Phase one of the pilot looked at using machine learning to find violative seafood shipments. “The pilot program will help the agency not only gain valuable experience with new powerful AI-enabled technology but also add to the tools used to determine compliance with regulatory requirements and speed up detection of public health threats,” FDA stated in a news release. “Following completion of the pilot, FDA will communicate on our findings to promote transparency and facilitate dialogue on how new and emerging technologies can be harnessed to solve complex public health challenges.”
It is fair to say that 2020 was a challenging year with wide-ranging effects, including significant effects on our ongoing efforts to ensure food integrity and prevent fraud in the food system. COVID-19 caused major supply chain disruptions for foods and many other consumer products. It also highlighted challenges in effective tracking and standardization of food fraud-related data.
Let’s take a look at some of the notable food fraud occurrences in 2020:
Organic Products. The Spanish Guardia Civil investigated an organized crime group that sold pistachios with pesticide residues that were fraudulently labeled as organic, reportedly yielding €6 million in profit. USDA reported fraudulent organic certificates for products including winter squash, leafy greens, collagen peptides powder, blackberries, and avocados. Counterfeit wines with fraudulent DOG, PGI, and organic labels were discovered in Italy.
Herbs and Spices. Quite a few reports came out of India and Pakistan about adulteration and fraud in the local spice market. One of the most egregious involved the use of animal dung along with various other substances in the production of fraudulent chili powder, coriander powder, turmeric powder, and garam masala spice mix. Greece issued a notification for a turmeric recall following the detection of lead, chromium, and mercury in a sample of the product. Belgium recalled chili pepper for containing an “unauthorized coloring agent.” Reports of research conducted at Queen’s University Belfast also indicated that 25% of sage samples purchased from e-commerce or independent channels in the U.K. were adulterated with other leafy material.
Dairy Products. India and Pakistan have also reported quite a few incidents of fraud in local markets involving dairy products. These have included reports of counterfeit ghee and fraudulent ghee manufactured with animal fats as well as milk adulterated with a variety of fraudulent substances. The Czech Republic issued a report about Edam cheese that contained vegetable fat instead of milk fat.
Meat and Fish. This European report concluded that the vulnerability to fraud in animal production networks was particularly high during to the COVID-19 pandemic due to the “most widely spread effects in terms of production, logistics, and demand.” Thousands of pounds of seafood were destroyed in Cambodia because they contained a gelatin-like substance. Fraudulent USDA marks of inspection were discovered on chicken imported to the United States from China. Soy protein far exceeding levels that could be expected from cross contamination were identified in sausage in the Czech Republic. In Colombia, a supplier of food for school children was accused of selling donkey and horse meat as beef. Decades of fraud involving halal beef was recently reported in in Malaysia.
Alcoholic Beverages. To date, our system has captured more than 30 separate incidents of fraud involving wine or other alcoholic beverages in 2020. Many of these involved illegally produced products, some of which contained toxic substances such as methanol. There were also multiple reports of counterfeit wines and whisky. Wines were also adulterated with sugar, flavors, colors and water.
We have currently captured about 70% of the number of incidents for 2020 as compared to 2019, although there are always lags in reporting and data capture, so we expect that number to rise over the coming weeks. These numbers do not appear to bear out predictions about the higher risk of food fraud cited by many groups resulting from the effects of COVID-19. This is likely due in part to reduced surveillance and reporting due to the effects of COVID lockdowns on regulatory and auditing programs. However, as noted in a recent article, we should take seriously food fraud reports that occur against this “backdrop of reduced regulatory oversight during the COVID-19 pandemic.” If public reports are just the tip of the iceburg, 2020 numbers that are close to those reported in 2019 may indeed indicate that the iceburg is actually larger.
Unfortunately, tracking food fraud reports and inferring trends is a difficult task. There is currently no globally standardized system for collection and reporting information on food fraud occurrences, or even standardized definitions for food fraud and the ways in which it happens. Media reports of fraud are challenging to verify and there can be many media reports related to one individual incident, which complicates tracking (especially by automated systems). Reports from official sources are not without their own challenges. Government agencies have varying priorities for their surveillance and testing programs, and these priorities have a direct effect on the data that is reported. Therefore, increases in reports for a particular commodity do not necessarily indicate a trend, they may just reflect an ongoing regulatory priority a particular country. Official sources are also not standardized with respect to how they report food safety or fraud incidents. Two RASFF notifications in 2008 following the discovery of melamine adulteration in milk illustrate this point (see Figure 1). In the first notification for a “milk drink” product, the hazard category was listed as “adulteration/fraud.” However, in the second notification for “chocolate and strawberry flavor body pen sets,” the hazard category was listed as “industrial contaminants,” even though the analytical result was higher.1
What does all of this mean for ensuring food authenticity into 2021? We need to continue efforts to align terminology, track food fraud risk data, and ensure transparency and evaluation of the data that is reported. Alignment and standardization of food fraud reporting would go a long way to improving our understanding of how much food fraud occurs and where. Renewed efforts by global authorities to strengthen food authenticity protections are important. Finally, consumers and industry must continue to demand and ensure authenticity in our food supply. While most food fraud may not have immediate health consequences for consumers, reduced controls can lead to systemic problems and have devastating effects.
