2
Plenary and Working Group Presentations and Discussions

SUMMARY OF PLENARY PRESENTATIONS

Plenary 1:
Introduction to the Forum

The plenary discussions at the 2nd International Forum on Biosecurity began with an overview of the issues to be dealt with during the meeting. Roderick Flower (William Harvey Research Institute, Queen Mary, University of London) introduced the Forum and highlighted the goals, objectives, and structure of the meeting. He placed the 2nd Forum into the context of a selected time line of international biosecurity initiatives undertaken since 2001, including release of several influential studies, convening the 1st International Forum on Biosecurity in 2005 and a Royal Society-hosted meeting in 2006, production of the Statement on Biosecurity by the InterAcademy Panel on International Issues (IAP) and the development of further initiatives such as a code of conduct for biosecurity produced by the Royal Netherlands Academy of Arts and Sciences (KNAW) in 2007. The talk highlighted the progress made by the international scientific community in considering dual use issues in the life sciences, the challenges that remained to be addressed, and some of the opportunities that might be presented by the current intersessional process of the Biological and Toxin Weapons Convention (BWC).

Robin Coupland (International Committee of the Red Cross [ICRC]), Ottorino Cosivi (World Health Organization [WHO]), and Alexandre Bartsev (Organisation for Economic Co-operation and Development [OECD]) next formed an introductory panel to provide further context in



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2 Plenary and Working Group Presentations and Discussions SuMMARy OF PLENARy PRESENTATIONS Plenary 1: Introduction to the Forum The plenary discussions at the 2nd International Forum on Bio- security began with an overview of the issues to be dealt with during the meeting. Roderick Flower (William Harvey Research Institute, Queen Mary, University of London) introduced the Forum and highlighted the goals, objectives, and structure of the meeting. He placed the 2nd Forum into the context of a selected time line of international biosecurity ini- tiatives undertaken since 2001, including release of several influential studies, convening the 1st International Forum on Biosecurity in 2005 and a Royal Society-hosted meeting in 2006, production of the Statement on Biosecurity by the InterAcademy Panel on International Issues (IAP) and the development of further initiatives such as a code of conduct for biosecurity produced by the Royal Netherlands Academy of Arts and Sciences (KNAW) in 2007. The talk highlighted the progress made by the international scientific community in considering dual use issues in the life sciences, the challenges that remained to be addressed, and some of the opportunities that might be presented by the current intersessional process of the Biological and Toxin Weapons Convention (BWC). Robin Coupland (International Committee of the Red Cross [ICRC]), Ottorino Cosivi (World Health Organization [WHO]), and Alexandre Bartsev (Organisation for Economic Co-operation and Development [OECD]) next formed an introductory panel to provide further context in 2

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2 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY which to locate the Forum discussions and possible frameworks within which to consider dual use life sciences issues. Drs. Coupland and Cosivi focused on public health approaches to the potential risks posed by the misuse of products of life sciences and bio- technology, particularly infectious microorganisms. Both the ICRC and the WHO have focused their efforts on analyzing risk factors, effects, and preventive measures. The ICRC has developed the concept of a “web of prevention,” in which complementary and interacting efforts from multi- ple stakeholders combine to offer protection from an outbreak of disease. The presentation drew an analogy to the multiple layers of protection that help prevent or reduce injuries from fires, including smoke alarms, flame-retardant materials, sprinkler systems, and dedicated fire depart- ments. The talk also highlighted the role of the scientific community in fostering a safety and security culture and in raising awareness among scientists of potential risks related to the development, production, and delivery of microbial agents. Ottorino Cosivi provided Forum participants with a complementary framework used by the WHO in considering global health security. This consisted of a series of interlocking puzzle pieces representing contribu- tions from the areas of ethics, policy, collaborations and support, and labo- ratory safety and security, which together combined to form the norms, standards, and supporting activities to help manage health security risks. Risk management in this public health context could also be viewed as a matrix in which diverse actors on individual to international levels (including scientific associations, public health laboratories, publishers, funding partners, security communities, and the public) each undertake a range of activities to address components of this puzzle. As an intergovernmental body, WHO has focused many of its efforts on assisting member countries by working to develop risk assessment methodologies and to produce a tool kit of resources with multiple risk management options. WHO has formed a scientific working group on life science research and global health security that recommended five areas for action: education and training, disease outbreak preparedness, risk assessment methodology development, stakeholder engagement, and capacity building.1 WHO held a regional workshop in Thailand in Decem- ber 2007 that recommended further actions by both WHO and its member countries in many of these areas. 2 1 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_. 2 Research Policy and Management of Risks in Life Science Research for Global Health Security, Bangkok, Thailand, December 10-12, 2007.

