Thông tư 02/2014/TT-BNNPTNT

CIRCULAR

REGULATING THE ORDER AND PROCEDURES FOR ISSUING AND REVOKING THE CERTIFICATE OF GENETICALLY MODIFIED PLANTS ELIGIBLE FOR USE AS FOOD AND FEED

Pursuant to Decree No.199/2013/ND-CP dated November 26, 2013 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms;

Pursuant to Decree No. 108/2011/ND-CP dated November 30, 2011 of the Government amending a number of articles of Decree No. 69/2010/ND-CP on biosafety of genetically modified organisms, genetic specimens materials and products of genetically modified organisms;

Pursuant to Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing the implementation of a number of articles of the Law on Food Safety;

At the request of the Director Department of Science, Technology and Environment;

Minister of Agriculture and Rural Development issues Circular regulating the order and procedures for issuing and revoking Certificate of genetically modified plants eligible for use as food and feed;

Chapter I

GENERAL REGULATION

Article 1. Scope of adjustment

This Circular regulates the order and procedures for issuing and revoking Certificate of genetically modified plants eligible for use as food and feed;

Article 2. Subject of application

This Circular applies to foreign and domestic organizations and individuals (hereafter referred to as organizations and individuals) engaged in activities related to the issue and revocation of Certificate of genetically modified plants eligible for use as food and feed (hereafter referred to as Certificate) in the territory of Vietnam;

Article 3. Explanation of terms

In this Circular, the terms below are construed as follows:

1. Genetically modified plants are the genetic specimens, plants and direct products of plants carrying one or more new genes created by recombinant DNA technology

2. Risk assessment of genetically modified plants for human and animal health (hereafter referred to as risk assessment) is the activities to determine potential risks and the likelihood of risks of genetically modified plants when used as food and feed.

3. Transgenic event is the result of targeted DNA recombination to a certain position in the genome of a plant varieties in order to create a similar tree carrying the targeted gene;

4. Developed countries are countries with advanced biotechnology in the group of countries in the Organisation of Economic Cooperation and Development - OECD and the group G20 major economies

5. Unique identification code is the code identified by the Organization for Economic Cooperation and Development for each transgenic event.

Article 4. Risk assessment criteria for genetically modified plants eligible for use as food and feed

1..Comparing the nutrient composition of genetically modified plants with the equivalent traditional plants;

2. Assessing the ability to metabolize the nutrient compositions, especially the new substances as the product of transgene expression when used as food and feed.

3. Assessing the potential toxicity of new substances as the product of transgenic expression when used as food and feed.

4. Assessing the allergenicity of new substances as the product of transgenic expression when used as food and feed.

5. Assessing the ability to form new compounds, the likelihood of causing diseases or other adverse effects on human and animal health (eg, the potential impacts from the processing, the change in nutritional quality, functional nutrition, the accumulation of new substances; antibiotic resistance genes).

Chapter II

ISSUING AND REVOCATION OF CERTIFICATE

Article 5. Cases of required registration for issuing Certificate

1. The genetically modified plants carry the single transformation event as a result of transformation of a gene specifying a desired trait by the transgenic technology;

2. The genetically modified plants carry the vector stacked transformation event as a result of transformation of two or many genes specifying one or many desired traits by the transgenic technology;

Article 6. Conditions for issuing Certificate

The genetically modified plants issued with the Certificate must meet one of two conditions as follows:

1. The genetically modified plants are permitted for use by at least 05 (five) developed countries as food and feed without any risk in these countries;

2. The genetically modified plants whose registration dossiers for issuing Certificate of genetically modified plants eligible for use as food and feed are appraised by the Council of food and feed safety (hereafter referred to as Council) for conclusion that the genetically modified plants have no uncontrollable risks for human and animal health;

3. Other cases

a) Where the event of genetically modified plants has been issued with Certificate of eligibility for use as food, then the event of genetically modified plants is used as feed;

b) Where the plants carrying the vector stacked transformation event as the result of convergence hybridization by the method of traditional hybridization from two or single transformation events that have been issued with Certificate, these plants shall be used as food and feed;

Article 7. Registration dossier for issuing Certificate

1. A number of dossier: 03 (three) sets including 01 (one) original and 02 (two) copies;

2. In case of registration for issuing Certificate to the persons specified in Clause 1, Article 6 of this Circular. The dossier includes:

a) Registration application for issuing Certificate under the form specified in Appendix 1 of this Circular;

b) Risk assessment report (attached to the electronic file) on the genetically modified plants for human and animal health (hereafter referred to as risk assessment report) under the form prescribed in Appendix 2 of this Circular;

c) Summary of risk assessment report under the Form specified in Appendix 3 of this Circular (attached to the electronic file);

d) Information declaration published for public opinion under the form prescribed in Appendix 4 of this Circular;

dd) The original or certified copy and the Vietnamese translation (with notary’s certification) of the Certificate or equivalent documents of the competent authorities permiting for use as food and feed in at least 05 developed countries;

