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C Examples of Projects and Initiatives Ronald Atlas University of Louisville, United States Ronald Atlas is co-director of the Center for Health Hazards Pre- paredness at the University of Louisville in Kentucky. The Center pro- vides training in responding to disasters, including infection control in the event of bioterrorism and medical and public health responses to pan- demics. He is former President of the American Society for Microbiology (ASM) and currently is co-chair of the ASM Biodefense Committee. He also chairs the Wellcome Trust Pathogens, Immunology and Population Health Strategy Committee. He is chairing a National Academy of Sci- ences-AAAS survey project aimed at assessing awareness of and reactions to the dual use dilemma among AAAS members in the life sciences. Martin Iain Bahl, Erik Heegaard, Nina Steenhard National Centre for Biological Defence, Denmark Summary of Activities at the National Centre for Biological Defence, Denmark The National Centre for Biological Defence (NCBD) coordinates all activities regarding surveillance of biological weapons (BW) and bioter- NOTE: This appendix contains material provided by participants in the 2nd International Forum and has been edited only to provide a common format and editorial style. 97
98 APPENDIX C rorism at Statens Serum Institut. The center constitutes the point of con- tact for both national and international BW alarms, requests and sample analysis. NCBD houses the national preparedness operation unit, per- forms and develops assays for sample analysis, and is engaged in several biodefense research projects as well as intelligence work. Furthermore, the center is developing a biosecurity program. NCBD participates actively in the Australia Group (AG) and has lately been especially involved in discussions related to the misuse potential of synthetic biology i.e., the de novo synthesis of genes or even organisms from chemically synthesised oligonucleotides. Tasks of the NCBD, Denmark: â¢ Operations (preparedness) (including analysis of samples) â¢ Development and testing of assays â¢ Biodefence research (European Union projects and national projects) â¢ Development of a Biosecurity programme for Denmark â¢ International BW work (i.e., EU, AG, Biological and Toxin Weapons Convention (BWC), UN Security Council Resolution (UNSCR) 1540) Biosecurity Biosecurity legislation in Denmark is expected to be passed by March 2008 and the centre therefore has many activities within the area of bios- ecurity research and development (R&D). Our activities within this area have focused on developing objective risk models for assessing the BW potential of various pathogens. We are currently working on an objective risk assessment model for sensitive equipment, technologies and know-how. Furthermore, we are outlining an implementation plan for biosecurity, including awareness activities and codes of conduct. Alexandre Bartsev OECD, France OECD Best Practice Guidelines on Biosecurity Innovations derived from research on pathogenic microorganisms promise astounding benefits in health, agriculture and other domains of economic activity. The tremendous advances in biology, biotechnol- ogy, genomics, proteomics, synthetic biology and bioinformatics in recent years are almost certain to lead to improved health and well-being. Some such biological resources employed in (R&D) for diagnostics, vaccines
APPENDIX C 99 and therapeutics, however, possess capacity for dual use; they may be misused to develop biological weapons. Research facilities entrusted with possession of such dual use materials have a responsibility to comply with biosecurity measures that are designed to prevent loss or theft and thereby reduce the probability of a bioterrorist attack. The OECD has provided a forum for its member countries to engage in a dialogue of international cooperation with a view to produce best practice that helps put in place biosecurity measures for Biological Resource Centres (BRCs), which are repositories and providers of high quality biological materials required for R&D and production in various areas of biotechnology. Some BRCs might handle and exchange hazardous biological materi- als that have a potential for so-called dual use. Society confers trust in BRCs as custodians of such materials, demanding that responsibility be taken for their safe keeping. In this context, culture collections have long recognized the duties of implementing proper containment procedures for hazardous biological material to safeguard workers against acciden- tal exposure and acting in accordance with legislation on export controls and transport safety measures. More recently, the menace of bioterrorism has added a new dimension to the responsibilities inherent in operating culture collections, namely ensuring security of biological materials with âdual useâ potential. One of the principal challenges in addressing the issues of biosecurity is to find a balance between biosecurity measures that might be applied to BRCs or other research facilities and the access to hazardous biological materials that forms the base for delivering biotechnology innovations. To qualify the intricacies of such balance, in 2007 the OECD delivered the Best Practice Guidelines on Biosecurity for BRCs, which are intended to ensure security of all types of biological materials held by BRCs (e.g., microorganism- and human-derived) in proportion to the risk they pres- ent, and thereby marginalize any obstacle that BRCs might face in carry- ing out their usual operations. Jane Calvert University of Edinburgh, United Kingdom Systems Biology Jane Calvert has been working for the last two years on the social dimensions of the new field of systems biology. She has been interviewing systems biologists, and has spent time at three systems biology laborato- ries. Dr. Calvert is planning to continue this work at the systems biology
100 APPENDIX C centers in Edinburgh and the Imperial College London. Both of these centers also have interests in synthetic biology. Her main areas of interest in systems biology are: â¢ the epistemic aspirations of the field â¢ interdisciplinarity and disciplinary identity Publication: OâMalley, M.A., J. Calvert, and J. Dupre. 2007. The socioethi- cal study of systems biology. American Journal of Bioethics 7(4):67-78. Synthetic Biology Calvertâs interests in synthetic biology have grown out of her inter- ests in systems biology. She is a member of the UKâs Royal Academy of Engineering working party on synthetic biology, and she is also part of two synthetic biology research networks, which bring together natural and social scientists across the United Kingdom. Calvertâs areas of interest in synthetic biology are: â¢ the relationship between systems biology and synthetic biology â¢ the relationship between biology and engineering in synthetic biology â¢ the treatment of complexity and its necessity for living systems â¢ modularity and open source in synthetic biology â¢ understandings of ânatureâ in synthetic biology â¢ the role of social scientists in synthetic biology Publication: OâMalley, M., A. Powell, J. Davies, and J. Calvert. 2008. Knowl- edge-making distinctions in synthetic biology. BioEssays 30(1):57-65. Intellectual Property in the Emerging Life Sciences Calvert has been working for several years on intellectual property (IP) issues in genomics and genetics and she is interested in pursuing those issues further relation to both systems biology and synthetic biol- ogy. She is interested in attempts to patent emergent biological systems and in the applicability of open source principles to the biosciences. Publication: Calvert, J. 2007. Patenting genomic objects: genes, genomes, function and information. Science as Culture 16:207-223.
APPENDIX C 101 Translational Research Dr. Calvert is also interested in the category of âtranslational researchâ and asking exactly what this means in policy and scientific terms. David Carr The Wellcome Trust, United Kingdom The Wellcome Trust is the largest charity in the United Kingdom. It funds innovative biomedical research, in the United Kingdom and internationally, spending around Â£650 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and well-being. Â Over recent years, the Wellcome Trust has contributed actively to pol- icy discussions at the UK and international level on addressing risks that life sciences research could be misused forÂ terrorist purposes. We pub- lished a position statement on âBioterrorism and Biomedical Researchâ in November 2003, which sets out our position on these issues. In September 2005, the Biotechnology and Biological Sciences Research Council, the Medical Research Council and the Wellcome Trust published a joint policy statement on managing risks of misuse associated with grant funding activities. This statement identified a series of agreed actions that the three organizations have implemented to raise awareness and to help ensure that any risks of misuse associated with research proposals are considered at the grant application stage. We have introduced a standard question on application forms, and ask both our expert referees and our funding committees to consider any risks of misuse associated with the proposals they review. Further information on our policy work in this area can be found at: www.wellcome.ac.uk/About-us/Policy/index.htm. George Chakhava Tbilisi State Medical University, Republic of Georgia My group focuses on biosecurity issues and national policy as it relates to health and biological sciences. These two areas have melded together in a number of ways since 2006, after avian flu attacks. First, there was a dramatic increase in research on bioterrorism threat agents including anthrax, tularemia, and others. One of the main topics of our interests are also neuroinfections caused by Herpes and Bunya viruses, slow viruses and other interested agents. With this increase came the frightening fact that we have also dramatically increased the number of scientists who have access to and the knowledge of how to handle these agents. Second,
102 APPENDIX C what we have not seen is a serious commitment to increasing our nationâs public health infrastructure to handle emergencies, including the threat of a pandemic outbreak of influenza. This is absolutely essential, not just for the nationâs national security as it pertains to bioterrorism, but for all public health emergencies. We seek contacts with other universities, societies and institutions to collaborate on joint projects in this field: building a âculture of responsibil- ityâ (education and awareness raising, codes of conduct, etc.). Dongli Chen China Arms Control and Disarmament Association, China The Biosecurity Program in the China Arms Control and Disarma- ment Association has joint projects with Beijing STS Advisory Center. Current projects include: â¢ Policy study on strengthening the Biological Weapons Convention; â¢ Research and dissemination of international and national policies on biological non-proliferation and export control; â¢ Impact of bioterrorism on bio-arms control and biosecurity; â¢ Training and education on biosecurity and dual use issues of bio- technology. The project aims to improve awareness of officials, scien- tists, students and other people from government; medical institutions; research institutions; universities; and industry. This is the emphasis of our current activities. Peter Clevestig Stockholm International Peace Research Institute (SIPRI), Sweden Dr. Peter Clevestig (Sweden) is a researcher in the Chemical and Biological Warfare Programme of the SIPRI Nonproliferation and Export Controls Project. He is studying the role and responsibility of the Swed- ish biomedical research community in preventing acts of mass-impact terrorism (funded by the Swedish Emergency Management Agency). The main objective of his project is to raise awareness of biosecurity issues in life science research at academic institutions. He is also developing documentation on biosecurity for use by researchers, heads of laboratories and laboratory management. An additional goal is to review how dual use research of concern is reviewed and assessed from initial conception through to final publication. Dr. Clevestig also has interests in the devel- oping field of microbial forensics in investigating bio-related terrorism
APPENDIX C 103 and crimes, as well as how emerging fields within life science research are considered from the perspective of dual use and biosecurity. A virolo- gist, Dr. Clevestig holds a doctorate in Infection Biology through his work on HIV-1 in vertical transmission from the Department of Microbiology, Tumor, and Cell Biology at the Karolinska Institute. He also holds a B.Sc. in biomedical laboratory science and B.M.Sc. in biomedical laboratory science. Before joining SIPRI, Dr. Clevestig was administrator of the Karo- linska Institute Biosafety Committee and has been an active member of the Nordic Biosafety Network. Ottorino Cosiviï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ and Emmanuelle Tuerlings Biorisk Reduction for Dangerous Pathogens Team, Department of Epidemic and Pandemic Alert and Response, ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ World Health Organization (WHO) Life Science Research and Development for Global Health Security The overall goal of the project is to raise awareness and provide infor- mation and guidance to WHO Member States on the possible options for risk management to address dual use life science R&D. It underlines the importance of carrying out life science R&D for improving public health and, at the same time, highlights the necessity of understanding that access to, and research on, any type of dangerous agent or new agents may pose risks to public health and raise ethical and security concerns. It therefore aims at involving the public health community on this issue because poorly designed risk management measures will have implica- tions for public health. Tï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ he issue is a cross-cutting oneâit involves those working with dan- gerous pathogens but also those working on health research policy, col- laboration and support, global health security and ethics. Hence our partnership with WHO departments and external experts that reflect such expertise. The project started in July 2004 with a grant from the Alfred P. Sloan Foundation. The following phase (2005-2006) of the project was finan- ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ cially supported by the Sloan Foundation and the Ford Foundation. A third phase started (2007-2009) with the support of the Sloan Foundation. Others have expressed interest in financially supporting the project. Main Achievements â¢ Establishment of an international network of experts on this subject and in-house collaboration with other WHO programs.
