Circular No. 69/2009/TT-BNNPTNT provides regulations on testing and risk assessment for biodiversity and the environment concerning genetically modified crop varieties.

CIRCULAR

Article on risk assessment testing for biodiversity and the environment of genetically modified crop varieties

and the environment of genetically modified crop varieties

________________

Based on Decree No. 01/2008/NĐ-CP dated January 3, 2008, issued by the Government, stipulating the functions, tasks, authorities, and organizational structure of the Ministry of Agriculture and Rural Development;

Based on Decision No. 212/2005/QĐ-TTg dated August 26, 2005, issued by the Prime Minister, promulgating the Regulations on biosafety management for genetically modified organisms and products, goods derived from genetically modified organisms;

Based on Decision No. 11/2006/QĐ-TTg dated January 12, 2006, issued by the Prime Minister, approving the "Key Program for Developing and Applying Biotechnology in Agriculture and Rural Development until 2020";

Based on Decision No. 102/2007/QĐ-TTg dated July 10, 2007, issued by the Prime Minister, approving the "Comprehensive Plan to Strengthen Management Capacity for Biosafety of Genetically Modified Organisms and Products, Goods Derived from Genetically Modified Organisms from now until 2010 to Implement the Cartagena Protocol on Biosafety";

The Ministry of Agriculture and Rural Development hereby stipulates the risk assessment testing for biodiversity and the environment of genetically modified crop varieties as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the risk assessment testing for biodiversity and the environment of genetically modified crop varieties.

Article 2. Applicability

This Circular applies to organizations and individuals, both domestic and foreign, who have genetically modified crop varieties registered for risk assessment testing (hereinafter referred to collectively as the Applicant); domestic organizations conducting risk assessment testing (hereinafter referred to collectively as the Testing Organization); and organizations and individuals related to the management of risk assessment testing activities for biodiversity and the environment of genetically modified crop varieties within the territory of Vietnam.

Article 3. Explanation of Terms

In this Circular, the following terms shall be understood as follows:

1. Risk assessment is the activity aimed at identifying potential adverse impacts on biodiversity and the environment in activities related to genetically modified crop varieties. Risk assessment is a process starting from the research creating genetically modified crop varieties up to commercialization, including qualitative and quantitative assessments. The content of risk assessment includes determining the risk, assessing the likelihood of occurrence, the severity of the risk when it occurs, and estimating the risk.

2. Genetically modified crop variety is a crop with its genetic structure altered through gene transfer technology for the purpose of being used as a crop variety.

3. Test permit is a state management document of the Ministry of Agriculture and Rural Development authorizing the risk assessment testing of genetically modified crop varieties for biodiversity and the environment.

4. The National Biosafety Committee in agriculture (hereinafter referred to as the National Biosafety Committee) established by the Minister of Agriculture and Rural Development for a three-year term has the task of reviewing registration files, evaluating test results, and advising the Minister of Agriculture and Rural Development on issuing test permits and recognizing test results.

5. Risk assessment testing (hereinafter referred to as testing) is the activity of assessing the impact on biodiversity and the environment of genetically modified crop varieties under specific conditions in Vietnam with the aim of providing data for the quantitative risk assessment of genetically modified crop varieties.

6. Risk management is the process of estimating risks, identifying and handling risks through management measures to limit risks to an acceptable level for biodiversity and the environment in activities related to genetically modified crop varieties.

7. Gene flow is the natural movement of genes transferred from a genetically modified plant to another plant of the same or different species.

8. Risk is indirect or direct, unintended impacts that may be harmful to biodiversity and the environment due to activities related to genetically modified crop varieties.

Transformation event is the insertion of a target gene into a specific location on the chromosome of a crop to create a corresponding genetically modified variety, which differs from other crop varieties created by different transformation events.

9. Risk monitoring organization (hereinafter referred to as the Monitoring Organization) established by the Minister of Agriculture and Rural Development has the task of monitoring and inspecting the risk assessment testing process of genetically modified crop varieties for each specific test registration to promptly detect and handle any cases of non-compliance with safety requirements that may occur during the testing process.

