1

INTRODUCTION

BACKGROUND

During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council (NRC) on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State’s Biosecurity Engagement Program (BEP) sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The attendees included laboratory directors, scientists, engineers, and members of governmental and non-governmental organizations. The participants were active in the fields of biosafety, biosecurity, scientific research, disease surveillance, and public health. Some came from countries with a long history of operating multiple laboratories, while others were from countries that had only recently opened their first biological containment (biocontainment) lab. Many were affiliated with groups contemplating the construction of new laboratories or interested in improving their existing facilities. The workshop agenda and biographies of participants and the NRC organizing committee are included as appendixes A-C at the end of this summary.

The workshop was multi-national in recognition of the international nature of the issue. Containment labs are no longer solely the province of “high resource” or developed countries. Low resource countries are also investing in labs to produce livestock vaccines matched to local strains, perform research on endemic diseases, and combat local human and animal disease outbreaks. Many nations are enhancing their laboratory and surveillance capabilities to comply with the World Health Organization’s (WHO) International Health Regulations (IHR) (2005), which require States Parties to have the capacity to detect unusual levels of disease or death in all parts of their territory and to be able to analyze samples either domestically or through a collaborative agreement (WHO, 2008). Furthermore, infectious diseases do not respect national borders (NRC, 2010a), and biocontainment labs often play an integral part in global disease surveillance efforts. The full statement of task is in Box 1-1.

This chapter provides an overview of the topics discussed in the workshop and assembles background information that was presented throughout the workshop in one place as an introduction and guide to the reader. This information is included at the beginning of the workshop summary to give the reader an appropriate level of context to understand the more detailed talks and discussion summarized in the later chapters.



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1 INTRODUCTION BACKGROUND During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council (NRC) on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State’s Biosecurity Engagement Program (BEP) sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The attendees included laboratory directors, scientists, engineers, and members of governmental and non-governmental organizations. The participants were active in the fields of biosafety, biosecurity, scientific research, disease surveillance, and public health. Some came from countries with a long history of operating multiple laboratories, while others were from countries that had only recently opened their first biological containment (biocontainment) lab. Many were affiliated with groups contemplating the construction of new laboratories or interested in improving their existing facilities. The workshop agenda and biographies of participants and the NRC organizing committee are included as appendixes A-C at the end of this summary. The workshop was multi-national in recognition of the international nature of the issue. Containment labs are no longer solely the province of “high resource” or developed countries. Low resource countries are also investing in labs to produce livestock vaccines matched to local strains, perform research on endemic diseases, and combat local human and animal disease outbreaks. Many nations are enhancing their laboratory and surveillance capabilities to comply with the World Health Organization’s (WHO) International Health Regulations (IHR) (2005), which require States Parties to have the capacity to detect unusual levels of disease or death in all parts of their territory and to be able to analyze samples either domestically or through a collaborative agreement (WHO, 2008). Furthermore, infectious diseases do not respect national borders (NRC, 2010a), and biocontainment labs often play an integral part in global disease surveillance efforts. The full statement of task is in Box 1-1. This chapter provides an overview of the topics discussed in the workshop and assembles background information that was presented throughout the workshop in one place as an introduction and guide to the reader. This information is included at the beginning of the workshop summary to give the reader an appropriate level of context to understand the more detailed talks and discussion summarized in the later chapters. 5

