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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. EU regulations.
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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
EU regulations Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:262:0021:0045:EN:PDF Directive 2003/85/EC Minimum Standards for Laboratories Working with FMDV in Vitro/in Vivo www.fao.org/ag/againfo/commissions/docs/genses38/Appendix_10.pdf Directive 2009/41/EC on the contained use of micro-organisms http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:125:0075:0097:EN:PDF
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
BIOSAFETY-EUROPE Co-ordination, harmonisation and exchange of biosafety and biosecurity practices within a pan-European network http://www.biosafety-europe.eu
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
EU CBRN Action Plan 2009ftp://ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf 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