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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities IV. Biosecurity and Dual-Use Research in the Life Sciences In the life sciences, dual-use research “encompasses biological research with legitimate scientific purpose, the results of which may be misused to pose a biologic threat to public health and/or national security.”65 Generally, the term tends to refer to technologies that have both a civilian and a military use. The dual-use research dilemma in the life sciences refers to the conundrum of producing and publishing research within the life sciences that is directed toward or intended to improve public health, animal health, or agricultural productivity, but that in the hands of a rogue state, terrorist group, or individual, could be used to impair public health. As early as the 18th century, greater understanding of the smallpox virus led to the first viral vaccine, as well as use of the virus as a bioweapon.66 In the wake of the anthrax attacks of 2001 and heightened concerns regarding terrorism, the more tangible possibility of bioterrorism has increased fears and concerns regarding the performance and publication of dual-use research. Within the last 50 years alone, the scientific community has solved the structure of DNA and sequenced the entire genomes of 10 mammals (including the human, chimpanzee, mouse, rat, dog, and cat), 2 other vertebrates, 6 invertebrates, 3 protozoa, 9 plants, and 14 fungi,67 not to mention numerous viruses and bacteria. Only 30 years ago, one could spend years on a doctoral thesis to sequence one gene. In contrast, with current technology, the sequencing of one gene can occur in a matter of hours. In 2002, a group of researchers published its work describing the synthetic reconstruction of poliovirus, a project that took three years.68 The next year, the reconstruction of an equivalently sized virus took only two weeks.69 The exponential increase in sequencing and synthetic biology technologies reflects the increased productivity and advancement throughout the life 65 The NSABB dual-use research definition is available at www.biosecurityboard.gov/faq.asp#14. 66 National Research Council. 2004. Biotechnology in an Age of Terrorism. Washington, D.C.: The National Academies Press. p. 34. 67 See www.ncbi.nlm.nih.gov/mapview/. 68 J. Cello, et al. 2002. Chemical synthesis of Poliovirus cDNA: Generation of infectious virus in the absence of natural template. Science. 297(5583):1016-1018. 69 H. O. Smith, et al. 2003. Generating a synthetic genome by whole genome assembly: X174 bacteriophage from synthetic oligonucleotides. Proceedings of the National Academies. 100(26):15440-15445.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities sciences in general. The rise of biotechnology, informatics, and automation has decreased the labor required and the time to knowledge acquisition, while increasing productivity and the number and types of questions that biologists can address. Such a convergence of biology and technology increases the pace of biological findings and the creation of new fields within biology in unpredictable ways. The discoveries and innovations that are happening today will precipitate advances over the next 30 years, and most likely even over the next 5 to 10 years—discoveries and innovations that have not even been envisioned at this time. In addition, life sciences research occurs in an increasingly interdisciplinary and international environment. As George Church, Director of the Center for Computational Genetics at the Harvard Medical Center, pointed out at the May 2006 regional meeting, “Biology has a thousand journals and the Internet allows rapid information dispersion.”70 Just as computing and other technological innovations have created new industries and sectors toward the end of the 20th century and during the early part of the 21st, technology also has pushed the boundaries of the life sciences. Now, when research in the life sciences is considered, computational biology, systems biology, nanotechnology, and synthetic biology are at the forefront of such discussions. These fields blend biology—from whole organismal biology to microbiology—with computer science, the physical sciences, engineering, and mathematics. Although the risk that pathogens will be used for harm has been around for centuries, the emerging global, fast-paced, and collaborative nature of the life sciences now makes protecting information, personnel, and materials from abuse that much more difficult. To effectively identify dual-use research of concern, and perhaps restrict it, techniques must be available to determine what types of biological agents could stand as threats, as well as what types of mathematics, software programs, physical materials, and computational tools could enhance biological threats. The ability to understand the ways that these emerging biology applications could be used for offensive purposes poses a formidable challenge because of the unpredictable nature of science and the ways in which new technologies that come along completely alter what can be accomplished. 70 George Church. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Northeast Regional Meeting at MIT. May 16. Available at www7.nationalacademies.org/stl/032895.pdf. Accessed February 14, 2007.