1
Introduction

THE PROMISE AND PERFORMANCE OF BSAT RESEARCH

More than 300 years ago, Antonie van Leeuwenhoek constructed a primitive microscope and made the first detailed descriptions of microorganisms. More than 200 years ago, Edward Jenner carried out the first experimental vaccination, using cow pox virus to build immunity in humans against the deadly smallpox virus. More than 100 years ago, Robert Koch isolated the Bacillus anthracis bacterium and postulated a causal relationship between specific microorganisms and disease.

From these early discoveries, scientists have built more than a century of research on microorganisms and infectious disease, including research on some of the most dangerous pathogens. Enormous advances have resulted in the development of vaccines and other treatments that have greatly diminished the risks posed by infectious disease agents. It is not an exaggeration to attribute increased human lifespan and better human health to the research of legions of microbiologists and other biomedical researchers on the biology of bacteria and viruses and the toxins they produce.

At the same time, these researchers have maintained safety and responsibility in the laboratory. Notwithstanding the enormous volume of infectious disease research that has been accomplished, there have been few incidents of pathogenic organisms being released into the environment by accident, negligence, or deliberate action. The incidence of laboratory-acquired infection is similarly exceedingly rare, even though many thousands of scientists handle highly pathogenic organisms daily. Moreover, scientists have become less tolerant of the possibility of release or accidental infection, working to improve biosafety as our understanding of biological materials and the risks they pose has increased. Scientific research is safer than it has ever been because of the



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1 Introduction THE PROMISE AND PERFORMANCE OF BSAT RESEARCH More than 300 years ago, Antonie van Leeuwenhoek constructed a primi - tive microscope and made the first detailed descriptions of microorganisms. More than 200 years ago, Edward Jenner carried out the first experimental vaccination, using cow pox virus to build immunity in humans against the deadly smallpox virus. More than 100 years ago, Robert Koch isolated the Bacillus anthracis bacterium and postulated a causal relationship between spe- cific microorganisms and disease. From these early discoveries, scientists have built more than a century of research on microorganisms and infectious disease, including research on some of the most dangerous pathogens. Enormous advances have resulted in the development of vaccines and other treatments that have greatly diminished the risks posed by infectious disease agents. It is not an exaggeration to attribute increased human lifespan and better human health to the research of legions of microbiologists and other biomedical researchers on the biology of bacteria and viruses and the toxins they produce. At the same time, these researchers have maintained safety and responsi - bility in the laboratory. Notwithstanding the enormous volume of infectious disease research that has been accomplished, there have been few incidents of pathogenic organisms being released into the environment by accident, negli - gence, or deliberate action. The incidence of laboratory-acquired infection is similarly exceedingly rare, even though many thousands of scientists handle highly pathogenic organisms daily. Moreover, scientists have become less tol - erant of the possibility of release or accidental infection, working to improve biosafety as our understanding of biological materials and the risks they pose has increased. Scientific research is safer than it has ever been because of the 

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS increasing concern for safety and security and implementation of protective measures that minimize risk. Among the larger group of pathogenic materials is a set of organisms and chemicals that pose not only a severe threat to the health of humans, plants, and animals, but also have the potential to be used deliberately to cause disease, prompt fear, or destroy agricultural or animal products. More than 80 of these most dangerous bacteria, viruses, toxins, and fungi have been officially listed as biological select agents and toxins (BSAT) and are subject to special security requirements.1 Whether deliberately deployed as a biological weapon or the result of a natural outbreak, the potential for mass human casualty or potentially cata - strophic impact on plants or animals as a direct or indirect result of select agents is omnipresent. As the National Institute of Allergy and Infectious Dis - eases (NIAID) opened its most recent strategic plan for biodefense research, “biological weapons in the possession of hostile states or terrorists, as well as naturally occurring emerging and reemerging infectious diseases, are among the greatest security challenges to the United States” (NIAID 2007). The security and safety of our nation—as well as human and agricultural health around the world—depend upon a deep understanding of these organisms and toxins. The most direct impact of research with BSAT is in the development of countermeasures against the agents themselves. Previous investment in research using what are now classified as select agents has yielded vaccines, drugs, and other treatments to combat agents such as smallpox, anthrax, and Ebola virus (Auchincloss 2007). Continuing efforts against these dangerous pathogens will improve our capacity to treat and prevent outbreaks when they occur, and ad- vances in technology will enable more rapid detection of the presence of BSAT materials in the environment. But the value of BSAT research is not limited to the development of medi- cal countermeasures; in fact, greater understanding of BSAT materials will also enhance our ability to respond to a wide range of infectious diseases (NIAID 2008). What is learned about this small subset of pathogens can lead to strate- gies for responding to a much wider range of infectious diseases, extending the reach of BSAT research beyond the agents of acute concern to the much wider array of organisms with significant public health implications. The nation’s capacity to conduct research on BSAT materials has expanded significantly over the past several years. For example, the number of laborato - ries either in operation or under development that have the capacity to conduct research on the most dangerous pathogens—agents that pose the highest risk of life-threatening disease for which no vaccine or therapy is available, including 1 These agents are defined in three sections of federal regulations: 42 CFR 73 for threats to “public health and safety,” 7 CFR 331 for threats to “plant health or to plant products,” and 9 CFR 121 for threats to “animal health or to animal products.”

