Tag Archives: FSMA

Biros' Blog

Food Safety Fate

By Rick Biros
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How often do you talk to strangers? For many, not too often. It has become very easy to avoid talking to people. For example, most people in a crowded hotel elevator either look at their phones, listen to their noise cancelling headphones or silently watch the progress of the elevator’s decent waiting for the doors to open. Yet, chance encounters with strangers can make life interesting and sometimes be impactful.

Two weeks ago, on the morning of the last day of our Food Safety Hazards Conference in St. Louis, while descending down in a crowded but silent hotel elevator. A women noticed my wife’s Food Safety Hazards Conference badge and asked Beth about the conference. The women remarked she used to volunteer for STOP Foodborne Illness. I asked, “I know STOP. Why were you volunteering?” As the elevator came to the lobby floor and the doors opened, we took the conversation into the lobby where she told us that her daughter had died of e-coli and shared some of the details of their tragedy. I gave her my business card and asked if we could reconnect in the near future.

Shortly before I was about to deliver the opening remarks at the conference, I received an email that read “My name is Dana and we met at the Hilton in Downtown St Louis and this is my daughter Kayla that passed away from Ecoli in 2007. It was nice to visit with you and here is her story.”

Kayla’s story was outlined in a letter Dana read at a U.S. Congressional hearing asking them to make the Food Safety Modernization Act law. Here it is:

Kayla Boner, 1993 – 2007

Every day, I ask myself, “Why did this have to happen?”  We put so much faith in the food on our shelves, only to find out one day that the safeguards needed to protect us are not there.  Because our food safety system has been reactionary instead of preventive for too long, I watched my healthy teenage daughter endure excruciating pain.  I was helpless.  There was nothing I could do.

Before the fall of 2007, Kayla loved to play basketball and softball.  She was incredibly social and enjoyed hanging out with a great group of friends.  She was full of life.  I don’t think there was a person who knew her who didn’t love her right away.  I distinctly remember Kayla’s 14th birthday — October 22, 2007.  She was thrilled because she could, at long last, get her learner’s driving permit.  Kayla, giddy with excitement, peppered my cell phone with calls until I agreed to drive her to the local department of transportation to take her test.  Watching Kayla become an independent young woman was thrilling. 

After a successful visit to the D.O.T it was time to get new contact lenses.  While at the optometrist she began complaining of serious stomach pains. Thinking this was nothing more than the stomach flu we decided to go home.  The next day, Kayla had not improved.  That evening Kayla woke up with bloody diarrhea.  The next day, she was admitted to Pella Community Hospital.  Kayla’s condition only got worse.

A week later, after countless tests, the physicians of Pella Community Hospital confirmed Kayla had contracted an E. Coli 0111 infection. Shortly after, Kayla’s kidneys shut down.  Requiring dialysis, she was transferred to Blank Children’s hospital in Des Moines, Iowa.

A few more days had passed when she woke up with a smile on her face.  She looked over and said “Mommy I am sorry.” 

Perplexed as to why a child who had spent days in agony would feel the need to apologize for anything, I asked why.

“Because I kept you up all night,” Kayla responded.

 “Sweetheart, that is what mommies do — and I love you” I said. At that very moment I remember hoping this was the beginning of the positive breakthrough for which we were desperately hoping.

“I love you too” were the last words my child ever spoke.

On Friday November 2nd, Kayla’s blood pressure spiked to dangerous levels. Doctors ran into her room trying everything they could muster to bring Kayla back to us. At 10:00 that morning, after seizures and many rounds of dialysis, Kayla’s 14 year old body couldn’t take it anymore.  She was gone.

I came to this hearing in an effort to tell you all how important it is that we put in place effective policies that spare other parents the horror I have experienced. Enactment of the FDA Food Safety Modernization Act is one such step but, for it to work, we need all of the regulations finalized as soon as possible.

Kayla dreamed of one day becoming a pediatrician. If this new law is implemented and enforced, I believe Kayla will get her wish.  She truly will be saving children’s lives.

Instead of doing my usual opening remarks to start the conference, I read the letter to the attendees and there was not a dry eye in the audience. Kayla’s sad but powerful story certainly hit home and if nothing else added motivation to an already passionate group of food safety professionals. For the rest of the conference, we kept coming back to Kayla’s story reminding us of why we do what we do.

