Tag Archives: regulatory

Roberto Bellavia, Kestrel
FST Soapbox

How Integrated Compliance Management Systems Maximize Efficiency

By Roberto Bellavia
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Roberto Bellavia, Kestrel

Managing the complexities of a management system is challenging for any food and beverage company, particularly for the team tasked with implementing the system throughout the organization. That is because every regulatory agency (e.g., FDA, USDA, OSHA, EPA) and voluntary certification (e.g., GFSI-benchmarked standards, gluten-free, organic, ISO) calls for companies to fulfill compliance requirements—many of which overlap. Supply chain and internal requirements can create further complications and confusion.

In today’s “New Era of Smarter Food Safety,” having a common system to organize, manage and track compliance offers an ideal solution. Dynamic tools are becoming available—systems that can manage employee training, pest control, laboratory testing, supply chain management tools, regulatory compliance and certification requirements, etc.

Unfortunately, these systems are often not set up to “talk” to each other, leaving company representatives to navigate many systems, databases, folders, and documents housed in many different locations.

The Solution: Compliance Management Systems

An integrated compliance management system (CMS) is intended to bring all these tools together to create one system that effectively manages compliance requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data that is collected daily by the team charged with implementation.

A CMS is used to coordinate, organize, control, analyze and visualize information to help organizations remain in compliance and operate efficiently. A successful CMS thinks beyond just access to documents; it manages the processes, knowledge and work that is critical to helping identify and control business risks. That may include the following:

  • Ensuring only authorized employees can access the right information.
  • Consolidating documents and records in a centralized location to provide easy access
  • Setting up formal business practices, processes and procedures
  • Implementing compliance and certification programs
  • Monitoring and measuring performance
  • Supporting continuous improvements
  • Documenting decisions and how they are made
  • Capturing institutional knowledge and transferring that into a sustainable system
  • Using task management and tracking tools to understand how people are doing their work
  • Enabling data trending and predictive analytics

CMS Case Study: Boston Sword and Tuna

In early 2019, Boston Sword and Tuna (BST) began the process of achieving SQF food safety certification. We initially started working with BST on the development, training and implementation of the program requirements to the SQF code for certification—including developing guidance documents for a new site under construction.

The process of attaining SQF certification included the development of a register of SQF requirements in Microsoft SharePoint, which has since evolved into a more comprehensive approach to overall data and compliance management. “We didn’t plan to build a paperless food safety management system,” explains BST President Larry Dore, “until we implemented our SQF food safety management program and realized that we needed a better way to manage data.”

We worked with BST to structure the company’s SharePoint CMS according to existing BST food safety management processes to support its certification requirements and overall food safety management program. This has included developing a number of modules/tools to support ongoing compliance efforts and providing online/remote training in the management of the site and a paperless data collection module.

The BST CMS has been designed to support daily task activities with reminders and specific workflows that ensure proper records verifications are carried out as required. The system houses tools and forms, standards/regulatory registers, and calendars for tracking action items, including the following:

  • Ambient Temperature
  • Corrective and Preventive Action (CAPA)
  • Chemical Inventory/Safety Data Sheets (SDS)
  • Compliance Management
  • Customer Complaints
  • Document Control
  • Employee Health Check
  • Food Safety Meetings Management Program
  • Forklift Inspections
  • Good Manufacturing Practices (GMP) Audit
  • SQF Register
  • Maintenance (requests/work orders/assets/repairs)
  • Nightly Cleaning Inspections
  • Operational/Pre-Operational Inspections
  • Sanitation Pre-Op Inspections
  • Scale Calibration
  • Sharp/Knife Inspections
  • Shipping/Receiving Logs
  • Thawing Temperature Log
  • Thermometer Calibration

Key Considerations for Designing a Successful CMS

An effective CMS requires an understanding of technology, operational needs, regulatory compliance obligations and certification requirements, as well as the bigger picture of the company’s overall strategy. There are several key considerations that can help ensure companies end up with the right CMS and efficiency tools to provide an integrated system that supports the organization for the long term.

Before design can even begin, it is important to first determine where you are starting by conducting an inventory of existing systems. This includes not only identifying how you are currently managing your compliance and certification requirements, but also assessing how well those current systems (or parts of them) are working for the organization.

As with many projects, design should begin with the end in mind. What are the business drivers that are guiding your system? What are the outcomes you want to achieve through your system (e.g., create efficiencies, provide remote access, reduce duplication of effort, produce real-time reports, respond to regulatory requirements, foster teamwork and communication)? Assuming that managing compliance and certification requirements is a fundamental objective of the CMS, having a solid understanding of those requirements is key to building the system. These requirements should be documented so they can be built into the CMS for efficient tracking and management.

While you may not build everything from the start, defining the ultimate desired end state will allow for development to proceed so every module is aligned under the CMS. Understand that building a CMS is a process, and different organizations will be comfortable with different paces and budgets. Establish priorities (i.e., the most important items on your list), schedule and budget. Doing so will allow you to determine whether to tackle the full system at once or develop one module at a time. For many, it makes sense to start with existing processes that work well and transition those first. Priorities should be set based on ease of implementation, compliance risk, business improvement and value to the company.

