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Biosafety laboratory risk assessment
Journal of Biosafety and Biosecurity xxx (xxxx) xxx
Contents lists available at ScienceDirect
Journal of Biosafety and Biosecurity journal homepage: www.elsevier.com/locate/jobb
Research Article
Biosafety laboratory risk assessment Li Na, Hu Lingfei, Jin Aijun, Li Jinsong ⇑ State Key Laboratory of Pathogen and Biosecurity, National Engineering Research Center of Biological Protective Equipment, Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, 100071 Beijing, China
a r t i c l e
i n f o
Article history: Received 30 October 2018 Accepted 3 January 2019 Available online xxxx Keywords: Biosafety laboratory Risk assessment Pathogenic microbial
a b s t r a c t Biosafety laboratory risk assessment is a dynamic and systematic work. The scope of the assessment involves evaluation of pathogenic microbial hazards, experimental activities, facilities and equipment, personnel, experimental methods, etc. The four-level evaluation method for pathogenic microorganisms is used for hazard assessment. The aerosol exposure risk is the most common in experimental activities. Facilities and equipment are the basis for the safe operation of biosafety laboratories. Laboratory biosafety risk assessments should be conducted regularly to ensure the safe operation of the laboratory. Ó 2019 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
In recent years, with the continuous innovation of biotechnology and the frequent outbreak of new infectious diseases, countries around the world have continued to study infectious diseases and invested in the construction of several high-level biosafety laboratories.1 The biosafety laboratory is a necessary place for conducting experimental research on pathogenic microorganisms and the prevention of infectious diseases. Through protective barriers and management measures, it can avoid or control harmful biological agents that could be harmful to people and the environment. The safe operation of biosafety laboratories is not only related to the life and health of the experimental staff, but also impacts public safety and social stability. Therefore, it is vitally important to maintain safe laboratory operation, the safety of personnel, public safety by conducting risk assessments of biosafety laboratories and adopting correct prevention and control measures (Table 1). 1. Related concepts of biosafety risk assessment 1.1. Biosafety Broadly speaking, biosafety refers to the hazards and potential risks of various biological factors to the country’s social, economic, human health, and ecological environments, and is an integral part of national security. More narrowly defined, biosafety refers to the existing or potential hazards to humans, animals, or plants caused by a biological vector, by directly infecting or indirectly destroying the environment. ⇑ Corresponding author. E-mail address: [email protected] (J. Li).
1.2. Risk Risk is the probability of an unfortunate event or the sum of the likelihood and consequences of a particular dangerous situation. The estimated severity of a given risk can vary between people, as their different previous experiences lead to different perceptions of risk.2 Biological risk refers to potential harm to individual citizens, the environment, and wider society caused by certain pathogenic microorganisms and their associated operational procedures or experimental activities.3
1.3. Risk assessment Risk assessment refers to the possibility of quantitatively measuring the impact or loss caused by a particular phenomenon. Risk assessment is a process that includes three steps: risk identification, analysis, and assessment, and provides a basis for risk management.
