Tag Archives: traceability

Katy Jones, Foodlogiq
FST Soapbox

The Clock is Ticking: Technology to Effectively Manage Recalls

By Katy Jones
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Katy Jones, Foodlogiq

It seems there isn’t a day that goes by without a food recall being announced. National brands like General Mills, Kellogg’s and Kraft alone have all experienced major recalls over products contaminated with such hazards as E. coli or undeclared allergens in the last few months. Food recalls are incredibly costly to a company, but can be handled effectively and efficiently with good planning, proper execution and the right technology to back it up.

Fortunately, the food industry is moving in the right direction to encourage better recall management by way of regulations under FSMA. Underscored by these federal mandates, the industry as a whole is moving away from a reactive approach to quality and safety issues within the supply chain, instead adopting a preventative plan of action.

The Multiplier Effect: How One Ingredient Can Lead To Multiple Recalls | Learn more at the 2016 Food Safety Consortium | December 7-8 | Schuamburg, ILRecalls are inevitable in the food industry, and in reality every company has, or will, experience one at some point. What sets a company apart essentially boils down to how they prepare for and react to a recall situation. If a company has done its due diligence to prepare for the inevitable (i.e. putting a recall team in place and implementing the right traceability technology), dealing with a quality or contamination issue can be less painful. Additionally, taking the right preventative steps can ensure a recall situation is proactively handled, rather than leading to a brand’s nightmarish public meltdown.

Getting Beyond “One-up and One-Back”

The industry has relied on a more linear approach to supply chain transparency—the “one-up and one-back” method (OUOB). Knowing where a product has come from one step back in the chain and where it is being sent or sold one step forward is no longer enough. To properly prepare for a recall, and manage product quality, it is imperative that a company employ whole chain traceability software, rather than relying solely on the movement of product within its own four walls.

The OUOB traceability approach is especially dangerous when handling high-risk, perishable foods, like produce or meat—which are often the culprit for recalls. According to a recent study in the Journal of Business Logistics titled, “Tracing Bad Products in Supply Chains” by Kaitlin Wowak, assistant professor of management at Notre Dame, “perishable products, like fresh produce and meats, flow through the supply chain very quickly. And while federal regulations mandate that firms have traceability one step up and down the chain, this may not be sufficient for these perishable products. In those situations, there is often a gap in the information received about the product, say a positive Listeria test, and where that product went in the supply chain.”

Root Cause Analysis is Key

When faced with a recall situation, time is of the essence. The time it takes for the recall team to identify the root cause of an issue and remove it from the supply chain could be the difference between sick consumers and serious brand implications. Being fully cognizant of the entire supply chain via a whole-chain traceability solution allows you to visualize a contaminant’s exact location; this information ultimately helps a brand streamline and manage the issue quickly and effectively.

Wowak’s research profiles a series of recall scenarios. One that was studied found that 50% of the food removed from the supply chain during that recall was actually affected—the other half was perfectly fine. Take the example of a batch of tainted tomatoes in your supply chain. Without being able to identify the root cause at the lot level, a company might be forced to remove all of the tomatoes from its supply chain.

Rather, by utilizing end-to-end traceability software, they can identify the specific farm, pack date and lot from which the produce originated. Tracing that information through each step in the supply chain—hether the tomatoes ended up on a pizza, in a can of salsa, or in a farmer’s market—allows the brand to manage the bad products without disrupting their entire chain or wasting perfectly good produce.

Unfortunately, without the visibility of whole-chain traceability, companies do not have the option to cherry pick tainted vs. untainted food from their chain. This is especially relevant as up to 40% of food in the United States goes to waste, according to the NRDC.1

Centralized Recordkeeping

When faced with a safety or quality issue, communicating information to relevant parties is necessary throughout the process. Especially with FSMA coming into play, if a company experiences a quality issue, they must promptly notify regulatory establishments and be sure to submit documentation and data in an immediate manner for investigative purposes. This can be hindered if a brand does not have a good handle on their supply chain data and must spend hours sorting through file cabinets, emails, or Excel sheets for proper documentation, or coordinating with suppliers for records. The longer it takes to comply with federal regulations and submit data around a recall, the more likely consumers, and the brand, are at risk.

The industry’s shift towards a preventative approach to safety is hitting a milestone as FSMA compliance periods have already taken effect. With this change, the FDA will no longer tolerate poor handling of contamination or quality issues. A company cannot get away with blaming a partner’s lack of transparency, or a supplier’s inconsistent records— the brand is now always accountable. In the coming months, we can anticipate added scrutiny from auditors, more mandatory recalls, even the shutting down of facilities due to noncompliance or negligence around safety concerns.

Having a robust supplier management system in place enables a company to be prepared for a recall situation. With all of your product and supplier data in one place, companies can quickly gather and allocate necessary data like audits and assessments to the appropriate officials, complying with the new required recordkeeping rules. By streamlining the availability of key information, and supporting seamless communication, a brand can be empowered to navigate a quality or safety issue.

