IT ' S SMART

The regulation of biological safety in research activities,

development of the technology of genetically modified organisms

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Base of Protocol 28 /2008/NĐ-CP March 14, 2008 the Government regulates the function, mandate, jurisdiction, and organizational structure of the Ministry of Science and Technology;

Base of Protocol 81 /2002/NĐ-CP October 17, 2002 of the Government Regulation details of some of the provisions of the Law of Science and Technology;

Base of Protocol 69 /2010/NĐ-CP June 21, 2010 and Decree No. 108 /2011/NĐ-CP November 30, 2011 amendment Decree 69 /2010/NĐ-CP of the Government on Biosafety for genetically modified organisms, genetic specimens, and products of genetically modified organisms;

Base Decision Base 79/2007/QĐ-TTg May 31, 2007, the Prime Minister approved the "National Action Plan on Biological Diversity to 2010 and the Orientation Of 2020 to implement the Convention for Biological Diversity and the Cartagena Protocol on Biological Safety";

At the suggestion of the Secretary of the Science and Technology of the Economics of Economics;

The Minister of Science and Technology issued a Biosafety Regulation of Biosafety in Research Operations, the development of technology on genetically modified organisms, among others.

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This information regulates biological safety management in research activities, technological development of genetically modified organisms, genetic specimens, and the product of genetically modified organisms (later called research on genetically modified organisms).

What? 2. Subject applies

This information applies to organizations, domestic and foreign individuals (later known as organizations, individuals) related to management and implementation of scientific research activities, technological development of genetically modified organisms, genetic specimens, and genetic research. It ' s transgenation and the product of genetically modified organisms on the territory of the Socialist Republic of Vietnam.

What? 3. Explain words

In this message the words below are understood as follows:

1. Research on genetically modified organisms, genetic specimens and products of genetically modified organisms in the world. (the following is the study of genetically modified organisms) as the study of scientific research and technological development to create, analyze, test for the isolation of genetically modified organisms, genetic specimens, and the product of genetically modified organisms; the assessment of the impact. of the genetically modified organisms and the product of genetically modified organisms to human health, livestock, biodiversity, and the environment.

2. Risk are factors that have direct or indirect harm to the environment, biodiversity, human health, crops or pets, which can be easily detected or potential due to activities related to the study of genetically modified organisms.

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

What? 4. Principles of biosafety management in the study of genetically modified organisms.

1. All research activities on genetically modified organisms must comply with the existing regulations on management of scientific and technological tasks (KH&CN) at Articles 19, Article 20 of the Law of Science and Technology; Article 87 of the Environmental Protection Law; Article 7 of the General Law. biological form; Article 44, Article 50 of the Law Safety Law and other laws of law are related.

2. Research on genetically modified organisms must be conducted within the framework of KH&CN tasks (subject matter, project) granted approval authorship: state-level KH&CN mission approved by the Ministry of Science and Technology; KH&CN mission, Ministry of Provincial Affairs, sector, the People ' s Committee of the Provinces, the central city of approval; the KH&CN mission level is administered by the direct management organization.

3. Research on genetically modified organisms performed only in the laboratory has been granted a Certificate of Qualified Research for genetically modified organisms according to biological safety levels.

a) Level 1 Biosafety Laboratory: Carried Out Gene Transfer Research; analysis of the detection of genetically modified organisms, genetic specimens, and genetic mutable products; assessment, quality standard testing, risks of those on the site. Not or less likely to occur to the environment, biodiversity, and human health, livestock; and so on.

b) Level 2 Biosafety Laboratory: In addition to the regulations at Point A of this paragraph also carried out the study of gene transfer in objects that may be at risk of risk occurring on the environment, biodiversity;

c) Level 3 Biosafety Laboratory: In addition to the regulations at the points a and b of this paragraph is also carried out the study of gene transfer in subjects that are at risk risk to the environment, biodiversity, and human health, livestock;

d) Level 4 biosafety laboratory: in addition to regulations at points a, b and c of this paragraph are also carried out the study of gene transfer in subjects with high risk risk, risk to humans, potentially causing disease.

