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Circular No. 68/2009/tt-Bnnptnt: Assay Evaluation Rules Risks To Biodiversity And The Environment Of The Genetically Modified Crop Varieties

Original Language Title: Thông tư 69/2009/TT-BNNPTNT: Quy định khảo nghiệm đánh giá rủi ro đối với đa dạng sinh học và môi trường của giống cây trồng biến đổi gen

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Pursuant to decision No. 212/2005/QD-TTg dated 26 August 2005 from the Prime Minister's issuance regulations biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;

Pursuant to decision No. 11/2006/QD-TTg dated 12 January 2006 by the Prime Minister on the approval of the "key program of development and application of biotechnology in the agricultural sector and rural development to 2020";

Pursuant to decision No. 103/2007/QD-TTg dated July 10, 2007 by the Prime Minister on the approval of "the project of strengthening overall management of biosafety with respect to genetically modified organisms and products the goods derived from genetically modified organisms from now until 2010 implementation of Cartagena Protocol on Biosafety" the Ministry of agriculture and rural development regulation assay reviews risks to biodiversity and the environment of the genetically modified crop varieties as follows: chapter I GENERAL PROVISIONS article 1. Scope the provisions of this circular assay reviews risks to biodiversity and the environment of the genetically modified crop varieties.

Article 2. The object that applies to this circular apply to organizations and individuals in the country and abroad have genetically modified crop varieties assay registration risk assessment (hereinafter referred to as The register); domestic organizations perform assay risk assessment (hereafter referred to collectively as the assay organization); organizations and individuals related to the management of the assay activity risk assessment with regard to biodiversity and the environment of the genetically modified crop varieties on the territory of Vietnam.

Article 3. Explanation of terms In this circular the terms below are interpreted as follows: 1. Risk assessment is the activity to determine the adverse effects that may occur with regard to biodiversity and the environment in the activities related to genetically modified cultivars. Risk assessment is the process of starting the research to create the same GM crops genetically modified until the trade, including both qualitative and quantitative assessments. Content of the risk assessment includes identifying risks, assessing the possibility, the level of experience of the risk occurring and the estimate of risk.

2. Plant breeding genetically modified plants containing gene structure is changed by the creation of gene transfer technology used for plant breeding.

3. assay license text is the governance of the Ministry of agriculture and rural development, allowing assay risk assessment of GMO crop varieties for biodiversity and the environment. .

4. Biological Safety Council agricultural sector (below referred to as the biological Industry Safety Council) by the Minister of agriculture and rural development, established for a term of 3 years have the task of appraising the registration profile assay, assay results review and advise the Minister of agriculture and rural development, licensing and recognition assay assay results.

5. assay risk assessment (hereinafter referred to as the assay) is active for the impact assessment of biodiversity and the environment of the genetically modified crop varieties in specific conditions of Vietnam aims to provide data for the quantitative assessment of risk with respect to biodiversity and the environment of the genetically modified crop varieties.

6. Risk management is the process of estimating the risk, identify and handle risk management measures intended to limit the level of risk can be accepted with regard to biodiversity and the environment in the activities related to genetically modified crops.

7. gene dispersal is the natural flow of the gene is transferred genetically modified tree is loaded from the same or other species to tree species.

8. Risk is the impact indirectly or directly, not intent can be harmful with regard to biodiversity and the environment due to the activities related to genetically modified crops.

9. gene transfer events (transformation event) is the transfer of loading a target gene in a certain location on the chromosomes of plants to create a genetically modified varieties with corresponding gene transfer events that, with other cultivars differences caused by a different gene transfer events create.

10. risk monitoring organization (referred to as the monitoring organization) by the Minister of agriculture and rural development has established the monitoring task, check the assay process risk assessment of GMO crop varieties for each register specific assay to timely detect and handle the case does not ensure safety can occur during translations experience.

11. assay is the Organization of science and technology, scientific and technological services that qualify the assay performs risk assessment of GMO crop varieties for biodiversity and environment in Vietnam are the Ministry of agriculture and rural development.

12. Transport of genetically modified crop varieties and materials of the genetically modified crop varieties (hereinafter referred to as transport) is the active movement of GMO crop varieties and materials of the genetically modified crop varieties with intent of the Organization, individuals are responsible in the time from when the assay licensed until end field monitoring management the assay after harvesting.