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6 Biosecurity Challenges Box 1-1 Statement of Task This international workshop will examine issues related to the design, construction, and operation of high-containment biological laboratories—equivalent to United States Centers for Disease Control and Prevention Biological Safety 3 or 4 level labs. Although these laboratories are needed to isolate some highly dangerous pathogens, they are complex systems with inherent risks. The workshop will aim to engage scientific experts and policy makers both from countries experienced in operating laboratories and from countries that are contemplating or undertaking the construction of new facilities. Possible areas for discussion include: • Technological options to meet diagnostic, research, and other goals; • Laboratory construction and commissioning; • Operational maintenance to provide sustainable capabilities, safety, and security; • Measures for encouraging a culture of responsible conduct. Additionally, some workshop participants will develop and present case studies. Case studies may describe a country’s facilities, capabilities, and regulations as well as past accidents, safety and security issues, and lessons learned. Workshop participants will explore possible strategies for enhancing biological safety and security worldwide and will offer practical suggestions to countries considering constructing or expanding their high biocontainment facilities. An individually authored workshop summary will be issued. WORKSHOP STRUCTURE A number of international organizations have encouraged countries to improve their laboratory biosafety and biosecurity,1 and workshop participants were asked to examine the growing number of high biocontainment labs in the context of the full biosafety and biosecurity spectrum (see Box 1-2). Box 1-2 Biosafety and Biosecurity: Historical Context In general, this report uses the term ‘biosecurity’ to refer to measures intended to reduce the deliberate misuse of biological materials or biotechnologya while ‘biosafety’ refers to protecting laboratory workers, community members, and the environment from accidental exposure to pathogens (NRC, 2009d; see pages 8-9). Nonetheless, the topics are interrelated. Proper maintenance and operations increase the ability to secure a facility, and a well-trained staff that takes pride in their work is less likely to cause an accidental breach and more likely to detect an insider threat and successfully guard against deliberate breaches (Franz and Le Duc, 2011). 1 In 2005, the World Health Assembly adopted Resolution WHA58.29, which encourages the use of national and international resources to improve laboratory biosafety (WHO, 2005). In 2004, the United Nations Security Council passed Resolution 1540, which requires States to take measures to stop the proliferation of weapons of mass destruction, including biological weapons, by State and non-State actors (U.N. Security Council, 2004).

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7 Introduction As a source of pathogens, equipment, and expertise, all of which could be misused, many aspects of biocontainment labs have dual-use potential (NRC, 2009a).b Although the Biological and Toxin Weapons Convention (BWC), which entered into force in 1975, bans the development, production, and stockpiling of biological agents and toxins for all but “prophylactic, protective, or other peaceful” purposes,c concerns remain. Examples of recent threats include an attempted theft of a lab’s pathogen collection by an external groupd and a purported biological attack by a rogue biocontainment lab employee.e Concerns about the possibility of events of this nature following the breakup of the Soviet Union led to the creation of the United States Department of Defense’s Biological Threat Reduction Program (BTRP), as part of the Defense Threat Reduction Agency’s (DTRA) Cooperative Threat Reduction (CTR) Programf (NRC, 2009b; 2009c). Initially, the BTRP worked with states of the former Soviet Union to redirect to peaceful projects facilities, research, and people that had been engaged in the USSR’s bioweapons program. The redirection work included facility upgrades to improve safety and security, cooperative research, and consolidation and protection of pathogen collections. Since the program’s inception, U.S. concerns have broadened, and in 2006, the United States Department of State’s Biosecurity Engagement Program (BEP) began funding cooperative efforts to promote responsible biological practices and use of biological materials in regions outside the former Soviet Union (NRC, 2009c; see page 147). The G-8 Global Partnership Against the Spread of Weapons and Materials of Mass Destruction also finances activities to support biological non-proliferation, biological safety (biosafety), and biological security (biosecurity). Not all threats emanating from containment labs, however, are deliberate in nature. Accidental pathogen releases can also occur and have serious consequences. Accidents could, for example, include a worker developing a laboratory-acquired infection and then inadvertently exposing the communityg or improper maintenance leading to environmental contamination.h Regardless of the accidental or intentional nature of a release, the result can be expensive both in terms of loss of life, economic losses, and erosion of public confidence in those conducting important research for the purpose of protecting humans, animals, and plants from infectious diseases. a The meaning of the term “biosecurity” can vary widely. “The term does not exist in some languages, or is identical to ‘biosafety’ in others. In addition ‘the term is already used to refer to several other major international issues. For example, to many ‘biosecurity’ refers to the obligations undertaken by states adhering to the Convention on Biodiversity and particularly the Cartagena Protocol on Biosafety, which is intended to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. ‘Biosecurity’ has also been applied to efforts to increase the security of dangerous pathogens, either in the laboratory or in dedicated collections” (NRC, 2009d; see pages 8-9). b See reference for more information on the dual use dilemma and attitudes towards the dual use issue among life scientists. c The complete text of the BWC is available at: http://www.opbw.org/. Accessed September 8, 2011. d A pathogen collection at an animal laboratory in Indonesia was the target of a theft attempt in 2007 (NRC, 2007a). e A chronicle of the events surrounding the mailing of anthrax-containing letters in the United States in 2001 that the United States Federal Bureau of Investigation concluded was the work of Bruce Ivins, an employee of the United States Army Medical Research Institute of Infectious Diseases, may be found in (NRC 2011a). f The CTR program also worked to reduce nuclear and chemical threats. g In Beijing, China in 2004, two lab workers acquired severe acute respiratory syndrome (SARS). Ultimately, seven additional people contracted the disease, one of whom one died. Available at: http://www.who.int/csr/don/2004_04_30/en/. Accessed September 9, 2011. h The foot and mouth disease (FMD) outbreak in the U.K. in August 2007 was likely caused by FMD virus from one of the laboratories at the Pirbright site and escaped through poorly maintained pipes. See: http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf. Accessed September 19, 2011.

