E5

HIGH-CONTAINMENT LABORATORIES – SWEDEN CASE STUDY

Ingegerd Kallings, Swedish Institute for Communicable Disease Control
SE-171 82 Solna, Sweden

High-containment biological facilities in Sweden

Work with risk class 3 or 4 biological agents requires a permit from the competent authority, which reviews and evaluates that the containment measures chosen are adequate. Thus, one way to address the question of the number of containment laboratories is to look at the number of applications for such a work permit. There are currently 32 employers in Sweden with (one or more) permits to work in 40 sites with (one or more) risk class 3 biological agents. The risk classification in EU Directive 2000/54/EC applies. Most of these permits are for clinical diagnostic work with biological agents that are not airborne e.g., HIV, EHEC, and other gastrointestinal biological agents and thus requirements are less than for a complete containment level (CL) 3 laboratory. One permit is for storage of biological agents in a culture collection. Eleven employers have a permit to work in full CL 3 at 11 sites e.g., clinical mycobacterial laboratories. One employer may have one or more permits for work in one or more laboratories at different sites. There is one containment level 4 facility in Sweden.

National governance of high-containment biological laboratories

Government agencies in Sweden subordinate to a Government Department (Ministry) are responsible for implementing public policies, overseeing the provision of public services, and executing a range of regulatory functions. The Government decides on the preconditions for agencies’ operations through appropriation directions and ordinances.

The Swedish Work Environment Authority (SWEA)1 is an independent government agency authorized by the Labour Ministry. With regard to biosafety, SWEA is responsible for the implementation of the EU Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work2 and EU Directive 2009/41/EC on the contained use of genetically modified micro-organisms (GMM).3 EU Directives contain minimum requirements and Member States may add national requirements. Sweden has done so. EU Directive 2000/54/EC is implemented through national provisions: AFS 2005:01 Microbiological Work Environment Risks—Infection, Toxigenic Effect, Hypersensitivity.4 Regarding GMM, the SWEA provisions AFS 2000:05 Contained Use of Genetically Modified Micro-organisms5 following the previous EU Directive 98/86/EC are still in use but will be reviewed and updated to reflect changes in the most recent EU Directive 2009/41/EC6 on GMM. The regulatory text of the SWEA statute books is complemented by extensive recommendations on how to interpret and implement the law. A statute book on blood-borne infections will be updated shortly to follow the recent EU Directive,7 which will also be reflected in the AFS ordinance regulating biosafety.

Criteria for establishing containment facilities

There are no national criteria for the establishment of containment facilities in Sweden, neither for justification of the work nor for selection of sites. The respective management/owner of a facility in any sector (government/university/county level public health /private industry) decides what they intend to do and makes a proposal to SWEA for a work permit. SWEA does not question the rationale for the intended work; they check that safety criteria are pertinent for the work planned and that safety measures will be effective. Thus, the work permit is based on a case-by-case risk assessment and does not strictly follow a checklist for different containment levels.

images

1www.av.se

2http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:262:0021:0045:EN:PDF

3http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:125:0075:0097:EN:PDF

4http://www.av.se/dokument/inenglish/legislations/eng0501.pdf

5http://www.av.se/dokument/inenglish/legislations/eng0005.pdf

6 Op. cit. see note 3

7http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:134:0066:0072:EN:PDF



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E5 HIGH-CONTAINMENT LABORATORIES – SWEDEN CASE STUDY Ingegerd Kallings, Swedish Institute for Communicable Disease Control SE-171 82 Solna, Sweden High-containment biological facilities in Sweden Work with risk class 3 or 4 biological agents requires a permit from the competent authority, which reviews and evaluates that the containment measures chosen are adequate. Thus, one way to address the question of the number of containment laboratories is to look at the number of applications for such a work permit. There are currently 32 employers in Sweden with (one or more) permits to work in 40 sites with (one or more) risk class 3 biological agents. The risk classification in EU Directive 2000/54/EC applies. Most of these permits are for clinical diagnostic work with biological agents that are not airborne e.g., HIV, EHEC, and other gastrointestinal biological agents and thus requirements are less than for a complete containment level (CL) 3 laboratory. One permit is for storage of biological agents in a culture collection. Eleven employers have a permit to work in full CL 3 at 11 sites e.g., clinical mycobacterial laboratories. One employer may have one or more permits for work in one or more laboratories at different sites. There is one containment level 4 facility in Sweden. National governance of high-containment biological laboratories Government agencies in Sweden subordinate to a Government Department (Ministry) are responsible for implementing public policies, overseeing the provision of public services, and executing a range of regulatory functions. The Government decides on the preconditions for agencies' operations through appropriation directions and ordinances. The Swedish Work Environment Authority (SWEA)1 is an independent government agency authorized by the Labour Ministry. With regard to biosafety, SWEA is responsible for the implementation of the EU Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work2 and EU Directive 2009/41/EC on the contained use of genetically modified micro-organisms (GMM).3 EU Directives contain minimum requirements and Member States may add national requirements. Sweden has done so. EU Directive 2000/54/EC is implemented through national provisions: AFS 2005:01 Microbiological Work Environment Risks—Infection, Toxigenic Effect, Hypersensitivity.4 Regarding GMM, the SWEA provisions AFS 2000:05 Contained Use of Genetically Modified Micro-organisms5 following the previous EU Directive 98/86/EC are still in use but will be reviewed and updated to reflect changes in the most recent EU Directive 2009/41/EC6 on GMM. The regulatory text of the SWEA statute books is complemented by extensive recommendations on how to interpret and implement the law. A statute book on blood-borne infections will be updated shortly to follow the recent EU Directive,7 which will also be reflected in the AFS ordinance regulating biosafety. Criteria for establishing containment facilities There are no national criteria for the establishment of containment facilities in Sweden, neither for justification of the work nor for selection of sites. The respective management/owner of a facility in any sector (government/university/county level public health /private industry) decides what they intend to do and makes a proposal to SWEA for a work permit. SWEA does not question the rationale for the intended work; they check that safety criteria are pertinent for the work planned and that safety measures will be effective. Thus, the work permit is based on a case-by-case risk assessment and does not strictly follow a checklist for different containment levels. 1 www.av.se 2 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:262:0021:0045:EN:PDF 3 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:125:0075:0097:EN:PDF 4 http://www.av.se/dokument/inenglish/legislations/eng0501.pdf 5 http://www.av.se/dokument/inenglish/legislations/eng0005.pdf 6 Op. cit. see note 3 7 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:134:0066:0072:EN:PDF 165

