Tag Archives: contamination

Spices, Paprika, Curry

Q3 Hazard Beat: Herbs and Spices

By Food Safety Tech Staff
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Spices, Paprika, Curry

The following infographic is a snapshot of the hazard trends in herbs and spices from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the next several weeks, Food Safety Tech will provide readers with hazard trends from various food categories included in this report.

Hazards, Herbs, Spices
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in meat and meat products.

John McPherson, rfxcel
FST Soapbox

End-to-End Supply Chain Traceability Starts with High-Quality Data

By John McPherson
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John McPherson, rfxcel

End-to-end traceability technology across the food and beverage (F&B) supply chain has many benefits for companies at all nodes of the chain, not least of which is the ability to act to prevent problems such as irreversible damage, loss, and theft. For these technologies to best deliver on their promise, however, they need standardized and quality-assured data. F&B supply chain stakeholders need to take steps to achieve effective data management to truly take advantage of the benefits of traceability and real-time monitoring technologies.

Since FSMA was introduced in 2011, actors across the F&B supply chain have had to change their behavior. Prior to FSMA, companies tended to react to events; today, proactive and preemptive measures are the norm. This is in line with what the legislation was designed to do: Encourage the prevention of foodborne illness instead of responding after their occurrance.

F&B manufacturers and distributors rely on technology to help predict potential obstacles and mitigate issues along their supply chains. But expressing a desire to embrace technologies such as real-time monitoring solutions and predictive analytics isn’t enough to achieve ultimate supply chain efficiency. Only by taking the necessary steps can companies get on track to ensure results.

Any company that is thinking about deploying a traceability solution has a lot to consider. Foremost, data must be digitized and standardized. This might seem challenging, especially if you’re starting from scratch, but it can be done with appropriate planning.

Let’s examine what F&B companies stand to gain by adopting new, innovative technologies and how they can successfully maximize data to achieve end-to-end supply chain traceability.

New Technologies Hold Huge Potential for F&B Supply Chains

The advantages of adopting new technologies far outweigh the time and effort it takes to get up and running. To smooth the process, F&B companies should work with solution providers that offer advisory services and full-service implementation. The right provider will help define your user requirements and create a template for the solution that will help ensure product safety and compliance. Furthermore, the right provider will help you consider the immediate and long-term implications of implementation; they’ll show you how new technologies “future-proof” your operations because they can be designed to perform and adapt for decades to come.

Burgeoning technologies such as the Internet of Things (IoT), artificial intelligence (AI) and blockchain are driving end-to-end traceability solutions, bridging the gap between different systems and allowing information to move seamlessly through them.

For example, real-time tracking performed by IoT-enabled, item-level sensors allows companies to detect potential damage or negative events such as theft. These devices monitor and send updates about a product’s condition (e.g., temperature, humidity, pressure, motion and location) while it is in transit. They alert you as soon as something has gone wrong and give you the power to take action to mitigate further damage.

This is just one example of how data from a fully implemented real-time, end-to-end traceability platform can yield returns almost immediately by eliminating blind spots, identifying bottlenecks and threats, and validating sourcing requirements. Such rich data can also change outcomes by, for example, empowering you to respond to alerts, intercept suspect products, extend shelf life, and drive continuous improvement.

As for AI technologies, they use data to learn and predict outcomes without human intervention. Global supply chains are packed with diverse types of data (e.g., from shippers and suppliers, information about regulatory requirements and outcomes, and public data); when combined with a company’s internal data, the results can be very powerful. AI is able to identify patterns through self-learning and natural language, and contextualize a single incident to determine if a larger threat can be anticipated or to make decisions that increase potential. For example, AI can help automate common supply chain processes such as demand forecasting, determine optimal delivery routes, or eliminate unforeseeable threats.

Blockchain has garnered a lot of buzz this year. As a decentralized and distributed data network, it’s a technology that might help with “unknowns” in your supply chain. For example, raw materials and products pass through multiple trading partners, including suppliers, manufacturers, distributors, carriers and retailers, before they reach consumers, so it can be difficult to truly know—and trust—every partner involved in your supply chain. The immutable nature of blockchain data can build trust and secure your operations.

