Press release ¤ Information de presse

May 11, 2009

Biosafety Regulations - how can we find a proper level?

Panel Disussion, Forum, Ebene 0, Discussion Corner
Tuesday, 12 May 2009, 11:00 a.m. 
                                                        More information and facts on the discussion topic              

Current developments and the search for the right balance in legislation of biosafety regulations are discussed by:

  • Prof. Dr. Bernd Appel,
    Head of the Department Biological Safety at the Federal Institute for Risk Assessment, Berlin/Germany

  • Prof. Dr. Helmut Bachmayer,
    Member of the Commission for Gene Technology of the Austrian Ministry of Health, Vienna/Austria

  • Dr. Hubert S. Bernauer,
    CEO of ATG:biosynthetics GmbH, Merzhausen/Germany

  • Prof. Dr. Dr. Peter Kämpfer,
    Professor for Recycling Microbiology at the University Gießen/Germany

  • Heather Sheeley,
    Head of Safety at Health Protection Agency, Salisbury/UK

  • Albrecht Werner,
    Directorate Health and Consumer Protection at European Commission, Brussels/Belgium

  • Dr. Helmut Klein (moderation),
    Federal Ministry of Labour and Social Affairs (BMAS), Bonn/Germany

Biological Safety is a very complex topic. It ranges from occupational safety, disease protection and microbiological quality control to the handling of gene-tically modified organisms and synthetically generated nucleic acids to the defence of bioterrorism.

Whereas in Germany broad statutory provisions regulate biological safety, this is not the case in many European countries yet. But there are efforts to esta-blish a Europe-wide system of rules, which would refer to the German regula-tions in many ways. The European Committee for Standardization (CEN) has startet an initiative for the standardisation of the handling of biorisks on behalf of the European and American Biosafety Association and compiled a draft of a CEN Workshop Agreement (CWA) which shall be the base for a standardisa-tion procedure. Main aim of the CWA is to anchor an external certification system for a uniform „laboratory biorisk management standard“, which is compulsory for all facilities that work with biological agents.

The draft of this system of rules is in a test phase at present. Until the rules become obligatory comments and modification proposals are possible. There-fore inconsistencies, redundancies and synergies compared to the German statutory provisions have to be identified to get the best possible harmonisati-on – otherwise a contradictory over-regulation could be the consequence in Germany.

About the participants:
Prof. Dr. Bernd Appel studied microbiology and biochemistry at Freie Universität Berlin. After dissertation and postdoctoral lecture qualification he had a professorship for molecular bio-technology at the University of Applied Science in Berlin. Afterwards he was head of the de-partment genetics and genetic engineering at German Health Authority, Berlin. From 1998 to 2005 Appel worked at the Robert Koch Institute in Berlin, where in 2002 he became assistant manager of the Centre for Biological Safety. Since 2005 Appel is head of the department biological safety at the Federal Institute for Risk Assessment, Berlin/Germany.

Prof. Dr. Helmut Bachmayer is pensioner. Previously he was at the Novartis Institute for Bio-medical research and is at present member of the Commission for Gene Technology of the Austrian Ministry of Health in Vienna/Austria.

Albrecht Werner works at the directorate health and consumer protection at the European Commission. He is also member of the taskforce on bioterrorism.

Prof. Dr. Dr. Peter Kämpfer has a professorship for recycling microbiology at the Justus-Liebig-University Gießen. Furthermore he is chairman of the commission for biological working mate-rials (ABAS) in the German Federal Institute for Occupational Safety and Health (BAuA).

Dr. Hubert S. Bernauer is CEO of ATG:biosynthetics GmbH in Merzhausen/Germany. In addition he is second assistant chairman and treasurer of the Arbeitsgemeinschaft Gen-Diagnostik e. V. (AGD, working group gene diagnostics).

Heather Sheeley is head of safety at the Health Protection Agency in Salisbury/UK and in this position responsible for construction and operation of high security laboratories (biosafety levels 3 and 4). Besides she advises other organisations on the construction of high security laboratories and is president of the European Biosafety Association (EBA).

The moderator Dr. Helmut Klein is chemist and since 1980 at the German Federal Ministry of Labour and Social Affairs (BMAS), where he became head of division in 1991. He is respon-sible for the fields fire and explosion protection, plant safety, noise and vibrations, chemical safety, dangerous substances, biological working materials and biological and genetic engi-neering.

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