Editor’s note: This is part one of a two-part series focused on dust hazard analysis. In this article, we focus on the dust hazard analysis process. In part two, we take a look at how to put the analysis into practice at your food plant.

Confused about the dust hazard analysis (DHA) process? You’re not alone. Many bakers and food processors have questions about DHA requirements. Here’s what you need to know and how to get it done.

Why Do You Need a Dust Hazard Analysis?

A DHA is required for facilities that handle combustible dust, which includes most food processing facilities. Dry food dust—including dust from sugar, flour, starches, cocoa powder, dry spices and flavorings, dehydrated milk products, and dust from processing grains and nuts—is combustible under the right conditions. These conditions include:

• Suspension of dust in the air in a cloud;
• Confinement of the dust cloud in an enclosed space, such as a storage silo, enclosed conveyor system or mixer, or dust collection system);
• Oxygen to fuel a combustion reaction (e.g., oxygen found in atmospheric air); and
• An ignition source, such as an open flame or high heat from ovens, sparks from friction in mechanical systems or conveyors, or static electricity.

Under the National Fire Protection Association (NFPA) standard 61, “Standard for the Prevention of Fires and Dust Explosions in Agricultural and Food Processing Facilities,” Chapter 7.1.2.2, a DHA is required for bakeries and food processing facilities every five years. A new analysis may also be required if the facility introduces new dust types, processes, or equipment that will substantially change the risk profile.

The DHA Process

NFPA 61 requires that “the DHA shall be led by a qualified person.” For most food processors and bakeries, that will mean getting outside help from an expert to complete the process. The organization does not mandate a specific format for the DHA but, in general, the process will include the following:

• Material characterization;
• Process characterization and hazard identification;
• Evaluation of existing safeguards;
• Mitigation recommendations; and
• Verification.

Material Characterization

The first step in the DHA process is to determine the material characteristics of the dust. In some cases, it may be possible to use published industry values for your dust type; however, your dust must be substantially similar to the dust used for comparison in the published values. The explosibility of dust is dependent not only on its chemical composition but on factors such as particle size distribution, particle morphology, moisture content, and other variables. For this reason, it is usually advised that facilities collect a sample of their specific dust for analysis. The sample must be sent to an independent accredited laboratory (ISO17025 Accredited Lab or Calibration Round Robin Lab) and tested using NFPA-approved analytical processes covered by the accreditation. You can find an accredited laboratory at dustsafetyprofessionals.com.

Testing may include all or some of the following:

• Go/no-go testing: A simple screening test to determine whether dust will ignite in a pile and/or explode in a cloud.
• Explosion severity testing: These tests are conducted in a pressure vessel to determine the explosion indices, measures of how severe an explosion would be if one were to occur. These indices include K_ST (the speed of pressure rise) and P_max (the maximum pressure rise in a closed vessel).
• Additional explosion testing: Other testing may include indices such as mini­mum explosive concentration (MEC), minimum ignition energy (MIE), and minimum ignition temperature (MIT). These values provide insight into the specific conditions under which an explosion is likely to occur.

Process Characterization and Hazard Identification

The DHA will also include measurement of pre-mitigation conditions, analysis of the processes in the facility, and identification of specific hazards. For example, it can pinpoint:

• Where dust clouds tend to form (e.g., places where dust is disturbed);
• Where dust accumulates on surfaces;
• Where dust clouds are under confinement (e.g., enclosed conveyor systems, silos, dust collectors); and
• What potential sources of dust ignition exist.

Evaluating Existing Safeguards

The DHA should note the safeguards that are already in place and their effectiveness in reducing a combustible dust explosion risk. These may include:

• Housekeeping practices (e.g., wet or dry sanitation type and frequency);
• Administrative controls (e.g., training programs, access limits, hazard communication);
• Engineering controls (e.g., dust collection); and
• Safety systems (e.g., deflagration systems, fire breaks, fire suppression/sprinkler systems).

Mitigation Recommendations

The DHA will include a set of recommendations specific to the facility. These recommendations will address the hazards identified in the DHA; they may include updates to existing safeguards as well as new recommendations. Examples could include:

• New housekeeping procedures;
• Upgrades to dust collection systems;
• Changes to process controls (e.g., changing the operating parameters of conveyance systems or mixers to reduce dust cloud formation);
• Removal of enclosures that create ­dangerous confinement of dust; and
• Removal of ignition sources.

Verification

The final step of the DHA should include measurements to determine whether the mitigations have been effective. Specifically, have levels of dust been reduced on surfaces and in the air and have hazards identified in the DHA been removed?

Collecting Your Dust Sample for a DHA

Collect dust samples in a clean, static-free container and follow all laboratory guidelines for storing and shipping your dust. Courtesy of RoboVent.

When preparing for laboratory testing of combustible dust, the dust must be collected in accordance with NFPA 652 Chapter 5.5. This document outlines procedures for safe collection of a representative dust sample. Some things to keep in mind:

• Contact your laboratory for specific requirements for collecting, storing, and shipping your dust sample. Sample size requirements may vary by laboratory and test type.
• Dust samples must be representative of the dust present in your facility. If you have different types and levels of dust in different places, you may want to collect multiple samples from different locations. Elevated surface samples will identify hazards of dust accumulation in the facility. Raw material and final product samples provide a baseline for understanding hazards related to material unloading and conveyance or packaging.
• Be careful not to introduce new hazards while collecting the sample. Samples should be collected without introducing an ignition source or dispersing dust into the air. Use non-sparking equipment such as plastic antistatic shovels and natural bristle brushes when collecting dust. When collecting samples from elevated locations, be sure to follow all safety guidelines for working at heights.
• Take care to preserve sample integrity when collecting and storing the dust sample to avoid the introduction of contaminants that could confound the investigation. Samples should be collected with clean equipment and placed in a clean plastic bag or non-conductive container.
• Consult the U.S. Department of Transportation’s hazardous materials regulations prior to shipping your sample and take all required shipping precautions.