To date, many F&B companies have been hesitant to start a blockchain initiative because of the capital risks, complexity and time-to-value cost. However, you don’t have to dive in head-first. You can start with small pilot programs, working with just a few stakeholders and clearly defining pilot processes. If you choose the right solution provider, you can develop the right cultural shift, defining governance and business models to meet future demands.

To summarize, new technologies are not disruptive to the F&B industry. If you work with an experienced solution provider, they will be constructive for the future. Ultimately, it’s worth the investment.

So how can the F&B industry start acting now?

How to Achieve End-to-End Traceability

Digitize Your Supply Chain. We live in a digital world. The modern supply chain is a digitized supply chain. To achieve end-to-end traceability, every stakeholder’s data must be digitized. It doesn’t matter how big your company is—a small operation or a global processor—if your data isn’t digitized, your supply chain will never reach peak performance.

If you haven’t begun transitioning to a digitalized supply chain, you should start now. Even though transforming processes can be a long journey, it’s worth the effort. You’ll have peace of mind knowing that your data is timely and accurate, and that you can utilize it to remain compliant with regulations, meet your customer’s demands, interact seamlessly with your trading partners, and be proactive about every aspect of your operations. And, of course, you’ll achieve true end-to-end supply chain traceability.

Standardize Your Data. As the needs of global F&B supply chains continue to expand and become more complex, the operations involved in managing relevant logistics also become more complicated. Companies are dealing with huge amounts of non-standardized data that must be standardized to yield transparency and security across all nodes of the supply chain.

Many things can cause inconsistencies with data. Data are often siloed or limited. Internal teams have their own initiatives and unique data needs; without a holistic approach, data can be missing, incomplete or exist in different systems. For example, a quality team may use one software solution to customize quality inspections and manage and monitor remediation or investigations, while a food safety team may look to a vendor management platform and a supply chain or operations team may pull reports from an enterprise resource planning (ERP) system to try and drive continuous improvement. Such conflict between data sources is problematic—even more so when it’s in a paper-based system.

Insights into your supply chain are only as good as the data that have informed them. If data (e.g., critical tracking events) aren’t standardized and quality-assured, companies cannot achieve the level and quality of information they need. Data standards coming from actors such as GS1 US, an organization that standardizes frameworks for easy adoption within food supply chains, can help with this.

There are many solutions to ensure data are standardized and can be shared among different supply chain stakeholders. With recent increases in recalls and contamination issues in the United States, the need for this level of supply chain visibility and information is even more critical.

Data Security. Data security is crucial for a successful digital supply chain with end-to-end traceability, so you must plan accordingly—and strategically. You must ensure that your data is safe 24/7. You must be certain you share your data with only people/organizations who you know and trust. You must be protected against hacks and disruptions. Working with the right solution provider is the best way to achieve data security.

Incentive Structures. Incentives to digitize and standardize data are still lacking across some parts of the F&B supply chain, increasing the chances for problems because all stakeholders are not on the same page.

Companies that continue to regard adopting traceability as a cost, not an investment in operations and brand security, will most likely do the minimum from both fiscal and regulatory standpoints. This is a strategic mistake, because the benefits of traceability are almost immediate and will only get bigger as consumers continue to demand more transparency and accuracy. Indeed, we should recognize that consumers are the driving force behind these needs.

Being able to gather rich, actionable data is the key to the future. Industry leaders that recognize this and act decisively will gain a competitive advantage; those that wait will find themselves playing catch-up, and they may never regain the positions they’ve lost. We can’t overstate the value of high-quality digitized and standardized data and the end-to-end traceability it fuels. If companies want to achieve full visibility and maximize their access to information across all nodes of their supply chains, they must embrace the available technologies and modernize their data capabilities. By doing so, they will reap the benefits of a proactive and predictive approach to the F&B supply chain.

