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Public Health Weekly Report 2022; 15(10): 638-646

Published online March 10, 2022

© The Korea Disease Control and Prevention Agency

Necessity and improvement plan for the revision of laboratory biosafety guidelines for biorisk assessment and risk management

Seunghyun Lim1, Minwoo Park1, Haengseop Shin1, Won-Jong Jang2

1Division of Biosafety Evaluation and Control, Bureau of Healthcare Safety and immunization, Korea Disease Control and Prevention Agency (KDCA)
2Department of Microbiology, College of Medicine, Konkuk University

Abstract

Sections

As the importance of ensuring biosafety has been emphasized in domestic as well as international community relevant laws and guidelines are being revised. Due to the COVID-19 pandemic, the national disease prevention and response system can not be overstressed. It needs to address major issues such as the scientific basis of infectious disease pathogens which is essential for developing effective policy, and main principles and procedures of biosafety, risk assessment conducted with respect to domestic situation, designation of risk groups based on those risk assessment conducted. These matters should be addressed and reorganized in accordance with related international guidance of the World Health Organization and related domestic laws. The Korea Laboratory Biosafety Guidelines, first established by the Korea Centers for Disease Control and Prevention in 2006 for any biomedical institution that operated laboratory to facilitate compliance with voluntary biosafety standards and establishment of risk management system. It has been revised in line with changes in the policy environment, including related laws and regulations. In this study, it was confirmed that laboratory biosafety guidelines need to be revised according to recent changes in the domestic and international biosafety environment, and improvement should be made in terms of direction and contents as proposed in this article. These findings can be used to improve national system and guidelines for enhancing laboratory biosafety, and ultimately contribute to national health security.

Key words Biosafety, laboratory biosafety guidelines, infectious disease management

Sections
Table 1. The fourth edition of the WHO Laboratory biosafety manual (LBM4) described core requirements for risk management
1. Good microbiological practice and procedure, GMPP
2. Personnel competence and training
3. Facility design
4. Specimen receipt and storage
5. Decontamination and waste management
6. Personal protective equipment, PPE
7. Laboratory equipment
8. Emergency/incident response
9. Occupational health

Table 2. Area of improvement in revised Korea Laboratory Biosafety Manual
· Providing updated biosafety practice based on recently published international biosafety guidelines and standards by WHO
· Providing risk assessment methodology and risk mitigation measures to safely handle pathogen
· Expending terminology of newly added words on biosafety guidelines
· Including principles and regulations associated with laboratory biosecurity

Figure 1. Biosafety documents system of Canadian Public Health Agency.
HPTA: Human Pathogens and Toxins Act, HPTR: Human Pathogens and Toxins Regulations HAA: Health of Animals Act, HAR: Health of Animals Regulations.

References

Sections
  1. 코로나바이러스감염증-19 대응 실험실 생물안전 가이드, 질병관리본부, 2021.
  2. 심경종, 박민우, 신행섭, et al. 이동식 생물안전 3등급 시설의 국내·외 개발 동향. 주간 건강과 질병 2022;15(2):104-113.
  3. 질병관리청 감염병포털 https://www.kdca.go.kr/npt/biz/npp/portal/nppLwcrIcdMain.do, 2022
  4. 실험실 생물안전지침, 질병관리본부 국립보건연구원, 2019.
  5. Lee KM, et al. Emerging Infectious Diseases Require Biosafety Awareness and Procedures. J Bacteriol Virol. 2016;46:104-107.
    CrossRef
  6. 「감염병의 예방 및 관리에 관한 법률」 [시행 2022. 4. 20.] [법률 제18507호, 2021. 10. 19., 일부개정].
  7. 「연구실 안전환경 조성에 관한 법률」 [시행 202 2. 6 . 10.] [법률 제17350호, 2020. 6. 9., 전부개정].
  8. 「생명공학육성법」 [시행 2020. 11. 20.] [법률 제17261호, 2020. 5. 19., 일부개정].
  9. 「유전자변형생물체의 국가간 이동 등에 관한 법률」 [시행 2019. 6. 12.] [법률 제15868호, 2018. 12. 11., 일부개정].
  10. 유전자변형생물체의 국가간 이동 등에 관한 통합고시(보건복지부고시 제 2018-243호). 2018.
  11. 유전자재조합실험지침, 보건복지부, 2019.
  12. Laboratory Biosafety Manual 4th, World Health Organization, 2020.
  13. Laboratory biorisk management : CWA 15793:2011, CEN, 2011.
  14. Biosafety microbiological and biomedical laboratories, 6th, CDC, NIH, 2020.
  15. Canadian Biosafety Standard 2nd, Public Health Agency of Canada, 2020.
  16. The Canadian Biosafety Guideline-Pathogen Risk Assessment, Public Health Agency of Canada, 2020.
  17. 고위험병원체 취급시설 및 안전관리에 관한 고시(질병관리청고시 제2020-5호). 2020.

Policy Notes

Public Health Weekly Report 2022; 15(10): 638-646

Published online March 10, 2022

Copyright © The Korea Disease Control and Prevention Agency.