Everstine, K., Popping, B., and Gendel, S.M. (2021). Food fraud mitigation: strategic approaches and tools. In R.S. Hellberg, K. Everstine, & S. Sklare (Eds.) Food Fraud – A Global Threat With Public Health and Economic Consequences (pp. 23-44). Elsevier. doi: 10.1016/B978-0-12-817242-1.00015-4
Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].
The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.
With the COVID-19 pandemic continuing to take a toll on live events, Innovative Publishing Company, Inc. has made the careful decision to convert the Food Safety Consortium, which historically has taken place in Schaumburg, IL, to a virtual conference. This move takes into consideration Illinois’ COVID-19 plan to reopen its economy, which is a Five-Phase Plan. Phase 5 occurs when groups larger than 50 (conferences and conventions specifically mentioned) will be allowed. The state enters Phase 5 only when a vaccine or an effective treatment is in place. The decision to take the Food Safety Consortium virtual is based on the Illinois reopening plan, along with considering the safety and well being of staff, attendees, speakers and sponsors.
Every Thursday, beginning on September 10 through November 12, the Food Safety Consortium Virtual Conference Series will host two presentations and two sponsored Tech Talks, followed by a panel discussion with attendees. Food Safety Tech is the media sponsor.
“This will be much more than a bunch of webinars. We are excited to offer a virtual platform that facilitates greater human interaction,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium. “Whether it’s a random connection in a hotel lobby, a stroll by a booth at a trade show, or a seat next to a new friend in a learning session, we recognize that human connection is important for events. That’s why we’ve invested in new tools for the FSC Conference Virtual Platform to ensure those discussions, discoveries and connections can go on whether our event is offline or online. The new platform provides attendees with a way to keep track of live sessions, connect with sponsors and engage with peers, all in a familiar way. It will also include an event App that offers interactive features.”
Frank Yiannas, FDA deputy commissioner for food policy and response, will remain a keynote speaker, with the new presentation date to be announced.
Call for Abstracts
We are accepting abstracts for participation in the Food Safety Consortium Virtual Series. On the Submit an Abstract page, select Food Safety Consortium 2020 in the drop-down menu.
Food safety supply chain management
Lessons learned COVID-19
C-suite executive forum
Tech Talk Sponsorship
Companies that are interested in sponsoring a 10-minute technical presentation during the series can also submit their abstract through the portal. For pricing information, contact IPC Sales Director RJ Palermo.
Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.
About the Food Safety Consortium Conference and Expo (The live event)
Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy.
The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.
The legal cannabis-infused products industry is growing with impressive and predictable rapidity. But because the rollout of new regulations occurs in an awkward and piecemeal fashion, with stark differences from one state to another, and sometimes even one county to another, uncertainty reigns.1 Many entrepreneurs are diving headlong into the nascent industry, hoping to take advantage of an uncertain regulatory environment where government audits and inspections are rare. These business owners will see quality assurance and product safety as burdens—costs to be avoided to the greatest extent possible.
I have seen this time and time again, even in the comparatively well-regulated food industry, and it is always a mistake.
If you find yourself thinking about quality assurance or food safety as a prohibitive cost, annoyance or distraction, I encourage you to change your thinking on this issue. The most successful businesses realize that product safety and quality assurance are inextricably linked with profitability. They are best thought of not as distractions, but as critical elements of an efficient and optimized process. Proper QA and safety are not costs, they are value.
Food safety and quality assurance should be seen as important elements of the process that you undertake to enforce the high standards and consistency that will win you repeat customers. The fact that they guard against costly recalls or satisfy meddlesome auditors is only a bonus. Realizing this will make your business smarter, faster and more profitable.
