Tag Archives: Focus Article

2019 Food Safety Consortium, Bayer

Moments from the 2019 Food Safety Consortium

By Food Safety Tech Staff
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2019 Food Safety Consortium, Bayer

The 7th annual Food Safety Consortium Conference & Expo featured dynamic discussions both in the sessions as well as on the exhibit floor. A special thank you to our Advisory Board, who contributed tremendously to the educational content, as well as our sponsors and exhibitors. (Click on the images to enlarge)

All image credit: amyBcreative

Susanne Kuehne, Decernis
Food Fraud Quick Bites

I Have a Beef with You

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

Over the course of three years, wholesale meat fraudsters in Brooklyn, NY, removed the USDA stamp on “Choice” beef and applied a counterfeit USDA “Prime” stamp to sell the fraudulently labeled meat at a premium price. A conviction can get the defendants a prison sentence of up to 20 years, even public health was not endangered, however, the USDA is taking integrity and quality of food very seriously.

Resources

  1. John Marzulli, U.S. Attorney’s Office (September 24, 2019). “Two Defendants Charged in Scheme to Sell Fraudulently Misbranded Beef Products”. Department of Justice, U.S. Attorney’s Office, Eastern District of New York
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.

Aaron Riley, CannaSafe
In the Food Lab

How To Ensure Cannabis and CBD Edibles And Beverages Are Safe

By Aaron Riley
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Aaron Riley, CannaSafe

As cannabis and CBD edibles and beverages gain in popularity among consumers, the rush to cash-in on market opportunities has resulted in an influx of unregulated and untested products. Recently the FDA increased its scrutiny of cannabis and CBD company websites and social media accounts to make sure they were not making unverified or misleading marketing statements about their products.

To exacerbate the problem of unregulated products, recent scares around vape-related hospitalizations have flooded the news, and the public is looking to the cannabis industry for answers about what it will do to ensure CBD and cannabis products are safe for consumption.

The first step the cannabis business community can take is educating the public on the two types of edibles— tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is heavily regulated. Every batch must be tested before it is released to retail ensuring labeling and dosages are consistent.

Since CBD does not have psychoactive properties, most products do not go through the same testing standards and are far less regulated. An estimated 75% of CBD-only companies do not test their products. Even worse, independent testing has shown that CBD labels are often incorrect or inconsistent with its dosage and ingredient labels.

Both cannabis and CBD companies must advocate for a more regulated and legitimate market. Stricter regulations and testing standards will eventually weed out the bad players who are hoping to make a quick buck from those that intend to manufacture quality products that can benefit the health of consumers.

Short Cuts To Boost Profits

The current vape pen crisis underscores the lack of regulation and inconsistency in the CBD market. CBD-exclusive vapes are more likely to use cutting agents, whereas licensed THC vape companies are more likely to use pure cannabis oils and are required to undergo quality control testing.

Using cutting agents may lower operating costs, but often results in an inferior or dangerous product. Cutting agents also inhibit crystallization in CBD oils and increase the shelf life of a product. The cost of production for pure THC or CBD oil is $5–6 per gram, but a cutting agent can reduce the cost down to $0.10–$2 per gram.

With edibles, untested CBD products can introduce Salmonella or E.coli into the supply chain. This oversight could severely hurt the reputation of growers and manufacturers if a serious outbreak occurred.

Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry JournalThe Solution Is in Testing

Unlike food manufacturing, where quality controls are in place at the plant, the quality measures for edibles happens in a lab, after a product is manufactured.

Labs test edibles for potency. Both THC and CBD are used for medicinal purposes, and potency testing is critical for accurate dosing. A patient under or over dosing, or taking a poor quality CBD product with additives could detrimentally affect their long-term health.

They will also test for product contamination. Both CBD and THC cannabis can become contaminated with microbes (i.e., mold, mildew, bacteria and yeast), pesticides and heavy metals throughout the process of growing, cultivation and processing. Contamination is especially concerning because many medical marijuana patients are immunosuppressed and cannot fight off potentially dangerous infections and illnesses arising from these contaminants.

But even for the general population, cannabis and CBD contamination can cause serious health issues. Molds and bacteria such as aspergillus, Salmonella and E. coli present safety risks, and toxicity from sustained exposure to heavy metals can lead to high blood pressure, heart issues and kidney failure, among other issues. Fortunately for consumers, cannabis products sold in licensed dispensaries must all undergo contamination and quality control testing per state regulations.

