7

IDENTIFYING AREAS FOR POSSIBLE ACTION (BREAKOUT SESSIONS)

The goals for this group of breakout sessions were to (1) generate strategies and suggestions for countries building/upgrading or considering building/upgrading labs, (2) consider what data on biosafety would be most useful to generate, and (3) identify areas where current biosafety practices are not well-matched to actual needs. In order to facilitate discussions, participants in each session first listened to several brief talks.

BREAKOUT SESSION 1: DETERMINING NECESSARY AND APPROPRIATE PRECAUTIONS
Chair: Michael Callahan
Rapporteur: J. Craig Reed

In view of the increasing range of available biosafety options, from expensive engineered solutions to lower-cost microbiological techniques, breakout session 1 examined how to select combinations of precautions that best meet individual needs. Each precaution adds to a facility’s complexity, and safeguards need to be maintained during both normal operations and emergency conditions including natural disasters.1 Components, such as backup power systems intended to maintain the required airflow during loss of primary power, may have non-trivial interactions that make understanding and testing the overall system difficult.2 Personnel require regular refresher training to maintain competencies, and complex regulations can be difficult to implement and verify.3

Laboratory authorities, while acknowledging the infeasibility of conducting zero-risk operations, rarely specify the level of risk they consider acceptable. Often the incremental reduction in risk from each layer of precautions is unclear. Lack of quantitative information makes prioritizing options difficult, particularly when constrained by finite budgets for both containment labs and competing priorities. Additionally, complying with funding requirements often requires laboratories to adhere to the recommendations for standard BSL levels, even if some aspects of those recommendations are excessive for a facility’s particular mission. Furthermore, universal recommendations, while convenient and simple, do not afford opportunities to factor in additional information about the setting in which the work is performed, such as disease endemicity, local immunity, and community concerns. Unnecessary precautions increase expense, decrease efficiency, and tempt workers to circumvent safeguards (United States HHS, 2009; see page xxxi).

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1 For example, the Shope Lab and the Galveston National Laboratory’s BSL-4 facilities at the University of Texas Medical Branch in Galveston developed plans for dealing with hurricanes, floods, and earthquakes (Federal Register, 2005).

2 The United States Centers for Disease Control and Prevention’s new BSL-4 in Atlanta, Georgia has had several problems with its backup power system including nearby construction cutting a grounding cable and whether to share a backup power plant with other facilities or to have its own plant (United States GAO, 2007).

3 CDC inspections of laboratories at Texas A&M University failed to find any evidence of an occupational exposure that later resulted in a case of brucellosis (United States GAO, 2009).



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7 IDENTIFYING AREAS FOR POSSIBLE ACTION (BREAKOUT SESSIONS) The goals for this group of breakout sessions were to (1) generate strategies and suggestions for countries building/upgrading or considering building/upgrading labs, (2) consider what data on biosafety would be most useful to generate, and (3) identify areas where current biosafety practices are not well-matched to actual needs. In order to facilitate discussions, participants in each session first listened to several brief talks. BREAKOUT SESSION 1: DETERMINING NECESSARY AND APPROPRIATE PRECAUTIONS Chair: Michael Callahan Rapporteur: J. Craig Reed In view of the increasing range of available biosafety options, from expensive engineered solutions to lower-cost microbiological techniques, breakout session 1 examined how to select combinations of precautions that best meet individual needs. Each precaution adds to a facility’s complexity, and safeguards need to be maintained during both normal operations and emergency conditions including natural disasters.1 Components, such as backup power systems intended to maintain the required airflow during loss of primary power, may have non-trivial interactions that make understanding and testing the overall system difficult.2 Personnel require regular refresher training to maintain competencies, and complex regulations can be difficult to implement and verify.3 Laboratory authorities, while acknowledging the infeasibility of conducting zero-risk operations, rarely specify the level of risk they consider acceptable. Often the incremental reduction in risk from each layer of precautions is unclear. Lack of quantitative information makes prioritizing options difficult, particularly when constrained by finite budgets for both containment labs and competing priorities. Additionally, complying with funding requirements often requires laboratories to adhere to the recommendations for standard BSL levels, even if some aspects of those recommendations are excessive for a facility’s particular mission. Furthermore, universal recommendations, while convenient and simple, do not afford opportunities to factor in additional information about the setting in which the work is performed, such as disease endemicity, local immunity, and community concerns. Unnecessary precautions increase expense, decrease efficiency, and tempt workers to circumvent safeguards (United States HHS, 2009; see page xxxi). 1 For example, the Shope Lab and the Galveston National Laboratory’s BSL-4 facilities at the University of Texas Medical Branch in Galveston developed plans for dealing with hurricanes, floods, and earthquakes (Federal Register, 2005). 2 The United States Centers for Disease Control and Prevention’s new BSL-4 in Atlanta, Georgia has had several problems with its backup power system including nearby construction cutting a grounding cable and whether to share a backup power plant with other facilities or to have its own plant (United States GAO, 2007). 3 CDC inspections of laboratories at Texas A&M University failed to find any evidence of an occupational exposure that later resulted in a case of brucellosis (United States GAO, 2009). 65

