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Committee on India-United States Cooperation on Challenges of Emerging Infections and Global Health Safety; Policy and Global Affairs; National Academy of Sciences; Indian National Science Academy. Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety: Summary of a Workshop. Washington (DC): National Academies Press (US); 2016 May 6.
Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety: Summary of a Workshop.
Show detailsOver the past 20 years, Robert Martin was of the opinion that while efforts to strengthen laboratories rely on various factors, including education, training, accreditation, and so on, the importance of leadership and management responsibilities has been underestimated. He therefore focused on the critical importance of strong leadership and management in order to create a culture of safety in the laboratory.1
Martin noted that a baseline definition of safety when working with potentially infectious microorganisms addresses a combination of laboratory practices and procedures, and of laboratory facilities and safety equipment. Another definition of biosafety addresses why researchers would implement those practices, namely the reduction or elimination of individual and environmental exposure to potentially hazardous pathogens. It should be clear that there must be a biosafety policy from laboratory leadership. And there must be someone designated as the person responsible for the implementation of strong biosafety practices.
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. They can look at Biosafety in Microbiological and Biomedical Laboratories, published by the U.S. Centers for Disease Control and Prevention (CDC)2 and the National Institutes of Health (NIH); resources from the American Association for Laboratory Animal Science; the Laboratory Biosafety Manual,3 published by the World Health Organization; and the Laboratory Biosafety Guidelines,4 published by the Public Health Agency of Canada. 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? In Martin's opinion, part of the reason is that when training of laboratory workers is discussed, there is an implication that the workers are ultimately responsible for biosafety. There is often no mention of management responsibilities in these documents or discussions. In a article, “Why Is Safety So Hard?,” Dan Hebert addresses the topic by stating that the majority of accidents occur because organizations have failed to implement best practices and guidelines on process safety.6 Despite widespread reference to safety in corporate mission statements and communications, the changes in culture that basic safety principles entail have not sufficiently permeated the entire workforce.
Clearly, not having demonstrable and visible commitment by leadership throughout the organization sends a signal to employees that safety requirements are suggestions, as opposed to requirements. An unfortunate example to drive this point home was a deadly fire at a University of California, Los Angeles (UCLA) laboratory in 2009. A young student died as a result of burns from this fire (see Figure 6-1).
FIGURE 6-1
University of California, Los Angeles laboratory after the deadly fire in 2009. SOURCE: Robert Martin, presentation at the workshop.
UCLA was found negligent and was fined, because several significant safety weaknesses were uncovered. The student was working with a liquid that was combustible when exposed to air, had not been properly trained in the techniques used to manipulate the substance, was not wearing a lab coat, and there were other volatile chemicals unrelated to her experiment in the hood in which she was working. Although the principle investigator claimed the student had received training, there was no documentation indicating safety training had taken place at all.
In 1986, a survey by Vesley & Hartmann of 4,000 laboratory workers in 54 public health and 165 hospital laboratories in the United States revealed that in hospital laboratories the rate of laboratory acquired infections was 3.5 per 1,000, and in public health labs, the ratio was 1.4 per 1,000.7 Exposures were cited as resulting from needle sticks, aerosolizations, hood failures, and microscope contamination. A review of weekly morbidity and mortality reports also documents a number of laboratory acquired infections. While it is not possible to eliminate accidents, it is clear that we can do better.
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 taking. Sometimes they are pressured to complete work more quickly or cheaply, and corners are cut. Often employees are not aware of the infection risks they are taking. For example, even now some laboratory workers are more concerned about contracting HIV from a blood sample, when there is a much greater risk of contracting hepatitis B, or in some countries, hepatitis C infection from samples. So while all these are reasons why accidents may occur, many of these issues stem from a lack of leadership and poor management practices in the laboratory. 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. They include the following elements:
- Organization
- Personnel
- Equipment
- Purchasing and Inventory
- Process Control
- Information Management
- Documents and Records
- Occurrence Management
- Assessment
- Process Improvement
- Customer Service
- Facilities and Safety
In many countries, there is a drive to ensure that laboratories are accredited, not only to provide better services for health care, but also because accreditation of laboratories is a significant step toward assuring that a country meets its obligations under the International Health Regulations of 2005. To implement the quality management system, it has become clear that laboratory directors not only need technical knowledge, but they also need to be leaders and managers as well, and often leadership and management skills are lacking. In part, those skills are lacking because many laboratory directors have come into their position through seniority or through a strong grounding in technical skills, but they have never received training, or they have limited skills, in leadership and management.
The University of Washington created a nine-month blended learning certificate program that helps improve skills related to leadership and management for mid-career senior managers and laboratory directors. This program was developed because a laboratory director or manager has the ultimate responsibility for the laboratory and its practices. He or she is the recognized leader and has the responsibility for not only ensuring accuracy and timeliness of testing, but is also responsible for assuring that testing is carried out safely. The laboratory director certainly needs technical knowledge, but he or she also must possess good leadership qualities to ensure a high functioning laboratory.
In addition to a director who clearly accepts responsibility for safety in the laboratory, the laboratory requires a biosafety officer and quality assurance officer who are organizationally positioned to be independent of the section supervisors, and who report directly to the laboratory director. 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. That individual must ensure adequate funding for personnel and resources and must develop an environment of trust that enables a reporting culture. These attributes will help lead to a culture of safety. These leaders, the laboratory director, biosafety officer, and quality assurance officer, have responsibilities to encourage compliance with the safety program by both new and long-term employees. They have to manage change towards the safety culture. They must establish effective health and safety committees, and collect and provide essential information and statistics relevant to a culture of safety.
Within the laboratory, a safety management system is directed by the safety officer who has responsibilities for the development of the safety manual where laboratory specific policies and procedures are maintained, and where standard operating procedures are maintained. There must also be training available to laboratory staff that aims at identifying risks in the laboratory and safety procedures to mitigate those risks. Even if all of these steps are taken, unless there is demonstrable interest by the laboratory director, the biosafety officer, and supervisors of the laboratory, attitudes of employees will not change and the level of safety awareness will not be what it should be.
