1
Introduction

BACKGROUND

In mid-November 2009, more than sixty people from almost thirty countries gathered at the Polish Academy of Sciences in Warsaw for a workshop devoted to expanding education about so-called “dual use” research among the life sciences community. (As used here and throughout this report, the term refers to the possible beneficial or malevolent use of reagents, organisms, technologies, or information.) The workshop resulted from a request by the U.S. Department of State to the IAP, the Global Network of Science Academies, which is committed to making the voice of science heard on issues of crucial importance to the future of humankind.1 The State Department provided funding through its Biosecurity Engagement Program, which is committed to developing cooperative international programs that promote the safe, secure and responsible use of biological materials that are at risk of accidental release or intentional misuse. The IAP also provided funding to support travel by participants from developing counties.

The IAP carries out its work through groups of member academies; in this case its Biosecurity Working Group, which was created in 2004

1

The IAP, formerly known as the InterAcademy Panel on International Issues, currently has a membership of 106 scientific academies from around the world; these include both national academies/institutions as well as regional/global groupings of scientists. A number of other scientific organizations participate in IAP meetings and activities as observers. Additional information may be found at http://www.interacademies.net/.



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1 Introduction BACKGROUND In mid­November 2009, more than sixty people from almost thirty countries gathered at the Polish Academy of Sciences in Warsaw for a workshop devoted to expanding education about so­called “dual use” research among the life sciences community. (As used here and through­ out this report, the term refers to the possible beneficial or malevolent use of reagents, organisms, technologies, or information.) The workshop resulted from a request by the U.S. Department of State to the IAP, the Global Network of Science Academies, which is committed to making the voice of science heard on issues of crucial importance to the future of humankind.1 The State Department provided funding through its Biosecurity Engagement Program, which is committed to developing cooperative international programs that promote the safe, secure and responsible use of biological materials that are at risk of accidental release or intentional misuse. The IAP also provided funding to support travel by participants from developing counties. The IAP carries out its work through groups of member academies; in this case its Biosecurity Working Group, which was created in 2004 1 The IAP, formerly known as the InterAcademy Panel on International Issues, currently has a membership of 106 scientific academies from around the world; these include both national academies/institutions as well as regional/global groupings of scientists. A number of other scientific organizations participate in IAP meetings and activities as observers. Addi­ tional information may be found at http://www.interacademies.net/. 

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 DUAL USE ISSUES IN THE LIFE SCIENCES and includes the academies of China, Cuba, the Netherlands (chair through 2009), Nigeria, the United Kingdom and the United States. The Polish Academy of Sciences served as the host for the workshop, 2 and the National Research Council (NRC) of the U.S. National Academy of Sciences took responsibility for preparing the report. The two academies and IAP shared the organizing and arrangements, and were joined by two international scientific unions—the International Union of Biochemistry and Molecular Biology and the International Union of Microbiological Societies—as partners in the project. The NRC followed its normal practices and appointed an ad hoc com­ mittee to help organize the workshop with the partner organizations and be responsible for the report. In keeping with the international nature of the project, a majority of the committee members were non­U.S. citizens; brief biographical sketches may be found in Appendix A. The specific task given to the committee was to: develop recommendations for the most effective education internation ­ ally of life scientists on dual use issues. To inform its work the committee will convene a workshop to: • survey strategies and resources available internationally for educa­ tion on dual use issues and identify gaps, • consider ideas for filling the gaps, including development of new educational materials and implementation of effective teaching methods, and • discuss approaches for including education on dual use issues in the training of life scientists. Based on the workshop and additional data gathering, the committee will produce a consensus report, which will make recommendations on the topics addressed in the workshop. The two­and­a­half­day meeting combined plenary sessions with smaller working group discussions to facilitate the exchange of informa­ tion and the development of ideas to support increased implementation of education on dual use issues. The agenda and participants list for the workshop may be found in Appendix B. The workshop sought to take advantage of the substantial amount of work that had already been done to prepare the ground for implementing significant new educational efforts. Workshop participants included practicing life scientists, bioethics and biosecurity practitioners, and experts in the design of educational programs, reflecting two basic themes for the workshop: 2 The Polish Academy became a member and chair of the Working Group in early 2010.

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 INTRODUCTION • To engage the life sciences community, the particular security issues related to dual use research would best be approached in the context of responsible conduct of research, the wider array of issues that the community addresses in its efforts to fulfill its responsibilities to society. • Education about dual use issues would benefit from the insights of the “science of learning,” the growing body of research about how individuals learn at various stages of their lives and careers and the most effective methods for teaching them, which provides the foundation for efforts in many parts of the world to improve the teaching of science and technology at all levels of instruction. This chapter and Chapter 2 explain and develop these two themes in more detail, with Chapter 2 providing a primer on the results of research about learning and effective approaches to teaching. They are followed by two chapters devoted to the specific issues addressed during the work ­ shop and the committee’s findings, conclusions, and recommendations about them. The workshop and the committee’s report are intended to inform a number of audiences, including decision­makers at the national and international level and the community of experts about dual use issues and biosecurity in many sectors. One important audience is those carry­ ing out education in the life sciences in colleges and universities, with an emphasis on graduate students and postdoctoral fellows. The findings and recommendations are also relevant for those charged with the educa­ tion of technical and professional staff in settings such as research insti ­ tutes or other laboratories, although they do not receive as much attention in the report. The report does not address education about dual use issues for students at the secondary level, although the resources and methods discussed may be relevant and the increasing availability of equipment and techniques to ever­younger students suggests that this is an audience to be considered in future efforts. THE BROAD CONTEXT OF SCIENCE AND SOCIETY Science is not conducted in a social vacuum; as the most recent edi ­ tion of On Being a Scientist, the widely used introduction to responsible conduct of research from the National Academies notes: The standards of science extend beyond responsibilities that are internal to the scientific community. Researchers also have a responsibility to reflect on how their work and the knowledge they are generating might be used in the broader society. (NRC 2009a:48)

