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Globalization, Biosecurity, and the Future of the Life Sciences (2006)

Chapter: 4 Conclusions and Recommendations

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Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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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-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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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.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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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-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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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.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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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-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

tions and influence. In many ways, the “genie is out the bottle” and it is difficult to envision how it can be put back in.

Fifth, unlike nuclear physics, there is no accepted culture of secrecy or control on the flow of research information in the life sciences. The very real dual-use potential of atomic physics was made forcefully evident 60 years ago with the explosion of the first nuclear device at the Trinity Test site in Alamagordo, New Mexico. In contrast, despite a long global history of limited attempts to use biological agents as weapons, realization of the magnitude of the dual-use implications of advances in biotechnology and the life sciences has come only much more recently. No doubt, this reflects the pace and timing of advances in these two fields over the past century. High-end research in the life sciences is also generally much less capital intensive than research in nuclear physics. The result is that the research culture in the life sciences is generally one that has been historically open, international in scope, and widely distributed.

Few molecular biologists or biomedical research institutions have any experience with classified, or secret, research. There are nationally operated biological research laboratories with missions focusing on defense against potential biological agents [such as the United States Army Medical Research Institute for Infectious Diseases (USAMRIID20) at Fort Detrick in the United States or Porton Down in the United Kingdom], but no laboratories exist that have openly declared missions to develop, test, or stockpile biological weapons—all of which of would be in flagrant violation of the biological weapons convention. This is in stark contrast to research activities in nuclear physics, which while also encompassing a great deal of open, fundamental research historically have included the use of facilities that are openly acknowledged to have missions related to the development and testing of nuclear weapons. Such laboratories, involved in the production and processing of special nuclear materials, are operated with special security clearances that restrict access to a small number of scientists and technicians who, in effect, constitute a closed society.21 To be clear, the work at these laboratories is a small subset of all research in nuclear physics, which as a field has strongly embraced openness in the conduct and dissemination of its science.

Current U.S. laws and policies have the potential of creating de facto “closed” facilities focusing on research with category A select agents. Although these select agent laboratories, both in the federal government and the academic sector, have been and would be focused on the development of purely defensive countermeasures against perceived biological threat agents, the restrictions surrounding access to the laboratories has raised concerns in some quarters that some research may be more offensive in nature.22 Such fears and misperceptions can only be alleviated by policies

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

that promote transparency and encourage widespread dissemination of the research results generated in such facilities.

Although the principles that underlie the design of nuclear warheads are well understood by scientists around the world, details of nuclear weapons design remain largely classified. Except during the period following World War II, when the United States managed a mostly classified offensive biological weapons program, biology has enjoyed a long history of openness and free exchange of materials, personnel, and ideas. As the evidence presented in Chapter 2 strongly demonstrates, this open exchange of information is necessarily and increasingly global. Both basic research and the development of commercial products utilizing life sciences technology increasingly involves international collaboration and partnerships, many of which are outside of formal bilateral controls. Changing the open nature of the life sciences culture, or attempting to change it, could have unintended consequences by discouraging graduate students and postdoctoral researchers—in many cases the best minds engaged in rapidly developing fields—from becoming involved in restricted fields or even communicating with people who are involved in those fields, as major universities that accept classified research usually create separate facilities where access is limited and controlled.23

While not classified, research on category A select agents now requires special security safeguards that are both unusual and unsettling for the academic research centers that are being asked to pursue this research by the National Institutes of Health (NIH) and other federal agencies in the search for better countermeasures against possible bioterrorism attacks.24 These include background security checks on all personnel involved, tightly restricted access to the laboratories involved, and in some institutions the presence of an armed security force “24/7.” Such measures, irrespective of their degree of merit or utility, are likely to segregate a group of research scientists from their peers and perhaps make the recruitment of the best and brightest to an important enterprise more difficult.

Despite all of the above, the committee recognized that in relatively rare instances there may still exist a need for the U.S. government and the larger scientific community to impose some restrictions on the conduct of research and/or on the publication of results, a point made by the Fink committee in its 2004 report, Biotechnology Research in an Age of Terrorism.25 The committee labored without much success to define such circumstances. Explicit, specific, detailed “recipes” concerning how to make and deliver a weapon might certainly be worthy of attempts to suppress dissemination. However, defining what specifically constitutes such a “recipe” is difficult. Research designed to create or exploit a critical host vulnerability for which no countermeasures are available would trigger review under recommendations 2, 3, and 4 of the previously cited Fink

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

committee report. The potential value of focusing on such “functional” criteria for defining problematic research should be further explored (e.g., research that deliberately seeks to exploit critical public health vulnerabilities). Of course, in some cases, proprietary interests may dictate that information be kept confidential.

The recent PNAS publication alluded to above has been considered by some to be a roadmap for the introduction of botulinum toxin into the U.S. milk supply. Although opinions are split, there were cogent reasons to support its publication. While only time will tell whether the work by Wein et al. was beneficial or detrimental to the security of the milk supply, its formal publication was likely moot. The analysis described in the manuscript had been previously presented, and the manuscript itself was widely disseminated in advance of its publication, highlighting once again the difficulties inherent in attempts to suppress information in the “Internet era.”

The scientific and intelligence communities will need to define narrowly those “special circumstances” when classification is warranted and allow public scrutiny of the process used to arrive at those definitions. The scientific and intelligence communities will also need to devise effective methods to keep a close hold on information that truly needs to be kept secret. At the same time, these communities need to maintain an environment that promotes the advancement of science and technology both domestically and globally. As the committee completes its report, it notes that HHS Secretary Leavitt has formally established the National Science Advisory Board for Biosecurity (NSABB), following a recommendation in the Fink report, and that the board has begun its work. The NSABB has among its charges the development of specific guidelines to meet these challenges.

The committee, therefore, strongly reaffirms the principles embodied in NSDD-189 (Box 4-2), which defines the national policy for controlling the flow of science, technology, and engineering information produced in federally funded fundamental research at academic institutions, governmental and nongovernmental facilities, and private laboratories receiving federal funds. Issued by President Reagan on September 21, 1985, NSDD-189 has not been superseded and continues to be the official U.S. government policy. Indeed, then Assistant to the President for National Security Affairs, Condoleeza Rice, reaffirmed NSDD-189 on November 1, 2001, in a letter to Harold Brown of the Center for Strategic and International Studies. As she stated, “This Administration will review and update as appropriate the export control policies that affect basic research in the United States. In the interim, the policy on the transfer of scientific, technical, and engineering information set forth in NSDD-189 shall remain in effect.” The director of the Office of Science and Technology Policy, John

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

BOX 4-2
NSDD-189

NSDD-189 states that, “to the maximum extent possible, the products of fundamental research remain unrestricted. It is also the policy of this Administration that, where the national security requires control, the mechanism for control of information generated during federally funded fundamental research in science, technology and engineering at colleges, universities and laboratories is classification. Each federal government agency is responsible for: a) determining whether classification is appropriate prior to the award of a research grant, contract, or cooperative agreement and, if so, controlling the research results through standard classification procedures; b) periodically reviewing all research grants, contracts or cooperative agreements for potential classification. No restriction may be placed upon the conduct or reporting of federally funded fundamental research that has not received national security classification, except as provided in applicable U.S. Statutes.”

NSDD-189 defines fundamental research as “basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons.”

Marburger, reaffirmed this position in a talk at the National Academy of Sciences on January 9, 2003.26 A number of recent publications and statements by other organizations also endorse the principles set forth in NSDD-189.27

Recommendation 1b. Ensure that any biosecurity policies or regulations implemented are scientifically sound and are likely to reduce risks without unduly hindering progress in the life sciences and associated technologies.

Although the regulatory environment for life sciences research has evolved over the course of several decades, the United States is witnessing a rapid transition from a scientific environment based on voluntary compliance with recommended practices to one based on the imposition and enforcement of statutes and regulations, particularly with respect to the control of biological materials and personnel, leading in some cases to the imposition of criminal penalties and sanctions. The high-profile case brought against an infectious disease research scientist, Dr. Thomas

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Butler, by the federal government following his self-disclosure of missing plague bacillus inventory provides a stark example of the changes wrought since the terrorist attacks of September 11, 2001.28 Now serving a prison sentence following his conviction on several counts unrelated to his handling of Yersinia pestis, his actions, however inappropriate, are unlikely to have prompted such a response in prior years. Although the transition started before the terrorist attacks of 9/11 (e.g., the 1996 Antiterrorism and Effective Death Penalty Act enacted new regulatory controls regarding transfers of dangerous pathogens), two major pieces of relevant legislation were passed into law less than a year after the attacks on the World Trade Center and the Pentagon, and subsequent anthrax mailings: “The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of October 2001” Act (i.e., the PATRIOT Act)29 and “The Public Health Security and Bioterrorism Preparedness and Response Act” (i.e., the Bioterrorism Response Act).30 These new security provisions have radically transformed the research environment for those who work with category A select agents in the United States from one that was traditionally open to one that is highly restricted and regulated in a number of ways. Of note, the PATRIOT and Bioterrorism Response Acts represent only 2 of 17 bioterrorism bills introduced by the 107th Congress (2001-2002) with potential ramifications for the research scientists who are funded by NIH to work on these agents and on whom the nation is dependent, in part, for the development of effective vaccines, therapies, and related diagnostics.31

Here, the committee emphasizes that these and any additional related proposed policies or regulations must be carefully and scientifically evaluated to ensure that they do more good than harm. Examples of regulations and policies that may potentially do more harm than good include the extension of the “deemed export” regulations under the Export Administration Act to information exchanges in the life sciences and unnecessarily onerous VISA requirements for foreign scientists to study and work in the United States.

An additional example is the extension of security provisions for select agents in the PATRIOT Act to foreign laboratories funded by NIH, often under subcontract to an American academic institution. While this is consistent with the treatment of other federal policies and regulations in such contracts, such provisions may be impossible for many foreign laboratories to meet or unpalatable to local authorities in countries where the restricted select agents are endemic and readily available in the environment or in other research or clinical settings. The net result is likely to be a reduction in the number of foreign collaborators with U.S. scientists, with the result that the nation’s ability to understand the epidemiology and evolution of these biological agents in their native settings is de-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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graded. It is questionable whether such a policy effectively promotes global awareness of the “culture of responsibility” sought by many in the study of such agents. The potential adverse impacts of policies such as these32 need to be studied in an evidence-based manner, and decisions concerning continued or future implementation should be made on the basis of the balance between the harm done to the scientific establishment charged with protecting society against such threats and any additional direct security such policies may provide.

In addition to the many beneficial applications of life sciences knowledge and technologies that were highlighted in Chapter 2, the promises offered by the 13-year Human Genome Project provide an exemplary case of a recent advance in life sciences made possible by the unrestricted exchange of information and technology. The International Human Genome Sequence Consortium involved hundreds of scientists from 20 sequencing centers in China, France, Germany, Japan, the United Kingdom, and the United States.33 The ability of the scientific community to respond rapidly and rationally to the SARS epidemic was based in large part on recognition of the offending etiologic agent, SARS coronavirus (SARS-CoV). Within six weeks, the virus that causes SARS, SARS-CoV, had been isolated and its complete 29,727-nucleotide sequence determined and posted on the Internet.34 The rapidity with which this happened was dependent in part on technology developed to advance the Human Genome Project and on the sharing of data as they were generated in multiple laboratories on different continents. In the months that followed, dozens more SARS-CoV isolates were sequenced and published. Not only did availability of the sequence data put to rest fears that SARS was the result of a laboratory-fabricated agent, such data allowed researchers in open laboratories worldwide to begin immediately to analyze the virus’ structure, function, and molecular pathogenic mechanisms, as well as develop rapid nucleic acid-based diagnostic tests and identify potentially useful antiviral lead compounds targeting the viral protease that were already on the shelf.35 The use of these sequences by scientists addressing the SARS crisis globally is a prime example of the crucial role that the free exchange of international information and technology can play with respect to, in this case, a rapid response to a public health crisis. It would likely be much the same should a manmade infectious disease threat be unleashed.

