IT ' S SMART

Sequencing procedure, acute procedure and paper recovery validation of the fully qualified gene variable plant

use as food, blanket food. i

_________________

Base of Protocol 199 /2013/NĐ-CP November 26, 2013 of the Government regulates the functions, duties, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Base of Protocol 69 /2010/NĐ-CP June 21, 2010 of the Government on Biosafety for genetically modified organisms, genetic specimens, and products of genetically modified organisms;

Base of Protocol 108 /2011/NĐ-CP 30 November 2011 of the Government amended some of the number of quantitative provisions. 69 /2010/NĐ-CP Biological safety for genetically modified organisms, genetic specimens, and products of genetically modified organisms;

Base of Protocol 38 /2012/NĐ-CP April 25, 2012 of the Government Regulation details the implementation of some of the provisions of the Food Safety Law;

At the suggestion of the Chief of Science, Technology and the Environment;

The Minister of Agriculture and Rural Development issued the Sequencing Procedure, the granting and recovery of the Certificate of genetically modified plants that were eligible for use as food, livestock feed.

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This information regulates the sequence, procedure, and recovery of the Certificate of genetically modified plants that are eligible for use as food, livestock feed.

What? 2. Subject applies

This information applies to organizations, domestic and foreign individuals (later called organizations, individuals) that are involved in the granting of the granting and recovery of the Certificate of genetically modified plants eligible for use as food, livestock feed (after the end of the year). It ' s called a Certificate in Vietnam.

What? 3. Explain words

In this message the words below are understood as follows:

1. Genetically modified plants is plants, genetic specimens, direct products of plants that carry one or more new genes produced by recombinable DNA technology.

2. Assessment of the risk of genetically modified plants on human health and livestock. (the following call for risk assessment) is the operation to determine the potential risk and risk of the risk of genetically modified plants when used as food, livestock feed.

3. Gene transfer event is the result of the recombination of the target DNA into a certain position in the genome of a plant to produce a target gene that carries the target gene.

4. Developed Water is the country with advanced biotechnology in the group of countries of the Organisation for Economic and Economic Development-OECD and the group of countries with the G20 economy.

5. Unique identifier is the code created by the Organization for Economic cooperation and Development for each gene transfer event.

What? 4. The criteria for assessment of risk for genetically modified plants are eligible for use as food, livestock feed and food.

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

2. Evaluation of the ability to metabolize nutrient components, especially the new substances that are the expression products of the gene transfer if used as food, livestock feed.

3. Evaluation of the ability to cause toxins of new substances is the expression product of the transfer gene if used as food, livestock feed.

4. Evaluation of the allergen potential of new substances is the expression product of the transfer gene if used as food, livestock feed.

5. Evaluation of the ability to form new compounds, the ability to cause disease or other adverse impacts to human health and livestock (e.g., potential effects from processing; changes in nutrient quality, nutritional function; and the impact of the disease). The accumulation of new substances; the antiantibiotic gene.

Chapter II

LEVEL AND RECOVER CONFIRMATION PAPER

What? 5. The cases must register for confirmation

1. The single transformation event is the result of a gene transfer process that regulates a desired trait using gene transfer technology.

2. The genetically modified plants that carry a combination gene transfer event are the result of the transition from two or more genes that define one or more of the desired traits using gene transfer technology.

What? 6. Paper Level Conditions confirmed

Genetically modified plants are granted a validation of one of the following conditions:

1. The genetically modified plants are at least 05 (the year) of developed water for food use, livestock feed, and no risks in those countries.

2. The genetically modified plants are food-safe, herding food (later called the Council) appraisal of a Certificate in Certificate of Genetically Modified Plants that are eligible for use as food, livestock feed, and plant conclusions. That gene has no uncontrollable risks to human health and livestock.

