Tag Archives: FSMA

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

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 is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.

Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.

A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.

Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.

Class OSHA Workplace Violence Offender Description Motivation Translated to the Food and Beverage Industry
1 The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame. Behavioral Health Patient *
Social Media Fame Seeker *
Copycat *
Extortion *
Economic motivation *
2 The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category. My load isn’t ready, you are costing me money
3 The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace. I am upset with a coworker and adulterate to create problems for that person *
I am upset with the company and adulterate as retribution and to harm the brand *
Youthful stupidity
I am not paid enough *
4 The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim. I am upset with an intimate partner/ coworker and adulterate to create problems for that person
5 Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs. Radicalized Insider
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.

A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.

Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.

Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”

The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.

Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more. Read Part II of this series on intentional adulteration.

FDA

FDA Receives Record Turnout As Industry Eager to Discuss New Era of Smarter Food Safety

By Maria Fontanazza
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FDA

Industry from the public and private sector joined for a record turnout during the FDA public meeting yesterday to discuss the agency’s initiative, a new era of smarter food safety. The meeting, which was at maximum capacity for both in-person as well as webcast attendance, began with a call to action from FDA Deputy Commissioner, Office of Food Policy and Response, Frank Yiannas on the importance of all stakeholders in the industry to work together to drive the change. As Yiannas has previously commented, the food industry is in the midst of a revolution. The world is changing faster than ever, and the FDA is challenged with not just creating a safer, more technology-centric and traceable food system, but also getting there faster and more effectively. “I’ve always believed that words we use are important,” he said. As the day’s various discussions would be around the new era of smarter food safety, Yiannas gave the audience a definition to consider: “A new era is a memorable or important date or event, especially one that begins with a new period in our history.”

FDA held breakout sessions centered on areas critical to the initiative:

  • Tech-enabled traceability and outbreak response
  • Smarter tools and approaches for prevention
  • Adapting to new business models and retail modernization
  • Food safety culture

During each session, FDA facilitators asked the audience questions. The following are some key points brought out during the breakouts.

Tech-Enabled Traceability and Outbreak Response

  • FDA should consider all parts of the supply chain when thinking about traceability
  • Take into account considerations for sharing sensitive data along the supply chain
  • Speaking a common language and creating data standards, along with necessary minimum data elements for traceability is critical
  • Better communication related to data sharing as well as more meetings with FDA and stakeholders, especially during outbreaks
  • Show industry the ROI of the data
  • Provide a roadmap or recommendation for companies on where they can begin on their traceability journey
  • Request for unity across government agencies (i.e., FDA, USDA), as it would provide more clarity during an outbreak

Smarter Tools and Approaches for Prevention

  • Trust and transparency are key
  • Safeguards that address privacy concerns and liability
  • Data
    • Data sharing: Concern about retroactive investigations
    • Types of data: With the “treasure trove” of existing data out there, which is the most important and helpful in improving food safety?
  • Environmental assessments and root cause analysis—more dialogue between FDA and industry

Adapting to New Business Models and Retail Food Safety Modernization

  • More need for collaboration
  • Globalization and use of best practices
  • Establishing a common standard to level the playing field
  • Establish best practices for tamper resistance
  • The last mile: Food safety training for food delivery personnel as well as harmonization for last mile delivery
  • More consumer education

Food Safety Culture

  • Emphasis on behavior and humanizing the work: Focusing on what happens within organizations at all levels
  • Clarity and communication are important
  • Leveraging current food safety culture best practices as well as any relevant existing standards (i.e., ISO, Codex)
  • Partnerships are critical, finding the balance between compliance and collaboration

Other Factors FDA Must Consider

The FDA meeting also included panel discussions that drew out the realities FDA must consider in this rapidly changing environment. “These are exciting times and this initiative is recasting our thinking in a whole new light,” said CFSAN Director Susan Mayne, adding, “We need to get ahead of these challenges and not be in reactive mode.”

