Tag Archives: compliance

Produce Traceability: 4 Steps to Get Started

By Samantha Humphrey
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With the effective date for updated traceability recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

On November 21, 2022, the Food and Drug Administration (FDA) published the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). With the effective date for updated recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

Most produce companies are no strangers to the importance of traceability. In fact, the Produce Traceability Initiative (PTI) was created over 15 years ago as a voluntary, industry-wide effort designed to help the industry maximize the effectiveness of current track and trace procedures, while developing a standardized industry approach to enhance the speed and efficiency of traceability systems for the future. The PTI has set dozens of companies throughout North America—ranging from small farms to international retailers—on the path to enhanced traceability and compliance with the FDA’s Food Traceability Rule.[i]

The following steps can help any produce company, whether it currently follows the PTI or not, prepare to meet FDA’s traceability requirements:

  1. Understand the Food Traceability Rule.

While the FDA has had traceability requirements in the past, the FSMA Food Traceability Rule is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one step forward, one step back” traceback approach. The objective of the Rule is to help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.[ii]

In comparing the FSMA Rule to the PTI, a recent PTI press release states that the requirements of the PTI for case-level traceability are aligned with the Final Rule and cover approximately 90-95% of the requirements, with major differences stemming from the Traceability Lot Code Source and Traceability Lot Code Source Reference.[iii]

The key elements of the FDA Rule are built into several acronyms:

  • FTL (Food Traceability List): This list identifies the categories of high-risk foods that require additional traceability records under the Food Traceability Rule. The FTL currently comprises the following produce commodities: cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, and fresh cut fruits and vegetables. Other non-produce foods on the FTL include cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads.
  • TLC (Traceability Lot Code): This descriptor, often containing a combination of letters and numbers, is used as a unique identifier for product as it moves through the supply chain. The TLC is to be established by entities that originate, transform, or create food on the FTL. Once a food has been assigned a TLC, the TLC must be included in traceability program records collected at each Critical Tracking Event (CTE) and as a part of all Key Data Elements (KDEs) (see below). The TLC remains the same throughout the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
  • CTE (Critical Tracking Event): CTEs are the events in the food supply chain that require additional recordkeeping. These include harvesting, cooling before initial packing, packing, transforming, shipping, and receiving. At each CTE, the responsible entity must record the TLC.
  • KDE (Key Data Element): KDEs comprise the information associated with a CTE for which a record, including a TLC, must be maintained. Examples of KDEs include location description of the food being harvested; name of the field or growing area where the produce was harvested; date of harvest; quantity and unit of measure of the produce; date when the produce went from harvest, to cooling, to packing, to shipping, etc.
  1. Interpret the Rule and Determine its Applicability.

To determine the Rule’s applicability, it is important to first take an inventory of your operations and products:

  • Do you grow cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, or tropical tree fruits?
  • Do you process fresh cut fruits, leafy greens, or vegetables other than leafy greens?
  • Do you manufacture a product that contains any of the foods listed above?

If the Rule applies (i.e., you answered yes to any of the three questions above), you must:

  • Maintain specific data records (i.e., KDEs) for at least two years.
  • Keep records of all CTEs.
  • Maintain an approved, updated Traceability Plan.
  • Ensure all data is easily accessible so it can be provided to the FDA within 24 hours of a request.

Note that there are a few nuanced exemptions that apply to farms, as noted on this FDA flow chart.[iv]

  1. Perform a Gap Assessment.

Most produce companies are likely capturing at least some of the information needed to comply with the Food Traceability Rule, particularly if they already implement the PTI requirements. Conducting a gap assessment will help identify missing elements that may be required for compliance with FDA’s Rule. The following questions can help guide this assessment:

  • Does your organization already capture data that may be considered a KDE? For example, do you apply lot codes to your products? Do you collect location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information or data points you are missing and how you can gather that data.
  • Do you have a sufficient Traceability Plan? Does it cover all the elements required in the Food Traceability Rule?
  • Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Having a good document/records management system is essential for maintaining and sharing the data required by the Food Traceability Rule.
  • What collaborative activities can you and your suppliers/buyers perform to ensure that data is shared efficiently and encourage compliance?
  1. Create a Plan of Implementation.