4. KH&CN missions, provincial levels, junior levels of genetically modified organisms that organisms for and organisms receive a high risk risk affecting the environment, biodiversity, and human health, livestock belonging to a high school safety level division and a high degree of biodiversity. Level 4 must be approved by the Ministry of Science and Technology prior to approval.

5. The KH&CN mission theory on genetically modified organisms in addition to existing regulations must have content on biological safety management: risk assessment and risk management methods.

6. Research activities on genetically modified organisms must be subject to the supervision of the Ministry of Science and Technology and related departments.

Chapter II

BIOSAFETY REGULATION IN RESEARCH, TECHNOLOGICAL DEVELOPMENT OF GENETICALLY MODIFIED ORGANISMS

What? 5. Regulation of biosafety levels in the risk of risk of genetically modified organisms and the product of genetically modified organisms

1. Level 1 includes genetically modified organisms, products from genetically modified organisms not or at low risk risk to the environment, biodiversity, and human health, crops, livestock.

2. Level 2 includes genetically modified organisms, products from genetically modified organisms at an average risk to the environment, biodiversity, and human health, crops, livestock.

3. Level 3 includes genetically modified organisms at a high level of risk to the environment, biodiversity, and human health, crops, livestock, but have managed.

4. Level 4 includes genetically modified organisms, products from genetically modified organisms that risk a high degree of risk to the environment, biodiversity, and danger to human health, crops, livestock, but have no risk management. It works.

What? 6. Risk assessment and risk management in the study of genetically modified organisms

1. The assessment of the risk must be done in accordance with every single phase in the study of genetically modified organisms. If the risk assessment at work has concluded there is a risk of developing a risk that is unlikely to be controllable, it is not implemented at the next stage.

2. The risk assessment content includes: identifying risk risk, analysis, assessment of possible risk levels according to the risk of loss of biological safety on biodiversity, environment, and human health, livestock.

3. Identilocate the risks of risk according to the degree (less likely to occur, the ability to occur at a high level, inevitably occurring) of the following object groups:

a) The risk of risk for soil, water and air environment: levels of pollution, degradation;

b) The risk of risk to biodiversity: change to species composition in adverse direction;

c) The risk of risk to human health, pets: toxins, allergens.

4. For the expected risks that will inevitably occur, the risk of potentially occurring at a high level must perform a risk assessment of the risk of the content:

a) Analysis, assessment of risk risks to human health and with the environment;

b) The analysis, forecasting of the problem can occur the harmful effects of the risk;

c) Analysis, forecasting the risks that arise from harmful effects;

d) Analysis, proposed appropriate measures for risk management;

Forecasting overall impact on the environment, including positive effects on the environment and human health.

5. Depending on the risk assessment outcome, the KH&CN mission dean builds a risk management method that includes risk mitigation solutions, monitoring plans, and implementation of the implementation:

a) The solution risk minimization solution built under the principle of prevention is the main;

b) The execution plan and evaluation of the implementation must be built based on the content, progress of research;

c) Building the prevention plan, which processes when there is a biological safety loss at the laboratory.

6. The assessment report and the risk management method are built according to the prescribed form at Annex 1 issued by this Information.

What? 7. Biosafety regulation in the study of producing genetically modified organisms.

1. Common Regulations

a) The study of the creation of genetically modified organisms performed only at the Laboratory obtained the Research Certificate Laboratory for genetically modified organisms Level 1, level 2, level 3, and level 4;

b) Must comply with the current regulations of safety and sanitation;

c) Full preparation of specimens, materials and tools, experimental equipment. Materials, materials, experimental specimens, vitro, specialized tools used in the study of genetically modified organisms must be labeled with the name and date of execution;

d) The activity of recombinable vector creation, gene transfer is only performed in the first-degree biomarecologist ' s first-grade safety laboratory.

We only do transfer of the gene pool to one of the subjects in one experiment;

e) The transfer of the gene must wear a blouse, wearing a page, with a glove. When doing the right to sit in front of an active bio-safety cabinet, get all the necessary ingredients and avoid falling out of it.

g) A biological safety cabinet, the experimental equipment must be hygienated with 70-degree alcohol. The specimen crashed, raw materials, excess materials, cotton, lab tools, tubes, and other instruments that were used to be collected, classified, and processed before the release of the environment;

h) A weekly periodic disinfection of a laboratory and a biosafety cabinet with a chloramine solution or 70-degree alcohol or other antiseptic substances used by regulation;

i) The experimental products are preserved and managed by regulation, not to go outside the laboratory when the manager is not permitted. If you lose your sample or have a disturbance, you have to tell the manager to have a timely treatment of the release of the lack of environmental control.

