4
Conclusions and Recommendations

Future applications of advances in the life sciences and related technologies are likely to have a profound impact on human health and well-being, as well as promote the efficiency of crop production and animal husbandry. Continuing advances in biotechnology hold promise for improved nutrition, a cleaner environment, a longer, healthier life span, and cures for many once-formidable diseases. Even older technologies, such as classic methods for vaccine manufacture, have enabled the eradication or reduction of many once-dreaded diseases such as smallpox, poliomyelitis, diphtheria, tetanus, and whooping cough. Newer reverse genetic technologies for RNA viruses may facilitate the rapid, rational development of vaccines for such agents. In the developing world, broader application of biotechnology may make it economically feasible for resource-limited countries to produce vaccines locally that are capable of protecting their populations against endemic infectious diseases but for which there is little or no economic incentive for large multinational vaccine producers. In addition to improved health, world agriculture stands to benefit greatly from new discoveries in the life sciences and growing technological capabilities.

To a considerable extent, new advances in the life sciences and related technologies are being generated not just domestically, but also internationally. The preeminent position that the United States has enjoyed in the life sciences has been dependent on the flow of foreign scientific talent to its shores and is now threatened by the increasing globalization of science and the international dispersion of a wide variety of related tech-



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Globalization, Biosecurity, and The Future of the Life Sciences 4 Conclusions and Recommendations Future applications of advances in the life sciences and related technologies are likely to have a profound impact on human health and well-being, as well as promote the efficiency of crop production and animal husbandry. Continuing advances in biotechnology hold promise for improved nutrition, a cleaner environment, a longer, healthier life span, and cures for many once-formidable diseases. Even older technologies, such as classic methods for vaccine manufacture, have enabled the eradication or reduction of many once-dreaded diseases such as smallpox, poliomyelitis, diphtheria, tetanus, and whooping cough. Newer reverse genetic technologies for RNA viruses may facilitate the rapid, rational development of vaccines for such agents. In the developing world, broader application of biotechnology may make it economically feasible for resource-limited countries to produce vaccines locally that are capable of protecting their populations against endemic infectious diseases but for which there is little or no economic incentive for large multinational vaccine producers. In addition to improved health, world agriculture stands to benefit greatly from new discoveries in the life sciences and growing technological capabilities. To a considerable extent, new advances in the life sciences and related technologies are being generated not just domestically, but also internationally. The preeminent position that the United States has enjoyed in the life sciences has been dependent on the flow of foreign scientific talent to its shores and is now threatened by the increasing globalization of science and the international dispersion of a wide variety of related tech-

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Globalization, Biosecurity, and The Future of the Life Sciences nologies. The increasing pace of scientific discovery abroad and the fact that the United States may no longer hold a monopoly on these leading technologies means that this country is, as never before, dependent on international collaboration, a theme explored in depth in Chapter 2. Although this report is concerned with the evolution of science and technology capabilities over the next 5 to 10 years with implications for next-generation threats, it is clear that today’s capabilities in the life sciences and related technologies have already changed the nature of the biothreat “space.” The accelerating pace of discovery in the life sciences has fundamentally altered the threat spectrum. Some experts contend that bioregulators, which are small, biologically active compounds, pose an increasingly apparent dual-use risk. This risk is magnified by improvements in targeted-delivery technologies that have made the potential dissemination of these compounds much more feasible than in the past. The immune, nervous, and endocrine systems are particularly vulnerable to bioregulator modification. The growing concern regarding novel types of threat agents does not diminish the importance of naturally occurring threat agents—for example, the “classic” category A select agents—or “conventionally” genetically engineered pathogenic organisms. However, it does mandate the need to adopt a broader perspective in assessing the threat, focusing not on a narrow list of pathogens, but on a much wider spectrum that includes biologically active chemical agents. The potential threat spectrum is thus exceptionally broad and continuously evolving—in some ways predictably, in other ways unexpectedly. The viruses, microbes, and toxins listed as “select agents” and on which our biodefense research and development activities are so strongly focused today are just one aspect of this changing landscape of threats. Although some of them may be the most accessible or apparent threat agents to a potential attacker, particularly one lacking a high degree of technical expertise, this situation is likely to change as a result of the increasing globalization and international dispersion of the most cutting-edge aspects of life sciences research. The committee has proposed a conceptual framework in Chapter 3 for how to think about the future threat landscape. The task here will be never ending, and as the world becomes more competent and sophisticated in the biological sciences, it is vitally important that the national security, public health, and biomedical science communities have the knowledge and tools to address both beneficial and harmful applications of advances in the life sciences. In interpreting its charge, the committee sought to examine current trends and future objectives of research in the life sciences, focusing particularly on applications that might be relevant to the development of “next-generation” agents of biological origin 5 to 10 years into the future.

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Globalization, Biosecurity, and The Future of the Life Sciences While the committee understood that readers of this report might hope to find a well-defined list or set of lists of future threats, perpetrators, and timelines for the acquisition and exploitation of certain technologies for malevolent purposes, the committee also realized the futility of this approach. The global technology landscape is shifting so dramatically and rapidly that it was simply not possible for this committee—or any committee—to devise a formal risk assessment of the future threat horizon, based on the possible exploitation of dual-use technologies by state actors, nonstate actors, or individuals. Given that within just the past few years the global scientific community has witnessed the unexpected development and proliferation of important new technologies, such as RNA interference, nanobiotechnology, and synthetic biology, biological threats of the next 5 to 10 years could extend well beyond those that can be predicted today. The useful life span of any such list of future threats developed in 2006 would likely be measured in months, not years. Instead, the committee sought to define more broadly how continuing advances in technologies with applications to the life sciences’ enterprise can contribute to the development of novel biological weapons and to develop a logical framework for analysts to consider as they evaluate the evolving technology threat spectrum. While evaluating the rapidly evolving global landscape of knowledge and capability in the life sciences and associated technologies, the committee agreed on five key findings and recommendations that it believes are strongly supported by the information presented in this report, as summarized in Box 4-1, that build on and reinforce the findings and recommendations put forward in earlier National Research Council reports, including, but not limited to, Biotechnology Research in an Age of Terrorism.1 Because it believes that continuing advances in science and technology are essential to countering terrorism, the committee’s recommendations affirm policies and practices that promote the free and open exchange of information in the life sciences (Recommendation 1). The committee also recognized the need to adopt a broader perspective on the nature of the “threat spectrum” (Recommendation 2) and to strengthen the scientific and technical expertise available to the security communities so that they are better equipped to anticipate and manage a diverse array of novel threats (Recommendation 3). The recommendations call for the global community of life scientists to adopt a common culture of awareness and a shared sense of responsibility and include specific actions that would promote such a culture (Recommendation 4). Finally, the committee recognized that no set of measures can ever provide complete protection against the malevolent use of life sciences technologies, and its recommendations reaffirm previous calls to strengthen the public health infrastructure and the nation’s existing response and recovery capabilities (Rec-