3. In case of registration for issuing Certificate to the persons specified in Clause 2, Article 6 of this Circular, the dossier includes:

a) Documents specified at Points a, b, c and d, Clause 2 of this Article;

b) The original or certified copy and the Vietnamese translation (with notary’s certification) of the Certificate or equivalent documents of the competent authorities permiting for use as food and feed in other countries (if any);

c) The scientific references, unpublished studies and data from the assessment, testing, or other scientific evidences (if any) that organizations and individuals register to use as the basis for conclusion of genetically modified plants (if issued with Certificate not causing adverse effect on human and animal health).

4. In case of registration for issuing Certificate to the persons specified in Clause 2, Article 5 of this Circular, the dossier includes:

a) Documents specified in Clause 2 of this Article (in case of registration for issuing Certificate to the persons specified in Clause 1, Article 6 of this Circular);

b) Documents specified in Clause 3 of this Article (in case of registration for issuing Certificate to the persons specified in Clause 2, Article 6 of this Circular);

c) The additional data of risk assessment report on the interaction of transgenes in the structure, the conservation and integrity of structure and function and expression of targeted gene in gene-receiving plants;

Article 8. Receiving and verifying registration dossier for issuing Certificate

1. Organizations and individuals registering the issue of Certificate shall send their dossiers directly or by post to the standing organs of the Ministry of Agriculture and Rural Development (Department of Science, Technology and Environment).

2. The Department of Science, Technology and Environment shall verify and give a written notice (under the Form specified in Appendix 5 of this Circular) to the organizations and individuals that perform registration within 07 (seven) working days after the receipt of valid dossier or requirement for addition and completion of dossier. The time for addition and completion of dossier is not included in the time to verify the validity of dossier;

3. After receving vlid dossier, the Department of Science, Technology and Environment shall publish information and summary of report on risk assessment on the website of the Ministry of Agriculture and Rural Development to gather public opinions for submission to the Council. The maximum time to gather public opinions is 30 (thirty) days after the information is published;

4. After receiving valid dossier, the Department of Science, Technology and Environment shall set up a Council to evaluate the registration dossier for issuing Certificate within 30 (thirty) days for dossiers registered under Clause 1, Article 6 of this Circular and 180 (one hundred and eighty days) for dossiers registered under Clause 2, Article 6 of this Circular;

Article 9. Issue of Certificate

Based on the result of assessment of the Council, the Department of Science, Technology and Environment shall submit it to the Minister of Agriculture and Rural Development for consideration and decision on issuing Certificate to the registering organizations and individuals;

2. Where the registration dossier is eligible for issue of Certificate, the Minister of Agriculture and Rural Development shall make a decision on issuing Certificate (under the Form specified in Appendix 6 of this Circular) within 30 (thirty) days from the date of appraisal result of the Council;

3. Where the registration dossier is not eligible for issuing Certificate, the Department of Science, Technology and Environment shall notify in writing specifying the reason to the registering organizations and individuals;

Article 10. Revocation of Certificate

1. The Certificate shall be revoked in cases specified in Clause 1, Article 29 and Clause 1, Article 34 of Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for the genetically modified organisms, genetic specimens, and products of genetically modified organisms (hereafter referred to as Decree No. 69/2010/ND-CP).

2. Based on each specific case, the Ministry of Agriculture and Rural Development shall consider and decide upon the revocation of Certificate;

a) For cases specified at Point a and b, Clause 1, Article 29 and Point a and b, Clause 1, Article 34 of Decree No. 69/2010/ND-CP the Ministry of Agriculture and Rural Development shall set up a Council to appraise dossier and consider the revocation of Certificate;

b) For cases specified at Point c, Clause 1 Article 29 and Point c, Clause 1, Article 34 of Decree No. 69/2010/ND-CP the Department of Science, Technology and Environment shall request the consideration and decision from the Ministry of Agriculture and Rural Development;

3. The Department of Science, Technology and Environment shall:

a) Hold meetings of the Council or independent consultation Council (in case of violation of provisions at Point c, Clause 1, Article 29 and Point c, Clause 1, Article 34 of Decree No. 69/2010/ND-CP) to appraise dossier for revocation of Certificate for cases of violation;

b) Based on appraisal result of the Council, submit it to the Minister of Agriculture and Rural Development to consider and make a decision on revocation of Certificate;

c) Make an announcement on mass media and organs concerned within 03(three) days from the date of decision on revocation of Certificate and send the Decision (the original) to the organizations and individuals whose Certificates have been revoked;

