Pastorino Boris, de Lamballerie Xavier, Charrel Rémi
UMR "Emergence des Pathologies Virales" (EPV: Aix-Marseille Univ - IRD 190 - Inserm 1207 - EHESP - IHU Méditerranée Infection), Marseille, France.
UMR 190 "Emergence des Pathologies Virales", Virology, 19-21 bd jean moulin faculté de medecine de la timone, Institut hospitalo-universitaire Méditerranée infection, APHM Public Hospitals of Marseille, Marseille, France.
Front Public Health. 2017 May 31;5:121. doi: 10.3389/fpubh.2017.00121. eCollection 2017.
Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC , 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.
即使欧盟成员国必须执行欧盟第2000/54/EC号指令，但各国的国家生物安全法规和做法仍存在差异。事实上，欧盟关于生物制剂和转基因微生物的立法往往不够具体，无法确保协调一致，这给大多数实验室的实施带来了困难。同样，生物安全是一个相对较新的概念，已知只有少数欧盟成员国出台了国家实验室生物安全立法。在法国，最近的法规加强了三级防护实验室（CL-3）的生物安全/生物安保，但这些法规涉及的是一份特定的病原体清单，与其他欧洲成员国没有关联。本综述的目的是总结欧洲关于CL-3设施的生物安全/生物安保措施，重点关注法国的特殊性。强调了在处理风险等级为3的生物制剂时保持有效生物安全措施所需的基本要求。此外，还描述了与防护实验室规划、操作或生物安全设备相关的国际、欧洲和法国标准，以阐明最佳的生物安全和生物安保要求。