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Globalization, Biosecurity, and The Future of the Life Sciences BOX 4-1 Recommendations 1. The committee endorses and affirms policies and practices that, to the maximum extent possible, promote the free and open exchange of information in the life sciences. 1a. Ensure that, to the maximum extent possible, the results of fundamental research remain unrestricted except in cases where national security requires classification, as stated in National Security Decision Directive 189 (NSDD-189) and endorsed more recently by a number of groups and organizations. 1b. Ensure that any biosecurity policies or regulations implemented are scientifically sound and are likely to reduce risks without unduly hindering progress in the biological sciences and associated technologies. 1c. Promote international scientific exchange(s) and the training of foreign scientists in the United States. 2. The committee recommends adopting a broader perspective on the “threat spectrum.” 2a. Recognize the limitations inherent in any agent-specific threat list and consider instead the intrinsic properties of pathogens and toxins that render them a threat and how such properties have been or could be manipulated by evolving technologies. 2b. Adopt a broadened awareness of threats beyond the classical “select agents” and other pathogenic organisms and toxins, so as to include, for example, approaches for disrupting host homeostatic and defense systems and for creating synthetic organisms. 3. The committee recommends strengthening and enhancing the scientific and technical expertise within and across the security communities. 3a. Create by statute an independent science and technology advisory group for the intelligence community. 3b. The best available scientific expertise and knowledge should inform the concepts, plans, activities, and decisions of the intelligence, law enforcement, homeland security, and public policy communities and the national political leadership about advancing technologies and their potential impact on the development and use of future biological weapons.

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Globalization, Biosecurity, and The Future of the Life Sciences 3c. Build and support a robust and sustained cutting-edge analytical capability for the life sciences and related technologies within the national security community. 3d. Encourage the sharing and coordination, to the maximum extent possible, of future biological threat analysis between the domestic national security community and its international counterparts. 4. The committee recommends the adoption and promotion of a common culture of awareness and a shared sense of responsibility within the global community of life scientists. 4a. Recognize the value of formal international treaties and conventions, including the 1972 Biological and Toxin Weapons Convention (BWC) and the 1993 Chemical Weapons Convention (CWC). 4b. Develop explicit national and international codes of ethics and conduct for life scientists. 4c. Support programs promoting beneficial uses of technology in developing countries. 4d. Establish globally distributed, decentralized, and adaptive mechanisms with the capacity for surveillance and intervention in the event of malevolent applications of tools and technologies derived from the life sciences. 5. The committee recommends strengthening the public health infrastructure and existing response and recovery capabilities. 5a. Strengthen response capabilities and achieve greater coordination of local, state, and federal public health agencies. 5b. Strengthen efforts related to the early detection of biological agents in the environment and early population-based recognition of disease outbreaks, but deploy sensors and other technologies for environmental detection only when solid scientific evidence suggests they are effective. 5c. Improve the capabilities for early detection of host exposure to biological agents, and early diagnosis of the diseases they cause. 5d. Provide suitable incentives for the development and production of novel classes of preventative and therapeutic agents with activity against a broad range of biological threats, as well as flexible, agile, and generic technology platforms for the rapid generation of vaccines and therapeutics against unanticipated threats.

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Globalization, Biosecurity, and The Future of the Life Sciences ommendation 5). All of the insight and capabilities generated by advances in the life sciences and related technologies must be brought to bear on the problem of building a more robust public health defense. The committee could not envision any sort of “silver bullet” capable of providing absolute protection against the malevolent application of new technologies. Rather, the actions and strategies recommended here are intended to be complementary and synergistic. An effective system for managing the threats that face society will require a broad array of mutually reinforcing actions in a manner that successfully engages the variety of different communities that share stakes in the outcome. As in fire prevention, where the best protection against the occurrence of damage from catastrophic fires comprises a multitude of interacting preventive and mitigating actions (e.g., fire codes, smoke detectors, sprinkler systems, fire trucks, fire hydrants, fire insurance), rather than any single “best” but impractical or improbable measure (e.g., stationing a fire truck on every block), the same is true here. The committee envisions a broad-based, intertwined network of steps—a web of protection—for reducing the likelihood that the technologies discussed in this report will be used successfully for malevolent purposes. While recognizing that all of its recommended measures, taken together, provide no guarantee that continuing advances in the life sciences and the new technologies they spawn will not be used with the intent to cause harm, the committee members agreed that implementation of these recommendations in aggregate will likely decrease the risk of inappropriate application or unintended misuse of increasingly widely available knowledge and technologies, favor the early detection of malevolent applications, and mitigate the loss of life or other damage sustained by society in both the short and the long term, should the worst-case scenario occur. CONCLUSION 1: THE COMMITTEE CONCLUDES THAT THERE IS A NEED TO MAINTAIN FREE AND OPEN EXCHANGE OF SCIENTIFIC AND TECHNOLOGICAL INFORMATION. In general, restrictive regulations and the imposition of constraints on the flow of information are not likely to reduce the risks that advances in the life sciences will be utilized with malevolent intent in the future. In fact, they will make it more difficult for civil society to protect itself against such threats and ultimately are likely to weaken national and human security.2 Such regulations and constraints would also limit the tremendous potential for continuing advances in the life sciences and its related technologies to improve health, provide secure sources of food and energy, contribute to economic development in both resource-rich and resource-