Article 11. Making a list, adding and deleting the name of genetically modified plants in the List of genetically modified plants issued with Certificate

The Department of Science, Technology and Environment shall:

1. Establish and publish the List of genetically modified plants issued with Certificate on the website of the Ministry of Agriculture and Rural Development;

2. Add and publish on the website of the Ministry of Agriculture and Rural Development: the genetically modified plants issued with Certificate in the List of genetically modified plants issued with Certificate of eligbility for use as food and feed  within 10 (ten) days from the date of the decision on issue of Certificate.

3. Delete and publish on the website of the Ministry of Agriculture and Rural Development: the genetically modified plants subject to cases of violation in the List of genetically modified plants issued with Certificate in the List of genetically modified plants issued with Certificate of eligbility for use as food and feed  within 10 (ten) days from the date of the decision on revocation of Certificate.

Chapter III

COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY

Article 12. Organization of Council

1. The Council is an organization which is established by the decision of the Minister of Agriculture and Rural Development to advise the Minister in issuing and revoking the Certificate.

2. The Council has 11 (eleven) members including the Chairman, Vice Chairman as representative of the Ministryof Agriculture and Rural Development: 01 representative of Ministry of Industry and Trade; 01 representative of the Ministry of Science and Technology; 01 representative of Ministry of Agriculture and Rural Development; 01 representative of Ministry of Health and experts in the relevant areas. The term of Council is 03 (three) years;

3. The funds for Council’s operation shall comply with the current regulations of law;

Article 13. Activities of the Council

1. The Council works on the principle of democracy, objectivity and take personal responsibility for the scientific aspect and accuracy of the independent comments and assessment and collective responsibility for the general conclusion of the Council.

2. The Council’s meetings must be presented by at least two thirds of the members under the chairmanship of the Chairman or Vice Chairman of the Council (in the case of absence of the Chairman of the Council). The Council shall meet at least two sessions.

3. In addition to the general conditions specified in Clause 1 and 2 of this Article, the second meeting session is only conducted when there is the presence of Secretary of Council and administrative Secretary; 02 opponent commissioners and written comments of independent opponents (if any);

4. In case of necessity, the Council may request the standing organ to invite representatives of organizations and individuals to register to their meeting participation to provide and and add information and answer answer questions asked by members of the Council or public opinion.

Article 14. Contents and sequence of Council’s meeting sessions

1. The first meeting session:

a) The administrative secretary (as representative of standing organs and the Ministry of Agriculture and Rural Development) introduces delegates, states the reasons for meeting session and briefly reports the validity of dossier;

b) The Chairman of Council chairs the meeting and assigns 01 (one) Council secretary and 02 (two) dossier opponents. In case of necessity, the Council may propose the addition of 2-3 independent opponent experts who are experienced scientists in the relevant areas;

c) The Council shall elect the vote counting Board consisting of 03 (three) members of the Council including 01 (one) head of committee;

d) The Council shall agree upon the time of the second meeting session and working plan;

2. The second meeting session:

a) The administrative secretary reads the reports to summarize the public opinion on registration dossiers for issue of Certificate and comments of independent opponent experts under the Form specified in Appendix 7 of this Circular (if any);

b) The Council members comment on the registration dossier under the Form specified in Appendix 7 of this Circular;

c) The Council shall discuss the registration dossier for issue of Certificate under the requirements specified in this Circular;

d) The Council shall vote to evaluate the registration dossier under the Form specified in Appendix 8;

dd) The vote counting Board shall summarize and report the result of vote counting under the Form specified in Appendix 9 of this Circular;

e) The satisfactory registration dossier is the dossier has at least ¾ (three quarters) of a number of evaluating votes “satisfactory” of the Council members attending the meetings;

g) The Council shall discuss, conclude and propose the necessary addition and changes for the contents stated in the dossier (if any) and approve the minutes under the provisions in Appendix 10 of this Circular;

3. In addition to the two above meeting sessions, the Council may request the Minister of of Agriculture and Rural Development to hold irregular meetings and other activities in direct service of appraisal;

4. Based on the minutes, the Council secretary shall complete the summary report for each dossier evaluated and the concluding opinion and advice for the Minister of of Agriculture and Rural Development on the issue of Certificate (under the Form specified in Appendix 11 of this Circular);

