One in five U.S. households adopted a pet during the COVID-19 pandemic, according to the most recent statistics from the American Society for the Prevention of Cruelty to Animals, highlighting the importance of safe food for dogs and cats as they become part of the family for companionship, protection, and comfort.

People increasingly want a balanced diet derived from safe, high quality ingredients for both their pets and human family members, and both types of foods are regulated by FDA. But, there are some key differences that make food quality and safety for pet food challenging says Austin Therrell, PhD, executive director of the Association of American Feed Control Officials (AAFCO), a Champaign, Ill.-based nonprofit that guides state, federal, and international feed regulators with ingredient definitions, labels, and laboratory standards, adding, “Complete and balanced pet food is comparable to baby formula for humans in many ways [in that] in most cases our pets rely on the same source of food every day to meet all their nutritional needs.”

He says that any nutrient imbalances in pet food can potentially cause deficiencies or toxicities that are food safety challenges. Therefore, he says, it’s important for regulators to ensure that ingredients used in commercial pet foods have gone through the appropriate reviews to confirm that they are safe for their intended use and diet because animals have different needs at different ages.

The nutritional needs of dogs and cats also differ. “With pets mainly eating one brand of pet food that is complete and balanced, it is essential [that] all the nutrition they require for their species and life state is maintained in the product in every single batch,” he says. “There have been several instances of recalls related to nutritional toxicities or deficiencies.”

At the federal level, section 210(f) of the Federal Food, Drug, and Cosmetic Act defines food as articles intended for food or drink for man and other animals. There are similar definitions in title 21 of the Code of Federal Regulations parts 117 and 507. Dr. Therrell says that, while regulations for food for humans and for other animals are closely related, there are some big differences in nutritional and labeling requirements due to the number of different types of animals.

Cross Contamination, Other Risks

Another safety risk is potential sickness, because more pets are living in homes and acting as part of the family, even sleeping with their owners. People may feed their pets at the same time they are preparing their own food, increasing the risk of cross contamination between the foods. Their close proximity as family members puts humans and their animals at risk if the pet food is contaminated, Dr. Therrell says.

If pet food were contaminated with a zoonotic pathogen such as Salmonella, humans handling the food or those who are exposed to pets that consumed it could get sick even if the pet is not showing symptoms of salmonellosis, he adds, noting that children are particularly at risk. “Regulators have to account for more transmission pathways of any contaminants or adulterants in pet food,” Dr. Therrell says. “The pet food industry has to consider many of the same risks that the human food industry does, if not more, because of the diversity of the animals consuming the products and the humans handling the products.”

Another difference between animal and human food is regulations for allergens, which do not apply to pet food. Food ingredients rarely cause allergic reactions in pets, says Marissa Herchler Cohen, PhD, area specialized agent for animal food safety at North Carolina State University in Raleigh, N.C. Allergens are also not typically a consideration in assessing exotic ingredients. They have to go through the same approval process at the FDA level with a food additive petition, be generally regarded as safe, or go through the AAFCO definition process, each of which shows the ingredient is proven to be safe for its intended use, she adds.

Imported ingredients are addressed through FSMA both in pet and human food using the Foreign Supplier Verification Program (FSVP). For countries with less stringent food safety rules than the United States, importers must evaluate their food safety system and ensure that it meets FSMA specifications. Imported ingredients from countries whose food safety systems are considered equal to or better than that in the U.S. require FSVP approval. Ways to comply with FSVP requirements include on-site audits of supplier facilities, documentation reviews, or product ingredient testing, depending on the nature of the facility, Dr. Cohen says.

Day to day, pet food producers must address different challenges depending on the type of food they are producing. Raw pet food manufacturers need to closely monitor temperature changes within their production to ensure that products do not thaw enough to create an environment where pathogens can thrive, she adds. Producers also must be careful about sourcing and storing ingredients to minimize the presence of pathogens.

Since the raw pet food industry has no kill step, there is potential for pathogens growth, Dr. Cohen says. Some raw food pet manufacturers are using methods such as high-pressure processing, a non-cooking method for destroying microorganisms that maintains the raw product. Consumers need to be made aware of the potential risks with feeding these diets and understand how to handle them safely, she adds.

States’ Roles in Labeling

Regulations for labeling pet food can be inconsistent from state to state, which is challenging for producers that ship their products to different states; they must meet the labeling requirements in each state in which their product sells. FSMA federal regulations for pet food remain the same regardless of the state where the manufacturing occurs.

Each state can adopt all, some, or none of the AAFCO recommendations for labeling. There are some rules, however, that dictate what can and cannot appear on a label. Misleading information or claims cannot appear on a label—for example, “human grade” or “human quality”—nor can drug claims that a food or ingredient has a medical benefit. “The terms ‘human grade’ or ‘human quality’ only refer to products that are ready to eat and produced under the Current Good Manufacturing Practice regulations enforced by the FDA,” says Dr. Cohen. They don’t apply to raw pet food, she adds, because it generally is not ready to eat. Also, once a pet food is mixed with an ingredient that is not considered edible by humans, the end product cannot be considered “human grade,” she says.

Dr. Therrell says there is a need for additional state feed laws. Some states accept the use of ingredients tentatively approved by AAFCO, while others require them to be “officially approved.” Other states accept ingredients that are “self-affirmed GRAS” because they have qualified staff to review data.

PURR Act Aims to Streamline Regulations

Congress introduced a new act to streamline the federal regulatory process for pet food on February 15, 2024. H.R. 7380, the Pet Food Uniform Regulatory Reform Act of 2024, or PURR Act, has been widely supported by pet food manufacturers and the industry group, the Pet Food Institute, in Washington, D.C. 

The act would prohibit state governments from directly or indirectly establishing or enforcing any authority on the marketing or labeling of pet food. It would place label and ingredient approvals in FDA hands. State agriculture departments still would oversee quality inspections and product registrations.

“We are supporting federal legislation that would replace the current inefficient patchwork approach between states and the federal government with consistent national standards that are predictable, clearly defined, and encourage innovation and speed to market,” Dana Brooks, president of the Pet Food Institute (PFI), said in a statement.

Pet food makers produce nearly 10 million tons of food annually, and outdated regulations have made it difficult for pet food manufacturers nationwide to invest in research and development for new and improved products, said Rep. Jake LaTurner (R-Kansas), in a statement in February 2024 when PFI announced its support of the legislation. Rep. LaTurner, along with Henry Cuellar (D-Texas), Sharice Davids (D-Kansas), Josh Harder (D-Calif.), and Steve Womack (R-Ark.), sponsored the bipartisan legislation.

AAFCO, however, has concerns about the current version of the legislation, saying it could have negative impacts on consumer protection and reduce pet food label transparency. “State feed programs are the first line of defense protecting consumers from misleading or mislabeled pet food products,” Dr. Therrell says. State regulators proactively inspect pet food labeling before products hit the market, he says, and ensure that marketing claims on the label are accurate and have scientific data to validate them. “Under the new PURR Act, this important layer of consumer protection would completely go away,” he adds.

He says there are ways to improve efficiency and bring more innovation to the market, but it needs to be done in a safe and transparent manner and requires states to remain involved.

The PURR Act also could impact more than dog and cat food producers, Dr. Cohen says. Because it is specific to food for those animals, the legislation could increase the regulatory burden for producers who make dog and cat food, as well as livestock feed or pet foods for rabbits, rodents, and other small animals. Those manufacturers would have to comply with different regulations, as would ingredient processors and suppliers to both the dog and cat food industries, as well as to producers of food for other animals.

“Though having uniform expectations for labeling and expedited ingredient approval is helpful to the industry as a whole, I think there are some unintended consequences that should be considered,” Dr. Cohen says. “There may be room for compromise.”

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The food and beverage landscape is rapidly evolving, driven by shifting consumer preferences, emerging market opportunities, and changing trends. Food and beverage manufacturers in the U.S. and worldwide face a host of pressures that demand a fresh approach to stay competitive.