As testing across the supply chain increases and the demand for fresh food rises, recalls are not going away. Fortunately, the move to a preventative approach to safety comes at a time where traceability technology is more comprehensive than ever. Food companies have the opportunity to invest in themselves with end-to-end traceability, arming the brand for the inevitable occurrence of a safety or quality issue. By enhancing visibility of the supply chain via an all-encompassing whole-chain platform, it is possible to track a product through each stopover to the consumer, from farm to fork. At the same time, housing all data in one efficient platform can ease the pressure of liaising with supply chain partners and regulatory bodies and streamline communications when faced with a safety situation.

While recalls are an inescapable part of the food industry, what sets a brand apart is how well they prepare and arm themselves with the technology to stay ahead. Implementing supplier management and whole-chain traceability software can help a company stay one step ahead of a recall, which makes all the difference when consumer wellness and brand reputation are on the line.

Reference

  1. Gunders, D. (August 2012). “Wasted: How America Is Losing up to 40 Percent of Its Food from Farm to Fork in Landfill”. NRDC Issue Paper. Retrieved from https://www.nrdc.org/sites/default/files/wasted-food-IP.pdf

8 Food Industry Trends Fueled by FSMA

By Lori Carlson
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FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.
Gina Kramer
Food Safety Think Tank

Mobile Technology Could Help Your Business in an Outbreak

By Gina R. Nicholson-Kramer
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Gina Kramer

Join Gina Kramer at the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREI recently spoke with Wes Billingslea, one of the co-founder’s of Till Mobile Corp., a company founded because its team realized large brands needed to connect all the way down to the smallholder and grower level. There are more than 6 billion mobile devices on earth and only a small percentage of them are smartphones. Till uses voice, text, and SMS-mobile to enable two-way communication with smallholders, and to deliver visibility and traceability. The company is able to collect massive amounts of data from growers because there is no resistance to using mobile phones. It works with your existing systems to identify and fill data gaps that create risk. The big brands access detailed analytics and can communicate directly throughout their supply chain to accelerate supplier onboarding, support local and alternate sourcing, and check inventory, pricing, and food safety standards.

I asked Wes, as a food company, how could this technology save me money? To start, it allows you to check inventory and pricing, and helps you adhere to your food safety standards beyond the packinghouse or distributor. It can also help you get more out of your existing systems to protect your IT infrastructure.

In the following video, we discuss the Salmonella outbreak in cucumbers that occurred last summer. In such a scenario, this new technology could help save food retailers money during an outbreak or recall by giving them greater visibility and real-time data, and help them source alternatives directly.

How Automated Inventory Tracking Systems Contribute to Food Safety

By Ryan Hardy
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When a business decides to invest in technology, the primary driver is usually to save money over the long term. As with most automated systems, inventory management tools can reduce costs by saving time and resources used to manage inventory.

But the benefits that automated inventory tracking can provide through traceability (of lots, batches, and even individual items) go beyond the financial. These systems can also be used in every aspect of your food safety program from helping with compliance, to improving your quality controls.

Exchange knowledge about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MORE

In a nutshell, having an automated system that allows full visibility into the supply chain—that is, one that identifies in real time where items are being used and where they are sent, while retaining a historical record of that flow through the chain—makes it much simpler and faster to implement procedures to ensure the safety of the food you produce.

All about Accuracy and Speed

Speed and accuracy make a huge difference when it comes to dealing with potentially contaminated food. Being faster and more accurate than a manual inventory method is the most immediate benefit that an automated system brings to your food safety program.

The most compelling reason for having accurate and readily accessible track-and-trace data is to handle food recalls and to comply with requests for documentation from government agencies such as the FDA. In cases where consumer health is at risk, that information needs to be delivered quickly to prevent further harm, and it must be accurate to enable investigators to move in the right direction. Responding to requests for detailed documentation within a 24-hour timeframe can be nearly impossible if you are not using an automated system.

Even when the situation doesn’t involve a federal investigation, once a situation in which possible contamination or mislabeling arises, the faster you have accurate and detailed data, the faster your internal processes can move forward.

If the issue is identified through your quality control process, you will be more likely to be able to prevent contaminated product from reaching the retail outlet and thus getting into the hands of the consumer. Having traceability built into your inventory management systems provides immediate knowledge about whether a product using ingredients from the same batch have entered the distribution chain, and if so, where they are going. This greatly improves the likelihood of limiting the cost and scope of a recall.

Depending on the specific technology you employ, an automated system can provide immediate access to the track and trace information for specific ingredients at least one step backward and one step forward, as required by the Bioterrorism Act of 2002. A supply chain that integrates the most sophisticated technology, such as DNA tracking, can trace an item all the way from the farm or border to the individual consumer or restaurant kitchen.