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2 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS Finally, Alexandre Bartsev spoke to the Forum about how OECD has incorporated biosecurity into several of its recent initiatives. The OECD considers having effective biosecurity procedures to be an enabling tool for economic development and innovation in science and technology. It supports the concept of Biological Resource Centers (BRCs) serving as important repositories of materials and information and has devel- oped best practice guidelines for biosecurity at such Centers. 3 The OECD guidelines address maintenance, access, and distribution of biological materials held in BRC collections; the guidelines include recommenda- tions for undertaking risk assessments and for developing risk manage- ment procedures for pathogens with dual use potential. While the OECD currently consists of 30 industrialized nations, additional countries are in the process of accession and this organization has increased engagement with other rapidly developing countries, including China, India, and Brazil. OECD member countries will report to the Council in 2010 on the implementation of the BRC biosecurity guidelines; the OECD considers prospective member countries’ implementation of relevant OECD acts and guidelines, including those on BRC biosecurity, as part of the acces- sion process. To assist member countries, the OECD will convene an inter- governmental forum to consider some of the issues remaining with regard to biosecurity risk assessments for microorganisms, including assessment methodologies, how to share and communicate assessments, how to con- sider local differences in risks and how to balance governance, so as to best enable continued science and technology innovation. Looking to the future, the OECD plans to hold a workshop in 2009 with the U.S. National Science Foundation. The workshop will focus on the biosecurity implica- tion of emerging technologies such as synthetic biology, and will explore ways to incorporate biosecurity practices into the internationally mobile scientific workforce. Plenary 2: Emerging Life Science and Technology: Challenges and Opportunities for Biosecurity The second plenary session of the Forum also looked to the future of the life sciences and addressed some selected highlights of recent scientific work. The three panelists for this session were Jason Chin (Cambridge University), Jörg Stelling (ETH-Zurich), and Jane Calvert (Edinburgh University). 3 OECD (Organisation for Economic Co-operation and Development). 2007. OECD Best Practice Guidelines on Biosecurity for BRCs (Biological Resource Centers). Paris: OECD. Available at: http://www.oecd.org/dataoecd//27/87782.pdf. Accessed December 11, 2008.

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2 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY Jason Chin spoke to the Forum about some of his work in synthetic biology, particularly on designing biological entities with new functions. He explained that the complexity of biological systems has led synthetic biologists to seek ways to reduce some of this complexity and introduce design principles by creating discrete modules to perform particular func- tions. The hope is that such modules could then be built up into larger assemblies to perform larger and more complicated functions. Analo- gies can be drawn to building circuits from combinations of resistors and capacitors, and then assembling such circuits into more and more complicated systems until a computer is constructed. Discrete biological modules have already been created to function as on/off toggle switches, oscillators, and edge detectors, for example. Although synthetic biology is still a fairly new field, it builds on advances in areas such as molecular biology and genetics and in technolo- gies such as rapid DNA synthesis. Improvements in rapid DNA synthesis and assembly and in the fidelity of synthesized and amplified DNA are both important developments for synthetic biology, allowing functional DNA products to be generated from databases or novel sequences. Tech- niques for generating mutations within DNA and for selecting mutations that lead to desirable phenotypes are also useful. However, the success rate is still very low and there are still limits on the DNA that can be suc- cessfully encapsulated into particular cell membrane shells. With further technological developments, the creation of a synthetic bacterium may be only several years away. However, Dr. Chin highlighted the conceptual difference between modifying something that already exists and creating something totally new. Jörg Stelling continued the discussion by considering the ways in which bioinformatics and computational tools contribute to designing new systems in biology, and the limits of these tools. The desired charac- teristics of a designed synthetic circuit include robustness (insensitivity to perturbations and noise), stability within the context of a biological system, tunability to control desired properties, and construction feasibil- ity. Dr. Stelling highlighted two large challenges that remain in working with biological systems—the complexity of such systems and the still incomplete characterization of all of the system components and their properties. Dr. Stelling presented a time-delay-switch circuit as an example. He compared a representation of a simple electronic circuit diagram with the biological version that consists of multiple interacting modules with overlapping functions. Principles of computational modeling and design can produce mathematical equations to describe how to characterize and fine-tune the biological “circuit,” but they are complicated by the pres- ence of unknown parameters, lack of quantitative characterization for many components, and nonlinear behavior. Although such model-based

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27 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS rational design of complete biological circuits is feasible in principle, it is currently only possible for simple designs. Rational, computational model-based design in biology poses some challenges that are new com- pared to traditional engineering disciplines. The expression of biology in terms of mathematical equations scalable to more complex systems remains the key challenge. The presentation ended with a quotation from the statistician G.E. Box that “all models are wrong; the practical question is how wrong do they have to be to not be useful.” Finally, Jane Calvert addressed the Forum to place some of the devel- opments in systems and synthetic biology into the broader context of changes in the life sciences. Dr. Calvert highlighted how systems biology, which studies the ways in which molecules work together in complex systems, opened the path to synthetic biology which aims to create and build new organisms. Both fields also consider the concept of modularity, where a discrete component is separated and studied from its surround- ing environment, leading to a goal in synthetic biology, standardized bio- logical parts. However, biological systems may also display principles of “emergence,” where a system’s properties may turn out to be greater than the sum of the properties of its individual components. This property may then complicate the synthetic design goals of creating systems by linking together individual parts. A fundamental question also remains regarding the extent to which biology, with its inherent complexity and “messiness,” can be made into a fully quantitative field analogous to other branches of traditional engineering. Dr. Calvert stressed that both fields of systems and synthetic biology have become highly interdisciplinary and can draw on expertise outside of traditional life sciences departments. The presen- tation raised the question of whether new types of academic structures would be needed to house this type of cross-disciplinary research. The new developments in these fields also raise interesting questions about data sharing and intellectual property. Electronic information, such as DNA sequences or computer code, is often the material being shared rather than physical samples. An “open source” ethic currently exists in some parts of the field, embodied by groups such as the BioBricks Reg- istry of biological parts. Having such open source biological information available to the research community might speed developments in the field in the same way that an open-source computer code can speed com- puter software developments. Another interesting question to consider is how easy synthetic biol- ogy currently is for nonexperts to perform. Despite the successes achieved in student competitions such as iGEM,4 practical applications remain 4 The 2008 International Genetically Engineered Machine (iGEM) competition Web site is available at: http://2008.igem.org. Accessed December 11, 2008.

