Tag Archives: allergens

Allergens

How Can US Food Businesses Navigate Labeling Regulations While Ensuring Compliance?

By Fred Whipp
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Allergens

With nearly 1 in 4 US citizens reporting a food allergy, the importance of mitigating against cross-contamination in-store and throughout the whole supply chain is becoming increasingly recognized. As reports of allergy tragedies related to food negligence continue to spiral, it begs the question as to whether the food industry is truly and wholly compliant with regulations, such as the FASTER Act.

The Food Allergy Safety, Treatment, Education and Research Act or FASTER Act marks the first time that food allergen labeling has been expanded since the Food Allergen Labeling and Consumer Protection Act (FALCPA). Launched on January 1st, 2023, in the US, the FASTER Act identified sesame as the ninth major food allergen, requiring manufacturers to list and specify the allergen’s presence in packaged foods.

Despite more rigorous regulations being put in place, cases relating to the misleading labeling of food products remain an issue. Earlier this year, the FDA issued a warning to Bimbo Bakery for falsely listing allergens, including sesame, on its food labels in the US. The warning comes amid reports of manufacturers adding allergens to product labels and recipes to rule out the risk of cross-contamination and cleaning procedures required by new labeling laws.

What is the FASTER Act?

The FASTER Act is both a recognition and validation of the seriousness of sesame allergies and sensitivities, promoting R&D for more effective diagnosis and prevention. The Act requires all restaurants and catering companies to ensure all food produced and packed for sale in the same premises has a complete ingredient list identifying all ingredients on the product label, including sesame, the ninth major allergen. It also requires that food manufacturers using sesame in their products ensure procedures are in place, such as thoroughly cleaning equipment across production lines, to avoid cross-contamination.

However, as we have seen, despite more stringent regulations being put in place, there have been numerous cases of manufacturers responding to new labeling laws by intentionally adding sesame as a listed allergen on previously allergen-free products to avoid the rigorous cleaning processes needed to avoid any points of cross-contamination. This practice has been criticized by various organizations, including most notably the Center for Science in the Public Interest (CSPI), which filed a regulatory petition to the FDA in 2023, urging the FDA to address manufacturers intentionally or unnecessarily adding sesame to their formulations or product labels.

Despite the introduction of the Act, reports of negligence are still occurring, exposing a somewhat backward approach to the future of food safety. Not only does this actively risk undermining customer trust, but it also further limits food choices for individuals with allergies.

Keeping compliance central

To remain compliant, food providers and catering companies must establish robust channels of communication with their suppliers to remain informed of any changes to formulations or manufacturing and production processes. Alongside this, staff training in allergens is essential, making employees aware of changes to in-house menus, recipes or stock to provide a comprehensive allergen list to customers upon request.

Manually checking ingredients across every PPDS (prepacked for direct sale) item is not always practical in large facilities, especially when multiple players in the supply chain are involved. One of the most effective ways to maintain accurate ingredient and allergen details is with the help of specialist software that automates updates to nutritional and allergen information across various systems and sites, saving valuable time while ensuring labelling remains accurate by leveraging real-time updates and data.

The future of process management platforms

Food businesses must consider using process management platforms in 2024 to not only ensure but also document that staff follow protocol stringently. This could involve assigning employees digital checklists or logbooks to complete to make certain they have understood new formulations or changes to an existing one. By automating these processes, the highest levels of compliance will be met, both assuring head offices of proper in-house operations and providing records of this in case of inspection.

By integrating IoT technology embedded in process management platforms leveraging sensors, RFID tags and smart thermostats, food businesses can ensure the real-time monitoring of food storage conditions like temperature, humidity and expiration dates, as well as improved supply chain visibility and end-to-end traceability. Examples include cold storage facilities, delivery trucks and even stockrooms equipped with IoT sensors that systematically check, log and alert staff to changes in temperatures or changes to products in the stockroom. When employees are made aware of the storage location of food products and their various allergen content within the stockroom, cross-contamination is more easily avoided, allowing for the easier identification and separation of food products and taking extra precautions to ensure packaging is kept intact when handling.

Improved supply chain traceability

Integrating advanced technologies throughout the supply chain further safeguards against food contamination and promotes confidence, compliance and thus protection from food to farm. Radio frequency identification (RFID) tags document the complete journey from origin to destination by transmitting location and sourcing data to companies, updating them on the exact whereabouts of each product throughout its journey to them. This way, any issues relating to product recall or batch contamination can be traced back through the chain, identifying locations of potential food safety breaches, such as a facility also handling other allergen products.