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66 Biosecurity Challenges Before the session opened for general discussion, several speakers addressed a number of issues related to the topic including whether adding additional engineering controls always increases safety, the reality that regulations and guidelines rarely keep up with technology, and the benefits of making risk assessments more quantitative and pathogen- specific. Speakers also commented on the need for and difficulties in obtaining quantitative data and offered suggestions to address this problem. Following the presentations, Michael Callahan (Defense Advanced Research Projects Agency, United States) led a discussion. BREAKOUT SESSION PRESENTATIONS Evidence-Based Biosafety: Ensuring Precautions are Adequate and Appropriate Allan Bennett (Health Protection Agency, U.K.) discussed the main causes of laboratory-acquired infections (LAI) and argued that the combination of building engineering, equipment, and practices commonly used today are neither economical nor maximally effective. While the best direct evidence that labs are not serving as sources of infection and that a set of precautions is effective would be accurate counts of the number of LAIs, lack of governmental reporting requirements make such data scarce. In the absence of direct evidence, he suggested that applied biosafety data could serve as indirect evidence. Mr. Bennett started by pointing out that of the three main routes of laboratory infection— inhalation of aerosols, surface contact with the agent, and punctures from needles or other sharps—aerosols have historically received the most attention. Starting in the early 1980s, regulations began requiring a number of expensive technologies to reduce aerosol exposure including HEPA filters, directional air flow, multiple air exchanges per hour (ACH), and biological safety cabinets (BSC). Since then, materials and practices have evolved to offer additional ways to minimize the creation of aerosols, such as the use of sealed centrifugation rotors and the substitution of plastic flasks and bottles for glass ones. He believes that many research spaces, as a result, are now over-engineered. This can cause both unnecessary expense and a reduction in overall safety. As an example, he pointed out that many of the precautions used to reduce aerosol exposure (e.g., flexible film isolators, half suit isolators, respirators, and Class II BSCs) reduce vision and manual dexterity, which can increase splashes (Sawyer et al., 2006). As such, he believes that when evaluating protocols the whole set of precautions and their side effects should be considered collectively. Glove usage and hand hygiene constitute another set of practices that Mr. Bennett believes should be altered. For example, the thick household gloves used in Class III BSCs and in BSL-4 conditions significantly decrease both gross dexterity of the hand as well as fine finger dexterity. Similarly, although latex gloves cause no loss in manual dexterity (Sawyer et al., 2006) and are critical for preventing direct contact infections, many BSL-2 lab workers, even in high resource countries, do not use latex gloves consistently. He cited a study conducted at the University of Utah and presented at the 2010 American Biological Safety Association (ABSA) Conference where James Johnston4 (University of Utah) found that only 46 percent of staff removed gloves on leaving a BSL-2 lab, hand hygiene compliance before exiting a lab was 10 percent, and 72 percent of individuals touched their face while working. In the study, compliance varied widely between labs and could not be predicted by training. Mr. Bennett also stated that in the developed world, workers might become overly reliant on engineering and let down their guard with respect to biosafety procedures and good 4 James Johnston, Ph.D., C.I.H.: Hand Hygiene in the Biosafety Level-2 Lab: Is it a Matter of Training? (Tuesday, October 5, 2010) ABSA 53rd Annual Biological Safety Conference, September 30-October 6, 2010 Denver, CO. Available: www.absaconference.org/pdf53/Session8-Johnston.pdf.

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67 Identifying Areas for Possible Action microbiological practices. He feels the recent outbreak of Salmonella typhimurium in teaching and clinical microbiology labs in the United States is likely an example of the phenomenon.5 Due to the development and widespread use of advanced diagnostic techniques, he speculated that improper inactivation is likely to become a major source of infection in the future. Risk-Based Design of Facilities for High Consequence Animal Pathogen . Uwe Mueller-Doblies (Institute for Animal Health, Pirbright Laboratory, U.K.) described the benefits of taking quantitative, risk-based approaches to laboratory safety and gave examples of how such approaches could be implemented. Dr. Mueller-Doblies began by suggesting that people should move from a compliance- based approach to a risk-based approach. Compliance-based approaches, he argued, consist largely of checking boxes and often lead to over-engineering. Instead, he feels that we should learn to better understand, quantify, and communicate risks. As eliminating all risk is not achievable, a key component of the approach is defining an acceptable risk level. His institution (Institute for Animal Health), for example, uses one consequential release every 500 years as its target risk level. Other institutions may need to define targets for an acceptable risk of operator exposure or cross contamination. He suggested that communities or countries with multiple facilities may want to consider risk/year/facility (i.e., risk per facility per year). After selecting a target risk, Dr. Mueller-Doblies feels labs must determine both what their risks are and implement appropriate controls to reduce those risks to an acceptable level. He noted that controls for human pathogens (operator protection) and animal pathogens (requiring environmental and veterinary protection) differ significantly and that plant pathogens present their own challenges. Furthermore, the consequences of an event often depend on issues such as the proximity of the surrounding community and whether or not a particular disease is endemic. Thus, he argued that risk assessments should be specific to regional and local requirements and should not be blindly accepted by facilities in other countries. Dr. Mueller-Doblies then introduced the bow-tie risk management model for visualizing and calculating risks (Figure 7-1) and gave examples of many types and classes of threats. For example, aerosols, needles and sharps, ingestion from fomites, and infected animals are all threats that could lead to human exposure, while threats that could lead to environmental release include operator error, solid waste, animal carcasses, fomites, effluent, and aerosol escape through ventilation. From a biosecurity point-of-view, deliberate threats such as intruders, insiders, a theft in transit, or illegitimate material receipt could also lead to a release event. 5 Investigation Announcement: Multistate Outbreak of Human Salmonella Typhimurium Infections Associated with Exposure to Clinical and Teaching Microbiology Laboratories. Available at: http://www.cdc.gov/salmonella/typhimurium-laboratory/042711/index.html. Accessed October 17, 2011.

