Tag Archives: regulation

Steven Blonder, Much Law
FST Soapbox

Food Litigation Trends Lay the Foundation for an Industry-Defining 2021

By Steven Blonder
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Steven Blonder, Much Law

The year 2020 brought with it continued court filings within the food safety litigation space, and it should come as no surprise the pandemic presented its own set of unique challenges. We’ve seen disruptions to the food and beverage supply chain, noteworthy changes with recalls, and continued developments in litigation specific to product labeling. These challenges have impacted everyone involved in the industry and laid the groundwork for what’s to come in 2021.

The most notable impact the food industry has faced as a result of the pandemic has been the massive disruption of the food supply chain. Grocers and other retail food providers have seen an immense spike in demand, whereas foodservice locations, such as restaurants, universities, and hotels, have seen the exact opposite. This disruption to the supply chain has required regulatory agencies to take notice and implement temporary policies to support these businesses and consumers alike. Employees across the food industry supply chain, including agriculture and food processing, have further been classified as essential, leading federal agencies to issue guidance to these employers to help them assess COVID-19 control plans and protect their employee’s health. Further, safety concerns and bumps in unemployment compensation have imposed additional strains on worker retention and attendance.

Another interesting facet of the pandemic’s impact on the industry has been its influence in the product recall space. Believe it or not, companies have strayed from pulling their products off the shelf even if it subjects them to potential liability. Why is this? Because as mentioned earlier, the demand for food in the retail space has increased so much, it has become a necessary choice to avoid food shortages across the United States. Don’t worry, if a product possesses a health or safety threat, companies are still recalling those to protect consumers and address safety concerns, but voluntary non-health or safety related recalls may have become a thing of the past. For example, rather than recall a box of cereal or other dry good for not meeting a fill-line requirement, providers may elect to risk a false-advertising lawsuit to meet the recent shift in retail food demand.

Since 2012, there have been more than 200 class action lawsuits filed related to the labeling on food products. This past year, we observed a continuation of this trend. Class action lawsuits were filed addressing the authenticity of “all-natural” products or claims based on the “origin” of a product, while we witnessed a sharp decline in slack-fill lawsuits. Consumers are becoming increasingly aware of the ingredients in food products and are continuing to demand transparency from companies to disclose how their products are made. There has been a particular increase in claims related to the definition of vanilla—is it pure? Is it natural? The same goes for citric acid, a product that can be made naturally or synthetically. There has been continued debate within the industry about citric acid in its use within other products where some citric acid is naturally occurring either from citrus fruit, tomatoes or other fruits with citric acid. If all-natural citric acid is added into tomato paste to help with the taste, can the tomato paste still be classified as being all-natural, even if the use of citric acid is displayed on the label?

To help combat the discrepancies around all-natural products, the USDA is currently working on developing an official definition of “all-natural,” which upon its completion is anticipated to have a major impact on the labeling industry and the number of false-advertising class actions. This definitional development comes at a crucial time especially as plant-based protein continues to rise in popularity.

The next wave of claims are being filed related to plant-based protein products. These claims include trademark and First Amendment issues. For example, when is a burger, a burger? Everyone assumes a burger means a hamburger, traditionally deriving from beef, and there has been an increase in debate around when the sale of plant-based products infringe on the rights of ranchers selling traditional beef products. Can food created in a petri-dish claim the same title as products created through traditional harvesting methods? What about other genetically modified products? These issues will likely spawn additional litigation in the coming year.

Looking ahead towards 2021, we can fully anticipate cases addressing food labeling issues to continue. Historically many of these claims were filed in Northern California with one federal court there earning the moniker of the “Food Court”. Recent years have seen increased filings in New York and Illinois, but the coming year may see a decrease in cases filed in New York as a result of recent court decisions relating to pre-emption and a recent opinion of a federal appellate court disallowing the settlement of class claims on an injunction-only basis. California may also see changes in their total cases as food producers curtail product sales in California to avoid the ambit of Prop 65.1

2021 will continue to bear witness to the effects of the COVID-19 pandemic. The supply chain will continue to adjust to the varying demands of the public as they navigate safety regulations, and companies will maintain an “only-recall-if-absolutely-necessary” mindset. Many of the adjustments that businesses, consumers and regulators have had to make in light of the pandemic may also lead to long-term or permanent shifts. In fact, the Consumer Brands Association has identified a few select areas ready for change, such as the maintenance of flexibility in food labeling to ease the transfer process of products between foodservice and food retail providers. We just might find 2021 to be one of the most industry-defining years in the food safety litigation space.

Reference

  1. California Office of Environmental Health Hazard Assessment. (n.d.). Proposition 65. Accessed December 17, 2020. Retrieved from https://oehha.ca.gov/proposition-65
April Kates, EAS Consulting
Retail Food Safety Forum

Labeling Impact of FDA’s Nutrition Innovation Strategy

By April Kates
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April Kates, EAS Consulting

On March 29, 2018, FDA announced the Nutrition Innovation Strategy, which signaled their intention to take a fresh look at what can be done to “reduce the burden of chronic disease through improved public nutrition.” The agency wants to facilitate consumers making better food choices to improve their health. At the same time, FDA has acknowledged that in many cases, changes in food processing technology has rendered outdated certain provisions of the regulations once written to both inform and protect the public. Therefore, FDA has developed a plan to move ahead to update its policy toolkit.