5. In case of revocation of Certificate, the Council shall review each specific case on the basis of dossier and advise the Minister of Agriculture and Rural Development of the revocation of Certificate;

Article 15. Responsibility and power of Council members

1. Carefully looking at registration dossiers for issue and revocation of Certificate of genetically modified plants eligible for use as food and feed and relevant documents provided by the Ministry of Agriculture and Rural Development;

2. Fully participating in the Council’s meetings during the appraisal of dossiers; giving a written comment under the Form specified in this Circular and other comments at the proposal of the Ministry of Agriculture and Rural Development;

3. Managing the documents provided to ensure no loss and no information transferred to the third party and return these documents at the proposal of the Ministry of Agriculture and Rural Development after completion of duties;

4. Evaluating and assessing the dossiers objectively, independently, on the scientific basis and being willing to talk with the community about their scientific assessment opinions;

5. Being entitled to remuneration under current regulations of law;

Chapter IV

IMPLEMENTATION ORGANIZATION

Article 16. Responsibility of Department of Science, Technology and Environment

1. Assuming the prime responsibility for and coordinating with the organs and units to implement this Circular;

2. Coordinating with the organs concerned to collect and use the fees of dossier appraisal under the current regulations of law;

3. Summarizing and reporting the Ministry on the issue and revocation of Certificate of genetically modified plants eligible for use as food and feed as prescribed;

Article 17. Responsibility of organizations and individuals registering for issue of Certificate

1. Paying the fees of dossier appraisal as prescribed. These fees shall not be refunded even in case where the products are denied to be issued with Certificate;

2. Taking responsibility for the authenticity of information in the registration dossier for issue of Certificate;

3. Providing and adding information under the requirement of the Ministry of Agriculture and Rural Development;

4. Taking responsibility before law if failing to comply with the conditions of Certificate;

5. Organizations and individuals issued with Certificate shall inform the Ministry of Agriculture and Rural Development of the adverse effect and new information about the risks of genetically modified plants (if any);

6. Informing other organizations and individuals related to the genetically modified plants when the Certificate is revoked;

Article 18. Effect

1. This Circular takes effect on March 10, 2014;

2. Within one (01) year from the effective date of this Circular, the events of genetically modified plants must be filed to register the issue of Certificate before they continue to be used as food, feed on the territory of Vietnam.

3. Any difficulty arising during the implementation of this Circular should be promptly reported to the Ministry of Agriculture and Rural Development for consideration and settlement;

Appendix 1. Registratin Form for issue of Certificate of genetically modified plants eligible for use as food and feed

 (Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

REGISTRATION APPLICATION

FOR ISSUE OF CERTIFICATE OF GENETICALLY MODIFIED PLANTS ELIGIBLE FOR USE AS FOOD AND FEED

To: The Ministry of Agriculture and Rural Development

Pursuant to Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic specimen and products of genetically modified organisms, Decree No. 108/2011/ND-CP dated Novermber 30, 2011 of the Government amending a number of Articles of Decree No. 69/2010/ND-CP on biosafety for genetically modified organisms, genetic specimen and products of genetically modified organisms and Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Ministry of Agriculture and Rural Development regulating the order and procedures for issue and revocation of Certificate of genetically modified plants eligible for use as food and feed,……(name of registering organizations and individuals)….we hereby submit our registration dossier for issue of Certificate of genetically modified plants eligible for use as food and feed to the Ministry with the contents as follows:

1. Information about registering organizations and individuals:

- Name organizations and individuals:

- Name of organizations and individuals’ representatives:

- Address:

- Tel:                             Fax:                   E-mail:

2. Information about genetically modified plants:

- Common name:

- Scientific name:

- Trade name:

- Name of genetically modified event:

- Traits related to the genes modified:

- Name of organizations and individuals creating the genetically modified plants:

- Unique identification code (if any):

3. Attached dossier (01 original and 02 copies) :

……………….

4. Commitment:

We hereby commit that the above information is true and shall take full responsibility before law of the Socialist Republic of Vietnam for the truthfulness of information and data provided in the attached dossier;

We kindly request the Ministry of Agriculture and Rural Development to consider and conduct necessary procedures to appraise our dossier and issue the Certificate of genetically modified plants eligible for use as food and feed;

Appendix 2. Form of report on risk assessment of genetically modified plants for human and animal health

 (Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

REPORT ON RISK ASSESSMENT OF GENETICALLY MODIFIED PLANTS FOR HUMAN AND ANIMAL HEALTH

I. General information

1. Registering organizations and individuals:

- Name of registering organizations and individuals: 

- Organizations and individuals’ representatives:

- Contacts of organizations and individuals:

- Address:

- Tel:                               Fax:                            Email:

2. Name of genetically modified plants:

- Common name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Traits related to the genes modified:

- Unique identification code (if any)

II. Information about gene-receiving host plant:

1. Name of gene-receiving host plant:

a) Common name;

b) Scientific name;

c) Classification position.