Installing IoT cameras in manufacturing facilities further enforces quality control by inspecting food products, flagging lapses in improper packaging or the presence of allergens in the facility, automating much of the processes behind compliance with food safety practices. Although the upfront cost of implementing such technologies is expensive, businesses will, in time, reap the benefits of reduced labour costs and improved operational consistency, bolstering their supplier-to-customer relations.

Supply chain traceability is equally important when considering downstream supply chain operations, such as in-country transportation. IoT sensors fitted in refrigerated packaging or vehicles track shipment and courier conditions in real-time, automatically alerting drivers to allergen products on board or changes in temperatures. If the reason for improper storage conditions proves challenging to rectify, drivers will be redirected to nearby facilities where food products can be temporarily stored when equipment malfunctions to ensure the longevity, hygiene and quality of perishable goods.

Time saving without cutting corners

The FASTER Act recognizes and highlights the importance of strict quality control, regulating the accurate labeling of products and mitigating cross-contamination in manufacturing and production facilities. With the right technology and systems in place, equipping businesses with the necessary tools, such as mpro5, the task at hand becomes significantly more manageable.

Process management platforms that automate lengthy manual tasks provide time-saving benefits and further reduce the likelihood of businesses cutting corners when allergen labeling by enforcing compliance. By integrating technologies to create an IoT infrastructure from food to farm, all stakeholders will benefit from the assurance that their products are safe for consumption, whatever the dietary or allergen requirement.

By improving traceability, providing real-time data and ensuring correct storage, waste is reduced, and customer safety is rightfully centered at the heart of all operations. In doing so, food businesses can maintain compliance with safety standards and identify and address potential food safety risks within the wider supply chain whilst cultivating customer confidence and trust once the products are in-store.

Ainsley Lawrence
Allergen Alley

Food Allergen Management in Manufacturing: Best Practices and Regulatory Compliance

By Ainsley Lawrence
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Ainsley Lawrence

Minimizing the risk of contamination is a must if you work in food manufacturing. Accidentally including allergens in your products can cause harm to consumers, undermine your brand image, and lead to hefty lawsuits.

Even major food industry brands like McDonald’s fall foul of food safety laws from time to time. Recently, a man with a dairy allergy was allegedly served cheese in his Big Mac1, resulting in anaphylactic shock. This caused a large lawsuit and could damage the global food giant’s reputation.

You can take steps to stay in line with regulations and best practices by training your staff and implementing proper procedures. This will reduce the risk of human error and help you produce food that is both tasty and safe for consumers.

Food Safety Modernization Act

Most people think of food contamination as a thing of the past. However, 1 in 6 Americans2 fell ill due to foodborne diseases last year. This led to 128,000 hospitalizations and 3,000 deaths. The FDA’s Food Safety Modernization Act (FSMA) seeks to end this issue by bringing food manufacturing standards into the modern age. This means you may need to revise your approach to manufacturing to stay on the right side of changing guidelines. At its core, the FSMA includes:

  • Preventive Controls for Human Foods: Since 2015, food manufacturers have been required to produce a food safety plan. This plan should include key details like potential hazards and risk-mitigation strategies that are currently in place.
  • Third-Party Accreditation: Receiving a third-party authentication can keep you up to date with changing guidelines. Similarly, only working with suppliers who have been verified via third parties who work to ISO/IEC standards ensures that allergens don’t enter your facility from suppliers.
  • Preventing Intentional Adulteration: No employer wants to believe that their employees would intentionally harm consumers — but it does happen. The FSMA ruling against intentional adulteration means that you can seek support from the intelligence community if you suspect that a stakeholder is intentionally contaminating your supply.

These FSMA regulations aren’t exhaustive and should be seen as the bare minimum. You’ll still need to take proactive steps to improve communication on the food plant floor3 and should implement policies like proper labeling to keep contaminants and allergens separated.

Proper Labeling

If you’re producing food for public consumption, you must properly label your food. Failing to declare that allergens may enter a certain product will land you in legal trouble and will put consumers at risk. Rather than risking an allergic reaction, follow FDA labeling guidelines4 which include:

  • Clearly labeling the eight major allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans).
  • Including the source name of foods (for example, the source name of whey is milk, meaning your label should include “whey (milk)”).
  • Provide advisory statements like “may contain [allergen]” and “produced in a facility that also uses [allergen].”
  • Conduct regular testing and monitoring of products and processes to ensure that allergens have not entered the batch.

Taking these steps minimizes the risk of labeling errors and protects consumers. This is particularly important if you want to produce a product that is specifically allergen-free (for example, gluten-free or dairy-free). Failing to declare ingredients properly puts consumers at risk and will land you in hot legal water.