New product development (NPD) and reformulation are pivotal in keeping these companies at the forefront of the food industry; however, the journey from concept to consumer is complex, marked by a failure rate ranging from 30% to 40%, according to a 2022 report published in the Journal of Marketing and Consumer Behaviour in Emerging Markets. (doi: 10.7172/2449-6634.jmcbem.2022.1.4) To launch to market quickly, companies must rapidly translate consumer insights into innovative products, source safe ingredients, and navigate the commercialization process while avoiding compliance issues that erode consumer trust.

Embedding compliance insights throughout the product development process can not only enhance innovation but also increases speed, collaboration, data utilization, productivity, and resilience. Additionally, taking a proactive approach to compliance can lead to stable and future-proof products that are capable of meeting ever-evolving regulations and customer requirements.

Navigating Product Development Challenges

Guarding against safety and compliance risks is critical for food and beverage brands, and the stakes are high; compliance issues can erode consumer trust and result in substantial costs, both as an immediate financial impact and for a brand’s reputation. The average cost of a product recall, including notification, product retrieval, storage, replacement, and destruction, can reach up to $10 million, while larger recalls can exceed $100 million.

The complexities of the global market have further amplified these risks. As supply chains expand and become more interconnected across borders, the integrity and transparency of these networks are tested. Natural disasters, geopolitical events, cyberattacks, and other disruptions are increasingly commonplace, with 56% of companies worldwide suffering some form of supply chain disruption each year, according to a 2022 report published in the Annals of Operations Research (doi: 0.1007/s10479-020-03912-1). Risks now cascade worldwide through supply networks, emphasizing the need for agility and resilience in product development, procurement, and compliance.

In this pressurized environment, the U.S. food and beverage industry is experiencing a surge in workload. This increase is straining processes and tools that were once effective. To adapt to this new landscape, innovative solutions are required to handle the heightened volume and complexity while providing superior quality, efficiency, and insights.

The Power of Regulatory Insight

Regulatory insight is the key to navigating this challenging terrain. In the current product development model, organizational silos often hinder efficient innovation. Compliance is viewed as an obstacle rather than an enabler, while manual processes slow down data sharing and impede productivity. Outdated systems are ill equipped to handle the ever-increasing complexity of requirements.

In addition, legacy workflows can also struggle to support the industry’s evolving needs. Rigid hand-off sequences between functions create bottlenecks that prolong development cycles, increase risk exposure, delay product launches, and affect revenue generation. Meanwhile, the late-stage discovery of compliance issues frequently leads to expensive modifications that eat into profit margins.

Compliant Design

To address these challenges, the food and beverage industry is turning to an approach called compliant design, which involves proactively embedding compliance checks and data-driven insights into the product development process—from the concept stage onward. Compliant design not only accelerates innovation but also reduces risk and improves opportunities for collaboration, leading to more stable and future-proof products.

By understanding today’s key regulations and anticipating those of tomorrow, brands can begin to think in the longer term, avoiding decisions that could lead to product reformulation shortly after launch. Improved tools and enhanced compliance visibility empower teams to make decisions that satisfy initial requirements, while also ensuring the ease of future compliance and increased sales through additional claims that enhance market opportunities.

For example, when choosing flavorings or colorings, manufacturers can simulate product scenarios to ensure that compliance is met in multiple markets. This strategy guarantees informed choices that maximize resources and opportunities. Plus, it prevents costly late-stage redesigns that occur when compliance issues are discovered at the last minute, and fosters faster, more resilient innovation cycles that are driven by real-time data.

Shift Left to Achieve Efficiency

Inspired by the world of software development, shifting left moves testing and QC processes to a point earlier in the development cycle so that manufacturers can tackle unforeseen issues before it is too late or added costs occur.

Considering compliance during design stages also offers several organizational advantages, including reduced time to market through faster, informed decision-making that reduces costly holdups that can occur when regulatory input is provided later in the process. Additionally, by empowering non-regulatory stakeholders to access compliance insights independently, organizations can reduce issues with prototypes while minimizing back-and-forth communication during the process.

A shift-left approach also enables product developers to take multiple market formulations into consideration by including potential additional markets’ regulatory requirements from the outset. This subsequently improves second-round innovation speed by ensuring the early selection of appropriate ingredients and suppliers. The early identification of potential ingredient risks can help mitigate issues involving safety, quality, or scarcity caused by factors such as supplier quality, geopolitical conditions, or climate. Insights into changes in consumer trends and the regulatory landscape can also help prevent unnecessary reformulations.

Improve Collaboration

Compliance in design helps to break down organizational silos between teams such as R&D and regulatory affairs, promoting greater organizational efficiency. This, in turn, reduces churn and disconnect across these teams, minimizing iterations and latency throughout the process. By integrating compliance intelligence into product design and fostering cross-functional transparency, R&D teams can make supported decisions early on, creating innovative prototypes that are highly compliant from the outset.

This approach provides the various business functions with improved visibility into all processes and constraints, promoting cross-departmental understanding and connection. It also reframes the regulatory team as an essential collaborator rather than a roadblock, shifting the focus toward creating more value-added opportunities that drive innovation and transformation for the business, while reducing the time spent on monotonous validation exercises, such as searching for regulations, inputting data, and manually assessing compliance requirements. By capturing organizational knowledge within a centralized hub integrated with product lifecycle management (PLM) and enterprise resource planning (ERP) tools, decision makers can leverage organizational standards and historical insights to drive continuous improvement, resulting in higher quality products.

Centralized, up-to-date regulatory and product data repositories also reduce the time spent scanning fragmented information sources. Proactive alerts on regulatory and supply chain issues enable a “manage by exception” approach to risk mitigation, replacing the effort required for manual issue monitoring. R&D teams can dedicate more time to “Big I” innovation, as opposed to reworking products to meet compliance requirements. Regulatory teams spend less time trying to connect the dots; instead, they create the space to pursue important objectives, including policy feedback, advocacy, and stakeholder education.

An essential success factor for compliant design is having these capabilities thoughtfully integrated into the process. Integrating compliant design solutions into current PLM and ERP systems fuels transformation without disruption, enhancing existing development and NPD processes and leading to high-value realization for the effort. Integration for ease of adoption is crucial, as it minimizes the need for retraining and keeps change management minimal. Organizational buy-in is the natural result, as teams watch the technology take on many more tasks and improve outcomes.

Harmonize AI and Human Expertise

Compliant design harnesses machine learning and artificial intelligence (AI) alongside human expertise to unlock the true value of compliance data. AI can not only accelerate assessment and identify risks but can also alert teams to issues that might be difficult to identify manually. Advanced algorithms, often trained on your specific historical data and best practices, can generate profound and actionable insights throughout the product development lifecycle.

Machine learning technology supports proactive risk mitigation by detecting patterns and trends that can predict regulatory or supply chain issues. This data is then validated by human experts for accuracy and contextual meaning, facilitating proactive engagement with regulatory bodies for official guidance on their interpretation.

AI has the ability to generate trend insights in relation to specific ingredients, applications, and consumer sentiment, helping manufacturers to better understand their market and leverage this understanding to gain competitiveness. This technology can also simulate and scenario test virtual formulations, accelerating development and supporting successful launches. By adopting an expertise-augmented approach, organizations can achieve better insight quality and forecasting than either human experts or AI can achieve in isolation.

Organizational Evolution through Compliant Design

With the evolution of the food and beverage industry progressing at an unprecedented pace, embracing innovative approaches to product development is key for both competitive advantage and consumer trust. Compliant design is transformative, modernizing product development lifecycles by providing relevant insights to the right people at each stage, identifying issues faster, and supporting more effective and decision making. Compliant design not only accelerates innovation but also establishes product stability and compliance in a changing regulatory landscape.