Restrictive policies and regulations that unduly hinder scientific and technological progress would keep scientists and society from achieving important goals, like sequencing the human genome or developing a rapid response to a new disease outbreak, like SARS, not to mention the development of effective countermeasures for bioterrorism.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Recommendation 1c. Promote international scientific exchange(s) and the training of foreign scientists in the United States.

Foreign scientific exchange is an integral and essential component of the culture of science. As technological growth becomes increasingly dependent on international exchange, it is also an increasingly vital component of U.S. technological capacity, including biodefense technological capacity. Weakening this link by prohibiting or discouraging foreign scientific exchange—including the engagement of foreign students and scientists in U.S. laboratories, meetings, and business enterprises and vice versa—could impede scientific and technological growth and have counterproductive, unintended consequences for the biodefense enterprise. As described in Chapter 2, international scientific exchanges and the training of foreign scientists in the United States have played integral roles in the scientific and technological development of this country over the past few decades. Such exchanges will continue to play important roles in maintaining the international linkages that are so vital (and are only becoming more so) for both basic and applied research and development in the life sciences. Moreover, from the perspective of enhancing biosecurity, these exchanges will be essential for the development of a shared global culture of awareness and responsibility with respect to the dual use potential of many future advances in the life sciences.

The implementation of the regulatory regime imposed by the PATRIOT and Bioterrorism Response Acts on the life sciences community have raised concerns that qualified individuals may be discouraged from conducting biomedical and agricultural research of value to the United States because of the apparent infringement of these rules and regulations on individual liberties. Included among these measures are policies directed at individuals based on their country of birth, rather than current citizenship. As emphasized in Chapter 2, foreign interest in U.S. graduate education in science and technology is waning, as the increased competitiveness of graduate schools elsewhere in the world attracts gifted students who, in the past, may have emigrated to the United States to study and because of perceived and actual difficulties with obtaining entry to the United States. For example, according to a February 24, 2004 General Accounting Office report, between April and June 2003, it took an average of 67 days to complete the security checks associated with visa applications, due to the wait time for required interviews (as long as 12 weeks in India and 6 weeks in China) and Visas Mantis clearance.36 (The committee notes, however, that by November 2004, review time had reportedly dropped to 15 days.37)

Moreover, there have been recent indications that other steps are being taken, or pressures exerted, which may curtail foreign national par-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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ticipation in U.S. scientific activity. For example, in March 2004 the Inspector General of the U.S. Department of Commerce issued recommendations for regulatory changes that would affect existing requirements and policies for “deemed export” licenses. A deemed export occurs when a foreign national working in the United States gains access to or uses export-controlled technology or information, including many types of standard laboratory equipment. The recommendations include regulatory or other administrative action that would clarify the definition of “use,” base the requirement for a deemed export license on the foreign national’s country of birth; and modify regulatory guidance on the licensing of technology to foreign nationals involved with government-sponsored or university research.38 In March 2005, the Bureau of Industry and Security (BIS) solicited comments on the proposed requirements (through May 27, 2005). In a letter sent to Peter Lichtenbaum, assistant secretary of commerce for the Export Administration, the presidents of the National Academy of Sciences, Institute of Medicine, and National Academy of Engineering, provided formal comments on the effect that this Advanced Notice of Proposed Rulemaking would have on the scientific enterprise (Annex 4-1).

On May 6, 2005, the National Academies hosted a workshop on the proposed changes and their implications.39 On May 18, 2005, the presidents of the National Academies, along with the presidents and executive directors/CEOs of leading domestic and international scientific and educational associations including, but not limited to, the Association of American Universities, the American Association for the Advancement of Science, the National Association of State Universities and Land Grant Colleges, the American Council on Education, the Council on Competitiveness, the American Physical Society, NAFSA: Association of International Educators, the Council of Graduate Schools, and the Institute of International Education jointly issued six recommendations for enhancing the U.S. visa system to advance America’s national security interests while promoting its economic and scientific competitiveness. The text of the announcement can be found in Annex 4-2.

CONCLUSION 2: THE COMMITTEE CONCLUDES THAT A BROADER PERSPECTIVE MUST BE ADOPTED WHEN CONSIDERING THE SPECTRUM OF PRESENT AND FUTURE THREATS.

U.S. national biodefense programs currently focus on a relatively small number of specific agents or toxins, chosen as priorities in part because of their history of development as candidate biological weapons agents by some countries during the 20th century. The committee believes

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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that a much broader perspective on the “threat spectrum” is needed. While current biodefense programs40 do consider the future potential for specific pathogenic agents to be manipulated in ways that make them, for example, more virulent or more resistant to available antimicrobial drugs, even this approach is too narrowly focused. Recent advances in understanding the mechanisms of action of bioregulatory compounds, signaling processes, and the regulation of human gene expression—combined with advances in chemistry, synthetic biology, nanotechnology, and other technologies—have opened up new and exceedingly challenging frontiers of concern. Future advances that cannot now be described will continue to extend these frontiers.

Recommendation 2

The committee recommends adopting a broader perspective on the “threat spectrum.”


Recommendation 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.

Lists are inherently problematic. As explained in detail in Chapter 1, the spectrum of threats is much broader than the U.S. select agents list might suggest. As one example, the current select agents list does not include the uncounted numbers of biologically active molecules identified annually through industrial or federal government-sponsored (NIH Roadmap) drug discovery processes, many of which could be construed as potential threats. Nor does it include synthetic molecules or life forms, such as those that could be created using a variety of emerging techniques as described in Chapter 3, for example, through the application of reverse genetic engineering of RNA viruses, the use of purely synthetic biology, or DNA nanotechnology. Moreover, as described in Chapters 2 and 3 of this report, propelled by a variety of powerful economic and scientific drivers, biotechnology is developing, diversifying, and proliferating rapidly and globally, in largely unpredictable ways, with all its attendant, potential, dual-use applications. New capabilities, for either good or bad purposes, including the manipulation of gene expression in mammals through the use of RNA interference, have achieved prominence even within the life span of the present committee. Committee members were repeatedly reminded to “expect the unexpected.” Against this central reality, it is doubtful that any authority could enumerate a “select agents list” that is sufficiently comprehensive, robust, or of enduring relevance,

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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although most currently listed agents, such as smallpox, are likely to remain a potential menace even as new threats emerge.

The select agents list had its origins in the Antiterrorism and Effective Death Penalty Act of 1996, which required the secretary of HHS to establish and enforce safety procedures for the transfer of biological agents considered to be the greatest threats to human health—that is, “select agents”—including measures to ensure proper training and appropriate skills to handle such agents and proper laboratory facilities to contain and dispose of such agents. The PATRIOT and Bioterrorism Response Acts imposed additional physical security requirements and regulatory obligations for laboratories working with these select agents. The Bioterrorism Response Act made it a criminal offense for any person to possess knowingly any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purpose.41 In addition, the new laws prohibited transfer or possession of a listed biological agent or toxin by a “restricted person.”42 Among other requirements, the Bioterrorism Response Act added new criteria for consideration by the secretary in listing agents43 among other things, requiring that the secretary ensure the appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.

On February 7, 2003, the CDC’s interim final rule (42 CFR 73) for the possession, use, and transfer of select agents went into effect, changing the way that select agents and toxins are managed in the United States. Originally, the CDC was authorized to require laboratories transferring select agents to register, as a way to ensure the safe transfer and shipment of lethal pathogens and not with the intent to collect any specific information. In accordance with the PATRIOT and Bioterrorism Response Acts, the new regulations established additional requirements for those who may possess select agents as well as those who might send and receive those agents (e.g., the new regulations involved the U.S. Department of Justice in performing background checks on individuals who may have access to or conduct research on select agents). An expanded list of pathogens and toxins, including agricultural plant and animal pathogens, went into effect on February 11, 2003.44

The interim final rules were initially met with many protests by scientists and universities who argued that some of the rules were ambiguous, would be expensive to implement, did not offer significant protection to the public (because of the availability of some agents in nature), and could delay or impede research.45 With respect to the list of category A select agents covered under the interim final rule, the life sciences research community raised many concerns about the extent to which decisions to list particular pathogens, toxins, and nucleic acids had been reached on the

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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basis of the best scientific advice, as opposed to perceived or hypothetical risks. For example, several rickettsial agents have been employed by state-sponsored biological warfare programs in the past—they can be readily disseminated, are highly pathogenic, and may not be easily diagnosed by physicians in the United States today. While treatable, the number of infected persons could easily overwhelm antibiotic supplies. Moreover, these agents can be readily engineered today for antibiotic resistance. Thus, many rickettsial agents share these features and are not on the list. More importantly, the select agents list does not include many classes of future potential dual-use agents. In addition, there is considerable uncertainty about the risks that many of the currently listed items actually pose to public health and safety and whether those risks are great enough to warrant such restrictions. Smallpox and anthrax are obvious concerns, but are the filoviruses worthy of their position on the list given the dangers and difficulties inherent in working with them?

On March 18, 2005, the CDC issued the Final Rule for (42 CFR Part 73), Possession, Use, and Transfer of Select Agents and Toxins, which implements the provisions of the Bioterrorism Response Act and updates the interim final rule. Although some changes were made in response to submitted comments, the select agents list was not modified (although some language was clarified), as many scientists and scientific organizations had requested (e.g., the American Society for Microbiology46). Concerns remain also about the status of cDNA clones of select RNA viruses—the generation of infectious virus from such clones, when they represent the complete genome sequence, is becoming increasingly facile. Yet their status as select agents in the absence of overt infectivity remains poorly defined and represents a potential illogical loophole in the control regime.

The main concern with the select agents list remains the extent to which decisions to list particular pathogens, toxins, and nucleotide sequences are based on the best scientific evidence, with respect to their risk of being used for malevolent purposes or the danger they pose to public (or plant or animal) health should they fall into the wrong hands. A list may also provide an unwarranted sense of security because of what is not on it. Moreover, while any approach to meeting the diversity of biosecurity threats that society faces today will require prioritization in the application of resources, and this requires the development of a “list,” the intelligence and scientific communities must be careful not to let any established, agreed-upon list act to retard continued, intense surveillance of the technological horizon for newly emerging threats. In fact, multiple lists may be necessary for the disparate purposes of research prioritization, public health surveillance and response to outbreaks, development of practical countermeasures, and intelligence activities.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Recommendation 2b. Adopt a broadened awareness of threats beyond the classical “select agents” and other pathogenic organisms, to include, for example, approaches for disrupting host homeostatic systems and/or the creation of synthetic organisms.

The limitations of the current select agents list, and indeed any list, point to the need for a broadened awareness of the threat spectrum. Mechanisms must be put in place that ensure regular and deliberate reassessments of advances in science and technology and identification of those advances with the greatest potential for changing the nature of the threat spectrum. The process of identifying potential threats needs to be improved. This process needs to incorporate newer scientific methodologies that permit more rigorous assessment of net overall risks. Rather than adopting a static perspective, it will be important to identify and reassess continually the degree to which scientific advances or current or future biological “platforms” hold the potential for being put to use by potential adversaries. This will require engagement of the scientific community in new ways and an expansion of the science and technology expertise available to the intelligence community (as outlined in Recommendation 3).