Segregating Allergens

Managing potential allergens is crucial if you work in a food manufacturing plant that produces multiple products. Failing to properly segregate allergens undermines your labeling system and increases the risk of cross-contamination between workstations.

You can minimize the risk of allergens entering the system by using simulations to improve business processes5. Virtual simulations are capable of generating scenarios that you may not have thought of but are likely to occur. You can also use constructive simulations to visualize what might happen should an allergen make its way into the supply. This is particularly important when onboarding new employees who may not understand the risk that allergens present to the food production process.

You can also use emerging technology to improve production6 and reduce the risk of contamination. For example, as your firm grows, you may want to invest in AI and advanced robotics. Robotics can react quickly to changing demand and are less likely to inadvertently spread allergens throughout your supply. This is particularly important when carrying out repetitive tasks, like filling pre-packaged sandwiches or seasoning foods. Automated robots can take care of these mundane tasks, leaving human workers to focus on more creative tasks.

Some food manufacturers, like Walmart, are also using blockchain technology to trace and track contamination. This can improve your crisis management plan7 and bolster operational resilience. Your crisis management team leader can tap into tech to improve communications and simulate potential breaches. This will help you practice your crisis management plan and will ensure that you’re able to pinpoint errors to learn from in the future.

Sanitary food handling

Sanitation Procedures

Regularly sanitizing your workspace is crucial if you want to produce clean, allergen-free goods. This applies to your people, too, who may inadvertently bring allergens in with them when they arrive at work or move between stations.

However, you can’t expect regular handwashing to be enough. Instead, embrace the digital revolution and use data8 to clean up your production line. This will improve reporting and ensure that compliance guidelines are followed at all times. For example, if you suspect that your employees are not washing their hands thoroughly enough, you can use digital products to track employee handwashing and time folks while they apply hot, soapy water.

Digital tracking can also alert you to potentially unclean workstations. For example, if you work in a bakery and typically produce most of your dough before dawn, a digital program can track the contaminants that have entered the workspace in order to produce your bread or baked goods. This will alert you to potential allergen risks and ensure that any workstation that has used an ingredient like gluten is properly sanitized in a timely fashion.

Staff Training

Properly training your employees is key to minimizing contamination risk and staying on the right side of regulatory compliance laws. A proper approach to training will empower employees and help them understand the potential risks involved with food manufacturing.

However, proper training doesn’t mean that you should force your workers to sit through hours of PowerPoint. Instead, train smarter, not harder9 by conducting training that is:

  • Legitimate. Before asking folks to engage in further training, ask yourself whether or not you are qualified to speak on the subject. If not, consider bringing in a speaker who is well-respected in the food safety industry.
  • Authentic. Build a culture of trust and engagement at your workplace by working with speakers and programs that are accredited and up to date with compliance law. This will convince folks that your speakers are worth listening to and that your training programs are worth completing.
  • Engaging. Don’t force your employees to sit through lengthy seminars without an opportunity to engage. Instead, encourage participation by creating engaging training programs that help folks learn skills as they go.
  • Simplistic. Food safety can be complex. Cut through this complexity by giving folks simple, actionable steps to take. This will minimize the risk of folks forgetting your policies and will empower employees who want to improve safety at work.

These training principles are well-established in the food production and safety world. Even simple changes, like including a quiz or mock preparation test, will pique people’s interest and ensure that employees are engaged when receiving training. If you fail to run engaging, intelligent training, you put yourself at greater risk of contamination during production.

Conclusion

Following FDA guidelines should keep your consumers safe by minimizing the risk of an allergen entering your workspace. However, you’ll need to go above and beyond minimum requirements if you want to completely eliminate the risk of contamination. Get the ball rolling by embracing the digital revolution and using automation or robotics to handle more mundane tasks. This empowers employees and reduces the risk of human errors during production.

References:

  1. https://www.nbcnews.com/news/us-news/man-dairy-allergy-sues-mcdonalds-alleging-cheese-big-mac-caused-anaphy-rcna137252
  2. https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma
  3. https://foodsafetytech.com/column/improving-communication-on-the-food-plant-floor/
  4. https://www.fda.gov/food/food-labeling-nutrition/food-allergies
  5. https://www.lucidchart.com/blog/business-process-simulation
  6. https://foodsafetytech.com/column/four-influential-technologies-changing-food-manufacturing/
  7. https://riskonnect.com/business-continuity-resilience/crisis-management-plan-create/
  8. https://foodsafetytech.com/column/managing-food-safety-testing-and-sanitation-data-should-be-easier/
  9. https://foodsafetytech.com/feature_article/train-smarter-not-harder-utilizing-effective-training-to-empower-employees/
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Highlights from the 2023 Food Safety Consortium

By Food Safety Tech Staff
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Last week, hundreds of food safety professionals, members of the FDA and USDA, and leaders in academia, food safety testing and cybersecurity met in Parsippany, New Jersey, for the 2023 Food Safety Consortium.

