In November 2022, FDA published the long-anticipated final rule addressing food traceability. The rule, titled “Requirements for Additional Traceability Records for Certain Foods,” establishes certain traceability recordkeeping requirements for a variety of foods. This rule continues FDA’s work to implement the Food Safety Modernization Act (FSMA), and the additional traceability requirements imposed are due to the requirements of FSMA. These additional requirements go beyond the standard “one up, one down” tracking that currently occurs to better allow FDA to respond to and investigate foodborne illnesses.

The requirements of the rule apply only to the foods identified by FDA as high risk and listed by FDA on the Food Traceability List (FTL). FDA evaluated a comprehensive list of foods based on historical illnesses associated with the food, the potential for contamination and pathogen growth within the food, and consumption rates of the food, among other factors. From that evaluation, FDA identified certain types of food that presented a higher risk of foodborne illness. The FTL generally includes products such as soft and semi-soft cheese, shell eggs, nut butters, fresh produce items, deli salads, and fish and shellfish. Unless an exception exists, foods that contain even a single item on the FTL are also subject to the requirements of the traceability rule.

What’s Required in the Food Traceability Rule

Companies subject to the additional requirements must develop a traceability plan that applies to each food on the FTL that is manufactured, processed, packed, or held by the company. The traceability plan must include procedures for maintaining the required records, procedures used to identify which foods are subject to the requirements, procedures to assign traceability lot codes (when applicable), and a statement identifying a point of contact for questions about the traceability plan. In addition, for farms or aquaculture operations, a farm map must be included showing the location and name of each separate growing area or container, including geographic coordinates and other information necessary to identify the specific growing location.

Traceability lot codes are assigned only at three points of operations: the initial packing of a raw agricultural commodity (other than food obtained from a fishing vessel), the first land-based receiving of a food obtained from a fishing vessel, and every time the food is transformed. Transformation is any point in a food’s supply chain that involves changing a food through manufacturing, processing, packing, or labeling, for example, where the output food is also on the FTL. When the processing of a food listed on the FTL results in an output food that is not on the FTL, records are required under the rule for receipt of the food, but generally speaking, the food is no longer subject to the requirements of the rule after such processing.

Records required under the rule depend on the stage of the supply chain. Generally, however, records must include the location information for the immediate subsequent recipient, for the immediate previous recipient, and for any processing that occurred. In addition, quantity and product descriptors are required. Finally, for each transfer throughout the supply chain, a specific reference document must be associated with the transfer. Reference documents are business transaction documents that reflect the transaction or process, and may include purchase orders, invoices, batch logs, or production logs.

After a request by FDA, companies subject to the requirements of the Rule must provide an electronic sortable spreadsheet with the required data. Certain companies with annual values of sales below designated levels do not need to provide the electronic spreadsheet (and can instead provide the information in any format). After a request by FDA, the spreadsheet (or alternative data formats) must be provided within 24 hours unless FDA has agreed to a longer timeframe.

Who Has to Comply

Generally, all companies that handle a human food type on the FTL are subject to the rule; however, FDA has provided certain exceptions based on company size or company type. In addition, certain products that may otherwise be subject to the requirements of the rule are exempt from the requirements in certain circumstances. When an exemption is available and applicable, however, modified record requirements are typically triggered to demonstrate that the exemption is applicable and to ensure that the traceability chain is intact until the exemption applies. Product-based exemptions include produce that is rarely consumed raw, food that has been subjected to a kill step, and food that has been transformed such that the final product is no longer listed on the FTL.

Here, FDA has provided an example of canned spinach as a product that would be exempt from the requirements. Prior to treatment, leafy greens are listed on the FTL and, as such, spinach would be subject to the traceability requirements. However, canning acts as a kill step and transforms the product, a fresh leafy green, into a cooked, non-fresh leafy green, which is not listed on the FTL. The canning processing step would, regardless, be subject to recordkeeping to demonstrate why the exemption applies, and the canner would still need to comply with record requirements applicable to receivers of foods on the FTL, as the food was received while not eligible for an exemption.

In addition to product-based exemptions, exemptions or modified requirements exist for small producers, small retail food establishments and restaurants, and operations engaged in certain types of processing or holding of food. In addition, the requirements of the rule do not apply to transporters of food, but both intra- and inter-company transport of food would require recordkeeping of the shipping and receiving activities.

When Do We Need to Comply

FDA has determined that a single compliance date would be best for the rule due to the interconnectedness of the food supply chain. Thus, all companies subject to the requirements of the rule must comply by January 20, 2026.

FDA’s final rule requiring additional traceability records for foods identified as high risk will require substantial changes to the information-sharing practices within the food industry but will provide FDA with the information necessary to take rapid, effective action in cases of foodborne illnesses.

Stevens is a food industry attorney and founder of Food Industry Counsel, LLC, and a member of the Food Quality & Safety Editorial Advisory Panel. Reach him at stevens@foodindustrycounsel.com. Presnell, a food industry consultant and lawyer who is also with Food Industry Counsel, has worked in the food industry for nearly a decade. Reach her at presnell@foodindustrycounsel.com.

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Over the past 25 years, food allergies have been recognized worldwide as an important public health issue. Specific avoidance diets remain the primary approach to the prevention of reactions among consumers with food allergies. The simple advice, for those who are allergic to peanuts or milk, for example, is just to avoid those foods or any ingredients derived from those foods. For packaged foods, ingredient statements on food labels are the key source of information for allergic consumers wishing to avoid specific foods.

Consumers with food allergies and their caregivers are likely the most diligent label readers in the marketplace, as their health and safety depend upon careful selection of food products. But, in reality, the seemingly simple advice to avoid allergenic ingredients can become quite challenging. Consumers with milk allergies must learn that casein and whey are terms that signify the presence of milk, that gluten and semolina mean wheat, and that tahina means sesame seeds, among many more examples.

General Labeling Regulations

Historically, many countries have stipulated general food labeling laws and regulations that served to protect food-allergic consumers to some degree. These general food labeling laws and regulations required that the ingredients intentionally used in the formulations of the foods should be declared on an ingredient list on the package label; however, these general food labeling provisions did not fully protect food-allergic consumers for a variety of reasons.

First, many exemptions and exceptions existed. Declaration of the sources of some ingredients was not required. Ingredients were often declared by using their common and usual names, which meant using technical terms (e.g., casein) that did not directly reveal the true source. Thus food-allergic consumers found that allergens were often “hidden” in packaged food products. Furthermore, they had to learn to identify technical ingredient terms such as “casein” that indicated the presence of specific allergenic foods. Vague terms such as “hydrolyzed vegetable protein” were allowed in some countries and these did not reveal the source. Some countries had regulations that did not require the labeling of ingredients in complex formulations when the ingredient comprised less than 25% of the finished food; other countries exempted labeling of minor ingredients comprising less than 2% of the formulation.

The History of Food Allergen Labeling Regulations

The plight of food-allergic consumers and their struggles in implementing specific food-avoidance diets were first recognized in the 1990s. Several Nordic countries developed a working paper on food allergens and labeling in 1993 that was submitted to the Codex Alimentarius Commission (CAC), an organization that oversees the Food and Agricultural Organization (FAO) and the World Health Organization (WHO) to develop food standards and guidance that could be recognized and harmonized worldwide. CAC does not promulgate regulations but does provide guidance that individual countries and regulatory jurisdictions may consider and use as they develop regulations.

In response to the Nordic working papers on food allergens, a FAO Technical Consultation was formed in 1995, which led to the development of the first global list of priority allergenic foods (see Table 1). This list was formally adopted by CAC in 1999. The CAC list of priority allergenic foods served as guidance to all countries, but individual countries had the option to adopt this list or to modify the list as they might choose.

Several comments are appropriate regarding the approaches used by the 1995 expert panel to develop this priority list of allergenic foods. In 1995, the level of published information regarding the comparative prevalence of allergies to specific foods was rather limited and primarily consisted of information on pediatric populations of allergic individuals. These data were primarily from referral centers, which see more allergic patients so extrapolation of the prevalence of pediatric allergies to the overall population may have been slightly biased. Data were lacking on adults with food allergies and on the prevalence of specific food allergies in the general population.

Accordingly, the panel relied, in part, on expert judgment to develop the 1999 priority allergen list. The main criterion for inclusion was comparative prevalence, although the differential severity of certain allergenic foods was also recognized. On this basis, milk, eggs, fish, crustacean shellfish, peanuts, soybeans, tree nuts, and cereal grain sources of gluten were considered the priority allergenic foods. The FAO group also considered celiac disease, intolerances, and sensitivity reactions, in addition to food allergies. Thus, gluten was included because of its association with celiac disease, and sulfites were included because of the documented severity of sulfite-induced asthma, even though these illnesses are not true food allergies.

