Tag Archives: FSMA

March 11, 2020

Food Labs / Cannabis Labs 2020 Agenda Announced

By Food Safety Tech Staff

The agenda for the 2020 Food Labs / Cannabis Labs conference has been announced. The event, which will address regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management, is scheduled to take place on June 3–4 in Rockville, MD.

Some agenda highlights include a special morning session on June 3 that discusses the proposed FSMA rule on lab accreditation: “FSMA and the Impact on Laboratories and Laboratory Data Users” and “FSMA Proposed Rule on Laboratory Accreditation: What it says and what it should say” presented by Reinaldo Figueiredo of ANSI and Robin Stombler of Auburn Health Strategies, respectively. FDA has also been invited to speak on the proposed rule. Sessions will also cover the role of labs as it relates to pathogens, with presentations from Benjamin Katchman, Ph.D. (PathogenDx) about a novel DNA microarray assay used for detecting and speciating multiple Listeria species and Dave Evanson (Merieux Nutrisciences) on pathogen detection and control. The full agenda is listed on the Food Labs / Cannabis Labs website.

The early bird discount of $395 expires on March 31.

Innovative Publishing Company, Inc., the organizer of the conference, is fully taking into considerations the travel concerns related to the coronavirus. Should any
disruption that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. More information is available on the event website.

February 25, 2020

Webinar Next Week: How Technology Impacts Pest Management

By Food Safety Tech Staff

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Haven’t mastered your pest management processes yet? Don’t miss next week’s complimentary webinar, “New Technology’s Impact on Pest Management in the FSMA Regulated World”. Steven Sklare, president of Food Safety Academy, will guide attendees through how technology can help with FSMA compliance, namely as it relates to pest management. He will also discuss how the IoT has made the mouse trap concept smarter, and how you can use this to your advantage in your company’s facility.

The event, which takes place Thursday, March 5 at 12 pm ET, is sponsored by Bayer Digital Pest Management.

February 24, 2020

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.

February 14, 2020

FDA Releases Supplemental Draft Guidance for Intentional Adulteration Rule

By Food Safety Tech Staff

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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.

February 12, 2020

Bug Bytes

How ERM Can Simplify Pest Management

By Benjamin Schreiber

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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.

January 22, 2020

Food Labs Conference Announced for Spring 2020

By Food Safety Tech Staff

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— UPDATE — March 9, 2020 – IPC and the Food Labs/Cannabis Labs Conference want to reassure you, that in case of any disruption that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. Please note that if you initially register as a virtual participant (meaning you have no intentions of traveling to the event regardless) and the on-site event is not cancelled, you will ONLY be able to listen to the General Sessions and the Cannabis Sessions. You will have not have access to the Food Labs Sessions and there will be NO recording of these sessions. If you have any questions, please contact Veronica Allen, Event Manager.

–END UPDATE —

EDGARTOWN, MA, Jan. 22, 2020 – Innovative Publishing Co., the publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo is announcing the launch of the Food Labs Conference. The event will address regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management. It will take place on June 3–4 in Rockville, MD.

Some of the critical topics include discussion of FDA’s proposed FSMA rule, Laboratory Accreditation Program for Food Testing; considerations in laboratory design; pathogen testing and detection; food fraud; advances in testing and lab technology; allergen testing, control and management; validation and proficiency testing; and much more.

The event is co-located with the Cannabis Labs Conference, which will focus on science, technology, regulatory compliance and quality management. More information about this event is available on Cannabis Industry Journal.

“By presenting two industry conferences under one roof, we can provide attendees with technology, regulatory compliance and best practices that cannabis and food might share but also focused topics that are unique to cannabis or food laboratory industry needs,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Labs Conference.

The call for abstracts is open until February 28.

The agenda and speakers will be announced in early March.

About Food Safety Tech
Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

December 23, 2019

2020 Priorities: Sanitation, Automation and Brand Transparency in Supply Chain

By Maria Fontanazza

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In a Q&A with Food Safety Tech, Eddie Hall, business development director and food safety expert at Vital Vio looks ahead to 2020 and how technology will be impacting food safety, the additional measures that the industry will be taking to protect consumers, and the critical emphasis on sanitation.

Food Safety Tech: What are some of the touch points for food safety innovation in the supply chain in 2020?