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 INTRODUCTION several select agents—has increased from two before 1990 to five before the ter- rorist attacks of 2001 to 15 or more that are operational or under development at the time of this report (GAO 2007).2 Such laboratories are no longer limited to the federal government but now include facilities in academic institutions, state and local public health departments, and in the private sector. This expan - sion can be attributed to growing concerns about our limited understanding of dangerous pathogens, increasing ability to add to this understanding, and an influx of federal support for these activities. One large federally supported program highlights the growth as a result of increasing government support: since 2003, NIAID has supported the development of 11 Regional Centers of Excellence (RCEs) for Biodefense and Emerging Infectious Diseases, 3 which involve nearly 500 principal investigators (PIs)—most new to biodefense—at al- most 300 institutions participating in RCE research activities (Concept Systems 2008). The laboratories provide a venue for work with potentially dangerous pathogens, including those on the list of select agents and toxins. THE NATURE OF THE THREAT BSAT materials have the potential for dramatic impact on human, plant, and animal health. For this reason, there is a growing concern that these agents may be used for intentional harm or to induce public panic. The anthrax attacks of 2001 are a prime example. In addition to killing five people and infecting 22, this attack had a dramatic impact on our nation and was estimated to have had a direct economic impact of more than $1 billion. Clearly, there is genuine and legitimate concern that laboratories working with select agents and toxins should receive special security and safety attention that other types of biological research would not require. Even though many of the materials on the select agent list may be found in natural environments, some laboratories maintain purified strains of the most dangerous pathogens. In addition, laboratory workers not only have access to these materials but also may possess the technical knowledge of how to grow them in the laboratory, although not necessarily the technical knowledge needed to weaponize them. This report therefore addresses policies and practices directed at securing those laboratory facilities in which work is done with BSAT materials. The in - tent is to protect the laboratories and the agents from threats posed by outsiders as well as insiders. Although the report does not focus on biosafety, some of the methods that prevent accidental infection or release also serve to enhance 2A 2009 Government Accountability Office (GAO) report lists seven operational labs as of 2009—four operated by the federal government, two by academic institutions, and one by a private nonprofit organization. GAO counts seven additional facilities in development, including one that will replace an existing facility (GAO 2009c). 3 See for more information about the RCEs.