1.4. Risk identification Risk identification refers to the process of systematically, comprehensively, and continuously discovering, exemplifying, and describing risk factors using relevant knowledge and methods. The purpose is to find the main risk factors and the relationship between various risk factors to provide a basis for further research and decision-making. Risk identification is the basis of risk management.4
https://doi.org/10.1016/j.jobb.2019.01.011 2588-9338/Ó 2019 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article as: N. Li, L. Hu, A. Jin et al., Biosafety laboratory risk assessment, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j. jobb.2019.01.011
2
N. Li et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
Table 1 Risk analysis of common experimental activities. Risk factor
Experimental activity
Aerosol exposure risk
Acupuncture
Blood collection, sampling, tissue grinding, animal inoculation Tissue sampling, dissection of animals throat swab, animal inoculation Pathogen culture, pipetting, animal inoculation, lyophilization of pathogens, sample preservation Centrifugation, homogenization, sonication, tissue grinding, pathogen culture, lyophilization of pathogens, sample preservation, animal culture Animal inoculation
Very small
Pathogen culture, lyophilization of pathogens, sample preservation
High
Cut Scratch, bite Sample spill
Container broken
Jetting during injection Sample drop
Very small Very small High
High
Higher
1.5. Risk analysis The purpose of risk analysis is to understand the nature of risk, to provide information support for risk assessment and determination of the most appropriate risk management strategy and method. 1.6. Risk assessment Risk assessment is the process of comparing the results of a risk analysis with a given risk criterion or comparing the results of a personalized risk analysis to determine the severity of the risk and make a decision.5 2. Contents and methods of risk assessment in biosafety laboratories Biosafety laboratory risk assessment is a dynamic, systematic work involving pathogenic microbial hazards, laboratory activities, facilities and equipment, personnel, laboratory methods, natural disasters, fire protection, electrical appliances, hazardous chemicals and related gases, etc. Risk analysis methods are commonly divided into qualitative and quantitative analysis, including brainstorming, scenario analysis, pre-hazard analysis, hazard and operability analysis, fault tree analysis, event tree analysis, etc. A comprehensive assessment of risk is usually performed by matrix analysis or risk mapping. 2.1. Risk assessment of pathogenic microorganisms Infectious diseases caused by exposure to pathogenic microorganisms are a long-standing and certain risk to humans. In the national standard ‘‘General Requirements for Laboratory Biosafety” (GB 19489-2008), the laboratory biohazard assessment is as follows: ‘‘When the laboratory activities involve infectious or potentially infectious biological factors, the assessment of the extent of the hazard should be carried out”.6 The microbiological hazard assessment should be based on the degree of pathogenic ability of microorganisms, transmission route, stability, infection dose, concentration and scale of operation, source of the subject, availability of animal experimental data, and effective prevention and treatment. The assessment method can use four-level evaluation methods, namely hazard identification, dose-response assessment, exposure assessment, and risk characterization. Hazard identification includes the identification
of microbial factors and the range of human diseases associated with the microorganisms, and needs to be combined with epidemiological studies. The purpose of the dose-response assessment is to mathematically characterize the relationship between the dose and the probability of infection or disease in the exposed population, to determine the risk of the target pathogenic microorganism infecting the population. Exposure assessment attempts to determine the number, nature, microbial transmission route, concentration, distribution, and exposure time of exposed populations, to determine the risk of exposure to pathogenic microorganisms. Risk characterization is the integration of hazard identification, doseresponse assessment and exposure assessment, quantifying the scope of public health implications, determining the confidence limits of the dose-response model, and determining the microbial concentration distribution and exposure profile.7 Through the risk assessment of pathogenic microorganisms, it can be determined at which level of biosafety laboratory the target microorganism should be housed, and the corresponding experimental standard operating procedures, laboratory management systems, and emergency treatment methods should be formulated to avoid biosafety risks. 2.2. Risk assessment of experimental activities The experimental activities in the biosafety laboratory mainly involve sample collection, transportation, receiving, processing, experimental operation and preservation, waste disposal, etc. for each activity, there is a risk that if control methods are improper, pathogens can infect the experimental staff or spread outside the laboratory to infect people in society. The reasons for biosafety laboratory infections mainly include cuts, acupuncture, direct exposure of skin, mucosa, and eyes directly exposed to infectious microorganisms, animal bites, inhalation of infectious aerosols, etc.12 Among them, aerosol infection is the most common, because aerosols are ubiquitous during experiments and are difficult to detect. Laboratory workers at high risk during testing are the key target for prevention of infections in biosafety laboratories. Studies have shown that there