Tag Archives: compliance

The FSMA Companion Training Program Series 1 – May 2024

Series 1 of the FSMA Companion Training Programs focuses on the Hazards and Hazard Analysis components in PCHF Subpart C. From learning how to navigate the new Regulatory Dashboard for insight into upcoming regulations, to developing a comprehensive testing plan for Chemical and/or Biological Hazards, this training will simplify and streamline the food safety plan review process or support the creation of a new plan.

Jennifer McEntire
Women in Food Safety

Building a Satisfying Career in Food Safety

By Food Safety Tech Staff
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Jennifer McEntire

With so many potential paths available to food safety and quality assurance professionals, how do you narrow your career path goals, and when is it time to move on to a new opportunity? These were two of the themes of last month’s Women in Food Safety gathering. Featured speaker, Jennifer McEntire, Ph.D., founder of Food Safety Strategy and former Chief Food Safety & Regulatory Officer at the International Fresh Produce Association (IFPA), discussed her 25-year career path and why she chose to step out on her own as an independent food safety consultant.

The keys to a long and satisfying career are to keep an open mind and explore opportunities, said McEntire. Having trained as a food microbiologist, her career was heavily influenced by an early internship at the National Food Processors Association (later to become the Grocery Manufacturers Association) in Washington, DC. She later worked with IFPA and regulatory consultancies including the Acheson Group and Leavitt Group. Her experiences in DC instilled in her an appreciation for regulations and an interest in what she referred to as “being in front of the debate in forming legislation.”

“I love reading regulations, I love DC and I enjoy learning how decisions are made, the debate of a bill and finally how it gets passed,” said McEntire. “So I have always worked in the regulatory area.” However, as she moved up the ladder, she realized that she was spending more time in meetings than rolling up her sleeves and working and decided to go out on her own as a consultant. “I am naturally risk adverse,” said McEntire. “So, I made this transition very cautiously.”

Questions to Ask

The questions that have guided her career decisions, which she encourages other professionals to ask themselves are, “What am I good at? What do I like to do?”

Although she has a very strong background in regulations and compliance, when launching her own company she wanted to take the opportunity to broaden that scope and work with companies in building better food safety management systems. “I didn’t want to focus just on audit compliance as these clients are often just compliance focused. Instead, I wanted to work with companies that wanted to be better, build and improve their operations,” said McEntire. Key questions she encourages companies to ask (that she asks clients) are, “Where do we go from here? What does success look like?”

Owning and managing her own company gave her the opportunity to build her skill set outside of food safety regulation. “Owning my own business isn’t easy, but at each stage I learn something new. For example, how to build a website and how to manage my company email accounts,” said McEntire. “Although there are many new things, I enjoy being responsible for my own schedule. I don’t have to ask anyone for permission and I actually don’t miss working for an employer anymore.”

Tips for Success

McEntire shared several tips that contributed to her success, including:

  • surround yourself with the right people.
  • stay informed and keep up-to-date
  • take advantage of the opportunities that arise

“Throughout your career, it’s important to let your opinion be heard,” she said. As you move into leadership positions, “I ask everyone what they think, then gather all information and make sure I understand it. If you have to make the decision, make a decision that you are confident in based on the information available. You may get challenged, but be strong, defend it and don’t hesitate in making the final decision.”



USDA Appoints New Members to Food Safety Advisory Committee

By Food Safety Tech Staff
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The USDA has appointed 21 new members and nine returning members to the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). The purpose of the committee is to provide impartial scientific advice and recommendations to federal food safety agencies. Members of the committee are chosen based on their expertise in microbiology, risk assessment, epidemiology, public health, food science and other relevant disciplines. One individual affiliated with a consumer group is included in the membership of the committee and five members are federal government employees representing the five federal agencies involved in NACMCF—USDA FSIS, FDA, CDC, the Department of Commerce National Marine Fisheries Service, and the Department of Defense Veterinary Services.

“NACMCF members bring a wealth of expertise and dedication to the critical mission of ensuring the safety of our nation’s meat and poultry products,” said Agriculture Secretary Tom Vilsack. “Their contributions will help us continue to strengthen our nation’s food supply and protect the health and well-being of American consumers.”