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28 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY some time away and, as the two previous presenters also highlighted, the inherent complexity of biological systems remains a great challenge. How- ever, the synthetic biology community has taken several steps to openly discuss and write about potential risks that might be posed by techno- logical developments in the field. Ethics-related sessions are included at the annual International Meeting on Synthetic Biology (SynBio), and the social science community has engaged the scientific community in considering the issues posed. In general synthetic biologists favor a self- governance model. However, such self-governance may not be as accept- able to all members of the NGO and public communities, some of whom have called for having a more inclusive public debate on the technologies and have pointed to a need to develop additional strategies to manage the potential risks that could arise from this technology. Plenary 3: Introduction of the Breakout Sessions After listening to the introductory panel survey several possible ways that the international community might think about life sciences and biosecurity issues, and also to the presentations highlighting scientific advances in emerging fields such as computational, systems and synthetic biology, the Forum participants considered the topics of the three working groups: (1) education and awareness, (2) oversight models, and (3) science advising. The chairs of each working group briefly summarized the objec- tives for their groups as well as some recent developments of relevance to their topics, so that all Forum participants would have a good sense of the workshop themes. Leiv Sydnes (University of Bergen and past President of the Interna- tional Union of Pure and Applied Chemistry [IUPAC]), Chair of working group 1 on education and awareness-raising, spoke on building a culture of responsibility. He highlighted some of the links between chemistry and biology and spoke of several ways in which the Chemical Weapons Con- vention (CWC) has brought chemical safety and security responsibilities into greater focus for practicing chemists. Industry initiatives including Responsible Care,5 REACH,6 and SAICM,7 have also contributed to a greater emphasis on chemical safety and will lead to enhanced under- standing of the toxicology of many chemicals being used. There has also been a greater focus on chemical safety and security as part of university 5 More information is available at: http://www.responsiblecare.org. Accessed December 11, 2008. 6 Registration, Ealuation, Authorisation and Restriction of Chemical Substances. Available at: http://ec.europa.eu/enironment/chemicals/reach/reach­intro.htm. Accessed December 11, 2008. 7 Strategic Approach to International Chemicals Management. Available at: http://www.chem. unep.ch/saicm/. Accessed December 11, 2008.

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2 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS chemistry education than has been the case in biology. Dr. Sydnes spoke of the need for collective understanding and acceptance of the reasons for building a culture of responsibility among practicing scientists to make such a culture an integral part of each given discipline. He highlighted several features of an effective culture of responsibility, including: wide- spread acceptance of the scientific basis for professional responsibility; risk assessment as an integrated aspect of the profession; the inclusion of ethics; and continuous evaluation and adjustment as necessary. He con- cluded by suggesting several types of educational measures that might contribute to the development of cultures of responsibility, including greater focus on ethical considerations as part of school curricula at mul- tiple levels, and greater incorporation of risk assessments into research projects as appropriate. In a similar manner, he suggested that greater awareness of the BWC and CWC and their implications might be useful tools to help educate both chemical and biological scientists. David Franz (Midwest Research Institute), Chair of working group 2 on oversight models, spoke to the Forum next. Dr. Franz emphasized that the key challenge in considering standards and methods for research oversight is to protect scientific creativity and discovery, while simulta- neously reducing the chances of the misuse of science to cause harm. He then explained the background of the creation and mission of the U.S. National Science Advisory Board for Biosecurity (NSABB), an advisory group created by the U.S. government and managed by the National Institutes of Health (NIH). The NSABB consists of 25 voting members appointed by the Secretary of Health and Human Services, and its charges include making recommendations to the U.S. government on criteria for identifying dual use research of concern (DURC), guidelines for over- sight of dual use research, needs in biosecurity education, creation of a scientific code of conduct, policies governing publication, communication and dissemination of dual use research, and strategies for engaging the international community in a dialogue on dual use biology research.8 The NSABB undertakes its mission through working groups on these various topics, and holds periodic public meetings to discuss the issues and prog- ress. Dr. Franz presented the definitions of dual use research and dual use research of concern adopted by the NSABB, as well as highlights from the Draft Proposed Framework for the Oersight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information sub- mitted by the NSABB to the U.S. government.9 This document considers 8 More information about the NSABB is available at: http://oba.od.nih.go/biosecurity/. Ac- cessed on December 13, 2008. 9 Available at: http://oba.od.nih.go/biosecurity/pdf/Fframework%20for%20transmittal%200807_ Sept07.pdf. Accessed December 11, 2008. DURC is a more limited category than the NSABB’s original charter, which was intended to cover general issues related to dual use research.

