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High containment microbiology laboratories in Europe

High containment microbiology laboratories in Europe

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High containment microbiology laboratories in Europe

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  1. High containment microbiology laboratories in Europe Ingegerd Kallings, Swedish Institute for Communicable Disease Control, Stockholm, Sweden and Kathrin Summermatter, Institute for Virology and Immunoprophylaxis, Mittelaeusern, Switzerland

  2. EU regulations Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work Directive 2003/85/EC Minimum Standards for Laboratories Working with FMDV in Vitro/in Vivo Directive 2009/41/EC on the contained use of micro-organisms

  3. Worker protection Genetically Modified (Micro) organisms Directive 2009/41/EC on the contained use of micro-organisms Directive 2001/18/EC on the deliberate release into the environment Regulation (EC) 1829/2003 on genetically modified food and feed Dual use Regulation (EC) No. 1334/2000 setting up a Community regime for the control of exports of dual-use items and technology Environment Directive on hazardous waste 94/31/EC(2) Animal Health Plant pathogens and protection of the environment Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Directive 95/44/EC … harmful organisms, plants, plant products and other objects …may be introduced into or moved within the Community Environmental liability Directive 2004/35/EC Transboundarymovement of GMOs Regulation (EC) No.1946/2003 on transboundary movements of genetically modified organisms EC regulatory framework related to biosafety/biosecurity

  4. BIOSAFETY-EUROPE Co-ordination, harmonisation and exchange of biosafety and biosecurity practices within a pan-European network

  5. BIOSAFETY-EUROPE • 85 CL 3 laboratories responded (of 319 identified) • 13 CL 4 laboratories • Wide variety of biosafety/biosecurity EU legislation implemented in Member States (MS) • 20/27 MS have regulations regarding genetically modified microorganisms • There is a wide variety in the interpretation of the biosecurity concept and its implementation • Underreporting (possibly deficient identification) of LAIs

  6. EU CBRN Action Plan 2009 An all-hazard approach to reduce the threat of and damage from CBRN incidents of accidental, natural or intentional origin, including acts of terrorism. Three areas: prevention, detection, preparedness and response: 14 B-specific actions: EU list of hazardous biologicla agents a nd toxins, overview of the relevant regulations or standards, registration of containment facilities, facilitate a national authorization or accreditation process, consider the implementation of management standards (CWA 15793), codes of conduct; identify biosafety officers (roles, competences and training), transport, validation of methods, quality assurance, international cooperation and networking, research, implementation of good practices, improved cooperation between relevant agencies in crisis situations