Circular No. 23/2010/TT-BNNPTNT Recognizing Biotechnology Technological Advances in Agriculture and Rural Development

CIRCULAR

Recognize technological advances in biotechnology of the Agriculture and Rural Development sector

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Based on the Law on Science and Technology issued on June 22, 2000;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

On the basis of Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development and Decree No. 75/2009/NĐ-CP of the Government amending Article 3 of Decree No. 01/2008/NĐ-CP dated January 3, 2008 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Decree No. 127/2007/NĐ-CP dated  01  August  2007 of the Government stipulating implementation of certain provisions of the Law on Standards and Technical Regulations;

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

Based on Decision No. 97/2007/QĐ-TTg dated June 29, 2007 of the Prime Minister approving the "Project for Developing and Applying Biotechnology in Aquaculture until 2020";

AND OF AGRICULTURE AND RURAL DEVELOPMENT guiding the process ofrecognizing technological advances in biotechnology of the Agriculture and Rural Development sector as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

 This Circular stipulates the procedures and formalities for registering and recognizing technological advances in biotechnology to be applied in agriculture, forestry, aquaculture, and rural development under the management of the Ministry of Agriculture and Rural Development.

Article 2. Applicability

 This Circular applies to domestic and foreign organizations registering recognition of technological advances in biotechnology (hereinafter referred to collectively as the Registering Organization) and organizations and individuals related to evaluating and recognizing technological advances in biotechnology under the management of the Ministry of Agriculture and Rural Development.

Article 3. Explanation of Terms

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

1. Technological advances in biotechnology are technical processes, technologies, and products created using biotechnological techniques, methods, and approaches that meet the requirements and conditions as prescribed in this Circular shall be recognized and permitted for application in agricultural production by the Minister of Vietnam.

2. Agriculture and Rural Development issuing a decision to recognize and allow their application. Scientific and technological council at the grassroots levelis the Scientific and Technological Council  established by the organization applying for recognition of the technological advance in biotechnology or the Scientific and Technological Public Service Unit specialized in the field proposed for establishment by the organization applying for recognition of the technological advance in biotechnology.is the Scientific and Technological Council  of Scientific and Technological Council at the grassroots levelhas the task of evaluating research results, experimental production outcomes, and recommending recognition or not recommending recognition of technological advances in biotechnology based on the registration dossier as prescribed in this Circular. Research and Testing Organizations/Units/Bases recognized or designated

3. are scientific and technological organizations, public service units, or scientific and technological service organizations recognized or designated by competent state management agencies to conduct research and testingfor recognizing crop varieties, livestock breeds, plant protection chemicals, fertilizers, soil improvement products, animal feed, veterinary drugs, vaccines, products used in storage and processing of agricultural, forestry, and aquatic products, and environmental treatment. RECOGNITION OF TECHNOLOGICAL ADVANCES IN BIOTECHNOLOGY 1. Technological advances in biotechnology created in Vietnam

Chapter II

REGISTRATION Technological advances in biotechnology created in Vietnam shall be registered for recognition when meeting one of the following conditions:

Article 4. Conditions  registration             

a) They are the results of national-level, ministry-level, or equivalent scientific and technological research projects (topics, programs) that have been accepted and recommended for recognition by the Scientific and Technological Acceptance Council;

b) They are part of the results of national-level, ministry-level, or equivalent scientific and technological research projects recommended for recognition by the Scientific and Technological Council at the grassroots level;

c) The results of scientific and technological research projects conducted by scientific and technological organizations, enterprises, or professional social organizations that have been accepted and recommended for consideration for recognition by the Scientific and Technological Council at the grassroots level. 

2. Technological advances in biotechnology created abroad 

Technological advances in biotechnology created abroad shall be registered for recognition

when they have been effectively used abroad and included in the list

of high-tech technologies and high-tech products encouraged for transfer and use in Vietnam according to current legal regulations.  when it has been effectively used abroad and included in the list specialized agency under the People's Committee of the province/city.of high-tech industries and high-tech products encouraged for transfer and use in Vietnam under the current legal regulations.

