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LiteratureCBM submissions under the Biological Weapons Convention, Germany, 2000-2010, http://www.unog.ch/80256EE600585943/ %28httpPages%29/4FA4DA37A55C7966C12575780055D9E8?OpenDocument.Center for Arms Control and Non-Proliferation (2009) Ensuring compliance with the Biological Weapons Convention. Meeting Report, Washington, DC, 25 February 2008.Franco C, Sell TK (2010) Federal agency biodefense funding FY2010-FY2011, Biosecurity and Bioterrorism 8 (2), p. 129-149. Leitenberg M, Leonard J, Spertzel R (2004) Guest commentary: Biodefense crossing the line, Federation of American Scientists, http://www.fas.org/irp/threat/cbw/biodefense.pdf.Mancini GM (2010) The EU survey and follow-up activities in Europe, presentation at the ESRC-JSPS Collaborative Seminar “Dual-Use Education for Life Scientists”, 15-16 July 2010, Bradford, http://www.brad.ac.uk/acad/sbtwc/dube/resource/ ESRC_seminar_web/ppt/Mancini_2010_14_7.pdf.

(Part of) The SolutionUrgently needed is a global understanding on where the limits of biodefence activities lie, and what rules are to be applied to dual use research. 1) Any research that involves the weaponization of biological agents, even if it is for threat assessment purposes, is prohibited. 2) Biodefence projects should be regularly assessed to ensure their compliance with the international bioweapons prohibition. 3) Research of concern should be subject to strict national and international oversight. 4) The principle of „maximum disclosure“ must be applied to biodefence and biosecurity research and dual use research of concern. In order to avoid misinterpretation, such activities need to be understandable to others, i.e. they need to be open and transparent to the largest extent possible. 5) All life scientists, and biodefence scientists in particular, should receive training to recognize the misuse potential of their work and learn how to deal with it. There would also be use in thinking about a code of conduct for biodefence and biosecurity programmes.

Risks Associated with Biosecurity ResearchThe recent proliferation of biodefence and biosecurity research has created several problems. 1) A growing number of people and places is involved in research of concern. This increases the number of access points for bioterrorists, be they insiders or outsiders. (Tucker 2004) 2) There has been a recognizable change in research focus away from basic health needs and diseases of high public health impact towards very specific pathogens of bioterrorism concern. (Sunshine Project 2005) 3) Research culture has changed; in particular the openness of the scientific enterprise has been questioned and at times been restricted. (Pearson 2007) 4) And last but not least, questions have arisen whether some of the activities in biodefence and biosecurity research may have crossed the border into territory prohibited by the international norm against biological weapons. (Leitenberg et al. 2004, Rosenberg 2003, Wright 2004)

US government civilian biodefence funding (in billion

USD) (excluding BioShield funds)

Increase in Biodefence and Biosecurity Activities GloballyBiodefence and biosecurity activities have proliferated during the last 15 years. Funding for existing military biodefence programmes has increased in many states. A number of states, formerly without military biodefence programmes - Australia, Belgium, Italy, Japan, Poland, South Africa, Spain, Switzerland and Ukraine among them - have initiated such programmes during that period. In addition, biodefence activities have left their traditional military sphere: civilian biodefence programmes have been set up in many places. In 2005, Germany started declaring civil protection research projects funded by the Ministry of Interior (CBM submission Germany 2005). The German Research for Civil Security programme, established in 2007 and funded by the Ministry of Education and Research, includes a considerable number of biodefence projects. By far the largest civilian biodefence programme is being conducted in the USA: almost 62 billion USD have been spent on it since 2001. (Franco and Sell 2010)

Defining Research of Concern - 1The famous Fink Report (National Research Council 2004) defines to be of concern experiments that:Would demonstrate how to render a vaccine ineffective. This would apply to both human and animal vaccines. Creation of a vaccine resistant smallpox virus would fall into this class of experiments.

Would confer resistance to therapeutically useful antibiotics or antiviral agents. This would apply to therapeutic agents that are used to control disease agents in humans, animals, or crops. Introduction of ciprofloxacin resistance in Bacillus anthracis would fall into this class.

Would enhance the virulence of a pathogen or render a nonpathogen virulent. This would apply to plant, animal, and human pathogens. Introduction of cereolysin toxin gene into Bacillus anthracis would fall into this class.

Would increase transmissibility of a pathogen. This would include enhancing transmission within or between species. Altering vector competence to enhance disease transmission would also fall into this class.