Keynote speaker Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS, and Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, opened the Consortium to discuss their agencies’ priorities for 2024 and took part in a town hall Q&A with attendees.

Eskin and Mettler
Sandra Eskin and Erik Mettler

In April, the USDA FSIS declared salmonella an adulterant in raw breaded chicken products. The agency is now reviewing comments and finalizing a framework for other poultry products and examining how to substantiate claims, such as “Pasture Raised,” “Grass Fed” and “Raised without Antibiotics.” Cell-cultured meat is another key focus for FSIS, and it is requiring labeling of “Cell Cultivated” on the packaging of these products.

Mettler discussed the “mass reorganization” of the FDA that is currently underway following the 2022 Reagan Udall report, noting that Jim Jones, the new Deputy Commissioner for Human Foods will have full control of policy and resources of the Human Foods program. A key focus will be risk management prioritization. Expect to see full reorganization in late summer or early fall of 2024.

Reorganization of the FDA’s Human Foods program was a hot topic that was also discussed in depth during Modernizing the U.S. Food Safety System with panelists Stephen Ostroff, former FDA commission, Barbara Kowalcyk, faculty at Georgetown University, and Bill Marler, food safety attorney with Marler Clark.

Session Highlights

This year, attendees had the opportunity to take part in full-day pre-conference workshops, including Food Safety Auditor Training with Trish Wester, president of the Association for Food Safety Auditing Professionals, and the Food Safety Culture Design Workshop with Gina Nicholson Kramer, Associate Director of Partnerships, Policy, & Learning at The Ohio State University, and Richard Fleming and Austin Welch of Sage Media.

Sessions during the two-day Consortium covered everything from data analytics to risk mitigation, grassroots food safety culture and recall trends.

Steven Gendel
Steven Gendel

Attendees were able to take part in a Panel Discussion with the Producer and Food Safety Experts Behind “Poisoned: The Dirty Truth About Your Food” Documentary with producer Kristin Lazure and featured members of the film, including Dr. Darin Detwiler, CEO of Detwiler Consulting Group, and professor at Northeastern University, attorney Bill Marler, and Brian Ronholm, director of food policy at Consumer Reports.

Steven Gendel spoke on regulatory guidance, thresholds and best practices for Allergen Advisory Labeling, followed by Tracie Sheehan of Mérieux Nutrisciences who presented Protecting Allergic Consumers through Audited and Validated Allergen Control Plans.

Cybersecurity panel FSC2023
Food Safety and Cybersecurity panel discussion

Two sessions highlighted the growing threat of cyber attacks. Attendees gained valuable insights from Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security, in Re-Imagining Food Protection as a National Security Issue – DHS Perspective, and Scott Algeier of the Food-Ag ISAC, who led a panel discussion on Food Safety and Cybersecurity.

“We’d like to thank all of our attendees, speakers and sponsors for helping make this year’s Food Safety Consortium a success. Through discussion, sharing of knowledge and building industry connections, the food industry will be better prepared to tackle the biggest challenges facing food safety, ensuring a safer and more resilient food supply for consumers,” said Rick Biros, founder and program director of the Consortium and publisher of Food Safety Tech. “We look forward to welcoming everyone to next year’s program in Washington, DC.”

Save the Date: The 2024 Food Safety Consortium will take place October 20-22 in Washington, DC. The call for abstracts is now open.

Reception at 2023 Consortium

About the Food Safety Consortium: ​Organized by Food Safety Tech, the Food Safety Consortium Conference, launched in 2012, is an educational and networking event that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology, best practices and compliance, the “Consortium” features critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers.

 

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FDA Releases New Draft Guidance Chapters on Food Allergens and Acidified Foods

By Food Safety Tech Staff
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The FDA has released two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and how to ensure that food products are properly labeled with respect to the major food allergens. It provides examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. The chapter also discusses circumstances in which, despite adherence to appropriate CGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided and provides options to consider in these scenarios, including the voluntary use of allergen advisory statements when appropriate.

Chapter 16—Acidified Foods—applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers or cabbage that have an overall pH of 4.6 or below). It provides procedures, practices and processes to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.