Subsequently, an International Life Sciences Institute (ILSI) Europe Task Force on Food Allergy took a more in-depth look at foods that merited placement on the priority allergenic foods list (Allergy. 1998;53:3-21). The criteria used by this group included clinical evidence of an allergic reaction through double-blind, placebo-controlled food challenge (DBPCFC) and published evidence of severe and/or fatal anaphylactic reactions. Data on prevalence were considered insufficient. This task force determined that the priority list should include milk, eggs, fish, crustacean shellfish, peanuts, soy, tree nuts, wheat, and sesame seeds. Several subsequent groups within ILSI Europe have continued to develop criteria for the selection of allergenic foods of public health significance (Regul Toxicol Pharmacol. 2008;51:42-52; 2011;60:281-289). The criteria have been expanded to include prevalence, severity, and potency.

The adoption by CAC of the priority list of allergenic foods prompted numerous countries to develop their own regulatory lists for the labeling of priority allergenic foods. The eight foods or food groups from that 1999 CAC list were represented on the vast majority of the priority food allergen lists recognized by specific countries; this group of allergenic foods began to be referred to as the “Big 8.”

Several countries, however, decided to include additional foods on their priority allergen lists. As a result, the regulatory framework for the labeling of allergenic foods differs from country to country. The basis for inclusion of additional foods on the priority lists for specific countries has not been clearly delineated but is based, in part, on regional differences in the prevalence, severity, and potency of specific allergenic foods. The role of scientific criteria in these judgments appears to be secondary in many cases. While the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures recognizes the 1999 CAC list, the existence of different priority lists in various parts of the world can lead to trade disputes and consumer confusion.

Global Differences in Lists of Priority Allergenic Foods

Regional differences appear to exist in the prevalence of food allergies around the world. For example, buckwheat allergy is much more common in Southeast Asian countries where soba noodles are frequently consumed but is a rare form of food allergy in North America and most other parts of the world. The identity of the most common allergenic foods differs among countries/regulatory jurisdictions (such as EU and Australia/New Zealand) in part as a result of these regional differences.

In the U.S., the priority list of allergenic foods was established by action of the United States Congress when it passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004. FALCPA established a list of priority allergenic foods that was quite similar to the 1999 CAC list (see Table 2). The only exception was that FALCPA specifically identified wheat as a cause of food allergies and does not recognize other grain sources of gluten. More recently, the U.S. Congress passed a bill that has prompted the FDA to include sesame seeds on the list of the priority allergenic foods, effective this year.

The first priority list of allergenic foods for the EU was established by EC Directive 2003/89 but has been subsequently expanded by more recent directives (see Table 2). The EU list includes sesame seeds, mustard, celery, molluscan shellfish, and lupine in addition to the Big 8. The European Commission relied upon the expert opinion of the European Food Safety Authority (EFSA) Scientific Panel on Dietetic Products, Nutrition, and Allergies for the addition of molluscan shellfish and lupine to the EU priority allergen list (EFSA J. 2006;327:1-25; 2005;302:1-11).

The decision on lupine appeared to be based upon the recognition that some peanut-allergic individuals will experience allergic reactions to ingested lupine. Several non-EU countries have adopted the EU priority list of allergenic foods (Ukraine, United Kingdom, Iceland, Switzerland, Turkey, and Russia).

In Canada, the original priority allergen list included the Big 8 list with the addition of molluscan shellfish and sesame seeds. More recently, Canada has added mustard to its list. In Australia and New Zealand, the priority list has gone through a couple of iterations but now includes the Big 8 plus sesame seeds, molluscan shellfish, lupine, bee pollen, propolis, and royal jelly (see Table 2).

Japan has a rather unique approach to its priority list, with a short mandatory labeling list and a longer recommended labeling list. The mandatory priority list in Japan comprises wheat, milk, eggs, peanuts, buckwheat, and crustacean shellfish (see Table 2). Crab and shrimp are identified as the only crustacean shellfish of concern. Japan and Korea are the only countries that list buckwheat on their priority allergen lists. Buckwheat is known to cause frequent and occasionally severe allergies in Japan (Adv Food Nutr Res. 2011;62:139-171; Allergy Clin Immunol Int. 2003;15:214-217).

The recommended priority list in Japan is extensive and includes several molluscan shellfish (abalone, squid), several fish (mackerel, salmon, and salmon roe), several fruits (orange, kiwi, peach, apple, banana), one tree nut (walnut), several meats (pork, chicken, beef), soybeans, matsutake mushrooms, yams, and gelatin. The basis for the Japanese priority list was a survey of allergy clinics in Japan in which the causative foods in more than 1,500 cases of food allergy were compared (Allergy Clin Immunol Int. 2003;15:214-217).

The 1999 CAC priority list includes several food groups: tree nuts, fish, and crustacean shellfish. In most countries, fish refers to all species of finfish. The exception is Japan, where only mackerel and salmon are included on the recommended priority list for allergenic foods. Similarly, crustacean shellfish refers to all species of shrimp, crab, and lobster in most countries; in Japan, only crab and shrimp are included on the mandatory priority list for allergen labeling. In several countries including Canada, the labeling regulations refer only to shellfish and not specifically to crustacean shellfish or molluscan shellfish.

Greater differences occur among various countries as to which tree nuts are recognized as part of the group covered by allergen labeling regulations. In Europe, the tree nuts group includes walnuts, pecans, cashews, pistachios, almonds, hazelnuts, Brazil nuts, and macadamia nuts. In Canada, these same eight nuts are listed along with pine nuts; however, the U.S. Congress did not identify specific tree nuts that required mandatory labeling under the provisions of FALCPA. Subsequently, FDA issued a draft guidance document in October 2006 that included a very long list of 19 tree nuts that would need to be specifically included on U.S. food labels. Unfortunately, this list includes several foods that are not tree nuts by botanical definition (coconut and litchi).

Recent FAO/WHO Recommendations

In 2020, on request from the Codex Committee on Food Labeling (CCFL), an ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens was established. In the first of a series of meetings held in late 2020 and early 2021, the consultation developed recommendations relating to the priority list of allergenic foods based on updated information. Considerably more scientific and clinical information was available than had been the case in the previous FAO consultation in 1995. The expert panel based their updated recommendations on the prevalence, potency (threshold dose considerations), and severity of allergic reactions to specific foods.

As a result of these deliberations, a new, revised list of priority allergenic foods was established (see Table 3) that included eight foods or food groups, as before; however, the experts recommended deletion of soybeans from the priority list along with the addition of sesame seeds. This recommendation has been forwarded to the CCFL for consideration and, if approved at that level, will be forwarded to the CAC to create the basis for revised worldwide guidance on allergenic food labeling.

Soybeans were removed from the priority list of allergenic foods based on the low prevalence of soybean allergy, especially among older children and adults, the decline in soybean allergy in infancy, possibly owing to a decreased use of soy-based infant formula, the lower potency of soy protein for elicitation of allergic reactions, and an observed low degree of severity of allergic reactions to soybean reported across all Codex regions. Sesame seed was added to the priority list because of moderate levels (compared with other priority allergenic foods) of prevalence, potency, and severity of allergic reactions. Also, many individual countries had already added sesame seeds to their priority allergenic food lists based on their own assessment of risk factors for sesame seed allergy.

In the recommendation from the expert consultation, the category of tree nuts was restricted to those tree nuts for which evidence of prevalence, potency, and/or severity merited their inclusion. The tree nut list included hazelnut, walnut, pecan, cashew, pistachio, and almond.

The expert consultation also pointed out that regional differences could exist with respect to prevalence, potency, and severity that could merit the inclusion of additional foods on the priority list of allergenic foods in certain countries. Examples might include buckwheat in Japan and Korea and celery tuber in the EU.

Ingredients Derived from Priority Allergenic Foods

The original 1995 list of priority allergenic foods also referred to “products of” those foods. Many food ingredients are derived from the priority allergenic foods that were shown to have medium to high potency and a higher proportion of reported anaphylaxis in more than three Codex regions.

Examples of such ingredients contain large amounts of protein from the allergenic source, while other ingredients contain very low levels of residual protein from the source food. Several countries have exempted certain ingredients from their source labeling provisions. In the U.S., all highly refined oils, including those made from peanuts and soybeans, are exempt. In the EU, highly refined soybean oil is exempt but highly refined peanut oil is not. The EU has also exempted certain other derivatives from source allergen labeling, including wheat starch hydrolysates and fish gelatin for vitamin encapsulation; however, until now, no global consensus has existed to make decisions about source labeling exemptions for certain food ingredients derived from priority allergenic foods.

The ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens took up the topic of assessment of the allergenicity of derivatives from priority allergenic foods at its most recent meeting in November 2022. The recommendations of that consultation are not yet public, but recommendations for a framework by which labeling exemption considerations could be evaluated were made for further consideration by CCFL to create a basis for global scientific consensus on source labeling exemption decisions.

The authors are with the Food Allergy Research and Resource Program in the Department of Food Science and Technology at the University of Nebraska-Lincoln. Reach Dr. Taylor at staylor2@unl.edu and Dr. Baumert at jbaumert2@unl.edu.

