Circular No. 20/2012/TT-BKHCN guiding conditions, procedures, and formalities for recognizing Research Laboratories on Genetically Modified Organisms

CIRCULAR

Detailed guidance on conditions, procedures, and formalities for recognizing Genetic Engineering Research Laboratories

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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 amending Decree No. 69/2010/NĐ-CP dated November 30, 2011 of the Government on biosafety regarding 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 issues this Circular providing detailed guidance on conditions, procedures, and formalities for recognizing Genetic Engineering Research Laboratories,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular provides detailed guidance on conditions and formalities for recognizing laboratories that meet the requirements to conduct scientific research and technological development on genetically modified organisms, genetic material, and products derived from genetically modified organisms (hereinafter referred to as Genetic Engineering Research Laboratories).

Article 2. Applicability

This Circular applies to domestic and foreign organizations and individuals involved in management and implementation of activities related to research on genetically modified organisms, genetic material, and products derived from genetically modified organisms within 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. Decision on Recognizing Genetic Engineering Research Laboratories (hereinafter referred to as Recognition Decision) is a document issued by the Minister of Science and Technology to recognize laboratories meeting the conditions to carry out research activities on genetically modified organisms as stipulated in Article 5 of this Circular.

2. Certificate is an attachment to the Recognition Decision, clearly stating the name of the laboratory, the name of the scientific and technological organization owning the laboratory, the name of the managing authority, the contents of research activities, the issuance date, and the validity period of the Certificate.

3. Managing Authority of the Laboratory is the agency or unit directly managing the scientific and technological organization owning the laboratory.

4. Genetic Engineering Research Laboratory is a laboratory belonging to a scientific and technological organization that meets the conditions, equipment, and has a team of scientific and technical staff capable of conducting scientific research and technological development on genetically modified organisms, genetic material, and products derived from genetically modified organisms.

5. Recognized Genetic Engineering Research Laboratory is a Genetic Engineering Research Laboratory recognized by the Ministry of Science and Technology through a Recognition Decision as meeting the conditions to carry out research activities on genetically modified organisms as stipulated in Article 5 of this Circular.

6. Training Certificate on Biosafety is a document issued by the head of the unit authorized by the Minister of Science and Technology to provide training on biosafety.

Chapter II

ACTIVITIES OF THE LABORATORY

RESEARCH ON GENETICALLY MODIFIED ORGANISMS

Article 4. Principles of Operation of the Genetically Modified Organism Research Laboratory

1. Research activities on genetically modified organisms may only be conducted at the corresponding genetically modified organism research laboratory according to four levels of biosafety.

2. The genetically modified organism research laboratory may only conduct research activities on genetically modified organisms in accordance with the contents recorded in the Certificate issued together with the Decision recognizing the laboratory by the Ministry of Science and Technology.

3. In cases where there is a need to implement research activity contents on genetically modified organisms outside the approved scope, the laboratory or the managing agency of the laboratory must register to adjust the scope of research activities recorded in the Certificate.

4. The research activities of the genetically modified organism research laboratory shall be subject to supervision by agencies approving research tasks on genetically modified organisms and other competent authorities.

5. The laboratory and organizations with recognized laboratories shall be responsible under the law for biosafety when researching genetically modified organisms.

Article 5. Contents of Activities of the Genetically Modified Organism Research Laboratory

1. Research to create genetically modified organisms, genetic material samples, and products of genetically modified organisms with potential for economic and social development:

a) Research to create genetic material samples;

b) Research to create genetically modified organisms using genetic techniques;

c) Research on the biological characteristics of genetically modified organisms;

d) Research on breeding, planting, cultivation, harvesting, storage, processing techniques;

đ) Research on biomass production and manufacturing products from genetically modified organisms;

e) Research to assess the potential for exploitation and use of genetically modified organisms and their products.

2. Risk assessment research:

a) Risks caused by hazards;

b) Management measures for risks and biosafety for genetically modified organisms and their products.

