3
Guiding Principles for Science and Security

This chapter proposes a set of guiding principles on how research with biological select agents and toxins (BSAT) should be viewed and conducted. These principles provide the lens through which the committee considered the specific concerns of laboratory security and personnel reliability discussed in Chapters 4 and 5.

PRINCIPLE 1: Research on biological select agents and toxins is essential to the national interest.

BSAT research is invaluable in addressing national priorities such as national security and public health. Each of the 80+ items included on the list of select agents and toxins compiled by the U.S. Department of Agriculture and Department of Health and Human Services has the potential to pose a significant threat to the health of the public or to plants or animals. Research which enhances our understanding of these agents and toxins can help diminish the threat they pose. For example, the highly successful campaign to eradicate smallpox followed from an aggressive vaccination strategy that essentially eliminated the variola virus that causes smallpox from the wild. It also enabled the United States to stockpile sufficient quantities of the smallpox vaccine to vaccinate every person in the country in the event that large-scale vaccination was ever needed. The eradication of smallpox from natural populations and stockpiling of vaccine would not have been possible without research on this dangerous select agent.

BSAT research is almost certain to have benefits both for public health and for national security. Discovery of vaccines or treatment strategies enables both preventive action and rapid response in the wake of an outbreak. Enhanced



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3 Guiding Principles for Science and Security This chapter proposes a set of guiding principles on how research with biological select agents and toxins (BSAT) should be viewed and conducted. These principles provide the lens through which the committee considered the specific concerns of laboratory security and personnel reliability discussed in Chapters 4 and 5. PRINCIPLE 1: Research on biological select agents and toxins is essen- tial to the national interest. BSAT research is invaluable in addressing national priorities such as na - tional security and public health. Each of the 80+ items included on the list of select agents and toxins compiled by the U.S. Department of Agriculture and Department of Health and Human Services has the potential to pose a significant threat to the health of the public or to plants or animals. Research which enhances our understanding of these agents and toxins can help dimin - ish the threat they pose. For example, the highly successful campaign to eradi - cate smallpox followed from an aggressive vaccination strategy that essentially eliminated the variola virus that causes smallpox from the wild. It also enabled the United States to stockpile sufficient quantities of the smallpox vaccine to vaccinate every person in the country in the event that large-scale vaccination was ever needed. The eradication of smallpox from natural populations and stockpiling of vaccine would not have been possible without research on this dangerous select agent. BSAT research is almost certain to have benefits both for public health and for national security. Discovery of vaccines or treatment strategies enables both preventive action and rapid response in the wake of an outbreak. Enhanced 6

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0 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS technology to detect and diagnose the presence of select agents in a patient or in an environment will greatly enhance our ability to respond to—and potentially contain—the release of the agent, whether it occurs from natural infection or the deliberate use of select agents.1 At the same time, enhanced understanding of these agents and the ability to prevent or mitigate their effects diminishes the potential impact of these agents, and thereby decreases their value as a potential terrorist weapon. PRINCIPLE 2: Research with biological select agents and toxins intro- duces potential security and safety concerns. Because BSAT materials can pose such a severe threat to health and the environment, institutions housing BSAT laboratories must do everything in their power to prevent the release of these dangerous pathogens, whether by accident or deliberate act. In fact, many of the elements of a biosafety labora - tory are designed for just this purpose, but there are steps, in addition to safety procedures, that can be taken in the name of security. The potential for use of BSAT materials in criminal or bioterrorist acts cannot be disputed. Carus (2001) has identified a number of confirmed uses of biological agents in the conduct of criminal or terrorist acts. While many in - volved materials not on the select agent list, several did involve the use of select agents and toxins, including Bacillus anthracis (anthrax), ricin toxin, Yersinia pestis (plague), botulinum toxin, and Burkholderia mallei (glanders)—which cause disease in both animals and humans. Bioagent cases are not new, extend- ing back to the 1900s and even earlier in human history. This emphasizes the need for robust security infrastructure designed to prevent unauthorized access to select agents facilities and to the agents them - selves, as well as appropriate procedures to guard against potential insider threats, beyond those that are customary in non-select agent research. The specific security requirements should be based upon a risk analysis applicable to the particular situation and environment. Many of these procedures will also protect personnel working with select agents, as well as others, from accidental exposure in the laboratory or in the surrounding community. PRINCIPLE 3: The Select Agent Program should focus on those biologi- cal agents and toxins that might be used as biothreat agents. As described in more detail in Chapter 2, the listing of select agents and toxins is motivated primarily by concerns about security, not about safety. 1 For example, the BioWatch program includes a network of monitoring units to detect the presence of harmful agents (see IOM/NRC 2009 for an interim report from an ongoing National Academies evaluation).

