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

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          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.

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          Most cited references26

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          Particle size and pathogenicity in the respiratory tract

          Particle size dictates where aerosolized pathogens deposit in the respiratory tract, thereafter the pathogens potential to cause disease is influenced by tissue tropism, clearance kinetics and the host immunological response. This interplay brings pathogens into contact with a range of tissues spanning the respiratory tract and associated anatomical structures. In animal models, differential deposition within the respiratory tract influences infection kinetics for numerous select agents. Greater numbers of pathogens are required to infect the upper (URT) compared with the lower respiratory tract (LRT), and in comparison the URT infections are protracted with reduced mortality. Pathogenesis in the URT is characterized by infection of the URT lymphoid tissues, cervical lymphadenopathy and septicemia, closely resembling reported human infections of the URT. The olfactory, gastrointestinal, and ophthalmic systems are also infected in a pathogen-dependent manner. The relevant literature is reviewed with respect to particle size and infection of the URT in animal models and humans.
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            A literature review of laboratory-acquired brucellosis.

            Brucellosis is a bacterial zoonotic disease which has been associated with laboratory-acquired infections. No recent reviews have addressed the characteristics of laboratory-acquired brucellosis (LAB). English-language literature was reviewed to identify reports of laboratory exposures to Brucella spp. and LAB cases between 1982 and 2007. Evaluation of 28 case reports identified 167 potentially exposed laboratory workers, of whom 71 had LAB. Nine reports were identified that summarized an additional 186 cases of LAB. Only 18 (11%) exposures were due to laboratory accidents, 147 (88%) exposures were due to aerosolization of organisms during routine identification activities, and the circumstances of 2 (1%) exposures were unknown. Brucella melitensis was the causative agent in 80% (135/167) of the exposures. Workers with high-risk exposures were 9.3 times more likely to develop LAB than workers with low-risk exposures (95% confidence interval [CI], 3.0 to 38.6; P < 0.0001); they were also 0.009 times likelier to develop LAB if they took antimicrobial PEP than if they did not (95% CI, 0 to 0.042; P < 0.0001). The median incubation period in case and summary reports was 8 weeks (range 1 to 40 weeks). Antimicrobial PEP is effective in preventing LAB. The incubation period may be used to identify appropriate serological and symptom surveillance time frames for exposed laboratory workers.
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              Survey of laboratory-acquired infections around the world in biosafety level 3 and 4 laboratories

              Laboratory-acquired infections due to a variety of bacteria, viruses, parasites, and fungi have been described over the last century, and laboratory workers are at risk of exposure to these infectious agents. However, reporting laboratory-associated infections has been largely voluntary, and there is no way to determine the real number of people involved or to know the precise risks for workers. In this study, an international survey based on volunteering was conducted in biosafety level 3 and 4 laboratories to determine the number of laboratory-acquired infections and the possible underlying causes of these contaminations. The analysis of the survey reveals that laboratory-acquired infections have been infrequent and even rare in recent years, and human errors represent a very high percentage of the cases. Today, most risks from biological hazards can be reduced through the use of appropriate procedures and techniques, containment devices and facilities, and the training of personnel.
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                Author and article information

                Contributors
                Journal
                Front Public Health
                Front Public Health
                Front. Public Health
                Frontiers in Public Health
                Frontiers Media S.A.
                2296-2565
                31 May 2017
                2017
                : 5
                : 121
                Affiliations
                [1] 1UMR “Emergence des Pathologies Virales” (EPV: Aix-Marseille Univ – IRD 190 – Inserm 1207 – EHESP – IHU Méditerranée Infection) , Marseille, France
                [2] 2UMR 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
                Author notes

                Edited by: Tim J. J. Inglis, Pathwest Laboratory Medicine, Australia

                Reviewed by: Gary Lum, Australian Government, Australia; Kevin R. Martin, Defence Science and Technology Laboratory (DSTL), United Kingdom

                *Correspondence: Boris Pastorino, boris.pastorino@ 123456univ-amu.fr

                Specialty section: This article was submitted to Infectious Diseases – Surveillance, Prevention and Treatment, a section of the journal Frontiers in Public Health

                Article
                10.3389/fpubh.2017.00121
                5449436
                28620600
                fae42065-043e-46d7-b3a3-c9f2bf4ea1f8
                Copyright © 2017 Pastorino, de Lamballerie and Charrel.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 09 February 2017
                : 08 May 2017
                Page count
                Figures: 2, Tables: 4, Equations: 0, References: 33, Pages: 11, Words: 8771
                Categories
                Public Health
                Review

                biosafety,bsl-3,european union,regulations,infectious disease transmission,vertical,containment level 3,france

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