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities Despite these important advances, in contrast with other weapons, the materials and equipment required to create and propagate a biological attack using naturally occurring or genetically manipulated pathogens remain decidedly “low-tech,” inexpensive, and widely available. In the case of the physical sciences and nuclear proliferation, the development of nuclear weapons R&D required equipment that was specialized and expensive. As a result, the ability to engage in research promoting nuclear proliferation was restricted to the global superpowers and other well-funded nonstate entities. In addition, nuclear weapons R&D could be detected by monitoring the acquisitions of the specialized equipment needed for such programs and by other technical means. By contrast, much of the same equipment that can be used to create a dangerous biological agent is also a key part of benign biological research programs. Moreover, in the case of life sciences research, it is not just that much of the same materials and equipment can be used for illegal and benign research, but also that biological research can produce agents and knowledge that in the hands of some would promote human health and welfare, but that in the hands of others would be used for harm. This is the crux of what is called “dual-use research of concern.” Oversight of Dual-Use Life Sciences Research In the late 1970s, scientists conducting research in the emerging field of recombinant DNA developed a model of oversight that involved 1) personal responsibility and accountability of the researcher to conduct his or her research safely; 2) deliberations by a nationally convened advisory group to provide recommendations regarding biosafety with recombinant DNA research; and 3) local oversight by the institution through a committee of peer researchers and biosafety professionals to assure that appropriate facilities, practices, personnel, and training were in place. Although all of these components of self-governance and local assurance were recommended for all U.S. researchers regardless of affiliation, the practical outcome of this system is that only institutions accepting federal funding for recombinant DNA research are obligated to use this model of oversight. Discussions of oversight for dual-use life sciences research have centered on the same components as those considered 30 years ago for recombinant DNA. In 2003 the National Academies published Biotechnology Research in an Age of Terrorism, also referred to as the “Fink Report,” after the committee chair, Gerald Fink. The Fink Report was
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities compiled by experts mostly from the academic community and therefore largely represented the response of the scientific community to increased concerns about bioterrorism. The report concluded that many of the current structures and regulations used to monitor and mitigate risk resulting from dual-use research were sufficient for that task; however, they needed to be enforced at a greater and more comprehensive level. The report also outlined seven categories of experiments of concern that should be scrutinized by “informed members of the scientific and medical community” as a part of any research program and in any publication. These experiments of concern generally were those that would greatly alter the transmissibility, detectability, and/or pathogenicity of a biological agent for greater use in bioterror. Such dual-use research, the report suggested, should not be prohibited, but should be scrutinized carefully, and if undertaken, should be performed under the pronounced awareness of the threat of bioterrorism.71 The Fink Report endorsed, among other things, expanded self-governance by researchers toward issues of biosecurity, as well as the formation of a national advisory board to help guide both the government and research community in addressing issues involving dual-use research. The report also advocated expanding the responsibilities of Institutional Biosafety Committees (IBCs), the local committees formed to oversee recombinant DNA research, to include biosecurity and dual-use concerns. The National Science Advisory Board on Biosecurity In response to the recommendation that a national advisory board be formed to address issues regarding dual-use research of concern, the National Science Advisory Board on Biosecurity (NSABB) was chartered by the Executive Office of the President “to provide advice, guidance and leadership regarding biosecurity oversight of dual-use research, defined as biological research with legitimate scientific purpose that may be misused to pose a biologic threat to public health and/or national security.”72 The board was formed to serve in an advisory capacity to the “secretary of HHS, the director of NIH, and the heads of all federal agencies and departments that conduct or support life sciences research.”73 In addition to the voting members, the board includes ex officio representatives from each of the 71 National Research Council. 2004. Biotechnology Research in an Age of Terrorism. 72 See www.biosecurityboard.gov. 73 Ibid.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities interested federal agencies. When the NSABB became fully operational in June 2005, five working groups were created to 1) outline the criteria for dual-use research; 2) assemble a code of conduct for scientists; 3) develop strategies and guidelines for the communication of dual-use research; 4) advise on the usage and regulation of synthetic genomes; and 5) foster international cooperation regarding the oversight of dual-use research. To date, the NSABB has been involved in defining dual-use research that may be of concern, creating guidelines for communication of the results of such research, developing the principles of a code of conduct, and making preliminary recommendations regarding the nascent field of synthetic genomics. It also was asked by the Secretary of HHS to review one manuscript prior to publication.74 In 2006, the NSABB formed a working group that was to focus on the “oversight of dual-use research.”75 Specifically, this working group has made recommendations regarding 1) the review of research with dual-use potential by local entities, the government, and/or NSABB; 2) risk assessment of research; 3) risk management of dual-use research; and 