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1 Background INTRODuCTION From March 30 to April 2, 2008, more than 80 people from 31 countries and from 6 international organizations took part in the 2nd International Forum on Biosecurity (Forum) in Budapest, Hungary.1 The Forum was cosponsored by the InterAcademy Panel on International Issues (IAP), the InterAcademy Medical Panel (IAMP), the International Union of Micro- biological Societies (IUMS), the International Union of Biochemistry and Molecular Biology (IUBMB), and the International Union of Biological Sciences (IUBS). The Hungarian Academy of Sciences was the host of the Forum, and the U.S. National Academies (NA) served as the conference secretariat. The Forum reflected a growing awareness that, while the rapid devel- opments in the life sciences2 offer great benefits, they also pose the risk that the knowledge, tools, and techniques that enable these advances might also be used to cause deliberate harm. The Forum brought together organizations and individuals active in the field of biosecurity to discuss 1 Appendix B contains a copy of the agenda and a list of participants. Almost all of the individual presentations made in the plenary sessions and working groups are posted on the U.S. National Academies Web site at: http://www7.nationalacademies.org/biosecurity/ 2nd%20International%20Forum%20on%20Biosecurity.html. Accessed on December 10, 2008. 2 “Life sciences” is a broad category that includes agricultural sciences, biological sciences, and the health sciences. In addition, there is some overlap with the physical sciences (e.g., biochemistry in chemistry and biophysics in physics) and engineering (e.g., bioengineering or biomedical engineering). 

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2 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY the roles and responsibilities of the international scientific community in fostering policies to address these risks, in order to promote both continu- ing scientific progress and greater international security. More specifically, the meeting addressed the challenges and opportunities to: • Build a culture of responsibility within the science community regarding biosecurity, through education and awareness raising, codes of conduct, and other mechanisms; • Identify standards and practices for research oversight from the review of proposals through the conduct of research, publication and communication, and the range of approaches to achieving their wide- spread adoption; • Provide scientific advice to governments and international orga- nizations and develop the role of the science community in global governance. The participants came from all over the world because the life sciences are a genuinely global enterprise, and thus any policies must include international as well as national measures. As described later in this chapter, the Forum in Budapest was the second international meeting organized by international scientific bod- ies to address these issues. The first International Forum was held in Como, Italy, in March 2005.3 The Forum is thus part of a broader process of engagement by the scientific and policy communities in considering biosecurity issues. The structure of the Forum was intended to encourage discussion and to identify common ground where possible. Working groups were organized to run through the course of the Forum, so that ideas could percolate and develop. These groups, organized to reflect each of the Forum’s goals, became the heart of the meeting. On the final morning, plenary sessions offered the opportunity to report back and to discuss the results of the working groups. The 2005 Forum in Como did not produce a final report, but this time the organizers wanted a written record. The sponsoring organizations agreed that the 2nd Forum would not produce recommendations, and that the final report would be only a summary of what occurred dur- ing the meeting. However, each of the working groups held during the Forum was encouraged to make suggestions for next steps and needed actions. These were reported to and discussed in the final plenary, and 3 The agenda, list of participants, and copies of the presentations from this Forum can be found at: http://www7.nationalacademies.org/biso/Biosecurity_Forum.html. Accessed on Decem- ber 10, 2008.

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 BACKGROUND are included in the final report. Since the Forum secretariat was in the National Academies, the National Research Council (NRC), its operating arm, appointed a committee to oversee the preparations for the meeting (see Appendix A). The planning committee did not participate in the drafting of this summary, which was written by the NRC staff who sup- ported the secretariat, serving as workshop rapporteurs.4 The rest of this chapter attempts to synthesize the history of recent developments that provided the context for the Forum. This material was presented by participants throughout the plenary sessions and working groups. Some of the details reappear in the summaries of the presenta- tions and discussions at the Forum, but they are assembled here in one place in hopes of providing a more coherent narrative of events. Chapter 2 then provides a summary of the plenary sessions and discussions, fol- lowed by the reports of the three working groups. The final chapter offers a brief summary of the major themes and suggestions for possible actions and next steps that emerged from the discussions. DEvELOPMENT OF THE ISSuE Continuing advances in the life sciences over the last 50 years, sup- ported by enabling technologies such as vastly increased computing power, have brought great benefits for health, the economy, and the envi- ronment, and promise far more in the future. Along with the hopes, however, have come concerns that the knowledge, tools, and techniques gained through these developments might also be used in state or terrorist pursuit of biological weapons (BW). A frequently quoted warning about the potential risks came in 2000 from Matthew Meselson, a leading figure in the life sciences on issues related to biological weapons: Every major technology—metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy—has been intensively exploited, not only for peaceful purposes but also for hostile ones. Must this also happen with biotechnology, certain to be a dominant technology of the coming century? During the century just begun, as our ability to modify fundamental life processes continues its rapid advance, we will be able not only to devise additional ways to destroy life but will also be able to manipulate it—including the processes of cognition, development, repro- duction, and inheritance. A world in which these capabilities are widely employed for hostile purposes would be a world in which the very na- 4 The NRC is part of the National Academies, which also include the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Created in 1916, the NRC has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities.