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Globalization, Biosecurity, and The Future of the Life Sciences poor parts of the world, and enhance the overall quality of human life. In the past, society has gained from advances in the life sciences because of the open exchange of data and concepts. One of the main challenges to the committee was to formulate measures that would continue to benefit human development3 while taking into account legitimate national security needs. The goal of the committee was to ensure that scientific progress and industrial development advance expeditiously while not unduly aiding state or nonstate actors that may wish to exploit these tools and technologies for malevolent purposes. The recommendations put forth in this section consider policies and actions that are balanced with respect to national security needs and the multiple and varied beneficial applications of science and technology. Recommendation 1 The committee endorses and affirms policies and practices that, to the maximum extent possible, promote the free and open exchange of information in the life sciences. The many ways that biological knowledge and its associated technologies have improved and can continue to improve biosecurity, health, agriculture, and other life sciences industries are highlighted in Chapter 2. Reducing or restricting the open exchange of information would over time reduce the ability of the United States to remain competitive in the global marketplace and to build robust defenses against future potential biological threats. Equally important, it would deny many individuals, both within and outside the United States, the tremendous health, agricultural, and other benefits likely to be derived from advanced technologies. The committee’s recommendation has three components. The first focuses on the openness of information generated from fundamental scientific research, the second concerns policies and regulations, and the third relates to international exchanges between scientists who are working in the life sciences. Recommendation 1a. Ensure that the results of fundamental research remain unrestricted except in cases where national security requires classification, as stated in National Security Decision Directive (NSDD)-189 and endorsed more recently by a number of groups and organizations. Like all sciences, the life sciences have relied on a culture of openness in research, where the free exchange of information and ideas allows researchers to build on the results of others, while simultaneously opening scientific results to critical scrutiny so that mistakes can be recognized and corrected sooner rather than later. Recent and proposed changes in

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Globalization, Biosecurity, and The Future of the Life Sciences the existing classification system threaten this culture in ways that are potentially harmful to national and human security. For example, the recent extension of classification authority to agencies not previously involved in these matters (e.g., the U.S. Department of Agriculture,4 the Environmental Protection Agency,5 and the U.S. Department of Health and Human Services6) raises questions about the criteria for classification that might be applied to federally funded research. Under the current system, in most agencies the task of applying classification standards is so large that information classification authority has been delegated to literally thousands of government officials. While detailed guides purport to offer classification standards, the usefulness of these standards as clear and objective tools fails and subjectivity intervenes when the subject matter and associated risks—and the direct and indirect costs of overclassification—are less well defined or understood.7 In 2002, a draft U.S. Department of Defense regulation, if enacted, would have required researchers “to obtain DoD approval to discuss or publish findings of all military-sponsored unclassified research.”8 Such a process would have made it possible for the department to prevent any of its funded life sciences research that it considered “sensitive” (because it could theoretically aid terrorists or be used in the production of biological weapons) from entering the public domain, thus in effect allowing the department to treat it as secret. The draft was withdrawn in the face of considerable criticism from the scientific research community.9 This proposal reflected the current opinion of some that government control should go further than the regulations imposed by “The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of October 2001” Act (i.e., the PATRIOT Act10), and “The Public Health Security and Bioterrorism Preparedness and Response Act” (i.e., the Bioterrorism Response Act11), and that it should include broad controls on the dissemination of the results of scientific research. In fact, current controls on dissemination of research now in place within the pharmaceutical industry or at many federal institutions, including, for example, Los Alamos National Laboratory, do extend beyond current regulations for publicly funded research. There are many reasons why such restrictions may be imposed, such as a desire to confirm scientific validity of reports through an independent review process prior to public release or a desire to protect intellectual property important to commercialization. Restrictions based on a desire to prevent the potential misuse of information are more problematic. Proposals to institute such controls on basic, fundamental research reflect a long-standing tension between those who believe that limiting the dissemination of such information may provide a margin of safety and others who believe that the free and open exchange of fundamental research results is critical for

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Globalization, Biosecurity, and The Future of the Life Sciences maintaining the technological and scientific prowess and agility required for a robust national security enterprise.12 As discussed in Chapter 1, it would be beyond the scope of this committee’s charge to evaluate and articulate recommendations regarding the U.S. system of data and information classification and other means of data and information control (e.g., categorizing information as “sensitive but unclassified”). However, the committee did recognize the limits of any such system (as it currently exists or otherwise) with respect to its ability to control the practically immeasurable amount of data and information already extant in the public domain (e.g., freely available on the Internet) and/or generated by non-U.S.-funded sources. The U.S. classification system primarily applies to work done in government laboratories or that is funded by the government. It does not extend to the vast, growing, and increasingly accessible global knowledge base being built by private interests or in foreign countries. For example, as detailed in Chapter 2, China, France, Germany, Japan, the United Kingdom, and other countries are now making proportionately greater contributions to the scientific literature and knowledge base than they did in the past (i.e., the entire scientific literature and knowledge base, including but not limited to the life sciences). Although many consider that a restrictive approach has been largely successful in slowing the proliferation of nuclear weapons technology, many of the same conditions do not apply regarding matters involving the potential “dual use” of life sciences research and living organisms. Various arguments suggest that overly restrictive regulations on the conduct and funding of research, the dissemination of research results, and the industrial development of biotechnology will not prevent state and non-state actors from gaining access to and using advances in research to develop novel agents of biological origin. Some of these arguments are presented below. First, and perhaps most important, efforts to restrict the flow of information in the life sciences are likely to impede the ability of the scientific establishment to keep ahead of potential threats. Not only is an open exchange necessary for the recognition of potential threats in advance of their realization, but it is also essential for the creation of effective countermeasures. Science does not advance in a linear fashion, and typically it is a development in an unrelated field that suggests a novel approach to a particular problem. Great advances often come from the seemingly random blending of technical approaches and theoretical insights from different fields, as, for example, the application of semiconductor chip manufacturing technologies to the development of ultradense DNA oligonucleotide microarrays synthesized in situ. Another example is the application of knowledge concerning transcriptional silencing in plants