3. Other cases.

a) The case of a genetically modified plant event that has been granted a certificate of sufficient conditions for food, the event that the genetically modified plant event is used as a livestock feed;

b) The case of plant transfer event combo is the result of a hybridiation process by a two or more single gene transfer events that have been issued for validation, and that plant is used as a food, food, and food. Hey,

What? 7. Record-level registration confirmed

1. The number of records: 03 (three) sets, including 01 (one) and 2 (two) copies.

2. The case of registration of the Certificate of Confirmation for the specified object at paragraph 1 Article 6 of this Information, the profile includes:

a) The application of the Certificate Level validation by the specified template at Appendix 1 of this Information;

b) The risk assessment (accompanied by electronic) of genetically modified plants on human health and livestock (later called a risk assessment report) by the prescribed form at Annex 2 of this Information;

c) The summary of the risk assessment report by the prescribed pattern at the Annex 3 of this Smart (accompanied by an electronic copy);

d) The publication of the information posted to the public opinion according to the specified pattern at Appendix 4 of this Information;

The main body or copy of the Vietnamese language certificate and translation (which has a confirmation translation) or the equivalent text of a competent organ for the use of food, feed on at least five developed countries.

3. The case of registration of the Certificate of Confirmation for the specified object at paragraph 2 Article 6 of this Information, the profile includes:

a) Regulatory documents at points a, b, c, d paragraph 2 This;

b) The main copy or copy of the certificate and translation of the Vietnamese language (which has a confirmation translation) or the equivalent text of the competent authority to allow for use as food, feed on livestock in other countries (if any);

c) The scientific literature references, the unpublished studies, figures from reviews, tests, or other scientific evidence (if any) that the organization, the individual regioners use as a base for the conclusion of genetically modified plants if issued by the certificate level. does not affect the health of humans and pets.

4. Case-level registration confirmed for the specified object at paragraph 2 Article 5 of this message, the profile includes:

a) The specified documents at paragraph 2 (the case of registration of the Certificate of Identification for the specified object at 1 Article 6 of this Information);

b) The documents specified at paragraph 3 This Article (registration of the Certificate of Identification for the specified object at paragraph 2 Article 6 of this Information);

c) The additional data of the report review the risk assessment of the interaction of the gene transfer genes in the structure, the integrity conservation of the structure, function and expression of the target gene in the gene recipient.

What? 8. Continue, specify a Certificate Certificate Profile

1. Organization, registered individuals grant a Certificate of Certificate of Direct or Post-mail to the Permanent Authority of the Ministry of Agriculture and Rural Development (Department of Science, Technology and Environment).

2. The Department of Science, Technology and the Environment review the profile and written notice (prescribed at Appendix 5 of this Notice) to the organization, the individual registered in the period 07 (seven) day of work, since the date of the filing of the filing of valid records. or request additional, complete records. The additional time, fining the uncalculated profile at the time of the valid case review.

3. After receiving valid records, the Department of Science, Technology and the Environment posted information and the summary of the risk assessment report on the Department of Agriculture ' s electronic information page and rural development to take public opinion; to sum up and send the Council. The duration of the public opinion is a maximum of 30 (thirty) days, since the date of the information is posted.

4. After receiving valid records, the Department of Science, Technology and the Environment of the Council to evaluate the registration record of the certificate issued in the 30 (thirty-thirty) date for the registration record under paragraph 1 Article 6 of this Notice and 180 (one hundred and eighty) days. for the registration file under paragraph 2 of Article 6 of this message.

What? 9. License Level

The Council ' s Appraisal Results, Science, Technology and Technology.

The environment for the Minister of Agriculture and Rural Development review, the decision to issue a Certificate of Identification for the organization, the individual registered.

2. The case of eligible registration records to grant the Certificate, the Minister of Agriculture and Rural Development issued a decision to grant the Certificate (according to the prescribed pattern at Annex 6 of this Notice) in the 30 (thirty) date, since the date of the results. The Council's appraisal.

3. The case of registration records is not eligible to grant the validation, the Department of Science, Technology and the Environment to issue a written notice and specify the reason for the organization, the individual registered.

What? 10. confirm certificate

1. The confirmation certificate is reviewed in the prescribed cases at 1 Article 29 and paragraph 1 Article 34 of the Decree. 69 /2010/NĐ-CP June 21, 2010 of the Government on Biosafety for genetically modified organisms, genetic specimens, and products of genetically modified organisms (abbreviated as Decree Protocol). 69 /2010/NĐ-CP).

