Decree No. 92/2010/ND-CP provides detailed regulations on ensuring biosafety in laboratories under the Law on Prevention and Control of Infectious Diseases.

DECREE

Detailed regulations on implementing the Law on Prevention and Control of Infectious Diseases concerningensuring biosafety in laboratories

THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to Article 24 of the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;

Considering the proposal of the Minister of Health,

DECREE:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree stipulates the classification of pathogenic microorganisms and laboratories according to biosafety levels; conditions for ensuring biosafety in laboratories; authorities, files, procedures for issuing, reissuing, and revoking Certificates of Biosafety Standards compliance; biosafety inspections; prevention, handling, and remediation of biosafety incidents.

Article 2. Applicability

This Decree applies to laboratories conducting tests on microorganisms that pose a risk of causing infectious diseases in humans (hereinafter referred to as laboratories).

Chapter II

CLASSIFICATION OF PATHOGENIC MICROORGANISMS AND LABORATORIES

ACCORDING TO BIOSAFETY LEVELS

Article 3. Classification of pathogenic microorganisms by risk groups

1. Pathogenic microorganisms that can cause infectious diseases in humans are divided into four groups:

a) Group 1 includes those with little or no risk of infection to individuals and communities, including microorganisms not known to cause disease in humans;

b) Group 2 includes those with moderate risk of infection to individuals but low risk to communities, including microorganisms capable of causing disease in humans but rarely causing severe illness, transmissible to humans, and for which effective preventive and treatment measures exist;

c) Group 3 includes those with high risk of infection to individuals but moderate risk to communities, including microorganisms capable of causing severe illness in humans, transmissible to humans, and for which effective preventive and treatment measures exist;

d) Group 4 includes those with high risk of infection to both individuals and communities, including microorganisms capable of causing severe illness in humans, transmissible to humans, and for which there are no effective preventive and treatment measures.

2. The Minister of Health shall specify the list of pathogenic microorganisms classified under each group as provided for in Clause 1 of this Article.

Article 4. Classification of laboratories according to biosafety levels

1. Laboratories testing pathogenic microorganisms that cause infectious diseases are classified into four biosafety levels as follows:

a) Biosafety Level I laboratories conduct tests on microorganisms belonging to Group 1 as specified in Point a, Clause 1, Article 3 of this Decree and products from other groups of microorganisms that have been treated and no longer pose a risk of causing disease;

b) Biosafety Level II laboratories conduct tests on microorganisms belonging to Group 2 as specified in Point b, Clause 1, Article 3 of this Decree;

c) Biosafety Level III laboratories conduct tests on microorganisms belonging to Group 3 as specified in Point c, Clause 1, Article 3 of this Decree;

d) Biosafety Level IV laboratories conduct tests on microorganisms belonging to Group 4 as specified in Point d, Clause 1, Article 3 of this Decree.

2. A laboratory with a higher biosafety level may perform tests that can be conducted in a laboratory with a lower biosafety level.

3. Laboratories conducting tests on pathogenic microorganisms must apply the biosafety level classification as provided for in Clause 1 of this Article.

4. The Minister of Health shall specify the testing techniques required for pathogenic microorganisms that need to be performed in laboratories requiring appropriate biosafety levels.

Chapter III

BIOLOGICAL SAFETY LABORATORY SAFETY CONDITIONS

IN TESTING LABORATORIES

Article 5. Conditions for a Level I Biological Safety Laboratory

1. Physical conditions:

a) The laboratory must have a minimum area of 12 square meters² (excluding the area for administrative work related to testing);

b) It must have sturdy doors and windows with locks, walls, and testing tables that are flat, waterproof, heat-resistant, and resistant to corrosive chemicals;

c) It must have a hand washing sink, emergency eye wash station, and first aid kit;

d) It must have electricity and clean water; the water supply pipes directly connected to the laboratory must have backflow preventers to protect the public water system;

đ) It must have fire and explosion prevention equipment.

2. Equipment conditions:

a) Testing equipment suitable for the techniques and types of microorganisms being tested;

b) Containers for waste that meet the standards specified for each type of waste;

c) Equipment for sterilizing tools and specimens;

d) Personal protective equipment appropriate for the testing techniques performed in a Level I Biological Safety Laboratory.

3. Personnel Conditions

The head and staff of the laboratory must have qualifications and certificates in training suitable for the type of testing and confirmation papers showing they have completed training on biological safety at Level I or higher from healthcare facilities designated by the Minister of Health, except for those who already have confirmation papers showing they have completed training on biological safety at Level I or higher from foreign authorities.