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 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY ture of conflict has radically changed. Therein could lie unprecedented opportunities for violence, coercion, repression, or subjugation. 5 Yet even work in the life sciences that might have the greatest appar- ent potential for misuse may offer significant benefits as well. The pos- sibility that advances in the life sciences intended for legitimate and beneficent purposes might also be used for malevolent ends is often called the “dual use” dilemma.6 This is somewhat different from the classic defi- nition in defense and security of dual use that focuses largely on equip- ment or technology—high-performance computers, advanced materials, “stealth” technology—that could be applied for either civilian or military purposes.7 This definition reflects increasing attention to developments in science and technology that, although arising largely from academia and the commercial sector rather than from military-related research, raise significant concerns for security. Nanotechnology, microcomputing, and civilian nuclear power are three other areas that are often cited as posing similar dual use issues. Current concerns about the dual use potential of advances in the life sciences date largely from the beginning of this century and reflect differ- ent perceptions—and sometimes sharp disagreement—about the relative risk between the development of national biological weapons programs and the potential for bioterrorism, and between these and other threats to international security. President Yeltsin’s admission in early 1992, fol- lowing years of accusations, that the Soviet Union had maintained a huge clandestine biological weapons program, in violation of the Biological and Toxin Weapons Convention (BWC), came as the revelations of Iraq’s efforts to create biological weapons were unfolding in the wake of the first Gulf War.8 The first World Trade Center bombing in 1993, the Oklahoma City bombing in 1995, and the 1995 Aum Shinrikyo attack in Tokyo with chemical agents, spurred increasing concern with “catastrophic” terror- ism.9 The terrorist attacks of September 11, 2001, and the subsequent 5 Meselson, M. 2000. The problem of biological weapons. Symposium on Biological Weap- ons and Bioterrorism, National Academy of Sciences, Washington, DC, May 2. 6 NRC (National Research Council). 2004a. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press. 7 Knowledge and skills are included in traditional definitions of dual use, but the emphasis tends to be more on actual items. For a discussion of current debates over dual use, see Rep- py, J. 2007. The end of dual use? Implications for export control policy. Paper prepared for presentation at the 48th Annual Meeting of the International Studies Association, Chicago, IL. March. Available at: http://www.allacademic.com/meta/p_mla_apa_research_citation//7/8/8// p7880_index.html. Accessed December 10, 2008. 8 Rossiskiye Vesti. 1992. Interview with President Boris Yeltsin. Washington, DC: Foreign Broadcast Information Service, FBIS-SOV-92-103, May 27. 9 Carter, A., J. Deutch, and P. Zelikov. 1998. Catastrophic terrorism: Tackling the new danger. Foreign Affairs 77(6):80-94.

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 BACKGROUND anthrax letters in October of that year turned those already existing con- cerns into the highest national security priority, particularly in the United States. In addition, the U.S. response to the perceived threats of bioterror- ism included a massive increase in funding for activities of the type most likely to raise concerns, and led some to question whether “defensive” work was becoming increasingly problematic in terms of compliance with the BWC.10 In addition to increased concerns about terrorism and state BW pro- grams, a number of articles in scientific journals sparked controversy about whether some research that might be misused should not be con- ducted, or if conducted, should not be published. Critics charged such publications could provide a “blueprint” or “roadmap” for terrorists or countries seeking to carry out bioterrorism or to acquire biological weap- ons.11 Gerald Epstein of the Center for Strategic and International Studies labeled such studies “contentious”; his article was an early review of the issues and policy options then under discussion.12 Before proceeding further, it is important to acknowledge that the potential risks of the misuse of advances in the life sciences are not univer- sally accepted. Part of engaging the scientific community in these issues is therefore discussing and debating the nature and seriousness of the risks. On a technical level, some argue that “Mother Nature is the best terror- ist” and, therefore, that there exists little reason for terrorists or for less technologically advanced countries to do more than take advantage of the highly dangerous pathogens already abundantly available in nature.13 On the level of general policy, some consider concerns about bioterrorism to be part of a general U.S. tendency to exaggerate the threat of terror- 10 Miller, J., S. Engelberg, and W. Broad. 2001. Germs: Biological Weapons and America’s Secret War. New York: Simon and Schuster. 11 A review of some of the best known articles from that period may be found in Biotechnol­ ogy Research in an Age of Terrorism (National Research Council 2004a, pp. 25-29). An example of the concern in the defense policy community is Zilinskas, R. and J.B. Tucker. 2002. Limiting the contribution of the open scientific literature to the biological weapons threat. Online Journal of Homeland Security (December). Available at: http://www.homelandsecurity. org/journal/Articles/tucker.html. See also Vogel, K.M. 2008. Framing biosecurity: An alternative to the biotech revolution model? Science and Public Policy 35(1):45-54. 12 Epstein defines “contentious research” as “fundamental biological or biomedical in- vestigations that produce organisms or knowledge that could have immediate weapons implications, and that, therefore, raise questions concerning whether and how that research should be conducted and disseminated.” Epstein, G.L. 2001. Controlling biological warfare threats: Resolving potential tensions among the research community, industry, and the na- tional security community. Critical Reiews in Microbiology 27:321-354. 13 For a review of these discussions and debates, see Frerichs, R.L., R.M. Salerno, K.M.Vogel, N.B. Barnett, J. Gaudioso, L.T. Hickok, D. Estes, and D.F. Jung. 2004. Historical Precedence and Technical Requirements of Biological Weapons Use: A Threat Assessment. SAND2004- 1854. Albuquerque, NM: Sandia National Laboratories.