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Globalization, Biosecurity, and The Future of the Life Sciences to the development of novel therapeutics for humans. Such associations, in effect a convergence of technologies and unrelated hypotheses, cannot be predicted effectively in advance, nor managed in any directed fashion. They require the dissemination of the requisite information bits into the scientific ferment, and the maintenance of an open environment for research—including the open publication of research results. Such an environment will hasten the development of effective countermeasures against biological threats. An open approach to the dissemination of information may also aid intelligence and law enforcement agencies in their efforts to predict, assess, and deter the malevolent applications of new tools and technologies as they arise. Second, unlike research relevant to the design of nuclear weapons, the fields of research in the life sciences with potential dual-use applications cover a very broad range of disciplines (see Chapter 3 for some examples) and a large number of individuals and institutions. Potential dual-use applications may only become apparent long after an initial discovery. Undoubtedly, the majority of life sciences research would probably be of little interest to state-level offensive weapons programs or nonstate actors. Nonetheless, life 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 remediation; and even microfabrication of electronic circuits. It is likely that some work in each of these diverse areas offers significant dual-use possibilities. Thus, the range and number of scientists and institutions that would be affected by any attempt to impose new information controls would be vast and difficult to list, let alone monitor. The magnitude of the task becomes even more daunting given the lack of any international body that is in a position to assume responsibility for this on a global scale, even if all parties involved were agreeable with such controls, which is highly unlikely to be the case. Third, the financial costs associated with any regime aimed at restricting the flow of information would be very high. An estimate of the costs of the U.S. nuclear weapons program between 1940 and 1996 suggests a rough figure of $1 trillion for protecting the secrecy of classified information.13 The costs that would be involved in any attempts to control information related to biological research would include those involved in the screening of personnel; acquisition of secure storage facilities, guards, materials management, and maintenance of routine inventories of controlled material.14 These financial costs would need to be borne by academic, commercial, and governmental institutions complying with government regulations. While U.S. institutions engaged in research on category A select agents already bear the costs of security screening of personnel, maintenance of secure storage facilities, guards, and routine

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Globalization, Biosecurity, and The Future of the Life Sciences maintenance of inventories of controlled material to meet current U.S. regulations, any program aimed at regulating the dissemination of results of potential dual-use research in the biological sciences would of necessity need to be much, much broader in scope, and thus would be enormously more expensive. Importantly, as discussed below in Recommendation 2, any regime designed to control information related to research on the currently listed select agents only would miss most potential dual-use developments that are likely to emerge in the life sciences over the next decade or more. It is unlikely that many foreign nations would consider such costs justifiable, and any regime adopted only within the United States in isolation from the remainder of the global life sciences would be futile and likely counterproductive. Fourth, history has demonstrated that efforts to impose restrictions on the flow of information are generally unrealistic and may lead to a black market that is much more difficult to monitor and oversee than an open market.15, 16 In particular, this is very likely to be the case in the life sciences where large international networks of scientists in many specific fields of research have been accustomed to the free and rapid exchange of information. A recent request by the U.S. Department of Health and Human Services (HHS) to suppress or alter the publication of a recent paper accepted by the Proceedings of the National Academy of Sciences USA concerning the risks of botulinum toxin being introduced into the U.S. milk supply rapidly led to a much larger awareness of the manuscript on the part of the biomedical research community and the greater public.17, 18 Indeed, some of the information contained in the manuscript in question was published six weeks earlier in the New York Times,19 demonstrating the determination of some authors to share the results of their research with the public and the willingness of the lay press to disseminate such putatively “sensitive” information if it is considered sufficiently news-worthy (as many new dual-use developments are likely to be). While some aspects of this particular incident may be unusual, it demonstrates the difficulties inherent in attempting to control information generated by the academic sector in the United States, from which many if not most novel developments in the life sciences currently emerge. The nature of the biological research enterprise is very different from that of research related to nuclear weapons and even more different than fundamental nuclear physics research: Most of the world already has access to and cannot possibly be denied further access to the knowledge, materials, and equipment necessary for developing or disseminating potentially “dual use” knowledge in the life sciences. Unlike the relative U.S. monopoly on nuclear knowledge and technology during the early years of the Cold War, today’s advancing technologies with biological dual-use potential are for the most part beyond the reach of U.S. regula-

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Globalization, Biosecurity, and The Future of the Life Sciences George R. Boggs President and CEO American Association of Community Colleges Felice J. Levine Executive Director American Educational Research Association Roger Bowen General Secretary American Association of University Professors Richard S. Dunn Co-Executive Officer American Philosophical Society Richard L. Ferguson CEO and Chairman of the Board ACT Jerome H. Sullivan Executive Director American Association of Collegiate Registrars and Admissions Officers Elizabeth A. Rogan CEO Optical Society of America Alyson Reed Executive Director National Postdoctoral Association Stephen J. Otzenberger Executive Director College & University Professional Organization for Human Resources Marc H. Brodsky Executive Director and CEO American Institute of Physics James E. Morley, Jr. President and CEO National Association of College and University Business Officers Norman B. Anderson Chief Executive Officer American Psychological Association Mary Maples Dunn Co-Executive Officer American Philosophical Society John A. Orcutt President American Geophysical Union Steven Block President The Biophysical Society Richard W. Peterson President American Association of Physics Teachers Robert P. Kirshner President American Astronomical Society

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Globalization, Biosecurity, and The Future of the Life Sciences ENDNOTES 1   It should be noted that the committee is in fundamental agreement with the findings and recommendations of the National Research Council’s report Biotechnology Research in an Age of Terrorism (2004). 2   As defined by the United Nations Commission on Human Security, human security means “to protect the vital core of all human lives in ways that enhance human freedoms and human fulfillment. Human security means protecting fundamental freedoms—freedoms that are the essence of life. It means protecting people from critical (severe) and pervasive (widespread) threats and situations. It means using processes that build on people’s strengths and aspirations. It means creating political, social, environmental, economic, military and cultural systems that together give people the building blocks of survival, livelihood and dignity.” UN Commission on Human Security. 2003. Human Security-Now. Available online at www.humansecurity-chs.org/finalreport/English/FinalReport.pdf [accessed January 5, 2006]. 3   As defined by the Human Development Reports of the United Nations Development Programme, “human development is a process of enlarging people’s choices. Enlarging people’s choices is achieved by expanding human capabilities and functionings. At all levels of development the three essential capabilities for human development are for people to lead long and healthy lives, to be knowledgeable and to have a decent standard of living. If these basic capabilities are not achieved, many choices are simply not available and many opportunities remain inaccessible. But the realm of human development goes further: essential areas of choice, highly valued by people, range from political, economic and social opportunities for being creative and productive to enjoying self-respect, empowerment and a sense of belonging to a community.” Available online at hdr.undp.org/hd/glossary.cfm [accessed January 5, 2006]. 4   Order of December 10, 2001—Designation Under Executive Order 12958. Federal Register 66 (December 12):64345-64347. 5   Order of September 26, 2002—Designation Under Executive Order 12958. FederalRegister 67 (September):61463-61465. 6   Order of May 6, 2002—Designation Under Executive Order 12958. Federal Register 67(90):31109. 7   National Research Council. 2004. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press, see Chapter 3, reference 24, page 103. 8   Department of Defense Security Directive 106. 2002. Mandatory Procedures for Research and Technology Protection Within the DOD (March). Available online at www.fas.org/sgp/news/2002/04/dod5200_39r_dr.html [accessed January 5, 2006]. 9   Knezo, G.J. 2003. ‘Sensitive but Unclassified’ and Other Federal Security Controls on Scientific and Technical Information: History and Current Controversy. Washington, DC: Congressional Research Service (April 2). 10   The PATRIOT Act makes it illegal in the United States for anyone to possess any biological agent, including any genetically engineered organism created by