This multi-pronged approach includes modernizing food labeling, including food standards, health claims policy, ingredient labeling requirements and continuing implementation of the updated nutrition facts label, menu labeling, and reducing sodium in processed food products.

In particular, in trying to gather information to help determine the best approach to revising food standards of identity, FDA held a public meeting on September 27, 2019. FDA is attempting to provide room in the regulations for industry to be able to use modern and hopefully more healthful manufacturing methods while at the same time retaining the traditional characteristics and nutritional value of standardized food products.

During the public meeting, consumer advocacy groups, food industry trade groups and medical associations expressed many points of view as to what FDA should do to make the more than 250 food standards of identity more applicable to the modern food supply. FDA also took comments on updating food ingredient labeling requirements, including simplifying terms for ingredients such as vitamins. Because each food standard of identity is a regulation, it will be no small effort for the agency to update, remove or add standards of identity as needed. This meeting was a way to get input to help guide their decisions and priority—making for food standards and ingredient labeling revisions.

Obviously, with such a broad-based effort, the revisions and changes will be incremental. But the thing to keep in mind is that it all points to an effort to improve public health through the food supply as well as an effort to impactfully modernize the regulations. What follows is a very brief summary of some of FDA’s recent actions in this regard.

On December 30, 2019, FDA announced the final guidance on Serving Sizes, Dual-Column Labeling, which provided additional information about when dual column labeling for nutrition is required and what exemptions are in place to provide relief for certain products or package sizes.

On December 27, 2019, FDA reopened the comment period on the use of ultrafiltered (UF) milk in certain cheeses. When the proposed rule for UF milk in cheeses originally published in 2005, FDA received many comments. Essentially, ultrafiltration was a means to enhance the speed of cheese production, and the standard of identity cheeses were written before this technology was common and did not permit this type of process. FDA seeks to modernize the cheese standards while keeping intact the nature of these cheeses, and so the agency is eager to learn about what can be done to accommodate the new technology without losing the essence of the standards that consumers have come to expect. Because of the time lapse since the previous comment period, FDA is seeking more information to inform their rulemaking.

On October 25, 2019, FDA released a final rule revising the type size for calorie declarations on front of pack labeling for glass-front vending machines. The 2014 rule establishing calorie labeling for products sold from vending machines had provisions that were difficult for certain products to meet. This new rule recognizes those challenges and was an attempt by the agency to provide a middle ground for the industry to meet the requirements of visible calorie labeling on small packages sold in vending machines.

On August 15, 2019, FDA announced final guidance on converting units of measure for Folate, Niacin, and Vitamins A, D and E on the nutrition and supplement facts labels. The guidance provides help to the industry in meeting the requirements of the revised nutrition facts label.

Regarding updating the “healthy” claim on food products, when this term was originally defined by the agency, saturated fat was the nutrient of focus for these claims. However, since then, there are new focuses on health, such as added sugar and calories. In September 2016, FDA sought to modernize the claim, and provided an interim policy to guide its use.

In May 2019, FDA published a draft guidance to provide enforcement discretion for the use of the term “potassium chloride salt” on ingredient statements. In addition, in April 2019, FDA provided a draft guidance for the calculation of calories from a newer sweetener, Allulose.

As you can see, there are a lot of moving parts to FDA’s effort. What will be the impact on the food industry? Changes will most likely be gradual. Over time, there will be modifications to food standards of identity, and potentially claims, and both of these will cause label revisions. And, typically, there may be enforcement discretion by FDA to allow the industry time to revise their products and /or labeling as needed.

You will see FDA requests for information from the public and the industry on various related topics to the Nutrition Innovation Strategy, and guidance documents will be updated.

Laura Nelson, Alchemy

Changing Consumer Preferences and Employee Compliance Training Driving Industry Evolution

By Maria Fontanazza
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Laura Nelson, Alchemy

The food industry is undergoing considerable change, especially as consumers become increasingly more vocal about their preferences and concerns, and as technology improvement and adoption plays a larger role in the conversation. In a recent Q&A with Food Safety Tech, Laura Dunn Nelson, vice president of food safety at Alchemy, shares her thoughts about current industry trends and how they are impacting food companies, where more help is needed, as well as ways in which companies can help advance food safety culture internally.

Food Safety Tech: The food industry is rapidly evolving. What are some of the trends you’re seeing and are these posing different challenges to food manufacturers?

Laura Dunn Nelson: The food industry is rapidly evolving in three key areas: Who produces our food, the variety of our food, and how consumers access our food.

As consumers continue to shift their food preferences toward an increase in healthy ingredients, locally sourced products, and clean labels, companies in turn continue to innovate and reformulate. Mergers and acquisitions continue as larger companies look to partner with niche companies that are focused on products marketed to the health-conscious consumer. Companies like Impossible Foods and Beyond Meat are expanding rapidly, reaching both vegans and meat eaters in the United States and expanding into international markets. Ever-changing consumer preferences create challenges for the industry to accelerate their research and development processes in order to remain competitive in the marketplace.