Was this random hotel elevator connection fate or divine intervention? I don’t know. What I do know is because Dana was willing to talk to a stranger, she was able to share her daughter’s story to an audience of food safety professionals and now to you. Hopefully, as the food safety and quality community, we all can help support Kayla’s dream by saving children’s lives.

Ask The Expert

Food Safety as Business Infrastructure

By Azure Edwards, M.S.
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Fifteen years after FSMA reoriented food safety around prevention, the technical infrastructure is largely in place. What is becoming visible at this maturity point is the layer beneath it — the business decisions, governance structures, and organizational design that determine whether that infrastructure actually holds under real operational conditions.

This five-part series examines food safety through the business realities that leaders already navigate: profitability, risk, growth, brand trust, and organizational function. Not to reframe food safety as a business problem, but to make visible what the industry has earned the right to see clearly. Food safety outcomes are shaped upstream of the technical program, in the structures responsible for decision-making and execution. Each article stands alone. Together they trace a single line of thinking about where the conversation goes next.

The Business Layer of Food Safety

Fifteen years after FSMA reoriented the food safety conversation from response to prevention, the industry is taking stock of how far it has come and beginning to ask what comes next. The technical infrastructure that the regulation called for is largely in place. Preventive controls, environmental monitoring, supplier verification, documented systems designed to demonstrate control: organizations have invested heavily in building these programs, and the investment has mattered. What is becoming visible at this maturity point, precisely because the technical layer is now developed enough to examine clearly, is the layer beneath it. The decisions that shape how work actually happens, the authority structures that determine who can act and when, and the resource allocations that establish what the system can realistically do under pressure. The industry recognizes this layer. Food safety is earning a seat at the leadership table, and the conversation arriving with it is more sophisticated than it has ever been. What is still being built is the shared language that allows that recognition to move from individual insight into organizational practice — the clarity that lets the governance layer function not just as something experienced professionals can describe, but as something the organization can deliberately act on.

That gap between recognition and shared operational language is where most recurring food safety instability actually lives. A single deviation is an event. The same deviation returning across multiple corrective action cycles, under different operators and different supervisors, despite documented resolution, is something else. It is the friction that has become familiar, and the category of work the organization has silently learned to expect rather than eliminate. Fifteen years of investment in preventive infrastructure has produced something valuable that the industry hasn’t fully used yet — a record precise enough to show, over time, not just what went wrong, but what keeps returning and why. The correction closed the record. It did not reach the source.

Consider what that looks like on the floor. A food manufacturing facility has a recurring GMP issue: sanitation tools left on the floor rather than returned to storage after use. The expectation is documented, the procedure exists, and the team has been trained far more than once. When the issue surfaces again, the response follows the familiar path: a reminder, a retraining, a corrective action that closes with appropriate documentation. And for a period things improve… until they don’t. What finally shifted the outcome wasn’t a stronger procedure or more consistent enforcement. It was a different question: not what are people doing wrong, but what is the system making it easier to do? When I examined the actual conditions rather than the behavior, the answer was immediate. Storage locations were positioned away from where the tools were used, the hardware didn’t fit the tools being issued, and returning equipment properly required extra movement that, under the pace of a working shift, simply didn’t happen reliably. Once the storage locations were repositioned and the hardware matched the tools, the issue resolved without additional training, without escalation, without any of the interventions that had been tried before. The behavior changed because the conditions changed.

What that case reveals extends well past its specific details. Through multiple corrective cycles, the investigation had been aimed at the people in the system — their knowledge, their habits, their compliance — when the actual source of the pattern was sitting in the design of the environment they were working in. This is the structure of most recurring food safety problems: not absent standards, not insufficient commitment, but a mismatch between where the response is directed and where the condition actually originates. The organization had a functioning program and genuine investment in food safety outcomes, but neither were sufficient to stabilize a condition that lived upstream of where the program was looking. That gap between where the system looks and where the condition lives is precisely what the governance layer is responsible for closing, and precisely what the industry’s next conversation needs to address.

