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This production is a supplement to Focus 15, July 2013. NEWSLETTER OF FEMS

FEDERATION OF EUROPEAN MICROBIOLOGICAL SOCIETIES

Biosecurity in the microbiological sciences – a Code of Conduct that affects us all Dr. Christine Rohde Leibniz Institute DSMZ – German Collection of Microorganisms and Cell Cultures “A Hippocratic Oath for Life Scientists” was a fundamental biosecurity publication under the EMBO (European Molecular Biology Organization) Science & Society programme (J. Revill & M. Dando, 2006: EMBO reports 7). It reflects what a code of conduct on biosecurity should expect from the life sciences. When the OECD BRC Initiative was created, it soon aimed at developing a code of conduct specifically dedicated to biosecurity. At that time, shortly after the turn of the millennium, several codes of conduct or ethical codes were developed (e.g., IUMS Code of Ethics, http://www.iums.org/index.php/codeof-ethics). In 2007, the OECD Best Practice Guidelines on Biosecurity for BRCs were released (OECD 2007, rights@oecd.org) covering all possible issues relevant for culture collections in the biosecurity context. The guidelines include biorisk assessment and risk management practices considering the special and global role of culture collections and their responsibilities in the complex ever-changing legislative world. BRC, Biological Resource Centre, means the modern-day culture collection adding value to the holdings and implementing best practices, for improved standards in global R & D in the life sciences. In 2010, key principles for the Code of Conduct introduced here were compiled by experts of the demonstration projects EMbaRC (www.embarc.eu) and GBRCN (www.gbrcn.org). Two milestones followed: the Code was agreed upon by the partners of both projects, and was presented few months later at the 7th Review Conference to the Biological and Toxin Weapons Convention - BTWC (UN, Geneva, December 2011): The UN States Delegates welcomed this Code as a “long-lasting model Code of global relevance” pointing

out that bottom-up and top-down processes are prerequisites for a “living” Code of Conduct on biosecurity with the desired outreach into the microbiological sciences. The BTWC is not comparable to the CWC, Chemical Weapons Convention that bears much stronger verification mechanisms. Regulations in the life sciences have never been part of non-proliferation policies, but of biosafety considerations (health, containment, quarantine etc.). Codes of Conduct seem the only realistic way to raise awareness, to self-regulate activities where necessary, and to address the “dual-use dilemma” in microbiology and hence, to strengthen the BTWC. Since 2001, several Codes were developed in the bio-sciences, but without explicit biosecurity focus. It is a remarkable coincidence that this Code presented here i), co-developed with the EU CBRN Action Plan for protecting Europe against highly hazardous substances (CBRN = Chemical, Biological and RadioNuclear) and ii), has been introduced at the beginning of a new BTWC intersessional process. The Code itself is open-structured. It does not restrict research, is not restricted to application by culture collections/BRCs, and follows the UN and OECD recommendations. Also, it adheres to the WHO Laboratory biosecurity guidance (WHO/CDS/ EPR/2006.6). This Code can be broadly used by any laboratory and facility in the microbiological sciences. The Code shall be a tool to help protect all microbiologists and their research activities, their facilities and stakeholders. Finally, it is to protect the countries where they are located from malicious misuse of bio-resources and their data and associated critical know-

how, with export control being the sensitive part of biosecurity (global exchange of microbial resources!). The Code will not restrict scientific work and does not add more legislation. It is best practice, no more and no less. MIRRI, the Microbial Resource Research Infrastructure (www. mirri.org) will further focus on biosecurity implementation and develop harmonized biorisk assessment tools for open access to the microbiological user community. The Code of Conduct on Biosecurity for Biological Resource Centres (BRCs) addresses the following key issues and is embedded in a procedural implementation guidance document (IJSEM Papers in Press. Published May 10, 2013 as doi:10.1099/ ijs.0.051961 http://ijs.sgmjournals.org/content/early/ 2013/05/09/ijs.0.051961-0.full.pdf+html): • Biorisk Management • Raising Awareness • Reporting Misuse • Internal and External Communication • Research and Sharing Knowledge • Accessibility • Supply, Shipment and Transport The FEMS Focus is published by: FEMS Central Office Keverling Buismanweg 4 2628 CL Delft The Netherlands Tel: +31-15-269 3920 Fax: +31-15-269 3921 E-mail: fems@fems-microbiology.org FEMS is a registered charity (no. 1072117) and also a company limited by guarantee (no. 3565643). © 2013 Federation of European Microbiological Societies Design: Zak Princic Production: Ilumina.si


Focus 15 (supplement) July 2013