This traceability means that if an ingredient was already contaminated before it entered your production line, the inventory tracking system can identify all products using that ingredient from the contaminated lot and thus will help you define the scope of the problem. This automation can go a step further by identifying where the ingredient lot originated, and thus help trace the ingredient at least one step backward to the vendor. If the vendor (whether a distribution company or a direct supplier) has traceability in an automated system, or if you are using a system hosted by a distribution partner, tracing the source farther back than one step is possible.

Such information can help you respond more quickly to FDA requests for product information and support the agency’s efforts in product traceability.

Protect Your Reputation

Just as using tracing technology can help identify potential contamination sources quickly, it can also be used to eliminate sources more quickly and accurately, thereby speeding up investigations into food contamination incidents. The faster a company can be eliminated from an investigation, the less time is taken away from normal production. In addition, quick exclusion can protect a company’s reputation from harm.

Additional Benefits

Through their ability to store specific data that can be used to identify potential risks, automated track and trace systems contribute to many preventive food safety measures as well as to the following corrective responses:

  • For perishable products, automated traceability can identify how long specific perishables have been in supply chain. This allows you to avoid using ingredients close to spoilage and to remove overdue products from the distribution chain.
  • During mock recalls, automated tracking systems reduce the time spent away from regular production and allow you consistent information throughout the organization, eliminating wasted effort due to miscommunications.
  • Automated systems reduce the time needed for notifications both internally and externally in the case of an incident affecting food quality or safety. This leads to faster line clearance and faster isolation of the possibly contaminated product.
  • With more effective accounting for possibly affected batches, you can better identify where to apply cleanup measures in the production chain.

In short, automated tracking can improve implementation of preventive controls to stop the contaminated product from reaching the marketplace, and in cases in which corrective actions are required, the automated system can help you respond more quickly and can reduce the scope of risk.

Not just Foodstuffs

Although raw ingredients and food products obviously require traceability, they aren’t the only traceable inventory that can impact food safety. Automated lot tracking can enhance food safety efforts related to all inventory items used in food processing/manufacturing:

  • Packaging. A sub-standard packaging lot can allow incursion of harmful substances or the growth of harmful bacteria. Leakers can contaminate an entire batch of meat or poultry product. Automated lot tracking can help you rapidly isolate the bad lot and know which production lines have already used the sub-standard materials.
  • Labeling. If an inferior adhesive has been applied to a batch of labels, you can identify which product lots to pull from the distribution chain. You can do the same if your quality controls find a batch of inaccurate labels.
  • Protective equipment and clothing. Gloves, masks and other protective gear must function properly to ensure the safety of your workers and also to prevent contamination from being introduced on the production line. An inferior batch of protective gloves that tear during use, for example, could violate your food safety practices. Identifying the bad batch quickly and removing it from the operations area immediately can save potential contamination.
  • Cleaning solutions. Even a batch of cleaning solution can be sub-par. If tests show that cleaning has not eliminated the targeted bacteria, for example, you can more quickly take measures to determine whether the root cause of the problem was a procedural issue or a quality issue with the batch of cleaner.

Beyond the Production Line

The benefits of automated tracking systems to your food safety program extend beyond the production line. They can also enhance decision-making, vendor management and communications functions.

When it comes to potential contamination, decision making needs to be both timely and based on the best information available. Automated systems can provide you with accurate information quickly to help you answer these and other key questions, so that the decision on what actions to take can be based on good information:

  • How widespread is the potential contamination?
  • Where is the product in the production and distribution chains?
  • Have we already exposed consumers?

These systems can put the answers to these questions in front of the appropriate decision makers early in the process. The technology can be configured to allow access to the data via a browser, so if those who make the final decisions are located elsewhere, they can see in real time the same information that you are seeing in the plant. This makes communication about potential contamination more effective and clear, since everyone can see the same thing at the same time, and it can eliminate the potential for miscommunication up the chain of command.

By identifying where bad lots entered your supply chain, automated track-and-trace can enhance supplier accountability. You can accurately see if you have vendors with recurring issues in the quality of the supplies they are providing.

Automated Inventory Tracking Technologies

An automated inventory tracking system depends on three components:

  • A physical component, such as a label or tag, which contains detailed information identifying the specific lot or item.
  • A database, where each discrete data item is stored.
  • A reporting interface that allows people to access and use the identification information. This is the programming code that performs searches, retrieves the data, and formats the information in a formatted report, which is then presented on the screen, saved to a file, or sent to a printer.

The most common physical components used by automated inventory tracking systems rely on barcode or RFID technology, or a combination of both. The choice of which technology to use to integrate into the inventory management database layer of the system depends on a number of factors, but both have been proven extremely accurate (some sources say up to 99%). What is more important than the choice of tracking tools is the quality of the data encoded in them.

