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.
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
5 Op. cit. see note 2
6 Op. cit. see note 4
7 Op. cit. see note 3
8 Op. cit. see note 4