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 DUAL USE ISSUES IN THE LIFE SCIENCES The second edition of the guide had already made clear that these obligations extended across the scientific community: Even scientists conducting the most fundamental research need to be aware that their work can ultimately have a great impact on society. Construction of the atomic bomb and the development of recombinant DNA—events that grew out of basic research on the nucleus of the atom and investigations of certain bacterial enzymes, respectively—are two examples of how seemingly arcane areas of science can have tremendous societal consequences. The occurrence and consequences of discoveries in basic research are virtually impossible to foresee. Nevertheless, the scientific community must recognize the potential for such discoveries and be prepared to address the questions that they raise. If scientists do find that their discoveries have implications for some important aspect of public affairs, they have a responsibility to call attention to the public issues involved. . . . science and technology have become such integral parts of society that scientists can no longer isolate themselves from societal concerns. (NRC 1995:20­21) The conduct of science itself may also be shaped by changing social attitudes. A clear example is the development of standards for the treat­ ment of human subjects in experiments, which developed over time, par­ ticularly during the twentieth century in response to what were judged to be egregious abuses by researchers (IOM 2001). The standards for the treatment of laboratory animals have continued to evolve as well (NRC 2010). More generally, the ability to conduct science depends on public trust and support, not least because a substantial portion of research fund­ ing comes from governments. The loss of public trust in particular areas of science could mean that research could not proceed or that its results would be the subject of controversy. Ultimately, this could prevent science from serving one of its key social functions—informing policy decisions with important scientific or technical components. Most contemporary articulations of the social responsibilities of sci ­ entists focus on the most general duties and obligations of scientists and researchers. At this level of granularity, obligations must be interpreted and contextualized. That is, norms and general sentiments (e.g., Do No Harm), do not provide guidance to individuals about specific situations. Furthermore, any given norm or general obligation allows for innumer­ able unique interpretations. This most general level of obligation can answer only those questions about science’s responsibility to society that are solely ethical, rather than legal or professional. Such norms do not translate into a single set of specific or explicit actions for those engaged in the scientific enterprise. This has the drawback of being ostensibly unenforceable or not codifiable into anything but tenets, but constructing

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 INTRODUCTION an ethical framework with any greater degree of specificity is problem ­ atic. Even if we believed that a system encompassing all possible ethical problems in the life sciences could be conceived or developed, such a framework would be untenably inflexible (i.e., it could not grow as the life sciences develop). Perhaps more importantly, while specific obligations may be too grounded in a distinct sociohistorical setting to be useful out ­ side of that particular context,3 meaningful responses to concerns about the responsibility of science to society are best articulated as general and universalizable norms and obligations. That these issues are both ethical and best framed in abstract or gen ­ eral ways has a significant impact on the way education in social respon ­ sibility of science is conducted. Any training or education that arises out of this theoretical groundwork, because of its contingency, also needs to focus on the general and abstract moral duties in play, rather than context­ specific obligations. This may be reflected in the distinctions among vari ­ ous kinds of codes to govern scientific conduct.4 Aspirational codes (often designated as ‘codes of ethics’) set out ideals that practitioners should uphold, such as standards of research integrity, honesty, or objectivity. . . . Educational/Advisory codes (often designated as ‘codes of conduct’) would go further than merely setting aspirations by providing guidelines suggesting how to act appropriately. . . . Enforceable codes (often designated as ‘codes of practice’) seek to further codify what is regarded as acceptable behavior. Rather than inspiring or educating in the hopes of securing certain outcomes, enforce­ able codes are embedded within wider systems of professional or legal regulation. (Rappert 2004:14­17) Another response to the question of providing practical guidance to scientists about appropriate conduct that could go beyond generalizations is the widespread use of case studies or scenarios, to encourage students to work through the ethical issues and develop their own views about appro­ priate responses. NRC’s On Being a Scientist (2009a), for example, contains short case studies to illustrate each of the basic ethical issues it addresses. The fundamental question in developing standards for responsible conduct of research may be one of degree: whether the social responsibility 3 For a brief but insightful discussion of internalized and externalized obligations see Kuhlau et al. (2008:480). 4 Proponents of codes of conduct do not argue that they will prevent an individual deter­ mined to do harm from carrying out his or her intentions. Rather codes serve as evidence of the commitment of individuals and organizations to use the results of science only for beneficial purposes and as educational tools to foster a broader culture of responsibility.

