Circular No. 21/2012/TT-BKHCN on biosafety in research and development activities related to genetically modified organisms

CIRCULAR

Regulations on biosafety in research and development activities related to genetically modified organisms

 technology

_____________________

 

Pursuant to Decree No. 28/2008/NĐ-CP dated March 14, 2008, promulgated by the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

Pursuant to Decree No. 81/2002/NĐ-CP dated October 17, 2002 of the Government detailing the implementation of certain provisions of the Law on Science and Technology;

Pursuant to Decree No. 69/2010/NĐ-CP dated June 21, 2010 and Decree No. 108/2011/NĐ-CP dated November 30, 2011 amending Decree No. 69/2010/NĐ-CP of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms;

Pursuant to Decision No. 79/2007/QĐ-TTg dated May 31, 2007 of the Prime Minister approving the "National Action Plan on Biodiversity until 2010 and orientations until 2020 to implement the Convention on Biological Diversity and the Cartagena Protocol on Biosafety";

Considering the proposal of the Director of the Department of Science and Technology for Economic and Technical Sectors;

The Minister of Science and Technology promulgates these Circulars on regulations on biosafety in research and development activities related to genetically modified organisms,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

These Circulars regulate the management of biosafety in research and development activities related to genetically modified organisms, genetic material, and products derived from genetically modified organisms (hereinafter referred to as research on genetically modified organisms).

Article 2. Applicability

These Circulars apply to organizations and individuals within and outside Vietnam (hereinafter referred to as organizations and individuals) involved in the management and implementation of scientific research and technological development activities related to genetically modified organisms, genetic material, and products derived from genetically modified organisms on the territory of the Socialist Republic of Vietnam.

Article 3. Explanation of Terms

In this Circular, the following terms shall be understood as follows:

1. Research on genetically modified organisms, genetic material, and products derived from genetically modified organisms (hereinafter referred to as research on genetically modified organisms) is scientific research and technological development activities aimed at creating, analyzing, isolating, testing genetically modified organisms, genetic material, and products derived from genetically modified organisms; assessing the impact of genetically modified organisms and products derived from genetically modified organisms on human health, livestock, biodiversity, and the environment.

2. Risk are factors that directly or indirectly harm the environment, biodiversity, human health, crops, or livestock, which may be easily detected or hidden due to activities related to research on genetically modified organisms.

3. Biosafety management includes measures to ensure safety for the environment, biodiversity, human health, crops, and livestock.

Article 4. Principles of biosafety management in research on genetically modified organisms

1. All research activities on genetically modified organisms must comply with current regulations governing scientific and technological tasks (S&T) under Articles 19 and 20 of the Law on Science and Technology; Article 87 of the Environmental Protection Law; Article 7 of the Biodiversity Law; Article 44 and Article 50 of the Food Safety Law, and other relevant laws.

2. Research on genetically modified organisms must be conducted within the framework of approved scientific and technological tasks (projects): national-level S&T tasks approved by the Ministry of Science and Technology; provincial-level S&T tasks approved by ministries, sectors, provincial People's Committees; and grassroots-level S&T tasks approved by direct managing organizations.

3. Research on genetically modified organisms can only be carried out in laboratories certified to meet the conditions for research on genetically modified organisms according to biosafety levels.

a) Level 1 biosafety laboratory: can conduct gene transfer research; analyze and detect genetically modified organisms, genetic material, and products derived from genetically modified organisms; assess and test quality standards and risks of objects that are unlikely or minimally harmful to the environment, biodiversity, and human health, livestock;

b) Level 2 biosafety laboratory: in addition to the provisions in Point a of this Clause, it can also conduct gene transfer research on objects that may pose risks to the environment and biodiversity;

c) Level 3 biosafety laboratory: in addition to the provisions in Points a and b of this Clause, it can also conduct gene transfer research on objects that pose risks to the environment, biodiversity, and human health, livestock;

d) Level 4 biosafety laboratory: in addition to the provisions in Points a, b, and c of this Clause, it can also conduct gene transfer research on objects that pose high risks and dangers to humans, capable of causing epidemics.

4. Provincial and grassroots-level S&T tasks on genetically modified organisms where both donor and recipient organisms have high risk potential impacts on the environment, biodiversity, and human health, livestock, belonging to Levels 3 and 4 biosafety must be agreed in writing by the Ministry of Science and Technology before approval.