are risks of aerosol exposure in a variety of experimental operations, including high concentration of suction and mixing, ultrasonic lysis, accidental dropping of highconcentration culture bottles, rupture of centrifuge tubes, accidental spillage of freeze-dried powder, accidental squirting when injecting an animal, and animal dissection, etc. Of these, the accidental squirting of the challenged animal produces the highest aerosol concentration, which can reach 104 CFU/m3. The accidental drop of the culture bottle and the accidental spill of the lyophilized powder will also produce a higher risk aerosol exposure. Aerosol particles are mostly less than 5 lm of accessible lung particles.8–11 The risks in the experimental activities are varied. Through risk assessments of experimental activities, the sources of risk are identified, and corresponding personal protective measures are proposed to avoid accidental injuries and exposure to pathogenic microorganisms, to ensure the safety of the experimental personnel. 2.3. Risk assessment of facilities and equipment The biosafety laboratory is composed of two types of hardware: a primary protective barrier (safety equipment) and a secondary protective barrier (facilities). Different combinations of safety equipment and facilities constitute a four-level biosafety protection level. Facility equipment is the basis for the safe operation of biosafety laboratories. If the biosafety protection requirements of the laboratory are not met, there is a safety risk. The risk assessment of facilities and equipment is to test and demonstrate the compliance of existing hardware. If the facility
Please cite this article as: N. Li, L. Hu, A. Jin et al., Biosafety laboratory risk assessment, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j. jobb.2019.01.011
3
N. Li et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
equipment meets the requirements of security protection, its risk will be reduced. If it does not meet the requirements, its risk will increase. By testing the protection ability of biosafety cabinets, animal feeding isolators, life support systems, exhaust air efficient air filtration units, airtight doors, airtight enclosures, positive pressure protective clothing, etc.—which are in operation in some biosafety laboratories—the protection efficiencies are all above 99.9%, meeting the requirements of biosafety protection.13 In laboratory management, it is necessary to strengthen the daily inspection of facilities and equipment, regularly replace and maintain important components, strictly implement the instrument operation specifications, which ensure the normal operation of facilities and equipment, and control the risk points to the lowest level.
and minimize the risk of biosafety laboratory operations with minimal cost. In actual work, the construction structure, facilities, and equipment conditions and personnel quality of each laboratory are different. Therefore, the source, degree, and control measures of risks cannot be universal. The biological risk management system has no fixed methods and modes. The laboratory should proceed from the actual situation, formulate a risk assessment model suitable for the laboratory according to certain principles and rules, and establish and improve the safety management system and norms. Only effective management can complement laboratory safety and protect personnel, public health, and environmental safety.
3. Principles of risk assessment in biosafety laboratories
National Key (2016YFC1202202).
The complexity of laboratory risk assessment and risk control activities depends on the actual hazard characteristics of the experimental activities. Risk assessment and risk control activities should be carried out according to the characteristics and intensity of the risk sources. Therefore, risk assessment should adhere to the principle of pre-assessment, integration with reality, whole process assessment, and scientific rationality. The professional technicians are responsible and the experimenters participate together. Biosafety laboratory risk assessment has a fixed scope and appropriate timing. It is not constantly occurring, nor does it happen only once. Risk assessment is a dynamic development that reassesses risks when special circumstances occur. When starting a new pathogen experiment or a significant change in the original work plan, the project’s experimental activities should be evaluated. When the pathogenicity, virulence, or mode of transmission of the pathogen is found to change, the background information should be changed in time and the safety of the experimental operation should be re-evaluated. When the facility unit, critical equipment, or standard operating procedures are increased or significantly changed, the safety of the protection should be assessed. When highly pathogenic microorganisms not covered in the original assessment report are separated in the experimental activities, the risk assessment should be re-evaluated. Reevaluation should be carried out immediately when an accident such as animal escape, pathogenic microbial leakage, or personal infection occurs during the experimental activity. Reassessment should be made when a safety hazard is discovered during the course of the experiment or if biosafety issues develop during the inspection and supervision process. When relevant policies, regulations, standards, etc. change re-evaluation needs to occur. The biosafety laboratory should perform at least 1–2 systematic periodic risk assessments each year during operation.13 4. Summary The purpose of risk assessment is to conduct risk control, decrease the frequency of accidents, reduce the severity of accidents,
5. Fund project Research
and
Development
Plan
Conflict of interest No conflict of interest.