) During the implementation process, if the risk detection is difficult to detect, then stop the study and process in accordance with the guidelines specified at Article 12 of this Information.

2. Regulation of biosafety management in a number of research activities with particular properties:

In addition to the specified regulations at Clause 1 of this need to comply with the following regulations:

a) multiply human activity with gene transfer objects as plants: In the process of conducting an absolute gene transfer object isolation to other organisms. Damage patterns or no need for use must be destroyed by regulation;

b) The multiline worker with gene transfer subject is microorganism: having to closely manage the biomass patient tubes, for non-successful adopter artificial tubes that must be destroyed by regulation;

c) The line worker with gene transfer object is the animal: must closely manage the number of cell lines that have moved the gene before they implanted the host. If the sample is broken or there is no need for use to proceed with the specified destruction.

What? 8. Regulation of biological safety in the laboratory for the biological properties of genetically modified organisms in the field.

1. Research activities on the biological properties of genetically modified organisms conducted in the laboratory of the main laboratory must follow the provisions at Clause 1 Article 7 of this Information.

2. Research activities on the biological properties of genetically modified organisms are plants that must comply with the following regulations:

a) The study of biological properties is only allowed to proceed in greenhouses or in houses, to ensure the isolation of the animal objects together;

b) The care kits, tree trimers are used separately for a type of genetic crop;

c) To use shoes, separate slippers when entering the greenhouse, the mesh;

d) No land, specimens from plants that grow their genes out of the greenhouse area, the grid when not permitted;

When you take the samples, you have to make sure that it ' s going to be safe to fall, and the sample and need to manage safety when analyzing samples;

e) At the end of the experiment, the plants that have moved the gene enough or not eligible for the same condition must be managed tightly, if not continuing to use the specified destruction.

3. The study of the biological properties of animals is carried out in the auxiliary zone:

a) The stable site for genetically transferred objects must ensure isolation of the external environment, which has its own waste collection system, wastewater. The fated and sewage are collected and processed by toxic chemicals, not directly into the general sewage system. Solid waste, stables (if any) are processed according to the method of burning in the furnace;

b) tightly managed animals that have been channelled: Must mark and manage numbers. Dead or unqualified, specimens of genetically modified animals need to be destroyed according to the method of incineration in the furnace.

4. In the course of the biological properties of genetically modified organisms, if found there is a high risk of harm to the environment, biodiversity, and human health, livestock, the host of tasks must report directly to the authorities. I don't know, and I'm sorry about the risk of stopping the risk.

What? 9. Biosafety regulation in analytical activity detection, analysis of the quality of genetically modified organisms and the product of genetically modified organisms

1. The analysis activities detected, the analysis of the quality of genetically modified organisms and the product of genetically modified organisms only performed at the Research Laboratory on genetically modified organisms has been granted certification.

2. Biosafety management in operation implementation pursues to regulations at Article 8, Article 9, Article 10 of this Information.

What? 10. Record registration and KH&CN mission collection on genetically modified organisms

1. KH&CN mission registration records on genetically modified organisms built under the current regulation of KH&CN mission registration records. The theory has to give a full overview of the information about biological properties, KH&CN research results and biological safety problems for gene transfer organisms. In the approach section, the method of study, the technique of use is part of the analysis and construction of the risk management method in accordance with Article 6 of this Information.

2. KH&CN mission records for genetically modified organisms built by current regulation. The report summup the task in addition to the specified content, obligated to have a report content on the risks that occurred and the risk management measures have taken place.

What? 11. Biosafety Regulation for Laboratory staff Research on Genetic Genetically Modified Organisms

1. Full complete implementation of the interiors of the laboratory.

2. Do not reserve food, drinks in the freezer of the lab.

3. Not eating in the lab.

4. Do not use oral suction when manipuling the experiments of genetically modified organisms.

What? 12. Regulation of Management when the attempted safety loss at the Laboratory for Research on Genetic Genomics

1. In the event of the loss of biological safety, the task dean, who is responsible for the management of the Laboratory must organize:

a) immediately report to the direct and determined host agency, which is defined by the location of the risk points at the laboratory;

b) A maximum collection of dead objects in the case: breaking the sample test tube; insects, invasive mice; failure of the device led to the release of the laboratory specimen; the laboratory failure. After collecting samples to repair, sanitation, and disinfection of the equipment, the laboratory was broken.