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166 Biosecurity Challenges Different Government Departments (e.g., Ministries of Defense, Foreign Affairs, Social Affairs, and Health) and agencies are usually involved in the process of funding high-containment facilities, seeking competent advice from several national expert agencies e.g. Swedish Institute for Communicable Disease Control,1 National Veterinary Institute,2 Swedish Defense Research Agency,3 National Board of Health and Welfare,4 universities, and committees. Standards The EU Directive 2000/54/EC5 and the SWEA statute book AFS 2005:16 provide the overarching regulatory framework for construction of containment facilities. In addition there are numerous EN standards for construction and engineering. It is not mandatory for EU Member States to follow the EN standards, but Sweden has adopted most EN standards as national standards (SIS), which makes compliance necessary. AFS 2000:057 and AFS 2005:018 specify how and when to apply to SWEA for permission to work with risk class 3 and 4 biological agents. Application has to be renewed every 3-5 years. There are no specific laboratory biosecurity regulations in Sweden but the AFS 2000:5 and 2005:1 dealing extensively with biosafety cover most aspects of laboratory biosecurity. The Ministry of Defense with the Swedish Defense Research Agency as an adviser ensures compliance with the Biological and Toxin Weapons Convention but with little application for laboratories. There is a dialogue between the Swedish Institute for Communicable Disease Control (SMI), where the CL 4 facility is located, and the Swedish Security Service,9 who informs SMI about any changes in the terrorism situation that may call for additional biosecurity provisions. SWEA has 10 regional inspectorate offices with general work environment inspectors, but biosafety competence is rather scarce and containment facilities are rarely inspected. Laboratory-associated Infections (LAI) There is mandatory notification to SWEA of work-related illness, including laboratory-associated infections, as well as of serious incidents with a potential for harm. Employers that run containment labs are required to have a system in place for internal reporting and authority notification when deemed necessary. The employer is required to investigate incidents and accidents and take corrective actions. SWEA can inspect any time they choose to do so. In practice this is done if the safety representative, mandatory in every work place with >5 employees, requests an inspection or if misconduct is suspected. According to the Work Environment Act, the employer is always accountable for the conditions in the workplace and legal actions can be taken if safety precautions are not in place. Imprisonment is possible but is extremely rarely effectuated. Actions to prevent laboratory incidents The Swedish Institute for Communicable Disease Control (SMI) and other Government expert authorities together with the profession conduct awareness raising events. SMI initiated the Nordic Biosafety Network in 2004. Work is underway to foster the implementation of The Laboratory Biorisk Management standard, CWA 15793.10 As in other countries, underreporting and lack of communication of laboratory incidents is an unresolved issue. No specific actions have been taken on the national level to increase laboratory biosecurity, but there is an increased awareness of the need for precautionary measures among government agencies, the 1 www.smi.se 2 www.sva.se 3 www.foi.se 4 www.socialstyrelsen.se 5 Op. cit. see note 2 6 Op. cit. see note 4 7 Op. cit. see note 3 8 Op. cit. see note 4 9 www.sakerhetspolisen.se 10 ftp://ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf

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167 Appendix E: Country and Region Overviews profession, and the management of containment facilities. An example of this is the publication Handbook of Applied Biosecurity for Life Science Laboratories11 issued by the Stockholm International Peace Research Institute (SIPRI). The European Commission has adopted an EU CBRN Action Plan12 on strengthening chemical, biological, radiological, and nuclear (CBRN) security in the European Union. The overall goal is an all- hazard approach to reduce the threat of and damage from CBRN incidents of accidental, natural, or intentional origin, including acts of terrorism. The Action Plan has set up a number of goals in three areas: prevention, detection, and preparedness and response. The implementation of the EU CBRN Action Plan is now in its second year. Sweden is a keen participant in frequent meetings with Member States experts. 11 http://books.sipri.org/product_info?c_product_id=382 12 http://register.consilium.europa.eu/pdf/en/09/st15/st15505-re01co02.en09.pdf

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