Stakeholders can submit comments on the new chapters at Regulations.gov (Docket No. FDA-2016-D-2343). Comments should be submitted within 180 days of September 26, 2023, to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.

Food Safety Consortium 2023
From the Editor’s Desk

Tackling Today’s Greatest Food Safety Challenges:  The 2023 Food Safety Consortium

By Food Safety Tech Staff
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Food Safety Consortium 2023

Food safety and quality professionals can take advantage of three days of education, networking and panel discussions at the 11th Annual Food Safety Consortium, October 16-18 in Parsippany, New Jersey. This year’s event is co-located with the Cannabis Quality Conference and Food Defense Consortium.

In-person and virtual registration options available

Erik Mettler and Sandra Eskin

Keynote Speakers: Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Partnerships and Operational Policy, Office of Regulatory Affairs (ORA) at FDA, and Sandra Eskin, Deputy Undersecretary Food Safety, USDA, Food Safety & Inspection Service.

Following the keynote presentations, attendees can take part in a Town Hall Q&A with Mettler and Eskin, followed by a panel discussion on Modernizing the U.S. Food Safety System, featuring Stephen Ostroff. Former FDA Commissioner, Barbara Kowalcyk, Executive Director of the Center for Foodborne Illness Research and Prevention, and Bill Marler, Attorney with Food Safety Law Firm Marler Clark.

This year’s program includes four pre-conference workshops, taking place on Monday, October 16:

  • Food Safety Culture Design Workshop
  • CP-FS Credential Review Course
  • Food Safety Auditor Training
  • The Seed to Sale Safety Workshop

Days two and three feature panel discussions covering food safety culture, supply chain, recall patterns and succession planning, as well as breakout sessions on prevention, mitigation, control and regulation of key food safety hazards. Session highlights include:

Re-Imagining Food Protection as a National Security Issue – DHS Perspective, Presented by Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security.

The Rise of Previously Unforeseen Hazards, Presented by Tim Lombardo, EAS Consulting

Food Safety Supply Chain Management, Presented by Celso Pagutalan, ASR Group

Succession Planning for Food Safety Inspectors, Panelists: Gina Nicholson Kramer, April Bishop of TreeHouse Foods, Barbara Kowalcyk, Executive Director of the Center for Foodborne Illness Research and Prevention, Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA) at FDA, Rance Baker of NEHA, and Jorge Hernandez of Wendy’s

Food Safety Culture: Creating a “Speak Up Culture,” Presented by Austin Welch, Sage Media

Risk Mitigation through Assessment, Testing, Monitoring and Compliance, Presented by Dr. Sandra Johnson, SGS North America

Recalls Trends, Regulation and Lessons Learned, Panelists: Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA) at FDA, Shawn Stevens, attorney with the Food Industry Counsel, and Stephen Ostroff, M.D. former Acting FDA Commissioner.

Food Allergen Advisory Labeling, Presented by Dr. Steven Gendel

View the full agenda.

Don’t miss out on opportunities to network with other food safety and quality professionals during the opening night reception, networking lunches and coffee breaks.

Registration options are available for in-person and hybrid team attendance.

Event Hours

  • Monday, October 16: 8:30 am – 5:00 pm (ET)
  • Tuesday, October 17: 9:00 am – 6:30 pm (ET)
  • Wednesday, October 18: 9:00 am – 4:00 pm (ET)

 

Sonia Acuña-Rubio
Allergen Alley

Reducing the Risk of Undeclared Food Allergens

By Sonia Acuña-Rubio
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Sonia Acuña-Rubio

Each year, 200,000 people in the U.S. require emergency medical care due to allergic reactions to food. Common foods that trigger allergic reactions include certain types of seafood, dairy, nuts, wheat, soy and sesame. For some, food allergy reactions can be serious and even life-threatening, requiring immediate treatment via the drug epinephrine.

Allergens are also one of the leading causes of food recalls globally. As food allergies continue to impact individuals and families across the nation, food manufacturers and distributors must be vigilant when manufacturing, packaging and selling foods to consumers.

Understanding Allergen Regulations

Many countries aim to protect individuals with food allergies by enforcing government regulations. Such regulations can require product manufacturers to disclose ingredients in packaged food and beverages.

In the U.S., the FDA recognizes nine major food allergens: crustacean shellfish, eggs, fish, milk, peanuts, tree nuts, sesame, soybeans and wheat. Sesame is the newest recognized allergen and was added in 2022 as part of the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. These allergens must be identified on labels for American food products.