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 GUIDING PRINCIPLES FOR SCIENCE AND SECURITY Although safety concerns are present with any human pathogen—and environ - mental concerns with plant and animal pathogens—inclusion of an item on the list of select agents and toxins means that it poses a security risk—namely, there is reason to believe that it could be used as a potential bioweapon. Stated another way, the requirements for select agent research, includ - ing both personnel reliability and physical security, are motivated by—and indeed, designed to enhance—security, not safety. There is no need for secu - rity strategies unless security is the predominant consideration. Addition of unnecessary procedures will inevitably slow the development of vaccines and therapeutics—and even the public health response in the event of a biological emergency—with the unintended consequence of making the public less safe. With these considerations in mind, the committee takes as a guiding prin - ciple that items on the list of select agents and toxins should be limited to those materials that there is reason to believe could be used as a potential biothreat agent. In addition, there should be reason to believe that enhanced security could reduce the risk of that agent being used as a bioweapon. Discussion throughout this report takes this observation as a given, and all conclusions and recommendations are based on interpreting the list of select agents and toxins—whatever its composition—as those items that pose a legitimate secu - rity risk. PRINCIPLE 4: Policies and practices for work with biological select agents and toxins should promote both science and security. It is common to talk about the need for a “balance” between science and security. However, this committee rejects the notion that science and security are inversely related and that there is an inherent tension between these two elements. While there may be specific circumstances when a particular ac- tion conducted to enhance security may be seen at odds with the conduct of scientific research, the two aims are not fundamentally opposed. Rather, the policies that support science and those that promote security operate in differ- ent but overlapping spheres. The goal for this report and for the community is to optimize the mix of policies that promotes both high-quality science and appropriate security. PRINCIPLE 5: Not all laboratories and not all agents are the same. As described in Chapter 2, there is significant diversity among those institu- tions that conduct BSAT research. Academic, government, and private-sector select agent laboratories span a wide range in mission, size, type of research, level of activity, and many other characteristics. Colloquially, “if you’ve seen one lab, you’ve seen one lab.” While this phrase may downplay the common elements found in multiple environments, it is critical to acknowledge that each

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS setting has its own unique set of circumstances and issues. This speaks to the continued need for site-specific risk assessments and security approaches with enough flexibility to both promote security and safety and properly address the characteristics specific to that institution. It is also critical to recognize that not all select agents and toxins are the same, nor do they all pose the same risks. This speaks to the need for a graduated set of risk-based policies and practices that adequately addresses the specific needs of each facility and program, as opposed to a one-size-fits-all approach that is not optimized for any given setting. PRINCIPLE 6: Misuse of biological materials is taboo in every scientific community. Despite diversity in the facilities and agents used in BSAT research, there is a shared ethos throughout the scientific community that any misuse of biologi- cal materials is taboo. The intentional use of disease to cause harm is contrary to the fundamental goals of the life sciences to contribute to the welfare of all living things and to the safety of the environment. The use of biological materi - als as a weapon is simply not accepted as legitimate by almost every scientist and country: no reputable scientist or scientific organization would purposely perpetrate an action that puts the public at risk.2 These principles have been enshrined in numerous international agree- ments (see discussion in Chapter 2), and they are seen to be absolute. The sci - entific community has a responsibility for helping to make sure that the misuse of biological materials remains taboo. Individual scientists cannot be expected to do the impossible, so scientists cannot be expected to ensure that the knowl- edge they generate will never contribute to the advancement of biowarfare or bioterrorism. But scientists can and should be expected to take reasonable steps to reduce the risk that their science, and the results of life sciences research more generally, could be misused. Scientists, and the scientific community more broadly, can exercise this responsibility in many ways. Individual awareness is important, as is education and training to create and maintain a culture of trust and responsibility that is central to sustaining good scientific conduct. Professional societies play an essential role, through their own training programs, by promoting responsible behavior through codes of conduct, and by supporting policies and practices that can help reduce the risks of misuse. 2 To be sure, there may be some discussion about which experiments are risky, but there is general agreement that the science itself should not be misused.