13. breeding material of genetically modified crop varieties are plants or parts of plants have the ability to grow into a new tree used for breeding or cultivation as: seeds, seedlings planted from seeds, trees, branches of philosophy or seeds, shoots, grafted, tubers, fruits, buds, flowers, tissue , cells, spores, fungal strands.

14. harvest of material genetically modified crop varieties are plants or any parts of the plant are obtained from the cultivation of breeding material of genetically modified crop varieties.

Chapter II ASSAY article 4. General requirements of the assay 1. Species of plants allowed the assay must be in "species genetically modified crops allowed assay for plant varieties in Vietnam" by the Minister of agriculture and rural development.

2. All varieties of genetically modified crops before the planting fields are to assay.

3. The Ministry of agriculture and rural development is only licensed to assay for genetically modified crop varieties on the basis of the conclusions of the Industry Council of biological safety.

4. The Ministry of agriculture and rural development to recognize organizations that qualify the assay. Assay work must be performed by a recognized organization of the assay.

Article 5. Assay principle 1. The assay is performed in two steps: the steps an assay limit, until one day the two wide area after the assay the assay limit granted the request.

2. assay must stop immediately, as if each step in the process of risk detection assay could not control.

Article 6. This form of the assay 1. Assay limitations include experiments performed in conditions of physical isolation and the field test an enclosed narrow conditions aimed at ensuring the maintenance of control over genetically modified crops and manage the risks of genetically modified crop varieties assay for biological diversity and the environment. Limit assay was performed at least in 2 consecutive service for short crops growth cycle and for crops.

2. assay an extensive field experiments are to be deployed in the eco region, not marginalize aims to evaluate the effectiveness of agricultural GMO crop varieties and the impact of genetically modified crops for bio-diversity of insect populations in the different ecological regions. Wide assay be performed a minimum of 1 service for short crops growth cycle and for crops.

Article 7. The Organization organized The sufficient assay the following conditions registered with the Ministry of agriculture and rural development to be assigned is held assay.

1. conditions for organizing a assay) have sufficient technical facilities, equipment, process engineering and professional staff with suitable species of genetically modified crops allowed assay;

b) surveillance measures and risk management process in the assay;

c) features the grid, greenhouses and fields to perform the assay limit guarantee required under article 10, article 11 of chapter II of this circular.

2. The procedure indicated assay a) Organization filing: assay organization would sign specify submission assay for science, technology and the environment, including:-organization application form assay in annex 1.1 of this circular;

-Demonstration of proficiency, capacity and technical infrastructure of the Organization the assay according to the form in Appendix 1.2 of this circular;

-Proven record of competence and proficiency in the technical infrastructure of the Organization the assay;

-A copy of the decision stipulates functions and tasks of the unit please register specifies the Organization of the assay.

b) science, technology and environment organization of appraisal, evaluation and the Organization's capacity in the assay would sign, the Minister of agriculture and rural development, the decision to designate the Organization assay.

Article 8. Assay registration 1. Registration requirements a assay) products created in Vietnam Like genetically modified crops produced in the country are the result of the process of scientific research has been the competent State bodies.

b) imported products have been allowed exporting countries used as seed; risk assessment in specific conditions and establish safety management mechanism viable seed on the territory of that country.

2. a registration profile) the application form in annex 2.1 of this circular;

b) certificate products or research results:-the product is generated abroad: the document recognized the seed or the equivalent in the native place of origin;

-The product was created in Vietnam: report on the experience of the Council of science and technology Ministerial level or equivalent and above.

c) risk evaluation report form in annex 2.2 of this circular;


d) biological safety certificate or equivalent document; the assay profiles and profile management of biological safety at the place of origin of origin for imported products.

3. Submission and confirmation of a profile) Who sign the records in item 2 article 8 of chapter II of this circular for science, technology and environment, Ministry of agriculture and rural development.

b) within 5 working days from the receipt of the record, the science, technology and the environment confirmed and notified in writing to the registrant know profile meet the requirements have been received.

c) in the case of incomplete records, the science, technology and the environment require additional registrant. The waiting period provides additional information not included in the profile confirmation time.