In addition to the importance of relying on the best-available science and technology expertise for assessing the nature of the future threat spectrum and for integrating such expertise within and across the national security communities, there is an equally important need for providing the same kind of expertise to the public policy community and senior decision makers in the U.S. government. The structure and charge of the entity that might fill this role are beyond the purview of this committee; however, the committee recommends that further serious discussions be held to consider how the following goals might be accomplished:

  • Regular, independent peer review of policies, rules, and regulations that address future threats, including an independent review of the PATRIOT Act and other related statutes and regulations to ensure their relevance and effectiveness in enhancing biosecurity with respect to intelligence, law enforcement, and homeland security (see Recommendation 1b).

  • Establish measures of effectiveness for science and technology-based programs in the intelligence, homeland security, and law enforcement communities that address emerging and future biothreats and technologies.

  • Create and evolve a cross-agency strategy and implementation plan for scientific countermeasures and operational capabilities related to emerging and future biological threats and technologies—in essence, an integrated future-oriented national biodefense plan. This plan

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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should guide policy makers in their long-term investment planning for biodefense.

CONCLUSION 3: THE COMMITTEE RECOGNIZES THE IMPORTANCE OF A PROACTIVE, ANTICIPATORY PERSPECTIVE AND ACTION PLAN THAT RELIES ON AN EVALUATION OF STATE-OF-THE-ART SCIENCE, SO THAT FUTURE BIOLOGICAL THREATS CAN BE BETTER UNDERSTOOD, ADDRESSED, AND MINIMIZED.

A sound defense against the misuse of the life sciences and related technologies is one that anticipates future threats that result from misuse, one that seeks to understand the origins of these threats, and one that strives to prevent the misuse of science and technology before it happens. It would be tragic if society failed to consider, on a continuing basis, the nature of future biological threats, using the best-available scientific expertise, and did not make a serious effort to identify possible methods for averting such threats. Interdiction and prevention of malevolent acts are far more appealing than treatment and remediation. The committee, therefore, urges the adoption of a broader perspective in considering the threat spectrum (Recommendation 2). And the committee urges a proactive, anticipatory perspective and action plan for the national and international security communities.

These perspectives and plans must be based on a current working familiarity with the life sciences and related technologies, especially those that pose a clear and significant opportunity for misuse (Chapter 3), as well as an appreciation for the future trajectories of these sciences and technologies across the globe (Chapter 2). To meet these challenges effectively, the committee recognizes an urgent need to establish new processes, resources, and organizational structures that will enhance the breadth and level of sophistication of the scientific expertise residing in agencies concerned with national security.

Recommendation 3

The committee recommends strengthening and enhancing the scientific and technical expertise within and across the security communities.


Recommendation 3a. Create by statute an independent science and technology advisory group for the intelligence community.

The national security community and its assessments of future biological threats must be informed by the best-available scientific expertise.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Expertise can be acquired through outside collaboration as well as internal investments. With respect to the former, there have been several noteworthy efforts to build useful outside advisory groups for the life sciences, including the Defense Intelligence Agency’s (DIA) Bio-Chem 2020. However, as discussed in greater detail below, Bio-Chem 2020 and other existing advisory groups do not have the resources, expertise, administrative charge, independence, and statutory standing that are needed. The committee, therefore, recommends the creation of an independent advisory group that would work closely with the national security community for the purpose of anticipating future biological threats based on an analysis of the current and future science and technology landscape and current intelligence. In proposing the creation of this group, the committee supports Recommendation 13.1 of the Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction (March 31, 2005), which suggests the creation of an advisory group similar to the one recommended here.47

In making this recommendation the committee did consider other options, including, whether this responsibility could be tasked to an existing entity, such as DIA’s Bio-Chem 2020, or the recently created the NSABB. The committee concluded that the mandate, structure, and functions of the proposed advisory group are sufficiently distinct from those of existing entities as to warrant the creation of a new science and technology advisory group for the national security and intelligence communities. While either of these two existing advisory bodies could, in theory, be restructured and provided with a new charter that would accomplish the aims envisioned by the committee in this recommendation, in practice they would be so altered from their present structure and purpose as to render them, in essence, new entities. In addition, while the advisory group proposed here might make the functions of DIA’s Bio-Chem 2020 redundant and could possibly supplant this group, it cannot and should not replace the NSABB, which has a large and important charge distinct from that envisioned for the advisory group proposed in this section.

Red Team Bio-Chem 2020 was established by the DIA in 1998, as a group of government and nongovernment experts in the life sciences and related technologies whose mission was to lead and focus the defense intelligence community’s assessments of emerging technologies that nation-states or terrorists could use for biological or chemical warfare and to mitigate technological surprise from foreign biological warfare programs. It has met three to four times per year since then and serves as an ad hoc partnership between leading life scientists in academia, industry, government, and science and technology analysts from the intelligence community. It produces analyses on emerging technologies and innovative approaches to threats for use by the broader intelligence community. One of

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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the most important successes of this group has been the establishment of close, productive working relationships between outside scientists and science and technology analysts from within the intelligence community. While Bio-Chem 2020 encompasses some of the features that the committee finds most important for an external advisory group, the committee concludes that major restructuring would be necessary for it to take on the functions that are critical for all relevant stakeholders.

Bio-Chem 2020 operates under several limitations. First, its primary responsibility is to the DIA and the DOD. Even though other agencies participate in Bio-Chem 2020 meetings, the group is not formally charged with addressing the needs of the entire intelligence community.48 Second, it is not permanent; it exists at the behest of the director of the DIA. Third, the group of outside experts is small and therefore lacks expertise in some important areas. Fourth, it has operated at no higher than the secret classified level and has not engaged in analysis of primary sources and methods, or perform real-time, independent assessments of intelligence pertaining to potential threats in the life sciences arena.

The committee also considered whether the NSABB was an appropriate body for implementing this new advisory function. However, upon further analysis, there were at least two fundamental reasons why the committee concluded that the NSABB could not, and should not, attempt to address this critical unmet need.

In making its recommendation for the creation of the NSABB the Fink committee envisioned that this new advisory body would “provide advice to the government and guidance and leadership for the system of review of life sciences research …” The Fink committee encouraged the HHS to model the NSABB after the Advisory Committee on Immunization Practices (ACIP)—an independent advisory body to the federal government.49

In implementing this recommendation, however, the Director of the National Institutes of Health created the NSABB as a federal advisory committee under the Federal Advisory Committee Act.50 As such, the NSABB has no independent budget or staffing authority, serves at the direction of the federal department or agency that created it, and can be “retired” at any time.51 These structural features prevent the NSABB from establishing the kinds of long-term working relationships and providing the kinds of functions to the necessary stakeholders that would address the crucial needs of the national security and intelligence communities, as described in more detail below.

In addition, the NSABB’s charter defines a relatively narrow charge that does not include the type of advisory and ongoing analytical and evaluative functions that this committee envisions the advisory group ful-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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filling for the national security and intelligence communities, as proposed in this section:

The NSABB will advise the Secretary of the Department of Health and Human Services (HHS), the Director of the National Institutes of Health (NIH), and the heads of all federal departments and agencies that conduct or support life science research. The NSABB will advise on and recommend specific strategies for the efficient and effective oversight of federally conducted or supported dual-use biological research, taking into consideration both national security concerns and the needs of the research community.52

Addressing these current responsibilities has and will continue to consume all of this board’s resources for the foreseeable future. As has been pointed out, “its role resembles that of the Recombinant DNA Advisory Committee that was established [by law] within the NIH in 1974, and that played an important part in setting guidelines and reviewing research protocols.”53 Restructuring the NSABB would make little sense given that the board’s current membership has been selected by the secretary with the current charge in mind.

The advisory group proposed by the committee in this section would be tasked with forecasting the applications and implications of technological developments in the life sciences; providing expert analysis of relevant collection information; providing guidance on intelligence targeting and collection requirements; and providing an independent, outside “reality check” on technical assessments in the life sciences. Not only are these needed functions outside the charge and purview of the NSABB, but to provide them an advisory board will need a membership with expertise and background complementary to but distinct from those of the NSABB.

The committee elaborates further below on the nature and functions of such an advisory body for the national security and intelligence communities.

  • This advisory group should operate under the auspices of the national security community leadership and provide direct input at the highest levels of this community. The recommendation of the Weapons of Mass Destruction (WMD) Commission that such a group report to the Director of National Intelligence should be given serious consideration, as this would increase the likelihood that the group serves the entire intelligence community. The advisory group should also have an independent source of funding and a dedicated staff. These latter features will help strengthen its independence and stability, insulate it from short-term budgetary pressures, and enhance the dedication of its members to the demands of membership.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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  • To provide objective technical assessments, the advisory group should be made independent of any specific agency. The functions of this group should be codified in law, and include self-initiated as well as externally requested analyses of science and technology with special relevance to future potential threats, independent technical review of national security intelligence assessments in the life sciences, and real-time assessments of relevant raw intelligence when deemed to be of special current importance. This group might review and enhance intelligence targeting and collection in the life sciences. It would provide an outside “reality check” on technical assessments in the life sciences. The larger set of members might constitute a network of available experts to whom national security officials and policymakers might turn for technical advice on matters of timely and special importance.

  • It should be composed of leading experts from academia, industry, and government in a wide spectrum of disciplines relevant to the life sciences and related technologies. The government members should represent the broad national security community, and include those scientists most familiar with the “state of the art” in these disciplines. Membership should take into account possible future threats to livestock and agriculture, as well as threats to physical or information technology infrastructure, when related to the life sciences and associated technologies.

  • The size of the group should be sufficient to represent all important areas of the life sciences and related technology in some depth and yet small enough to allow close working relationships and trust to develop among members of the group. Because these two needs may conflict, the advisory group should consist of a small core of elite experts who are broadly versed in cutting-edge developments with applications to the life sciences enterprise and who meet on a regular basis, much like BioChem 2020, as well as a larger set of members that provide greater indepth expertise for a more complete set of disciplines and who meet less frequently or on an as-needed basis.

  • The advisory group should publish both open and classified reports on current, emerging, and future biological threats. The output of the group should be shared widely with the intelligence, national security, and policy communities and to the maximum degree possible the general scientific and public health communities and, in particular, with the NSABB. The output should inform national decision makers in the relevant areas of science and technology developments and policy options.

  • It is critical that members of this Advisory group develop relationships of trust and familiarity among themselves. Preexisting differences in culture between the national security community and the outside science community pose barriers that must be overcome. Frequent and

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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regular meetings among a group with reasonably stable membership would help in this regard. The advisory group should be given access to any and all classified intelligence that is directly relevant to their tasks.

Recommendation 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 national political leaders about advancing technologies and their potential impact on the development and use of future biological weapons.

Given the broad and constantly changing nature of future potential biological threats, as highlighted in Conclusion 2 and as illustrated throughout this report, the committee believes there is an urgent need to create an agile, anticipatory system to recognize and, rapidly and effectively, respond to emerging threats. If the national security and public policy communities are to fulfill this mission, they must be well-informed about scientific and technological advances in a variety of disciplines relevant to the life sciences. This committee recognizes several as yet unsolved and ongoing challenges for the national security community in this area and takes note of the expert judgments of recent national investigatory bodies54 as background for its recommendations here. The power of this science and technology is increasingly wielded by individuals. Understanding the intent of a would-be malfeasant, a “holy grail” of the intelligence community, becomes ever more necessary. The committee fully recognizes that the challenges associated with the collection of useful and actionable intelligence on the potential malevolent use of biological agents are substantial. These challenges will only grow, as the life sciences and their associated enabling technologies evolve, expand, and disseminate at a dizzying rate. However, as one senior intelligence analyst working on biological threats has said, “We have no choice, but to try as hard as we can.”