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 DUAL USE ISSUES IN THE LIFE SCIENCES of science is negative (e.g., the Hippocratic “Do No Harm” or Google’s “Don’t Be Evil”) or positive (i.e., scientists have an obligation or duty to work to promote public welfare, such as the UK Government Office for Science’s Rigour, Respect, and Responsibility: A Uniersal Ethical Code for Scientists [2007]). Responses to this question of degree vary among institu­ tions, but policy and scientific communities have worked to generate and expand current guidelines and codes of conduct. The attention devoted to social responsibility by scientific societies, advocacy groups, and aca ­ demic communities has helped to establish conventions and norms, as well as a theoretical grounding for training and education in these areas. A number of high­level declarations and statements in recent years have reinforced the ethical imperatives involved in scientific research across the global scientific community. For example, the 1999 World Confer­ ence on Science, a collaboration of the International Council for Science (ICSU) and the UN Educational, Scientific, and Cultural Organization (UNESCO), produced the Declaration on Science and the Use of Scientific Knowledge, which proclaimed that: The practice of scientific research and the use of knowledge from that research should always aim at the welfare of humankind, including the reduction of poverty, be respectful of the dignity and rights of human beings, and of the global environment, and take fully into account our responsibility towards present and future generations, and further that All scientists should commit themselves to high ethical standards, and a code of ethics based on relevant norms enshrined in international human rights instruments should be established for scientific professions. The social responsibility of scientists requires that they maintain high stan ­ dards of scientific integrity and quality control, share their knowledge, communicate with the public and educate the younger generation. Political authorities should respect such action by scientists. Science cur­ ricula should include science ethics, as well as training in the history and philosophy of science and its cultural impact. (UNESCO 1999) 5 In 2006, ICSU disbanded its Standing Committee on Freedom in the Conduct of Science and replaced it with a new standing Committee on Freedom and Responsibility in the Conduct of Science (emphasis added). 5 Key documents from the World Conference on Science are available at http://www. unesco.org/science/wcs/, including the text of the Declaration on Science and the Use of Scientific Knowledge in six languages, http://www.unesco.org/science/wcs/eng/ declaration_e.htm.

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 INTRODUCTION Without in any way diminishing its commitment to the principles of the universality of science, such as the rights of scientists to travel, associate, and communicate freely, the new committee “differs significantly from its predecessors in that it has been explicitly charged with also considering the responsibilities of scientists” (ICSU 2008:2).6 THE LIFE SCIENCES AND DUAL USE ISSUES Continuing advances in the life sciences over the last 50 years, sup­ ported by new enabling technologies, have brought great benefits for health, the economy, and the environment. Many believe that the life sci ­ ences hold far greater promise for the future. Biology is at a point of inflection. Years of research have generated detailed information about the components of the complex systems that characterize life—genes, cells, organisms, ecosystems––and this knowl­ edge has begun to fuse into greater understanding of how all those com­ ponents work together as systems. Powerful tools are allowing biologists to probe complex systems in ever­greater detail, from molecular events in individual cells to global biogeochemical cycles. Integration within biology and increasingly fruitful collaboration with physical, earth, and computational scientists, mathematicians, and engineers are making it possible to predict and control the activities of biological systems in ever greater detail. . . . [T]he life sciences have reached a point where a new level of inquiry is possible, a level that builds on the strengths of the traditional research establishment but provides a framework to draw on those strengths and focus them on large questions whose answers would provide many practical benefits. (NRC 2009b:12­13) A wide range of national governments and regional and international organizations are creating visions and implementing strategies to apply these advances to the needs and ambitions of the developed and develop­ ing world (e.g., OECD 2009; African Union 2006). Along with the achievements and hopes, however, have come a range of concerns about the implications and impacts of current and potential advances. These range from a fundamental unease about how the increas­ ing knowledge of basic life processes will be applied to specific concerns about unintended effects on health or the environment (NRC 2002, 2005a, 2009c; IOM 2010). Among these specific concerns is the potential security risk that states or terrorist groups or even individuals could misuse the knowledge, tools and techniques gained through life sciences research for 6 The ICSU statement on the universality of science may be found at http://www.icsu. org/5_abouticsu/INTRO_UnivSci_1.html.

