Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety Summary of a Workshop (2016) / Chapter Skim
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6 Applying and Using New Tools and Knowledge Safely
6 Applying and Using New Tools and Knowledge Safely
Pages 129-158
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From page 129... ...
From those rather simple definitions, a great deal of work has arisen. There is no dearth of material available to those interested in learning more about biosafety and the implementation of biosafety practices.
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From page 130... ...
There is even a journal called the Applied Biosafety Journal from the American Biological Safety Association. 5 Given all of the material available, and numerous training activities held by institutions, and the standards written and legislation passed in countries, why do safety practices appear to be so hard to implement?
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From page 131... ...
Sometimes the individual laboratory worker involved is the source of the problem. Some individuals may feel safety training and safety practices are cumbersome, an attitude that may lead to excessive risk 7 D
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From page 132... ...
It is the laboratory director's job to ensure that adequate safety training has taken place, that adequate instructions have been provided on working with equipment and reagents, that adequate space is available, and that there is ongoing oversight of safety practices in the laboratory. Martin then outlined the 12 Quality System Essentials related to the international standard for medical laboratories, or ISO 15189.
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From page 133... ...
In some cases, a biosafety officer may have other responsibilities inside one of the sections, and while there may be some small laboratories where that is necessary, in a larger laboratory biosafety is a full time job, as is quality assurance. Although implementation of safety practices is dependent on multiple champions -- the laboratory director, the biosafety officer, the quality assurance officer, supervisors, as well as laboratory staff -- the laboratory director must be viewed as the ultimate champion for laboratory safety.
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From page 134... ...
In summary, the key to creating an environment of safety is to ensure that leaders and managers have the skills to do their job properly, that there is an identified biosafety officer who has responsibility for developing a safety manual and appropriate standard operating procedures, that ongoing training is provided, that appropriate risk assessments are conducted, and that adequate space is available for the laboratory experiments being performed. Neglecting laboratory safety can be extremely costly, as in the case of the UCLA laboratory, a life was lost and the reputation of the facility was damaged.
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From page 135... ...
That position now includes fire safety, physical safety, chemical safety, and radiological safety. Therefore this person is now called a safety officer, rather than biosafety officer.
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From page 136... ...
At the Indian Biological Center, researchers try to develop novel platforms to work within the biocontainment requirements for these kinds of organisms. Subramanian and his colleagues also conducted work on the rabies virus isolates collected by others from various parts of India between 2002 and 2012.
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From page 137... ...
Discussion The discussion after Subramanian's presentation focused on biosafety measures for rabies surveillance. One participant asked Subramanian about the rabies survey, stating that the work is very important in terms of surveillance.
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From page 138... ...
PUBLIC OUTREACH ON BIOSAFETY In his presentation, Kanabrocki shared some of his experiences conducting and supporting laboratory research at the University of Chicago. The university is a mid-sized academic research institution at the Hyde Park campus, one mile from Lake Michigan, about six miles south of downtown Chicago.
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From page 139... ...
. Kanabrocki was the official responsible for the select agent program, and the biosafety officer for the Ricketts Lab, located at ANL, about 25 miles southwest of downtown Chicago.
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From page 140... ...
Part of the mission as a regional biocontainment lab is to be a resource to the region in the event of a public health emergency, so an emergency response training component was added. The facility has trained local first responders on how to respond to an emergency involving a high containment setting, such as training clinicians for Ebola preparedness.
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From page 141... ...
Ricketts Lab has a full-time biosafety officer, who is there every day. Kanabrocki is also there one to two times a week.
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From page 142... ...
Kanabrocki then shared his experience with making biosafety "cool." The biosafety officers at the Ricketts Lab wanted to encourage investigators at the Hyde Park campus to think of the biosafety officers as a helpful resource. They developed a poster campaign that used the image of Michael Jackson's Billie Jean album cover with the gloved hand in a creative and effective way.
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From page 143... ...
There was television coverage on the training, and there was an article in a University of Chicago publication about the biosafety program as the resource for Ebola preparedness training. In conclusion, Kanabrocki recounted that one of his biosafety officers wanted to film the training, and he obtained permission from the incident commander.
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From page 144... ...
