Detailed regulations of operation of GMO laboratories in Vietnam

According to Article 9 of the Circular No. 20/2012/TT-BKHCN of the Ministry of Science and Technology of Vietnam, regulations of operation of GMO laboratories (genetically modified organisms) are specified as follows:

- The biosafety level 1 laboratory shall:

+ 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;

+ put up signs using P1-PTN form prescribed in Appendix I issued together with Circular No. 20/2012/TT-BKHCN;

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

+ prepare adequate experiment specimens and chemicals;

+ prepare and provide adequate protective equipment to ensure the biosafety;

+ 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;

+ 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;

+ keep a log of process and results of experiments, biosafety information and risk analysis.

- The biosafety level 2 laboratory shall:

+ 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;

+ comply with regulations in Point b, c, d, dd, e, g, h of Clause 1 Article 9 of Circular No. 20/2012/TT-BKHCN. All activities, especially those relating to gas, alcohol lamps shall avoid affecting air circulation of biosafety cabinets.

- The biosafety level 3 laboratory shall:

+ 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;

+ comply with regulations in Point b, c, d, h of Clause 1 of Clause 1 Article 9 of Circular No. 20/2012/TT-BKHCN;

+ 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;

+ 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;

+ carry out experiment techniques: Equipment that may generate steam shall be preserved and used in biosafety cabinets. The person who drops something in biosafety cabinets shall sterilize them with chloramine or 70% alcohol or other antiseptics in accordance with regulations. Two experiments shall not be carried out at the same time. The person who doesn’t carry out experiments shall not enter the laboratory which hasn’t been sterilized;

+ 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.

- The biosafety level 4 laboratory shall:

+ 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;

+ comply with regulations in Points b, c, d and h of Clause 1 and Points d and dd of Clause 3 Article 9 of Circular No. 20/2012/TT-BKHCN.

+ prepare protective equipment: Employees shall change clothes before entering the laboratory and only use protective clothes and shoes inside the laboratory. When getting out of the laboratory, employees shall change clothes before having a bath. Protective clothes shall be sterilized in hermetic bags or boxes and dry-steamed at high temperature.

+ 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.

+ 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.

+ 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.

View more details at the Circular No. 20/2012/TT-BKHCN of the Ministry of Science and Technology of Vietnam, effective from January 04, 2013.

Le Vy

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