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 DUAL USE ISSUES IN THE LIFE SCIENCES biological weapons or bioterrorism. In May 2000, Matthew Meselson, a leading figure in the life sciences on issues related to biological weapons, offered a warning at the annual meeting of the U.S. National Academy of Sciences: 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, develop ­ ment, reproduction, and inheritance. A world in which these capabilities are widely employed for hostile purposes would be a world in which the very nature of conflict has radically changed. Therein could lie unprec ­ edented opportunities for violence, coercion, repression, or subjugation. (Meselson 2000) Concerns about the potential security risks posed by life sciences research can be seen in the context of rising concerns—and sometimes sharp disagreements—about the more general risks of weapons of mass destruction (WMD), including biological weapons and bioterrorism, following the end of the Cold War (see, for example, Carter, Deutch, and Zelikov 1998). More specifically, a number of articles in scientific journals early in this decade sparked controversy about whether the risks cited by Meselson were already present, with critics charging that the publications could provide a “blueprint” or “roadmap” for nations or terrorists.7 Yet even work with the greatest seeming potential for misuse most often also offers significant potential benefits, and judgments about the implications of research were seldom simple or definitive. Box 1­1 contains examples of some of the contentious articles; in every case the reality and extent of the risk were vigorously debated. The possibilities—and attendant uncertainties—regarding whether and how advances in the life sciences intended for legitimate and benefi­ cent purposes might also be used for malevolent ends has come to be called the “dual use dilemma” (NRC 2004a:1), a term that is the subject of considerable debate. For the purposes of the workshop, Professor Michael Imperiale, a member of the NRC organizing committee and the U.S. 7 A review of some of the best known articles from that period may be found in Bio­ technology Research in an Age of Terrorism (NRC 2004a:25­29), while a review of the issues and policy options then under discussion may be found in Epstein (2001). An example of the concern in the defense policy community is Zilinskas and Tucker (2002).

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 INTRODUCTION BOX 1-1 Examples of Research with Dual Use Potential The debates sparked by the publication of data related to the reconstruction of the 1918 influenza virus1 illustrated how scientific achievements may also generate security concerns. The additional recent research endeavors listed below were all identified as having the potential for misuse. In all cases, there was debate and discussion within the scientific community and between the scientific and security communities about whether these cases indeed presented security risks. • ynthesis of infectious poliovirus.2 Researchers sought to resolve the S unusual nature of poliovirus, which behaves as both a chemical and a “living” entity. They succeeded in recreating the virus by chemically synthesizing a cDNA of its genome. Some critics assert that the publication of their methods provided a recipe for terrorists by showing how one could create any virus from chemical reagents purchasable on the open market. The researchers acknowl- edged this potential but noted that a threat of bioterrorism arises only if mass vaccinations against polio end. • evelopment of “stealth” viruses that could evade the human immune D system.3 These viruses are being developed to serve as molecular means for introducing curative genes into patients with inherited diseases. However, the research has raised questions about whether they could potentially be induced to express dangerous proteins, such as toxins. • method for the construction of “fusion toxins” derived from two distinct A nontoxic chemical predecessors.4 This technique was originally investigated for the purpose of killing cancer cells, but some argue that it might be redirected to develop novel toxins that could target the normal cells of almost any tissue when introduced into a human host. • enetic engineering of the tobacco plant to produce subunits of cholera G toxin. Because tobacco is easy to engineer, it is a likely candidate for producing plant-based vaccines. The technique could be used to produce large quanti- ties of cholera toxin cheaply and relatively easily, paving the way for fast and efficient vaccine production. Concerns have arisen that it might also have a potential for misuse.5 • evelopment of new technologies for delivering drugs by aerosol spray D in individual doses. Some have expressed concern that this development, intended to improve the ease of use and rate of compliance among diabetic users of insulin, could be adapted to allow aerosol sprays to cover wider areas in an attack.6 Nonlaboratory research may also lend itself to possible misuse. Investigation of the potential effects of a deliberate release of botulinum toxin into the U.S. milk supply recommended aggressive pursuit of early detection measures and new research on means to inactivate the toxin. Publication of the studies pinpointed weaknesses in the system that critics argue could help direct a terrorist to the most vulnerable points in the milk supply.7 _______ 1Gibbs, M. J., J. S. Armstrong, and A. J. Gibbs. 2001. Recombination in the hemagglutinin gene of the 1918 “Spanish flu.” Science 293(5536):1842-1845. continued

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0 DUAL USE ISSUES IN THE LIFE SCIENCES BOX 1-1 Continued 2 Cello,J., A. V. Paul, and E. Wimmer. 2002. Chemical synthesis of poliovirus cDNA: generation of infectious virus in the absence of natural template. Science 297(5583):1016-1018. 3 Aldous, P. 2001. Biologists urged to address risk of data aiding bioweapon design. Nature 414(6861):237-238 as cited in R. A. Zilinskas and J. B. Tucker (2002), Limiting the contribution of the open scientific literature to the biological weapons threat. Journal of Homeland Security. Available online at www.homelandsecurity.org/journal/Articles/tucker.html. 4 Arora, N., and S. H. Leppa. 1994. Fusions of anthrax toxin lethal factor with Shiga toxin and diphtheria toxin enzymatic domains are toxic to mammalian cells. Infection and Immunity 62(11):4955-4961. 5 Wang, X. G., G. H. Zhang, C. X. Liu, Y. H. Zhang, C. Z. Xiao, and R. X. Fang. 2001. Purified cholera toxin b subunit from transgenic tobacco plants possesses authentic antigenicity. Bio- technology and Bioengineering 72(4):490-494. 6 Boyce, N. 2002. Should scientists publish work that could be misused? US News and World Report 132(22):60. 7 Wein, L. M., and Y. Liu. 2005. Analyzing a bioterror attack on the food supply: The case of botuli- num toxin in milk. Proceedings of the National Academy of Sciences USA 102(28):9984-9989. National Science Advisory Board for Biosecurity (NSABB) (see below), presented and discussed definitions of several key concepts as an aid to common understandings during the first plenary session.8 Dual Use Research: In the life sciences, dual use refers to the pos­ sible beneficial or malevolent use of reagents, organisms, technologies, or information. 8 The term “biosecurity” illustrates some of the difficulties, for example. At its most basic, the term in some languages does not exist or is identical with “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 by living modified organisms resulting from modern biotechnology. (Further information on the convention may be found at http://www.cbd.int/convention/ and on the Protocol at http://www.cbd. int/biosafety/). “Biosecurity” has also been narrowly applied to efforts to increase the secu­ rity of dangerous pathogens, either in the laboratory or in dedicated collections; guidelines from both the World Health Organization (WHO 2004) and the Organization for Economic Cooperation and Development (OECD 2007) use this more restricted meaning of the term. In an agricultural context, the term refers to efforts to exclude the introduction of plant or animal pathogens. (See Rusek 2009 for a discussion of this and other issues related to ter­ minology.) Earlier NRC reports (2004a,b, 2006, 2009d,e,f) confine the use of “biosecurity” to policies and practices to reduce the risk that the knowledge, tools, and techniques resulting from research would be used for malevolent purposes. This report uses the term to cover security for both pathogens and for the information that results from research.