These dust sample collection guidelines provide additional information for NFPA 652 compliance for sample collection, types of laboratory testing, and tips on finding an accredited laboratory for combustible dust testing.

Dust Hazard Analysis Outcomes

The DHA should be considered a living document. While completion of a DHA is required for compliance with Occupational Safety and Health Administration regulations and NFPA guidelines, it should be the first step in an ongoing combustible dust safety plan.

The DHA will help you determine risks associated with your specific dust, identify areas of your facility in which specific combustible dust hazards exist, and make effective recommendations for the mitigation of combustible dust risks.

Once you understand your current state, risk profile, and mitigation options, it is time to put the recommendations into place and conduct validation testing to determine whether goals have been met. Risk assessment and validation should be an ongoing process. While the DHA is only required to be reevaluated every five years, facilities should take steps to ensure continued compliance and improvement. This includes:

• Monitoring airborne and surface dust levels;
• Ensuring compliance with administrative controls and housekeeping procedures;
• Maintaining safe operating limits for equipment as outlined by the DHA;
• Evaluating any changes in equipment, procedures, or processes to ensure that new hazards are not introduced;
• Training all employees in the hazards of combustible food dust and ensuring that they have job-specific training for their areas of responsibility; and
• Updating the DHA when significant changes to materials or processes have been made.

Few bakers and food processors have the necessary skill sets on staff to conduct a formal DHA and make mitigation recommendations. It is usually advisable to work with a qualified engineering partner when conducting the DHA and implementing recommendations.

Yinger is director of engineering at RoboVent. Reach her at info@robovent.com. For more information about the DHA process, view the Visual Guide to Combustible Dust, available at robovent.com.

Image 1: EXPLOSION PENTAGON

CAPTION: All five elements of the Explosion Pentagon must be present for a combustible dust explosion to occur.

Credit: Courtesy of RoboVent.

Image 2: STATIC-FREE CONTAINER

CAPTION: Collect dust samples in a clean, static-free container and follow all laboratory guidelines for storing and shipping your dust.

Credit: Courtesy of RoboVent.

The post Dust Hazard Analysis for Food Facilities appeared first on Food Quality & Safety.

The supply chains that industries rely on to carry products around the world are undergoing a seismic transformation. Upheavals triggered by the COVID-19 pandemic and its seemingly never-ending repercussions continue to impede the flow of goods in every sector, including the global food supply. Shoppers are no longer surprised to discover that their favorite grocery products are out of stock; even restaurants are reporting availability issues that affect their menu offerings on a daily basis.

Unpredictable supply timelines can cripple the provision of goods across all industries, impacting production, sales, and customer satisfaction. The food industry faces the additional challenges related to maintaining food safety through the distribution of perishable items. Grocery stores and restaurants manage their supply chains and inventory with meticulous attention to temperature control requirements and expiration dates to ensure that food is safe to eat when it is sold. Delayed shipments can compromise freshness and elevate the risk of spoilage or contamination, posing a threat to public health.

Meanwhile a massive, technology-based evolution of traceability systems connecting suppliers and retailers across the entire supply chain is underway. This system hinges on effective teamwork among trading partners to facilitate real-time data exchanges so that all stakeholders can quickly pinpoint the location and disposition of a particular product at any time throughout its journey to point of sale.

In order for this system to work, all parties in the supply chain must be engaged in a collaborative approach based on standardized data that will allow clear and timely information exchanges. System compatibility and data standards are essential to enable full visibility and traceability so that buyers will know which products are available or out of stock, where they are in the distribution chain, and when delivery can be expected, for starters.

Sharing pertinent supply chain information helps all trading partners anticipate, plan, and optimize their ordering, delivery, and inventory management, as long as the data is exchanged in a standardized format that all parties can understand. This is the premise behind the adoption of data standards to enable clear and accurate exchange of information.

The momentum to incorporate technology for supply chain improvement also coincides with and supports two major initiatives driving the food industry’s adoption and implementation of data standards: FDA’s proposal to heighten traceability requirements for certain foods and a movement toward labeling products with two-dimensional (2D) barcodes that enable access to unprecedented levels of product information and transparency.

FDA Heightens Traceability Requirements for High-Risk Foods

Data show that most foodborne illness outbreaks in the U.S. are caused by certain food categories that are particularly susceptible to pathogenic contamination. The Food Safety Modernization Act (FSMA) directed FDA to develop a standardized mechanism to identify these foods that pose a higher risk to consumers and to monitor these specific products with extra vigilance: to know where they are at all times, enabling fast, accurate removal from the supply chain if needed, as in the event of a recall or market withdrawal.

That’s why FDA is now imposing extra, mandatory traceability requirements for producers of foods they have designated as “high risk” under Section 204 of FSMA. The agency’s new Food Traceability Rule, with a proposed compliance date in January 2026 for all producers, will require that all supply chain partners that harvest, produce, handle, and acquire foods on FDA’s Food Traceability List (FTL) must keep more detailed records to drive greater transparency, helping to prevent or better mitigate outbreaks of foodborne illnesses.

The rule specifically requires those who “manufacture, process, pack, or hold” foods on the FTL to record certain key data elements (KDEs) associated with different critical tracking events (CTEs) in the supply chain. CTEs include growing, receiving, creating, transforming, and shipping; different KDEs will be required for each event, depending on the commodity being tracked.

The new mandatory recordkeeping procedures go beyond the typical “one up, one back” traceability to incorporate more robust data; under 204(d), each product needs its own unique identifier, batch/lot code, and serial number to be captured at every step of the supply chain process. Supply chain partners will have to maintain the data in their systems for two years and provide it to FDA within 24 hours of official request in the event of a recall so that affected products can be removed from the supply chain as quickly and with as much precision as possible.