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68 Biosecurity Challenges Figure 7- 1 Bow-tie Risk Management Model. The center of the tie represents the hazard release, threats are on the left, and consequences are on the right. Risk paths connect each threat to the release event, and threat control measures are visualized along the appropriate risk path. Paths from the release to consequences have recovery and mitigation measures such as vaccination and isolation of exposed workers for human threats and exclusion zones and quarantine periods for environmental threats. SOURCE: Copyright © 2011 ABSG Consulting Inc. All rights reserved. Used with permission. Dr. Mueller-Doblies explained that threat control measures often include a number of layers of protection: passive controls, dynamic controls, and management controls. Passive controls include airtight barrier construction and double exhaust HEPA filtration. Dynamic controls include air changes, directional inward airflow, steam autoclaves, leak alarms, and shower protocols. Management controls include alarm response protocols, HEPA filter validation, and protective clothing. Threat control measures for biosecurity threats include physical security, security procedures, inventories, security staff, and security services. A number of elements go into effectively using the bow-tie model. In particular, one needs to know how much each threat control measure reduces risk and the likelihood and consequences of failure for any measure. Furthermore, Dr. Mueller-Doblies argued that one should be able to detect failure in a control measure, and control measures should be independent, i.e., no two active engineering controls in the same risk path should be dependent upon the same service, such as electricity or steam. He mentioned that a number of assessment methodologies such as failure mode effect analysis and hazard operability studies can assist with such an analysis. Control of Emerging Infections Onder Ergonul (Koç University, Turkey) discussed the high incidence of secondary infections, some fatal, among health care workers and demonstrated how examination of data on secondary infections among health care workers in conjunction with details about the precautions used and types of exposures received can provide valuable information about routes of infection and what precautions are necessary and appropriate. Many emerging and reemerging diseases, including Crimean-Congo hemorrhagic fever

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69 Identifying Areas for Possible Action (CCHF), Ebola, and Rift Valley fever are zoonotic diseases. CCHF is transmitted by ticks of the genus Hyalomma and has a particularly high incidence in Turkey, Russia, and other countries in the region. Like Ebola and Marburg, CCHF has a high risk of human-to-human transmission in the health care setting, and Dr. Ergonul showed data that since 1950, at least 94 workers have been infected by CCHF, 38 fatally. Both needlesticks and exposure to contaminated blood have caused infections in health care workers (van de Wal et al., 1985). By following up in Turkey on health care workers who had previously treated CCHF patients, Dr. Ergonul found no evidence of infections from inhalation and concluded that standard precautions, including those to protect against bloodborne pathogens, are usually adequate (Ergonul et al., 2007). He feels that use of gloves, gowns, and facial protection for the eyes, nose, and mouth are particularly indicated by risk assessments based on documented transmissions. While N95 respirators are usually not necessary for health care workers, he noted that they might be advisable for lab workers engaged in aerosol-generating activities. Dr. Ergonul explained that increasing worker use of the recommended standard precautions requires both more resources and more education. For example, needlestick injuries, a major cause of CCHF transmission to workers, can be reduced by safety-engineered devices, appropriate sharps containers, and education on best practices. Dr. Ergonul observed that, unfortunately, increasing compliance with sharps protocols is almost as difficult as increasing compliance with hand hygiene recommendations, another inexpensive, but effective precaution. To illustrate the general utility of using data to evaluate the effectiveness of potential precautions, Dr. Ergonul described a metaanalysis of studies that examined the ability of various barrier interventions to reduce severe acute respiratory syndrome (SARS) transmission (Jefferson et al., 2008). The work provided strong statistical support for the effectiveness of frequent hand washing and the use of masks, gowns, and gloves to protect against transmission to healthcare workers. Dr. Erogonul also presented data indicating that treatment of CCHF with ribavirin is most effective during the disease’s pre-hemorrhagic stage (Ergonul, 2008), which coincides with the time the virus is detectable by polymerase chain reaction (PCR), but not yet detectable with enzyme-linked immunosorbent assay (ELISA) tests (Ergonul, 2006). BREAKOUT GROUP 1 DISCUSSIONS To foster discussion, several questions were posed to the group: • Are there any common procedures for which specific baseline minimum biosafety requirements have not been determined (and that are likely performed using unnecessary precautions)? • Are any procedures commonly done using safeguards that do not enhance safety? • What data on biosafety would be most useful to generate? • To what extent should the setting in which work is performed (endemicity, local immunity, local risk tolerance, etc.) affect the precautions employed? In discussing the presentations and the above questions, participants identified two main issues. Difficulties in Implementing Good Practices Several participants indicated that it is frequently difficult to convince lab and healthcare workers to use good practices, even in cases where the techniques, such as glove use and hand hygiene, are both inexpensive and known to be effective. To address this issue, one