Article 9. Licensing sequence assay, assay results recognition 1. License restriction assay a) science, technology and the environment based on the records of The register advice the Minister of agriculture and rural development appointed assay organization to perform the assay.

b) assay in collaboration with organizations Who filed the registration plan limited assay according to Appendix 3 of this circular and the monitoring plan, risk management during the assay.

c) science, technology and the environment registration transfer assay, assay planning restrictions and other relevant records for the Council Biosafety assessment industry and advise the Minister of agriculture and rural development assay license restrictions on genetically modified crops.

d) science, technology and the environment of the conclusion of the Biosafety board industry and results evaluation of the content of the record, the Minister of agriculture and rural development assay license restrictions on genetically modified crops. Cases are not eligible for licensing restricted assay The Ministry of agriculture and rural development have text answers and stating the reason.

DD) valuation time, license restriction assay is 60 days. The sign, held responsible assay provides additional information when the Ministry of agriculture and rural development asked. The waiting period provides additional information not included in the evaluation period, a license restriction assay.

2. wide area assay license a) held the assay results reported limited assay according to the form in annex 4 of this circular for science, technology and environment, plans extensive assay and proposed the Ministry of agriculture and rural development permit wide area assay.

b) Council on Biosafety organized sector reviews assay results is limited, if satisfactory progress evaluation assay plans and advise the Minister of agriculture and rural development of licensing widespread assay for genetically modified crop varieties.

c) pursuant to the conclusion of the Biosafety board industry, science, technology and the environment to the Minister of agriculture and rural development of licensing widespread assay for genetically modified crop varieties.

d) time evaluation, licensing widespread assay is 45 days. The sign, held responsible assay provides additional information when the Ministry of agriculture and rural development asked. The waiting period provides additional information not included in the valuation time, permit wide area assay.   DD) Ministry of agriculture and rural development reported to the Ministry of natural resources and the environment, the provincial people's Committee, the central cities of the licensing of an assay of GMO crop varieties and plan on assay of related provinces and cities.

3. assay results recognized a) after the end of the assay, assay organizations report widespread assay results under the form in annex 5, and the vote-tracking assay in annex 6 (from 6.1 to 6.7) of this circular for science, technology and the environment for science , Technology and the environment.

b) science, technology and the environment gathered together the assay results of monitoring organization profile and other relevant records, sent to the Council of the biological safety industry.

c) Council on Biosafety organized sector reviews and assay results to advise the Minister of agriculture and rural development of assay results satisfactory or unsatisfactory under the provisions of this circular.

d) bases the conclusion of the Biosafety board industry, science, technology and the environment to the Minister of agriculture and rural development to recognize the request reaches the assay results. The case of the assay does not meet the requirements, the Ministry of agriculture and rural development reported to The register, the Organization of written assay and stating the reason.

DD) Ministry of agriculture and rural development reported to the Ministry of natural resources and the environment, the provincial people's Committee, the central cities of assay results are an extension of GMO crop varieties on the area of the province, the city involved.

Article 10. Requirements for home greenhouse, grid used for grid Home restriction assay, assay used in greenhouse must be designed and constructed to ensure prevent unauthorized intrusions from the outside and the seed dispersal, breeding materials and materials after the harvest of genetically modified crops into the environment.

Article 11. Requirements for field trials 1. Not been flooding and in accordance with the requirements of growth conditions, development of assay plant species.

2. Ensure the maintenance of conditions of reproductive isolation for narrow assay according to the guidelines in article 20 Chapter III of this circular.

3. Advantages for the management and supervision during the assay, harvest track management.

4. Ensure the biodiversity law and relevant regulations of the State.

5. The area of paddy fields depend on the content assay each experiment but not exceed 300 square meters for a narrow assay and the total area of the extensive assay point cannot exceed 2 ha/service for agricultural crops.

6. assay an narrow Rice must have fence surrounded the secured to prevent unauthorized intrusion of humans and animals.

Article 12. Assay of content 1. Assay of content depending on genetically modified crops and the results determine the risks of genetically modified crops with respect to biological diversity and the environment on the basis of risk analysis and the results of the research there were. Assay of content must be the Ministry of agriculture and rural development approved in response to identified the following issues: a) the risk to become invasive weeds and the natural environment.

b) risk of becoming pests.

c) risk of adverse effects to organisms, not intent.

d) the risk of changing the management mode of negative influence on the environment.

e) risk of altering the birth process, the chemical in the soil and the adverse impact is not deliberate.

2. assay content base, organizations deploying the assay laboratory in scope limited assay or assay secured wide area computer science, consistent with the ecological conditions of the genetically modified crops and the object needs risk assessment.

