Circular No. 19/2010/TT-BTNMT on registering for circulation of biological products in waste treatment in Vietnam

CIRCULAR

Regulations on Registration for Circulation of Biological Products

in Waste Management in Vietnam

__________________

MINISTER OF NATURAL RESOURCES AND ENVIRONMENT

The Prime Minister issues this Decision amending and supplementing certain provisions of the Regulation on Response Activities to Oil Spill Incidents issued together with Decision No. 02/2013/QĐ-TTg dated January 14, 2013 of the Prime Minister.

Pursuant to Decree No. 80/2006/NĐ-CP dated August 9, 2006 of the Government detailing and guiding the implementation of certain provisions of the Environmental Protection Law; Decree No. 21/2008/NĐ-CP dated February 28, 2008 amending and supplementing certain provisions of Decree No. 80/2006/NĐ-CP dated August 9, 2006 of the Government detailing and guiding the implementation of certain provisions of the Environmental Protection Law;

Pursuant to Decree No. 25/2008/NĐ-CP dated March 4, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Natural Resources and Environment;

Upon the proposal of the Director General of the Department of Environment and the Head of the Legal Department;

c) Enterprises may be granted permission for no more than one block out of the total three dual-frequency blocks (FDD) B

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. These Circulars stipulate the procedures and formalities for registering biological products for circulation in waste prevention, reduction, and treatment in Vietnam to issue the List of Biological Products Used in Waste Prevention, Reduction, and Treatment in Vietnam (hereinafter referred to as the List of Biological Products for Waste Treatment in Vietnam).

2. Biological products used in waste prevention, reduction, and treatment (hereinafter collectively referred to as biological products) that have been registered according to current laws are not within the scope of regulation of these Circulars.

Article 2. Applicability

These Circulars apply to state management agencies; domestic organizations and individuals, foreign organizations and individuals (hereinafter collectively referred to as organizations and individuals) engaged in activities related to evaluating registration dossier for circulation of biological products for waste treatment; production, business, import, and testing of biological products for waste treatment in Vietnam.

Article 3. Explanation of Terms

1. Biological products for waste treatment are biological-origin products used to treat waste, including microorganisms, enzymes, and extracts from animals, plants, and microorganisms, excluding genetically modified organisms.

2. Testing of biological products for waste treatment is the activity of assessing the characteristics, effectiveness, and safety of biological products for waste treatment under specific conditions and scale.

Article 4. Principles for Circulation of Biological Products

1. Organizations and individuals with biological products must register with the competent authority for examination and issuance of the Certificate of Circulation of Biological Products before circulation and use.

2. The Certificate of Circulation of Biological Products shall be issued by the competent state agency based on the results of testing and the conclusion of the Scientific Council evaluating the registration dossier for circulation of biological products.

3. Organizations and individuals registering for circulation of biological products must pay fees and charges as prescribed by current laws.

Article 5. Establishment, Functions, and Working Principles of the Scientific Council Evaluating the Registration Dossier for Circulation of Biological Products

1. The Director of the General Department of Environment shall be responsible for establishing the Scientific Council Evaluating the Registration Dossier for Circulation of Biological Products (hereinafter referred to as the Council). The Council must ensure at least seven members including: the Chairman of the Council, the Secretary, and Council members who are persons with a bachelor's degree or higher in relevant fields, having experience in the specialized field of biology, biotechnology, and environmental technology.

2. The Council has the function of advising the Director of the General Department of Environment to evaluate the effectiveness and safety for human health and wildlife of biological products.

3. The Council operates on the principle of collective work, open discussion among Council members, and concludes by majority decision.

Article 6. Responsibilities and Authorities of the Council

1. Responsibilities and authorities of Council members:

a) Participate in activities before, during, and after formal Council meetings when required;

b) Study files and documents related to registered biological products and provide written comments on the contents of the file;

c) Perform duties at Council meetings in a scientific, honest, and impartial manner. Write evaluation forms at formal Council meetings;

d) Manage provided documents in accordance with the law and return these documents to the Council's Standing Office upon completion of tasks;

đ) Be entitled to remuneration according to current financial regulations when performing tasks;

2. Responsibilities and authorities of the Chairperson of the Council:

In addition to the responsibilities and authorities of Council members as stipulated in Clause 1 of this Article, the Chairperson of the Council also has the following responsibilities and authorities:

a) Control Council meetings in accordance with this Circular and relevant laws;

b) Summarize and process opinions exchanged and discussed at formal Council meetings, prepare conclusions for approval by the Council and announce the Council's evaluation results;

c) Bear responsibility for Council activities and evaluations and conclusions made by the Council;

