Circular No. 20/2012/TT-BKHCN dated November 20, 2012, providing detailed guildance on conditions and procedures for Accreditation of genetically modified organisms laboratories

• Official number: 20/2012/TT-BKHCN
• Legislation Type: Circular
• Organization: The Ministry of Science and Technology
• Signer: Chu Ngoc Anh
• Issued Date: 20/11/2012

MINISTRY OF SCIENCE AND TECHNOLOGY --------	THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom - Happiness ----------------
No. 20/2012/TT-BKHCN	Hanoi, November 20, 2012

CIRCULAR

 PROVIDING DETAILED GUILDANCE ON CONDITIONS AND PROCEDURES FOR ACCREDITATION OF GENETICALLY MODIFIED ORGANISMS LABORATORIES

Pursuant to The Government’s Decree No. 28/2008/ND-CP dated March 14, 2008 on defining the functions, tasks, powers and organizational structure of the Ministry of Science and Technology;

Pursuant to the Government’s Decree No. 81/2002/ND-CP dated October 17, 2002 on detailing the implementation of a number of articles of the Ministry of Science and Technology Law;

Pursuant to Decree No. 69/2010/ND-CP dated on June 21, 2010 and Decree No. 108/2011/ND-CP on amendments to the Government’s Decree No. 69/2010/ND-CP dated November 30, 2011  on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms;

Pursuant to the Prime Minister’s Decision No.79/2007/QD-TTg dated May 31, 2007 approving the national action plan on biodiversity up to 2010 and orientations towards 2020 for implementation of the Convention on biodiversity and the Cartagena Protocol on biosafety;

Considering the suggestion of Directors of Department of Science and Technology for Economic-Technical Branches;

Minister of Science and Technology promulgates the Circular provides detailed guidance on conditions and procedures for Accreditation of laboratories conducting research into genetically modified organisms.

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GENERAL PROVISIONS

Article 1. Scope

This Circular provides detailed guidance on conditions and procedures for accreditation of laboratories which are eligible for conducting research and developing technology related to genetically modified organisms, genetic specimens and products of genetically modified organisms (hereinafter referred to as GMO laboratories).

Article 2. Regulated entities

This Circular applies to domestic and foreign organizations and individuals that are involved in management and research into genetically modified organisms, genetic specimens and products of genetically modified organisms in the territory of The Socialist Republic of Vietnam.

Article 3. Definitions

For the purpose of this Circular, the terms below shall be construed as follows:

1. Decision on Accreditation means a document issued by Minister of Science and Technology to accredit a laboratory which is eligible for conducting GMO research as prescribed in Article 5 of this Circular .

2. Certificate means a document issued together with Decision on Accreditation which includes names of the GMO laboratory, the science and technology organization that owns this GMO laboratory and the supervisory authority and research contents, the time of issuance and effective period of that Certificate.

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4. A GMO laboratory means a laboratory that belongs to a science and technology organization and has adequate facilities and research staffs who are capable of conducting research and developing technology related to GMOs, genetic specimens and GMOs’ products.

5. A GMO laboratory which is accredited means a GMO laboratory which is granted Decision on Accreditation of eligibility to conduct GMO research as prescribed in Article 5 of this Circular by Ministry of Science and Technology.

6. Certificate of Training in Biosafety means a document issued by the head of the unit that is authorized to train in biosafety by Minister of Science and Technology.

Chapter 2.

ACTIVITES OF GMO LABORATORIES

Article 4. Rules for genetically modified organism laboratories

1. GMOs research is only allowed in GMO laboratories at the appropriate biosafety level (04 levels).

2. A GMO laboratory is only allowed to conduct  GMO research in accordance with its Certificate issued together with Decision on Accreditation of Ministry of Science and Technology.

3. If the GMO laboratory wishes to conduct GMO research beyond the approved scope, this GMO laboratory or its supervisory authority shall apply for adjustment to its Certificate.