4) education of institutions and individuals regarding dual-use research. Nearly all presenters addressing the dual-use dilemma at the regional meetings stressed that life sciences research is now nearly borderless and is a global collaborative activity. In this era of globalization, the boundaries of national security do not end at our borders—they extend across the world. It has been stated that if controls and regulations regarding dual-use research are instituted or followed only in the United States, they will be meaningless because the scientific enterprise is global. Unilateral regulations will disproportionately affect U.S. science, threatening our dominance in certain areas and hampering crucial collaborations with non-U.S. scientists. These factors make it necessary to include in a conversation about dual-use research and national security the ways in which the United States can work with other nations to fortify our biosecurity measures for their ultimate effectiveness. In this regard, several national and international scientific bodies have released statements regarding biosecurity and their stances toward the movement, procurement, and use of bioterrorist and dual-use agents for malevolent purposes.76 Although developing individual statements 74 Donald Kennedy. 2005. Better never than late. Science. 310(5746):195. 75 NSABB meeting July 13, 2006. Available at www.biosecurityboard.gov. 76 Biotechnology and Biological Sciences Research Council, Medical Research Council, Wellcome Trust. 2005. “Managing risks of misuse associated with grant funding activities: a
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities regarding dual-use research is a necessary first step, it is still critical to harmonize international efforts to inhibit the misuse of dual-use research. Self-Governance Versus Regulation To date, the response of the scientific community largely has been to assert the value of open scientific dialogue and exchange of information, self-governance, and increased communication among all affected sectors. However, others support mandatory government regulations in addition to, or in lieu of, voluntary measures.77 For example, Elisa Harris told the committee at the June 2006 regional meeting that “The choice is not between regulation or self-governance. Neither one on its own is sufficient to be effective. To develop an effective response, we need to do both. We need self-governance and we need regulation.”78 Others at the regional meetings suggested the need for more strenuous measures in certain areas of the life sciences. For example, at the May 2006 regional meeting, George Church proposed surveillance measures, in synthetic biology, “of the whole stream of chemicals from precursors, which are unique to oligonucleotides, to synthetic genes to instruments that employ these, to even experts in the field.”79 At their 2006 meeting, Synthetic Biology 2.0, synthetic biologists were offered a draft “community declaration” regarding the ethical use of synthetic biology and the governance of synthetic biology research as it relates to the threat of bioterrorism. This proposal for self-governance would have been consistent with the “culture of responsibility” that NSABB is urging the life sciences community to develop, and it also might have had the effect of staving off “attempts to set controls or limits on the field.”80 Draft Joint BBSRC, MRC and Wellcome Trust policy statement,” September 2005; InterAcademy Panel. 2005, “IAP Statement on Biosecurity,” November 2005. InterAcademy Panel. 77 D. Malkoff and M. Enserink. 2003. Researchers await government response to self-regulation plea. Science. 302(5644):368; GeneWatchUK, May 19 2006 press release, Global Coalition Sounds the Alarm on Synthetic Biology, Demands and Societal Debate. 78 Elisa D. Harris. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Southeast Regional Meeting at the Georgia Institute of Technology. June 5. Available at www7.nationalacademies.org/stl/Partnership-6-6-06.pdf. Accessed February 15, 2007. 79 George Church. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Northeast Regional Meeting at MIT. May 16. Available at www7.nationalacademies.org/stl/032895.pdf. Accessed February 14, 2007. 80 E. Check. 2006. Synthetic biologists try to calm fears. Nature. 441(7092):388.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities recommendations dealt with the stated need to promote, establish, and/or standardize monitoring systems within companies, domestically and internationally, that can detect potentially harmful sequences or combinations of sequences and also to improve such monitoring technologies.81 At the June 2006 regional meeting, Gigi Gronval, University of Pittsburgh, cautioned against an overly restrictive approach: …I would recommend that we have to accept some level of risk from dual-use research. Scientists need to recognize that their work could be misused, and there need to be mechanisms to make sure that they do the work safely and smartly. But on the other hand, and this is more addressing a code of conduct discussion, but I don't think that scientists can promise to do no harm. They can promise to intend to do no harm, but what they uncover is very often by serendipity and there should be some mechanism to deal with the consequences of an experiment, as well as just the intent. So what is at stake if we don't accept some of this risk and push forward? We will harm research that needs to be done in a time of crisis. In conclusion, I would recommend three things, [first] that we promote self governance and we promote self awareness as scientists as best we can to make sure that work is done safety and is done as fast as possible in the public interest. Second, that the information that is uncovered that is dual use be used to inform strategy. Third, we need to get better at response in general, because eventually prevention efforts are going to fail for a deliberate attack, and it is certain, certain, certain that we are going to have another natural epidemic of a new disease that we don't know how to deal with.82 Related to these issues of openness and self-governance is the issue of whether the presentation of dual-use research (e.g., publication, papers at conferences, seminars) should be restricted. The practice of science being an 81 R.F. Service. 