Kanabrocki added that all of the work at the Ricketts Laboratory is funded with public money, so it is already in the public record. As far as security is concerned, there are seven barriers between the person and the agent on the vivarium side, and five on the laboratory side.
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From page 145... ...
For example, the word, "mutation," has a completely different meaning to a scientist than to a person on the street. Another example is a listing of the number of lab incidents in the newspaper: fifteen hundred biosafety incidents in one year may sound ominous to the public, but these incidents are often far from dangerous and may simply mean that a light went out somewhere and it was not clear where the light bulb was located.
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From page 146... ...
Both the animal area and the molecular biology area have double door autoclaves. For any infectious material, the outer door is shut, the inner door is opened and the material is put in and the inner door is shut, and the material is autoclaved.
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From page 147... ...
Discussion The discussion following Bhatnagar's presentation focused on lab validation, determining the appropriate number of BSL-3 labs, the levels and types of labs needed to meet specific needs, oversight and inspection of individual labs, and finally, funding to sustain the labs. The opening question referred to laboratory validation.
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From page 148... ...
A participant suggested that BSL-4 laboratories could perhaps be placed strategically in state capitals and the central capital for example, due to international flights. BSL-4 labs can also be downgraded and used as BSL-3 labs, and upgraded again if necessary.
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From page 149... ...
Another participant noted that in sustainability models, single income sources will not be sufficient. It is necessary to build a corpus of funders for each biocontainment lab.
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From page 150... ...
: "Any occurrence that causes damage, ecological disruption, loss of human life or deterioration of health and health services on a scale sufficient to warrant an extraordinary response from outside the affected community." 8 India, along with six other countries, Canada, Indonesia, Italy, Mexico, Philippines, and Turkey, was rated at a ‘high risk' for natural disasters in absolute terms, and the World Bank has reported that direct losses from natural disasters is estimated to be up to two percent of India's GDP and twelve percent of central government revenue, which is quite high. Fifty percent of India's landmass is prone to earthquakes.
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From page 151... ...
There is also a national policy on disaster management, which has been approved by the government and finalized with a vision "to build a safe and disaster resilient India by developing a holistic, proactive, multi-disaster-oriented, technologydriven strategy through a culture of prevention, mitigation, preparedness and response." 9 India has a dedicated National Disaster Response Force, which was established under the act. It is a specialized force trained not only in search and rescue, but also in response to chemical, biological, 9 For more information, see: http://pib.nic.in/newsite/mbErel.aspx?
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From page 152... ...
The 12-battalion National Disaster Response Force is drawn from various central police forces, and is located in various regions across the country for more efficient deployment. They can be used for international assistance.
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From page 153... ...
Therefore, he recommended adding to the list of areas for potential bilateral cooperation the strengthening of capacity to conduct robust epidemiologic studies during disasters so that the cycles of disease can be broken. BIOSAFETY NEEDS AND PARTNERSHIPS Ganguly began his presentation by emphasizing that biosafety is critical at biocontainment labs, and needs to be ingrained in the day-today practices of handling human samples.
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From page 154... ...
Then, Ganguly recounted, the next plague outbreak occurred and again partnership was invaluable. To respond to these emergencies, establishing a lasting partnership is essential.
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From page 155... ...
Through sequencing, they established that the genealogy was different in Malaysia strains, in Indian strains, and in Bangladesh strains. When the SARS outbreak occurred, Indian scientists found SARS virus not only in people with symptoms, but also in the urine and excretions of people who had no symptoms.
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From page 156... ...
, and is slowly trying to develop collaboration on regulatory practices and regulatory science, including regulations related to biosafety, biosafety of recombinant products, biosafety of normal products, and biosafety containment facilities. It is helpful to compare the rules and regulations within the two countries and learn from each other about whether the rules are effective.
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From page 157... ...
Human resources are inadequate: Many young people may choose not to obtain a Ph.D; instead, they are interested in technical skills to maintain these labs. Sustained collaboration is called for in all areas of biosafety, including developing training programs and workshops for biocontainment labs, and India would be very happy to partner with any of the regulatory bodies abroad, especially with U.S.
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From page 158... ...
Another example of effective cooperation was demonstrated in the visit of a CDC consultant who advised Indian contractors and others on structural changes to NCDC labs to strengthen biosafety and biosecurity.
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