Tag Archives: Focus Article

FDA

FDA’s Pesticide Analysis Finds Most Foods Tested Below EPA Tolerance Levels

By Food Safety Tech Staff
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FDA

Today FDA released the results of its yearly report on pesticide residues, and the good news is that of the 6504 samples taken, most of them were below EPA tolerance levels. As part of the Pesticide Residue Monitoring Program for FY 2017, FDA tested for 761 pesticides and industrial chemicals in domestic and imported foods for animals and humans. The following are some highlights of the FDA’s findings:

  • Percentage of foods compliant with federal standards
    • 96.2% of domestic human foods
    • 89.6% of imported human foods
    • 98.8% domestic animal foods
    • 94.4% imported animal foods
  • Percentage of food samples without pesticide residues
    • Milk and game meat: 100%
    • Shell egg: 87.5%
    • Honey: 77.3%
  • Percentage of food samples without glyphosate or glufosinate residues
  • Milk and eggs: 100%
  • Corn: 82.1%
  • Soybeans: 60%

“Ensuring the safety of the American food supply is a critical part of the work of the U.S. Food and Drug Administration. Our annual efforts to test both human and animal foods for pesticide residues in foods is important as we work to limit exposure to any pesticide residues that may be unsafe,” said Susan Mayne, Ph.D., director of FDA’s CFSAN, in an agency release. “We will continue to do this important monitoring work, taking action when appropriate, to help ensure our food supply remains among the safest in the world.”

Matrix Sciences and Savour Food Safety International

Matrix Sciences Acquires Savour Food Safety International and Savor Safe Food

By Food Safety Tech Staff
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Matrix Sciences and Savour Food Safety International
Gina Kramer
Gina (Nicholson) Kramer, executive director of Savour Food Safety International

Matrix Sciences International, Inc. has announced the acquisition of Savour Food Safety International and Savor Safe Food, organizations that provide consulting, auditing and training services in food safety and quality, and product development.

“Gina and her teams have built two strong companies with outstanding reputations that come from providing a unique level of service to their customers,” said Robert Wiebe, CEO of Matrix Sciences, in a company press release. “This strategic investment adds to the scope and depth of our Advisory business and has real linkage to our other services. ” Gina (Nicholson) Kramer is the executive director of Savour Food Safety International and also a member of Food Safety Tech’s Editorial Advisory Board. She will continue to serve in the same role and said the acquisition will not change how Savour Food Safety does business. However, the deal will give the firm access to new services, including laboratory testing, process validation, environmental monitoring program assessments, and R&D and sensory testing. “Matrix Sciences is creating an unparalleled team of expert services to provide customers with resources of a large company while maintaining a very focused, personalized approach to service for every client,” said Kramer.

Matrix Sciences has operations nationwide to address the needs of food and beverage industries and has grown through acquisitions of Richter International and Neumann Risk Services as well.

Gina (Nicholson) Kramer will be moderating Salmonella Detection & Control Sanitation Workshop at the 2019 Food Safety Consortium Conference & Expo.

Data protection, security

Threat of Cyberattacks to Food Safety on the Rise

By Food Safety Tech Staff
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Data protection, security

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

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

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

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

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

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

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

Marc Pegulu, Semtech
FST Soapbox

Increasing Food Safety and Spoilage Prevention in the IoT Era

By Marc Pégulu
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Marc Pegulu, Semtech

According to the Food and Agriculture Organization of the United Nations, it is estimated that nearly one third of the food produced (about 1.3 billion tons) globally is not consumed. To help tackle this billion-dollar problem, an innovative solution is being deployed to detect one of the key factors driving food waste: Spoilage due to fluctuations in temperature.

To get to the dinner table, food must travel great lengths to preserve that farm fresh quality. Refrigerated shipping units and storage facilities are essential to reducing bacteria growth and by using an automated smart-refrigeration solution, a food-safe environment can be maintained throughout the journey with little supervision. Traditional food temperature monitoring is reliant on staff to periodically check temperature levels and make adjustments as necessary. This process is not scalable, meaning that with a larger facility or an increased number of food displays, it becomes increasingly labor intensive and inefficient. If employees are preoccupied, periodic check-ins may be delayed or missed entirely, leading to gaps where temperature fluctuations are not addressed, opening the door for increased bacteria growth and food waste.

