Decision No. 212/2005/QĐ-TTg On the issuance of the Biosafety Management Regulation for genetically modified organisms and products derived from genetically modified organisms

DECISION OF THE PRIME MINISTER

Regarding the issuance of the Biosafety Management Regulation for genetically modified organisms; products, goods derived from genetically modified organisms

PRIME MINISTER

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

On the basis of the Environmental Protection Law dated December 27, 1993;

CONSIDERING THE PROPOSAL OF THE MINISTER OF NATURAL RESOURCES AND ENVIRONMENT,

DECISION:

Article 1. The Biosafety Management Regulation for genetically modified organisms; products, goods derived from genetically modified organisms is hereby issued together with this Decision.

Article 2. The Minister of Natural Resources and Environment shall take the lead and coordinate with relevant ministries, sectors, and localities to guide and implement the Regulation issued together with this Decision.

Article 3. This Decision takes effect fifteen days from the date of publication in the Official Gazette.

The Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial People's Committees under the central city, and organizations and individuals concerned are responsible for implementing this Decision.

REGULATIONS

Biosafety management for genetically modified organisms;

products, goods derived from genetically modified organisms

(Issued together with Decision No. 212/2005/QĐ-TTg
dated August 26, 2005 of the Government)

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Regulation stipulates the state management on biosafety in activities such as scientific research, technological development, and field trials; production, business, and use; import, export, storage, and transportation; risk assessment, risk management, and issuance of biosafety certificates for genetically modified organisms; products, goods derived from genetically modified organisms to protect human health, the environment, and biodiversity.

Article 2. Applicability

This Regulation applies to organizations and individuals within the country and foreign organizations and individuals (hereinafter referred to as organizations and individuals) engaged in activities related to genetically modified organisms; products, goods derived from genetically modified organisms on the territory of Vietnam.

In cases where international treaties to which the Socialist Republic of Vietnam is a party have provisions different from those set forth in this Regulation, the provisions of such international treaties shall apply.

Article 3. Explanation of Terms

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

1. Biosafety refers to management measures for safety in activities such as scientific research, technological development, and field trials; production, business, and use; import, export, storage, and transportation of genetically modified organisms; products, goods derived from genetically modified organisms.

2. Gene is a unit of heredity, a segment of genetic material that determines the inheritance of traits in living organisms.

3. DNA (deoxyribonucleic acid) is the genetic material of living organisms, having a double helix structure, consisting of many genes (units of heredity).

4. Genetic engineering technology involves transferring genes from one organism to another, requiring the DNA chain of the recipient organism to accept new genes.

5. Genetically modified organism refers to animals, plants, microorganisms whose gene structures have been altered through genetic engineering technology.

6. Products, goods derived from genetically modified organisms are products, goods created entirely or partially from genetically modified organisms.

7. Release of genetically modified organisms refers to the active introduction of genetically modified organisms into the environment.

8. Risk assessment involves identifying potential hazards and the extent of damage that may occur in activities related to genetically modified organisms, especially their use and release; to products, goods derived from genetically modified organisms concerning human health, the environment, and biodiversity.

9. Risk management involves implementing safety measures to prevent, address, and mitigate risks in activities related to genetically modified organisms; products, goods derived from genetically modified organisms concerning human health, the environment, and biodiversity.

10. Testing is the activity of assessing the level of biosafety of genetically modified organisms; products, goods derived from genetically modified organisms under specific conditions in Vietnam before they are put into production, business, and use.

PART II
SCIENTIFIC RESEARCH, TECHNOLOGICAL DEVELOPMENT
AND FIELD TRIALS

Article 4. Scientific research, technological development

1. Activities of scientific research and technological development on genetically modified organisms; products, goods derived from genetically modified organisms must comply with current regulations on science and technology management and other relevant laws.

2. Organizations and individuals are only permitted to conduct scientific research and technological development activities on genetically modified organisms; products, goods derived from genetically modified organisms when they have adequate technical facilities, equipment, technology, and specialized staff suitable for the type of scientific research and technological development on genetically modified organisms; products, goods derived from genetically modified organisms.

3. Organizations and individuals conducting scientific research and technological development activities on genetically modified organisms; products, goods derived from genetically modified organisms must register with the Ministry of Science and Technology and the sectoral management ministry regarding these issues.

4. Organizations and individuals conducting scientific research and technological development activities on genetically modified organisms; products, goods derived from genetically modified organisms are responsible for safely keeping and preserving, preventing the loss of genetically modified organisms and other hazardous materials from entering the environment.