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 INTRODUCTION Dual Use Research of Concern: Dual use research of concern refers to a subset of dual use research that poses the greatest risk of harm. “Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly mis­ applied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or materiel” (National Science Advisory Board for Biosecurity [NSABB] 2007:17). Biosafety: “Laboratory biosafety describes the containment principles, technologies and practices that are implemented to prevent the uninten­ tional exposure to pathogens and toxins, or their accidental release (World Health Organization” [WHO] 2006:iii). Biosecurity: “The objective of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research­related information” (Centers for Disease Control and Prevention [CDC] and U.S. National Institutes of Health [NIH] 2007:105). Prof. Imperiale acknowledged, however, that some level of confusion and debate was probably unavoidable and that the best approach would be to present the terms in as unambiguous a manner as possible with an explanation in the context in which they are being used. The types of life sciences research potentially affected by the dual use dilemma are much broader than the infectious disease agents that have been the traditional focus of biological weapons research programs (Wheelis, Rózsa, and Dando 2006). [L]ife sciences research is being pursued for a variety of purposes: improved prevention, diagnosis, and treatment of human and animal diseases; enhanced production of food and energy; environmental reme­ diation; and even microfabrication of electronic circuits. It is likely that some work in each of these diverse areas offers significant dual­use possibilities. (NRC 2006: 222) The increasing capacity to construct living organisms de noo through the rapidly growing field of synthetic biology simply expands this potential security concern further (Ball 2004; Check 2006; Tucker and Zilinskas 2006; Garfinkel et al. 2007).9 9 It is important to acknowledge that the potential risks of the misuse of advances in the life sciences are not universally accepted. On a technical level, some argue that “Mother Nature is the best terrorist,” so there is little reason for terrorists or less technologically advanced countries to do more than take advantage of the highly dangerous pathogens already abundantly available in nature; a review of these discussions and debates may be found in Frerichs et al. (2004). 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 ism involving weapons of mass destruction (WMD); a detailed and skeptical assessment of this phenomenon related to biological issues may be found in Leitenberg (2005). Among

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 DUAL USE ISSUES IN THE LIFE SCIENCES Many assessments of dual use issues nevertheless conclude that the research within these broad categories posing genuine risks will be quite limited (NRC 2006; Steinbruner et al. 2007; NSABB 2007). The NSABB, an advisory body to the U.S. Department of Health and Human Services, for example, makes a distinction between “dual use research” and the narrower “dual use research of concern,” with the latter defined as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or materiel” (NSABB 2007:17).10 This report, which is focused on education for the broad community of life scientists about the general problem rather than issues of policy and oversight where precise definitions become important because of their practical effects, uses the more general term. Even if their own research poses no actual risks of misuse, scientists in many areas of life sciences are potentially affected. Perceptions about a particular field or focus could lead to policy actions with both direct and indirect effects on the research enterprise.11 All life scientists are potentially affected by public perceptions about security and other risks arising from continuing advances in knowledge and capabilities. Despite the recent attention to dual use and other security issues, however, the level of awareness among the broad community of life scientists is low (Rappert 2008, NRC 2009d). Moreover, the life sciences have had far fewer connections to the national security branches of government than other areas of science such as nuclear physics or parts of engineering; this lack of experience makes communication between scientists and security experts more difficult (NRC 2004a). This has led to a number of recom ­ mendations about the need for scientists to become aware of and engaged in discussions about dual use issues and their roles in helping mitigate the potential risks of misuse in ways that will enable scientific progress to continue (NRC 2004a,b; IAP 2005; NRC 2006; WHO 2007). the U.S. responses to the anthrax letters was a massive increase in funding for research activities of the type most likely to raise concerns (Klotz and Sylvester 2009); some critics of the biodefense program have charged that the “defensive” work has become increasingly problematic in terms of compliance with the BWC (Leitenberg, Leonard, and Spertzel 2003). 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 (Vogel 2006, 2008). 10 It is dual use research of concern that would be subject to the NSABB’s proposed over­ sight framework (NSABB 2007). 11 An example from the United States is the Select Agent program, which regulates research with a list of over 80 biological agents and toxins. For an account of the develop ­ ment and implementation of the program, including its future directions, see NRC 2009e.