3. Research and analytical services:

a) Detection of genetically modified organisms and their products;

b) Evaluation and certification of quality standards regarding safety of genetically modified organisms and products derived from them for human health, livestock, environment, and biodiversity.

4. Exchange of genetically modified organisms and their products with domestic and foreign organizations in accordance with the provisions of the law.

Chapter III

CONDITIONS FOR RECOGNITION OF THE GENETICALLY MODIFIED ORGANISM RESEARCH LABORATORY

Article 6. Human Resources

1. The genetically modified organism research laboratory must have a minimum of seven permanent staff members with employment decisions or long-term contracts from scientific and technological organizations having the laboratory, including four staff members with university degrees or higher and three technicians with experience in biotechnology or relevant fields in accordance with the registered scope of activities.

a) Biosafety Level 1 Laboratory: At least two staff members with post-university qualifications. The laboratory leader must have a master's degree or higher and at least three years of professional experience in the field of biotechnology;

b) Biosafety Level 2 Laboratory: At least two staff members with post-university qualifications. The laboratory leader must have a doctoral degree and at least three years of professional experience in the field of biotechnology;

c) Biosafety Level 3 Laboratory: At least three staff members with post-university qualifications. The laboratory leader must have a doctoral degree and at least five years of professional experience in the field of biotechnology;

d) Biosafety Level 4 Laboratory: At least three staff members with post-university qualifications. The laboratory leader must have a doctoral degree, at least five years of professional experience in the field of biotechnology, at least three years of management experience in a unit, and at least one publication in specialized journals related to the registered research on genetically modified organisms.

2. Scientific and technical personnel must hold biosafety training certificates (in form P8-CC stipulated in Appendix II attached hereto) issued by the agency authorized by the Ministry of Science and Technology (except in cases where scientific and technical personnel have been issued biosafety training certificates by laboratories meeting international standards).

Article 7. Infrastructure

1. General conditions

a) A genetic engineering research laboratory shall be divided into a main experimental area and an auxiliary area (if necessary) based on the content of its activities;

b) Ensure isolation from the external environment and between different research subjects;

c) Ensure an electrical system (with backup power supply), water supply, and fire prevention systems; provide washing facilities, handwashing sinks, and eye-washing stations;

d) The sample processing system, cleaning of experimental equipment, waste disposal, wastewater treatment, and destruction of waste materials must comply with regulations before being discharged into the environment;

e) Personal protective equipment must be fully equipped and appropriate for the level of biosafety requirements;

f) The main experimental area and auxiliary area must establish protective boundaries and display signs according to the models P2-KTNC and P3-KPT specified in Appendix I attached to this Circular;

g) Ventilation, temperature, and humidity control systems must meet conditions for research activities.

2. Main Experimental Area

a) For Biosafety Level 1 laboratories:

The minimum area is 20 square meters; the floor, walls, ceiling, and doors must be smooth, easy to clean, waterproof, fire-resistant, and shatterproof. Laboratory benches should be made of heat-resistant, chemical-resistant, and impact-resistant materials. All research equipment must be present, and the main experimental area must be divided into three zones: preparation zone, processing zone, and operation zone; equipment must be arranged within these zones to facilitate operations and safety management;

b) For Biosafety Level 2 laboratories:

The minimum area is 30 square meters and must meet other conditions stipulated in Clause 2, Point a of Article 7 of this Circular; the operation zone must be separated with a door that can be locked;

c) For Biosafety Level 3 laboratories:

The minimum area is 40 square meters and must meet other conditions stipulated in Clause 2, Point a of Article 7 of this Circular; there must be a liquid waste treatment system that meets national technical standards for the environment before discharging into the common sewage system;

The operation zone must be divided into two separate rooms: buffer room and operation room. These rooms must have automatic door systems that only allow access to either the buffer room or the operation room to ensure continuous isolation of the operation room from the outside; they must have unidirectional air filtration systems ensuring lower pressure in the buffer room compared to the outside, and lower pressure in the operation room compared to the buffer room; telephones and alarm bells must be installed;

d) For Biosafety Level 4 laboratories:

The minimum area is 50 square meters and must meet other conditions stipulated in Clause 2, Point c of Article 7 of this Circular;

There must be a shower and changing room between the buffer room and the operation room; an independent gas supply system must be provided when necessary.