Article 5. Testing

Organizations and individuals conducting field trials on genetically modified organisms; products, goods derived from genetically modified organisms must comply with the following regulations:

1. Conditions for registering field trial activities:

a) Having sufficient technical facilities, equipment, technology, and specialized staff suitable for field trials on genetically modified organisms; products, goods derived from genetically modified organisms to effectively control and manage risks according to the regulations of the sectoral management ministry;

b) Genetically modified organisms; products, goods derived from genetically modified organisms to be tested must be the result of scientific research and have been evaluated and accepted by competent state authorities;

c) Having monitoring and risk management measures during the field trial process;

d) The area for conducting field trials must be isolated from residential areas and natural reserves according to the regulations of the sectoral management ministry.

2. Contents of the registration documents

a) Application for registration of trial;

b) Written consent of the People's Committee of the province or centrally governed city where the trial is expected to be implemented;

c) Documents proving compliance with the conditions stipulated in Clause 1 of this Article;

d) Other necessary information as required by the registration authority.

3. Procedure and formalities:

a) Submit the application for registration of trial to the competent ministry or agency;

b) Within sixty days from the date of receipt of complete and valid documents, the competent ministry or agency shall examine the application and issue a decision to permit the trial for cases meeting the conditions; in cases where permission is not granted, the ministry or agency receiving the application must respond in writing and specify the reasons.

4. The competent ministry or agency shall report to the Ministry of Natural Resources and Environment and the central agency of the Government when granting permission to organizations and individuals to conduct trials.

CHAPTER III
PRODUCTION, BUSINESS AND USE

Article 6. Conditions for production and business

1. Organizations and individuals may only carry out production, business and put into use genetically modified organisms; products, goods derived from genetically modified organisms when they meet the following conditions:

a) Genetically modified organisms; products, goods derived from genetically modified organisms have been issued a certificate of biosafety;

b) Genetically modified organisms; products, goods derived from genetically modified organisms are included in the list of genetically modified organisms, products, goods derived from genetically modified organisms permitted for production, business, and use as prescribed by the competent ministry or agency.

2. Organizations and individuals producing, trading and putting into use genetically modified organisms; products, goods derived from genetically modified organisms must hold a registration certificate for production and business in the relevant field.

Article 7. Product labeling

Organizations and individuals selling products, goods that are genetically modified organisms or products, goods derived from genetically modified organisms on the market, in addition to complying with current laws on product labeling, must also include on the packaging the phrase: "product using gene transfer technology" for consumers to consider and choose.

Article 8. Monitoring, supervision and reporting

Organizations and individuals producing, trading genetically modified organisms; products, goods derived from genetically modified organisms must continuously monitor and supervise the level of safety of these organisms for human health, the environment, biodiversity; in case of risk occurrence, they must immediately report to the Ministry of Natural Resources and Environment and the competent ministry or agency.

PART IV
IMPORT, EXPORT, STORAGE AND TRANSPORTATION

Article 9. Conditions for importing genetically modified organisms

1. Genetically modified organisms imported into Vietnam for research purposes must comply with the following conditions:

a) They have been approved for use for the same purpose within the territory of the exporting country;

b) Effective risk management measures are in place.

2. Genetically modified organisms imported into Vietnam for trial, production, business, and use must comply with the following conditions:

a) They have been approved for use for the same purpose within the territory of the exporting country;

b) They have been assessed for risk under specific conditions of that country; in cases of import for production, business, and use, genetically modified organisms must also ensure they have been assessed for risk under specific conditions of Vietnam;

c) The exporting country has established an effective safety management mechanism for those genetically modified organisms.

Article 10. Conditions for Importing Products and Goods Originating from Genetically Modified Organisms

1. Products and goods originating from genetically modified organisms imported into Vietnam for research purposes must comply with the provisions set forth in Clause 1, Article 9 of this Regulation.

2. Products and goods originating from genetically modified organisms imported into Vietnam for trial, production, business, and use purposes must meet the following conditions:

a) They have been approved for use for the same purpose within the territory of the exporting country;

b) Have been assessed for risk under specific conditions of that country;

c) The exporting country has established an effective management mechanism for ensuring safety of products and goods originating from genetically modified organisms;

d) In cases where there is a mutual recognition document between the exporting country and Vietnam regarding products and goods originating from genetically modified organisms and import conditions, such document shall be applied.