Consumer awareness and demands for healthy, locally sourced and minimally processed food, for example, are creating increased pressures on food companies and retailers. In addition, the digital savvy and diverse Generation Z (the population born between 1990 and 2010, which will comprise nearly 40% of the U.S. population by 2020) has buying habits and a strong desire for transparency that is shifting how food companies will need to do business, according to Mary Wagner, president of MX Wagner & Associates.

“Trust represents safety, quality and commitment on a much more personal level to our consumers,” said Dirk Herdes, senior vice president at the Nielsen Company, emphasizing the need to communicate with authenticity. “Consumers have never been more informed, but never have been more overwhelmed with information. It’s not data—it’s trust. Trust is the new currency with which we’ll operate.”

FDA and USDA also remain committed to building a stronger relationship between the agencies, said Mindy Brashears, Ph.D., deputy undersecretary for food safety at USDA. “As science moves forward, we have to allow our policies to move forward to keep consumers safe,” she added.

The comments shared during yesterday’s meeting, along with written and electronic comments (with a deadline of November 20), will be considered as FDA puts together its blueprint document for a new era of smarter food safety. More information about providing comments can be found on the Federal Register page.

Megan Nichols
FST Soapbox

Tips to Train Employees and Maintain FSMA Compliance

By Megan Ray Nichols
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Megan Nichols

Eight years ago, the government passed FSMA. As a manufacturer, training new and existing employees to remain compliant with legislation is paramount. The goal isn’t to make life harder for business owners—it’s to protect American consumers from unsafe food handling and transportation practices.

The following are five tips to help warehouse managers train employees while maintaining FSMA compliance.

Understand FSMA Final Rules

It’s essential for everyone in the facility, from the CEO to the newest hire, to understand the FSMA rules. According to current Good Manufacturing Practices (cGMP), everyone who works in manufacturing, processing or packaging of food is required to train in food hygiene and safety. Managers can offer training in one of two ways—through on the job experience or via an FSMA-accredited classroom curriculum.

For individuals with specialized jobs, such as quality auditors or preventative controls qualified individuals (PCQI), the training option that allows compliance with FSMA rules is an accredited curriculum.

Utilize Warehouse Management Systems

FSMA gives the FDA authority to issue mandatory recalls for any food products if deemed necessary. To meet FSMA standards, record keeping and lot tracking is a necessity. If a product type is linked to a disease outbreak, the FDA wants to know where each product in that lot is within 24 hours. Having the ability to track and trace 100% of the products ensures that the company is FSMA compliant.

A warehouse management system (WMS) can track products, but only if you train employees in its use. While the average employee won’t be responsible for tracing a production lot in the event of a recall, each worker needs to know how to enter data into the system correctly, and how to retrieve the information if necessary. Include training in your WMS to ensure compliance.

Warehouse management systems, when paired with IoT sensors, can prevent recalls and ensure compliance by monitoring temperature fluctuations in climate-controlled areas. According to the Department of Agriculture, frozen food stored at temperatures at or below -0.4° F is always safe. A comprehensive WMS can monitor the temperature inside a facility’s freezers and alert workers or management if there are dramatic fluctuations that may result in a recall.

Seek Out Alliances

Warehouse managers are not alone when it comes to creating a compliant workplace. The FDA has established and funded three alliances—Produce Safety, Food Safety Preventative Controls, and Sprout Safety—each with their own standardized curriculum designed to help those who fall under FSMA rules.These alliances work for the majority of those in the food production industry, though they may not work for everyone.

Seek out the applicable food safety alliance and see if their training curriculums apply to your facility. Even if they don’t fit directly, these alliances can give managers an excellent place to start creating their training curriculum.

Create a Culture of Compliance

FSMA isn’t designed to make life harder for warehouse managers. Its goal is to keep people safe when buying their weekly groceries. Don’t just focus on training to meet FSMA standards. Instead, create a culture of compliance throughout the facility. Make FSMA everyone’s responsibility, and make it easier for employees to communicate with management if they notice a problem that normal channels don’t address.

As part of this culture of compliance, create incentives that reward employees for reporting problems, maintaining compliance levels and completing accredited training. Sometimes incentives can be the best way to motivate employees, whether you’re offering money, paid vacation or other benefits. Walk employees through the process of how to spot a problem and report it to management.