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 INTRODUCTION THE “CULTURE OF RESPONSIBILITY” IN THE LIFE SCIENCES In responding to dual use issues, the life sciences can draw on a strong tradition of addressing societal concerns by developing norms and practices to govern scientific research. The iconic case is the response to the development of gene splicing techniques in the early 1970s that would enable research with recombinant DNA (rDNA) from different organisms. A Gordon Conference in June 1973 discussed safety issues related to laboratory workers and a number of well­known scientists sent letters to Science and Nature calling for a temporary moratorium on rDNA experiments until the potential risks could be assessed. This was followed by the famous 1975 Asilomar Conference where scientists gath ­ ered to discuss the safety of manipulating DNA from different species.12 The conference concluded that most rDNA work should continue, but appropriate safeguards in the form of physical and biological contain­ ment procedures should be put in place. In 1976 the National Institutes of Health (NIH) issued Guidelines for Research Inoling rDNA Molecules to govern the conduct of NIH­sponsored recombinant DNA research and established a mechanism for reviewing proposed experiments in this field. More recently, the 13­year Human Genome Project (1990–2003) created the Ethical, Legal, and Social Implications (ELSI) Program at the outset of its work to explore how advances in genetics intended to improve human health could proceed while addressing a variety of potential societal concerns.13 Over time, the life sciences community has developed three strands of ethical and safety norms and practices to guide research. The primary approaches are described briefly here and in somewhat more detail at the beginning of Chapter 3. Researchers working with dangerous bio­ logical agents and toxins developed a set of biosafety practices to protect the health of laboratory workers and avoid accidental or inadvertent releases.14 With a more explicitly normative focus, bioethics is a diverse, interdisciplinary field that includes several distinct areas, such as ethical issues related to the practice of medicine, or the ethical controversies brought about by advances in biology and medicine. Responsible conduct 12 The Asilomar Conference addressed only the accidental creation of recombinant micro­ organisms with increased virulence and other dangerous properties. It did not address the deliberate creation of such organisms for offensive applications in warfare and terrorism, although security concerns had also been raised (Wade 1980; Budianski 1982). 13 For further information, see http://www.ornl.gov/sci/techresources/Human_Genome/ project/hgp.shtml. NIH and the Department of Energy devoted three to five percent of their annual project budgets to studying ELSI issues. 14 This is also the primary channel by which research technicians, who have access to and knowledge of dangerous pathogens that make them important participants in laboratory biosecurity, are included in the process of creating a culture of responsibility (NRC 2009e).

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 DUAL USE ISSUES IN THE LIFE SCIENCES of research (RCR) is a U.S.­based approach that requires students at various levels who are funded by the NIH and the National Science Foundation (NSF) to receive education about professional standards in areas such as plagiarism and data fabrication, as well as wider societal issues and responsible conduct. Depending on their field, where they are studying, and where they are in their education, students may learn about some or all of these norms and practices through formal coursework or more informal mecha­ nisms, including mentoring by senior researchers. Taken together, these are the primary avenues by which life scientists acquire their knowledge of responsible conduct and broader community norms, which is often referred to as a “culture of responsibility.” It is important to note that not all students in the life sciences receive education about responsible conduct and the quality and comprehen ­ siveness of what is available varies widely. This has led to a number of proposals and activities, within particular countries and internationally, to expand and improve the quality of education that life scientists are receiv ­ ing about responsible conduct. At the same time, as discussed below and in Appendix C, there is growing support for education as part of efforts to address the security concerns related to advances in the life sciences. Exploring the ways in which these efforts might complement one another is one of the themes running through this report. THE LIFE SCIENCES AND THE “WEB OF PREVENTION” Dual use issues pose serious policy challenges, in particular the search for a mix of measures at the national, regional, and international level that can mitigate the risks of misuse while enabling continuing sci ­ entific advances—and ensuring the availability of those advances to all. This is part of broader security challenges posed by several key features of biological weapons.15 For example, the wide availability of biological materials in nature, including the most dangerous pathogens, and the ability of these materials to replicate means that there are no technical “chokepoints” where restricting access to materials poses a formidable barrier to acquisition.16 As already discussed, the broad array of life sci­ 15 A more detailed discussion of the fundamental differences between biological and nuclear materials, the two most frequently compared types, may be found in Responsible Research with Biological Select Agents and Toxins (NRC 2009e:116­117). 16 It is also important to note that constructing a biological weapon capable of inflicting mass casualties involves much more than simply isolating or synthesizing a dangerous pathogen. Instead, a biological weapon is a system that requires the processing of a patho ­ genic agent into a concentrated wet slurry or a dry powder, the development of a suitable chemical formulation to stabilize the agent during storage and delivery, and the engineering

