Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety

Foodborne diseases, especially those caused by zoonotic agents, pose a significant threat to human health. Food business operators are therefore responsible for producing safe food. To do this, they must regularly carry out appropriate sample investigations to detect zoonotic agents in their food be...

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Main Authors: Cara Förster, Katja Nordhoff, Jörg Fritzemeier, Fritjof Freise, Lothar Kreienbrock
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:Journal of Food Protection
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Online Access:http://www.sciencedirect.com/science/article/pii/S0362028X24001728
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author Cara Förster
Katja Nordhoff
Jörg Fritzemeier
Fritjof Freise
Lothar Kreienbrock
author_facet Cara Förster
Katja Nordhoff
Jörg Fritzemeier
Fritjof Freise
Lothar Kreienbrock
author_sort Cara Förster
collection DOAJ
description Foodborne diseases, especially those caused by zoonotic agents, pose a significant threat to human health. Food business operators are therefore responsible for producing safe food. To do this, they must regularly carry out appropriate sample investigations to detect zoonotic agents in their food before it leaves the factory. Depending on the issue investigated, there may be legal requirements for food business operators, usually specifying minimum sample sizes, such as Commission Regulation (EU) No 2073/2005. However, in most cases, there is no information on the precision, and therefore, on the significance of the results for these sample sizes.Regulatory veterinary authorities have a control function and, as a result, they are required to regularly evaluate the available investigations and their results. In addition, in certain crisis situations (e.g., foodborne outbreaks or suspected food contamination), authorities may guide food business operators in their investigations and conduct their own investigations to assess food safety measures. In such cases, as there are no legally defined sample sizes to be taken, the appropriate sample sizes must be determined by the authorities. This can lead to a conflict between the need for feasibility and the need for conclusiveness of the investigation potentially being a challenge for the regulatory authority in charge.This paper highlights the importance of thoughtful study design and the critical communication of available results by veterinary authorities on the background of a use case involving Listeria monocytogenes findings in a crisis situation. Using the minimum sample size, n = 5, required by Commission Regulation (EU) No 2073/2005 for the pathogen Listeria monocytogenes as a guide, the uncertainties associated with small sample sizes are highlighted. It also aims to facilitate the evaluation of studies performed and the assessment of further sample sizes.
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spelling doaj-art-8fd9f49fef7f40eab0b9e31e5d99bfba2024-12-04T05:12:11ZengElsevierJournal of Food Protection0362-028X2024-12-018712100388Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food SafetyCara Förster0Katja Nordhoff1Jörg Fritzemeier2Fritjof Freise3Lothar Kreienbrock4Department of Biometry, Epidemiology and Information Processing, WHO Collaborating Centre for Research and Training for Health in the Human-Animal-Environment Interface, University for Veterinary Medicine, Bünteweg 2, 30559 Hannover, Germany; Corresponding author.Task Force Consumer Protection, Lower Saxony State Office for Consumer Protection and Food Safety, Stau 75, 26122 Oldenburg, GermanyVeterinary Service Osnabrück, Am Schölerberg 1, 49082 Osnabrück, GermanyDepartment of Biometry, Epidemiology and Information Processing, WHO Collaborating Centre for Research and Training for Health in the Human-Animal-Environment Interface, University for Veterinary Medicine, Bünteweg 2, 30559 Hannover, GermanyDepartment of Biometry, Epidemiology and Information Processing, WHO Collaborating Centre for Research and Training for Health in the Human-Animal-Environment Interface, University for Veterinary Medicine, Bünteweg 2, 30559 Hannover, GermanyFoodborne diseases, especially those caused by zoonotic agents, pose a significant threat to human health. Food business operators are therefore responsible for producing safe food. To do this, they must regularly carry out appropriate sample investigations to detect zoonotic agents in their food before it leaves the factory. Depending on the issue investigated, there may be legal requirements for food business operators, usually specifying minimum sample sizes, such as Commission Regulation (EU) No 2073/2005. However, in most cases, there is no information on the precision, and therefore, on the significance of the results for these sample sizes.Regulatory veterinary authorities have a control function and, as a result, they are required to regularly evaluate the available investigations and their results. In addition, in certain crisis situations (e.g., foodborne outbreaks or suspected food contamination), authorities may guide food business operators in their investigations and conduct their own investigations to assess food safety measures. In such cases, as there are no legally defined sample sizes to be taken, the appropriate sample sizes must be determined by the authorities. This can lead to a conflict between the need for feasibility and the need for conclusiveness of the investigation potentially being a challenge for the regulatory authority in charge.This paper highlights the importance of thoughtful study design and the critical communication of available results by veterinary authorities on the background of a use case involving Listeria monocytogenes findings in a crisis situation. Using the minimum sample size, n = 5, required by Commission Regulation (EU) No 2073/2005 for the pathogen Listeria monocytogenes as a guide, the uncertainties associated with small sample sizes are highlighted. It also aims to facilitate the evaluation of studies performed and the assessment of further sample sizes.http://www.sciencedirect.com/science/article/pii/S0362028X24001728Confidence levelConclusivenessRegulationSamplingZoonotic pathogen
spellingShingle Cara Förster
Katja Nordhoff
Jörg Fritzemeier
Fritjof Freise
Lothar Kreienbrock
Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety
Journal of Food Protection
Confidence level
Conclusiveness
Regulation
Sampling
Zoonotic pathogen
title Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety
title_full Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety
title_fullStr Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety
title_full_unstemmed Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety
title_short Informative Value of a Sample Investigation with a Predefined Sample Size using the Example of Listeria monocytogenes in Food Safety
title_sort informative value of a sample investigation with a predefined sample size using the example of listeria monocytogenes in food safety
topic Confidence level
Conclusiveness
Regulation
Sampling
Zoonotic pathogen
url http://www.sciencedirect.com/science/article/pii/S0362028X24001728
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