Tag Archives: FSMA

Why Are Food Manufacturers Still Struggling to Prevent Recurring Food Safety Incidents

By Shammi Thakur
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Food safety programs can generate extensive records without necessarily producing a complete explanation of why a problem occurred. A positive environmental sample, a failed sanitation inspection, or a deviation in a critical process parameter may trigger an immediate response. However, if the investigation stops after the affected product is contained and the corrective-action report is closed, the underlying risk may remain.

The challenge is not simply to detect more problems. It is to translate the available evidence into changes that prevent similar failures from recurring.

Why Existing Preventive Controls Do Not Always Work

Food manufacturers operate under established systems for hazard analysis, sanitation, process monitoring, environmental testing, and verification. Under the U.S. Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule, applicable facilities must implement preventive controls and take corrective action when controls are not properly implemented or prove ineffective. Those actions must address the problem, reduce the likelihood of recurrence, and ensure affected food is handled appropriately.¹

Yet documented procedures cannot guarantee effective execution under every production condition. Equipment changes, maintenance activities, production pressures, inconsistent sanitation practices, and supplier variations can introduce weaknesses that existing controls do not adequately address.

Correcting a Deviation Is Not the Same as Removing Its Cause

Consider a ready-to-eat food facility that repeatedly detects Listeria monocytogenes in the same processing area. Recleaning the affected surface may be necessary, but it may not resolve contamination associated with an inaccessible equipment junction, persistent moisture, ineffective sanitation access, or movement between processing zones.

The initial correction addresses the finding. Root-cause analysis investigates why the conditions that produced the finding existed and whether similar conditions remain elsewhere.

The FDA’s guidance on strengthening food safety through root-cause analysis recommends gathering relevant records, examining possible causes, documenting conclusions, and verifying whether the resulting interventions work.²

For manufacturers, this means resisting the temptation to select the first plausible explanation. Retraining an operator, replacing a component, or revising a cleaning procedure may be appropriate, but the action should follow evidence demonstrating what contributed to the incident.

Testing Has Limits

Microbiological testing and environmental monitoring are important tools for identifying potential contamination. However, a sample provides evidence about the material and location tested, not necessarily the condition of every product lot, surface, or production shift.

The FDA’s environmental sampling guidance explains how environmental sampling helps identify harmful bacteria in food-processing environments and supports risk-based investigation.³ Sampling plans, site selection, timing, and the response to findings therefore matter as much as the number of tests performed.

A negative result after corrective action may be encouraging, but its meaning depends on the hazard, sampling design, operating conditions, and other evidence. Repeated testing without investigating earlier positive findings can create a cycle of detection and recleaning without establishing that contamination has been controlled.

What Recurring Incidents Reveal About Investigations

A particularly important example appears in the FDA’s October 2026 CORE+EP 2025 Annual Report. A historical Listeria outbreak linked to frozen supplemental shakes was investigated in 2018, 2021, and 2023 before being resolved in 2025. The outbreak involved 42 illnesses across 21 states, 41 hospitalizations, and 14 deaths. FDA sampling at the manufacturer identified three positive environmental swabs from a processing area, and whole-genome sequencing found the detected Listeria closely related to the outbreak strain. New traceback information, historical illness records, updated epidemiological evidence, and laboratory findings helped investigators connect the evidence.⁴

The report does not establish that the manufacturer ignored previous warnings or repeatedly failed to implement corrective actions. Instead, the case illustrates the difficulty of resolving an outbreak when relevant evidence is distributed across different investigations and time periods.

For manufacturers, the operational lesson is to examine how information from separate activities can be connected. A laboratory result may become more meaningful when reviewed alongside maintenance records, sanitation history, ingredient traceability, production dates, and previous findings from related locations.

Useful investigation questions include:

  • Have similar findings occurred at the same location, on the same equipment, or during particular shifts?
  • Do deviations coincide with cleaning cycles, product changeovers, maintenance work, or changes in ingredients?
  • Have previous corrective actions produced only temporary improvements?
  • Could the same risk mechanism exist on another production line or at another facility?

The purpose is not to assume that every repeated result has the same cause. It is to identify patterns that warrant investigation and test possible explanations against the available evidence.

How Manufacturers Can Strengthen Root-Cause Analysis

Effective investigations require a documented process that links immediate containment to preventive action and subsequent verification.