Article 6. Conditions for a Level II Biological Safety Laboratory

1. Physical conditions:

a) The laboratory must have a minimum area of 20 square meters² (excluding the area for administrative work related to testing);

b) The conditions stipulated in points b, c, d, and đ of Clause 1 of Article 5 of this Decree;

c) A wastewater treatment system that meets national technical standards before discharge into the common sewage system;

d) It must be separate from other laboratories in the testing facility;

đ) There must be biohazard warning signs as prescribed in the Appendix issued together with this Decree on the entrance door of the laboratory.

2. Equipment conditions:

a) The equipment conditions stipulated in points a and b of Clause 2 of Article 5 of this Decree;

b) It must have a Level II biosafety cabinet and a wet autoclave;

c) Personal protective equipment appropriate for the testing techniques performed in a Level II Biological Safety Laboratory.

3. Personnel Conditions

The head and staff of the laboratory must have qualifications and certificates in training suitable for the type of testing and confirmation papers showing they have completed training on biological safety at Level II or higher from healthcare facilities designated by the Minister of Health, except for those who already have confirmation papers showing they have completed training on biological safety at Level II or higher from foreign authorities.

Article 7. Conditions for a Level III Biological Safety Laboratory

1. Physical conditions:

a) It must have two rooms: a testing room and a buffer room before entering the testing room. The testing room must have a minimum area of 20 square meters²;

b) The conditions stipulated in points b and c of Clause 1 of Article 6 of this Decree; it must have a liquid waste treatment system using chemicals that meet national technical standards before discharging into the common drainage system;

c) It must be separated from other laboratories in the testing facility; if in the same building, it must be located at the end of a hallway with little foot traffic;

d) Before entering the testing room, one must pass through the buffer room. The buffer room must have a lower air pressure than the outside;

đ) The testing room must be sealed for sterilization; the air pressure inside the testing room must be lower than the air pressure in the buffer room;

e) The door system must meet the following conditions:

- All windows and doors must use fireproof and shatterproof materials;

- There must be biohazard warning signs as prescribed in the Appendix issued together with this Decree on the entrance door of the laboratory;

- There must be an automatic door opening and closing system for the buffer room and the testing room. This system must ensure that only one of these doors can be opened at any given time;

g) The ventilation system must meet the following conditions:

- It must be designed with a unidirectional flow principle; air leaving the Level III Biological Safety Laboratory must pass through a filtration system meeting national technical standards before being discharged into the environment;

- There must be a system to control the direction of airflow supplied to the testing room;

- There must be an alarm system when the temperature or pressure in the testing room does not meet standards;

h) There must be an emergency shower in the testing area and an escape route in case of emergency.

2. Equipment conditions:

a) The equipment conditions stipulated in points a and b of Clause 2 of Article 5 of this Decree;

b) It must have a Level II or higher biosafety cabinet and a wet autoclave placed within the testing room;

c) Personal protective equipment appropriate for a Level III Biological Safety Laboratory.

3. Personnel Conditions

The head and staff of the laboratory must have qualifications and certificates in training suitable for the type of testing and confirmation papers showing they have completed training on biological safety at Level III or higher from healthcare facilities designated by the Minister of Health, except for those who already have confirmation papers showing they have completed training on biological safety at Level III or higher from foreign authorities.

Article 8. Conditions for a Biosafety Level 4 Laboratory

1. Physical conditions:

a) The conditions stipulated in points a, b, c, d, đ, e, and h of Clause 1, Article 7 of this Decree;

b) Must have a shower and changing room between the buffer room and the laboratory;

c) In addition to complying with the provisions set out in point g of Clause 1, Article 7 of this Decree, the ventilation system of the laboratory must also meet the following conditions:

- A non-circulating ventilation system for Biosafety Cabinet Class III;

- An independent air supply system for protective clothing capable of providing an additional 100% air volume in case of biological safety incidents;

2. Equipment conditions:

a) The equipment conditions stipulated in points a and b of Clause 2 of Article 5 of this Decree;

b) Must have a Biosafety Cabinet Class III and a two-door autoclave;

c) Personal protective equipment suitable for a Biosafety Level 4 laboratory.

3. Personnel Conditions

The person in charge and staff of the laboratory must hold appropriate certificates and training credentials for the type of testing conducted and have a confirmation certificate of training on Biosafety Level 4 from healthcare facilities designated by the Minister of Health, except for individuals who already possess a confirmation certificate of training on Biosafety Level 4 issued by foreign authorities.