Article 5. Procedure and formalities for registration and recognition

1. Application dossier for registration and recognition of technological advances in biotechnology services developed in Vietnam (hereinafter referred to as the application dossier)  (hereinafter referred to as the application dossier) The documents specified in point a, Clause 1 of this Article;

a) Registration form for recognition of technological advances in biotechnology (Annex 1);

b) Report on research and experimental production results of the registering organization (Annex 2);

c) Written comments from organizations and individuals applying the technological advances in biotechnology (Annex 3);

d) Decision establishing the Scientific and Technological Acceptance Council or the Scientific and Technological Basic Council, and minutes of meetings of the Scientific and Technological Acceptance Council or the Scientific and Technological Basic Council as stipulated in Clause 1, Article 4 of this Circular;

đ) Results of seed, livestock variety trials, plant protection chemicals, fertilizers, soil improvement products, animal feed, veterinary drugs, vaccines,  products used in storage, processing of agricultural, forestry, aquatic products, and environmental treatment according to current regulations implemented by the registering organization for technological advances in biotechnology created from state-funded science and technology tasks or by Organization/Unit/Cfor recognizing crop varieties, livestock breeds, plant protection chemicals, fertilizers, soil improvement products, animal feed, veterinary drugs, vaccines, products used in storage and processing of agricultural, forestry, and aquatic products, and environmental treatment. a) Report to the Ministry of Natural Resources and Environment on the results of training and upgrading, including listing the teaching staff participating in teaching, evaluating the participation of trainees in the training process, the results of organizing examinations for completing the training and upgrading program on land valuation business, the issuance of Certificates and the use of Certificate codes, summarizing the feedback from trainees on the quality of the training and upgrading program on land valuation business, and other relevant matters.;

e) In addition to the documents specified in points a to đ above, in the case where the registered technological advance is a crop variety, livestock variety, genetically modified microorganism, or product of a genetically modified organism, the application dossier must also include copies of certificates  of biosafety  of issued by competent state management agencies;

g) Other related documents (if any).

2. Application dossier for registration and recognition of technological advances  developed in Vietnam developed abroad shall include the following documents:

a) Registration form for recognition of technological advances in biotechnology (Annex 1);

b) Report on research and experimental production results of the registering organization (Annex 2);

c)Documents certifying technological advances developed in Vietnam or equivalent at the place of origin;

d) Results of seed, livestock variety trials, plant protection chemicals, fertilizers, soil improvement products, animal feed, veterinary drugs, vaccines,  products used in storage, processing of agricultural, forestry, aquatic products, and environmental treatment according to current regulations implemented by Organization/Unit/Cfor recognizing crop varieties, livestock breeds, plant protection chemicals, fertilizers, soil improvement products, animal feed, veterinary drugs, vaccines, products used in storage and processing of agricultural, forestry, and aquatic products, and environmental treatment. a) Report to the Ministry of Natural Resources and Environment on the results of training and upgrading, including listing the teaching staff participating in teaching, evaluating the participation of trainees in the training process, the results of organizing examinations for completing the training and upgrading program on land valuation business, the issuance of Certificates and the use of Certificate codes, summarizing the feedback from trainees on the quality of the training and upgrading program on land valuation business, and other relevant matters.;

đ) In addition to the documents specified in points a to d above, in the case where the registered technological advance is a crop variety, livestock variety, genetically modified microorganism, or product of a genetically modified organism, the application dossier must also include copies of certificates  of biosafety  of issued by competent state management agencies in Vietnam;

f) Other related documents (if any).

3. Submission and acceptance of application dossiers    

a) The application dossier consists of the documents prescribed in Clause 1 and 2  of this Article, packed in a sealed envelope containing one (01) original dossier and ten (10) copies of the original dossier, sent  to Department of Science, Technology and Environment, Ministry of Agriculture and Rural Development through postal service or submitted directly;

b) Within five working days from the date of receipt of the dossier registration, the Department of Science, Technology and Environment confirms and notifies in writing to Organization the applicant that the dossier meets the requirements and has been accepted;

c) In case the dossier registration if it is not complete, the Department of Science, Technology and Environment requests Organization the applicant to supplement. The waiting time for providing additional information is not counted towards the dossier confirmation period. The time for waiting to provide additional information shall not be counted towards the confirmation period of the dossier.

Chapter III

RECOGNITION, SUSPENSION, REVOCATION OF BIOTECHNOLOGY TECHNICAL PROGRESS

Article 6. Conditions for recognition Conditions for recognition

of technological advances in biotechnology

Technological advances in biotechnology are recognized when they meet the following conditions:

1. Higher economic, social, environmental protection, and food safety benefits compared to existing commonly used techniques, technologies, and products in production.

2. Suitable for production requirements (crop structure, season; reduced pest and disease levels; clean production, environmentally friendly, adaptable, avoiding adverse external conditions, higher competitiveness, protecting human health, developing traditional industries, better product quality, suitable for production conditions, customs and traditions, and other advantages).