3. Responsibilities and authorities of the Secretary of the Council:

In addition to the responsibilities and authorities of Council members as stipulated in Clause 1 of this Article, the Secretary of the Council also has the following responsibilities and authorities:

a) Record Council meeting minutes comprehensively and truthfully;

b) Provide evaluation forms for Council members; the evaluation form includes the following main contents: evaluate the composition, characteristics, effectiveness of the biological product compared to the manufacturer's documentation; safety for human health and living organisms;

c) Complete and transfer formal Council meeting minutes, all files, and related documents to the Council's Standing Office;

d) Read relevant reports during Council meetings;

Article 7. Activities of the Council

1. Conditions for organizing formal Council meetings:

a) Presence of the Chairperson of the Council and at least 2/3 of the number of Council members as decided by the organization establishing the assessment and evaluation;

b) Presence of representatives of organizations and individuals proposing registration for circulation of biological products and the testing agency of biological products;

c) Availability of complete files and comments from Council members;

2. Content and sequence of formal Council meetings:

a) Representatives of organizations and individuals registering for circulation of biological products present the origin, production process, composition, usage method, effectiveness, efficacy, and safety of the biological product;

b) The Council secretary reads the report on the testing results of the testing agency of biological products; report on monitoring and inspection results of the implementation of the testing plan;

c) Question-and-answer session between Council members and representatives of organizations and individuals registering for circulation of biological products, and the testing agency of biological products regarding unclear issues;

d) Council members present their comments and evaluations;

đ) Council members, delegates, and representatives of organizations and individuals registering for circulation of biological products, and the testing agency of biological products proceed to discuss;

e) The Chairperson of the Council announces the evaluation result and reads the proposed conclusion of the Council;

g) Council members propose recommendations (if any) for revising and supplementing the proposed conclusion of the Council;

h) Representatives of organizations and individuals registering for circulation of biological products make statements;

i) The Chairperson of the Council announces the Council's conclusion; this conclusion must be agreed upon by at least 2/3 of the total number of Council members and clearly recorded in the evaluation form;

3. Formal Council meeting minutes record the proceedings of the meeting and the discussion and comments of Council members at the formal Council meeting and are signed by the Chairperson and Secretary of the Council with their full names.

Article 8. Standing Office of the Council

The Director of the Environmental Protection General Department shall arrange one (01) specialized organization or department under the General Department that has appropriate functions and tasks to serve as the Standing Office of the Professional Science Council for reviewing registration files for biological product circulation.

Article 9. Tasks and Activities of the Standing Office of the Council

1. Assist the Director of the Environmental Protection General Department in receiving, studying, and processing registration files and related documents submitted by organizations or individuals applying for biological product circulation.

2. Prepare, provide, and facilitate conditions for Council members to study registration files and related documents to support the Council's activities.

3. Publish registration files for circulation on the electronic information website (website) of the Ministry of Natural Resources and Environment, the Environmental Protection General Department, or other means of communication to collect opinions from relevant organizations and individuals.

4. Propose the Director of the Environmental Protection General Department to organize or delegate to the Provincial Environmental Protection Agencies (hereinafter referred to as Local Environmental Protection Agencies) to inspect and supervise the testing plan for using biological products.

5. Prepare necessary conditions for the Council to convene meetings.

6. Receive registration files, testing results, and Council's evaluation results to process and carry out necessary procedures to submit to the Director of the Environmental Protection General Department for consideration and decision to issue a Circulation Permit for Biological Products.

7. Review registration files and propose the Director of the Environmental Protection General Department to extend the Circulation Permit for Biological Products.

Article 10. List of Biological Products for Waste Treatment in Vietnam

1. Biological products granted a Circulation Permit for Biological Products must be compiled into a List of Biological Products for Waste Treatment in Vietnam and published on the electronic information website (website) of the Ministry of Natural Resources and Environment, the Environmental Protection General Department.

2. Every six months, the Director of the Environmental Protection General Department is responsible for compiling and submitting the List of Biological Products for Waste Treatment in Vietnam to the Minister of Natural Resources and Environment for approval.

Chapter II

PROCEDURE AND REGULATIONS FOR REGISTERING CIRCULATION OF BIOLOGICAL PRODUCTS

Article 11. Biological Products Required to Register for Circulation

1. Domestic-produced or imported biological products not listed in the List of Biological Products for Waste Treatment in Vietnam.

2. Biological products listed in the List of Biological Products for Waste Treatment in Vietnam but with changes in composition or active substance concentration affecting treatment effectiveness and safety for human health and living organisms.

Article 12. Registration Files for Circulation of Biological Products

1. A request for registration for circulation of biological products according to the form prescribed in Appendix 1 attached to this Circular.

2. A copy of the Business Registration Certificate or equivalent, certified by the organization or individual.

3. Production process of the biological product.

4. Test result certificate or quality analysis report of the biological product issued by a domestic or foreign certification unit.