Changes in product formulas and increases in product lines create the need for new ingredient procurement, changes in production schedules, and new operating procedures. There has been a proliferation of start-up companies using CBD as an ingredient for food and beverages despite the lagging food safety regulations forcing some city and state regulators like New York City to create their own ban of CBD products. As the FDA explores future regulations, producers and consumers are left to determine the safety of these products.

Home delivery of food continues to be a hot trend as the market continues to grow for companies like UberEats, Grubhub, retailers and foodservice companies like Domino’s Pizza where you can Tweet your pizza order. The home delivery service area presents new considerations for food safety including monitoring appropriate product temperatures.

Finally, discussion around blockchain technology continues to gain prominence as companies work to develop transparency within their supply chain. For many companies, this will translate into a significant shift in technology adoption and a move away from disparate data sources and therefore an investment in not only the technology but in revising their procurement processes.

Laura Nelson, Alchemy
Laura Nelson is vice president of food safety at Alchemy and currently serves as the vice-chair of the Food Safety Culture Professional Development Group (PDG) for IAFP.

FST: What are the areas in which you feel companies need a bit more guidance?

Nelson: How we effectively train our employees to ensure learning and comprehension is paramount to our success in the future. IBM Institute for Business Value recently completed their study “The Enterprise Guide to Closing the Skills Gap,” and noted “120 million workers in the world’s biggest economies may need to be retrained as a result of artificial intelligence (AI) and automation in the workplace.” Reskilling will be the new norm as new technologies and automation of equipment disrupt the current state.

Deloitte noted that “reinventing the way people learn” was the number one trend in the 2019 Global Human Capital Trends Report. Many companies are focused almost exclusively on mandatory compliance training and conducting the training the same way they have for years. Typically, orientation food safety training is provided during the employee’s first week of work and annual refreshers are given every year. In the Global Food Safety Training Survey that Alchemy provides to the global industry with Campden BRI, we consistently find that 67% of responding QA managers report that employees do not follow their food safety programs, despite their food safety training. Unfortunately, the emphasis on food safety is often relegated to that one day a year of refresher training with little reinforcement the remaining 364 days of the year. The ‘noise’ of competing priorities of production and customer expectations often distracts employees from their food safety responsibilities.

Some companies still define training as classroom training when, in fact, employees are being trained each and every day by their supervisors and peers. Companies that put additional emphasis in not only their training but validation of training through observations of employees’ food safety behaviors achieve higher food safety compliance. The power of two-way conversations between the employee and the supervisor as a coach creates an environment of communication and trust.

Alchemy worked with independent researchers to determine the effect of active coaching with prescribed behavior feedback on the plant floor. The results were conclusive: every facility included in the study revealed a 38% improvement in aligned employee behaviors.

Ultimately, companies need to evaluate their current learning organization for effectiveness and focus on job competencies and their ongoing assessment of compliant employee behaviors.

FST: What maturity level are you seeing in the industry related to food safety culture and the related implementation of best practices?

Nelson: The food industry is still relatively new to the concept of a mature food safety culture, and even how to define that. The industry focus of this topic has largely been driven by efforts within the GFSI community, particularly with the publication of the position paper “A Culture of Food Safety.” Pioneers in food safety culture research, like Dr. Lone Jespersen, and emerging training assessment tools are working toward pushing these newer concepts to the mainstream of our industry.

As with many important constructs, the QA/QC team is typically tasked with introducing this concept to their organization, defining their company’s level of food safety culture maturity, and establishing a continuous improvement plan. This is a tough ask from individuals who typically have a technical education background with little experience in behavioral science. To address these challenges, there are a growing number of consultants, books, and resources to help define a company’s food safety culture maturity and establish improvement strategies.

To help frame the benefits of a mature culture, a recent publication by Lone Jespersen et al, “The Impact of Maturing Food Safety Culture and a Pathway to Economic Gain,” notes the value of a mature food safety culture in reducing the cost of poor quality and food safety risks. Research indicates that many companies are currently in mid-maturity of their food safety culture. Suggested best practices to help an organization mature their food safety culture include:

  1. Foster cross-company ownership of food safety.
  2. Move from compliance driven operations to risk reduction through continuous improvement.
  3. Improve engagement skills of technical staff.

The first step is an assessment to understand the company’s unique performance gaps, either through an internal review or an external assessment. Once the specific gaps are identified, companies can develop their food safety culture improvement plan and execute. It’s helpful to conduct a reassessment over time to ensure the established improvement strategies are successful.

The effort can be challenging but research confirms that a more mature food safety culture will deliver improved food safety performance of food safety behaviors, improved product quality, and a reduction in food safety risks.

Craig Powell, Natura Life ≠ Science
FST Soapbox

Standardization of the Cannabis Supply Chain Drives Product Safety and Consumer Trust

By Craig Powell
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Craig Powell, Natura Life ≠ Science

When it comes to mainstream consumer food brands, customers expect to receive the same product each time they buy it. That consistency brings consumers back to the same brands over and over again. Unfortunately, the same can’t be said about products sold in the cannabis industry. Consumers aren’t building long-term relationships with brands because consumers don’t have consistent product experiences and often take their business to other brands.