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS security and may be discussed. But the focus of the report is on the security of the agents, facilities, and personnel. There are specific issues concerning BSAT research that will be addressed in this report, but it is important first to consider the threat itself. What are the specific scenarios of concern and which eventualities are to be prevented? While a fully deliberative consideration of the threat is beyond the scope of this report, the committee selected several examples of possible threats as the context for discussion: • A dedicated terrorist or criminal who may break into a BSAT labora- tory with the intent to steal dangerous pathogens or to cause an inten- tional release. • An individual working in a BSAT laboratory, with access to pathogens, who may take them out of the laboratory for improper use. • An individual working in a BSAT laboratory who may serve as an accomplice or conduit for others wishing to do harm, whether delib- erately or unwittingly. Some individuals cited as examples above are motivated by ideology, while others are subject to pressure from the promise of money or other benefits; still others have their judgment compromised by a temporary or permanent condition or personal crisis. Although some security and personnel reliabil - ity strategies serve to address multiple threats, others are specific to a given population. It is important to keep in mind that access to a pure culture of a select agent or toxin alone does not represent a major biothreat, although it can be more than sufficient for an act that is intended to evoke fear rather than mass casualty. To have widespread impact on health, the agent must be grown in reasonable quantity with technically complex facilities and specialized equip - ment, and may need to be stabilized to remain viable, packaged, delivered to a susceptible population, and dispersed in a method that allows the organisms to retain their virulence. Access to the starting material represents only the first and, in many cases, least sophisticated step in this process. Nonetheless, denying would-be terrorists ready access to BSAT materials is an important component of national security. SUMMARY OF THE CURRENT SELECT AGENT PROGRAM4 After the anthrax attacks of 2001, the United States expanded the exist - ing regulations governing the transfer of BSAT materials among laboratories 4 Throughout this report, the term “Select Agent Program” is used to refer to the National Select Agent Registry Program, which oversees activities related to biological select agents and toxins.

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 INTRODUCTION registered with the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS) and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) into a rigorous formal oversight system to decide that persons seek - ing to possess, use, or transfer select agents or toxins have a lawful purpose. It also defined how facilities possessing BSAT materials would be protected. Appropriately defined, such a system would ensure that pathogens and toxins would be accessible only to legitimate researchers. The objective of material control for the life sciences focuses on methods to ensure that any individual with access to select agents would be trustworthy and that the agents would be secure within each facility housing BSAT materials. Chapter 2 describes in greater detail the current policy and regulatory framework governing BSAT research in the United States. The scope of the Select Agent Program is circumscribed by those agents and toxins on the formal select agent list. CDC maintains the list for human pathogens, while APHIS maintains the list for plant and animal pathogens.5 The list, first introduced in 1997, has grown from an initial 42 CDC agents and toxins to its current 82 CDC and USDA agents and toxins. The current list includes 40 HHS-only agents, 10 overlap agents, and 32 USDA-only agents (24 animal pathogens and 8 plant pathogens).6 A formal process for determining whether an agent or toxin should be on the select agent list has been developed. In July 2009, for example, a notice in the Federal Register began the process of public comment on a proposal to add the SARS-associated coronavirus to the list (HHS 2009a), followed by a second notice in August 2009 of a proposal to add Chapare virus to the list (HHS 2009b). Regulations require a formal bien - nial review process during which the entire list is reviewed and agents or toxins may be added or removed. The USA PATRIOT Act of 2001 (Public Law 107–56, October 26, 2001) established prohibitions on the possession of select agents by several categories of “restricted persons,” including convicted felons or those who had received a dishonorable discharge from the U.S. military, foreign nationals from countries designated as supporting terrorism, and current users of illegal drugs. The Act also made it an offense for a person to knowingly possess any biological agent, toxin, or delivery system of a type or in a quantity that, under the cir- cumstances, is not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purpose. The provisions of the USA PATRIOT Act were subsequently augmented It is a joint activity of the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service and the Department of Health and Human Services’ Centers for Disease Control and Prevention. 5 A few BSAT materials that affect both humans and animals are considered “overlap agents” and appear on both the CDC and APHIS lists. 6 See Table 2-2 for the current list of select agents and toxins.