5. Project descriptions for S&T tasks on genetically modified organisms, in addition to current regulations, must include biosafety management content: risk assessment and risk management plans.

6. Research activities on genetically modified organisms must be subject to supervision by the Ministry of Science and Technology and relevant ministries and sectors.

Chapter II

BIOSAFETY REGULATIONS IN RESEARCH AND DEVELOPMENT OF GENETICALLY MODIFIED ORGANISMS TECHNOLOGY

Article 5. Regulations on categorizing biosafety levels according to the risk level of genetically modified organisms and products derived from genetically modified organisms

1. Level 1 includes genetically modified organisms and products derived from genetically modified organisms that have no or low risk to the environment, biodiversity, human health, crops, and livestock.

2. Level 2 includes genetically modified organisms and products derived from genetically modified organisms that have moderate risk to the environment, biodiversity, human health, crops, and livestock.

3. Level 3 includes genetically modified organisms that have high risk to the environment, biodiversity, human health, crops, and livestock but have management measures in place.

4. Level 4 includes genetically modified organisms and products derived from genetically modified organisms that have high risk potentially occurring to the environment, biodiversity, and human health, crops, and livestock but lack effective risk management measures.

Article 6. Risk assessment and risk management in research on genetically modified organisms

1. Risk assessment must be conducted at each stage of the research process involving genetically modified organisms. If the risk assessment concludes that there is a risk that cannot be controlled at any stage, the subsequent experimental stages shall not be carried out.

2. The content of risk assessment includes identifying risks, analyzing, and evaluating the potential level of risk according to the categories of biological safety risk to biodiversity, the environment, and human health, and livestock.

3. Identify risks according to their likelihood (unlikely to occur, likely to occur, certain to occur) among the following groups:

a) Risks to soil, water, and air environments: degree of pollution, degradation;

b) Risks to biodiversity: adverse changes in species composition;

c) Risks to human health and livestock: toxins, allergens.

4. For risks predicted to certainly occur, and those with a high likelihood of occurrence, the following risk assessment contents must be performed:

a) Analyze and assess risks to human health and the environment;

b) Analyze and forecast potential harmful impacts of risks;

c) Analyze and forecast risks arising from harmful impacts;

d) Analyze and propose appropriate measures for risk management;

e) Forecast overall impact on the environment, including positive impacts on the environment and human health.

5. Depending on the results of risk assessment, the head of the scientific and technological task shall develop a risk management plan including risk reduction measures, monitoring plans, and evaluation of implementation:

a) Risk reduction measures shall be developed based on the principle of prevention;

b) Monitoring and evaluation plans must be developed based on the content and progress of the research;

c) Develop a prevention and response plan for laboratory biosafety incidents.

6. The risk assessment report and risk management plan shall be prepared according to the model prescribed in Appendix 1 issued together with this Circular.

Article 7. Biological safety regulations for research creating genetically modified organisms

1. General provisions

a) Research to create genetically modified organisms can only be conducted in laboratories certified with a Certificate for Genetically Modified Organism Research Laboratories at Biosafety Level 1, Level 2, Level 3, and Level 4;

b) Must comply with current regulations on laboratory safety and hygiene;

c) Prepare sufficient samples, materials, and experimental equipment. All materials, experimental samples, test tubes, specialized tools used in genetically modified organism research must be labeled with their name and date of implementation;

d) Activities to create recombinant vectors and gene transfer can only be carried out in biosafety level 1 or higher laboratories within the main experimental area;

đ) Only one subject shall be subjected to gene transfer in one experiment;

e) The person performing gene transfer must wear a lab coat, mask, and gloves. During operations, they must sit before an operating biosafety cabinet, take the necessary quantities of materials, and avoid spillage;

g) Biosafety cabinets and experimental equipment must be cleaned with 70% alcohol. Spilled samples, excess materials, alcohol swabs, used experimental tools, test tubes, and other used items must be collected, sorted, and safely processed before disposal;

h) Regular weekly disinfection of laboratories and biosafety cabinets using chloramine solution or 70% alcohol or other disinfectants as prescribed;

i) Experimental products must be stored and managed according to regulations and not removed from the laboratory without permission from the manager. If samples are lost or signs of disturbance appear, immediate notification to the manager is required to implement timely measures to limit uncontrolled spread into the environment;

k) During implementation, if risks that are difficult to control are discovered, research activities must be immediately halted and handled according to the guidelines stipulated in Article 12 of this Circular;