Article 11. Import Procedures

The importation of genetically modified organisms; products and goods originating from genetically modified organisms must comply with current laws on importation, and in addition, the following procedures must be carried out:

1. The importer organization or individual must submit an import request letter along with necessary information according to the form prescribed in Appendix I of this Regulation to the relevant sectoral ministry for consideration.

2. The relevant sectoral ministry will examine the file and issue a decision in writing regarding the safety issues in importing genetically modified organisms; products and goods originating from genetically modified organisms, and notify the Ministry of Natural Resources and Environment to monitor together.

Article 12. Export

The export of genetically modified organisms; products and goods originating from genetically modified organisms to foreign countries must comply with Vietnamese laws on exportation, the laws of the importing country, and international treaties to which the Socialist Republic of Vietnam is a party.

Article 13. Storage and Transportation

1. Genetically modified organisms; products and goods originating from genetically modified organisms when stored and transported must be carefully packaged and measures to ensure safety must be implemented to prevent loss during transportation; labels must be affixed in accordance with current Vietnamese laws and international practices.

2. In cases of domestic transportation, before transporting genetically modified organisms; products and goods originating from genetically modified organisms, the consignor must notify in writing the relevant sectoral ministry, specifying the information on the packaging label, place of production, storage warehouse, preservation method, means of transport, departure point, destination, safety measures during transportation, and specific transportation period.

3. In cases of transiting genetically modified organisms; products and goods originating from genetically modified organisms through Vietnam's territory and requiring unloading at a port, the consignor must submit a letter with necessary information according to the form prescribed in Appendix I of this Regulation to the relevant sectoral ministry for consideration. The General Department of Customs will only proceed with related procedures after receiving the biosafety opinion from the relevant sectoral ministry regarding these products and goods.

4. In cases of transiting genetically modified organisms; products and goods originating from genetically modified organisms through Vietnam's territory without unloading at a port, the consignor must notify in writing the relevant sectoral ministry about the safety measures during transit for consideration and decision. The General Department of Customs will only proceed with related procedures after receiving the approval from the relevant sectoral ministry regarding this matter.

CHAPTER V

RISK ASSESSMENT, RISK MANAGEMENT AND ISSUANCE OF BIOSAFETY CERTIFICATE
BIOSAFETY CERTIFICATE ISSUANCE

Article 14. Risk Assessment

1. Organizations and individuals must conduct a risk assessment before introducing genetically modified organisms; products, goods derived from genetically modified organisms into the environment or producing, trading, using them to determine the likelihood of risks posed by genetically modified organisms; products, goods derived from genetically modified organisms to human health, the environment, and biodiversity according to the regulations of the competent ministry or agency overseeing the relevant sector or field.

2. The risk assessment must be conducted strictly in accordance with recognized scientific and technical methods for risk assessment, based on information specified in Appendix II of this Regulation and other relevant scientific evidence.

3. The risk assessment must be carried out under the supervision of one or more specialized scientific agencies recognized by the competent ministry or agency overseeing the relevant sector or field for their supervisory capacity.

4. The results of the risk assessment shall be reflected in a risk assessment report prepared by the organization or individual conducting the risk assessment in accordance with the form prescribed in Appendix II of this Regulation.

Article 15. Risk management

Article 15. Compliance with Preventive Measures, Handling, and Mitigation of Risks

1. All research activities, technological development, testing; production, trading, use; import, export, storage, transportation of genetically modified organisms; products, goods derived from genetically modified organisms must strictly comply with preventive measures, handling, and mitigation of risks.

2. Organizations and individuals conducting research, technological development, testing of genetically modified organisms; products, goods derived from genetically modified organisms have the responsibility to assist related organizations and individuals in applying preventive measures, handling, and mitigation of risks during the testing and application processes of genetically modified organisms; products, goods derived from genetically modified organisms they create.

3. Organizations and individuals importing, exporting, using genetically modified organisms; products, goods derived from genetically modified organisms have the responsibility to apply appropriate management measures to prevent and promptly detect risks to handle and mitigate the consequences of risks; when risks occur during the implementation of their activities, organizations and individuals must promptly report to the Ministry of Natural Resources and Environment and the competent ministry or agency overseeing the relevant sector or field for resolution.