Section 204 is an important part of FDA’s commitment to dramatically improve food safety. The blueprint calls for a new, technology-driven approach to food safety that enables supply chain partners to effectively communicate details about products on order, in inventory, and in distribution.

To ensure the traceability data recorded at every stop along the way can be understood and shared by all stakeholders in the chain of custody, the blueprint specifies that “existing consensus standards” be used to ensure that systems are designed with interoperability as a foundation. It calls for the use of global data standards to help industry speak the same language in transmitting product, location, and event information across the supply chain.

GS1 US is working with the food industry to help stakeholders understand how standards can be leveraged to enable better traceability and meet FSMA requirements. By using standards, foods harvested, processed, or manufactured can be identified with specific global trade item numbers. These numbers can be embedded along with expiration dates, batch/lot/serial numbers, quantities, weights, and other product information in a barcode on each product case. The barcode enables automated data capture at every point along the supply chain. Each stop is identified with a unique location number. Transaction events such as shipping or receiving can be recorded and shared using an information service to maintain a complete product history and pass updated information along to the next entity in the supply chain.

The Barcode as Information Powerhouse

Retailers have been scanning barcodes to facilitate product identification at checkout, primarily for pricing information, for 50 years. Modern, digital technology has enabled development of new, 2D barcodes that are capable of carrying a large amount of data, including the traceability details required under FDA rules and regulations. Product information such as ingredients, nutritional information, batch/lot numbers, country or place of origin, and expiration dates can all be encoded into a 2D barcodes—such as QR codes and data matrix barcodes—and ensure regulatory compliance with the newly proposed traceability rule.

Consumers, who are increasingly interested in learning more about the foods they buy and eat, can quickly find detailed information with a simple scan of this barcode on their smartphones. This enables consumers to make more informed decisions based on their personal values and concerns. In addition to ingredients and allergens, today’s consumers are focused on a product’s place of origin, its producer’s fair trade and sustainability practices, and other sourcing and processing details. Brands can increase consumer engagement by providing easy access to all this information, as well as promotional offers, recipes, and more.

Complete and accurate product information that is consistent between the in-store and online shopping experience is vital for consumer engagement today. The UPC cannot accommodate the growing demands for greater product information transparency, traceability, and authentication. By transitioning to 2D barcodes on product packaging, brands can provide more robust data. This migration will support a multitude of uses, including better recall management.

Retailers can leverage the information contained in a 2D barcode to highlight specific, verified product attributes that shoppers are looking for, details that cannot be encoded in a traditional UPC code, but that could be made accessible via a web-enabled data matrix barcode or QR code. These advanced data carriers also support retailer business processes and supply chain needs, enabling faster and more accurate product traceability, efficient inventory management, recall readiness, sustainability, and product authentication through access to expanded product details.

Increased product transparency will help retailers nurture relationships with shoppers and encourage brand loyalty. People shop where they know they can find what they need. This becomes even more important when they are frustrated by uneven product availability and must resort to finding replacement products. The availability of detailed product information can help retailers convert shoppers into buyers.

Grocery and other retail industries have made a collective commitment to enable broadly accessible 2D scanning capability at the point of sale by 2027. While linear barcodes will remain, the 2D barcodes will add significant functionality and benefits to better enable consumer engagement.

The Supply Chain of the Future

Information is power, as the saying goes, and when it comes to supply chain operations, it certainly is. The more stakeholders know about food products traveling through the supply chain and at retail, the better equipped they are to handle fluctuations in supply and demand, to meet evolving consumer needs, and to take swift, appropriate action when necessary.

Interoperable supply chain data that can be captured and shared by trading partners throughout a product’s journey from “farm to fork” is fundamental to the advancements needed. Transitioning to the supply chain of the future—including more granular track-and-trace capabilities and data-rich 2D barcodes to increase transparency and consumer engagement—is happening. As these changes take hold, the food industry will realize greater resilience and better operational performance. Better food safety is possible with the help of new technology and industry collaboration.

Fernandez is a vice president at GS1 US, a global standards agency. Reach her at info@gs1us.org.

The post Traceability Standards Can Help Improve Food Safety appeared first on Food Quality & Safety.

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.

The post Monitoring Temperature Data for Food and Beverages appeared first on Food Quality & Safety.

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.”

The post FDA Declines to Regulate Edible CBD Products appeared first on Food Quality & Safety.

In March 2020, the Department of Homeland Security designated food and agriculture production one of 16 critical infrastructure sectors. This was a significant recognition, as it allowed food processing plants to continue their activity during the pandemic. Even with the pandemic mostly in our rearview mirror, this designation shelters the sector from future disruptions.

The classification also comes with additional compliance and regulatory ­issues. While health and safety are the top concerns in these industries, production efficiency and business operations are not to be neglected. With a more and more ­unstable geopolitical climate, a lot rests on the shoulders of food processing facilities.

Video monitoring can help take some of that burden off your shoulders. It can improve processes and compliance, and help streamline processes. When you hear “video monitoring,” security is often the first thing that springs to mind. Granted, enhanced security is not a small feat, but video monitoring in food processing plants can help with a lot more. Here are five advantages to using this technology in your food facility.

1. Ease FDA Inspections

Thanks to the Food Safety Modernization Act (FSMA), FDA’s regulatory requirements with regard to food processing has increased significantly.

FDA inspections aren’t always easy to pass. Everything is under scrutiny, from your processes to the equipment you use. While using the right food processing equipment to avoid contamination is a fairly straightforward guideline, when it comes to procedures and the way they are implemented, things can get murkier. This is where the right surveillance equipment can assist.

Video surveillance can help you prove your point, especially through the technology’s physical security component: You can prove that your processing plant was not contaminated by unauthorized personnel or intruders by showing footage of who had access inside. Moreover, video monitoring can help prove that you’ve thoroughly secured the storage and use of toxic chemicals. When combined with access control systems, video surveillance can be your best ally during an FDA inspection.