Continue Education Throughout Employment

FSMA compliance training isn’t something you should restrict to an employee’s onboarding. It’s something you should continue throughout their time at your facility. Make FSMA education a priority for every worker in your facility. While you want to start their training with onboarding, it shouldn’t stop there. Offer new training courses once a month or every three months—as often as you’d like without compromising productivity.

As the day-to-day grind continues, most workers forget about rules and regulations. Continuing education ensures FSMA compliance is at the forefront of everyone’s mind throughout their careers. Continuing your employee’s education is also shown to increase loyalty and reduce turnover, keeping things running smoothly and preventing warehouse managers from training new workers every quarter.

Looking Forward

The FDA oversees food safety and can issue a recall when a problem occurs. Yes, as a whole, it’s the responsibility of every single person working in the food production industry—from the highest-paid CEO to the newest employee on the production floor—to maintain compliance. It’s not enough to review guidelines with new employees during onboarding.

Training is essential to ensure everyone in a facility maintains the rules laid down by FSMA. Seek out assistance in the form of the FDA-funded alliances, continue employee education and make it a point to create a culture of compliance from the moment employees walk through the door. Offer continuous training opportunities and you’ll never have to worry about breaking FSMA rules.

Food Safety Consortium, Frank Yiannas, FDA

Industry in Midst of a Revolution, Tech Must Help Advance Food Safety, Says FDA

By Maria Fontanazza
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Food Safety Consortium, Frank Yiannas, FDA

The industry has evolved quite a bit since FSMA was passed eight years ago, and there’s been an overarching recognition that more modern methods to addressing food safety challenges—especially traceability—are essential. “The agency is at the threshold of a sea change in how we’re going to oversee food safety in the nation’s food supply,” said Frank Yiannas, deputy commissioner for food policy & response at FDA at the 2019 Food Safety Consortium. The first driver is the FDA’s new initiative announced earlier this year, coined the “New Era of Smarter Food Safety”. The agency will be looking at how new and emerging technologies can help advance food safety.

“I believe that we’re in the midst of a food revolution,” said Yiannas, pointing to the level of investment in food globally. “Products will be reformulated… new food sources and production approaches will be realized, and the food system will become increasingly digitized.” It will be the job of food safety professionals to adapt to this changing landscape and to ensure that innovation does in fact happen (and safely) in order to feed the growing population.

FDA is taking a new mindset that builds on the success of FSMA but also leverages a people-led, technology enabled method to get there. Just a few days ago the agency launched FDA-TRACK, a new food safety dashboard through which FDA intends to track and measure the performance of the seven FSMA rules—and these measurements will be publicized and available for all stakeholders. Initial available metrics will be tracking outcomes for the FSMA Preventive Controls and the Foreign Supplier Verification Program related to inspections and recalls.

The second driver of this sea change at the FDA involves a shift in its current approach to FSMA and the evolution of the regulation. While the agency continues to educate while it regulates, this past summer FDA took actions that are indicating a shift in its approach to FSMA compliance. On July 30, FDA issued its first warning letter using FSVP authorities to a tahini importer for lack of FSVP compliance. This was followed a month later by actions surrounding the most recent Salmonella outbreak linked to imported papaya. “If you pause and look back, there have been eight outbreaks in eight years,” said Yiannas. The outbreak involved 500 documented cases, 100 hospitalizations and two deaths. “I thought, enough is enough,” he added, and this prompted Acting FDA Commissioner Ned Sharpless, M.D. and Yiannas to issue a statement asking the papaya industry to do more—and urged them to work together to review their practices and make necessary changes to ensure that the papayas they’re offering to the public are safe. The FDA also issued a warning letter to the papaya importer, with the possibility of barring the company for the next five years. “When there’s a public health hazard, FDA will act decisively,” said Yiannas, stating that parity and oversight is important, and domestic and imported food must be safe. “We regulators, we’re going to strike the right balance, and are committed and as passionate as ever in trying to bend the foodborne illness curve.”