This inconsistency plaguing the cannabis industry can be attributed to an unreliable supply chain, which plays out in multiple ways.

First, cannabis companies are having difficulty meeting state regulations. This happens because the legal cannabis industry is still relatively young and there isn’t a substantial institutional knowledge about regulatory compliance, nor are there any standardized best practices in place. Regulation is expensive and requires human and financial capital that most cannabis companies don’t have in place. Complicating things further, regulations keep changing, making it more difficult for compliant businesses to keep up, even when they have the best intentions.

Second, testing of cannabis products has been complicated. Because cannabis isn’t federally legal, standardized testing guidelines have not been developed, leaving individual states in charge of dictating their own requirements and enforcement framework. There have been numerous reports in the past few years of labs in California either improperly reporting testing results, or worse, submitting fraudulent results.

Third, problems also arise on production end of the supply chain—not only with consistency, but also with consumer safety. According to an estimate from New Frontier Data, approximately 80% of sales are still conducted through the black market. Many growers are using banned pesticides in amounts way beyond recommended levels. In addition, as the recent vape issue has demonstrated, black market manufactured products are being adulterated with toxic substances that pose significant health hazards to consumers.

Given these consistency challenges, the standardization of the supply chain—especially compliance, testing and safety measures—should be a top priority for new cannabis brands. Luckily, many best practices and standardized procedures can be adopted from the food, agriculture and pharmaceutical industries, where companies have successfully developed protocols to ensure safe and reliable products.

In addition to standardization and best practices, cannabis companies should also utilize the following recent innovations in transaction technology to provide peace-of-mind to both new brands and consumers that cannabis products are tested and safe.

Modernized Retail POS systems. Common in other consumer packaged goods industries, such as food, wine, beverages and soft drinks, RFID tags can be used throughout the supply chain to track products from seed to sale. These tags, like the “chips” on credit cards, hold electronically stored information about a product that can be accessed to verify compliance and safety.

QR Codes. While QR codes are mostly used today as marketing gimmicks, they actually have potential to provide true value for curious customers. Batch-specific QR codes could be applied to cannabis products to show detailed information about when and where it was made, what strains of cannabis were used, and testing results. This technology could be used to increase transparency between companies and to consumers.

Data Informatics. A strong information technology infrastructure can be put in place to collect and store inventory and customer data. That data can then be run through algorithms, AI and machine learning systems to help cannabis brands make better decisions about how to optimize the production of their products and how to achieve better results on future batches.

Video Surveillance. Granted, this is a more ‘low-tech’ approach, but effective, nonetheless. Video cameras can go way beyond security purposes. Footage can be viewed and compared to collected data sets to gain a deeper understanding of product flows, personnel movement and logistics that might impact a company’s final product. Video can also be analyzed automatically using AI to provide important insight to help a company fine tune their business strategies.

Consumers want to know that the cannabis products they purchase are safe, compliant and tested. Consumers also have a right to know what they are buying and expect product consistency over time from companies they trust. Ensuring supply chain consistency is key to making this happen as the industry matures. An experienced and trusted supply chain partner can help companies across different cannabis sectors, ranging from medical to food, and ensure product safety and consumer trust today through standardization and consistency. Ultimately, cannabis businesses want to cultivate a culture of excitement, not fear or uncertainty, to help the market flourish and bring quality products to our customers.

Megan Nichols
FST Soapbox

Tips to Train Employees and Maintain FSMA Compliance

By Megan Ray Nichols
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Megan Nichols

Eight years ago, the government passed FSMA. As a manufacturer, training new and existing employees to remain compliant with legislation is paramount. The goal isn’t to make life harder for business owners—it’s to protect American consumers from unsafe food handling and transportation practices.

The following are five tips to help warehouse managers train employees while maintaining FSMA compliance.

Understand FSMA Final Rules

It’s essential for everyone in the facility, from the CEO to the newest hire, to understand the FSMA rules. According to current Good Manufacturing Practices (cGMP), everyone who works in manufacturing, processing or packaging of food is required to train in food hygiene and safety. Managers can offer training in one of two ways—through on the job experience or via an FSMA-accredited classroom curriculum.

For individuals with specialized jobs, such as quality auditors or preventative controls qualified individuals (PCQI), the training option that allows compliance with FSMA rules is an accredited curriculum.

Utilize Warehouse Management Systems

FSMA gives the FDA authority to issue mandatory recalls for any food products if deemed necessary. To meet FSMA standards, record keeping and lot tracking is a necessity. If a product type is linked to a disease outbreak, the FDA wants to know where each product in that lot is within 24 hours. Having the ability to track and trace 100% of the products ensures that the company is FSMA compliant.

A warehouse management system (WMS) can track products, but only if you train employees in its use. While the average employee won’t be responsible for tracing a production lot in the event of a recall, each worker needs to know how to enter data into the system correctly, and how to retrieve the information if necessary. Include training in your WMS to ensure compliance.

