Technical specifications on the collection, management and analysis of data on the surveillance of transmissible spongiform encephalopathies (TSEs) in ruminants and other animals in the EU
EFSA has received a mandate from the European Commission (EC) regarding the transfer to EFSA of (1) the data collection system for transmissible spongiform encephalopathies (TSE) under Regulation (EC) No 999/2001 starting from 2018 and (2) the preparation of the annual summary report (EUSR) on TSE. Currently the data collection (aggregated and ‘case’ data) is carried out by the EC. The TSE data collection and reporting requirements for the Member States (MSs) are spelled out in detail in Regulation (EC) No 999/2001. In order to analyse and summarise the data collected for bovine spongiform encephalopathy (BSE)/TSE in a harmonised and consistent way, EFSA needs to define the technical specifications for the collection, management and analysis of data on the surveillance of TSEs in ruminants in the EU. The main purpose of the specifications described in this report is to ensure consistency and comparability of the TSE data with European data collections from other food safety domains within the EFSA Scientific Data Warehouse. Moreover, the specifications spelled out in this report aim to support reporting countries with their submission of data collected under the framework of the Regulation (EC) No 999/2001. These guidelines are intended to be used in conjunction with the Standard Sample Description version 2.0 (SSD2) and the Guidance on Data Exchange version 2.0 (GDE2) and they provide specific guidance on the BSE/TSE data model, data elements, the controlled terminology values and specific business rules which are applicable to BSE/TSE data. The guidelines are compatible with the SSD2 and GDE2 framework for data submission to EFSA in eXtensible Markup Language format via the Data Collection Framework. A pilot study will be organised to validate the data model described. The specifications described in this report may change according new insights on TSE surveillance in EU.