Yiannas added that over the next eight years, the trajectory of papaya-related illness will look very different from the last eight years, thanks to the adoption of better technologies—and that’s part of what the FDA’s New Era of Smarter Food Safety is about. “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency,” said Yiannas. There’s a lack of knowledge in where food comes from, where it’s produced, and the fact that many companies simply don’t know as much about their supply chains as they think. With FSMA, Congress anticipated the need to track and trace food, and now the agency is exploring how new technology can enhance tracking and tracing. With regards to tracking foodborne illnesses, the food industry has been in a race between detection and prevention. “We’re getting so good at finding the needle in the haystack, but we can’t find the haystack,” said Yiannas. “We have to provide the same level of investment for technologies for trace backs….we will do that together.”

Food Safety Consortium, Frank Yiannas, FDA
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium (Image Credit: amybcreative)

When looking at implementing smarter tools and approaches for prevention, the industry needs to work together at not just collecting the data but also converting this data into actionable information. Yiannas emphasized that the agency is not chasing the shiny object—new technology will not be a distraction; it will help solve industry problems and address the new issues that arise with the evolving food system (i.e., cell-cultured meat, plant-based meat, etc.). The agency is also holding a public meeting on October 21 to encourage discussion between the public and private sector, all surrounding this new initiative on smarter food safety.

“What’s become clear to me is [that] there’s so much we an do working together—the public and private sector… Think. Think about how you can do your work differently,” said Yiannas. “We’re all working for the same boss, the consumer. [We have the] same mission and they’re counting on us.”

FST Soapbox

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

By David Hatch
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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.

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.

FDA

FDA and NASDA Collaborate on $1.3 Million Produce Safety Program

By Food Safety Tech Staff
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FDA

Yesterday FDA announced a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to enable more support of developing, implementing and improving programs related to the Produce Safety rule. The agreement will provide funding to help NASDA work with state and territorial produce safety regulatory programs to facilitate the safe production of fresh fruits and vegetables, along with better understanding of the Produce Safety Rule and its requirements.

“This advances the agency’s efforts to develop a nationally integrated food safety system by helping to ensure consistency of state and territorial produce safety regulatory programs with the Produce Safety Rule,” FDA stated in a release.

The current program has $1.3 million in funding. During the first two years of the cooperative agreement, NASDA will work with FDA on implementing and updating the On-Farm Readiness Review system with the agency and its partners in state and territorial produce safety programs. During the third through fifth years of the program, NASDA will help FDA in establishing and promoting a “uniform foundation of produce safety” to help create a national produce safety regulatory program.

Melody Ge, Corvium
FST Soapbox

Compliance with the Intentional Adulteration Rule: Using FMEA for Your Vulnerability Assessment

By Melody Ge
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Melody Ge, Corvium

What is FMEA? What is a vulnerability assessment (VA)? How can these two be linked? Despite what you may think, there are similarities between these two methods. FMEA (Failure Modes and Effects Analysis) methods can be utilized to help objectively assess the vulnerable steps within your process.

After July 26, 2019, businesses other than small and very small businesses (defined by FDA) must comply with the FSMA Intentional Adulteration (IA) Rule. The rule is intended to enforce industry regulation to conduct vulnerability assessments and address proper mitigation plans to prevent any potential fraud risks within the food defense plan. For small businesses, the compliance date is July 27, 2020; for very small businesses, the compliance date is July 26, 2021.

Although the IA rule does not specify a particular method that you must use to conduct your VA and address proper mitigation plans, the following elements must be considered during your evaluation and mitigation strategy and must be implemented at each actionable step afterwards:

  • The potential public health impact (e.g., severity and scale) if a contaminant were added (21 CFR 121.130(a)(1))
  • The degree of physical access to the product (21 CFR 121.130(a)(2))
  • The ability of an attacker to successfully contaminate the product (21 CFR 121.130(a)(3))

During the 2019 Food Safety Consortium, Melody Ge will present: How to prepare ourselves in this data-driven transitioning time for the smart food safety era? | October 2 @ 10 am FMEA is a Six Sigma method widely used in operations when implementing a new process. It is a structured approach to discover potential failures that may exist within the design of a product or process. Within FMEA, the RPN (Risk Priority Number) score is used to prioritize risks and is calculated by Severity × Occurrence × Detection. RPN is a quantified number that helps you prioritize risks when determining actions. If we employ the same mentality, FMEA is a useful method in helping to identify vulnerable steps based on the risk within your process. Take a close look at how the RPN is generated; the following three components are also important during the vulnerability assessment.