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0 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY DURC to be only a small subset of dual use research. Oversight should focus on effective identification of such research followed by responsible conduct of research and dissemination of research results, not on prohib- iting or restricting the research itself from being carried out. He raised several broad questions for working group 2 to consider, including what was needed versus what was being done, key international challenges, and areas of scientific consensus. He concluded with a suggestion that perhaps consensus could be found on the global nature of science, the rapid pace of scientific developments and the many benefits provided by these scientific advances, the need for a culture of responsibility and awareness, and the need for multiple approaches to address biosecurity and dual use issues. Finally, Angelo Azzi (Tufts University and President of the Interna- tional Union of Biochemistry and Molecular Biology [IUBMB]), Chair of working group 3, spoke about the roles of the scientific community in providing advice on biosecurity policy issues. Dr. Azzi explained that IUBMB, like IUPAC, was interested in codes of conduct. He suggested that life science organizations consider drafting a universal code of conduct as a unique document to be made available to everyone. He explained that IUBMB has used science as a vehicle to reach out to many countries including Iran, where IUBMB recently held a conference. IUBMB can also help contact and inform publishers and journal editors about these issues. Dr. Azzi also emphasized that it is important to present a clear case as to why the life sciences community is undertaking work on bios- ecurity issues. Bertrand Russell and Albert Einstein, for instance, were motivated to write their Manifesto in reaction against the proliferation of the hydrogen bomb. Dr. Azzi suggested that the community could create similar statements to better illustrate the level of danger from dual use biotechnology. He also suggested that realistic scenarios and better risk assessment tools could be helpful in presenting the problem. The concept of biosecurity can be used to move from a culture of fear to a culture of peace. Plenary 4: Awareness About and Attitudes Toward Biosecurity Plenary session 4 explored the results of several recent projects. Li Huang (Chinese Academy of Sciences [CAS]) discussed the history of biosecurity activities through the IAP, including the production and dis- semination of the 2005 IAP Statement on Biosecurity. The IAP, then consist- ing of 93 academies of science throughout the world, formed a Biosecurity Working Group (BWG) in 2004 composed of the academies of science of China, Cuba, the Netherlands, Nigeria, the United States, and the United Kingdom. The working group drafted a biosecurity statement, which

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 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS was launched in 2005, and has been endorsed by 69 of the IAP member academies (see Appendix D). It has also cosponsored several meetings including the first and second International Forums on Biosecurity, is planning to conduct biosecurity surveys in sub-Saharan Africa, and is developing an online biosecurity resource tool kit for member academies to help further their own national activities. The BWG followed up the biosecurity statement launch by conduct- ing two surveys of IAP member academies to examine ways in which academies have made use of the statement. The IAP statement consisted of a set of guiding principles that should be considered in developing biosecurity codes of conduct; and the results of the two surveys show that it has been translated into 8 languages, has been posted on numerous academies’ Web sites, and presented to national authorities by 20 acad- emies. Furthermore, seven academies have subsequently developed their own code of conduct and others have held conferences on topics related to biosecurity. Dr. Huang also reported to the Forum several of the issues that the IAP BWG had encountered as it developed and disseminated the biosecu- rity statement. Some member academies felt that biosecurity as conceived in the IAP statement was not a high priority, or that natural biorisks were of far greater immediate concern than was laboratory biosecurity. Issues were also raised about risks from possible restrictions on sharing bio- logical knowledge and information, and that such restrictions would be counterproductive to the goal of global biosecurity. In addition, there was concern about confusion over biosecurity terminology stemming from differing understandings and uses of the term. Dr. Huang reported on recent initiatives from the CAS as an exam- ple of one academy that has undertaken additional biosecurity-related activities. The CAS has established biosafety committees and training programs at each of its life science institutes, has actively participated in international biosecurity discussions through groups such as the IAP and the WHO, and through two workshops: the CAS-COMEST symposia on ethics in science in Beijing and Shanghai in 2005,10 and the upcoming international biosecurity workshop to be held in Beijing in late 2008. The U.S. National Academies also has an active program of engage- ment in biosecurity activities. Recently, for example, the National Acad- emies and the American Association for the Advancement of Science (AAAS) undertook a survey project on scientists’ attitudes about bio- security. Ronald Atlas (University of Louisville) served as the chair of the 10 COMEST is the World Commission on the Ethics of Scientific Knowledge and Technol- ogy of the United Nations Educational, Scientific, and Cultural Organization (UNESCO). More information on CAS activities is available at: http://english.cas.cn/.

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2 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY National Academies committee undertaking this work, and spoke to the Forum about the project. 11 The study was undertaken to help address the lack of quantitative data on life scientists’ attitudes toward biosecurity and dual use biology. By conducting surveys to gauge scientists’ views on potential biosecurity risks and the roles that various groups should play, and then relating these to particular subpopulation demographics, the study committee hoped to enable the design of effective methods to engage these various groups of life scientists in biosecurity concerns. The Web-based survey was conducted on a sample of 10,000 life scientist members of AAAS. Questions on the survey assessed respon- dents’ perceptions of: the risk of bioterrorist acts, whether the respondent believed that the current research that he/she conducted was dual use, acceptance of options to address potential dual use issues, whose respon- sibility it should be to address such issues, and whether the respondent had personally taken any actions in response to concerns about dual use research. The 20 percent response rate (typical of Web-based surveys) lim- ited the ability to generalize from the results. However, Dr. Atlas reported that the study committee was currently analyzing interesting trends in the data and looked forward to the public release. When finalized, the report will be made available on the National Academies Web site.12 Finally, Brian Rappert (University of Exeter) spoke about the project that he and Malcolm Dando (University of Bradford) had been undertak- ing along with additional international colleagues. The project explores the construction of effective biosecurity education methods, the purposes of such education, and how education might best engage its intended audiences. To help answer such questions, multiple seminars have been conducted in locations around the world. At the time of the presentation the group had conducted 26 seminars in life sciences departments in the United Kingdom and had conducted more than 70 seminars in the United States, South Africa, the Netherlands, Finland, Japan, Israel, India, Argen- tina, Uganda, Kenya, Ukraine, and Australia. The seminars developed by the group seek to bring biosecurity dis- cussions directly to researchers and students, and are usually held as part of regular university departmental seminars. They are also structured 11 The Committee on Assessing Fundamental Attitudes of Life Scientists as a Basis for Biosecurity Education. More information is available at: http://www8.nationalacademies.org/ cp/projectiew.aspx?key=882. Accessed December 11, 2008. The report of the survey results and analysis was still in progress at the time of the Forum, and official results could not be released to the group. 12 Information about how to obtain the report, as well as information about other proj- ects and events, is available on the National Academies Biosecurity Web site http://www7. nationalacademies.org/biosecurity/.

