential gap in a critical subject matter area. Physical security measures will make at least a partial contribution to food defense. Over 30 years, we have seen many organizations deploy electronic access control, video surveillance and lock and key control systems ineffectively, which provides a false sense of security and results in unidentified vulnerability. It is as important to select the right physical security measures to deploy, but also critical to administer them in a manner that meets the intended outcome. Most companies do not have the luxury of a full-time security professional, but someone at the plant needs to be provided with a basic level of competency in physical security to optimize your food defense posture. We have developed several online training modules that can help someone who is new to security on key food defense processes and security system administration.

Lesson 13: As companies move into ongoing implementation and execution of the mitigation strategies, it is important to check that your mitigation strategies are working correctly. You will be required to have a monitoring component, correction action and verification intended for compliance assurance. However, one of the most effective programs we recommend for our clients’ food defense and physical security programs is the penetration test. The penetration test is intended to achieve continuous improvement when the program is regularly challenged. The Safe Quality Food (SQF) Institute may agree with this and now requires facilities that are SQF certified to challenge their food defense plan at least once annually. We believe that frequency should be higher. Simple challenge tests can be conducted in 10 minutes or less and provide substantial insight into whether your mitigation strategies are properly working or whether they represent food defense theater. For instance, if a stranger were sent through the plant, how long would it take for employees to recognize and either challenge or report the condition? Another test might include placing a sanitation chemical in the production area at the wrong time. Would employees recognize, remove and investigate that situation? Challenge tests are easy high impact activities; and regardless of the outcome, can be used to raise awareness and reinforce positive behaviors.

Whether training a new security officer, reviewing existing security plans or preparing for an upcoming vulnerability assessment (due July 26, 2020), these lessons learned from experienced security consultants should help to focus efforts and eliminate unnecessary steps at your facility. The final installment in this series will address broad mitigation strategies, the “Three Element” approach and food defense plan unification. Read the final installment of this series on Lessons Learned from Intentional Adulteration Vulnerability Assessments, Part III.

FST Soapbox

A Digital Approach to Environmental Monitoring: Let’s Get Proactive!

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Technology and automation for safety and surveillance have already impacted nearly every industry in the world. For example, in the United States and many other developed regions, we have just lived through the transformation to electronic health records within the healthcare industry. Prior to that, we lived through the digital transformation of all of our banking information to an online banking platform—now the norm across the world.

However, the food and beverage industry is still learning how technology can improve their organizations. The food safety segment of this market is particularly in need of a digital transformation, as the risk associated with foodborne illness is potentially catastrophic to food companies, and moreso, to the end consumers who are impacted by preventable pathogenic outbreaks.

Along with regulation advancements, such as the timed roll-out of FSMA, the industry continues to work towards a more effective approach to food safety. But most regulations, and advancements in the industry are pointed toward a reactive stance to food safety issues, rather than a preventive stance. For example, although traceability is important in leading investigations to the source and taking remediation steps sooner, a more proactive approach to prevention should be considered when investing in food safety programs.

This is where the importance of an automated environmental monitoring program comes in. To be proactive requires a commitment to embracing data and digital technology. Knowing where to start to effectively pivot your digital approach can be a challenge.

Understanding the following thought process can help you to recognize areas of potential improvement and growth within your environmental monitoring program.

  • Define Your Business Objectives. Ask how profitability and production uptime is connected to food safety issues.
  • Verify Suppliers. Establish protocols for incoming product from external suppliers and validate their food safety performance and ability to maintain a clean facility.
  • Modernize Your Environmental Monitoring Program (EMP). Are you able to confirm that your EMP is being executed consistently? Across all facilities?
  • Understand Data Exhaust. See how your organization’s valuable data can be used to identify trends and accelerate root cause analysis that impact decision-making processes.

Define Your Business Objectives

Food companies large and small are being challenged to implement required processes and procedures to meet the demands of FSMA, and ultimately achieve a more proactive and preventative food safety stance. Transformation in this arena, led by government regulation, and enhanced by standards certification requirements, has highlighted the responsibility of suppliers and manufacturers to protect consumers.