3. Auxiliary Area

It must be equipped to meet the activities recorded in the Certificate of Registration, including: net houses, greenhouses, ponds, pens, drying areas, slaughterhouses, storage areas for raw materials, feed, product storage, and waste treatment areas;

b) It must be arranged appropriately for each research subject and ensure isolation of genetically modified organisms from the surrounding environment and protection against environmental impacts on genetically modified organisms.

Article 8. Equipment and Tools

1. The main laboratory area must be fully equipped with research equipment meeting the requirements of the content of activities according to the level of biosafety. The equipment must be calibrated and maintained regularly, ensuring good operation, and having user instructions and safe usage limit information provided in Vietnamese.

a) For Biosafety Level 1 laboratories:

The preparation zone has chemical storage cabinets, tools, ultra-low temperature freezers at -86°C, regular refrigerators, incubators, dryers, culture devices, analytical balances, microscopes, centrifuges, and other related equipment; the work zone has gene amplification machines, gene visualization equipment, DNA hybridization machines, electrophoresis units, shakers, pipettors, and other related equipment; the disposal zone has autoclaves for wet sterilization, specialized waste containers, and other related equipment; personal protective equipment includes masks, gloves, lab coats, and safety glasses (if necessary).

b) For Biosafety Level 2 laboratories:

In addition to the provisions in Point a Clause 1 Article 8 of this Circular, the work zone must also be equipped with genetic transfer equipment and Biosafety Level 2 cabinets.

c) For Biosafety Level 3 laboratories:

In addition to the provisions in Point b Clause 1 Article 8 of this Circular, rooms with negative pressure must be equipped with Biosafety Level 3 cabinets instead of Biosafety Level 2 cabinets.

d) For Biosafety Level 4 laboratories:

In addition to the provisions in Point c Clause 1 Article 8 of this Circular, the work zone must also be equipped with double-door autoclaves.

2. Auxiliary Area

There must be appropriate care equipment suitable for each type of genetically modified organism; tools and equipment for collecting, burning, and destroying genetically modified organisms and their waste products; fire prevention and explosion protection equipment; and personal protective equipment for workers.

Article 9. Operation Regulations for Genetically Modified Organism Research Laboratories

1. For Biosafety Level 1 Genetically Modified Organism Research Laboratories

a) Only conduct research on subjects specified in Point a Clause 3 Article 4 and Clause 1 Article 5 of the Circular on Biosafety in Research and Development Activities Related to Genetically Modified Organisms issued by the Ministry of Science and Technology.

b) Display signs consistent with the research content of the laboratory according to Model P1-PTN stipulated in Appendix I attached to this Circular.

c) Prepare all necessary tools and check the operational capability of equipment related to experimental activities.

d) Prepare sufficient samples and necessary chemicals for experiments.

đ) Prepare and equip full personal protective equipment to ensure biosafety.

e) Experimental operations: avoid spilling samples, minimize steam generation from equipment; ultrasonic and vortex mixing operations that may produce aerosols must be conducted within culture cabinets. After completing operations, wait five minutes for aerosols to settle before opening the equipment.

g) Post-experimental processing: clean up, autoclave experimental tools, dispose of excess samples according to regulations; for equipment that cannot be autoclaved, sterilize with 70-degree alcohol.

h) Record experimental logs: fully document the course of experiments, results, biosafety information, and risk assessments.