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6 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS by the Public Health Security and Bioterrorism Preparedness and Response Act, known as the Bioterrorism Act of 2002 (Public Law 107–188, June 12, 2002). This Act added requirements for regulations governing possession of select agents, including approval for laboratory personnel by the Attorney General following a background check by the Federal Bureau of Investigation (FBI). Entities possessing BSAT materials are required to register and have plans in place for ensuring: (1) the physical security of the BSAT materials in their possession; (2) appropriate biosafety to guard against an accident or an accidental release of BSAT materials; and (3) the ability to respond in the event that an accident, theft, or release did occur. Inspections by CDC and APHIS are used to assess adequacy of the plans; the two organizations also provide training and compliance assistance for those who are subject to the regula- tions. The Select Agent Program began operation with interim rules in 2003, and final rules were issued in April 2005, as three sections governing human, plant, and animal agents and toxins (HHS 42 CFR 73 (Humans); USDA 7 CFR 331 (Plants); and 9 CFR 121 (Animals)). APHIS and CDC work to ensure that their separate activities are coordinated and require the same types of policies, actions, and reporting from those they regulate. RELATIONSHIP BETWEEN BIOSECURITY AND BIOSAFETY7 The concepts of “biosafety” and “biosecurity” are related and frequently complement one another, but they also differ in important ways. The fifth edi- tion of the HHS manual Biosafety in Microbiological and Biomedical Laborato- ries (BMBL), which sets standards for how U.S. laboratories conduct research with biological agents and toxins, defines biosafety programs as those that “reduce or eliminate exposure of individuals and the environment to potentially hazardous biological agents,” while the “objective of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research- related information” (CDC/NIH 2007:105).8 One frequently used description 7 This section draws on the discussion in Biosafety in Microbiological and Biomedical Laboratories, 5th ed. (CDC/NIH 2007), Section VI, available at . 8 It should be noted that the use of the term “biosecurity” presents a number of difficulties. At its most basic, the term does not exist in some languages, or is identical with “biosafety”; French, German, Russian, and Chinese are all examples of this immediate practical problem. Even more serious, the term is already used to refer to several other major international issues. For example, to many “biosecurity” refers to the obligations undertaken by states adhering to the Convention on Biodiversity and particularly the Cartagena Protocol on Biosafety, which is intended to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. (Further information on the Convention may be found at and on the Protocol at .) “Biosecurity” has also been narrowly applied to efforts to increase the security of dangerous pathogens, either in the laboratory or in dedicated collections; guidelines from both the World Health Organization (WHO

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 INTRODUCTION of the difference offers a quick and accessible explanation: “Biosafety is about protecting people from bad ‘bugs’; biosecurity is about protecting ‘bugs’ from bad people.” As discussed in the BMBL, the systems developed for biosafety and bios- ecurity have a number of common elements: Both are based upon risk assessment and management methodology; person - nel expertise and responsibility; control and accountability for research ma - terials including microorganisms and culture stocks; access control elements, material transfer documentation, training, emergency planning, and program management. . . . Biosafety looks at appropriate laboratory procedures and practices necessary to prevent exposures and occupationally acquired infec - tions, while biosecurity addresses procedures and practices to ensure that biological materials and relevant sensitive information remain secure. Both programs assess personnel qualifications. . . . Both programs must engage laboratory personnel in the development of practices and procedures that fulfill the biosafety and biosecurity program objectives but that do not hinder research or clinical/diagnostic activities. The success of both of these programs hinges on a laboratory culture that understands and accepts the rationale for biosafety and biosecurity programs and the corresponding management over- sight. (CDC/NIH 2007:105-106) Not all aspects of biosafety and biosecurity are compatible. One widely used example is the kind of signs each would dictate for display in a labora - tory. For biosafety purposes, good practice would require having a sign on the outside of the laboratory door to alert people that work was going on with a potentially dangerous pathogen; the information would include the name of the agent, any specific hazards, and contact information for the researcher. From a security point of view, displaying this kind of information would only make the task of a would-be thief or saboteur easier. Sharing information about the type of research being carried out and the safety practices in place in a laboratory in the name of open communication and public trust with the surrounding community might also arouse the concern of security professionals who would prefer to see more restricted use of such information.9 2004) and the Organization for Economic Cooperation and Development (OECD 2007) use this more restricted meaning of the term. In an agricultural context, the term refers to efforts to exclude the introduction of plant or animal pathogens. (See NRC 2009a:8-9 for a discussion of this and other issues related to terminology.) Earlier NRC reports (2004ab, 2006, 2009ab) confine the use of “biosecurity” to policies and practices to reduce the risk that the knowledge, tools, and techniques resulting from research would be used for malevolent purposes. The BMBL and this report use the term to cover security for both pathogens and for the information that results from research. 9 To that end, some select agent laboratories do not broadcast their location, even if that infor- mation is considered public. Of course, emergency services and law enforcement are aware of the location and operation of these labs.