Would alter the host range of a pathogen. This would include making nonzoonotics into zoonotic agents. Altering the tropism of viruses would fit into this class.

Would enable the evasion of diagnostic/detection modalities. This could include microencapsulation to avoid antibody-based detection and/or the alteration of gene sequences to avoid detection by established molecular methods.

Would enable the weaponization of a biological agent or toxin. This would include the environmental stabilization of pathogens. Synthesis of smallpox virus would fall into this class.

AcknowledgmentsWe gratefully acknowledge funding for this project by the European Centre for Disease Prevention and Control and the German Ministry of Education and Research.

ContactDr. Iris Hunger. Research Group for Biological Arms ControlC. F. v. Weizsäcker Centre for Science and Peace Research. University of HamburgBeim Schlump 83. 20144 Hamburg. GermanyTel  +49 40 42838 4383. Fax  +49 40 42838 3052. E-mail iris.hunger@uni-hamburg.de www.biological-arms-control.org

The Problem:The Dual Use Potential of Biosecurity Activities

One of the areas in the life sciences, where the dual use potential – the potential to use the results of peaceful activities for hostile purposes – is particularly pronounced, is biodefence and biosecurity research. Such research frequently involves agents of bioterrorism concern such as anthrax and often aim at threat assessment such as identifying gaps in biopreparedness. This creates knowledge and materials that, if misused for hostile purposes, could have massive negative consequences. The drastic increase in biodefence activities over recent years, coupled with a lack of globally agreed rules on such activities, creates security risks that might outweigh the gains from biosecurity research.

LIMITS, RULES ANDTHE NEED FOR TRANSPARENCY

IN BIOSECURITY RESEARCH

German government military biodefence funding (in million

EUR)

Source: Franco and Sell 2010.

The Education GapLife scientists often do not know about dual use issues in their professional activities. Small wonder, given the lack of education. A recent survey of 142 degree courses in 57 universities in 29 European states showed that very little currently exists on biosecurity and dual use in life sciences and biotechnology university courses. (Mancini 2010) Preliminary results of our own survey of biology departments in German universities support this finding.

Defining Research of Concern - 2A recent assessment (Zmorzynska and Hunger 2009) of the misuse potential of life science research took not only the potential negative consequences of particular activities into account, but also the necessary capabilities in terms of equipment and expertise. This resulted in the following list of research of concern (ranked from the most risky to the least risky):1. Enhance the dissemination of a

biological agent by contamination of food

2. Enhance the dissemination of a biological agent by contamination of water supplies

3. Confer resistance to therapeutically useful antibiotics or antiviral agents

4. Increase the environmental stability of a biological agent by mechanical means, e.g. microencapsulation

5. Enhance the dissemination of a biological agent as powder or aerosol

6. Facilitate the production of biological agents

7. Render a vaccine ineffective8. Enhance the virulence of a

biological agent9. Increase the transmissibility of a

biological agent10.Enhance the infectivity of a

biological agent

11.Alter the host range of a biological agent

12.Render a non-pathogenic biological agent virulent

13.Insertion of virulence factors14.Enhance the resistance of a

biological agent to host immunological defence

15.Insertion of host genes into a biological agent to alter the immune or neural response

16.Synthetic creation of viruses17.Generate a novel pathogen18.Increase the environmental

stability of a biological agent by genetic modification

19.Enable the evasion of diagnostic or detection modalities

20.Targeting materials to specific locations in the body

Source: Mancini 2010.

Literature ctd.National Research Council (2004) Biotechnology research in an age of terrorism, Washington D.C.: National Academies Press.Pearson AM (2007) Written testimony for the Hearing “Germs, viruses, and secrets: The silent proliferation of bio-laboratories in the United States”, 4 October 2007, http://www.armscontrolcenter.org/assets/pdfs/ pearson_biolabs_written_testimony.pdf Rosenberg BH (2003) Defending against biodefence: The need for limits, BWC Special Paper No. 1, Acronym Institute, January 2003.Sunshine Project (2005) NIAID grant statistics, 1 February 2005, http://www.sunshine-project.org.Tucker JB (2004) Biological threat assessment: Is the cure worse than the disease?, Arms Control Today, October 2004.Wright S (2004) Taking biodefense too far, Bulletin of the Atomic Scientists, November/December 2004.Zmorzynska A, Hunger I (2009) Dual use life science research and its potential application in bioterrorism, final project report for the European Centre for Disease Prevention and Control, April 2009 (unpublished).

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Source: CBM submissions Germany 2000 -2010.

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