Eddie Hall, Vital Vio — Eddie Hall, business development director and food safety expert at Vital Vio

Eddie Hall: When we think of the supply chain, we often imagine food traveling during transportation—by road, rail and air. During transit, our food comes into contact with countless surfaces, hands, tools and bacteria that travels from the farm to the table. However, transit isn’t the only place for germ spread and bacteria growth. When food reaches the factory for processing and packaging, there are opportunities for contact with debris, mold and dust, along with un-sanitized machinery and employees. Not only does this negatively affect the health of our workers, but also the cleanliness and safety of the food that consumers are buying off the shelves. In food manufacturing plants, Zones 1 and 2 are the most obvious for safety innovation in the supply chain, given food is bound to come into contact with tools, conveyor belts, etc. However, processors must consider the touch points in Zones 3 and 4 as well—such as employee break rooms, bathrooms and offices around the plant that foster bacteria. If these areas are not cleaned, food manufacturers have a significantly higher chance of breeding bacteria in food production areas, even if the right protocols are put in place in those zones.

FST: How will the retail sector step up to the consumer demand for safer food?

Hall: Consumers are increasingly demanding transparency around how food ends up on their plate, and prioritizing purchasing from brands that they trust to be safe. Food suppliers are being careful to remove harmful chemicals from the manufacturing process, along with displaying ingredients and supply chain information. For example, Bumble Bee Foods is using blockchain technology for its tuna fish, allowing consumers to access detailed information around the tuna’s origin, authenticity, freshness and sustainability by scanning the QR code on its packaging. Panera Bread has been consistent in offering customers ingredient transparency [by] providing calorie counts on menu items and removing antibiotic-treated animal proteins, as well as vocalizing recent efforts to perform safety audits throughout its supply chain. Not only does tracking technology and clarity meet consumers’ demands, but [it] also helps retailers pinpoint locations of outbreaks, foodborne illness and mislabeling. We’re already seeing retailers step up to meet the growing demand for safer food, but in 2020 we will see an uptick in brand transparency around supply chain information, safety programs and ingredient clarity within restaurants, fast food chains, processing companies and grocery stores.

FST: How will automation play a role in advancing food safety?

Hall: Food processing companies and retailers are implementing remote monitoring technologies that track data and help measure protocol, temperature controls, sanitation, record-keeping and food traceability. Automation can also help advance food safety through methods such as enhance sanitation and sterilization efforts. It is critical for food industry employees to maintain clean environments, but continuously cleaning every hour of every day can become labor-intensive, and sometimes fall off the to-do list. Automated technologies can take on some of these tedious tasks and work in our favor to heighten food safety. For example, Stop and Shop’s new robot, Marty, patrols the aisles to detect food on the floor, torn packaging, empty shelves and more. However, robots aren’t the only place we’re seeing automation in action. Vital Vio has found a way to automate killing bacteria through antimicrobial LED lighting technology, which continuously kills pathogens with the flick of a switch. Automated tech isn’t meant to replace workers, but to enhance their work around cleaning, sanitizing and meeting safety requirements. In 2020, automation is expected to explode and it’s important for leaders in the food and beverage industry to take advantage of safety tech innovations to advance food safety in 2020 and beyond.

FST: How will food companies continue to work towards reducing contamination issues and recalls?

Hall: The U.S. government has stepped in to tackle issues in the food industry by implementing new regulations, such as FSMA. This regulation urges food companies to shift from reactively responding to safety and contamination issues, to proactively working to prevent them. In an effort to reduce recalls, retail giant Walmart recently employed blockchain to track its lettuce supply chains all the way back to the grower. For food companies to reduce contamination, they must also implement more automated sanitation technologies along the supply chain. The most common food contaminants are usually invisible to the naked eye, such as mold, Listeria, Salmonella and E. coli. Sanitation automation tech—such as antimicrobial LED lighting—can continuously kill microscopic bacteria and prevent regrowth, ensuring clean food and equipment. Not only will food companies begin implementing more sanitization technologies, but also focus on other ways, like blockchain traceability, to prevent food recalls and bacteria growth that pose serious health risks to their customers.

FST: Any additional comments?