104 APPENDIX C â¢ Publication of working paper identifying the issues from a public health perspective (2005). â¢ Meeting of a Scientific Working Group to provide guidance on the project activities and publication of the meeting report (October 2006). â¢ WHO co-sponsorship with the U.S. Government of the interna- tional meeting hosted by the U.S. National Science Advisory Board for Biosecurity (NSABB) "International Roundtable on Dual Use Life Sciences Research," Bethesda, MD, February 24-27, 2007. â¢ Organization and coordination of an online consultation (question- naire posted on WHO Web site) to receive feedback on the project activi- ties (June-September 2007). â¢ Organization of a regional workshop on "Research Policy and Management of Risks in Life Science Research for Global Health Secu- rity,â Bangkok, Thailand, December 10-12, 2007 (in collaboration with our WHO Regional Offices for South-East Asia and for the Western Pacific and support from WHO departments on Ethics, Equity, Trade and Human Rights and Research Policy Cooperation). â¢ Outreach activities to raise awareness about the project included publications and contributions to more than 30 international meetings and workshops. Technical support was also provided through the col- â WHO (World Health Organization). 2005. Life Science Research: Opportunities and Risks for Public Health. Geneva: World Health Organization. WHO/CDS/CSR/LYO/2005.20. Available at: http//www.who.int/csr/resources/publications/deliberate/WHO_CDS_CSR_LYO_ 2005_20/en/index.html. â WHO (World Health Organization). 2007. Scientific Working Group on Life Science Research and Global Health Security: Report of the First Meeting. Geneva: WHO. WHO/CDS/EPR/2007.4. Available at: http://www.who.int/csr/resources/publications/deliberate/WHO_CDS_EPR_2007_4. â Online consultation: Scientific working group report feedback form. Available at: http:// www.who.int/csr/bioriskreduction/lifescience_project/en/index.html. Accessed on December 11, 2008. â The report of the meeting is being drafted. 5Reis, A. and E. Tuerlings. 2007. Bioethics and Health Security: The use and misuse of results of life science research. Abstract submitted for the 5th World Conference on Bio- ethics, GijÃ³n, May 21-25; Tuerlings, E. 2007. ReflectionsâGoverning dual use life science research: Opportunities and risks for public health. In A Web of Prevention: The Life Sciences, Biological Weapons and the Future Governance of Research, B. Rappert and C. McLeish, eds. London: Earthscan; Tuerlings, E., and C. McLeish. 2004. Is risk assessment a useful method to govern dual use research? Discussion Paper. 21st Pugwash CBW Workshop: The BWC New Process and the Sixth Review Conference, Geneva, Switzerland, December 4-5; WHO (World Health Organization). 2005. Life Science Research: Opportunities and Risks for Public Health. WHO/CDS/CSR/LYO/2005.20. Geneva: WHO. Available at: http//www.who. int/csr/resources/publications/deliberate/WHO_CDS_CSR_LYO_2005_20/en/index.html; WHO (World Health Organization). 2007. Scientific Working Group on Life Science Research and Global Health Security: Report of the First Meeting. Geneva: WHO. Available at: http://www. who.int/csr/resources/publications/deliberate/WHO_CDS_EPR_2007_4.
APPENDIX C 105 laboration with WHO biosafety and laboratory biosecurity workshops in Iran (October 2006) and Kenya (May 2007). Forthcoming Activities (2008-2009) In collaboration with the scientific working group and other WHO departments, the project is now developing a draft guidance document that will complement the two previous project publications. The docu- ment will provide guidance on the process to assess national needs and capacities (i.e., how to evaluate needs and capacities to address such risks) and will provide a framework of possible options to manage the risks from a public health perspective (i.e., options will include biosafety and laboratory biosecurity, research policy, and ethical frameworks). The project will also develop technical materials to provide training. This will be done in collaboration with external partners. To develop the draft guidance and the training, the project is expected to hold two meetings. One meeting will be to review existing risk man- agement practices on the risks posed by life science research and inform the guidance document development. The other meeting, the second meeting of the scientific working group, will be to review the progress of the project, including the final draft guidance and other materials. Additional outreach activities will be done through non-WHO publi- cations and through contributions to international meetings. For instance, the project will continue its collaboration with the WHO project on Bio- safety and Laboratory Biosecurity and will contribute to their regional workshops. Similarly, it will contribute to relevant meetings organized by national academies of sciences and other external partners. Robin Coupland International Committee of the Red Cross (ICRC) The âWeb of PreventionââA Call for Synergy of Action to Prevent Poisoning and Deliberate Spread of Infectious Disease The International Committee of the Red Cross launched a Public Appeal in September 2002 on âBiotechnology, Weapons and Humanity.â The Appeal carried three messages: first, it drew attention to potential risks brought by advances in life sciences and biotechnology; second, it underscored the legal rulesâboth national and internationalâwhich might apply to poisoning and deliberate spread of infectious disease; and third, it identified responsibilities of both governments and the scientific community to ensure that such advances are used only for the benefit of humanity.
106 APPENDIX C The possible measures to reduce the risk of poisoning and deliber- ate spread of disease lie in multiple domains, e.g., disease surveillance, criminal law, public health preparedness, international law, codes of con- duct, education, etc. Each such measure is necessary but not, in itself, sufficient to reduce this risk. This means that all preventive measures work to enhance each other that is, there is a synergy of action or âWeb of Prevention.â This is a base concept of the ICRCâs initiative. The Web of Prevention makes obvious the links between different agencies working on issues related to biological weapons or chemical weapons, for example, police, scientists, nongovernmental organizations and diplomats. It also discourages compartmentalized thinking and action by different disci- plines. Codes of conduct and education within the scientific community only make sense if seen as part of the Web of Prevention. John Crowley United Nations Educational, Scientific and Cultural Organization (UNESCO) John Crowley is Chief of Section responsible for science and technol- ogy in the Division of Ethics of Science and Technology of UNESCOâs Sector for Social and Human Sciences (SHS). He is also editor of the InterÂ national Social Science Journal. He was previously (2005-2007) responsible for SHS information, communication and publications. Before joining UNESCO in 2003, Dr. Crowley worked as an economist in the oil industry (1988-1995) and as an academic political scientist at the French National Political Science Foundation (1995-2002). His research interests cover a number of areas in political theory and comparative politics including, in the areas relevant to his UNESCO responsibilities, environmental ethics and political technologies of securitization. The section of which Dr. Crowley is head is responsible for three components of UNESCOâs programme in the ethics of science and technology: â¢ Science ethics, including in particular international and interdisci- plinary cooperation on the development of codes of conduct for scientific activity, building on the 1974 UNESCO Recommendation on the Status of Scientific Researchers and on the outcomes of the 1999 World Science Conference; â¢ Environmental ethics, with particular current emphasis on climate change; â¢ Ethical challenges relating to emerging technologies, including in particular nanotechnologies, new information technologies and issues of biocontrol.
APPENDIX C 107 The section also provides the Secretariat for the World Commission for the Ethics of Scientific Knowledge and Technology (COMEST), a body of independent experts established by UNESCO to advise the Director General on issues requiring ethical consideration and, where appropriate, the development of new mechanisms or instruments. In 2008-2009, the work of COMEST, which will next meet in extraordinary session in Paris in November 2008, will focus on science ethics and on climate change. Malcolm Dando Bradford University, United Kingdom In cooperation with Alex Kelle and Kathryn Nixdorff, Malcolm Dando is developing the work they did on âControlling Biochemical Weapons,â looking specifically at the potential misuse of neuroscience. With Brian Rappert he is working on awareness raising and education for life scientists using the interactive seminar that Brian designed. Neil Davison The Royal Society, United Kingdom The Royal Society continues to engage on dual use and biosecurity issues through its membership of the InterAcademy Panel on Interna- tional Issues (IAP) Biosecurity Working Group and through involvement in UK and international workshops and meetings.Â The societyâs standing committee on the Scientific Aspects of International Security maintains a strong interest in this area.Â Other related areas of interest include export controls, particularly the UK governmentâs new Academic Technology Approval Scheme. Gerald Epstein Center for Strategic and International Studies, United States Global Forum on Biorisks (Initiated by the Center for Strategic and International Studies) The deliberate use of biology for harm can be at once a public health emergency, a crime, a terrorist incident, a disaster, a scientific investiga- tion, and a trade/travel crisis. Moreover, the problem is inherently inter- national, since groups based in one country can acquire resources in a second to attack a third, with the resulting disease spreading to additional countries and its indirect consequences being felt in yet more. Many dif- ferent professional communities have a role in preventing such incidents,
108 APPENDIX C or in managing their consequences. Each of these communities sees one aspect of such an incident, but each may be blind to its many other attri- butes. To deal with this problem, communities will have to work with one another, including some with which they may be quite unfamiliar, and which may have very different operating procedures, cultures, priorities, and contexts for comparison. Despite the requirement to work together, no integrated biological risk management governance structure currently exists that is at once comprehensive, international, and multisectoral. Existing governance approaches are not well suited to a problem with such a decentralized set of actors or diversity of perceptions. Intersectoral and international linkage mechanisms are weak and uncoordinated, and no effective way exists to take advantage of potential synergies between the many profes- sional communities that are involved. The Global Forum on Biorisks constitutes a governance approach that focuses on building linkages and connections among all of the relevant professional communities. The forum will develop a bottom-up, decen- tralized, adaptive, and interactive mechanism that provides the infor- mation and communications necessary to focus attention on biological challenges, facilitate assessment and adaptation among each component of this complex system, and promote interaction among its many moving parts. Implementing this approach involves: â¢ Working within each professional community to identify modes of operation that remain relevant to managing future biorisks, and those that must be revisited; â¢ Facilitating understanding within each community of the roles, assumptions, priorities, and values of those other communities with which it must interact; â¢ Promoting engagement and interaction among communities, shar- ing information, developing joint projects, and shaping new ways of working together; and â¢ Providing a driving force to motivate and catalyze action. The Global Forum on Biorisks is pursuing efforts to accomplish these tasks through two key mechanisms: a highly interactive and customizable Web portalânow under constructionâand a series of workshops around the world to introduce this concept and demonstrate the portal. The Web portal will create opportunities for each user to interact, engage, and col- laborate. It will introduce social networking tools to the field of biosecu- rity and host a growing database of information that will be developed and maintained by all of the Web communityâs participants. No Web site
APPENDIX C 109 run centrally by any one organization can have the breadth or the cur- rency of one for which all participants take collective responsibility. David Friedman Institute for National Security Studies and The Israel Academy for Sciences and Humanities Oversight of Dual Use Biotechnological Research in Israel Israeli scientists perform forefront research in the life sciences, bio- technology and biomedicine. They engage in a wide range of projects, using a wide variety of microorganisms, some of them virulent. Based on a heterogeneous research infrastructure, they use all internationally avail- able scientific methods. This research, and related routine work, is con- ducted in three major sectors: academia (universities and research insti- tutes), hospitals and the biotech industry. Researchers who use virulent microorganisms are obliged, under Israeli law, to follow specific protocols and safety standards, generally those required by such internationally respected groups as the World Health Organization and the U.S. Centers for Disease Control and Prevention. Israel has a comprehensive legislative infrastructure that mandates biological safety (biosafety) procedures. In contrast, Israel lacks a proper legal infrastructure for biosecurity (as distinct from biosafety), largely because no one has ever demanded one. Further- more, since the awareness of its importance is relatively new, it remains minimal. In practical terms, there is a certain amount of overlap between the demands of biosafety and of biosecurity. The existing biosafety pro- cedures do contribute somewhat to biosecurity, but this contribution is far from comprehensive and certainly imperfect. In particular, biosafety rules do not directly address the seepage of dangerous microorganisms and information to hostile elements. The big challenge is to incorporate biosecurity concerns into this system, in particular, to upgrade measures to prevent the leakage of dangerous organisms, information and tech- nologies to terror organizations. To this end the Israel National Security Council and the Israel Academy of Sciences and Humanities initiated a national project and formed a special Steering Committee on Biotechnol- ogy Research in an Age of Terrorism (COBRAT) to analyze and report on the current situation and to recommend future action. COBRAT took the above situation as its starting point in seeking more effective and system- atic ways to meet biosecurity concerns without compromising academic freedom and creativity. In its final report the Committee formulated spe- cific recommendations to address:
110 APPENDIX C â¢ Changes required in Israelâs existing legislative infrastructure. â¢ Compilation of an updatable list of biological agents and research topics requiring inspection and supervision. â¢ Establishment of a regime for tracking, supervising and enforcing all areas of biosecurity. â¢ The need for a national interministerial body or professional com- mittee to guide, monitor and maintain biosecurity. In pursuing these goals, COBRAT was confronted by several daunt- ing but not atypical facts: (1) no biosecurity legislation exists in Israel, (2) the legislative process, as practiced by the Israeli parliament (Knesset), is long, complicated and uncertain, (3) a response to the bioterror threat cannot wait for long-term solutions. COBRATâs innovative yet practical interim solution to this particular problem may also serve as a useful model for others. As mentioned above, Israel does have a well-developed legal regime that defines biosafety regulations and responsibilities in Israeli governmental, academic and private laboratories. COBRAT, there- fore, recommended modifying Israelâs biosafety committees and empow- ering them, by executive order, to undertake responsibility for biosecu- rity concerns as well. In addition to reducing duplication, disruption, and delay, this scheme avoids many of the sensitivities, suspicions, and conflicts inherent in the regulation of dual use research. The existing bio- safety committees are of long standing, they are sensitive to scientific (and personal scientist) concerns, they are well tolerated by the scientific and academic community, and they are unlikely to trigger the hostility and âgraft rejectionâ typical of introducing a âforeign bodyâ into academia. Trust and comfort are intangibles, but their effects are all too real. Current and Future Activities â¢ Committeeâs recommendations approved by Israeli Academy and National Security Council. â¢ Deliberations in the Israeli Academy and National Security Council on implementation of the committeeâs recommendations. â¢ Deliberations in the Ministry of Health on ways to implement recommendations. â¢ Deliberations in the Israeli Parliament on new legislation based on the recommendations of the committee. â¢ Dual use and biosecurity sessions in professional associations (e.g., Israeli Microbiological Association). â¢ Participation in dual use and biosecurity conferences and symposia. â¢ Preparation of suggestions for programs to raise awareness, con- sciousness and education in academia.