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70 Biosecurity Challenges person pointed out the value of vigorous mentoring programs that workers in some labs must complete (in addition to formal training) before being allowed to work independently. Another suggested that biosafety should be taught as, “This is why we do X, and this is why we do Y,” rather than simply as, “We do X and Y.” A third proposed that anyone who joins a lab, regardless of his or her previous experience, should undergo an apprenticeship that includes competency testing. Need for Applied Biosafety Data Many presenters as well as several members of the attendee group commented on the difficulty in obtaining good data on the effectiveness of particular precautions. To partially satisfy the need, one attendee suggested people make an effort to publish biosafety data they previously generated for their own internal use. Several people indicated that to generate useful data, perhaps a voluntary process for reporting LAIs and near misses to an international authority could be developed. One person cautioned that care must be taken to distinguish LAIs from background infections in regions where certain diseases of concern are endemic. In response to a comment on the need for more funding for applied biosafety research, one person indicated that the United States Defense Threat Reduction Agency (DTRA) plans to fund research on that topic. Someone else indicated that additional data are needed to determine if current designs, equipment, and procedures are reducing actual risks appropriately. The individual also suggested that evaluations might discover that many components of containment labs are over- engineered and that changes could potentially lead to decreased costs. Routine use of second HEPA filters was suggested as a possible example of engineering that may no longer be necessary given that when this practice started in the 1980s filters were much easier to damage. The participant stated that there is a clear need for data to inform decisions regarding ways to more economically maintain and operate containment laboratories while ensuring their safe and secure operations. In an attempt to answer the question of how the effectiveness of particular techniques can be measured, someone suggested using proxies for infection such as fluorescent splashes on clothing. BREAKOUT SESSION 2: IMPROVING ORGANIZATIONAL CULTURE AND PRACTICES Chair: Serhiy Komisarenko Rapporteur: Benjamin Rusek The session opened with three talks that illustrated different approaches to improving safety and security practices. The first focused on the importance of establishing an atmosphere of trust and avoiding over-regulation. The second described the use of twinning programs to “seed” a second lab with successful practices from a more established lab. The final talk described how a nation passed legislation to improve biosafety and biosecurity on a national scale. After the talks, Serhiy Komisarenko (Palladin Institute of Biochemistry, Ukraine) led a discussion that further explored the topic.

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71 Identifying Areas for Possible Action BREAKOUT SESSIONS PRESENTATIONS ‘Enlightened Leadership’: More Powerful Than Guns, Gates, and Guards David Franz (MRIGlobal, United States) warned the group about the dangers of over- regulation and argued that enlightened leadership and an atmosphere of trust should be key elements in any effort to increase biosafety and biosecurity. Dr. Franz started by reminding the audience that we should be careful to preserve the power of science to do ‘good’ in our often-dangerous world. He then familiarized the audience with the history of biosafety and biosecurity in the U.S, and explained that prior to the events of 2001; the focus in the United States was on laboratory biosafety. Then, in response to the 11 September 2001 attacks, the anthrax letters (2001), and the subsequent Amerithrax investigation that culminated in the Federal Bureau of Investigation’s (FBI) contention that an insider was responsible for the anthrax letters (2008), the focus shifted to biosecurity, and new regulations followed. He noted two: • The USA Patriot Act of 2001 (Public Law 107-56) and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188) enhanced controls on dangerous biological agents and toxins and required the registration of persons who work with Select Agents. • Army Regulation 50-1 (Department of the Army, 2008) established a biological ‘surety’ program that defined criteria for evaluating personnel reliability. While acknowledging that if the FBI is correct about the Amerithrax case, then the insider threat is more difficult to combat than he had initially believed, Dr. Franz warned against the “slippery slope” of increasing regulation. In particular, he expressed concern about the growing attention synthetic biology is garnering and wondered if nanotechnology and work on understanding the human immune system might also be targeted for unnecessary regulation that could impact the science. He argued that by reducing the efficiency of scientific research and encouraging scientists to change fields or relocate their research offshore, over-regulation could ultimately impact the security and economy of nations. Furthermore, he cautioned that it could take 5-10 years to realize that we have over-regulated and an additional 15-20 years to reverse course. Dr. Franz then defined ‘enlightened leadership’ and compared the ‘enlightened leadership’ and ‘regulatory oversight’ approaches to dealing with the insider threat. He explained that enlightened leadership involves leading with science and focusing on quality research, safety, vision, education, responsibility, honesty, transparency, and ethics. Ultimately, it creates a culture of trust and accountability. In contrast, the ‘regulatory oversight’ approach entails leading with security and implementing “guns, gates, and guards,” background checks, psychological evaluations, and pathogen controls and often results in a culture of mistrust. Dr. Franz acknowledged that while labs need varying levels of regulatory oversight, all labs can benefit from enlightened leadership. Dr. Franz then recommended ways to reduce the momentum towards unnecessary regulations in the life sciences. He suggested that scientists strive to increase transparency in science and communicate and demonstrate a culture of scientific responsibility to the public. Scientists should work with lawmakers and concerned citizens to regulate real risks, evaluate the value of proposed safety and security solutions, and examine the full costs of proposed regulatory solutions. These steps will help put in place effective regulation that limits the frustration to scientists. In closing, Dr. Franz observed that completely eliminating the insider threat in a given laboratory can only be done by stopping all research and firing the scientists. This society