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8 Biosecurity Challenges Introductory Plenary Sessions The workshop’s first day featured several plenary sessions that discussed the scope of the current worldwide laboratory expansion as well as many of the current issues facing labs throughout the world. The full agenda is in Appendix A. While the number of containment laboratories is clearly increasing, exact numbers are difficult to obtain. For example, the number of U.S. BSL-3 labs registered with the United States Centers for Disease Control and Preventions’ Select Agent Program increased from 415 in 2004 to 1495 in 2010 (Kaiser, 2011). However, BSL-3 labs that do not work with pathogens or toxins classified as “Select Agents”2 need not register with the United States government, and no federal agency is required to track the number of biocontainment labs (United States GAO, 2009). Growth is also taking place worldwide. BSL-3 labs have recently been built or are being built in Bangladesh, India, Indonesia, China, Brazil, and Mexico and other countries are expanding existing labs. India and China are interested in increasing their BSL-4 capacity (see Gaudioso, p. 26). Internationally, funding for new biological laboratories of all types and laboratory upgrades is coming from national governments as well as donors such as the World Bank, the Asian Development Bank, Fondation Mérieux, the Global Partnership, the Australian Government Overseas Aid Program (AusAID), CDC, the United States Defense Threat Reduction Agency (DTRA), BEP, the Japan International Cooperation Agency (JICA), and others. When contributing to a new laboratory, donor groups and national governments do not, however, always ascertain how the new facility will complement other existing and planned infrastructure. In the United States, for example, no single government agency is responsible for coordinating the on-going expansion in the number of biocontainment labs or determining the needed capacity (United States GAO, 2009). The workshop also examined the assessment process whereby a planned lab’s needs and available resources are characterized and the challenges likely to be encountered identified. The assessment process can help determine scientific, budgetary, and security requirements and provides an opportunity to build community support. Fully characterizing risks, which come not just from the design, standard operating procedures, and organisms to be studied, but also from the lab’s location, which includes factors such as endemicity of diseases, presence of immunity in the local population, population density, and reliability of utilities, can provide a valuable early warning for possible utility, security, or operational problems and suggest alternatives for consideration. The NRC has provided input on a number of risk assessments for planned containment labs in the United States including facilities at Fort Detrick, Maryland (NRC, 2010b), Boston, Massachusetts (NRC, 2007b), and Manhattan, Kansas (NRC, 2010c). Depending on their location and funding sources, containment labs may operate in drastically different regulatory environments. To illustrate the current variation, some participants wrote and presented papers that described their country's high-containment biological facilities, capabilities, and regulations as well as past accidents and safety and security issues (see Appendix E). While many countries have few or no regulations and little enforcement, others have elaborate and quite extensive requirements. Participants also discussed the need for national regulatory frameworks whose enforcement increases safety and security without imposing undue burdens on scientists. Guidance regarding these matters is increasingly available, not just from national and international legal frameworks, but also from national and regional biosafety associations (BSA). 2 National Select Agent Registry. Available at: http://www.selectagents.gov/select%20agents%20and%20Toxins%20list.html. Accessed September 14, 2011.