Food safety is one of the few functions in a business where this gap becomes consistently legible to both the people running the floor and the people running the business. A corrective action log read as a list of resolved tickets tells you how responsive the system is. The same log read as a transcript of what keeps coming back tells you something different — which areas generate repeated entries, which responses cycle through without producing stability, which categories of work the organization has learned to absorb as routine rather than resolve at the source. That second reading requires treating the pattern across entries as more informative than any individual entry, and asking what organizational conditions would have to be true for this pattern to keep generating itself. The data to answer that question already exists in most operations. What’s needed is the orientation to read it at the right level — one that connects what operators see on the floor to the decisions that executives are positioned to change.

The layer that determines whether those conditions get addressed is not the technical program layer. Everything built over the last fifteen years — the controls, the monitoring, the documentation infrastructure — operates within conditions established further upstream: in how decisions get made about work design and resource allocation, in how authority is distributed and what happens when it’s exercised under pressure, in how competing priorities get resolved when production demands and safety requirements arrive at the same moment. Those decisions, and the organizational structures that make them, are what food safety outcomes are actually built on. When that structure is coherent, the technical programs beneath it tend to function as designed. When it isn’t, those programs compensate by absorbing strain, generating more corrective activity, and requiring more verification while the conditions producing that activity remain in place.

Reading the pattern accurately means asking questions at the right level of the system, not about the procedure that was missed or the person who was present. What decisions and structures established the conditions those people were working within? That inquiry moves the conversation out of the technical program and into the business itself: into how the organization is structured to make and carry decisions under ordinary operational pressure, and whether that structure is coherent enough to support the systems that depend on it. What it costs when it isn’t (corrective cycles, absorbed inefficiency, work that keeps having to be done twice) is where the stakes become most visible to leadership, and most familiar to the people closest to the work.

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Beltway Beat

FDA Opens VQIP Application Portal for FY2027

By Food Safety Tech Staff
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The FDA’s Voluntary Qualified Importer Program (VQIP) application portal for fiscal year 2027 opens on January 1, 2026, providing food importers with an opportunity to streamline their import processes through expedited review and importation benefits.

VQIP is a voluntary, fee-based program that offers expedited review and importation benefits for human and animal foods when importers demonstrate control over their supply chain safety and security. To participate, importers must ensure their foreign supplier facilities are certified through FDA’s Accredited Third-Party Certification Program.

Key Application Details:

Application Window: January 1 – September 1, 2026

Program Year: FY2027 benefits

Getting Started:

• Create an account on the FDA Industry Systems website (https://www.access.fda.gov/)

• Contact FSMAVQIP@fda.hhs.gov for an informational meeting

• Review eligibility requirements and certification needs, as foreign supplier facilities must be certified by FDA-accredited third-party certification bodies.

VQIP supports FDA’s Strategy for the Safety of Imported Food by incentivizing importers to use certified suppliers and maintain robust processes to help ensure imported food meets U.S. food safety requirements.

Resources and Support:

For questions or assistance, contact the VQIP Importers Help Desk:

• Email: FSMAVQIP@fda.hhs.gov

• Phone: 301-796-8745

• Program Information: https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip

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Beltway Beat

FDA Releases the CORE 2023 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

By Food Safety Tech Staff
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Today, the U.S. Food and Drug Administration’s (FDA) Coordinated Outbreak Response & Evaluation (CORE) Network released its annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2023 calendar year.

The FDA’s CORE Network was established in 2011 with the mission to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC, state and local public health agencies, and international public health partners. Every year, CORE evaluates and responds to numerous foodborne outbreaks and adverse events linked to FDA-regulated products.

In October 2024, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) reorganized into FDA’s Human Foods Program (HFP). With this change, CORE reorganized into the Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP). This report is for the 2023 calendar year and reflects the work that was conducted by CORE, CFSAN, and other respective FDA offices prior to the reorganization.

In 2023, CORE evaluated 69 incidents, responded to 25, and issued advisories for 10. These numbers remain similar to recent years, with 65 incidents evaluated, 28 responses, and 11 advisories issued in 2022. CORE investigations resulted in numerous public health actions, including recalls, public health advisories, a Warning Letter, FDA prevention strategies, and country-wide Import Alerts. These are further described in the report.