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.
Discussion
The discussion after Martin's presentation focused how levels of leadership influence safety and the kind of oversight required for clinical laboratories.
Joseph Kanabrocki underscored that leadership at multiple levels is critical. One often hears that leadership from the top is most important, but he believes that top-down and bottom-up leadership are equally important. The culture of safety must be established at both the top of management structure and at the front line. If people at the front line hold their peers accountable, then the situation will be much safer. In the select agent world, people have to look out for one another, as well as focus on personnel reliability and security issues.
A participant asked whether it is necessary to have one manual on biosafety for public health labs and a different one for clinical labs. Are the requirements sufficiently different to warrant this? Kanabrocki answered that the oversight of clinical laboratories is much more regimented. There are certain standards that have to be met. In the United States, clinical laboratories have to satisfy certain certification requirements. This is different on the research side. There are some certification requirements, but they are not as rigorous or extensively documented as it is on the clinical side. Kanabrocki added that in the clinical realm, the same procedures must be followed exactly the same way each time for reproducibility and assuredness. Another participant added that researchers in Monterey, California work closely with the Monterey County Public Health Laboratory and they not only test blood samples and urine, they also test water, food, and conduct many other types of testing that has very little relationship to clinical laboratories.
A participant stated that facilities in India have biosafety officers. 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.
ANIMAL VACCINE MANUFACTURING
B.M. Subramanian began by stating that vaccines, like any other drug, must be produced under strict, current good manufacturing practices (CGMP), and the biocontainment component must also be followed when the vaccine involves the use of infectious agents.
When vaccine research is conducted in India, a proof of concept is developed by academia, and then it is transferred back to the cell line for industry to continue the process. The vaccine goes to the drug controller and clearance is obtained to make clinical grade material under its CGMP production facility. Clinical trials are the next step. Research results are then returned to the controller and market licensing is granted along with market authorization. At the point that industry takes over, CGMP is required, so many in academia work tirelessly to follow CGMP. If they do not have a CGMP facility, the company that pursues the product has to create the virus banks and the cell banks in their facility as per CGMP requirements, and this process continues back and forth. In India's animal vaccine development industry, this transition is not seamless. Subramanian then gave a brief introduction about CGMP. The practices of developing and implementing primary barriers, and the associated documents, are similar to those in biocontainment labs. But the actual facility design is significantly different for CGMP than for biocontainment facilities. In biocontainment facilities, infectious material is kept inside the room and progressively negative pressure ensures that the material does not escape. In CGMP facilities, such as the CGMP enabled clean room that Subramanian's institution is building, progressively positive pressure environments aim to protect the drug from outside contaminants. The number of air exchanges and particle counts are strictly monitored, but they are much higher than what is followed in a BSL facility.
Next, Subramanian discussed foot and mouth disease, which under U.S. Department of Agriculture (USDA) classification is a BSL-3Ag agent. The vaccine used around the world is produced by a known attenuated strain of the virus. The kind of facility that works with this vaccine is built with negative pressure; however, the facility also follows the CGMP procedures because negative pressure will bring all the contaminants inside, which is not allowed by CGMP. 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. Nearly 40 samples were sequenced, and two distinct pathogenic lineages for the Indian isolates were found. The predominant one has an Arctic-like lineage, and the other one has a Sub-continent lineage. The Sub-continent lineages were also found in the viruses from Nepal and Sri Lanka. They also conducted some evolutionary analysis, and found that the Arctic-like lineage in India appeared very recently compared with the Sub-continent lineage, and has spread south from the Arctic region. They also found that in India, the majority of rabies cases is due to dog bites. Little is known about the role of wildlife in the spread of rabies in India.
Further, wildlife in India is not vaccinated against rabies, unlike in European countries and America. In the Kheda district of Gujarat in December 2012, around a dozen buffalo and cattle died showing symptoms of rabies. There was also another case in Gandhinagar, a nearby district. A large number of buffalo died. Brain samples were collected from one of the dead buffalos and rabies and its sequences were identified. After three months, they found another district, Surendranagar, in which nilgai (a wild form of cattle) were infected. They isolated rabies virus from these animals also. After almost 15 months, in March 2014, they isolated the rabies virus from a mongoose in the same district of Gandhinagar. When they mapped these samples on the phylogenetic tree, they all had the Arctic-like lineage virus. The buffalo and mongoose isolates were from the same district, but the virus was isolated with a 15-month gap between collection dates. The other two, the nilgai and the buffalo, came together on the lineage map, and they were found only 50 kilometers apart. This indicates that although dogs are the major carrier and transmitter of the rabies virus in India, the role of wildlife has been neglected thus far.
Although there is no government policy on the vaccination of wildlife against rabies, when it is tried, the inactivated viral vaccine is commonly used. Subramanian's group used the rabies virus glycoprotein-free based subunit vaccine during experiments in mice. They vaccinated, boosted, and challenged the mice with the rabies virus, and after 35 days there was enough serum conversion to protect the animals. His group is also trying to develop another platform using a viral pseudotype technique. Due to the nature of the research, it can be conducted in labs without biosafety levels. One of his colleagues went to the United Kingdom and spent time with the viral serum tech groups to learn their technologies and how to incorporate them. Subramanian's group is now trying to implement these techniques in their institute for some of the high risk activity viruses.
In addition, they are working on bovine tuberculosis (TB). The organism was isolated in non-pasteurized milk and in pasteurized milk. They are trying to diagnose bovine TB from the release assay, because of the viscosity in the reagents.