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Globalization, Biosecurity, and The Future of the Life Sciences     using recombinant DNA technology, of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other oeaceful purpose. The Act also prohibits the transfer or possession of a listed biological agent or toxin by a “restricted person.” 11   The Bioterrorism Response Act added new requirements for the secretaries of the Departments of Agriculture and Health and Human Services to consider in listing agents and in preventing unlawful access to agents during transfers; established new requirements for registration with the appropriate secretary concerning possession and use of select agents and toxins; and required the establishment of rules for appropriate physical security requirements for listed agents and for the Department of Justice—through the Federal Bureau of Investigation—to conduct background investigations on individuals who are permitted access to select agents or who work in a facility where select agents are stored. 12   Center for Strategic and International Studies. 2005. Security Controls on Scientific Information and the Conduct of Scientific Research. Available online at thefdp.org/CSIS_0506_cscans.pdf [accessed January 5, 2006]. 13   No one knows precisely what nuclear secrecy cost the United States in monetary terms because the government has never tracked such costs. But Department of Energy officials routinely estimate that classified programs are 20 percent more expensive than unclassified ones. Using that rule of thumb, it is possible that up to $1 trillion of the $5.8 trillion in actual and anticipated nuclear weapons expenditures since 1940 was spent just on keeping things secret. Schwartz, S. 1998. Atomic Audit: The Costs and Consequences of U.S. Nuclear Weapons Since 1940. Washington, DC: Brookings Institution Press. Prepared for the 2004 Teaching Nonproliferation Summer Institute, University of North Carolina, Asheville, June 11-15, 2004. On an average annual basis, this would be equivalent to the total budget of the National Institutes of Health per year. 14   Schwartz, S.I. 1995. Four trillion dollars and counting. Bulletin of the Atomic Scientists 51(6):32-52. 15   National Academy of Sciences. 1982. Scientific Communication and National Security. Washington, DC: National Academy Press. Available at www.nap.edu/books/0309033322/html. 16   Carlson, R. Briefing remarks before the Committee, February 2004. 17   Wein, L.M. 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. 18   Alberts, B. 2005. Modeling attacks on the food supply. Proceedings of the National Academy of Sciences 102(28):9737-9738. 19   Wein, L.M. 2005. Got Toxic Milk? New York Times (May 30). 20   USAMRIID states publicly that it does not conduct classified research. 21   Gusterson, H. 1996. Nuclear Rites: A Weapons Laboratory at the End of the Cold War. Berkeley, CA: University of California Press, Chapter 4. 22   A very thin line separates offense and defense bioweapons research. Also biodefense research can be problematic as in many cases defensive work generates an offensive capability. For more on this issue see Choffnes, E. 2002 Bioweapons: New Labs, More Terror? Bulletin of the Atomic Scientists 58(5):28-32.

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Globalization, Biosecurity, and The Future of the Life Sciences 23   Ad Hoc Committee on Access to and Disclosure of Scientific Information. In the Public Interest. Massachusetts Institute of Technology, June 12, 2002. 24   See NIAID Strategic Plan for Biodefense Research. February 2002. Available online at www3.niaid.nih.gov/biodefense/research/strategic.pdf [accessed January 5, 2006]. See also NIAID Biodefense Research Agenda for CDC Category A Agents. February 2002; and NIAID Biodefense Research Agenda for CDC Category A Agents, Progress Report, August 2003. Available online at www2.niaid.nih.gov/Biodefense/Research/strat_plan.htm [accessed January 5, 2006]. 25   National Research Council. 2004. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press, see Chapter 4. 26   National Research Council. 2004. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press. 27   Alberts, B. 2005. Modeling attacks on the food supply. Proceedings of the National Academy of Sciences 102(28):9737-9738. Center for Strategic and International Studies. 2005. Security Controls on Scientific Information and the Conduct of Scientific Research. Available online at www.csis.org/hs/0506_cscans.pdf. American Civil Liberties Union. 2005. Science Under Seige: The Bush Administration’s Assault on Academic Freedom and Scientific Inquiry. Available online at www.aclu.org/Privacy/Privacy.cfm?ID=18534&c=39. Donohue, L.K. 2005. Censoring science won’t make us any safer. Washington Post (June 26). 28   Malakoff, D. and K. Drennan. 2004. Butler gets 2 years for mishandling plague samples. Science 303(5665)(19):1743-1745. Available online at www.sciencemag.org/cgi/reprint/303/5665/1743a.pdf [accessed January 5, 2006]. 29   The PATRIOT Act makes it illegal in the United States for anyone to possess any biological agent, including any genetically engineered organism created by using recombinant DNA technology, of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The Act also prohibits the transfer or possession of a listed biological agent or toxin by a “restricted person.” 30   The Bioterrorism Response Act added new requirements for secretaries of the Departments of Agriculture and Health and Human Services to consider in listing agents and in preventing unlawful access to agents during transfers; established new requirements for registration with the appropriate secretary concerning possession and use of select agents and toxins; and required the establishment of rules for appropriate physical security requirements for listed agents and for the Department of Justice—through the Federal Bureau of Investigation—to conduct background investigations on individuals who are permitted access to select agents or who work in a facility where select agents are stored. 31   See olpa.od.nih.gov/legislation/107/pendinglegislation/6bioterroism.asp for a list of all 17 bills introduced [accessed May 25, 2005]. 32   Indeed, such scientific exchanges and collaborations also increases the awareness within the United Sates of the extent and nature of technological capabilities of scientists from other countries. 33   See www.genome.gov/11006939 for a list of the 20 sequencing centers [accessed May 25, 2005]. 34   Institute of Medicine. 2004. Learning from SARS: Preparing for the Next Disease Outbreak. Washington, DC: The National Academies Press.