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The COVID-19 pandemic was the start of an influx of challenges for food retail and restaurant establishments, with lingering effects leading to labor shortages, supply chain disruptions, and inflationary pressures. This operational shift has forced these establishments to reassess current food safety standards and procedures and adjust where needed.

According to the World Health Organization, nearly 600 million people fall ill after consuming contaminated food every year. A single outbreak can cost a restaurant business upwards of two million dollars according to a 2018 study published in Public Health Reports and, with at least 31 different types of foodborne pathogens to worry about, food safety protocols should be at the top of every priority list for restaurant establishments.

To better protect customers, employees and restaurant owners and operators need to have confidence in their food safety programs. A proper food safety program doesn’t just “pass the test.” A solid food safety program ensures proper food safety practices happen every day, focuses on high-risk issues, and has buy-in from all employee levels, including from senior leadership.

To achieve this, restaurant owners and managers should be able to answer “yes” to the following three questions:

1. Is Food Safety Practiced Consistently?

According to Steritech assessment data, restaurant brands consistently experience a higher number of food safety issues on particular days of the week. The specific days of the week vary by brand, but virtually all brands have at least one day of the week when their issue count is consistently and significantly higher.

The data revealed that the location’s worst day often corresponded with the days when more personnel were present. This indicates that the issue is not always caused by a labor gap, but a leadership gap. The common factor seems to be that leadership is focused on something other than food prep on certain days: delivery days, inventory shifts, manager meetings or other tasks. It also correlates to the experience level of the leadership present; for example, issue counts often rise on the general manager’s regular day off.

The difference between a restaurant’s best day of the week and their worst day is typically between 12% and 18%, but for some brands, that variance is more than 30%. Restaurant owners and managers need to recognize and pay close attention to those “opportunity days” to ensure that proper and consistent food safety practices are being executed at every shift.

2. Is There a Plan in Place to Handle High-Risk Activities?

High-risk activities will be different for every establishment, but it’s likely that every brand has a few. Being able to identify which activities have the strongest links to foodborne illness for a particular restaurant is the first step toward handling those concerns. Some common high-risk activities include, but are not limited to:

• Cooling, reheating, and hot and cold handling;
• Cross-contamination during storage and handling practices;
• Cleaning, sanitizing, and handwashing; and
• Date marking and timely disposal of expired products.

Once a restaurant’s specific high-risk activities have been identified, the next step should be to implement documented food safety management systems for each critical process. A documented food safety management system should cover three parts: the procedures for each critical risk, the training to implement those procedures, and defined monitoring of the implemented procedures.

At first, creating a food safety management plan for each critical issue may appear to be a daunting task, but it’s a task that will better protect employees, customers, and the restaurant. When creating this food safety plan, take it one step at a time. Start with a task that will generate immediate success to get the ball rolling, and then use that positive momentum to further expand the plan.

3. Do Leadership and Management Understand Food Safety Protocols?

Building an effective restaurant food safety program requires engagement and buy-in from all stakeholders. Recent FDA studies found approximately 60% fewer critical issues cited when the person in charge could knowledgeably discuss their food safety management systems.

When food safety programs focus exclusively on location-level employees, the senior leadership team is left out of a crucial part of business operations. In successful organizations, senior company leaders drive processes and programs that keep the entire organization continuously improving.

Food retail and restaurant operators should train leadership and management teams to support food safety programs by practicing “S.A.F.E.” measures.

• Say: What managers say can provide vital reminders to keep food safety in everyone’s awareness every day. Managers and leaders can take simple food safety reminders a step further by also communicating the “why” behind each job. This will help to reinforce the importance of each task to front-line staff.
• Act: The way managers act is also a critical component of effective food safety programs. What leaders do—or fail to do—sends a message to everyone who sees them about the establishment’s food safety values. Simple actions such as hand washing when an employee enters the kitchen, wearing hair restraints, checking temperature logs, or reviewing recent inspection reports will illustrate the importance of those daily tasks to front-line staff.
• Feedback: Leaders are also responsible for being receptive to feedback from those they lead, but this is often overlooked. When leaders and managers can both provide feedback and be open to receiving feedback from their team members, it opens the door to positive two-way communication, which also helps foster a self-sustaining culture of food safety.
• Encourage: There is great power in encouraging positive behaviors. Traditional food safety programs typically focus on the bad findings. Instead, use positive recognition to reinforce good behaviors and send the message that excellent food safety will be rewarded. Positive recognition boosts morale and creates pride, which ultimately embeds itself into the culture. It also creates a platform for employees to receive constructive feedback when it becomes necessary.

Whether managing a single, family-owned restaurant, or a multi-location franchise establishment, creating a positive food safety culture is essential. In this new era of limited staff, high turnover rates, consistent supply chain demands and various other challenges impeding the restaurant industry, owners and operators certainly have a tough job ahead.

A system of strong procedures, training, and monitoring can ensure consistent food safety every day. Pair this with S.A.F.E. food safety practices by leadership at all levels to help build a solid food safety culture for everyone involved.

Boyles is vice president of food safety at Steritech.

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As of January 1, 2023, sesame became the ninth allergen required by FDA to be labeled on packaged foods in the United States. The update came as a part of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which outlined the agency’s approach to identifying and evaluating food allergens. In addition to updating product labels, food processors and manufacturers who work with sesame need to review their handling of the ingredient—and that’s where color-coding plans come in.

Color-coded tools and color-coded cleaning rely on a system in which colors are used to designate specific sets of tools for sensitive products in a food-safe or hygiene-sensitive facility to prevent product cross-contamination from allergens, chemicals, and unwanted foreign bodies. There are several different types of basic color-coding plans: zone color coding, assembly process color coding, shift color coding, and allergen color coding. The allergen plan type is going to be the one most relevant for producers that use sesame.

A color-coding-by-allergen plan, in its most basic form, designates two colors: one for all the handling and cleaning tools and food-safe wearables that come into contact with the identified allergen ingredient, and a second color for those that don’t. Facilities that handle multiple allergens or use special chemicals might add additional colors and will often designate a separate color for use in places like restrooms or on floors and drains.

The Benefits of Color Coding

Generally speaking, a color-coding plan has many benefits: a safer staff and product, a more hygienic facility, better tool longevity, and a stronger food safety culture. A color-coding-by-allergen plan doubles down on some of these benefits in a unique way.

For all the audit components and checklists, food safety inspections boil down to one thing: safety. The reason allergens are treated differently in food processing and handling stems from the possible risk associated with the ingredient. According to FARE, allergies of all kinds are on the rise and affect millions of people in the U.S. For some, unintended exposure can be life-threatening.

A food safety inspector entering a facility with an allergen present wants to see that it’s being handled in a way that acknowledges and accounts for that risk. A color-coding plan demonstrates that understanding and helps satisfy documentation requirements for brand reputation through compliance to global standards and U.S. regulations including FSMA’s Preventive Controls food safety plans, HACCP plans, and GFSI criteria.

The Dos and Don’ts

While it’s a best practice to keep a color-coding plan as simple as possible, there are some very important dos and don’ts for ensuring that it has been set up for success. For allergen plans specifically, there are some special considerations.

Most often, color-coding plans with allergens in the mix will designate bright colors, such as orange, pink, purple, and lime, for allergen contact. These hues are immediately eye-catching should anything be out of place. As with any color-coding plan, it’s best that they contrast with other colors in the plan. Additionally, many processors will choose an allergen color assignment that contrasts with the product itself to ensure that a tool or tool piece that may have found its way into the food product can be spotted easily.

Because of the importance of preventing cross-contamination with allergens—especially in a facility that produces multiple allergen-containing products—it’s vital that you have the right tool storage, training materials, and facility signage. Suppliers should be able to work with you to verify that you have the best tools for your specific needs, whether that means customizing tool storage materials and design to fit your facility environment and cleaning methods, creating multilingual signage to fit the makeup of your team, or maybe adding your color-coding plan to employee badges for easy reference. Take your time with this step and incorporate whatever might make your color-coding plan functional and easy to follow in your unique facility.

Finally, if you are in a facility with an existing color-coding plan that now needs modification, it’s important to roll out the update in one complete sweep to avoid any confusion. As always, train, train, and train on the plan—as you roll it out, as you gain new employees, and over time to ensure that it works well for everyone and is second nature for your team.

Serfas is owner and president of R.S. Quality Products. Reach him at adam.serfas@rsquality.com.

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Artificial intelligence (AI) is a term used to describe a computer-generated intellect that can learn to think, plan, comprehend, and analyze natural language. It’s the study and development of computer systems capable of doing things that would normally require human intelligence, such as vision, speech recognition, decision making, and language translation.

In other words, it’s an area of computer science that focuses on developing machines to act like humans.

In the food industry, where developing standard, reliable procedures to control product quality is a major goal, the search for new ways to reach and serve customers while keeping costs low has necessitated the use of AI. Today, the food industry uses AI to improve customer experience, supply chain management, operational efficiency, warehouse management, and vehicle activity minimization.