10. Testing organization is a scientific and technological organization or service provider with the necessary conditions to conduct risk assessment testing of genetically modified crop varieties for biodiversity and the environment in Vietnam designated by the Ministry of Agriculture and Rural Development.

11. Transport of genetically modified crop varieties and materials of genetically modified crop varieties (hereinafter referred to as transport) is the intentional movement of genetically modified crop varieties and materials of genetically modified crop varieties by organizations and individuals responsible from the time of obtaining a test permit until the end of post-harvest field monitoring supervision.

12. Propagation material of genetically modified crop varieties is a plant or parts of a plant capable of developing into a new plant for propagation or planting such as seeds, seedlings grown from seeds, grafts, cuttings, seeds, grafted branches, buds, tubers, fruits, shoots, flowers, tissues, cells, spores, fungal threads.

13. Harvested material of genetically modified crop varieties is a plant or any part of a plant obtained from planting propagation material of genetically modified crop varieties.

Chapter II

TESTING

Article 4. General requirements for field trials

1. Crop varieties permitted for field trials must be included in the "List of Genetically Modified Crop Varieties Permitted for Field Trials for Seed Production Purposes in Vietnam" issued by the Minister of Agriculture and Rural Development.

2. All genetically modified crop varieties must undergo field trials before being planted in fields.

3. The Ministry of Agriculture and Rural Development shall issue a field trial permit for genetically modified crop varieties based on the conclusion of the Sectoral Biosafety Council.

4. The Ministry of Agriculture and Rural Development recognizes organizations that meet the conditions for conducting field trials. Field trials must be carried out by recognized organizations.

Article 5. Principles of field trials

1. Field trials are conducted in two stages: stage one limited field trials, and stage two wide-scale field trials following the recognition of satisfactory results from the limited field trials.

2. Field trials must be immediately halted if unmanageable risks are detected at any stage during the field trial process.

Article 6. Forms of field trials

1. Limited field trials include experiments conducted under physical isolation conditions and narrow-scale field trials with conditions to ensure control over genetically modified crops and manage risks posed by genetically modified crop varieties to biodiversity and the environment. Limited field trials must be conducted for at least two consecutive growing seasons for short-day crops and one growth cycle for long-day crops.

2. Wide-scale field trials involve field experiments implemented in different ecological zones without physical isolation, aimed at evaluating the agronomic performance of genetically modified crop varieties and their impact on insect biodiversity in various ecological zones. Wide-scale field trials must be conducted for at least one growing season for short-day crops and one growth cycle for long-day crops.

Article 7. Field Trial Organizations

Organizations meeting the following conditions shall register with the Ministry of Agriculture and Rural Development to be designated as Field Trial Organizations.

1. Conditions for Field Trial Organizations

a) Possess adequate technical facilities, equipment, technical procedures, and specialized staff suitable for the genetically modified crop varieties permitted for field trials;

b) Have measures for monitoring and managing risks during the field trial process;

c) Have greenhouses, glasshouses, and fields to conduct limited field trials in accordance with Articles 10 and 11 of Chapter II of this Circular.

2. Procedures for Designating Field Trial Organizations

a) Submitting application: Field Trial Organizations applying for designation shall submit an application to the Department of Science, Technology, and Environment, including:

- A Field Trial Organization registration form according to Form 1.1 of this Circular;

- An explanation of the organization's qualifications, capabilities, and technical facilities according to Form 1.2 of this Circular;

- Documentation proving the organization's qualifications, capabilities, and technical facilities;

- A copy of the decision defining the functions and responsibilities of the organization applying for Field Trial Organization designation.

b) The Department of Science, Technology, and Environment shall organize the review and evaluation of the application and capabilities of the Field Trial Organization applicant, and report to the Minister of Agriculture and Rural Development to issue a decision designating the Field Trial Organization.

Article 8. Registration for Testing

1. Conditions for Registration for Testing

a) Products produced in Vietnam

Genetically modified crop varieties produced domestically must be the result of scientific research processes that have been accepted by competent state authorities.

b) Imported products

They must be permitted for use as crop varieties by the exporting country; risk assessment under specific conditions and establishment of effective safety management mechanisms for such crop varieties within the territory of that country.