Finally, the CMS will not work well without getting the right people involved—and that can include many different people at various points in the process (e.g., end user entering data in the plant, management reviewing reports and metrics, system administrator, office staff). The system should be designed to reflect the daily routines of those employees who will be using it. Modules should build off existing routines, tasks, and activities to create familiarity and encourage adoption. A truly user-friendly system will be something that meets the needs of all parties.

Driving Value and Compliance Efficiency

When thoughtfully designed, a CMS can provide significant value by creating compliance efficiencies that improve the company’s ability to create consistent and reliable compliance performance. “Our system is allowing us to actually use data analytics for decision making and continuous opportunity,” said Dore. “Plus, it is making remote activities much more practical and efficient”.

For BST, the CMS also:

  • Provides central management of inspection schedules, forms, and other requirements.
  • Increases productivity through reductions in prep time and redundant/manual data entry.
  • Improves data access/availability for reporting and planning purposes.
  • Effectively monitors operational activities to ensure compliance and certifications standards are met.
  • Allows data to be submitted directly and immediately into SharePoint so it can be reviewed, analyzed, etc. in real time.
  • Creates workflow and process automation, including automated notifications to allow for real-time improvements.
  • Allows follow-up actions to be assigned and sent to those who need them.

All these things work together to help the company reduce compliance risk, create efficiencies, provide operational flexibility, and generate business improvement and value.

Stephen Dombroski, QAD
FST Soapbox

Regulatory Issues and Transportation: Critical Factors in the Quest for Sustainability in Food Manufacturing

By Stephen Dombroski
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Stephen Dombroski, QAD

Over the last several months, we have been exploring the details of several critical factors that are impacting the food and beverage manufacturing sector in terms of sustainability, including:

Two additional factors that food manufacturers now have to manage regarding sustainable practices are transportation and regulatory restrictions. Each can be discussed as a separate topic, but they are intertwined, as there have always been regulations regarding food transportation, and obviously food has always needed to be transported. Now that sustainability is an important topic in all areas of food manufacturing, it makes sense to discuss these two subjects both individually and collectively.

Transportation and Regulatory Joint Concerns

Ensuring that all areas of food transportation incorporate sustainable practices is a critical component of achieving sustainability in food manufacturing. To this point, however, these types of practices have not fully been implemented or even designed. This area is still evolving. From a straight transportation point of view, governments globally have been imposing restrictions for decades. These restrictions vary from country to country, province to province, region to region, and so on, and this causes confusion when inter- or intra-region transportation of food is required. There are also several regulatory differences based on mode of transportation. Land, air and sea transportation can and should have different regulations.

Another ingredient that should be added to this product mix of sustainability, transportation and regulations is food safety and the integrity of the food materials being transported whether it is ingredients, work-in-process foods or finished products. Various modes of transportation can affect the chemical composition, physical appearance, nutritional value and quality and safety of food. It could be straightforward to start implementing restrictions, regulations and new methods of how to package, manufacture and transport food to satisfy the growing trend of sustainable food behaviors. However, what cannot get lost in this is the issue of food safety and integrity.

Sustainability More than Recycling and Litter

When discussing regulations around transportation and food, many people immediately think of littering, of some uncaring individual throwing a soda pop can out of a car window. Littering regulations, laws, fines, penalties and public service campaigns have been in place globally for more than 50 years. The next time you go outside, take a look around at how effective those have been. Sustainability goes far beyond the issue of litter. One area that works hand in hand with transportation of food is climate change. Governments have been evaluating the current practices and have begun implementing changes designed to positively affect climate change. Some examples include:

  • 23 American states and Washington, D.C. limit idling by some or all vehicles.
  • The California Air Resources Board adopted the TRU Airborne Toxic Control Measure in 2004 to reduce diesel particulate matter pollutant emissions.
  • In 2020, the International Maritime Organization will implement a new regulation for a 0.50% global sulfur cap for marine fuels.

The food and beverage industry is actively embracing other changes that affect sustainability. Electric trucks fit well with the F&B distribution hub model, with clean, quiet, short-run deliveries. Fuel usage during transportation is being considered from every angle. Local and regional food systems, where farmers and processors sell and distribute their food to consumers within a given area, use less fossil fuel for transportation because the distance from farm to consumer is shorter. This shorter distance also can help to reduce CO2 emissions.

Change Starts with Money

During many conversations I have had with my wife about a variety of subjects, especially those that can be considered controversial, one of us always raises the same question which is: “When in doubt, what is it all about?” And most of the time, the answer is money. Regulations around sustainability in food manufacturing are being driven by demands made by the consumer. The purchasers of the finished food product dictate almost every aspect of that product to the manufacturer because, let’s face it, if the consumer doesn’t like it, they won’t buy it. And if they don’t buy it, what will eventually happen to the manufacturer? That’s right—it goes out of business.