The latest in tracking technology uses an engineered DNA marker, in the form of an edible spray. When applied to produce, this DNA marker can track the individual item (i.e., an apple, head of lettuce or onion), along the entire food supply chain, identifying where it was farmed, the date it was picked, and where it was processed.

Whatever form of technology you employ, ensuring that your data is complete and accurate and can be integrated into both your supply and distribution chain is critical to realizing the benefits of that system in supporting your food safety efforts.

The WDS Food Safety Team also contributed to this article.

Rod Wheeler, The Global Food Defense Institute

Are Food Companies Prepared for Intentional Contamination?

By Maria Fontanazza
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Rod Wheeler, The Global Food Defense Institute

Unfortunately, quite often we are reminded of the vulnerabilities throughout the food supply chain. The latest E. coli outbreak linked to Chipotle restaurants in Oregon and Washington once again has consumers and the food safety industry on edge about traceability and a company’s ability to quickly identify the source of a serious outbreak. According to the CDC’s most recent update, laboratory testing is ongoing to find the DNA fingerprint of the bacteria. Concerning as this may be, no deaths have been reported thus far, but 42 people have been reported ill and 14 have been hospitalized in Washington and Oregon. In the most recent statement released on Chipotle’s website, the company said it is “aggressively” taking steps to address the problem, including by conducting deep cleaning and sanitization of its restaurants as well as environmental testing in its restaurants, and replacing all food items in the establishments that it closed “out of an abundance of caution”.

What if this were a situation of intentional contamination? Would Chipotle or any other company in this type of scenario really be prepared? These questions were posed by Rod Wheeler, CEO of The Global Food Defense Institute during a recent conversation with Food Safety Tech about food defense, and food tampering and intentional adulteration. Wheeler and Bruce Lesniak, president of Lesniak & Associates, shared their views on the threats that the food industry is facing and why companies need to have a strong plan in place to prepare for an attack on the food supply.

During next week’s Food Safety Consortium conference, Rod Wheeler will moderate the Ask the Experts session, “Engaging Food Tampering Discussion Surrounding Food Defense” on Wednesday, November 18.  LEARN MOREFood Safety Tech: What challenges do you see companies facing in the area of food tampering and adulteration?

Rod Wheeler: Our food supply is wide open. It accounts for 13% of the overall U.S. GDP. One thing we know about terrorists is that they want to affect our financial markets. What’s the best way to do that? You attack the 13% GDP – and what infrastructure is that? It’s our wireless systems, airline systems, transportation systems, medical supply, or our food and agricultural supply. Those are the top areas in which we need to focus, and we have to make sure the food & agriculture supply remains safe and secure in the United States.

On 9/11 the world changed, and the challenge for us becomes, within all of our 18 infrastructures, but how have we changed? Do we continue to do business the same way we always have, even prior to 9/11? Over the past few years, we’ve seen a significant increase in terroristic activity around the world—from France to Syria to Yemen to Pakistan. Here in the United States, we have to be mindful of what is happening.

Rod Wheeler, The Global Food Defense Institute
Rod Wheeler, CEO of The Global Food Defense Institute

We’ve always had food safety programs: HACCP, HARPC, GFSI, SQF, etc.—those are good for unintentional contamination. But what happens if someone wants to intentionally place a deadly contaminant into a product?

In this country, on a daily basis we see contaminations occurring.  We were recently notified of a massive outbreak of E. coli that has occurred throughout the Chipotle system: 47 Chipotle stores have been closed. What does that mean? Is that just a food safety issue? What if that E. coli could have been intentionally grown in a test tube and placed into the food supply? Going forward, we have a duty and an obligation to look at these things, not just at face value but think about whether they are intentional events.  

FST: Where are the biggest holes within food defense plans?

Wheeler: With more than 15 years of visiting food processing facilities, agricultural farms, dairy farms, and dairy processing facilities, the biggest concern that resonates with me is the fact that the culture of security is not there. The culture of security is simply security awareness—not planning. People in food plants are being taught to be mindful not vigilant. The largest of food companies have well thought out and active safety and defense plans, and their employees are educated, trained and empowered. We find that this falls off sharply with the mid-sized and small manufacturers and suppliers.  All food providers must have a comprehensive and strategic security plan that is active and measureable.

For example, let’s say a contractor is walking though a food plant. You have worked in that plant for five years but have never seen this person before. Would you question that person about their credentials? Are people thinking about the things they can personally do to reduce or mitigate the risk… are they empowered?