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 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS to engage seminar attendees and to foster conversation about topics on which there may not be consensus, such as the extent to which publica- tion of dual use research should be restricted. Dr. Rappert reported on the broad results from the seminars. He indicated that, in general, partici- pants felt that potential dual use experiments should or would be done, that the publication of research results should not be restricted, and that additional oversight was unlikely to be viable or desirable. He further reported that the interactive nature of the seminars demonstrated the importance of the process of active discussion and deliberation, as most participants initially felt that biosecurity was not an important issue, but became more engaged with the issue through participation. The results highlight the need for further education and awareness raising. Finally, Dr. Rappert reported on continuing activities and initiatives in several of the countries visited as part of the seminar series, including the development of an educational module in South Africa and the imple- mentation of additional biosecurity legislation in Australia. Looking to the future, he concluded by suggesting that further dual use education could serve different purposes in different contexts. In countries where biosecu- rity concern is currently high, such education might help support national calls to action. In countries in which there is some degree of awareness of biosecurity, it might help promote partnerships among countries and promote existing resources. Finally, in countries with no current interest in biosecurity, education could serve as the means to raise the issue and begin the process of engagement. Plenary 5: The 2008 BWC Intersessional Meetings Ambassador Georgi Avramchev (Permanent Mission of the Republic of Macedonia to the United Nations Office at Geneva and Chair of the 2008 Meetings of the Biological Weapons Convention) described his vision for the upcoming BWC meetings. He emphasized the importance that he placed on including the voices of the international scientific community in the discussions. The Ambassador summarized the BWC provisions and described the current intersessional process, which has proven to be a valuable mechanism to address technical topics agreed on by States Parties to be of particular importance. Although the intersessional meet- ings do not negotiate international treaty commitments, they serve to help bridge differences of opinion among member states by promoting common understanding, discussion, and an atmosphere of collaboration. The meetings have also proven to be valuable in broadening the participa- tion and engagement of stakeholders beyond the diplomatic and security communities, and particularly expert communities in the life sciences, agriculture, public health, and education.

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 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY building. She also emphasized the interdisciplinary nature of many of the activities in which UNESCO is engaged and the collaborations that arise between various UNESCO divisions, UN sister agencies such as the FAO, the WHO, and partners in the nongovernmental community. Dr. Hoareau highlighted several UNESCO programs that might pro- vide opportunities to consider topics in biosecurity, bioethics, and bio- safety. For example, the UNESCO Division of Science Policy and Sustain- able Development works on policy guidelines and methodologies for the formulation of science policy, particularly to support sustainable devel- opment and peace. The Division of Basic and Engineering Sciences also maintains the International Basic Sciences Program, a platform for interna- tional cooperation; its aim is to strengthen national capacities in the basic sciences and science education. The ethics of science and technology is also a priority theme for UNESCO. John Crowley of UNESCO’s Social and Human Sciences Sector noted that UNESCO incorporates several poten- tially relevant initiatives including the Bioethics Program, COMEST, and the Global Ethics Observatory databases, which can serve as resources to the community and to member states. Recently, an interagency task group has also been established among WHO, FAO, and UNESCO on biotech- nology, and this might provide yet another forum to raise and discuss issues related to biosafety and biosecurity. During the group discussions, it was also pointed out that it could be useful if a statement from scientific bodies was made to the UNESCO Director General that further activities by UNESCO in the area of biosecurity would be relevant. WHO. Ottorino Cosivi had spoken during the first plenary session about the spectrum of risks posed to global health security in the 21st century and on efforts that WHO has made to support the elimination of chemical and biological weapons and to promote global health security. Although not making a second formal presentation to the working group, Dr. Cosivi further highlighted the need to speak about a range of biological risks and the likelihood that the prioritization of biological risks will vary from country to country. From this starting point more focused efforts could then be made on managing these risks. OECD. Alexandre Bartsev (OECD) also spoke to the Forum in Plenary 1 on the roles that the OECD has assumed in addressing both biosecurity and emerging technology. Within the working group, Dr. Bartsev contrib- uted several further comments on the ways in which biosecurity may help to create an environment of trust. This could, in turn, help promote indus- try investment as part of the cycle from basic science research through innovation. Addressing security issues could thus help to provide part of the enabling environment for research and development.