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9 Introduction These professional associations bring together members from a variety of backgrounds including scientists, administrators, engineers, architects, and technicians as well as stakeholders from multiple agencies including those responsible for human health, animal health, and domestic security. By providing a neutral, national platform, BSAs can educate workers as well as key officials and politicians and help encourage the adoption of a culture supportive of biosafety and biosecurity in the labs in their networks. In 2001, national and regional BSAs and non-governmental and governmental organizations banded together to form the International Federation of Biosafety Associations (IFBA).3 Table 1-1 contains a list of BSAs that are IFBA members or observers. IFBA’s goals include serving as an international biosafety advisory body, compiling and disseminating information about best practices, and supporting applied biosafety research. On 15-17 February 2011 in Bangkok, Thailand, IFBA held its first international conference, which sought to identify gaps in global biosafety and biosecurity practices, engage senior governmental officials, and attract funding to the field. During IFBA’s conference, participants developed an agenda for advancing global biosafety and biosecurity that emphasizes raising awareness, education, and development and implementation of regulatory frameworks.4 Table 1-1 Biosafety Associations That Are Members or Observers of IFBA as of September 2011. Association Date Founded Afghan Biorisk Association (ABA) African Biosafety Association (AfBSA) 2007 1984b American Biological Safety Association (ABSA) Asia-Pacific Biosafety Association (A-PBA) 2005 Associacao Nacional de Biossegurance, Brasil (ANBio) 1999 Association of Biosafety for Australia and New Zealand (ABSANZ) 2011 Azerbaijan Biological Safety Association (ABTA) 2009 Belgian Biosafety Professionals (BBP)a 2006 Biological Safety Association of Pakistan (BSAP)a 2007 Biosafety and Biosurity Network, Thailand (BSNT) 2009 Biosafety Association for the Central Asia and Caucasus (BACAC) 2008 Canadian Association of Biological Safety (CABS) 1990 Egyptian Biosafety Association (EGBSA) 2009 European Biological Safety Association (EBSA) 1996 Georgian Biosafety Association (GeBSA) 2009 Japanese Biosafety Association (JBSA) 2001 Korean Biosafety Association (KOBSA) 2008 Mexican Biosafety Association (AMEXBIO) 2009 Moroccan Association of Biosafety (AMBS) 2009 Moroccan Biosafety Association (AMABIOS) 2009 Pakistan Biological Safety Association (PBSA) 2008 Philippine Biosafety and Biosecurity Association (PHBBA) 2006 SOURCE: http://www.internationalbiosafety.org/. Accessed September 30, 2011. a Denotes observer; all others are IFBA members. b ABSA was formally incorporated as a professional organization in 1984; United States biosafety professionals started holding informal, annual conferences in 1955. 3 IFBA was originally called the International Biosafety Working Group. The present name was adopted in 2009. 4 The full declaration is available at: http://2011.absa.org/pdf/IFBABangkokDeclaration.pdf. Accessed September 9, 2011.

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10 Biosecurity Challenges Breakout Sessions At the end of the first day of the present workshop and during much of the second day, participants divided into groups for a series of breakout sessions. These small sessions allowed more participants to share their experiences and develop a sense of the current norms in the world. During the first set of breakout sessions (Chapter 5), participants described the history and current challenges they face in their individual laboratories. Speakers described steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and creating pathogen inventories. The second set of breakout sessions (Chapter 6) examined the present and future role of containment labs in human and animal disease diagnostics. Presenters described their current protocols and precautions and discussed the potential for the use of molecular diagnostics, which unlike traditional culture-based assays do not use viable pathogens or require containment labs. The third and final set of breakout sessions (Chapter 7) asked the attendees to identify high-priority areas for taking action to improve biosafety and biosecurity. Some groups discussed the need for more applied biosafety data, the benefits of laboratories tracking and reporting accidents, and approaches to improving organizational culture and practices. Another group defined the key events in each stage of a laboratory’s life cycle from the planning phase through on-going maintenance. Concluding Plenary Sessions After the final breakout session, all attendees participated in a plenary session on the unique challenges associated with BSL-4 labs. While there are many fewer BSL-4 labs than BSL-3 labs, the approximately two dozen operational BSL-4 labs located throughout the world pose a unique challenge (see Table 8-1 in Chapter 8) and several additional facilities are planned or under construction (Kaiser, 2011). Participants discussed BSL-4 laboratories that community opposition has prevented from operating at their originally intended biosafety level (see Table 8-2 in Chapter 8). In addition to examining the impact of a community’s perceptions on laboratory operations, workshop attendees also commented on gaps in the world’s BSL-4 capacity and the usefulness and ethics of personnel reliability measures. On the final morning, Adel Mahmoud, the chair of the NRC committee that guided workshop preparations, led a discussion to draw attention to the main themes of the workshop, and discuss possible next steps. Many participants sought ways that the present workshop could extend progress made during previous, related meetings and activities (see Box 1-3). Immediately following the workshop, many participants visited the nearby Pendik Veterinary Control and Research Institute and toured their new BSL-3 facility, which was in the final stages of construction (see Appendix D). Box 1-3 Contributions of International Scientific Organizations to Biosafety and Biosecurity Many national academies of science have contributed to discussions on biosafety and biosecurity. The InterAcademy Panel on International Issues (IAP), a global network of science academies, released a statement on biosecurity in 2005.a The statement, which was endorsed