2. Information about the history of agriculture and development in breeding, particularly information related to the traits that may cause adverse effects on human and animal health;

3. Information about the safety of gene-receiving plant trees including toxicity and allergenicity (including information on plants of the same species that can be used as genetic background to receive similar genes);

4. Information about the history of using host plant as food and feed (Detailed description of farming practices, transportation, storage, preservation and specific conditions necessary in the processing (if any) for safe use in food and feed, role, value, nutrient composition of plant parts used for food and feed.

III. Information about gene-giving organisms

1. Name o gene-giving organisms:

a) Common name;

b) Scientific name;

c) Classification position.

2. Information about the natural history related to the safety of food and feed.

3. Information about the finding of anti-nutrients, toxins and allergens in nature. For the case of gene-giving organisms as the ones that require information about the pathogenicity and interactive relationships with the known pathogens.

4. Information about having been used (if any) in the food and feed chain and other exposures other than intentional use (for example, the possibility of unintentional contamination).

IV. Information about genetically modified plants

A. Information about transgene

1. Providing sufficient information concerning the genetic modification process to be able to determine all genetic materials capable of transferring into the host plant and providing sufficient information to analyze and assess the database to confirm the characteristics of DNA segment that is inserted into a host plant.

2. The detailed process of genetic modification includes:

a) Information about methods used for transgene

b) Information about the sequence, origin, vector, plasmid, homology and expected function of the transgene in the transgenic plants.

c) Information about intermediate host organisms including the organisms (eg, bacteria) used to create or clone DNA in transgene into host plants.

d) Full provision of information about DNA segment including:

- Full description of characteristics of genetic components: indication gene, moderating parts and the other components that affect the genetic function;

- Size and similarity of the components;

- Location and dimensions of transgene sequences in the final structural system / vector

- Function of transgene

B. Information about genetically modified plants

1. Fully providing information and describing in detail the molecular and biochemical characteristics of genetically modified food and feed and their effect on the nutrient composition and safety of these products.

2. Fully providing information about DNA segment inserted into the genome of the gene-receiving plant including:

a) Description of characteristics of genetic material which has been genetically modified;

b) A number of positions to be inserted;

c) The host plant carrying the transgene at each position to be inserted includes a number of copies and database on DNA sequence of gene to be inserted and the surrounding positions to identify any compound created due to the result of genetic insertion or other information related to the analysis of coding products or expression products to identify any new substance which can be found in food and feed from the genetically modified plants;

d) Identification of open reading frame in DNA inserted or created by insertion segment with DNA of genome of adjacent host plant of possible fusion of protein molecules.

1. Fully providing information about the level of gene expression in the genetically modified plants including:

a) Genetic products (eg, protein molecules or non-coding RNA).

b) Functions of genetic products;

c) Description of phenotypic characteristics of the trait;

d) Extent and position (part) of transgenic expression and the extent of their metabolites in plants, especially in the parts used to produce food / feed;

e) Quantity of content of genetic expression products if any when the transgenic functions change the accumulation of messenger RNA molecules or proteins.

2. Addition of relevant information includes:

Demonstration of structural conservation of genetic material or change of position in structure during the transgene;

a) Demonstrating the change in the amino acid sequence of the protein molecules product transgene expression is the result of intentional modification;

b) Demonstrating the intentional impact of modification achieved, the new trait is expressed and inherited in a stable manner over many generations and in accordance with the genetic rule. If the new characteristics can not be identified by phenotypic expression, there should be information on the molecular level.

c) Demonstrating the new traits expressed in necessary parts at the appropriate levels in relation to regulatory sequences that control the expression of corresponding genes.

d) Showing the evidence that one or more genes in the host plant affected by the process of transgene (if any).

e) Confirming the similarity and type of expression of any fusion protein molecules.

3. Information on the history of licensing and use of genetically modified plants in the world.

V. Risk assessment of impact of genetically modified plants for human and animal health

1. Comparing the differences in nutrient composition between the genetically modified plants and gene-receiving plants;

2. Assessing the ability to metabolize the nutrient composition, especially the new substance as the product of transgenic expression when used as food and feed.