They tested their diagnostic procedure on a bovine farm, and found four of the 10 animals examined for TB tested positive using the IFN-gamma kit. They sent these ten samples to Chennai for spoligotyping, and four of those samples were confirmed positive for lung tuberculosis. Some wild animals also tested positive for tuberculosis, including a sloth bear. They tried to diagnose TB inwildlife, but the World Health Organization (WHO) does not recommend this approach. However, Subramanian's group recommends serology for bovines, and they also recommend the serology for wild animals due to other logistical problems. Therefore, they tried to develop a lateral flow serology test specifically for pathogenic tuberculosis. Then they developed a kit and presented it to some of the wildlife rescue centers, such as Wildlife SOS. Using Subramanian's kit, postmortem animals were tested for tuberculosis, and from that they created a collection of serum samples that tested positive. They send these kits to wildlife institutes all over India for TB testing; they are also using them to predict tuberculosis serology from elephant and bear samples. Further, they are trying to develop BCG knock outs as a vaccine against bovine tuberculosis in collaboration with Bruce Martin and Chris McFadden at Surrey.
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. How were the specimens handled, and how were the specimens gathered at the field site? These steps also constitute important aspects of biosafety measures. Subramanian agreed that biosafety measures are critical, right from the collection of samples. These locations are remote, and the people who collect the samples place them in double bin containers. These are then hand-delivered to the researchers. All of the laboratory staff, from the cleaning staff to the engineers to the scientists are vaccinated annually, and the serum neutralization end-point titer is checked. If the person is found to have less than one international unit, the person receives a booster.
Subramanian continued by noting that in the field, brain samples are collected from various parts of the brain, not only the hippocampus. Generally the postmortems on animals are not done in laboratory areas. They are conducted outside only. They try to conduct a proper inspection of the body, and then dispose of the body with antiseptic and boric acid solutions. With that they also bury the carriers deeply. That is a very important aspect to be considered in terms of biosafety measures.
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. It is also the home of the University of Chicago Medical Center, which is one of the major medical centers in the Chicago metropolitan area. UC Medicine is one of the four designated hospitals for the Chicago metro area to receive Ebola patients, should they arrive in or near the city. In addition, the Ricketts Regional Biocontainment Laboratory is a biosafety level 3/Agricultural Biosafety Level 3 (BSL-3/ABSL-3) facility built on the campus of Argonne National Laboratory (ANL), managed by the University of Chicago.
Kanabrocki shared a quote from Jim Welch, who is the Executive Director of the Griffin Research Foundation: “The collateral damage of unsafe research is science itself.” The safe conduct of research is a shared responsibility. It is the responsibility of scientists to perform a comprehensive risk assessment of their research—before they begin that research—to weigh the risks and benefits of the work itself, whether it should be undertaken, and, if so, under what conditions? It is the responsibility of scientists to convey to the public the importance of the work they do. By nature, scientists like to work in laboratories, and often they are not the most social creatures in the world, however, such communication is an obligation that all scientists have and it should not be neglected.
It is important for those who work in high-containment laboratories, or who conduct infectious diseases research, to engage the public. It is important that they explain the value of the work itself, and the direct benefits of that research activity to their local community. Finally, it is important to explain the safety and security measures in place that help ease concerns about the type of activities that may be conducted in those laboratories. This work needs continuous community engagement.
A number of incidents that happened in U.S. government laboratories—U.S. Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Food and Drug Administration (FDA) under the Department of Health and Human Services (DHHS)—in 2014 brought negative attention to biocontainment research and infectious diseases research and created a very negative reaction to scientists in general. When the public is upset, politicians become engaged, and if the politicians are engaged, they tend to act.
During the subsequent biosafety stand down at DHHS laboratories, research was halted, extensive reviews of inventories were conducted, and any strains that were no longer needed were removed. The goals of the stand down were to inventory thoroughly what researchers had in their possession, and to promote laboratory safety as a priority. Following that was a halt from DHHS on funding of gain-of-function research on influenza, Severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS). Hence, collateral damage from unsafe research is science itself.
In 2007, the University of Chicago competed for, and was awarded, funding to build one of 12 Regional Biocontainment Laboratories together with two national laboratories that were built through a funding initiative from National Institute of Allergy and Infectious Diseases (NIAID). 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. A security advantage of this site is that Argonne's whole site has restricted access, unlike the University of Chicago main campus.
Before the lab opened, Kanabrocki and his colleagues engaged the public, conducting dozens of tours through the facility for whoever wanted to come. They walked through the facility, and researchers explained the type of work being done there. The importance of the research at the lab includes the development of vaccine therapeutics, including two Tier-I pathogens. For this reason, the entire facility operates under the Tier-1 regulations. One of the activities they had at an open house early on was a slide show of photos from inside the facility. Kanabrocki also brought a long sheet of paper, and children lined up as far as you could see to use a pipette on the paper. This was another way of engaging the public and saying, “come on in.” During that time, the facilities engineers really learned how to run the building. They tested each system and actively failed everything that could fail during that waiting period before approvals for operations were obtained.
ANL also has a legacy of community engagement regarding hazardous material. The laboratory itself stemmed from Enrico Fermi and the Manhattan Project during the World War II era. A liaison committee was formed for the Ricketts Lab that involved leadership from all the surrounding communities as well as people from the ANL and the Department of Energy (DOE), which runs that laboratory. The committee met monthly until the lab opened. Kanabrocki found it interesting that as time went by, and as the date for the opening of the lab grew closer, fewer and fewer people attended the meetings.
Turning to the research benefits to the community and to public health, Kanabrocki explained that the training resources available through the Ricketts Lab have been invaluable. The first focus was on training scientists who would be working at the Ricketts Lab, or at other comparable facilities. 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. First responders come into the facility and conduct drills with lab biosafety staff and researchers. They enter containment facilities, and evacuations are performed on simulated medical emergencies. Many of the local first responders were anxious when they first walked into the building. Some of them had envisioned vats of anthrax sitting around in the lab, but when working with an organism that replicates, large quantities are not needed at any point of time. That reduced many people's anxiety. Another helpful tool was having first responders enter the lab before it was opened. There were researchers fully dressed in their protective garments, simulating “experiments,” and the first responders could ask questions, understand what scientists were doing, and understand the equipment they were using.