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11 Introduction by 70 member academies, advocates education and “awareness raising” by creating scientific codes of conduct and presents five principles for consideration when formulating codes: 1. Scientists should be aware of the possible consequences of their work. 2. Scientists have the responsibility to use safe and secure practices. 3. Scientists should educate others to prevent the misuse of research. 4. Scientists have an obligation to report activities that violate the BWC or international norms. 5. Scientists should keep these principles in mind when acting in supervisory roles. Soon after the statement was released, the IAP formed the IAP Biosecurity Working Group (IAP BWG) to take up and coordinate similar biosecurity related work on behalf of IAP.b Recently the IAP, in conjunction with the Polish and United States Academies of Sciences, the International Union of Biochemistry and Molecular Biology, and the International Union of Microbiological Societies, organized a November 2009 workshop on ways to educate life scientists about dual use issues associated with biological research (NRC, 2010d). Working with the same two professional societies and in close cooperation with the Biological and Toxin Weapons Convention (BWC), the Chinese and United States Academies of Sciences and the IAP organized an international meeting to inform governmental and non- governmental organizations about current trends in science and technology in preparation for the 7th Review Conference of the BWC in December of 2011 (NRC, 2011b). This meeting followed a similar meeting at the U.K. Royal Society in 2006 in advance of the 6th Review Conference. Additionally, the Uganda National Academy of Science (UNAS) organized workshops on promoting biosafety and biosecurity in East Africa (UNAS, 2008) and promoting good laboratory practices in Sub-Saharan Africa (UNAS, 2009). UNAS also wrote a report analyzing biosafety and biosecurity in Uganda (UNAS, 2010). a The full IAP Statement on Biosecurity is available at: www.interacademies.net/File.aspx?id=5401. Accessed September 9, 2011. b As of September 2011, the IAP BWG includes Poland (chair), the United States, the U.K., China, Cuba, Nigeria and recently added countries Australia, Egypt and India. Russia will join soon. Development of the Issue In many of the workshop presentations, speakers reflected on the evolution of the techniques used to handle dangerous pathogens, current practices, and desirable future directions. They presented information on the historical prevalence of laboratory-acquired infections, the range of precautions available, and the basis of commonly used approaches to biosafety and biosecurity. In order to increase the coherence of the following chapters, this section assembles information that was presented as part of the workshop plenary, working group sessions, discussions or appended country study background papers in a single location to inform the reader. THE FUNCTION AND EVOLUTION OF BIOCONTAINMENT LABS In the late 1800s, soon after scientists began isolating and studying microorganisms that cause infectious diseases, reports of workers suffering from laboratory-acquired infections (LAIs) started to appear (Table 1-2). Since that time, understanding of the risks associated with working with pathogens and options for protecting laboratory workers and the communities in which laboratories reside have greatly improved.

