A NEW APPROACH

Abstract

This article describes the status of biosafety, biosecurity, and biorisk management worldwide and, considering the difficulties of enforcing and monitoring compliance with the Biological Weapons Convention (BWC), analyzes how institutions’ effective biorisk management can help in responding to concerns regarding the prevention of the development of bioweapons that would otherwise be difficult to address. The biorisk management approach aims to ensure responsible, safe, and secure handling of biological materials. Developed with the support of the life sciences community, it contributes to the objectives of international organizations to respond to natural or deliberate biological threats to public health and the environment. Achieving effective biorisk management across all institutions still requires increased awareness at the highest level, as well as allocation of appropriate resources and efforts in both biosafety and biosecurity training and development and transfer of expertise. However, establishing and valuing a culture of ethical and safe behavior and implementing effective biorisk management appear likely to prevent misuse of biological materials and significantly improve control of potential dual-use issues in the life sciences community. For these reasons, the BWC should not only encourage state parties to take a more active part in ensuring the development of biosafety, biosecurity, and biorisk management, but also promote relevant non-state actor programs.

Keywords:

• Biological Weapons Convention
• biorisk management
• life sciences

Notes

1. World Health Organization (WHO), “Laboratory Biosafety Manual,” 3rd. ed., WHO/CDS/CSR/LYO/2004.11, 2004, < www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf>; WHO, “Biorisk Management: Laboratory Biosecurity Guidance,” WHO/CDS/EPR/2006.6, September 2006, <www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf >.

2. On good manufacturing practices in Europe, see for instance, “EudraLex Volume 4: Good Manufacturing Practice (GMP) Guidelines,” in “The Rules Governing Medicinal Products in the EU,” <ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm>; for practices in the United States, see Code of Federal Regulations, Title 21, sections 210, 211, revised April 1, 2001, <www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210&showFR=1>.

3. European Committee for Standardization (CEN), “Laboratory Biorisk Management Standard,” CEN Workshop Agreement (CWA) 15793, February 2008, <ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf>. The CEN standard is an international reference document analogous to and compatible with related management systems, such as OHSAS 18001 for occupational health and safety, and ISO 14001 for environmental management.

4. WHO, “International Health Regulations (Second Edition, 2005),” 2008, <whqlibdoc.who.int/publications/2008/9789241580410_eng.pdf>.

5. Nicoletta Previsani, “Biosafety and Biosecurity in Laboratories,” lecture delivered to the Second Global Conference of OIE Reference Laboratories and Collaborating Centres, Paris, France, June 21–23, 2010, <www.oie.int/doc/ged/D7760.PDF>.

6. The Cartagena Protocol on Diversity to the Convention on Biological Diversity, September 11, 2003, <bch.cbd.int/protocol/>.

7. UN Office at Geneva, BWC National Implementation Database, <www.unog.ch/80256EE600585943/%28httpPages%29/4ADF8E868AAE82B3C1257578005563E1?OpenDocument>; Verification Research, Training and Information Centre (VERTIC), BWC Legislation Database, <www.vertic.org/pages/homepage/databases/bwc-legislation-database/introduction.php>.

8. National Select Agents Registry, “HHS and USDA Select Agents and Toxins,” US Department of Agriculture, <www.selectagents.gov/>.

9. Philippe Stroot, “Overview of Dual-Use Control at International and Institutional Levels,” lecture delivered at the Third International Symposium on Biosecurity and Biosafety: Future Trends and Solutions, Milan, Italy, October 13–15, 2010, <www.bioemergency.eu/pdf/01Stroot.pdf>.

10. UK House of Commons, “Innovation, Universities, Sciences and Skills—6^th Report, Pre-Appointment Hearing with the Chair-Elect of the Biotechnology and Biological Sciences Research Council, Professor Sir Tom Blundell,” 2008; Institut Scientifique de Sante Publique-Wetenschappelijk Instituut Volksgesondheid, “Rapport: Les Installations de Haut Niveau de Confinement en Belgique: Période 1995–2008” [Report: High-Containment Facilities in Belgium: From 1995–2008], 2009, <www.biosafety.be/CU/PDF/Rapport_ISP_FR_D_2009_2505_40.pdf>.

11. Nicoletta Previsani, “The WHO Global Biosafety and Laboratory Biosecurity Programme,” lecture delivered to the Latin America Laboratory Biosafety and Biosecurity Conference, Rio de Janeiro, Brazil, May 13–15, 2008, <www.biosafetyandbiosecurity.org/pdfs/2/Previsani.pdf>; International Federation of Biosafety Associations (IFBA), “The IFBA Declaration on Advancing Global Biosafety and Biosecurity,” IFBA International Conference, Bangkok, Thailand, February 17, 2011, <www.internationalbiosafety.org/English/pdf/2011/IFBA-Bangkok-Declaration.pdf>.

12. See for example WHO, “Global Biosafety and Laboratory Biosecurity Programme,” <www.who.int/ihr/biosafety/collaborating-centres/en/index.html>; and IFBA, <www.internationalbiosafety.org/english/index.asp>.

13. Jonathan E. Suk, Anna Zmorzynska, Iris Hunger, Walter Biederbick, Julia Sasse, Heinrich Maidhof, and Jan C. Semenza, “Dual-Use Research and Technological Diffusion: Reconsidering the Bioterrorism Threat Spectrum,” PLOS Pathogens 7 (2011), <edoc.rki.de/oa/articles/reEB2cQKhvoh/PDF/293v2z90FHRRQ.pdf>.

14. Emmanuelle Brun, “Expert Forecast on Emerging Biological Risks Related to Occupational Safety and Health,” European Agency for Safety and Health at Work, European Risk Observatory Report EN 3, 2007, <osha.europa.eu/en/publications/reports/7606488>.

15. WHO, “Responsible Life Sciences Research for Global Health Security: A Guidance Document,” WHO/HSE/GAR/BDP/2010.2, 2010, <whqlibdoc.who.int/hq/2010/WHO_HSE_GAR_BDP_2010.2_eng.pdf>.

16. CEN, “Biosafety Professional Competence (BSP),” CEN Workshop 53, Frankfurt, Germany, December 17, 2009, <www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/Workshops/Pages/WS53-BSP.aspx>.

17. CEN, “Biosafety Professional Competence,” CWA 16335, September 1, 2011, <www.cen.eu/CEN/sectors/technicalcommitteesworkshops/workshops/Pages/ws53-bsp.aspx>.

18. CEN, “Laboratory Biorisk Management Standard.”

19. Goedele De Bruyne and Philippe Stroot, “Management Systems, CWA 15793 and Implementation of Biorisk Management,” Pre-Conference Workshops of the European Biosafety Association, Ljubljana, Slovenia, June 21, 2010.

20. CEN Workshop Agreements are peer-established consensus-based specifications drawn up in an open workshop according to specific procedures; their application is voluntary and not limited to CEN member states. ISO Standards are standards developed by the International Organization for Standardization though specific and more demanding processes involving multiple stakeholders; their application is in principle also voluntary, but they have a wider recognition.

21. IFBA, “Biosafety and Biosecurity: Building Sustainable Capacity,” Second Annual Biosafety Conference, to be held in Johannesburg, South Africa, June 28–29, 2012, <www.internationalbiosafety.org/english/index.asp>.