3. Assessing the potential toxicity of new substance as the product of transgenic expression when used as food and feed.

4. Assessing the allergenicity of new substance as the product of transgenic expression when used as food and feed.

5. Assessing the ability to form new compounds, the ability to cause diseases or other adverse effects on human and animal health (eg, the potential impacts from the processing, the change in nutritional quality, nutritional function, the accumulation of new substances; antibiotic resistance genes...).

VI. Proposed measures to manage the potential risks of genetically modified plants for human and animal health

VII. Conclusion and proposal

Appendix 3. Form of brief report on risk assessment of genetically modified plants for human and animal health

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

BRIEF REPORT ON RISK ASSESSMENT OF GENETICALLY MODIFIED PLANTS FOR HUMAN AND ANIMAL HEALTH

I. General information

1. Name and address of registering organizations, their heads and main contacts;

2. Name of genetically modified plants: scientific name, common name, code of transgene event and unique identification code (if any).

II. Information related to gene-receiving host plant:

Briefly describing the receiving plants including the name, biological characteristics of receiving organisms, relationship with the natural environment and biodiversity in Vietnam, usage history of receiving organisms;

III. Information about gene-giving organisms

Briefly describing the gene-giving organisms including the name, biological characteristics of giving organisms, relationship with the natural environment and biodiversity in Vietnam, usage history of giving organisms;

IV. Information about genetically modified plants

Describing the process to create the genetically modified plants including the brief description of method of transgene;

Stating the new traits and characteristics of genetically modified plant compared with corresponding conventional plants;

Information about the history of licensing and use of these genetically modified plants in the world;

V. Risk assessment of the impact of genetically modified plants for human and animal health

Briefly describing the activities of risk assessment done for these genetically modified plants and the result of risk assessment mentioned above;

Briefly describing the potential toxicity, allergenicity, pathogenicity or other impacts on human health if used as food.

VI. Proposed measures to manage the risks of genetically modified plants for human and animal health: Briefly describing the measures of risk management proposed (if any);

VII. Conclusion and proposal

Appendix 4. Form of information declaration published for public opinions about registration dossier for issue of Certificate

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

INFORMATION DECLARATION PUBLISHED FOR PUBLIC OPINIONS

1. Name of registering organizations and individuals:

2. Contact address:

3. Full name of responsible person:

4. Description of genetically modified plants registered for licensing:

5. Origin of genetically modified plants: (country)

6. Registration purpose:

For further information about the genetically modified plants registered for issue of Certificate of genetically modified plants eligible for use as food and feed, please contact the person responsible for the genetically modified plants:

- Full name:

- Contact address

- Tel:

- E-mail:

- Fax:

We request all organizations and individuals to send your comments on the issue of Certificate of genetically modified plants eligible for use as food and feed within 30 days from the date the information is posted to the address:

Department of Science, Technology and Environment

Ministry of Agriculture and Rural Development

No. 2 Ngoc Ha Street, Ba Dinh District, Ha Noi

Appendix 5. Notification form of validity of registration dossier for issue of Certificate

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

Notification of validity of registration dossier for issue of Certificate

1. Name of organizations and individuals:

- Organizations’ representatives:

- Organizations’ contacts:

- Address:

- Tel:                                           Fax:

2. Name of genetically modified plants:

- Common Name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Unique identification code (if any):

3. Date of dossier receipt:

4. Appraisal time from date…………. To date…………………

5. Contents of required addition ( specify each document)

6. Comment and proposal

Appendix 6. Form of Certificate of genetically modified plants eligible for use as food and feed

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

CERTIFICATE

(Attached to Decision No…./QD-BNN-KHCN dated….by the Minister of Agriculture and Rural Development)

1. The genetically modified plants are issued with Certificate of eligibility for use as food and feed

- Common Name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Trait related to transgene:

- Unique identification code (if any):

2. Organizations and individuals issued with Certificate:

- Name of organizations and individuals issued with Certificate

- Address:

- Tel:                                      Fax:

3. Organizations and individuals issued with Certificate of genetically modified plants eligible for use as food and feed are responsible for fulfilling the following requirements:

-

-

Appendix 7. Form of comment and assessment of dossier of Council members and opponent experts

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

COMMENT AND ASSESSMENT OF COUNCIL MEMBERS AND OPPONENT EXPERTS

I. General information about dossier:

1. Name of registering organizations and individuals:

2. Name of genetically modified plants:

- Common Name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Unique identification code (if any):

3. Dossier code:

II. Information about Council member/opponent expert

1. Full name (scientific titles, degrees):

2. Working place:

3. Position:                                                                               as:

III. Contents of dossier assessment (The Council member gives brief assessment about the contents in the report on risk assessment and conclusions corresponding with each content);