LoRa fights food waste
LoRa devices and LoRaWAN protocol are being integrated into smart refrigeration solutions to fight food waste. Image courtesy of Semtech.

To solve this issue, Internet of Things (IoT) sensors can be deployed in shipping vehicles, displays, refrigerators, and storerooms to provide accurate and consistent monitoring of temperature data. When a temperature fluctuation occurs, the sensors will send a signal to a low power, wide area network (LPWAN) gateway application. The information is then relayed to a network server, where it is routed to application servers or Cloud IoT services. The data is then processed and sent to the end user through a desktop or smartphone application. What’s more, in the event of a power outage, these long range, low power wireless enabled IoT devices are battery powered and consume minimal energy, allowing for consistent off-grid temperature tracking.

These connected devices can be found globally in a variety of use cases ranging from quick service restaurants to full service grocery stores, with an end goal of ensuring appropriate temperature levels for food. To support connectivity for these devices, an open network protocol is used to ensure the devices can be scalable and globally deployed. Two recent use cases where the long range, low power wireless devices and LoRaWAN protocol were used to actively monitor temperature fluctuations are Axino Solutions (Axino) and ComplianceMate.

Axino recently integrated LoRa devices and LoRaWAN protocol into its line of smart refrigeration solutions with the goal of combatting food waste. The solution combines sensor technology with automated data communication providing a substantial increase in measurement quantity and quality. Additionally, stores found a significant reduction in metering and operating costs after sensor deployment. This smart refrigeration solution has been globally deployed and is currently used by Switzerland’s largest supermarket chain, Migos. Axino’s sensors can be quickly installed, utilizing a magnet to attach to a refrigerator’s infrastructure. The sensors monitor temperature in real time, are accurate to one degree Celsius and can be pre-programmed to adjust refrigerator temperatures to ensure that food is stored in a safe environment. By having access to real time data and automatic temperature adjustment, supermarkets were able to eliminate human error, prolong shelf life and pass energy savings off to the customers.

The challenge for any wirelessly connected device is the presence of physical barriers that will block signals. Steel doors, concrete and insulation are some of the key considerations when developing a smart solution, especially in restaurants using large freezers. ComplianceMate partnered with Laird Connectivity and found that devices on a LoRaWAN-based network produces a more reliable signal than its Bluetooth counterpart. This IoT solution has been deployed in some of your favorite restaurant chains such as Shake Shack, Five Guys, Hard Rock Café, City Barbeque, and Hattie B’s and has already proved to be a huge asset. For instance, a sensor deployment saved $35,000 to $50,000 worth of inventory in a Hattie B’s location when downtown Nashville experienced a sudden power outage in 2018. The LoRa-based alert system immediately notified store management, allowing them to act quickly and prevent food spoilage.

Reducing global food spoilage is a monumental task. From farms to grocery stores and restaurants, technology must play a critical role, ensuring food remains at a safe temperature, preventing unnecessary spoilage. In the era of connectivity, businesses will turn to LoRa-based IoT deployments for its flexibility, durability and ability to provide real-time information to employees and decision makers to not only maintain strict industry standards in food safety, but to also pass savings on to their valued customers.

Steve Sands, Performance Food Group
FST Soapbox

Redesigning Supply Chains to Match Evolving Consumer Demands

By Steve Sands
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Steve Sands, Performance Food Group

Food is no longer a commodity. With an increase in special interest consumer groups, it’s taking on a more nuanced character. Consumers are increasingly seeking out specific attributes for their food. Whether the focus is on organic and natural, foods with superior eating quality, or simply a better price—consumers are more discerning than ever.

Their expectations around transparency and authenticity are growing as well.

According to Food Marketing Institute research, nearly 93% of consumers are more likely to be loyal to a brand when it commits to full transparency. Transparency and traceability go hand in hand. In a study conducted by SMS Research, traceability was at least somewhat important to 75% of participants and very important to 45%.* Animal welfare emerged as a contributing factor with 75% of consumers claiming they would be at least somewhat more likely to buy beef if they knew about the animal’s living conditions.

These are useful insights but challenging to make fully actionable in our commodity-focused infrastructure that’s simply not built for the nuance of our new reality. Successful companies will design a supply chain within the existing infrastructure and industry capabilities that meets customers’ unique needs and desired attributes.