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 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY ism involving weapons of mass destruction.14 Other research suggests that absorbing and using new technology may require substantial tacit knowledge that is not easily transferred or acquired by states or terrorists, particularly through published research results.15 THE ROLE OF THE SCIENTIFIC COMMuNITy Responding to the dual use potential of the life sciences is a challenge in which the scientific community has an essential role. The heart of the challenge is developing the mix of policies at the national, regional, and international levels that can mitigate the risks of misuse, while enabling continuing scientific advances and the availability of those advances to all. For many, as illustrated in Figure 1-1, measures to address the risks of BW or bioterrorism are thus best seen in the context of the spectrum of risk to global health and the environment—ranging from chronic dis- ease threats to natural disease outbreaks to the accidental or inadvertent spread of disease to the deliberate use of disease to cause harm. 16 Sustained effort by the scientific community, drawing on traditions of self-governance and social responsibility, is considered to be an essential component of a broader strategy to respond to the risks of bioterrorism or BW proliferation. In the United States, for example, a number of reports from the NRC have made the aforesaid argument.17 The scientific commu- nity also has an important role to play as advisor to policy makers about trends in science with dual use implications, in assessments of the balance of potential risks and benefits in new and continuing activities, and about the implications of proposed policies for both science and security. To be effective, responses to the dual use dilemma cannot be confined to national measures. Capacity in the life sciences is diffusing around the world, and thus a meaningful response must include global approaches 14 A detailed and skeptical assessment of this phenomenon related to biological issues may be found in Leitenberg, M. 2005. Assessing the Biological Weapons and Bioterrorism Threat. Carlisle Barracks, PA: Strategic Studies Institute, U.S. Army War College. 15 Vogel, K.M. 2006. Bioweapons proliferation: Where science studies and public policy collide. Social Studies of Science 36(5):659–690; and Vogel, K.M. 2008. Framing biosecurity: An alternative to the biotech revolution model? Science and Public Policy 35(1):45-54. 16 WHO (World Health Organization). 2005. Life Science Research: Opportunities and Risks for Public Health. Geneva: WHO. WHO/CDS/CSR/LYO/200.20. Available at: http://www. who.int/csr/resources/publications/deliberate/WHO_CDS_CSR_LYO_200_20/ en/index.html. Ac- cessed December 10, 2008. 17 NRC (National Research Council). 2004a. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press; National Research Council. 2004b. Seeking Security: Pathogens, Open Access, and Genome Databases. Washington, DC: The National Acad- emies Press; and National Research Council 2006. Globalization, Biotechnology, and the Future of the Life Sciences. Washington, DC: The National Academies Press.

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7 BACKGROUND The Bio-risk Spectrum Absolutely Certainly Maybe ? Don’t know Chronic Emerging Misuse of Biological Bi olo gical Dual-use Disease Terrorism Warfare Disease Technologies Hypothesis: The PROCESS of working together, INTERNATIONALLY, ACROSS THE SPECTRUM of biological challenges will: 1) Reduce the impact of the left end of the spectrum, 2) reduce the likelihood of the right half of the spectrum, 3) undermine the popular support for terrorism and 4) provide some transparency regarding capabilities and intent. FIGuRE 1-1 The bio-risk spectrum. SOURCE: Franz, D.R. 2007. Challenges and Opportunities. Princeton University, December 18. as well as national.18 The failure to undertake compatible international efforts risks, among other things, disrupting the international collabora- tion that is so much a part of the modern scientific enterprise; scientists sometimes point to the example of the barriers raised by legislation in the United States after September 11 as an example of what should be avoided.19 Lack of care in the design and implementation of measures to address dual use concerns risks denying access to knowledge and tech- nology in the name of security, or risks driving work into areas where there is less oversight. Fortunately, an extensive network of national, regional, and interna- tional scientific bodies—national professional associations and interna- 18Ibid. 19See, for example, the results of a survey reported in Fischer, J.E. 2006. Stewardship or Censorship: Balancing Biosecurity, the Public’s Health, and the Benefits of Scientific Open- ness. Washington, DC: Stimson Center. Available at: http://www.stimson.org/globalhealth/pdf/ Stewardship.pdf. Accessed December 10, 2008.

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8 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY tional scientific societies, academies of science and medicine, and nongov- ernmental scientific organizations—offer the opportunity to engage the scientific community. A number of them are active participants in policy debates related to issues of science and society. These bodies are also the most likely and appropriate vehicles to ensure continued commitment to the issues, both within the life sciences community and between those engaged in the life sciences and decision makers. It must be noted, however, that until recently the life sciences com- munity has not been much engaged in the dual use implications of its work. After the Biological Weapons Convention was signed in 1972, most life scientists had little experience with the issues of biological weapons or bioterrorism; national programs related to biological weapons permitted under the BWC are confined to ”prophylactic, protective, or other peace- ful” measures. Thus without conscious personal effort or systematic edu- cation, very few life scientists working today would have reason to know the details of past offensive weapons programs or have knowledge of the BWC and their responsibilities under that treaty. They also have few con- nections to the national security branches of government. Moreover, the image of themselves as being engaged in work that is meant only for the benefit of humankind is deeply engrained in the way life scientists view themselves and their role in society. An essential first step is thus raising awareness about the issues within the scientific community. THE “LANGuAGE BARRIER”: ISSuES OF TERMINOLOGy20 One of the immediate difficulties that arise in a discussion of the possible potential misuse of the life sciences is the lack of common terms to describe the problem. The term most commonly used, “biosecurity,” presents many difficulties. At its most basic, the term does not exist in some languages, or is identical to “biosafety”; French, German, Russian, and Chinese are all examples of this immediate practical problem. Even more serious, the term is already used to refer to several other major international issues. For example, to many “biosecurity” refers to the obligations undertaken by states adhering to the Convention on Biodiversity and particularly the Cartagena Protocol on Biosafety, which is intended to protect biological diversity from the potential risks posed 20 “Dual use” is a term that frequently evokes confusion and controversy, but did not receive the same attention in discussions during the Forum. For a review of the multiple meanings of the term, see Atlas, R., and M. Dando. 2006. The dual use dilemma for the life sciences: Perspectives, conundrums, and global solutions. Biosecurity and Bioterrorism: Bio­ defense Strategy, Practice, and Science 4(3):276-286.