However, because quality control measures are not required for edible manufacturers, there is no oversight that food-grade ingredients are used or that practices to avoid cross-contamination are used.

What Companies Can Do To Win Back Trust

Customers around the country are rightfully concerned about the safety and quality of their cannabis and CBD products in light of recent news surrounding vape-related illnesses. This is the perfect opportunity for manufacturers and consumer brands to seize on the subject and educate consumers about cannabinoids so they aren’t turned off from incorporating CBD into their lifestyles.

  1. First and foremost, test all products. At a minimum, companies should be adhering to state cannabis market regulations, even if they are just producing CBD. As the FDA rolls out more concrete regulations for CBD, which was only federally legalized last year, it is in the best interest of all CBD companies to meet FDA guidelines preemptively so products can pass inspection at a later date.
  2. Find a good credible lab to help with formulations and inputs. With edibles and beverages, there is more room to introduce contaminants within that scope.
  3. Hire food safety experts to help elevate safety standards and meet FDA regulations. Some forward-thinking companies are starting to hire quality experts from food manufacturing to get ready for broader federal acceptance.
  4. Help educate consumers on why the brand is better, based on inputs and testing.

Consumers should also conduct their own research regarding individual CBD companies’ supply chains and manufacturing standards. Transparent companies will do this proactively, providing cultivation information and lab results for their customers.

In the end, the safest place to buy cannabis and CBD products is a licensed dispensary. It is the responsibility of growers, distributors, manufacturers and retailers to keep the legal market safe and free from contaminants that could threaten the industry. The regulated cannabis space has advanced significantly in the past few years, and companies must set the highest manufacturing standards to maintain this forward momentum. Education and testing are the best solutions to ensure a safe and trusted cannabis marketplace.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Read Your Tea Leaves Carefully

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

Tea adulteration is a very common and recurring issue. Indian Officials, such as the Food Safety and Standards Authority of India (FSSAI), keep seizing teas adulterated with artificial colorants and dyes. Tea dust and low-quality teas are adulterated by adding coal tar dyes, sunset yellow, tartrazine and other artificial colorants, some of them rendering the teas unfit for human consumption and endangering consumer health.

Resources

  1. Staff Reporter Coimbatore (August 29, 2019). “FSSAI seizes 1.5 tonnes of adulterated tea dust”. Retrieved from The Hindu.

More Sources

  1. Beware! The tea you sip may be adulterated“. On Manorama.
  2. Over four tonnes of adulterated tea dust seized; one arrested“. The Hindu. 
Don Groover, DEKRA OSR
FST Soapbox

Why Changing Workplace Safety Culture Must Start From the Top

By Don Groover
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Don Groover, DEKRA OSR

Workplace safety in the food industry can be challenging. The precision required of workers in slaughter, meat packing or wholesale processing facilities can lead to serious harm or worse. The Bureau of Labor Statistics reports that the potential hazards in this industry are many: Knife cuts to the hands and the torso, falls, back injuries, exposure to toxic substances, carpal tunnel syndrome, and even infectious diseases.

This industry may have more challenges in safety than any other industry. Yet, there are companies that excel in safety performance, even given these challenges.

Organizations that are serious about protecting their workers must do far more than react after an injury or rely on awareness-based safety efforts. Typically this approach only delays the next injury. Safety is not just about responding to injuries, but is about the ongoing identification of exposure, the implementation of control systems, and assuring these controls are used to neutralize the exposure.

The challenge is that the root of why an exposure exists or can even thrive in an organization maybe due to culture, organizational urgency, operational instability or a lack of understanding about the concept of exposure, to mention a few. Because the issue is bigger than safety programs, safety excellence requires all levels of an organization, from the C-Suite to the frontline worker, committing to a process that focuses on exposure. This needs to be done in a way that creates trust that safety is a value and if there is a values conflict, that safety has top priority.

Ultimately, it’s about shifting culture by making a safety excellence a priority.

Oftentimes leaders articulate that they want a safe culture, but they may not fully understand their role in creating the culture they desire and how they sustain the change. Senior leaders must go beyond a catch phrase approach to safety and actually articulate what are the cultural attributes they want to see firmly embedded in their organization.