Similarly, in Canada, the Canadian Food Inspection Agency (CFIA) has a list of 11 priority allergens, which includes eggs, milk, mustard, peanuts, crustaceans and mollusks, fish, sesame, soy, sulfites, tree nuts, wheat and triticale, which must be disclosed on pre-packaged foods sold in the country.

In both countries, products may be recalled due to improper labeling and announced via public notice. (A comprehensive list of recognized food allergens by country can be found on the Food Allergy Research and Resource Program (FARRP)’s website.)

Activating Your Allergen Management Program

A comprehensive and effective allergen management program protects your consumers and your company and is necessary to meet regulatory and GFSI (Global Food Safety Initiative)–benchmarked standard requirements. Creating an allergen management program involves developing processes and protocols and training employees to follow them.

Allergen cross-contact can occur when an allergenic food or ingredient is unintentionally incorporated into a food product. Food manufacturers and distributors should have a program that includes an allergen risk assessment, which helps to identify and manage any unintentional allergen contamination throughout the supply chain while tracing them throughout the facility. Good Manufacturing Protocols (GMP) should be followed for personal hygiene, handwashing, sanitation programs and more.

Managing Your Suppliers

Supplier communication is key to identifying allergens in raw materials. Use current supplier specifications and ingredient statements to identify allergens coming into the facility. Be alert for “may contain” statements and review your supplier’s allergen control policies and procedures.

In today’s food production environment, there are more supply chain disruptions than ever before. If there is a change in your raw materials or supplier, make sure that all documentation and finished product labels are updated.

Additional best practices when working with suppliers include:

  • Have a policy in place for label changes, noting that if a label from a product you purchase from a supplier changes, you must be notified of the change prior to the change being made and put into effect.
  • Ask for updated specifications/allergen information from suppliers on an annual basis. This could help to quickly identify issues if the supplier neglected to inform you of a change.

By identifying and listing sources in the facility, you can detect any ingredients and processing aids that contain or may contain allergens due to cross-contact or carry-over products. It is also important to prepare a master list of all ingredients in the facility and consider both primary and secondary ingredients, such as spices, colors and flavors.

Ask questions along the production process, identifying potential risks in recipes/formulas, traffic flow (of people, materials, and waste), potential crossovers of conveyors or pipe systems, shared equipment, storage practices, material segregation and airflow.

Avoiding Allergen Cross-Contact

Ensure that raw materials are labeled and segregated with incoming ingredient specification checks by weighing powders containing unique allergens in a separate and labeled area, covering totes or containers containing allergenic ingredients during transfer, and controlling the ventilation over lines where protein powders are dumped. Use product scheduling to maintain proper segregation.

Designate dedicated equipment, including utensils, if possible, as well as production sequencing or cleaning between allergen changeovers. Refrain from using original ingredient containers that previously held allergens. At the end of an allergen production run, conduct a complete and validated allergen clean.

Use documented visual inspection on each piece of equipment and environment between allergen changeovers and conduct regular labeling checks against the approved label/package design for each item produced. A third-party partner can be used to help develop and maintain supplier specifications, audit formulations, and review current packaging.

Protecting Consumers and Business Reputation

While ensuring products are free of any undeclared allergens may seem more challenging than ever before, establishing the right programs and practices can keep both your business and consumers healthy and safe. Implementing an allergen management plan, supplier checks, and allergen controls is key to avoiding cross-contact in the production process and throughout the supply chain, ensuing fewer disruptions in the manufacturing process, and ultimately, building trust with consumers.

Food Safety Consortium 2023
From the Editor’s Desk

Registration Open for the 2023 Food Safety Consortium

By Food Safety Tech Staff
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Food Safety Consortium 2023

Registration for the 11th Annual Food Safety Consortium, which will take place October 16-18 at the Hilton Parsippany in New Jersey, is now open.

Presented by Food Safety Tech, the Food Safety Consortium is a business-to-business conference that brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry today.

In addition to two full days of high-level panel discussions, this year’s program will include a second Food Safety Hazards track. These “Boots on the Ground” sessions provide education on the detection, mitigation, control and regulation of key food hazards.

New this year is a strategic co-location with the Cannabis Quality Conference (CQC), a business-to-business conference and expo where cannabis industry leaders and stakeholders meet to build the future of the cannabis marketplace. Registered attendees get full access to both conferences.

Registration options are available for in-person and virtual attendance.

The Consortium will kick off with presentations from Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs (ORA), and Sandra Eskin, Deputy Under Secretary for Food Safety at the USDA FSIS, followed by a Town Hall with the regulators.