Article 16. Issuance of Biosafety Certificates

1. Genetically modified organisms; products, goods derived from genetically modified organisms that have been tested and assessed for risks, if meeting biosafety conditions as stipulated in Clause 2 of this Article, shall be considered by the competent ministry or agency overseeing the relevant sector or field for issuance of a biosafety certificate and inclusion in the list of genetically modified organisms; products, goods derived from genetically modified organisms permitted for production, trading, and use. The ministry or agency issuing the biosafety certificate for genetically modified organisms; products, goods derived from genetically modified organisms has the right to revoke such certificates.

2. Genetically modified organisms; products, goods derived from genetically modified organisms recognized as meeting biosafety requirements must satisfy the following conditions:

a) Not posing a risk of toxicity or allergenicity to human health;

b) Not causing adverse effects on the environment and biodiversity.

Chapter VI
STATE MANAGEMENT TASKS REGARDING BIOLOGICAL SAFETY

Article 17. Contents of state management regarding biological safety for genetically modified organisms; products and goods derived from genetically modified organisms

1. Developing and promulgating strategies, mechanisms, policies, plans, and regulatory legal documents on biological safety for genetically modified organisms; products and goods derived from genetically modified organisms;

2. Building and developing information systems and databases on biological safety for genetically modified organisms; products and goods derived from genetically modified organisms;

3. Reviewing applications for testing, release, production, business operation, use, export, import, storage, and transportation of genetically modified organisms; products and goods derived from genetically modified organisms; issuing and revoking certificates and permits related to biological safety for these objects;

4. Training, publicizing, and educating organizations and individuals to enhance their awareness about biological safety for genetically modified organisms; products and goods derived from genetically modified organisms;

5. International cooperation and participation in implementing international treaties related to genetically modified organisms; products and goods derived from genetically modified organisms;

6. Inspecting and supervising compliance with and implementation of legal regulations on biological safety for genetically modified organisms; products and goods derived from genetically modified organisms.

Article 18. Tasks of the Ministry of Natural Resources and Environment

1. Serving as the lead agency of the Government for managing biological safety for genetically modified organisms; products and goods derived from genetically modified organisms, with the responsibility of assisting the Government in uniformly managing state affairs regarding biological safety for genetically modified organisms; products and goods derived from genetically modified organisms throughout the country;

2. Developing and submitting for promulgation or promulgating within its authority strategies, mechanisms, policies, plans, and regulatory legal documents on biological safety for genetically modified organisms; products and goods derived from genetically modified organisms;

3. Organizing and directing coordination among relevant agencies in carrying out state management tasks regarding biological safety for genetically modified organisms; products and goods derived from genetically modified organisms;

4. Cooperating with relevant ministries and sectors to train, publicize, and educate organizations and individuals to enhance their awareness about biological safety for genetically modified organisms; products and goods derived from genetically modified organisms;

5. Receiving and processing information and data on genetically modified organisms; products and goods derived from genetically modified organisms provided by sectoral and field management ministries and related organizations and individuals; building and developing information systems and databases on biological safety for genetically modified organisms; products and goods derived from genetically modified organisms; serving as the focal point for participating in international information exchange mechanisms on this issue;

6. Inspecting, auditing, and handling violations related to genetically modified organisms; products and goods derived from genetically modified organisms.

Article 19. Tasks of the Ministry of Science and Technology

1. Implement state management tasks regarding research on science, development of technology for genetically modified organisms; products, goods originating from genetically modified organisms;

2. Draft and submit for promulgation or promulgate within its competence mechanisms, policies, regulatory legal documents related to research on science, development of technology for genetically modified organisms; products, goods originating from genetically modified organisms;

3. Guide organizations and individuals on specific procedures and conditions for registering research on science, development of technology related to genetically modified organisms; products, goods originating from genetically modified organisms. Appraise, select, approve and direct the implementation of programs, topics, projects of research on science, development of technology related to genetically modified organisms; products, goods originating from genetically modified organisms;

4. Build and develop potential capacity serving research on science, development of technology related to genetically modified organisms, products, goods originating from genetically modified organisms;

5. Provide regularly information and data related to genetically modified organisms; products, goods originating from genetically modified organisms to the Ministry of Natural Resources and Environment and the lead agency of the Government on this issue.

