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Rethink Biosafety

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Rethink Biosafety COMMENT BIOETHICS Four questions face CANCER A stirring memoir HISTORY Kepler cast women EMISSIONS Russia’s coast holds delegates of gene-editing of crude therapies and as knowledge-makers to rich potential for renewable- summit p.159 internecine politics p.162 save his mother p.164 energy generation p.165 DOUGLAS C. PIZAC/AP/PA IMAGES DOUGLAS C. PIZAC/AP/PA Biosafety-level-3 protection at the US Army’s Dugway Proving Ground, Utah. Rethink biosafety Tim Trevan calls on those working with organisms that are hazardous, or could be so, to take lessons from the nuclear industries, hospitals and other sectors that have established a safety culture. wo months ago, the US Department workers at a US Centers for Disease factors meant that 41 people were potentially of Defense froze operations at nine Control and Prevention (CDC) biosafety- exposed to live bacteria1. Then in May biodefence laboratories where work level-3 laboratory in Atlanta, Georgia, sent this year, an investigation revealed that for Tis done on dangerous pathogens. Inspec- anthrax samples to three other laboratories several years, staff at Dugway had been tors had discovered live anthrax outside a on the same campus. The samples were improperly sterilizing anthrax samples, containment area at the US Army’s Dugway meant to have been sterilized but several and that live spores may have been sent to Proving Ground — a facility in Utah that 52 laboratories in the United States, Canada, tests defence systems against biological and CRISPR GENE EDITING Australia and South Korea. chemical weapons. A Nature collection These mishaps — which are by no The discovery at Dugway is the latest nature.com/crispr means unique to anthrax — are worry- of several concerning finds. In June 2014, ing on two levels. First, the handling of 12 NOVEMBER 2015 | VOL 527 | NATURE | 155 © 2015 Macmillan Publishers Limited. All rights reserved COMMENT FOLLOW THE LEADER Hospitals throughout the United States are taking steps to become ‘high-reliability organizations’ (HROs). The US Centers for Disease Control and Prevention (CDC) should follow suit. 25% reduction in 80% reduction in Increased eciency Reduction in number KEY mortality rate in patients errors in patient care and reduced costs for of infections OBJECTIVE admitted with sepsis. over two years. medication dispensing. following surgery. 187–191 (2008); AHRQ, USDHHS 187–191 (2008); AHRQ, USDHHS 34, ET AL. JT COMM. J. QUAL. PATIENT SAF. SAF. AL. JT COMM. J. QUAL. PATIENT ET + + + + CHRISTIANA SENTARA EXEMPLA CINCINNATI’S ARE C OSPITAL LUTHERAN CHILDREN H EDICAL HOSPITAL YSTEM HOSPITAL M S ENTER C SOURCES: M. T. ZUBROW ZUBROW M. T. SOURCES: per 100 RESULT procedure 49% US$0 million 62% from 0.76 to 0.30 days reduction in mortality rate reduction in insurance claims decrease in stocked but class II (deep incisional) in 3 years over a 3-year period unused medications infections reduced dangerous pathogens within a controlled shutdown of important research, that areas, best practice focuses on preventing environment is one of the easier biological mindset must be transformed. failure rather than on maximizing output. risks to contain. Much harder is ensuring I never thought I’d write this, but I believe The result is what is called a ‘high-reliability that basic biological research that is known that it is time for experts who advise on organization’ (HRO). to be potentially dangerous, or that turns biosafety and biosecurity to learn from spe- HROs feature the following five charac- out to be so, is carried out safely. Second, cialists in nuclear security. I define biosafety teristics2. First, everyone within the organi- it is only going to get harder to ensure the and biosecurity as the prevention of the acci- zation constantly asks, ‘What can go wrong safe and secure use of organisms and their dental release of potentially harmful organ- and how do we prevent it?’ Second, work- products — whether in basic research or in isms or their products and the prevention ers are sensitive to any deviation from the detecting and preventing the development of the deliberate release of such agents for norm, such as an unexpected change in the of biological weapons. nefarious purposes. Leaders in these areas temperature of the reactor core in the case Relatively inexpensive and easy-to-use include the CDC, the World Health Organi- of a nuclear power plant, and learn to ascer- tools and approaches are greatly expand- zation (WHO), and Public Health England tain which variances can snowball into cata- ing the possibilities for genetic engineer- in the United Kingdom. strophic failure. Third, systems are designed ing, including for would-be terrorists. to be resilient so that if they do fail, they do Among them are the gene-editing technique OUTSIDE THE BOX so with minimal damage and recovery can CRISPR/Cas9, and the use of gene drives — The reluctance of those of us in biosecurity be quick. Fourth, workers recognize that where the biased inheritance