The gap assessment will identify elements that you need to implement to help ensure compliance. Use that information to create a game plan, working backwards from the Rule’s January 20, 2026 effective date. Doing so now affords time to test solutions, see how they work in practice, problem solve, and find the right solutions for your organization.

At a minimum the implementation plan must include two key elements that will be vital for compliance:

  • Traceability Plan. Every organization must develop a new (or update an existing) Traceability Plan for collecting the KDEs that are required by the Rule, as outlined in the CFR[v] (see also the FDA example of a Traceability Plan for Farms[vi]). The Traceability Plan must be updated annually, and old plans must be maintained for at least two years. The Traceability Plan must include:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how TLCs are assigned.
    • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
    • Map identifying the farms where FTL produce is grown.
  • Document/Records Management System. Produce companies who manufacture, process, pack, or hold foods on the FTL will need to implement a document/records management system to fulfill the Food Traceability Rule’s recordkeeping requirements. While hard copies in binders can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data.

As produce companies work through this process, it is important to remember the objective of the Food Traceability Rule. Ultimately, the Rule will allow the food industry to quickly remove potentially harmful foods from the supply chain and make the entire recall process more efficient. Even if the FTL list does not apply to all your products, your customers may still require that all produce they purchase meet the same requirements as foods listed on the FTL. Creating this end-to-end traceability will save time, money, and most importantly, human lives.

[i] Produce Traceability Initiative. The Produce Traceability Initiative: Working to achieve standardized, electronic (computerized) traceability across the supply chain. September 2011. https://producetraceability.org/wp-content/uploads/2022/03/PTI-Flyer_FNL_v2-2011-10-20.pdf.

[ii] Food and Drug Administration. What you need to know about the Food Traceability Rule: Recordkeeping Information for Produce Farms. June 2023. https://www.fda.gov/media/169510/download.

[iii] The Produce Traceability Initiative. Produce Traceability Initiative (PTI) Releases FSMA 204 Implementation Guidance. February 13, 2024. https://producetraceability.org/produce-traceability-initiative-pti-releases-fsma-204-implementation-guidance/.

[iv] Food and Drug Administration. Exemptions to the Food Traceability Rule. https://collaboration.fda.gov/tefcv13/.

[v] National Archives and Records Administration. CFR Title 21, Chapter I, Subchapter A, Part 1, Subpart S, Traceability Plan. May 21, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S/subject-group-ECFRe6c9096adb572d4.

[vi] Food and Drug Administration. Traceability Plan Example for Farms (§1.1315). November 2023. https://www.fda.gov/media/174057/download?attachment.

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/
Sayed M Naim Khalid
FST Soapbox

Food Safety: The Responsibilities of Government vs. The Private Sector

By Sayed M Naim Khalid
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Sayed M Naim Khalid

The role of government oversight versus private efforts in ensuring food safety is a comparatively new topic. Recent cases, including the hefty fines against Family Dollar for major violations in relation to sanitary conditions, highlight the importance of strong safeguards. But a key question lingers: Would a shift from government inspections to private audits truly benefit both businesses and consumers?

Government food safety inspections have traditionally operated on a risk-based model, aiming to identify and mitigate potential hazards in food production facilities. However, recent incidents such as the Family Dollar case raise concerns about the adequacy of government oversight. Did the absence of high-risk products at Family Dollar prompt less frequent inspections, leaving the facility unchecked for sanitation and safety standards? And what about past outbreaks like the 2009 Salmonella outbreak linked to the Peanut Corporation of America’s products or the subsequent recalls of Wright County/Hillandale Farms Eggs in 2010 and Cargill Ground Turkey in 2011? Weren’t these crises preventable with proper oversight?