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5. GMO laboratories and organizations owning accredited GMO laboratories shall be legally responsible for biosafety when conducting GMO research.

Article 5. Activities of GMO laboratories

1. Research into creation of GMOs, genetic specimens and GMOs’ products that are potential to serve the development of economy and society:

a) Research into creation of genetic specimens;

b) Research into creation of GMOs by using genetic technique;

c) Research into biological characteristics of GMOs;

d) Research into techniques of culture, cultivation, care, harvest, preservation and processing;

dd) Research into creation of the biomass and produce GMOs’ products;

e) Research into the potential use of GMOs and their products;

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a) Risks;

b) Measures for risk management and biosatety related to GMOs and their products.

3.  Research and service of analysis:

a) To discover GMOs and their products;

b) To analyze and inspect conformity with quality standards and safety of GMOs and their products with regard to health of human, domestic animals, environment and biodiversity.

4. To exchange GMOs and their products with domestic and foreign organizations in accordance with regulations of Law.

Chapter 3.

CONDITIONS FOR ACCREDITATION OF GMO LABORATORIES

Article 6. Personnel

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a) A biosafety level 1 laboratory shall have at least 02 employees having postgraduate degree. The Head of this GMO laboratory shall have MA decree or over and at least three-year experience of biological technology;

b) A biosafety level 2 laboratory shall have at least 02 employees having postgraduate decree. The Head of this GMO laboratory shall have PhD decree and at least three-year experience of biological technology;

c) A biosafety level 3 laboratory shall have least 03 employees having postgraduate degree. The Head of this GMO laboratory shall have PhD decree and at least five-year experience of biological technology;

d) A biosafety level 4 laboratory shall have at least 03 employees having postgraduate decree. The head of this GMO laboratory shall have PhD decree, at least five-year experience of biological technology, at least three-year experience of management of a unit and have at least one article published on an academic journal related to GMOs registered to be researched.

2. Research employees shall have Certificate of Training in Biosafety (using P8-CC form prescribed in  Appendix II issued together with this Circular) granted by the authority that is authorized by Ministry of Science and Technology (except for those whose Certificates of Training in Biosafety have been granted by qualified foreign laboratories).

Article 7. Infrastructure

1. General conditions

a) A GMO laboratory is divided into work area and auxiliary area (if necessary) according to their activities;

b) A GMO laboratory shall be isolated from external environment and different research subjects are isolated from each other;

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d) The systems for specimen treatment and cleaning of experiment equipment, waste, waste-water and destruction of waste materials shall comply with regulations;

dd) Personal  protective equipment shall be sufficient and appropriate for the level of biosafety;

e) The perimeters of the  work area and auxiliary area shall be established  and marked with signs using P2-KTNC and  P3-KPT forms prescribed in Appendix I issued together with this Circular;

g) Ventilation, air-conditioning and humidity regulation systems shall be adequate for research activities.

2. The work area

a) Conditions to be satisfied by a biosafety level 1 laboratory:

The minimum area is 20 square meters; the grounds, walls, ceilings and doors are smooth, easy to clean, waterproof, fireproof and hard to break. Work tables are made of heatproof, corrosion-resistant and impact-resistant materials Research equipment is adequate. The work area is divided into 3 sectors (preparation sector, treatment sector and work sector) to which the equipment is distributed in manner that facilitates the work and safety management.

b) Conditions to be satisfied by a biosafety level 2 laboratory:

The minimum area is 30 square meters. The biosafety level 2 laboratory shall comply with other conditions prescribed in Point a Clause 2 of Article 7 of this Circular. In addition, the work sector shall be separated from other sectors and have doors and locks.

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The minimum area is 40 square meters. The biosafety level 3 laboratory shall comply with other conditions prescribed in Point a Clause 2 of Article 7 of this Circular. The liquid waste is treated by a system that meets the national environment standards before being discharged into the common treatment sewage system.