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72 Biosecurity Challenges cannot afford to do. While we will always live with some risk, he emphasized that we can control the amount and type of regulation that we chose to impose and the leadership and culture of our laboratories in which we work. Laboratory Twinning – A Tool to Improve Global Disease Security Keith Hamilton (World Organisation for Animal Health [OIE], France) described OIE, its laboratory network, and the twinning program OIE is using to expand and strengthen that network. OIE, which is an intergovernmental organization with 178 member countries, produces manuals and international standards for animal health, disease surveillance, laboratory diagnostics, trade, vaccine production, veterinary laboratories, and animal facilities. It also oversees a network of OIE Reference Laboratories (OIE RL) and OIE Collaborating Centers (OIE CC). An OIE RL serves as a center of expertise and standardization for a particular disease and offers technical advice, training, and diagnostic services (e.g., confirmatory testing, agent characterization, pathogen isolation, and production and distribution of reagents) and ultimately disseminates useful information including positive test results to the international community. Rather than focusing on a particular disease, an OIE CC is recognized for a particular sphere of expertise, such as epidemiology or veterinary medicinal products. An OIE CC provides technical advice and training, develops new techniques and procedures, disseminates useful information, and places expert consultants at OIE’s disposal. He emphasized that both OIE RLs and OIE CCs provide international support and make an impact far beyond their national borders and pointed to the recent worldwide eradication of rinderpest as a major success of the network. To expand its current network of 225 OIE RLs and 40 OIE CCs, Dr. Hamilton explained that OIE has instituted a twinning concept6 that establishes a link between a parent OIE RL or OIE CC and a candidate national laboratory. As OIE does not provide funding for hardware or facility upgrades, the focus is on transferring expertise and improving practices. While formal twinning lasts between 1-3 years, the experience is intended to form lasting links between the two institutions. Dr. Hamilton identified several objectives of twinning: • To build scientific communities; • To help countries enter the scientific debate on an equal footing; • To improve access to high quality diagnostics and technical assistance for OIE members; • To extend the OIE network of expertise and provide better geographic coverage for priority diseases; • To strengthen global disease surveillance networks; • To harmonize procedures globally, allowing for the generation of comparable results and increasing confidence in lab test results; and • To improve the ability of the candidate lab to meet OIE international standards. To help achieve the final goal, all twinning projects include subjects such as quality management, biosafety, and biosecurity. Often countries have more specific goals like combating an endemic disease or creating the capacity for pre-export testing to facilitate trade. While another goal of twinning is for candidate labs to successfully apply for OIE RL or OIE CC 6 A Guide to OIE Certified Laboratory Twinning Projects. Available at: http://www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/docs/pdf/A_Twinning_Guide_2010.pdf. Accessed August 29, 2011.

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73 Identifying Areas for Possible Action status, he acknowledged that that will not happen in all cases. Nonetheless, he expects the twinning experience to bring candidate labs closer to OIE RL or OIE CC status. Currently, OIE has about 30 active twinning projects and 10 more waiting to start. Singapore’s Response to Biorisk Events at Home and Abroad Teck-Mean Chua (Asia-Pacific Biosafety Organization, Malaysia) gave a presentation prepared by Ai Ee Ling (Singapore General Hospital, Singapore) describing the events that convinced Singapore that the country needed to improved its national biosafety and biosecurity practices and the actions the country ultimately took. Dr. Chua explained that while the Malaysian Nipah virus outbreaks in the late 1990s, the Anthrax letters in the United States in 2001, and the country’s growing biomedical industry attracted attention to the problem of naturally occurring and deliberate biological threats, the severe acute respiratory syndrome (SARS) epidemic of 2003 was the true wakeup call for Singapore. In addition to causing loss of life, the disease also had a massive economic impact on the country. Furthermore, after the outbreak had been contained, a researcher’s laboratory- acquired infection led to the reappearance of SARS in Singapore. An investigation of that lab revealed structural problems, insufficient training, overcrowding, and the lack of an inventory or tracking system for infectious samples. The investigation also identified the lack of a regulatory framework and national biosafety standards as contributing factors and recommended legislation to create such standards, as well as a process for certifying laboratory structural integrity and operating procedures and a system for tracking agent import, export, and transfer. The Biological Agents and Toxins Act (BATA), which was passed by Parliament in October 2005 and enacted in January 2006, implemented those recommendations in an enforceable way. Dr. Chua then gave several examples of the changes produced by BATA. As part of the new system, the Internal Security Department of the Ministry of Home Affairs began vetting personnel with access to containment labs that were determined to be protected facilities, and the Singapore Civil Defense Force assumed responsibility for laboratory emergency response. The Ministry of Health approved laboratory certifiers and trainers and required annual certification of BSL-3 labs. He noted that BATA complements the Animals and Plants Act of 1965 and the Genetically Modified Organisms Guidelines of 2006. The Ministry of Health also issued two sets of guidelines concerning the 2009 H1N1 influenza epidemic. The first set (May 2009) dictated that culture work take place in BSL-3 labs and that diagnostic work be done in BSL-2 labs using BSL-3 practices. The second set, which followed an improved risk assessment, allowed the virus to be handled in BSL-2 conditions in Class II BSCs. Dr. Chua also described some of the non-regulatory steps Singapore has taken to improve biosafety: • Delegations took study trips to CDC and the Canadian Biosafety Office and Office of Laboratory Security in 2002. • Starting in 2002 with the National University of Singapore, many universities established Institutional Biosafety Committees. • In 2005, the Ministry of Health granted the Asia-Pacific Biosafety Association status as an approved trainer, and the Biorisk Association of Singapore was formed in 2010.