2. The base used to be a member of the Ministry of Agriculture and Rural Development consider, deciding on the recovery of the confirmation Paper.

a) For the specified cases at point a, point b paragraph 1 Article 29 and point a, point b paragraph 1 Article 34 of the Decree 69 /2010/NĐ-CP The Ministry of Agriculture and Rural Development organizes the Council to determine the case and consider the recall of the Certificate;

b) For the specified cases at point c 1 Article 29 and point c 1 Article 34 of the Decree 69 /2010/NĐ-CP, The Department of Science, Technology and Environment Minister for Agriculture and Rural Development reviewed, decided.

3. The Science, Technology and Environment Service performs the following tasks:

a) Organization of the Council meetings or independent advisory council (in the case of a regulation at the point of paragraph 1 Article 29 and point c 1 Article 34 of the Decree) 69 /2010/NĐ-CP ) appraisal appraisal of the recovery of the Certificate for Infringement Cases;

b) The Council ' s appraisal results base, the Minister of Agriculture and Rural Development review review, decision to recover the confirmation Paper;

c) Notice on the mass media and relevant agencies in the time of not over 03 (three) days from the date of the decision to recover the confirmation of the confirmation, and submit the Decision (the main version) to the organization, the individual is revoked of the Certificate.

What? 11. Set up a catalog, add and remove the name of the genetically modified plant in the Genetically Modified Plants Category.

The Science, Technology and Environment Service performs the following tasks:

1. Set up and published on the electronic information page of the Ministry of Agriculture and Rural Development of the Genetically Modified Plants under the Certificate issued.

2. Supplements and publish on the electronic information page of the Ministry of Agriculture and Rural Development: genetically modified plants are issued for the identification of the genetically modified plant Catalogue that is granted a certificate of sufficient conditions for food, livestock feed. for a time of 10 (ten) days, since the date of the decision to issue a confirmation.

3. Remove the name and publication on the electronic information page of the Ministry of Agriculture and Rural Development: genetically modified plants belonging to cases of violation in the Catalogue of genetically modified plants issued by the Certificate of Qualified Food for Food, Food Feed. raised in the 10 (ten) days, since the date of the decision to recover the confirmation.

Chapter III

FOOD SAFETY COUNCIL, GENETICALLY MODIFIED BREEDING FOOD

What? 12. The organization of the Council

1. The Council is organized by the Minister of Agriculture and Rural Development to establish a position to advise the Minister of Agriculture and Rural Development to review the grant, revoking the confirmation.

2. The Council has 11 (eleven) members including the Chairman, Vice President, as representative of the Ministry of Agriculture and Rural Development; 01 representatives of the Ministry of Industry; 01 representative of the Ministry of Science and Technology; 01 representative of the Ministry of Natural Resources and Environment; 01 representative of the Ministry of Health And some experts in the field of relevance. The term of the Council is 3 (3) years.

3. The funding for the operation of the Council does by the regulation of the existing law.

What? 13. Council activities

1. The Council works in principle, democracy, objective; personal responsibility for the scientific calculation, accuracy for the opinions of comment, independent assessment and collective responsibility for the general conclusion of the Council.

2. Session of the Council must be present at least two-thirds of the members under the chairperson of the President of the Council or the Vice President of the Council (in the case of the Speaker of the Council absent). The board meets at least two sessions.

3. In addition to the general conditions stipulated at paragraph 1 and 2 of this, the second session of the Council is only conducted when: there is the Secretary of the Council and Administrative Secretary; 02 protest commissioners; the written comments by the expert counter-protest experts. (if any).

4. In the case of necessity, the Council may ask the body to often directly invite the organization, the individual registered to attend the session to provide additional information, answer questions of questions of the members of the Council or the opinion of the public.