Work sector is divided into 02 separating rooms: anteroom and workroom. These rooms must have automatic door system that only allows either anteroom’s door or workroom’s door to be opened at a time to make sure that workroom is always isolated from outside. These rooms must have one-way air filter system to make sure that anteroom’s pressure is lower than outside pressure and higher than  the workroom’s pressure. In addition, these rooms must have telephones and alarm bells.

d) Conditions to be satisfied by a biosafety level 4 laboratory:

The minimum area is 50 square meters. The biosafety level 4 laboratory shall  comply with other conditions prescribed in Point c Clause 2 Article 7 of this Circular.

The biosafety level 4 laboratory shall have bathrooms and locker-rooms between the anteroom and workroom and  independent air provider system in case of necessary.

3. The auxiliary area

a) The auxiliary area has net houses, greenhouses, ponds, cages, drying places, slaughterhouses, storage of raw materials, feed, storage of products and waste treatment area in order to serve the activities written in the Certificate;

b) The auxiliary area layout is suitable for each research subject and makes sure that GMOs are isolated from surrounding environment and effects of surrounding environment.

Article 8. Equipment

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a) Equipment of biosafety level 1 laboratory:

The preparation sector shall have chemical cabinets, tool boxes, -86°C Ultra-Low Freezers, refrigerators, incubator chambers, drying ovens, culture cabinet, analytical balance, microscope, centrifuge system and other relevant equipment. The work sector shall have DNA thermal cycler, hybridization machine, electrophoresis systems, shakers, pipetmans and other relevant equipment. The treatment sector shall have wet autoclaves, laboratory waste bins and other relevant equipment. Protective equipment shall include face masks, gloves, lab coats and eyeglasses (if necessary).

b) Equipment of the biosafety level 2 laboratory:

The work sector shall have equipment prescribed in Point a Clause 1 Article 8 of this Circular. Beside, this sector shall be equipped with genetically modified machines and biosafety cabinets at level 2.

c) Equipment of the biosafety level 3 laboratory:

The workroom shall have equipment prescribed in Point b Clause 1 Article 8 of this Circular. Besides, the workroom having minus pressure shall have biosafety cabinets at level 3 instead of biosafety cabinets at level 2.

d) Equipment of the biosafety level 4 laboratory:

The workroom shall have equipment prescribed in Point c Clause 1 Article 8 of this Circular. Besides, this room shall be equipped with two-door wet autoclaves.

2. The auxiliary area

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Article 9. Regulations of operation of GMO laboratories

1. The biosafety level 1 laboratory shall:

a) only research into subjects prescribed in Point a Clause 3 Article 4 and Clause 1 Article 5 of the Circular promulgated by Ministry of Science and Technology on biosafety in conducting research and developing technology related to GMOs;

b) put up signs using P1-PTN form prescribed in Appendix I issued together with this Circular;

c) prepare adequate equipment and check the state of equipment relating to experiment activities;

d) prepare adequate experiment specimens and chemicals;

dd) prepare and provide adequate protective equipment to ensure the biosafety;

e) carry out experiment techniques: avoid dropping specimens, minimize generation of steam by the equipment. Some activities such as ultrasound scan, vortex shaking, etc which may generate steam shall be carried out in culture cabinets. Wait 5 minutes for water spray to condense before opening the cover of such equipment.;

g) carry out post-experiment tasks: clean, steam experiment equipment and handle redundant specimens as prescribed. Equipment that is unable to be dry-steamed or sterilized by steam must be sterilized by 70 % alcohol;

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2. The biosafety level 2 laboratory shall:

a) only research into subjects prescribed in Point b Clause 3 Article 4 and Clause 2 Article 5 of the Circular promulgated by Ministry of Science and Technology on biosafety in conducting research and developing technology related to GMOs;

b) comply with regulations in Point .b, c, d, dd, e, g, h of Clause 1 of this Article.

All activities, especially those relating to gas, alcohol lamps shall avoid affecting air circulation of biosafety cabinets.