References 1. Hottes AK, Rusek B, Sharpies F. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories. Washington, DC: National Academies Press; 2012. 2. Jiang Jianmin, Zhang Shuangfeng, Zhou Xiaohong, et al. Examples of Risk Assessment Reports for Pathogenic Microbial Laboratory Activities. Hangzhou: Zhejiang University Press; 2016. 3. Huang Weihua, Shi Guiwen, Li Shaolian, et al. Research and analysis on biological risk assessment carried out by biosafety laboratory in CDC. J Med Pest Control. 2012;28:909–910. 4. Zhou Hongdong, Chang Sun. Analysis of risk of pathogenic microorganism laboratory. Mod Prev Med. 2010;37:4238–4240. 5. Certification and Accreditation Administration of the People’s Republic of China. Biosafety Laboratory Accreditation and Management Basics Risk Assessment Technical Guide. Beijing: Chinese Quality Inspection Press, Chinese Standard Press; 2012. 6. General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, Chinese National Standardization Administration Committee. General Requirements for Laboratory Biosafety (GB 19489-2008). Beijing: Chinese Standard Press; 2008. 7. Haas Charles N, Rose Joan B, Gerba Charles P. Quantitative Microbial Risk Assessment. Beijing: Chinese Environment Press; 2017. 8. Wen Zhanbo, Chen Yong, Du Qian, et al. Contamination of microbiological aerosol generated by pathogenic microbiological labs. Mil Med Sci. 2013;37:1–5. 9. Du Q, Wang H, Liu K, et al. Risk quantification of microbiological aerosol generated by experimental operations in pathogenic microbiological labs. Mil Med Sci. 2015;39(12):926–928. 10. Hu Lingfei, Wen Zhanbo, Li Jinsong. Quantitative analysis of biological pollution generated by a series experiments in BSL-2 laboratory. Chin J Disinfect. 2016;10:951–957. 11. Jin Aijun, Hu Lingfei, Zhang Ke, et al. Quantitative analysis of bio-contamination generated during experiment activities and accidents on the indoor environment in BSL-3 laboratory. Chin Med Biotechnol. 2018;13(2):97–103. 12. Hu Lingfei, Jin Aijun, Zhang Ke, et al. Biological protection test of facilities and key equipment in BSL-4 laboratory. Chin Med Biotechnol. 2018;13(2):104–109. 13. Liu Hongying. Subject construction and risk assessment of biosafety laboratory. Occup Health. 2010;26(14):1650–1652.
Please cite this article as: N. Li, L. Hu, A. Jin et al., Biosafety laboratory risk assessment, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j. jobb.2019.01.011
Contents lists available at ScienceDirect
Journal of Biosafety and Biosecurity journal homepage: www.elsevier.com/locate/jobb
Research Article
Biosafety laboratory risk assessment Li Na, Hu Lingfei, Jin Aijun, Li Jinsong ⇑ State Key Laboratory of Pathogen and Biosecurity, National Engineering Research Center of Biological Protective Equipment, Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, 100071 Beijing, China
a r t i c l e
i n f o
Article history: Received 30 October 2018 Accepted 3 January 2019 Available online xxxx Keywords: Biosafety laboratory Risk assessment Pathogenic microbial
a b s t r a c t Biosafety laboratory risk assessment is a dynamic and systematic work. The scope of the assessment involves evaluation of pathogenic microbial hazards, experimental activities, facilities and equipment, personnel, experimental methods, etc. The four-level evaluation method for pathogenic microorganisms is used for hazard assessment. The aerosol exposure risk is the most common in experimental activities. Facilities and equipment are the basis for the safe operation of biosafety laboratories. Laboratory biosafety risk assessments should be conducted regularly to ensure the safe operation of the laboratory. Ó 2019 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
In recent years, with the continuous innovation of biotechnology and the frequent outbreak of new infectious diseases, countries around the world have continued to study infectious diseases and invested in the construction of several high-level biosafety laboratories.1 The biosafety laboratory is a necessary place for conducting experimental research on pathogenic microorganisms and the prevention of infectious diseases. Through protective barriers and management measures, it can avoid or control harmful biological agents that could be harmful to people and the environment. The safe operation of biosafety laboratories is not only related to the life and health of the experimental staff, but also impacts public safety and social stability. Therefore, it is vitally important to maintain safe laboratory operation, the safety of personnel, public safety by conducting risk assessments of biosafety laboratories and adopting correct prevention and control measures (Table 1). 1. Related concepts of biosafety risk assessment 1.1. Biosafety Broadly speaking, biosafety refers to the hazards and potential risks of various biological factors to the country’s social, economic, human health, and ecological environments, and is an integral part of national security. More narrowly defined, biosafety refers to the existing or potential hazards to humans, animals, or plants caused by a biological vector, by directly infecting or indirectly destroying the environment. ⇑ Corresponding author. E-mail address: [email protected] (J. Li).