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 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS BWC Implementation Support Unit. As a complement to the plenary presen- tation delivered by Ambassador Avramchev, Chair of the 2008 BWC inter- sessional process Piers Millett (UN Office for Disarmament Affairs, BWC Implementation Support Unit) highlighted the desire to make the BWC process more inclusive and to continue to incorporate scientific input. He reported that scientists already had roles as members of the national del- egations from many of the larger member states. He noted that progress within the BWC has benefited from scientists participating as experts, and pointed to the ability of scientific side events to be organized in conjunc- tion with Convention meetings. International scientific bodies and NGOs may also attend sections of Convention meetings as observers, although Dr. Millett cautioned that there could be the perception that some NGOs might come with their own agendas, which could make member states suspicious of their motives and could make it harder to achieve goals. Biotechnology Research Center, Tripoli, Libya. The group heard a brief pre- sentation from Mohamed Sharif (Biotechnology Research Center). Libya has partnered with UNESCO and recently established the Biotechnology Research Center, as well as a Bioethics and Biosafety Committee. The Cen- ter has initiated collaborations with laboratories and institutions in other countries and was holding national conferences and training programs, while also focusing on issues of laboratory safety. Dr. Sharif highlighted the growth of the biological sciences around the world, and the value that counties with less-developed biological sciences initiatives derived from international collaborations as they worked to build their programs, and the need to provide training in both biological techniques and in labora- tory safety and ethics. OPCW and IUPAC. Ralf Trapp discussed the structure of the OPCW, which administers the Chemical Weapons Convention, and how science advising works in this context. The OPCW includes a Scientific Advisory Board composed of experts from States Parties to the Convention, and this provides an integrated mechanism to feed scientific input directly into the Convention review conferences. However, there was a desire to extend the source of science advice beyond the Scientific Advisory Board and to incorporate expert perspectives from the broader chem- istry community. IUPAC, as a neutral, international, nongovernmental body of chemists, was thus able to effectively partner with the OPCW and has hosted two workshops on trends in science and technology relevant to the CWC. One workshop was held in 2002 prior to the First Review Conference, and one was held in 2007 prior to the Second Review Conference (see Chapter 1). Dr. Trapp’s remarks pointed out an

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 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY opportunity in which an international science union was able to provide advice to a policy community in the context of a treaty organization. The partnership also catalyzed an internal process within IUPAC that has led to many further activities addressing issues related to dual use of chemicals and scientific responsibility. Uganda National Academy of Science (UNAS). Patrick Rubaihayo (UNAS) spoke to the group about a regional workshop UNAS organized in March 2008 on biosafety and security in the life sciences and on providing the opportunity for African scientists to have a voice in such discussions. In surveying existing Ugandan laws on biosafety, UNAS found that they did not address biosecurity concerns. The workshop raised the question of whether countries in East Africa need to adapt existing safety laws and/or create new legal and policy frameworks to capture aspects of biosecurity. Issues of enhancing compliance with existing regulations and incorporat- ing education on biosecurity were also raised. The workshop highlighted the need to reach a common understanding of the scope of biosafety and biosecurity. Although laboratory biosafety and biosecurity are required, workshop participants felt that the primary security risk within Africa arises from natural sources such as disease outbreaks, rather than from research facilities. The issue of intellectual property rights and concerns of biopiracy also loomed large for many African scientists, because of the lack of capacity on the continent and the need to form partnerships with more developed countries. Dr. Rubaihayo explained that the African participants wished to implement safety and security curricula and standards quickly in order to catch up with the developed world, but lacked infrastructural, human, and financial capacity; and they would need assistance in achieving these goals. He felt that it might be particularly valuable for the developed world to create educational and training materials that could be shared with the developing world to facilitate this process, and that the African science academies should assume more prominent roles in spearheading safety and security awareness and in advising their governments. Royal Netherlands Academy of Arts and Sciences (KNAW). Finally, Koos van der Bruggen (KNAW) spoke to the working group participants on biosecurity activities that had been undertaken by KNAW. The KNAW has served as the lead academy for the IAP Biosecurity Working Group and played an active role in the formulation of the 2005 IAP Statement on Biosecurity. Following the release and dissemination of this statement, the Dutch Ministry of Science asked KNAW to prepare a code of conduct on biosecurity for scientists and organizations involved with dual use research in the Netherlands. In preparing this code, KNAW held extensive

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7 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS discussions with stakeholders and produced a document of principles that could be translated by each particular organization into its own appro- priate context. The code was published in October 2007 and is available online.24 Follow-on activities such as presentations, articles, and a movie are being prepared. Dr. van der Bruggen explained that, although such a code did not replace existing laws and might not prevent intentionally malicious behavior, it can serve as a useful tool to raise awareness and stimulate discussions. Participants in working group 3 commented that a theme that had emerged from several of the group presentations was that the process of developing a product related to ethical principles could sometimes be even more valuable than the content of the final product. Working Group Discussions The working group discussed questions and issues raised by the presentations, as well as reflected on several suggested questions that were posed to the group to help initiate dialogue on these topics. These questions were: 1. What are the different ways in which scientific groups can provide scientific advice on issues related to biosecurity? Which organizations might be interested in having input from the scientific community and where are there such opportunities? 2. What are some examples in which the scientific community has been able to provide advice on biosecurity-related topics to other govern- mental and nongovernmental, national, and international groups? How did these opportunities arise and how can they be built upon? What were the challenges and lessons learned? 3. Where are there unmet needs and are there ways that the scientific community could start moving to help address these? Starting Points on the Role of Science Adising. The working group took as its common starting point that the scientific community should provide advice about how to deal with the benefits and potential risks of advances in biology, biotechnology, and the life sciences, including biosecurity mat- ters. Such advice should begin by highlighting the benefits of scientific development and should also be provided within a wider context of biosafety for the following purposes: 24 Royal Netherlands Academy of Arts and Sciences. 2007. A Code of Conduct for Biosecu- rity. Report by the Biosecurity Working Group. Amsterdam: Royal Netherlands Academy of Arts and Sciences. The code is available at: http://www.knaw.nl/cfdata/publicaties/detail. cfm?boeken__ordernr=200702.