The newly appointed NACMCF members, who will serve two-year terms are:

  • Dr. Bledar Bisha. University of Wyoming, Laramie, Wyoming
  • Dr. Heather Carleton. Centers for Disease Control and Prevention, Atlanta, Georgia
  • Dr. Anna Carlson. Cargill Protein, Wichita, Kansas
  • Dr. Hayriye Cetin-Karaca. Smithfield Foods, Springdale, Ohio
  • Dr. Ben Chapman. North Carolina State University, Raleigh, North Carolina
  • Dr. Vik Dutta. bioMérieux, Chicago, Illinois
  • Dr. Larry Figgs. Douglas County Health Dept., Omaha, Nebraska
  • Dr. David Goldman. Groundswell Strategy, Arlington, Virginia
  • Dr. Michael Hansen. Consumer Reports, Yonkers, New York
  • Dr. Arie Havelaar. University of Florida, Gainesville, Florida
  • Dr. Ramin Khaksar. Clear Labs, San Carlos, California
  • Lieutenant Colonel Noel Kubat. Department of Defense, U.S. Army Veterinary Corps, Fort Knox, Kentucky
  • Dr. KatieRose McCullough. North American Meat Institute, Washington, D.C.
  • Dr. Indaue Giriboni de Mello. Newman’s Own, Westport, Connecticut
  • Dr. Eric Moorman. Butterball, LLC, Garner, North Carolina
  • Dr. Abani Pradhan. University of Maryland, College Park, Maryland
  • Mr. Shivrajsinh Rana. Reckitt, Parsippany, New Jersey
  • Dr. Marcos Sanchez Plata. Texas Tech University, Lubbock, Texas
  • Dr. Kristin Schill. University of Wisconsin – Madison, Madison, Wisconsin
  • Dr. Nikki Shariat. University of Georgia, Athens, Georgia
  • Dr. Abigail Snyder. Cornell University, Ithaca, New York

The returning NACMCF members are:

  • Dr. Yaohua (Betty) Feng. Purdue University, West Lafayette, Indiana
  • Ms. Janell Kause. U.S. Department of Agriculture, Food Safety and Inspection Service, Washington, D.C.
  • Dr. Elisabetta Lambertini. Global Alliance for Improved Nutrition, Washington, D.C.
  • Ms. Shannara Lynn. U.S. Department of Commerce, National Seafood Inspection Laboratory, Pascagoula, Mississippi
  • Dr. Maxim Teplitski. International Fresh Produce Association, Washington, D.C.
  • Dr. Bing Wang. University of Nebraska – Lincoln, Lincoln, Nebraska
  • Dr. Benjamin Warren. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland
  • Dr. Randy Worobo. Cornell University, Ithaca, New York
  • Dr. Teshome Yehualaeshet. Tuskegee University, Tuskegee, Alabama

NACMCF will hold a virtual public meeting of the full committee and subcommittees from November 14, 2023, to November 16, 2023. In addition to welcoming the new members, the committee will introduce a new charge from FSIS on genomic characterization of pathogens and continue working on the response to the FDA’s charge on Cronobacter spp. in Powdered Infant Formula. Register here to attend the meeting.


Gitte Barknowitz

Technology and Farming: An Essential Relationship as Pesticide Restrictions Impact Agriculture in the EU

By Gitte Barknowitz, Ph.D.
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Gitte Barknowitz

Pesticides and other chemical compounds are widely used in agriculture because they protect crops and improve the efficiency of food production. However, it is necessary to identify what type and how much chemical residues are in food, water and soil as these residues may pose a potential threat to human health as well as the environment. Reducing pesticides in food will result in a lower toxic chemical burden entering the body and accumulating in the tissues and organs, but it will take a concerted effort.

The European Union (EU) member states are implementing extensive policy changes to improve soil quality and ultimately improve the quality of crops. Among them is a “proposal for a new Regulation on the Sustainable Use of Plant Protection Products, including EU wide targets to reduce by 50% the use and risk of chemical pesticides by 2030.” In July 2023, the European Commission also “adopted a package of measures for a sustainable use of key natural resources, which will also strengthen the resilience of EU food systems and farming.”

Reducing the use of chemicals is an important step to ensuring enough safe food for the growing human population. This challenge comes at a time when arable land is being lost, the demand for food is increasing and the world population is expected to increase to 9.7 billion in 2050, according to the United Nations. This will require food growers and processors to implement more sustainable growing practices often referred to as Integrated Pest Management (IPM). While the benefits of natural pest control are already well understood—clean water, healthy soil and improved biodiversity—reducing reliance on synthetic pesticides will require increased analysis, and as a result, generating a lot of data.