As for biosafety, the lab has a walk-in autoclave with biometric access control and vaporized hydrogen peroxide (VHP) large-space decontamination is conducted. Personal protective equipment (PPE) is worn in containment, and there are Magnehelic differential pressure gauges and readouts for negative air flow. In addition, there are ventilated cage rack systems for animal research, and a Class 3 cabinet for aerosol challenges. Biosecurity is equally important. They have 62 closed-circuit television cameras monitored around the clock, and perimeter accesses control with proxy card and fingerprint access. Once a person is in containment, each individual has a PIN code to enter when moving through the lab. Access records are maintained and examined on a regular basis. The responsible officer receives daily readouts of access records.
A code of conduct has also has been developed for personnel reliability. Beyond plagiarism, fabrication of data, collegiality, and sharing of reagents, the code also contains a statement that commits all those who sign to adhere to safety practices. Very importantly, signatories are also required to report deviations from standard protocols.
Ricketts Lab has a full-time biosafety officer, who is there every day. Kanabrocki is also there one to two times a week. He and the researchers know each other on a first name basis, and researchers come to him with issues, such as problems with someone at the laboratory. They are trying to develop a community environment because it is the heart and soul of their personnel reliability program.
Shared governance is also critical. All of the protocols at Ricketts Lab and all the research activities are reviewed by the Institutional Biosafety Committee (IBC). The committee has membership from UC faculty and staff, members of ANL, members of DOE, and community members. Transparency is the foundation of their engagement. The lab wants the public to know what they are doing and if there are incidents, then the public is told about the incidents, too.
The responsible officer for Ricketts Lab also attends weekly Monday morning meetings at ANL to talk about safety on the Argonne campus. Safety and security are ongoing activities. Although Kanabrocki often does not have anything to contribute during the meetings, he attends because just being there helps to maintain a comfort level between the leaders of both labs.
The Biosafety Training Corps has also been developed at the Ricketts lab, using an approach that integrates the various activities that make these facilities function well. The training is for scientists, students, trainees, some support staff, biosafety professionals, and the biocontainment facility engineers. An environment is created where all of these people can come together and discuss issues. In addition, there is a mentoring program that is probably the most important piece of the training. Along with routine training, a week-long course is offered and anyone that has any role in a containment laboratory is welcome to attend. The lab also has a year-long fellowship program designed to train post-graduate scientists in the realm of biosafety. The fellows do everything the biosafety officers do: they attend IBC meetings, laboratory inspections, and training. When the lab is inspected by external agencies, the fellows are also involved. The fellowship is a full immersion in a biosafety program. There is also an Institutional Animal Care and Use Committees protocol for the course, because they use live animals.
It is critical, however, that training be relevant because otherwise it is ineffective. Every lab is approached as an individual entity and training is provided in that context. Lab inspections are approached in the same way. Kanabrocki and his colleagues do not walk into a lab without knowing exactly what experiments are being conducted, so scientists are engaged in a very active way on their real safety issues. There are no generic inspections.
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.
Scientists often walk in the corridors with their gloves on, so biosafety officers are trying to teach researchers to take off one glove and hold reagents in the gloved hand so they can open door knobs, etc., with their bare hand. Who could better exemplify one glove than Michael Jackson?
Regarding Ebola preparedness, the UC Medical Center is an Ebola-patient designated hospital. It was a major effort to prepare to receive potential Ebola patients. Kanabrocki was surprised to find that infection control at the center was not as robust as he would have expected. To improve infection control, they used the Ricketts Lab standard operating procedures (SOPs) as a model, first asking for a floor plan of the isolation ward. From there they developed the center's SOPs, and then conducted training for two full days for all clinical staff. The first day of training was basic, donning and doffing PPE, entry and exits, waste management, and movement of materials into and out of the isolation room. Day two covered how to conduct clinical procedures in full PPE; a veterinarian taught that section.
This training effort was received quite well by the University and by the Medical Center, and as a result, they wanted to publicize the preparedness at the Medical Center. 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. The video included elements of popular culture. The success made Kanabrocki conclude that popular culture can promote biosafety and make it cool.
Discussion
The discussion after Kanabrocki's presentation included questions about incidents and safety, the pop culture campaign, and transparency in, and effectiveness of, communications.
To begin, a participant asked if there had been any incidents at the lab. Kanabrocki replied that there have been some near misses, but no exposures. There was one fatal lab acquired infection (LAI), and one very serious LAI about two years earlier; both of which occurred in BSL-2 labs. Kanabrocki does not worry as much about the BSL-3 lab as he does about the BSL-2 labs. In BSL-2 labs, people are not as respectful of the materials they work with and they certainly are not as well trained. Competency is not verified, and that is where there are problems.
David Franz then asked if the ANL director attends the weekly safety meeting. Kanabrocki answered that yes, the majority of the time he does, and if he does not, his deputy director attends.
Another participant asked about the pop culture campaign, and if he has noticed a positive response from the community, and if people ask questions. Also, have there been any negative reactions to the campaign? Kanabrocki said that there have been both positive and negative reactions to the campaign. He does not mind the negative responses because those still indicate that the people are aware of the message, which means that the campaign is working.
There are other communities in the United States where a public campaign did not have such a positive outcome. There is a potential down side, however, to being so vocal. There is a great deal of concern from a security perspective. How can these negatives be avoided? There's always a lot of concern about showing photographs of the inside of a laboratory, or allowing public access, even before a lab opens. Kanabrocki believes that unless one can develop a roadmap to the pathogen itself, the security concern is not great. They do take precautions such as not photographing room numbers, and during tours, people are not allowed to take photos. As for public backlash, in his view, that occurs if there has not been enough face-to-face communication with the community in advance of a laboratory opening or of a project beginning. Engagement has to happen early, and has to continue throughout the life of the project.
Franz added that he was involved peripherally with the opening of the BSL-3 lab at Kansas State University. There were public meetings, and the same pattern occurred; people finally stopped coming, but the meetings were packed at the beginning. There is a requirement in Kansas to hold an annual public IBC meeting with the details of the meeting to be published in the newspaper. Anything we can do to decrease speculation about what is going on in the lab reduces fear. Anything that implies that the public cannot hear about what is happening, in generalities of course, adds fuel to their concerns. People get bored with the issues once they are familiar with them, and they go on to other matters. Thus, these meetings are very helpful in engaging with the community.