2. For Biosafety Level 2 Genetically Modified Organism Research Laboratories

a) Only conduct research on subjects specified in Point b Clause 3 Article 4 and Clause 2 Article 5 of the Circular on Biosafety in Research and Development Activities Related to Genetically Modified Organisms issued by the Ministry of Science and Technology.

b) Operations of Biosafety Level 2 Genetically Modified Organism Research Laboratories must comply with the provisions in Points b, c, d, đ, e, g, h of Clause 1 of this Article.

All operations, especially those involving gas and alcohol lamps, must avoid affecting the airflow of Biosafety Cabinets.

3. For Biosafety Level 3 Genetically Modified Organism Research Laboratories

a) Only conduct research on subjects specified in Point c Clause 3 Article 4 and Clause 3 Article 5 of the Circular on Biosafety in Research and Development Activities Related to Genetically Modified Organisms issued by the Ministry of Science and Technology.

b) Operations of Biosafety Level 3 Genetically Modified Organism Research Laboratories must comply with the provisions in Points b, c, d, h of Clause 1 of this Article.

c) Prepare personal protective equipment: protective clothing must be sterilized in sealed bags or boxes and autoclaved at high temperatures with steam; protective clothing must not be worn outside the laboratory.

d) Regularly check the air pressure of the buffer room and workroom to ensure the buffer room has lower pressure than the outside and the workroom has lower pressure than the buffer room.

đ) Experimental operations: equipment generating aerosols must be kept and used inside Biosafety Cabinets; if spills occur, sterilize the Biosafety Cabinet with chloramine or 70-degree alcohol or other approved disinfectants; do not conduct two experiments simultaneously; non-operating personnel must not enter the laboratory until it has been sterilized.

e) Post-experimental processing: waste and used equipment must be individually packaged in secure containers and not removed from the laboratory until processed. Autoclave before washing or disposing of in the environment.

4. For Biosafety Level 4 Genetically Modified Organism Research Laboratories

a) Only conduct research on subjects specified in Point d Clause 3 Article 4 and Clause 4 Article 5 of the Circular on Biosafety in Research and Development Activities Related to Genetically Modified Organisms issued by the Ministry of Science and Technology.

b) Operations of Biosafety Level 4 Genetically Modified Organism Research Laboratories must comply with the provisions in Points b, c, d, h Clause 1 and Points d, đ Clause 3 of this Article.

c) Prepare personal protective equipment: change clothes before entering the laboratory; only use protective clothing and shoes in the laboratory, change before bathing when leaving. Protective clothing must be sterilized in sealed bags or boxes and autoclaved at high temperatures with steam.

d) Record experimental logbook: must fully document the course of events, experimental results, biosafety information, risk assessment, and the entry and exit times of the laboratory personnel conducting the experiments;

đ) Research samples of genetically modified organisms that are surplus or unused must be classified, thoroughly collected, individually packaged in sealed containers ensuring safety, and subjected to autoclaving before being washed or disposed of;

e) Post-experimental handling: waste materials and used equipment must be individually packaged in sealed containers ensuring safety and can only be opened after complete isolation from the laboratory. They must be subjected to autoclaving before washing or disposal;

Chapter IV

PROCEDURE AND PROCEDURES FOR RECOGNITION OF GENETICALLY MODIFIED ORGANISM RESEARCH LABORATORIES

Article 10. Registration for Recognition of Genetically Modified Organism Research Laboratories

1. Organizations with laboratories conducting research on genetically modified organisms must submit an application to the Ministry of Science and Technology for recognition consideration.

2. The application for recognition of genetically modified organism research laboratories may be submitted directly or through postal service to the Ministry of Science and Technology.

3. Within five working days from the date of receipt of the application, the unit receiving the application at the Ministry of Science and Technology shall respond to the organization applying regarding the completeness of the application or any additional requirements according to regulations.