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 BACKGROUND by living modified organisms resulting from modern biotechnology. 21 “Biosecurity” has also been applied to efforts to increase the security of dangerous pathogens, either in the laboratory or in dedicated collections; both the World Health Organization (WHO) and the Organisation for Eco- nomic Co-operation and Development (OECD) have recently produced guidelines related to practices within this meaning of the term. 22 The term may also have specific national meanings; in New Zealand, for example, the term applies to protecting the island nation from invasive species. Whatever the problems and limitations with the term “biosecurity,” so far no one has been able to develop a better term to describe the poli- cies and practices intended to reduce the risk of misuse of the results of biotechnology. This is the context within which the term was generally used in the international forum described in this report. Adding descrip- tive adjectives or phrases, such as WHO’s use of “laboratory biosecurity,” may provide additional clarity. Biosecurity is also linked to “biosafety.” Many of the practices intended to improve laboratory safety and to protect workers and the environment from the accidental or inadvertent release of dangerous organisms have an important relationship to efforts to reduce the risk of deliberate misuse. As will be discussed later in this report, good biosafety practices are part of the foundation for creating a “culture of responsibility” among scien- tists toward dual use issues. This may be especially true in developing countries where improved biosafety comes as part of building capacity in the life sciences. The distinction between biosafety and biosecurity is primarily that the latter term, as used here, includes the additional consid- eration of measures to prevent deliberate misuse; biosecurity represents broader societal and ethical issues that are not always included in discus- sions of laboratory practices to ensure biosafety. DEvELOPMENT OF SCIENTIFIC ENGAGEMENT Early Initiatives: Setting the Stage Many individuals and organizations have played a role in the increas- ing interest of the scientific community in the dual use dilemma. What 21 Further information on the Convention may be found at: http://www.cbd.int/conention/ and on the Protocol at: http://www.cbd.int/biosafety/. Accessed December 11, 2008. 22 WHO (World Health Organization). 2004. Laboratory Biosafety Manual, 3rd ed. Geneva: WHO.WHO/CDS/CSR/LYO/2004.11. Available at: http://www.who.int/csr/resources/ publications/biosafety/WHO_CDS_CSR_LYO_200_/en/ and OECD (Organisation for Economic Co-operation and Development). 2007. OECD Best Practice Guidelines on Bio­ security for BRCs (Biological Resource Centers). Paris: OECD. Available at: http://www.oecd. org/dataoecd//27/87782.pdf.

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0 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY follows is a rough and necessarily incomplete chronology of some of the efforts, mingling actions by both international and nongovernmental organizations (NGOs). The fundamental commitment not to use disease as a weapon is embodied in the Biological and Toxin Weapons Convention which was signed in 1972 and entered into force in 1975.23 As Ambassador Masood Khan of Pakistan, president of the treaty’s sixth review conference, stated: The BWC has had marked success in defining a clear and unambiguous global norm, completely prohibiting the acquisition and use of biologi- cal and toxin weapons under any circumstances. The preamble to the Convention so forcefully states: the use of disease as a weapon would be “repugnant to the conscience of mankind.” It captures the solemn undertaking of the states parties “never in any circumstances to develop, produce, stockpile or otherwise acquire or retain” such weapons. With 155 states parties, the treaty is not universal, but no country dares argue that biological weapons can ever have a legitimate role in national de- fense. Such is the force of the treaty.”24 In 2002, following the collapse of efforts to negotiate a protocol to the BWC to provide for verification of treaty compliance, the states parties agreed to a series of intersessional meetings before the next full treaty review conference in 2006. Each year focused on a different topic and included both a two week meeting of experts and a one week meeting of the states parties. The topic chosen for 2005 was “content, promulgation, and adoption of codes of conduct for scientists.”25 The role of codes of conduct for scientists has been a continuing focus of interest with regard to dual use issues. (There are, in fact, several kinds of codes, each with a different purpose;26 as used here and elsewhere, “codes of conduct” is the commonly used general term.) In addition to 23 UN Security Council Resolution 1540, passed in 2004, adds a further binding inter- national commitment against support for non-state actors seeking to acquire weapons of mass destruction or means of their delivery. Available at: http://www.un.org/Docs/sc/unsc_ resolutions0.html. Accessed December 11, 2008. 24 Khan, M. 2006. Preparations and expectations. Presentation to the United Nations General Assembly First Committee. Sixth Review Conference of the Biological and Toxin Weapons Convention: New York: United Nations, October 11. Available at: http://www. unog.ch/802EDD00B8/(httpAssets)/28DFC7CC2CDBC2720D00BC8/$file/First_ Committee_BWC_thematic_presentation_slides.pdf. Accessed December 11, 2008. 25 Additional information about the topics and contents of other intersessional meetings can be found at: http://www.opbw.org/ under “Strengthening the Convention.” 26 Rappert, B. 2004. Towards a Life Science Code: Countering the Threats from Biologi- cal Weapons. Bradford Briefing Paper No. 13. Available at: http://www.brad.ac.uk/acad/sbtwc. A ccessed December 11, 2008.