Hall: Our Dirty Truth report reveals disturbing stats around Americans’ cleaning habits, such as 1 in 4 (27%) do not sanitize their hands after traveling on public transportation. This means that factory or grocery employees that commute to work via bus, train, etc. are bringing bacteria and other germs with them. What’s worse, 1 in 6 Americans get sick and 3,000 die each year from consuming contaminated foods or beverages. This alarming rate can only be improved if we see effort from all sides of the industry—including food processors, manufacturers, workers throughout the supply chain and retailers. Continuous cleaning and sanitation measures can be labor-intensive and sometimes impossible to tackle throughout the day. Luckily, automated technology exists and is expected to address this growing issue of contamination, the spread of bacteria, recalls, and consumer demand for safety and transparency.

December 20, 2019

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.

December 3, 2019

FST Soapbox

Prevention Takes Center Stage to Address Food Recalls

By Colleen Costello

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In the complex food supply chain, a single product travels a long journey before reaching consumers’ plates. It’s no wonder that it has become so difficult to control the quality and safety of food. As food moves from trucks to conveyor belts and through grocery store shelves and shopping carts, the risk for harmful bacteria to contaminate products rises immensely. What’s worse is pinpointing the source of contamination can be nearly impossible, leaving food manufacturers scrambling to “fix” the error without even knowing the cause.

In recent recalls, processing plants completely shut down operations in an effort to resolve the issue and thoroughly sanitize their entire facilities. While this is good news for consumers, this type of reactive response will undoubtedly have a long-term, irreversible impact on the business—both financially and potentially for the brand’s reputation. Consumers remember the name of the company they heard on the evening news that had to pull thousands of pounds of products from shelves in their city or region. Then, when they make their weekly trip to the grocery store, they likely make sure to avoid that company’s products in fear of potential quality issues that could make them and their families sick. It’s a deadly cycle for consumers and public health, as well as business livelihood.

Product and consumer safety must continue to be the top priority for the food industry. The success of these companies literally depends on it. With so much on the line, the food industry must come together to spark a shift in how they operate to prevent food recalls rather than having to respond to them.

Stopping Recalls to Save Lives and Businesses

To move in the direction of mitigating pathogens from ever coming into contact with food and therefore preventing recalls altogether, processors must develop and deploy new strategies that keep facilities consistently clean. The U.S. government is stepping in with regulations such as FSMA that urge companies to shift from reactively responding to safety issues, to proactively working to prevent them. This is the fundamental shift that is needed across the food supply chain in order to protect consumers and food producing businesses.

Important new technologies have emerged in recent years that can add new layers of meaningful protection to continuously combat contamination across the supply chain. When coupled with existing disinfection and cleaning practices, these new technologies can help mitigate the introduction of harmful pathogens as food moves from point A to point B, with all the stops made in between.

One example is the advent of a new class of technology that incorporates antimicrobial LED lighting, which enables food processors to take an “always on” approach to keeping surfaces free of harmful pathogens. Since these lights meet international standards for unrestricted and continuous use around people, they’re able to irradiate large places and the smallest of spaces, all while workers are present.

However, simply deploying these new technologies isn’t enough. For new prevention strategies to be truly successful, food processors should consider the bigger picture. A large percentage of food processors focus primarily on bolstering their sanitation approaches in the areas that have the highest likelihood of coming into contact with food products. This is logical, as Zone 1 and Zone 2 are typically the highest risk for contracting and spreading harmful pathogens.

Environmental Safety Zones — Environmental safety zones. Figure courtesy of Vital Vio.

However, processors are leaving holes in their sanitation strategies by not taking measures to keep areas, such as Zone 3 and Zone 4, also well protected. To ensure food remains free of contaminants, plant managers must ensure the entire environment is fully protected, including the belts and vessels that the food touches, as well as the break rooms where employees rest and offices where management holds meetings. If these areas aren’t kept equally as clean, facilities are risking outside contaminants to enter Zone 1 that can ultimately compromise their food products.

Food recalls have become eerily common, putting a strain on public health and businesses. To stop what seems to be rising to crisis level, all companies involved in the food supply chain need to take a proactive stance toward prevention. This means deploying advanced technologies that continuously prevent harmful pathogens from taking root anywhere in their facilities. Simple yet thoughtful solutions, such as antimicrobial LED lighting, ensure food companies are one step closer to keeping all of us and their businesses safe.

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