2. Identify and Resolve Equipment Failure via Video Monitoring

When essential equipment is down, your entire plant may have to stop working. Depending on how long it takes to get to the root of the problem, you can lose hundreds of thousands of dollars due to activity disruptions. According to a 2015 study from research firm Aberdeen Strategy and Research, a food processing plant can lose up to 20% of its capacity because of downtime.

Through intelligent video surveillance systems, you can see all the activities that led to an equipment’s failure in real time, and you can identify the sequence of events at fault and solve the issue quickly. More importantly, you can prevent downtime from happening altogether. While some equipment malfunctions are easily missed by workers in a noisy plant area, they often can be easily spotted by an operator in a remote location who may be viewing from a different perspective.

3. Streamline Operations and Prevent Losses

Real-time monitoring can help identify staff effectiveness, as well as faulty processes that may lead to losses. The traditional way of identifying process faults—through human inspectors monitoring the lines—can’t be as comprehensive as video surveillance. Moreover, the latter comes with a hard-to-beat advantage: the bird’s-eye-view perspective, which is impossible to achieve using human eyes alone.

This is why 93% of companies that use video systems for cross-functional benefits report a positive impact on operations, according to 2013 research from the Loss Prevention Research Council.

4. Expand New Employee Training

Video monitoring can help pinpoint common knowledge gaps for your new training—before they become serious issues.

5. Improve Health and Safety

Employee health and product safety are the biggest concerns at food processing plants, and they can be aided by video monitoring. In complex food supply chains, there are far more chances for food to become contaminated are increased by each additional step. Each new stage has its own risks. Video surveillance can help identify the riskiest stages and address each problem before they escalate.

Choosing a Video Monitoring System

Every plant manager knows that choosing the right food processing equipment for their facility is crucial. Video surveillance systems should be treated the same way. While off-the-shelf cameras are definitely more affordable, they are also more likely to contribute to food contamination because they are not made of bacteria-resistant materials. Furthermore, store-bought solutions don’t have the longevity and endurance you need in harsh environments such as food processing plants. Extreme temperatures and extreme temperature variations, humidity, noise, and steam are just a few of the things that impact a cameras’ lifespan.

Dedicated cameras meet the Stainless AISI 316 standard, which means they are compliant with FDA regulations. It’s not just the equipment used in food processing directly that can contaminate the food; it’s also the additional devices and tools. This is why it’s important to use video monitoring systems that don’t increase your contamination risks.

Dedicated food processing facility cameras also have a long life advantage. They are built to withstand humidity, noise, extreme temperature, temperature changes, and high vibration levels. This means that the investment in specialized cameras is protected for a longer period of time. Additionally, food processing managers can rest assured knowing that their monitoring feed won’t be interrupted by yet another camera failure due to the harsh environment to which it has been exposed.

Schmidt is a global sales manager at Opticom Tech. Reach her at heidi@opticomtech.com.

The post Five Advantages to Using Video Monitoring in Your Food Facility appeared first on Food Quality & Safety.

In October 2023, Orkin released its annual “Top 50 Rattiest Cities List” and, while many might assume that New York City would be No. 1 on this list, it was in fact the Windy City that stole the least-coveted spot for the eighth consecutive year.

With the drastic increase in rodent sightings during the COVID-19 pandemic, consumers and businesses alike have been concerned about their health and safety. For food manufacturers and distributors, the increase in rodent activity isn’t something that should be ignored.

While gradually resuming pre-pandemic activities has helped to reduce the number of public rodent sightings, the pests’ threat to public health hasn’t decreased. In fact, these filthy pests can spread dozens of harmful diseases—directly and indirectly—such as hepatitis E, leptospirosis, and hantavirus, in addition to contaminating food products and causing structural damage in buildings.

Left unaddressed, rodent sightings within a commercial facility can lead to ongoing infestations and, eventually, failed inspections and stalled operations—costly blows to your bottom line. Knowing how to spot rodent activity is essential in stopping them early. If you notice any of the following signs around your food facility, you might have a rodent problem:

• Capsule-like droppings;
• Grease marks along skirting boards, walls, and tight spaces;
• Gnaw marks on walls, wires, and other materials; and
• Nests in dark areas such as crawl spaces, roofing, and garbage dumps.

So, how does a food manufacturing and handling facility protect itself against rats? By implementing an integrated pest management (IPM) program.

Preventive Measures

Most food-handling businesses likely have heard about IPM programs, especially if they are regularly audited by third-party food quality and safety auditors or subject to frequent regulatory inspectors. These programs are implemented by qualified pest control technicians in collaboration with a business’s food safety and quality assurance team to help deter pest activity and prevent infestations. IPM programs focus on preventive techniques such as exclusion, sanitation, and maintenance to keep pests where they belong—outside of your food facility. When it comes to rodent control, exclusion is particularly important for facility managers.

Because food processing facilities receive and send shipments daily, it’s easy for rats and other rodents to slip into transportation vehicles, packaged goods and, eventually, your building. Not only does this jeopardize your business’s products and your reputation, but employee health is also at risk. Exclusion helps keep rodents outdoors by making sure potential entry points are quickly sealed and any maintenance work is completed in a timely manner. While each business’s exclusion plan will vary based on local pest pressures, climate, and location, the majority of pest control technicians will begin with a comprehensive facility inspection prior to implementing specific tactics. These tactics can include sealing cracks and crevices that rats can slip through, installing weatherstripping, and performing door sweeps.

Another preventive measure you can add to a plan is remote pest monitoring. When you’re running a round-the-clock operation like most food-handling facilities do, your employees might not have time to monitor for pests while also performing their production responsibilities. Remote pest monitoring can help flag pest issues for you to address with your pest control provider before a bigger problem arises. There are a variety of devices that can be used during remote monitoring, depending on your facility’s specific needs and structure, but the results are primarily the same: You’ll be able to track pest activity from any location and involve your pest control provider when needed to identify pest activity trends.