2. Application Documents

a) A registration form according to Form 2.1 of this Circular;

b) Product certification or research results certificate:

- For products produced abroad: documentation recognizing the crop variety or equivalent at the place of origin;

- For products produced in Vietnam: acceptance report from a Ministry-level Science and Technology Council or higher.

c) Risk assessment report according to Form 2.2 of this Circular;

d) Biosafety certification or equivalent document; testing dossier and biosafety management dossier at the place of origin for imported products.

3. Submission and Confirmation of Application

a) The applicant submits all application documents stipulated in Clause 2 of Article 8, Chapter II of this Circular to the Department of Science, Technology and Environment, Ministry of Agriculture and Rural Development.

b) Within five working days from receipt of the application, the Department of Science, Technology and Environment confirms and notifies the applicant in writing that the application has been received and meets the requirements.

c) In case the application is incomplete, the Department of Science, Technology and Environment requests the applicant to supplement it. The waiting time for providing additional information does not count towards the application confirmation period.

Article 9. Procedure for Issuing Testing Permits and Recognizing Testing Results

1. Issuance of Restricted Testing Permit

a) Based on the applicant's application documents, the Department of Science, Technology and Environment advises the Minister of Agriculture and Rural Development to designate the Testing Organization to conduct the testing work.

b) The Testing Organization collaborates with the applicant to submit a restricted testing plan according to Form 3 of this Circular and a monitoring and risk management plan during the testing process.

c) The Department of Science, Technology and Environment forwards the testing registration documents, restricted testing plan, and other related documents to the Sectoral Biosafety Council for review and advice to the Minister of Agriculture and Rural Development to issue a restricted testing permit for genetically modified crop varieties.

d) The Department of Science, Technology and Environment compiles the Sectoral Biosafety Council's conclusions and reviews other contents of the application documents, and reports to the Minister of Agriculture and Rural Development to issue a restricted testing permit for genetically modified crop varieties. If the conditions for issuing a restricted testing permit are not met, the Ministry of Agriculture and Rural Development will provide a written response stating the reasons.

đ) The review and issuance of a restricted testing permit take 60 days. The applicant and the Testing Organization are responsible for providing additional information when requested by the Ministry of Agriculture and Rural Development. The waiting time for providing additional information does not count towards the review and issuance period of the restricted testing permit.

2. Issuance of Wide-Scale Testing Permit

a) The Testing Organization reports the restricted testing results according to Form 4 of this Circular to the Department of Science, Technology and Environment, proposes a wide-scale testing plan, and requests the Ministry of Agriculture and Rural Development to issue a wide-scale testing permit.

b) The Sectoral Biosafety Council evaluates the restricted testing results, if satisfactory, conducts a review of the wide-scale testing plan and advises the Minister of Agriculture and Rural Development to issue a wide-scale testing permit for genetically modified crop varieties.

c) Based on the Sectoral Biosafety Council's conclusions, the Department of Science, Technology and Environment reports to the Minister of Agriculture and Rural Development to issue a wide-scale testing permit for genetically modified crop varieties.

d) The review and issuance of a wide-scale testing permit take 45 days. The applicant and the Testing Organization are responsible for providing additional information when requested by the Ministry of Agriculture and Rural Development. The waiting time for providing additional information does not count towards the review and issuance period of the wide-scale testing permit. đ) The Ministry of Agriculture and Rural Development informs the Ministry of Natural Resources and Environment, People's Committees of provinces and centrally governed cities about the issuance of a wide-scale testing permit for genetically modified crop varieties and the testing plans in relevant provinces and cities.

3. Recognition of Testing Results

a) After completing wide-scale testing, the Testing Organization reports the wide-scale testing results according to Form 5 and observation forms from Form 6 (from 6.1 to 6.7) of this Circular to the Department of Science, Technology and Environment.

b) The Department of Science, Technology and Environment compiles the testing results together with supervision organization documents and other related documents, and sends them to the Sectoral Biosafety Council.

c) The Sectoral Biosafety Council evaluates the testing results and advises the Minister of Agriculture and Rural Development on whether the testing results meet the requirements as stipulated in this Circular.

d) Based on the Sectoral Biosafety Council's conclusions, the Department of Science, Technology and Environment reports to the Minister of Agriculture and Rural Development to recognize the testing results as meeting the requirements. If the testing results do not meet the requirements, the Ministry of Agriculture and Rural Development will notify the applicant and the Testing Organization in writing and state the reasons.