Warehouse management systems, when paired with IoT sensors, can prevent recalls and ensure compliance by monitoring temperature fluctuations in climate-controlled areas. According to the Department of Agriculture, frozen food stored at temperatures at or below -0.4° F is always safe. A comprehensive WMS can monitor the temperature inside a facility’s freezers and alert workers or management if there are dramatic fluctuations that may result in a recall.

Seek Out Alliances

Warehouse managers are not alone when it comes to creating a compliant workplace. The FDA has established and funded three alliances—Produce Safety, Food Safety Preventative Controls, and Sprout Safety—each with their own standardized curriculum designed to help those who fall under FSMA rules.These alliances work for the majority of those in the food production industry, though they may not work for everyone.

Seek out the applicable food safety alliance and see if their training curriculums apply to your facility. Even if they don’t fit directly, these alliances can give managers an excellent place to start creating their training curriculum.

Create a Culture of Compliance

FSMA isn’t designed to make life harder for warehouse managers. Its goal is to keep people safe when buying their weekly groceries. Don’t just focus on training to meet FSMA standards. Instead, create a culture of compliance throughout the facility. Make FSMA everyone’s responsibility, and make it easier for employees to communicate with management if they notice a problem that normal channels don’t address.

As part of this culture of compliance, create incentives that reward employees for reporting problems, maintaining compliance levels and completing accredited training. Sometimes incentives can be the best way to motivate employees, whether you’re offering money, paid vacation or other benefits. Walk employees through the process of how to spot a problem and report it to management.

Continue Education Throughout Employment

FSMA compliance training isn’t something you should restrict to an employee’s onboarding. It’s something you should continue throughout their time at your facility. Make FSMA education a priority for every worker in your facility. While you want to start their training with onboarding, it shouldn’t stop there. Offer new training courses once a month or every three months—as often as you’d like without compromising productivity.

As the day-to-day grind continues, most workers forget about rules and regulations. Continuing education ensures FSMA compliance is at the forefront of everyone’s mind throughout their careers. Continuing your employee’s education is also shown to increase loyalty and reduce turnover, keeping things running smoothly and preventing warehouse managers from training new workers every quarter.

Looking Forward

The FDA oversees food safety and can issue a recall when a problem occurs. Yes, as a whole, it’s the responsibility of every single person working in the food production industry—from the highest-paid CEO to the newest employee on the production floor—to maintain compliance. It’s not enough to review guidelines with new employees during onboarding.

Training is essential to ensure everyone in a facility maintains the rules laid down by FSMA. Seek out assistance in the form of the FDA-funded alliances, continue employee education and make it a point to create a culture of compliance from the moment employees walk through the door. Offer continuous training opportunities and you’ll never have to worry about breaking FSMA rules.

2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Say What? Perspectives We Heard at the 2019 Food Safety Consortium

By Maria Fontanazza
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2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Last week’s seventh annual Food Safety Consortium brought together a variety of industry experts to discuss key topics around regulation, compliance, leadership, testing, foodborne illness, food defense and more. The following are just a few sound bytes from what we heard at the event. (Click on any photo to enlarge)

Food Safety Consortium, Frank Yiannas, FDA “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency.” – Frank Yiannas, deputy commissioner for food policy & response, FDA. Read the full article on Yiannas’ keynote session

“A typical food company only has about 5% visibility into known supply chain threats.” – Ron Stakland, senior business development, FoodChain ID, Inc.

“For most of us, our supply chain is a big black hole. Why are we so fearful of technology? Is it the implementation itself? What if technology could help us solve some of those perennial problems? There are resources available to help us get there.” – ¬ Jeremy Schneider, business development director, food safety and quality assurance, Controlant

“The records tell the story of how well the facility is being managed. It’s the first thing the regulators are going to look at.” – Glenn Black, Ph.D., associate director for research, CFSAN, FDA, on validation considerations and regulations for processing technologies in the food industry 2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

“We’ll see more robotics enter the food space.” – Gina Nicholson Kramer, executive director, Savour Food Safety International

Melody Ge, Corvium, 2019 Food Safety Consortium “Changes are happening; you can choose to face it or ignore it. We’re at least 10 years behind on technology. Automation/technology is not a new term in aerospace, etc., but to us [the food industry], it is. We will get there.” – Melody Ge, head of compliance, Corvium, Inc., on how industry should prepare for the data-driven transformation occurring in the smarter era of food safety

It’s okay to risk and fail, but how are going to remediate that with your employee? The more learners practice in different scenarios, the less they rely on specific examples. [They] become more adept with dealing with decision making.” – Kathryn Birmingham, Ph.D., VP for research and development, ImEpik, on employee training

“As a contract lab with the vision of testing for foodborne viruses for about 10 years—it wasn’t until about three or four years ago that we had the test kits to turn that into a reality. We also didn’t have a reference method.” – Erin Crowley, chief scientific officer, Q Laboratories, on the viral landscape of testing in the food industry

“You have to be strong and you have to believe in yourself before you get into any situation—especially as a food safety professional.” – Al Baroudi, Ph.D., vice president of quality assurance and food safety at The Cheesecake Factory, on what it takes to earn respect as a food safety professional Jorge Hernandez, Al Baroudi, Ph.D., 2019 Food Safety Consortium

“’See something, say something’ is likely not enough. We recommend that companies develop a formal detection program that includes management buy-in, HR and governance, and policy documents, formal training and an awareness program…While FDA focuses on the insider threat, we feel that using a broader mitigation approach works best.” – R. Spencer Lane, senior security advisor, Business Protection Specialists, Inc. on lessons learned from food defense intentional adulteration vulnerability assessments

“Food safety is a profession, a vocation, [and] a way of life.” – Bob Pudlock, president of Gulf Stream Search

Cannabis, gavel

CBD Marketplace: How Should We Navigate It?