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 BACKGROUND the BWC intersessional meeting, as a result of the recommendations of the UN Policy Working Group on the United Nations and Terrorism, the UN General Assembly and Security Council passed resolutions in September 2002 calling on the UN Secretariat to reinforce ethical norms and to pre- pare relevant codes of conduct for scientists involved in technologies that could produce weapons of mass destruction. The Under-Secretary-Gen- eral for Disarmament Affairs initially asked the International Centre for Genetic Engineering and Biotechnology (ICGEB) to assist the Secretariat in this task in relation to the life sciences.27 In 2002, the International Committee of the Red Cross (ICRC) launched an initiative on “Biotechnology, Weapons, and Humanity,” calling for a “web of prevention” to address the risk that technologies from the life sciences could be used for hostile purposes. In addition to a number of proposals for national and international legal measures to support the implementation of the BWC, the initiative recommended including edu- cation about risks, rules, and responsibilities as part of the overall ethical training for life scientists. 28 In January 2003, in response to the controversy over scientific publica- tions mentioned above, a group of editors and authors from some of the leading scientific journals met in Washington, DC, along with experts in security policy and biological weapons. The group drafted a “Statement on Scientific Publication and Security,” at the heart of which was the acceptance of responsibility for screening manuscripts to reduce the risk of misuse of scientific information. The statement was simultaneously published in Science, Nature, the Proceedings of the National Academy of Sci­ ences (PNAS), and in the journals of the American Society for Microbiol- ogy (ASM).29 The overarching principle accepted by the Journal Editors and Authors Group stated that “there is information that, although we 27 Ripandelli, D. 2005. Building blocks for a code of conduct for scientists, in relation to the safe and ethical use of biological sciences. Presentation to the 2005 Meeting of Experts of the Biological Weapons Convention. Geneva. June 13. Available at: http://www.opbw.org/. Accessed on December 11, 2008. 28 More information may be found at: http://www.icrc.ch/Web/eng/siteeng0.nsf/html/bwh!Open. Also see presentation by Coupland on page 23 in this report. Earlier, Graham Pearson coined the phrase “web of deterrence,” but he did not address dual use research issues (Pearson, G.S. 1993. Prospects for chemical and biological arms control: The web of deterrence. The Washington Quarterly 16(Spring):145-162.) 29 Journal Editors and Authors Group. 2003a. Uncensored exchange of scientific results. Proceedings of the National Academy of Sciences 100(4):1464; Journal Editors and Authors Group. 2003b. Statement on the consideration of biodefense and biosecurity. Nature 421:771; and Journal Editors and Authors Group. 2003c. Statement on scientific publication and se- curity. Science 299(5610):1149; Fox, J.L. 2003. Bioterrorism threat could make some research too “sensitive” to disclose. ASM News 69(3):112-114. Available at: http://www.asm.org/microbe/ index.asp?bid=7.

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2 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY cannot now capture it with lists or definitions, presents enough risk of use by terrorists that it should not be published.” The Group indicated that if “the potential harm of publications outweighs the potential soci- etal benefits,” manuscripts may be rejected. The statement also notes that publications are not the only place where science is communicated, and that all scientists are responsible for monitoring their communication to maximize the benefits and minimize the risks of their research.30 Several journals subsequently adopted formal policies to consider “dual use” and the potential for misuse of the information in the manu- script during the review. Today, the Nature Publishing Group, PNAS, the ASM journals, and Science have review policies in place, and although the policies are not uniform, they signify continuing concern regarding science and security. In October 2003, the U.S. National Research Council released a pre- publication version of a report that focused specifically on the potential risks of dual use research, Biotechnology Research in an Age of Terrorism, often called the “Fink report,” after the study’s chair, Gerald Fink of MIT.31 Planning for the project had begun prior to the events of September 11, and prior to the anthrax mailings; but those events gave the report much greater visibility. The report made a series of recommendations, largely focused on enhancing self-governance by the scientific commu- nity, but also with a role for federal guidelines and an advisory body modeled on the Recombinant DNA Advisory Committee of the National Institutes of Health. Although the Fink report focused on the United States, it argued that effective efforts to reduce the risk that biotechnology could be misused would depend on international action. Any serious attempt to reduce the risks associated with biotechnology must ultimately be international in scope, because the technologies that could be misused are available and being developed throughout the globe. A number of countries and regional and international organiza- tions are already moving forward to develop programs and policies on aspects of the problem; the initiatives include consultations among the parties to the BWC on best practices for the security and oversight of pathogens and toxins. These approaches must be harmonized and wide- ly adopted in order for them to be effective. Just as the scientific commu- nity in the United States must become deeply and directly engaged, the commitment of the international scientific community to these issues is needed to implement the recommendations contained in this report. 32 30Ibid. Science. 31 NRC (National Research Council). 2004a. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press. 32 Ibid., p. 12.

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 BACKGROUND A number of other important efforts were launched during the same period by nongovernmental organizations (NGOs) or scholars, most often from the United States or the United Kingdom. These include but are not limited to the Controlling Dangerous Pathogens Project at the Univer- sity of Maryland, educational seminars conducted by Malcolm Dando and Brian Rappert through the University of Bradford, the International Council for the Life Sciences, and the Center for Biosecurity at the Uni- versity of Pittsburgh Medical Center.33 Each had a slightly different focus and a more or less explicit policy agenda, but all were concerned in large measure with the issues surrounding what the OECD called “responsible stewardship of the biosciences.”34 2005 as a Turning Point One of the challenges for those interested in engaging the international scientific community is the wide array and variety of organizations. There are hundreds, if not thousands, of international scientific meetings every year in all parts of the globe, and a multitude of national and regional groups and groupings. But there are remarkably few genuinely indepen- dent international scientific organizations devoted to bringing science to bear on policy issues. This is important because such organizations have a particular advantage in being able to work directly with international and intergovernmental organizations.35 Many national scientific organizations have a significant international membership (for example, an estimated 30 percent of the membership of the ASM is international), but there are still significant limits on what such national organizations can do in the 33 See Appendix C for a description of these and other efforts. 34 OECD (Organisation for Economic Co-operation and Development). 2004. Promot- ing Responsible Stewardship in the Biosciences: Avoiding Potential Abuse of Research and Resources. Chairman’s Summary. Paris: OECD. Available at: http://www.oecd.org/ dataoecd/0//8.pdf. Accessed December 11, 2008. 35 An example is the collaboration that has developed between the Organisation for the Prevention of Chemical Weapons (OPCW), charged with implementation of the Chemical Weapons Convention (CWC), and the International Union of Pure and Applied Chemistry (IUPAC). For example, in 2002 IUPAC held a workshop at the request of OPCW on trends in chemical sciences and technology as input to the first CWC review conference in 2003. The report of that workshop, which was used extensively by the OPCW secretariat in preparing for the review conference, can be found in a special issue of the union’s journal (Parshall, G.W., G.S. Pearson, T.D. Inch and E.D. Becker. 2002. Impact of Scientific Developments on the Chemical Weapons Convention (IUPAC Technical Report). Pure and Applied Chemistry 74(12):2323-2352. Available at: http://www.iupac.org/publications/pac/2002/72/index.html. The technical papers presented at the workshop are also contained in Pure and Applied Chemistry 74(12). A second IUPAC-OPCW workshop on trends is described later in the chapter.