3. Have undergone trials and tests meeting current regulations on trials and tests for recognizing crop varieties, livestock varieties, plant protection chemicals, fertilizers, soil improvement products, animal feed, veterinary drugs, vaccines, products used in storage, processing of agricultural, forestry, aquatic products, and environmental treatment.  4. Crop varieties, livestock varieties, genetically modified microorganisms, and products of genetically modified organisms can only be recognized as Technological Advances in Biotechnologywhen they have been granted certificates of safety for biodiversity, environment, and/or.

Article 7. Special Recognition

certificates of suitability for food or animal feed , process, formalities prescribed in  registration.

1. For Technological Advances in Biotechnology registered for recognition as the result of national-level, ministry-level, or equivalent state-funded scientific and technological projects (topics, projects) that have been accepted and recommended for recognition by the Scientific and Technological Acceptance Council, the Department of Science, Technology and Environment will base on the application dossier to submit to the Minister of Agriculture and Rural Development for issuance of a recognition decision within five working days from the date of acceptance 2. For Technological Advances in Biotechnology registered as crop varieties, livestock varieties, genetically modified organisms already included in the list of permitted production and business activities in Vietnam with gene events that have been grantedcertificates of safety for biodiversity, environment, or certificates of suitability for food or animal feed , process, formalities prescribed in  registration.

Article 8. Recognition through Independent Expert Advisory Group

1. In cases where necessary, the Ministry of Agriculture and Rural Development shall establish an Independent Expert Advisory Group (hereinafter referred to as the Expert Group) to evaluate applications for registration of biotechnology technological progress as results of state-level, ministry-level, or equivalent scientific and technological tasks that have been accepted and recommended for recognition by the Scientific and Technological Acceptance Council. The Expert Group shall consist of 3 to 5 members who are knowledgeable about the field being recognized, including: 01 Chairperson, 01 Secretary, and other members; none of whom shall be representatives of the registering organization.

2. Procedures for the Expert Group's work:

a. The Secretary of the Expert Group reads the decision establishing the Expert Group and introduces the attending delegates;

b. The Chairperson of the Expert Group chairs the meeting in the following sequence:

- Members of the Expert Group read their comments and evaluations of the application for registration according to the form (Appendix 4);

- Secretary The Expert Group reads the evaluation forms of absent members (if any) for The Expert Group reads reference;

- The Expert Group discusses and conducts voting to assess the biotechnology technological progress registered for recognition;

- The Chairperson of the Expert Group announces the voting results and drafts the assessment conclusion biotechnology technological progress registered for recognition;

- The Expert Group discusses to unify the content of the conclusion and approves the minutes of the meeting The Expert Group according to the form (Appendix 5);

3. The Science, Technology and Environment Department bases its recommendation on the conclusions of the The Expert Group Expert Group and submits it to the Minister of Agriculture and Rural Development for issuance of the recognition decision within 5 working days from the date the application has been completed according to the Expert Group's conclusions.

Article 9. Recognition through Scientific and Technological Council

1. For technological progress that is part of the results of state-level, ministry-level, or equivalent scientific and technological tasks; research results of scientific and technological tasks conducted by scientific and technological organizations, enterprises, and social-professional organizations that have been accepted and  recommended for recognition by the Basic Scientific and Technological Council, the Science, Technology and Environment Department, based on the application for registration, requests the Minister of Agriculture and Rural Development to establish a Scientific and Technological Council to evaluate the technological progress (hereinafter referred to as the Council),  consisting of 7 to 9 members who are knowledgeable about the field being recognized, including 01 Chairman, 01 Secretary, and 02 reviewing members. The number of Council members representing enterprises, localities, and management agencies shall not exceed 50%. In cases where necessary, Council members may be staff currently employed by the registering organization,  but not more than 01 person and shall not serve as Chairman, Vice-Chairman, or reviewing expert.Council members evaluate the application for registration according to the form in Appendix 4 and send it back to the Science, Technology and Environment Department at least one day before the Council meeting.

2. Procedures for the Council's work:

a) The Council Secretary reads the decision establishing the Council and introduces the attending delegates;

b) The Council Chairman chairs the meeting in the following sequence:

- Representatives of the Organization registration present a summary of the content of the biotechnology technological progress;

Ministry of Science and Technology: The Minister and Deputy Ministers, agencies and units under the Ministry;Reviewing members read their evaluation forms of the application for registration- The Council Secretary;

reads the evaluation forms of absent members (if any) for the Council to refer to;đ) Effectiveness and sustainability (intellectual property rights protection and/or practical applicability of products and results) of the project; - Council members ask questions to the

registering organization regardingThe Director of the Office, the Head of the Banking Inspection and Supervision Agency, the Heads of units under the State Bank of Vietnam, and commercial banks are responsible for organizing the implementation of this Circular. the content of the biotechnology technological progress Representatives of the Organization;