Here, we look at how AI is helping the food industry to better meet consumer expectations.

Artificial Intelligence and the Food Industry

Here are some of the most important ways that AI is helping the food industry to reshape its approach toward consumer expectations.

1. Automation during Food Sorting. Many food processing facilities today use manual sorting to sift and separate food items such as vegetables, resulting in decreased efficiency and higher prices. These facilities can achieve substantial automation during this process with AI, which uses a mix of cameras, scanners, and algorithms to enable more efficient food sorting. For example, by using AI with sensor-based optical sorting technologies, the time-consuming processes for sorting fresh produce can be eliminated, resulting in higher yields with better quality and less waste. The same applies to optimizing portion control cutting in the meat industry: AI assesses the primary product for the optimal yield of cut sizes. The technology is also used to better calibrate machines to manage several product sizes while reducing waste and expenses.
2. Organized and Quick Supply Chain Management. Efficient supply chain management is a critical responsibility for all food producers. Food safety monitoring and testing at every level of the supply chain can help guarantee compliance with industry standards. Now, cost and inventory management can be made much easier with more precise predictions, which is where AI comes in: AI-based picture recognition solutions allow for more efficient and effective product procurement, and many companies have started to adopt them. AI also aids in efficient and transparent product tracking all the way from farms to the consumer, increasing customer confidence in a product.
3. Compliance with Food Safety Protocols. Many food facilities today use AI-enabled cameras to ensure that food employees comply with safety regulations. These cameras use image recognition and object identification algorithms to detect whether workers are following food safety regulations for personal hygiene. If a breach is discovered, the screen pictures are extracted for examination, and the mistake can be corrected in real time. There are also AI-powered applications that allow you to write a HACCP plan.
4. Self-Optimizing Cleaning Systems. Traditional periodic cleaning systems are set up to clean equipment in scheduled cycles, but they operate blindly and are not very resource efficient. With the use of AI-enabled technologies, food processing facilities can clean equipment more efficiently. One example is the self-optimizing clean-in-place system (SOCIP), which uses ultrasonic sensors and optical fluorescence imaging to analyze food residue and microbiological debris in a piece of equipment, enhancing the cleaning process. SOCIP saves water, time, and energy; the cleaning time can be reduced by more than half.
5. Predicting Consumer Preferences. Food producers today also employ AI-based solutions to anticipate and model their target consumers’ flavor preferences, as well as to forecast their reactions to novel flavors. For example, in 2017, Kellogg introduced AI-enabled technology that assists customers in choosing which granola to use from a list of 50 components when creating a personalized product. The AI gives suggestions for what items to use in the granola and tells the consumer whether or not the ingredients will work well together. Customers aren’t the only ones who benefit from this technology. The data generated from flavor combinations, the selections people really make, and the variations they reorder is highly useful to any manufacturer when creating new products. Similarly, Coca-Cola has put self-service soft drink fountains at many restaurants and other venues, allowing customers to create their own beverages. Customers can make hundreds of different soda cocktails using these self-service devices by mixing different flavors into their basic beverages. Thousands of drink fountains, each pouring a multitude of new beverages every day, generate a vast quantity of consumer preference data, which Coca-Cola can then use AI to analyze.
6. AI-Based Revenue Predictions. Predicting sales production is an important aspect of any food business. For greater business growth and profit, food chain or restaurant owners must develop solid business strategies for their future operations. Finding an appropriately fitting algorithm for sales forecasts in the food sector, whether it’s one for five months of sales predictions or one for 14 months, is typically time-consuming work. But in this age of data science, it’s now possible to acquire sales forecasts at the touch of a button. Data science allows businesses to discover the optimal algorithm for predicting sales and achieve the rapid deployment of that algorithm within the organization with the help of an expert AI development team.

How AI Helps Consumers Directly

But what about consumers in the food industry? Can AI help them as well? Here are four ways AI does just that:

1. Food Discovery and Recommendation Engines. Food discovery and recommendation engines based on AI are now assisting consumers in making educated decisions about what to eat by learning about consumer taste preferences and then recommending curated dishes.
2. AI-Powered Chatbots. Food establishments can now use AI-powered virtual assistants and chatbots to guarantee that clients do not have to wait too long while making inquiries or customizing orders. These bots have come a long way from the days of their inception and have now been optimized to a great degree, resulting in a better client experience.
3. AI-Based Kiosks. Self-ordering robots powered by AI are now providing a better experience by lowering customer wait time and eliminating the need to stand in line to pay. That’s because AI can take consumer orders and process payments can be made using integrated card readers, eliminating the need for human intervention.
4. AI Robots. Robots are commonly accepted in the food processing industry due to their sterile nature, a characteristic that is critical in reducing the number of foodborne illnesses. This is especially useful now that The Food Safety Modernization Act (FSMA) has developed more stringent sanitary requirements that apply to whole supply chain systems. AI-based robots are incapable of transmitting certain diseases in the same way that humans are, but must be maintained at an appropriate level of cleanliness to prevent transmission of contaminates such as Salmonella, Listeria, or E. coli. Plus, the upkeep of an AI-based system is basic and straightforward. According to a forecast issued by Technavio, the use of robots in the food processing industry increased by 29% from 2015 to 2019. Robots are also making an appearance in restaurants, boosting the speed and capacity of food preparation as well as reducing the time it takes for meals to be delivered.

AI is improving the efficiency and quality of the food sector in many ways, and the technology promises to bring about many more improvements in the near future. Due to its potential to decrease waste, anticipate product markets, enable around-the-clock efficient and effective monitoring, improve sanitation, control costs, and increase revenue, AI’s position in the food sector is becoming increasingly robust.

The earlier you adopt it, the more future proof your business will become.

Hanson is digital food safety specialist for FoodDocs.

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Metallic inclusions are the No. 1 contaminant in food products, causing product quality and consumer safety issues; however, the orientation of a metal contaminant can affect a metal detector, as the size, shape, and symmetry of metal contaminants cannot be controlled.

As an odd-shaped piece of metal passes through a machine in different orientations, the response to each one will be different. For this reason, we use spheres to test a metal detector: A sphere does not exhibit orientation effect and will always produce the same signal when passed through the same position within a metal detectors aperture. But if you flatten out the metal or roll it into a needle or wire shape, there will be a significant difference in signal, depending on how it passes through, due to the physics of disturbing the electromagnetic field.

The general rule for like metals is that if any of the dimensions are less than the detectable metal’s sphere size, the machine may have trouble detecting it in the hardest-to-detect orientation. Depending on the orientation in which it passes through, the signal will likely be much larger than that of the sphere.

These spherical test samples showcase advances in sensitivity and provide machine suppliers and buyers with a comparative benchmarking tool. They provide a solid and reliable gauge to measure machine sensitivity against. So, when a supplier reports a sensitivity improvement of 0.5 mm, this is a major concern.

Overcoming Orientation Effect

Orientation effect is a result of asymmetrical metal contaminant shards being more easily detected if they pass through the metal inspection system in one direction rather than another. Often, it’s easier to detect stainless steel and nonferrous wires when they pass through the aperture space sideways or upright, rather than in alignment with the conveyor. The reason for this is related to the magnetic permeability of the metal, which for stainless steel is much lower than for other metals.

One solution could be to position several metal detectors at various angles along the conveyor; however, this often results in a significant increase in aperture size, which diminishes the performance and sensitivity of the metal detector. Placing systems upstream throughout the process is usually more advisable.

Reducing the aperture size is another simple and effective way to increase metal detector sensitivity. Because sensitivity is measured at the geometric center of the aperture, the ratio of the aperture to the size of the product should be considered. Maximum sensitivity occurs when the contaminate is closest to the aperture walls where the electromagnetic field is strongest. It therefore makes sense that as the size of the aperture decreases, the performance of the metal detector improves.

During regular testing of food metal detectors, manufacturers should insert FDA-approved test pieces in various locations along the product—for example in the front, center, and back—and then run consecutive tests in which the metal sphere is travelling as close to the geometric center of the aperture as possible. These tests should be performed for all package sizes and configurations. This provides extra assurance that metal detectors are performing as they should, picking up the test contaminants, regardless of metal type, size, or product masking.

Know Your Metals

The type of metal contaminant also needs to be factored into the equation. All industrial metal detectors will exhibit a different level of sensitivity for the three main groups: ferrous (such as iron or steel), nonferrous (including aluminum foil), and stainless steel. Because metal detectors work by spotting materials that create a magnetic or conductive disturbance as they pass through an electro-magnetic field, stainless steel (300 series) is typically the most difficult to detect.

Figure 2. Stainless steel detection signals can be swamped by product effect in wet or salted products. Courtesy of Fortress Technology Inc.

