Guidance on validation of lethal control measures for foodborne pathogens in foods

Abstract

Food manufacturers are required to obtain scientific and technical evidence that a control measure or combination of control measures is capable of reducing a significant hazard to an acceptable level that does not pose a public health risk under normal conditions of distribution and storage. A validation study provides evidence that a control measure is capable of controlling the identified hazard under a worst‐case scenario for process and product parameters tested. It also defines the critical parameters that must be controlled, monitored, and verified during processing. This review document is intended as guidance for the food industry to support appropriate validation studies, and aims to limit methodological discrepancies in validation studies that can occur among food safety professionals, consultants, and third‐party laboratories. The document describes product and process factors that are essential when designing a validation study, and gives selection criteria for identifying an appropriate target pathogen or surrogate organism for a food product and process validation. Guidance is provided for approaches to evaluate available microbiological data for the target pathogen or surrogate organism in the product type of interest that can serve as part of the weight of evidence to support a validation study. The document intends to help food manufacturers, processors, and food safety professionals to better understand, plan, and perform validation studies by offering an overview of the choices and key technical elements of a validation plan, the necessary preparations including assembling the validation team and establishing prerequisite programs, and the elements of a validation report.

Headspace control and antimicrobials: Inhibition strategies to prevent the growth of Alicyclobacillus acidoterrestris in orange juice

“…Considering that a microbial validation study must provide evidence that a processing measure controls the micro‐organism of concern under a worst‐case scenario, for the process and product parameters tested (Ceylan et al . 2021), juice storage temperature of 45°C was selected considering that this value represents the optimal growth temperature for A. acidoterrestris (Goto 2007).…”

Microbial decontamination assisted by ultrasound‐based processing technologies in food and model systems: A review

“…Enteritidis and S . Typhimurium (Ceylan et al., 2021; Doyle & Mazzotta, 2000; Froning et al., 2002; Mañas et al., 2003; Shah et al., 1991). However, S .…”

“…Data on target microorganisms and target reductions for conventional processing are extracted from the review by Ceylan et al., 2021.…”

Hazard control through processing and preservation technologies for enhancing the food safety management of infant food chains

“…In these cases, appropriate non-pathogenic microbial surrogates are often used to mimic the behaviour of the target relevant pathogen in the evaluated process. 5 Also here the meta-analyses can give guidance and can be used as benchmark to evaluate whether the surrogate of choice is a good alternative for the target pathogen. In the SAFFI project, experimental work will also address the occurrence of sublethal injury of pathogens upon product treatment, because sublethally injured cells might recover and growth out in the food product during shelf lifeFig.…”

“…A validation study aims to provide the evidence that the process and product parameters associated with the control measure, if properly implemented, can control the hazard under a worst-case scenario. 5 Conducting validation studies may be resource intensive. Several complementary approaches can be useful, including (i) the scientific and technical literature, international standards and recognised guidelines, gathering data from previous validation studies and the historical knowledge of the proper performance of the control measure; (ii) scientifically sound experimental approaches based on microbial challenge testing (either with pathogenic microorganisms or qualified surrogates), pilot plant or industrial trials designed and carried out to mimic process conditions and (iii) mathematical models that integrate scientific data on how product and processing factors affect the relevant hazards enabling the assessment on the ability of one or a combination of control measures to achieve the intended food safety outcome.…”