There are several existing problems in the national security community and national political leadership related to the task of anticipating future biological threats. First, these groups have not developed the kinds of working relationships with the “outside” (nongovernmental) science and technology communities that are needed (and feasible). Second, “inside” groups (national security community and national political leadership) have been unable to establish and maintain the breadth, depth, and currency of knowledge and subject matter expertise in the biological sciences and related technologies that are needed. The number of analysts in the national security community who have professional training in the life sciences and technologies is small and insufficient; these analysts often lose touch with the cutting-edge of science and technology over time

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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and tend to be moved from position to position, preventing them from developing any particular depth of expertise and experience. Some of the same problems are also true of intelligence collection and the collectors. And to the degree that the right kinds of expertise do exist within the intelligence community, this expertise is unevenly distributed. Moreover, intelligence assessments are not always shared among the different member agencies of the national security community. Finally, historical, political, and cultural barriers have prevented the national security community from working closely with counterparts from other nations and regions of the world. Yet the life sciences and related technologies are distributed around the globe in a seamless fashion, and future threats that arise from this science and technology will be distributed globally as well. This committee addresses each of these three problem areas with the preceeding subrecommendation, and the following two subrecommendations.

Recommendation 3c. Build and support a robust and sustained cutting-edge analytical capability for the life sciences and related technologies within the national security community.

Analytical capability is a function of both the quality and quantity of the relevant resources. The committee views people as the most important resource for the national security community in building an internal expertise in the life sciences and related technologies. Thus, it is suggested that the national security community be provided the means to hire and sustain significant additional personnel with current expertise in the scientific disciplines discussed in Chapter 3. Open-source intelligence and human intelligence are the most useful kinds of data today for identifying and anticipating future threats from the life sciences and related technologies. Collection and analysis of both kinds of data will require intimate familiarity with the scientific and technology workplace. Researchers with state-of-the-art, hands-on experience in relevant areas of science and technology should be recruited at the completion of their doctoral or postdoctoral training. Retaining these individuals and sustaining their capabilities and currency are not easy tasks. They will need to maintain close contact with the outside scientific world, for example, through attendance at scientific meetings, courses, workshops, and perhaps sabbaticals “at the bench.” Their employers should refrain from frequent reassignment of these valuable experts to unrelated jobs and responsibilities.

Scientific expertise must inform intelligence collection in a meaningful manner. In much the way that foreign-language expertise can be critical for some areas of intelligence assessment, working familiarity with the language of modern molecular biology (and other scientific dialects) will be essential for both analyst and collector in assessing potential future biological threats. It goes without saying that if relevant information is

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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not recognized as such, it cannot be collected for analysis. Conversely, an inadequate understanding of today’s life sciences can lead to the collection of massive quantities of irrelevant information, resulting in degradation of overall analytical capabilities.

Recommendation 3d. To the maximum extent possible, encourage the sharing and coordination of future biological threat analysis between the domestic national security community and its international counterparts.

As described in Chapter 2 of this report, the future of the life sciences and related technologies reaches all corners of the globe, and the implications of future trajectories in these areas pose potential problems and opportunities for all of us. Not only do potential threats cross national boundaries, but so do potential solutions. The power of international collaborations in addressing future biological threats cannot be underestimated. For these reasons the committee recommends that the analysis and assessments of potential biological threats be shared across international boundaries wherever and whenever possible.

While general concerns about the sensitivity of sources and methods will lead to caution and a reluctance to share data, the open nature of the life sciences enterprise and the important role of open-source material in the assessment of potential threats suggest that sharing of intelligence assessments by the national security community with international counterparts may be more feasible than might have been assumed as well as desirable. In addition, the sharing of biological threat assessments becomes increasingly practical when adopting a later time frame further into the future.

CONCLUSION 4: THERE IS A CRITICAL NEED TO ADVANCE A GLOBAL PERSPECTIVE IN ADDRESSING THE INAPPROPRIATE USE OF EMERGING TECHNOLOGIES IN THE LIFE SCIENCES.

The committee appreciates that the threat posed by the potential dual-use applications of advancing technologies is a global problem, one that can be mitigated successfully only by actions taken in a global context. A purely national policy, executed in the absence of engagement with and participation of the global community, is unlikely to have a significant impact on reducing these dangers. This is made abundantly evident by the global dispersion of advanced technologies in the life sciences, as described in Chapter 2. Recent years have witnessed the rapid growth of biotechnology-related research and commercialization efforts in countries of the Asian-Pacific rim, Latin America, and elsewhere. U.S. preeminence in the life sciences is not only being challenged by other nations but may

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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soon be lost. In October 2005 a National Academies panel delivered a dire warning to Congress: Give science an extra $10 billion annually or watch jobs and national status disappear to Asia. Many people may agree with the message, but details of the panel’s ambitious prescriptions are already drawing criticism.55

The committee therefore sought to develop an international perspective in formulating its recommendations and recognizes an urgent need to engage the global community further in addressing these issues.

Recommendation 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.

Even while considering steps that can and must be taken to strengthen biodefense efforts at the national level, a proactive strategy against next-generation threats will require collective and concerted global action. This four-part recommendation outlines actions that could enhance the global capacity to mitigate the biosecurity risks associated with advanced technologies.

Recommendation 4a. Recognize the value of formal international treaties and conventions, including the 1972 Biological and Toxin Weapons Convention and the 1993 Chemical Weapons Convention.

The biological weapons control regime of the 20th century dates back at least to the 1925 Geneva Protocol, which entered into force in 1928.56 The protocol, which was supported by one of the most outspoken and ferocious public appeals that the International Committee of the Red Cross has ever made, was drafted in response to the horrific consequences of the extensive use of poison gas in World War I. It prohibits the wartime use of “asphyxiating, poisonous, or other gases, and of all analogous liquids, materials, or devices” and of “bacteriological methods of warfare.” The most important international step taken to strengthen the biological weapons regime occurred decades later, with the 1972 Biological and Toxin Weapons Convention (BWC), which entered into force in 1975. The BWC prohibits the development, production, stockpiling, or acquisition of biological agents or toxins of any type or quantity that do not have protective, medical, or other peaceful purposes or any weapons or means of delivery for such agents or toxins.57 According to the treaty, all such materials had to be destroyed within nine months of its entry into force. As of December 2004, there were 169 signatories, including 153 ratifying and acceding countries.58

Despite its relatively long history, beginning with the Geneva Proto-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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col, the biological weapons control regime and the BWC in particular have been fraught with challenges, not the least of which is the lack of a treaty compliance verification protocol.59 Many of these challenges are related to the unique characteristics of biological weapons, as discussed in Chapter 1 (i.e., unique in comparison to nuclear, chemical, and other weapons of mass destruction).

The chemical weapons control regime, also rooted in the 1925 Geneva Protocol, has been strengthened by the 1993 Chemical Weapons Convention (CWC), which entered into force in April 1997.60 It is the only multilateral treaty that seeks to eliminate an entire category of weapons of mass destruction within an established time frame (by 2012) and to verify destruction through inspections and monitoring by the Organization for the Prohibition of Chemical Weapons (OPCW). Moreover, the CWC verification regime extends to dual-use industrial facilities judged especially vulnerable to abuse for proliferation purposes. Although the CWC has helped reduce chemical weapons risks, member states are experiencing delays in meeting CWC requirements. For example, neither Russia nor the United States is expected to have completed destruction of their stockpiles until after 2012.61 Also, only a minority of member states have adopted national legislation to criminalize CWC-prohibited activities, and many have not yet put in place, as the CWC requires, the measures necessary to ensure that toxic chemicals and their precursors are used only for nonprohibited purposes. Moreover, although the OPCW, as of September 2005, had conducted 2,195 inspections in 72 member states over the eight-plus years since the CWC went into force, the organization does not have enough resources to conduct all the inspections that many consider necessary.

Despite the difficulties of implementing the BWC and CWC properly, the two conventions serve as the cornerstones of the global biological-chemical control regime, which has expanded to include rules and procedures rooted in measures ancillary to the two treaties (such as the Australia Group62 and United Nations Security Council Resolution 154063). The biological-chemical regime as it currently exists—including the BWC, CWC, Australia Group, SCR 154064, and other measures—must be recognized for its positive contributions and placed within the overall array of measures taken to prevent biological warfare.

In particular, the committee concluded that the BWC and CWC embody and codify international norms of behavior that should govern all policies, actions, and strategies implemented both nationally and internationally. The biological-chemical regime encompasses more than law: It is based on long-standing taboos stemming from public abhorrence to poison and the deliberate spread of disease. The original BWC and CWC negotiators largely defined the scope of their treaties not in terms of lists

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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of agents or devices that could quickly become outmoded by technological change but in terms of a general-purpose criterion whereby all biological or chemical agents became subject to the constraints of the regime unless they were intended for nonprohibited purposes. Where specific lists were deemed useful, however, they are incorporated into these regimes, as evidenced by the three schedules of materials that are subject to verification within the CWC. Such lists do not, of course, limit the scope of the prohibitions set out in the two treaties, which remains set by the general purpose criterion. It is this device that enables the biological-chemical regime in principle to control dual-use technologies and to keep up with scientific advance.

Such international conventions should not be considered the solution to the issues society confronts today with respect to potential harmful use of advances in the life sciences, nor should they be cast aside and ignored. Despite their limitations, the committee appreciates their value in articulating international norms of behavior and conduct and suggests that these conventions serve as a basis for future international discussions and collaborative efforts to address and respond to the proliferation of biological threats. Important opportunities will arise when states parties conduct their next quinquennial reviews of the operation of the BWC (in 2006) and the CWC (in 2008).

The present report has several times noted that technologies are bringing chemistry and biology closer together. That toxins and synthetic biological agents, including bioregulators, immunoregulators, and small interfering RNAs, fall within the scope of both treaties is one such linkable feature. These two review conferences will as always be dominated by political considerations, but in view of the profound developments now under way in the life sciences, the committee draws attention to the possibilities held out by the 2008 conference for building on the parallel or linkable features of the BWC and the CWC.

Recommendation 4b. Develop explicit national and international codes of conduct and ethics for life scientists.

The committee reviewed the potential for codes of conduct or codes of ethics to mitigate the risk that advances in the life sciences might be applied to the development or dissemination of biological weapons. Codes for professional behavior date back at least two millennia to the Hippocratic Oath, which provided guidance for the conduct of physicians in ancient Greece. A code of conduct (also known as an educational or advisory code) provides relatively specific guidelines with respect to what is considered appropriate behavior.65 A code of conduct developed for the life sciences could thus assist those working in the field to become sensitive to specific actions in the course of their work or that are carried

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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out by their colleagues. In the absence of a code, such actions might otherwise go unnoticed. In contrast, rather than suggesting how to behave specifically, a code of ethics (also known as an aspirational code), lays forth the ideals to which practitioners should aspire, such as standards of objectivity or honesty. In the case of the life sciences, such a code might call for biologists to consider the ethical implications of their work or to discourage generally the use of biology for malevolent purposes. Clearly, many codes, including the Hippocratic Oath, may address elements of both conduct and ethics.

