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Anticipating Biosecurity Challenges of the Global Expansion of High Containment Biological Laboratories Istanbul, Turkey 11-13 July 2011 International regulatory frameworks, standards and guidelines Ingegerd Kallings Swedish Institute for Communicable Disease Control Stockholm, Sweden WHO Collaborating Center on Biological Safety Laboratory acquired infections, 1997-2007 SARS 44lab labstaff, staff,77secondary secondarycases cases SARS Singapore,Taiwan,

Taiwan,Beijing: Beijing:11 Singapore, N.meningitidis 2 x clinical lab. UK Melioidosis, USA Herpes B encephalitis 23-y woman 1997 Vaccinia, ocular inf., USA Vaccinia, Brazil 2000 Ebola, Russia 2003 FMD,UK UK FMD,

2007 West Nile virus Tb; 3 cases, USA 2 cases, USA Cutaneous anthrax: Tb, UK 2 cases, Texas Tularaemia, 3 cases, USA Legionella pneumonia, Sweden 201107/Kallings Brucella 2 cases, USA International/global National regulations Treaties/ Conventions Guidelines/ / Practices Resolutions

201107/Kallings Codes Manuals/ Standards International Conventions, Declarations, Agreements The 1925 Geneva Protocol ..for the Prohibition of the Use in War of Asphyxiating, Poisonous, or Other Gases, and of Bacteriological Methods of Warfare Biological Weapons Convention (BWTC),1975 7th Review Conf. Dec 2011 United Nations Security Resolution (UNSCR) 1540, 2004: Nonproliferation of weapons of mass destruction http:// enElement Convention on Biological Diversity, 1993; Cartagena Protocol

on Biosafety, 2000 Global Health and Security Action Group (G8), 2001 Global Partnership Program against spread of Weapons of Mass Destruction http:// spx?menu_id=1&view=d 201107/Kallings International declarations, recommendations, guidelines Australia Group export control list (1985) UNESCO Declaration on Bioethics and Human Rights 2005 http.// OECD BEST PRACTICE GUIDELINES ON BIOSECURITY FOR Biological Research Centers (2007) Recommendations on the Transport of Dangerous Goods. Model Regulations 16th rev. 2009 WHO, World Health Organization

OIE, World Organization for Animal Health FAO, Food and Agriculture Organization of the UN IPPC, International Plant Protection Convention INTERPOL 201107/Kallings Code of conduct CODE OF CONDUCT / CODE OF ETHICS / CODE OF PRACTICE Non-legislated guidelines which one or more organisations voluntarily agree to abide by, and which sets out the standard of conduct or behavior with respect to a particular activity Ex: A Code of Conduct for Biosecurity Royal Netherlands Academy of Arts and Sciences, Amsterdam, August 2007 de_of_conduct_biosecurity.pdf 201107/Kallings

The role of the World Health Organization (WHO) for biosafety and biosecurity governance . .. 201107/Kallings WHO Laboratory Biosafety Manual . the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release. WHO Laboratory Biosafety Manual, 3rd ed., 2004

http:// safety/en/Biosafety7.pdf 201107/Kallings WHO Laboratory biosecurity guidance describes the protection, control and accountability for valuable biological materials, VBM, within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release. Valuable biological materials (VBM) Biological materials that require (according to their owners, users, custodians, caretakers or regulators) administrative oversight, control, accountability, and specific protective and

monitoring measures in laboratories to protect their economic and historical (archival) value, and/or the population from their potential to cause harm. http:// 201107/Kallings DS_EPR_2006_6/en/index.html WHO/CDS/EPR/2006.6 WHO Transport Guidance In effect 1 January 2011 http:// who_hse_ihr_20100801/en/ind ex.html International Civil Air Organization (ICAO)

201107/Kallings The Air Transport (IATA) Association International biosecurity initiatives - NGOs NTI/Global Health and Security Initiative 2003 Pugwash Workshop on Science, Ethics and Society 2005 International Council of Life Science (ICLS) 2005 International Forum on Biosecurity Professional Biosafety Associations; ABSA, EBSA, ANBio, A-PBA, JBA, IVBWGIFBA Red Cross and other non-governmental organisations >30 meetings annually on biosecurity 201107/Kallings

IFBA International Federation of Biosafety Associations International Biosafety Compendium on Regulations, Guidelines and Information Sources from around the world http :// e_Feb_10_2010.pdf 2011 The Year of Building International Biosafety Communities 201107/Kallings EC regulatory framework related to biosafety/biosecurity Worker protection Directive 89/391/EEC on the

introduction of measures to encourage improvements in the safety and health of workers at work Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work 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 201107/Kallings 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 Environment Directive on hazardous waste 94/31/EC(2) ISO/EC (CEN) standards related to biosafety/biosecurity ISO/EC Standards on quality, technical installations and equipment, and management systems ISO EN 15189:2003 Medical laboratories Particular requirements for quality and competence CEN/CR 12739:1998 Biotechnology - Laboratories for research, development and analysis - Report

on the selection of equipment needed for biotechnology laboratories according to the degree of hazard And many more..... CWA 15793:2008 Laboratory Biorisk 201107/Kallings Mangement Standard Laboratory Biorisk Management standard CWA 15973:2008 Risk based approach Performance oriented Generic document Can never supersede national regulations voluntary standard Consistent with EN ISO 9001:2000 Quality, EN ISO 14001:2004 Environment and OHSAS 18001:2007 Suitable for internal and external audits,

voluntarily May be used for third party certification, 201107/Kallings voluntarily Guidance to Laboratory Biorisk Management standard CWA 15793:2008 CEN WS 55 Increase the likelihood of CWA 15793 being adopted by the user community; Ensure that users of CWA 15793 are able to easily understand and confidently implement all the recommendations of the CWA; Increase the confidence of stakeholders (including regulators, funding organizations and the community) that there is consistency in the application of CWA 15793 across laboratories in different countries. 201107/Kallings Biosafety Professional (BSP) Competence

CEN Workshop 53 Define the Roles and responsibilities of the BSP Competencies required for activities within Appointed by?, Reports to? all laboratories containment level 1-4 use of animals, plants or insects large scale production GMM and gene therapy

.. Develop a training curriculum for BSP; what? where? CEN Workshop Agreement, CWA Expected early autumn 2011 201107/Kallings Regional and National Biosecurity Regulations Africa, South America, EU Australia (4), Austria, Belgium, Brazil, Canada (4), China (4), Cuba (2), Czech Republic (4), Denmark, Finland (3), France (4), Germany (5), India (3), Israel, Italy, Japan (11), Kazakhstan (4), Russia (6), Singapore, South Africa (3), South Korea (2),

Switzerland (3), United Kingdom (5), United States (14) 201107/Kallings BMBL 5th ed (2009) blications/bmbl5/ 201107/Kallings Conclusions The character and extent of bio-threats should be carefully analysed There are currently sufficient biosafety and laboratory biosecurity guidelines and regulations on the international arena, however clarifications of existing regulations and guidelines and their status are needed any gaps in existing biosafety/laboratory biosecurity

regulations and guidelines must be identified and covered many countries still lack a national regulatory framework Increased awareness of and compliance to existing regulations should be encouraged and fostered - preceding new regulations 201107/Kallings

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