By Richard Blau
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Cannabis, gavel

Retired NFL player Rob Gronkowski, formerly of the New England Patriots, recently signed a deal with Abacus Health Products in Woonsocket, Rhode Island that includes buying a stake in the company and agreeing to promote its products. His decision reflects his belief that cannabidiol or “CBD” products made by the company under the brand CBDMEDIC can help others manage pain the way it has helped him.

Former world champion boxer Mike Tyson is developing a cannabis farm called “Cannabis Resort” for smokers and growers on his 40-acre land in California City. His company Tyson Holistic Holdings also owns Tyson Ranch, his own cannabis strain company and recently launched his CBD brand named CopperGel, which includes roll-on relief items.

Lifestyle maven Martha Stewart has entered into a deal with cannabis and CBD company Canopy Growth to be an adviser to the company. Her role will be to help it develop a new line of CBD-based products for both humans and animals.

Learn more about the direction of the cannabis industry at the 2019 Cannabis Quality Conference & Expo, which is co-located with the Food Safety Consortium Conference & Expo | October 1–3, 2019 | Schaumburg, IL The involvement of these and other celebrities in the emerging CBD industry signals an escalation in the evolution of cannabis as a legal consumer product. CBD products are sold today not only through licensed dispensaries and pharmacies, but also in specialty cafes, smoke shops, grocery stores and general retailers. This reflects the degree to which cannabis has become increasingly integrated into mainstream society.

Thirty-three states and the District of Columbia have legalized medical cannabis products, and 11 states plus D.C. have legalized cannabis for recreational use by adults. Affecting industries as diverse as cosmetics, food and beverage and pharmaceuticals, the exponentially expanding CBD market has generated analyses forecasting that the collective market for CBD sales in the United States will surpass $15–20 billion by 2025, according to the firms BDS Analytics, Arcview Market Research and Cowen & Co.

Cannabis, gavel
Legal Recreational Use of Cannabis: Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington, plus the District of Columbia
Illinois became the second most-populous state (after California) to legalize recreational marijuana in June
Vermont was the first state to legalize marijuana for recreational use through the legislative process. The state law allows for adults age 21 and over to grow and possess small amounts of cannabis. The sale of nonmedical cannabis is not allowed.

Yet, many government officials at the state and local levels, as well as industry members and consumers, justifiably question whether CBD products are legal. For example, in January 2019, New York City’s health department started prohibiting restaurants from adding any CBD supplement to food or drink, saying CBD was not approved by the federal government as a safe ingredient for human consumption. “The Health Department takes seriously its responsibility to protect New Yorkers’ health,” a spokeswoman said in a February 2019 email to media outlet CNBC. “Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.”

Is CBD legal in America? The answer is: “It’s complicated.”

The Details Behind CBD, Legalization and Marketing

CBD is the acronym for cannabidiol, a chemical compound found in cannabis plants—both hemp and marijuana. Unlike the chemical compound tetrahydrocannabinol (THC), which also is found in those plants, CBD does not induce a “high.”

The main difference between marijuana and hemp is the amount of THC in the plants. If the cannabis plant contains more than 0.3% of THC, federal law defines the plant as “marijuana.” Hemp is a cannabis plant with less than 0.3% of THC. While CBD produced from hemp often is sold as an oil, it actually is a chemical compound.

The Agricultural Improvement Act of 2018 (commonly known as the “2018 Farm Bill”) removed industrial hemp and hemp-derived CBD from Schedule 1 of the Controlled Substances Act. Thus, by legalizing the production of hemp, the 2018 Farm Bill removed hemp and hemp seeds from the schedule of Controlled Substances maintained by the federal Drug Enforcement Administration (DEA). That change effectively legalized hemp-derived CBD, which contains only trace amounts of THC, subject to federal agency health and safety regulations that govern all foods, beverages, supplements and other consumer products marketed in the United States. The new law also allows for increased research and product development of CBD extracted from hemp.

Not waiting for the regulators or scientists, enthusiastic entrepreneurs have produced extraordinary growth in the creation of markets for hemp CBD oil tinctures, topical creams, edibles, pet oil tinctures, vaping-liquids and a host of other consumer products purportedly containing CBD. The increase in CBD-related medical research, as well as the decreasing stigma surrounding CBD, has led to an industry boom, enticing celebrities and generating mass market growth for CBD products and sales.