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 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY international arena.36 There are also a number of important international science policy organizations, such as the ICRC and the Pugwash Confer- ences on Science and World Affairs, but these have a policy agenda and less of a base in the general scientific community. Beyond the limited number of genuinely international science bodies, none of the obvious candidates among existing organizations—the Inter- national Council for Science (ICSU), the IAP, or the IAMP, as described in Box 1-1—had been engaged in issues of science and security beyond the questions of the openness of scientific research and the human rights of science, engineering, and health professionals. As mentioned above, the topic for the 2005 BWC intersessional meet- ings was “content, promulgation, and adoption of codes of conduct for scientists.” The choice of codes provided an excellent opportunity to encourage scientific organizations to pay attention to biosecurity issues. The IAP emerged as the primary actor among the three international scientific organizations, but its partnerships with other scientific groups were essential to the broader task of engaging the scientific community. In February 2004, the IAP Executive Committee adopted a Biosecurity Initiative, and formed a small working group under the leadership of the Accademia Nazionale dei Lincei of Italy.37 Other members of the Bios- ecurity Working Group (BWG) included the academies of China, Cuba, Nigeria, and the United States. The UK Royal Society became part of the working group in September 2004; later that year the Royal Netherlands Academy of Arts and Sciences took over as chair of the BWG. The BWG had rather quickly decided to focus its efforts on drafting a statement of principles that could provide the basis for efforts by acad- emies and other science bodies to develop codes of their own rather than attempting to develop a full-blown IAP code of conduct. This reflected in part a view that codes are most effective when those adhering to them have some sense of “ownership,” and that this is best achieved when codes come from local or national sources with which people have closer, more direct ties. 36 The special advantages of international status can, of course, be overstated; for example, the Monterey Institute for International Studies has forged a close working relationship with the International Atomic Energy Agency and international and regional organizations work with and support national groups. 37 The IAP General Assembly had received a proposal in December 2003 from the In- ternational Centre for Genetic Engineering and Biotechnology (ICGEB) to collaborate on preparing a code of conduct. It became clear by the fall of 2004, however, that the process needed to create and then gain the endorsement of an IAP statement could not proceed quickly enough to meet the ICGEB’s desire to fulfill the UN’s request to have a completed code in time for the BWC experts meeting in June 2005. The two efforts, therefore, went forward separately.

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 BACKGROUND BOX 1-1 Some Key International Scientific Organizations The International Council for Science (ICSU), founded in 1931, is a non- governmental organization representing a global membership that includes both national scientific bodies (111 members) and international scientific unions (29 members).a As its Web site notes: “Because of its broad and diverse membership, the Council is increasingly called upon to speak on behalf of the global scientific community and to act as an advisor in matters ranging from ethics to the environ- ment.” Approximately a dozen of ICSU’s unions can be considered to be part of the “life sciences”—reflecting the breadth and fragmentation of the field, unlike the single unions for physics and chemistry. ICSU also has a standing Committee on Freedom and Responsibility in the Conduct of Science. The InterAcademy Panel on International Issues (IAP), founded in 1993, is another global network, comprised of approximately 100 of the world’s science academies.b It is designed “to help its members develop the tools that they need, in order to participate effectively in science policy discussions and decision making.” The current co-chairs are from Canada and China. As one of its major activities, the IAP issues statements that are endorsed by its member academies; the first two statements, on population (1994) and urban development (1996) were timed to coincide with special sessions of the United Nations on those topics. The InterAcademy Medical Panel (IAMP), launched in 2000, is a global network of 64 academies of science and medicine, committed to improving health world- wide. IAMP activities focus on “institutional collaboration to strengthen the role of all academies to alleviate the health burdens of the world’s poorest people; build scientific capacity for health; and provide independent scientific advice on promoting health science and health care policy to national governments and global organizations.” aThe ICSU Web site is: http://www.icsu.org/index.php. bThe IAP Web site is: http://www.interacademies.net. cThe IAMP Web site is: http://www.iamp-online.org. In November 2004, the IAP Executive Committee agreed to a proposal from the U.S. National Academy of Sciences to serve as a co-convener for an International Forum on Biosecurity. The IAMP and ICSU also agreed to serve as co-conveners at approximately the same time. The International Forum was held in late March 2005, at a conference center in Como, Italy, with the stated goals of: • Broadening the debate and advancing the awareness in the life sciences and biomedical research communities—and in the international

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 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY scientific community more generally—about the challenges posed by the dual use dilemma; • Serving as a major convening and coordinating mechanism to share information about activities already under way or being planned to address biosecurity issues; • Providing an opportunity for a discussion of these activities, for identifying potential gaps and needs and for how they might be filled, and, in this context, exploring opportunities for future international coop- eration and collaboration. Just over 50 participants from 20 developed and developing countries and from several international organizations took part in the Forum, which included both plenary sessions and day-long parallel sessions devoted to specific topics—codes of conduct, “sensitive” information and publication policy, and research oversight—that enabled in-depth discussion. The IAP draft statement was discussed extensively during the small group session on codes of conduct, for example, and was revised in response to the comments and suggestions. Although the participants were largely scientists identified through IAP or ICSU, participants also included people from a number of the other policy projects on biosecurity, as well as staff from the ICRC, the WHO, and the OECD. 38 The rules of the Forum precluded reaching formal conclusions or making recommendations—a condition from the IAP and ICSU boards when they agreed to serve as cosponsors—but the ideas generated in the working sessions were summarized and circulated informally among the convening organizations as a basis for their future activities. For example, at its meeting in April 2005, the ICSU Executive Board endorsed further work on biosecurity by the organization and its member unions, thus set- ting the stage for future engagement and collaboration. The 3rd Meeting of Experts of the Biological Weapons Convention took place in Geneva, Switzerland in June 2005. As already mentioned, the meeting’s focus on codes of conduct had provided an opportunity to encourage scientific organizations to pay attention to biosecurity issues. Moreover, in an important departure from tradition, the chairperson of the meeting offered a variety of professional organizations, NGOs, and outside experts the chance to make brief presentations to the meeting as “guests of the chair,” in addition to the usual NGO statements that were part of many such meetings. The chairperson also encouraged member states to include additional experts as part of their delegations. The for- eign secretary of the Cuban Academy of Sciences presented the draft IAP 38 The agenda and participants list, as well as other information and copies of the presenta- tions, can be found at http://www7.nationalacademies.org/biso/Biosecurity_Forum.html.

