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Risks, Trade-Offs & Responsible Science

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Risks, Trade-Offs & Responsible Science 21ST CENTURY BIODEFENCE: RISKS, TRADE-OFFS & RESPONSIBLE SCIENCE The dramatic increase in the number of laboratories and scientists working on dangerous pathogens and toxins has exacerbated safety and security risks By Gregory Koblentz & Filippa Lentzos Paper No 3 of 3 BWC Review Conference Series #BWCRC8 ▪ There has been a dramatic increase in biodefence activities and in the number of facilities and researchers working with dangerous pathogens around the world. ▪ This has generated a number of trade-of risks related to safety, security, responsible science and transpar- ency. ▪ The 2016 BWC Review Conference must encourage states to implement stringent national biosafety, bios- ecurity and dual-use research regulations; task the science advisory group to develop clear, internationally- recognised guidelines governing dual-use research of concern (DURC); establish a working group to revise the CBMs; and encourage states to participate in the CBM mechanism as well as more interactive information exchanges such as peer review and compliance assessment. The biodefence boom Over the last two decades, there has been a dra- or the environmental release of a pathogen. matic increase in biodefence activities and in These laboratories might be run by the military the number of facilities and researchers work- or public health agencies or be privately-owned ing with dangerous pathogens around the facilities working on government contracts. world. The biodefence activities of greatest rel- evance to the Biological Weapons Convention Declarations about biodefence programmes (BWC) are those that involve scientifc research were frst introduced on the BWC Confdence on dangerous pathogens that could be used as Building Measures in 1992. That year, 13 states weapons, activities to assess the threats posed declared programmes. In 2004, 22 states de- by such pathogens, and capabilities for test- clared programmes. In the most recent submis- ing the efcacy of medical countermeasures. sions, 29 countries declared biodefence pro- Most of these activities occur in laboratories grammes. equipped with special biological safety features to prevent accidental infections of researchers Gregory D. Koblentz, PhD, is an Associate Professor and Director of the Biodefence Graduate Programme in the Schar School of Policy and Government at George Mason University. Filippa Lentzos, PhD, is a Senior Research Fellow in the Department of Global Health & Social Medicine at King’s College London. 2 Concerns about bioterrorism and emerging in- around the world as countries upgrade their fectious disease have also triggered a construc- public health infrastructure, but exact numbers tion boom in high biocontainment laboratories, are unknown. called biosafety level 4 (BSL4) labs, around the world. There are thirteen BSL4 laboratories in operation or under construction in the United The antiviral drugs and States and at least twenty-four such laboratories vaccine candidates deployed in operation in the rest of the world.2 In addi- tion, there are more than 1400 BSL3 laborato- to Western Africa in response ries registered to work with dangerous human, to the recent Ebola outbreak plant, or animal pathogens in the United States.3 originated in the US Such laboratories are increasingly common biodefence programme.4 Risks associated with biodefence The biodefence research boom has increased ently released from labs run by the Centers for risks in four domains: biosafety, biosecurity, Disease Control and Prevention (CDC), National dual-use research and BWC compliance. Sound Institutes of Health (NIH), and Dugway Proving biodefense policy must continually evaluate Ground. Lesser breaches don’t usually make it these trade-of risks in decisions on how best to into newspapers, but their sheer volume led one prevent, prepare for and respond to existing and newspaper to publish a series of reports docu- emerging biological threats.5 menting hundreds of accidents, safety viola- tions and near misses at public and private re- BIOSAFETY RISKS search facilities in the United States.8 One of the key risks from increased biodefence activities and increased numbers of facilities A thorough investigation in and researchers working with dangerous patho- the UK revealed more than gens is that pathogens are accidentally released from a laboratory. Accidental releases include 100 accidents or near-misses accidental infections of laboratory workers who at the high security labs that then transmit the disease to members of the handle the most dangerous community, a breach of containment that al- lows a pathogen into the environment, and the viruses and bacteria in escape of an infected animal from a lab. Britain.9 