By shifting left and breaking down silos, manufacturers can streamline processes while leveraging the combined power of AI and human expertise, achieving greater efficiency and value. The future of the industry belongs to those who can adapt, innovate, and respond swiftly to the complex challenges it presents.

Frierson is vice president of digital solutions at FoodChain ID, a Fairfield, Iowa-based firm that provides expertise and technology-driven services to support the food industry. Reach him at wes.frierson@foodchainid.com.

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In an era defined by the growing urgency of environmental concerns, one resource stands as a profound global challenge: water. As one of the planet’s most precious and scarce natural resources, water ranks as a top environmental, social, and governance (ESG) concern. While various industries worldwide grapple with the challenges of resource scarcity and environmental degradation, the food and beverage processing sectors require substantial water consumption for their everyday operations.

The Hidden Costs of Water Consumption

Whether used as an ingredient, an essential component of food preparation and production, or a tool for upholding workplace hygiene, the quantum of water consumed by a processor’s operations can quickly add up. According to Food Northwest, poultry processing can utilize anywhere from 3.5 to 7.0 gallons of water for each four-pound bird. For tasks like carcass washing and cleanup, beef processing can require a range of 350 to 550 gallons per animal. Meanwhile, contingent on their respective efficiencies, breweries can use between seven and 10 gallons of water to craft a single gallon of beer, and cold soft drink plants generally require between 1.3 and three gallons of water per gallon of packed soft drink.

The intricacies of the water–energy nexus further compound the cost of water. When water needs to be heated—for activities such as cooking, pasteurization, or cleaning—energy is expended to raise its temperature. This correlation holds true for various processes in the food and beverage industry, such as heating, cooling, pumping, mixing, and more. In essence, the greater the volume of water involved, the higher the concurrent energy consumption will be.

Amidst these complex dynamics, the consequences of substantial water consumption extend not only to food and beverage processors, but also to the environment. As ESG concerns rise to the forefront of many corporate agendas, food and beverage processors find themselves under growing pressures to align their operations with sustainable practices to manage water responsibly.

Safeguarding Operational Efficiency, Food Safety, and Hygiene

As the industry looks for ways to reduce water consumption, the quality of water used in food and beverage processing also has a significant impact on a facility’s long-term success. From the perspective of operational efficiency, pristine water quality ensures that equipment remains free of excessive scaling and fouling, which not only helps to extend the lifespan of machinery, but also reduces the need for frequent maintenance. In turn, this can lead to improved process efficiency and minimized downtime.

Courtesy of Diversey.

Additionally, water used for processes such as heating and cooling is more effective when it’s free from impurities or those impurities are managed properly. Clean water heats and cools more quickly and requires less energy to reach the desired temperature, leading to energy savings and more streamlined processing. According to the Bureau of Standards, steam boiler systems with only 1/16” scale formation can result in 11% efficiency losses, while cooling systems with biological film as thick as a piece of scotch tape are four times more insulative than mineral scaling and can reduce heat transfer efficiency by 7% to 10%.

Even more critical than operational efficiency is the importance of water quality in upholding the strict standards of food safety. Because water serves as an essential component for cleaning and sanitizing, it’s critical to keep this water free from harmful microorganisms. Contaminated water can introduce pathogens into the processing environment, leading to compromised products and the potential for an outbreak of foodborne illnesses—a grave scenario that no processor can afford to overlook. Furthermore, a clean processing environment, supported by high-quality water, contributes to a safer workplace for employees.

Enhancing and Understanding Your Current System

Despite the inevitable need for many water-intensive processes in the food and beverage sector, various methods exist to help processors optimize their water use and, ultimately, consume less over time.

One approach lies in elevating the efficiency of wastewater treatment processes. Since wastewater treatment is already necessary, simply enhancing your current process for reuse in non-potable processes can be a huge advantage. Effectively treating wastewater laden with organic matter often involves methods of filtration, sedimentation, coagulation, and chemical treatment to disinfect and purify the water. Utilizing reclaimed water provides an alternative water supply, enhances operational efficiency, helps cut costs, and strengthens profitability.

The growth of data tracking and analysis presents another method by which food processors can aim to optimize their water use and progressively reduce consumption over time. By leveraging data tracking, food processors can gain a comprehensive understanding of their current water consumption patterns and identify areas of improvement. Monitoring these insights in real time not only helps processors identify deviations from expected consumption levels but also provides an opportunity to predict and anticipate future trends. By embracing data-driven decision making, processors can track their progress over time, examine real-time cost of water and energy consumption, and develop customized water management strategies to fit their specific needs.

A Path to a More Sustainable Future

As the processing industry looks toward a greener future, the management of water use and water quality is a strategic method for a more sustainable transformation. Much like any systemic shift, the journey toward optimized water use must begin with a deeper understanding of the current processes in place. Providing a tangible “value advantage” as a supplier is a critical component needed for both customer and supplier to be successful. By integrating advanced water treatment technologies and continually measuring growth and development when it comes to water use, processors can minimize waste, harness their water’s potential for multiple cycles of use, and optimize processes to save time and energy, all while quantifying the value of these improvements.

Ultimately, water use for the food and beverage processing industry extends beyond mere consumption; it also comes down to responsible stewardship and maximizing the value of every drop.

Sperling is a project manager at Diversey, Food and Beverage and has 25 years of experience with food and beverage applications. Reach him at barry.sperling@diversey.com. Burke is an application project manager at Solenis and has 31 years of experience in water treatment. Reach him at mburke@solenis.com.

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In response to the U.S. Supreme Court’s May 2023 decision in National Pork Producers Council v. Ross to uphold California’s farmed animal confinement law, Proposition 12, Senator Roger Marshall (R-KS) and Representative Ashley Hinson (R-IA) introduced the Ending Agricultural Trade Suppression (EATS) Act. If enacted, this legislation would federally overrule California’s law that, in part, prohibits the sale of pork from pigs confined to gestational crates, and similar state and local health, safety, and animal welfare laws.

The EATS Act is the most recent incarnation of legislation initiated by former Representative Steve King (R-IA) to counter state animal protection laws, which was unsuccessful in being included in both the 2014 and 2018 U.S. Farm Bills. New efforts, however, are underway to include the EATS Act in the next Farm Bill, which is expected to be finalized by the end of 2023.

In its decision, the U.S. Supreme Court acknowledged that California’s law highlighted the constitutional power Congress possesses to “regulate commerce … among the several states,” and suggested that Congress could displace the legislation by exercising its commerce power and enact legislation that regulates the interstate trade of pork.

Still, plenty of opposition to the EATs Act exists, with many claiming that the proposed legislation would curtail the ability of state and local governments to regulate the production and sale of agricultural products, potentially nullifying more than a thousand state laws.

In an August 2023 letter to the House Agriculture Committee, 150 lawmakers cautioned that the act would harm America’s small farmers, threaten numerous state laws, and infringe on the fundamental rights of states to establish laws and regulations within their own borders. “The EATS Act goes beyond overturning Proposition 12 to threaten many other state laws,” the letter stated. “The bill is particularly draconian in that it aims to negate state and local laws even if there is no federal standard to take their place, creating an overnight regulatory vacuum. In doing so, [it] would drastically broaden the scope of federal preemption and impede the ability of voters and elected officials to enact laws that address local concerns.”

State Sovereignty

A July 2023 report by the Brooks McCormick Jr. Animal Law & Policy Program at Harvard Law School in Cambridge, Mass., analyzed the legislation and presented potential widespread consequences if the EATS Act passes. The report called the proposed legislation “unconstitutional” and said it would threaten states’ rights, consumer safety, and farmer livelihood.

Kelley McGill, a regulatory policy fellow at the program and author of the report, says the act raises potential constitutional questions related to the 10th and 11th Amendments in addition to state sovereignty. “Enactment of the EATS Act likely would spawn litigation that could tie up the legislation in courts for years to come,” she says. “This litigation would create years of regulatory uncertainty for food and agriculture industry participants, regulators, and consumers. Without regulatory certainty, it will be difficult for the industry to accurately conduct the forecasting necessary to make business decisions and move forward with plans.”