Remote pest monitoring is especially beneficial in automated food manufacturing and processing facilities that see little human activity, reducing the amount of time employees spend spotting pest issues in real time.

While monitoring pest activity remotely is beneficial in places in which staff aren’t always present, it’s helpful to have other observation methods in place. Staff training in pest control might not be high on your list of priorities, but take it from the experts in commercial pest control: It can save you a lot of money and time. Your employees, primarily those on the production floor, see and hear more than you might know, which makes them invaluable in helping to identify pest issues. Once your staff knows the types of pests that frequent your facility, can identify the persistent hot spots, and understands the process for reporting activity, they’ll be able to help you kick these pests to the curb. Don’t forget to do your part as a leader by making sure pest activity logs are accessible to your employees and including your sanitation team in trainings, as they’re most likely to spot pest issues during cleanings.

Now that you know how to spot signs of rodent activity and can implement processes and procedures to reduce their impact on your business, don’t forget to review your IPM plan frequency with your pest control provider. Rodent activity can fluctuate with the seasons, so it is important to regularly evaluate the effectiveness of your plan to make sure food safety remains a top priority.

If you don’t currently have an IPM program in place or employ a reliable pest control provider, now’s the time for action. Whether your food facility is located in one of the top 50 rattiest cities or not, prioritizing preventive pest control measures will help you avoid extensive problems down the line, and your customers and employees will appreciate that you are prioritizing their health and safety.

Ramsey is a senior technical services manager for Orkin. Reach him at gramsey1@rollins.com.

The post How to Prevent Rodent Issues in Your Food Facility appeared first on Food Quality & Safety.

With the proliferation of tools to collect and analyze data that can inform problem solving and decision making, the use of big data and data analytics has become ubiquitous throughout many industries. While the food industry may be slower to adopt big data and data analysis than some other industries, such as healthcare, it’s catching up as food scientists and other experts recognize its potential as a powerful tool to address large, complex problems in the food industry.

Food safety is one such problem. Affecting every step along the food supply chain, food safety relies on a company’s ability to gather reliable data in a timely manner and then act on that information as needed. From food traceability to digital pest management to better detection of foodborne illness breakouts to reductions in food spoilage, big data and data analytics are being employed to advance food safety at the local and global levels.

“Big data can be used at all steps of the food value chain to improve food safety,” says John Donaghy, PhD, head of food safety at Nestle in Switzerland. On the farm or at primary processing steps, he cites several data types that can be collected to improve food safety, such as water analytical test data, hygiene status of workers, and certification status of farms/processors. At the consumption/public health end of the food chain, he cites the use of big data and data analytics for communicating recalls to consumers and for source tracking foods that cause foodborne illness outbreaks. Between these end points, he indicates numerous areas during manufacturing where data can be collected, e.g., microbiological verification testing, process control data, and environmental monitoring data. “Data relevant to food safety and quality can be collected at so many steps throughout [the] food chain; even real-time monitoring of temperature during logistics and transport in the supply chain can be incorporated into dynamic risk management,” he adds.

For food manufacturers and processors, from small to large businesses, the potential impact of big data and data analytics to improve food safety can be enormous. A 2022 report by the Global Food Safety Initiative (GFSI) Science and Technology Advisory Group (STAG) describes the potential impact on business, as well as what businesses should be thinking about when considering the use of big data and data analytics in their own organization (see Tables 1 and 2, below).

A final key question for businesses, according the GFSI report, is: “Do businesses understand the strategic impact of big data on their operations and do they have the appropriate talent strategy for these changes?”

Several food safety experts offer their views on the value of big data and data analytics for food manufacturers and processors that may help businesses better answer these questions.

Collecting Big Data: Internal and External Sources

Suzy Sawyer, food safety, quality and regulatory digital and analytics leader at Cargill underscored the growing role that data plays for food companies to ensure safe, quality products. “What we’ve discovered at Cargill is that the vast amount of data collected from internal and external sources can be used to help identify potential food safety improvements, analyze, and manage quality control, and mitigate food supply chain risks,” she says.

She cited a number of internal sources of data collection, including data gathered manually (plant floor quality and safety checks and observations), as well as sources from digitized technologies such as sensors (inline processing from machines/processes), data loggers (sensors capturing characteristics such as temperature and humidity), and instrumentation (near infrared detection instruments).

External data sources include technologies designed to exchange data collection to improve food safety, such as regulatory notifications or alters, food-related media, weather, and commodity prices.

Digitizing data across the food supply chain enables companies to amass large quantities of internal data and to capture new data sources to improve food safety risk. New sources of data, such as those available on smartphones and social media, are creating massive data sets, while new technologies allow for the sharing of big data through what is called the internet of things (IoT). Data from sensors, devices, machines, and computing services can now be shared via the internet or a communication medium such as Bluetooth. One example of this is the large amount of data captured by RFID technology, providing information such as batch dates, product variables, weights, and sizes. Wireless devices can be used to automatically read data from RFID tags to improve stock management. Connecting sensors to this system could provide additional data on the environmental condition of goods as they move through the supply chain, such as temperature, humidity, dust, dirt, microbes, or food spoilage chemicals.

Other sources of data that are being generated from whole genome sequencing (WGS) and other “omics-based” methods offer a way to more precisely identify and characterize, for example, a specific bacterium within a food system. These data rely on advances in technology, such as machine learning and artificial intelligence, to generate algorithms that can offer predictive models of risk. FDA’s GenomeTrakr network, for example, uses WGS to help reduce foodborne illnesses and deaths. Another potential use of GenomeTrakr is to sequence pathogens that are not foodborne but that may still be linked to disruptions in the food supply chain; to date, the GenomeTrakr network has performed WGS on bacteria such as Salmonella, Listeria, E. coli, Campylobacter, Vibrio, and Cronobacter, as well as parasites and viruses, all of which are publicly available via the National Center for Biotechnology Information website.