  1. Define the problem precisely. Establish what occurred, where it happened, when it was detected, which products may be affected, and which controls were expected to prevent it. Vague descriptions such as “sanitation failure” can conceal several distinct mechanisms.
  2. Assemble cross-functional evidence. Bring together laboratory results, environmental monitoring records, sanitation logs, production data, equipment history, employee interviews, and supplier records where relevant. Involving personnel from quality assurance, sanitation, production, maintenance, and supplier management helps reveal relationships that may be missed by a single department.
  3. Test competing explanations. Use process mapping, cause-and-effect diagrams, structured questioning, and risk assessment to examine plausible causes. Distinguish confirmed causes from hypotheses that still require evidence.
  4. Design actions around the identified mechanism. Corrective measures may involve equipment redesign, improved sanitation access, changes to process controls, supplier interventions, revised procedures, or clearer responsibilities. Retraining should be used where a demonstrated knowledge or competency gap exists, rather than as an automatic response to every deviation.
  5. Define effectiveness criteria before closing the investigation. Establish what evidence will demonstrate that the problem has been addressed. Depending on the hazard, verification may involve targeted environmental sampling, process-record reviews across several production cycles, inspection of modified equipment, or reassessment of supplier controls.
  6. Reopen the investigation when evidence warrants it. A related finding, repeated deviation, or failure to meet the agreed verification criteria should trigger reassessment. Closure should follow demonstrated effectiveness, not simply completion of the assigned tasks.²

Table 1. Translating Recurring Findings Into Preventive Action

 

Recurring finding Why the immediate response may be insufficient More effective investigation
Repeated environmental pathogen detection Recleaning may leave a persistent source or contamination route unresolved Examine equipment design, moisture, sanitation access, traffic patterns, and related locations
Repeated process deviations Retraining may not address equipment limitations or unrealistic procedures Review process parameters, operating conditions, competency, supervision, and workload
Recurring ingredient-related failures Retesting a new delivery does not establish that supplier controls are reliable Review supplier performance, traceability, incoming verification, and corrective-action evidence
Similar audit findings across shifts Reminders may not resolve inconsistent working conditions Compare actual practices, staffing, resources, procedure usability, and supervisory expectations

 

As Table 1 shows, the response should target the conditions that enable a problem rather than repeat the same immediate correction.

Food Safety Culture and Organizational Accountability

Recurring incidents cannot always be resolved through technical controls alone. Employees must understand why procedures matter, recognize conditions requiring escalation, and be able to report concerns without pressure to prioritize production targets over food safety.

A deviation may appear to be a training issue when the underlying problem is a procedure that is difficult to follow, insufficient time for sanitation, inadequate equipment access, unclear responsibility, or inconsistent management expectations.

The FDA identifies food safety culture as a core element of its New Era of Smarter Food Safety blueprint. The agency emphasizes the beliefs, attitudes, behaviors, and organizational actions that support effective food safety management.⁵

Manufacturers can translate this principle into daily operations by ensuring that:

  • Employees can report hazards and deviations without fear of retaliation.
  • Supervisors reinforce safe practices during routine production, not only before audits.
  • Procedures reflect actual operating conditions and are supported by appropriate equipment and resources.
  • Quality, production, sanitation, maintenance, and procurement teams understand their responsibilities.
  • Lessons from investigations are communicated to teams working with similar processes or hazards.

Accountability should extend beyond the quality department. Quality teams may lead an investigation, but other functions often control the conditions that allowed the incident to occur. Management must ensure that assigned actions receive the resources and authority needed for implementation.

Using Food Safety Data More Effectively

Digital records, laboratory information systems, environmental monitoring databases, and production management platforms can help organizations identify recurring patterns. Their value depends on whether the information can be compared and interpreted across functions.

For example, repeated findings may become easier to investigate when an environmental sample is linked to the relevant production schedule, cleaning record, equipment maintenance history, and previous results from nearby sampling locations.

Manufacturers should prioritize a few practical capabilities:

  • Consistent records: Use comparable incident categories, location identifiers, dates, and equipment references to make similar events easier to identify.
  • Trend analysis: Review recurrence by hazard, location, process, shift, supplier, and corrective-action type where the data supports those comparisons.
  • Escalation rules: Define when repeated or higher-risk findings require broader investigation or management review.
  • Integrated review: Bring together laboratory, sanitation, maintenance, production, and complaint information where relevant to the incident.
  • Documented verification: Record what changed, how the action was assessed, and whether the evidence supports closure.

Advanced analytics may help flag unusual patterns, but they cannot independently establish a root cause. Data quality, domain knowledge, and effective follow-up remain essential.

Testing Investment Does Not Guarantee Better Outcomes

Demand for food pathogen testing is one indicator of attention to food safety controls.  Vyansa Intelligence forecast for Saudi Arabia’s food pathogen testing sector estimates that the sector will grow from USD 61.77 million in 2025 to USD 126.37 million by 2032, representing a projected compound annual growth rate of 10.77% for 2026–2032.⁶ 

These figures describe projected industry value, not a reduction in foodborne illness or proof that testing investment has improved prevention. The distinction matters because a larger testing program can generate more information without necessarily improving the decisions made from it.