Learn more about the science, technology, regulatory compliance and quality management issues surrounding cannabis at the Food Labs / Cannabis Labs Conference | June 2–4, 2020If today you cannot clearly communicate your product standards to your employees and to your customers, then you have some work to do. That’s because quality assurance always begins with precise product specifications. (A good definition of “quality” is “conformance to specifications.”) How can you assess quality if you don’t have a definitive standard with which to evaluate it? My consulting firm works with food businesses both small and large, and this is where we begin every relationship. You might be surprised how often even a well-established business has a difficult time naming and describing every one of its products, let alone articulating objective standards for them.
This may be doubly difficult for fledgling businesses in the cannabis world. Because the market is so new, there are fewer agreed-upon standards to fall back on.
When we help businesses create specifications, we always look at the relevant regulations while keeping in mind customer expectations. In cannabis, the regulations just aren’t as comprehensive as they are for conventional food and agriculture. Laws and guidelines are still in flux, and different third-party standards are still competing for market dominance. Different states have entirely different standards, and don’t even agree, for example, whether cannabis edibles should be considered pharmaceuticals or food. To some extent, it’s the wild west of regulation, and as long as the federal government remains reluctant to impose national guidelines, it’s likely to remain so.
The wild west may be a good place for the unscrupulous, but it’s not good for business owners that care about the health of their customers and the long-term health of their brand. Don’t take advantage of confusing quality and safety standards by doing the least possible to get by. At some point there will be a scandal in this country when a novel cannabis product makes dozens of customers sick, or worse. You don’t want it to be yours.
With cannabis-infused products, there is a unique additional factor at play: The strength of THC and other psychoactive compounds. Again, there are few agreed-upon standards for potency testing, and relatively little oversight of the laboratories themselves. This allows labs to get sloppy, and even creates an incentive for them to return inflated THC counts; at the very least, results may hugely differ from one lab to another even for identical products.2 Some labs are ISO 17025 accredited, and some are not. Using an unaccredited laboratory may prevent your efforts to create consistent and homogeneous products.
Even in comparatively well-regulated states, such as Colorado, it is ultimately your responsibility to create products that are safe and consistent. And in the states where the politicians haven’t even figured out which department is regulating cannabis products, your standards should be tougher than whatever is officially required.
And so we look to the more established world of conventional food and agriculture as a guide for the best practices in the cannabis industry.
The most constructive way to look at food safety, and the way your (eventual) auditors and regulators will view it, is to look at your product and process from the perspective of the potential hazards.
Some day, when regulation finally gets sorted out, you are likely to be asked to implement a Hazard Analysis and Critical Control Points (HACCP) safety system. HACCP framework recognizes three broad categories of hazards:
Physical hazards: Foreign material that is large enough to cause harm, such as glass or metal fragments.
Chemical hazards: Pesticides and herbicides, heavy metals, solvents and cleaning solutions.
Biological hazards: The pathogens that cause foodborne illness in your customers, such as E. coli, and other biological hazards, such as mycotoxins from molds.
All of these hazards are highly relevant to cannabis-infused product businesses.
The HACCP framework asks us to consider what steps in our process offer us the chance to definitively and objectively eliminate the risk of relevant hazards. In a cannabis cookie, for example, this might be a cooking step, a baking process that kills the Salmonella that could be lurking in your flour, eggs, chocolate or (just as likely!) the cannabis extracts themselves.
A good HACCP system is merely the capstone resting atop a larger foundational system of safety programs, including standard operating procedures, good manufacturing practices, and good agricultural practices. It’s important to use these agreed-upon practices and procedures in your own facility and to ensure that your suppliers and shippers are doing the same. Does your cultivator have a culture of safety and professionalism? Do they understand their own risks of hazards?
HACCP offers a rigorous perspective with which to look at a process, and to examine all of the places where it can go wrong. The safety system ultimately holds everything together because of its emphasis on scrupulous documentation. Every important step is written down, every time, and is always double-checked by a supervisor. It sounds like a lot of paperwork, but it is better viewed as an opportunity to enforce consistency and precision.
When you thoroughly document your process you’ll create a safer product, run a more efficient business, and make more money.
— UPDATE — March 9, 2020 – IPC and the Food Labs/Cannabis Labs Conference want to reassure you, that in case of any disruption that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. Please note that if you initially register as a virtual participant (meaning you have no intentions of traveling to the event regardless) and the on-site event is not cancelled, you will ONLY be able to listen to the General Sessions and the Cannabis Sessions. You will have not have access to the Food Labs Sessions and there will be NO recording of these sessions. If you have any questions, please contact Veronica Allen, Event Manager.