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. What is there to keep secret other than how to get to the materials?
Another participant noted that transparency is absolutely paramount, not only because people are concerned and afraid that they might be affected by a release, but also to avoid conspiracy theories on a personal and national level. It is very important that BSL-4 labs are open for people from other countries to at least tour, if not to participate in scientific exchange programs following proper protocols. The worst thing that could happen is that other countries believe that secret research is being conducted that is prohibited by the Biological Weapons Convention.
Another concern is that scientists often speak a bit too fancifully about their work, and use terms that have very different meanings for the public. 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. Perhaps when biosafety protocols are being devised, the scientific nomenclature could be balanced with the use of more common terms. Finally, there are scientists who do not engage, which can contribute to conspiracy theories because few people know what they are doing. However, there are also scientists who engage too much, to further their own scientific programs. Not talking about Ebola is as harmful as saying that Ebola will kill us all. There has to be a middle ground, and a little bit of control is necessary.
BUILDING AN AFFORDABLE AND EFFECTIVE BSL-3 LABORATORY
Rakesh Bhatnagar began by providing an example of the BSL-3 laboratory at Jawaharlal Nehru University (JNU) funded by DBT, created by cutting costs without compromising safety. First, he and his colleagues determined that they would build a two-story building with the BSL-3 lab on the ground floor, and another laboratory on the first floor for experiments not requiring high-containment facilities (see Figure 6-2).
FIGURE 6-2
Layout of Biocontainment facility (BSL-3 lab and animal house) at the school of Biotechnology in New Delhia Facility. SOURCE: Rakesh Bhatnagar, presentation at the workshop.
The whole structure is about 8,000 square feet. The left side has a plant room (utility room) with a chiller plant and a generator for complete electrical backup, so that all the critical equipment, particularly those maintaining negative pressure, temperature, humidity, and so forth, do not have an interruption of power. There are panels that can monitor temperature, humidity, heating, cooling, and filters (microbial filters, pre-filters, and HEPA filters). All this information is provided on a computer as part of the building management system. Everything is continuously monitored and recorded. If there are any problems, the system provides a warning so that maintenance can be performed.
Bhatnagar then described the BSL-3, in which two rooms have been dedicated as an animal facility. The other two rooms are mainly for molecular biology work. There are two air handling units. One takes care of the air in the animal area, and the other air handling unit takes care of the air in the molecular biology area.
Although there is a pass box, everything can be done inside. 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. The wash room provides the space and necessities to clean cages, and also has washing machines.
When JNU received the funding for the BSL-3 facility, Bhatnagar and his colleagues chose a place behind the School of Biotechnology. It was a green area and the building was constructed specifically for the BSL-3 laboratory. The design and execution were done by a German company, and all of the engineers and workers were from India. The installation, commissioning, and validation were done by M+W Zander and Company. They have commissioned more than 300 BSL-3 labs all over the world. After the lab opened, M+W Zander ran it for about a month, while local researchers and staff were trained. They have a comprehensive contract with a company called Biosave. There are many BSL-3 labs in Delhi, and Biosave stores all the spare parts that are needed. SOPs and written instructions are provided to all employees who work in the lab and each employee is trained in advance of beginning work as well as periodically thereafter.
The total cost of construction and equipment was approximately $500,000, and it took about one year and eight months total to design, erect, create, and validate the building. Planning began three years prior, for a total of four and a half years from conception to completion. Maintenance costs are also affordable. In conclusion, Bhatnagar said that despite the excellent facilities at the lab, they are unable to do experiments with some viruses which need a BSL-3+ or a BSL-4 lab; such facilities are badly needed in India.
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. Are there certified, validated agencies in India that perform independent assessments? Bhatnagar confirmed that there are some consultants who are trained to validate, however, India does not have an equivalent to CDC. Those trained for validation come to the lab and bring their machine for particle counts, and so forth, and confirm that all equipment is functioning properly. In the end, they ensure that the air is clean and without any contamination; that is what they check primarily. A certificate of validation is then provided. This process is undertaken twice a year to be certain that the environment is safe.
Bhatnagar noted that many scientists from India who have visited the lab have noted that they consider it to be a model. It is a small facility, which is easier to maintain. Often BSL-3 labs are much bigger, and they are much more expensive to maintain. This is also a challenge in the United States. It is important not to build too many or too few labs, and it is critical to learn from each other's experiences.
This raised another question about how to determine the right number of BSL-3 facilities. Is there a correct ratio of the number of labs per million people and how should they be geographically distributed? A participant responded that perhaps the calculation should be based upon the needs of the work requiring these labs. Those needs may vary not only from one region to another or one country to another, but also may vary with time, which of course makes the issue of sustainability complicated, because what might be needed for a sustained research effort for one period of time, such as for a decade, may evolve into a series of research questions that have been addressed, no longer necessitating the same level of research effort. The United States has not found a solution to the question of the necessary number and location of labs. Many people believe there are too many BSL-3 labs and that much of the work being done in them is not absolutely necessary or could be done with less dangerous organisms at lesser bio-containment levels.
Another participant added that when one considers the kind of load assigned to a specific facility with relation to the population, it essentially means that there is a certain incidence of disease in the population. As the incidence of disease fluctuates, so does the need for such facilities, requiring a dynamic equation rather a stationary situation. Bhatnagar commented that this means there should be a limited number of facilities constantly available for monitoring dangerous organisms which could suddenly arise.
How do we decide what is required for surveillance? Agra has two BSL-3 labs that were built to conduct research on drug resistance. 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. This upgrade-downgrade solution could be an option.