APPENDIX C 111 Katsuhisa Furukawa Research Institute of Science and Technology for Society, Japan Katsuhisa Furukawa is in charge of the program of Research on Sci- ence and Technology for Counter-Terrorism (RISTEX) under coordination with the R&D activities under the Ministry of Education, Culture, Sports, Science and Technology (MEXT) initiative on Science and Technology (S&T) for Safety and Security. The RISTEX team will collect information about current trends and updates about the R&D in this area both in Japan and abroad, analyze them and share the findings with relevant actors in Japan, with the objective to forge a network among researchers, officials and experts as well as between institutions. Through the conduct of this project, the RISTEX project team aims to contribute to making plans and strategies for S&T for counterterrorism as well as their implementation. This project is intended to be one of the efforts to forge a bridge between the scientific community and the national security community both in Japan and abroad. Within this broad objective, one of the core pillars is to manage dual use aspects of R&D of S&T in order to minimize the risk of misuse of S&T by state actors and nonstate actors. With the objective to develop and institute appropriate governance structure for R&D of S&T at the Japanese universities and research institutions, the RISTEX project team has conducted the following activities: â¢ Raising awareness among the relevant stakeholders about the importance of the problems of the potential misuse of science and tech- nology, through holding seminars bringing together relevant stakeholders and briefing to officials, experts and political authorities as well as mem- bers of the Science Council of Japan. â¢ Collaborating with the Japanese government in order to develop appropriate measures and policy, including â Assisting the development of a guideline for universities and research institutions over the management of R&D activities involving sensitive technologies, within the study group of the Ministry of Econ- omy, Trade, and Industry; â Assisting the efforts to develop appropriate measures for bioÂ security at universities and research institutions by the Ministry of Educa- tion, Science, and Technology; â Assisting the efforts of the Ministry of Foreign Affairs to prepare for international cooperation for biosecurity, including the BWC Expert group meetings, the Japan-U.S.-Australia Trilateral Conferenceâs Com- mittee on Counter-Bioterrorism and associated efforts to support capacity building for counter-bioterrorism among ASEAN countries;
112 APPENDIX C â Promoting international cooperation by inviting foreign experts and officials in areas associated with biosecurity and participating inter- national conferences and seminars abroad; and â Aiming to establish best practice at universities in Japan. Jennifer Gaudioso Sandia National Laboratories, United States Overview â¢ Sandia National Laboratories provides innovative, science-based, systems-engineering solutions to the United Statesâ most challenging national security problems. â¢ Sandiaâs Global Security Center reduces current and emerging pro- liferation and terrorism threats by creating sustainable system solutions through international cooperation. â¢ The International Biological Threat Reduction program, a division of Sandiaâs Global Security Center, enhances U.S. and international secu- rity by reducing biological threats worldwide. Goals The three highest goals of Sandiaâs International Biological Threat Reduction program are: 1. Enhance safety, security, and containment of dangerous biological agents in bioscience facilities. 2. Strengthen capacities to detect and control dangerous biological agents. 3. Improve understanding and mitigation of biological threats. The International Biological Threat Reduction program advances interna- tional threat reduction goals by promoting safe, secure, and responsible use of dangerous biological agents across the globe. Laboratory Biosafety, Biosecurity, and Biocontainment â¢ Working with domestic and international bioscience facilities and government agencies to conduct risk, threat, and vulnerability assessments. â¢ Designing and implementing laboratory biosafety, biosecurity, and biocontainment systems at biomedical and bioscience research facilities across the globe.
APPENDIX C 113 â¢ Providing technical assistance to maintain safe and secure trans- port of dangerous biological agents between facilities. Infectious Disease Diagnostics and Control â¢ Designing and implementing modern molecular diagnostics to enhance infectious disease detection and reduce reliance on live, danger- ous biological agents. â¢ Developing outbreak control programs that maintain safe and secure handling of dangerous biological agents in the event of a natural outbreak. Training and Workshops â¢ Conducting training to U.S. and international scientists, laboratory managers, and policy makers on the importance of biosecurity, biosafety, biocontainment, and infectious disease diagnostics and control. â¢ Hosting laboratory biosafety, biosecurity, and biocontainment sym- posia worldwide, at the request of the international community. Policy, Regulatory, and Guidelines Support â¢ Assisting partner countries by reviewing and drafting biosafety, biosecurity, and biocontainment procedures and plans designed to pro- tect dangerous biological agents during handling, research, storage, and transport. â¢ Helping to develop national and international biosafety, biosecurity, and biocontainment policies, regulations, standards, and guidelines. Assessments and Analysis â¢ Conducting assessments and analysis to better understand global biological threats and risks. â¢ Performing country and regional studies that focus on highly infec- tious diseases, and the bioscience technologies, expertise, and infrastruc- ture around the world to combat those diseases. â¢ Developing systematic approaches to prioritize biological threats worldwide, and identifying the best technical solutions to mitigate those threats. â¢ Writing peer-reviewed publications in the biological threat reduc- tion, nonproliferation, and counterterrorism fields For more information, visit us online at http://www.biosecurity.sandia.gov.
114 APPENDIX C Andrzej GÃrski Polish Academy of Sciences, Poland The misuse of research results for malevolent purposes poses a threat to public health and national security. On February 26-27, 2007, at the invitation of the Director of NIH, Andrzej GÃ³rski participated in an inter- national roundtable on dual use life science research held in Bethesda, MD. In his talk presenting the administrative/regulatory activities of the Polish Academy of Science he suggested that an international conference addressing those issues be held in Poland later that year. Its major tasks should be to provide more information about the nature of the dual-use dilemma, to increase the level of awareness of the risks involved, and to discuss possible means of safeguarding research with potential dual use application. The conference was held under the auspices of UNESCO and the President of the Polish Academy of Sciences (PAS) on November 9-10, 2007 at the Presidential Palace in Warsaw. The conference presentations are available on the PAS Web site: http://www.pan.pl/english/index.php?option=com_content&task=view&id= 1346&Itemid=287. A special issue of Science & Engineering Ethics with the conference proceedings will be published later this year. Furthermore, at the invitation of the European Commission Andrzej GÃ³rski presented a talk at the National Ethics Committees Forum in Lubliana (March 2008) entitled âIs Dual Use Adequately Defined and Addressed in Current Research Ethics Guidelines?â In his talk he dis- cussed the definitions, history, examples, and current approaches to dual use, emphasizing the differences between the United States and Europe (regulatory vs. self-regulatory models). The paper is available at the Web site: http://europa.eu/sinapse/directaccess/NEC/Public-Library/ (page 13). A manuscript under the same title will be submitted for publication in September. In conclusion, the conference contributed significantly to the dissemi- nation of knowledge of the dual use dilemma and emphasized the need to further discuss and implement methods to safeguard research with such potential. ChandrÃ© Gould Institute for Security Studies, South Africa ChandrÃ© Gould is a senior researcher in the Crime and Justice Pro- gramme of the Institute for Security Studies, an African policy research institute. For the past nine years she has been involved in efforts to
APPENDIX C 115 strengthen the norms against chemical and biological weapons at a national and international level. She is currently involved in the develop- ment of an educational module for South African scientists to make them aware of dual use issues and their responsibilities in relation to prevent- ing the misuse of science. She has worked with Dr. Brian Rappert and Dr. Malcolm Dando to organize and present interactive seminars on dual use issues to scientists in South Africa, Kenya, and Uganda. Elisa Harris Center for International and Security Studies, University of Maryland, United States Controlling Dangerous Pathogens Project Dual use biotechnology research poses global challenges that cannot be managed effectively either by traditional arms control or by voluntary self-governance. Legitimate science can create new dangers if a cutting- edge experiment has unexpected results, if findings from research done for benign purposes are misapplied by someone else, or if the line between defensive and offensive biological weapon activities becomes blurred in practice or perception. Moreover, the relevant pathogens, equipment, and knowledge are widely distributed in medical and agricultural research institutions around the world. Efforts to protect against the misuse of biotechnology without impeding beneficial research will require new approaches developed cooperatively by a broad range of stakeholders. The Controlling Dangerous Pathogens Project brings together leading scientists, security experts, government officials, lawyers, and industry representatives in the United States and in other countries and regions around the world to address the issue of dual use research. As part of this effort, the project has examined the risk that advances in dual use research could lead either inadvertently or deliberately to destructive con- sequences and explored various national and international mechanisms that could help mitigate this threat.Â The Project has developed a detailed proposal for protective oversight of dual use research that would apply comprehensively to all relevant research institutions, whether government, academic or private sector, would rely on mandatory requirements rather than self-governance, and would be global in scope. The project is also seeking to raise awareness on the dual use issue and effective policy responses through a variety of outreach activities, including a series of workshops being held in regions around the world. (Further information on the project can be found at: http://cissm.umd.edu/projects/pathogens.php/#papers.)