Widely used in food preparation and production areas, stainless steel comes in various grades. The 300 series stainless steel is recommended for performance verifications, as it is non-magnetic and a poor electrical conductor, making it the hardest to detect. Consequently, a sphere of stainless steel hidden in a dry product typically needs to be 50% larger than a ferrous sphere to generate a similar signal size. This disparity can rise to 300% in wet products, such as fresh meals, meat, fish, sauces, preserves, and bread, because moisture in these products creates a conductive signal, and the metal detection can be swamped by product effect, which resembles the stainless-steel product effect phase characteristics.

Conversely, any product that is iron enriched, such as fortified cereals, supplements, or breakfast bars, creates a large magnetic signal that the detector must overcome in order to detect small pieces of metal. These are referred to as “dry” products and tend to be a lot easier in terms of detection capability, because there’s less worry about the product effect.

To identify a metal contaminant within conductive products, a metal detector must eliminate or reduce this product effect. The solution is to change the frequency of operation to minimize the effect of the product; however, when a metal detector’s operating frequency is altered, there’s usually a trade-off in performance.

Figure 3. The ratio of the aperture to the size of the product is an essential consideration as sensitivity is measured at the geometric center of the aperture. Courtesy of Fortress Technology Inc.

Simultaneous frequency is the most reliable way to remove product effect without compromising the sensitivity of a metal detector.

Finding Flat Flakes

Depending on how a metal flake is lodged within a product, there is also the potential for it to completely evade a metal detector by sneaking perfectly through the electromagnetic flux without causing a disturbance in the field. Inspection systems that use multiple oriented electromagnetic fields can cover each fields’ respective weakness; this technology is especially beneficial for upstream premium applications, such as confectionery and chocolate, and has proved to be reliable at detecting very thin flakes and foils that could be introduced in the mixing, rolling, scoring, molding, or baking processes.

Sphere Size Test Thresholds

The metal detection industry has general sphere size guidelines for food producers. These are based on whether the product being inspected is wet or dry, as well as the overall size of the product. For a wet block of cheese measuring approximately 75mm high, the sphere size parameters are currently ferrous 2.0 mm, nonferrous 2.5 mm, and stainless steel 3.5 mm.

Many variables can affect a metal detector’s performance, including orientation of contaminants, the type of product passing through the detector, product size, and even at times, the surrounding environment. Machine sensitivity remains a solid and reliable gauge, however.

As with any aspect of food safety, there’s always a cause and a consequence. The value of deeply rooted experience about how different food applications behave and change, about the conditions that cause these reactions, and about the relearning limits of inspection equipment, should never be underestimated.

Garr is a regional sales manager at Fortress Technology Inc.

The post How Metal Test Spheres Can Measure Metal Detection Performance in Food Products appeared first on Food Quality & Safety.

In the summer of 2022, Rep. Rosa DeLauro and Sen. Dick Durbin introduced the Food Safety Administration Act, which essentially calls for FDA to be divided into two agencies: one responsible for food and one responsible for drugs/medical devices.

“Food safety is currently a second-class citizen at the FDA,” DeLauro said when she introduced the bill. “Right now, there are no food policy experts in charge of food safety at the FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices, and in many cases, result in consumer illness and death.”

One needs only to look at 2022’s infant formula crisis, in which Abbott Laboratories’ Sturgis, Mich., facility was allegedly responsible for producing formula contaminated with Cronobacter sakazakii, to understand the Senator’s concern.

This type of issue is one reason the bill is looking to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market.

Tyler Williams, CEO of ASI Food Safety, which oversees the certification process in more than 3,000 audits annually and has trained and consulted with numerous major food and beverage companies around the world to help improve their food safety practices, notes that longtime critics of FDA have been pushing for a split in the agency for several years. “Food safety experts argue that food safety and security is a secondhand thought after drugs and medical devices, whereas the pharmaceutical industry feels drug approvals are slowed down by the FDA being distracted by food industry recalls,” Williams says. “It feels like the food sector has been the red-headed stepchild of the FDA, or maybe the agency just simply has too much on its plate, but either way, the legislation being introduced by food policy experts calls for a division of power that will hopefully prioritize food safety and protect consumers.”

Cassandra LaRae-Perez, a food and beverage attorney at Gravel and Shea in Burlington, Vt., notes that proponents of the bill argue that a separate agency would bring leadership more focused on food safety, more accountability, and a unified and efficient structure, but it is unclear how a separate agency would perform better, and whether additional resources would be devoted to ensuring its success. “In short, the bill seeks to tighten regulation on food producers and to increase credibility and autonomy of the regulators responsible for food safety, but without a significant, perhaps outsized dedication of monetary and human resources and willing participation in the Senate to swiftly appoint a leader for the agency, it’s not clear how its aims can be achieved,” she says.

Reagan-Udall Foundation Report

Brian Ronholm, director of food policy for Consumer Reports, says that FDA has inadequately responded to outbreaks and missed deadlines for implementing critical food safety initiatives, which has undermined consumer confidence in the agency’s food program. “One of the big proposals that gets support is creating an empowered deputy commissioner position that would have oversight authority over the foods program at the agency,” he says. “That would put someone in charge of food, because that’s what is lacking.”

In July 2022, a few months after the infant formula crisis that was responsible for the death of at least two infants, FDA commissioner Robert Califf, MD, commissioned a review of the Human Foods Program by the Reagan-Udall Foundation, an independent group of experts. Their findings, released in December 2022, recommended a major overhaul and reform of FDA, essentially backing up the bill.

David Acheson, founder and CEO of The Acheson Group and former FDA associate commissioner for foods, notes that a split isn’t a new idea, but legislation has never gained much traction before. He says Dr. Califf’s call for the Reagan-Udall Foundation report is a good sign—much needed—that change is possible.

The report outlined several key problems within the agency’s culture, structure, resources, and authority. “The report uncovered several issues ranging from reporting structures and clear lines of authority to a lack of a clear and compelling vision, mission, and value statement specific to the Human Foods Program,” Williams says. “While some of these issues could be fixed with an agency split, most of these issues require a cultural change from a reactive approach to food safety to a proactive approach.”

Some recommendations from the report to improve the agency included requesting records from food manufacturers in advance of or in lieu of an inspection; being notified when designated food categories, such as infant formula, are likely to experience shortages or when supply chain disruptions are anticipated; expanding the criteria for suspension of registration for food facilities; invoking civil monetary penalties for various violations; and granting administrative authorities that allow FDA to use a progressive enforcement strategy that does not require a determination of serious adverse health consequences or death to humans or animals.

Additionally, the report recommended that FDA be bolder in strengthening its implementation and use of existing FSMA authority to collect user fees; use its mandatory recall authority more frequently—especially for life-sustaining products that are the only source of nutrition for certain populations; and more effectively identify opportunities to monitor both industry and consumer behavior to better understand industry implementation and consumer response to FDA’s nutrition initiatives.

Some recommendations called for radical changes within the agency, Acheson says, and now the industry is waiting for Dr. Califf to respond. “The priorities on the hill are not this, however, so, it may be more about what can be done without congressional approval, and that would mean an internal restructuring,” he adds. One example of this restructuring could involve creating a new component within FDA that would effectively contain everything that a new agency would contain, but with lower costs being and without the disruption and need for statute change, which Acheson believes is highly unlikely at the moment, despite the bill.

The Advantages of an Agency Split

While it’s hard to say whether there would be any immediate benefits for either industry or consumers without seeing a detailed action plan, Acheson believes one of the biggest potential benefits of separating FDA into two agencies is having a split leadership team. “Currently, most of FDA’s leadership comes from the drug and medical device industry,” he says. “By splitting the agency, we could see leaders with extensive knowledge in the industry they are regulating ensuring that doctors are not responsible for developing food safety policies and food safety experts aren’t weighing in on drug approvals.”

Additionally, a potential split of FDA between food and drugs could lead to a potential merger between USDA’s food safety responsibilities and those of FDA. “We’ve experienced so many issues within the food supply chain that come from the farming sector, later trickling down to manufacturing, then to retail, that it has left many food industry professionals questioning the separation of powers between the two agencies,” Williams says. “Due to the already existing overlap between the FDA and USDA, this could make regulating these products much easier in the future.”

Is a Split Really Possible?

While there are plenty of advocates for a split, making it happen would come with challenges. FDA would need to allocate team members to oversee each sector, hiring more experts to work on one side of the agency or even both, to keep things moving. Challenges within the food supply chain or the drug supply chain may also be burdensome.

Still, Williams says, “Never say never.”

“I think if the FDA is supportive of it, Congress will likely align with whatever the FDA thinks is best, as long as it’s not costing them more money,” he adds. “However, the split could mean a more immediate need for an increase to the FDA’s budget, which some members of Congress would likely not support. I also think the push from big pharma and their powerhouse of lobbyists could help push this along. The pharmaceutical industry feels that they would be able to get drugs approved faster if the agency was split, which has a direct impact on a pharmaceutical company’s bottom line.”

Ronholm agrees and expects more dialogue on the idea to happen in 2022. And even if it doesn’t, the Reagan-Udall Foundation report revealed a lot of organizational failures that validated what many food safety experts have been saying for years, and he believes FDA will take many of the ideas for betterment into consideration, which would have a huge impact on food safety going forward.