Alert

Q3 Hazard Beat: Meat and Meat Products Trends

By Food Safety Tech Staff
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Alert

The following infographic is a snapshot of the hazard trends in meat and meat products from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the next several weeks, Food Safety Tech will provide readers with hazard trends from various food categories included in this report.

HorizonScan, Meat hazards
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in poultry.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

A Broken Record

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food Fraud, E.Coli, Decernis
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 almost a full year, laboratory documents were falsified by the owner and the quality control officer of a Connecticut meat processing company. None of the reported beef samples were actually taken and tested for E. coli. The letterhead of a formerly utilized inspection laboratory was fraudulently used to falsify the test documents, an act that carries a maximum term of five years in prison. Fortunately, no illness was reported from consumers who purchased the meat products.

Resources

  1. The United States Attorney’s Office (September 23, 2019). “Quality Control Officer of Connecticut Meat Supplier Admits Fabricating E. Coli Test Results”. Department of Justice, U.S. Attorney’s Office, District of Connecticut.
Brett Madden, Aviaway
Bug Bytes

Bird Problems and Control Methods for Food Production Facilities

By R. Brett Madden
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Brett Madden, Aviaway

Various types of pest birds can impact food plant structures and facility surroundings. Even a single bird that finds its way into a food plant can trigger a host of concerns such as, failed audits, product contamination, plant closure, production stoppage, lost revenues, fines, structural damage, health hazards to occupants and fire hazards.

In most cases, a food plant operation has a bulletproof pest control plan; however, in most cases, birds are always an afterthought in most pest management plans. After inspecting and consulting numerous food plants, I hear the same story over and over: “I have a person in the warehouse that can chase them out” or, “are birds really a big deal?” or, “why do I have to be concerned about birds?” and on and on. Despite what you may think, birds are a big deal, and you should take them seriously!

Pest management, pigeon droppings HVAC
Larger birds, such as pigeons, can cause more problems around the exterior of a facility on HVAC units as seen here. (Image courtesy of Aviaway Bird Control Services & Consulting)

Since food processing plants contain areas that have very sensitive environments, birds can introduce various adulterants and harmful contaminants. Birds can cause potential harm to humans due to foodborne illness.

Pest Bird Species

There are four main pest birds: Pigeon, Starling, Sparrow and Seagull. Each one of these birds can cause a host of concerns and issues for food processing facilities. Just one bird can cause catastrophic damage. In most cases, small pest birds such as Sparrows and Starlings can gain access into a facility through a variety of ways:

  • Damaged bumpers around truck bay loading dock doors.
  • Open doors (seems obvious, but I always find doors wide open during audits).
  • General building deficiencies.

Larger birds, such as Pigeons and Seagulls, typically cause more problems around the exterior of a facility on ledges, rooftops, HVAC units, loading docks and related areas.

In either case, these various types of pest birds can cause significant problems on the interior and exterior of food plants.

Conducive Conditions

In most cases, facilities want to reduce as many conducive conditions as they can around and within the facility in a timely fashion. A conducive condition is one whereby due to a building condition, structural design, equipment operation, food or water source, or surrounding conditions (i.e., near a public landfill, raw materials mill or body of water) can attract pest birds to a facility. With each of these conditions, great care must be taken to reduce as many conducive conditions as possible.

Examples of Conducive Conditions

Structural Conditions

  • Loading docks/canopies with open beams and rafters
  • HVAC equipment
  • Pooling water (roof and landscaping)
  • Structural overhangs and ledges
  • Open access points
  • Landscaping (types of plantings)
  • Damaged truck bay bumpers
  • Gaps and opening around the structure
  • Doors with improper sealing

Human Conditions

  • Open dumpsters
  • Overflowing dumpsters
  • Dirty dumpsters
  • Product spillage
  • Employees feeding birds
  • Doors left open

All these conducive conditions, if left unresolved, can lead to significant bird problems. Reducing as many conducive conditions as possible will be the first step of any bird management program.