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 INTRODUCTION ences research that might be of proliferation concern covers many fields and types of research institutions; commercial research and applications are equally diverse, so that monitoring potentially relevant activities would be a formidable task. And the rapid pace of scientific advances makes it difficult to keep abreast of potential risks and then to craft legal or regulatory measures that can stay current and relevant without unduly hampering scientific research.17 The nature of the policy challenges posed by biological weapons and bioterrorism has led to widespread recognition that the risks should be addressed through the creation of a “web of prevention.”18 The concept of the web includes legal measures, such as national laws and regula­ tions, and international agreements. The fundamental international norm against biological weapons is embodied in the Geneva Protocol, which was signed in 1925 and entered into force in 1928, and the Biological and Toxin Weapons Convention (BWC), which was signed in 1972 and entered into force in 1975.19 Ambassador Masood Khan of Pakistan, president of the BWC’s sixth review conference, commented that: 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 and construction (or acquisition) of a delivery system capable of disseminating the agent as a fine­particle aerosol over a large area. Each step in the development process is complex, and the integrated weapon system requires realistic field testing. 17 For an example of an effort to design such a legal/regulatory regime see Steinbruner et al. (2007). 18 As discussed in Appendix C, the term “web of prevention” was coined by the Inter­ national Committee of the Red Cross (ICRC) as part of its Biotechnology, Weapons, and Humanity campaign launched in 2002. Graham Pearson had proposed a “web of deter­ rence,” but he did not address dual use research issues (Pearson 1993). 19 The formal title of the Geneva Protocol, which prohibits first use of chemical and biological weapons, is the “Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare.” The BWC’s formal title is the “Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction.” Article I of the BWC states: Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protec ­ tive or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict. UN Security Council Resolution 1540, passed in 2004, adds a further binding interna ­ tional commitment against support for non­state actors seeking to acquire weapons of mass destruction or the means of their delivery.

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 DUAL USE ISSUES IN THE LIFE SCIENCES 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,20 the treaty is not universal, but no country dares argue that biological weapons can ever have a legitimate role in national defense. Such is the force of the treaty (Khan 2006). The BWC calls on its member states to develop national implement­ ing legislation to support the treaty with formal legal measures. In addi ­ tion, countries may have an array of laws and regulations that address biological weapons and bioterrorism directly or contribute indirectly by governing various aspects of research and commercial activities. But the concept of a web also includes an important role for measures of self­governance drawing on the culture of responsibility among those doing life sciences research, as well as guidelines and other voluntary practices that could have both government and nongovernment compo ­ nents. Sustained engagement by scientists and scientific organizations is thus considered an essential component of the broader strategy. In the United States, for example, a number of reports from the National Research Council have made this argument (NRC 2004a,b, 2006, 2007a, 2009d,e,f), and the theme is echoed in the U.S. National Strategy for Counter­ ing Biological Threats released in late 2009.21 Life scientists are best positioned to develop, document, and reinforce norms regarding the beneficial intent of their contribution to the global community as well as those activities that are fundamentally intolerable. Although other communities can make meaningful contributions, only the concerted and deliberate effort of distinguished and respected life scientists to develop, document, and ultimately promulgate such norms will enable them to be fully endorsed by their peers and colleagues. (White House 2009:8) Other international organizations have become engaged in dual use issues as well, including the ethical and normative dimensions and efforts to expand the engagement of scientists. In 2005 the World Health Organization (WHO) released a background paper, Life Science Research: Opportunities and Risks for Public Health, as an initial step toward increas­ 20As of August 2010, the BWC had 163 states parties. 21The scientific community also has an important role as advisors to policy­makers about trends in science with dual use implications, assessments of the balance of potential risks and benefits in new and continuing activities, and the implications of proposed policies for both science and security (NRC 2004a,b, 2006, 2007a, 2009e,f).

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 INTRODUCTION ing engagement in the issue (WHO 2005).22 WHO then held a workshop in October 2006 on “Life Science Research and Global Health Security.” The workshop report recommended the creation of a standing scientific advisory group to the WHO Director­General on biosecurity, including both improved biosafety and responsible oversight of research (WHO 2007). The WHO also undertook a number of collaborative activities, including regional workshops addressing both biosafety and biosecurity issues. The OECD Global Futures Programme created a website (www. biosecuritycodes.org) to provide information about national and interna­ tional activities. The involvement of organizations such as the WHO and the OECD added the important elements of global health and economic development to the more traditional security concerns represented by the BWC in considering dual use issues. THE EMERGENCE OF EDUCATION AS A FOCUS As already discussed, in spite of the interest in increasing the aware­ ness of scientists and the recognition of the importance of self­governance and norms of responsible conduct, the vast majority of life scientists remain unengaged in dual use issues. This has led to an increasing focus on education as an essential foundation for effective development and implementation of a web of prevention. A longer account of efforts to promote engagement, especially in the last decade, by national and inter­ national scientific organizations, and the growing support for education on the part of international bodies such as the WHO, UNESCO, and the OECD and from the activities associated with the operation and imple­ mentation of international agreements such as the BWC, may be found in Appendix C. A few examples, which underscore the importance of connections between formal and informal components of the web, are provided here. In 2002, following the collapse of efforts to negotiate a protocol to the BWC to provide verification of treaty compliance, the states parties agreed to a series of meetings before the next full treaty review conference in 2006. Each year focused on a different topic and included both a one­ or two­week meeting of experts and a one­week meeting of the states par­ ties. The program of intersessional meetings was continued between 2007 and 2010. In 2005 and 2008 the topics of the intersessional meetings were directly relevant to the interests of scientists. The 2005 meeting focused 22 Much earlier, in May 1967 the WHO’s World Health Assembly had approved a state ­ ment that “scientific achievements, and particularly in the field of biology and medicine— the most humane science—should be used only for mankind’s benefit, but never to do it any harm” (WHO 1967).