5. Summary introduction of the biological product according to the form prescribed in Appendix 2 attached to this Circular and related documents:

a) Composition;

b) Characteristics, efficacy, usage instructions, storage;

c) Safety for human health and living organisms;

d) Documentation on the origin of the original microorganism strain for microbial products.

6. Evaluation report of the management-level scientific council for biological products resulting from scientific research projects.

7. Testing or trial results of the biological product (if available).

8. Proposed official label, packaging design for circulation, along with the storage and usage guide for the biological product and warnings about risks to human health and living organisms.

9. Patent protection certificates or commitments not to infringe intellectual property regulations for domestically produced products applying for registration for circulation according to the form prescribed in Appendix 3 attached to this Circular; Circulation Permit for Biological Products issued by the competent authority of the producing country for imported biological products.

10. Detailed testing plan, including the following main contents: testing content, time, location, and testing agency for biological products without recognized testing results.

Article 13. Submission, Review, and Evaluation of the Biological Product Registration File

1. Organizations and individuals with biological products as specified in Article 11 of this Circular shall prepare two (2) sets of biological product registration files in accordance with Article 12 of this Circular to be submitted to the General Department of Environment for review, evaluation, and issuance of the Certificate of Circulation of Biological Products in Vietnam.

2. Within ten (10) working days from the date of receipt of the file, the General Department of Environment shall be responsible for reviewing the completeness and validity of the file. In cases where the file is incomplete or invalid, a written notice must be issued to the organization or individual applying for registration to make corrections and supplements.

3. Within ten (10) working days from the completion of the review of the completeness and validity of the file, the General Department of Environment shall be responsible for issuing a written notification regarding the monitoring and inspection program according to the detailed testing plan contents of the organization or individual applying for circulation of biological products and the testing agency as stipulated in Clause 10 of Article 12 of this Circular.

4. Within fifteen (15) working days from the date of receipt of a valid biological product circulation registration file, the Director of the General Department of Environment shall be responsible for establishing a specialized scientific board to evaluate the biological product circulation registration file in accordance with Articles 5, 6, and 7 of this Circular.

Article 14. Procedures for Issuing the Certificate of Circulation of Biological Products

1. Based on the results of the evaluation of the biological product circulation registration file by the Board, within seven (7) working days from the date of receipt of the file, the General Department of Environment shall be responsible for issuing the Certificate of Circulation for each type of registered biological product. The Certificate of Circulation of Biological Products shall follow the model prescribed in Appendix 4 attached to this Circular.

In cases where the Certificate of Circulation of Biological Products is not issued, the General Department of Environment shall be responsible for issuing a written notice to the organization or individual applying for circulation of biological products and clearly stating the reasons.

2. The Certificate of Circulation of Biological Products is valid for no more than sixty (60) months from the date of issuance.

Article 15. Procedures for Extending the Certificate of Circulation of Biological Products

1. The Certificate of Circulation of Biological Products may be extended when the previously issued Certificate of Circulation of Biological Products has expired.

2. Organizations and individuals requesting an extension of the Certificate of Circulation of Biological Products shall prepare two (2) sets of files to be submitted to the General Department of Environment thirty (30) days before the expiration of the previously issued Certificate of Circulation of Biological Products. The extension application file includes:

a) A request for extension of the Certificate of Circulation of Biological Products following the model prescribed in Appendix 5 attached to this Circular;

b) A report on the results of using the biological product including: quality stability, effectiveness, safety for human health and living organisms of the currently used biological product at specific projects accompanied by analysis and evaluation result sheets from competent units;

c) A copy of the previously issued Certificate of Circulation of Biological Products.

3. Within five (5) working days from the date of receipt of the file, the General Department of Environment shall be responsible for reviewing the completeness and validity of the file. In cases where the file is incomplete or invalid, a written notice must be issued to the organization or individual requesting an extension of the Certificate of Circulation of Biological Products to make corrections and supplements.

4. Within five (5) working days from the date of the on-site inspection of the application facility for the biological product requesting an extension of the Certificate of Circulation of Biological Products, the Permanent Office of the Board shall proceed with necessary procedures to submit to the Director of the General Department of Environment for consideration and decision to extend the Certificate of Circulation of Biological Products.

The on-site inspection of the application facility for the biological product shall be carried out in accordance with Article 16 of this Circular.

5. The Certificate of Circulation of Biological Products can be extended multiple times, each extension being valid for no more than thirty-six (36) months from the date of issuance.

Article 16. On-site inspection of facilities applying biological products requesting extension of Biological Product Circulation Certificate

1. Within 10 (ten) working days from the date of completing the examination of the completeness and validity of the application for extending the Biological Product Circulation Certificate, the General Department of Environment shall establish an on-site inspection team or authorize the local Environmental Protection Agency to establish an on-site inspection team to inspect the use of biological products at the location where they are currently being applied according to the application for extending the Biological Product Circulation Registration Certificate.