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Globalization, Biosecurity, and The Future of the Life Sciences 35   National Research Council. 2004. Seeking Security: Pathogens, Open Access, and Genome Databases. Washington, DC: The National Academies Press. 36   General Accounting Office. 2004. Border Security: Improvements Needed to Reduce Time Taken to Adjudicate Visas for Science Students and Scholars. GAO-04-371 (February). As referenced in Brown, H.A. and P.D. Syverson. 2004. Findings from U.S. Graduate Schools on International Graduate Student Admission Trends. Available online at www.cgsnet.org/pdf/Sept04FinalIntlAdmissionsSurveyReport.pdf [accessed January 4, 2006]. 37   General Accounting Office. 2005. Border Security: Streamlined Visas Mantis Program has Lowered Burden on Foreign Science Students and Scholars, but Further Refinements Needed. GAO-05-198 (February):7. Available online at www.gao.gov/new.items/d05198.pdf [accessed January 5, 2006]. 38   The question of shifting from country of citizenship to country of birth has been raised in the context of deemed exports. The Inspector General of the Department of Commerce has recommended consideration be given to changing to country of birth. At the meeting on this topic at NAS (2005) it seemed apparent that the Department of Commerce was listening but not pressing for this change. The responses by NAS and various academic organizations all speak to limiting changes and reducing the impact of deemed export regulations. 39   See www7.nationalacademies.org/rscans/IG_Workshop_Transcripts.pdf [accessed January 5, 2006]. 40   For example, programs organized within the Department of Homeland Security’s Science and Technology Directorate. 41   The terms “bona fide” and “legitimate” are not defined in the statute. 42   A “restricted person” is defined as “anyone who: is under indictment for or has been convicted in any court of a crime punishable by imprisonment for a term exceeding one year; is a fugitive from justice; is an unlawful user of any controlled substance; is an alien illegally or unlawfully in the United States; has been adjudicated as a mental defective or has been committed to any mental institution; is an alien who is a national of a country which is currently designated by the Secretary of State as a supporter of terrorism; or has been dishonorably discharged from U.S. armed forces.” Currently there are seven countries on the State Department’s List of State Sponsors of Terrorism: Cuba, Libya, Iran, Iraq, North Korea, Sudan, and Syria. 43   There are four basic criteria used to evaluate whether an agent or toxin should be listed: 1) The effect on human health of exposure to the agent or toxin (or, in the case of the USDA list of plant and animal agents and toxins, the effect of an agent or toxin on animal or plant health or products). 2) The degree of contagiousness and the methods by which transfer of the agent or toxin to humans can occur (or, in plants and animals, the virulence of an agent or degree of toxicity of the toxin and the methods by which the agents or toxins are transferred to animals or plants). 3) The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from exposure (or, in the case of USDA agents, the availability and effectiveness of medicines and vaccines to treat and prevent any illness caused by an agent or toxin) 4) Any other criteria, including the needs of children and other vulnerable populations that the Secretary considers appropriate (or, in the case of USDA agents, other criteria that the

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Globalization, Biosecurity, and The Future of the Life Sciences     Secretary considers appropriate to protect animal or plant health, or animal or plant products). 44   U.S. Congress. Antiterrorism and Effective Death Penalty Act of 1996, P.L. 104-132 (April 24), sec. 511. 45   Malakoff, D. 2003. Security Rules Leave Labs Wanting More Guidance. Science 299(5610):1175. 46   See www.asm.org/Policy/index.asp?bid=8648 [accessed May 25, 2005]. 47   See www.wmd.gov/report/. 48   “A senior National Security Council official is said to have praised Bio-Chem 2020 but was quick to note that it is a ‘cottage program,’ not part of a broader Intelligence Community endeavor.” From Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction. Report to the President of the United States, March 31, 2005. Chapter 13 “The changing proliferation threat and the intelligence response.” See www.globalsecurity.org/intell/library/reports/2005/wmd_report_25mar2005_chap13.htm [accessed January 6, 2006]. The Committee believes that there may be current on-going discussions among officials in the national security and intelligence communities about the need for such an advisory group. 49   Based on a personal conversation with Dr. David Sencer, former director of the CDC, the ACIP was informally created in 1964 by combining several small ad hoc committees into one, unified committee to advise the CDC on topics related to vaccines (personal communication with Dr. David Sencer, January 9, 2006). The ACIP was formally created in 1993 under the statutory authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended. The committee is governed by the provisions of Public Law 92-463, the Federal Advisory Committees Act of 1972, as amended (5 U.S.C. A 2), which sets forth standards for the formation and use of advisory committees. In addition, the ACIP was given a statutory role, and budget, under Section 13631 of the Omnibus Budget Reconciliation Act of 1993, Public Law 103-66 (42 U.S.C. 1396s(c)(2)(B)(i) and (e), subsections 1928(c)(2)(B)(i) and 1928(e) of the Social Security Act) to provide advice and guidance to the Secretary; the Assistant Secretary for Health, HHS; and the Director, CDC, regarding the most appropriate application of antigens and related agents for effective communicable disease control in the civilian population. The committee develops written recommendations for routine administration of vaccines to the pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. ACIP is the only entity in the federal government which makes such recommendations. For more information regarding the structure and functions of the ACIP please see www.cdc.gov/nip/acip/charter.htm. 50   Federal Advisory Committee Act. - 483 -. Federal Advisory Committee Act. 5 USC a, as amended. See www.usdoj.gov/04foia/facastat.pdf. 51   Under the Federal Advisory Committee Act, a federal advisory committee shall terminate in two years after it is established, unless a statute authorizing the committee specifically provides for a different duration or the agency head renews its charter. In addition, the President or agency head can terminate the advisory committee earlier if he or she determines that the committee has fulfilled its purpose, it is no longer carrying out its purpose, or the cost of operation is too much relative to