Manufacturers should assess testing by its contribution to risk control: whether results prompt appropriate investigation, whether corrective actions address the identified risks, and whether follow-up evidence demonstrates that the controls work.

Technology and testing are most effective when integrated into a broader preventive system that includes sound process design, sanitation, supplier controls, employee competence, and management oversight.

Measuring Whether Recurrence Is Declining

Audit completion rates, testing volumes, training records, and corrective-action closure times can reveal whether activities are being performed. They do not necessarily establish whether food safety risks are being reduced.

A more informative assessment also tracks repeated findings, effectiveness-verification results, overdue high-risk actions, and incidents that recur after closure. These measures should be interpreted according to the facility’s hazards and operating context; no single metric demonstrates that every risk has been controlled.

The central question is whether the organization has changed the conditions that contributed to the incident and gathered sufficient evidence to support that conclusion.

Food manufacturers cannot guarantee that every hazard will be identified before it causes harm. They can, however, make recurring failures less likely by investigating beyond the immediate symptom, connecting evidence across functions, assigning meaningful corrective actions, and verifying that those actions remain effective under routine production conditions.

An investigation is complete not when its paperwork is closed, but when the organization has established what must change, implemented the change, and assessed whether it works.

References

  1. U.S. Food and Drug Administration. “FSMA Final Rule for Preventive Controls for Human Food.” FDA, Food Safety Modernization Act. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food. Accessed October 12, 2026.
  2. U.S. Food and Drug Administration. “Strengthening Food Safety Through Root Cause Analysis.” FDA, Outbreaks of Foodborne Illness. https://www.fda.gov/food/outbreaks-foodborne-illness/strengthening-food-safety-through-root-cause-analysis. Accessed October 12, 2026.
  3. U.S. Food and Drug Administration. “Environmental Sampling.” FDA, Sampling to Protect the Food Supply. https://www.fda.gov/food/sampling-protect-food-supply/environmental-sampling. Accessed October 12, 2026.
  4. U.S. Food and Drug Administration. “CORE+EP 2025 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods.” FDA, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/coreep-2025-annual-report. Accessed October 12, 2026.
  5. U.S. Food and Drug Administration. “Food Safety Culture—Core Element 4 of the New Era of Smarter Food Safety Blueprint.” FDA, New Era of Smarter Food Safety. https://www.fda.gov/food/new-era-smarter-food-safety/food-safety-culture-core-element-4-new-era-smarter-food-safety-blueprint. Accessed October 12, 2026.
  6. Vyansa Intelligence. “Saudi Arabia Food Pathogen Testing Market Insights 2032.” Industry Report, report code VI1468. https://www.vyansaintelligence.com/industry-report/saudi-arabia-food-pathogen-testing-market-size. Accessed October 12, 2026.
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Beltway Beat

FDA Finalizes Guidance for Ready-to-Eat Fresh-Cut Produce Operations under Preventive Controls for Human Food Rule

By Food Safety Tech Staff
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Dole Organic Lettuce

On August 11, 2026, the FDA released final guidance called “Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce” to help manufacturers and processors of fresh-cut produce comply with the FSMA Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls (PCHF) rule.

According to the FDA’s website, Fresh-cut produce can be particularly susceptible to contamination, which can be introduced in the environment where it’s grown, during transport, during manufacturing, when it’s commingled with other products or at retail, and the opportunity for contamination can be amplified through each of these steps as it makes its way to consumers. Fresh-cut produce does not receive a kill step to eliminate pathogens that may be introduced during these processes and most are sold ready-to-eat.  The guidance provides recommendations and examples of how the PCHF requirements can be implemented to protect fresh-cut ready-to-eat produce from contamination with biological hazards.

Fresh-cut produce includes any fruit or vegetable that has been physically altered from its whole state (e.g., by chopping, dicing, peeling, shredding) without additional processing (such as freezing or cooking) and distributed in fresh form.  Examples of fresh-cut produce include chopped lettuce, cut cantaloupe, diced onions, and shredded carrots.

The final guidance reflects public comments received on the October 2018 draft guidance and replaces the 2008 FDA fresh-cut produce guidance. This guidance represents the agency’s current thinking on the issues related to preventing contamination in fresh cut produce.  The agency encourages the industry to continue advancing and improving food safety practices, including through the development and implementation of Best Practice documents tailored to their specific commodities and processes.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe 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 FDA guidance means that something is suggested or recommended but not specifically required.

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

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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.