116 APPENDIX C Alastair Hay University of Leeds, United Kingdom Multiple Uses of Chemicals: Making the Right Choice (A Joint IUPAC/OPCW Project) Chemical processes determine how we live. From bodily functions through to lifestyle purchases, chemistry is an integral part of who we are and what we aspire to be. But it is not limited to these examples. Many of the major global issues we face will require chemical solutions, be it understanding what happens in the Earthâs atmosphere, provid- ing clean water, improving food supplies or discovering new medicines. Chemistry thus has enormous potential to contribute positively to global well-being. But it has not always been like this. In World War I, chemists and chemical engineers were actively perfecting weapons that relied on the physical and toxic properties of chemicals. Eighty years later the advent of the Chemical Weapons Convention (CWC) changed the rules. The CWC requires states not to develop or promote chemical weap- ons. Chemists have a crucial role to play in this process. If the proscrip- tions of the CWC are to succeed, chemists will have to support them. Many chemists do not know about the CWC. There is a need to inform them about the treaty and about their responsibilities. To enable this process the Organisation for the Prohibition of Chemi- cal Weapons (OPCW), which is responsible for implementation of the CWC, and the International Union of Pure and Applied Chemistry (IUPAC) have supported a small international working group to develop educational tools to foster debate. Four working papers have been pro- duced which cover multiple uses of chemicals, the CWC, the toxicology of selected chemical warfare agents, and codes of conduct. These papers are available in Arabic, Chinese, French, English, Russian, and Spanish, the working languages of the OPCW. The working papers are designed for use by teachers of chemistry either in universities or high schools. They provide ample material for a one-hour lecture and much more. With questions at the end to encourage debate and further recommended reading matter there is sufficient mate- rial for workshops and projects. Approximately six A4-pages long, the papers have been peer reviewed and tested in workshops in the United Kingdom, Russia, South Korea, and Italy. Participants in the workshops have included chemistry students, teachers, university professors, diplo- mats and specialists in chemical warfare. Working papers are currently available in English on the IUPAC Web site (http://www.iupac.org/multiple-uses-of-chemicals) in the education sec-
APPENDIX C 117 tion. More papers will be produced and eventually all will be available on the Internet in a form that is useful for teaching. There is a need to produce material that deals with a range of issues specific to chemistry and that will be attractive and engaging for school- children. This material will deal with ethical issues and direct students to an ethical toolkit that can be adapted for any issue. Work is underway on this programme but is at an early stage. Li Huang Chinese Academy of Sciences Li Huang received his Ph.D. in the Department of Microbiology at the University of Guelph, Ontario, Canada, in 1988. He was a postdoctoral fellow in the Department of Biochemistry of the School of Hygiene and Public Health at the Johns Hopkins University, Maryland (1988-1993). He became assistant professor in the Department of Biology at Pomona College, California, in 1993 before joining the faculty in the Institute of Microbiology, Chinese Academy of Sciences, in 1996. He was appointed to full professorship in 1998 and is now director of the State Key Laboratory of Microbial Resources. Dr. Huangâs scientific work concerns the isolation and biotechnological exploitation of microorganisms from various envi- ronments. He has also been working on biosecurity-related issues since 2001, and is currently a member of the Biosecurity Working Group of the InterAcademy Panel on International Issues. Iris Hunger Research Group for Biological Arms Control, Carl Friedrich von WeizsÃ¤cker Centre for NATURAL Science and Peace Research, University of Hamburg, ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ Germany Iris Hunger heads the Research Group for Biological Arms Control at the Carl Friedrich von WeizsÃ¤cker Centre for Natural Science and Peace Research at the University of Hamburg. The aim of the Research Group is ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ to contribute, through innovative research and outreach activities, to the universal prevention of biological weapon development, production, and use. The development of new verification and compliance strategies and concepts and concrete verification measures is the core research area. The following projects are currently carried out by the Research Group for Biological Arms Control: â¢ Economic, social and legal aspects of biodefence research. â¢ Role of non-state actors in promoting nonproliferation and arms control against biological weapons.
118 APPENDIX C â¢ Strengthening the confidence building measure regime under the Biological Weapons Convention. â¢ Monitoring trade of biological dual use items. â¢ Harmonizing regulations on research of concern in the life sciences. Past projects include: â¢ Controlling weapons by controlling science? The role of natural scientists in bioweapon programs of states. â¢ International impact of national biosecurity legislation. â¢ Biosecurity policies at international life science journals. â¢ Lessons learned from the UNSCOM/UNMOVIC inspections in Iraq. â¢ New developments in aerosolization technology and implications for biological arms control. Ferenc JordÃ¡n Collegium Budapest, Institute for Advanced Study and Animal Ecology Research Group, Hungarian Academy of Sciences, Hungarian Natural History Museum, Budapest, Hungary The Ecology of Security Ecology is the science of interactions and relationships. Complex ecological systems (like forests or lakes) are complex because they have a large number of parts connected by a large number of interactions. The stability and vulnerability of such systems depends on their topol- ogy: critical nodes in interaction networks need to be studied for better understanding dynamics (5). Quantifying key nodes in networks is a cen- tral issue in more and more disciplines. Network analysis helps in their identification and characterization. It is the ecological nature of various systems that interacting parts form a whole whose properties depend on the parts but also pose constraints on the partsâ behavior. This hierarchi- cal view on many complex systems is the way to predict which parts to defend and which ones to attack in them. It is important to note, however, that structurally reliable networks behave in a persistent way only if their interaction pattern is plastic: for example, prey-switching of predators is a key condition for ensuring stability in model ecosystems. Thus, it may be a key aim to incorporate a desirable extent of flexibility in man-made interactive systems (like governments, armies or other social structures, see (3)). I compare the ânetwork ecologyâ of ecosystems (6), wasp colo-
APPENDIX C 119 nies (1), African nations (2) and the London underground (4). In the last example, it seems to be the case that the terrorist side had performed sophisticated network analysis before the July 7, 2005 attacksâsince they wanted to bomb at the optimal three stations out of more than 3 million combinations. References Bhadra, A., F. JordÃ¡n, A. Sumana, S. Deshpande, and R. Gadagkar. In press. A comparative social network analysis of wasp colonies and classrooms: Linking network structure to functioning. Ecological Complexity, submitted. Johnson, D., and F. JordÃ¡n. 2007. The web of war: A network analysis of the spread of civil wars in Africa. Paper presented at the annual meeting of the American Political Science Association, Chicago, August 30. JordÃ¡n, F. 2008a. Network analysis: Linking parts to the whole in nature and society. Pp. 240-260 in Darwinian SecurityâPerspectives from Ecology and Evolution, R. Sagarin and T. Taylor, eds. Berkeley and Los Angeles: University of California Press. JordÃ¡n, F. 2008b. Predicting target selection by terrorists: A network analysis of the 2005 London underground attacks. International Journal for Critical Infrastructures 4:206-214. JordÃ¡n, F., and I. Scheuring. 2004. Network ecology: Topological constraints on ecosystems dynamics. Physics of Life Reviews 1:139-172. JordÃ¡n, F., I. Scheuring, and G. Vida. 2002. Species positions and extinction dynamics in simple food webs. Journal of Theoretical Biology 215:441-448. Serhiy Komisarenko Ukrainian Commission on Biosafety at the National Security and Defense Council, Ukraine Main occupation: Academician-Secretary of the Division for Biochem- ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ istry, Physiology, and Molecular Biology of the National Academy of Sciences of Ukraine. Other ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ current responsibilities: Chairman of the Com- ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ mission on Biosafety of the National Security and Defence Council of Ukraine, and Director of Palladin Institute of Biochemistry, Kiev. Main scientific interests are in immunochemical analysis of proteins and peptides and in interrelation between protein immunochemical struc- ture and their biological function. S. Komisarenko and his pupils are studying extensively the fibrin polymerization sites and fibrin degradation products with the aid of monoclonal antibodies (and their Fabs) as well as nicotinic acetyl- choline receptors and PAR3 on B lymphocytes at different stages of their differentiation. His team also explores immunity of diphtheria and tuberculosis infec- tion using recombinant proteins and peptides: rA and rB Diphtheria toxin subunits, recombinant surface antigens of various Mycobacteria as well as scFv fragments (single-chain antibodies) against these antigens. They are also using nanoparticles and immunochromatography for the devel-
120 APPENDIX C opment of rapid diagnostic tools. He is also interested in Biosafety and Biosecurity issues, and in chemical and biological warfare implementa- tion in particular. Gabriele Kraatz-Wadsack United Nations Development of a Single Comprehensive Database on Biological Incidents Under the mandate of General Assembly resolution 60/288 entitled âThe United Nations Global Counter-Terrorism Strategy,â the annexed âPlan of Actionâ contained elements that aimed to strengthen interna- tional capacity under item II.11. One such element was to invite the United Nations system, together with Member States, to develop a single comprehensive database on biological incidents. The database is intended to serve as a platform for receiving detailed technical information on bio- logical incidents worldwide in order to build state capacity to prevent and combat bioterrorism. Â At present no international comprehensive data resource exists in this area, where data are directly provided by Member States and by this considered âquality-controlled.â The biological incident database is currently being developed, together with input from interested Member States and relevant international organizations. Discussions were held on the scope and format of the Biological Incident Database and the provision of actual data. Â In this context an informal consultative meeting of Governmental experts and representatives from relevant international organizations was convened by the Office for Disarmament Affairs (ODA) in New York from July 24-26, 2007. It is envisaged that the database will be accessed as a secure Web-based application on the Web site of the ODA. Access to any sensitive data will be controlled to address possible proliferation concerns. Expert Meetings to Update the Technical Guidelines and Procedures to Investigate Alleged Use The ODA organized two meetings of specialized experts in 2007 in pursuance of the General Assembly resolution 60/288 entitled âThe United Nations Global Counter-Terrorism Strategyâ of September 8, 2006, which encouraged âthe Secretary-General to update the roster of experts and laboratories, as well as the technical guidelines and procedures, avail- able to him for the timely and efficient investigation of alleged use.â The roster of experts and laboratories has been updated and currently contains 191 biological experts and 41 chemical experts as well as 59 analytical
APPENDIX C 121 laboratories. The expert meetings to update the technical guidelines and procedures were attended by experts from 10 Member States, 5 interna- tional organizations and 1 nongovernmental organization. In its discus- sions, the group considered the significant scientific advances that had occurred since the initial drafting of the guidelines and procedures in 1989, particularly in health surveillance, detection and diagnosis. Â The experts produced a unanimous report which takes into account the sub- stantial developments in the biological area since 1989. In their review and update, the experts also noted the entry into force of the Chemical Weapons Convention and the establishment of the OPCW in 1997 and made reference to the UN-OPCW relationship agreement of 2001. The experts assessed that at this stage only an update of the provisions of the technical appendices of the original guidelines was advisable. The report of the expert group has been transmitted to the Secretary-General. David Mbah Cameroon Academy of Sciences, Cameroon Brief Summary of the Cameroon Biosecurity Project The biosecurity project Cameroon is working on is aimed at building national capacity to safeguard, control, monitor and manage genetically modified organisms and invasive alien species including pathogens for the sustainable management of Cameroonâs biodiversity and building capac- ity to implement the Cartagena Protocol on Biosafety and Cameroonâs biosafety legislation. Project components include institutional capacity building for management and control of invasive alien species including pathogens and implementation of the Cartagena Protocol, development of legislative/regulatory instruments (IAS, policy on biotechnology/ biosecurity/access and benefit sharing), production of documents, trans- action/interpretation and management. The project has already received Global Environmental Facility (UN Environment Programme) approval. Lorna Miller DefenCe Science and Technology Laboratory, United Kingdom Lorna Miller is Senior Biological Advisor/Non-Proliferation at the Defence Science and Technology Laboratory, Porton Down, United King- dom, providing scientific and technical advice on biological arms control and non-proliferation issues to policy makers and implementers. This includes the role of scientific and technical advisor to the UK delegation to the Biological and Toxin Weapons Convention, and support to UK
122 APPENDIX C policy on biological export controls. She has provided the technical lead for UK input to the previous BWC Meetings of Experts. Her current work involves preparation for UK contributions to the 2008 Meeting of Experts topics related to biosafety and biosecurity and to oversight, education, awareness raising and codes of conduct to prevent misuse of advances in bioscience and biotechnology research. She is also involved in providing and coordinating technical support to UK initiatives to provide assistance to other countries in meeting arms control and non-proliferation objec- tives, particularly with regard to implementation of the BWC; biosafety and biosecurity standards and training; and capacity building in infec- tious disease control. Sospeter Muhongo ICSU Regional Office for Africa, South Africa Professor Sospeter Muhongo, a Tanzanian, is the founding and the current Regional Director of the International Council for Science (ICSU) Regional Office for Africa. He is the chair of the Science Programme Com- mittee of the UN-proclaimed International Year of Planet Earth (IYPE). Professor Muhongo is the Chairperson of the Steering Committee of the Scientific, Technical and Research Commission of the African Union. He is the chairperson of the UNESCO/International Union of Geological Sciences/International Geological Correlation Programme Scientific Board and Vice President of the Commission of the Geological Map of the World. Professor Muhongo is a Full Professor of Geology, a Chartered Geologist (UK) and the first recipient (2004) of the Robert Shackleton Award for Outstanding Research in the Precambrian Geology of Africa. In 2006, Professor Muhongo won the prestigious National Award for Outstand- ing Research in S&T in Tanzania. The Geological Society of South Africa conferred the prestigious âHonours Awardâ upon Professor Muhongo for his meritorious contribution to the Earth Science profession in 2007. He is an Honorary Professor of Geology at the University of Pretoria (South Africa). Professor Muhongo has established excellent and reliable contacts with senior scholars, business executives, politicians and government officials throughout the world. He is actively mentoring young scientists around the world and has developed a special interest in the application of science, research, technology and innovation for the sustainable socio- economic development of the global society.