1. Assessment of dossier (The completeness of dossier and contents under the provisions in Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development regulating the order and procedures for issue and revocation of Certificates of genetically modified plants eligible for use as food / feed)

2. Assessment of report on risk assessment and attached documents

Information about gene-receiving host plants and gene-giving organisms

Information about genetically modified process

- Method of transgene used

- Function and regulation of transgene

- Transgenic expression in transgenic plants

- Genetic stability of modification

- Conclusion

General information about the safety

- History of use (receiving and giving organisms)

- Characteristics of new protein molecules

- Expression of new proteins through the analysis of biological molecules (Western blot and ELISA analysis);

- Effect on human health in case where the new genetic materials may be transferred into the cells of human digestive system

- Conclusion

Information about issues related to the toxicity

- Natural toxic contents in products of genetically modified plants

- Potential toxicity of new protein molecules as the product of transgenic expression

- Potential allergenicity of the new proteins as the product of transgenic expression

- Conclusion

Information on issues related to nutrition

- Analysis of the composition: Specify the method of sampling, sample preparation, method of analysis and statistical processing, the typical analytical experiments in several countries on the composition of main nutrients;

- Analysis of testing of new protein molecules as the product of the transgenic expression on animals and pets;

- Conclusion

On measures to manage the risks of genetically modified plants for human and animal health

IV. Conclusion and proposal

1. Conclusion (Based on the demonstrating documents and scientific information, draw some conclusions to confirm or deny the genetically modified plants ….are safe as equivalent traditional food/feed);

2. Proposal

Proposing the Ministry of Agriculture and Rural Development to issue/not to issue the Certificate…..eligible for use as food and feed; the conditions for the issue of Certificate (if any).

……………………………………………………………………………………………………

……………………………………………………………………………………………………

Appendix 8. Form of assessment slip of registration dossier for issue of Certificate of genetically modified plants eligible for use as food and feed

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

Assessment slip of registration dossier for issue of Certificate of genetically modified plants eligible for use as food and feed

I. General information about dossier

1. Name of registering organizations and individuals:

2. Name of transgenic organisms:

- Common Name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Unique identification code (if any):

3. Dossier code:

II. Information about Council member

1. Full name (scientific title and degree):

2. Working place:

3. Position:

III. Conclusion and proposal

1. Conclusion

2. Proposal

3. Other opinions:

…………………………………………………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

Appendix 9. Form of vote counting record of Council of genetically modified food and feed safety 

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

Vote counting record of Council of genetically modified food and feed safety 

I. General information

1. Name of registering organizations and individuals:

2. Name of genetically modified plants:

- Common Name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Unique identification code (if any):

3. Condition of transgene:

4. Place and time for Council meeting: Date........month ..........year…

5. A number of members present out of the total members:

- A number of votes issued:

- A number of votes collected:

- A number of valid votes:

- A number of invalid votes

6. Result of vote counting:

- A number of dossier assessment votes: Satisfactory without modification and addition:

- A number of dossier assessment votes: Satisfactory but modification and addition required:

- A number of dossier assessment votes: Unsatisfactory

- A number of votes requesting the issue of Certificate:

- A number of votes not requesting the issue of Certificate

II. Conclusion

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

Hanoi, date          month            year

Appendix 10. Form of meeting minutes of Council of genetically modified food and feed safety 

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

Meeting minutes of Council of genetically modified food and feed safety

I. General information

1. Name of registering organizations and individuals:

2. Name of genetically modified plants:

- Common Name:

- Scientific name:

- Trade name:

- Genetically modified event:

- Unique identification code (if any):

3. Trait of transgene:

………………………………………………………………………………………….

4. Decision on establishment of Council (if any): No…./QD-BNNPTNT dated …..by the Minister of Agriculture and Rural Development on establishment of Council of genetically modified food and feed safety

II. Preparatory meeting:

1. Place and time of Council meeting:

…………………………………………………………………………………………

2. A number of members present out of the total members: ............/...........

Absent: ........ persons, including the members:

..........................................................................................................................................

3. Guests attending the meeting:

4. Content of work:

- The Council has discussed and agreed to assign tasks of members and requested the Ministry of Agriculture and Rural Development to invite the independent opponent experts (if any) to comment and assess the dossiers registered for selection. The experts are listed as follows:

- The Council unanimously appoints:

+ Mr/Mrs :..............................................................is the scientific secretary of the Council

+ The vote counting Board consists of:

Head of Board: ………………………………………..

Members: ………………………………………….

             ………………………………………….

- The Council has discussed to thoroughly grasp the principles, procedures and criteria for assessment of dossiers as prescribed;

- The Council members receive dossier and dossier assessment slip

- The Council agrees upon the formal meeting on date…. ..........