According to predictive analysis and market research company Brightfield Group, $620 million worth of CBD products were sold last year in the United States. The same research team is projecting year-over-year CBD product sales growth in the United States of 706% in 2019 to reach approximately $5 billion, and sales of $23.7 billion by 2023.

Similarly, cannabis industry research firm BDS Analytics is predicting a compound annual growth rate of 49% by 2024 for all cannabis products across all distribution channels. The industry researchers also project that the CBD market, combined with other cannabis products, will create a total U.S. market of $45 billion for cannabinoids by 2024.

Another data group, New York-based Nielsen, estimates total sales of all legalized cannabis, which includes CBD products, reached $8 billion in the United States in 2018. According to Nielsen, U.S. cannabis sales should reach $41 billion by 2025, with marijuana products accounting for $35 billion, presuming 75% of the U.S. adult population has consistent access to legal marijuana by 2025.

In this context, there was only limited surprise in the marketplace when U.S. cannabis retailer Curaleaf Holdings Inc. disclosed in March 2019 that big-box retailer CVS Health Corp. will carry its line of CBD products. CVS, which is the largest drugstore chain by total sales in the United States, already has started to sell CBD products in eight states, including creams, sprays, roll-ons, lotions and salves.

Follow the link below to access page 2 of the article, which covers Regulatory Oversight and Emerging Enforcement.

Pages: 1 2
2018

The Future of Food Safety: A Year in Review

By Mahni Ghorashi
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2018

We started this Q&A series earlier this year with a clear vision—to gather the success stories, best practices, hurdles and achievements from the best in our industry. Our hope is that as the series expands and evolves, food safety professionals everywhere will be informed and inspired by what the future holds.

Over the course of the year, I had the pleasure of interviewing three such experts: Bob Baker, corporate food safety science and capability director at Mars, Inc, Frank Yiannas, vice president of food safety at Walmart, and Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill.

I encourage you to read the interviews for their unique perspectives, but here are a few of the biggest insights that we can all take with us into 2019.

The Continued Rise of New Technologies

Mike Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace.

Frank Yiannas: The emergence of blockchain technology has also enabled food system stakeholders to imagine being able to have full end-to-end traceability at the speed of thought. The ongoing U.S.-wide romaine lettuce E.coli outbreak showed us, once again, that our traditional paper-based food tracking system is no longer adequate for the 21st century. An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.

Blockchain has the potential to shine a light on all actors in the food system. This enhanced transparency will result in greater accountability, and greater accountability will cause the food system to self-regulate and comply with the safe and sustainable practices that we all desire.

The Most Exciting Shifts

Baker: What’s encouraging is we’re seeing is a willingness to share information. At Mars we often bring together world experts from across the globe to focus on food safety challenges. We continue to see great levels of knowledge sharing and collaboration.

There are also new tools and new technologies being developed and applied. Something we’re excited about is a trial of portable ‘in-field’ DNA sequencing technology on one of our production lines in China. This is an approach that could, with automated sampling, reduce test times.

Yiannas: While there is no doubt that there are numerous new and emerging challenges in food safety, the many advancements being made should give us hope that we can create a safer, more efficient and sustainable food system.

There is progress being made on many fronts: Whole genome sequencing is becoming more accessible; new tools are being developed for fraud detection; and FSMA is introducing stringent public-health surveillance measures that have dramatic implications for U.S. retailers and suppliers and our import partners.

Most importantly, consumers are now overwhelmingly interested in transparency. People today are further removed from how food is grown, produced and transported than at any other time in human history. Plus, they increasingly mistrust food and food companies due to the food outbreaks and scares we have faced in recent years.

Recalls and the Role of Regulation

Robach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Baker: At Mars, quality is our first principle and we take it seriously—if we believe that a recall needs to be made in order to ensure the safety of our consumers, then we will do it. We also share lessons from recalls across our business to ensure that we learn from every experience.

Unfortunately, there does not seem to be a safe place for businesses to share such insights with each other. So although we are seeing more collaboration in the field of food safety generally, critical knowledge and experience from recalls is not being shared more broadly, which may be having an impact.

Looking Ahead

Baker: The food safety challenges facing us all are complex and evolving. Water and environmental contaminants are areas that industry and regulators are also looking at, but all of these challenges will take time to address. It’s about capturing and ensuring visibility to the right insights and prioritizing key challenges that we can tackle together through collaboration and knowledge sharing.

…

We’re looking forward to continuing our quest in the new year and already have a few exciting experts lined up. Stay tuned!

Randy Fields, Repositrak
FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
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Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

AJ McCardell, Food safety technology
In the Food Lab

New Food Safety Technology Addresses FSMA Rules

By AJ McCardell
1 Comment
AJ McCardell, Food safety technology

In ongoing efforts to eliminate foodborne illness, the FDA recently issued the next step in rules designed for the enforcement of FSMA. The rules are aimed at modernizing food manufacturing processes after a wave of deadly outbreaks in the past decade stemming from contaminated cantaloupes, apples, spinach, lettuce, peanut butter, ice cream, cucumbers and other products. The rules require companies to draw up and implement written plans for keeping food safe. An important part of any food safety plan is the implementation of methods to verify that the controls put in place are working.