- answer the Council's questions; registration - The Council discusses and conducts voting to assess the

application for recognition technological advances developed in Vietnam - The Council elects a ballot counting committee consisting of 3 members, including one head;;

- The head of the ballot counting committee announces the counting results;

The Council Chairman drafts the assessment conclusion

- - The Council discusses to unify the content of the conclusion and approves the minutes technological advances developed in Vietnam - The Council elects a ballot counting committee consisting of 3 members, including one head;;

of the Council meeting (Appendix 6  according to the form The Science, Technology and Environment Department bases its recommendation on the Council's conclusions and submits it to the Minister of Agriculture and Rural Development for issuance of the recognition decision within 5 working days from the date the application has been completed according to the Council's conclusions.);

3. The Department of Science, Technology and Environment, based on the conclusion of the Council, shall submit to the Minister of Agriculture and Rural Development for issuance of the decision recognizing the technical progress within five working days from the date the application dossier has been completed according to the Council's conclusion.

Article 10. Suspension and Restoration of Effectiveness of Decision on Recognition

1. The Ministry of Agriculture and Rural Development recognizes biotechnology technical progress and has the right to suspend and restore the effectiveness of the recognition decision. and has the right to temporarily suspend, restore the effectiveness of the recognition decision.

2. The effectiveness of the recognition decision for biotechnology technical progress shall be suspended when there is a violation of any of the following cases: a) An organization with biotechnology technical progress does not implement its responsibilities as stipulated in Clause 2, Article 12 of this Circular;

b) Biotechnology technical progress, after being applied in practice for a period of time, fails to meet the requirements specified in Points a and b, Clause 5 of this Circular or adversely affects production, living conditions, and the environment; c) Violation of relevant provisions of the Intellectual Property Law.

b) Biotechnology technical progress 3. When there are signs of violation, the Science, Technology and Environment Department shall organize the determination of the violation and submit to the Minister of Agriculture and Rural Development for issuance of a decision to suspend the effectiveness of the recognition decision for biotechnology technical progress.  as stipulated in Clause a, b Article 5 of this Circular or adversely affecting production, living conditions, environment;

4. The recognition decision for biotechnology technical progress may have its effectiveness restored when the organization or individual with biotechnology technical progress whose effectiveness has been suspended has remedied the reasons for suspension as stipulated in Clause 2 of this Article. The procedure for restoring the effectiveness of the recognition decision for biotechnology technical progress is as follows:

a) Submit a report on the results of remedying the reasons for suspending the effectiveness of the recognition decision for biotechnology technical progress to the Science, Technology and Environment Department;

b) The Science, Technology and Environment Department shall organize the determination of the results of remedying the reasons for suspending the effectiveness and submit to the Minister of Agriculture and Rural Development for issuance of a decision to restore the effectiveness of the recognition decision for biotechnology technical progress. Article 11. Revocation of Effectiveness of Recognition Decision 1. Has the right to revoke the effectiveness of the recognition decision.

b) Biotechnology technical progress, after being applied in practice for a period of time, fails to meet the requirements specified in Points a and b, Clause 5 of this Circular or adversely affects production, living conditions, and the environment; 2. The recognition decision for biotechnology technical progress shall be revoked in the following cases:

a) Voluntary request for revocation;

b) After being applied in practice, biotechnology technical progress no longer meets the requirements specified in Points a and b, Clause 5 of this Circular and causes adverse consequences to production, living conditions, and the environment and cannot be remedied;

1. The Ministry of Agriculture and Rural Development recognizes biotechnology technical progress and has the right to suspend and restore the effectiveness of the recognition decision. c) Within one month from the date the suspension decision takes effect,

if the organization with biotechnology technical progress whose effectiveness has been suspended fails to remedy the reasons for suspension as stipulated in Clause 2 of Article 10 of this Circular.  Recognition decision of biotechnology technical progress Article 12. Rights and Obligations of Organizations with Recognized Technical Progress

b) Biotechnology technical progress, after being applied in practice for a period of time, fails to meet the requirements specified in Points a and b, Clause 5 of this Circular or adversely affects production, living conditions, and the environment; 1. Rights of organizations with recognized biotechnology technical progress:

a) To advertise, announce, apply biotechnology technical progress in production, transfer, assign, and other benefits as prescribed by law; b) To lodge complaints and denunciations regarding violations of their legitimate rights as prescribed by law and as stipulated in Clause 1 of this Article in the evaluation of their own biotechnology technical progress.  as stipulated in Clause a, b Article 5 of this Circular and causing adverse effects on production, living conditions, environment that cannot be remedied;