2. The on-site inspection team shall consist of representatives from the General Department of Environment or the local Environmental Protection Agency and experts in biotechnology.

3. Contents of the on-site inspection include reviewing the stability, effectiveness, and safety to human health and living organisms when using the product compared to the initial registration certificate for biological products; recommending whether to extend or not extend the Biological Product Circulation Registration Certificate.

4. The results of the inspection shall be recorded in a report, signed by all parties involved and representatives of the facility applying the biological product.

Article 17. Revocation of Biological Product Circulation Certificate

1. The Biological Product Circulation Certificate shall be revoked in the following cases:

a) The Biological Product Circulation Certificate was issued in violation of regulations;

b) Changes in the composition of the biological product;

c) There is confirmation by the competent authority regarding the infringement of industrial property rights for registered circulating biological products;

d) The Biological Product Circulation Certificate has expired.

2. Organizations and individuals whose Biological Product Circulation Certificate is revoked shall be responsible for recalling and disposing of the biological products that have been produced, imported, and circulated according to the provisions of the law.

3. When the Biological Product Circulation Certificate is revoked, the General Department of Environment shall be responsible for removing the biological product from the list of biological products for waste treatment in Vietnam and publishing it on the website of the General Department of Environment.

Chapter III

BIOPRODUCT TESTING IN VIETNAM

Article 18. Testing Facility for Biological Products

1. A testing facility is an organization with the function of researching and transferring biotechnology or environmental technology (as per the establishment decision or scientific and technological activity registration certificate issued by the competent authority) which possesses adequate equipment, raw materials, and personnel to implement applications at the site according to the biological product usage guidelines.

2. Organizations and individuals proposing to register the circulation of biological products may select the agency and location for testing and must pay the costs of conducting the test as agreed in the contract.

3. After signing the contract, the testing agency prepares necessary procedures, contents related to the implementation process and plan, and submits a detailed testing program plan for using biological products to the General Department of Environment within 5 (five) working days. The detailed plan content is stipulated in Clause 10, Article 12 of this Circular.

4. The testing facility shall independently choose cooperating agencies during the testing period and shall bear legal responsibility for the published testing results; shall be responsible for storing the testing result files for at least 60 (sixty) months after the end of the testing period.

Article 19. Content and methods for testing biological products

1. The content of testing for each type of biological product includes:

a) The composition and quality of the biological product according to the published standards;

b) The effectiveness of using the biological product according to the instructions for using biological products;

c) Safety for human health and living organisms during the use of biological products.

2. Testing methods shall be carried out in accordance with relevant technical standards and regulations or other methods ensuring objectivity and scientific accuracy.

Article 20. Report on Testing Results of Biological Products

The report on testing results of biological products by the testing facility must include the following contents:

1. Name of the testing facility and name of the organization or individual requesting the test.

2. Name of the tested biological product along with the file containing information about its composition, effectiveness, storage, usage, labeling, and packaging.

3. Condition of the biological product before testing.

4. Content of the requested testing.

5. Location, time, scale, and method of testing.

6. Testing results.

7. Conclusions and recommendations.

Article 21. Supervision and Inspection of Testing of Biological Products

1. The General Department of Environment shall be responsible for supervising, inspecting, or delegating the local Environmental Protection Agency to carry out supervision and inspection of the testing of biological products for use in accordance with the notification provisions set forth in Clause 3, Article 13 of this Circular.

2. The inspection team shall consist of representatives from the General Department of Environment or the local Environmental Protection Agency and experts in biotechnology.

3. The content of supervision and inspection shall be conducted in accordance with the provisions stipulated in Article 19 of this Circular.

4. The results of supervision and inspection must be documented in writing together with discussion opinions and recommendations with the presence and confirmation of all members of the inspection team and representatives of the biological product testing facility.

Chapter IV

IMPLEMENTING PROVISIONS

Article 22. Implementation organization

1. Organizations and individuals having biological products for waste treatment in Vietnam that have registered for circulation in accordance with the law prior to the effective date of this Circular shall be responsible for compiling and submitting a list of circulating biological products to the General Department of Environment for inclusion in the List of Biological Products for Waste Treatment in Vietnam.

2. The Director of the General Department of Environment shall be responsible for organizing the registration of circulation of biological products for waste treatment in Vietnam; guiding, inspecting, monitoring, and urging the implementation of this Circular.

3. The Minister, Head of a ministry-level agency, Head of an agency under the Government, Chairperson of People's Committees at all levels, and organizations and individuals related thereto shall be responsible for implementing this Circular.

Article 23. Effectiveness of Implementation

This Circular takes effect from December 10, 2010.

During the implementation of this Circular, if there are difficulties or obstacles, please promptly reflect them to the Ministry of Natural Resources and Environment for consideration and resolution./.