“CORE has also played a central role in developing and implementing key regulations, including the Final Rule for Traceability under the Food Safety Modernization Act (FSMA). CORE members are participants in the FDA Cyclospora Task Force focused on reducing the public health burden of foodborne illness caused by C. cayetanensis in produce. Additionally, our office actively works with food safety partners outside the agency to continue progress of the FDA-SENASICA-COFEPRIS Food Safety Partnership (FSP) with Mexico. These examples highlight just a few of the activities CORE engages in outside of outbreak and adverse event investigations. Dr. Stic Harris, CORE Network Director noted. I’m pleased to share with you some of CORE’s many achievements highlighted in the 2023 annual report.”

The 2023 annual report highlights a few noteworthy outbreaks: illnesses linked to toxins from morel mushrooms, lead linked to cinnamon in applesauce pouches, and Listeria monocytogenes linked to soft serve ice cream cups.

Imports
Food Safety Attorney

The Ins and Outs of FSMA’s Foreign Supplier Verification Program

By Jennifer Allen
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Imports

In recent years, through regulations created under the Food Safety Modernization Act, the FDA has adopted a preventive approach to food safety, in contrast to the Whack-A-Mole strategy of dealing with foodborne illness that proceeded the FSMA. Thus, an alphabet soup of new processes, such as HACCP and HARPC, have taken center stage. But with so much food being imported from other countries, these regulations could very easily be undermined. Enter the Foreign Supplier Verification Program, or FSVP (found at 21 CFR 1.500 et seq.).

The FSVP’s purpose is to ensure that importers of foods from outside of the United States have adequate assurance that these foods were harvested, grown, manufactured, processed and/or packaged using protections equivalent to those imposed by the FDA on U.S. foods. The regulations define a foreign supplier as the establishment that manufactures, processes or grows the food, or raises the animal, for export to the United States, without further manufacturing or processing by others (besides labeling or other similar de minimis activities). Absent an exemption, importers of foreign foods and the foreign suppliers themselves must comply with the FSVP.

Under the FSVP, importers must conduct a hazard analysis for each type of food they import. They must then approve each foreign supplier they use, taking into consideration the results of that analysis; the identity of the entity that will be minimizing or preventing any hazards; the foreign supplier’s performance; and any other relevant factors. And importers must document this process and their approval of each foreign supplier. This process should take place every three years or whenever circumstances change. And since having an approved foreign supplier has limited effect if importers don’t limit their food imports to those approved suppliers, importers must also have written processes in place to ensure that they import foods only from approved suppliers.

The FSVP is not a one-and-done process. After approving a particular foreign supplier, and before actually importing food for the first time, importers must determine which verification activities they will conduct to provide assurance that any identified hazards have either been significantly minimized or prevented, as well as the frequency of those activities. Depending on the particular food and the type of hazard, the importer must decide whether to conduct onsite audits, sampling and testing of food, a review of the foreign supplier’s relevant food safety records, any other appropriate activity, or a combination of these activities. And if the foreign supplier at any time fails to significantly minimize or prevent any identified hazards, then the importer must have steps in place to take corrective measures.

There are some foods that are exempt from the FSVP’s requirements. The requirements do not apply to juice and fish, food imported for research or personal consumption, alcoholic beverages, foods regulated by the USDA (meat, poultry, egg products), food that is merely shipped through the United States, and food that is manufactured, grown or raised in the United States, exported, and returned. In addition, imported canned foods are exempt, but only if the importer verifies and documents the foreign supplier’s compliance with the requirements of 21 CFR 113. There is also a partial exemption if the imported food will be incorporated into a canned product that complies with part 113. And importers are deemed to be in compliance with the FSVP if they are considered a “receiving facility” under 21 CFR 117 or 507 (hazard planning for human and animal food respectively) and if they either implement preventive controls for the imported food, are not required to do so, or have established and implemented a risk-based supply-chain program.

Last but not least, under 21 CFR 1.512, very small importers and those who import food from certain types of small foreign suppliers are required to adhere to a less burdensome set of regulations. A very small importer is one whose sales of human or animal food, in the previous three years, adjusted for inflation, totaled less than $1 million or $2.5 million per year respectively, when combined with the U.S. market value of any human or animal food imported, manufactured, processed, packed, or held without sale. Foreign suppliers are considered small if they are a qualified facility under parts 117 or 507, are a farm that is not considered to be a covered farm under 21 CFR 112, or if they export shell eggs and have fewer than 3,000 laying hens. Importers must keep records showing that part 1.512 applies.