In considering such codes, the committee concluded that their primary effect would be to create an enabling environment that would facilitate the recognition of potentially malevolent behavior (i.e., experiments aimed at purposefully developing potential weapons of biological origin) or potentially inappropriate experiments that might unwittingly promote the creation of a more dangerous infectious agent. The committee also recognized that such codes could generally be expected to achieve their desired effect only when reinforced by a substantial educational effort and appropriate role modeling on the part of scientific leaders.

In addition to “codes of conduct” and “codes of ethics,” there are “codes of practice,” also known as enforceable codes. Regulations controlling research with the select agents derived from the PATRIOT Act and other national legislation, including that enacted in response to the BWC as discussed above, may be considered examples of an enforceable code. The desired effects of such codes are to a considerable extent dependent on the ability of enforcing agencies to detect proscribed behavior and the nature of the consequences imposed on the offending individual. In making this recommendation, the committee focuses on the potential utility of “codes of conduct” and “codes of ethics” that may arise primarily from within the life sciences professions, rather than enforceable codes that may arise from legislative or regulatory bodies that are largely outside the life sciences in an attempt to regulate them.

Today, a wide variety of professional organizations, research institutions, and scientific societies active in the life sciences have adopted codes to guide the conduct of their members, and many other societies and institutions are considering what such codes should comprise. Of relevance to research aimed at developing offensive biological weapons, the aspirational 2000 American Society of Microbiology (ASM) Code of Ethics states that “ASM members aspire to use their knowledge and skills for the advancement of human welfare.”66 In 2002, the ASM reaffirmed that bioterrorism and “the use of microbes as biological weapons” violated its code of ethics.67 The code of ethics of the Australian Society of Microbiology is somewhat more direct: “The Society requires each member … not to engage knowingly in research for the production, or promotion of bio-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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logical warfare agents.”68,69 The fact that the Australian Society affirmatively “requires” something of its members indicates that it is an “enforceable code,” and in fact, members who are found to have violated this or any component of the society’s code are subject to expulsion from the Society. The BIOTECanada Statement of Ethical Principles states unequivocally that the organization, “oppose[s] the use of biotechnology to develop weapons.”70 Similarly, the EuropaBio Core Ethical Values document states: “We oppose the use of biotechnology to make any weapons and will not develop or produce biological weapons.”71

Recently, several international forums have made efforts to construct globally applicable sets of principles guiding the development of specific codes of conduct related to potential dual-use research in the life sciences.72 For example, in November 2002, at the conclusion of their intersessional meeting of the Fifth Review Conference, States Parties to the Biological and Toxin Weapons Convention agreed that the topic for the 2005 intersessional meetings would be “the content, promulgation, and adoption of codes of conduct for scientists.”73 Also in 2002, the United Nations General Assembly and Security Council endorsed a report by the Policy Work Group on the United Nations and Terrorism recommending the establishment of codes of conduct for scientists related to weapons technologies.74 The International Centre for Genetic Engineering and Biotechnology is in the process of developing a draft code of conduct, and the International Institute for Strategic Studies/Chemical and Biological Arms Control Institute (CBACI) have already drafted a relevant charter.75 The International Committee of the Red Cross (ICRC) also has been considering the establishment of a “principles of practice” code that could serve as the life sciences equivalent to the Hippocratic Oath.76

However, despite the presumption that ethical codes foster ethical conduct, little is known about the effectiveness of these codes in practice.77 People may not comply with codes or even consult them.78,79,80 Nor will codes of ethics likely deter anyone who is firmly committed to applying biotechnology for malevolent purposes, such as a disgruntled scientist with a deep-seated animosity and intent to “get even” or a dedicated member of a terrorist group. Nonetheless, codes may be useful in raising awareness, fostering norms, and establishing public accountability.81,82,83,84 A code may sensitize researchers who might be unknowingly or unwittingly used by such individuals to aid and abet their plans by supplying knowledge or materials and may therefore make it less likely that such aiding and abetting will occur. Moreover, codes may create a climate in which voluntary reporting of suspicious activities on the part of colleagues is more likely to occur and hence change the risk calculus of potential offenders.

It seems clear that a widely promulgated code of conduct could raise

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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the awareness of scientists concerning the risks posed by certain types of experiments, much as the list of the seven types of “experiments of concern” contained in the Fink report have heightened awareness and prompted debate among scientists engaged in microbiological research. A widely accepted code of ethics or conduct would appear to be an integral component of any plan to promote the development of a culture of awareness and responsibility. Of note, HHS Secretary Leavitt has recently charged the NSABB to develop such a code for scientists working in the United States.85 However, as suggested above, a national code will have little effect on the global behavior of life scientists. While there is thus a need to promote the development of such codes globally, it is unlikely that any single code will be uniformly acceptable, especially if it contains the relatively specific features of a “code of conduct”. Thus, the efforts of the international bodies referred to above may be particularly useful in creating sets of principles as guides to the development of such codes.

The risk with any code or policy is that it will sit on the shelf gathering dust. To prevent this, it needs to become part of the lived culture of a social group. The first step to establishing this culture will be to develop educational programs for scientists. Indeed, education may ultimately be more valuable than a formal code of conduct, particularly if it encompasses not just ethical but also legal norms with regard to dual-use agents, information, and technologies.86 Many scientists today are unaware of the BWC, and the laws and regulations that have been enacted in the United States and elsewhere for the control of biological materials and personnel.87 It would be relatively straightforward to incorporate the concept that a large proportion of current research in the life sciences has dual-use potential into the formal training in research ethics that the NIH mandates for postdoctoral trainees, for example. Efforts to expand awareness concerning the risks of potential dual-use research and technologies could also be integrated into continuing education courses, licensure courses, or other regular sets of activities in which experts engage as a way to update their credentials or resumes.

However, all the education in the world will not be as important as the role modeling provided by respected figures in the scientific community, both locally, nationally, and internationally. This “informal curriculum” probably drives what students learn and emulate more powerfully than the formal curriculum. Identifying, celebrating, and rewarding senior scientists who through word and deed serve as role models in preventing the malicious application of advances in biotechnology is perhaps the most important element in creating an environment that enables ethical and appropriate behavior. To the extent that such role modeling extends to the training of foreign nationals in the United States, it may also help establish a global culture of awareness and responsibility when

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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such trainees return to their countries of origin to continue their professional careers. Foreign trainees will also be exposed to explicit codes of ethics and/or conduct adopted within the United States, further reinforcing Recommendation 1c that encourages foreign scientific exchanges and the training of foreign nationals in the life sciences here in the United States.

Recommendation 4c. Support programs promoting beneficial uses of technology in developing countries.

As highlighted in Chapter 1, advancing technologies possess a “dark side”—their potential to be used with the intent to cause harm. While this is the focus of much of this report, the “bright side” of advancing technologies holds great promise for health and economic development, especially for people in developing countries. Significantly, there is evidence that developing countries themselves—especially the “innovating developing countries” such as India, China, Brazil, and South Africa—are harnessing biotechnology and other emerging technologies to meet their local health needs. Biotechnology, nanotechnology, and other emerging technologies have the potential to improve human security by addressing threats to human security such as disease and hunger.88 Moreover, continued progress in this sector, with structural reforms in the science, technology, and innovation systems of developing countries, will be crucial to meeting the UN Millennium Development Goals.89

However, this biodevelopment agenda is on a potential collision course with the biosecurity agenda. This is exemplified by the restrictions on U.S. visas for foreign scientists described in Chapter 2 and in the requirement that NIH grantees directing research on emerging infections in a developing country comply with American laws and regulations concerning select agents at their overseas study sites. Many developing nations face urgent public health crises, including outbreaks of emerging infectious diseases, on a daily basis. There are legitimate questions about whether and how such countries should respond to the risk of biological terrorism. Few of these countries are likely to perceive themselves as being at risk or that the risk is significant against the backdrop of the natural infectious disease threats they face daily. Some analysts warn that, in some cases, biodefense policies designed to prevent or mitigate the risk of a bioterrorist attack could create hardships and even be counterproductive—for example, by pressuring countries burdened with other problems to satisfy regulatory and other biodefense-related demands.90 Requirements to establish a regulatory authority and to promulgate intricate safety and protection measures with respect to select agent pathogens could divert already scarce resources from less formal but more immedi-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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ately effective operational systems in place for treating sick or vulnerable populations.91

Biosecurity should not, and need not, come at the expense of lost potential for promoting health and economic development in developing nations through biotechnology. Efforts to promote the development of peaceful uses of biotechnology in poorer countries can enhance biosecurity by strengthening international relationships. These relationships provide opportunities for building a common culture of awareness and responsibility. As we defend against the dark side of the life sciences, the bright side should continue to shine—not only because the lives of millions in the developing world may depend on it, but also because it is likely to promote a common global approach to the dual-use conundrum.

Recommendation 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.

Under this recommendation, the committee envisions the establishment of a decentralized, globally distributed network of informed, concerned scientists who have the capacity to recognize when knowledge or technology is being used inappropriately or with the intent to cause harm. This network of scientists and the tools that they use would be adaptive in the sense that the capacity for surveillance and intervention must evolve along with advances in technology. Such intervention could take the form of informal counseling of the offending scientist when the use of these tools appears unwittingly inappropriate or reporting such activity to national authorities when it appears potentially malevolent in intent.

The rapid pace of growth in the life sciences and its associated technologies—as described in Chapters 1 and 3—can lead to the unexpected emergence of new techniques and entirely new disciplines (e.g., RNA interference) in a very short period of time. Scientists working in the life sciences are best suited to recognize the dual-use implications of these newly emerging technologies and fields of knowledge, but they must develop a broadly distributed culture of awareness and responsibility if they are to recognize and shed light on potentially dangerous activities as they occur.

Because of the key features of this proposed “bottom-up” culture of awareness and responsibility—its globally distributed and decentralized adaptability—the committee likened it to the mammalian immune system, arguably the most spectacular example of a spatially distributed, decentralized, adaptive system. The hallmark of the mammalian immune system is its ability to respond to transgressions by microorganisms in ways that limit the growth of the transgressor and afford protection

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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against its detrimental consequences. The responses of the immune system include both specific (adaptive immune system) and nonspecific (innate immune system) components. These are intricately linked but react in different ways to structures (antigens) that are foreign to the host. The innate immune system includes components that are present and pre-programmed for action even before an antigen challenge is encountered. The adaptive immune system, on the other hand, involves components that react to an antigen challenge with a high degree of specificity but only after some delay.92 Through a complex network of local mechanisms involving both the innate and the adaptive immune systems, the essential global functions of immune surveillance, recognition, response, learning, and memory are constantly adapting to new microbial threats without central direction. Perhaps the global scientific community could fruitfully mimic this system.

The analogy between the global scientific community and the mammalian immune system is intended to be merely illustrative, not strict. The concept proceeds from two salient facts. First, as argued throughout the previous chapters of this report and under Recommendation 2, life science technologies with potential for dual use are developing and diversifying very rapidly. Any controlling mechanisms must therefore be dynamic and adaptive to the rapid pace of technological change. Second, as argued throughout Chapter 2 and above, the global decentralized nature of the problem demands that strategies for anticipating, identifying, and mitigating potential future threats must necessarily have global reach. Despite the existence of international conventions and related national legislation, no “top-down” solution presents itself at the moment with respect to the global regulation of dual-use agents and knowledge.