It all begins with the analysis of chemical residues found on crops.

Naming the Culprits

With more than 1,000 pesticides in use around the world, it is important to know the properties and toxicological effects of each. A group of pesticides commonly used to curb weeds is herbicides. Glyphosate, (N-(phosphonomethyl)glycine), a widely-used, broad-spectrum, systemic herbicide and crop desiccant, has in the recent years come under scrutiny as the International Agency for Research on Cancer (IARC), a branch of the World Health Organization, classified glyphosate as “probably carcinogenic to humans.”

In the coming years, more data will be gathered on pesticides in the EU, with part of that information coming from control measures and agricultural practice reviews. A large part will come from laboratory measurements to meet data requirements mandated by the new regulations. Compiling consistent, accurate data depends on the equipment that produces it. This is particularly important for food safety.

As technologies advance and more information can be obtained, including residues on food, the requirements for the type of data are also changing. For example, quantifying how much of a predetermined pesticide residue is in a sample is a narrow parameter. Identifying all of the compounds that can be found will provide more data to characterize the sample. Ideally, collecting both will provide the most complete answer to the question, “How much and what kinds of pesticides remain on our food?”

Once that information is available, it is possible to choose appropriate remediation steps. But it takes sensitive laboratory equipment to both identify and quantify residues.

Connecting the Dots Between Pesticides and Food

The most common technology currently used to monitor pesticides is liquid chromatography-mass spectrometry (LC-MS). First, the sample (e.g., soil, water, fruit or vegetable) is injected onto the liquid chromatograph (LC). The LC separates the complex mixture based on the chemical properties of the individual pesticides before being analyzed by the mass spectrometer (MS). MS instruments analyze samples based their masses—or more correctly their mass-to-charge ratio—in a very accurate and precise manner. MS/MS instruments also break apart the pesticides and are able to look for these fragments. These are used to quickly determine if a specific compound is present and in what amount, known as identification and quantitation.

Amadeo Rodríguez Fernández-Alba, professor in analytical chemistry at the University of Almeria and head of the European Reference Laboratory for Pesticide Residues, has valued the benefits of using LC-MS/MS for pesticide residue analysis for years. Over time, the technology and methods have evolved to identify and measure the amount of chemicals in food plants and soil.

In his recent work, Fernández-Alba showed the analysis of 30 compounds of emerging concern (CECs) in soils irrigated with simulated reclaimed water on trial farmland using a targeted MS/MS approach. An accumulation of 13 pesticides and 5 pharmaceuticals could be found at different rates, highlighting the importance of increased analysis for reclaimed water testing.

Regarding the testing method, the authors pointed out that, “a modified QuEChERS method showed the best results in terms of extractability and accuracy. The extraction procedure developed provided adequate extraction performances (70% of the target analytes were recovered within a 70–99% range), with good repeatability and reproducibility (variations below 20%) and great sensitivity (LOQ < 0.1 ng/g in most cases). No matrix effects were observed for 70% of the compounds. Finally, the analytical methodology was applied in a pilot study where agricultural soil was irrigated with reclaimed water spiked with the contaminants under study. Of the 25 CECs added in irrigation water, a total of 13 pesticides and 5 pharmaceutical products were detected…”

Reduction in pesticide usage needs to be monitored in both field and food samples for a wide range of analytes including unknown substances to build confidence in the food system. Using mass spectrometry can provide that data.

Glyphosate, mentioned above, is one of the most widely used agrochemicals in the world and also one of the most difficult to detect. In Europe, EFSA has proposed MRLs for a wide range of commodities for glyphosate. Monitoring this kind of highly polar, small-organic pesticide in food and water from diverse sources can be complex, time-consuming and expensive. NofaLab, a sampling and testing lab in the Netherlands, collaborated with SCIEX to create a high throughput method using LC-MS/MS to test for as many polar pesticides in a single analysis as possible.

The final method utilized the sensitivity of QTRAP technology and was “found to be considerably more robust and sensitive than other approaches described in various publications and have achieved the target limits of detection required to meet existing and proposed future regulations.” In addition, the “ion chromatographic approach to the analysis of polar pesticides offers the ability to include multiple analytes in a single injection without derivatization…allowing high-throughput laboratories to manage samples efficiently and minimize running costs.”

