Globalization, Biosecurity, and the Future of the Life Sciences (2006) / Chapter Skim
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4 Conclusions and Recommendations
4 Conclusions and Recommendations
Pages 213-282
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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.
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214 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES nologies. The increasing pace of scientific discovery abroad and the fact that the United States may no longer hold a monopoly on these leading technologies means that this country is, as never before, dependent on international collaboration, a theme explored in depth in Chapter 2.
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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)
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1a. Ensure that, to the maximum extent possible, the results of funda mental research remain unrestricted except in cases where national secu rity requires classification, as stated in National Security Decision Direc tive 189 (NSDD-189)
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and the 1993 Chemical Weapons Convention (CWC)
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218 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES ommendation 5)
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Ensure that the results of fundamental re search remain unrestricted except in cases where national security requires classification, as stated in National Security Decision Di rective (NSDD) -189 and endorsed more recently by a number of groups and organizations.
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220 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES the existing classification system threaten this culture in ways that are potentially harmful to national and human security. For example, the recent extension of classification authority to agencies not previously involved in these matters (e.g., the U.S.
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CONCLUSIONS AND RECOMMENDATIONS 221 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")
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222 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES to the development of novel therapeutics for humans. Such associations, in effect a convergence of technologies and unrelated hypotheses, cannot be predicted effectively in advance, nor managed in any directed fashion.
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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, 16In 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.
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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 )
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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.
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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.
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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.
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228 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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)
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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.
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230 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES Recommendation 1c. Promote international scientific exchange(s)
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CONCLUSIONS AND RECOMMENDATIONS 231 ticipation in U.S. scientific activity.
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232 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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.
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CONCLUSIONS AND RECOMMENDATIONS 233 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.
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234 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES basis of the best scientific advice, as opposed to perceived or hypothetical risks. For example, several rickettsial agents have been employed by statesponsored 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.
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CONCLUSIONS AND RECOMMENDATIONS 235 Recommendation 2b. Adopt a broadened awareness of threats be yond 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.
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. And the committee urges a proactive, anticipatory perspective and action plan for the national and international security communities.
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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.
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238 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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.
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CONCLUSIONS AND RECOMMENDATIONS 239 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)
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240 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES · 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.
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CONCLUSIONS AND RECOMMENDATIONS 241 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.
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242 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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.
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CONCLUSIONS AND RECOMMENDATIONS 243 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.
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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)
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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.
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246 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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.
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CONCLUSIONS AND RECOMMENDATIONS 247 out by their colleagues. In the absence of a code, such actions might otherwise go unnoticed.
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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)
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CONCLUSIONS AND RECOMMENDATIONS 249 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.
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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.
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CONCLUSIONS AND RECOMMENDATIONS 251 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.
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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
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Among the outbreaks first reported on ProMED-mail were the early re ports of SARS in both China and Toronto in 2003; Venezuelan equine encephalitis in Venezuela in 1995; H5N1 influenza in Indonesia Novem ber 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.
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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.
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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.
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256 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES Admittedly, there is a thin line between vigilance and vigilantism. The former is the state of being watchful (i.e., without necessarily acting)
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CONCLUSIONS AND RECOMMENDATIONS 257 Recommendation 5 The committee notes with urgency the need to enhance public health infrastructure, achieve greater coordination among respon sible federal agencies, and substantially strengthen existing re sponse 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.
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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)
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CONCLUSIONS AND RECOMMENDATIONS 259 Recommendation 5b. Strengthen efforts related to the early detec tion 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 sci entific evidence suggests they are effective.
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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)
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CONCLUSIONS AND RECOMMENDATIONS 261 Recommendation 5d. Provide suitable incentives for the develop ment and production of novel classes of preventative and therapeu tic agents with activity against a broad range of biological threats, as well as flexible, agile, and generic technology platforms for the rapid generation of vaccines and therapeutics against unanticipated threats.
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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.
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CONCLUSIONS AND RECOMMENDATIONS 263 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.
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264 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES ANNEX 4-1 June 16, 2005 Secretary Carlos M Gutierrez Office of the Secretary U.S.
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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)
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266 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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.
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CONCLUSIONS AND RECOMMENDATIONS 267 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.
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268 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 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.
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CONCLUSIONS AND RECOMMENDATIONS 269 · 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.
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270 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES · 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.
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CONCLUSIONS AND RECOMMENDATIONS 271 President President Institute of Medicine Council on Competitiveness Marlene M Johnson Marvin L
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272 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES George R Boggs Marc H
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2004. Biotechnology Research in an Age of Terrorism.
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12 Center for Strategic and International Studies.
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:9737-9738. Center for Strategic and International Studies.
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276 GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES 35 National Research Council.
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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.
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2004. Nonproliferation: Delays in Implementing the Chemical Weapons Convention Raise Concerns about Proliferation.
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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 IranIraq war and that Iraq had obtained many of the materials for their chemical weapons program from the international chemical industry.
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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?
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2003. Microbial Threats to Health: Emergence, Detection, and Response.
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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]
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