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The United States imported approximately 17% of its food supply in 2021, according to USDA’s Economic Research Service. The amount of imported food has continued to rise over the last 15 years, in both the total volume of products and the number of discreet line items submitted for import. Currently, approximately 125,000 food facilities and farms located in more than 200 countries and territories supply about 32% of the fresh vegetables, 55% of the fresh fruit, and 94% of the seafood that Americans consume annually.

“When these foods are imported, there may be a greater chance for biological, chemical, and physical hazards to occur due to agricultural practices, growing conditions, infrastructure, and transportation in foreign countries,” says Ben Miller, PhD, MPH, vice president of scientific and regulatory affairs at The Acheson Group in Northfield, Minn. “Each of these food categories has experienced both domestic and international outbreaks.”

In 2022, approximately 15 million imported food shipments entered the United States. “This increasingly globalized and complex marketplace has placed new challenges on America’s food safety system,” says Robert Tuverson, a retired international policy analyst for FDA’s Center for Food Safety and Applied Nutrition in College Park, Md., and USDA’s Food Safety and Inspection Service (FSIS) in Washington, D.C.

Foods imported into the U.S. are regulated by two agencies, Tuverson says. Imports of meat, poultry, and certain egg products are the jurisdiction of USDA’s FSIS. FSIS regulations necessitate that imported products only come from establishments that fully comply with food safety requirements in countries maintaining foreign food safety control systems evaluated by FSIS and determined to be equivalent to that of the U.S. All other imported food products are regulated by FDA and may enter U.S. commerce from FDA-registered foreign facilities located in any country, as long as they comply with the requirements of the Food, Drug and Cosmetic Act of 1938 and, since 2011, The Food Safety Modernization Act (FSMA).

FDA Initiatives

Prior to 2011, FDA relied on physical inspections at the port of entry to screen imported foods for product safety. Years of budget limitations to hire inspectors, along with the increase in imported goods, resulted in an inspection rate of lower than 2%. To increase oversight without significantly increasing inspection staff, FDA has taken many other steps to ensure the safety of foods that enter the U.S. A series of large multi-state outbreaks in the U.S. during the early to mid 2000s also contributed to the passage of FSMA. Its rules specify that foreign companies that export food into the U.S. must meet the same regulatory requirements as companies that produce food domestically, Dr. Miller says. Until the passage of FSMA, compliance to U.S. laws and regulations was not required or verified, a gap that surprised many.

The U.S. Congress tasked FDA to develop specific regulations for food importers to improve oversight and prevent future outbreaks. The FSMA final rule on Foreign Supplier Verification Programs (FSVP), published by FDA in 2015, the rule applies to both human and animal food. “FSVP is in place to protect consumers and to prevent a problem from arriving at the port of entry,” says Tracy Fink, MSc, PCQI, director of Scientific Programs and Science and Policy Initiatives at the Institute of Food Technologists in Chicago. “U.S. importers that haven’t developed or implemented FSVPs for their products to meet the FSVP regulation are subject to warning letters, import alerts, and other regulatory actions by the FDA.”

By requiring U.S. food importers to ensure their overseas suppliers’ compliance with FSMA’s preventive controls for food safety requirements, FSMA legislation has shifted the burden to importers and producers to ensure that food products are safe before they’re shipped, rather than relying exclusively on port-of-entry inspection to ensure food safety. “Product-by-product inspection of import shipments is not possible given FDA’s finite resources and the current volume of food imports,” Tuverson says.

With FSMA in place, FDA can better allocate its limited resources to audit-based verification of producer compliance, including risk-based foreign facility inspections, FSVP audits, and the Accredited Third Party Certification program, Tuverson adds. In this voluntary program, FDA recognizes the accreditation bodies responsible for third-party certification bodies. The certification bodies conduct food safety audits and issue certifications of foreign food facilities. Certification audits can be used to demonstrate compliance by multiple importers, thereby reducing the number of audits necessary.

Regulatory Partnerships

Systems Recognition (SR), a partnership between FDA and a foreign government agency, is a tool used to support FSMA initiatives. The agencies operate comparable regulatory programs that yield similar food safety outcomes. Currently, three countries—New Zealand, Canada, and Australia—have SR arrangements in place with the U.S that were put in place in 2012, 2016, and 2017, respectively. “These partnerships give consumers increased confidence in the safety of the foods regulated by participating agencies because the FDA has determined that these agencies have strong food safety controls,” Dr. Miller says. SR is a voluntary program; it isn’t required for access to the U.S. market.

Because the food safety agencies in these governments agree that their regulatory programs will yield similar food safety outcomes, certain foods imported from these countries to the U.S. qualify for modified verification requirements from the FSVP rule, Dr. Miller says. Specifically, the food importer doesn’t have to assess the product’s safety by conducting a hazard analysis, evaluating the foreign supplier’s performance to define the risk posed by the food, or determine the required oversight actions needed, which includes conducting the foreign supplier verification activities.

Since 2020, the failure to develop a required FSVP plan has accounted for more than 43% of FDA’s citations, according to the agency. “This suggests that many importers and food companies are still unaware of FSVP requirements, when these requirements apply, and how to comply,” Dr. Miller says. “This is important from a food safety standpoint, because unless someone is importing certain foods from countries with SR, the importer is required to conduct a hazard analysis, evaluate the foreign supplier’s performance and the risk posed by the food, or determine and conduct foreign supplier verification activities. If these activities don’t occur, then the importer hasn’t documented that they’ve determined what biological, chemical, or physical hazards could be associated with the food they’re importing into the U.S.”

Announced by FDA in 2020, The New Era of Smarter Food Safety harnesses the power of technology and data to further improve the safety of imported and domestic food. “It aims to create a new, smarter, and more digital food safety system that will be more effective, efficient, and resilient in preventing foodborne illnesses,” Dr. Miller says. The initiative is focused on four elements, including tech-enabled traceability, smarter tools and approaches for prevention and outbreak responses, new business models and retail modernization, and food safety culture.

Collaboration Worldwide

The Global Food Safety Initiative (GFSI) is a collaboration between some of the world’s leading food safety experts and major retail food companies. Since 2000, the private organization has aimed to improve food safety standards and practices globally, Dr. Miller says. By working as a coalition of action, GFSI is helping to address challenges facing food safety systems in supply chains and the emerging markets they operate in several ways:

Benchmarking food safety standards: GFSI benchmarks food safety standards against a set of rigorous criteria, which helps to raise the bar for food safety globally. “By benchmarking food safety standards, GFSI helps to ensure that food safety systems in different countries and regions are equivalent in terms of their level of protection for consumers,” Dr. Miller says.

Facilitating collaboration and sharing best practices: GFSI facilitates collaboration between food safety experts and major food companies, which helps them to share best practices and knowledge about food safety. This can help to improve food safety systems in different countries and regions.

Improving supply chain traceability: GFSI encourages the use of traceability systems that can help to quickly identify and respond to food safety incidents, which can help to minimize the impact of any food safety incidents that occur.

Enhancing food safety culture: GFSI helps to enhance food safety culture by encouraging companies to adopt a risk-based approach to food safety, which can help to identify and mitigate potential food safety risks.

Supporting food safety in developing countries: GFSI supports the development of food safety systems in developing countries, helping them to improve food safety and reduce the burden of foodborne diseases.

“All of these initiatives are helping to raise the food safety bar globally, by promoting the adoption of best practices and standards, supporting the development of food safety systems in developing countries, and encouraging collaboration and knowledge sharing among food safety experts and major food companies,” Dr. Miller said.

In 2020, GFSI launched its “Race to the Top Framework” to improve the effectiveness of its food safety certification and audit programs, Tuverson says. This initiative emphasizes four areas of investment:

• Feature 1: Develop harmonization and benchmarking requirements for providers of food safety auditor training and ongoing continuing professional development. A pilot program to test new benchmarking requirements for validating food safety auditor credentials was launched in March 2022.
• Feature 2: Deliver a process of ongoing assessment and continuous alignment to the GFSI requirements for Certificate Program Owners (CPOs).
• Feature 3: Develop a collaborative approach to managing certification bodies among CPOs, accreditation bodies, and GFSI.
• Feature 4: Develop a certificate platform enabling access to certificate data of all food business operators who are certified in a GFSI-recognized program.

World Health Organization Efforts

The World Health Organization (WHO) is also at the forefront of ensuring food safety worldwide. The WHO Global Strategy for Food Safety 2022-2030 aims to reduce the burden of foodborne diseases by fostering a coordinated, multi-sectoral approach to food safety. “The strategy is designed to guide countries in strengthening their food safety systems and to enhance collaboration among countries, international organizations, and other stakeholders to improve food safety globally,” Dr. Miller says. It focuses on key areas such as strengthening food safety governance, improving risk assessment and risk communication, enhancing food safety capacity and surveillance, and promoting research and innovation.