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS Despite these types of differences, good biosafety practices can provide an essential foundation for biosecurity.10 But biosafety alone will not provide all of the aspects of good biosecurity, which must also address the risks posed by those with malevolent intent. Responding to these risks while also enabling a vigorous and productive research environment is the challenge to which this report attempts to respond. THE IMPACT ON SCIENTIFIC RESEARCH While the scientific community is vitally concerned about security threats posed by BSAT research, it is also cognizant of the possible unintended con - sequences on the scientific community by overzealous application of policies and procedures implemented in the name of enhanced security. If procedures are beyond that necessary to address the risk, the unintended consequence may be that top scientists are dissuaded from engaging in BSAT research, perhaps especially younger researchers. This will threaten the security of the nation because knowledge of pathogens and the public health measures to protect against them will be diminished. Therefore, the challenge for BSAT research is to implement those measures that promote security and simultaneously fa - cilitate scientific progress in research. Similar concerns apply to others subject to the select agent regulations, including public health professionals who are essential to the nation’s response to biological emergencies. Future discoveries and successful research on select agents specifically— and in the life sciences more generally—depend on a healthy, vibrant, and sustainable research environment. Scientific progress requires that the best and most creative researchers be encouraged to seek out and solve interesting and important problems. This, in turn, requires minimizing the amount of unneces - sary regulation and burdensome recordkeeping, which serve as impediments, and providing clear justification and transparency regarding those adopted for legitimate reasons, such as enhancing security. Science is characterized by the free flow of information and the ability of research scientists to pursue lines of investigation that yield the most promising results. Publishing is the coin of the realm in science, and life scientists conduct research that is published in many thousands of peer-reviewed journals. The vast majority of research—including research with select agents and toxins—is not classified and not subject to restriction with respect to publication. Open exchange of ideas is essential because it encourages researchers to pursue re - search questions in a given area of science, and it allows scientists to share their research findings and follow new directions wherever they lead. For years, when a research project has raised safety or ethical concerns, the 10 Thismay be particularly important in developing countries, where improving biosafety can also bring many other benefits.

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 INTRODUCTION work has been subjected to oversight. In most cases, this has been local to the institution, with committees designated by the federal government to carry out the review. These review committees usually comprise scientific peers and those from other fields of study who have appropriate expertise, as well as representa- tives of the public (see Box 1-1 for examples of oversight committees operated at the institutional level). Where safety concerns extend beyond the institution, national-level bodies provide oversight that is consistent across the country. Most prominent in basic research is the Recombinant DNA Advisory Committee (RAC), established by the National Institutes of Health (NIH) in 1974 in response to public concerns BOX 1-1 Scientific Oversight Committees Several areas of research are monitored by scientific oversight committees. In each case, these committees operate at the level of individual institutions, provid- ing oversight for research conducted at that institution. In most cases, however, they are designated by the federal government, allowing a mix of institutional de- cisions with national reporting and allowing one institution to rely upon decisions made by similar committees at other institutions. These oversight committees comprise scientific peers along with experts in other appropriate fields of study as well as members of the public. Institutional Review Boards (IRBs) are charged with protecting the rights and welfare of human research subjects recruited to participate in research activities. IRBs are required to register with HHS’ Office of Human Research Protections. Institutional Biosafety Committees (IBCs) are charged with reviewing re- search involving recombinant DNA, although many IBCs have chosen to re- view other forms of research that involve potential biohazards—including some BSAT research. IBCs are required to register with NIH’s Office of Biotechnology Activities. Institutional Animal Care and Use Committees (IACUCs) are charged with ensuring the appropriate care and use of all animals involved in research, training, and biological testing by overseeing an institution’s animal program, facilities, and procedures. The existence of IACUCs is stipulated in the Animal Welfare Act. Embryonic Stem Cell Research Oversight (ESCRO) Committees are recom- mended by the National Academies’ Guidelines for Human Embryonic Stem Cell Research to provide ethical oversight on the field of human embryonic stem (hES) cell research (NRC/IOM 2005, 2007, 2008). ESCRO committees oversee all issues related to derivation and use of hES cell lines, review and approve the scientific merit of research protocols, review compliance with relevant regula- tions, maintain registries of hES cell research, and facilitate education of hES cell researchers.