Darin Detwiler of STOP Foodborne Ilness, PCA sentencing
“When Someone Dies, It’s Not Business as Usual”: Darin Detwiler of STOP Foodborne Illness discusses the impact of the PCA sentencing on the food industry. Watch the video

So, the question is “what do you do when/if”: This is one of the topics we will be discussing at the [Food Safety Consortium] conference. It’s interesting that when we present this scenario to the management of a food company, many answer back with a blank stare. We ask, do you shut down your facility? Do you notify your customers? Do you notify the national media? This question goes to the root of the company’s security culture and the strength of its strategic planning. Until we develop the necessary plans, processes and protocols to respond proactively, we will continue to remain vulnerable.  

FST: Do you think many food companies assume something catastrophic won’t happen to them?

Wheeler: I always ask why it is that we don’t anticipate these things in advance. People are complacent. “It’s not going to have happen here,” they say. “What terrorist would come to our small town and do this? We’re just a small mom and pop [business].”

Recently, I received a call from a 17-employee company in Tennessee. This particular company processes honey for 100 large box retail stores. I received a call from the CEO who said, “My client wants us to have one of those vulnerability things.” He was referencing the vulnerability assessment. He said, “I don’t know why they’d want us to have one of those. We’re a small company down here in Tennessee, why does my client think some terrorist would come here?” The fact is, attackers will find the weakest link to attack: The small honey company is not the target; they are the vessel by which the attackers get to the primary target, and in this case, the big box retailer. The big box retailer/supplier is the target and the simplest, most effective way to get to them is through the hundreds of small, low to no protection suppliers.

These are the issues we need to enlighten and educate companies about; we need to get them thinking differently, because this way of thinking is completely different. If you ask someone who’s been in this industry for years, they’ll say, we never had to worry about locking our doors, or use biometrics to gain access to certain areas. We never had to think about these things in the Food & Ag supply before.

During our front line training course, we place a significant amount of focus on the food plant blending areas and why it is the number one threat area for intentional/unintentional contamination of our food supply in the United States. The blending area is exposed to a number of vulnerabilities and once attacked, the tainted ingredients are spread among numerous products that once distributed, are not necessarily quickly traced once they are blended into the final product.

Bruce Lesniak: The consequences of such an emergency are multifaceted; they affect the consumer and their product confidence, the manufacturer through recall and the retailer through recall, brand damage and loss of consumer loyalty. Often, this ripple effect begins with the small supplier and works its way upstream to affect the entire process.

We are seeing this scenario unfold in real time with Chipotle—this is huge in the food industry. FDA has not been able to determine exactly where that genetic fingerprint has originated resulting in location closures, shaken consumer confidence and brand damage. –Rod Wheeler

FST: What will it take the industry to wake up to what could become a serious reality?

Wheeler: Unfortunately it’s probably going to take a major incident for people to wake up and smell the coffee. With that said, we firmly believe that it is critical to awaken the sleeping giants before something happens. We must increase the awareness and provide education to heighten the reality of what can potentially happen and promote proactive engagement of risk mitigation.

FST: In the context of FSMA, are companies prepared for the compliance stage?

Wheeler: Over the years, I’ve seen a number of companies begin to ramp up security at their facilities. But a number of them are doing it because they realize they need to comply with the food defense elements of FSMA; the larger companies are driving compliance and are requiring that their suppliers comply. But I think convincing companies about “Why” this is important, is the challenge. Often times companies will say, “we’re doing this training”, or “we’re doing this vulnerability assessment because it’s a requirement of FSMA.”

We feel that if being compliant is your “Why “reason, then you are spending time and money for the entirely wrong reason. You don’t do vulnerability assessment or training in food defense because you want to comply with the law. You do it because you want to protect your company and the consumer from the reality of what can happen and proactively work to avoid a threat.

Lesniak: We see the adoption trend take hold as it has traditionally, in three phases. First are the early adopters—they understand the importance of compliance for the right reasons and the need for food defense, Second are those who feel the urgency to comply due to a compelling issues (an incident or have been instructed to do so by larger suppliers in order to retain contracts), and third are those who will come kicking and screaming.

Wheeler: A lot of the requirements of FSMA were generated as a result of the PCA event in 2009. The prosecution and subsequent conviction of the Parnell brothers isn’t the last prosecution we’re going to see for someone violating a food safety protocol. This is the first, and it’s a wake up call.

Ryan Gooley, Mock Recalls

Practice, Practice, Practice. Why Mock Recalls Are So Important

By Maria Fontanazza
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Ryan Gooley, Mock Recalls

Being recall ready goes beyond checking off the boxes for meeting traceability requirements, qualification standards, or meeting auditing requirements for certifications. “It’s really a discussion that needs to happen from a business continuity standpoint within an organization so that should there be an issue, the team has actually talked through different strategies and ways of technically executing a recall within the organization,” says Ryan Gooley, recall consultant at Stericycle ExpertSolutions. During an interactive workshop at next week’s Food Safety Consortium conference, Gooley will lead attendees through recall scenarios and help them create a recall plan to address global needs, communications strategies, resource allocation, and business continuity requirements. Gooley recently sat down with Food Safety Tech to discuss the importance of mock recalls within the food industry.