What? 14. Content, sequence of council sessions

1. First Session:

a) The administrative secretary (which is representative of the permanent body, the Ministry of Agriculture and Rural Development) introduced the delegate, which declared the reason for the session and the summary report on the validity of the case;

b) Chairman of the session presiding officer, assigned 1 (one) the Council Secretary and 2 (two) members of the filing counter. In case of necessity, the Council can petition the addition of 2-3 independent counter-protest experts who are experienced in the field of relevance;

c) The board of voting votes, which comprises 3 (three) members are Council Commissioners, including 1 (a) Head of the Board;

d) The council agreed to the time of the second session session and the work plan.

2. Second Session:

a) The executive secretary reads the public opinion aggregation report on the registration of the confirmation post issued and comments by the independent protest expert on the prescribed form at Appendix 7 of this Information (if any);

b) Member of the Board of Identification of the Registration Profile under the prescribed pattern at Annex 7 of this Information;

c) The exchange council, which discusses the registration of the Registration Level confirmation by the regulatory requirements at this Smart;

d) The ballot board evaluated the registration filing by the prescribed pattern at Annex 8;

The total board of voting and reporting results by the prescribed form at Appendix 9 of this Information;

e) The registration record is required as a record of at least ¾ (three quarters) the number of "required" votes of the Council member to attend the session;

) The panel discussed, concluded, and petits additional points, the revision required of the contents stated in the profile (if any) and the passage of the meeting in accordance with the provisions at Appendix 10 of this Information.

3. In addition to the two sessions mentioned above, the Council may petition with the Minister of Agriculture and Rural Development to hold groundbreaking meetings and other activities to serve directly to the appraisal work.

4. On the basis of the plenum of sessions, the Council Secretary perfated the summline report for each assessment profile and the opinion of consultation conclusions for the Minister of Agriculture and Rural Development on the review of the confirmation certificate (according to the prescribed form at Annex). 11 of this.

5. In the case of a confirmation recall, the Council meets every single case based on the case and has an advisory opinion to the Minister of Agriculture and Rural Development on the recovery of the confirmation paper.

What? 15. Responsibility, the powers of the Council members

1. Study of acute registration records, recovery of the Certificate of genetically modified plants that are eligible for use as food, livestock feed, and related materials provided by the Ministry of Agriculture and Rural Development.

2. Participate in full meeting of the Council during the filing of the filing; there is a comment by the prescribed text in the prescribed form at this Notice and other comments at the suggestion of the Ministry of Agriculture and Rural Development.

3. Manage the documents provided, ensure that no escape, do not transfer information to the third party and submit these documents at the request of the Ministry of Agriculture and Rural Development after the completion of the mission.

4. Evaluation, appraisal appraisal objectively, independent, on a scientific basis and willingness to trade with the community on its scientific assessment opinions.

5. Enjoy the conduct of the existing law.

Chapter IV

THE ORGANIZATION.

What? 16. Responsible for the Department of Science, Technology and Environment

1. Host, coordinate with the agencies, the relevant unit, implement this Information.

2. Coordinate with the relevant agency and use case appraisal fees under the existing law regulations.

3. General, report the Ministry of Criminal Affairs, revoking the Certificate of Genetically Modified Plants to be eligible for use as food, prescribed food, as prescribed.

What? 17. The organization ' s responsibility, the individual registers the certificate level.

1. The file fee is specified by the specified case. The case appraisal fee is not reimbursable even in the case of a rejected product grant.

2. Take responsibility for the authenticity of the information in the Certificate Certificate Profile.

3. Provide additional information at the request of the Ministry of Agriculture and Rural Development.

4. Accountable to the law if you do not comply with the conditions of the Certificate.

5. Organization, individuals granted a Certificate of Confirmation Accountability for the Ministry of Agriculture and Rural Development on adverse effects, new scientific information on the risk of genetically modified plants (if available).

6. Notice for organizations, individuals with regard to genetically modified plants when the Certificate is revoked.

What? 18. The execution clause

1. This message came into effect from 10 March 2014.

2. In a time of one (01) years, since this date has been in effect, genetically modified plant events must be filed with a Certificate of Confirmation Certificate before continuing to use as food, livestock feed on Vietnamese territory.

3. In the course of execution, if there is difficulty, entanged, offer in time to reflect on the Ministry of Agriculture and Rural Development for consideration, resolve.