Many organizations are not aware that a single failure in their food safety program could actually be the most devastating profitability risk that the organization faces today. When your organization is focused on production uptime and profitability, it can be easy to overlook the details involved in maintaining a strong food safety program. In reality, though, food safety and profitability are inextricably linked due to the risk of production interruptions that can be caused by safety issues.

Whenever a food recall occurs, it has the potential to start the dominoes falling, with major implications regarding costs, reputational damage, compliance penalties, supply chain interruption, and sales declines. Worse yet, these impacts can last for years after the actual event. By delaying both the importance of recognizing the seriousness of this risk as well as taking necessary steps to prevent it, your organization’s reputation could be on the line.

Unfortunately, planning is often sacrificed when managers fail to implement the proper technological solutions. Fulfilling fundamental documentation requirements involves a smart, automated approach. This is the best way to optimize recall prevention. By incorporating an automated EMP process, a supplier management system, and other FSMA Preventive Controls measures, suppliers ultimately improve the strength of the entire chain for their partners, consumers and themselves.

There are many other facets to food safety, but the EMP is where inspectors and auditors will look to see the indicators of contamination and the efficacy of your sanitation controls. Therefore, it is critical that your organization exhibit not only that you are on top of things and are following your EMP procedures consistently, but that you can analyze and pinpoint issues as they arise, and that you have a track record of corrective actions in response to those issues. This, in-turn, allows you to see where your business objectives are most at-risk.

Regardless of which specific food industry segment your company operates in, or which governing body it reports to, it’s essential to stay informed and compliant with changing regulations in order to reduce the risk of experiencing a recall. In a strategic operational role, intelligent environmental monitoring allows companies to not only proactively work to avoid public health issues, but is vital to retaining a consistent bottom line.

Verify Suppliers

Earlier this year, the FDA heralded what they call a “New Era of Smarter Food Safety”. As technology becomes increasingly accessible, more and more companies are investigating how technology can be used to harness and control the growing complexity of supply chain implications.

The challenge of making sure your organization is doing its due diligence to prevent recalls is further complicated when incorporating outside suppliers. For example, 15% of the United State’s overall food supply is imported from more than 200 other countries, according to the FDA. Making sure the product coming into a facility is also meeting your standards is vital to preventing pathogens from entering your supply chain either through containers, people, or the incoming product itself.

The complexity grows exponentially when we contemplate what this means for tracking food safety across a supply chain of this scope. Generally suppliers are asked to provide verification for the cleanliness of the product they are bringing into your facility. However, by going a step further and establishing test points for the product when it comes in, you will be better equipped to catch pathogens before they can enter into your own supply chain and potentially contaminate other products. While you may already have a good relationship with your suppliers, being able to independently verify the safety of their products and that their own processes are working, creates a mutually beneficial relationship.

Modernize Your Environmental Monitoring Program

Food experts at the World Health Organization headquarters in Geneva discussed the critical nature of ensuring food safety across geographic boundaries, as it is an issue that affects everyone. Incidents of pathogen outbreaks around the world have a direct impact on the health of global citizens, with one in 10 people falling ill due to food contamination.

A traditional EMP allows organizations to continuously verify that their sanitation programs are working by scheduling testing, monitoring results for any signs of pathogens, and maintaining compliance with regulatory bodies. Historically, this type of program is documented in spreadsheets and three-ring binders, but today the acceptance of new tools being offered by vendors and labs are expanding offerings to modernize the monitoring process.

Food safety professionals, many of whom are trained microbiologists, should have better tools at their disposal than spreadsheets that force them to manually sift through data. All regulatory bodies in the food industry have guidelines when it comes to where, what, and when you should be testing in your facilities. Ensuring that this is happening is a basic requirement for meeting regulatory mandates.