đ) The Ministry of Agriculture and Rural Development informs the Ministry of Natural Resources and Environment, People's Committees of provinces and centrally governed cities about the wide-scale testing results of genetically modified crop varieties in relevant provinces and cities.

Article 10. Requirements for greenhouses and net houses used for limited field trials

Greenhouses and net houses used in field trials must be designed and constructed to ensure prevention of unauthorized intrusion from outside and the spread of genetically modified plant varieties, propagation materials, and post-harvest materials into the environment.

Article 11. Requirements for trial fields

1. Not prone to flooding and suitable for the growth and development conditions of the crop being tested.

2. Ensure maintenance of reproductive isolation conditions for narrow-scale field trials in accordance with the provisions of Clause 20, Chapter III of this Circular.

3. Facilitate management and monitoring during the trial period and post-harvest monitoring.

4. Ensure compliance with biodiversity laws and related state regulations.

5. The area of trial fields depends on the specific experiment but shall not exceed 300 square meters for a narrow-scale trial and the total area of wide-scale trial points shall not exceed 2 hectares per crop season for agricultural crops.

6. Narrow-scale trial fields must be surrounded by fences to prevent unauthorized entry by people and animals.

Article 12. Content of Field Trials

1. The content of field trials depends on the genetically modified crop and the results of risk assessment of the genetically modified crop's impact on biodiversity and the environment based on risk analysis and existing research results. The content of the field trial must be approved by the Ministry of Agriculture and Rural Development to address the following issues:

a) Risk of becoming a weed and invading natural environments.

b) Risk of becoming a pest.

c) Risk of adversely affecting non-target organisms.

d) Risk of changing management practices negatively impacting the environment.

e) Risk of altering soil biochemical processes and other unintended adverse effects.

2. Based on the content of the field trial, the testing organization implements trials at limited or wide-scale levels ensuring scientific rigor and suitability with the ecological conditions of the genetically modified crop and the risks to be assessed.

Article 13. Monitoring of Field Trials

1. Based on the genetically modified crop to be tested, the testing location, and the monitoring and risk management plan of the Applicant, the Department of Science, Technology and Environment proposes the Minister of Agriculture and Rural Development to assign risk monitoring tasks to the Monitoring Organization. The Monitoring Organization is responsible for implementing the tasks stipulated in Article 22 of this Circular.

2. The testing organization is responsible for monitoring risks during the trial period according to the plan approved by the Ministry of Agriculture and Rural Development, reporting to the Ministry when there are changes to the trial plan, and may only continue the trial upon written approval from the Ministry.

3. Provincial People's Committees under the Central Government and the Ministry of Natural Resources and Environment have the right to inspect and monitor wide-scale field trials and provide opinions to the Ministry of Agriculture and Rural Development to handle violations or risks that cannot be controlled.

Article 14. Requirements for Providing Information

1. The applicant and the Testing Organization shall be responsible for providing complete information on the level of risk and risk management measures concerning biodiversity and the environment for genetically modified crop varieties under the Ministry of Agriculture and Rural Development.

2. Greenhouses, glasshouses, and experimental fields must have signs clearly indicating the objectives, implementation time frame of the testing activities, and the testing permit number.

3. A warning sign reading "Genetically Modified Crop Testing Area, Unauthorized Entry Prohibited" must be placed 10 meters before the testing area.

Chapter III

MANAGEMENT OF RISKS IN TESTING

Article 15. General Requirements

1. Testing activities and importation of genetically modified crop varieties (if applicable) must strictly comply with preventive, handling, and remediation measures for risks.

2. The applicant and the Testing Organization shall be responsible for applying appropriate management measures to prevent and promptly detect risks to handle and mitigate their consequences. In case risks occur during the conduct of their activities, they must immediately report to the Ministry of Agriculture and Rural Development.

