Infection control and biological substances
In addition to the Genetic Engineering Act (Gentechnikgesetz; GenTG), the stipulations of the Infection Protection Act (Infektionsschutzgesetz; IfSG) and the Biological Agents Ordinance (Biostoffverordnung; BiostoffV) must also be adhered to when conducting biological-medical experiments.
If you carry out experiments with reproductive pathogens, conduct microbiological tests to identify notifiable pathogens or breed pathogens, you must have the appropriate handling permission according to §§ 44 and 49 IfSG. Form § 49 IfSG (German) together with the necessary documents must be submitted to the supervisory authority Regierungspräsidium Tübingen. A permission is required for anyone who wishes to bring pathogens into the territory where the IfSG applies, export them, store them, deliver them or work with them. Permission is only granted if the applicant has the necessary expertise and has proven to be reliable with regards to the activity applied for and suitable premises or facilities are available.
The required expertise is usually demonstrated by a degree in human medicine, dentistry, veterinary medicine or pharmacy or by a degree in natural sciences at a university of applied sciences or university with microbiological content and a minimum of two years' full-time work with pathogens under the supervision of a person in possession of a permit to work with pathogens. The responsible authority shall also recognise as evidence of competence another main occupation of at least two years in the field of bacteriology, mycology, parasitology or virology where the applicant has acquired an equivalent level of competence in that occupation.
Anyone wishing to take up activities for the first time as defined in § 44 IfSG must notify the responsible authority at least 30 days before taking up such activities. The notification must contain the following: a certified copy of the permit, unless the permit was issued by the authority in accordance with sentence 1, or details of the exemption from requiring a permit (Erlaubnisfreiheit) as defined in § 45, details of the type and scope of the intended activities as well as details of disposal measures and the nature of the rooms and facilities. Where the information has already been provided in another procedure governed by federal law, reference may be made to the documents submitted there. Any person carrying out an activity referred to in § 44 shall immediately notify the responsible authority of any significant change in the nature of the rooms and facilities, the disposal measures and the nature and scope of the activity. The termination or resumption of the activity shall also be notified.
Responsible supervisory authority is the Referat für Ärztliche und Pharmazeutische Angelegenheiten (Department of Medical and Pharmaceutical Affairs) at the Regierungspräsidium Tübingen. In contrast to the Gentechnikgesetz, the permit holder is directly responsible to the authority.
The Biological Agents Ordinance (BiostoffV) is a European regulation in contrast to the Gentechnikgesetz and the Infektionsschutzgesetz, which are part of the German legislation. This ordinance for the implementation of EC directives on safety and health protection at workplaces involving biological agents puts the Act on Health and Safety at Work (Arbeitsschutzgesetz; ArbSchG) in concrete terms and regulates occupational activities involving biological agents, i.e. microorganisms/pathogens in the broadest sense. It contains regulations for the protection of employees involved in these activities. The Biological Agents Ordinance divides biological agents into four risk groups. These essentially correspond to those of the Gentechnikgesetz and are classified according to the risk of infection. The protection levels range from access restrictions to structural separation. The Biological Agents Ordinance requires a risk assessment for the handling of biological agents. In addition to the classification into protection levels, it also differentiates between targeted (e.g. conducting an experiment with a defined, known microorganism) and non-targeted handling (e.g. handling microorganisms of previously unknown genesis in diagnostics, handling blood samples) of biological agents. If the biological agents also fall under the provisions of the Gentechnikgesetz and/or the Infektionsschutzgesetz, the requirements of the Biological Agents Ordinance are generally already met.
The Regierungspräsidium Tübingen has a guideline with regard to the concrete implementation of the Infektionsschutzgesetz and the Biological Agents Ordinance.
The Biological Safety Officer (BBS) and the staff of the Occupational Safety and Environmental Protection department are happy to assist you with questions relating to the Infektionsschutzgesetz and the Biological Agents Ordinance.