Article 9. Practices in Biosafety Laboratories

1. Biosafety laboratories at Levels I, II, III, and IV must comply with regulations on management and operation; usage and practice; health monitoring and medical care; maintenance, repair, calibration of laboratories; supervision of practices within biosafety laboratories.

2. The Minister of Health shall issue national technical standards on practices and biosafety in laboratories.

Chapter IV
AUTHORITY, FILES, PROCEDURES FOR ISSUING NEW, RENEWING AND REVOKING BIOSAFETY STANDARDS CERTIFICATES

Article 10. Authority for Issuing New, Renewing and Revoking Biosafety Standards Certificates

1. The Director of the Provincial Department of Health shall review, issue new, renew and revoke Biosafety Standards Certificates for Level I and Level II laboratories under their jurisdiction, excluding laboratories under the jurisdiction of the Ministry of Public Security and the Ministry of National Defense.

2. The Minister of Health shall review, issue new, renew and revoke Biosafety Standards Certificates for Level III and Level IV laboratories, excluding laboratories under the jurisdiction of the Ministry of Public Security and the Ministry of National Defense.

3. The Minister of Public Security and the Minister of National Defense shall organize the review, issuance of new, renewal and revocation of Biosafety Standards Certificates for laboratories under their jurisdiction based on the provisions of this Decree and national technical standards on biosafety in laboratories.

Article 11. Application Files for Issuing New and Renewing Biosafety Standards Certificates

1. Application files for issuing new Biosafety Standards Certificates:

a) Request letter for issuing Biosafety Standards Certificate;

b) Staff list, equipment inventory, floor plan of the laboratory;

c) Legal copies of certificates and qualifications of laboratory staff;

d) Legal copies of documents proving establishment and operation of the facility housing the laboratory according to the law.

2. Application files for renewing Biosafety Standards Certificates when the certificate expires, is damaged, lost, or the name of the facility changes:

a) Request letter for renewing Biosafety Standards Certificate, specifying the reason for renewal;

b) Original Biosafety Standards Certificate (if available).

Article 12. Procedures for Issuing and Reissuing Safety Biosafety Standards Certification

1. Application dossier for issuing and reissuing Safety Biosafety Standards Certification for Level I and Level II laboratories shall be submitted to the Department of Health where the laboratory is located. Application dossier for issuing and reissuing Safety Biosafety Standards Certification for Level III and Level IV laboratories shall be submitted to the Ministry of Health.

2. Within thirty working days from the date of receipt of complete application dossier, the agency receiving the dossier as stipulated in Clause 1 of this Article must organize assessment and issue Safety Biosafety Standards Certification; in case of non-issuance, a written response with clear reasons must be provided.

3. Validity period of Safety Biosafety Standards Certification:

a) Safety Biosafety Standards Certification for Level I laboratories has a validity period of five years from the issuance date;

b) Safety Biosafety Standards Certification for Level II laboratories has a validity period of three years from the issuance date;

c) Safety Biosafety Standards Certification for Level III and Level IV laboratories has a validity period of one year from the issuance date;

4. The competent authority for issuing and reissuing Safety Biosafety Standards Certification as prescribed in Article 10 shall collect fees for issuing certification according to regulations.

5. The Minister of Health shall specify detailed procedures for issuing and reissuing Safety Biosafety Standards Certification.

Article 13. Revocation of Safety Biosafety Standards Certification

1. Cases for revoking Safety Biosafety Standards Certification:

a) Failure to meet biosafety safety assurance conditions;

b) Safety Biosafety Standards Certification issued beyond authority;

c) Safety Biosafety Standards Certification containing content contrary to the law;

d) Laboratory not operating within twelve months from the date of issuance of Safety Biosafety Standards Certification;

đ) The entity owning the laboratory being declared bankrupt, dissolved, or merged;

e) Change in location of the laboratory;

g) Laboratory operating when Safety Biosafety Standards Certification has expired.

2. The competent authority issuing Safety Biosafety Standards Certification or the authorized person of the specialized health inspection agency shall decide on the revocation of Safety Biosafety Standards Certification in cases as specified in Clause 1 of this Article.

Chapter V
BIOSAFETY INSPECTION

Article 14. Content of Biosafety Inspection

1. Inspection of compliance with technical procedures during testing processes.

2. Inspection of biosafety assurance conditions as prescribed in Chapter III of this Decree.

Article 15. Responsibilities of Entities with Laboratories

Entities with laboratories are responsible for establishing and implementing self-inspection regulations for biosafety. Self-inspection regulations for biosafety include specific inspection contents as prescribed in Article 14 of this Decree, adapted to the characteristics of the laboratory, inspection procedures, and inspection timeframes.