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Globalization, Biosecurity, and The Future of the Life Sciences     the benefits of the committee. See www.redlodgeclearinghouse.org/legislation/faca3.html [accessed January 6, 2006]. 52   The NSABB is specifically charged with guiding the development of a system of institutional and federal research review that allows for fulfillment of important research objectives while addressing national security concerns; guidelines for the identification and conduct of research that may require special attention and security surveillance; professional codes of conduct for scientists and laboratory workers that can be adopted by professional organizations and institutions engaged in life science research; and, materials and resources to educate the research community about effective biosecurity. The NSABB Charter was signed March 4, 2004. See www.biosecurityboard.gov/SIGNED%20NSABB%20Charter.pdf, emphasis added [accessed January 6, 2006]. 53   Steinbrook, R. 2005. Biomedical Research and Biosecurity. New England Journal of Medicine 353(21):2212-2214. 54   Report of the Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction, March 31, 2005. Available online at www.wmd.gov/report/wmd_report.pdf [accessed January 6, 2006]; National Commission on Terrorist Attacks Upon the United States. 2004. The 9/11 Commission Report. Available online at www.9-11commission.gov/report/index.htm [accessed January 6, 2006]. 55   For more on this issue see The National Academies. 2005. Rising Above the Gathering Storm. Washington, DC: The National Academies Press. 56   A regime comprises the multitude of cooperative and coercive measures—including international agreements, multilateral organizations, national laws, regulations, and policies—intended to prevent the spread of dangerous weapons and technologies. 57   The Biological and Toxin Weapons Convention can be viewed online at www.opbw.org/convention/documents/btwctext.pdf. The fact that its prohibitions do not expressly extend to ‘research’ is sometimes cited as a loophole or as an obstacle to raising awareness of the BWC within the research community. It should be recalled, however, that the original negotiators of the BWC differentiated ‘pure’ and ‘applied’ research. Although the precise meaning of ‘development’ is unclear, at least some of the negotiators understood it to subsume end-item and process research; others, however, took a contrary view. This is a matter that states partiers could perhaps clarify at a future BWC review conference. 58   BWC/MSP/2004/INF.2, 3 December 2004 See www.opbw.org. 59   For a detailed discussion on the challenges that the BWC currently faces see National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks. Washington, DC: The National Academies Press. Available online at www.nap.edu/catalog/11301.html. 60   The Chemical Weapons Convention can be viewed online at www.opcw.org/html/db/cwc/eng/cwc_frameset.html. 61   General Accounting Office. 2004. Nonproliferation: Delays in Implementing the Chemical Weapons Convention Raise Concerns about Proliferation. Report to the Chairman, Committee on Armed Services, House of Representatives. GAO-04-361. Available online at www.gao.gov/new.items/d04361.pdf [accessed January 6, 2006].

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Globalization, Biosecurity, and The Future of the Life Sciences 62   The Australia Group (AG) is an informal consultative group of nations (38 countries plus the European Commission) which meet annually with the objective “to ensure, through licensing measures on the export of certain chemicals, biological agents, and dual-use chemical and biological manufacturing facilities and equipment, that exports of these items from their countries do not contribute to the spread of CBW.” See www.australiagroup.net. The group formed in 1985, in response to evidence that Iraq had used chemical weapons in the Iran-Iraq war and that Iraq had obtained many of the materials for their chemical weapons program from the international chemical industry. In 1990, the AG group expanded its efforts to address the increasing spread of bioweapons materials and technology. 63   UN Security Council Resolution 1540 (2004) obliges all UN member states to have national laws in place to prohibit the proliferation of terrorism with biological materials. In effect, the resolution obliges all UN member states, not just BWC States Parties, to comply with Articles III and IV of the BWC, both of which apply to non-state actors. Article III creates a very clear obligation not to transfer to any recipient whatsoever any sort of material, equipment, or know-how for making biological weapons. Article IV obliges all States Parties to take national measures to fully implement these obligations and responsibilities, which means that all States Parties must enact legislation containing the prohibitions of the BWC and penalties for noncompliance. 64   SCR 1540 was a resolution passed by the United Nations Security Council requiring all U.N. member states to establish effective domestic controls to prevent non-state actors from acquiring nuclear, chemical, or biological weapons, their means of delivery, and related materials. 65   For more information, see Rappert, B. 2005. Towards a Life Science Code: Possibilities and Pitfalls in Countering the Threats from Bioweapons. Available online at www.ex.ac.uk/codesofconduct/Publications/Bradford%2012.7.4.doc [accessed January 6, 2006]. 66   See www.asm.org/ASM/files/CCLIBRARYFILES/FILENAME/0000000656/Council%20approved%20Code%20of%20Ethics2.pdf [accessed January 6, 2006]. 67   See www.ex.ac.uk/codesofconduct/Chronology/index.htm [accessed January 6, 2006]. 68   See www.theasm.com.au/ [accessed January 6, 2006]. 69   Somerville, M.A. and R.M. Atlas. 2005. Ethics: A weapon to counter bioterrorism. Science 307(5717):1881-1882. 70   See www.biotech.ca/EN/ethics.html [accessed January 6, 2006]. 71   www.europabio.org/documents/corevalues.pdf. 72   Institute of Medicine/National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks. Washington, DC: The National Academies Press. Available online at www.nap.edu/catalog/11301.html. 73   For a discussion of what happened at this experts group meeting—MX 2005—see The CBW Conventions Bulletin, No. 68, June 2005 online at www.sussex.ac.uk/Units/spru/hsp/CBWCB68.pdf [accessed January 6, 2006]. 74   The recommendation reads as follows: Relevant United Nations offices should be tasked with producing proposals to reinforce ethical norms, and the

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Globalization, Biosecurity, and The Future of the Life Sciences     creation of codes of conduct for scientists, through international and national scientific societies and institutions that teach sciences or engineering skills related to weapons technologies, should be encouraged. Such codes of conduct would aim to prevent the involvement of defence scientists or technical experts in terrorist activities and restrict public access to knowledge and expertise on the development, production, stockpiling and use of weapons of mass destruction or related technologies. Available online at www.un.org/terrorism/a57273.htm [accessed January 6, 2006]. 75   Institute of Medicine/National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks. Washington, DC: The National Academies Press. Available online at www.nap.edu/catalog/11301.html. 76   Ibid. 77   Iverson M., M. Frankel, and S. Siage. 2003. Scientific societies and research integrity: what are they doing and how well are they doing it? Science and Engineering Ethics 9(2):141-158. 78   Doig, A. and J. Wilson. 1998. The effectiveness of codes of conduct. Journal of Business Ethics 7(3):140-149. 79   Higgs-Kleyn, N. and D. Kapelianis. 1999. The role of professional codes in regulating ethical conduct. Journal of Business Ethics 19:363-374. 80   Luegenbiehl, C. 1991. Codes of ethics and the moral education of engineers. In: Johnson, D. 1991. Ethical Issues in Engineering. Upper Saddle River, NJ: Prentice Hall:136-154. 81   Davis, M. 1998. Thinking Like an Engineer. Oxford: Oxford University Press. 82   Meselson M. 2000. Averting the exploitation of biotechnology. FAS Public Interest Report 53:5. 83   Unger, S. 1991. Code of engineering ethics. In: Johnson, D. 1991. Ethical Issues in Engineering. Upper Saddle River, NJ: Prentice Hall:105-130. 84   Reiser, S. and Bulger, R. 1997. The social responsibilities of biological scientists. Science and Engineering Ethics 3(2):137-143. 85   The NSABB is charged specifically with guiding the development of: A system of institutional and federal research review that allows for fulfillment of important research objectives while addressing national security concerns; Guidelines for the identification and conduct of research that may require special attention and security surveillance; Professional codes of conduct for scientists and laboratory workers that can be adopted by professional organizations and institutions engaged in life science research; and Materials and resources to educate the research community about effective biosecurity. For more information on the NSABB, see www.biosecurityboard.gov/. 86   As of this writing, Duke University, MIT, Princeton, and the University of California, San Diego have education modules; The University of California, Berkeley and SUNY Stonybrook are in the process of developing education modules. The Arms Control Association has also developed an education module on the history of biological weapons, arms control treaties and the “dual use” dilemma. The Federation of American Scientists is also developing an interactive teaching module to promote awareness of biosecurity issues among bioscience researchers.” See www.fas.org/main/content.jsp?formAction=297&contentId=146.