Other agenda highlights include:

  • The Future of Food Safety Culture
  • The Rise of Previously Unforeseen Hazards,
  • FSMA 204: The Final Rule – Looking Ahead,
  • Anti-Food Fraud Tactics for the Entire Supply Chain
  • Bridging the gap between food safety and cybersecurity
    Protecting Allergic Consumers through Audited and Validated Allergen Control Plans
  • Succession Planning for Food Safety Inspectors
    Utilizing Food Quality Plans to Ignite Positive Food Safety Culture
  • Recalls Trends and Predictions

View the full agenda and register here.

Attendees will also have the opportunity to take part in pre-conference workshops on Monday, October 16, including:

  • Food Safety Auditor Training
  • CP-FS Credential Review Course
  • The Food Safety Culture Design Workshop
  • The Seed to Sale Safety Workshop

Event Hours

Monday, October 16: 8:30 am – 5:00 pm (Pre-conference Workshops)

Tuesday, October 17: 8 am – 6:30 pm

Wednesday, October 18: 8:30 am – 3:45 pm

Register now

Tabletop exhibits and custom sponsorship packages are available. Contact Sales Director RJ Palermo.

About Food Safety Tech

Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.

About the Food Safety Consortium

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore high-level educational tracks, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

 

Matthew Taylor

Mitigating the Risks of Food Fraud in an Inflationary Environment

By Matthew Taylor
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Matthew Taylor

Inflation can create a challenging environment for the food industry, making it more difficult to maintain product quality, safety, and transparency. In August 2022, U.S. food inflation hit a 40-year high of 11.4% and has since remained persistently high, at 10.1% in January 2023. Manufacturers and suppliers must stay vigilant and take proactive steps to mitigate the risks posed by stubbornly high food inflation and increasingly complex supply chains.

Inflation can be a catalyst for risk in food supply chains for several reasons. Rising prices could encourage bad actors or tempt manufacturers and suppliers to cut corners or compromise quality to maintain profit margins. This can lead to an increased risk of food fraud, where lower-quality or counterfeit ingredients are substituted for genuine ones or where mislabeled products are sold to unsuspecting consumers. Supply chain disruptions could increasingly affect manufacturers as suppliers struggle to manage the increased costs of raw materials, transportation, and labor, as seen this winter in Europe, with the UK experiencing shortages of tomatoes and eggs. This can result in delays, shortages, and other logistical challenges that can make it difficult to maintain product quality and safety.

Inflation can also increase food allergy and sensitivity incidents. Mislabeling or allergen contamination due to substituted alternative ingredients could put allergen or intolerance sufferers at greater risk, as well as your brand. With the threat of food fraud lurking in increasingly complex and volatile supply chains, what steps can food manufacturers take to protect themselves and their customers?

Tackling Food Fraud and Allergen Incidents

Despite legislative and industry process improvements, food fraud continues to be a significant risk in the food industry, costing businesses an estimated $30 to $40 billion annually. Food fraud refers to any act of deception, intentional or otherwise, that is intended to result in the sale of a food product that is not what it purports to be. This can take many forms, from adulterating ingredients to misbranding and counterfeiting.

The consequences of food fraud can be severe and include economic losses, harm to human health, damage to the reputation of food companies and loss of consumer confidence in the food supply. Food fraud can also cause environmental consequences, including the illegal use of pesticides, or overfishing, which can have long-term effects on the environment, wildlife, and ecosystems.

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In recent years, several high-profile cases of food fraud have occurred, including the widespread contamination of infant formula with melamine in China and the horse meat scandal in Europe. These incidents have highlighted the need for better measures to prevent food fraud and to ensure the safety of the food supply.

To protect the integrity and bolster consumer and producer confidence in organic food, which has long been a target of food fraud, the USDA published one of the largest-ever reforms to their organic program in January 2023. However, many risks remain as legislation tries to catch and close loopholes.

One of the challenges of preventing food fraud is that the supply chain is often complex and global, making it difficult to track the origin of ingredients and monitor their quality. In addition, many food frauds are not detected until they reach the end-consumer, making it difficult to recall contaminated products. In order to mitigate the risk of food fraud, it is essential to plan ahead and implement strong supply chain management practices, including the use of technology such as traceability systems and predictive analytics.

A good starting point to mitigate your risk of food fraud is to conduct a deep dive into your highest-risk raw materials and suppliers instead of trying to tackle everything at once, particularly if you have a large number of raw materials to assess. For instance, you may want to prioritize raw materials that have been linked to recent fraud incidents, such as infant formula, honey, and olive oil.