2006. ScienceNow Daily News. Available at sciencenow.sciencemag.org/cgi/content/full/2006/523/1. Accessed February 15, 2007. 82 Gigi Gronval. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Southeast Regional Meeting at the Georgia Institute of Technology. June 5. Available at www7.nationalacademies.org/stl/Partnership-6-6-06.pdf. Accessed February 15, 2007.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities open, public forum that stimulates discussion and furthers the advancement of the scientific enterprise is a long-standing tenet of scientific research and one that is embraced within the life sciences community. However, there is concern that the ability of terrorists to glean information from scientific publications poses a severe risk to the public. It is possible that bioterrorists could directly or indirectly use published scientific information related to pathogens or the delivery of pathogens to plan a terrorist attack. Within the last two years, two publications precipitated a public debate regarding whether dual-use research should be openly published and disseminated. In June 2005, an article appeared in the Proceedings of the National Academy of Sciences that modeled a bioterrorist attack on the milk supply of the United States.83 In October 2005, Science published the reconstructed genome of the 1918 pandemic human influenza virus.84 While some argued that publishing these data was irresponsible, the prevailing view among many scientists appearing before the committee was that, generally, the risk of bioterrorism is far outweighed by the benefit of further scientific work based upon openly disseminated information and also that open dissemination, in virtually all cases, is best for national security as well.85 The reasoning is that the ability to further the scientific frontier is based upon knowledge of where the frontier lies. Obscuring the scientific frontier could limit the progress of the scientific enterprise as a whole and perhaps would limit the abilities of terrorists very little, if at all.86 It has been acknowledged, however, that there may be cases in which open publication of research would not be in the best interest of national security and, therefore, some form of restriction would be needed. How that determination would be made and by whom is not clear. To determine when restriction, or other lesser measures, should be incurred, scientists and government and intelligence officials have repeatedly stated the need for 83 L.M. Wein and Y. Liu. 2005. Analyzing a bioterror attack on the food supply: The case of botulinum toxin in milk. Proceedings of the National Academy of Sciences. 102(28):9984-9989. 84 T. Tumpey, et al. 2005. Characterization of the reconstructed 1918 Spanish influenza pandemic virus. Science. 310(5745):77-80. 85 P. Sharp. 2005. 1918 flu and responsible science. Science. 310(5745):17. 86 Gigi Gronval. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Southeast Regional Meeting at the Georgia Institute of Technology. June 6. Available at www7.nationalacademies.org/stl/Partnership-6-6-06.pdf. Accessed February 15, 2007.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities standardized, commonly practiced guidelines and regulations for dual-use research.87 Editors of scientific journals have emphasized that openness in research and publication procedures and continued self-governance are the best tools to advance science and to mitigate the threat of a successful bioterrorist attack. 88 At the September 2006 regional meeting, Donald Kennedy, Stanford University, and editor of Science magazine, emphasized the sense of responsibility that most editors feel: I think that almost everybody I know who is in the business of evaluating, peer reviewing and publishing scientific work realizes that they have some kind of a responsibility to reassure the public that they are conscious of this problem and watchful for it.89 Local Oversight and Assurance IBCs normally handle biosafety issues within the life sciences, in particular with regard to recombinant DNA research. The Fink Report suggested that the IBCs also should monitor institutional biosecurity issues. Critics have argued that IBCs are not properly trained to oversee biosecurity issues and are already overburdened with tasks. In 2004, an organization known as “The Sunshine Project” requested and surveyed the minutes of IBCs and reported that, based on its undisclosed criteria, few IBCs were equipped to operate in a fully compliant and transparent manner. 90 The real problem, however, is that IBCs currently are not properly constituted to assess biosecurity risks. At the September 2006 regional meeting, David Relman, Stanford University, noted that “Today’s IBC's can't do biosecurity 87 Elisa D. Harris. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Southeast Regional Meeting at the Georgia Institute of Technology. June 5. Available at www7.nationalacademies.org/stl/Partnership-6-6-06.pdf. Accessed February 15, 2007. 88 D. Kennedy, op. cit. 89 Donald Kennedy. 2006. Remarks made at the Committee on a New Government-University Partnership for Science and Security Western Regional Meeting at Stanford University. September 28. Available at www7.nationalacademies.org/stl/202006.pdf. Accessed February 14, 2007. 90 The Sunshine Project. 