In India, the BSL-4 labs in Bhopal and Pune are in very large cities, but there are no BLS-3+ or BSL-4 labs in the biggest cities of New Delhi, Mumbai, Calcutta, and Chennai. However, V. M. Katoch said that the government of India is taking a regional approach by building ten federal labs in the major metropolitan centers and approximately 48 labs in districts along with smaller medical school labs. There are also plans to extend this lab network to 168 sites with BSL-2 labs. The idea is to be able to detect an epidemic before it becomes even larger. These labs may not be able to detect unknown pathogens, which requires rapid sequencing, cloning, and sequence analysis. The labs in the network are not all planned to be culture labs. Many will be located in medical schools that may be upgraded into culture labs. They are to be epidemiological labs to detect anomalies in a particular region. If something is identified, the samples will be referred to other labs at higher levels. Some workshop participants, however, were skeptical that these labs would be sufficient to detect outbreaks.
Perhaps, contributed another participant, even within a particular category of lab, for example, a BSL-2 surveillance lab, it might make sense to think about whether all of the labs should be exactly the same or whether there should be specialization, and whether there are certain kinds of tests or certain kinds of surveillance methods or approaches that might be followed in one or a certain subset of the labs while other approaches are followed in other labs. There may be no right answer, but it might be of some value to have specialization and preferred places that develop expertise in a particular kind of disease or syndrome and develop people with the appropriate experience within the facilities. At times it is hard to know where a sample should be sent when the diagnosis is unknown. However, when the syndrome or the suspected problem is known from the start, then a certain small number of places that have specific expertise in that problem may be more efficient and effective. In this way, investments in labs could be made without too much duplication of resources.
The discussion transitioned to the frequency of oversight and inspection. Some participants suggested that here should be standards that are followed, and a third party should oversee and verify the labs and procedures. India needs to develop greater capacity to conduct these oversight and certification functions.
Furthermore, sustainability and maintenance require committed funds, which need to be requested and appropriated from the government, university, or some other source such as outside grants. The United States has these challenges as well. Ten BSL-3 labs were built by NIAID, and two BSL-4 labs were built, one at the University of Texas, Galveston, and one in Boston. The U.S. government is the only entity that has funding for sustainment as a part of the original lab agreement. The lab receives a specific amount of funding each year for a specified number of years. Other labs must identify their own funds. Even military labs now receive a small portion of their sustainment funds from the U.S. government, and approximately 20 percent of the funding comes from the work for others; overhead is included in contract work to help fund the building. 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. A corpus is generally built on several principles. One of which is that these are big facilities, which not all institutions can afford. There will be smaller companies that will want to use a biocontainment lab and this work can be subcontracted at the BSL-3 level with supervision by the regular staff.
Nath added that as the Indian network is considered based on needs and sustainability, perhaps it would be wise to consider the needs of the Asian region, because it was shocking to learn that the Indian BSL-4 lab was the only one in the region, and there are few BSL-3s. If there is an epidemic, it is not going to respect borders. Dengue comes from southeast Asia, and hemorrhagic fever and Ebola, for example, also do not know borders, so India should look outward as well as consider how to help the region. To plan for this, a participant added, it will be important to consider which countries to include. Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, Pakistan, and Sri Lanka are important. The Indian National Science Academy has a joint meeting once a year with experts from countries of the region, and they expanded to include other countries such as Australia, Indonesia, and Malaysia.
MANAGEMENT OF NATURAL DISASTERS
Muzzafar Ahmad opened by noting that there are many definitions of “disasters,” including one by World Health Organization (WHO): “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. In addition, droughts, floods, cyclones, and tsunamis create hazards for every state in the country.
In addition to natural disasters, manmade disasters such as chemical, biological, radiological, and nuclear disasters as well as road traffic accidents and air traffic accidents also pose threats. India has the world's longest railway network, which, as with all other modes of transport, may be susceptible to accidents. The country has experienced urban flooding, riots, and terrorism.
Ahmad recounted recent and past disasters. Examples included the Kashmir earthquake of 2005, and the Leh cloudburst and mudslide, which was caused by recurring climate and ecological changes. In 2013, almost 6,000 people were missing or dead as a result of the flooding in Uttarakhand. The Bhopal gas tragedy was one of the worst global chemical disasters. In two days of rain in Mumbai, almost 1,000 people died. The Indian oil depot fire in Jaipur led to damages of more than 15,000 crores Indian rupees (approximately 2.5 billion U.S. dollars). Every year, disasters occur where fireworks are made for Diwali in Tamil Nadu, including one in which more than 100 people died. Fortunately, as a result of preparedness efforts, there were no deaths during Cyclone Phailin in 2013, as compared to the 1999 super cyclone of the same intensity when many people died. The cyclone coincided with the biggest festival, Dushhera, and government, in some places, had to use force to evacuate people from the coastline. In September 2014, three days of unprecedented rain led to the worst floods in recent times which caused massive destruction and the near submersion of the capital. The secretariat and major hospitals were also submerged. The medical college hospital was also severely affected and all medical services were disrupted for a number of days.
As a result, Ahmad explained, there has been a paradigm shift in disaster management. Initially, it was relief-centric; now the approach has been on prevention, mitigation, and preparedness. In December 2005, the Indian Parliament passed the National Disaster Management Act, which provides a legal definition of disaster in India, and includes the degradation of the environment. 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, technology-driven 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, radiological and nuclear incidents. Their instructors have been trained in premier institutions, including the U.S. Federal Emergency Management Agency (FEMA), and they are proactively deployed during impending disasters. They also help various state governments with training. 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. For example, the force from Andhra was deployed to Japan during the Fukushima disaster.
In addition, there are various nodal agencies in the country involved in the early warning system. Specifically, the India Meteorological Department conducts weather forecasting and earthquake recording. It has substantially improved its early warning capabilities, which was evidenced by the early warning given of the Phailin event. India's Central Water Commission provides early warning of floods and the Geological Survey of India is responsible for landslide warnings. As a result of the 2004 tsunami, they now have advanced equipment. The Indian National Centre for Ocean Information Services, located in Hyderabad, provides early warning to vulnerable areas, including the Andaman Islands, the coastal village of Colva, Mumbai, and other cities; the data is also used by other countries. The National Remote Sensing Centre of the Indian Space Research Organization uses satellite imagery in the prediction of floods, cyclones, and droughts.