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Globalization, Biosecurity, and The Future of the Life Sciences 87   For a discussion of the laws and regulations in the United States governing the handling and control of biological materials and the rules governing who may or may not work with these materials, please see National Research Council, 2004, Biotechnology Research in an Age of Terrorism. Washington DC: The National Academies Press; Chapter 2. 88   Daar, A.S. and P.A. Singer. 2005. Biotechnology and Human Security. In: Helsinki Process Papers on Human Security. Foreign Ministry’s Publications: Helsinki:120-162. Available online at www.utoronto.ca/jcb/home/documents/Biotech_human_security.pdf [accessed January 6, 2006]. 89   UN Millennium Project Task Force on Science, Technology and Innovation. 2005. Innovation: Applying knowledge to development. London: Earthscan. 90   Kellman, B. The global bargain for biosecurity. Unpublished manuscript distributed to committee (June 2004). 91   Ibid. 92   This description of the mammalian innate and adaptive immune systems is adapted from Kathryn Nixdorff, briefing to the Committee at the Committee’s International Workshop. Institute of Medicine/National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks. Washington, DC: The National Academies Press; 44-49. Available online at www.nap.edu/catalog/11301.html. 93   See www.promedmail.org. 94   Jackson, R.J. et al. 2001. Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. Journal of Virology 75(3):1205-1210. 95   Linux is a free Unix-type operating system. See www.linux.org. 96   Young, H.P. 1998. Individual Strategy and Social Structure: An Evolutionary Theory of Institutions. Princeton: Princeton University Press; Axelrod, R. 1984. The Evolution of Cooperation. New York: Basic Books; Axelrod. R. 1986. An Evolutionary Approach To Norms. American Political Science Review 80(4):1095-1111; Epstein, J.M. 2001. Learning to be Thoughtless: Social Norms and Individual Competition. Computational Economics 18:9-24. 97   Fox, J.A. and A.R. Piquero. 2003. Deadly demographics: Population characteristics and forecasting homicide trends. Crime & Delinquency 49(3):339-359. 98   National Research Council. 2004. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press. Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities. Washington, DC: The National Academies Press; Institute of Medicine. 2003. Microbial Threats to Health: Emergence, Detection, and Response. Washington, DC: The National Academies Press. NIAID Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research, February 2002. More information on the NIAID Blue Ribbon Panel is available online at www.niaid.nih.gov/publications/btbluribbon.htm [accessed January 6, 2006]. 99   Chyba, C.F. 2001. Biological Terrorism and Public Health. Survival 43(Spring):93-106. 100   Prevention is a cornerstone of public health. Just as mosquito netting can be used to prevent the spread of malaria, the built environment can be used to minimize risks of exposure to airborne biological agents. See www.cdc.gov/niosh/bldvent/2002-139.html#foreward;

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Globalization, Biosecurity, and The Future of the Life Sciences     www.cdc.gov/niosh/docs/2003-136/2003-136.html; and www.ashrae.org/content/ASHRAE/ASHRAE/ArticleAltFormat/20053810917_347.pdf. 101   October 2, 2001: infectious-disease specialist Dr. Larry Bush found a high white blood cell count and rod-shaped bacilli in Robert Stevens, 63, photo editor at the supermarket tabloid The Sun. He soon was convinced Stevens had contracted anthrax. He then notified the Palm Beach County Health Department. See en.wikipedia.org/wiki/Timeline_of_the_2001_anthrax_attacks_in_Florida [accessed January 6, 2006]. Feb 28, 2003: World Health Organization officer Carlo Urbani, MD, examines an American businessman with an unknown form of pneumonia in a French hospital in Hanoi, Vietnam. March 10, 2003: Urbani reports an unusual outbreak of the illness, which he calls severe acute respiratory syndrome or SARS, to the main office of the WHO. He notes that the disease has infected an usually high number of healthcare workers (22) at the hospital. March 29, 2003: Carlo Urbani, who identified the first cases of SARS, dies as a result of the disease. Researchers later suggest naming the agent that causes the disease after the infectious disease expert. See my.webmd.com/content/article/63/72068.htm [accessed January 6, 2006]. 102   Wysocki, B. 2005. U.S. Struggles for Drugs to Counter Biological Threats. Wall Street Journal (July 11). 103   The failure of the government to get the countermeasures it needs to protect its citizens is a major problem. BioShield gives HHS more flexibility to purchase countermeasures but there is a critical piece missing—funding of initial product development, the so-called “Valley of Death” for new drugs. BioShield does not provide sufficient financial incentives for pharmaceutical companies to invest years of research into a product. For a detailed description of what BioShield does and does not do, as well as the difficulties in getting countermeasures for biodefense, see Borio, L.L. and Gronvall, G.K. 2005. Anthrax countermeasures: current status and future needs. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 3(2):102-112. 104   Institute of Medicine. 2003. The Resistance Phenomenon in Microbes and Infectious Disease Vectors. Washington, DC: The National Academies Press. 105   The areas of science reflected in the Nobel Prize include chemistry, medicine and physiology, and physics. Areas of science for which the National Medal of Scinece is awarded include biology, chemistry, engineering, and math and physics. 106   This reference can be found online at www.nap.edu/books/0309053382/html/89.html. 107   See www4.nationalacademies.org/news.nsf/isbn/s05182005?OpenDocument