Targeted MS/MS analysis has long been the gold standard for pesticide analysis in the industry, but advanced high-resolution MS systems enable even greater accuracy and confidence, helping to identify more contaminants, even unknowns. The ZenoTOF 7600 system uses electron activated dissociation (EAD) to create a higher number of fragments as compared to collision induced fragmentation (CID), which is traditionally used in targeted MS/MS analysis on other systems, allowing for highly confident identifications of pesticides in food samples. The ZenoTrap technology additionally enhances sensitivity, which is needed in pesticide analysis to meet regulatory limits. Regardless of the type of sample, whether taken from the soil in a field or from harvested crops, mass spectrometers can identify the type and amount of chemicals present in a sample within several minutes of run time and analyze hundreds of samples in a day.

Streamlining Data Review and Adhering to Data Standards

In an effort to standardize pesticide use, the Codex Alimentarius Commission (CAC) established standards for pesticide residues and developed international standards for food products. This framework for providers at various points in the food supply chain can help reduce the risk of contamination and toxicity.

In the U.S., the Environmental Protection Agency (EPA) establishes tolerances, also known as maximum residue limits (MRL) in other countries, for the type and quantity of pesticides that can remain on food. The agency sets these to ensure pesticides can be used with “reasonable certainty of no harm.”

Producers adhering to these guidelines must handle and present extensive data sets from test results, and any new future regulations will require robust data to track the success of the initiatives and effectively enforce their use. Reviewing and understanding data in order to make decisions is tricky and labor-intensive. It can take laboratories hours every day to process, interpret and manage the data. Software enables fast data processing and fast review by exception flagging, which is valuable in food safety laboratories that typically see a high turn-around in samples every day.

Maintaining resilient food systems will be rooted in data-driven decisions that improve food safety, including limiting pesticide and other chemical uses. By using modern mass spectrometry technology, researchers can be more confident that their food analyses will lead to better-informed policies, more sustainable agricultural practices, and healthier food for future generations.

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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.



USDA FSIS Implements Quantitative Chemical Residue Testing Method

By Food Safety Tech Staff
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The USDA Food Safety and Inspection Services (FSIS) has developed a new method to quantify chemical residues using beef muscle samples and modern chemistry instrumentation. The agency’s laboratory system plans to implement the new quantitative method for veterinary drug residue analysis in bovine muscle samples on October 1, 2023. The method, “Quantitation of Animal Drug Residues by High-Resolution, Accurate-Mass Liquid Chromatography Mass Spectrometry (HRAM LC-MS)” (CLG-MRQ1), has the ability to:

  • Quantitate multiple veterinary drug residue amounts simultaneously in a single analysis with high mass accuracy.
  • Quantitate several veterinary drugs that were previously difficult to measure.
  • Archive several single analyte or specific drug class quantitation methods that use older technology.
  • Archive traditional residue bioassay for several analytes.
  • Align detection limits with established drug residue tolerances.
  • Decrease time to result for presumptive positive residues.

In addition to this change, FSIS has recently updated three methods that will be posted to the new Chemical Laboratory Guidebook no late than September 30, 2023. They include: Quantitation of Salt (CLG-SLT); Quantitation of Fat (CLG-FAT); and Screening, Quantitation, and Confirmation of Beta-Agonists by UHPLC-MS-MS (CLG-AGON1).


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FDA Announces Public Meeting on Modernizing Food Recalls

By Food Safety Tech Staff
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The FDA Center for Food Safety and Applied Nutrition (CFSAN) is hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session” on September 29, 2023, from 9:00am-5:00pm ET.

Join the discussion on “Recalls Trends, Regulation and Lessons Learned,” a Panel Discussion with FDA at the Food Safety Consortium, October 16-18

The listening session will provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization, for FDA-regulated products. The FDA is inviting comments from all interested stakeholders and has identified the following examples of topic categories of the type of information the agency is interested in obtaining:

  • General recall preparations / contingency planning
  • Creating successful recall strategies, including methods to reach underserved communities
  • Initiating a recall
  • Strategies for public warning, including press releases, social media, and other communication tools
  • Increasing efficiency and effectiveness of recall information exchange
  • Ensuring effective recalls
  • Terminating a recall
  • Strategies for reducing recall recurrence for similar situations

The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993. Virtual registration is also available.

Registration is required to attend in person or virtually.


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.