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7 BACKGROUND statement.39 Three of the ICSU unions, as well as ICSU’s Deputy Execu- tive Director, also made presentations. Following her presentation and her experience with the meeting, the President of the International Union of Biochemistry and Molecular Biology (IUBMB) convened a working group, which created a code of ethics for the IUBMB; among the obliga- tions to the public, members “will not engage knowingly in research that is intended for the production of agents of biological warfare or bioter- rorism, nor promote such agents.”40 The International Union of Microbio- logical Societies also created a brief code and has urged national affiliates to adopt it, and to craft their own, more extensive codes relevant to local conditions.41 The final IAP statement was released on December 1st, just in time for the 2005 States Parties meeting. A copy of the statement, which was formally endorsed by 69 of the then 93 IAP member academies, can be found in Appendix D. The chair of the BWC meeting mentioned the state- ment in his opening remarks and officially circulated the statement to all the delegations. In addition to the BWC process, two other important international organizations had also become engaged in biosecurity and dual use issues by 2005. The involvement of WHO and OECD added the elements of global health and economic development to the more traditional security concerns represented by the BWC, and also served to emphasize the need for a mix of policies to ensure that efforts to reduce the risk of misuse also allowed for continued scientific progress. Of particular relevance, the OECD Global Futures Program created a website (www.biosecuritycodes. org) to provide information about national and international activities, and the WHO released a background paper, Life Science Research: Oppor- tunities and Risks for Public Health, as an initial step toward increasing engagement in the issue.42 Finally, there were important developments at the national level. In 39 Further information on the meeting, copies of many of the presentations, and a copy of the chair’s final report, which cites the IAP statement extensively, along with the key points made by the Royal Society and other science organizations, can be found at http://www. opbw.org/. 40 The code can be found on the IUBMB Web site at: http://www.iubmb.org/index.php?id=. The description of its origins may be found at: http://www.iubmb.org/index.php?id=#c. Accessed December 11, 2008. 41 The IUMS Code of Ethics against Misuse of Scientific Knowledge, Research, and Resources is available at: http://www.iums.org/about/Codeethics.html. Accessed December 11, 2008. The code was formally adopted by the IUMS General Assembly on August 10, 2008. 42 WHO (World Health Organization). 2005. Life Science Research: Opportunities and Risks for Public Health. Geneva: WHO. WHO/CDS/CSR/LYO/2005.20. Available at: www. who.int/csr/resources/publications/deliberate/WHO_CDS_CSR_LYO_200_20/ en/index.html. Ac- cessed December 11, 2008.

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8 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY particular, the three largest funders of biomedical research in the United Kingdom announced in September 2005 that applicants for funding would now be asked to indicate whether their proposed research had dual use potential, and that dual use considerations would be included in reviews. The joint policy statement from the Biotechnology and Biological Sciences Research Council, the Medical Research Council, and the Wellcome Trust identified a series of agreed actions that the three organizations would implement to raise awareness and to help ensure that any risks of misuse associated with research proposals were considered at the grant applica- tion stage.43 Developments between 2005 and 2008 The years between 2005 and 2008 saw the international community continue to cooperate on biosecurity issues, although raising awareness among and educating the broad life sciences community remain formi- dable challenges. This section briefly describes some of the efforts by both independent scientific organizations and international organizations. Other activities and projects are described in Chapter 2 and are listed in Appendix C. The WHO continued to engage on biosecurity issues by creating a working group and holding a small international workshop in October 2006 on “Life Science Research and Global Health Security.” The work- shop report recommends the creation of a standing scientific advisory group to counsel the WHO Director-General on biosecurity, including both improved biosafety and responsible oversight of research.44 WHO has also undertaken a number of collaborative activities, including regional workshops that address both biosafety and biosecurity issues. In April 2006 the UN Secretary General issued a report calling for a global strategy to counter terrorism. The report covered many aspects of the problem and included the statement: “The most important under- addressed threat relating to terrorism, and one which acutely requires 43 The joint statement is available at: http://www.bbsrc.ac.uk/organisation/policies/position/ public_interest/misuse_of_research_joint.pdf. Accessed December 11, 2008. 44 WHO (World Health Organization). 2007. Scientific Working Group on Life Science Research and Global Health Security: Report of the First Meeting. WHO/CDS/EPR/2007.4. Geneva: WHO. Available at: http://www.who.int/csr/resources/publications/deliberate/WHO_ CDS_EPR_2007_. Accessed December 11, 2008.