The food industry faces many challenges in meeting these new regulations. Two significant technical challenges for control verification are that the testing process takes too long and the sampling plans are often inadequate.

The pathogen testing process for all commercially available diagnostic tests requires an upfront culture or growth step to allow any pathogens present to multiply to a level that they can be detected by the test in use. This growth step, referred to by microbiologists as enrichment, is especially challenging in heavily processed foods and environmental samples, because the bacteria present in the sample have been stressed and are not in a rapid growth phase at the time of sampling. Advances in diagnostic sensitivity and robustness have reduced the amount of time required for enrichment from three or more days with traditional methods to about 24 hours on average with rapid methods. Even with rapidly growing and low-stress organisms such as E. coli O157:H7, enrichments take more than eight hours before implementing the diagnostic. The time required for this growth step creates a bottleneck in the production and distribution process. Although diagnostic companies are continuously improving the sensitivity of their methods and new methods are constantly being developed, there are practical limitations that have thus far prevented the elimination of the upfront culture step prior to testing. Historically, improvements in the sensitivity of rapid food pathogen diagnostics have been traded for time. In other words, having a more sensitive test means that fewer bacteria are needed for detection and therefore, less time is needed for bacteria to divide during the enrichment step.  Some commercially available assays require as few as 1,000 to 10,000 target cells in the sample for detection. Since the purpose of the enrichment step is to increase the number of target pathogens in the sample to a detectable limit and bacteria reproduce by cell division, further diagnostic sensitivity improvements would need to be greater than ten-fold to have a significant impact on further reducing enrichment times.

Unreliable sampling methods are an even bigger issue for industry. An example demonstrating current practice is a field of 40,000 heads of lettuce with four (.01% of the total) heads of lettuce contaminated by a pathogen. The current best practice is to go into the field and collect 60 (.15% of the total) leaves from the heads of lettuce, mash them together and test them for contamination. The probability of this sampling method finding the four contaminated heads of lettuce in the sample is much less than 1%. When the undiscovered four heads of lettuce are washed with the other 39,996 heads of lettuce, cross contamination occurs and people get sick.

Technology advances that reduce or eliminate the requirement for enrichment and make the sampling process more reliable could have a big impact on improving control verification testing. But, those advances need to be delivered in a practical and affordable manner. I recently learned about a technology that has great potential to make improvements on both of these fronts, especially for the produce industry and any process that is able to use a wash step as a control point. The recently patented OmniFresh sampling system (developed by OmniFresh, LLC) concentrates a sample from the food processing wash water, allowing immediate testing representative of the food being processed. The concentration process is performed during the entire washing cycle for a lot and is consequently representative of the entire lot.

Concentration technology has been used for many years by academic researchers and scientists to collect samples for biological testing.  Ultrafiltration methods for concentrating samples have typically used smaller sample sizes in the 1-10 liter range.  The OmniFresh system allows for very large samples to be concentrated, typical volumes of 400 liters are concentrated to 50 ml.

The concentration process takes about one hour to complete after the first wash cycle.  During processing, a side stream of water from the first wash tank is diverted to the concentrator unit. Tens to hundreds of gallons of wash water, depending on the size of the wash tank and the type and amount of produce being washed, flows into the concentrator. Throughout the sample collection period, large particulates are removed through a course filtration. Using ultra-filtration, bacteria and other small particles are isolated from the large volume of wash water into a much smaller, concentrated final sample. This concentrated sample can then be tested directly by a diagnostic test, eliminating the need for enrichment.1

OmniFresh System with diagnostic platform
The OmniFresh System with diagnostic platform installed at a processing facility. (Click to enlarge)

The wash water in the tank comes into contact with all of the produce being washed, the majority of bacteria is removed from the produce, and it then enters the wash water.2-4 This process, combined with the continuous sampling of wash water, means that low levels of intermittent contamination can be detected without testing high numbers of samples. Field testing of the OmniFresh System has returned promising results. The ability to rapidly screen produce for contamination could also provide a practical lot definition instead of cumbersome field-based definitions that can impact multiple processors.

Improvements in sample preparation and sampling technologies have much to offer the industry. Improved sampling methods which are representative of entire lots identify contaminated food earlier and with high confidence.  Additionally, the negative test result is of much higher quality and will result in an increase in the overall confidence of the food supply.

The OmniFresh technology is one example of the type of improvements that are needed. More research that focuses on these most challenging aspects of control verification testing is needed.

References

  1. Dyer, M.A. (2009). “New biosensors for food safety screening solutions.”  SPIE.
  2. Beuchat, L. R., and Ryu, J.-H. (1997). “Produce Processing Practices,” Emerg. Infect. Dis 3 (4), 459-465.
  3. Sapers, G. M, (2001). “Efficacy of washing and sanitizing methods for disinfection of fresh fruit and vegetable products,” Food Technol. Biotechnol. 39 (4), 305-311.
  4. U.S. Food and Drug Administration. (1998). “Water: Control of Potential Hazards: Wash Water.” Chap. II.B.2.3 in Guide to minimize microbial food safety hazards for fresh fruits and vegetables, by US FDA.