Tom Woodbury

IoT Technology To Boost Safety, Compliance, and Efficiency: How to Get Started

By Tom Woodbury
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Tom Woodbury

Using Internet of Things (IoT)-based systems to automate temperature monitoring in refrigerators and freezers offers several benefits to restaurants. Following we look at how automated temperature monitoring works and how to get started with IoT.

How it Works: Automated Temperature Monitoring in Action

IoT-based systems use sensors to continuously monitor temperatures in refrigerators and freezers. These sensors are mounted inside the cold storage units in the warmest part of the unit, typically near the door or opening. The sensors collect temperature readings periodically and transmit the data to the cloud. As the data is recorded, the system can detect and report any anomalies.

If the conditions inside a refrigerator or freezer fall outside of predetermined thresholds, managers and staff can be notified (via text, email, or in-store apps) so they can take quick corrective actions outlined in their risk mitigation plans. In addition, the data that is recorded and stored can be analyzed to help identify trends that can be used to inform maintenance schedules and make operations more efficient. For example, the data may show how many years (on average) a refrigerator will last before it fails, so an organization can plan to buy replacement units before a failure occurs.

Benefits of Automated Temperature Monitoring

The positive impacts of automated temperature monitoring, enabled by IoT, are often realized in four key areas:

Food Safety. Maintaining a controlled environment in refrigerators, freezers, and other food storage areas reduces the risk of spoilage. By automating the monitoring process, organizations can keep a continuous watch on cold storage units and alert staff if temperatures rise above predetermined thresholds, allowing them to take immediate corrective action based on their risk mitigation processes. This is particularly beneficial in situations where a refrigerator door might be kept open too long, a freezer door is not entirely shut, or during a power outage.

Regulatory compliance. Regulatory agencies require reporting of food safety compliance. Typically, this is a human-driven process, with manual checks of thermometers and handwritten logs. IoT technologies that automatically monitor and record temperatures provide easy reporting of temperature levels over time. This streamlined process makes it much faster—and easier—to demonstrate compliance.

Efficiency. Automated temperature monitoring can make back-of-house restaurant processes more efficient by eliminating the manual “check and record” processes mentioned above. This frees up staff time to focus on other important tasks, such as serving customers.

Sustainability. By reducing food waste due to spoilage, automated temperature monitoring supports sustainability goals.

How to Get Started

With a wide range of IoT devices and systems available, selecting the right one can be overwhelming. How can you get started? First, identify your organization’s overall goals in incorporating the new technologies, and then review those high-level goals as you investigate options. Here are some criteria to consider:

Device selection: When selecting IoT devices, one size does not fit all. Different devices deliver varying degrees of functionality. Some devices support a single use case, while others have multiple sensors to enable diverse use cases for scalability. Another consideration is battery life. Seek devices that offer extended battery life by leveraging user-replaceable batteries designed for low temperature environments. Other features to look for include use of food-grade plastics and support for firmware updates over the air (FUOTA).

Wireless technology: To effectively penetrate dense refrigerator materials (typically metal), most food service operators are using the open standard, LoRaWAN due to its ability to penetrate walls and maximize battery life.

Data caching: In the event of an interruption in connectivity, you must know what the refrigerator or freezer temperatures were during the outage. Some devices and gateways can cache data and resend as soon as they reconnect, while others cannot. Temperature data caching is critical for applications related to food safety, so be sure to ask for this during the research and evaluation process.

Deployment capabilities: Deployments are complex, and a provider that can navigate deployments at scale is vital. It is important to look at each provider’s technology offerings, installation, and deployment capabilities.

There are many benefits to using IoT to deliver automated temperature monitoring, and these benefits extend beyond food safety to sustainability and improved efficiency. They key is to identify the right devices for your organization’s specific needs.

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FDA Releases Small Entity Compliance Guide for the Food Traceability Rule

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The FDA has released a Small Entity Compliance Guide for the FSMA Food Traceability Rule. This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule. It offers recommendations—unless specific regulatory or statutory requirements are cited—on how small entities can comply with the new regulations, which were issued in November 2022. The compliance date for recordkeeping requirements is Jan. 20, 2026.

The guidance document covers:

  • Who is subject to the traceability rule
  • Who is exempt
  • What records must be kept, and for how long
  • How to apply for a modification or exemption
  • How to petition the FDA for waivers
  • Consequences of failure to comply

Download the compliance guide here.