Two major retailers are developing their own supply chains to control quality. Last year, Costco announced it is bringing chicken production in-house, largely driven by its rotisserie program, to ensure size specifications are met. In April, Walmart announced it is developing an end-to-end supply chain for Angus beef. Companies like Tyson are upgrading some of their supply chains with improved traceability systems using DNA technology. The use of this technology was pioneered in North America a decade ago in partnership with IdentiGEN, a global expert identifying and tracing food products with greater precision and accuracy.

Leveraging DNA Technology

DNA traceability was first developed nearly 20 years ago in Ireland by IdentiGEN to protect market access for Irish beef. The technology can serve as the backbone for a comprehensive set of origin, handling and processing practices that work together to guarantee quality. Beyond genetics, a company’s quality improvement program should consider standards for feeding, animal health, humane treatment, environmental impact and the processing of the animal. DNA technology can help uphold these standards throughout the supply chain, providing a cost-effective way of tracking product and establishing meaningful accountability.

Here’s how the technology works. At the slaughterhouse, a DNA sample is taken from the animal, and the ear tag is then scanned to create a digital link. With this information, the origin and handling of product throughout the supply chain is verifiable, even after disassembly and packing. From a safety standpoint, the technology can support recall mitigation efforts, allowing for swift and specific identification of the animals involved, helping protect consumers and limiting financial damages.

To create the most effective supply chain, companies should still supplement DNA testing with time-tested initiatives for quality improvement, such as customer feedback mechanisms and facility audits conducted both by internal groups as well as external partners and USDA-approved auditing companies. The data collected should not be siloed but rather correlated in some capacity to create a holistic view of all supply sources and the quality they deliver.

Building a Foundation for Success

There are many elements beyond technology that come together to make traceability and quality initiatives successful. One is a company’s big-picture, strategic view. It helps to look at these programs and systems as supporting an evolving process. Continuous improvement means creating and refining the right mix of methodologies, partners and technology—it’s about evaluating and eliminating anything that no longer adds value. Some companies have banned electric cattle prods, for example, because they cause stress on the animal that negatively impacts quality. As standards continue to strengthen and the supply chain is better organized, everything works together more cohesively, and it becomes easier to continue updating and adding new elements.

The foundation for any initiative of this type must be built on a shared vision, strategy and end goals, starting at the organizational level, and then with external partners. A supply chain should be organized for better production, but it also should be organized for mutual benefit, recognizing that everyone has different goals and interests. Structure your economic models so that every link in the supply chain is pulling in the same direction. Participating in the supply chain should mean doing at least a little bit better, however each partner defines it—enhanced financial performance, higher quality, lower shrinkage or improved safety and compliance. Farmers and packers will be willing to participate in the systems—and use tools like DNA technology—if they gain insights that help them achieve their goals, sell more product and improve their bottom line. It’s all about building a system that works for everyone involved.

Consumer demand for foods that offer greater choice and a wider variety of attributes will only continue to grow. Companies can successfully mature brands through a customized supply chain grounded in increased accountability and traceability. The potential to re-engineer supply chains and meet customer needs more effectively exists across many different product categories and attributes. It’s a valuable opportunity many companies may find well worth exploring.

* The survey was conducted by SMS Research on behalf of PFG among a sample of 2,001 general consumers in the U.S., weighted to census. This survey was live on March 28 – April 1st, 2019. All statistical tests were performed at a 5% risk level. PFG had no role in survey design, data collection, data analysis or data interpretation.

Karen Everstine, Decernis
Food Fraud Quick Bites

Lead in Spices

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Food fraud usually does not make people sick, but we know that it can. Fraud in spices, and particularly lead adulteration of spices, appears to be getting more attention lately. Herbs/spices is one of the top five commodity groups prone to fraud, according to the data in our Food Fraud Database. Looking at the past 10 years of data for herbs/spices, chili powder, turmeric, and saffron have the highest number of fraud records and chili powder, turmeric, and paprika have the highest number of distinct adulterants associated with them (see Figure 1).*

Adulterants, herbs and spices
Comparison of herb/spice ingredients by the number of distinct adulterants and number of records (2010-2019). Source: Decernis Food Fraud Database

Fraud in spices usually involves “bulking up” the spice with plant materials or other substances or the addition of unapproved coloring agents. A wide range of pigments have been detected in spices, from food-grade colors to industrial pigments, including lead-based pigments. Lead oxide was added to paprika in Hungary in the mid-1990s to improve the color, causing lead poisoning in many consumers. Lead chromate is another lead-based pigment that has been used to add color to spices. In 2017, ground cumin was recalled in the United States due to “lead contamination,” which was determined by the New York State Department of Agriculture and Markets to be lead chromate.