3. The biosafety level 3 laboratory shall:

a) only research into subjects prescribed in Point c Clause 3 Article 4 and Clause 3 Article 5 of the Circular promulgated by Ministry of Science and Technology on biosafety in conducting research and developing technology related to GMOs;

b) comply with regulations in Point .b, c, d, h of Clause 1 of this Article;

c) prepare protective equipment: protective clothes shall be sterilized in hermetic bags or boxes and dry-steamed by steam at high temperature. Protective clothes shall not be worn outside the laboratory;

d) check regularly the air pressure of anteroom and workroom to make sure that anteroom’s pressure is lower than outside pressure and higher than workroom's pressure;

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e) carry out post-experiment tasks: Waste, used equipment shall be individually sealed and put into containers to ensure safety. They shall not be taken out until being treated. Waste and used equipment shall be dry-steamed before being washed or discharged into the environment.

4. The biosafety level 4 laboratory shall:

a) only research into subjects prescribed in Point d Clause 3 Article 4 and Clause 4 Article 5 of the Circular promulgated by Ministry of Science and Technology on biosafety in conducting research and developing technology related to GMOs;

b) comply with regulations in Points b, c, d and h of Clause 1 and Points d and dd of Clause 3 of this Article.

d) keep a log of process and results of experiments, biosafety information and risk analysis, time of entering and leaving the laboratory of people who carry out experiments.

dd) classify, collect thoroughly and seal individually redundant or used specimens of GMOs; put them into containers to ensure safety and dry-steam them before they are washed or discharged into the environment.

e) carry out post-experiment tasks : Waste and used equipment shall be individually sealed and put into containers to ensure safety. They shall not be opened until being completely isolated from the laboratory. Waste and used equipment shall be dry-steamed before being washed or discharged into the environment.

Chapter 4.

PROCEDURES FOR ACCREDITATION OF GMO LABORATORIES

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1. The organization owning the GMO laboratory that needs accreditation shall submit an application to Ministry of Science and Technology.

2. The application for accreditation of GMO laboratories shall be submitted directly or sent by post to Ministry of Science and Technology.

3. Within 05 working days from the day on which the application is received, the application-receiving department of Ministry of Science and Technology is responsible for informing the applicant of sufficiency of the application or necessary additions.

Article 11. Application for accreditation of GMO laboratories

1. An application consists of:

a) P4-DK form prescribed in Appendix II issued together with this Circular;

b) A copy of the decision on establishment, role and objectives of the applicant;

c) A copy of decision on establishment of the GMO laboratory and other documents related to GMO laboratory;

d) Description of ability of the GMO laboratory (using P5-NL form prescribed in Appendix II issued together with this Circular);

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e) A copy of certificate of equipment’s origin and certificate of inspection and calibration of equipment (if any);

g) By-Laws on operating the laboratory.

2. Quantity of documents that shall be submitted: 01 original file, 02 copies and 01 electronic file.

Article 12. Inspection of Application accreditation of GMO laboratories

1. Within 45 working days from the day on which the valid application is received, Ministry of Science and Technology shall establish the Inspection Board and organize the Inspection. Form P9-PNX in Appendix III issued together with this Circular shall be sent to members of Inspection Board at least 05 days before site inspection and 10 days before the Meeting of Inspection Board.

2. Composition and principles of Inspection Board

a) The Inspection Board shall include from 07 to 09 members: Chairperson who is the Director of Department of Science and Technology for Economic-Technical Branches; 01 Vice chairman and 02 critics who are professors in biological technology; 01 secretary who is a specialist of Department of Science and Technology for Economic-Technical Branches and 01 representative of the supervisory authority of the GMO laboratory or the supervisory authority of the applicant. Other members are deeply professional in biological technology. Site inspection group shall include a group leader and 02 members;

b) Every meeting of the Inspection Board shall be attended by at least two-third of its members, where including Chairman or Vice Chairman, 02 critics and 01 secretary. The Inspection Board considers fulfillment of conditions for accreditation by GMO laboratory in accordance with requirements prescribed in Chapter II and Chapter III of this Circular, the application and the site inspection record. Members of the Inspection Board are responsible for inspecting correctly and objectively and also take responsibility for Inspection Board’s conclusion and suggestion.