Very small importers must obtain written assurance from their foreign suppliers before importing any food and every two years thereafter that the supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as U.S. regulations provide. Those importing food from certain small foreign suppliers must obtain written assurances from those suppliers that generally provide assurance that the food is safe.

As always, the devil is in the details. Before importing any food, importers should carefully review the regulations, preferably with legal assistance, to ensure that they do not run afoul of the law and inadvertently undermine the safety measures in place here in the U.S.

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Beltway Beat

FDA Publishes New Guidance Document for Voluntary Qualified Importer Program

By Food Safety Tech Staff
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FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import.  Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

The guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.  This document provides guidance on:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated.  FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance means that something is suggested or recommended, but not required.  This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how VQIP will expedite entry of imports.

The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP.  “Agency” and the pronouns “we” and “our” are used to refer to FDA.  The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 136(u).

Download the Guidance

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It’s 5 o’clock somewhere! A Happy Hour conversation about food safety & quality

Episode 1: A Conversation with Dr. David Acheson, President & CEO, TAG. In 2012, David was an early advisor to Rick in the launch of FoodSafetyTech.com and the Food Safety Consortium conference. Back then, many things were new and evolving including the proposed Food Safety Modernization Act (FSMA). Rick and David will look back at FSMA, how it has evolved and discuss the future FSQA risks and challenges.

Biros' Blog

It’s 5 o’clock somewhere!

By Rick Biros
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Join me in a happy hour conversation with David Acheson, President and CEO of TAG called “It’s 5 o’clock somewhere!” Podinar Broadcast: Thursday, August 22 at 5 o’clock EST.

In 2012, David Acheson of TAG was an early advisor in the launch of Food Safety Tech and the Food Safety Consortium conference. Back then, many things were new and evolving including the proposed Food Safety Modernization Act (FSMA). David and I will look back at FSMA, how it has evolved and discuss the future FSQA risks and challenges.

This is the premiere of a new podinar series. What’s a podinar? Simply, a podcast using a webinar platform. It’s a conversation. Unscripted. No slides. Just talk… over an adult beverage.

Join me and David in a casual but engaging conversation. Adult beverage is optional but encouraged!

Complimentary but advanced registration required. Click Here.

Traceability in food manufacturing, Honeywell
Beltway Beat

Produce Traceability: Uncovering the Gaps in Your Program

By Samantha Humphrey
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Traceability in food manufacturing, Honeywell

The produce industry handles an estimated six billion cases of produce in the U.S. each year. [i] Because a significant portion of this produce travels through the supply chain to reach customers, many produce companies already have traceability program in place. With the finalization of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods [ii] (Food Traceability Rule), the question is whether these existing traceability programs, systems, and procedures meet new FDA requirements.

A gap assessment can do just that—determine what requirements your existing programs already meet and identify where improvements are needed to comply with the final Food Traceability Rule by the January 2026 deadline.

Steps for Conducting a Gap Assessment

Not surprisingly, many produce companies already have elements of a traceability program that fulfill some of the Final Rule’s requirements. A gap assessment serves as the starting point for:

  • Understanding your regulatory obligations compared to your current compliance status.
  • Determining if existing programs, procedures, and systems are good as is, need improvement, or are missing and need to be developed.

Performing a gap assessment will help you compare what you have to what you need. The following steps will get you started:

  1. Find the most current copy of the standard you will compare against your programs. You will likely want to use the Code of Federal Regulation (CFR) Title 21, Chapter 1, Subchapter A, Part 1, Subpart S [iii], as it outlines specific expectations for general provisions, Traceability Plan, records of Critical Tracking Events (CTEs), and more.
  2. After you are familiar with the rule, review the most current version of your own program. A systematic review over time may make conducting a gap analysis more manageable. Start by identifying which of your products are on the Food Traceability List (FTL) [iv], what CTEs you perform, and which Key Data Elements (KDEs) you are already collecting. Have you overlooked a CTE? Have you forgotten a KDE? Refer to the questions below as you conduct this gap assessment. Document all missing elements.
  3. Compare your Traceability Plan to what is required by the new rule. Document the items you have identified as missing from your Traceability Plan.
  4. Develop and document your strategy to address each gap identified in steps 2 and 3 above. There may be some items that can be addressed immediately, while others may require additional time and support. You may need to create new logs, enlist the help of other departments, or acquire approval from your supervisors to make the necessary changes. Set realistic goals to implement the required updates by the compliance date.
  5. Train or retrain employees. Tell them why the changes are happening, acknowledge the importance of compliance with the new rule, and empower them to make the necessary changes.
  6. Notify management, customers, and suppliers of changes to your program to ensure everyone involved is on the same page.