Food Safety Tech: What are the most common mistakes food companies make in preparing (or not preparing) for a recall?

Ryan Gooley: One of the mistakes companies make is not having the discussion internally about a recall and whether they are ready and able to respond to and support a recall. Although it’s becoming less of an issue, people still don’t want to talk about recalls—they’re afraid if they talk about it, it will happen to them.

They also take their industry partners, whether supply chain partners or existing vendors, for granted.

Ryan Gooley is leading a session, The Multiplier Effect: How One Ingredient Can Lead to Multiple Recalls, at the 2016  Food Safety Consortium conference  on Thursday, December 8 | Learn More In addition, companies miss the amount of effort and resources it takes to properly support a recall once a communication goes out. This specifically relates to class I or class II recalls that go down to the consumer level and involve press releases and media exposure.

In any industry, your resources are geared toward producing product and getting it into the market; it’s not the reverse of managing take-backs and returns, and communicating to customers. A lot of it comes down to resource allocation.

FST: What are the most important elements of a recall plan in the food industry?

Gooley: Traceability is huge. Most companies have a pretty good understanding of traceability as it relates to where they receive ingredients, where the ingredients go within their processes, and ultimately where they are distributed. Traceability is important, because you can’t initiate a recall if you cannot identify where the suspect product went.

The other part of the recall plan is testing the plan. Going through your recall plan and testing it pulls together the different departments that are responsible for supporting the recall exercise and effort within the company. Having conversations about who is responsible for what, the information [that should be] pulled, and who needs that information is really important for building the team. [It ensures that] should a company need to initiate a recall, the team members who are engaged and responsible have actually talked through the process and practiced. With more practice comes more efficiency and less chance for error or oversights.

Another important element of a recall plan is understanding your communication plan and communication crisis management plan. A lot of people talk about recalls as just identifying the product and notifying downstream what to stop selling, etc., but a lot of what goes into the recall plan is business strategy—how are you going to manage not only retailer and customer calls, but consumer calls and media calls? Who is responsible for communicating what, when and where? Do you notify just your impacted customer or do you notify your non-impacted customers? What type of communication and messaging do you have? When companies have not done a mock recall exercise, oftentimes they have not had these conversations, and they really struggle on the communications piece, especially because it needs to be drafted, approved, and communicated in a very short period of time.

Integrated informatics and food labs

Using Data to Ensure Food Chain Security

By Maria Fontanazza
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Integrated informatics and food labs
Integrated informatics and food labs
Integrated informatics enable labs to execute and manage all lab processes easily, with the data rigor and intelligence that lab managers require to drive efficiency and profitability, for the lab and for the business. Image courtesy of Thermo Fisher Scientific. (Click to enlarge)

Moving forward, if food manufacturers, suppliers and distributors want to be ahead of the game, they’ll need to have the ability to view their product throughout the supply chain. During a discussion with Food Safety Tech, Trish Meek, director of product strategy at Thermo Fisher Scientific, explains the importance of product traceability in the food chain, from both a consumer and food producer’s perspective.

Food Safety Tech: In your recent article about Integrated Informatics, you cite it as an ideal solution to modernizing a highly distributed food chain. What are the challenges you see companies facing in managing their global supply chain?

Trish Meek: We’ve seen the issues related to intentional adulteration documented throughout the media, and they extend to traceability. For example, what Tesco experienced during the horsemeat scandal wasn’t necessarily intentional adulteration, but rather a matter of not understanding the supply chain. Horsemeat was introduced in France as legitimate meat and then it ended up in the UK. In this case, you have a lack of traceability and thus a lack of understanding of what has happened to your product in its lifecycle.

Trish Meek, Thermo Fisher Scientific
“With consumer demand for foods that are free of gluten, GMOs and antibiotics, it’s becoming more important to customers that they understand everything that has happened to the animal and the food source.” –Trish Meek

In this complex world of suppliers, distributors and food producers, having the ability to pull in analytical data and manage it regardless of the source (whether it’s from the initial ingredient supplier or the final manufacturer) is a critical piece in understanding the overall lifecycle picture. An integrated informatics solution provides a single source of truth for that information: From the technician operating the lab process to the lab manager who is overseeing to the integration into the enterprise-level system. It provides a complete view on everything that has happened to your data, while also enabling the management of regional specifications.

FST: What are the biggest concerns in the area of food chain security?

Meek: Traceability is key, and the common denominator is food chain security: Ensuring that you’re providing security and with an understanding of everything that happened to your product, which leads to quality assurance and brand security.

FST: What are the concerns related to food chain security?