Necessity and improvement plan for the revision of laboratory biosafety guidelines for biorisk assessment and risk management

Seunghyun Lim1, Minwoo Park1, Haengseop Shin1, Won-Jong Jang2

1Division of Biosafety Evaluation and Control, Bureau of Healthcare Safety and immunization, Korea Disease Control and Prevention Agency (KDCA)
2Department of Microbiology, College of Medicine, Konkuk University

Abstract

As the importance of ensuring biosafety has been emphasized in domestic as well as international community relevant laws and guidelines are being revised. Due to the COVID-19 pandemic, the national disease prevention and response system can not be overstressed. It needs to address major issues such as the scientific basis of infectious disease pathogens which is essential for developing effective policy, and main principles and procedures of biosafety, risk assessment conducted with respect to domestic situation, designation of risk groups based on those risk assessment conducted. These matters should be addressed and reorganized in accordance with related international guidance of the World Health Organization and related domestic laws. The Korea Laboratory Biosafety Guidelines, first established by the Korea Centers for Disease Control and Prevention in 2006 for any biomedical institution that operated laboratory to facilitate compliance with voluntary biosafety standards and establishment of risk management system. It has been revised in line with changes in the policy environment, including related laws and regulations. In this study, it was confirmed that laboratory biosafety guidelines need to be revised according to recent changes in the domestic and international biosafety environment, and improvement should be made in terms of direction and contents as proposed in this article. These findings can be used to improve national system and guidelines for enhancing laboratory biosafety, and ultimately contribute to national health security.

Keywords: Biosafety, laboratory biosafety guidelines, infectious disease management

Body

The fourth edition of the WHO Laboratory biosafety manual (LBM4) described core requirements for risk management
1. Good microbiological practice and procedure, GMPP
2. Personnel competence and training
3. Facility design
4. Specimen receipt and storage
5. Decontamination and waste management
6. Personal protective equipment, PPE
7. Laboratory equipment
8. Emergency/incident response
9. Occupational health

Area of improvement in revised Korea Laboratory Biosafety Manual
· Providing updated biosafety practice based on recently published international biosafety guidelines and standards by WHO
· Providing risk assessment methodology and risk mitigation measures to safely handle pathogen
· Expending terminology of newly added words on biosafety guidelines
· Including principles and regulations associated with laboratory biosecurity

Figure 1. Biosafety documents system of Canadian Public Health Agency.
HPTA: Human Pathogens and Toxins Act, HPTR: Human Pathogens and Toxins Regulations HAA: Health of Animals Act, HAR: Health of Animals Regulations.

Fig 1.

Download
Figure 1.Biosafety documents system of Canadian Public Health Agency.
HPTA: Human Pathogens and Toxins Act, HPTR: Human Pathogens and Toxins Regulations HAA: Health of Animals Act, HAR: Health of Animals Regulations.
Public Health Weekly Report 2022; 15: 638-646
The fourth edition of the WHO Laboratory biosafety manual (LBM4) described core requirements for risk management
1. Good microbiological practice and procedure, GMPP
2. Personnel competence and training
3. Facility design
4. Specimen receipt and storage
5. Decontamination and waste management
6. Personal protective equipment, PPE
7. Laboratory equipment
8. Emergency/incident response
9. Occupational health
Area of improvement in revised Korea Laboratory Biosafety Manual
· Providing updated biosafety practice based on recently published international biosafety guidelines and standards by WHO
· Providing risk assessment methodology and risk mitigation measures to safely handle pathogen
· Expending terminology of newly added words on biosafety guidelines
· Including principles and regulations associated with laboratory biosecurity

References

  1. 코로나바이러스감염증-19 대응 실험실 생물안전 가이드, 질병관리본부, 2021.
  2. 심경종, 박민우, 신행섭, et al. 이동식 생물안전 3등급 시설의 국내·외 개발 동향. 주간 건강과 질병 2022;15(2):104-113.
  3. 질병관리청 감염병포털 https://www.kdca.go.kr/npt/biz/npp/portal/nppLwcrIcdMain.do, 2022
  4. 실험실 생물안전지침, 질병관리본부 국립보건연구원, 2019.
  5. Lee KM, et al. Emerging Infectious Diseases Require Biosafety Awareness and Procedures. J Bacteriol Virol. 2016;46:104-107.
    CrossRef
  6. 「감염병의 예방 및 관리에 관한 법률」 [시행 2022. 4. 20.] [법률 제18507호, 2021. 10. 19., 일부개정].
  7. 「연구실 안전환경 조성에 관한 법률」 [시행 202 2. 6 . 10.] [법률 제17350호, 2020. 6. 9., 전부개정].
  8. 「생명공학육성법」 [시행 2020. 11. 20.] [법률 제17261호, 2020. 5. 19., 일부개정].
  9. 「유전자변형생물체의 국가간 이동 등에 관한 법률」 [시행 2019. 6. 12.] [법률 제15868호, 2018. 12. 11., 일부개정].
  10. 유전자변형생물체의 국가간 이동 등에 관한 통합고시(보건복지부고시 제 2018-243호). 2018.
  11. 유전자재조합실험지침, 보건복지부, 2019.
  12. Laboratory Biosafety Manual 4th, World Health Organization, 2020.
  13. Laboratory biorisk management : CWA 15793:2011, CEN, 2011.
  14. Biosafety microbiological and biomedical laboratories, 6th, CDC, NIH, 2020.
  15. Canadian Biosafety Standard 2nd, Public Health Agency of Canada, 2020.
  16. The Canadian Biosafety Guideline-Pathogen Risk Assessment, Public Health Agency of Canada, 2020.
  17. 고위험병원체 취급시설 및 안전관리에 관한 고시(질병관리청고시 제2020-5호). 2020.

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