When it comes to states’ rights, McGill says that the EATS Act would upset the long-standing, constitutional balance of power between the 50 states and the federal government. “It would shift agricultural oversight power away from the states and to the federal government,” she says. “Federal agencies, such as USDA and FDA, would need to fill regulatory voids created by the EATS Act, and the federal judiciary would have to review a likely onslaught of challenges brought against and under the legislation.”

What’s more, her report says the act could prohibit the enforcement of numerous state and local regulations related to food safety, food quality, and product labeling, exposing consumers to new risks. “The EATS Act also could affect certain state and local regulations on pesticides and fertilizers as well as future restrictions on the use of antibiotics or growth hormones, soil or irrigation quality requirements, PFAS contamination thresholds, manure management practices, and limitations on genetic engineering and other technological processes,” McGill adds.

The livelihoods of farmers would also be affected, she says. “The EATS Act could prohibit certain state and local regulations governing pests and diseases, removing critical tools that help protect farmers and their crops and livestock from the spread of invasive pests and disease,” McGill says. “The prohibition of these regulations by the EATS Act could jeopardize entire sectors of the agricultural economy and threaten the livelihoods of local producers. The EATS Act also would devalue significant infrastructure investments made by certain farmers in order to comply with state laws.”

The Cost of Compliance

Shawn Stevens, a food industry attorney with the Food Industry Counsel and a member of the Food Quality & Safety Editorial Advisory Board, says that certain states, such as California, have essentially come close to reaping havoc on the food industry on a national level by creating their own sets of rules that apply to various food commodities, and he believes this isn’t good for business or for the consumer. “If we harken back to Upton Sinclair, who wrote The Jungle in the early part of the last century, what he described was a mishmash of rules and regulations—and in some cases, no regulations—applicable to the slaughter and processing of beef,” Stevens says. “Because of this, every state was doing their own thing, and it made it difficult, if not impossible, to efficiently produce and sell food products throughout the U.S.”

In response, Congress passed the Federal Meat Inspection Act (FMIA) in 1906, which set a single set of standards applicable to slaughter and processing facilities throughout the country, for all meat and poultry. “The idea was to create a uniform set of standards so everyone was operating on the same level and the consumer knew what he or she was getting,” Stevens says. “It enhanced, improved, and supported interstate commerce.”

There’s also a clause in FMIA that prohibits states from creating any additional or different rules than those set forth in the act. “The EATS Act, in essence, is mirroring the preemption clause in FMIA, but extending that clause to agricultural products, through the raising of cattle or other animals intended for slaughter,” Stevens says. “I think it’s a great idea, and I don’t see why anyone would oppose this, unless you’re a senator from California. Therefore, this is as constitutional as you can get.”

The National Pork Producers Council (NPPC) is one group that supports the EATS Act, citing concerns about the cost of compliance with certain state laws for some pork producers. The group also notes that U.S. pork producers are struggling economically. Since Proposition 12 requires capital investment that many producers will not have access to and that will lead to further consolidation between producers who have financial resources and those who don’t, fewer family farmers would continue to operate, says the organization.

Scott Hays, NPPC’s president and a pork producer from Missouri, says that a bipartisan, legislative solution to Prop 12 that ensures affordable, healthy pork products remain available to all Americans, including Californians, is fundamentally important for America’s pork producers. “Therefore, NPPC supports a legislative solution that helps us achieve that goal, which gets right at the fabric of our democracy—by not restricting trade between states,” Hays adds. “The implications are far reaching for agriculture and will stretch to other industries if a solution is not reached.”

Potential Impact on the Food Industry

McGill believes that if enacted, the legislation would cause significant disruption and uncertainty for producers and regulators in the food industry. “Many key terms are undefined in the legislation, leaving open the potential scope and effects that it might have,” she says. “State and local governments may stop enforcing a wide swath of their food and agriculture regulations rather than risk being sued under the expansive private right of action created in section 3 of the legislation. State and local governments also may be chilled from enacting new regulations related to food production to avoid costly litigation.”

Stevens disagrees that it would be that disruptive and stresses that it’s an important piece of legislation that must be passed. “If it is approved by congress and signed by the President, nothing will change; it will be the status quo, and everyone will be happy,” he says. “If it’s not passed, it could be seen as an endorsement to California and other states to go and make whatever rules they want and apply them to the raising of livestock, and we can end up in this crazy swirl where the only place you can get affordable beef is at your local corner butcher shop.”

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To ensure that only the best and safest food products reach consumers, processors constantly test and monitor contaminants in their inbound raw materials, which is not an easy feat. That’s where high-sensitivity analysis and accurate data comes in, allowing decision makers at the quality management level to effectively screen raw materials to determine their suitability for use, and to ensure product value, safety, and compliance.

Proper screening ensures that contaminants don’t exceed the maximum residue levels (MRLs) in the food product. Compliance risk aside, food processors want to put their brand name on only the highest quality food products. Brand reputation suffers when a product’s quality does not line up with the brand promise stamped on its packaging. For example, “all natural” or “100% organic” claims may invite further scrutiny if it’s revealed the food contains higher levels of contaminants. The impact can be far reaching, leading to media attention, a loss of consumer trust, recalls, and costly litigation.

A New Way to Test for Residue

Processors know that early detection of contaminants, such as glyphosate and mycotoxins, within inbound products saves time and money; however, such testing historically requires sending samples to a qualified lab for analysis by liquid chromatography (LC), sometimes coupled with advanced detection using mass spectrometry (MS). It can take days or even weeks for the test results to come back from the lab.

Imagine this all-too-common experience for food and agricultural facilities: A supplier pulls up with a truckload of grain. You collect and send a sample of the grain off to a lab to be screened for mycotoxin or pesticide residue. In the meantime, the grain sits in storage, risking cross-contamination with other raw materials. While waiting for laboratory results to arrive, you are left wondering how much time—and money—you could save if you could screen the raw materials for contaminants before the supplier unloads or leaves the premises?

The good news is that on-site testing technologies are available that can produce precise results in minutes, not days or weeks. The aim of both a laboratory-based analytical technique, such as high-performance liquid chromatography (HPLC), and a rapid test is the same: to measure whether a sample contains certain compounds. That’s where the similarities end. LC requires an accomplished laboratory technician to extract the target analyte from the sample and perform the analysis with an organic solvent according to a well-documented standard operating protocol (SOP).

Everyone is familiar with lateral test strips, the same format used with COVID-19 diagnostic test kits. Quantitative lateral flow strip tests can, in a matter of minutes, alert test users to the presence or absence of a specific target, whether it is SARS-CoV-2, mycotoxins, or glyphosate. Further, unlike LC, rapid test strips employ a water-based extraction method that any company owner, quality control professional, USDA or FDA licensed inspectors, or factory worker can perform on site. Administering on-site testing with lateral test strips is less costly and increasingly more sustainable given that samples never leave the site, which eliminates the packaging, shipping costs, and transportation emissions necessary to send samples to a lab for analysis.

The benefits of rapid on-site testing are that data-informed decisions can be made in the moment, allowing time for action and remediation. Processors can decide sooner whether to use a particular batch of raw materials or to source a substitute or replacement ingredient instead. Quality control managers can make specific plans for each raw material based on its quality. Operational efficiency improves and quality teams can have greater confidence in the quality of the inbound materials faster, eliminating the worry and uncertainty that attends untested inbound raw materials until they are confirmed clean. All of these are reasons to turn to rapid test methods at the food manufacturing facility.

Out of the Lab

Still, as with any new form of technology, some will remain hesitant or skeptical about implementing a new, unfamiliar way of testing. After all, results so important to their business and human safety cannot be left to chance.