Meek: There are a few concerns:

  1. Adulteration
  2. Correct label claims. For example, 30% of the populous is trying to avoid gluten. While 1% is truly allergic to it, there’s a lot of gluten intolerance. Take, for example, recent commercials from Cheerios saying they are ensuring traceability and can say with confidence that their product no longer comes into contact with wheat in any part of the process. There’s an understanding that consumers want to believe what’s on the label, from both a health and allergy perspective as well as a concern in the public around unhealthy ingredients added or antibiotics used. As a food producer, you want to make sure you can honestly state what has happened to the food and that what you’ve put on your label is true. People are willing to pay a premium, and so there’s a drive towards the premium of being able to claim no GMOs on a label or an organic product.
  3. From a food producer’s point of view, having traceability from all suppliers is key. They want to ensure that any raw materials have been handled and managed with all the same scrutiny and adherence to regulatory requirements as their own processes. With ingredients coming from all over the world, manufacturers are relying on multi-sourcing ingredients from places they don’t necessarily control, so they need to have the traceability before the ingredients appear in the final product.

Using an Integrated Informatics Platform

Trish Meek: Through an integrated informatics platform, users can manage the entire lab process and integrate it into the enterprise system. Having the ability to incorporate the lab data is critical to ensuring product safety, quality and traceability throughout the entire supply chain. Because the solution encompasses lab processes and required lab functionalities, it enables efficiency both in the laboratory as well as across the entire operation. The solution provides an opportunity not just to the top-tier food producers but also the regionally based middle-tier companies that want to set themselves up for future growth.

The reality of the regulations today is that you must look towards the future. Twenty years ago, we weren’t including information about what nuts were present in the labeling. Now there’s consumer awareness and a change in labeling. And five years from now, there could be a different allergy that needs to be documented in the labeling. Integrated informatics gives you the business agility to take on that next step of analysis and adapt to the marketplace.

Traceability in food manufacturing, Honeywell

Traceability Not a Trend. It’s a Reality.

By Maria Fontanazza
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Traceability in food manufacturing, Honeywell

Businesses throughout the food supply chain are using a variety of traceability tools to capture critical information during the path from the field to the consumer. Traceability has always been viewed as an important capability within the supply chain, but FSMA, coupled with retailer and consumer demand, is pushing it to the highest levels yet.

Technology solutions that provide continuous identification and verification include mobile computers, scanners, RFID and mobile printers. While growers, packers, wholesalers, distribution centers and retailers involved in the fresh produce, poultry, meat, and seafood segments are using these technologies, speculation continues about adequate adoption levels.

The larger food providers are embracing track and trace technologies, while smaller business have been much slower to adopt, according to Bruce Stubbs, director of industry marketing at Honeywell Sensing & Productivity Solutions. “It’s going to be difficult to convince the smaller growers to invest in the technology—a lot of them see it as a cost,” he says. “What’s helping is that the retailers are starting to push back and say they are going to require their suppliers to be compliant with [traceability] mandates and if not, they won’t do business with them.”

Out in the field, companies are leveraging scanning and printing technologies, including smart printing technology (essentially a PC with printing capability). The printer hosts data capture and traceability software, providing the tasks and traceability through the software to the scanning devices. It can capture and print the food traceability label, which contains the discreet information, at the point of harvest. At the transportation level, businesses are using mobile computers to scan and capture product information that tracks down to the details from what part of a field, or even which tree in an orchard, a product has been harvested. Traceability technologies are including sensors throughout the cold chain to monitor temperature and humidity as the product is transported from point A to B. All information moves forward into the production facility and the retailer’s distribution center. Once at the retail store level, grocers will be able to pinpoint, within potentially thousands of stores, the specific batches and lots, a key capability in the instance of product issues and recalls.

Traceability is a holistic process, and the potential for its continued growth within the food industry is high. “I see it becoming more prevalent as consumers demand it, and retailers and manufacturers must adapt. I also see them moving away from paper,” says Stubbs. “We’re close; it’s almost like there’s a trickle in the dam right now, but I really believe that over the next couple years, the dam will break and most [companies] will need to adopt [traceability solutions] or they won’t be able to effectively do business with a lot of the food retailers.”

Stubbs also anticipates an increased adoption of 2-D barcodes versus 1-D linear laser barcodes, as 2-D barcodes can contain far more information. “We are at the tip of those technologies—they exist. It’s just the integration of these systems and providing the information in a format at the supplier or food manufacturer level,” he says.

How is your company implementing traceability solutions? What challenges and benefits are occurring as a result?

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.

RFID tags on drying marijuana flowers

Marijuana Edibles: Update on a Rapidly Developing Market

By Aaron G. Biros
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RFID tags on drying marijuana flowers

A lot has changed since last year’s article, “Marijuana Edibles: A Regulatory Nightmare.” Marijuana has since catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry. According to an article from the Washington Post, Colorado’s legal marijuana industry reached $700 million in 2014 and is expected to grow to $1 billion by 2016.