3. If risks appear in other countries on the genetically modified crop varieties being tested, the applicant shall be responsible for immediately notifying the Testing Organization and the Supervisory Organization. Relevant organizations, individuals, and units must immediately implement risk control measures and report to the Ministry of Agriculture and Rural Development.

4. Forms related to risk management for genetically modified crop varieties and genetic material of genetically modified crop varieties during the testing process are detailed in Appendix 6 of this Circular.

Article 16. Transporting Genetically Modified Crop Varieties and Genetic Material of Genetically Modified Crop Varieties

1. Imported genetically modified crop varieties and genetic material of genetically modified crop varieties for testing must undergo quarantine according to regulations and meet the requirements set forth in Articles 7, 8, 9, 10, 12, 13, and 18 of the Cartagena Protocol on Biosafety.

2. During transportation, genetically modified crop varieties and genetic material of genetically modified crop varieties must be separately packaged from other plant materials to ensure they do not escape into the environment. Packaging must be clearly labeled.

3. In case of loss during transportation, the applicant and the Testing Organization must recover all lost materials and destroy them using appropriate methods, mark the location of the incident for monitoring, supervision, and handling to ensure that all lost materials have been completely destroyed, and simultaneously report to the Ministry of Agriculture and Rural Development.

4. The Testing Organization shall complete the transport tracking form according to the form in Appendix 6.2 of this Circular.

Article 17. Storage and Preservation of Genetically Modified Crop Varieties and Genetic Material of Genetically Modified Crop Varieties

1. Genetically modified crop varieties and genetic material of genetically modified crop varieties must be stored and preserved under conditions ensuring protection against unintended intrusion from outside and preventing their escape into the environment.

2. The storage and preservation areas for genetically modified crop varieties and genetic material of genetically modified crop varieties must be clearly labeled.

3. Organizations and individuals entrusted with storing and preserving genetically modified crop varieties and genetic material of genetically modified crop varieties shall be responsible for regularly inspecting and inventorying the storage and preservation process. Inspection results must be kept in the storage and preservation records for genetically modified crop varieties and genetic material of genetically modified crop varieties.

4. In case of loss, organizations and individuals entrusted with storage and preservation shall be responsible for applying measures to recover as much lost material as possible and destroy it using appropriate methods, mark the location of the incident for monitoring, supervision, and handling to ensure that all lost materials have been completely destroyed, and simultaneously report to the Ministry of Agriculture and Rural Development.

Article 18. Harvesting for Testing

1. The testing organization shall be responsible for harvesting all genetically modified crop varieties and post-harvest materials of genetically modified crop varieties, including crop materials within the buffer zone, and destroying them using appropriate methods, except when they need to be retained for subsequent research. Post-harvest materials from genetically modified crop varieties used for testing shall not be used as food for humans or livestock.

2. Genetically modified crop varieties used for subsequent research shall be transported, stored, and preserved according to the requirements set forth in Articles 15, 16, and 17, Chapter III of this Circular.

3. The testing organization shall apply appropriate measures to clean all tools used for harvesting testing to ensure that genetically modified crop varieties and post-harvest materials of genetically modified crop varieties are not disseminated outside the testing site or introduce other crop materials unintentionally into the testing site. Crop materials obtained during the cleaning process must be destroyed using appropriate methods.

4. The destruction of genetically modified crop varieties, post-harvest materials of genetically modified crop varieties, or crop materials obtained during the cleaning process shall be carried out immediately at the testing site.

5. The testing organization shall complete the harvest monitoring form according to the template in Appendix 6.3 of this Circular.

Article 19. Post-Harvest Field Management

1. After the completion of the testing, the testing organization shall be responsible for monitoring narrow test fields to control the unexpected growth of genetically modified crop varieties. The field monitoring period shall last at least three months from the end of the harvest, depending on the reproductive characteristics and dormancy period of the tested crop variety. In cases where the post-harvest test field is used for subsequent testing with the same genetically modified crop variety, the post-harvest monitoring period will be calculated from the end of the subsequent testing.