APPENDIX C 123 Paul Nampala Uganda National Academy of Sciences (Unas@infocom.co.ug) Promoting Biosafety and Biosecurity within the Life Sciences The overall aim of this project is to promote policies and practices that will reduce the likelihood of the inadvertent or deliberate spread of disease stemming from life science research. It is intended to serve as a model for other undertakings on laboratory biosafety and biosecurity for African researchers and others around the world. It will also ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ educate and further develop the sï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ kills of media representatives in reporting on ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ issues of biosafety and biosecurity. This project was designed to bring together leading scientific and policy experts in Africa at a workshop held in Kampala, Uganda, March 11-12, 2008, to discuss biosafety and biose- curity and to build capacity within research institutions in East Africa to devise and undertake laboratory biosafety and biosecurity oversight review procedures. Beyond the workshop, the project will provide an opportunity to disseminate emerging educational materials and tools and raise the profile of Africa and African countries in international biosecu- rity deliberations. The workshop attracted 75 participants consisting of practicing sci- entists, biosafety officers, policy officials, media representatives, non-gov- ernmental organizations, policy analysts and African and U.S. Academy representatives. The symposium topics presented over the course of the two days included the following, among others: â¢ Overview of laboratory biosafety and biosecurityâInternational discussion â¢ Laboratory biosafety and laboratory biosecurityâEast African perspective â¢ Promoting wider engagement about biosecurity and laboratory biosafety â¢ Educating the media on communicating issues of dual use research and bioterrorism The symposium raised more questions than answers and a common understanding was sought to clarify the scope of biosafety and biosecu- rity. The key issues raised include the following: â¢ Biosafety is accepted as essential to keep up with the rapid devel- opments in biotechnology. â¢ In Africa, primary biosecurity risk stems from nature and not lab- oratory undertakings but there is potential for some infectious agents
124 APPENDIX C to spread either accidentally or deliberately from the laboratory and endanger the public so attention to laboratory biosafety and biosecurity is critical. â¢ Individual countries need to adapt their existing or new legal pol- icy frameworks to capture aspects biosafety and biosecurity. â¢ There is need for compliance and enforcement of existing laws and regulations, including biopiracy and intellectual property rights. â¢ The responsibility of biosafety and biosecurity lies at multiple lev- els including individual, institutional, and oversight responsibilities at national levels. â¢ The need to educate and sensitize at all levels is apparent. Simi- larly, capacity building is critical at all levels. To ensure cost-effective approaches, it is important to share training and educational resource materials. Thus, collaboration and effective partnerships should be encouraged. â¢ African academies should play a more active role in advising gov- ernments on biosafety and biosecurity. Stuart Nightingale Consultant, National Institutes of Health, Office of Biotechnology Activities, Office of Science Policy, Office of the Director, U.S. Department of Health and Human Services The National Science Advisory Board for Biosecurity (NSABB) The NSABB is a critical component of a set of federal initiatives to promote biosecurity in life sciences research. The U.S. government estab- lished this advisory body to recommend ways to minimize the risk that information from legitimate life sciences research could be intentionally misused to threaten public health and other aspects of national security. The NSABB consists of 25 nongovernment voting members with a broad range of expertise, including molecular biology, microbiology, infec- tious diseases, biosafety, public health, veterinary medicine, plant health, national security, biodefense, law enforcement, scientific publishing, and related fields. Representatives from 15 federal agencies and departments are nonvoting members. The NIH Office of the Director administers and manages the board. The NSABB is charged specifically with providing recommendations for the development of: â¢ A system of institutional and federal oversight that allows for fulfillment of important research objectives while addressing national security concerns;
APPENDIX C 125 â¢ Guidelines for the identification and conduct of research that may require special oversight; â¢ Codes of conduct for scientists and laboratory workers that can be adopted by professional organizations and institutions engaged in life science research; â¢ Materials and resources to educate the research community about effective biosecurity; and â¢ Strategies for fostering international engagement on dual use bio- logical research issues. To date the NSABB has developed two major reports that have been transmitted to the U.S. government for consideration during the policy development process: âProposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Informationâ and âAddressing Biosecurity Concerns Related to the Synthesis of Select Agents.â In fulfillment of its charge to recommend strategies for fostering inter- national dialogue on dual use research issues, the NSABB has hosted two International Roundtables, the first co-sponsored by the U.S. government and the World Health Organization. The purpose of the Roundtables is to begin a dialogue with scientists and representatives from interested coun- tries, relevant intergovernmental organizations, and scientific professional associations; hear the perspectives of scientists in other countries; learn about relevant activities; and share the tools developed by the NSABB for the identification, conduct, and review of dual use life sciences research. The summaries of these International Roundtables (February and October 2007) are posted on the NSABB Web site. A third International Roundtable is planned for late 2008 and will facilitate outreach to and feedback from scientists and representatives from additional countries. For more information, please visit the NSABB Web site: http://oba. ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ od.nih.gov/biosecurity/. Kathryn Nixdorff Department of Microbiology and Genetics, University of Darmstadt, Germany Life Sciences Revolution and Biochemical Arms Control Characteristic of the developments in science and technology over the past three decades is the explosive nature of the accumulation of knowl- edge concerning the mechanisms and functions of biological systems. The revolution in biotechnology is continuing on into the revolution in pharmacology with the emphasis on drug discovery and drug delivery,
126 APPENDIX C in which biochemical bioregulators (organic chemical substances that regulate the function of biological systems) and systems biology will be gaining more and more significance for biochemical arms control as time progresses. Bioregulators used in a malign way pose a particular threat in that they can be used to disrupt the balanced operation of interacting physiological systems. An example can be found in the interactions of the neuroendocrine and immunological systems, with their vulnerability to compounded modulation. The interdependence of the reaction pathways of these systems raises the dual use dilemma to a whole new order of complexity. Trying to deal with this complexity in order to exploit the benefits while minimizing the risks is going to be an enormous task in the future. This constellation of factors raises the question as to whether the Biological and Toxin Weapons Convention, which has no treaty organiza- tion and does not contain adequate measures for assuring compliance, is running into the danger of being completely overwhelmed by scientific and technological advances in the future in the sense that States will be reluctant to devote appropriate attention to these developments in all their complexity. Under Article IV of the BWC States Parties have an obligation to take all ânecessary measuresâ not only to âprohibitâ but also to âpreventâ the malign misuse of biological materials. While penal legislative measures can contribute significantly toward prohibition of misuse, monitoring of developments in science and technology along with the formulation of biosecurity regulations that take these developments into account are counteractive measures that can help prevent the misuse of biological materials. In the research project, developments in science and technology will be monitored and an in-depth analysis of several main targets of inter- acting physiological systems that may be used malignly for offensive military purposes will be provided, along with an analysis of the conse- quences of modulating these targets with biochemical bioregulators. In addition, new developments in pertinent delivery systems that could be used to direct bioregulators to their targets will be investigated, and the feasibility of their application analyzed. Suggestions will be offered for minimizing the risks posed by these developments. This is a summary of part of a project being conducted in collabora- tion with Professor Malcolm Dando of the University of Bradford, United Kingdom, and Dr. Alexander Kelle of the University of Bath, United King- dom, funded by the German Foundation for Peace Research (http://www. bundesstiftung-friedensforschung.de).
APPENDIX C 127 Alan Pearson Center for Arms Control and Non- Proliferation, United States Alan Pearson, Ph.D., is the Director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Prolif- eration, where he is responsible for coordinating the work of the Scientists Working Group on Biological and Chemical Weapons, monitoring U.S. biodefense activities, and promoting national and international efforts for biological and chemical weapons control. He is currently working on issues of national BWC compliance review and enhancing transparency of biodefense and other dual use life sciences research. He is co-editor of the book Incapacitating Biochemical Weapons: Promise or Peril? (Lexington Press, 2007). In 2003-2004, Dr. Pearson was an American Association for the Advancement of Science/Nuclear Threat Initiative science policy fel- low at the Department of Homeland Security, where he worked in the Biological and Chemical Countermeasures Portfolio of the Science and Technology Directorate. Dr. Pearson was a Research Fellow at the Harvard University School of Medicine and a postdoctoral Research Fellow of the American Cancer Society. He received his Ph.D. in biology from the Mas- sachusetts Institute of Technology. Simon Takalani Rambau Academy of Sciences of South Africa Simon Takalani Rambau is a National and International Liaison Officer at the Academy of Sciences of South Africa (ASSAf). His main responsibil- ity is to coordinate all ASSAf international activities such as to maintain the bilateral and multilateral engagements with other international sci- ence academies and organizations such as the InterAcademy Medical Panel, IAP, Network of African Science Academies, African Academy of Sciences, G8 + 5, IBSA (India/Brazil/South Africa) activities, African Union, NEPAD (New Partnership for Africaâs Development), ICSU, the Academy of Sciences of the Developing World (TWAS), and the Southern Africa Development Community in order to advance scientific work in Africa. Other responsibilities include serving as an Executive Secretary for Committee of Heads of Organisation for Research and Technology, coor- dinating the establishment of ASSAf Standing Committee on Biosafety and Biosecurity as well as facilitating the establishment of a South African Chapter of the World Academy of Young Scientists in Africa. He is cur- rently a Ph.D. student at the University of Pretoria conducting research on disaster education in the informal settlements.