Continuous learning is a proactive way to ensure ongoing success with any monitoring tool. Implementing rapid test methods outside of the lab is no exception. Annual retraining and simple procedure posters hung around the facility with QR codes that lead straight to full guides or step-by-step videos online help to improve the confidence of test operators and help to ensure consistent, accurate data collection. Scientist or not, the user’s confidence in their ability to perform the test will make all the difference in day-to-day work satisfaction, as well as obtaining sensitive, and accurate results.

On-site testing is a first line of defense in keeping low quality raw materials out of the facility and out of the global food chain. Access to rapid strip test screening kits has the potential to change the way raw materials are cultivated, harvested, and processed. Being able to customize a cultivation plan or harvest crops in a way that minimizes worker exposure to contaminants or microfungal toxins enables producers to make data-informed decisions that impact how they perform their jobs. Ultimately, the highest value is to protect consumers by ensuring food is free of contamination. Rapid test technologies mitigate risk much earlier in the value chain, which bolster preventive strategies and offers a more holistic approach to food safety.

Jackson is VICAM market development manager for Waters Corporation. Reach her at patricia_jackson@waters.com.

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According to data from the Food and Agriculture Information Sharing and Analysis Center on the 200 to 300 ransomware attacks tracked each month in the U.S., approximately 10 to 20 are directed at agrifood businesses. The most famous case in recent years was the attack on JBS in May 2021, which resulted in an $11 million ransom payment after the meat giant had to close all of its beef plants across the country.

Even when no ransom is paid, the consequences of a cyberattack include high direct costs, disruptions up and down the supply chain, and damaged brand reputation, with the possible addition of theft of trade secrets and legal consequences. In April 2023, a network breach forced cold storage and logistics company Americold to take compromised servers offline, blocking all inbound and outbound deliveries. “With an attack like the one that hit Americold, you’ll have damages on both sides of the equation,” says Michael Delaney, corporate attorney at legal firm Bryan Cave Leighton Paisner, based in St. Louis. “The manufacturer will have to either stop production because they don’t have enough storage space at the plant, or find an alternative distributor. On the other side, the distributor cannot get the product out to the retailer. The manufacturer may sue the distributor, while the retailer may sue both, if they breached the contract.”

Although most cases of cyberattacks that we read about on the news affect large public companies, smaller businesses are not exempt from risk. In an FBI notification issued in September 2021, the agency warned that larger agrifood businesses “are targeted based on their perceived ability to pay higher ransom demands, while smaller entities may be seen as soft targets.”

Food Safety Risks

Ransomware attacks tend to hit IT environments, which focus on data storage and communication. For food manufacturers, however, the risk extends to the operational technology side of the business that controls production. In a hypothetical attack, cybercriminals could exploit the vulnerability of industrial control systems (ICS)—the hardware and software that control equipment and processes—finding their way to the production floor and putting the quality and safety of food products at risk. “ICS systems control all sorts of devices, such as temperature sensors, gate valves, or automatic sampling systems,” says Col. John Hoffman, senior research fellow with the Food Protection and Defense Institute at the University of Minnesota in St. Paul. “By taking control of them, one could increase the temperature of an oven, shut down a refrigerator, or change parameters of a recipe, possibly adding an unwanted allergen.”

Most ICS systems used in the food industry are built on legacy technology that wasn’t designed to be connected to the internet. Now that they are plugged in for data collection and remote monitoring and servicing, their lack of protection is putting production plants at risk. Their gradual replacement with modern IoT devices might actually create new vulnerabilities, rather than reduce them. “Smart devices that send and receive data over the internet tend to bypass a lot of the security measures—such as firewalls—that protect both modern and legacy systems, exposing them to attacks,” says Rich Witucki, principal industrial consultant at industrial cybersecurity company Dragos.

As Eran Fine, CEO and co-founder of NanoLock, an Israel-based developer of cybersecurity solutions for industrial systems, says, connectivity itself is a variable that increases risk: “Hybrid systems are not necessarily more secure, but create different problems. While legacy technology is extremely vulnerable, it’s also less connected. IoT devices bring about more connectivity. They may be harder to breach, but once that happens, intruders may jump from the legacy into the new and vice versa.”

Even a single act of sabotage could have disastrous consequences. In 2015, 300,000 chickens in South Carolina were killed after someone tampered with the barn’s climate controls. In 2018, 1,200 pigs died of suffocation in an automated barn in the Netherlands, due to a malfunction of the remotely-controlled ventilation system. Although neither case was a cyber­attack, as the industry is relying more on remotely controlled equipment, autonomous tractors, and smart sensors, the risk of something similar being done by cybercriminals is real.

Cyberattacks may start long before they are discovered: “Cybercriminals usually do some kind of recon first, looking for vulnerable targets,” says Witucki. “Once they’re in, they try to elevate their user privileges so they can exploit other pieces of software. For example, they might move from the enterprise resource planning (ERP) to the manufacturing execution system (MES), to the supervisory control and data acquisition (SCADA) system, which monitors and controls all phases of food preparation, such as recipes, time, and temperature.”

In most cases, what allows the intrusion is human error: “Employees are the biggest vulnerability,” says Hoffman. “They may compromise their home computer and then use it to log into the company’s system to clock in work hours or check their email on their work computer and click on something they shouldn’t  click on. Insufficient cyber hygiene is a big issue.”

National Security

Ransomware cases are increasing across all industries, as they are a quick and effective way to make money. But a criminal’s motive can be more than purely financial: “Companies sometimes are targeted by competitive moves,” says Hoffman. “Imagine a supplier that won a bid for a large contract, and a competitor breaks into its ICS to compromise the quality and safety of products. The company wouldn’t be able to comply with its obligations, eventually losing the contract. These attacks occur especially in China and Asian markets, but we’re beginning to see them in the U.S. and Europe, too.”

The breach can also be caused by insiders: “A criminal might pay a disgruntled employee one year’s worth of salary just to plug a USB stick into the system during a night shift, to change the ingredients’ dosage and cause severe quality issues,” says Fine.

But motives could be even more worrying. The Cybersecurity and Infrastructure Security Agency (CISA) identified food and agriculture as one of the 16 sectors that are critical to the country’s security, health, and safety. Such strategic importance makes the industry an appealing target of state-sponsored cyberattacks: “If you wanted to take out a country, the first thing you would do is contaminate their food and water,” says Kristin Demoranville, CEO and founder of AnzenSage, a cybersecurity advisory consultancy for the food sector. “Thankfully, right now, cybercriminals are financially motivated, so they’re not going to kill anybody, at least not intentionally. But if they decide to flip the switch, the food supply chain is still so legacy driven that it could have horrible consequences.”

Recent attacks on producers of staple foods offer a glimpse of what could happen on a larger scale. In 2021, an Iowa farming co-op had to go completely offline and use manual processes after being hit by a ransomware; in 2022, a similar attack forced H.P. Hood Dairy to close its 13 plants; in 2023, a cyberattack shut down 10 water controllers in agricultural areas in Israel, temporarily halting the irrigation systems. “A synchronized cyberattack that completely disrupts the supply of water, bread, or milk could bring a country to its knees,” says Fine. “Besides, food is necessary not only for consumers, but also to armies. And when you starve an army, you’re in a better position to win.”

Risk Aversion in the Food Industry

The increasing attacks on agrifood businesses are a signal that the response to these threats is still insufficient: “In the food industry, cybersecurity is usually considered of secondary importance compared to production uptime and safety,” says Demoranville. “With food contaminations, the reaction is instant and visceral, because it’s clear to everyone that people might die. The same goes for cyberattacks, but people don’t understand it yet.”

“Many companies have an ‘if it ain’t broke, don’t fix it’ mentality,” says Hoffman. “The legacy operating systems they’ve been using for years still work fine, and they like the convenience of connectivity, so they decide to keep them without segregating them into a separate network.”

One symptom of insufficient cybersecurity culture is lack of alignment within organizations: “Cybersecurity officers and production managers speak different languages,” says Fine. “While one will want to implement stronger passwords and multifactor authentication, the other needs to keep up with the production schedule and might see those measures as a waste of time.”