2. The event of a biological safety loss that exceeds the organization ' s ability to have a laboratory must report immediately to the competent authorities to organize the monitoring of the crime scene and rectify the incident.

3. After processing the incident, the KH&CN missions on genetically modified organisms belonging to the third-level biological safety level division and the 4th level are only continued to deploy when there is a written consent of the competent authority.

Chapter III

MANAGEMENT RESPONSIBILITY AND BREACH PROCESSING

What? 13. Responsible for the management of biosafety in research activity on genetically modified organisms.

1. Ministry of Science and Technology:

a) It is responsible for organizing biological safety management in the study of genetically modified organisms according to this Information.

b) It is responsible for the direct approval and management of the state-level KH&CN missions of genetically modified organisms.

c) In the 30-day period from the receiving of the recommended filing of the prescribed duties at paragraph 4 Article 4 of this Information, including the mission theory was corrected after evaluation, appraisal, and proposed work of the Ministry, the industry, the People ' s Commission of People. The province, central city, organization KH&CN (prescribed at Annex II issued by this message), the Ministry of Science and Technology has a written responsibility for the permission or not permission to perform (the case does not allow for permission). to do so, it is necessary to specify why) to set up, industry, local, KH&CN organization approx by regulation.

2. The ministries, the industry, the People ' s Committee of the provinces, the central city of the central city:

a) There is a responsibility for the management of biosafety management of KH&CN tasks on the student-grade, provincial-level, provincial-level genetically modified organism.

b) Coordinated with the Ministry of Science and Technology to test, monitor, the implementation of biological safety regulations in the study of genetically modified organisms within the management range.

c) The annual report with the Ministry of Science and Technology to implement KH&CN missions on genetically modified organisms within the scope of management (prescribed in Annex III issued by this message).

3. technology scientific organizations, laboratories, individuals engaged in research activity on genetically modified organisms:

a) There is a responsibility for biosafety management when implementing the implementation of KH &CN;

b) The implementation of the implementation of the KH&CN missions on genetically modified organisms has been approved in accordance with the regulation;

c) There is a responsibility to monitor the risk in research activity, report the Ministry of Science and Technology (for the mission approved by the Ministry of Science and Technology) or the Ministry, the industry, the Provincial People ' s Committee, the direct central city of management (for example). ministry, industry, local approx) when there is regulation or change in content, research plans, and only continue to proceed after being questioned by competent authorities in writing.

What? 14. Waste Processing

1. The authority with the authority to approve the research missions on the Genetically Modified Organism in paragraph 2 Article 4 of this Smart decision decides to stop or suspend research activities on genetically modified organisms in the case of detection of a violation of regulations. Biological safety or birth of any risk that is severely harmful to human health, livestock, biodiversity, and the environment.

2. Organization, personally violating the regulation of this Smart or other laws of law, depending on the nature, the specific level that is revoked of the Certificate of Research Laboratory on genetically modified organisms, administrative detention, or reprimand pursuit. The criminal justice of Vietnam.

Chapter IV

EXECUTION CLAUSE

What? 15.

This announcement comes into effect after 45 days from the date of the issue.

What? 16. The transition clause

Laboratories that were working on the study of genetically modified organisms prior to the time of the issue were taken back in time to implement the provisions of the LIT until 1 January 2014.

What? 17. Organization to execute

1. The Faculty of Science and Technology of the Economy-Engineering of the Ministry of Science and Technology is the lead to the Minister of Science and Technology that organizes and manages the implementation of this Information.

2. The ministries, the People ' s Committee of the Provinces, the central city of the Central Committee, organizes management, guiding scientific and technological institutions that implement the regulation of biological safety management within the management range.

3. During the course of execution, if there is an entangrium or recommendations for the content to adjust, the offer has a written reflection on the Department of Science and Technology to review, adjust ./.