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 DUAL USE ISSUES IN THE LIFE SCIENCES on the “content, promulgation, and adoption of codes of conduct for sci ­ entists.” The 2008 meeting addressed: 1. National, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins; and 2. Oversight, education, awareness raising, and adoption and/or devel ­ opment of codes of conduct with the aim of preventing misuse in the context of advances in bio­science and bio­technology research with the potential of use for purposes prohibited by the Convention. A number of international scientific organizations were invited to make formal presentations to the plenary sessions in 2005 and 2008. There were also opportunities for informal sessions and personal interactions. All of these served to raise the visibility of the issues within the international diplomatic and security community. The meetings in 2005 and 2008 provided a focal point around which efforts to raise awareness and engagement by the life sciences community could organize. For example, with an eye to the 2005 BWC meetings, the IAP Biosecurity Working Group decided to focus its first effort on draft­ ing a statement of principles that could provide the basis for efforts by academies and other science bodies to develop codes of their own rather than attempting to develop a full­blown IAP code of conduct. In part this reflected 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 whom people have closer, more direct ties. “Education and information” is one of the core elements that any code should address: “Scientists should be aware of, disseminate information about and teach national and international laws and regulations, as well as policies and principles aimed at preventing the misuse of biological research” (IAP 2005).23 The statement was introduced in Geneva in draft form during the experts meeting and the final version, endorsed by 69 IAP member academies, was released in time for the states parties meeting at the end of the year. In addition to the 2005 statement, the IAP Working Group orga­ nized two international conferences on biosecurity, one in 200524 and one 23 The other elements are Awareness, Safety and Security, Accountability, and Over­ sight. The full statement may be found at http://www.interacademies.net/Object.File/ Master/5/399/Biosecurity%20St..pdf. 24 Just over fifty participants from twenty developed and developing countries took part in the first forum, which included both plenary sessions and day­long parallel sessions devoted to specific topics—codes of conduct, “sensitive” information and publication policy, and research oversight—that enabled in­depth discussion. Although the participants were

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 INTRODUCTION in 2008.25 Both meetings were done in cooperation with other interna­ tional scientific organizations—the International Council for Science, the InterAcademy Medical Panel, and several international scientific unions. Each forum took place in the early spring before the BWC experts meet ­ ing, and each served as an important convening mechanism to help pre ­ pare for the meetings, to share information among individuals and groups working on dual use issues, and also to encourage scientific organizations to become more active generally. A significant portion of the progress in engaging the international scientific community in dual use issues described in Appendix C can be attributed to opportunities provided by occasions such as the BWC meetings and the ability of nongovernmental organizations to make productive use of them. Organization of the Remainder of the Report Chapter 2 offers a brief introduction to the results of research on the science of learning about more engaged and interactive approaches to education. Chapter 3 addresses the first part of the committee’s charge, assessing the current extent of education on dual use issues internation ­ ally and the range of online materials available to support this education, and presents the committee’s findings. Chapter 4 then takes up the other parts of the committee’s charge, the gaps and needs with regard to current dual use education, and the committee’s conclusions and recommenda­ tions about how to address them. It relies on the discussions during the Warsaw workshop, supplemented by additional examples and materials gleaned from other sources. largely scientists, they also included people from a number of the other policy projects on bio­ security, as well as staff from the International Committee of the Red Cross (ICRC), the WHO, and the OECD. The agenda and participants list, as well as other information and copies of the presentations, may be found at http://www.nationalacademies.org/biosecurity. The IAP draft statement was discussed extensively during the small group session on codes of conduct and revised in response to the comments and suggestions. 25 More than eighty participants from thirty­one countries, as well as the BWC, UNESCO, WHO, UN headquarters, the ICRC, and the OECD, attended the meeting hosted by the Hungarian Academy of Sciences in Budapest. The participants discussed the challenges and opportunities to: (1) build a culture of responsibility within the science community regard ­ ing biosecurity; (2) identify standards and practices for research oversight; and (3) provide scientific advice to governments and international organizations and develop the role of the science community in global governance. The working group on building the culture of responsibility focused most of its time on issues related to dual use education. An inter­ national committee appointed by the National Research Council of the U.S. National Acad ­ emies prepared a report of the meeting (NRC 2009f).

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