These may be:

  • Workers watching out for each other and a willingness to step in if somebody is at risk.
  • Excellent housekeeping.
  • Workers stepping up to address physical hazards without being asked.
  • A willingness to report safety concerns and incidents.

Once the attributes are defined, then the organization is ready to understand what it takes to support that culture.
However, senior leadership needs to drive that change. Once upper management understands that accountability starts with them and not with the worker, they can move forward and create a culture that reinforces practices that identify potential exposure before incidents take place and not after. Doing so not only has the potential to lower incident rates, but it also:

  • Boosts morale. Workers believe the company has their backs and will commit to safety principles.
  • Strengthens trust between workers and management. Workers believe that safety excellence is a shared responsibility.
  • Increases commitment to all organizational objectives. Social theory research has shown that if you do something for someone else, they experience a pull to reciprocate. The more we do, the stronger the pull. When management shows that they can be trusted with employee safety, employees are free to reciprocate in other areas.

Our strongest and deepest relationships are built on a foundation of safety—not just physical safety but also psychological safety. If we come to believe that another person is interested in our physical or mental wellbeing, the foundation strengthens.

When leadership uses the power of safety they will see employee engagement increase. And the safety implications of worker engagement are profound: Disengaged workers are focused on their own safety. Involved workers are concerned with their own safety but are likely also concerned with the safety of their workmates and perhaps certain other people they interact with. Fully engaged workers are concerned with the safety of everyone around them and without prompting take proactive actions to help others.

Engaged workers are more likely to follow rules and procedures, be more receptive to change, and give discretionary effort. It seems like all companies are doing some type of engagement survey, yet the actions they develop to try and raise their scores are often lacking. Organizations that are serious about having an engaged workforce must fully understand how safety is foundational to engagement. More importantly, safety involvement activities need to be designed and implemented in a way that moves employees beyond mere involvement to full on engagement.

When a company demonstrates it values safety, workers will volunteer to get involved. Leadership must carefully consider what safety involvement activity is right for the culture. When employees participate in a successful and rewarding involvement activity, their personal level of engagement will move upward. Leadership must then figure out how to expand safety involvement. This isn’t done by demanding involvement. It requires purposeful planning and patience.

Chelle Hartzer, Orkin
Bug Bytes

Stay Audit-Ready, Anytime with Integrated Pest Management

By Chelle Hartzer
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Chelle Hartzer, Orkin

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

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

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

Open Lines of Communication

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

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

Inspect Regularly

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

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

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

Keep It Clean

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

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

Monitoring

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

Maintain Proper Documentation

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

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

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
No Comments
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.

Sasan Amini, Clear Labs
FST Soapbox

Beyond the Results: What Can Testing Teach Us?

By Sasan Amini
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Sasan Amini, Clear Labs

The microbiology lab will increasingly be understood as the gravitational center of big data in the food industry. Brands that understand how to leverage the data microbiology labs are producing in ever larger quantities will be in the best position to positively impact their bottom line—and even transform the lab from a cost center to a margin contributor.

The global rapid microbiology testing market continues to grow at a steady pace. The market is projected to reach $5.09 billion by 2023, up from $3.45 billion in 2018. Increased demand for food microbiology testing—and pathogen detection in particular—continues to drive the overall growth of this sector. The volume of food microbiology tests totaled 1.14 billion tests in 2016—up 15% from 2013. In 2018 that number is estimated to have risen to 1.3 billion tests, accounting for nearly half the overall volume of industrial microbiology tests performed worldwide.

The food industry is well aware that food safety testing programs are a necessary and worthwhile investment. Given the enormous human and financial costs of food recalls, a robust food safety testing system is the best insurance policy any food brand can buy.

We are going through a unique transition where food safety tests are evolving from binary tests to data engines that are capable of generating orders of magnitude of more information. This creates a unique opportunity where many applications for big data collected from routine pathogen testing can help go beyond stopping an outbreak. Paired with machine learning and other data platforms, these data have the opportunity to become valuable, actionable insights for the industry.

While some of these applications will have an impact on fundamental research, I expect that big data analytics and bioinformatics will have significant opportunity to push the utilities of these tests from being merely a diagnostic test to a vehicle for driving actions and offering recommendations. Two examples of such transformations include product development and environmental testing.