Article 20. Tasks of Ministries managing sectors and fields

1. General tasks of Ministries managing sectors and fields

a) Ensure necessary conditions for the operation of specialized agencies; build and develop the capacity of agencies responsible for biological safety appraisal and evaluation for genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

b) Organize and direct state management activities on biological safety for genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

c) Draft and promulgate within its competence regulatory legal documents, industry standards on state management of biological safety for genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

d) Specify procedures, processes and conditions for conducting risk assessment for activities related to genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

đ) Designate specialized scientific agencies to supervise the process of risk assessment for activities related to genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

e) Appraise registration for field trials, release, production, business, use, export, import, storage, transportation of genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

g) Appraise, issue, revoke certificates of biological safety for genetically modified organisms; products, goods originating from genetically modified organisms and compile lists of genetically modified organisms; products, goods originating from genetically modified organisms permitted for production and business within the scope of the Ministry's management;

h) Inspect compliance with and implementation of legal provisions on biological safety for genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

i) Direct handling and remediation of risks and incidents affecting the environment and human health caused by activities related to genetically modified organisms; products, goods originating from genetically modified organisms within the scope of the Ministry's management;

k) Provide information and data related to genetically modified organisms; products, goods originating from genetically modified organisms to the Ministry of Natural Resources and Environment and the lead agency of the Government on this issue.

2. Specific tasks of some Ministries

a) the Ministry of Agriculture and Rural Development have the task of state management over biological safety for genetically modified organisms; products, goods originating from genetically modified organisms in the agriculture and forestry sector;

b) Ministry of Fisheries have the task of state management over biological safety for genetically modified organisms; products, goods originating from genetically modified organisms in the fisheries sector;

c) Ministry of Health have the task of state management over biological safety for genetically modified organisms; products, goods originating from genetically modified organisms in the health sector; biological safety and food hygiene and safety for genetically modified organisms; products, goods originating from genetically modified organisms used as pharmaceuticals, foods, and cosmetics.

d) Ministry of Industry have the task of state management over biological safety for genetically modified organisms; products, goods originating from genetically modified organisms in the industrial sector.

Article 21. Tasks of the People's Committee of the province and centrally governed city

1. Implement state management activities concerning biosafety for genetically modified organisms; products and goods derived from genetically modified organisms at the local level;

2. Popularize, disseminate, and educate organizations and individuals to enhance their awareness about biosafety for genetically modified organisms; products and goods derived from genetically modified organisms at the local level;

3. Coordinate with relevant ministries, sectors, organizations, and individuals in the implementation of regulations concerning activities related to genetically modified organisms; products and goods derived from genetically modified organisms at the local level;

4. Plan areas for testing and producing genetically modified organisms; products and goods derived from genetically modified organisms at the local level;

5. Inspect, supervise, and handle violations within their authority concerning activities related to genetically modified organisms; products and goods derived from genetically modified organisms at the local level.

Chapter VII
HANDLING VIOLATIONS

Article 22. Handling of Violations

1. Organizations and individuals who violate the provisions on biosafety management for genetically modified organisms; products and goods derived from genetically modified organisms under this Regulation shall be subject to disciplinary action, administrative penalties depending on the nature and degree of violation; if damage occurs, they must compensate according to the law.

In cases where violations cause serious consequences, individuals will be held criminally responsible according to the law.

2. Any person who abuses their position or power and violates the laws on biosafety management for genetically modified organisms; products and goods derived from genetically modified organisms shall be subject to disciplinary action or criminal prosecution depending on the nature and degree of violation; if damage occurs, they must compensate according to the law.

Article 23. Handling Violations in Import Activities

1. In import contracts for genetically modified organisms; products and goods derived from genetically modified organisms into the territory of Vietnam, the importer must require the exporter to commit to compensating for any damage caused by the use of imported products and goods; commit to providing technical and financial support to address and mitigate adverse effects on human health, the environment, and biodiversity where risks occur.

2. If the importer fails to agree with the exporter on safety measures as prescribed and compensation commitments in case of incidents and still intentionally imports genetically modified organisms; products and goods derived from genetically modified organisms, resulting in risks due to the use of these imported products and goods causing damage to human health, the environment, biodiversity, economy, and society, the importer shall bear responsibility for compensating for damages and all costs for handling and mitigating adverse effects. In cases of serious consequences, the individual importer will be held criminally responsible according to the law.

Chapter VIII
IMPLEMENTING PROVISIONS

Article 24. Implementation Provisions

During the implementation of this Regulation, if there are contents that need supplementation or amendment, ministries, sectors, and localities shall reflect them to the Ministry of Natural Resources and Environment for consolidation and submission to the Prime Minister for consideration and decision./.