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8 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY • To build consensus on key issues within the science community, promote proper scientific/ethical conduct, and prevent hindrances of scientific progress; • To advise policy makers (in different policy areas) on benefits and potential risks, and in this context, on sensible and necessary courses of action; • To inform, educate, and engage with the public about the risks, and about what is, or should be, done to manage these risks. The group also considered some of the general aspects that will be needed to provide effective science advice. The participants agreed that science advice happens at different levels, from the personal to the institu- tional to the national level, as well as regionally and internationally. Thus, the messages that come from the scientific community need to be sincere, consistent, evidence-based, and targeted to the intended audience(s). Effective and relevant policy advice from the science community pres- ents concrete national, regional, and international political strategies and objectives. Science advice will need to be tailored to the expectations, perceptions, experiences, needs, priorities, and political desires of a given context. The science community will also need to get the additional seg- ments of the community, including politicians, parliamentarians, and the general public on board. Context for Science Adice on Biosecurity. Group discussions returned several times to the varying definitions and interpretations of the term biosecurity. However, the group agreed that biosecurity can be broadly understood as an integrated and interdisciplinary approach to manage biological risks. Biosecurity is therefore about risk perceptions, risk assess- ment, risk management and risk communication. Science advice has a role to play in all of these areas and scientists need to be involved as part of the policy-shaping processes. For science advice to be effective, however, it is often necessary to be clear about what is meant by “biosecurity,” since the term means different things to different communities. Within the context of the working group discussions at the Forum, the group agreed that the term was referring to a particular set of measures to address the risks emanating from the life sciences, and in particular was addressing scenarios where large num- bers of people, animals, plants, or significant parts of the environment, are at risk. It was also understood that the concept of biosecurity is not limited to issues relating to biological weapons or bioterrorism, but must proceed from the recognition of the existing biological risks under given circumstances. It was felt that the argument for enhancing biosecurity needed to

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 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS build on well-known historical examples of the risk of abuse of the life sciences for malign purposes, which might include the history of biologi- cal weapons and of past biological weapons programs. However, science advice must also account for other evidence (e.g., the cross-border spread of particular animal or plant diseases with severe economic impact), and both current national and regional perceptions and strategies. Within Africa, for example, biotechnology is seen as a strategic opportunity to address key development challenges such as poverty, population growth, and malnutrition. Science advice on biosecurity should be “packaged” into this context, in order to be taken seriously by policy makers and populations. It was pointed out that biosecurity could be a facilitating condition for innovation cycles and thus for economic development, and, therefore, it should not be viewed solely in terms of cost. An opportunity exists to gain much-needed political support, if biosecurity can be inte- grated into the wider policies of developing countries toward achieving the Millennium Development Goals. In 2007, for example, the Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, South Africa, and Thailand issued the Oslo Ministerial Declaration—Global Health: A Pressing Foreign Policy Issue of Our Time, as part of their initiative on Global Health and Foreign Pol- icy.25 The declaration recognized the importance of health issues in policy discussions and the interplay of health with other challenges; the theme on “Capacity for Global Health Security” included item 7.2, namely: “Recognize that the potential of biotechnologies to help developing coun- tries achieve the Millennium Development Goals should not be eclipsed by otherwise legitimate security concerns: establish robust governance mechanisms to prevent misuse of the biological sciences, without hinder- ing their positive contribution to development.” The working group emphasized that advice on biosecurity needed to be multidisciplinary and multisectoral, and had to appreciate that bio- security is a multistakeholder issue, and hence has to be inclusive. At the international level, this requires coordination and collaboration among the different organizations that have relevant mandates. This could include the UN system and its specialized agencies, as well as organiza- tions outside the UN family such as the OECD, ICRC or OPCW. At the national level, the involvement of many stakeholders in government, sci- ence, industry, the NGO community and civil society at large is required, and the communication barriers between these different actors have to be broken down. The group also agreed that, since the responsibilities for 25Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, South Africa, and Thailand. 2007. Oslo Ministerial Declaration—Global Health: A Pressing Foreign Policy Issue of Our Time. Lancet 369(9570):1373-1378.

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0 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY biosecurity exist at the levels of the individual, the institution, and nation- wide, advice should be targeted to the respective audience(s). Measures to deal with the risks should therefore be complementary, should address ethical matters as well as proper professional conduct more generally, and should be complemented by regulatory instruments and guidelines. Ways and Means of Science Adising. The group noted that a variety of ways of providing effective scientific advice have been developed and can operate at the several different levels required. At the national level, advice is being provided by science academies, professional scientific associations and societies, expert committees, and national commissions and advisory boards (e.g., national science and technology ethics commissions, research policy committees). In addition, the working group suggested that scientists should be directly included in national delegations attending negotiations in the area of biosecurity, or areas that are relevant to it. At the national level, it is important for the scientific community to be involved in the review of existing regulatory frameworks within which biosecurity objectives can be accomplished, and for the scientific community to participate in any necessary adapta- tion of existing regulations and guidelines, or in the creation of additional regulatory mechanisms. It was felt by the group that such reviews will need to be repeated and updated periodically to take account of new developments. At the regional level, science advice is needed when regional pri- orities, policies, and capacity-building projects are being discussed and implemented. Regional organizations are important in shaping effective policies and in organizing regional collaborations. Biosecurity should be incorporated into the policy agendas of regional organizations, and regional resources and capacities in the field of biosecurity should be enhanced. At the international level, a number of organizations have mandates with regard to providing, or facilitating the provision of, advice on bios- ecurity, and these groups may also facilitate capacity building. These include UNESCO, WHO, FAO, OIE, the International Cooperative Bio- diversity Groups, the United Nations Environment Program, the BWC Implementation Support Unit, OECD, and others. International organiza- tions, including specialized agencies, can play important roles with regard to involving the scientific community and in seeking their advice, and providing the governments of their member states with advice based on sound scientific principles and evidence. At the academic level, organizations such as ICSU, the IAP, and the Academy of Sciences for the Developing World (TWAS) bear a specific responsibility for developing and channeling science advice. International