Given that unanticipated threats are virtually certain to emerge, decentralized and adaptive solutions, while potentially limited in effectiveness, are nonetheless of substantial interest. Their usefulness may be limited to their ability to engender public opprobrium, but active steps to promote the development of distributed, decentralized networks of scientists will at the least heighten awareness while potentially enhancing surveillance. These networks might be linked through a system analogous to the Program for Monitoring Emerging Diseases, which hosts the ProMED-mail Web site (see Box 4-3).93 ProMED-mail was established in 1994 with the support of the Federation of American Scientists and SatelLife. Since October 1999, it has operated as an official program of the International Society for Infectious Diseases, a non-profit professional organization with 20,000 members worldwide. The ProMED-mail Web site has become an extremely useful locus for the posting of reports of infectious disease outbreaks by any concerned infectious disease specialist or expert, or lay person, including press reports, from around the globe. Such reports, while

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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BOX 4-3
ProMED-mail

ProMED-mail—the Program for Monitoring Emerging Diseases—a spinoff of the nonprofit Program for Monitoring Emerging Diseases, and now a project of the International Society for Infectious Diseases—is an Internet-based reporting system dedicated to rapid global dissemination of information on outbreaks of infectious diseases and acute exposures to toxins that affect human health, including those in animals and in plants grown for food or animal feed. Electronic communications enable ProMED-mail to provide up-to-date and reliable news about threats to human, animal, and food plant health around the world, seven days a week.

Among the outbreaks first reported on ProMED-mail were the early reports of SARS in both China and Toronto in 2003; Venezuelan equine encephalitis in Venezuela in 1995; H5N1 influenza in Indonesia November 2003; and the 2005 outbreak of human disease in China attributed to Streptococcus suis.

By providing early warning of outbreaks of emerging and reemerging diseases, public health precautions at all levels can be taken in a timely manner to prevent epidemic transmission and to save lives.

ProMED-mail is open to all sources and is free of political constraints. Sources of information include media reports, official reports, online summaries, local observers, and others. Reports are often contributed by ProMED-mail subscribers. A team of expert human, plant, and animal disease moderators screen, review, and investigate reports before posting to the network. Reports are distributed by e-mail to direct subscribers and posted immediately on the ProMED-mail Web site. ProMED-mail currently reaches over 30,000 subscribers in at least 150 countries.

A central purpose of ProMED-mail is to promote communication among the international infectious diseases community, including scientists, physicians, veterinarians, plant pathologists, epidemiologists, public health professionals, and others interested in infectious diseases on a global scale. ProMED-mail encourages subscribers to participate in discussions on infectious disease concerns, to respond to requests for information, and to collaborate in outbreak investigations and prevention efforts. ProMED-mail also welcomes the participation of interested persons outside the health and biomedical professions.

often uncertain in their accuracy or significance early on, prompt the attention of recognized infectious disease experts who moderate and help facilitate an international Web-based dialogue, including comments on what is and is not known about the suspect disease. Although supported by a specific organization operating a centralized Web site, the reporting

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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system represented by ProMED-mail is essentially decentralized, distributed, and adaptive. It has no direct investigative or public health authority, but it serves as an early warning system, capable of earlier recognition of disease outbreaks than established institutional systems of public health surveillance and free of the potential political constraints on reporting infectious diseases that may be felt by national epidemiological and public health reporting systems.

A useful parallel to ProMED-mail would seem possible in the creation of a similarly distributed system for reporting potential inappropriate applications of emerging life sciences research and technologies. Candidate activities for reporting might include, for example, (1) experiments leading to the insertion of certain genes (e.g., interleukin-4) into known pathogens (e.g., orthopox viruses) for no identifiable therapeutic or scientific reason; (2) directed evolution (breeding) of novel pathogens for no identifiable therapeutic or scientific reason; or (3) the acquisition of supplies, equipment, or biological reagents by groups or individuals in the absence of any identifiable appropriate scientific aim.

Unanticipated results that generate a new and substantial dual-use threat need not be considered indicative of malevolent intent by the individuals involved in such a distributed reporting system. It is possible, indeed likely, that novel pathogens or other dual-use technologies of security concern will emerge through sheer serendipity in the course of legitimate research—that is, research undertaken and funded explicitly for identifiable therapeutic or bone fide scientific purposes; neither incompetence, idle curiosity, nor intentional malevolence need be involved. The research may actually be consistent with what had been initially proposed, peer reviewed, and funded by government or not-for-profit agencies. For example, the introduction of interleukin-4 into ectromelia virus, an experiment that was supported by the Australian government, aimed to improve vaccine responses but achieved quite different and unexpected results.94 Nonetheless, a reporting system similar to ProMED-mail can call attention to the hazards of such experiments, and thereby sensitize the scientific community to their potential implications.

Unlike ProMED-mail, however, where the adversary is Mother Nature (often abetted by human activities impacting on the environment for infectious disease transmission), it is possible that the posting of certain information concerning dual-use applications of life sciences technology on a public Web site could have unintended negative consequences, perhaps informing those with purposeful malevolent intent. Such postings would thus need to be screened by a group of informed and concerned moderators, as they are today for ProMED-mail. However, the main intent of such a distributed reporting system would be to promote the free flow of information in real time, with the view, as expressed in Recom-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

mendation 1, that the open and free exchange of information may be one of the most important means of ensuring that risks are considered, appropriate countermeasures are developed, and possible consequences are mitigated in a timely fashion.

In the event that it is a colleague or superior who is engaged in the questionable activity, a scientist may need a way to report the suspect activity anonymously (so that fears of reprisal do not deter reporting). One possibility is that a Web site could be maintained by the science community (like Linux95). Even with the most secure technology, however, in any country where penalties may be grave, there will still be deterrence against reporting questionable activities if there is any perception that it might lead to the identification of the reporting person. Efforts would also need to be taken to ensure that inappropriate allegations are not made against scientists in situations where the reporter may be trying to right a perceived wrong or to “get even” with an individual with whom they have a personal or professional dispute. The committee acknowledges these issues yet believes that an open global forum of the type envisioned may be able to overcome some of these problems by shining the light of public attention on them and that such a forum will prove useful despite such obvious limitations.

The committee was under no illusions that interventions and responses by the global scientific community that do not involve responses by law enforcement agencies—for example, the threat of professional ostracism and/or academic sanction—would deter potential terrorists or determined state actors. Presumably, few terrorists worry about their stature in the scientific community or tenure at an institution. The distributed reporting and response network described above would be directed primarily at the embedded community of legitimate scientists, its aggregate aim being to stimulate creativity in anticipating activity that could be malicious and to stimulate vigilance in detecting and reporting such activity. The collective experience of the entire scientific community would be accumulated into one online memory, available to participants in the network.

The existence of such a network could profoundly alter the risk calculus for potential offenders. That is, they would know that the embedding community is alert to anomalous behavior; and, when appropriate, can alert enforcement agencies that are capable of formal investigation, at least in those countries that have enacted appropriate national legislation. Indeed, it is probable that security agencies in multiple countries would monitor this reporting network, for both good and possibly also inappropriate reasons. Again, the aim is to self-organize a body of norms and a climate of vigilance across the global community of legitimate scientists in order to change the risk calculus of potential offenders.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

Admittedly, there is a thin line between vigilance and vigilantism. The former is the state of being watchful (i.e., without necessarily acting), whereas the latter refers to a reactive behavior. The presence of vigilantism could be as devastating as the absence of vigilance. Frivolous charges will need to be deterred and censured as surely as legitimate ones need to be followed up. In the social sciences, this involves the notion of a metanorm.96 Metanorms already exist in the scientific community. For example, it is a central meta-norm of researchers to report falsification of data or abuse of human subjects, and it is seen as a violation of the meta-norm to not do so, given knowledge. Frivolous witch hunts and overreporting are considered violations as well. The search for a balanced strategy between under- and overreporting may take time and effort, but is probably worth the investment.

Other methodologies, in addition to these Internet-based approaches, may contribute to the development of a globally dispersed sense of awareness and responsibility on the part of legitimate scientists. Social norms, conventions, and institutions of many sorts emerge without central direction and are maintained by local conformity effects.97 Educational efforts, scientific exchanges, international conventions, and codes of conduct and ethics—in effect, all of the measures suggested above—can contribute to the development of such norms for the global life sciences community over time. Once in effect, social scientists would view these norms as stable equilibria—social configurations from which no individual has any incentive to depart. Recognizing departures from the scientific norm will require subtle discrimination. Yet humans are capable of developing a very finely tuned sense of those behaviors that fall within a social norm and those that do not.

CONCLUSION 5: REGARDLESS OF THE STEPS TAKEN TO PREVENT SUCH EVENTS, THE COMMITTEE CONCLUDES THAT THERE IS A NEED TO RECOGNIZE THE VIRTUAL INEVITABILITY OF THE MALEVOLENT APPLICATION OF NEW TECHNOLOGIES AND AN OVERARCHING NEED FOR A RAPID, AND EFFECTIVE RESPONSE TO MITIGATE THE CONSEQUENCES SHOULD SUCH AN EVENT OCCUR.

Human history is replete with applications of technology for hostile purposes, and indeed the committee can think of no major category of technology that has not been used for such. The life sciences are no different, and it is only reasonable to expect that a technology derived from the life sciences will be used for malevolent purposes in the future. This likelihood dictates the need to be prepared for a rapid and effective response.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Recommendation 5

The committee notes with urgency the need to enhance public health infrastructure, achieve greater coordination among responsible federal agencies, and substantially strengthen existing response and recovery capabilities.

The committee recognizes 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. No simple or fully effective solutions exist where there is malevolent intent, even in cases where only minimal resources are available to individuals, groups, or states. Thus, the committee’s recommendations recognize a critical need to strengthen the public health infrastructure and our existing response and recovery capabilities. In keeping with the focus of this report, the committee urges that the insights and potential benefits gained through advances in the life sciences and related technologies be fully utilized in the development of new public health defenses. It must be noted, however, that many of the concepts and suggestions embodied in these recomendations were articulated in the 2002 National Research Council Report, Making the Nation Safer: The Role of Science and Technology in Countering Terrorism (see 69-79) and remain as relevant and needed today as they were then.

An effective civil defense program will require a well-coordinated public health response, and this can only occur if there is strong integration of well-funded, well-staffed, and well-educated local, state, and federal public health authorities. Despite substantial efforts since September 11, 2001, few if any experts believe that the United States has achieved even a minimal level of success in accomplishing this goal, which is as important for responses to naturally emerging threats, such as pandemic influenza, as for the threat of a deliberate biological attack against one or more population centers. Current efforts to accomplish these aims have been woefully ineffective and have not provided the nation with the infrastructure it needs to deal rapidly, effectively, and in a clearly coordinated manner when faced with a catastrophic event such as an overwhelming tropical cyclone, a rapidly spreading pandemic, or a large-scale bioterror attack. These efforts need to be enhanced and expanded.

In making the recommendations that follow below, the committee recognizes that similar ones have been made in many different settings in response to the challenges of bioterrorism.98 However, it is not dissuaded by the lack of novelty in such recommendations, given their overriding importance, and given the fact that, despite efforts to accomplish many of these goals, much remains to be done before the nation can be considered to be protected by the best possible public health infrastructure. In keep-

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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ing with the focus of this report, the committee urges that the insights and potential benefits gained through advances in the life sciences and related technologies be fully utilized in the development of new public health defenses.

Recommendation 5a. Strengthen response capabilities and achieve greater coordination of state, local, and federal public health agencies.