Abani K. Pradhan, PhD, professor in the department of nutrition and food science and Center for Food Safety and Security Systems at the University of Maryland in College Park, sees the increasing use of “omics-based” methods as a paradigm shift in bacterial surveillance. He says that machine learning has the potential to “extract useful patterns that could help improve current methods and models to predict risk or help improve manufacturing- and processing-related decision making.”

Dr. Pradhan emphasizes, however, that current risk assessment frameworks and predictive models don’t typically incorporate useful information such as pathogen genomics data. He and his colleagues at the University of Maryland are currently testing ways to improve food safety by integrating experimental and field data with mathematical modeling and developing predictive and risk models to help guide policymakers, government agencies, and the food industry in making informed risk management decisions. They are also developing models to use bacterial genomic data, along with the accompanying metadata, to help predict whether a bacterium is more or less virulent in host systems. Further research involves developing a new method to incorporate bacterial genomic data into a dose-response modeling framework is underway (Risk Analysis. 2022;43:440-445).

“The primary advantage of these models is that they introduce a way to predict microbial behavior from a genomic perspective, particularly in microbial species that are known to have several subtypes (with potentially different characteristics) that can cause human infection and illness,” he adds.

Whether collecting data internally or externally, big data is just the source. And as indicated by the research just described, the real impact of big data is analyzing it and interpreting what the information means for an actionable goal.

Data Analysis: Translating Data into Actionable Information

To harness the ability of big data to improve food safety, analytics to translate data into actionable information is needed. The term “precision food safety” is now being applied to refer to the use of big data, particularly the new data sources obtained from genomic sequencing and other “omics-based” methods, to improve food safety.

Strategic use of big data relies on the ability to analyze the information, whether by a food scientist within a company or a researcher working on developing predictive and risk models to help the food industry mitigate food safety risks.

Experts cite several challenges to this goal, one of which is precisely the “bigness” in big data. Dr. Donaghy refers to this as the volume and veracity of data. “The user has to understand where they can get the most value from all of this data and whether it is reliable enough,” he says.

Dr. Pradhan describes this challenge to processing large quantities of data as needing to “extract meaningful information from it, while ignoring ‘noise’ or irrelevant data.”

Another challenge is the need to digitize data so that it is in a form that can be analyzed, either by machine algorithms or trained personnel. Sawyer notes that in companies that have not modernized and are still working with legacy technology or manual processes, collecting data digitally or in a structured format may not be possible. She says a common theme Cargill hears when benchmarking with companies is that there are large amounts of unstructured data exchange between organizations. “Companies need to have the ability to extract meaningful information from these inconsistent formats and languages,” she says.

Another challenge is the lack of data standardization. “In the absence of industry-wide and cross-industry data standards, sources of data have established their own definitions that don’t always translate between systems internal to an organization or externally,” says Sawyer.

Not only does this make it difficult to connect or exchange data across multiple sources to make information consumable and informative, Sawyer says that the lack of data standards can affect the ability to filter big data sets that can be relevant to an organization or to a problem to be solved. “One way Cargill addresses some of these challenges is through the use of metadata and data science concepts such as natural language processing,” she adds. “Our team of digital, data, and analytics experts within our food safety, quality, and regulatory organization is also focused on new ways of working and improving food safety through data-generating technologies.”

Dr. Donaghy underscores that not all companies will be able to easily meet these challenges. “Companies need to see the value/benefit of moving from their current ways of working,” he says. He cites examples of how different-sized companies can begin to use big data in their operations. For smaller companies, he cites the many off-the-shelf digital solutions that can be purchased, such as recall-ready software that companies can plug into, and programs for ready-made environmental monitoring that companies can use to plug in their test data results.

Larger companies, he says, may employ data scientists who can understand and help improve their internal data—such as supplier management data, certification/audit data, incident management data, cleaning program data, and environmental monitoring data—through data analytics, such as predictive analytics. 

Dr. Donaghy notes, however, that companies will still need food safety and quality experts to direct data scientists. He cited the example of next-generation sequencing as a diagnostic/investigation tool for food safety. “Companies can employ a third-party laboratory to do this for them, or they can do this internally,” he says. “If they do the latter, it will require food safety specialists as well as bio-informaticians.”

For Dr. Pradhan, hiring a data analyst to process and analyze big data may seem logical, but he thinks that food manufacturers or other stakeholders may benefit by getting training from subject matter experts, such as scientists and researchers who have a good understanding of the food processing, manufacturing, and safety paradigms in these techniques.

Whether a company hires someone new or educates current employees, a certain skillset will be needed to navigate this new terrain of big data and data analytics as applied to food safety. Sawyer lists four primary skillsets: data literacy (the ability to read, understand, and interpret data), data translation (the ability to understand the business needs, to speak technology, and to translate between the entities), data analytics (the ability to analyze data for insights and decision making), and data science (the ability to uncover patterns in data and build predictive models with artificial algorithms such as machine learning).

Data Sharing

To realize the full potential of big data and data analytics to improve food safety, data sharing among companies, regulatory bodies, and researchers is vital. Amassing large amounts of data inputs from large numbers of sources, and the more data that is available to work with strengthens a company’s ability to use the data to see patterns, predict risks, and make decisions.

Barbara Kowalcyk, PhD, director of the Center for Foodborne Illness (CFI) Research and Prevention and associate professor of food safety and public health at The Ohio State University in Columbus, and her colleagues have been working on how to facilitate data sharing, given the need to aggregate data across industry to best inform algorithms based on artificial intelligence and machine learning. “Data sharing between organizations in the [food] industry is difficult from a proprietary perspective, so we need to figure out a way to share data and aggregate it,” she says. “If you have enough data, you can mine the data to help inform specific situations on what works best and then share it.” For example, if an intervention has worked well for one company, sharing that with others may allow those companies to direct resources toward that intervention.

