A process that has worked for years is not automatically validated
Why process validation is critical to product safety: Lessons from the Castleberry’s botulism case, Codex definitions, and five questions for your facility.
In the summer of 2007, health authorities in Texas and Indiana reported four cases of botulism. Two of the patients were siblings. All four required mechanical ventilation. The common denominator: canned hot dog chili sauce produced by the Castleberry's Food Company in Georgia.
Subsequent inspections by the FDA and FSIS revealed flaws in the sterilization process that could have allowed for the survival of spores of Clostridium botulinum . Out of 17 swollen cans from the same production batch, 16 tested positive for botulinum toxin type A. The recall was expanded to 91 products under 25 private labels, distributed across approximately 8,500 retail locations in 49 states. The plant was shut down.
The context is remarkable: according to the CDC, this was the first botulism outbreak in the U.S. linked to a commercial cannery in about 30 years. The facility had been operating for decades. Until it didn't.
What validation actually means
The Codex Alimentarius, in its guideline CXG 69-2008, defines validation as obtaining evidence that a control measure or combination of control measures, if implemented correctly, is capable of controlling a hazard to a specified outcome. The European Commission adopted this definition in its Notice 2022/C 355/01 on food safety management systems, adding a crucial caveat: revalidation may be necessary when changes occur.
Validation is therefore distinct from verification and monitoring. Monitoring answers the question: Is the process currently running within the specified limits? Verification answers the question: Are we following what we established? Validation answers the preceding question: Is what we established actually correct? Are 72 degrees Celsius for 15 seconds sufficient for this product, in this container, on this equipment?
A thermometer that reliably displays 121 degrees Celsius does not prove that 121 degrees Celsius is reaching the coldest point in the can. This is exactly where validation comes in.
Why changes are the problem
The EU Notice is clear: control measures must be validated, and HACCP-based procedures must be reviewed whenever there is a change to the product, the process, or a process step. The legal basis is Article 5 of Regulation (EC) No 852/2004, which explicitly lists the validation of the HACCP plan as one of the seven principles.
In practice, it is rarely major structural changes that create validation gaps. It is the small steps: a recipe with a higher solids content, switching from a can to a glass jar, a larger container, a new heat exchanger, or a shortened holding time to increase capacity. Each of these changes alters heat penetration, viscosity, or water activity. The old validation report then describes a process that no longer exists.
A 2021 review by Ceylan et al. in Comprehensive Reviews in Food Science and Food Safety hits the nail on the head: a validation study must prove that the control measure manages the hazard under worst-case conditions for both product and process. It must also define the critical parameters that are subsequently controlled, monitored, and verified. The authors also point out that methodological discrepancies between food safety experts, consultants, and third-party laboratories are a real problem. This is precisely why the guideline was written.
The numbers behind the risk
A 2024 analysis published in the Journal of Food Protection of over 35,000 FDA-regulated recalls between 2002 and 2023 shows that under-processing—i.e., incomplete acidification, pasteurization, drying, or sterilization—accounts for only about one percent of all recalls, totaling 468 cases. However, the authors emphasize that these few cases often trigger broad, complex recall responses and can have significant financial consequences.
A 2024 case demonstrates that this issue is not just historical. Snapchill LLC in Wisconsin recalled all of its canned coffee products within their shelf life after the FDA determined that the process for these low-acid canned foods had not been filed with the agency. The reason for the recall was not a detected pathogen, but a lack of documentation.
For Germany, the Robert Koch Institute notes: spores of Clostridium botulinum are not killed if heating is insufficient, for example due to inadequate sterilization measures during the canning process. According to the Federal Institute for Risk Assessment, between zero and 24 cases of botulism were reported to the Robert Koch Institute annually between 2001 and 2018. The number is small. The severity of each individual case is not.
Questions every facility should be able to answer
- For which products, containers, and systems is a validation report available, and does it describe the process that is actually running today?
- For thermal processes: Has the coldest point in the product and the system been determined using more than one measuring point?
- For foreign bodies: Has the most unfavorable shape and the most unfavorable position within the product been identified?
- For chemical processes: Have potential reaction products been taken into account?
- What changes to the recipe, packaging, system, or parameters have been made since the last validation, and who assessed the need for revalidation in each case?
- Are the acceptance criteria documented, such as the target F-value or P-value, and was the test design configured for worst-case conditions?
- Is the validation integrated into the change management process so that a recipe change automatically triggers the question of verification?
Anyone who can answer these questions without looking them up has a handle on their processes. Anyone who stumbles at question five has an issue.
Conclusion
Castleberry's had a functioning facility, experienced staff, and decades of routine. What was missing was robust evidence that the process performs as intended under all conditions. Validation is not a formality for an audit. It is the only proof that the process makes the product safe.
If you would like to evaluate the validation status of your critical processes together with experienced practitioners, you will find FIT Process Validation a practical format that addresses exactly this.
Sources
- Centers for Disease Control and Prevention (2007): Botulism Associated with Commercially Canned Chili Sauce, Texas and Indiana, July 2007. MMWR Dispatch, July 30, 2007. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d730a1.htm
- U.S. Food and Drug Administration (2007): Castleberry's Food Company, consumer warning and inspection report. https://fda.gov/media/72963/download
- Codex Alimentarius: Guidelines for the Validation of Food Safety Control Measures, CXG 69-2008. https://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines
- European Commission (2022): Notice 2022/C 355/01 on the implementation of food safety management systems. Official Journal of the European Union C 355 of September 16, 2022.
- Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Article 5.
- Ceylan, E., Amézquita, A., Anderson, N., Betts, R., Blayo, L., Garces-Vega, F., Gkogka, E., Harris, L. J., McClure, P., Winkler, A., den Besten, H. M. W. (2021): Guidance on validation of lethal control measures for foodborne pathogens in foods. Comprehensive Reviews in Food Science and Food Safety 20(3), 2825–2881. https://doi.org/10.1111/1541-4337.12746
- DeBeer, J., Blickem, E. R., Rana, Y. S., Baumgartel, D. M., Bell, J. W. (2024): An Analysis of Food Recalls in the United States, 2002–2023. Journal of Food Protection 87(12), 100378. https://doi.org/10.1016/j.jfp.2024.100378
- U.S. Food and Drug Administration (2024): Snapchill LLC Recalls Canned Coffee Products Due to Potential Clostridium botulinum. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/snapchill-llc-recalls-canned-coffee-products-due-potential-clostridium-botulinum
- Robert Koch Institute: RKI Guide to Botulism. https://www.rki.de/DE/Aktuelles/Publikationen/RKI-Ratgeber/Ratgeber/Ratgeber_Botulismus.html
- German Federal Institute for Risk Assessment: Consumer information on foodborne botulism. https://www.bfr.bund.de/cm/350/hinweise_fuer_verbraucher_zum_botulismus_durch_lebensmittel.pdf
Publications & Technical Papers
Practical experience — passed on in specialist literature, training courses and contributions on food safety.
Director Food Safety Senior Experts, Microbiologist & Food Safety Expert
With decades of experience in audits, quality management and crisis situations, she combines scientific principles with operational practice. Her publications make complex topics such as HACCP, food safety culture and risk analysis understandable and directly applicable. For companies that not only pass certifications, but also want to sustainably improve their systems.
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