Innovators are beginning to analyze trends on a national level, looking toward federal rescheduling of the drug as a catalyst for more state reforms and wider legalization measures. Federal legalization is in the back of many minds, as the introduction of pivotal state and federal legislative reforms promises more access to banking services, medical research, and more state independence.

While a black market mentality remains prevalent, widespread state reforms, increased venture capital investment, and further legitimization of an industry with less barriers of entry have fostered a perceived reduction in risk. States like Oregon, Washington, and Colorado that have already legalized marijuana for recreational and medical sales are beginning to implement strict packaging rules, requirements for traceability, QA programs, testing and laboratory monitoring requirements, and other regulations that would suggest FDA oversight down the road.

marijuana buds drying in racks biotrackthc
Dried marijuana buds curing with RFID tags as part of the traceability system of BiotrackTHC

State regulatory bodies such as the Colorado Marijuana Enforcement Division (MED) have matured and expanded their oversight to include certifications and requirements for lab testing and analysis. Marijuana testing facilities can now be certified by the MED to test for residual solvents, poisons or toxins, harmful chemicals, dangerous molds, mildew or filth, harmful microbials such as E. coli or Salmonella, pesticides, and THC levels and Cannabinoid potency.

According to an article from theCannabist.com, edible marijuana took 45% of the market share in 2014 and continues to grow, proving that food manufacturers and processors will gain a bigger share of the market.

BioTrackTHC develops a seed-to-sale traceability system that is the state-mandated reporting system used by any business that touches the plant in compliance with Washington’s i502 regulations (The company also won the contract bid for New Mexico’s and New York’s state-run traceability systems). “From day one, all retail products under i502, including infused edibles, must have laboratory-submitted passing test results and data in the traceability system before it can be unlocked for shipment to retailers,” says Patrick Vo, CEO of BioTrackTHC.

RFID tags on drying marijuana flowers
RFID tags on drying marijuana flowers, from BioTrackTHC

Regulations, especially those addressing traceability, are crucial for advancing the industry and fighting the black market, performing recalls, and improving product quality and safety. Vo adds, “As more states adopt a centralized traceability system, food safety will improve as we see the industry grow.”

“Most of the marijuana edibles producers we advise are working comfortably within their state health department regulations versus a year ago when they were struggling to implement routine compliance,” says Stephen Goldner, CEO of Regulatory Affairs Associates.  “But there is a long way to go to make this new marketplace meet the standards routinely met by US food producers in other markets such as nutritional supplements and medical foods.”

Many edible producers are sadly mistaken to ignore FDA labeling and production regulations just because the producer only ships within their own state, according to Goldner. “Whenever FDA has found label or food safety violations of products, whether they are food, drugs or any other product, it has always acted quickly to seize the product, inspect the producer and insist that violative labeling or production practices be remedied,” he says, adding that it won’t be surprising to see FDA start to “seize marijuana-infused food products that make drug claims, especially from the leading current producers” as a way for the agency to insert itself into the inspection and compliance process. “These companies need to have FDA food GMP’s solidly in place and properly documented,” says Goldner.

“Those who have experienced the most consistent and long term success in this industry are those who play above board, those who take the extra effort and make the investment in effort, time, and money to treat their business as if it was already federally legal and had to adhere to standards that other industries must follow,” says Vo. He agrees with the view held by many that long term planning is vital in this industry. “Those who have implemented best practices, QA programs, and traceability software will succeed in the long run, and the bad actors will eventually, by their own poor practices, be filtered out by regulatory and market forces.”

In the near future, the industry will look to other states in regulatory experiments on opposite sides of the spectrum. “New York, which legalized medical marijuana in 2014, is handing out 5 licenses to operate 4 dispensaries each, and allowing licensees to have a grow facility to supply their respective dispensaries. The Commissioner of the New York State Department of Health will have authority on licensing, testing, and medical requirements for patients seeking treatment with medical marijuana,” says R. David Marquez, who operates a Long Island law firm focusing on the cannabis industry.

New York is implementing very strict rules regarding cultivating and processing the plant. California, on the other side of the spectrum, already operates a somewhat loosely regulated medical marijuana market and has been doing so since 1996. The bill to legalize marijuana recreationally in the state is widely expected to pass vote and be implemented in 2016. This would open up an enormous market potential and contribute to the growth of the industry on a national level.

Because marijuana edibles are theoretically both a food and a drug, it is only appropriate that the FDA should look to regulate the industry in the future. In the meantime “Those who have invested the time and money in staying compliant now will be far ahead of the game tomorrow,” says Patrick Vo, who is looking toward federal legalization.

It seems that manufacturers and processors at the forefront of quality and safety testing will succeed in the long run.

Footnote: This is a regulatory update on the cannabis industry with an emphasis on edible marijuana. CannabisIndustryJournal.com, the newest publication, will be launched in September of this year. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!