Food-Safety Testing Data and Product Development

Next-generation-sequencing (NGS) technologies demonstrate a great deal of potential for product development, particularly when it comes to better understanding shelf life and generating more accurate shelf-life estimates.

Storage conditions, packaging, pH, temperature, and water activity can influence food quality and shelf life among other factors. Shelf-life estimates, however, have traditionally been based on rudimentary statistical models incapable of accounting for the complexity of factors that impact food freshness, more specifically not being able to take into consideration the composition and quantity of all microbial communities present on any food sample. These limitations have long been recognized by food scientists and have led them to look for cost-effective alternatives.

By using NGS technologies, scientists can gain a more complete picture of the microbial composition of foods and how those microbial communities are influenced by intrinsic and extrinsic factors.

It’s unlikely that analyzing the microbiome of every food product or unit of product will ever be a cost-effective strategy. However, over time, as individual manufacturers and the industry as a whole analyze more and more samples and generate more data, we should be able to develop increasingly accurate predictive models. The data generation cost and logistics could be significantly streamlined if existing food safety tests evolve to broader vehicles that can create insights on both safety and quality indications of food product simultaneously. By comparing the observed (or expected) microbiome profile of a fresh product with the models we develop, we could greatly improve our estimates of a given product’s remaining shelf life.

This will open a number of new opportunities for food producers and consumers. Better shelf-life estimates will create efficiencies up and down the food supply chain. The impact on product development can hardly be underestimated. As we better understand the precise variables that impact food freshness for particular products, we can devise food production and packaging technologies that enhance food safety and food quality.

As our predictive models improve, an entire market for these models will emerge, much as it has in other industries that rely on machine learning models to draw predictive insights from big data.

Data Visualization for Environmental Monitoring

In the past one to two years, NGS technologies have matured to the point that they can now be leveraged for high-volume pathogen and environmental testing.

Just as it has in other industries, big data coupled with data visualization approaches can play a mainstream role in food safety and quality applications.

Data visualization techniques are not new to food safety programs and have proven particularly useful when analyzing the results of environmental testing. The full potential of data visualizations has yet to be realized, however. Visualizations can be used to better understand harborage sites, identifying patterns that need attention, and visualize how specific strains of a pathogen are migrating through a facility.

Some of this is happening in food production facilities already, but it’s important to note that visualizations are only as useful as the underlying data is accurate. That’s where technologies like NGS come in. NGS provides the option for deeper characterization of pathogenic microorganisms when needed (down to the strain). The depth of information from NGS platforms enables more reliable and detailed characterization of pathogenic strains compared to existing methods.

Beyond basic identification, there are other potential use cases for environmental mapping, including tracking pathogens as they move through the supply chain. It’s my prediction that as the food industry more broadly adopts NGS technologies that unify testing and bioinformatics in a single platform, data visualization techniques will rapidly advance, so long as we keep asking ourselves: What can the data teach us?

The Food Data Revolution and Market Consolidation

Unlike most PCR and immunoassay-based testing techniques, which in most cases can only generate binary answers, NGS platforms generate millions of data points for each sample for up to tens to hundreds of samples. As NGS technologies are adopted and the data we collect increases exponentially, the food safety system will become the data engine upon which new products and technologies are built.

Just as we have seen in any number of industries, companies with access to data and the means to make sense of it will be in the best position to capitalize on new revenue opportunities and economies of scale.

Companies that have adopted NGS technologies for food safety testing will have an obvious advantage in this emerging market. And they won’t have had to radically alter their business model to get there. They’ll be running the same robust programs they have long had in place, but collecting a much larger volume of data in doing so. Companies with a vision of how to best leverage this data will have the greatest edge.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Not a Well-Oiled Machine

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

A large recall was initiated by the Brazilian Ministry of Agriculture, Livestock and Food Supply for Brazilian olive oil unfit for human consumption, and retailers and traders are requested to report and pull faulty products off the shelves. Large fines will be issued for non-compliance. The fake olive oils are sold very cheaply, but may be a health hazard. An infrared analysis was made to check the composition of fatty acids, which uncovered the fraud.

Resource

  1. Janete Lima – Coordenação-geral de Comunicação Social (July 5, 2019). “Ministério proíbe venda de azeite de oliva de seis marcas após descoberta de fraudes”. The Ministry of Agriculture, Livestock and Food Supply, Brazil.