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 BACKGROUND new thinking on the part of the international community, is that of ter- rorists using a biological weapon.”45 The report then recommended that: What we need now is a forum that will bring together the various stake- holders—governments, industry, science, public health, security, the public writ large—into a common program, built from the bottom up, to ensure that biotechnology’s advances are used for the public good and that the benefits are shared equitably around the world. Such an effort must ensure that nothing is done to impede the potential posi- tive benefits from this technology. The United Nations is well placed to coordinate and facilitate such a forum, and to bring to the table a wide range of relevant actors. I urge Member States to consider this proposal in the near future.46 In September 2006, the United Nations General Assembly passed a resolution creating a UN Global Counter­Terrorism Strategy, including a proposal to bring together “the major biotechnology stakeholders, includ- ing industry, the scientific community, civil society and governments, into a common program aimed at ensuring that biotechnology advances are not used for terrorist or other criminal purposes, but for the public good.”47 It was hoped that this could become a regular event. Although the transition to a new Secretary General slowed progress, the Secretary General’s office is currently developing plans for a major new initiative. The 6th Review Conference for the BWC held in late 2006 offered an opportunity for some of the international scientific organizations to pro- vide input to the review of the implications of trends in the life sciences for the implementation and operation of the treaty. The Royal Society, in collaboration with the IAP and ICSU, organized a workshop in London to assess the implications of rapid developments in the life sciences. 48 Among its results, the workshop highlighted the importance of monitor- ing technological developments, such as improved aerosol delivery tech- 45Annan, K. 2006. Uniting Against Terrorism: Recommendations for a Global Counter- Terrorism Strategy. Report of the Secretary-General. A/60/825. New York: United Nations, p.11. Available at: http://www.un.org/terrorism/unitingagainst terrorism/contents.htm. Accessed December 11, 2008. Ibid., p. 11-12. 46 47 United Nations. 2006. The United Nations Global Counter-Terrorism Strategy. UNGA Resolution A/RES/60/288. New York: United Nations, Annex II-11. Available at: http://www. un.org/terrorism/strategy­counter­terrorism.shtml#resolution. Accessed December 11, 2008. 48 Royal Society. 2006. Report of the RS-IAP-ICSU International Workshop on Science and Technology Developments Relevant to the Biological and Toxin Weapons Convention. London: The Royal Society. Available at: http://royalsociety.org/displaypagedoc.asp?id=2278. Accessed December 11, 2008.

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20 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY niques, in addition to purely scientific developments.49 It also highlighted the increasingly blurred lines among fields such as chemistry and biology in many areas of particular interest and concern, with the emerging field of synthetic biology as a prime example.50 One of the decisions made at the 6th BWC review conference in December 2006 was to continue the intersessional meetings until the next review conference in 2011. Reflecting the increasing level of engagement and international interest, the topics chosen for 2008 were: • National, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins. • Oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential of use for purposes prohibited by the Convention. 51 The choice of topics for the 2008 meetings provided another oppor- tunity to encourage further engagement by national and international scientific organizations in convening a meeting directly relevant to their interests. In April 2007, IUPAC organized its second workshop on trends in chemical sciences and technology for the Organization for the Prohibi- 49 A similar argument is made in the 2006 report from the National Research Council, Globalization, Biosecurity, and the Future of the Life Sciences (Washington, DC: The National Academies Press). 50 This growing field combines elements of biological science, chemistry and engineering into a highly interdisciplinary area of the life sciences. Synthetic biology offers the potential to construct bioengineered microorganisms that might, for example, enable the mass-pro- duction of drugs to treat disease, detect and break down toxic chemicals to reverse polluted sediments and water, and generate new energy forms to help solve the energy crisis. There are also substantial concerns, however, regarding the potential for the creation of “dual use” products, either intentionally or unintentionally, that could function as biological weapons or lethal pathogens in the hands of terrorists. For further information and discussion of policy options, see Bügl, H., J.P. Danner, R.J. Molinari, J. Mulligan, D.A. Roth, R. Wagner, B. Budowle, R.M. Scripp, J.A L. Smith, S.J. Steele, G. Church, and D. Endy. 2006. A Practical Perspective on DNA Synthesis and Biological Security. International Consortium for Poly- nucleotide Synthesis. December 4. Available at: http://pgen.us/ICPS.htm. Accessed December 11, 2008. See also Garfinkel, M.S., D. Endy, G.L. Epstein, and R.M. Friedman, eds. 2007. Working Papers for Synthetic Genomics: Risks and Benefits for Science and Society. Avail- able at: http://hdl.handle.net/72./8. Accessed December 11, 2008. 51 Biological Weapons Convention Meetings Secretariat. 2006. Sixth Review Conference of the States Parties to the Biological Weapons Convention. Final Document. Geneva: United Nations Department for Disarmament Affairs. Available at: http://www.opbw.org. Accessed December 13, 2008.

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2 BACKGROUND tion of Chemical Weapons. The workshop, held in Zagreb, Croatia, was intended to inform the preparations for the 2nd review conference of the Chemical Weapons Convention in April 2008. A number of topics and themes overlapped with those in the Royal Society-IAP-ICSU workshop on trends in life sciences.52 SuMMARy These are only examples of some of the events that have taken place in the last few years, focusing primarily on international interactions. Other international events, and additional national and regional activi- ties, are described later in the report. Taken together they underscore the increasing opportunities for scientists and scientific organizations to engage with policy makers to develop ways to address biosecurity issues and to provide expert advice about trends in the life sciences, so that poli- cies are based on realistic assumptions. It is important to recognize that these growing opportunities also pose challenges. Biosecurity is at a relatively early stage of development as an international issue. Because of the complexity of the problem and the importance of reaching diverse constituencies, it is necessary and desir- able to have many stakeholders addressing biosecurity through different venues and approaches. In some cases there are genuine disagreements about both the nature and the scope of the problem. Such diversity creates the potential for overlap and duplication of effort, or even for unintention- ally working at cross purposes. Multiple approaches are important, but the chances for success are increased if these various efforts communicate and, where reasonable, coordinate their work. With this as background, we now turn to our account of the 2nd Inter- national Forum. 52 Balali-Mood, M., P.S. Steyn, L.K. Sydnes, and R. Trapp. 2008. Impact of scientific de- velopments on the Chemical Weapons Convention (IUPAC Technical Report). Pure and Applied Chemistry 80(1):175-200. Available at: http://www.iupac.org/publications/pac/80//07/. Accessed December 11, 2008.

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