1.2. Risk Risk is the probability of an unfortunate event or the sum of the likelihood and consequences of a particular dangerous situation. The estimated severity of a given risk can vary between people, as their different previous experiences lead to different perceptions of risk.2 Biological risk refers to potential harm to individual citizens, the environment, and wider society caused by certain pathogenic microorganisms and their associated operational procedures or experimental activities.3
1.3. Risk assessment Risk assessment refers to the possibility of quantitatively measuring the impact or loss caused by a particular phenomenon. Risk assessment is a process that includes three steps: risk identification, analysis, and assessment, and provides a basis for risk management.
1.4. Risk identification Risk identification refers to the process of systematically, comprehensively, and continuously discovering, exemplifying, and describing risk factors using relevant knowledge and methods. The purpose is to find the main risk factors and the relationship between various risk factors to provide a basis for further research and decision-making. Risk identification is the basis of risk management.4
https://doi.org/10.1016/j.jobb.2019.01.011 2588-9338/Ó 2019 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article as: N. Li, L. Hu, A. Jin et al., Biosafety laboratory risk assessment, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j. jobb.2019.01.011
2
N. Li et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
Table 1 Risk analysis of common experimental activities. Risk factor
Experimental activity
Aerosol exposure risk
Acupuncture
Blood collection, sampling, tissue grinding, animal inoculation Tissue sampling, dissection of animals throat swab, animal inoculation Pathogen culture, pipetting, animal inoculation, lyophilization of pathogens, sample preservation Centrifugation, homogenization, sonication, tissue grinding, pathogen culture, lyophilization of pathogens, sample preservation, animal culture Animal inoculation
Very small
Pathogen culture, lyophilization of pathogens, sample preservation
High
Cut Scratch, bite Sample spill
Container broken
Jetting during injection Sample drop
Very small Very small High
High
Higher
1.5. Risk analysis The purpose of risk analysis is to understand the nature of risk, to provide information support for risk assessment and determination of the most appropriate risk management strategy and method. 1.6. Risk assessment Risk assessment is the process of comparing the results of a risk analysis with a given risk criterion or comparing the results of a personalized risk analysis to determine the severity of the risk and make a decision.5 2. Contents and methods of risk assessment in biosafety laboratories Biosafety laboratory risk assessment is a dynamic, systematic work involving pathogenic microbial hazards, laboratory activities, facilities and equipment, personnel, laboratory methods, natural disasters, fire protection, electrical appliances, hazardous chemicals and related gases, etc. Risk analysis methods are commonly divided into qualitative and quantitative analysis, including brainstorming, scenario analysis, pre-hazard analysis, hazard and operability analysis, fault tree analysis, event tree analysis, etc. A comprehensive assessment of risk is usually performed by matrix analysis or risk mapping. 2.1. Risk assessment of pathogenic microorganisms Infectious diseases caused by exposure to pathogenic microorganisms are a long-standing and certain risk to humans. In the national standard ‘‘General Requirements for Laboratory Biosafety” (GB 19489-2008), the laboratory biohazard assessment is as follows: ‘‘When the laboratory activities involve infectious or potentially infectious biological factors, the assessment of the extent of the hazard should be carried out”.6 The microbiological hazard assessment should be based on the degree of pathogenic ability of microorganisms, transmission route, stability, infection dose, concentration and scale of operation, source of the subject, availability of animal experimental data, and effective prevention and treatment. The assessment method can use four-level evaluation methods, namely hazard identification, dose-response assessment, exposure assessment, and risk characterization. Hazard identification includes the identification