Article 11. Application Documents for Recognition of Genetically Modified Organism Research Laboratories

1. The registration documents include:

a) Application form (in accordance with Form P4-ĐK stipulated in Appendix II issued together with this Circular);

b) Copy of the Decision on establishment and functions and tasks of the organization;

c) Copy of the Decision on establishment of the laboratory and other related documents of the organization concerning the laboratory;

d) Description of the laboratory's capacity for genetically modified organism research (in accordance with Form P5-NL stipulated in Appendix II issued together with this Circular);

đ) Summary of the organization's activities, scientific curriculum vitae of permanent staff members, biosafety training certificates (in accordance with Forms P6-NLTC, P7-NLCN, and P8-CC stipulated in Appendix II issued together with this Circular), copies of recruitment decisions or long-term contracts of permanent staff members, appointment decision for the laboratory director;

e) Copies of the origin of equipment, calibration certificates of equipment (if available);

g) Laboratory operation rules.

2. The number of applications required to be submitted includes: one original copy, two copies, and one electronic copy.

Article 12. Examination of Applications for Recognition of Genetically Modified Organism Research Laboratories

1. Within forty-five days from the date of receipt of a valid application, the Ministry of Science and Technology shall establish an Examination Board and organize the examination process. The examination files and review forms (in accordance with Form P9-PNX stipulated in Appendix III issued together with this Circular) must be sent to the board members at least five days prior to the on-site examination and ten days prior to the evaluation meeting of the Board.

2. Composition and principles of operation of the Board:

a) The Board consists of seven to nine members: the Chairman is the leader of the Department of Science and Technology for economic and technical sectors, one Vice-Chairman, two opposing members who are experts in biotechnology, one secretary member who is a specialist from the Department of Science and Technology for economic and technical sectors, one representative from the management agency of the laboratory or the direct state management agency of the applying organization, and other members are specialists in biotechnology. The on-site examination team consists of: the team leader and two members;

b) Principles of operation of the Board: The examination session must have at least two-thirds of the members present, including the Chairman or Vice-Chairman, two opposing members, and the secretary member. The Board evaluates the conditions for recognizing genetically modified organism research laboratories based on the requirements stipulated in Chapters II and III of this Circular, using the application documents and on-site examination records. Board members are responsible for accurate and objective evaluations, and they collectively bear responsibility for the conclusions and recommendations of the Board.

3. The applying organization is responsible for providing full information and creating favorable conditions for the on-site examination team to perform their duties.

Article 13. Procedure for reviewing the application dossier to recognize a Research Laboratory on Genetically Modified Organisms (GMOs)

The Review Board conducts the review in two steps:

1. On-site review

The on-site review team arranges to work at the registering organization, carries out an actual inspection of the laboratory's infrastructure and equipment conditions, and prepares a review report (in accordance with Form P10-BBTĐ stipulated in Appendix III issued together with this Circular) to be sent to the members of the Review Board before the formal evaluation meeting. The on-site review team's report is supplementary documentation to the review dossier.

2. Review of the registration dossier

a) The Chairman or Vice-Chairman of the Review Board (in the absence of the Chairman) chairs the Review Board meeting. The Review Board listens to the opinions and evaluations of two opposing members and other members; the Review Board discusses and evaluates the dossier based on the recognition conditions: human resources, infrastructure, equipment, and the ability to meet the registered activities. The Secretary member records the opinions and evaluations of the members and prepares the meeting minutes (in accordance with Form P11-BBHĐ stipulated in Appendix III issued together with this Circular);

b) The Review Board appoints a ballot committee and conducts a voting process to evaluate (in accordance with Form P12-PĐG stipulated in Appendix III issued together with this Circular). The evaluation results are compiled by the ballot committee (in accordance with Form P13-KP stipulated in Appendix III issued together with this Circular);

c) The Review Board concludes and recommends that the Ministry of Science and Technology recognize or not recognize the Research Laboratory as having the necessary conditions to conduct research on GMOs.

Article 14. Decision to Recognize a Research Laboratory on GMOs

1. Based on the Review Board's evaluation results, the Minister of Science and Technology considers issuing a Recognition Decision along with a Certificate of the Research Laboratory on GMOs (in accordance with Form P14-GCN stipulated in Appendix III issued together with this Circular) to the registering organization.