Bird Control Methods

From the start, your facility should have a bird management plan of action. For the most part, bird problems should not be left to be handled internally, unless your staff has been properly trained and has a bird management plan in place.
Most birds are protected by the Federal Migratory Bird Treaty Act of 1918. However, Pigeons, Sparrows, and Starlings are considered non-migratory birds and are not protected under this Act. Even though these three bird species are not protected, control methods still need to be humane. More specifically, your bird control program must also comply with is the American Veterinary Medical Association (“AVMA”) Guidelines for the Euthanasia of Animals if this is the control method selected. The AVMA considers the House Sparrows, Feral Pigeon, and the Common Starling “Free-Ranging Wildlife.” And Free-Ranging Wildlife may only be humanely euthanized by specifically proscribed methodology.

In addition to the above-mentioned regulations, various regulations regarding the relocation of birds/nests may also apply. I also always recommend checking with local and state agencies to ensure that there are no local regulations that may apply. Bottom line: Don’t rely on untrained internal practices; one misstep could result in heavy financial fines and penalties.

Bird Management Strategies

First Line Defense

  • Stop any bird feeding around the facility immediately
    • Any bird management plan should have a clear policy prohibiting employees from feeding birds. Once birds have been accustomed to routine feeding, the birds will continue to return.
  • Eliminate Standing Water Sources
    • All standing or pooled water needs to be eliminated. Thus, routine roof inspections need to be conducted to ensure drains are working properly.
    • Landscape irrigation needs to be calibrated to ensure no puddling of water in areas of low sun exposure.
  • Proper Sanitation Practices
    • Ensure that dumpster lids are closed when not in use.
    • Trash removal frequency adequate.
    • Routine cleaning of trash receptacles.
    • Immediate removal of spilled food.
  • Eliminate Entry Points
  • Survey the facility to ensure that all holes are properly sealed.
    • Around truck bay bumpers and doors
  • Exhaust vents are properly screened.
  • Windows are closed and have screens when in use.

The most appropriate bird control strategy will be determined based on the severity of the bird pressure. For example, if the bird pressure is high (birds have nested), then in most cases, you will only be able to use bird exclusion methods. Whereas, if the bird pressure is light to moderate (birds have not nested), bird deterrent methods can be used. This is an important distinction. Bird exclusion is physically changing the area to permanently exclude said pest birds. Whereas, bird deterrent devices inhibit birds from landing on treated areas.

Bird Deterrent Methods

After the previously mentioned first-line strategies have been implemented, the next step would be to install bird deterrent products (birds have not nested).

  • Bird Spikes
  • Bird Wire
  • Electrified Shock Track
  • Bird Gel
  • Sonic & Ultra Sonic Devices
  • Lasers and Optical Deterrents
  • Hazing & Misting Devices
  • Pyrotechnics
  • Live Capture

Bird Exclusion Methods

If the birds have nested in or around the facility, the next step would be to install bird exclusion products (birds have nested).

  • Bird Netting
  • Ledge Exclusion (AviAngle)
  • Architectural modifying structural
  • Aggressive Harvesting (Targeting)

Prevention Strategies

The best prevention strategy is planning and knowledge. Conduct a bird audit and develop a bird management plan before birds get near or inside the facility. The key is to act quickly, as soon as an incident occurs. I find countless times when I am called in to consult or service a food plant, that the birds got into the facility and no one knew what to do, and as a result, the birds remained within the facility for an extended period, thus increasing the risk of exposure. It is always much easier to remove a bird when they are unfamiliar with their surroundings. Whereas, it is much more difficult to remove birds from a facility that has had a long-standing bird problem.

Once you have a plan, who oversees the bird management plan? Are thresholds determined and set for various areas of the facility? For example, a zero threshold in production areas? Threshold levels will be set based upon by location and sensitivity of the said location. What steps are going to be taken to remove the bird? For how long is each step conducted? These questions need to be answered and developed to stay ahead of bird problems.

