02261nas a2200241 4500000000100000008004100001260005300042653001600095653002300111653002300134653003000157653002800187100001500215700001500230700001800245700001300263700001800276245006500294300001100359490000800370520162700378022001402005 2022 d c11/2022bSchlütersche Fachmedien GmbHaHannover10asample size10afoodborne outbreak10azoonotic pathogens10aveterinary administration10ameasurement uncertainty1 aC Förster1 aK Nordhoff1 aJ Fritzemeier1 aJ Breuer1 aL Kreienbrock00aA Framework for Study Planning in Food Safety Investigations a1–100 v1353 a

In investigations related to foodborne outbreaks and evaluation of food safety, the responsible veterinary authorities are usually required to make rapid decisions and take related action. These steps are based on an assessment based on a representative sampling procedure with sufficient precision.

However, a variety of complex factors need to be considered to properly set up the investigation, including the characteristics of the pathogenic agent, the homogeneity of the distribution, and the matrix. Furthermore, to calculate its sample size, information on the epidemiological method used (e.g., prevalence estimation and freedom from contamination) and its related statistical parameters
(e.g., prevalence, alpha, and delta) must be considered.

These considerations and decisions are associated with far-reaching legal and economic consequences and must often be made immediately. This presents a great challenge for veterinary administration and creates the need for a smart and manageable solution. To achieve the best outcome, cooperation of practice and science is necessary.

To broach this complex topic, an approach is described in which use cases from administrative practice are presented that link all the essential components for determining the correct sample design and size. These practical examples incorporate the perspective of the veterinary authority and lead to the creation of specific concepts for individual pathogen-matrix combinations. The use cases serve as cornerstones for the development of a concept that can also be applied to other pathogens and matrices.

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