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12 Biosecurity Challenges Improvements, however, have been gradual, and LAIs continue to occur, albeit at a much lower frequency than in the past. Over 4,000 LAIs (168 fatal) were documented between 1930 and 1978 (Pike, 1979), and over 1,200 LAIs (22 fatal) occurred between 1978 and 1999 (Harding and Byers, 2000). As LAIs may go unreported, those numbers are likely to be underestimates. LAIs continue to occur today with notable instances including fatalities from Ebola5 and severe acute respiratory syndrome (SARS) in 2004.6 Table 1-2 Dates of First LAIs Caused by Selected Bacterial Species. Organism Date Isolated, Cultured, or Described First Reported LAI 1881-1884 1898 Corynebacterium diphtheriae 1883 1894 Vibrio cholerae 1884 1885 Salmonella typhi 1887 1887 Brucella melitensis 1889 1893 Clostridium tetani 1896 1904 Sporothrix schenkii SOURCE: NRC Staff; Adapted from Kruse et al., 1991. Laboratory practices and primary barriers have been developed to reduce occupational exposures through the four main routes of infection: ingestion; inhalation; parenteral inoculation; and direct eye, skin, or mucosal membrane contact (United States HHS, 2009). Good microbiological practices minimize aerosol generation and lessen the chances of ingestion and sharps injuries (e.g., needle sticks). A range of personal protective equipment (e.g., gloves, lab coats, eye protection, and respirators) can be used to protect against direct pathogen contact and inhalation. Class I and Class II biological safety cabinets (BSC) reduce aerosol exposure, and Class III BSCs and full-body, positive pressure suit technologies can fully-isolate workers from pathogens. In some cases, immunizations against specific pathogens are available, which provide a measurable decrease in LAIs compared to the use of personal protective equipment and BSCs alone, particularly for agents with low infective doses (NRC, 2011c, Rusnak et al., 2004). The laboratory itself functions as a secondary barrier that protects the community from the potential release of the pathogens contained within. Laboratories are typically constructed using materials that allow for easy decontamination and include equipment for this purpose (e.g., autoclaves, incinerators, liquid effluent decontamination systems, and chemical disinfectants). When deemed necessary, laboratories also include sophisticated air handling mechanisms such as inward airflow, negative pressure, filtering of exhaust air, or airtight construction, to reduce the chance of pathogen escape and enable gaseous decontamination. STANDARDIZING BIOSAFETY To help workers select the appropriate precautions, a number of organizations have assigned pathogens to risk groups based on the severity of disease they cause, the route of infection, the risk to the community, and the availability of effective prophylactic or therapeutic measures. As an example, the risk group definitions used by the United States National Institutes of Health (NIH) and the World Health Organization (WHO) are shown in Table 1-3.7 5 Ebola, Lab Accident Death: Russia (Siberia). Available at: http://www.promedmail.org/pls/apex/f?p=2400:1001:::NO::F2400_P1001_BACK_PAGE,F2400_P1001_P UB_MAIL_ID:1000,25465. Accessed September 19, 2011. 6 Available at: http://www.who.int/csr/don/2004_04_30/en/. Accessed September 9, 2011. 7 Some countries use alternative approaches. As an example, a description of Russian hazard groups may be found in Stavskiy et al., 2003.

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13 Introduction For a number of common pathogens, the Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual recommends suitable combinations of precautions for typical procedures based on risk assessments (United States HHS, 2009). Table 1-3 United States NIH and WHO Risk Group Definitions. Risk NIH Guidelines WHO Laboratory Biosafety Manual Example Group Organisms (NIH) Bacillus subtilis Agents not associated with (No or low individual and community 1 disease in healthy adult risk) A microorganism unlikely to cause humans. human or animal disease. Rabies virus; Agents associated with (Moderate individual risk; low Bacillus anthracis; human disease that is rarely community risk) A pathogen that can serious and for which cause human or animal disease but is preventive or therapeutic unlikely to be a serious hazard to interventions are often laboratory workers, the community, 2 available. livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. Human Agents associated with (High individual risk; low community immunodeficiency serious or lethal human risk) A pathogen that usually causes virus; disease for which preventive serious human or animal disease but Mycobacterium 3 or therapeutic interventions does not ordinarily spread from one tuberculosis may be available (high infected individual to another. Effective individual risk but low treatment and preventive measures are community risk). available. Ebola virus; Agents likely to cause serious (High individual and community risk) A Marburg virus or lethal human disease for pathogen that usually causes serious which preventive or human or animal disease and can be 4 therapeutic interventions are readily transmitted from one individual not usually available (high to another, directly or indirectly. individual risk and high Effective treatment and preventive community risk). measures are not usually available. SOURCE: Adapted from United States HHS, 2009. NOTES: The United States uses the Risk Group definitions of NIH Guidelines for Research Involving Recombinant DNA Molecules. Appendix B, Available at: http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm. Accessed September 19, 2011. WHO risk group definitions are in WHO’s Laboratory Biosafety Manual (WHO 2004). More generally, the BMBL describes four standard biological safety levels (BSL), each of which includes a combination of practices, safety equipment, and laboratory features that are summarized in .8 BSL levels roughly correlate with, but do not directly correspond to, risk group assignments. The workshop focused on laboratories that operate at the two most stringent BSL levels, BSL-3 and BSL-4, which are referred to as high and maximum containment, respectively.9 According to the BMBL, BSL-3 and BSL-4 are intended for: 8 WHO also describes four standard biosafety levels (WHO, 2004). Some countries use alternative approaches. Russia, for example, describes labs as being Zone I, Zone II, or Zone III, where Zone I labs are containment labs (Stavskiy et al., 2003). 9 Due to the variety of classification systems in use in the world, laboratories that provide roughly equivalent levels of containment were also discussed.