2. The Certificate clearly states the permitted activities of the Research Laboratory on GMOs.

3. The Certificate of the Research Laboratory on GMOs is valid for a period of five years from the date of issuance.

4. In cases where the conditions for recognition are not met, the Ministry of Science and Technology sends a letter specifying the reasons to the registering organization.

Article 15. Reissuing the Certificate Upon Expiry

1. At least 60 days before the expiry of the Certificate, if the Research Laboratory on GMOs wishes to continue its activities in this field, it must prepare one set of documents to request reissuance of the Certificate and send it via postal service or submit it directly to the Ministry of Science and Technology.

2. The documents for requesting reissuance of the Certificate upon expiry include:

a) A request form for reissuance of the Certificate of the Research Laboratory on GMOs (in accordance with Form P4-ĐK stipulated in Appendix II issued together with this Circular);

b) The Recognition Decision and the Certificate issued most recently;

c) Any documents specified in Point c, d Clause 1 Article 11 of this Circular, in case there have been changes compared to the previous application dossier for the Certificate.

3. The procedure for reissuing the Certificate upon expiry is carried out according to the procedures stipulated in Articles 12, 13, and 14 of this Circular.

4. If the Certificate does not follow the procedures for reissuance stipulated in Clause 1 of this Article, when requesting reissuance, the application dossier and procedures shall be conducted as for issuing a new Certificate as stipulated in Articles 11, 12, 13, and 14 of this Circular.

Article 16. Reissuing the Certificate when Adjusting Research Activities

1. In cases where it is necessary to adjust the registered research activity content, the Genetically Modified Organism Research Laboratory shall prepare a request for the Ministry of Science and Technology to consider and decide on reissuing the Certificate.

2. The application package for reissuing includes:

a) An application form for reissuing the Certificate (according to Model P4-ĐK stipulated in Appendix II issued together with this Circular);

b) Relevant documents related to the proposed adjusted activity content;

c) The recognition decision and previously issued Certificate.

3. The application package for reissuing specified in Clause 2 of this Article shall be sent via postal service or directly submitted to the Ministry of Science and Technology.

4. Within thirty working days from the date of receipt of the application package meeting the requirements stipulated in Clause 2 of this Article, the Ministry of Science and Technology shall be responsible for considering and reissuing the Certificate. If necessary, the Ministry of Science and Technology may organize a reassessment of the application package or on-site assessment. The organization of such assessments shall be carried out according to the provisions of Article 12 of this Circular. In case of non-approval, the Ministry of Science and Technology shall notify the applicant organization in writing.

Article 17. Reissuing the Certificate due to Loss or Damage

1. In cases where the Certificate is lost or damaged, the organization with the Genetically Modified Organism Research Laboratory shall submit an application for reissuance (according to Model P4-ĐK stipulated in Appendix II issued together with this Circular).

2. Within fifteen working days from the date of receipt of the reissuance application, based on the retained file, the Ministry of Science and Technology shall consider and reissue the Certificate. The validity period of the reissued Certificate shall be the same as that of the most recent issued Certificate.

Article 18. Reissuing the Certificate after Revocation

1. In cases where the Certificate is reissued after revocation, the procedures and requirements shall be the same as those for issuing a new Certificate as stipulated in Articles 11, 12, 13, and 14 of this Circular.

2. The organization with the Laboratory must attach an explanation document regarding the reasons for revocation of the Certificate and the capability to rectify any non-compliance issues if any.

Article 19. Budget for Recognizing Genetically Modified Organism Research Laboratories

1. The budget for the contents specified in Clause 2 of this Article shall be sourced from the science and technology public expenditure managed by the Office of the Ministry of Science and Technology.

2. The expenses for recognizing Genetically Modified Organism Research Laboratories include:

a) Assessment activities and printing of documents, Certificates;

b) Regular inspections and spot checks.