III. Formal meeting:

1. Place and time of Council meeting:

…………………………………………………………………………………………

2. A number of members present out of the total members: ............/...........

Absent: ........ persons, including the members:

                        ..................................................................

3. Guests attending the meeting:

……………………………………………………………………………………………

……………………………………………………………………………………………

……………………………………………………………………………………………

4. Content of work:

- The Council has talked, discussed and assessed dossiers under criteria specified in Cicrcular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development on the order and procedures for issue and revocation of Certificate of genetically modified plants eligible for use as food and feed;

- The Council has balloted to assess dossiers

The result of vote counting to assess registration dossiers for issue of Certificate of genetically modified plants eligible for use as food and feed presented in the attached record of vote counting.

IV. The Council’s conclusion

Result of vote counting:

- A number of dossier assessment votes: Satisfactory without modification and addition:

- A number of dossier assessment votes: Satisfactory but modification and addition required:

- A number of dossier assessment votes: Unsatisfactory

- A number of votes requesting the issue of Certificate:

- A number of votes not requesting the issue of Certificate

V. The Council’s proposal

Based on the assessment slip and result of vote counting, the Council of genetically modified food and feed safety  requests the Ministry of Agriculture and Rural Development to issue (or not to issue) the Certificate of eligibility for use as food and feed for.................

for the organizations and individuals:....................................

Proposing the conditions for issued with Certificate for registering organizations and individuals (if any)

Specify the reasons if proposing not to issue the Certificate

VI. Contents in need of modification and addition in dossier:

……………………………………………………………………………………………

……………………………………………………………………………………………

……………………………………………………………………………………………

VII. Other notes in completion of dossier (if any):

……………………………………………………………………………………………

……………………………………………………………………………………………

……………………………………………………………………………………………

Confirmation of the Ministry of Agriculture and Rural Development

Appendix 11. Form of report on dossier assessment of Council of genetically modified food and feed safety

(Issued together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of Agriculture and Rural Development)

REPORT ON DOSSIER ASSESSMENT OF COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY 

I. Summary and conclusion

1. Information about transgenic event and genetic modifications:

Briefly describing the transgenic event and information related to the transgene in the registration dossier;

Specifying general issues on safety

2. Information on issues related to toxicity used as food / feed

Briefly describing the transgenic products in the gene-receiving organisms and the resolution and metabolism process may produce toxins;

3. Information about issues related to nutrition

Briefly describing the nutritional component of parts of genetically modified plants on the basis of equivalent comparison with traditional products.

4. Conclusion

Based on the demonstrating documents and scientific information, draw some conclusions to confirm or deny the genetically modified plants ….are safe as equivalent traditional food/feed

II. Assessment report

1. Assessment of dossier (The completeness of dossier and contents under the provisions in Circular No. …/20…-BNNPTNT of the Minister of Agriculture and Rural Development regulating the order and procedures for issue and revocation of Certificates of genetically modified plants eligible for use as food / feed)

2. Assessment of report on risk assessment and attached documents

2.1. Information about gene-receiving host plant and gene-giving organisms

2.2. Information about genetically modified process

- Method of transgene used

- Function and regulation of transgene

- Transgenic expression in transgenic plants

- Genetic stability of modification

- Conclusion

2.3. General information about the safety

- History of use (receiving and giving organisms)

- Characteristics of new protein molecules

- Expression of new proteins through the analysis of biological molecules (Western blot and ELISA analysis);

- Effect on human health in case where the new genetic materials may be transferred into the cells of human digestive system

- Conclusion

2.4. Information about issues related to the toxicity

- Natural toxic contents in products of genetically modified plants

- Potential toxicity of new protein molecules as the product of transgenic expression

- Potential allergenicity of the new proteins as the product of transgenic expression

- Conclusion

2.5. Information on issues related to nutrition

- Analysis of the composition: Specify the method of sampling, sample preparation, method of analysis and statistical processing, the typical analytical experiments in several countries on the composition of main nutrients;

- Analysis of testing of new protein molecules as the product of the transgenic expression on animals and pets;

- Conclusion

2.6. On measures to manage the risks of genetically modified plants for human and animal health

III. Summary and draft answer of public opinions

IV. Conclusion and proposal

1. Conclusion (Based on the demonstrating documents and scientific information, draw some conclusions to confirm or deny the genetically modified plants ….are safe as equivalent traditional food/feed);

2. Proposal

Proposing the Ministry of Agriculture and Rural Development to issue/not to issue the Certificate…..eligible for use as food and feed; the conditions for the issue of Certificate (if any).