By choosing an automated EMP, FSQA teams are able to schedule testing plans including randomization and test point coverage rules, see what testing is being performed when, and obtain all testing data in one system for ease of access before or during an audit. This offers an “always-on” source of audit data and more importantly, trending and root-cause analysis capabilities to find and define actions to remediate recurring problems.

Further, an automated EMP that is integrated with your food safety plan allows you to set up workflows and automatically notify appropriate team members according to your organization’s policies. Each remediation step can be recorded and time stamped as the corrective action moves towards completion.

Understand Data Exhaust

A dominant theme pushed forward by FSMA is the need to document all aspects of your food safety plan, from the written outline to the records indicating proper implementation. Today’s manufacturers face a time of heightened regulation, and with stricter enforcement comes greater requirements for documentation. Automated EMPs not only provide your organization insight into what is happening within your facilities for documentation, it also gives time back to your FSQA team who, instead of spending their days with three ring binders, can analyze and investigate recurring issues in your facility to look for new, innovative ways for the organization to maintain a high standard of quality.

However, effective testing also means reading, understanding and responding to results. It is not enough to simply meet the required volume and frequency of environmental testing metrics. You need to use the resulting information to effect change and improvements by lowering the likeliness of pathogens, allergens and contaminants from entering the food supply chain. The more data collected, the more it leads to true understandings. What testing might show is just the symptoms of the problem—not the root cause of a far bigger problem. As more data is available, it becomes more valuable through the insights that can be gained through trend analysis. This, in turn, moves the conversation to higher levels within the organization who care about ensuring productivity and reducing avoidable risk.

Incorporating your lab into the equation is essential. Find a lab partner that offers an automated testing program that is integrated with their LIMS. Your organization will then be in a better position to ensure results are being responded to in an appropriate time frame.

There are many diagnostic tools in use today, both in-plant and at the lab. Each of these tools generates “data exhaust” in the form of a diagnostic result. But are your data streams being integrated and analyzed to find correlations and potential cause/effect relationships? Or does your ATP device simply record its data to a dedicated laptop or spreadsheet?

Testing, combined with an automated EMP, can allow you to combine data from various diagnostic systems (on-premise or from your lab partner) to identify trends and therefore a more holistic path to remediation. For this to occur, data must be accessible, aggregated and actionable, which an automated EMP achieves.

Forward-thinking companies and facility managers are leveraging valuable software solutions to improve processes, protect reputations, minimize inefficiencies, and simplify multifaceted compliance and audit tasks. Over the next three to five years, numerous organizations will reduce their risk of food recalls by combining their EMPs with analytics capabilities to reduce food risk and improve quality using diagnostic solutions and data assets. This change will be arduous, as all digital transformations in other industries have shown. But, in the end, they have shown the value and long-term success that the food industry now needs to experience.

Chelle Hartzer, Orkin
Bug Bytes

Stay Audit-Ready, Anytime with Integrated Pest Management

By Chelle Hartzer
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Chelle Hartzer, Orkin

The unlimited supply of food sources that manufacturing facilities provide can make pest management a daunting task, especially with the scrutiny of third-party auditors, government regulators and customers. These high standards, along with yours, mean that diligence is a key ingredient in the recipe for pest management success.

Why is this important? The steps you take to prevent pests, and how issues are resolved if pest activity is detected, affects the overall credibility of your business. After all, pest management can account for up to 20% of an audit score.

Auditors look for an integrated pest management (IPM) plan, which includes prevention, monitoring, trend reports and corrective actions. If you want to stay audit-ready, all the time, implement the following five principles.

Open Lines of Communication

A successful pest management partnership is just that: A partnership. Create an open dialogue for ongoing communication with your pest management provider. Everyone has a role to play from sanitation to inspection to maintenance. For example, if there are any changes in your facility, such as alteration of a production line, let your provider know during their next service visit. During each visit, it’s important to set aside time to discuss what was found and done during the visit, including new pest sightings and concerns.