Ahmad then turned to the management of response to biological disasters. In July 2008, the National Disaster Management Authority (NDMA) created national technical guidelines on management of biological disasters. A core group of experts, microbiologists and other scientists developed these national guidelines calling for greater attention to the prevention of biological disasters. Pharmaceutical and non-pharmaceutical interventions and biosafety measures were included. This group created a database of inventories of various laboratories handling hazardous microorganisms, and enhanced medical preparedness through the establishment of command, control, and coordination of infectious disease control efforts. They have also worked to develop human capacity and research. Critical infrastructure for management of biological emergencies, institutional mechanisms, public health responses, and provisions for management of pandemics are additional challenges undertaken by NDMA.
And finally, another important goal is the development of mechanisms for enhancing international cooperation, which includes upgrading the biosafety level of laboratories, developing bio-risk countermeasures, conducting risk and vulnerability assessments of livestock, and establishing legislative and regulatory frameworks and early detection facilities based on risk management practices. These preparations are to be brought together in the development of an all-hazards implementation strategy.
Discussion
The discussion following Ahmad's presentation focused on bilateral cooperation. In particular, Nirmal Kumar Ganguly cited a previous Indo-U.S. partnership that aided in rapid assessments that determined which vaccines should be used in which national disaster situations. There are many other critical components of disaster management including epidemiology. 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. Forty-five million Indians are either infected with or are potential carriers of Hepatitis B, two million are infected with Hepatitis C, and 2.3 million are infected with HIV. Samples are collected in the field, in hospitals, and a variety of other locations. Another example of the importance of biosafety in all areas, even beyond biocontainment labs, is India's recent resurgence of polio. India was free of type-2 polio for many years, and then suddenly in northern India, a type-2 polio outbreak occurred. When epidemiologic investigations and sequencing the virus, investigators ultimately were able to identify the source and determine that this outbreak occurred due to a lack of biosafety. It was determined that there was an Indian company that wanted to manufacture polio vaccine had a reference strain of type 2 wild polio virus that was not contained and led to the outbreak.
Biosafety measures must be followed across the board. One of the major programs undertaken through a partnership with CDC, the Indian Council of Medical Research, and CDC is mapping every public health laboratory and company in the country working with infectious organisms. The number of these labs is astonishing. The mapping project will not only list these labs, but will also include physical visits to the labs to learn what type of infrastructure, capacity, and training they have. This inventory should also provide a sense of available capabilities that could be drawn upon in emergency situations. For example, should an Ebola outbreak occur in India, it would be helpful to know that there are three or four people in India who have an in-depth knowledge of Ebola. This project would be an excellent target for collaboration between U.S. and Indian scientists and hopefully this workshop can catalyze cooperation that can eventual draw upon this information.
Ganguly noted that the need for cooperation was also demonstrated by an outbreak of plague after the September 1993 earthquake in Beed and Latur. People moved out of their homes to escape potential collapse, but they stored grain in their houses so that the grains would not be destroyed. Both Didorincus and Bandicota bengalensis, which are feral rat species, intermingled with the Rattus rattus norvegicus (house rats), and they started the spread of bubonic plague. By September 1994, it had spread to Surat, where a festival was being held, and the pneumonic plague killed a large number of people. When laboratories in India tried to identify the disease, they identified it as Pseudomonas pseudomallei, the causative agent of meliodosis. Papers were published with these results, but some medical personnel were not convinced and believed that it was a plague outbreak due to clinical observations. This led some experts to look further, and they sent strains to the appropriate labs, where it was identified as Pseudomonas stutzeri, which is a saprophyte.
Then, Ganguly recounted, the next plague outbreak occurred and again partnership was invaluable. To respond to these emergencies, establishing a lasting partnership is essential. Some Indian experts were told that an incidence of bioterrorism had occurred and that plague had been engineered and released in India. Researching this potential case required additional expertise, specifically, a mammologist who was an expert on rats. India has few such experts, so help was sought, which allowed for identification and isolation of bacilli. The next step was to prove to skeptics that the outbreak was not a bioterror event. Ganguly and his colleagues were horrified to find that there is no repository of plague found in India. Ganguly then turned to other outbreak instances and the partnerships that helped end the outbreak. The first outbreak was of the Nipah virus, which occurred in Malaysia, and Australian experts helped them. Then an outbreak occurred in Siliguri, West Bengal, resulting in a high fatality rate. Investigations concluded that it was a novel strain of measles virus so a sample was sent to CDC for confirmation. The CDC measles group found that the sequences were that of a measles vaccine strain, the Edmonston-Zagreb strain used in India. 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. They reported these findings; however, few believed that there could be asymptomatic cases of SARS. CDC did have knowledge of asymptomatic cases, and again it offered significant assistance so that the Indian government could be advised that asymptomatic SARS cases, which might carry the virus and excrete the virus, could and did exist.
U.S.-Indian partnership also established a special mechanism between the Indian National Institute of Biology and American institutes through which Indians could receive an expedited visa to the United States. This helped in establishing disease investigative centers in the region such as those in China and Thailand.
The avian influenza outbreak in Maharashtra was addressed through partnership with NIH, which helped in identifying strains that could be used in an H5N1 vaccine because at that time there was no H5N1 vaccine available. This partnership, unlike some others, was less successful in that the cost of the vaccine was unrealistic. The only challenge that emerged was how to address intellectual property rights (IPR) issues when an Indian strain was to be used in a vaccine. The current state of IPR management is much better, but additional work in this area is needed. Perseverance led to the development of the first H5N1 vaccine made in India through a partnership with the U.S. company Novavax. The seasonal flu vaccine in the virus-like particle platform with Novavax and an Indian company completed a clinical trial, and it will be used in India.
Ganguly concluded by stating that there is a need to consider how to connect all of the many existing Indo-U.S. partnerships and to ensure that they are mutually reinforcing and sustained.
Discussion
The discussion following Ganguly's presentation included comments about bilateral cooperation, especially in areas not yet benefiting from Indo-U.S. collaboration, and the different levels of cooperative relationships.