There has been a series of high-profle breach- A major biosafety concern with implications es in recent years where dangerous pathogens for public health is that a labora- have been improperly handled by or inadvert- BOX 1 WHAT IS BIODEFENCE? ‘Biodefence’ has traditionally been defined narrowly to describe military bioweapon programmes. But in recent years a broader definition tends to be adopted, encompassing activities to prevent, prepare for and respond to large-scale biological threats to both civilian and military populations from natural disease outbreaks, bioterrorism and biological warfare. The broader definition incorporates research and develop- ment related to prophylaxis, studies on pathogenicity and virulence, diagnostic techniques, aerobiology, detection, treatment, toxinology, physical protection and decontamination. At present, roughly one-third of the States Parties declaring national biodefence research programmes in their CBM submissions also report civilian research. For the remaining two-thirds of States Parties, it is not clear whether they have construed the request for information to apply only to military programmes, or whether they do not have biodefense research programmes conducted by civilians aimed at protecting the civilian population.1 3 tory accident could introduce a novel disease DUAL-USE RESEARCH RISKS or reintroduce a contagious disease that has al- ready been eradicated or otherwise contained. A diferent type of security risk is that the The last known cases of smallpox and SARS, for knowledge and methods used to understand example, were both caused by laboratory expo- and manipulate the biological and epidemio- sures, and both viruses were able to spread from logical properties of pathogens for peaceful pur- infected researchers to a small number of indi- poses is misused.13 Advances in science have the viduals outside of the laboratory.10 potential to provide new knowledge and tools to national militaries, international terrorist net- BIOSECURITY RISKS works, criminal groups, religious extremists, disgruntled or mentally ill scientists, or even ‘bi- Another key risk is that pathogens or other re- ohackers’—do-it-yourself biologists who aren’t lated material are stolen from a laboratory, and necessarily motivated by politics or religion, that insiders use their special knowledge and but by curiosity, revenge, greed or boredom.14 skills for malevolent purposes. Biodefence research on dangerous pathogens is especially susceptible to this ‘dual-use dilemma’ The dramatic increase in the number of labo- since it is frequently focused on studying char- ratories and scientists working on dangerous acteristics such as infectivity (ability of a micro- pathogens and toxins has created more oppor- organism to infect a host), pathogenicity (ability tunities for these agents to be stolen. Histori- of a microorganism to cause disease), virulence cally, laboratories and culture collections have (severity of the disease caused by the organism), been the preferred source of pathogens and tox- and transmissibility (ability of the pathogen to ins for terrorists and criminals; there is no evi- spread from person to person). dence that any terrorist or criminal group has successfully acquired a pathogenic microorgan- Early high-profle experiments that raised du- ism from nature.11 al-use concerns aimed to make mousepox—a skin disease of mice, similar to smallpox—more The increased number of individuals with ex- deadly, synthesize poliovirus from scratch and pertise that could be misused also poses a risk. reconstruct the extinct 1918 fu virus that may According to the Federal Bureau of Investiga- have killed as many as 100 million people. More tion (FBI), Bruce Ivins, a scientist at the US Army recently, entire felds of biological research have Military Research Institute of Infectious Diseas- raised concern. These include potentially pan- es (USAMRIID), the US military’s premier bio- demic pathogen research, synthetic biology, ge- defence facility, was the sole perpetrator of the nome editing, and neurobiology.15 2001 anthrax letter attacks in the United States that sickened 17 and killed fve.12 BOX 2 BIOSAFETY V. BIOSECURITY The terms ‘biosafety’ and ‘biosecurity’ have multiple meanings. In the context of biodefense, biosafety re- fers to measures taken by a laboratory to prevent the transmission of biological agents to researchers, the community and the environment. In the context of the BWC, biosecurity refers to “the protection, control and accountability measures implemented to prevent the unauthorized access, retention, loss, theft, mis- use, transfer, diversion or intentional release of biological agents and toxins.”6 A simple formulation that helps to distinguish between biosafety and biosecurity in the laboratory context is that biosafety protects people
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