However, there is also an issue with lead contamination of agricultural products due to environmental contamination and uptake from the soil. Therefore, when recalls are posted for spices due to “elevated lead levels,” it may not immediately be apparent if the lead was due to environmental factors or intentionally added for color.

Laboratory methods for detecting the form of lead present in food are challenging. Typical tests look to detect lead, but do not necessarily identify the form in which it occurs. Testing for lead chromate, specifically, may be inferred through a test for both lead and chromium, and recent studies have looked at the development of more specific methods. There is not currently an FDA-established guideline for lead levels in spices although, the maximum allowable level for lead in candy is 0.1 ppm (0.00001%). New York State recalls spices with lead over 1 ppm and a Class 1 recall is conducted with lead over 25 ppm.

Two recent public health studies have evaluated lead poisoning cases and have linked some of those cases to consumption of contaminated spices. One study, published earlier this year, analyzed spice samples taken during lead poisoning investigations in New York over a 10-year period. The investigators tested nearly 1,500 samples of spices (purchased both domestically and abroad) and found that 31% of them had lead levels higher than 2 ppm. This study found maximum lead levels in curry of 21,000 ppm, in turmeric of 2,700 ppm, and in cumin of 1,200 ppm.

Another study conducted in North Carolina looked at environmental investigations in homes and testing of various products related to 61 cases of elevated lead levels in children over an eight-year period. The investigators found lead above 1 ppm in a wide variety of spices and condiments, with some levels as high as 170 ppm (in cinnamon) and 740 ppm (in turmeric).

A separate study, conducted in Boston, involved the purchase and analysis of 32 turmeric samples. The researchers detected lead in all of the samples (with a range of 0.03-99.50 ppm), with 16 of the samples exceeding 0.1 ppm (the FDA limit for lead in candy). The paper concluded that turmeric was being “intentionally adulterated with lead” and recommended additional measures on the part of FDA to reduce the risk of lead-contaminated spices entering the U.S. market and the establishment of a maximum allowable level of lead in spices.

Although the above studies did not report the form of lead detected, the high level of lead in many of the samples is not consistent with environmental contamination. A newspaper report in Bangladesh indicated that turmeric traders used lead chromate to improve the appearance of raw turmeric and quoted one spice company as saying that some of their suppliers admitted to using lead chromate. Lead consumption can be extremely toxic, especially to children. There is evidence that lead contamination of spices in the United States is an ongoing problem and that some of it is due to the intentional addition of lead-based pigments for color. This should be one area of focus for industry and regulatory agencies to ensure we reduce this risk to consumers.

*Given the nature of food fraud, it is fair to say that the data we collect is only the tip of the food fraud “iceberg”. Therefore, while this data indicates that these ingredients are prone to fraud in a number of ways, we cannot say that these numbers represent the true scope of fraud worldwide.

FST Soapbox

Why I’m Attending the Food Safety Consortium Conference & Expo and You Should, Too

By Jill Droge
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As someone who recently switched industries and is now an executive in a business development role for a curriculum development company that provides a 100% online PCQI course, I was trying to determine which of the many events to attend in the food industry.

After some research, I decided to attend the 7th Annual 2019 Food Safety Consortium Conference & Expo and felt it would be helpful for anyone in a business development or sales/marketing role to have some details and tips about how I prioritize events. I also wanted to provide additional information for those in a C-level, Director, Manager, etc. position that are setting plans for the remainder of 2019 and establishing plans for 2020.

Location, Location, Location!!!

Rick Biros, president of Innovative Publishing Co., has more than 25 years of experience in the food industry and is very well known and respected. Rick saw the need for this type of event due to the variety of changes in the industry. Rick and his team did the research on the best place to have the event, which included considerations like ease of access to airports, hotel cost and percentage of food manufacturers in the area. His team found that the Schaumburg, IL area has the highest concentration of food manufacturers within a 200-mile radius. In addition, Chicago O’Hare airport is only a 30-minute ride to the beautiful Renaissance Schaumburg Convention Center where this event has been held. The Consortium team was able to negotiate a very reasonable hotel rate of around $175/night, which is a terrific deal for this area. It is also close enough to downtown Chicago that if you want to stay an extra day or two or take your team out, you have plenty of options available.