2. Biological safety management regulations for certain special research activities

In addition to the provisions stated in Clause 1 of this Article, the following regulations must also be adhered to:

a) Clonal propagation activities involving genetically modified plants: During clonal propagation, genetically modified organisms must be strictly isolated from other living beings. Defective or unused samples must be destroyed according to regulations;

b) Clonal propagation activities involving genetically modified microorganisms: Strict management of culture tubes is required, and unsuccessful culture tubes must be destroyed according to regulations;

c) Clonal propagation activities involving genetically modified animals: Strict management of the number of genetically modified cell lines prior to implantation into hosts is required. If samples are defective or unused, destruction must be carried out according to regulations;

Article 8. Biological safety regulations for laboratories conducting research on the biological characteristics of genetically modified organisms

1. Research activities on the biological characteristics of genetically modified organisms conducted in laboratories within the main experimental area must comply with the provisions of Clause 1 of Article 7 of this Circular;

2. Research activities on the biological characteristics of genetically modified plants must adhere to the following regulations:

a) Studies on biological characteristics may only be conducted in greenhouses or net houses, ensuring isolation between different biological entities;

b) Tools for plant care and trimming must be dedicated to a single type of genetically modified crop;

c) Separate footwear must be worn when entering greenhouses or net houses;

d) Soil and plant samples from genetically modified crops may not be taken out of greenhouses or net houses without permission;

đ) When collecting samples for analysis, ensure no spillage or mixing of samples and manage them safely during analysis;

e) At the end of experiments, genetically modified plants, whether suitable or unsuitable for breeding, must be strictly managed. If not reused, they must be destroyed according to regulations;

3. Research on the biological characteristics of animals is conducted in auxiliary areas:

a) Animal housing areas for genetically modified organisms must ensure isolation from the external environment, equipped with separate waste and wastewater systems. Waste and wastewater must be collected and treated with disinfectants, not directly discharged into the common wastewater system. Solid waste and bedding material (if present) must be treated through incineration in enclosed furnaces;

b) Strict management of genetically modified animals: They must be marked and their numbers tracked. Dead animals or those unsuitable for breeding, genetic samples of genetically modified animals must be destroyed through incineration in enclosed furnaces;

4. During research on the biological characteristics of genetically modified organisms, if high risks to the environment, biodiversity, and human and animal health are identified, the organization responsible for the task must immediately report to the competent authority and seek advice on risk prevention measures.

Article 9. Biological Safety Regulations in Activities of Detection Analysis and Quality Analysis of Genetically Modified Organisms and Their Products

1. Activities of detection analysis and quality analysis of genetically modified organisms and their products shall only be carried out at Research Laboratories on Genetically Modified Organisms that have been issued with a Certificate.

2. The management of biological safety in these activities shall be conducted in accordance with the provisions of Articles 8, 9, and 10 of this Circular.

Article 10. Registration and Acceptance Documents for Scientific and Technological Tasks on Genetically Modified Organisms

1. The registration documents for scientific and technological tasks on genetically modified organisms shall be established in accordance with current regulations on registration documents for scientific and technological tasks. The explanatory section must provide comprehensive information about the biological characteristics, scientific research results, and issues related to biological safety concerning genetically modified organisms. In the approach, research methods, and techniques used sections, there must be an analysis and development of risk management plans as stipulated in Article 6 of this Circular.

2. The acceptance documents for scientific and technological tasks on genetically modified organisms shall be established in accordance with current regulations. The final report of the task, in addition to the prescribed contents, must include a report on risks that occurred and the risk management measures that were implemented.

Article 11. Biological Safety Regulations for Laboratory Staff Engaged in Research on Genetically Modified Organisms

1. Fully comply with all laboratory rules.

2. Do not store food or drinks in laboratory refrigerators.

3. Do not eat or drink in the laboratory.

4. Do not use pipettes to suck liquids by mouth when handling experiments involving genetically modified organisms.

Article 12. Management Regulations When a Biological Safety Incident Occurs in a Research Laboratory on Genetically Modified Organisms

1. Upon occurrence of a biological safety incident, the head of the task and the person responsible for managing the laboratory must organize:

a) Immediately report to the direct supervisory authority and identify, isolate areas at risk of incidents within the laboratory;

b) Collect as many samples as possible in cases of broken test tube containing samples, insect or rodent intrusion, equipment failure leading to sample dispersion, or laboratory damage. After collecting the samples, repair, clean, and disinfect the damaged equipment and laboratory.