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0 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS about manipulation of genetic materials and use of recombinant DNA tech - nology. The RAC developed and maintains the NIH Guidelines for Research Inoling Recombinant DNA Molecules, which has become the standard of safe scientific practice in the use of recombinant DNA. It also considers other mat - ters relevant to recombinant DNA, including the review of human gene transfer trials or novel protocols that raise new scientific, safety, or ethical consider- ations. Even though the RAC is a federally chartered committee, its members are drawn from the extramural scientific community, i.e., outside NIH. Voluntary guidelines can have a significant impact within the scientific community. For example, there is no legislation mandating the use of the BMBL (CDC/NIH 2007), yet these guidelines are almost universally followed. 11 And the National Academies’ Guidelines for Human Embryonic Stem Cell Research (NRC/IOM 2005, 2007, 2008) has been adopted nationwide, even without federal legal standing.12 Unlike these models, the oversight and screening structures for the Select Agent Program are considerably more substantial than those applicable to other biological research, especially in the involvement of outside oversight bodies and groups not necessarily composed of scientific peers. Moreover, BSAT research is the only area of biological research that requires verifica- tion of personnel beyond assessment of technical competence to carry out the proposed research protocols. For non-BSAT research, there has been no issue as to whether the individual may be trusted not to do harm. Thus, select agent regulations will be unfamiliar to most scientists. Many researchers also may find the regulations to be a significant and unusual burden. Members of the com - munity have expressed concern about the potential impact of the regulations on recruiting and retaining scientists for select agent research—as well as public health professionals for detecting and responding to biological emergencies (e.g., HHS 2005; ABSA 2009; FASEB/AAMC 2009). Scientific careers often involve protracted mentored training, not to men - tion the pressure to produce publishable findings. With biomedical research - ers now on average well into their 40s before receiving their first independent research grant (NRC 2005), severe disincentives to pursue research careers already exist, and an additional burden placed on those who pursue research on select agents further challenges their decision to follow a career that involves select agents and toxins. During a visit to the New England Regional Center of Excellence, for example, the committee learned that a significant majority of 11 Although several parts of the BMBL are used by CDC and APHIS in enforcing the select agent regulations, the guidelines are utilized much more widely than these required elements, including in laboratories outside of the United States. 12 Even though the National Academies’ Guidelines have no federal standing, several states have incorporated aspects into state-level, legally binding regulations, and some research sponsors simi - larly require compliance for their grantees.

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 INTRODUCTION graduate students who began the clearance process to work with select agents did not complete all steps necessary.13 Finally, the committee has learned of a number of researchers at several institutions who chose to destroy their inventories of select agents and toxins rather than incur the cost and inconvenience of the security requirements and personnel screening of the Select Agent Program (e.g., Wilkie 2004). These research scientists chose to pursue other interesting research questions, rather than go through the arduous task posed by working with select agents and toxins. THE CONTEXT FOR THE CURRENT PROJECT: EXECUTIVE ORDER 13486 Concerns about whether the regulations in place for BSAT research in U.S. laboratories were adequate to address the risks of theft, misuse, or diver- sion of materials increased after the FBI announced in August 2008 that it had concluded that Bruce Ivins, a research scientist at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), was the perpetrator of the anthrax letter attacks in October 2001 (FBI 2008). There were other concerns from Congress and elsewhere about whether the “proliferation” of high containment laboratories as part of the increased funding for biodefense research after 2001 was increasing the risks of laboratory accidents as well as providing more targets for those who could pose security threats from either outside or inside the facilities (e.g., GAO 2007, 2008). The release of the report of the Congressionally chartered Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, chaired by former senators Bob Graham and Jim Talent, drew additional attention to the perceived risks. The Commission’s report, World at Risk, began its Executive Summary with the ominous conclusion that: …unless the world community acts decisively and with great urgency, it is more likely than not that a weapon of mass destruction will be used in a ter- rorist attack somewhere in the world by the end of 2013. The Commission further believes that terrorists are more likely to be able to obtain and use a biological weapon than a nuclear weapon. The Commission believes that the U.S. government needs to move more aggressively to limit the proliferation of biological weapons and reduce the prospect of a bioterror attack. (WMD Commission 2008:xv) 13 According to representatives of the laboratory, only about two of the 20 students who began the training and clearance process completed it.