–END UPDATE —
EDGARTOWN, MA, Jan. 22, 2020 – Innovative Publishing Co., the publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo is announcing the launch of the Food Labs Conference. The event will address regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management. It will take place on June 3–4 in Rockville, MD.
Some of the critical topics include discussion of FDA’s proposed FSMA rule, Laboratory Accreditation Program for Food Testing; considerations in laboratory design; pathogen testing and detection; food fraud; advances in testing and lab technology; allergen testing, control and management; validation and proficiency testing; and much more.
The event is co-located with the Cannabis Labs Conference, which will focus on science, technology, regulatory compliance and quality management. More information about this event is available on Cannabis Industry Journal.
“By presenting two industry conferences under one roof, we can provide attendees with technology, regulatory compliance and best practices that cannabis and food might share but also focused topics that are unique to cannabis or food laboratory industry needs,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Labs Conference.
The agenda and speakers will be announced in early March.
About Food Safety Tech Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.
To understand why an integrated informatics solution is important to manufacturers in the food and beverage industry, it helps to first consider the unique challenges this industry faces. Simply put, food production has scaled into a global business so rapidly that oversight has hardly kept pace. Even the stricter regulatory stances taken by the FDA and the European Union in the past decade are effectively catch-up efforts.
The broader food industry, which for purposes of this article will also comprise the beverage industry, has globalized quickly and, many would argue, haphazardly. It actually wasn’t that long ago that the products we purchased in our local food store were produced locally or regionally. Seasons determined selections as well—if you wanted a tomato in November, you would pay a premium for that indulgence.
Seasons and geography no longer constrain what we can buy and when. By far the world’s largest industry—with a combined revenue of more than $4 trillion, the food industry has used its massive scale to overcome historical limitations. We now take for granted that our grocery carts can be filled with fresh products that may come from thousands of miles away. And those products may have been grown, processed and shipped in multiple countries before they reach our local grocer.
The complexity and scale of this modern food supply chain is the industry’s greatest challenge and regulators’ greatest worry (on consumers’ behalf). How can growers, producers, processors, packagers, shippers and others in the global supply chain secure a food chain that’s so distributed? How can regulators ensure safety without restricting choice or inflating prices?
The Bits and “Bytes” of Food Safety
The food industry—and its regulators—would likely agree on one thing: A system this massive cannot operate on trust alone, as it once did. The grower with generations of experience on the land, for example, is now too far removed from end consumers. A finished product may contain one farmer’s product and those from five others, all from different regions worldwide.
Integrated informatics may seem like an unlikely fix for modernizing a highly distributed food chain, but it’s actually perfectly suited. An integrated informatics platform provides access to massive amounts of information in a timely fashion, dramatically improving decision-making. It does this by making information rapidly available to many stakeholders and by ensuring that it’s reliable.
Consider this example. A hypothetical lab uses an analytical instrument to detect pesticides in barley, and regulation dictates that this data be compared to allowable maximum residue limits (MRLs). If the barley sample exceeds allowable MRLs, the manufacturer must identify everywhere that ingredient is being used, quarantine it and determine who produced it. All this must happen quickly and according to strict procedures.
Procedures are critical. Not only must the lab have a process for checking against current limits for a pesticide, for example, but also that analytical information must be carefully tracked with the appropriate sample, and the method used to deliver the result must be consistent between different samples and users. Without an integrated informatics solution, adhering to these procedures, defending the quality of the data, and making it usable would be nearly impossible.
The Role of Informatics in Compliance
Gathering the bits and bytes of data, following procedures and making the data useful enterprise-wide is important, but regulatory compliance is where most industry attention is focused today. This is another area where integrated informatics provides significant benefits.
As mentioned above, food industry growth significantly outpaced regulatory oversight in the past decade. Globalization was rapid and inevitable, but so too were food safety breaches, and with progress came stories of tainted fruits, vegetables, meats, cereals, nut butters and much more. Suddenly we had a trust issue. With a food chain that’s distributed across many borders and jurisdictions, how is the public’s trust best protected and by whom?
From the Food Safety Modernization Act (FSMA) to EU Regulation No. 178/2002, we’ve seen a heightened regulatory focus, and the most common themes are traceability, authenticity and risk-based approaches. The common denominator here is food chain security.
So what does all of this mean for multinational food and beverage producers? It means having to conform to multiple regulatory requirements for each distribution market, and there are often many. And this is a data management and reporting headache. Fortunately, however, common standards such as ISO 22000 exist that enable companies to standardize their processes enterprise-wide, achieving levels of operational rigor and quality that satisfy multiple regulatory authorities at once.