The risk of such a siloed mentality is to leave large portions of a company’s network unprotected: “Devices such as electronic door locks, security cameras, and door security systems aren’t part of a food production line, but are usually connected to the network,” says Hoffman. “A lot of companies don’t realize that those devices are exposed too: Bad guys could get into the camera’s firmware, and from there to more critical items.”

Fine believes the food sector needs a specific approach to cybersecurity: “Food manufacturing is not like a bank, which is very structured and allows you to control who gets in and who stays out. It’s a high-traffic and chaotic environment, where hundreds of people can influence production. Floor staff, but also visitors and vendors, may—knowingly or unknowingly—bring malware in when they connect to your equipment. Trying to outsmart the bad guys is futile: They have enough time, resources, and motivation to find the vulnerability. What we see companies do is try to detect attacks, while what they should really do is prevent and protect and realize that cyberattacks can come from any direction.”

If attacks can come from anywhere, the best defense, says Witucki, “is a layered structure, with firewalls in front of the legacy devices, network monitoring, and regular backups, so if somebody exploits a vulnerability to attack your system, you could get back up to speed relatively quickly. Also, you should have an incident response plan specific to ICS, so you would know what to during an emergency.”

When responding to an attack, it’s also important to address all possible legal implications: “You should immediately check the contracts and purchase orders with your customers to see if you are under obligation to report the incident to them and if you have any liability. The next step is to check if you have any insurance coverage,” says Delaney.

For Demoranville, the change to increased security must come from the top: “The executive level and the board need to agree that cybersecurity is a priority,” she says. “If that doesn’t happen, anything that gets done will be disbanded quickly. More companies should set up a strong change management board where representatives from all departments, including production and quality, meet once a week to discuss what’s happening in their environment. Ultimately, you can save lives and money if you do that properly.”

Tolu is a freelance writer based in Spain. Reach him at andrea@andreatolu.com.

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For 30 years, Food Quality & Safety has chronicled some of the most significant advances in food safety, particularly in the field of microbiology. These advances took place in the lab, in the field or in the factory, and were led by some of the most knowledgeable people of the time. They faced previously unknown challenges, chased unseen threats, and worked feverously until they found answers. More than anything, a handful of leaders in the meat industry had the vision to establish food safety as a noncompetitive issue, a tenet followed by the entire food industry to this day.

New challenges will always test our food safety systems, and the leaders of the past taught us that the programs and policies that protect food safety must be flexible and readily adapted to meet them. Challenges such as a rapidly changing food supply chain during a pandemic or addressing infant formula shortages due to reduced production caused by bacterial contamination were covered in FSMA regulations or overcome by cooperation with FDA. That’s not to say we are now perfect, but we’re learning more and more how to apply the core principles in critical food safety situations.

All Experts Aren’t Created Equal

As we acknowledge the leaders who came before, we must also acknowledge the real heroes of food safety. They aren’t named. They aren’t remembered anywhere. They are the thousands of frontline workers that practice food safety every day. They are the essential workers who showed up every day during the peak of the pandemic. They are also the select few who stepped up to work on the food safety team. The hours are tough, the manufacturing conditions are often brutal, but they stick it out and do the job. They ensure that policies and procedures are followed and don’t hesitate to report when something goes wrong. They care about protecting consumers and take pride in product safety.

They do this from facilities located on the outskirts of cities and small towns across the country, in aging factories filled with old equipment and crumbling infrastructure. They often have limited resources and only the minimal training necessary to meet regulatory requirements. The internet provides some help, but they often find contrasting solutions. A lucky few get to attend food safety meetings and conferences to seek expert help, but they may or may not find the answers they seek. Food production facilities vary wildly in age, layout, and conditions, and food products vary in risk level so finding exact solutions is nearly impossible. A minor change in facts can have disastrous effects on the outcomes. They proceed with caution, knowing that they don’t know how much they don’t know. They ask for advice at every opportunity.

This is a good time to remind everyone that food safety experts are not created equally, and good intentions will not protect you from bad advice. To emphasize this point, the Jensen Farms cantaloupe recall in 2011 was responsible for one of the deadliest Listeria outbreaks in the U.S. Bad advice from an expert and a poorly executed third party audit were a lethal combination that resulted in a deadly outbreak that accounted for at least 33 deaths and 147 cases across 28 states.

FDA officials investigating the Jensen event found four strains of Listeria on dirty, corroded equipment, recently purchased second hand on the recommendation of an “expert.” Previously used for potato farming, the “equipment’s past use may have played a role in the contamination” according to the government’s final report. There was no clear evidence it was even cleaned before it was placed in the line. The use of sanitizer in the wash water, a process in use before this renovation, had been discontinued for some unknown reason. The fruit wasn’t being precooled, creating humid, damp conditions in the cooler that supported Listeria growth. This hardly sounds like an operation under the management of a food safety expert.

Jensen Farms declared bankruptcy in 2012 and, in 2013, charges were filed against the owners, who pleaded guilty to six counts of adulteration of a food and aiding and abetting. The owners also filed suit for negligence against the auditor hired to look at safety standards at their operations, but the work was assigned to a subcontractor, creating a conflict of interest. Since the subcontractor was involved in the renovations and operational changes that contributed to the outbreak, they never should have conducted the verification audit.

Sherri McGarry, a senior FDA adviser at the time, said: “We’re going to take these lessons learned, share that with our partners and industries, CDC and the states, and what we want to do is we want to really prevent this from happening in the future.” FSMA was signed into law in November 2011.

The Jensen Farms case is an extraordinarily sad example of bad expert advice and misguided good intentions. Most would agree that bringing in an outside party to assess your food safety program is a good idea, just as most would agree that a third-party audit is a great way to confirm that your operation is in good shape. But the owners in this case either failed to understand the most fundamental food safety principles, such as preventing cross contamination, the proper use of sanitizer, and the danger of dirty standing water, or they simply chose to ignore them. Certainly, the staff, if properly trained, would have noticed what the experts and owners missed. Clearly, using an expert does not replace the need for well-trained staff, or retaining a senior management that understands and supports product safety.

What’s In a Training

FSMA’s preventive controls (PC) rules recognized the need for better training than previously included in HACCP programs. HACCP required a trained HACCP manager that signs off on the HACCP plan, and that’s about it, although it has added some requirements and modified some terms since FSMA’s release. The PC rules now require all personnel to be qualified individuals (QIs) for their assigned roles and require additional training for the role of a Preventive Controls Qualified Individual (PCQI). Unlike the role of HACCP manager, the PCQI must also interact with senior management to ensure the Owner, Operator, or Agent in Charge signs off on the food safety plan. This seemingly small change makes senior management wholly responsible for the plan’s content and effectiveness, and that’s a big change. In short, with FSMA changes and USDA updates, both regulatory branches only require a one-time training course for the most senior food safety staff, while holding management ultimately responsible for the programs’ effectiveness.

It’s time to finally acknowledge what we all know: The required training alone is insufficient to prepare personnel for the job at hand, and the job at hand can be far tougher than just writing and following programs. We know that these jobs desperately need to be upgraded to acknowledge the true value of the critical thinking skills required to perform them effectively. In short, to build the leaders of the future, we need to create a true career path from entry-level food safety to advanced-level program management.

Once a PCQI training certificate is obtained, its applicable to any food sector, another potential gap our future food safety heroes must consider. From produce to candy to beverages, it’s all one course. It does include the requirement for a moderate amount of ongoing professional development, but this requirement is yet to be tested.

The necessary food safety knowledge to develop additional training for today’s food safety personnel is readily available. What is currently missing is the experience and knowledge in the science of teaching and learning. There are many methods for training development, delivery, and validating content retention. I’m not suggesting everyone rush off to write more in-house training plans; that would be wasteful and redundant. But there is an opportunity to increase training budgets when presenting the food safety plan for management’s signature.