It is evident that failures in both business management and government oversight contribute to lapses in food safety. While businesses are responsible for maintaining proper hygiene, temperature control, and product quality, government agencies play a crucial role in enforcement and inspection. The delay in detecting issues, whether due to resource constraints or bureaucratic inefficiencies, can have dire consequences for consumers and tarnish the reputation of businesses.

Consumers, too, play a pivotal role in the food safety equation. While cost often influences purchasing decisions, an increasing awareness of food safety issues has prompted many to prioritize product quality and trustworthiness. However, consumer vigilance alone cannot substitute for robust regulatory oversight and industry compliance.

The Value of Private Sector Audits

Private sector food safety audits offer a complementary approach to government inspections, providing businesses with standardized frameworks for assessment and improvement. Certifications from reputable third-party organizations such as the Global Food Safety Initiative (GFSI) can enhance consumer trust and facilitate market access. However, private audits should not serve as a replacement for government inspections. While they offer valuable insights, they lack the regulatory authority and enforcement capabilities of government agencies.

The crux of the issue lies in resource allocation and prioritization. Adequate funding for government food safety inspection departments at the federal, state, and local levels is essential to ensure timely and thorough oversight. Proactive inspections, coupled with stringent enforcement measures, can prevent crises before they escalate, ultimately saving businesses and consumers from costly repercussions.

Moreover, fostering a robust food safety culture requires collaboration and accountability across the entire supply chain. From farm to fork, stakeholders must adhere to best practices, comply with regulations, and uphold ethical standards. This includes not only businesses but also government agencies, industry associations, and consumers themselves.

The transition from government food safety inspections to private sector audits should not be viewed as a binary choice but as a symbiotic relationship. While private audits offer valuable insights and incentives for improvement, they cannot replace the regulatory authority and enforcement capabilities of government agencies. A balanced approach, characterized by proactive government oversight, industry compliance, and consumer awareness, is essential to safeguarding public health and ensuring the success of businesses in the food industry.

Sayed M Naim Khalid

The Imperative for an Integrated Food Safety Management System

By Sayed M Naim Khalid
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Sayed M Naim Khalid

As the global food industry continues to evolve, the importance of ensuring food safety has never been more critical. Various standards and certifications, such as GFSI, Organic, Global GAP, HACCP, and ISO standards, have been established to address different aspects of food safety. However, the proliferation of these diverse standards pose a significant challenge — especially for small businesses — in terms of cost, complexity, and overall compliance. In this article, we will explore the need for an integrated food safety management system (FSMS) that consolidates these standards into a comprehensive and unified framework.

Current Challenges in Food Safety Standards

The food industry is subject to a multitude of regulations and standards, each designed to address specific concerns related to food safety. The Global Food Safety Initiative (GFSI) aims to harmonize and strengthen food safety standards across the supply chain. Similarly, standards like Organic, Global GAP, HACCP, and ISO provide guidelines for organic production, agricultural practices, hazard analysis, and quality management systems, respectively.

While these standards individually contribute to enhancing food safety, their coexistence often imposes a heavy burden on businesses, particularly smaller ones. Each standard necessitates a separate certification process, involving costs related to preparation, audits, and ongoing maintenance. This fragmented approach can be overwhelming for businesses, leading to inefficiencies and potential gaps in compliance.

Cost Implications for Small Businesses

Small and medium-sized enterprises (SMEs) in the food industry face a unique set of challenges when it comes to adhering to multiple food safety standards. The financial implications of obtaining certifications for each standard can be prohibitive. For instance, a small-scale food producer dealing with organic products may also need to comply with GFSI standards for global market access.

Certification costs — including consulting fees, documentation, and audit expenses —  quickly accumulate. Moreover, the need for ongoing compliance monitoring and updates can strain the already limited resources of smaller businesses. This situation raises concerns about the equitable access to global markets for businesses of all sizes.

The Role of an Integrated Food Safety Management System

The call for an integrated FSMS is rooted in the idea of streamlining and unifying the various standards to create a more accessible and efficient framework. By integrating these standards, businesses could achieve a single certification that covers multiple aspects of food safety, reducing the financial and administrative burden.