of microbial factors and the range of human diseases associated with the microorganisms, and needs to be combined with epidemiological studies. The purpose of the dose-response assessment is to mathematically characterize the relationship between the dose and the probability of infection or disease in the exposed population, to determine the risk of the target pathogenic microorganism infecting the population. Exposure assessment attempts to determine the number, nature, microbial transmission route, concentration, distribution, and exposure time of exposed populations, to determine the risk of exposure to pathogenic microorganisms. Risk characterization is the integration of hazard identification, doseresponse assessment and exposure assessment, quantifying the scope of public health implications, determining the confidence limits of the dose-response model, and determining the microbial concentration distribution and exposure profile.7 Through the risk assessment of pathogenic microorganisms, it can be determined at which level of biosafety laboratory the target microorganism should be housed, and the corresponding experimental standard operating procedures, laboratory management systems, and emergency treatment methods should be formulated to avoid biosafety risks. 2.2. Risk assessment of experimental activities The experimental activities in the biosafety laboratory mainly involve sample collection, transportation, receiving, processing, experimental operation and preservation, waste disposal, etc. for each activity, there is a risk that if control methods are improper, pathogens can infect the experimental staff or spread outside the laboratory to infect people in society. The reasons for biosafety laboratory infections mainly include cuts, acupuncture, direct exposure of skin, mucosa, and eyes directly exposed to infectious microorganisms, animal bites, inhalation of infectious aerosols, etc.12 Among them, aerosol infection is the most common, because aerosols are ubiquitous during experiments and are difficult to detect. Laboratory workers at high risk during testing are the key target for prevention of infections in biosafety laboratories. Studies have shown that there are risks of aerosol exposure in a variety of experimental operations, including high concentration of suction and mixing, ultrasonic lysis, accidental dropping of highconcentration culture bottles, rupture of centrifuge tubes, accidental spillage of freeze-dried powder, accidental squirting when injecting an animal, and animal dissection, etc. Of these, the accidental squirting of the challenged animal produces the highest aerosol concentration, which can reach 104 CFU/m3. The accidental drop of the culture bottle and the accidental spill of the lyophilized powder will also produce a higher risk aerosol exposure. Aerosol particles are mostly less than 5 lm of accessible lung particles.8–11 The risks in the experimental activities are varied. Through risk assessments of experimental activities, the sources of risk are identified, and corresponding personal protective measures are proposed to avoid accidental injuries and exposure to pathogenic microorganisms, to ensure the safety of the experimental personnel. 2.3. Risk assessment of facilities and equipment The biosafety laboratory is composed of two types of hardware: a primary protective barrier (safety equipment) and a secondary protective barrier (facilities). Different combinations of safety equipment and facilities constitute a four-level biosafety protection level. Facility equipment is the basis for the safe operation of biosafety laboratories. If the biosafety protection requirements of the laboratory are not met, there is a safety risk. The risk assessment of facilities and equipment is to test and demonstrate the compliance of existing hardware. If the facility
Please cite this article as: N. Li, L. Hu, A. Jin et al., Biosafety laboratory risk assessment, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j. jobb.2019.01.011
3
N. Li et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
equipment meets the requirements of security protection, its risk will be reduced. If it does not meet the requirements, its risk will increase. By testing the protection ability of biosafety cabinets, animal feeding isolators, life support systems, exhaust air efficient air filtration units, airtight doors, airtight enclosures, positive pressure protective clothing, etc.—which are in operation in some biosafety laboratories—the protection efficiencies are all above 99.9%, meeting the requirements of biosafety protection.13 In laboratory management, it is necessary to strengthen the daily inspection of facilities and equipment, regularly replace and maintain important components, strictly implement the instrument operation specifications, which ensure the normal operation of facilities and equipment, and control the risk points to the lowest level.
and minimize the risk of biosafety laboratory operations with minimal cost. In actual work, the construction structure, facilities, and equipment conditions and personnel quality of each laboratory are different. Therefore, the source, degree, and control measures of risks cannot be universal. The biological risk management system has no fixed methods and modes. The laboratory should proceed from the actual situation, formulate a risk assessment model suitable for the laboratory according to certain principles and rules, and establish and improve the safety management system and norms. Only effective management can complement laboratory safety and protect personnel, public health, and environmental safety.
3. Principles of risk assessment in biosafety laboratories
National Key (2016YFC1202202).