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS The Commission recommended a number of steps to increase security at all U.S. high containment laboratories, not just those conducting BSAT research. As part of the response to the various calls for increased regulation of high containment laboratories and BSAT research, President George W. Bush is- sued Executive Order (EO) 13486, Strengthening Laboratory Biosecurity in the United States, on January 9, 2009 (White House 2009). The EO established an interagency Working Group on Strengthening the Biosecurity of the United States, charged with conducting a comprehensive assessment of the efficiency and effectiveness of all laws, regulations, guidance, and practices related to physical, facility, and personnel security and assurance for BSAT research. The heart of the group’s report, submitted to the President within 180 days (i.e., by July 9, 2009), would provide “recommendations for any new legislation, regula- tions, guidance, or practices for security and personnel assurance for all Federal and nonfederal facilities … and options for establishing oversight mechanisms to ensure a baseline standard is consistently applied for all physical, facility, and personnel security and assurance laws, regulations, and guidance at all Federal and nonfederal facilities…” (White House 2009). These recommendations would be supplemented by another extensive interagency review of biosafety practices being conducted by the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight.14 To provide additional input, the Homeland Security Council staff at the White House requested two other studies. The first, which focused only on personnel reliability, was carried out by the National Science Advisory Board for Biosecurity (NSABB) and issued in May 2009 (NSABB 2009). The second study was requested from the National Research Council (NRC), resulting in this report.15 In addition to the reports that provide formal input into Executive Branch deliberations, a number of other relevant reports have been issued in recent months. The Defense Science Board (DSB) released a report in May 2009, focused on the Department of Defense Biological Safety and Surety Program (DSB 2009). The Defense Health Board (DHB) issued a report in April 2009 that addressed whether the military services needed to own and operate their own biodefense infrastructure and research program, which affects whether and how it carries out physical security and personnel reliability programs (DHB 2009). Two workshops on education by the American Association for the Advancement of Science (AAAS), one on so-called dual use education (AAAS 2008) and one focused on biosafety training (AAAS 2009), offered a 14 Further information about the Trans-Federal Task Force, including a copy of its report (Trans-Federal Task Force 2009), may be found at . 15 The leadership of the National Interagency Biodefense Campus was also involved in requesting this study, which was conducted through a contract with NIAID.

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 INTRODUCTION number of findings and recommendations related to how the training could support personnel reliability.16 These reports, as well as numerous meetings and discussions, have contributed to a lively and sometimes heated discussion of appropriate approaches to optimizing the security and the quality of BSAT research. CHARGE TO THE COMMITTEE The NRC appointed a committee with a broad range of expertise to carry out its statement of task, which is reproduced in Box 1-2 (short biographies of the committee members and project staff are contained in Appendix A). The committee focused its attention on the environments in which BSAT research is conducted, which are a subset of the facilities cleared to work with select agents and toxins. While other entities such as state and local public health laboratories are subject to the select agent regulations, most do not have research as their primary focus. The committee carried out its work over approximately 3½ months, with two in-person meetings and several site visits, as well as conference calls to begin and conclude its work. A list of the meetings and site visits, including the briefings received by the committee, are contained in Appendix B. The com - mittee considered not only the experiences of select agent laboratories, but also related experiences in other sectors including nuclear power plants, academic nuclear research reactors, and the aviation industry—all of which have been concerned about personnel reliability for some time. In the end, time constraints meant that the committee could not give equal attention to all elements of its task. Therefore the committee decided to con - centrate on a set of issues that it believes are the most important, most critical, and most effective for both providing security and enabling the highest quality research to be carried out in an environment that can attract and retain the best scientists. The focus of the report was also informed by the elements that had prompted the greatest amount of discussion within the scientific community and at the public consultations organized by the NSABB and EO Working Group. There are two other items that elicited significant interest in the public consultations but that could not be considered in this report. The committee believes these are essential to the safe conduct of BSAT research, but time did not allow a thorough review and assessment: • Transportation of Select Agents Some have identified transportation of select agents and toxins as the weak link in security procedures. Agents taken from one highly secure facility to another may be at risk for 16 Theterm “dual use” refers to research that, although carried out for beneficial purposes, could yield knowledge, tools, or techniques with the potential to be misused to cause deliberate harm.