3. The applicant is responsible for providing adequate information and facilitating the operation of the site inspection group.

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The Inspection Board shall follow 2 steps:

1. The site inspection

The site inspection group shall inspect the infrastructure and equipment of the GMO laboratory at its premises and prepare a record (using P10-BBTD form prescribed in Appendix III issued together with this Circular) and send it to members of the Inspection Board before a meeting is held to give an official conclusion. The site inspection record shall be added to the inspection documents.

2. The application inspection:

a) The Chairman or Vice Chairman of the Inspection Board (in the cases where the Chairman is absent) shall chair the Inspection Board’s Meeting. The Board shall listen to comments of 02 critics and other members. The Inspection Board shall discuss and examine the documents in terms of the GMO laboratory’s fulfillment of conditions for accreditation, personnel, infrastructure and capacity of the registered operation. The secretary shall record comments of members and take the minutes of the Inspection Board’s meeting (using P11-BBHD form prescribed in Appendix III issued together with this Circular);

b) The Inspection Board shall establish the vote-counting board and cast vote (votes shall use P12-PDG form prescribed in Appendix III issued together with this Circular); The  vote-counting board shall collect the result of inspection (using P13-KP form prescribed in Appendix III issued together with this Circular);

c) The Inspection Board shall conclude and request  the Ministry of Science and Technology whether to grant accreditation to the GMO laboratory.

Article 14. Decision on Accreditation

1.  According to the results of the Inspection Board, the Minister of Science and Technology shall consider issuing the Decision on Accreditation together with the Certificate of GMO laboratory (using P14-GCN form prescribed in Appendix III issued together with this Circular) to the applicant;

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3. The Certificate of GMO laboratory is valid for 05 years from the day on which it is signed.

4. In the cases where the laboratory isn’t eligible for accreditation, the Ministry of Science and Technology shall send written explanation to the applicant.

Article 15. Reissue of expired Certificate

1. At least 60 days before the Certificate expires, the GMO laboratory that wishes to continue its operation shall make an application for reissue of the certificate and sent it by post or submit it directly to the Ministry of Science and Technology.

2. An application for reissue of the expired certificate consists of:

a) Form P4-DK in Appendix II issued together with this Circular;

b) The latest Decision on Accreditation and Certificate;

c) Documents prescribed in Point c, d Clause 1 Article 11 of this Circular if there is any different from the application for issuance of  the latest certificate.

3. Procedures for reissue of expired certificate are the same as those prescribed in Articles 12,13 and 14 of this Circular.

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2. An application for reissue consists of:

a) Form P4-DK in Appendix II issued together with this Circular;

b) Documents related to the adjustments;

c) The issued Decision on Accreditation and Certificate.

3. The application for reissue of certificate prescribed in Clause 2 of this Article shall be submitted directly or sent by post to Ministry of Science and Technology.

4. Within 30 working days from the day on which the application complying with Clause 2 of this Article is received, Ministry of Science and Technology shall consider reissuing the Certificate. Ministry of Science and Technology may organize the application inspection or site inspection again if necessary. The inspection shall comply with regulations of Article 12 of this Circular.  In the cases where the application for reissue of certificate is rejected, the Ministry of Science and Technology shall send a written notice to the applicant.

Article 17. Reissue of Certificate which was lost or destroyed

1. If the Certificate is lost or destroyed, the organization owning the GMO laboratory shall send an application form for reissue of certificate (using P4-DK form prescribed in Appendix II issued together with this Circular).