The complexity of laboratory risk assessment and risk control activities depends on the actual hazard characteristics of the experimental activities. Risk assessment and risk control activities should be carried out according to the characteristics and intensity of the risk sources. Therefore, risk assessment should adhere to the principle of pre-assessment, integration with reality, whole process assessment, and scientific rationality. The professional technicians are responsible and the experimenters participate together. Biosafety laboratory risk assessment has a fixed scope and appropriate timing. It is not constantly occurring, nor does it happen only once. Risk assessment is a dynamic development that reassesses risks when special circumstances occur. When starting a new pathogen experiment or a significant change in the original work plan, the project’s experimental activities should be evaluated. When the pathogenicity, virulence, or mode of transmission of the pathogen is found to change, the background information should be changed in time and the safety of the experimental operation should be re-evaluated. When the facility unit, critical equipment, or standard operating procedures are increased or significantly changed, the safety of the protection should be assessed. When highly pathogenic microorganisms not covered in the original assessment report are separated in the experimental activities, the risk assessment should be re-evaluated. Reevaluation should be carried out immediately when an accident such as animal escape, pathogenic microbial leakage, or personal infection occurs during the experimental activity. Reassessment should be made when a safety hazard is discovered during the course of the experiment or if biosafety issues develop during the inspection and supervision process. When relevant policies, regulations, standards, etc. change re-evaluation needs to occur. The biosafety laboratory should perform at least 1–2 systematic periodic risk assessments each year during operation.13 4. Summary The purpose of risk assessment is to conduct risk control, decrease the frequency of accidents, reduce the severity of accidents,
5. Fund project Research
and
Development
Plan
Conflict of interest No conflict of interest.
References 1. Hottes AK, Rusek B, Sharpies F. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories. Washington, DC: National Academies Press; 2012. 2. Jiang Jianmin, Zhang Shuangfeng, Zhou Xiaohong, et al. Examples of Risk Assessment Reports for Pathogenic Microbial Laboratory Activities. Hangzhou: Zhejiang University Press; 2016. 3. Huang Weihua, Shi Guiwen, Li Shaolian, et al. Research and analysis on biological risk assessment carried out by biosafety laboratory in CDC. J Med Pest Control. 2012;28:909–910. 4. Zhou Hongdong, Chang Sun. Analysis of risk of pathogenic microorganism laboratory. Mod Prev Med. 2010;37:4238–4240. 5. Certification and Accreditation Administration of the People’s Republic of China. Biosafety Laboratory Accreditation and Management Basics Risk Assessment Technical Guide. Beijing: Chinese Quality Inspection Press, Chinese Standard Press; 2012. 6. General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, Chinese National Standardization Administration Committee. General Requirements for Laboratory Biosafety (GB 19489-2008). Beijing: Chinese Standard Press; 2008. 7. Haas Charles N, Rose Joan B, Gerba Charles P. Quantitative Microbial Risk Assessment. Beijing: Chinese Environment Press; 2017. 8. Wen Zhanbo, Chen Yong, Du Qian, et al. Contamination of microbiological aerosol generated by pathogenic microbiological labs. Mil Med Sci. 2013;37:1–5. 9. Du Q, Wang H, Liu K, et al. Risk quantification of microbiological aerosol generated by experimental operations in pathogenic microbiological labs. Mil Med Sci. 2015;39(12):926–928. 10. Hu Lingfei, Wen Zhanbo, Li Jinsong. Quantitative analysis of biological pollution generated by a series experiments in BSL-2 laboratory. Chin J Disinfect. 2016;10:951–957. 11. Jin Aijun, Hu Lingfei, Zhang Ke, et al. Quantitative analysis of bio-contamination generated during experiment activities and accidents on the indoor environment in BSL-3 laboratory. Chin Med Biotechnol. 2018;13(2):97–103. 12. Hu Lingfei, Jin Aijun, Zhang Ke, et al. Biological protection test of facilities and key equipment in BSL-4 laboratory. Chin Med Biotechnol. 2018;13(2):104–109. 13. Liu Hongying. Subject construction and risk assessment of biosafety laboratory. Occup Health. 2010;26(14):1650–1652.
Please cite this article as: N. Li, L. Hu, A. Jin et al., Biosafety laboratory risk assessment, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j. jobb.2019.01.011