It remains unclear how the country’s response to a future biological attack will be managed. The committee remains concerned about how the responses of many different federal departments (e.g., the Departments of Homeland Security, Health and Human Services, Justice, Defense, and the myriad agencies within them) will be effectively integrated and who will control operations and ensure that they are adequately interfaced with local and state governments and public health agencies. Although well beyond the scope of the committee’s charge, the development of an effective means of integrating the responses by multiple governmental agencies would provide the nation with perhaps the most necessary of “tools” with which to meet any future challenge. Even current efforts to develop preventive measures are poorly coordinated and inappropriately placed into administrative “silos” with inadequate cross-fertilization and communication (e.g., environmental pathogen detection in Homeland Security versus disease diagnosis in Health and Human Services, or human infections in Health and Human Services and animal and zoonotic diseases in Agriculture and Homeland Security). Such an arrangement does not serve the nation’s needs well.

With the profusion of federal public health, environmental, law enforcement, defense, and security agencies now engaged in various aspects of prevention, response, mitigation, and attribution in the event of a putative bioterrorist attack, the need for better integration and a clear command and control structure is critical. Rather than considering agents of biological origin as simply another form of weapons of mass destruction, such agents should be placed within the context of naturally emerging infectious diseases, and the public health measures needed to combat them.99 “Defense” in the case of biological security means, above all, improvements in domestic and international disease surveillance and response.100 Current efforts to accomplish these aims should be enhanced and expanded, and federal, state, and local governments (working with the best advice of the scientific community) should carry out a variety of communications activities, through both targeted and mass media efforts, to inform members of the public as to what they may expect during a biological event and what realistic and practical steps they could take to protect themselves.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Recommendation 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.

Efforts are needed to improve the abilities of both the health care and public health communities to quickly detect disease outbreaks in human, plant, and animal populations caused by the intentional release of a biological agent. Ideally, surveillance systems should be sensitive enough to identify the emergence of an outbreak, categorize its nature, and identify those populations affected, so that an outbreak can be quickly and effectively contained. There are a variety of possible approaches today; some of them are based on the collection and analysis of population-based clinical, epidemiological, and even sociological data, including the number and nature of emergency room visits, types of prescriptions, calls to physicians, and so forth, and the careful application of public health informatics and computational modeling of epidemics. Other approaches in the future might be based on real-time monitoring of biological markers in individuals, on a massively parallel scale, including molecular markers of host response and profiles of indigenous microbial communities. It was beyond the scope of the committee’s charge to develop specific recommendations concerning how current epidemic surveillance efforts could be enhanced, but the committee recognizes a clear need to accelerate current efforts to do so.

There is also a need to enhance present capabilities for detecting the presence of a biological agent in the environment, measuring its abundance, and determining the level of associated risk to the health of the potential target host (human, animal, plant, etc.). Given that the number of infectious agents may be exceptionally low following their dispersal, there is a need to develop and evaluate new technologies to improve currently available monitoring and detection systems, as well as a need to characterize a wide variety of environments over time, in the absence of a health threat (i.e., the “background”). The difficulties of accomplishing this should not be underestimated. However, advances in the life sciences and biotechnology will aid in this task—providing yet another reason to promote the general advance of research.

Efforts are now under way at present to develop a variety of new biosensors that can rapidly detect one or more potential bioweapon agents. Questions remain about how such sensors can best be deployed to provide maximum surveillance capability at a cost that will be affordable. Communications efforts also will be needed to explain to the public the merits—and limitations—of such detection systems and to prepare the

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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public so that people can respond appropriately in the event that detection systems trigger an alert. Again, specific recommendations are beyond the scope of this committee’s charge. However, while recognizing the importance and potential utility of such sensor systems, the committee cautions against implementing monitoring activities with such devices without compelling data to support their effectiveness.

Recommendation 5c. Improve capabilities for early detection of host exposure to biological agents of disease and early diagnosis of disease caused by them.

Establishing a specific diagnosis is critical to implementing an appropriate public health response to a bioterrorism-related event, since the diagnosis will guide the use of specific therapies, immunizations, and other interventions. Efforts should thus be aimed at increasing the awareness of primary care and specialist clinicians to the potential for disease outbreaks initiated by the release of biological agents. As indicated in Recommendation 2, a broader perspective on the range of potential threats is essential, particularly in this age when relatively simple genetic engineering might easily change the pathogenicity of a relatively harmless microorganism. There is a strong need to improve the ability of clinicians to detect, report, and respond appropriately to patients who present with symptoms or signs consistent with a biological attack.

By making a specific diagnosis before the alarm has been raised, or by recognizing that a patient’s clinical presentation lies outside the expected norm, a physician confronting an early case in an epidemic or a biological attack can make a uniquely important contribution to the timeliness of the public health response.101 Better training should also be coupled with the availability of enhanced diagnostic tools that will provide physicians with a “real-time” bedside capacity to identify unusual infectious agents in patients with suspicious clinical signs and symptoms.

Early disease diagnosis, even prior to the onset of typical symptoms, should be the goal of research and development efforts. While it is reasonable to hope that improved diagnostic tests will be developed as a result of current federal biodefense research efforts, it is not clear that adequate attention, prioritization, or investment has been devoted to this important area, or that all of the potentially useful approaches (e.g., comprehensive monitoring of host-associated molecular biological markers) have been adequately explored. There is a similar need for early recognition and diagnosis of animal and plant diseases. As with Recommendation 5b, many of the concepts and suggestions mentioned above, were articulated in the 2002 National Research Council Report, Making the Nation Safer: The Role of Science and Technology in Countering Terrorism and remain as relevant and needed today as they were then.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Recommendation 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.

No credible defensive effort can move forward without accelerating the rate at which vaccines and other preventatives and therapeutic agents are developed. Having effective vaccines available not only will help protect U.S. citizens and military personnel, but limiting the efficacy of biological weapons will reduce the attractiveness of such weapons and thereby offer some means of deterring their use. Continued research is needed to develop, or in some cases improve, vaccines against specific biological agents that are already of concern (e.g., anthrax, smallpox, influenza) as well as to develop the capacity to design and produce new vaccines rapidly in response to new threats, including threats that might emerge from advances in the life sciences. A particularly desirable goal would be to develop a single vaccine or biological response modifier capable of providing protection against a relatively large class of diseases. To date, well-established companies in the pharmaceutical and vaccine industries have had little financial incentive to develop new vaccines or therapeutics for biological threat agents for which the market is extremely uncertain and dependent ultimately on government procurement decisions. Therefore, the government’s accomplishments in these areas have fallen far short of the goals regarding development of new vaccines and therapeutics.

The Bush administration’s $5.6 billion BioShield initiative sought to solve this problem by placing large sums of money at the finish line, as it were, allowing purchase following the development of an effective countermeasure. However, there is no evidence to date that this has succeeded, due to a variety of concerns on the part of “big pharma,” including the reliability of the government as a development partner, its previous threat to invoke eminent domain when concerned about the price of ciprofloxacin proposed by Bayer during the anthrax attacks of 2001, and (particularly in the case of vaccines) continuing worries about liability exposure.102 For small biotech companies with limited venture capital funding, BioShield represents a potential windfall, but for the large publicly traded industry giants that are most capable of delivering these products, the opportunity costs are unacceptable related to the diversion of corporate research resources.103

Many pathogens are becoming resistant to today’s antibiotics, and no new classes of drugs have been developed in recent years.104 Already a problem for naturally occurring diseases, the dearth of new antibiotics

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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may prove especially troublesome in the event of a biological attack with an engineered bacterial agent. In the initial phases of such an event, the level of antibiotic susceptibility will not be known, and more than one agent may be released simultaneously. Thus, new classes of broad-spectrum antibiotics are urgently needed, both for naturally acquired infections and to guard against the possibility of attacks with microbial agents resistant to current therapeutics. Advances in the fields of genomics, cell biology, structural biology, and combinatorial chemistry have resulted in the rapid development of some new antiviral agents, but no broad-spectrum antiviral agents are on the market, and there are no specific antivirals that are effective against the majority of the RNA and DNA viruses of concern. Expanded efforts are needed to develop new antiviral agents for specific diseases, but there is also a need to consider novel ways in which broad-spectrum antiviral agents could be developed. This might include the development of novel classes of immunomodulators for those agents for which there are no available therapeutics or vaccines.

Finally, in an age that bears witness to many newly emerging infections as well as the growing threat associated with the inadvertent or intentional creation of novel agents of biological origin, it is critical that the time to develop and license new therapeutics and vaccines be substantially shortened. The many years required for successful development and licensure of either drugs or vaccines is inconsistent with the flexible, agile responses required. The use of RNA silencing technologies offers promise for the rapid, sequence-specific development of therapeutic and possibly preventative antiviral compounds. Although many questions remain about the ultimate safety and efficacy of such approaches, the ability of this technology, as an example, to serve as a platform for rapid development of needed drugs makes it very attractive. Similarly, there is a need to develop vaccine platforms that are capable of being rapidly utilized to express novel immunogens and to elicit protective immunity against a newly appearing biological threat.

Again, it is not clear who might address these goals or how successful any such attempts will be. The committee believes that these are very important goals, however, and that their success will depend on the ability of science to continue to advance without being unduly fettered by overrestrictive laws and regulations, as well as novel approaches providing appropriate financial incentives to the industry entities most able to meet these challenges.

SUMMARY

Because it believes that continuing advances in the life sciences and related technologies are essential to countering the future threat of

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

bioterrorism, the committee’s recommendations affirm policies and practices that promote the free and open exchange of information in the life sciences. It also recognizes the need to adopt a broader perspective on the nature of the threat spectrum, and to strengthen the scientific and technical expertise available to the national security communities so that they are better equipped to anticipate and manage a diverse array of novel threats. Moreover, due to the global dispersion of life sciences knowledge and technological expertise, the committee recognizes the international dimensions of these issues, and makes recommendations that 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.

No single recommendation by itself can provide a guarantee against the eventual successful use of the life sciences and related technologies for malevolent purposes. Rather, the actions and strategies that the committee recommends 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 and 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. The committee believes that the actions suggested in its recommendations, taken in aggregate, will likely decrease the risk of inappropriate application or unintended misuse of these increasingly widely available technologies.

Nonetheless, the committee recognizes that all of its recommended measures, taken together, cannot guarantee that continuing advances in the life sciences and the new technologies they spawn will not be used with the intent to cause harm. No fully effective solution exists where there is malevolent intent. The committee therefore reaffirms previous calls to strengthen the public health infrastructure and the nation’s existing response and recovery capabilities, as it believes such steps will be essential for the early detection of malevolent applications and for mitigating the loss of life or other damage sustained by society in both the short and the long term should the worst-case scenario occur.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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ANNEX 4-1

June 16, 2005

Secretary Carlos M. Gutierrez

Office of the Secretary

U.S. Department of Commerce

Room 5516
14th Street and Constitution Avenue, N.W.
Washington, DC 20230

Dear Secretary Gutierrez:

We appreciate this opportunity to provide comments on the advanced notice of proposed rule-making (ANPR) on “Revisions and Clarification of Deemed Export Related Regulatory Requirements. One of the key roles of the National Academies, consistent with our 1863 Congressional Charter, is to advise the nation on important issues involving science, engineering, and medicine such as this one. The members of our three honorary academies—the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine—and the scientific experts who serve on the study committees of our operating arm, the National Research Council, are working at industrial, academic, and governmental institutions that are potentially affected by the proposed regulatory changes. We provide these comments in light of our background and experience with the U.S. scientific, engineering, and medical enterprise.