Article 16. Responsibilities of State Management Agencies in Health

1. Periodically or at random, the Ministry of Health shall inspect and audit laboratories that have been issued Safety Biosafety Standards Certification nationwide; the Department of Health shall inspect and audit laboratories that have been issued Safety Biosafety Standards Certification within their jurisdiction.

2. During inspections and audits, if it is found that biosafety laboratories do not meet the conditions stipulated in this Decree, measures must be taken or recommendations made to the competent state management authority to handle the situation according to Article 13 of this Decree.

Chapter VI
PREVENTION, HANDLING AND REMEDY OF INCIDENTS

BIOSAFETY

Article 17. Biological Safety Incidents

1. A biological safety incident is a situation involving errors in technical operations or the functionality of safety equipment in laboratories or leakage, dissemination of microorganisms within laboratories or from laboratories to the outside.

2. Biological safety incidents include two levels:

a) A minor-level biological safety incident is an incident occurring within the facility with a laboratory but with little risk of infecting laboratory staff and the facility has sufficient capacity to control it.

b) A severe-level biological safety incident is an incident occurring within the facility with a laboratory but with a high risk of infecting laboratory staff and the community or an incident that the facility with a laboratory cannot adequately control.

Article 18. Prevention of Biological Safety Incidents

1. Facilities with biosafety laboratories have the responsibility to:

a) Assess the risk of biological safety incidents occurring in laboratories;

b) Develop a prevention and response plan for biological safety incidents including the following basic contents: identifying and isolating areas at risk of biological safety incidents in laboratories; measures, equipment, and personnel to handle and mitigate incidents; plans to coordinate with relevant agencies to respond to biological safety incidents;

c) Train and instruct laboratory facility staff on preventive and mitigation measures for biological safety incidents;

2. Each year, level III and level IV biosafety laboratories must organize drills for prevention and mitigation of biological safety incidents according to the regulations of the Minister of Health.

Article 19. Handling and Mitigating Consequences of Biological Safety Incidents

1. When a biological safety incident occurs, the laboratory facility has the responsibility to:

a) Promptly mobilize personnel and equipment to handle the incident according to the prevention and response plan for biological safety incidents stipulated in point b, Clause 1, Article 18 of this Decree;

b) For minor-level biological safety incidents, the laboratory facility must conduct a record of handling and mitigating the incident and retain it at the unit;

c) For severe-level biological safety incidents, the laboratory facility must report the incident and the measures applied to handle and mitigate the biological safety incident to the Department of Health;

2. The Department of Health has the responsibility to direct specialized agencies where the laboratory facility is located to inspect the handling and mitigation of biological safety incidents by the laboratory facility;

3. In cases exceeding their own capacity, provincial Departments of Health must report to the People's Committee of the province to mobilize local resources or request support from the Ministry of Health for handling and mitigating biological safety incidents;

4. For laboratories managed by the Ministry of Defense or the Ministry of Public Security, in case of incidents, they must immediately report to responsible management agencies to handle and mitigate biological safety incidents;

5. In cases where biological safety incidents occur in level II, level III, and level IV laboratories and spread widely, significantly affecting the community or national security, the handling and mitigation of incidents shall be carried out according to the provisions in Section 2 Chapter IV of the Law on Prevention and Control of Infectious Diseases;

6. After handling and mitigating the consequences of biological safety incidents, the laboratory facility must conduct a review, analyze the causes of the incident, and revise and supplement the prevention and response plan for biological safety incidents;

Chapter VII
IMPLEMENTING PROVISIONS

Article 20. Effective Date

This Decree takes effect from November 1, 2010.

Article 21. Transitional Provisions

1. New laboratories built or renovated after this Decree takes effect must comply with the biosafety conditions specified for each level according to this Decree;

2. Laboratories operating before this Decree takes effect must be renovated to meet the biosafety conditions specified for each level according to this Decree by December 31, 2010;

Article 22. Responsibility for enforcement

1. The Minister of Health is responsible for guiding and supervising the implementation of this Decree;

2. The Ministers of National Defense and Public Security are responsible for guiding and supervising the implementation of this Decree for laboratories under their jurisdiction.

3. Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial People's Committees directly under the Central Government are responsible for implementing this Decree./.