Communication shouldn’t be limited to the management team; your entire staff should be on board. During their day-to-day duties, employees should know what to look for, and most importantly, what to do if they notice pests or signs of pests. Reporting the issue right away can make a huge difference in solving a pest problem before it gets out of hand. Also, most pest management providers offer staff training sessions. These can be an overview of the basics during your next staff meeting or a specialized training on a pertinent issue.

Inspect Regularly

A thorough inspection can tell you a lot about your facility and the places most at risk for pests. Your pest management provider will be doing inspections every visit, but routine inspections should be done by site personnel as well. Everyone at the site has a set of eyes, so why not use them? This way, you can identify hot spots for pests and keep a closer eye on them. Pests are small and can get in through the tiniest of gaps, so some potential entry points to look out for are:
• Windows and doors. Leaving them propped open is an invitation for all sorts of pests. Don’t forget to check the bottom door seal and ensure it is sealed tight to the ground.

  • Floor drains. Sewers can serve as a freeway system for cockroaches, and drains can grant them food, water and shelter.
  • Dock plates. A great entry point for pests, as there are often gaps surrounding dock plates.
  • Ventilation intakes. These are a favorite spot for perching, roosting or nesting birds, as well as entry points for flying insects.
  • Roof. You can’t forget about the roof, as it serves as a common entry point for birds, rodents and other pests.

Another thing to look for is conducive conditions, such as sanitation issues and moisture problems. These are areas where there may not be pests yet, but they provide a perfect situation that pests could take advantage of if they aren’t dealt with. Make sure to take pictures of deficiencies so that can be shared with the maintenance department or third-party who can fix it. You can also take a picture of the work when it has been finished, showing the corrective action!

Keep It Clean

Proper sanitation is key to maintaining food safety and for preventing and reducing pests. You need a written sanitation plan to keep your cleaning routine organized and ensure no spots are left unattended for too long. The following are some additional steps consider:

  • Minimize and contain production waste. While it’s impossible to clean up all the food in a food processing site (you are producing said food!), it’s important to clean up spills quickly and regularly remove food waste.
  • Keep storage areas dry and organized.
  • Remember FIFO procedures (first in, first out) when it comes to raw ingredients and finished products.
  • Clean and maintain employee areas such as break rooms and locker rooms.
  • Ensure the outside of your facility stays clean and neat with all garbage going into trash cans with fitted lids.
  • Make sure dumpsters are emptied regularly and the area around them kept clean.

Monitoring

Monitoring devices for many pests will be placed strategically around your facility. Some common ones are insect light traps (ILTs), rodent traps and bait stations, insect pheromone traps and glue boards. It’s important to let employees know what these are there for and to respect the devices (try not to run them over with a fork lift or unplug them to charge a cell phone). These devices will be checked on a regular basis and the type of pest and the number of pests will be recorded. This data can then be analyzed over time to show trends, hot spots, and even seasonal issues. Review this with your pest management provider on a regular basis and establish thresholds and corrective actions to deal with the issues when they reach your threshold. The pest sighting log can also be considered a monitoring tool. Every time someone writes down an issue they have seen, this can be quickly checked and dealt with.

Maintain Proper Documentation

Pest management isn’t a one-time thing but a cycle of ongoing actions and reactions. Capturing the process is extremely important for many reasons. It allows you to analyze, refine and re-adjust for the best results. It’s a great way to identify issues early. Also, it’s a critical step for auditors. Appropriate documentation must be kept on hand and up-to-date. There’s lots of documentation to keep when it comes to pest management and your provider should be keeping all of that ready—from general documentation like your annual facility assessment and risk assessment to training and certification records, pest sighting reports, safety data sheets and more.

The documentation aspect may seem like a lot at first, but a pest management provider can break it down and make it easier. It’s absolutely necessary for food and product safety and will become second nature over time.

FDA

FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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FDA

Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
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AFSAP

The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.

Reason

“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA

Charge

“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.