Article 13. Assay supervision 1. On the basis of GMO crops objects need assay, assay and areas supervisory plan, risk management of The register, the science, technology and the environment proposed to the Minister of agriculture and rural development, given the task of monitoring risk to the monitoring organization. Monitoring organizations have the responsibility to implement the tasks defined in article 22 of this circular.

2. assay organization responsible for monitoring risks in the assay process as planned was the Ministry of agriculture and rural development approved The report, when there is a change in assay and was planning to continue the assay after The comments agree in writing.

3. the people's committees, the central cities, the Ministry of natural resources and the environment is right to check, monitor the process and assay of the opinion to the Ministry of agriculture and rural development to handle the offense or risk is likely to be out of control.

Article 14. Requirements for provision of information 1. The registration and organization of the assay are responsible for providing full information about the level of risk and risk management measures with regard to biodiversity and the environment of the genetically modified crop varieties assay for the Ministry of agriculture and rural development.

2. mesh Home, greenhouse, field assay must be clearly sea targets, deployment time assay and assay license number.

3.10 m test area Before must have signage "area of GMO crop experiments, no long on".

Chapter III RISK MANAGEMENT in the ASSAY article 15. General requirements 1. The assay activity and import of genetically modified crop varieties (if any) must comply with strict preventative measures, handle and overcome risks.

2. The registration and organization of the assay is responsible for applying the appropriate management measures aimed at the prevention, timely detection of risks to handle remedial risks. Event risk in the process of conducting its activities must promptly report the Ministry of agriculture and rural development.

3. in case of occurrence of risk in other countries on genetically modified crop varieties are assay, subscribers are responsible to notify the organisation and supervision organization assay. The organizations, individuals and units concerned to implement immediately the measures to control risk and report the Ministry of agriculture and rural development.

4. The form related to the management of risk for genetically modified crop varieties and materials of the genetically modified crop varieties in the process are detailed assay reagent in annex 6 of this circular.

Article 16. Transport of genetically modified plant seeds and breeding material of genetically modified crop varieties


1. the genetically modified crop varieties, breeding material of genetically modified plant seeds imported for the assay must be quarantined under the regulations and ensuring the requirements enshrined in articles 7, 8, 9, 10, 12, 13 and 18 of the Cartagena Protocol on Biosafety.

2. GMO cultivars and breeding material of genetically modified crop varieties in transit must be separate packaging with other crop materials guaranteed not to going beyond the environment. Packaging must be clearly labelled.

3. where the loss occurred during transportation, The registered organization, the assay should recover all the material loss and being destroyed by the appropriate measure, mark the location of the crash to track, monitor and handle to ensure the material being losses have been destroyed completely the report at the same time, the Ministry of agriculture and rural development.

4. assay organization complete the shipping tracking votes according to the form in Appendix 6.2 of this circular.

Article 17. Retention, preservation of GMO cultivars and breeding material of genetically modified crop varieties 1. Genetically modified crop varieties and breeding material of genetically modified seed must be kept stored in the secured condition avoid the intrusion did not intent from the outside and not to the loss of outside environment.

2. the retention areas, preservation of GMO cultivars and breeding material of genetically modified crop varieties must be clearly labeled.

3. organizations and individuals was delivered, the preservation of GMO cultivars and breeding material of genetically modified crop varieties are responsible for periodic inventory checks, the process kept preserved. The test results, inventory must be kept in record keeping, preservation of GMO cultivars and breeding material of genetically modified crop varieties.

4. in the event of a loss of individual organizations are making to keep, preserve the responsibility to adopt measures to recover the lost material maximum escape and destroyed by suitable measures, marks the location of the incident to track, monitor and handle to ensure the material being losses have been destroyed completely , and report to the Ministry of agriculture and rural development.

Article 18. Assay harvest 1. Held responsible assay harvesting the entire GMO crop varieties, harvest material of genetically modified crop varieties, including plant material in the protective Strip and destroyed by suitable measures, except for the need to hold back for the next study. Harvest of material genetically modified crop varieties assay has not been used as food for humans and livestock.

2. the seed used for research are transported, stored, preserved as required in article 15, article 16, article 17, chapter III of this circular.

3. assay organizations are responsible to apply appropriate measures to clean up all the instruments used for the harvest to ensure assay do not distribute genetically modified plant seeds, harvest material of genetically modified crop varieties assay point out or take other crop materials do not intent to assay scores. Plant material obtained in the process of cleaning must be destroyed by appropriate measures.

