Transcript 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,

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://eurlex.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://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:125:0075:0097:EN:PDF
EC regulatory framework related to
biosafety/biosecurity
Worker protection
Genetically Modified (Micro) organisms
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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
Plant pathogens and protection of the
environment
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Dual use
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Regulation (EC) No. 1334/2000 setting up
a Community regime for the control of
exports of dual-use items and technology
Environmental liability
Directive on hazardous waste 94/31/EC(2)
Transboundary movement of GMOs
Environment
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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
Animal Health
201107/Kallings
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Directive 2004/35/EC
Regulation (EC) No.1946/2003 on
transboundary movements of genetically
modified organisms
BIOSAFETY-EUROPE
Co-ordination, harmonisation and exchange of
biosafety and biosecurity practices within a panEuropean 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 2009
ftp://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
201107/Kallings