To attract new talent, entry level personnel need standardized programs that can be delivered by modern web-based platforms easily accessible to the target audience—programs that can verify user participation and track an individual’s progress over time and portable achievements that follow the individual across job changes. Those that devote their time and energy to improving their work knowledge and skills should be recognized for their efforts through documentable achievements universally recognized.  

We owe it to our future leaders to share the knowledge and core food safety principles of the last 30 years so they can benefit from our collective past experiences. The food safety leaders of tomorrow depend on the proper development of the new employees of today.

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Keeping foods and beverages at recommended temperatures is a critical factor while they are in storage. But how do we make sure they are continuously stored correctly and are safe for the consumer? Any company that handles food must meet mandated requirements to safely store, move, and ship their goods. This requires checking temperature data at frequent intervals to make sure they meet FDA regulations for continuous storage conditions and provides proof that those thresholds weren’t exceeded.

When monitoring technology isn’t available, temperatures must be checked by someone who, with a clipboard or computer, walks to each freezer, refrigerator, or container, to make sure those storage places are kept at the correct temperatures. But human data collection also introduces the potential for human error. If a refrigeration unit goes down outside of the regularly scheduled temperature monitoring cadence, or if someone forgets to make the rounds, the product can quickly fall outside of temperature range that is designated to be safe. If the food is outside of the safe temperature range for an extended period, it must be disposed of, which could cost a food processor a tremendous amount of time and money.

Temperature Data Logging Devices

With an internet-connected data logging device, human error is far less of an issue. Technology-controlled data loggers help eliminate the miscalculations or errors that come with real-time monitoring. These data loggers allow warehouse and restaurant managers to easily collect temperature data without having to physically check in on storage. In addition, this data is stored on a server, which allows the user to show immediate proof of compliance with certain temperature-related regulations during audits.

Data loggers include a temperature monitoring sensor and data recorder that can send information to a cloud that is accessible to warehouse and restaurant managers. Monitoring schedules can also be set to any given interval specified by the individual setting up the logger—hourly or daily, for example. The logger can be set to send an immediate alert via text or email on anything that goes wrong, including specifics on what happened and identifying which storage facility or appliance needs attention.

There are many different types of data loggers and different functions that they serve. Portable data loggers allow you to monitor without a computer; some loggers come with a probing sensor that can be inserted into items such as meat to check internal temperatures and humidity monitors for food items such as certain types of produce that can be negatively affected by arid conditions, as well as those foods that require humidity to remain in peak condition.

Many data loggers can be ethernet connected, but they are also available via cellular, wifi, or Bluetooth connectivity. The communication type used will be based on the type of storage: transportation, warehousing, or in store. A Bluetooth or 4G data logger might be best for transporting goods and ethernet or wifi would be best for stationary storage, like that found at warehouses, restaurants, or grocery stores.

Case Report

A recent case from a U.S. meat distributor shows how temperature data loggers can help improve the efficiency and safety of a food handling operation.

To ensure the premium quality and safety of its inventory, which averages approximately $60 million worth of meat at one time, this distributor was required to manually measure its entire inventory frequently throughout the day. This process included having employees walk around the company’s storage facilities roughly 15 to 20 times per day to manually check and record multiple temperature gauges both inside and outside the facility’s freezers and refrigerators.

The many flaws of this approach included wasted time due to inefficiency and the introduction of human error, which included potentially missing a measurement cycle or misreading the gauges, leaving a refrigerator door open after reading a measurement, and other mishaps. All of these factors threatened the security and quality of the company’s inventory. It also made the required reporting of all temperature measurements to regulators, quality inspection organizations, and the grocers who purchase the meat more difficult.

The company engaged a data logging provider to leverage its technology to automate the storage/temperature management process. They purchased multiple wireless data loggers, which continuously measure temperature data and automatically uploaded it to a cloud service to be stored and viewed from computers and mobile devices, at any time and from anywhere. This data was ­simultaneously collected from multiple data loggers deployed in various locations, providing real-time reports to the company’s employees.

Using the data loggers, the distributor virtually mapped out each freezer/refrigerator to determine the temperature settings that are ideal for each room’s layout. The wireless functionality of the loggers allows employees to check the status of each loggers using an accompanying app. They can even tell immediately if a freezer or refrigerator door has been left open, causing temperatures to rise. This allows the company to ensure that proper conditions are being continuously maintained in real time.

One of the key activities in handling meat is taking inventory from a frozen to a thawed state safely. The temperature of the meat must be closely monitored throughout this process. With a data logger outfitted with a food probe made for measuring internal temperature, the company is also able to dial in on the exact parameters of this process. Overall, the company found a solution in which data loggers drastically improve the efficiency and accuracy of its inventory management.

Improve Productivity and Reduce Error

Making the relatively small investment in a data logger, which pales in comparison to the potential costs of product loss, can help eliminate errors and drastically improve productivity. The inaccurate data that can lead to spoiled food is no longer a threat. Protecting the consumer is the most important aspect of the food industry and data loggers can be a simple, cost-effective upgrade that fortifies safety procedures.

Knuth is president of TandD U.S.

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In January 2023, FDA announced that it would not regulate cannabidiol (CBD) edible products under the existing regulatory frameworks for dietary supplements, citing health concerns and a lack of safety data for the substance.

The agency said it had not found adequate evidence to determine how much CBD can be consumed and for how long before causing harm, so it would not pursue rulemaking for the substance in dietary supplements or conventional foods. “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” Janet Woodcock, MD, Principal Deputy Commissioner at FDA, said in the statement.

Consumers eat food for reasons other than to take CBD, and they may end up taking more CBD than they meant to, according to an FDA spokesperson. They might also confuse eating CBD-infused food with non-CBD food, which the agency says is especially concerning for children when CBD takes the form of a candy or snack.

FDA did state that it is prepared to work with Congress to develop a new cross-agency regulatory framework to oversee these products. Until then, regulation in the U.S. is in the hands of each state. Seventeen states plus the District of Columbia have fully legalized CBD products, with the remainder offering varying degrees of conditional approval (see “The State of CBD Legalization in the U.S.,” below).

The FDA news was disappointing to many in the CBD industry, but not entirely unexpected. Industry experts say they were waiting for FDA to proceed with federal oversight following the 2018 Farm Bill, which legalized hemp-based CBD. “The FDA has been dragging its feet for four years now,” says Jonathan Miller, general counsel for the U.S. Hemp Roundtable in Washington, D.C. “This was just another way to kick the can down the road.”

He agrees that Congress needs to step in to implement a regulatory plan, but he doesn’t want to wait years for that to happen. He would like to see CBD regulated in the same way FDA regulates other dietary supplements, with strict good manufacturing practices and labeling requirements. Miller adds that FDA’s inaction continues to be damaging for everyone—from the farmers planning their crops to the companies that sell products.

What Should Regulations Cover?

CBD products should be screened for any impurities or contaminants, says David Vaillencourt, CEO of The GMP Collective, a Denver-based organization that works with cannabis and hemp businesses. He adds that these products should also be screened for microbials and toxins produced by microbials, and labels should give an accurate and full disclosure of what is in the product and in what quantity. He says that there should also be a standard for the laboratory certificate of analysis, and that, ultimately, the products should be reasonably expected to be safe. “Consumers should go to reputable stores like Whole Foods or major retailers rather than gas stations or convenience stores, which could be risky,” he says. “Otherwise, they take a risk every time they buy a product.”

Right now, the lack of federal oversight leaves the CBD-infused food and beverage market as a “wild west” of food safety. States have moved to their own regulatory patchwork, making it difficult for companies to develop a national brand, says Steve Mister, president and CEO of Washington, D.C.-based Council for Responsible Nutrition, which represents the dietary supplement industry. “The FDA decision has stifled a market that was supposed to take off after 2018,” Mister adds.