4. The destruction of genetically modified crops, harvest material of genetically modified seed or plant material obtained in the process of cleaning done right at the point of the assay.

5. The organization completed the vote-tracking assay harvested according to the form in Appendix 6.3 of this circular.

Article 19. Manage fields after harvesting 1. After the end of the assay, assay organization responsible for monitoring assay narrow paddy fields to control growth beyond what is expected of GMO crops assay. Monitoring time field assay extends at least 3 months from the end of the harvest, depending on the characteristics of reproduction and sleeping time of assay plant seeds. In the case of rice harvest assay is used for the next assay for genetically modified crop varieties of the same species, the post-harvest monitoring period will be calculated from the end of the assay.

2. assay organizations are responsible for ensuring there is no plant species along the same species or any reproduction with genetically modified crop varieties are cultivated in the assay during monitoring field after harvest.

3. Organize the complete assay harvest tracking votes according to the form in annex 6.4 of this circular.

Article 20. Reproductive isolation in a narrow area rice field paddy field assay the assay must be reproductive isolation with the other plants of the same species or species the same reproduction with genetically modified crop varieties in the vicinity. Isolation must be maintained during the assay. Reproductive isolation measures proposed in the plan the assay with suitable plant varieties assay, according to one of the following measures: 1. Quarantine space: rice seed assay GMO must be insulated with the same plant species or species of the same reproductive system Isolation distance, depending on the characteristics of the species reproductive assay and was proposed in the plan. Held responsible for assay test and cancel the plant of the same species or species or the same reproduction assay with crops within quarantined by the appropriate measures and complete space quarantine tracking votes according to the form in annex 6.5 of this circular.

2. Quarantine period: genetically modified crop varieties assay was isolated from time to time by planting seed assay earlier or later than the other plants of the same species or species of the same reproductive systems in the vicinity, so that the process of flowering, pollination of cultivars assay does not coincide with the flowering time , pollinating the crops of the same species or species of the same reproductive system. Held responsible for assay test and cancel the plant of the same species or species of the same reproductive system with seed assay in the scope if no quarantine period secured by appropriate measures and and completed quarantine time tracking votes according to the form in annex 6.6 of this circular.

Chapter IV IMPLEMENTATION article 21. Science, technology and environment, science, technology and the environment is a permanent unit, do the clues help the Minister of agriculture and rural development, governing the implementation of the tasks involved, namely: 1. Receiving registration documents assay reviews risks to biodiversity and the environment of the genetically modified crop varieties of the Registrant and the registration organization profile organization's assay the assay.

2. Organized profile assessment and proposals to the Minister of agriculture and rural development assay licensing genetically modified crop varieties for The subscription and specify the Organization assay.

3. construction and the Minister of agriculture and rural development issued "species genetically modified crops allowed assay for plant varieties in Vietnam".

Article 22. The monitoring organization 1. Building plan check or unusual to timely detect and handle the case does not ensure safety can occur during the assay. Report of the Ministry of agriculture and rural development of periodic test results, test reports and irregular handling of the arising during the assay.

2. When found to have violated regulations assay or appear likely to risk control, monitoring organizations to immediately report the Ministry of agriculture and rural development consultation process.

3. During 15 days after the end of test, monitoring organizations report the Ministry of agriculture and rural development of the test results in writing.

Article 23. The register 1. Provide full and truthful information according to the requirements of this circular and the related updates during the assay for the Ministry of agriculture and rural development and is fully responsible for the information provided.

2. Pay the application fee, appraisal license assay according to the regulations and pays the costs related to the assay as agreed with the Organization of the assay.

Article 24. Assay organization 1. Assay organization responsible for performing the assay assure transparency objective, the plan has been the Ministry of agriculture and rural development approved and the related provisions of this circular. Complete assay organization responsible results by themselves make.

2. full, timely reports to the Ministry of agriculture and rural development under the provisions of this circular.

3. Confidentiality of information relating to The registration and the process of assay.

4. Not competent assay results.

Article 25. Terms of implementation 1. This circular effect 45 days from the date of signing.

2. In the process of implementation, if the appears stuck, difficult or new issues, the unit, officers, servants, employees in timely reflections on Science, technology and the environment to the Minister of agriculture and rural development to consider additional amendments./.