Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements.

Boris Pastorino,Xavier De Lamballerie,Rémi Charrel

doi:10.3389/fpubh.2017.00121

Abstract

Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, national biosafety regulations and practices varied from country to country. In fact, EU legislation on biological agents and genetically modified microorganisms is often not specific enough to ensure harmonization leading to difficulties in implementation for most laboratories. In the same way, biosecurity is a relatively new concept and a few EU Member States are known to have introduced national laboratory biosecurity legislation. In France, recent regulations have reinforced biosafety/biosecurity in containment level 3 (CL-3) laboratories but they concern a specific list of pathogens with no correlation in other European Members States. The objective of this review was to summarize European biosafety/biosecurity measures concerning CL-3 facilities focusing on French specificities. Essential requirements needed to preserve efficient biosafety measures when manipulating risk group 3 biological agents are highlighted. In addition, International, European and French standards related to containment laboratory planning, operation or biosafety equipment are described to clarify optimal biosafety and biosecurity requirements.

Highlights

Recent international events such as successive outbreaks (West Nile virus in North America, Chikungunya virus in the Indian Ocean and in the New World, Ebola virus in West Africa, and Zika virus in the New World) and the concomitant fear of bioterrorism have stimulated a grow ing reinforcement of biosecurity and biosafety measures (European Union Chemical, Biological, Radiological, and Nuclear action plan B2, March 2014) [1]
This review aims at compiling the principal concepts of Euro pean academic containment level 3 (CL-3) laboratory mana ge ment, biosafety, and biosecurity based on applicable European Union (EU) Directives and French regulations
European standards have been developed for biosafety equipment, e.g., autoclaves, biosafety cabinets (BSCs), and personal protective equipment (PPE), but regular oversight and recertification are guided by national specifications [17]

Summary

Introduction

Recent international events such as successive outbreaks (West Nile virus in North America, Chikungunya virus in the Indian Ocean and in the New World, Ebola virus in West Africa, and Zika virus in the New World) and the concomitant fear of bioterrorism have stimulated a grow ing reinforcement of biosecurity and biosafety measures (European Union Chemical, Biological, Radiological, and Nuclear action plan B2, March 2014) [1]. European labo ratories in which infectious microorganisms are manipulated were confronted to a drastic increase in biosafety/biosecurity regulations. Regulations can be different in European Union (EU) Member State countries and despite efforts of national agencies to place online specific information, European laboratories working with infectious pathogens are confronted to a large number of complex rules and regulations. This review aims at compiling the principal concepts of Euro pean academic containment level 3 (CL-3) laboratory mana ge ment, biosafety, and biosecurity based on applicable EU Directives and French regulations. It highlights essential information to ensure workers and environment protection according to com monly recommended biosafety measures

Objectives

Methods

Findings

Conclusion