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 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS disciplinary science unions also have important roles to play, given their wide geographical participation and legitimacy. Science unions, as well as international scientific bodies such as ICSU, IAP, and TWAS, can help create broad consensus within the scientific community itself. This is essential for consistent and relevant advice to policy makers, as well as for outreach and education directed at the scientific community and the public. The working group noted that international scientific consen- sus does not necessarily exist on the advantages and risks created by developments in the life sciences. Such dialogues among the scientific community should be played out not only within the policy sphere, but also addressed within the international scientific community as it moves toward achieving a level of consensus. Unions as well as ICSU, IAP, and TWAS can also help promote com- mon standards (including on professional ethics), foster the education of future generations of scientists and engineers, and inform both policy makers and the public. They can do this in collaboration with other inter- national agencies, but equally important is their ability to work through their own national constituent bodies to transmit these messages in a tailored and relevant fashion. Unions, as well as interacademy bodies, also can be effective channels to involve industry in the development of policy advice. Treaty-based institutional mechanisms such as the Scientific Advisory Board of the OPCW, or national governmental science advisory bodies involved in the CWC context, or in the BWC processes, have also been effective. The involvement of scientists as delegation members, or by serv- ing in capacities such as members of NGOs, scientific associations, or as individuals, has proven useful. The group noted that there is a need for effective and targeted out- reach and communication of biosecurity issues. Given the diverse audi- ences seeking or requiring advice, the variety of publications and other communications (e.g., press, electronic media, and the Internet) ought to be tailored to these different audiences. Such audiences will include scien- tists, media, policy makers, and the “general public.” There is also a need for education and training programs, including education and training for practicing scientists and other practitioners, training at the university level for upcoming generations of scientists, and also education for policy and law-makers. It would be desirable to share existing resources such as training materials, educational videos, and other tools on a wider basis. The working group also recognized that resources may need to be devoted to assist developing countries in building their capacities to pro- vide scientific advice.

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2 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY Some Pitfalls. The working group noted that, at the moment, there appears to be a lack of coordination among the various efforts to address biosecu- rity. There is no coherent international strategy, and a lack of collaboration among the different actors. There is a danger that efforts are being dupli- cated and a stock-taking exercise would be desirable to review which efforts are actually under way, and how effective they are. The group also emphasized that no single international organiza- tion can cover all issues related to biosecurity, let alone the overall issues related to risk assessment, management, and communication related to advances in the biosciences. The same applies at the national level. There is a need for coordination, networking, and information sharing. In some instances, for example, interministerial mechanisms may be needed. Dur- ing the discussions, it was noted that South Africa, for example, is already working to develop networks among groups such as university research directors, and has created the National Science and Technology Forum as a mechanism to bring together some of the relevant constituents. On the other hand, it must be understood that enhancing and enforc- ing regulatory frameworks, providing science advice, adopting ethical codes, and providing education and outreach can achieve only so much, and that these efforts cannot and should not be expected to completely deter or prevent acts of malevolence. Results The working group proposed the following four suggestions. 1. There is a need for better coordination at the international level. The United Nations should facilitate this and take the lead; it can and should bring together the major stakeholders, including industry, the scientific community, civil society and governments, into a common pro- gram aimed at ensuring that advances in the life sciences are used only for the benefit of humankind. Under a broad umbrella such as the UN could provide, it would be easier to synchronize the diverse and multifaceted efforts of specialized agencies, organizations such as the OECD, and many other international actors and to address these issues on the basis of well- established interagency coordination mechanisms. 2. Consideration should be given to the organization of sessions, side-events or other forums on biosafety and biosecurity issues in the context of forthcoming meetings. Some examples of possible opportuni- ties include:

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 PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS • World Conference on Science (Budapest + 10) in late 2009; • Global Ministerial Forum on Research for Health (Bamako, Mali) in November 2008; • UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (extraordinary session November 2008 in Paris, France, and an ordinary session June 2009 in Singapore); • UNESCO International Bioethics Committee (ordinary session November 2008 in Paris, France); • World Social Science Forum of the International Social Science Council (Bergen, Norway) in May 2009. 3. There is a need for improved networking and for building net- works of networks at national, regional and international levels. Different communities that have a contribution to make to biosecurity should be brought together, including life sciences, security and law enforcement, policy makers, lawyers, and others. ICSU, IAP, and TWAS should take the lead to create such networks of networks. Science unions should get involved as well, and can work through their national constituencies to promote biosecurity in the local/regional context and within a broader perspective on risk assessment, management, and communication regard- ing advances in the life sciences. 4. The existing connecting points between science and policy mak- ing at the national levels should be used and, where necessary, should be energized, in order to promote better communication and cooperation between the scientific and policy communities. Highlights of the group discussions and these four results were pre- sented by Ralf Trapp to the entire Forum in a plenary session.

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