3. Training organization costs include: lecture preparation, teaching fees, printing of materials, chemicals, other consumables serving safe biological practice, and support for trainees will be annually budgeted for units authorized by the Ministry of Science and Technology.

4. Expenditure standards shall be applied according to current regulations.

5. The unit entrusted by the Minister of Science and Technology to manage the issuance of Certificates shall be responsible for preparing and using the budget for recognition activities in accordance with the regulations.

Chapter V

RIGHTS AND OBLIGATIONS OF GENETICALLY MODIFIED ORGANISM RESEARCH LABORATORIES

Article 20. Rights and Obligations

1. Permission to conduct research activities on genetically modified organisms as recorded in the issued Certificate.

2. Priority from the State to lead tasks related to research on genetically modified organisms that are suitable for their capacity and scope of operation.

3. Priority in strengthening necessary equipment to serve state-level scientific and technological research tasks on genetically modified organisms.

4. Priority in training and instruction in fields related to research on genetically modified organisms.

5. Subject to supervision and management by the Ministry of Science and Technology, the supervising agency, and other competent state agencies regarding biosafety in research on genetically modified organisms.

6. All activities of the laboratory conducting research on genetically modified organisms must comply with the provisions of the Environmental Protection Law, the Biodiversity Law, and biosafety regulations.

Chapter VI

SUPERVISION IMPLEMENTATION

Article 21. Inspection and Evaluation

The Ministry of Science and Technology shall take the lead and coordinate with the supervising agency of the laboratory conducting research on genetically modified organisms to organize regular annual inspections or ad hoc inspections when necessary at the site, ensuring all activities of the laboratory conducting research on genetically modified organisms are carried out in accordance with regulations. The criteria and content of regular or ad hoc inspections are applied according to models P10-BBTĐ and P12-PĐG stipulated in Appendix III attached to this Circular.

Article 22. Handling of Violations

1. Temporary Suspension

a) The laboratory conducting research on genetically modified organisms may be temporarily suspended from operations if it violates the principles set forth in Clauses 1, 2, and 3 of Article 4 or there is evidence of biosafety risks due to violations of conditions specified in Chapter III of this Circular;

b) Within a maximum period of 45 days from the date of suspension, the laboratory conducting research on genetically modified organisms has the responsibility to rectify the violation and report in writing to the Ministry of Science and Technology and the supervising agency;

c) Within a maximum period of 15 days from receiving the written report, the Ministry of Science and Technology will review and decide on the resumption of the laboratory's operations.

2. Revocation of Certificate

The laboratory conducting research on genetically modified organisms will have its Certificate revoked if it violates any of the cases stipulated in Clause 1, Article 11 of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government.

3. The temporary suspension, revocation, and reissuance of the Certificate shall be decided by the Minister of Science and Technology.

Chapter VII

IMPLEMENTING PROVISIONS

Article 23. Effectiveness of Implementation

This Circular takes effect 45 days from the date of issuance.

Article 24. Transitional Provisions

Laboratories conducting research on genetically modified organisms before the date of issuance of this Circular shall be allowed to delay the implementation of the provisions of this Circular until January 1, 2014.

Article 25. Responsibilities for Implementation

1. Ministries, agencies equivalent to ministries, provincial People's Committees under the central government shall guide organizations and individuals within and outside the country to register and manage the operation of laboratories conducting research on genetically modified organisms within their jurisdiction based on this Circular.

2. The Ministry of Science and Technology shall notify the Ministry of Natural Resources and Environment and other ministries and agencies equivalent to ministries about the recognition or revocation of the Certificate of laboratories conducting research on genetically modified organisms.

3. The Minister of Science and Technology assigns the Department of Science and Technology of economic and technical sectors to be the main unit managing the issuance of Certificates and overseeing the activities of laboratories conducting research on genetically modified organisms.

4. During the implementation process, if there are difficulties or suggestions for adjustments to certain contents, please reflect them in writing to the Ministry of Science and Technology for consideration and adjustment./.