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74 Biosecurity Challenges BREAKOUT GROUP 2 DISCUSSIONS Participants were asked to consider several questions: 1. What organizational culture and practices are desirable? How universal is this list? 2. What types of training and educational programs are most effective? What types of content should be emphasized? 3. What factors are key to successfully changing a lab’s culture and practices? What motivates change? During the discussion many pointed to a lack of funding, demonstrating a lack of priority to improve practices, training, and education, which they attributed to insufficient understanding on the part of senior management and government, as the biggest impediment to change. Individual participants then suggested various solutions: • Individual “champions” could take up the cause and spread the message in their countries and regions. • Good biosafety practices could be taught at all levels of life sciences education to help change attitudes and behaviors. • Biosafety associations could (1) provide neutral, national platforms for discussions among stakeholders from multiple agencies, (2) provide people, including those not in the life sciences, a sense of community, and (3) encourage the adoption of a biosafety culture. • Scientists could advise politicians. One person noted the benefit of getting involved at the time an agency asks for public comments on a proposal rather than waiting to complain about the final result. Several people also commented on the legislative approach to affecting change. One person felt that it is difficult, but perhaps not impossible, to legislate human behavior. Others suggested that more thinking is needed about how to enforce national regulations at the local level as implementation is missing in many places. BREAKOUT SESSION 3: DESIGN AND OPERATIONAL OPTIONS FOR IMPROVING SUSTAINABILITY, BIOSAFETY, AND BIOSECURITY Chair: Willy Tonui Rapporteur: Jennifer Gaudioso Challenges and limitations notwithstanding, many laboratories would like to improve their operations, and this session was intended to offer some practical suggestions. The session started with a presentation that offered tips for each stage in the lab lifecycle from design through maintenance. The second speaker then shared the decision process he used to acquire a BSL-3 lab for his institute and the steps he took to ensure that they would obtain a quality facility that would be affordable to maintain. The third speaker offered suggestions for improving practices and argued that practices are much easier to change than equipment or lab designs, and the final speaker provided another perspective on the design decision process. Following the presentations, Willy Tonui (Kenya Medical Research Institute, Kenya) led a discussion to examine some of the issues in more depth.

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75 Identifying Areas for Possible Action BREAKOUT SESSION PRESENTATIONS Design and Operational Options for Improving Sustainability, Biosafety, and Biosecurity in Southeast Asia Stuart Blacksell (Mahidol University, Oxford University, Australia) proposed solutions to address common sustainability, biosafety, and biosecurity issues in the region. Dr. Blacksell shared a number of design, construction, and commissioning suggestions: • Make sure that a BSL-3 facility is really necessary. • Allow enough time for all aspects of the project. • Select and prequalify the commissioning agent, general contractors, project managers, biocontainment engineers, and others as soon as possible. Beware of contractors without local experience or who want to design “reverse clean rooms.” • Obtain approvals as soon as possible. • Document specification compliance, the budget, and contingencies. When multiple sets of standards must be met, make sure that each partner signs off. • Hire someone familiar with lab workflow. • Avoid common mistakes including: biosafety cabinets (BSCs) that are of the wrong type, incorrectly placed, or have interrupted air flow; hand sinks in the wrong location or of the wrong type; and rooms that cannot be sealed for decontamination. • Do not neglect the plant room, which should include sufficient space. • Keep air-handling systems simple to increase reliability. Make sure HEPA filters are accessible for future service. As single pass air is very expensive and wasteful, he recommended considering recirculating ~85 percent of the air with additional HEPA filtration on the recirculated component. • Perform accreditation against the design standard(s). Additionally, Dr. Blacksell made a number of operational suggestions: • Make sure that everything can be serviced locally. • Ensure that BSL-3 organisms are stored within the BSL-3 lab. • Arrange for a maintenance budget, and plan for routine upgrades and replacements. • Check Type II BSCs annually. • Increase security by restricting access and/or employing guards, proximity cards, fingerprint readers, iris readers, locks, and closed circuit television monitoring. Perform personnel background checks with the help of the police, security agencies, and previous employers. Dr. Blacksell also made a number of general suggestions: • As Asia currently lacks engineers with biocontainment and biosecurity design experience, local universities should develop biosecurity engineering curricula. He added that development funds might be used for training and scholarships and that regional training facilities may be a viable option. • Increase the number of accredited BSC and HEPA filter testers. • Donors and partners should increase their role in maintenance. He noted that getting funding for new labs is typically much easier than obtaining maintenance money and believes that part of the problem is the difficulty in seeing how maintenance money is spent. He suggested that more education and awareness be directed towards this issue.