Now there is a good definition of sustainability or at least of what is not sustainable. From the transportation side of things, manufacturers in almost all cases pay the freight of shipping their food products to the members of the value chain. This obviously affects the costs of goods sold, which is a direct component of the bottom line and the profitability of the business. And with margins typically low in food and beverage manufacturing, transportation costs are always on the minds of the executives. So as the drive for sustainable transportation practices rolls into food manufacturing, you can bet that in addition to meeting sustainable practices, they will fit into the financial plans of the organization as well.

Sustainability: Just Another Component in a Long Line of Disruptors in Food Manufacturing

Years ago, when the topic of disruption in food manufacturing came up, many would mention things like a customer changing an order, an ingredient not arriving on time, or a packaging line going down for an hour. Today, these occurrences are just part of the day-to-day process and reality of food manufacturing. They are going to happen, and disruptions are the things that will make a food manufacturer have to change their business model and force them to change their philosophy and begin to evaluate their business practices and systems to adjust to the world in which they operate.

Sustainability is another one of those disruptions that will impact the process of food transportation long term. Sustainability will be an area that eventually forces manufacturers to operate within new regulatory parameters imposed on how they produce and ship their food. Through these changes, manufacturers will have to ensure that food meets the current and future safety regulations while maintaining profitability. That is where real sustainability will be measured. Changes to business, movements like sustainability are adding to the disruption of the food industry at unprecedented rates of speed. In order to survive and thrive, and to meet these disruptions head on and be sustainable themselves, global food manufacturers must be able to innovate and adapt their business models.

FDA

FDA Issues Letter to Industry Addressing Efforts to Reduce Chemical Hazards in Foods for Babies and Young Children

By Food Safety Tech Staff
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FDA

A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.

In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.

“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”

The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:

  • “Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.

  • Focused compliance and enforcement activities, including inspections.

  • Providing guidance to industry on how to meet their obligations under current regulations.”

The agency will also continue its surveillance sampling assignment that focuses on these products.

FDA

FDA Begins Phase Two of Artificial Intelligence Imported Seafood Pilot Program

By Food Safety Tech Staff
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FDA

FDA is beginning phase two of its Artificial Intelligence Imported Seafood Pilot Program. The program, which is expected to run from February 1 through July 31, intends to improve FDA’s response in quickly and efficiently identifying potentially harmful imported seafood products.

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.”

The pilot program is part of the agency’s efforts that fall under the New Era of Smarter Food Safety.

Karen Everstine, Decernis
Food Fraud Quick Bites

Food Authenticity: 2020 in Review

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

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.
  • Honey. Greece issued multiple alerts for honey containing sugar syrups and, in one case, caramel colors. Turkey reported a surveillance test that identified foreign sugars in honeycomb.
  • 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

RASFF

RASFF, melamine detection
Figure 1. RASFF notifications for the detection of melamine in two products.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.

Reference

  1. 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
FDA

FDA Releases More Resources for Food Traceability Proposed Rule, Risk-Ranking Model for Food Tracing

By Food Safety Tech Staff
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FDA

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.

Other resources include a flowchart to assist with determining who is subject to the rule and a glossary of key terms.

Food Safety Consortium

2020 Food Safety Consortium Converted to Virtual Event Series

By Food Safety Tech Staff
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Food Safety Consortium

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.

Categories include:

  • Food safety
  • Food defense
  • Food integrity
  • Food safety supply chain management
  • Lessons learned COVID-19
  • Regulatory compliance
  • Facility design
  • 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.

Innovative Publishing has also converted the Cannabis Quality Conference to a virtual event. More information is available at Cannabis Industry Journal.

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.

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.

Michele Pfannenstiel, Dirigo Food Safety
FST Soapbox

Quality Assurance and Food Safety in Cannabis-Infused Products

By Michele Pfannenstiel, DVM
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Michele Pfannenstiel, Dirigo Food Safety

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.

Hazards

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.

References

  1. Rough, L. (2016, March 4). Leafly’s State-by-State Guide to Cannabis Regulations. Retrieved from https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations
  2. Jikomes, N. & Zoorob, M. (2018, March 14). The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities and Popular Consumer Products. Retrieved from https://www.nature.com/articles/s41598-018-22755-2

Food Labs Conference Announced for Spring 2020

By Food Safety Tech Staff
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— 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 call for abstracts is open until February 28.

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.

Thermo Scientific's Integrated Informatics LIMS

How Integrated Informatics Benefit Regulatory Compliance, Defensible Data, Traceability and Brand Protection

By Trish Meek
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Thermo Scientific's Integrated Informatics LIMS

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.

Defending Data

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.

Achieving Traceability

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.

Brand Protection

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.

Thermo Scientific's Integrated Informatics LIMS
Having access to data from all critical points in the food production chain is the most important safeguard against product recalls and loss of revenue for food manufacturers. Having an integrated informatics solution in place provides data when it is needed for quality checks in the production process, for management metrics reporting or to adhere to regulatory requirements. (Click to enlarge)

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.

Conclusion

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.