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Biosafety 

What do public health specialists and policy makers need to know about biosafety issues and practices in the EU?  

Research on pathogenic micro-organisms is vital to counteract the possible consequences of infectious disease outbreaks, whether natural or caused by malicious/accidental release. Only then can diagnostic methods and countermeasures to protect human and animal health be developed. However, the possibility of accidental or deliberate release of a pathogenic micro-organism from laboratories must be considered and controlled. The consequence of a release of biological agents from a single laboratory could be the spread of a disease throughout Europe.

Coordination of laboratory biosafety and biosecurity efforts across Europe is vital to ensure interoperability and preparedness. There are two key European Directives to which national regulations are based. Moreover, within the EU there is a wealth of expertise in the areas of biorisk management that can be harnessed to contribute to communication, and the establishment of best practices.

In recent years, this has been achieved through several European Commission funded projects. In addition, the European Biosafety Association (EBSA) is an important forum for networking, information exchange and training for biosafety professionals. 

Definitions:
Biosafety: The containment principles, technologies and practices that are implemented to prevent the unintentional exposure to biological agents and toxins or their accidental release.
Biosecurity: The protection, control and accountability for biological materials  within laboratories in order to prevent their unauthorised access, loss, theft, misuse, diversion or intentional release.
Biorisk Management: Encompasses hazard identification, risk assessment and risk control both in the fields of biosafety and laboratory biosecurity.   
BSL = Biosafety Level There are 4 accepted levels in the field of human health (containment levels 1, 2, 3 and 4). Community classification is available in Annex III of Directive 2000/54/EC (on the protection of workers from risks related to exposure to biological agents at work) and as well applying to containment and other protective measures as indicated in Annex IV of Directive 2009/41/EC (on the contained use of genetically modified organisms). There are differences in the nomenclature in different EU Member States to take into considerations.
BSL + = Biosafety Level  “+” Biosafety Level  “+” indications  only refers to additional procedures and methods of handling in place (i.e. handling methods of materials for example for decontamination and storage, type of personnel protective equipment used, etc…) and any other relevant considerations for the type of work being conducted within a BSL containment area .


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ECDC publishes its risk assessment on laboratory-created A(H5N1) viruses
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