S.R. Rao identified biosecurity, biosafety, and biocontainment as three primary areas of cooperation, and said there are many other areas that would benefit from partnership and collaboration. General scientific collaboration and cooperation in the area of diagnostics are frequent, but there are very few collaborations in the regulatory sciences and in risk assessment. Perhaps the only sustainable example of cooperation on risk assessment has been with U.S. Department of Agriculture on biosecurity issues related to plant pathogens and the invasion of certain species of plants across boundaries. The National Institute of Plant Health Management in Hyderabad has a sustained collaboration that includes convening workshops, reviewing guidelines, and updating handbooks on a long term basis under the Ministry of Agriculture. India does not have a similar arrangement with the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA), 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. A bill is before the Indian Parliament that will cover most of the Environmental Protection Act. It will fold many of the EPA requirements into the Biotechnology Regulatory Authority. There is also a biosecurity bill particularly addressing planned quarantine issues raised by the Department of Agriculture, which will be introduced soon.
An important element of collaboration is to compare what is meant by biosafety in the laws of both countries, and what efforts can be undertaken between the two countries. This has been done effectively in the case of agricultural cooperation; the same should be extended to cooperation with the U.S. FDA and EPA, and any other agencies involved in biosafety.
Another issue for India is to examine the 1990 guidelines addressing biosafety labs because they are outdated. There is a need to exchange experiences through a workshop or meeting to help build the capacity to update the guidelines to meet contemporary requirements.
S.R. Rao noted that he is responsible for promoting the establishment of BSL-3 labs. He often experiences a lack of capacity to construct BSL facilities in the country. There is a clear need to share experience in designing, developing, and maintaining BSL facilities. Further, in his experience, the ability to handle these laboratories after commissioning is poor. 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. regulatory bodies.
He restated that there is on-going research and collaboration in areas such as HIV research, but there is no solid collaboration between U.S. and Indian regulatory bodies to promote both regulatory scientific investigations and the regulation of existing facilities, as well as continuously building the human resources required for implementing biosafety protocols. S.R. Rao included animal houses in his consideration of biosafety. There is significant need for human resource development regarding how to maintain animal facilities. In particular, researchers are importing new mice and many experimental models from abroad, but when they are put into animal houses they become infected.
India is also creating a biosafety support unit under the Environmental Protection Act related to the 1989 rules that cover both pathogenic organisms and recombinant products. The office will be staffed with 20 to 25 people, one half of them dealing with the medical side, one half of them dealing with the agriculture side, mostly addressing risk assessment. They have asked USDA to help train the employees and a letter of intent has been exchanged. India has proposed to cover all travel costs for those being trained in the United States by USDA, and USDA will cover the training costs. The same approach can be taken for most risk assessment science related to pharmaceuticals and other biologicals. There is also a need to build capacity in the regulatory system to address nanotechnology, gene therapy, and other new products. These serve as outstanding examples of capacity building related to regulatory laws and guidelines, and much more could be accomplished through an organized effort. Thus far efforts to cooperate on these issues have not been well-coordinated. Workshops and other actions in this area are very much needed and requested, in particular to assist in updating guidelines and standards, specifically those dealing with BSL-3 facilities. Such efforts would be an excellent start to many other programs in the regulatory sciences.
Ganguly noted that there is an Indo-U.S. agreement on environmental health, to which EPA is a major party. This mechanism needs to be effective. Further, the Material Transfer Agreement (MTA) is presently a major hindrance to Indo-U.S. cooperation. He also suggested that all Indo-U.S. agreements should be archived so that all accumulated knowledge is located in one place. T.S. Rao agreed that the MTA should be addressed through the inter-ministerial group.
Another participant observed that there are currently four levels of Indo-U.S. cooperation. The first is nation-to-nation collaboration to sign fundamental agreements. The second is institution-to-institution collaboration, and the third is PI-to-PI. There is a fourth that has not yet been discussed: individual scientist-to-individual scientist collaboration, especially among young people. Younger people work more and more through social networks, so perhaps ResearchGate would be helpful. How many people are providing protocols to young people when they inquire? This is peer-to-peer exchange. Ganguly replied that there are many Indian scientists who have returned from U.S. institutes and they often collaborate and publish together. There should be an archiving platform under the Indo-U.S. Science and Technology Forum, for example, to track and monitor these collaborations so that they can be sustained.
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.
Footnotes
- 1
Robert Martin was unable to attend the workshop in person and his presentation was provided via recording.
- 2
The Biosafety in Microbiological and Biomedical Laboratories can be found at: http://www
.cdc.gov/biosafety /publications/bmbl5/; accessed April 10, 2016. - 3
The Laboratory Biosafety Manual can be found at: http://www
.who.int/csr /resources/publications /biosafety/en/Biosafety7.pdf; accessed April 10, 2016. - 4
The Laboratory Biosafety Guidelines can be found at: http://www
.phacaspc.gc .ca/publicat/lbg-ldmbl-04/index-eng .php; accessed April 10, 2016. - 5
The Applied Biosafety Journal can be accessed at: http://apb
.sagepub.com/; accessed April 10, 2016. - 6
Dan Herbert. “Why is Safety so Hard?” Available at: http://www2
.emersonprocess .com/siteadmincenter /PM%20DeltaV%20Documents /Articles/ControlMagazine /Why-is-Safety-so-Hard .pdf; accessed April 10, 2016. - 7
D. Vesley and H.M. Hartmann. “Laboratory-acquired infections and injuries in clinical laboratories: a 1986 survey.” American Journal of Public Health. September 1988. 78(9):1213-5.
- 8
Rashidi Ahmad. “Roles of the University in Disaster Management,” Malaysian Journal of Medical Sciences. 2007 Jul; 14(2): 1–3. Available at: http://www
.ncbi.nlm.nih .gov/pmc/articles/PMC3442620/; accessed April 10, 2016. - 9
For more information, see: http://pib
.nic.in/newsite/mbErel .aspx?relid=133377; accessed April 10, 2016.
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