Severity or the potential public health impact (e.g., severity and scale) if a contaminant were added.
Severity is identified when considering the consequence of when a processing step goes out of control; or thinking about the severity of the health impact. We can consider those impacts or consequences using four common categories:

  • Biological contaminants
  • Chemical contaminants
  • Physical contaminants
  • Intentional adulteration for economic gain contaminants

Occurrence or the degree of physical access to the product.

Occurrence is identified when considering how frequently a process step is expected to go out of defined controls. Is it once a week or once a month? Depending on how often the step goes out of defined controls, this will trigger different action steps as well as mitigation plans.

Detection or the ability of an attacker to successfully contaminate the product.

Detection is considered by how easy it can be detected when the failure occurs. For example, within the food production operation, mixing steps is relatively easier than a CIP step to be detected. More references could be found in FDA’s definition of KAT (Key Activity Types, as discussed in the draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration”), such as:

  • Bulk and liquid receiving and storage
  • Liquid storage and handling
  • Secondary ingredient handling
  • Mixing and similar activities

Once the RPN is identified, then the vulnerable steps can be sorted based on the RPN. To utilize this approach, Table 1 provides a template to be considered using FMEA for the vulnerability assessment.

Process Step Description Is it KAT? (Y/N) RPN Action Process Step Mitigation Strategy Explanation
Sev Occ Det RPN
Table 1: Determine the vulnerable steps (for reference)

As IA rules regulate, a mitigation plan must be generated once a vulnerable step is identified. The intention of the plan shall ensure those risks identified are mitigated and controlled so that the final finished products are not impacted or contaminated. One tip to begin this process is to start with reviewing your current control plan for potential food safety risks. As FSMA Preventive Controls are fully implemented, all food plants shall have a food safety plan in place with validated control plans that are intended to reduce risks for potential physical, chemical, biological and adulteration for economic gain. Sometimes, these risks are highly associated with potential vulnerable steps for intentional adulteration, especially those processing steps associated with potential economic gain hazards. If those controls are not working properly, then we can seek out other mitigation plans. Nevertheless, regardless of what steps are taken, they have to be validated to show that the IA risks are effectively mitigated. Monitoring and verification shall be conducted as well once the mitigation plan is implemented.

Of course, like all food safety management systems, every food plant should have its own designated plans based on the products being produced, operations implemented and the nature of the production. Ultimately, it will be your choice to find an effective method that fits your production culture. However, the intention should always be in compliance with the IA rules: Identify the vulnerable steps within the process, and conduct mitigation plans to control the risks of intentional adulteration.

Audit

Webinar Series: Improve Your Hazard Analysis

By Food Safety Tech Staff
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Audit
Patricia Wester, PA Wester Consulting
Patricia Wester, PA Wester Consulting and Founder, The Association for Food Safety Auditing Professionals

The most commonly cited observation during a Preventive Controls inspection is an incomplete or incorrect hazard analysis, according to FDA data. Food Safety Tech is hosting a special complimentary webinar series, instructed by Patricia Wester, founder of The Association for Food Safety Auditing Professionals, that will provide attendees with important tips on conducting and documenting a thorough hazard analysis. During the one-hour event, Wester will help participants understand how to recognize gaps in a hazard analysis as well as share best practices for closing those gaps. The content is geared toward food safety professionals and auditors who develop, manage or review food safety plans in a Preventive Controls landscape.

What: “Did You Know?” Tips on Improving Your Hazard Analysis
Date: Wednesday, September 18, 2019
Time: 12pm – 1pm ET
Register for the webinar