In addition to this, WHO is employing several initiatives to ensure food safety in developing nations, such as providing technical assistance and capacity building to countries to help them develop and implement food safety policies, laws, and regulations, Dr. Miller adds. This includes providing training for food safety officials and other stakeholders, as well as offering guidance on risk assessment and risk management.

WHO also works closely with other international organizations, such as the Food and Agriculture Organization (FAO) and the World Trade Organization (WTO), as well as with the private sector, to improve food safety in developing countries. This collaboration includes supporting research on food safety issues in developing countries, with the goal of developing new tools and approaches to improve food safety, Dr. Miller says.

Investing in Foreign Countries

In December 2022, USDA, the U.S Agency for International Development, and FDA announced the Food Safety for Food Security Partnership (FS4FS). The initiative includes a $15 million investment over the next five years to support the availability and trade of safe food products to reduce poverty, hunger, and malnutrition in low- and middle-income countries, Tuverson says.

The Foreign Agricultural Service maintains several fellowship and exchange programs, which provide training and development programs to researchers, policymakers, and other low- and middle-income country professionals to help promote food safety and security, as well as agricultural development and economic growth, Tuverson says.

Emerging Technologies

Some newer technologies show promise in improving food safety. One recent development is the White House’s September 2022 “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” This order calls for increased international cooperation to advance the use of biotechnology and bio-manufacturing in addressing climate change, supporting supply chain resiliency, and increasing food security, Tuverson says.

The order calls for U.S. engagement with developing countries, international organizations, and non-governmental organizations through joint research projects and expert exchanges, regulatory cooperation and sharing of best practices, and open sharing of scientific data, Tuverson says. USDA already supports a wide range of activities that connect biotechnology and bio-manufacturing to climate goals, including the BioPreferred Program.

Using emerging technologies such as low- or no-cost traceability solutions breaks down financial barriers and improves response time to food safety-related issues, says Kari Barnes, regulatory standards manager at TraceGains, a supply chain solutions company in Westminster, Colo. The use of whole genome sequencing (WGS) technology, for example, also improves response time to foodborne illnesses by providing an organism’s DNA fingerprint and linking it to other cases.

Blockchain technology is a digital ledger system that can collect blocks of information throughout the supply chain, with the potential to improve traceability, deter fraud, and improve responses to contamination and incidents of foodborne illness, Barnes says.

Currently, emerging technologies are limited to developed countries with more mature physical and information technology. Importantly, many developing nations also lack the needed public health infrastructure to quickly identify foodborne illness outbreaks using WGS technologies. Likewise, the use of technologies for traceability remains limited in most developing countries outside of some specific vertically integrated supply chains, Dr. Miller says.

The post The Safety of Imported Food appeared first on Food Quality & Safety.

Fires and explosions are a serious safety concern for food processing facilities, especially those working with dry powdered ingredients. An effective dust collection system is an essential element of plant safety—and also one of your biggest fire and explosion risks. Here’s what food processors should know about dust collector safety, National Fire Prevention Association (NFPA) compliance and safe system design.

How Dust Collector Fires and Explosions Occur

According to dustsafetyscience.com, dust collectors are responsible for nearly 15% of industrial fires and explosions in North America, resulting in 25 fires and four explosions in 2021 alone. Many of these were in the food and bakery industries.

The food industry is at high risk for dust collector fires and explosions due to the nature of the dust being collected. Dry, powdered organic materials such as sugar, flour, starch, cocoa, dehydrated milk products, and other food ingredients are combustible—sometimes, highly so. The Imperial Sugar factory explosion in 2008 in Savannah, Ga., is still a cautionary tale for the industry; it resulted in 14 deaths, 36 injuries, and widespread facility destruction. Food and agriculture were responsible for nearly 50% of industrial fires and explosions between 2018 and 2021, according to the “Combustible Dust Incident Report 2021,” available at dustsafetyscience.com.

Figure 1. The Fire Triangle. Fires require fuel, oxygen, and heat or ignition. Courtesy of RoboVent.

A dust collection system is used to prevent the buildup of dangerous dust in the facility as a whole and inside enclosed areas such as silos, conveyor systems, batch mixers, and other production equipment. But the dust collector and ductwork also provide many of the ideal conditions for a dust-based fire or explosion:

• The dust collector generates a lot of airflow, guaranteeing a ready supply of oxygen for a combustion reaction;
• The dust and filter media supply fuel;
• Dust inside the system is dispersed in a cloud during collection; and
• The dust cloud is contained in an enclosed area (ductwork or the dust collector filter chamber) where pressure can build up.

Under these conditions, only one more element is needed to start a combustion reaction: an ignition source, which may come from a spark from machinery or processes, an open flame or heat source, friction, or even static electricity. (Some highly combustible dusts can even self-ignite under the right conditions.) A dust collector fire may start when a spark hits a flammable filter media that is loaded with dust. If a combustion reaction starts within an airborne dust cloud inside the dust collection system, the result will be an explosion. The fire triangle and explosion pentagon show the difference (see figures 1 and 2).

Figure 2. The Explosion Pentagon. A combustible dust explosion requires fuel (combustible dust), oxygen from the air, and an ignition source, PLUS dispersion of the dust in a cloud and confinement of the dust cloud. In the absence of confinement, ignition of a cloud of combustible dust will result in a flash fire.Courtesy of RoboVent.

Once a fire or explosion starts in the dust collection system, it can rapidly spread to other parts of the facility, leading to widespread damage or a dangerous secondary dust explosion. For these reasons, dust collector fire and explosion safety are essential.

Five Essential Dust Collector Safety Elements

Fortunately, most dust collector fires and explosions are preventable. By removing any of the legs of the fire triangle or explosion pentagon, it is possible to prevent a combustion reaction from starting or stop one in its tracks. There are several critical elements to dust collector fire and explosion safety:

1. Fire/smoke detector. Every dust collector should be equipped with some type of smoke/fire detector. For dust collection systems, an ionization/thermal dual sensor is recommended; these types of detectors can respond to either smoke or heat. The detector should be wired to the control system so that it can stop the dust collector and cut off the supply of air if a fire is detected.

2. Fire suppression system. A fire extinguisher or suppression system is required for dust collectors working with flammable or combustible material. Fire suppression methods include:

• Water sprinkler system;
• Chemical foam extinguishers;
• Carbon dioxide (CO2) gas fire suppression system;
• Clean agent gas fire suppression system; and
• Dry chemical fire suppression systems.

An internal water sprinkler system, hooked up to the facility water supply, is a simple method of extinguishing flames; however, it can also be very messy and disruptive if it goes off. Likewise, chemical foams are very messy if deployed and can contaminate the facility with toxic chemicals. For this reason, a CO2 or clean agent gas system is often recommended as fire suppression for dust collection within a food production environment. Clean agent chemicals such as argon and nitrogen are non-toxic and do not leave any residue behind if deployed. They work by disrupting the combustion process.

Fire suppression may be passive, active, or a combination of both. A passive system—such as temperature-sensitive tubing that bursts when temperatures rise—automatically deploys the agent. An active system uses sensors to deploy agent from fixed nozzles inside the dust collector. A combination system offers the best of both worlds.

3. Oxygen dampers. A damper system shuts off the flow of air if a fire is detected. These systems can slow the progression of the fire by reducing the availability of oxygen. They can also prevent the spread of fire back into the ductwork.

4. Ignition control. Most food production activities (silo fill, conveyance, batch mixing, packaging, etc.) do not create sparks or take place near spark-producing processes. Still, ignition control is an important element of dust collector safety for food processing.

• Inspect and maintain all machinery and conveyor systems to reduce the risk of sparks created by friction of poorly lubricated parts, engine shorts, or other mechanical problems.
• Keep the dust collector away from sources of heat, sparks, or open flames.

A spark control system may be needed if there are spark-producing processes near the dust collector or intake. Spark control options include:

• Spark plates, baffle systems, or wire mesh/screen-type spark arrestors that block spark intake.
• Centrifugal spark arrestors, which strip the thermal envelope off the spark using centrifugal force.
• Active detect-and-suppress systems, which use sensors and a water or chemical extinguisher.

5. Deflagration system. An NFPA-compliant deflagration system is required when collecting combustible food dust. The system design will depend on the explosive potential of your dust and specific risks of your facility but will typically include the following elements.

• Explosion vents (standard or flameless) are designed to safely release pressure when it starts to rise inside the dust collection system. A flameless vent will also contain flames.
• Isolation valves are used to prevent the propagation of a pressure wave back into the facility.
• A rotary airlock is installed in between the hopper and the collection bin to prevent collected dust in the bin from becoming added fuel in an explosion.

Meeting Regulatory Requirements for Dust Collector Safety

Food processing facilities and bakeries in the U.S. must meet stringent requirements for dust collector fire and explosion safety governed by the Occupational Safety and Health Administration (OSHA). OSHA requires facilities handling combustible dust to follow guidelines developed by the NFPA for dust collection system design. Currently, there are several NFPA standards relevant to dust collection in food processing facilities or bakeries.

