The European Commission has published a draft regulation that, if adopted, would require EU Member States to conduct whole genome sequencing (WGS) analysis during foodborne illness outbreak investigations, and to report the results of WGS analyses. The draft regulation is open for comment until September 18, 2024.

WGS aids epidemiological investigations by enabling the identification of clusters of organisms to link pathogens isolated from humans, food, animals, feed, and the environment. The aim of the regulation is to facilitate the quick and reliable identification of foods causing illnesses during outbreaks to limit the public health and economic impact.

The draft regulation would require Member States to conduct WGS on the isolates of certain important pathogens during the investigations of foodborne illness outbreaks, specifically: Salmonella enterica, Listeria monocytogenes, Escherichia coli, Campylobacter jejuni, and Campylobacter coli. Member States would then be required to submit the results of WGS analysis to the European Food Safety Authority’s (EFSA’s) and European Center for Disease Prevention and Control (ECDC’s) joint One Health system, through which EFSA can compare isolates from foods and human cases of illness to identify the vehicle of an outbreak.

Compliance with the regulation would be expected 18 months following its enactment.

Update, Septmeber 26, 2024: In response to EFSA's call for comment on the draft regulation, the U.S. Food and Drug Administration (FDA) voiced its support, and suggested an additional requirement that the data being submitted to the One Health Database also be uploaded to the International Nucleotide Sequence Database Collaboration (INSDC).