2. Within 15 working days from the day on which the application form is received, the Ministry of Science and Technology shall consider reissuing the Certificate according to saved documents. b)The effective period of  reissued Certificate is the same as those of the latest Certificate.

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1. In case of reissue of the Certificate that was revoked, the application and procedures shall be the same as those for a new Certificate prescribed in Articles 11, 12, 13 and  14 of this Circular.

2. Organization owning the laboratory shall send a document to explain reasons why the certificate was revoked and its ability to fulfill the requirements (if any).

Article 19. Budget for accreditation of GMO laboratories

1. Budget for activities prescribed in Clause 2 of this article shall be a part of the budget for science and technology activities of the Office of Ministry of Science and Technology.

2.  Expenditures on accreditation of GMO laboratory

a) Carrying out inspections and printing documents and certificates;

b) Regular and unscheduled inspections.

3. Budgets for organizing training, including building curriculums, paying teachers, printing documents, paying for chemicals and other consumed materials that served practice of biosafety and supporting trainees, will be annually estimated and provided for units that are authorized by Ministry of Science and Technology.

4. Limits on expenditures shall comply with applicable regulations.

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Chapter 5.

RIGHTS AND OBLIGATIONS OF GMO LABORATORIES

Article 20. Rights and obligations

1. GMO laboratories may conduct GMOs research that is written in issued Certificate.

2. GMO laboratories will be given priority by State to conduct research missions related to GMO in accordance with their ability and operating scope.

3. GMO laboratories will be given priority to be provided with necessary equipment that serves the national science and technology mission of  GMO research.

4. GMO laboratories will be given priority to receive training in areas that related to GMO research.

5. GMO laboratories shall facilitate the supervision and management of Ministry of Science and Technology, supervisory authority and other competent authorities related to biosafety in GMO research.

6. All activities of GMO laboratories shall comply with regulations of Law on Environmental Protection, Law on Biodiversity and other regulations on biosafety.

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SUPERVISION OF IMPLEMENTATION

Article 21. Inspection and evaluation

Ministry of Science and Technology presides and co-ordinates with supervisory authority of the GMO laboratory to inspect, evaluate sites annually or surprisingly if necessary and ensure that all activities of the GMO laboratory are carried out in accordance with regulations. a) Criterions and contents of regular or unscheduled inspection shall use P10-BBTD and P12-PDG  forms prescribed in Appendix III issued together with this Circular.

Article 22. Action against violations

1. Suspension

a) The GMO laboratory shall be suspended if it violates rules prescribed in Clauses 1, 2 and 3 of Article 4 or there if evidences of  failure to ensure biosafety because of violation of regulations prescribed in Chapter III of this Circular;

b) Within 45 days from the day on which the GMO laboratory is suspended, this GMO laboratory shall remedy its violations and submit a written report to Ministry of Science and Technology and its supervisory authority;

c) Within 15 days from the day on which the written report is received, Ministry of Science and Technology will consider cancelling the suspension.

2. Revocation of the Certificate

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3. The suspension, revocation and reissue of the Certificate will be decided by Minister of Science and Technology.

Chapter 7.

IMPLEMENTATION CLAUSE

Article 23. Effect

This Circular shall take effects after 45 days from the day on which it is signed.

Article 24. Transition clause

Laboratories which are conducting GMO before this Circular is promulgated shall fulfill the requirements of this Circular by January 01, 2014.

Article 25. Execution obligation

1. Ministries, Ministry-level bodies, People’s Committee of provinces and central-affiliated cities will base on this Circular to instruct domestic and foreign organizations and individuals to register and manage GMO laboratories within the management scope.

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3. Minister of Science and Technology shall assign Department of Science and Technology for Economic- Technical Branches to manage issuance of Certificate and operation of GMO laboratories.

4. During process of implementation, if there is any query or suggestion on contents of this Circular that needs to be adjusted, these written queries and suggestions should be sent to Ministry of Science and Technology.

P.P. MINISTER
DEPUTY MINISTER




Chu Ngoc Anh