Two Great Events for One Price!

This year the Food Safety Consortium Conference & Expo is co-located with the Cannabis Quality Conference & Expo this year. Anyone in the food industry understands how fast things are expanding and changing within the cannabis industry, not to mention that the state of Illinois has approved adult use effective January 2020. Both events will share the same exhibit area, which is a tremendous plus for anyone who is trying to make contacts within both industries and has invested in a booth space. This also means that attendees from both events will be a part of the social mixer events on Tuesday and Wednesday evenings, facilitating additional networking opportunities.

Decision Makers Are Present

There are many different events within the food industry, but few have a high percentage of the actual decision makers in attendance. Often, they are made up of a variety of people from the education, government and industrial sectors of the industry that may be students, entry-level management, etc. Based on the attendance from the past, 98% of attendees to this event are within the Industrial sector of the food industry. More importantly, due to the contacts that Rick & team have made over the past years, the C-level and mid-level management make up a very large portion of those that attend this event. This enables attendees to network with those who can make the key decisions that may impact your company’s growth, as opposed to talking with someone about what your company offers only to find out they are multiple levels of approval that need to happen before even moving forward to present a proposal.

Training & Expo Discount Combinations

While there are numerous options provided within registering for this dual conference event, one option is to take advantage of the discounted rate on combining event attendance with training. One of these training options is offered by my company, ImEpik, which offers full-access to the Expo and conference sessions, and includes our 100% online PCQI course that is self-paced and available 24/7 for your convenience. The Innovative Publishing team has agreed to offer both for the low price of $895. That is lower than ImEpik’s retail cost, minus any promotions, for just the course itself –so the fact that you can get both our course and a full-conference pass to the Food Safety Consortium and the Cannabis Quality Conference is a tremendous value for any company. One other detail is the person attending doesn’t have to be the person that is given access to the training. The attendee may be senior level management who doesn’t need additional training but may need someone within his or her staff to receive PCQI training. Additional details about the training we offer are available on ImEpik’s website.

Team Building & Leadership Is a Priority

There are three breakout sessions that occur throughout the event. Each of those sessions will fall into one of the following categories:

  1. Food Safety & Testing
  2. Sanitation & Operations
  3. Food Safety Leadership

As many folks that I have personally spoken with at various events have attested, typically the leadership in the food industry is more “technical” in their leadership. One focus at the event this year is break-out sessions that focus on topics such as empowered leadership, team-building, and enabling teams that are afraid of making mistakes and therefore may not voice their opinion, which may include some positive ideas for company leaders. Come join Kathryn Birmingham, V.P. of Research & Development at ImEpik, and I as we present: Beyond meeting the FSMA regulations, the business case for PCQI, Wednesday, October 2 at 2:45 PM.

In summary, I hope this article is helpful in your 2019/2020 event planning. The networking opportunity as well as the chance to take advantage of combined training packages, multiple Expos (Food Safety and Cannabis) and access to decision makers make this event a “must” to attend. For more details on the agenda, hotel, etc. please visit the Food Safety Consortium website. Hope to see you there, and please visit Imepik at booth 105 on the Expo floor.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Palm Oil to Dye For

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

Sudan IV, a diazo dye widely used to stain fuel and industrial grease, is a carcinogen and therefore unsuitable for human consumption. In a recent case in Ghana, it was added to palm oil to achieve the typical reddish-brown color. Adulteration of palm oil is a recurring issue that has been taking place across Asian and African brands, including products sold in Europe, and authorities keep warning of the consumption of the tarnished palm oil.

Resource

  1. Times of Malta (June 28, 2019). “Palm oil contains dangerous dye, authorities warn”.

Additional Resources

  1. FDA food alert, April 2018, Palm oil recall due to the presence of Sudan IV
  2. Swiss government warns of cancerous palm oil, January 2018. Palm Oil adulteration with Sudan IV. Origin of the oil is unknown but most likely an African producer
  3. CFA Alert, August 2017, Food recall: Palm oil adulterated with Sudan IV
Melody Ge
FST Soapbox

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

By Melody Ge
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Melody Ge

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
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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.