Our most important observation is the following: We believe the rule changes that are being recommended by the Inspector General and the interpretation of existing regulations that are now being widely disseminated will serve to weaken both national security and the economic competitiveness of the United States. The impact will likely be to dramatically hinder American scientific, engineering, and health care research and innovation, factors that have been so vital to our quality of life.


The clearest problem now is that universities and industry are unable to specify the expected impact of attempting to comply with these rules. We believe that the Department needs to address the following issues in the existing and proposed rules before we can provide you with a categorical response and before the Department determines which interpretations

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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and rule changes to the Export Administration Regulations, if any, will make the nation safer.


First, the problems that these rule changes and new interpretations are attempting to address, as well as the costs and benefits of different regulatory approaches, need to be clarified. It is not simply that the affected communities will be more accepting of the need to tighten rules if they understand why (although that will help), but that complex problems require focused and tailored solutions. The measures being contemplated by the Department could be too broad, too narrow, or possibly irrelevant depending on whether one defines the challenge as primarily countering terrorist activities, political adversaries, or economic competitors.


Second, the new interpretations and proposed changes could eviscerate the Fundamental Research Exemption as enunciated in National Security Decision Directive (NSDD)-189 and reconfirmed by Secretary of State Rice and former Energy Secretary Spencer Abraham in November 2001 and May 2003, respectively. We favor a crisply defined regulatory “safe harbor” for fundamental research, so that universities can have confidence that activities within the “safe harbor” are in compliance, and so that the vital importance to national security of open fundamental research is reaffirmed as a matter of national policy. The new regulatory machinery could then be focused on university activities, if any, occurring OUTSIDE the “safe harbor.” Such activities might be conducted in separate facilities, or even off campus. And if the regulatory “safe harbor” is properly defined and constructed, a number of universities might not even have any such activities.


Third, it is necessary to determine whether the perceived national security benefits are worth the cost that universities and industry will incur to implement these proposed changes. While the financial costs would be a burden, both sectors would find ways to manage them over time. Of much greater concern is that these measures will pose an irretrievable cost to our nation—especially our competitiveness and national security which have relied so heavily for the last sixty years on the fruits of technology derived from basic science, and bringing the “best and brightest” people from other countries to the U.S. Losing the “best and the brightest” foreign students and researchers to other countries because they feel unwelcome here will have very serious consequences for the future of America. Eleven of the last 45 winners of the Nobel Prize in science105 from 1999-2004 were foreign-born Americans. In the same timeframe, fifteen of the last 51 recipients of the National Medal of Science, an annual award made by the U.S. President, were also immigrants to the United States.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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Fourth, it is necessary to assess whether these particular measures will not in fact staunch the flow of scientific information to potential terrorists, adversaries, and/or competitors. In a world where access to information is increasingly global, those who intend to do harm to the United States will simply go elsewhere for the scientific or technological information they seek; the U.S. is far from the only advanced, research-capable country.


These four issues are manifestations of a single principle of U.S. policy concerning classified information: “Construct high fences around narrow areas.” This refers to maintaining stringent security around sharply defined and narrowly circumscribed areas of critical importance in order to be able to maintain simultaneously the highest levels of national security and of scientific research. This principle was originally articulated in A Review of the Department of Energy Classification: Policy and Practice (1995)106 and acknowledges that an attempt to protect everything in fact dilutes attention and protects nothing. It is our sense that the recommendations expressed by C.D. Mote, President of the University of Maryland, at the National Academies’ May 6th workshop on the Department of Commerce Inspector General’s Report on deemed export policy, could help to operationalize this principle in the area of deemed exports. We urge you to give them serious consideration as a first step:

  1. Greatly narrow the scope of controlled technologies requiring deemed export licenses and ensure the list remains narrow going forward.

  2. Delete all controlled technology from the list whose manuals are available in the public domain, in libraries, over the Internet, or from the manufacturers.

  3. Delete all equipment from the list that is available for purchase on the open market overseas from foreign or U.S. companies.

  4. Clear international students and postdoctoral fellows for access to controlled equipment when their visas are issued or shortly thereafter so that their admission to a university academic program is coupled with their access to use of export-controlled equipment.

  5. Do not change the current system of license requirements for use of export-controlled equipment in university basic research until the above four recommendations have been implemented.

To date, the Commerce Department has gained substantial goodwill within the science, engineering, and medical communities through its policy of openness in discussing and seeking comments on these rules. We give considerable credit to you and other responsible officials, such as Peter Lichtenbaum of the Bureau of Industry and Security, who have

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

openly and willingly embarked on a dialogue that will ultimately make the research community more aware of how to secure our most advanced technologies from hostile entities. At the same time, we strongly recommend the Department embark on responses to the communities’ concerns before implementing regulations that may chill ongoing research of critical importance to the future of the U.S.

Sincerely,

Bruce Alberts

President

National Academy of Sciences


Wm. A. Wulf

President

National Academy of Engineering


Harvey V. Fineberg

President

Institute of Medicine

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
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ANNEX 4-2

Recommendations for Enhancing the U.S. Visa System to Advance America’s Scientific and Economic Competitiveness and National Security Interests107


May 18, 2005


Following the terrorist attacks of September 11, 2001, the U.S. government put in place new safeguards in the nation’s visa system that made it extremely challenging for bona fide international students, scholars, scientists, and engineers to enter this country. While intended to correct weaknesses exposed by the attacks, the changes proved to be significant barriers for legitimate travelers and created a misperception that these visitors were no longer welcome here.


Other countries have used this opportunity to attract these individuals to their own educational, scientific, and technical institutions. In addition, key sending countries have enhanced their higher education systems in an effort to keep their best students at home.


Despite significant recent improvements to the U.S. visa system, considerable barriers remain that continue to fuel the misperception that our country does not welcome these international visitors, who contribute immensely to our nation’s economy, national security, and higher education and scientific enterprises. These misperceptions must be dispelled soon, or we risk irreparable damage to our competitive advantage in attracting international students, scholars, scientists, and engineers, and ultimately to our nation’s global leadership.


One year ago, most of the undersigned organizations of higher education, science, and engineering, in an effort to enhance national security and international exchange made a joint commitment to work with the federal government to make sensible changes to the visa system. We recommended several improvements, some of which have been adopted in the past year. Today we come together again to express gratitude and support for the changes that have been made, to continue to urge approval of those that have not, and to recommend additional improvements, so that America can continue to compete for and welcome the world’s best minds and talents. We offer the following recommendations in the spirit of cooperation that has already resulted in improvements to the visa system:

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×
  • Extend the validity of Visas Mantis security clearances for international scholars and scientists from the current two-year limit to the duration of their academic appointment. While we appreciate that the limit has already been extended from one year to two years, this further extension would be comparable to that already provided for international students and would prevent redundant security checks that can waste resources and cause unnecessary delays and hardships.

  • Allow international students, scholars, scientists, and engineers to renew their visas in the United States. Allowing individuals to complete, or at least initiate, the visa revalidation process before leaving the country to attend academic conferences or to visit family would reduce, and in many cases eliminate, visa delays, thus permitting them to continue their studies and research uninterrupted.

  • Renegotiate visa reciprocity agreements between the United States and key sending countries, such as China, to extend the duration of visas each country grants citizens of the other and to permit multiple entries on a single visa. We applaud the State Department’s initial efforts to achieve this and encourage continued efforts. Improved reciprocity would allow the federal government to focus its visa screening resources by reducing the number of visa renewals that must be processed.

  • Amend inflexible requirements that lead to frequent student visa denials. The Immigration and Nationality Act of 1952 should place greater emphasis on student visa applicants’ academic intent and financial means to complete a course of study in the United States, instead of their ability to demonstrate evidence of a residence and employment in their home country and their intent to return home. Up to 40 percent of student visa applicants from key sending countries are rejected because they are unable to demonstrate to the satisfaction of consular officials their intent and ability to return home after completing their studies. The United States is losing too many top students to this policy, and the act should be revised.

  • Develop a national strategy to promote academic and scientific exchange and to encourage international students, scholars, scientists, and engineers to pursue higher education and research opportunities in the United States. In addition to visa reforms, this strategy should include a plan to counter prevailing negative perceptions of studying and conducting research in the United States and should promote study abroad by American students.

The following recommendation, while not related to visa issuance, addresses a potential barrier to international scientists and engineers seeking to study and conduct research in the United States.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×
  • The federal government should not require that export licenses be obtained for international scientists and engineers to use equipment required to conduct unclassified, fundamental research in the United States. The Department of Commerce is considering expanding existing regulations to require that licenses be obtained before certain foreign nationals are permitted access to specialized scientific equipment required for unclassified, fundamental research. Requiring such licenses would further discourage top international scientists and engineers from making the United States their destination, prompting them to seek research opportunities overseas.

Lastly, it is essential that adequate resources continue to be provided by Congress and the Administration to administer an effective visa system and to implement the above recommendations.


We reiterate our commitment to work with the federal government to improve the visa system. That system should maintain our nation’s security by preventing entry by those who pose a threat to the United States and encouraging the entry of the brightest and most qualified international students, scholars, scientists, and engineers to participate fully in the U.S. higher education and research enterprises. Such a system will foster American scientific and economic competitiveness. We commend the Administration for the improvements made to the visa system to date, and we look forward to continuing to work together for these further needed changes.


[signed]


Nils Hasselmo

President

Association of American Universities


Bruce Alberts

President

National Academy of Sciences


C. Peter Magrath

President

National Association of State Universities and Land Grant Colleges


Harvey V. Fineberg

President

Institute of Medicine


Alan I. Leshner

President

American Association for the Advancement of Science


David Ward

President

American Council on Education


Wm. A. Wulf

President

National Academy of Engineering


Deborah L. Wince-Smith

President

Council on Competitiveness

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

Marlene M. Johnson

Executive Director and CEO

NAFSA: Association of International Educators


Debra W. Stewart

President

Council of Graduate Schools

Education


Constantine W. Curris

President

American Association of State Colleges and Universities


Jerry P. Draayer

President and CEO

Southeastern Universities Research Association


Gerard A. Alphonse

2005 President

The Institute of Electrical and Electronics Engineers—USA


Eugene Arthurs

Executive Director

SPIE—The International Society for Optical Engineering


Rev. Charles L. Currie

President

Association of Jesuit Colleges and Universities


Judith Bond

President

American Society for Biochemistry and Molecular Biology


Marvin L. Cohen

President

American Physical Society


Allan E. Goodman

President and CEO

Institute of International


James M. Tiedje

President

American Society for Microbiology


Paul W. Kincade

President

Federation of American Societies for Experimental Biology


David L. Warren

President

National Association of Independent Colleges and Universities


Stephen Dunnett

President

Association of International Education Administrators


Sally T. Hillsman

Executive Officer

American Sociological Association


Katharina Phillips

President

Council on Governmental Relations

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

   

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.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

   

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

   

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].

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

   

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.

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

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;

Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: The National Academies Press. doi: 10.17226/11567.
×

   

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

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Biomedical advances have made it possible to identify and manipulate features of living organisms in useful ways--leading to improvements in public health, agriculture, and other areas. The globalization of scientific and technical expertise also means that many scientists and other individuals around the world are generating breakthroughs in the life sciences and related technologies. The risks posed by bioterrorism and the proliferation of biological weapons capabilities have increased concern about how the rapid advances in genetic engineering and biotechnology could enable the production of biological weapons with unique and unpredictable characteristics. Globalization, Biosecurity, and the Future of Life Sciences examines current trends and future objectives of research in public health, life sciences, and biomedical science that contain applications relevant to developments in biological weapons 5 to 10 years into the future and ways to anticipate, identify, and mitigate these dangers.

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