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76 Biosecurity Challenges Dr. Blacksell also emphasized that the client has a responsibility to be knowledgeable about what they want. Enhancing Biosafety and Biosecurity in North Africa and the Middle East: The Pasteur Institute of Morocco Experience Mohammed Hassar (Institut Pasteur du Maroc, Morocco) described the decision process the Institut Pasteur du Maroc (PIM) used to acquire an affordable, sustainable BSL-3 lab that met its scientific, biosafety, and biosecurity requirements. Dr. Hassar explained that in response to concerns about troop health and worries about epidemics entering the country, Morocco’s King, in collaboration with the army and the Ministry of Health, decided that Morocco needed to conduct disease surveillance. To accomplish that goal, he decided the country should build several BSL-3 labs. At the time, the PIM had a rudimentary BSL-3 that had been quickly built and had never functioned properly, and the PIM decided that building a new lab would be more economical than repairing the existing facility. Rather than put the project out for open bids, Dr. Hassar, who was then Director of the PIM, recounted that he requested and received special permission from the Minister of Finance to purchase a BSL-3 lab from the supplier that had just finished installing two other labs in Morocco. He felt that using the same supplier, who by that point had Moroccan experience, simplified operations and maintenance training and gave them confidence that they would receive a functional lab. The PIM built the facility’s shell, which has BSL-2 space and room for two BSL-3 suites. The supplier then assembled a single BSL-3 container (36 m2) in the shell; Dr. Hassar noted that a second suite may be added at a future date if the need arises. The BSL-3 component cost $450,000 U.S., while the whole facility (260 m2) cost $700,000 U.S. to build. He explained that the lab’s objectives are to isolate and analyze viruses, perform advanced scientific research in the field of viral infectious diseases, and protect workers and the environment from highly pathogenic agents. He indicated that the lab has an annual budget of $160,000 U.S., of which $30,000 goes to maintenance regardless of how much or little the BSL- 3 component is used. They also started training a local, private company to perform the necessary maintenance immediately after making the decision to build the lab. He reported that while the lab conducts some training, the overall BSL-3 usage is not high. Nonetheless, he finds it reassuring that the lab will be available when needed and indicated that in the future, the Institut Pasteur plans to install a BSL-3 lab at each of their locations. A Rational and Attainable Approach to Successfully Implementing Biosafety in Laboratory Settings Worldwide Barbara Johnson (Biosafety Biosecurity International, United States) discussed the role of good practices in addition to other controls in lowering risk and the need to let a detailed risk analysis rather than blind adherence to a general BSL recommendation or a set of standards guide decision-making. She acknowledged that in some cases regulations do not permit such flexibility. Dr. Johnson started by reminding the audience that many labs lack funding, well- maintained infrastructure, and equipment yet still need to perform critical public and animal health, medical, and research missions. She then related a number of examples from her experience of situations where lab workers used a risk analysis in combination with a detailed assessment of their needs and resources to develop creative solutions that improved the overall safety of their labs. For example, one group’s autoclave was fully used for sterilizing surgical packs, and hence they did not have sufficient capacity to sterilize lab ware like bacteriologic

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77 Identifying Areas for Possible Action loops. They decided that rather than flaming their loops inside their BSC, they could flame them outside their BSC and immediately place them inside a sterile can inside the BSC for later use. Other workers have employed homemade sharps containers (she indicated that any puncture and leak proof can is sufficient.) near the point of use. Similarly, she has seen a variety of reusable, resealable containers function as secondary containment to improve the safety of within and between room transport. The need to work in specifics rather than generalities is why Dr. Johnson feels that training that takes place largely inside the trainees’ own lab, directly addressing their situation and ultimately improving practices, is particularly valuable. In determining the appropriate primary containment, Dr. Johnson noted that it is often productive to determine if a lab’s procedures will aerosolize an organism that is infectious by inhalation. In resource constrained environments where purchasing and maintaining equipment that employs HEPA filtration is not feasible and when aerosols are not likely to be generated, a fan box without a HEPA filter that vents to the outside away from building air inlets and public spaces may be sufficient. Similarly, when organisms and procedures are not an aerosol risk, extensive HEPA-filtering of the lab itself may not be necessary. Additionally, HEPA-filtered exhaust air may be suitable for recirculation to the laboratory, but one should annually certify the building HEPA filters if this is considered. Another case where a situation-specific risk assessment can be useful is in determining the appropriate number of air changes per hour (ACH). While labs that work with volatile chemicals may need 10-12 ACH, in other cases the National Institutes of Health (NIH)- mandated minimum of 6 ACH for BSL-3 labs may be sufficient. Furthermore, if regulations and the heat load permit, it might be possible to reduce the number of air exchanges even further without compromising safety. While standby modes during times when there is no work ongoing in the lab may be acceptable, maintaining some airflow is usually necessary to prevent mold, humidity, and condensation inside the lab and ducts. A focus on functional requirements can also help labs avoid unnecessary, high-end construction. For example, ‘turnkey’ labs are often designed like clean rooms instead of containment labs and contain numerous HEPA filters that are expensive to maintain, impossible to test, and do not increase safety. A key attribute for BSL-2 labs is cleanability and in many cases vinyl flooring and painted gypsum wallboard suffices. In BSL-3 labs, seamless welded vinyl flooring and gypsum board walls covered with epoxy paint are often used to bear the weight of BSCs and allow for gas decontamination. More expensive floor and wall materials (poured concrete with troweled epoxy) can be reserved, if needed, for animal rooms where movement of racks and carts would quickly damage walls and floors. Rather than simply applying N+1 rules for mechanical equipment (e.g., redundant fans), the ease of repairs and the tolerance for downtime should be factored into calculations of the necessary level of redundancy. Dr. Johnson ended her presentation by observing that facilities, equipment, and practices all contribute to safety and that there is rarely a single correct way to do things. Engineering Control: Challenges in Maintaining a BSL-3 Pretty Sasono (National Institute of Health Research and Development [NIHRD], Indonesia) described the steps Indonesia has taken to improve its laboratory capabilities, biosafety, and biosecurity. Dr. Sasono opened by saying that diseases of concern in Indonesia include anthrax, tuberculosis, avian influenza, AIDS, malaria, dengue, typhoid, hantavirus diseases, and Nipah virus infections. To reduce the impact of disease, she explained that Indonesia would like to diagnose diseases in the shortest possible time, prevent diseases through vaccine development, and cure diseases through drug development, all of which require safe and secure labs.