2. Obligations of organizations with recognized biotechnology technical progress:  a) To provide necessary documents and materials about the recognized biotechnology technical progress upon request of competent state agencies; b) To guide the application procedures of biotechnology technical progress for organizations and individuals receiving transfers;

Article  c) To fully perform current national responsibilities; developed in Vietnam d) Not to exercise the rights stipulated in Clause 1 of this Article during the period when the effectiveness of the recognition decision for biotechnology technical progress is suspended. received

1. Rights of organizations with recognized biotechnology technical progress include:

a) Promoting, announcing, applying biotechnology technical progress in production, transferring, assigning and other benefits as prescribed by law;

b) Filing complaints and denunciations against acts violating their legitimate rights as prescribed by law and as stipulated in Clause 1 of this Article regarding the incorrect assessment of biotechnology technical progress of their own;

2. Obligations of organizations with recognized biotechnology technical progress:  

a) Providing necessary documents and materials about the recognized biotechnology technical progress when requested by competent state agencies;

b) Guiding the technical procedures for applying the recognized biotechnology technical progress to organizations and individuals receiving the transfer;

c) Fulfilling all responsibilities as currently prescribed by the State;

d) Shall not exercise the rights stipulated in Clause 1 of this Article during the suspension period of the recognition decision's effectiveness of biotechnology technical progress.

Article 13. Funding for the activities of evaluating and recognizing technological advances in biotechnology

1. The registering organization must pay the related expenses for the evaluation and recognition of technological advances in biotechnology in accordance with the regulations. In cases where there are no state regulations, the costs shall be agreed upon by the parties involved. 

2. The expenses for the activities of evaluating and recognizing technological advances in biotechnology shall be implemented in accordance with the current regulations on the acceptance of national-level scientific and technological tasks.

Chapter IV

IMPLEMENTATION

Article 14. Responsibilities of the Department of Science, Technology, and Environment

1. Receiving and organizing the assessment of registration files, submitting to the Minister of Agriculture and Rural Development for issuance of decisions recognizing technological advances developed in Vietnam, decisions to temporarily suspend, restore, or revoke decisions recognizing technological advances in biotechnology;

2. connection as stipulated in Clause 1, Article 4 of this Circular but cannot implement the signal connection, the managing organization of road traffic signals, the project investor shall report to the Ministry of Transport for consideration and decision. coordinating with relevant units inspecting, handling complaints and denunciations, and dealing with violations in registration, recognition, and application of technological advances in biotechnology according to the provisions of this Circular.

3. Summarizing and reporting periodically (every six months, annually) and ad hoc as required by the Minister of Agriculture and Rural Development on the results of registration and recognition of technological advances in biotechnology.

4. Coordinating with General Departments, Sector Management Agencies, Provincial Departments of Agriculture and Rural Development to organize inspections, assess the application of technological advances developed in Vietnam in production. Article 15. Responsibilities of General Departments, Sector Management Agencies

Directing the implementation and application of recognized technological advances

1. within their specialized fields developed in Vietnam throughout the country 2. Leading and coordinating with the Department of Science, Technology, and Environment Provincial Departments of Agriculture and Rural Development to organize inspections, and propose commendation forms for organizations that effectively apply technological advances.

in agriculture and rural development;, Summarizing and reporting periodically (every six months, annually) and ad hoc as required by assess the application of technological advances developed in Vietnam in production. the Minister of Agriculture and Rural Development (through the Department of Science, Technology, and Environment) developed in Vietnam on the results

3. of applying technological advances in management areas. Article 16. Responsibilities of Provincial Departments of Agriculture and Rural Development developed in Vietnam Directing the implementation

of supervision over the application of technological advances in biotechnology  2. Inspecting and assessing the results of applying technological advances

1.  within their jurisdiction  and Summarizing and reporting periodically (every six months, annually) and ad hoc as required by within their jurisdiction.

the Ministry of Agriculture and Rural Development (through the Department of Science, Technology, and Environment). developed in Vietnam During the implementation process, if difficulties arise, localities, organizations, and individuals are requested to promptly report and reflect these issues to the Ministry of Agriculture and Rural Development for review, amendment, and supplementation./..        

3. Summarizing and submitting regular reports (every six months, annually) and ad hoc reports as required by the Minister of Agriculture and Rural Development Article 16. Responsibilities of Provincial Departments of Agriculture and Rural Development developed in Vietnam within their jurisdiction.

Article 17. Implementation Provisions

1. This Circular takes effect 45 days from the date of issuance.

2. During implementation, if there are difficulties or obstacles, localities, organizations, and individuals are requested to promptly report and reflect to the Ministry of Agriculture and Rural Development for review, amendment, and supplementation./.