• NFPA 61 Standard for the Prevention of Fires and Dust Explosions in Agricultural and Food Processing Facilities (2020 latest version).
• NFPA 652 Standard on the Fundamentals of Combustible Dust (2019 latest version).
• NFPA 654 Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing, and Handling of Combustible Particulate Solids (2020 latest version).

Currently, NFPA is in the process of combining and updating these and other industry-specific standards into all-­encompassing combustible dust standard: NFPA 660. The new standard is expected to be finalized in the fall of 2023 and to go into effect in the fall of 2024.

Under these standards and other OSHA regulations, bakeries and food processing facilities must have a combustible dust plan in place and take steps to control dust in their facilities to reduce fire and explosion risks. In ­addition, the dust collection system must be designed in accordance with NFPA guidelines. Compliant system design includes the use of fire suppression and deflagration system elements appropriate for the application. These guidelines are outlined in NFPA 654 and in two specific standards for deflagration systems:

• NFPA 68 Standard on Explosion Protection by Deflagration Venting; and
• NFPA 69 Standard on Explosion Preventing Systems.

All facilities must also complete a dust hazard analysis, which includes dust analysis, process hazard analysis, and mitigation recommendations. Laboratory testing of dust samples in the facility may be advised to determine the explosion potential of the dust. The DHA provides a starting point for the design of a compliant fire and explosion prevention plan, including dust collection system design.

It is often advisable to work with a qualified engineering partner when designing a dust collection system for combustible food dust. These firms can help you conduct a process hazard analysis and make the right choices in system design, including:

• Deflagration system design;
• Selection of an appropriate fire suppression system; and
• Reduction in ignition risks, including spark control (if necessary).

A proactive approach to dust collector fire and explosion safety will go a long way toward preventing an expensive or tragic accident at your facility. It makes sense to work with an engineering expert for the design of a safe and compliant dust collection system.

Kreczmer is president of RoboVent. Reach him at info@robovent.com. To learn more about combustible dust, download RoboVent’s “Visual Guide to Combustible Dust.”

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In the United States, school counselors often meet with middle school students to discuss their future education plans and career objectives. Students who express an interest in advanced professional careers are given advice on an appropriate high school curriculum to follow that supports preparation for college. Those who plan to attend college but have not decided on a specific major will be directed to a general course of study while making a final decision.

Once in college, there is a grace period before a major must be declared, but eventually one must be selected so the appropriate elective courses can be completed. Students interested in obtaining an advanced degree must complete the required post graduate courses needed for a master’s or doctorate.

Not all students are college bound; students who may be interested in working in the trades (electrician, plumber, mechanic, computer technician) are directed accordingly to short term programs in their chosen field. Some of these skill sets can be obtained at local community colleges or through online certificate programs. Many of these professions are overseen by licensing entities to ensure that competence requirements are met on a continuing basis. Many students enter the workforce directly from high school, particularly in areas where large manufacturing facilities or distribution centers are located.

Until recent years, the traditional academic track was not available to students interested in a career in food safety. Even today, a mere handful of schools offer a food safety major, limiting access to the broader public and restricting the number of graduates annually available for employment. In fact, few were even aware there was such a track unless a food manufacturer was located nearby.

As a result, staffing in the field of food safety has traditionally prioritized ongoing workplace education coupled with skills development and formal external training as needed to meet regulatory requirements. Otherwise known as “workforce development,” this route allows employers to meet the job-specific needs of food safety in the absence of more traditional academic options.

Workforce development can be described as an interconnected set of solutions developed to meet employer needs for skilled workers. In food safety, this can include a wide range of knowledge, given the diversity of food manufacturing techniques and ever-increasing food hazards. The ideal goal of workforce development is to create a structure in which workers are placed in jobs where there are career development opportunities, providing an incentive for workers to systematically advance by acquiring the new skills and additional knowledge needed to achieve the goal of promotion to a management position. That’s quite a mouthful, just to say that there are limited opportunities to pursue a defined career path in food safety.

Along Came FSMA

As new microbiological hazards emerged in the 1990s, external training in Hazard Analysis and Critical Control Points (HACCP) became a USDA-FSIS requirement, and the position of HACCP manager represented an advanced career step for those in the meat and poultry industry. HACCP training was a one-time, three- or five-day course that did not typically require an exam for completion. A simple certificate of attendance was adequate to prove completion, and there was no requirement for ongoing professional development. This remained one of the most advanced food safety positions on the production floor until the Food Safety Modernization Act’s (FSMA’s) Preventive Controls regulations were published.

Under FSMA, the HACCP manager role in FSIS was elevated to the Preventive Controls Qualified Individual (PCQI) role for FDA-regulated producers. FSMA placed the ultimate responsibility for food safety on the “owner, operator, or agent in charge” and required all personnel to be qualified for their assigned positions. The role of PCQI expanded workforce training requirements, requiring a minimum of eight hours per year of ongoing professional development training, but still remained a single external course from an approved trainer accompanied by a certificate of completion that is applicable to all types of foods produced. From produce to cupcakes, a PCQI certificate is transferable to any FDA-regulated facility.

In other words, the majority of today’s food safety employees are developed internally with limited advancement choices. In fact, most food safety team staffing typically relies on an informal career path of internal promotion based on the completion of external workforce training such as HACCP or PCQI in conjunction with other basic job performance criteria.

Workforce Development

Workplace training is often focused on a specific job or skill that is necessary to perform an employee’s job. It is generally a compulsory component of employment and can be a regulatory requirement for HACCP or the PCQI role outlined in FSMA. Workforce development is different from workplace training; workforce development is considered a more long-term, ongoing strategy to help improve a workforce or build capacity.

Workforce development helps to create a culture of learning and constructive attitudes that builds a workforce’s tangible and intangible abilities to manage and deal with future challenges. Research shows that skills development and opportunities for professional and personal growth are important aspects of employee retention, especially among millennial workers. When an employee feels like their leadership skills are being valued and nurtured, they are less likely to leave a company.

In an industry already combating increasingly high rates of employee turnover, the need to shift from workforce training models to a workforce development model is crucial. Today it is reported that 36% of millennials and 53% of members of Gen Z would leave a job to join a new organization within two years if given the chance to advance elsewhere. In food safety, these numbers could be significantly higher.

Often, workforce development opportunities are highly sector specific, which is not a workable solution in food production. The current mandated workforce training doesn’t differentiate between the relatively safe production of cupcakes and cookies and foods such as refrigerated pasta salads that can present multiple hazards, leaving a gap that will require a modified approach that combines the broader workforce development theories with the specifics of workplace training models.

Food Safety Auditors

A similar situation applies to those who perform supplier or third-party audits. In addition to the food product sector-specific knowledge needed to adequately assess a facility, auditors must also acquire the skills and knowledge needed to perform an effective audit. Ironically, one must have auditing experience to become an auditor, but without auditing experience, one can’t audit. This perpetual circle creates a vacuum where auditors are receiving a wide range of initial auditing experience, with some good, some bad, and some downright awful. Unlike PCQI training, which covers all FDA foods, audit experience does take into account the types of products one is considered approved to audit, but there are still knowledge gaps to be addressed.

All Global Food Safety Initiative (GFSI) auditors must have a significant amount of auditing experience in each requested food category to be approved to perform an accredited certification audit, which helps address the experience component missing in the PCQI training; however, all food categories and prior audit experience are often treated as equivalent. There is no distinction between the higher risk, more challenging audits of a ready-to-eat food facility and the lower risk, more simplified audits of a cracker facility. This can easily be seen when reviewing job descriptions for food auditors. Most include a complete list of skills and knowledge needed to be able to audit any type of food, yet that may be overkill if the auditor will primarily be assessing pesticide applications in orchards. In terms of career advancements, once an auditor is approved to audit, they can request additional categories in a variety of ways, but there are no formal paths to achieve this growth and no additional advancement for those who do.

On the downside, limited mechanisms exist to remove auditors delivering unsatisfactory reports from a category or from the field of auditing in general. This is especially true for auditors operating as independent contractors. One certification body may stop using an auditor, but others may be unaware of the shortcomings of the auditor until they too receive unsatisfactory results.

Are Credential Programs the Answer?

Many industries find themselves in the same predicament as the food safety sector and have turned to the use of credential programs to solve their capacity and skills gaps. Unlike workplace training models, in which attendees receive a certificate of attendance or completion, credential holders must pass an exam to participate in the program and must then complete a required amount of approved, ongoing training for each two-year cycle. These programs offer a standardized record of accomplishments that can support career advancement. Further, a credential can be withdrawn if the participant does not continue to meet the program requirements.

The dedicated staff who protect our food supply every day deserve the recognition and rewards they have so clearly earned. It’s up to the industry to improve how we develop the leaders of tomorrow. These issues and potential solutions will be explored in future segments of this department in Food Quality & Safety.

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