Four Steps to Protecting Your Business

Know your supply chain. Controlling and understanding your supply chain is essential for minimizing risk. It is important to audit your supply chain back to the field, if possible, or at least to the production and processing facility. For smaller businesses, forensic auditing may not be feasible. However, there are still steps they can take to protect themselves, such as seeking third-party certification programs that verify the sustainability, quality, and ethical sourcing of ingredients. Going back by more than one step in your supply chain is crucial, and conducting a vulnerability assessment of your raw materials and suppliers is an excellent starting point.

Shop around safely. Review the market for potential alternate suppliers or less ‘at risk’ ingredients, subject to the required quality checks and labeling requirements. It is crucial to thoroughly assess current and potential new suppliers and ensure they meet the minimum Global Food Safety Initiative (GFSI) certification standards, wherever possible. Scrutinize all raw material specifications, including the country of origin, as countries with less established food safety regulations may pose a higher risk. Establishing solid relationships with your suppliers and engaging in regular communication with them is also essential to maintain a high standard of quality, safety, and sustainability.

Be vigilant about ingredients. Markets are constantly evolving, and economic, social, and environmental changes can impact the substitution risk profile of any ingredient that you purchase. To manage this risk, it is essential to have an up-to-date awareness of the various market forces that affect ingredients and their availability.

It is important to note that product adulteration may not always be motivated by economic factors. As ingredients become in short supply, manufacturers may make local substitution decisions to keep the supply available. Remember, there is no substitute for a thorough risk-assessed approach to managing this challenge with a complete and detailed understanding of your supply chains.

Utilize training to build awareness and readiness. Training employees on how to identify, prevent and respond to incidents of potential food fraud or allergens is essential but often challenging for food manufacturers. Regular training should include the types of fraud, how to recognize suspicious behavior, and the importance of accurate record-keeping. Ensuring your teams are trained on what to do is there is a food fraud issue is also key, as is testing the teams through mock exercises to see how they would manage a food fraud event in the business.

Persistently high food inflation rates have created a challenging environment for the food industry, making it harder for manufacturers and suppliers to maintain product quality, safety, and transparency. Food businesses must exercise extra vigilance to face an increased risk of food fraud, supply chain disruptions, and an increase in food allergy and sensitivity incidents. Now is the time to proactively mitigate these risks by prioritizing transparency, gaining control and understanding of supply chains, and acting to prevent food fraud.

It is important to note that no system is foolproof. Food manufacturers should regularly assess and improve their supply chain management practices to ensure they are up to date with industry best practices and changing threats. Increasing your transparency in the ingredient supply chain requires a commitment to responsible sourcing and a willingness to invest in traceability, certification, and supplier relationships. While the risks to food quality and safety are well known, businesses need to ask themselves the right questions and take the necessary steps to protect themselves and their customers. By doing so, they can protect their brand reputation and consumer confidence in the food supply and the environment.

 

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FDA Releases List of 2023 Priority Guidance Topics for Foods Program

By Food Safety Tech Staff
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The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.

The guidance documents do not impose legally enforceable requirements, but they can help stakeholders plan for potential changes that may impact their businesses and organizations. The agency anticipates it will publish many of the listed documents by January 2024.

The priority list of draft and final guidance topics include (by category):

Allergens

  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
  • Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
  • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders

Food Additives

  • Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
  • Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry

Food Safety

  • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
  • Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
  • Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
  • Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff

FSMA

  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
  • Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry

Labeling

  • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
  • Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
  • Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry

Public comments on the list of guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.

 

2022 FDA Food Code

FDA Issues 2022 Food Code

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2022 FDA Food Code

The FDA has issued the 2022 edition of the FDA Food Code, which contains some significant changes, including:

  • Adding sesame as a major food allergen to reflect that the Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen
  • Informing consumers, in writing, of major food allergens as ingredients in unpackaged food
  • Adding labeling of major food allergens in bulk food that is available for consumer self-dispensing
  • Creating new requirements for the allowance of pet dogs in outdoor dining spaces
  • Revising the definition of intact meat, including enhancements to clarify time/temperature cooking requirements

For the first time, the FDA Food Code specifically addresses food donations, included as part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. The National Strategy, which was rolled out in September at the White House Conference on Hunger, Nutrition, and Health, provides a roadmap of actions the federal government is taking to end hunger and reduce diet-related diseases by 2030.

The FDA noted that the 2022 edition reflects the input of regulatory officials, industry, academia, and consumers that participated in the 2020 biennial meeting of the Conference for Food Protection (CFP).

The Food Code is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Alternatives that offer an equivalent level of public health protection to ensure that food at retail and food service is safe are recognized in the Food Code.

View a full list of the Summary of Changes.