Data protection, security

Threat of Cyberattacks to Food Safety on the Rise

By Food Safety Tech Staff
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Data protection, security

A new report released by the University of Minnesota’s Food Protection and Defense Institute warns that the food industry is vulnerable to cyberattacks, suggesting that food companies need to beef up their security and IT systems. According to the report, “Adulterating More Than Food: The Cyber Risk to Food Processing and Manufacturing”, the systems that food companies use for processing and manufacturing could be the most vulnerable and as such, serve as an attractive target for an attack—especially as industries that are currently common targets improve their cybersecurity.

“The food industry has not been a target of costly cyberattacks like financial, energy, and health care companies have,” said Stephen Streng, lead author of the FPDI report, in a news release. “However, as companies in those sectors learn to harden their defenses, the attackers will begin looking for easier victims. This report can help food companies learn about what could be coming their way and how to begin protecting themselves.”

The report calls out that in 2011, researchers and manufacturers found more than 200 vulnerabilities in industrial control systems. In addition to the fact that these vulnerabilities are in many components from different vendors, many of these systems have obsolete operating systems and passwords that are easy to hack. Compounding this issue, “Companies often lack knowledge about how their industrial control systems and IT systems interact and lack awareness about cyber risks and threats,” the FPDI release notes.

And if you’re a small company, don’t think you’re immune, the report cautions. It cites that 74% of U.S. food manufacturers have fewer than 20 employees—yet software company Symantec Corp. points out that small companies have been targeted as often, or sometimes even more, than large companies.

How can food companies address this risk? The report recommends the following “critical” steps all companies should take:

  • Bridge the gap and facilitate more communication between OT (operational technology) and IT (information technology) personnel
  • Conduct risk assessments of inventory control systems and IT systems
  • Ensure that staff with the cybersecurity knowledge is involved in procuring and deploying inventory control system devices
  • Incorporate cybersecurity into your food safety and food defense culture.

FPDI’s full report is available on the organization’s website.

Alert

Flooding and Food Safety: A Two-Part Plan for Extreme Weather Season

By Paula Herald
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Alert

The spring of 2019 saw record rain fall across North America, causing historic, severe flooding in the Great Plains, parts of the Midwest, and the Southern United States. That above-normal precipitation doesn’t look to be ending, either. The National Oceanic and Atmospheric Administration’s Climate Prediction Center predicts that wide swaths of the United States could face above normal precipitation for the remainder of 2019.

In addition to disrupting power to critical equipment and damaging property, when food businesses flood, food safety is put at risk. Flood waters can be contaminated with debris, sewage, chemicals, pests and more. In a restaurant or foodservice operation, any product, object or surface that flood waters touch becomes contaminated.

Pre-Flood Preparation

Having a documented flood emergency plan in place can give location staff a step-by-step course of action to follow in times of increased stress and panic. It can also help minimize losses for a business.

For national chains in particular, it can be harder to ensure that all locations have the resources and tools available in their area. Corporate operations can assist by identifying vendors and resources ahead of time.

  • Designate roles and responsibilities. Having a clearly outlined plan with designated roles and responsibilities can prevent confusion and extra work during the crisis. Have an updated phone contact list of key contacts available for those with designated roles and responsibilities.
  • Sandbags. Placing sandbags in front of doors or other openings may help limit flood damage.
  • Vital records. Both paper and digital/electronic records can be at risk. Businesses using electronic records should ensure that files are automatically backed up regularly. Businesses using paper records should ensure that vital records are secured in such a way that they can be quickly removed to a safe place or elevated to prevent damage.
  • Equipment. Flood waters can damage or destroy expensive equipment. Have a plan in place to remove equipment to a safe place.
  • Food storage. If flood waters contact food supplies, many may need to be destroyed. Arranging for food storage in a secure place away from flood waters can help minimize losses. This may require refrigeration storage.
  • Turn off electric and gas. Turning off natural gas lines can prevent devastating damage and contamination from occurring. Turning off and unplugging equipment that uses electricity can help protect the safety of rescue workers or staff returning for cleanup.
  • Refrigeration. If it is not possible to remove food, be certain that all refrigerated units are equipped with accurate thermometers. If possible, monitor the temperature in the units during the disaster situation.

