Biological Containment for African Swine Fever (ASF) Laboratories and Animal Facilities: The Italian Challenge in Bridging the Present Regulatory Gap and Enhancing Biosafety and Biosecurity Measures.

Simple Summary: The African Swine Fever Virus (ASFV) is a DNA virus belonging to the Asfivirus genus and Asfarviridae family. In recent years, ASF has grown to be a significant concern for the pig industry worldwide. The ever-growing handling of ASFV pathological material in laboratories, for either diagnostic or research activities, requires particular caution to avoid accidental virus release from laboratories with consequent detrimental economic and environmental effects. This paper aims to describe the Italian National Reference Laboratory (NRL) efforts to develop a biological containment tool for ASF laboratories and animal facilities. The easy-to-apply recommendations focusing on the risk assessment system and internal audits used for enhancing Italian biosafety and biosecurity measures are reported. The African Swine Fever Virus (ASFV) is a DNA virus of the Asfarviridae family, Asfivirus genus. It is responsible for massive losses in pig populations and drastic direct and indirect economic impacts. The ever-growing handling of ASFV pathological material in laboratories, necessary for either diagnostic or research activities, requires particular attention to avoid accidental virus release from laboratories and its detrimental economic and environmental effects. Recently, the Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 repealed the Commission Decision of 26 May 2003 reporting an ASF diagnostic manual (2003/422/EC) with the minimum and supplementary requirements for ASF laboratories. This decision generated a regulatory gap that has not been addressed yet. This paper aims to describe the Italian National Reference Laboratory (NRL) efforts to develop an effective and reliable biological containment tool for ASF laboratories and animal facilities. The tool consists of comprehensive and harmonized structural and procedural requirements for ASF laboratories and animal facilities that have been developed based on both current and repealed legislation, further entailing a risk assessment and internal audit as indispensable tools to design, adjust, and improve biological containment measures. [ABSTRACT FROM AUTHOR]