Dr. Kowalcyk and her colleagues are working to develop a data governance framework for sharing public and private sector data that will support the development of risk assessment models and burden-of-disease estimates. The project will help answer questions that many people in the private and public sectors have regarding data sharing, such as who will have access to the data, how it will be used, and how confidentiality will be protected.

Initiatives underway are already highlighting both the reasons for and the benefit of sharing data to improve food safety. Along with the GenomeTrakr Network, FDA is piloting several other initiatives under FDA’s New Era of Smarter Food Safety. Launched in 2020, this initiative employs a number of “smarter” tools and approaches to improve food safety, such as root cause and predictive analyses, as well as other tools such as partnering with states to leverage data and analytics. Other FDA initiatives include the Artificial Intelligence Imported Seafood Pilot, the Domestic Mutual Reliance, and Remote Regulatory Assessments.

With access to new tools to capture large amounts of data and the means to interpret that data to improve food safety, food companies have a powerful new way to ensure the safety of their food product along the food supply chain—right at their fingertips. “All food sectors will benefit from the further use of big data interlinked from food source to consumption,” says Dr. Donaghy, “from the smarter way we do agriculture through to the more precise way authorities and manufacturers perform source attribution and investigation.”

The post How Data Analysis Is Revolutionizing Food Safety appeared first on Food Quality & Safety.

Most corn processors and consumer packaged goods (CPG) companies associate genetically modified (GM) high alpha-amylase corn with ethanol production. That association was true five years ago, but times have changed, and corn processors and CPG companies must be aware of a new risk profile this corn poses to their operations. High alpha-amylase corn production is growing by double digits each year in part due to its adoption as cattle feed.

The risk of cross pollination and cross contact has been growing in areas where both food-grade corn and GM corn intended for ethanol or livestock feed are planted. This growth has correlated with rise in the frequency of processing and product quality issues at major corn processors across the U.S. related to high alpha-amylase corn.

Corn processors and CPG manufacturers who want to keep their clients happy by supplying quality products are ­dealing with this new challenge by adopting new preventive controls that include implementing inbound corn testing.

High Alpha-Amylase Corn Adoption

The high level of alpha-amylase content in GM corn acts as a catalyst in breaking down complex starch into smaller chains called dextrins. The effect is demonstrated to be highly beneficial in saving time and energy when converting corn starch to sugar for ethanol manufacture, but there are also claims that it drives digestibility and efficiency in cattle feed. As a result, high alpha-amylase corn is an innovative, specialized value proposition benefiting both ethanol and cattle feed production. These applications account for 90% of domestic corn use, according to USDA. 

This value proposition for cattle feed is proving to be very successful. The cattle feed application for this corn first introduced in 2018 has witnessed dramatic adoption, with double-digit growth in sales of all high alpha-amylase corn seed in 2021. As a result, high alpha-amylase corn farms are no longer concentrated geographically only near ethanol plants. They are now all over the U.S. in every corn-growing region. With this growth in corn farms, the cross-contact risk is growing every year. Wind and weather, as well as shared equipment, storage, and transport, can all lead to high alpha-amylase corn contamination and product issues.

What Millers Should Know about High Alpha-Amylase Corn

For corn processors, there is a consequential side effect of the alpha-amylase produced in this GM corn when it mixes with their food-grade corn. All of the extra starch-digesting enzyme inherent in the GM variety does not simply dissipate during the milling process but remains intact in the individual fractions of the milled corn, whether wet milled or dry. The enzyme laced into the milled product can reach optimal activity rate when it is being processed at elevated temperatures during the cooking process. The result is accelerated, unintended starch breakdown, which causes product quality issues.

The enzyme sometimes remains active even after the food product is packed. The nature of the enzyme, which acts as a powerful catalyst that is not consumed in the starch hydrolysis process, results in carbohydrates continuously disintegrating into sugar to a point of dysfunction. This has been responsible for disastrous results in the real world, with processors citing issues that include:

• Sticky or fragile tortillas;
• Crumbly chips and cornbread;
• Soupy and runny corn grits; and
• Non-binding tamales.

The high overlap of high alpha-amylase corn growth areas and U.S. milling capacity poses significant risk to the food-grade corn that millers buy and, in turn, ship to their customers. Up until recently, however, the milling industry has been hesitant and skeptical about the need for testing for high alpha-amylase corn. Elevators, distributors, and operations managers fear that additional testing steps will disrupt procurement operations in the middle of a labor shortage. Onsite quality managers also have limited awareness of high alpha-amylase corn testing in root cause analyses for ­quality concerns.

However, firsthand experience with quality issues in production and customer complaints are changing that mindset with senior quality managers. CPG manufacturers cannot afford to work with food-grade corn commingled with high alpha-amylase corn. Processing and manufacturing with a contaminated supply can lead to production losses, consumer complaints, and—potentially—to the loss of customers.

CPG quality control managers are now starting to ask millers to evaluate food-grade corn for alpha-amylase levels at a high sensitivity before they agree to make the purchase, and testing for high alpha-amylase corn is becoming the standard at most major players in the corn milling industry for sensitive processes such as nixtamalization and baking. No CPG manufacturer wants their consumers unhappy due to sticky tortilla or runny grits, and the onus is on millers to heighten their vigilance and prevent the unintentional introduction of enzymes into the product they supply.

High-Sensitivity Case Report

In the fall of 2021, one of the largest U.S. corn millers was struggling with multiple batch failures of masa flour. The head of quality worked to uncover the root cause of the failures, and was surprised to discover that high alpha-amylase corn was the primary factor in the failures, even though they were testing every inbound truck using a test that was able to detect one in 400 kernels (0.25%) GM contamination. The root cause analysis demonstrated that the miller needed to revise their acceptance criteria for inbound corn to a much lower cross-contact level under 0.1%. The miller then employed a high-sensitivity test capable of detecting high alpha-amylase corn in the customer’s batches at one in 2,500 kernels (0.04%).