of particular and biosafety to learn from the nuclear the operating environment is complex and genes alters entire populations. Meanwhile, industry stems from the fact that many of changeable, and that mindlessly following myriad developments are undermining the practices in nuclear security and safety standard procedures without paying atten- existing approaches to non-proliferation. are not transferable to biology. For instance, tion to what else is going on in the environ- These include: the sale of equipment and monitoring the amount of materials enter- ment can be dangerous. Lastly, expertise is materials over the Internet; the accessibil- ing and leaving a complex makes little sense valued over seniority, with the recognition ity of computing power; and the rise of the when a tiny sample can contain militarily that it may be the newest or most junior open-science movement. significant amounts of a hazardous sub- member of a team who spots a problem or What are the prospects for managing the stance. And expensive security measures who knows best how to fix it. more intractable risks globally if measures — guns, gates, guards and cameras — make In HROs, safety is not ‘for them’ but ‘for to ensure the safe handling of dangerous sense at nuclear power plants, of which each and every one of us’, and is seen as an pathogens are failing at the best-equipped there are only a few hundred worldwide. investment rather than a short-term cost. facilities in the country with the most They are not feasible at the much greater Workers are encouraged to hold each other advanced biotechnology in the world? The number of labs and hospitals dealing with accountable and to report red flags, such as a anthrax incidents occurred despite the use hazardous biological agents. Moreover, change in behaviour that might make a col- of extensive legislation, protocols and pro- hospital accident-and-emergency buildings league more prone to mistakes. Mishaps and cedures. The problem with the CDC, the US and procedures are designed to get patients near misses too are reported without fear of Department of Defense, and the many labs inside as quickly as possible, not keep them blame, and mistakes are analysed to learn around the world who follow their lead, is out. And progress within public health how to prevent them from recurring. Finally, not a lack of knowledge or training, or even and research depends on transparency the process is one of continual improvement: a lack of engineering resources. It is the lack and open collaboration. attention to safety does not stop just because of a safety culture. What those working with biologicals certain targets have been met. Most laboratories handling potentially can learn from practitioners in the nuclear In biosecurity and biosafety, the CDC is dangerous biological materials are stuck industry — as well as from those in the widely seen as the global gold standard. The in compliance mode. To prevent human US Navy, offshore oil drilling, airlines and CDC’s handbook Biosafety in Microbiologi- and environmental catastrophes, and the utilities — is a culture of safety. In all these cal and Biomedical Laboratories has become 156 | NATURE | VOL 527 | 12 NOVEMBER 2015 © 2015 Macmillan Publishers Limited. All rights reserved COMMENT the reference for laboratories worldwide. more suitable to handling Ebola samples in rehearsals (training and commissioning). Other resources that it provides (posters, a laboratory. The PPE the hospital work- For example, the metals manufacturer training videos, data and information) ers initially used left areas of their face and Alcoa, based in New York, launched a safety along with documents from the WHO, are necks exposed. drive starting in the late 1980s using such used as core reference materials, even in Failure to consider context and all the techniques and saw the average rate of lost the most remote labs. Yet the world’s exem- links in the chain can similarly undermine workdays (due to work-related injuries) plars in the handling of the most dangerous the value of spending millions of dollars on drop over a ten-year period from 1.86 to pathogens, and therefore the multitude of building and operating containment labs just 0.18 per 100 work years4. As well as this public and private organizations who follow throughout the world. A recent inspection willingness to start afresh, three other steps them, are stuck in a very different culture at a major diagnostic lab for animal dis- are crucial. from that of HROs. eases in Afghanistan, for instance, revealed From the CDC to diagnostics and basic- that standard operating procedures (SOPs) Provide leadership, funds, time and research laboratories worldwide, the copied from Western labs, for ‘safe’ opera- commitment. The process starts with senior emphasis is on ticking boxes and on fol- tion, were being followed to the letter, management lay- lowing rules set by outside authorities, such including one for the handling of biologi- “People who ing out what safety as the Department of Health and Human cal waste.
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