Turning Gaps into Opportunities: Key Questions to Ask

Asking the right questions is key to ensure your gap assessment identifies required missing elements in your programs compared to the rule. The following questions can help guide your food traceability gap assessment:

  • Do you manufacture, pack, process, or hold any of the foods found on the FTL? The FDA developed the FTL considering a few specific food safety factors, including frequency of outbreaks, occurrences of illness, severity of illness, likelihood of contamination, potential for pathogen growth, process contamination, consumption rate, and cost of illness. Comparing your products to the FTL may indicate the likelihood of your produce being implicated in a recall or outbreak event and will underscore the importance of your organization’s compliance with the Traceability Rule.
  • Are you performing CTEs? These include harvesting, cooling, initial packing, first land-based receiving (food obtained from a fishing vessel), shipping, receiving, or transforming any of the foods on the FTL. If so, specific data must be collected. Do you understand and are you meeting these data collection requirements?
  • Does your organization capture data that is considered a KDE? For example, do you apply lot codes to your products? Do you collect detailed location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information, data points, or additional KDEs you must capture and maintain to meet FDA requirements (e.g., date, harvest crew, common name of the commodity and variety, etc.). The data required is dependent on which of the CTEs you are performing. This guide from the FDA[v] can help determine whether you are collecting all the required data. Once you know what data you are missing, as identified by your gap assessment, you can determine how to best record it (e.g., developing new processes and procedures, implementing a new lot code sticker program).
  • Do you have a sufficient Traceability Plan? Does your Plan cover all the elements required in the Food Traceability Rule? The Traceability Plan must include the following, at a minimum:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how lot codes 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.
    • Updates to reflect updated or new practices.
  • What recordkeeping system are you using? Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Can your system handle new requirements? Is required information readily retrievable? While hard copies in binders and Excel spreadsheets can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data. Your gap assessment can help you identify and better understand your needs and requirements prior to investing in an IT solution that helps streamline your traceability process and improve overall compliance efficiency.
  • How are you sharing data? What collaborative activities can you and your suppliers/buyers perform to ensure efficient data sharing? How do you communicate and with what frequency? What systems are your partners using? What is the best way to connect them to enable data sharing? It is important to ensure you have established processes, systems, and methods of communication throughout the supply chain to facilitate the required documentation, information sharing, and collaboration.

The answers to these questions will identify elements that you need to implement to help ensure compliance. Getting started on your gap assessment now affords time for produce companies to identify compliance program gaps, test protocols and verify their effectiveness, implement corrective actions, and ensure adequate traceability processes are in place before the January 2026 deadline.

[i] The Produce Traceability Initiative. https://producetraceability.org/.

[ii] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. June 27, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.

[iii] Code of Federal Regulation. Title 21, Chapter 1, Subchapter A, Part 1, Subpart S. July 3, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S?toc=1.

[iv] U.S. Food and Drug Administration. Food Traceability List. March 30, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.

[v] U.S. Food and Drug Administration. Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). https://www.fda.gov/media/163132/download?attachment.

New Era of Smarter Food Safety FSMA, FDA
Beltway Beat

Data and Technology in the New Era of Smarter Food Safety

By Food Safety Tech Staff
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New Era of Smarter Food Safety FSMA, FDA

There is only one week left to submit your comments to the docket on the New Era of Smarter Food Safety. FDA is seeking feedback on topics discussed during the public meeting as well as specific questions they have identified in the topics for consideration document on FDA’s meeting page. FDA encourages anyone interested in submitting comments to
the docket, to please do so by the June 24, 2024 deadline. Comments can be submitted at www.regulations.gov [2] to docket number FDA-2024-N-1744.