Reduce as many conducive conditions as possible. The longer a conducive condition stays active, the more likely birds, as well as other wildlife or rodents, will be attracted to the site and find a way into the facility.

Pathogen Contamination & Hazards

Birds present a host of problems, whether they are inside or outside of a facility. Birds can roost by air vents, and the accumulation of bird feces can enter the facility air system. Bird droppings on walkways and related areas allow for the possibility of vectoring of said dropping when employees step on droppings. Thus, spreading fecal matter/spores and other contaminants to areas throughout the facility.

If birds are within the facility, droppings can spread on product lines, raw materials, stored products, equipment and more, thus, causing contamination. Because of a bird’s ability to fly, they are perfect creatures to spread various diseases, pathogens, ectoparasites and fungal materials. Diseases such as Histoplasmosis, Salmonella, Encephalitis, E-coli, Listeria, and more. Birds have been known to transmit more than 60 infectious diseases!

Besides the spread of potentially harmful contaminants throughout the facility, bird droppings and nesting materials can also create a host of additional problems:

  • The acidity in bird droppings can damage building finishes, façade signs, lighting and more.
  • Wet bird droppings can create a slip and fall hazard.
  • Bird nesting materials can create a fire hazard around façade signs, exit signs and light fixtures.
  • Bird nesting and debris can clog roof drains and cause roof leaks from standing water.
  • Introduction of ectoparasites into the facility such as bird mites, lice, fleas, ticks and more.

Conclusion

In summary, taking a proactive approach to bird control is the best practice. Reduce food, water and shelter sources (aka conducive conditions) promptly. Pest management programs need to implement a more in-depth section of the program for bird control. Like integrated pest management, bird control should be based upon an integrated method. Each facility will have its unique challenges. As such, each bird management plan needs to be tailored to the specific site. A well designed and balanced, integrated bird management program will provide long-term and cost-efficient bird control.

The next article in this series will take a closer look at how to prepare an integrated bird management audit program.

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
No Comments
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. 
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.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Food (or Beverage) Fraud That Kills

By Susanne Kuehne
No Comments
Susanne Kuehne, Decernis
Food fraud, methanol, alcohol, Costa Rica
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

Methanol is highly toxic for humans, and increased amounts can show up in fraudulent or illegal alcoholic beverages. Dozens of methanol poisoning cases still happen every year around the world, some of them being deadly, according to the World Health Organization (WHO). The FBI is assisting the Costa Rican Police in the investigation of 20 recent deaths that are possibly methanol-related. Costa Rican authorities have searched a production facility, seized liquor and issued a nationwide alert.

Resource

Knowles, H. (July 24, 2019). “Tainted alcohol has led to 20 deaths in Costa Rica, authorities say”. The Washington Post.

FDA

FDA Sampling of Romaine Lettuce in Yuma Finds No Widespread STEC or Salmonella Contamination

By Food Safety Tech Staff
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FDA

Following last year’s widespread E.coli O157 outbreak involving romaine lettuce linked to the Yuma, Arizona growing region (Spring 2018), FDA launched a sampling assignment to test romaine lettuce for pathogenic Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. The microbiological surveillance sampling began on December 18, 2018 in the Yuma region and focused on 26 commercial coolers and cold storage facilities to allow FDA to sample multiple farms from several locations at once. The agency collected and tested a total of 188 samples for both pathogens. It did not detect Salmonella in any sample; STEC was detected in one sample, but additional analysis found that the bacteria was not pathogenic.

“The findings of this assignment suggest that there was no widespread Salmonella or STEC contamination of romaine lettuce from the Yuma growing region during the period when sampling occurred. As a next step, the FDA is working with leafy green stakeholders in the Yuma region to consider a longer-term environmental study to identify and control risks that will prevent future outbreaks, with the ultimate goal of protecting consumers. – FDA

The point of the sampling assignment was to determine whether target pathogens were present, and if so, to respond quickly before contaminated products reached consumers.