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS BOX 1-2 Committee Statement of Task An ad hoc committee will assess the efficacy of regulations, procedures, and oversight that have been instituted to safeguard the public and national security against the deliberate use of biological select agents and toxins (BSAT). The assessment will spe- cifically take into account programs for laboratory security to protect against external threats and, in particular, personnel reliability assurance programs (protection against internal threats). The committee will not address biosafety (protection against acci- dental releases) except to the extent that biosecurity impinges on biosafety measures. The committee will also assess the impact of biosecurity policies and regulations on the ability of the scientific community to conduct BSAT research. The committee will evaluate progress since 2001 and identify opportunities for the U.S. government to optimize the balance between controlling and mitigating security risks associated with BSAT research and ensuring the benefits of BSAT research for force and public health protection. The committee’s conclusions and recommendations will be designed to inform policy discussions in the United States regarding necessary steps to balance the security risks and benefits of BSAT research and to harmonize policies across the government, including government-funded extramural research. Based on expert knowledge of the current oversight systems for BSAT research, in- formation gathered in the course of the study about the specifics of the programs that have been implemented by each of the federal agencies with active BSAT research programs, and information about personnel assurance programs outside the federal government that might offer useful models or practices, the committee should: theft during transportation because security during this process may be minimal. In addition, the physical security solutions and workforce involved in transporting select agents may not adhere to the require- ments for select agent facilities (described in Chapter 2). The committee did not have the time to fully explore this issue, especially because shipping requirements are based upon international standards regarding the transportation of hazardous materials. There - fore, any changes to transportation procedures for select agents could have unintended consequences for shipping of other materials and could unintentionally complicate the international exchange of bio - logical materials. • Cybersecurity Because many of the physical security solutions depend on technology—such as cameras, electronic access cards, electronic inventory systems—there is a risk posed by those individuals able to hack into these command and control systems. To the extent that these systems may not be fully secure, additional risks exist.

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 INTRODUCTION 1. Develop a set of principles and questions to be addressed in developing a frame- work to guide programs that provide and oversee laboratory security and personnel reliability systems for BSAT research. This framework should optimize benefits, minimize risk, and facilitate the productivity of research. 2. Review and assess the efficacy and cost/benefit of similar laboratory security, per- sonnel reliability, and BSAT accountability programs of federal agencies to explore best practices across the federal government. The review should consider the implementation of existing legislation, regulations, guidance, policies, and practices as they relate to both federal laboratories or programs and research facilities at representative extramural laboratories funded by government programs. The assessment will include potential impacts on the ability to attract and sustain quality scientists to conduct research on BSAT and identification of factors respon- sible for barriers to research on BSAT in the extramural environment. The committee will make recommendations for refining existing programs and procedures affecting both intramural and extramural facilities that will achieve greater productivity in research objectives, optimize management to reduce risk, and produce improved uniformity, transparency, and efficiency in research on BSAT. 3. Make recommendations to inform policy decisions for achieving an effective system for oversight to ensure compliance with these programs and procedures. The committee may consider examples of facility security and personnel assurance programs in other settings, including those from outside the BSAT domain and those outside the federal government, that might offer lessons or best practices. The committee’s conclusions and recommendations were developed inde - pendent of the other reports on these topics including those identified above, although the committee did have access to those reports that had been released while the committee was engaged in its work (AAAS 2008, 2009; DHB 2009; DSB 2009; NSABB 2009). The committee did not have access to the reports from the EO Working Group or the Trans-Federal Task Force, which had not been released before the completion of this report. ORGANIZATION OF THE REPORT After the brief introduction to the issues addressed in the report in this chapter, Chapter 2 contains basic factual material describing the current regu - latory environment including the development and operation of current U.S. policies to govern BSAT research, a review of other federal regulations related to BSAT research, and a brief discussion of how BSAT research is regulated in other countries. Chapter 3 sets out some basic principles that guided the

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6 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS committee in selecting those issues it chose to emphasize and in reaching its conclusions and recommendations. Chapters 4 and 5 discuss specific issues and offer the committee’s analysis and assessments, including its conclusions and recommendations.