2. The testing organization shall ensure that no plants of the same species or species with the same reproductive system as the genetically modified crop variety are planted at the testing site during the post-harvest field monitoring period.

3. The testing organization shall complete the post-harvest monitoring form according to the template in Appendix 6.4 of this Circular.

Article 20. Reproductive Isolation in Narrow Test Fields

Test fields must be isolated from other crops of the same species or species with the same reproductive system in the surrounding area. Isolation must be maintained throughout the testing period. Reproductive isolation measures proposed in the testing plan shall be suitable for each tested crop variety, as follows:

1. Spatial isolation: Test fields of genetically modified crop varieties must be spatially isolated from other crops of the same species or species with the same reproductive system. The isolation distance depends on the reproductive characteristics of the tested crop species and is proposed in the testing plan. The testing organization shall be responsible for inspecting and removing crops of the same species or species with the same reproductive system within the isolation range using appropriate methods and completing the spatial isolation monitoring form according to the template in Appendix 6.5 of this Circular.

2. Temporal isolation: Genetically modified crop varieties tested shall be temporally isolated by planting the tested crop variety earlier or later than other crops of the same species or species with the same reproductive system in the surrounding area, so that the flowering and pollination periods of the tested crop variety do not coincide with those of other crops of the same species or species with the same reproductive system. The testing organization shall be responsible for inspecting and removing crops of the same species or species with the same reproductive system within the isolation range if temporal isolation is not ensured using appropriate methods and completing the temporal isolation monitoring form according to the template in Appendix 6.6 of this Circular.

Chapter IV

IMPLEMENTATION

Article 21. Department of Science, Technology and Environment

The Department of Science, Technology and Environment is a permanent unit responsible for assisting the Minister of Agriculture and Rural Development in organizing the management of the implementation of tasks related to the following specific activities:

1. Receiving registration files for risk assessment trials concerning biodiversity and the environment of genetically modified crop varieties submitted by the Applicant and registration files for trial organizations submitted by trial organizations.

2. Organizing the review of registration files and proposing the Minister of Agriculture and Rural Development to issue permits for trial planting of genetically modified crop varieties to the Applicant and designating trial organizations.

3. Drafting and submitting to the Minister of Agriculture and Rural Development for issuance the "List of Genetically Modified Crop Varieties Permitted for Trial Planting with the Purpose of Producing Crop Seeds in Vietnam".

Article 22. Supervisory Organization

1. Developing plans for regular or ad hoc inspections to promptly identify and address any cases that may arise during trials which could compromise safety. Reporting to the Ministry of Agriculture and Rural Development on the results of regular inspections, ad hoc inspections, and handling any issues arising during the trials.

2. When violations of trial regulations or risks that cannot be controlled are identified, the supervisory organization immediately reports to the Ministry of Agriculture and Rural Development for guidance on handling.

3. Within fifteen days after completing an inspection, the supervisory organization reports the results of the inspection in writing to the Ministry of Agriculture and Rural Development.

Article 23. Applicant

1. Providing complete and truthful information as required by this Circular and any updated information relevant to the trial process to the Ministry of Agriculture and Rural Development and being fully responsible for the information provided.

2. Paying registration fees and review fees for issuing trial permits according to current regulations and covering all costs related to the trial as agreed upon with the trial organization.

Article 24. Trial Organization

1. The trial organization is responsible for conducting impartial and transparent trials in accordance with the plan approved by the Ministry of Agriculture and Rural Development and the relevant provisions of this Circular. The trial organization is fully responsible for the results of its own conduct.

2. Reporting comprehensively and promptly to the Ministry of Agriculture and Rural Development in accordance with the provisions of this Circular.

3. Safeguarding information related to the Applicant and the trial process.

4. Not having the authority to publish trial results.

Article 25. Implementation Provisions

1. This Circular takes effect forty-five days from the date of issuance.

2. During implementation, if any difficulties, new issues, or obstacles arise, units, officials, civil servants, and employees shall promptly report them to the Department of Science, Technology and Environment for consolidation and submission to the Minister of Agriculture and Rural Development for consideration of amendments and supplements./.