Drug Preclusion Provisions

Other than safety concerns related to the lack of research data on CBD, there are drug preclusion provisions in the federal Food, Drug and Cosmetic Act that say if a drug company gets an ingredient to the market first, it has a monopoly over that ingredient. The drug Epidiolex, which contains CBD, is an FDA-approved treatment for epilepsy care that is on the market.

Two bills re-introduced in mid-March by U.S. Representatives Morgan Griffith (R-Va.) and Angie Craig (D-Minn.) would exempt CBD from the preclusion provisions. The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 would subject hemp extract products to the regulatory framework for dietary supplements, and the CBD Product Safety and Standardization Act of 2023 would establish regulations for CBD as a food and beverage additive.

Be Careful What You Wish For

FDA’s actions have been predictable, says Chris Fortes, CEO of Trojan Horse Cannabis, which sells infused seltzers that include both CBD and THC. “The FDA doesn’t really want to get involved unless they’re forced explicitly through Congressional action,” he says.

The industry would have been helped if FDA came up with even minor safety guidelines for products, such as child-resistant containers, he adds, but that would mean that the agency also is condoning that the product is acceptable. “They’re not willing to do that, but I’m disappointed that they haven’t put some safety precautions in place for consumers,” he says.

However, he admits that he is “semi-terrified” of asking FDA to regulate CBD-infused products, however, because he doesn’t think the agency understands them well. “You may get what you ask for, but you may not get what you want,” he says. He thinks a new cross-agency framework is a better option, and he would like to have USDA, the U.S. Drug Enforcement Agency, and the Alcohol and Tobacco Tax and Trade Bureau involved alongside FDA. He says the agencies should hold CBD companies to good manufacturing practices and truth-in-labeling standards.

Gabe Parton Lee, general counsel for Wyld, a cannabis edibles company based in Bend, Ore., says he expects a cross-agency framework would include USDA, because all cannabis products come from plants, but he thinks that any ingestible product clearly falls under FDA’s jurisdiction.

With the CBD market regulated at a national scale, he said products could be standardized to make sure they are clearly marked so that consumers know they are not buying an intoxicating product. Wyld also is working with state legislatures to develop standardized programs. “States are the laboratories of democracy,” he says. “There’s a real opportunity to develop regulated programs that the federal government can model after.”

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As FDA continues its mission to develop food safety into a separate agency, some vested organizations have doubts about the success of the proposed restructure.

On January 31, Robert M. Califf, MD, FDA’s Commissioner of Food and Drugs, announced a plan that calls for the functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) to be unified into a newly envisioned organization called the Human Foods Program. According to an FDA press release, the new program will be run by a single leader who reports directly to the commissioner. The agency says that this will unify and elevate the program while removing redundancies, enabling it to oversee human food more effectively and efficiently.

Critics of the plan say that it doesn’t follow the advice of a report conducted by the Reagan-Udall Foundation, an independent group of experts that Dr. Califf commissioned in 2022 to review the Human Foods Program following the powdered infant formula crisis; the report called for an overhaul and reform of the entire agency. “While we were first pleased by Dr. Califf’s announcement to advance an agency restructure, the details released on February 28, 2023, fall short of what is needed,” says Donna Garren, PhD, executive vice president of science and policy at the American Frozen Food Institute. “The plan fails to implement recommendations from the Reagan-Udall Foundation, including making bold structural changes to mitigate systemic cultural challenges within the organization.” She adds that FDA has indicated that it will continue to allow a divided and siloed organizational and leadership approach, which she says will ultimately impact the agency’s ability to set mission priorities and allow for quick and effective decision making regarding food safety.

Mitzi D. Baum, MSc, CEO of Stop Foodborne Illness, a nonprofit public health organization based in Chicago, also has concerns about the proposed restructuring. “The commissioner’s proposed incremental changes don’t get to the root of deeply embedded cultural issues,” she says. “The insularity of the ORA is of specific concern because it operates separately from science and policy areas. The plan will allow ORA to continue to have a culture of reaction rather than shifting to a proactive approach as mandated in FSMA.”

Specific Concerns of the Proposed Restructure

In particular, Baum says that the proposed changes don’t go far enough to provide consumers with the confidence that FDA leadership is doing everything possible to fix the fractured leadership and prevent another disaster like the powdered infant formula crisis. “Moreover, it’s essential to focus on the broader issue of food safety and prevention in today’s modern food system,” she adds. “It seems the commissioner chose the items and issues of least resistance to create this plan. He has ignored the experts he enlisted to provide recommendations and has continually dismissed the calls for change from external stakeholders. It’s a half measure that will not lead to safer food for consumers.”

Emily Moyer, PhD, vice president of regulatory compliance and global food safety standards at the International Fresh Produce Association in Washington, D.C., says that it’s unclear which functions of the ORA will become part of the Human Foods Program. ORA is the compliance arm that houses FDA’s inspectors and those who handle import safety, and it also oversees regulatory laboratories. “If they remain separate from the Human Foods Program, with different leadership, FDA would remain siloed, which would prevent FDA from fully embracing and achieving the preventive vision of FSMA,” she adds.

If the deputy commissioner’s role is to be truly empowered, this person needs to have a direct line of authority over the entirety of the Human Foods Program, Dr. Moyer says. Dr. Califf stated in a February 28 press release that the newly created deputy commissioner would set the strategic direction for food inspections and have budget authority, while also acknowledging that he is still “determining how to best empower the deputy commissioner, leaders of other programs, and the associate commissioner for regulatory affairs.”

Dr. Garren says that FDA, consumers, and the regulated community are best served by an empowered deputy commissioner of foods who has direct management authority over all components of FDA’s human and animal foods program, including CFSAN, the Center for Veterinary Medicine, and the food-related components of ORA. “Unfortunately, FDA’s current vision doesn’t pursue this bold approach to implement the needed structural changes to eliminate the existing inefficiencies and lack of transparency and collaboration,” she adds.

Tyler Williams, MS, chief technical officer at ASI Food Safety, a third-party food safety consulting agency based in St. Louis, Mo., is concerned about how the restructuring will impact FDA’s budget. Currently, FDA’s drug division already has a significantly higher budget when compared with food. “When politicians decide to increase FDA’s budget, more is always allocated to drugs and medical devices over food safety,” he says. “Currently, FDA doesn’t have the resources to inspect every food facility every two years as [FSMA] requires. I hope that when the restructuring comes to fruition, there’s not an increased difference between the food safety budget compared to drugs and medical devices.”

Some Positive Aspects

Despite its shortcomings, Dr. Moyer says that Dr. Califf’s restructuring plan is a significant step in the right direction because the foods program needs a single, empowered decision maker. “An external group of subject matter experts could provide great value in establishing a stronger collaboration between regulators, industry, and academia to address emerging food safety issues,” she says.

Williams says that having a split leadership team is one of the biggest potential benefits. Currently, most of FDA’s leadership comes from the drug and medical device industry. “Although clear roles are still undefined in FDA’s recent statement, food safety experts will be a part of the proposed Human Foods Advisory Committee to ensure that all of the agency’s decision-making activities are scientifically grounded, keeping emerging issues of our industry at the forefront,” he adds.

Ideal Outcomes of the Proposed Restructure

Dr. Garren hopes that any meaningful restructuring at FDA would result in a more unified foods program with a single chain of command and a prevention-focused approach to food safety as required under FSMA. “This would result in a more predictable regulatory process and an agency that could respond quickly and effectively on food safety matters,” she says.

As a result of creating an Office of Integrated Food Safety System Partnerships, Williams hopes that oversight will be more streamlined. This would unify FDA’s work with state and local regulators. “This is a step in the right direction, but I would like to see an actual plan on how it’s going to be implemented and what responsibilities will be held at local, state, and federal levels,” he adds.

While there might not be more oversight from a quantitative standpoint, Dr. Moyer says that, depending on the final structure, there’s an opportunity for FDA to become more targeted in its oversight, which would benefit public health.

FDA hopes to finalize its reorganization proposal this fall.

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