Appendix 1: Duties of BSO and Project Leaders
Duties of Biosafety Officer and Project Leaders
Biosafety Officer (BSO)
Duties: - The BSO regularly gets further training. - The BSO creates a lab safety concept for biological safety according to ESV guidelines and updates the concept periodically.
The BSO ensures: - that the laboratory managers or project leaders adhere to the principles of good microbiological practice and the safety regulations. - the safe use of equipment and methods. - the access rules for an organization in which only authorized persons are permitted access to the Level 2 area. - observance of correct room designation (access authorizations, biohazard signs for Level 2 areas, etc.) in relation to work with microbiological material. - the preparation of emergency measures (emergency plan). - that adherence to safety regulations is monitored. - that the regulations for correct disposal of microbiological waste are known. - that the guidelines for shipping and transporting biological material are known to the per-sons in charge of this. - coordination with other safety areas. - that the laboratory managers or project leaders send their reports and authorization re-quests to the Federal Office of Biotechnology Activities. The BSO provides consultative support. - that documentation from his area of responsibility is received by the authorities, i.e., via the reporting and authorization documents. This includes the type of activities and the organ-isms, number of exposed persons, names of project leaders, names of occupational physi-cians and other specialists of occupational safety (ASA), and the required protective measures and emergency plan.
Laboratory Manager and Project Leaders
Duties of the Project Leaders: - adhere to safety regulations and the principles of good microbiological practice by the laboratory staff. - correct disposal of microbiological waste. - create, update, and implement work instructions to ensure environmental and occupational safety by means of work regulations and rules of conduct. - organize and control health monitoring according to Art. 13 and Art. 14 SAMV. - submit reports and authorization requests to the Federal Office of Biotechnology Activities and the BSO. - record all activities with genetically modified or pathogenic organisms.
The Laboratory Managers or Project Leaders: - ensure that employees receive training and work-related instruction regarding safety in working with biological materials (at least once a year) and inform them – possibly in conjunction with the BSO – of the risks, required protective measures as well as of incidents and accidents (Art. 12, SAMV). - ensure that the proper protective equipment is available and make certain that, if indicated, the maintenance and cleaning of this equipment is regulated. - make sure that the cleaning of specific areas is arranged with the cleaning service, provided they have been assigned with this task. - keep a project-specific list of employees according to Art. 13 SAMV. This list provides information on the type of activities, type of organisms used, number of exposed persons, names of the persons working with Group 2 organisms, accidents and incidents that have occurred. - arrange for a health file to be drawn up by “the attending occupational physician, the company doctor or an independent medical examiner” for all employees for whom “special work-related protective health measures are required”, according to Art. 14 SAMV. - ensure that the in-house regulations for the shipping and transport of biological materials are observed.