128 APPENDIX C C. Kameswara Rao Foundation for Biotechnology Awareness and Education, India In the developing countries, the level of scientific/technical expertise and infrastructure to face sudden and unforeseen threats to health secu- rity is pathetically low. There is hardly any expertise for anticipating risk, its assessment and mitigation. Awareness of preparative and remedial action is totally lacking even among the professional and administrative circles, who should know better. The governments and health personnel are totally unprepared, helpless, and lost in times of crisis. It would take a decade for advancements in life sciences/biotechnology that would make significant difference to pathogen diagnostics, preventive and manage- ment protocols in the form of vaccines, antibodies, etc., to reach the devel- oping countries. By that time new developments would have replaced them in the West, leaving the developing countries chasing technological innovation forever. Vast numbers of the population are extremely vulnerable to disease outbreaks, even from conventional threats, resulting in an enormous human tragedy. This is acutely reflected in the past events in India, such as the Surat plague epidemic, outbreak of epidemics following the earth- quake in Gujarat, and several other disasters. The confusion and panic on epidemic outbreaks at the periodical and/or annual religious events at auspicious rivers where millions congregate have repeatedly shown the inadequacy of preparedness of public health authorities, and no lessons were ever learnt from the past nightmares. Risks from new epidemics such as bird flu are looming large with no one in authority being visibly conscious of the imminent threat as reflected by the recent outbreak of bird flu in the State of West Bengal. Dual use technologies are beyond all comprehension and remedy. In order to prepare the developing countries, even marginally, (a) to foresee and face unexpected events, (b) to avoid wasteful duplication of technical and financial resources, (c) to enable them to adopt new tech- nology sooner rather than later, and (d) to minimize, if not totally avoid, the confusion and panic that prevails in times of natural disasters and epidemic outbreaks that pose a serious risk to health security, the follow- ing international organizations need to be set up: 1. An international organization with units in different countries to (a) share and provide state-of-the-art technical know-how, and (b) to co- ordinate and monitor diagnostic, preventive and remedial action and 2. An international funding body to provide financial support to prevent human tragedy for want of technical know-how and financial resources, both lacking in the developing countries.
APPENDIX C 129 The mandate of these organizations would be to facilitate â¢ Improvements in state and local surveillance infrastructure, such as establishment of biodisaster control centers, to perceive and handle bioterrorism and biowarfare threats; â¢ Survey major hospitals for supplies of antidotes, drugs, ventilators, personal protective equipment, decontamination capacity, mass-casualty planning and training, isolation rooms for infectious disease, and famil- iarity of staff with the effects and treatment of biological threats; â¢ Encourage governmental and private agencies engaged in health and medical R&D to share their information on (a) diseases, (b) diagnos- tics (c) drugs, (d) personnel, (e) resources, and (f) on the sources of threats to health security and protocols to mitigate threats; â¢ Convene discussions among the appropriate agencies making them aware of current developments and on the use of investigational products in mass-casualty situations and on acceptable proof of efficacy for prod- ucts where clinical trials are not ethical or are otherwise impossible; â¢ Develop incentives for both public and private hospitals to be receiving hospitals, to stockpile antidotes and selected antitoxins and make them available to the first responders, by changing laws if needed; â¢ To purchase appropriate personal protective equipment and expandable decontamination facilities and train emergency department personnel in their use; â¢ Provide for state and central training initiatives with a programme to incorporate existing information on threats to health security and their preventive and treatment methods into the manuals and reference librar- ies of first responders, emergency departments and biotoxin control cen- ters; and â¢ Intensify Public Health Service efforts to organize and equip Urban Medical Response Teams and Community Response Teams, in high-risk cities and other locations, throughout the country. These measures would enhance the general ability of governments, public health authorities and the communities, to cope with mass-casualty events. In view of its expertise, influence and reach, the WHO is best suited to recommend and oversee the implementation of the suggested measures.
130 APPENDIX C Brian Rappert University of Exeter, United Kingdom Raising Awareness of Dual Use Research in the International Life Science Community A major plank of policy responses in relation to this has been devis- ing educational and awareness training for scientists regarding the âdual useâ potential of researchâits potential to be used for both beneficent and malevolent purposes. Yet, that overall agreement is belied by the lack of specification about the content and specific aims of such provisions. Should that, for instance, consist of providing information on the history of biological warfare, stimulating generic concerns about the responsibili- ties of scientists today, alerting researchers to security considerations for their individual consideration, or challenging certain presumptions about the malign potential of research? First as part of a grant funded by the Economic and Social Research Council and more recently through two Alfred P. Sloan Foundation grants, Malcolm Dando (University of Bradford) and Brian Rappert (University of Exeter) are conducting seminars for practicing researchers. There are two aims to this: first, to inform participants about current biosecurity dual use debates, and second, to generate interactive discussion about the merits of proposed policy responses. The work has been undertaken in collaboration with a number of individuals: Animesh Roul, Society for the Study of Peace and Con- flict, India; Peter Edopu and ChandrÃ© Gould of the Institute for Secu- rity Â Studies, South Afrcia; David Friedman at the Institute for National Security ÂStudies, Israel; Katsuhisa Furukawa, Rui Kotani, and Yu Sasaki at the Research Institute of Science and Technology for Society in the Japan Science and Technology Agency; Heide Hackmann, Laura van Veenendaal, and Rudie Trienes of the Royal Netherlands Academy of Arts and Sciences; Mari Linnapuomi of the Finnish Ministry for For- eign Affairs; ÂSerhiy Komisarenko of the National Academy of Sciences of Ukraine; Silvia Cucovaz of the Argentinean National Intelligence School; Paula Austin of Sandia National Laboratories, United States; Christian Enemark of the Centre for International Security Studies at the University of Sydney, Australia; and Thomas Egwang of Med Biotech Laboratories and the Ugandan National Academy of Sciences.Â Through this work we are developing a novel research method for engaging with practicing scientists about emerging areas of societal dis- cussion. We have also produced interactive educational material, in part, in collaboration with Marie Chevrier (University of Texas at Dallas).
APPENDIX C 131 Khalid Riffi Temsamani, El Majid Zayer Ministry of Higher Education & Scientific Research, Morocco Moroccoâs Current Biosecurity Projects â¢ Morocco participated with the U.S. National Science Advisory Board on Biosecurity in a roundtable on the dual use of life sciences research in February 2007 in Washington, DC. â¢ Morocco is a member of the Biosafety and Biosecurity core group for the Middle East and North Africa (MENA) region. â¢ The core group will meet in Abu Dhabi next March 2008. â¢ Morocco has been chosen to organize the Second International Conference on Biosafety and Biosecurity in March 2009 (BBIC09). â¢ Morocco is involved in the development of a regional strategy for the Middle East and North Africa, which would underpin and support national strategies, to enhance biosafety and biosecurity. Human, animal and agricultural sectors are targeted in this strategy. â¢ Academia, governments and private sectors will be part of the strategy elaboration. â¢ The core group has decided to establish regional biosafety and biosecurity training centers. â¢ Morocco has started discussions to put in place a National Sci- ence Ethics Commission and a national code of conduct for science and technology. Animesh Roul Society for the Study of Peace and Conflict, India Animesh Roul is involved as India coordinator in a Sloan Founda- tion funded âbiosecurityâ project under Professors Brian Rappert and Malcolm Dando, referenced above.Â In India, he is also involved in issues relating to bioterrorism and emerging and reemergingÂ infectious diseases and their sociologicalÂ impact. Lajos RÃ³zsa The Hungarian Academy of Sciences, Hungary A Drug Weapon Research Program (1962-1972) of the Warsaw Pact Contrary to widespread rumors in the Cold War era, there had been little, if any, evidence in the scientific literature to support the view that the Soviet Union or its Warsaw Pact allies considered the use psycho- chemical weapons within a military context.
132 APPENDIX C The Hungarian State Archives has recently opened up declassified records of Hungaryâs State Defence Councilâs meetings held between 1962 and 1978. Materials submitted to the Council include reports on the coordinative meetings of the Warsaw Pact military medical services. According to these reports, research into possible countermeasures against psychotropic drugs was a research priority assigned to Hungary in 1962. Hungary rejected this task in 1963, but joined the ongoing project again in 1965. Methylamphetamine was produced in Budapest for use as an experimental model of such weapons. Within the context of contemporary Western research, this drug was considered an effective interrogation tool. Similar to the contemporary CIA, Hungary also failed to develop an anti- dote against it and thus the project terminated fruitlessly in 1972. These documents serve evidence that a Warsaw Pact forum had, in fact, been considering a psychochemical as a weapon. Barbara Schaal Washington University, St. Louis, United States Barbara Schaalâs group studies the genetics of rice. In collaboration with scientists from Chiang Mai University, they are accessing the poten- tial environmental impact of genetically modified rice. Their work centers on gene flow between cultivated rice and native or weedy rice populations in Southeast Asia and in the United States. Their studies have quantified the levels of gene flow and have shown that gene flow between cultivated rice and its wild ancestor results in the development of a weedy variant of rice. Weedy rice is a serious pest in rice fields and can result in large losses of yield and potentially abandonment of rice fields. The implications for such gene flow and hybridization from genetically modified rice have been inferred by a study of comparative fitness of genetically modified rice, wild rice, and their hybrids. Daniel Sordelli University of Buenos Aires, Argentina Current Projects Dr. Sordelliâs work involves two different fields. As a basic science researcher, he is involved in work aimed at increasing the knowledge on mechanisms of pathogenesis and prevention of staphylococcal human bone infections, with special emphasis in capsule expression and infection chronicity. As president-elect of the International Union of Microbiologi- cal Societies (IUMS) and chair of the IUMS Public Policy Committee he
APPENDIX C 133 is leading the drafting of the Health and Science Diplomacy Initiative (HSDI). Health and Science Diplomacy Initiative The impact of scientific advances on the worldâs population, eco- nomic, social and political systems has grown dramatically in the last decade. New emerging and reemerging infectious diseases have taken at the same time a significant toll on many countries and populations. Biotechnology and environmental science issues have also had signifi- cant impact. Indeed, recent major disasters such as the tsunami affecting Northern Indonesia and many other countries in the region, or current threats such as the potential avian influenza pandemics or the misuse of microorganisms for terrorist acts are examples of scenarios that require immediate attention by a coordinated and balanced team of experts and politicians. The emergence of these and other multinational issues in the 1990s has redefined the scientific demands placed on those responsible for international relations. Indeed, the sciencesâand the microbiological dis- ciplines especiallyânow play a new role in countriesâ evolution and are becoming today a major component of government foreign policy. At a time of globalization, governmental institutions in both devel- oped and developing countries as well as international organizations are facing major challenges in finding effective ways to utilize state-of-the- art scientific and medical advances that offer opportunities that were unimaginable only a few years ago. As a consequence, policy makers worldwide are under increasing pressure and scrutiny to rapidly deter- mine the validity of the science through an understanding of the concepts and to accurately evaluate the potential advantages and disadvantages of each scientific advance for various societies. In this context, strengthening the role of scientists while educating the policy makers and diplomats has become a critical issue. The main objective of the HSDI would be to mobilize expertise to enable diplomats and government representatives to participate fully and to make informed decisions on emerging issues where science and health (especially from the microbiology viewpoint) play an important role. The Initiative would provide succinct briefs on emerging microbio- logical science and technology issues and would analyze information from international treaties, and protocols and international initiatives and events.Â It would examine the current and future place of science and health diplomacy as a tool for advancing collective interests, with atten- tion to security and globalization issues.