Integration can lead to a more cohesive approach to food safety, eliminating redundancies and ensuring a holistic understanding of potential risks throughout the supply chain. This not only simplifies the certification process but also facilitates better communication and collaboration among stakeholders, including producers, processors, distributors, and regulators. Benefits of an integrated FSMS include:

  • Cost Efficiency. An integrated FSMS would significantly reduce the costs associated with multiple certifications. Businesses can allocate resources more efficiently, making certification attainable for a broader range of enterprises.
  • Simplified Compliance. Streamlining standards into a unified system simplifies compliance efforts. Businesses can focus on meeting a comprehensive set of requirements rather than navigating the intricacies of various individual standards.
  • Enhanced Food Safety. Integration ensures a more comprehensive and interconnected understanding of food safety risks. This can result in a more effective preventive approach, addressing potential hazards at various stages of the production and distribution process.
  • Global Market Access. A single, globally recognized certification can facilitate market access for businesses, especially SMEs. This reduces barriers to entry and fosters fair competition in the global marketplace.
  • Improved Collaboration. Stakeholders across the supply chain can better collaborate when operating under a common framework. Enhanced communication and information sharing contribute to a more resilient and responsive food safety ecosystem.
  • Adaptability to Emerging Challenges. An integrated FSMS can be designed to incorporate emerging challenges and adapt to evolving risks in the food industry. This flexibility ensures that the system remains relevant and effective over time.

Challenges in Implementing an Integrated FSMS

While the benefits of an integrated FSMS are evident, the transition from the current fragmented system to a unified framework is not without challenges. Some potential hurdles include:

  • Resistance to Change. Stakeholders accustomed to existing standards may resist the shift towards integration. Overcoming resistance through education and awareness campaigns is crucial for successful implementation.
  • Technical Harmonization. Ensuring technical harmonization across different standards requires meticulous planning and collaboration. Consensus on common terminology, risk assessment methodologies, and other technical aspects is essential.
  • Regulatory Alignment. Coordinating with regulatory bodies to align an integrated FSMS with existing regulations is necessary. This involves addressing legal and regulatory challenges to ensure widespread acceptance.
  • Resource Allocation. Developing and implementing an integrated FSMS requires significant resources. Small businesses, in particular, may need support and incentives to make the transition feasible.
  • Global Acceptance. Achieving global acceptance of an integrated FSMS may take time. International cooperation and agreement on common standards are vital to ensure recognition across borders.

The need for an integrated food safety management system is evident in the face of an ever-evolving food industry. As standards such as GFSI, Organic, Global GAP, HACCP, and ISO play crucial roles in ensuring food safety, their integration into a comprehensive framework is imperative. The benefits, including cost efficiency, simplified compliance, enhanced food safety, global market access, improved collaboration, and adaptability to emerging challenges, make a compelling case for the adoption of an integrated FSMS.

While challenges in implementation exist, the long-term advantages for businesses, consumers, and the industry as a whole outweigh the difficulties. Governments, regulatory bodies, industry associations, and businesses should collaboratively work towards the development and adoption of an integrated FSMS that strengthens food safety practices, fosters innovation, and promotes equitable access to global markets. In doing so, the global food industry can move towards a more unified and resilient future, ensuring the safety and quality of food products for generations to come.

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FDA Issues Final Guidance on New Dietary Ingredient Notification Procedures

By Food Safety Tech Staff
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On March 5, the FDA issued the final guidance “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.”

Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce. The new guidance is intended to help manufacturers and distributors of NDIs and dietary supplements prepare and submit new dietary ingredient notifications (NDINs) to the FDA.

The guidance provides information about the NDIN submission and review process in a Q&A format. Topics include:

  • Who needs to submit an NDIN?
  • How should the information be organized and presented?
  • Where should an NDIN be submitted?
  • What happens after an NDIN is submitted?

Download the final guidance here.

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.”

 

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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.

 

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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).