Legal Regulation of Whole Genome Sequencing of Listeria monocytogenes in the Food Industry: Challenges, Attitudes, Possibilities

Abstract

This report presents the outcome of legal research conducted under the aegis of the project ‘Food Safety with High Precision—Pathogenomics for the Food Industry’ (short title: PathoSeq). A central objective of the PathoSeq project has been to prepare the Norwegian food industry for challenges accompanying the introduction of whole genome sequencing (WGS) of foodborne bacteria. The report elucidates the legal rules that may affect the implementation of WGS of bacterial pathogens in the food industry, using Listeria monocytogenes (Lm) as a case study. While the report focuses predominantly on the Norwegian context, account is also taken of the experiences and practices of certain other European states, particularly Austria, in light of EU food safety rules. Three key issues are canvassed: (i) the role of WGS data in assessing the safety of food; (ii) access by food safety authorities to WGS data, or to isolates on which to perform WGS, from the food industry; and (iii) food business operators’ ability to receive Lm isolates and sequences held by the authorities. A special feature of the report is that it builds on, and presents, an extensive mapping of stakeholder perspectives on these issues and, more generally, on potentials, hindrances and needs in respect of mitigating Lm-related risk through WGS technology.