2. In case of a biological safety incident exceeding the capacity of the organization with the laboratory, it must immediately report in writing to the competent authorities to organize on-site supervision and resolution of the incident.

3. After resolving the incident, scientific and technological tasks on genetically modified organisms belonging to biosafety level 3 and 4 subgroups may only continue to be implemented upon written approval from the competent authority.

Chapter III

RESPONSIBILITIES FOR MANAGEMENT AND VIOLATION HANDLING

Article 13. Responsibilities for Managing Biological Safety in Research on Genetically Modified Organisms

1. Ministry of Science and Technology:

a) Responsible for organizing the management of biological safety in research on genetically modified organisms in accordance with the provisions of this Circular.

b) Responsible for approving and directly managing state-level scientific and technological tasks on genetically modified organisms.

c) Within thirty days from receiving the application documents for implementing tasks specified in Clause 4, Article 4 of this Circular, including revised task descriptions after evaluation and determination, and letters of request from ministries, provincial people's committees, and scientific and technological organizations (in the format prescribed in Appendix II attached to this Circular), the Ministry of Science and Technology shall respond in writing regarding permission or non-permission to implement (if not permitted, the reasons must be clearly stated) for ministries, localities, and scientific and technological organizations to approve according to regulations.

2. Ministries, provincial people's committees:

a) Responsible for managing biological safety of scientific and technological tasks on genetically modified organisms at the ministry, provincial, and organizational levels that have been approved according to the provisions of this Circular;

b) Coordinate with the Ministry of Science and Technology to organize inspections and supervision of the implementation of biological safety regulations in research on genetically modified organisms within their jurisdiction.

c) Report annually to the Ministry of Science and Technology on the implementation of scientific and technological tasks on genetically modified organisms within their jurisdiction (in the format prescribed in Appendix III attached to this Circular).

3. Scientific and technological organizations, laboratories, individuals participating in research on genetically modified organisms:

a) Responsible for managing biological safety during the implementation of scientific and technological tasks;

b) Organize the implementation of approved scientific and technological tasks on genetically modified organisms in accordance with regulations;

c) Responsible for monitoring risks during research, reporting to the Ministry of Science and Technology (for tasks approved by the Ministry of Science and Technology) or the relevant ministry, department, or provincial people's committee (for tasks approved by ministries, departments, or localities) when there are adjustments or changes to the research content or plan, and can only continue after obtaining written consent from the competent authorities.

Article 14. Handling Violations

1. The authority approving scientific research tasks on genetically modified organisms as stipulated in Clause 2, Article 4 of this Circular decides to suspend or terminate research activities on genetically modified organisms if violations of biological safety regulations or any serious threat to human health, animal health, biodiversity, and the environment are discovered.

2. Organizations or individuals violating the provisions of this Circular or other laws will be subject to revocation of the Laboratory Research on Genetically Modified Organisms Certificate, administrative penalties, or criminal liability as provided by Vietnamese law depending on the specific nature and severity of the violation.

Chapter IV

IMPLEMENTING PROVISIONS

Article 15. Effective Date

This Circular takes effect forty-five days from the date of issuance.

Article 16. Transitional Provisions

Laboratories conducting genetic engineering research prior to the issuance of this Circular shall postpone the effective date for implementing its provisions until January 1, 2014.

Article 17. Implementation Organization

1. The Department of Science and Technology of Economic and Technical Sectors of the Ministry of Science and Technology shall be responsible for assisting the Minister of Science and Technology in organizing guidance and management of the implementation of this Circular.

2. Ministries, sectoral agencies, People's Committees of provinces and centrally governed cities shall organize management and provide guidance to scientific and technological organizations within their jurisdiction to implement regulations on biosafety management.

3. During the implementation process, if there are any difficulties or suggestions regarding matters requiring adjustment, please submit written feedback to the Ministry of Science and Technology for review and adjustment./.