Preventing Risk

At even the lowest levels, high alpha-amylase corn levels must be monitored to prevent the corn from moving through the food supply chain. This will ensure customer satisfaction and prevent business risk caused by poor-quality product. Quality managers across the industry are best positioned to mitigate this issue by identifying the sources of risk for their procured corn, thus protecting their brand and customers.

Vidwans is the global market segment lead at Envirologix. Reach him at arvidwans@envirologix.com.

The post Analyzing High Alpha-Amylase Genetically Modified Corn appeared first on Food Quality & Safety.

In early 2023, breakfast cereal manufacturer Post Consumer Brands announced the launch of a cereal called “Sweet Dreams.” The cereal will come in two flavors, blueberry and honey, and will be accentuated by lavender and chamomile and fortified with “a curated herbal blend and vitamins and minerals like zinc, folic acid, and B vitamins to support natural melatonin production.” A company press release stated: “More than ever, consumers are looking to embrace acts of self-care.”

The entrance of a major corporate cereal maker into the realm of these types of “self-care” foods is a reminder that, after a flare of popularity in the early years of the pandemic, “functional foods” are now becoming an established supermarket offering.

A few years ago, it might have seemed unlikely for consumers to expect food products to support claims that they can help prevent conditions such as cardiovascular disease; boost gut health and immunity, and promote mental health, well-being, and sleep. Today, food producers know that consumers are willing to pay a premium for those promised benefits.

Brian Chau, a food scientist and consultant based in San Jose, Calif., says the global “dietary supplements” market—which includes functional foods—is on track to hit $331.6 billion by the end of the decade. “The trend has accelerated since the pandemic,” Chau tells Food Quality & Safety, “but certainly has grown since the rise of the bar and powder supplement category. Functional foods are integrated into daily routines as pill [and] tablet fatigue is setting in for younger generations.  No longer do consumers expect just to eat when they’re hungry; they also see a meal or snack as an opportunity to improve health, without having to consume supplements separately in pill form.”

Chau notes that the increase of functional ingredients are primarily found in confections and beverages. He says that fortified gummy products are increasing in number, along with cookies, bars, chocolates, and drinks that are making functional claims.

Why Functional Foods?

Kantha Shelke, PhD, a senior lecturer at Johns Hopkins University in Baltimore and founder of nutrition research firm Corvus Blue, identifies a particular need that functional food serves for consumers. Generally, consumers choose functional foods because they feel these products reward their health, she says, but also because they see a social and moral incentive in taking care of themselves. For some, adding functional foods to their diet can be a way of advertising their lifestyle choices to others.

If consumers were already shifting away from taking vitamins and supplements in pill form, the pandemic was a mighty inducement. Sarah Johnson, PhD, director of the Functional Foods and Human Health Laboratory at Colorado State University’s College of Health and Human Sciences in Fort Collins, says the rise of functional foods was closely linked to the pandemic simply by how much more aware consumers became of health and disease. “Functional foods—or ‘superfoods,’ which is a more commonly used term—are definitely selling more than they were previously,” Dr. Johnson says. “Especially with the pandemic, consumers are looking for foods and beverages that can support their health, mitigate infection and adverse effects of COVID, and also promote mental health and well-being.”

What Are Functional Foods?

Dr. Johnson notes that “functional” foods are a difficult category to describe. Some foods—such as fruits, vegetables, nuts, legumes, and grains—are inherently functional and confer significant health value to consumers. Many other functional foods, however, are either designed to be functional or simply boast that they contain functional ingredients.

The functionality of this second class of foods is harder to measure. “Some of those ingredients are at levels that can provide physiological effects and health benefits,” Dr. Johnson says, “while others may just be in there because they are known to have health benefits but are not provided at levels to be functional.”

Dr. Johnson notes that many products boast that they contain an ingredient that has been subject to human or animal studies and has shown some proven effects, but the ingredient has not been studied as part of a product. She gives the example of the soluble dietary fiber inulin, whose health effects as an individual product have been studied, but whose efficacy as an ingredient to another product has never been assessed. This hasn’t prevented producers from adding health claims to products containing inulin.

A Rising Trend

Dr. Johnson says that, overall, functional foods do seem to be delivering more to consumers than they were a few years ago. “Consumers have driven functional food development to some degree because, as consumers learn about health and sustainability, the demand for certain products and types of products increase,” she says. But, she adds, researchers and food producers publicizing research on health effects has primed the public to demand foods that reflect such research. “I think both consumers and marketing or dissemination of health-related research drive demands and desires.”

Consider fermented foods, probiotics, oatmeal, and oat fiber, says Dr. Shelke. Consumers were already eating these products when researchers discovered the perceived gains associated with them. Both media and marketers immediately began reporting the potential health advantages of consuming these existing foods, and producers of such foods quickly got on board to market their products based on function. “Once food companies realized that people had interest in these types of products,” Dr. Shelke says, “they created more such products and then went on to expand the category with new types of nutraceuticals and functional foods. [Consumer] interest and market demand drove companies to innovate and create new functional products—and rinse and repeat.”

The problem with “functional foods,” she says, is that “all foods have functional properties, but it is the dose and frequency of consumption that matters most. The physiological [or] functional effects of functional foods depend on several factors besides just composition and the amount consumed.”

There’s no reason to presume that the functional foods boom is a passing fancy, Dr. Shelke says. Consumers may very well continue seeking out foods with perceived health rewards, but there remains the possibility that the field can expand. “Every food can be a functional food,” Dr. Shelke says. “It is how they are combined against the backdrop of lifestyle, other choices, inherent genetics, and the environment that makes even the seemingly lowly grains and tubers be dubbed as superfoods or functional foods.”

The post Functional Foods Continue to Gain Momentum appeared first on Food Quality & Safety.

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.

The post Will FDA’s Proposed Restructure Work? appeared first on Food Quality & Safety.