2004. Mandate for Failure: The State of Institutional Biosafety Committees in an Age of Biological Weapons Research. Available at www.sunshineproject.org/biodefense/ibcreport.html. Accessed January 12, 2007.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities because the members have not been adequately informed about how you think [about] biosecurity, how you think about the potential misuse of science.”91 Nonetheless, local oversight remains a key component in providing scientific and risk-based evaluation of biosafety and biosecurity, including dual-use concerns. The history of U.S. biosafety oversight of life sciences and biotechnology research hinges on self-governance by researchers and on local risk-based oversight. Such oversight generally is delegated to IBCs. However, the requirement for convening an IBC or a similar committee is limited to those institutions receiving federal funding for research involving recombinant DNA technology. In addition, few punitive mechanisms are ever used for institutions that fail to provide adequate local oversight. These local committees often lack the necessary resources, staff, and training. Additional proposed requirements toward oversight of biosecurity issues will further stress these institutions and committees, which are already struggling to stay in compliance. Meeting participants noted that if controls and regulations regarding dual-use research are instituted or followed only in the United States, they will be meaningless because the scientific enterprise is global. No longer are research programs relegated to one institution or even one country; many funded research programs include research professors both from within and outside of the United States. Therefore, having disparate international dual-use regulations can have negative effects for some institutions. In addition, the individuals that compose the review board for the journal Science and most scientific journals are located around the world,92 making open dissemination immediate and global. The NSABB has a working group specifically focused on bringing international harmonization to dual-use research guidelines. It is currently carrying out this task through the enlistment of several international scientific bodies. The scientific journal Nature, which is based in the United Kingdom, has set up advisory committees that include U.S. scientists for sensitive publications and biosecurity issues. Although having individual 91 David R. Relman. Remarks made at the Committee on a New Government-University Partnership for Science and Security Western Regional Meeting at Stanford University. September 27. Available at www7.nationalacademies.org/stl/202006.pdf. Accessed February 14, 2007. 92 Joanne P. Carney. 2006. Remarks made at a meeting of the Committee on New Government-University Partnership for Science and Security. The National Academies. January 12-13.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities national and international statements regarding dual-use research is a necessary first step, there still may be a need for a harmonized international effort to inhibit the misuse of dual-use research. An opinion often stated throughout the regional meetings is that an international agreement is needed regarding the dual-use publication review process, along the lines of previous international agreements that addressed the possession, import, and use of dual-use biological agents. Summary and Recommendations The international nature of science, scientific talent, and possible security threats requires a common international approach to overseeing policies pertaining to dual-use life sciences research. As recommended in the 2004 NAS report, Biotechnology Research in an Age of Terrorism, a mechanism is needed to “develop and promote harmonized national, regional, and international measures.”93 Recommendation 8: Taking full advantage of the National Science Advisory Board for Biosecurity’s international work, as well as that being undertaken by other Department of Health and Human Services agencies, the U.S. government should develop policies and procedures for the oversight of dual-use life sciences research that foster international collaboration and control strategies, with a goal of harmonizing the mechanisms of local oversight. The history of U.S. biosafety oversight of the life sciences and biotechnology research hinges on self-governance by researchers and on local risk-based oversight. Such oversight is generally delegated to local committees. In order to increase the culture of responsibility within these committees, their members will need to receive training on issues relevant to national security. Programs providing this training should be developed at the national level in collaboration with the university community. Recommendation 9: To strengthen and harmonize the institutional review of life sciences research, the Department of 93 National Research Council. 2004. Biotechnology Research in an Age of Terrorism.Wasington, D.C.: The National Academies Press.
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Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities Health and Human Services, in conjunction with other agencies that conduct and fund life sciences research, should develop an education program on the basic principles of risk-based biosafety and biosecurity review. To promote the importance of local oversight and to encourage institutions to fully support their committees, federal funding agencies should assure that 1) the institution has taken part in and disseminated information from the education program; 2) an oversight committee is appropriately constituted and convened; and 3) the research to be funded has been reviewed by the committee prior to commencement of the experiments. This is not dissimilar to the process for ensuring local review of research involving animals or human subjects.
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