134 APPENDIX C Proposals for pertinent training are expected for diplomats, scientists and policy makers to assist them in international negotiations (particu- larly those that take place under the UN and related organizations), with respect to the issues of emerging infections, biological diversity, biotech- nology, biosecurity, transfer of technology, trade, industry and sustainable development. T.S. Saraswathy Subramaniam Ministry of Health, Malaysia Current Research â¢ Acute Flaccid Paralysis Surveillance in Malaysia (Viral etiology and disease spectrum). â¢ HIVâImmunogenetic factors influencing disease progression Laboratory Biosafety and Biosecurity â¢ Chairperson, National Standards Sub-Committee reviewing Malay- sian Standards for Code of Practice for Safety in Microbiology Laborato- ries, 2008. â¢ Member, Expert Working Group, EWG-BWC, Ministry of Health Malaysia. â¢ Implementing programs for laboratory capacity and capability in biosafety and biosecurity at national level, code of ethics, practice or con- duct for scientists. â¢ Working Group preparing Guidelines for contained use of LMOs pursuant to Biosafety Act 2007. â¢ Secretary/Biosafety Officer, IMR Laboratory Biosafety & Biosecu- rity Committee. â¢ Implementing safe practices (documentation, manuals, guidelines) in biosafety at IMR. Terence Taylor International Council for the Life Sciences (ICLS) The Global Health and Security Initiative (GHSI) The Global Health and Security Initiative, a project of the Nuclear Threat Initiative (NTI), is working around the world to address the com- plex and multifaceted risks posed by biological agents. Infectious disease can emerge from many sources, afflicting humans and animals, or threat- ening the food and water supply. The biological threatâwhether from natural disease epidemics, the intentional use of pathogens for harm, or
APPENDIX C 135 the inadvertent release from a laboratory mishapâis a real and growing concern and challenges traditional ways of thinking about prevention, deterrence and response.Â Responding to the full spectrum of biological risks requires new thinking about how to identify and implement endur- ing solutions. GHSI seeks to raise awareness and leverage direct action through innovative partnerships and creative approaches to reducing these threats. A more secure world demands that gaps in the global public health capacity for rapid detection and response be addressed, as well as strengthening efforts to prevent the development and use of biological weapons. The two goals of the Initiative are to: 1. Promote the safe and secure practice of the life sciences by safe- guarding accessÂ to dangerous pathogens and preventing the misuse of technology and information. 2. Improve the global capacity for the prevention of and preparedness for biological threats through enhanced disease surveillance, in particular through early detection and response. Mission Approach and Funding Philosophy NTIâs Global Health and Security Initiative promotes threat reduc- tion solutions, raises public awareness, and undertakes sustainable direct action projects that demonstrate innovative ways to reduce threats. The majority of the Initiativeâs awards support operational activities that it has a strong hand in developing. The GHSI will undertake and support projects that: â¢ Address significant high-risk situations; â¢ Generate additional funding and leverage action for threat reduc- tion; and â¢ Promote the core objectives of the Global Health and Security Ini- tiative through sustained engagement. Projects Examples of projects currently under way to achieve the GHSI mis- sion include: â¢ Support for the International Council for the Life Sciences, which is the primary vehicle for GHSI in establishing and empowering standing national and regional networks for promoting best practices, standards and training in biosafety and security.
136 APPENDIX C â¢ Establishing and helping to maintain regional infectious disease surveillance consortia to improve their technical capacity in rapid detec- tion, identification and response to infectious disease outbreaks. The prin- cipal groups being supported at present are the Middle East Consortium for Infectious Disease Surveillance and, in cooperation with the Rock- efeller Foundation, the Mekong Basin Disease Surveillance Network. â¢ Support for specific facilities and individuals in Russia aimed at enhancing biological safety and security. A critical element in these strands is the engagement of all sectors of the life science community including academia, government and the pri- vate sector. Of particular importance is seeking and encouraging public/ private partnerships to bring novel technical solutions and approaches to help reduce biological risks along the full spectrum from naturally occur- ring events, through accidents or negligence in laboratories to deliberately induced disease outbreaks. For more information, please see www.ghsi.org and www.iclscharter.org. Ralf Trapp Independent consultant Ralph Trapp is an independent consultant on disarmament of chemi- cal and biological weapons. He advises the OPCW on the preparation of the Second CWC Review Conference and acts as legal coordinator of the European Union (EU) joint action in support of the BWC (working through the Biological Weapons Prevention Project in Geneva). Koos van der Bruggen Royal Netherlands Academy of Arts and Sciences A Code of Conduct for Biosecurity in the Netherlands: An Example to Be Followed? The Dutch Ministry of Education, Culture and Science asked the Royal Netherlands Academy of Arts and Sciences (KNAW) to provide it with advice and input for a national Biosecurity Code of Conduct for scientists, as recommended by the BWC, which was ratified in 1972. The request arose in part from the KNAWâs active contribution to the State- ment on Biosecurity issued by the InterAcademy Panel in 2005. If a code of conduct is to have the intended effect, it must reflect the experience and practice of the relevant actors. It was therefore decided to establish a focus group whose members would make comments and suggestions based on their practical experience as researchers and policy
APPENDIX C 137 makers. The first step of the project was to conduct a survey of measures already taken by central governments, fellow academies and research institutions in other countries, including the United States and the United Kingdom. A further survey was made of current legislation and existing codes of conduct for biotechnology and microbiology with relevance for biosecurity. The findings of these surveys were used to identify how the adoption of a code of conduct can help to ensure that biosecurity issues are effectively addressed in scientific research. The Dutch Biosecurity Code of Conduct, published in October 2007, is accompanied by an explanatory memorandum and a background review, which were also submitted to the working group and the focus group for comment. The aim of this code of conduct is to prevent life sciences research or its application from directly or indirectly contributing to the development, production or stockpiling of biological weapons, as described in the BWC, or to any other misuse of biological agents and toxins. Given this aim different target groups can be distinguished, varying from professionals engaged in the performance of biological, biomedical, biotechnological and other life sciences research to funding organizations and authors, editors and publishers of life sciences publications. The Code of Conduct on Biosecurity is intended to make all these groups aware of the potential dual use of the results of biological research and to make them follow some basic principles that can reduce the risks. How this process of this awareness raising on biosecurity issues can be organized will be elaborated and explained on the basis of the Dutch example. In the international context of the 2nd International Forum on Biosecurity attention will be paid to the question if and how the Dutch Code of Conduct on Biosecurity can be an example to be followed for other countries. Carrie Wolinetz Federation of American Societies for Experimental Biology (FASEB), United States FASEB Engagement in Dual Use Research Issues The Federation of American Societies for Experimental Biology com- prises 21 scientific societies representing more than 80,000 biomedical researchers. FASEBâs mission is to advance biological science through col- laborative advocacy for research policies that promote scientific progress and education and lead to improvements in human health. Our societiesâ members represent both basic and clinical researchers, primarily based in the United States but with a rapidly growing international membership as well.
138 APPENDIX C Dual Use/NSABB Subcommittee: FASEBâs policy development process occurs through its Science Policy Committee, which functions through subcommittees or working groups of experts. In response to the U.S. National Science Advisory Board on Biosecurityâs proposed oversight framework, FASEB formed a subcommittee to address dual use issues generally and the NSABB proposal specifically. The chair of that subcom- mittee, Dr. Avrum Gotlieb, participated in the November dual use meeting organized by the Polish Academy of Sciences (see above). The subcommit- tee and staff continue to monitor and respond to dual use issues as they arise and develop policy statements as appropriate. FASEB has worked to raise awareness of dual use research issues through periodic publications in society newsletters, as well as our own electronic newsletter. Related Activities: We have surveyed the FASEB leadership and mem- bership about dual use research issues and have found very low levels of awareness. Respondents suggested that scientific meetings would serve as a valuable outreach tool, although this conflicts with our experience. Typically, the attendance at policy sessions during society meetings is fairly low. Moreover, FASEB member societies have their own priorities for the limited policy sessions at scientific meetings and dual use research was identified as a low policy priority. FASEB has supplied a number of informative articles on dual use research and the activities of NSABB for society newsletters, as well as our own electronic newsletter, the FASEB Washington Update. In addition, FASEB has been actively engaged indi- vidually and with coalition partners in policy development on a number of related issues, including deemed exports, visa issues, and Select Agent regulations. The InterAcademy Panel on International Issues (IAP) The IAP, founded in 1993, is a global network of 100 science acad- emies in partnership designed âto help its members develop the tools they need to participate effectively in science policy discussions and decision making.â The current co-chairs are Chen Zhu (Minister of Health, China) and Howard Alper (RSC: The Academies of Arts, Humanities and Sci- ences of Canada). More information can be found on the IAP Web site at http://www.interacademies.net/. The IAP Executive Council established a Biosecurity Working Group (BWG) in 2004 to coordinate its activities in this area; its members are the academies of China, Cuba, the Netherlands (chair), Nigeria, the United Kingdom, and the United States. The BWG has undertaken a number of activities related to dual use issues. In March 2005, the IAP, the International Council for Science (ICSU), the InterAcademy Medical Panel (IAMP) and The National Academies of
APPENDIX C 139 the United States hosted the International Forum on Biosecurity in Como, Italy. The Forum was designed to serve as a convening and coordinating mechanism to share information about activities under way or being planned and to broaden the debate and advance the awareness in the life sciences and biomedical research communitiesâand in the international scientific community more generallyâabout the challenges posed by the âdual useâ dilemma. In December 2005, the IAP released a Statement on Biosecurity, which has been endorsed by over 70 national science academies. The statement provides principles for academies and other scientific bodies preparing codes of conduct that address five fundamental issues facing scientists working in the biosciencesâawareness; safety and security; education and information; accountability; and oversight. In September 2006, IAP, ICSU, and the Royal Society hosted the work- shop Scientific and Technological Developments Relevant to the Biologi- cal and Toxin Weapons Convention. The workshop brought together 84 scientific and policy experts from 23 countries to consider recent develop- ments in the biosciences and their potential implications. A statement and report were produced from the meeting that aimed to inform delegates at the Sixth Review Conference of the BWC. The InterAcademy Medical Panel (IAMP) The InterAcademy Medical Panel, a global network of academies of science and medicine, is committed to improving health world-wide. Â Â Cur- rently the IAMP has 64 members; more information can be found on its Web site (http://www.iamp-online.org/). The current co-chairs are Guy de ThÃ©, AcadÃ©mie de MÃ©dicine, France, and Anthony MBewu, Academy of Sciences of South Africa. Â Its activities focus on institutional collaboration to strengthen the role of all academies to alleviate the health burdens of the worldâs poorest people; build scientific capacity for health; and pro- vide independent scientific advice on promoting health science and health care policy to national governments and global organizations. The International Union of Biochemistry and Molecular Biology (IUBMB) The International Union of Biochemistry and Molecular Biologyâ founded in 1955âunites biochemists and molecular biologists in 66 countries that belong to the Union as Adhering or Associate Adhering Bodies, representing biochemical societies, national research councils, or academies of sciences. The IUBMB is devoted to promoting research and
