Potential Risks and Benefits of Gain-of-Function Research Summary of a Workshop (2015) / Chapter Skim
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5 Potential Risks: Biosafety and Biosecurity
5 Potential Risks: Biosafety and Biosecurity
Pages 47-64
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From page 47... ...
These were as follows: • The properties of newly created strains, their consequences, and alternative approaches; • Science and technology (S&T) trends over time; • The global distribution of risks and benefits, their relative weights, and questions of justice; • The types of possible misuse, in particular safety and security; • Moral and ethical responsibilities of scientists and issues of public trust; and • Risk assessment and mitigation But he began by stressing that he believed there was substantial agreement on a number of points, both by many at the symposium and within the larger scientific community.
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From page 48... ...
Such research is consequential because in some cases there are not adequate countermeasures available to thwart or contain these agents, and the results could be used in further research in less secure settings. He acknowledged that there are also potential risks in not doing experiments, but the question is how large they are and argued that there are ways of trying both to anticipate and address this concern.
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From page 49... ...
The discussion of potential risk is thus about safety and security. He underscored the range of motivations in the life sciences beyond a quest for knowledge or to help people.
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From page 50... ...
This should include support for democratic and deliberative processes of decisionmaking. Furthermore, modern science, much of which is funded by the public, demands consideration of morality because of the increasingly blurred line between basic and applied science.
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From page 51... ...
She asked how the National Science Advisory Board for Biosecurity could structure a more capacious and robust risk/benefit analysis that would capture some of these additional value considerations. Relman suggested that particular pieces of useful experience from other circumstances where scientists had to deal with difficult to quantify potential risks, such as the nuclear power industry or the creation of airplanes or even variability in the infectious disease community, all are worth capturing.
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From page 52... ...
Johnson provided information on the actions that had been taken in the United States in response to the recent spate of incidents. At the CDC, these included suspension of activities, review and remediation of all procedures, verification of adequate inactivation procedures, strengthening of biosafety agency-wide, the formation of an external group of experts to review and advise CDC, improvement of management of internal incidents, investigation of root causes and personnel issues, and a new requirement for single point of contact to be established for biosafety issues.
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From page 53... ...
H5N1 avian influenza and SARS-CoV are both classified as Select Agents and are subject to stringent regulation, but MERS-CoV has not yet been brought under this particular regulatory umbrella. Finally there are also the Recombinant DNA Advisory Committee at the NIH, which has oversight for certain kinds of experimental approaches, and the NSABB, which advises the NIH on policy.
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From page 54... ...
. The Program oversees the possession, use, and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal, or plant health or to animal or plant products.1 Weyant explained that the Select Agents and Toxins regulations require that any theft, loss, release causing an occupational exposure, or release outside of primary biocontainment barriers must immediately be reported to CDC or APHIS as well as to the appropriate federal, state, or local law enforcement agencies.
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From page 55... ...
She noted that "Select Agent research at the University of Wisconsin is considered a privilege, not a right." The UW IBC had a thorough discussion of Kawaoka's research before it was funded and approved the risk mitigation measures he proposed. Since the beginning of 2006, his influenza research protocol has been reviewed more than 40 different times.
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From page 56... ...
• Kawaoka has an elaborate exposure control plan that was devel oped in conjunction with UW health services and infection dis ease physicians and state, county, and city public health agencies. All researchers receive seasonal influenza vaccines as well as thermometers at home.
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From page 57... ...
He went through a series of calculations that he believes demonstrate that a release of an H5N1 or other pandemic influenza strain enhanced through GoF research to increase its transmissibility among mammals could result in a 0.01 percent to 0.1 percent chance of 2 million to 1.4 billion fatalities, or an expected death toll of 2,000 to 1.4 million per BSL-3 laboratory-year based on the Select Agent data LAI rate. Using the NIAID data, each full-time person-year of GoF research in a BSL-3 lab could produce a death toll of 10,000 to 10 million.
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From page 58... ...
Jim Welch of the Elizabeth R Griffin Foundation also agreed that there is a need to develop a repository for biosafety best practices, particularly with regard to LAIs, beyond simply Select Agents, where the option of noncompliance does not exist because you will be shut down by the CDC.
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From page 59... ...
Thus, while providing a foundation upon which to build biosecurity capacity, biosafety measures, in and of themselves, cannot fully address biosecurity risks. Consequently, some participants, such as Ed You of the Federal Bureau of Investigation, noted that both the biosafety and biosecurity environments are important to consider in any risk assessment, taking into account the organism/pathogen and its weaponization potential, capability (including both scientific knowledge, tacit knowledge, and technological know-how)
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From page 60... ...
Taken together, this means that any assessment of potential biosecurity risks would have to acknowledge and deal with substantial uncertainties across most, if not all, major parameters SPECIFIC TOPICS FOR CONSIDERATION Koblentz noted that today's concerns regarding possible biosecurity risks associated with GoF research in the United States are rooted in biosecurity risk discussions that stemmed from several events that occurred in the mid-1990s: the sarin gas attack in the Tokyo subway in 1995; the bombing of the federal building in Oklahoma City in 1995; and the 1995 attempts by Larry Wayne Harris to acquire plague samples through the mail. Koblentz offered an approach for assessing biosecurity risk, stating that risk assessment is a judgment about the likelihood that an event will occur and the consequence of that event: Risk = Threat (Capability + Intent)
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From page 61... ...
terrorists take risks and experiment with new ways to cause harm and death; 3. terrorists have employed increasingly lethal measures over time; 4.
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From page 62... ...
Koblentz thus argued it was essential to surface these assumptions early in any risk assessment process. Gronvall offered six key points to consider in any assessment of biosecurity risks stemming from GoF research: 1.
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From page 63... ...
He also suggested looking beyond the WHO to consider the convening capacity of the Biological Weapons Convention and the relevance of the Convention on Biological Diversity for some issues. Evans commented that any deliberative process going forward would need to recognize the possibility of incommensurate values regarding the bounds of public health value, the value of innovation, and the value of security.
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From page 64... ...
Too often much of the focus is on the scientist who is actually following the rules, as opposed to the individual who will not follow the rules, which should be of greatest concern. The core of the GoF issue is that someone might use the results to cause harm, and how to include that risk in the overall risk assessment.
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