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14 Biosecurity Challenges BSL-3: Indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure. BSL-4: Dangerous/exotic agents, which pose high individual risk of aerosol- transmitted laboratory infections that are frequently fatal, for which there are no vaccines or treatments; agents with a close or identical antigenic relationship to an agent requiring BSL-4 until data are available to redesignate the level; and related agents with unknown risk of transmission (United States HHS, 2009; see page 59). Table 1-4 Summary of BMBL Biosafety Levels for Infectious Agents. a BSL Practices Primary Barriers and Safety Facilities (Secondary Barriers) Level Equipment Standard microbiological No primary barriers required. Laboratory bench and sink required 1 practices PPE: laboratory coats and gloves; eye, face protection, as needed BSL-1 practice plus: Primary barriers: BSCs or other BSL-1 plus: Limited access, biohazard physical containment devices Autoclave available warning signs, “sharps” used for all manipulations of precautions, biosafety agents that cause splashes or 2 manual defining any aerosols of infectious materials needed waste PPE: Laboratory coats, gloves, decontamination or face and eye protection, as medical surveillance needed policies BSL-2 practice plus: Primary barriers: BSCs or other BSL-2 plus: Controlled access, physical containment devices Physical separation from access decontamination of all used for all open manipulations of corridors; self-closing, double-door waste, decontamination of agents access; exhausted air not 3 laboratory clothing before PPE: Protective laboratory recirculated; negative airflow into laundering clothing, gloves, face, eye and laboratory; entry through airlock or respiratory protection, as needed anteroom; hand washing sink near laboratory exit BSL-3 practices plus: Primary barriers: all procedures BSL-3 plus: Clothing change before conducted in Class III BSCs or Separate building or isolated zone, entering, shower on exit, all Class I or II BSCs in combination dedicated supply and exhaust, 4 material decontaminated with full-body, air-supplied, vacuum, decontamination systems, on exit from facility positive pressure suit and other requirements outlined in BMBL SOURCE: United States HHS, 2009; see page 59. (PPE: personal protective equipment) a Detailed design requirements may be found in the United States NIH Design Requirements Manual Version 1.7. Available at: http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandGuidelines/DesignRequireme ntsManualPDF.htm. Accessed September 19, 2011. While similar, the particulars of the recommendations for each BSL level differ among sources. BMBL recommendations are generally considered stricter than those in WHO’s Laboratory Biosafety Manual (LBM) (WHO, 2004). Furthermore, recommendations from a single source change over time, usually becoming more rigorous. For example, the 5th edition of the BMBL added the BSL-3 criterion that the inward flow of air into a laboratory will not be reversed even under failure conditions (United States HHS, 2009, see page 43). Similarly, the BMBL currently urges groups building new BSL-2 facilities to consider including systems that create an inward flow of air, a feature that is a traditional hallmark of BSL-3 laboratories (United States HHS, 2009, see page 38). Additionally, for many laboratories, such as those that are described as BSL-2 enhanced or BSL-3+, protections from a higher level have been incorporated with the result that such labs do not fit into the standard classification scheme.

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15 Introduction FUTURE TRENDS While following the recommendations of a pre-defined BSL level is comparatively convenient and simple, laboratory authorities are increasingly seeking the flexibility to tailor precautions to their particular risks. Additionally, awareness of the importance of a laboratory’s management system to safety and security is increasing (Gaudioso et al., 2009). Options such as the European Committee for Standardization’s (CEN) voluntary Laboratory Biorisk Management standard CWA (CEN workshop agreement) 15793:2008,10 which describes a system management approach to laboratory risk reduction centered on the principle of continual improvement, are growing in popularity. More detailed discussions of these and many related developments appear in the ensuing chapters. 10 Available at: ftp://ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf. Accessed September 19, 2011.

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