So where do informatics fit into this regulatory compliance landscape? In a typical multinational food producer, a significant amount of the quality data is delivered by the laboratory. Raw materials are analysed for pesticides, herbicides, nutritional content and so on. Packaged products are monitored for shelf-life compliance. Plant hygiene is monitored using microbiological samples taken from across the facility. Records from all of these distinct, but interrelated activities are critical for demonstrating compliance.
The shift in recent years has been toward prevention instead of crisis response. Regulators now focus on auditing food and beverage producers to assess their practices prior to any adverse event. For companies with good systems in place, time-consuming audits will be less frequent, so it pays to have systems in place that demonstrate that data is reliable and defensible.
Audits can be daunting. The producer must prove that activities were carried out correctly, that records are properly collected and that supporting information is accurate. Auditors typically pick a starting point in a process and follow the trail. They may start by looking at the data associated with a released batch of product; perhaps quality assurance samples; follow the trail to cleaning validation, and then review individual laboratory results, including entire methods, instrument calibration, user training, etc. At each point of the audit, producers must show evidence of compliance—even the smallest details.
With an integrated informatics solution, all evidence resides in a single platform. Hierarchies and relationships within the data records are automatically recorded and retained. Everything—from relationships between lots or batches of material; the connection between methods, specifications and results; the history of an instrument configuration, maintenance and calibration; and user training records—is in one place for easy retrieval and reporting.
Having one system of record not only codifies data capture, it also helps labs create standard operating procedures (SOPs). Establishing SOPs does several important things:
It ensures that all lab users are following the same process—no personal preferences for carrying out a specific test.
It makes sure that all necessary data is collected—by enforcing a series of data entry steps, labs can prevent a method from being marked complete until everything has been entered.
Labs can roll out updates to their processes by updating the method for all users at the same time.
Managing lab execution activities in this way means that data is more consistent; it is being collected in the same way for all users. It is also prone to fewer errors because users move stepwise through each stage of the measurement process, and they can stop a test whenever they encounter a problem.
Traceability, the ability to verify the history, location or application of an item using documented information, has become increasingly more important for the food industry. And traceability is closely linked to compliance and data defensibility. Fortunately, traceability is another strength of an integrated informatics solution.
In practical terms, to demonstrate traceability we must be able to go either backwards or forwards within a set of process items and understand the complicated relationships. An integrated informatics solution lets us map relationships between “child” and “parent” batches, information that can also come from integrating ERP or process or production information management (PIMS) systems. By integrating all this information, manufacturers can trace a product back through intermediate products and raw materials and then forward again to any resultant batches that may be contaminated. In other words, with an integrated informatics solution, traceability is built in.
Because of its size and fragmentation, the global food and beverage industry is a target for adulteration and counterfeiting. The Grocery Manufacturers Association estimates that these activities cost the industry $10–15 billion each year.
While the risk to consumers of adulteration can be deadly, as in the case of milk solids adulterated with melamine in China, much of the impact comes in the form of trust erosion and fraud. An example is Manuka honey, a premium product with purported health benefits that commands a high price. The entry of fraudulent producers into the market affects legitimate producers by creating uncertainly about all products, depressing sales and lowering prices.
This is only one example, but it illustrates the larger problem: Once consumer trust erodes, it’s hard to regain. As it happens, however, honey has unique chemical markers that can be used to determine whether it has been adulterated. But isolating these markers involves complex analysis, including ultra- high-performance liquid chromatography (UHPLC), and methods that are highly specific, consistent and defensible.
Consistency and defensibility are hallmarks of an integrated informatics solution. For the honey producers, an informatics solutions, such a LIMS, can automate processes so that no non-conforming product is missed, establish compliance rules and checks for instrument calibration so that results are defensible, and standardize methods through built-in laboratory execution system (LES) capability.
An integrated informatics solutions is designed to address multiple business needs in the food and beverage industry, from compliance and data defensibility to traceability and brand protection. The complexity and scale of the modern food supply chain demands it.
Growers, producers, processers, packagers, shippers and others in the global supply chain are now interdependent, but not necessarily integrated. The only way to protect consumers, however, is to achieve this integration through a combination of voluntary and imposed compliance. And to achieve this compliance without undue burden on the industry and imposing higher costs on consumers, we need technology that is built for integration at scale—and informatics solutions have proven they are more than capable.
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