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 regulationsDirective 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

EC regulatory framework related to biosafety/biosecurity

Worker protectionGenetically 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

Transboundary movement of GMOs Regulation (EC) No.1946/2003 on

transboundary movements of genetically modified organisms

201107/Kallings

http://www.biosafety-europe.eu

BIOSAFETY-EUROPE

Co-ordination, harmonisation and exchange of biosafety and biosecurity practices within a pan-

European network

BIOSAFETY-EUROPE85 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

201107/Kallings