140 APPENDIX C education in biochemistry and molecular biology throughout the world and gives particular attention to areas where the subject is still in its early development. It achieves this in several ways. Every three years the IUBMB sponsors an International Congress of Biochemistry and Molecular Biology. Cosponsorship of these Congresses by Regional Organizations of Biochemistry and Molecular Biology is an increasing trend. These Congresses are major international meetings where current research in all fields of biochemistry and molecular biology is considered. Thousands of individual research projects are presented in poster sessions and leading investigators from many nations survey their fields and describe their own research in symposia and plenary lectures. Since 1992 IUBMB has also sponsored IUBMB Conferences and Special Meetings, held in the years between the International Congresses. The IUBMB provides financial support for international symposia on biochemical and molecular biological research topics of current interest. It organizes or sponsors workshops, symposia and training sessions on bio- chemical and molecular biological education and provides free textbooks and journals to training institutions in developing nations. The IUBMB also funds short-term fellowships for younger biochemists and molecular biologists to travel to other institutions to perform research not possible in their own laboratories, and provides Travel Fellowships for young sci- entists to attend its Congresses. Sponsorship of meetings and fellowships is restricted to regions that belong to the IUBMB. As well as reaching biochemists through its own meetings, the IUBMB works closely with the four regional organizations that unite the bio- chemical societies of Asia and Oceania (Federation of Asian and Oceanian Biochemists and Molecular Biologists), Europe (Federation of European Biochemical Societies) the Americas (Pan-American Association for Bio- chemistry and Molecular Biology) and Africa (Federation of African Soci- eties of Biochemistry and Molecular Biology). Indeed all four are linked formally with the IUBMB as Associated Regional Organizations and three of them receive substantial financial support from the IUBMB. The Inter- national Federation of Clinical Chemistry and Laboratory Medicine, the International Society for Neurochemistry, the International Organization for Free Radical Research, and the International Society of Vitamins and Related Biofactors are also Associated Organizations of IUBMB. Reaching individual biochemists is also the purpose of another very important function of the IUBMB, that of publishing news, reviews, infor- mation, original research, and nomenclature. Trends in Biochemical Sciences (TiBS) is seen monthly by over 100,000 readers, keeping them informed of research progress across the broad field of biochemistry and molecular biology, as well as of news of meetings, people and biochemical events. Biotechnology and Applied Biochemistry publishes original research find-
APPENDIX C 141 ings and reviews in the expanding domain of the practical applications of the subject. IUBMB Life expedites the publication of short communica- tions, identified by their novelty and the need for urgent dissemination. Biochemistry and Molecular Biology Education is dedicated to publishing articles, reviews and editorials to assist the teaching of biochemistry and molecular biology to science and medical students throughout the world. BioEssays, cosponsored by the IUBMB and seven other ICSU biological Unions, is the monthly current-awareness journal that displays progress across the fields of molecular, cellular and developmental biology. BioFacÂ tors publishes reviews and original communications on growth factors and regulatory substances. Molecular Aspects of Medicine publishes reviews that aim to link clinicians and biomedical scientists. The IUBMB is one of 29 Scientific Unions affiliated with the Interna- tional Council of Science, an umbrella organization for scientists world- wide. ICSU was created in 1931 to encourage international scientific activity, to affirm the rights of scientists without regard to race, religion, political philosophy, ethnic origin, sex or language to join in international scientific affairs for the benefit of mankind. The IUBMB has been a mem- ber of ICSU since 1955 (until 1991 as IUB). The IUBMB representative serves as a member of the General Assembly of ICSU and ex-officio takes part in the work of the ICSU working group of the Biological Sciences. Through ICSU the IUBMB has been able to generate broad and often highly productive contacts with other international bodies, including some joint programs. Further information is available online at www.iubmb.org. The International Union of Biological Sciences (IUBS) The International Union of Biological Sciences is a non-governmental, non-profit, scientific network founded in 1919. The membership of IUBS presently consists of 44 Ordinary Members, adhering through Academies of Sciences, National Research Councils, national science associations or similar organizations, as well as 80 Scientific Members, all of which are international scientific associations, societies or commissions focusing on a wide array of biological disciplines. IUBS was one of the founding unions of the International Council for Science, and IUBS continues to contribute to the work of ICSUâs scientific committees and programs. The objectives of the IUBS are: to promote the study of biological sciences; to initiate, facilitate and coordinate research and other scientific activi- ties necessitating international, interdisciplinary cooperation; to ensure the discussion and dissemination of the results of cooperative research, particularly in connection with IUBS scientific programs; and to support
142 APPENDIX C the organization of international conferences and assist in the publica- tion of their reports. IUBS organizes triennial General Assemblies, which are flanked by a scientific symposium organized in cooperation with the National IUBS Committee of the host country. It also conducts scientific programs, which currently include Biological Diversity, Integrative Biol- ogy, Biological Education, Bioethics, Integrative Climate Change Biology, Bio-Energy, Biology & Traditional Knowledge and the 2009 Darwin Cel- ebration Year. IUBS publications include the quarterly periodical Biology International, the IUBS Monograph Series, the Methodology Manual Series and the Proceedings of the General Assemblies. Further information is available online at www.iubs.org. The International Union of Microbiological Societies (IUMS) The International Union of Microbiological Societies is one of the 29 Scientific Unions of ICSU. It was founded in 1927 as the International Soci- ety of Microbiology, and became the International Association of Micro- biological Societies affiliated with the International Union of Biological Sciences (IUBS) as a division in 1967. It acquired independence in 1980 and became a Union Member of ICSU in 1982. IUMS currently has 113 member societies and 14 associate members representing well over 100 countries. Members are National Societies and Associations for Microbi- ologists and associate members are other institutions with an interest in microbiological and connected sciences. The objectives of the Union are to promote the study of microbiologi- cal sciences internationally: initiate, facilitate and coordinate research and other scientific activities that involve international cooperation; ensure the discussion and dissemination of the results of international conferences, symposia and meetings and assist in the publication of their reports; rep- resent microbiological sciences in ICSU; and maintain contact with other international organizations. The major goal of IUMS is to promote research and the open exchange of scientific information for advancement of the health and welfare of humankind and the environment and strongly discourages any uses of knowledge and resources to the contrary. In particular, the IUMS strives to promote ethical conduct of research and training in the areas of bio- security and biosafety so as to prevent use of microorganisms as biological weapons and therefore to protect the publicâs health and to promote world peace. IUMS seeks that all its member societies adopt or develop a Code of Ethics to prevent misuse of scientific knowledge and resources. The IUMS Code of Ethics Against Misuse of Scientific Knowledge, Research and Resources is available from the IUMS Web site at http://www.iums.org/
APPENDIX C 143 about/about_us-Codeethics.html. The Code has been approved by the Execu- tive Board and the approval of the member societies has been requested. Further information is available online at: www.iums.org. The International Union of Pure and Applied Chemistry (IUPAC) The International Union of Pure and Applied Chemistry serves to advance the worldwide aspects of the chemical sciences and to contrib- ute to the application of chemistry in the service of humankind. As a scientific, international, nongovernmental and objective body, IUPAC can address many global issues involving the chemical sciences. IUPAC was formed in 1919 by chemists from industry and academia. Over nearly nine decades, the Union has succeeded in fostering world- wide communications in the chemical sciences and in uniting academic, industrial and public sector chemistry in a common language. IUPAC has long been recognized as the world authority on chemical nomenclature, terminology, standardized methods for measurement, atomic weights and many other critically evaluated data. The IUPAC continues to spon- sor major international meetings that range from specialized scientific symposia to CHEMRAWN (CHEMical Research Applied to World Needs) meetings with societal impact. During the Cold War, IUPAC became an important instrument for maintaining technical dialogue among scientists throughout the world. IUPAC is an association of bodies, National Adhering Organizations, which represent the chemists of different member countries. There are 45 National Adhering Organizations, and 20 other countries are also linked to IUPAC in the status of Associate National Adhering Organizations. Almost 1,000 chemists throughout the world are engaged on a voluntary basis in the scientific work of IUPAC, primarily through projects, which are components of eight divisions and several other committees. Further information is available online at: www.iupac.org. The International Union for Pure and Applied Biophysics (IUPAB) The International Union for Pure and Applied Biophysics is a mem- ber of the ICSU family. Affiliated to it are the national adhering bodies of 50 countries. Its main objectives are to support research and teaching in biophysics, promote communication between the various branches of biophysics and allied subjects, and to encourage cooperation between the societies that are interested in the advancement of biophysics in all of its aspects.
144 APPENDIX C In order to achieve these objectives, the Union organizes triennial International Congresses and General Assemblies, which will next be held in China in 2011. IUPAB has four Task Forces concerned with major areas of biophysics: Bioinformatics, Capacity Building and Education in Biophysics, Nuclear Magnetic Resonance in Biological Sciences, and Bio- medical Spectroscopy. The Task Forces also arrange specialist meetings either associated with the Congresses or, more commonly, in the intervals between Congresses. The Union also supports conferences, schools and workshops, with priority given to events that will promote biophysics in the developing countries and that will facilitate the participation of young scientists in the conferences that it supports. Further information is available online at www.iupab.org. The National Academies The National Academies of the United States comprises the National Academy of Sciences (NAS), the National Academy of Engineering (NAE), the Institute of Medicine (IOM) and the National Research Council (NRC).Â Some of the most relevant international Biosecurity work includes: â¢ The International Biosecurity Project works to promote imple- mentation of the international recommendations of the 2004 NRC report Biotechnology Research in an Age of Terrorism. A collaboration among sev- eral units at the National Academies, the projectâs overarching goal is to develop and promote more effective international strategies to reduce the risk that advances in life sciences research could be misused. A key ele- ment involves working with international partnersâother academies and international scientific organizations, as well as a wide range of intergov- ernmental and nongovernmental organizations. â¢ The Biological Threats Panel brings together National Academy of Sciences Committee on International Security and Arms Control (CISAC) and non-CISAC experts to address the scientific and technical dimensions of biological weapons, bioterrorism, issues related to successful imple- mentation of the Biological and Toxin Weapons Convention, biosecurity, and other contemporary challenges related to rapid growth in biotech- nology. The Panel coordinates across the Academies with ongoing efforts and develops its activities in partnership programs inside and outside the Academies. The Biological Threats Panel continues work started in 1986 by CISAC's Biological Weapons Working Group (BWWG), whose initial focus was on continuing concerns about Soviet compliance with the Bio- logical Weapons Convention. In the mid-1990s the BWWG played a lead- ing role in fostering U.S. government support for cooperative research programs between American scientists and scientists from former Soviet
APPENDIX C 145 biological weapons research institutes. Recently CISACâs Biological Threats Panel has established counterpart groups through the Russian Academy of Sciences CISAC and with the Chinese Biological Scientistâs Group of the Chinese Peopleâs Association of Peace and Disarmament. â¢ The Board on International Scientific Organizations (BISO) exam- ines issues related to the conduct of science, evaluates opportunities for international collaboration in scientific research, and strengthens U.S. participation in international scientific, engineering, and medical organi- zations. The Board also oversees a network of more than 20 U.S. national committees corresponding to ICSU scientific member bodies, seeks com- mittee input on issues confronting ICSU and its bodies, and informs them of the input NAS is considering in its role as a national member of ICSU. Scientific unions in the biological and chemical sciences with which BISO is involved include IUBS, IUBMB, IUMS, IUPAB, IUPAC, and others. Further information about The National Academies can be found at http://nationalacademies.org/. Information about its work in biosecurity can be found at http://www7.nationalacademies.org/biosecurity/.