Post-Flood Recovery

Even with a rock-solid pre-storm plan in place, Mother Nature’s extreme weather events can wreak havoc on facilities. In the wake of a storm, sorting out what needs to be done to restore order to operations can be a hefty task.

Post-storm recovery can be an extensive task, especially if flooding is involved. It may require work of many staff members or outside vendors, such as remediation specialists. Safety should be absolutely paramount. No one should enter a space that has been flooded without confirmation that there are no electrical shock hazards, gas leaks or debris that could harm people. Structural damage that could lead to collapse or other injury is possible. Mold is also a risk following floods. All personnel involved in flood clean-up must wear personal protective equipment—eye protection, gloves, disposable aprons, rubber boots, and masks or respirators, etc.

The following guidelines can help prioritize steps to ensure food safety won’t be a factor holding back a location from re-opening.

  • Safe water. Facilities cannot prepare food without a clean, potable water supply. If the water system was affected by flood or the local water supply was unsafe, the local health department should be involved in clearing re-opening.
  • Disinfection of equipment. Any food equipment that was exposed to flood water or other non-potable water must be disinfected prior to use, including ice machines, which are often overlooked. Discard any ice already present in a machine. Thoroughly clean and sanitize the machine before turning it on. Once the machine is running again, discard the first two cycles of ice.
  • Disinfection of surfaces. Any surface (countertops, walls, ceilings, floors, equipment surface, etc.) that was contacted by floodwaters must be disinfected before reopening.
    • Use a commercial disinfectant with effectiveness against norovirus or make a chlorine bleach solution to disinfect affected areas.
    • Use unscented bleach and wear gloves.
    • Make fresh bleach solutions daily.
    • Food contact surfaces that are disinfected must be rinsed with clean, potable water, and sanitized before use.
    • Discard any mop heads or absorbent materials used to clean flooded areas.
  • What to discard. Inevitably, there will be items that cannot be salvaged following a flood event. The following items should be discarded if they have come into contact with floodwater or non-potable water or were subjected to temperature abuse due to power outages. If there is any doubt, throw it out.
    • Unpackaged food (examples: fruits, vegetables)
    • Food in permeable packaging (examples: flour in bags, produce in cardboard boxes)
    • Food packaging materials
    • Refrigerated food in a refrigerated unit where the temperature rose above 41°F for more than four hours
    • Any refrigerated product that was not temperature-controlled for more than four hours
    • Frozen food product that has thawed to a temperature of above 41°F for more than four hours
    • Canned items with damaged seams, swelling or dents
    • Items with screw tops, twist-off caps, or other semi-permeable packaging
    • Single service/use items
    • Any linens that contacted floodwaters that cannot be laundered with bleach and dried in a mechanical dryer
  • What can be safely kept. Not everything will need to be discarded.
    • Canned foods free of dents or rust can be kept after labels are removed, they are disinfected, washed, rinsed in clean water, and sanitized; cans with any signs of bulging or leaking must be discarded; canned foods should be also be relabeled with the name of the food product, as well as the expiration date
    • Linens that can be safely laundered with bleach and dried in a mechanical dryer
    • Dishes, utensils, pots and pans, and other service items that are free of rust and can be disinfected, washed, and sanitized

As climate change continues to advance, the threat of extreme weather and flooding situations may soon be a reality for areas of the United States that have never experienced them before. In the Congress-mandated Fourth National Climate Assessment, compiled by the U.S. Global Change Research Program, the authors warn of the future of severe weather events.

“More frequent and intense extreme weather and climate-related events, as well as changes in average climate conditions, are expected to continue to damage infrastructure, ecosystems, and social systems that provide essential benefits to communities.” – Fourth National Climate Assessment

Even for businesses that have not had to consider flooding before, it may be time to sit down and develop a flooding and food safety plan of action. The time invested in training and educating staff members may help to protect investments and keep food safe in the event of flooding and weather emergencies.