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78 Biosecurity Challenges She then explained that to improve national laboratory capabilities, the Indonesian government recently funded construction of a BSL-3 lab. In 2005, an initial plan to retrofit an existing lab BSL-3 lab was considered but deemed infeasible. In 2006, NIHRD, with expert assistance from other countries and support from the United States State Department’s Biosecurity Engagement Program (BEP), considered BSL-3 designs based on WHO guidelines. She noted that local conditions, which include frequent floods and earthquakes, coupled with limited Indonesian BSL-3 expertise led to a decision to place a four room modular BSL-3 on the ground level of a new lab building. Construction started in 2007 and finished in 2008, and the lab was certified to international standards in 2009. The new BSL-3 laboratory complements about 20 other laboratories in NIHRD, a 44 lab network for infectious disease diagnosis that was originally assembled to combat avian influenza, 800 private laboratories, 9,000 Central Health laboratories, and other labs within hospitals and universities. Dr. Sasono went on to describe Indonesia’s biosafety and biosecurity efforts, which have included the introduction of training, guidelines, and regulations. Training has discussed weapons of mass destruction, bioterrorism, the National Biorisk Management Program, and biosecurity for avian influenza laboratories. NIHRD created an Instructor’s Guide for Biosafety Training based on a translation of WHO guidelines. A number of regulations have also been issued.7 She then explained that top managers as well as scientific and facility managers have taken steps to improve laboratory infrastructure and operational management. Facility managers are improving maintenance, control, calibration, certification, validation, and waste management, and security managers are improving physical, information, and personnel security. Occupational health improvements include keeping health records and providing vaccines, lab clothing, and personal protective equipment. Additionally, she reported that Biorisk Management Advisory Committees have been formed. Dr. Sasono also identified a number of on-going challenges and some possibilities for the future. She indicated that arranging for the rapid collection and testing of patient specimens in response to an outbreak is of the highest priority. Similarly, prompt and accurate reporting of confirmed diagnoses is also important. Another primary focus is making full use of qualified national laboratories and enhancing collaboration and networking within the country. While the Indonesian government has recently increased laboratory capacity, she noted these efforts should continue as should support for laboratory accreditation. She believes that additional technical expertise is needed and reported that Indonesia is considering a number of options including recruiting young engineers, offering special training, and increasing the availability of graduate studies. Possible training methods include in-house, hands-on training provided by an invited expert, training abroad, and participation in laboratory twinning programs. BREAKOUT GROUP 3 DISCUSSIONS In addition to discussing the presentations, the breakout session participants were asked to consider several questions: 7 Regulations include: Decree of the Minister of Trade and Industry of the Republic of Indonesia regarding the export and import of certain dangerous materials, including chemical and biological agents (2000); Decree of the Minister of Health of the Republic of Indonesia regarding safety and security guidelines for microbiology and biomedical laboratories (2009); Decree of the Minister of Health of the Republic of Indonesia regarding the delivery and use of clinical specimens, biological materials, and their information (2009); and Decree of the Minister of Health of the Republic of Indonesia to the National Commission regarding study and research on infectious diseases (2010).

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79 Identifying Areas for Possible Action 1. What options do countries have to improve the sustainability, biosafety, and biosecurity of their containment laboratories? 2. To what extent do donors influence laboratory design and operation and what is the impact of their involvement? 3. Is it possible to build a “green lab”? (Reducing operating costs increases sustainability.) 4. Are there some local industries that should be encouraged? 5. Should the world establish universal design and operational standards? Participants identified two topics to explore further. Green Labs While some participants felt it was possible to be greener and that “greenness” was generally desirable for economic and environmental reasons, others found discussion of the concept pointless, largely due to its incompatibility with regulations. One person described an existing modular lab capable of being shut down in parts, but most indicated that their labs shut down only for maintenance and inspections, both to comply with regulations and because their missions require them to be ready constantly. One person indicated that communities are often not receptive to the perceived risk of changing or reducing airflow to save energy even if evidence indicates that safety will not be affected. Someone noted that the American Society of Heating, Refrigerating, and Air-Conditioning Engineers8 publishes guidelines for green designs, including labs. Custom vs. Off-the-Shelf Many participants felt that selecting the “right” lab was critical to achieving the needed capabilities and noted that often one of the first decisions a group makes is whether to design a custom facility or to install an “off-the-shelf “ modular facility. One person from a country without any prior experience with containment labs recounted choosing a modular lab in the hope that it would be easier and still being surprised by the amount of expertise needed and the number of decisions required. Several people indicated that even with modular labs, there is no one size fits all solution and customers should shop around and make decisions based on their needs using the advice of their own technical advisors. Others cautioned that some modular labs are deceptively simple and include features such as an excessive number of HEPA filters with high maintenance requirements. Individual participants offered various suggestions for improving safety, security, and sustainability: • Require personnel to carry passes that track their location within the laboratory. • Start by focusing on demonstration sites. • Simulate both accidents and security breaches in order to identify weaknesses and improve; do not simply rely on preventative maintenance. • If funds allow, build a mock-up to train local workers on construction techniques. • Use the construction phase as a training opportunity for engineers and maintenance staff. • Use re-engineering and frugal engineering techniques to design cost-effective alternatives for equipment such as biosafety cabinets. 8 American Society of Heating, Refrigerating and Air-Conditioning Engineers. Available at: http://www.ashrae.org/. Accessed August 29, 2011.

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