MINISTRY
OF AGRICULTURE AND RURAL DEVELOPMENT
--------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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|
No.:
02/2014/TT-BNNPTTN
|
Hanoi, January
2014
|
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;
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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.
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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
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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;
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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:
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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;
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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;
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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.
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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);
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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;
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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;
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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;
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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.
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FOR THE
MINISTER
DEPUTY MINISTER
Le Quoc Doanh
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)
NAME
OF REGISTERING ORGANIZATIONS AND INDIVIDUALS
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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................, date…
month… year…
REGISTRATION
APPLICATION
FOR ISSUE OF CERTIFICATE
OF GENETICALLY MODIFIED PLANTS ELIGIBLE FOR USE AS FOOD AND FEED
First
registraiton:
□
Registration
for additional information:
□
Request
for issue of Certificate of eligibility for use as feed:
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Request
for issue of Certificate of eligibility for use as food:
□
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:
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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) :
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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;
.........., date.......month.....year............
Registering
organizations and individuals
(Signature,
full name, title and seal)
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(Issued
together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of
Agriculture and Rural Development)
NAME
OF REGISTERING ORGANIZATIONS AND INDIVIDUALS
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
................, date…
month… year…
REPORT ON RISK
ASSESSMENT OF GENETICALLY MODIFIED PLANTS FOR HUMAN AND ANIMAL HEALTH
I. General
information
1. Registering
organizations and individuals:
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- 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:
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- 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.
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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
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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
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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;
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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.
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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
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
.........., date.......month.....year............
Registering
organizations and individuals
(Signature,
full name, title and seal)
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)
NAME
OF REGISTERING ORGANIZATIONS AND INDIVIDUALS
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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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;
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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
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
.........., date.......month.....year............
Registering
organizations and individuals
(Signature,
full name, title and seal)
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:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
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:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
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)
MINISTRY
OF AGRICULTURE AND RURAL DEVELOPMENT
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
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:
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- Trade name:
- Genetically modified event:
- Unique identification code (if any):
3. Date of dossier receipt:
4. Appraisal time from date…………. To date…………………
No.
List of
dossier
Legal
grounds for appraisal
Review
results
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Requirement for
addition
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5. Contents of required addition ( specify each
document)
6. Comment and proposal
POWER AND POSITION OF SIGNER
(Signature and seal)
Full name
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(Issued
together with Circular No. 02/2014/TT-BNNPTNT dated January 24, 2014 of the Minister of
Agriculture and Rural Development)
MINISTRY
OF AGRICULTURE AND RURAL DEVELOPMENT
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
Hanoi, date… month.. year…
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
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- 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:
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-
-
POWER AND POSITION OF SIGNER
(Signature and seal)
Full name
Appendix 7. Form of comment and assessment of dossier
of Council members and opponent experts
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MINISTRY OF AGRICULTURE AND RURAL
DEVELOPMENT
COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
Hanoi, date
month 20…
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:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- 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:
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□
b) Opponent member
□
c) Independent expert
□
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
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- 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);
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- 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;
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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);
a) Assessment of
dossier: Satisfactory without modification or addition
□
b) Assessment of dossier:
Satisfactory but modification or addition required (specify the contents to
be modified or added)
□
c) Assessment of dossier:
Unsatisfactory
□
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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).
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Reviewer
(Sign, full
name)
Appendix 8. Form of assessment slip of registration
dossier for issue of Certificate of genetically modified plants eligible for
use as food and feed
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MINISTRY OF AGRICULTURE AND RURAL
DEVELOPMENT
COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
Hanoi, date
month 20…
Assessment
slip of registration dossier for issue of Certificate of genetically modified
plants eligible for use as food and feed
Opponent member:
□
Member:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
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:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Full name (scientific
title and degree):
2. Working place:
3. Position:
III. Conclusion and proposal
1. Conclusion
a) Assessment of dossier:
Satisfactory without modification or addition
□
b) Assessment of dossier:
Satisfactory but modification or addition required (specify the contents to
be modified or added)
□
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□
2. Proposal
a) Issue the Certificate
□
b) Do not issue the
Certificate
□
3. Other opinions:
…………………………………………………………………………………………………
…………………………………………………………………………………………………
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…………………………………………………………………………………………………
…………………………………………………………………………………………………
…………………………………………………………………………………………………
Council member
(Sign and
full name)
Appendix
9. Form of vote counting record of Council of genetically modified food and
feed safety
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MINISTRY OF AGRICULTURE AND RURAL
DEVELOPMENT
COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
Hanoi, date
month 20…
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:
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- 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:
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- 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
………………………………………………………………………………………………
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………………………………………………………………………………………………
Hanoi,
date
month year
Members of vote counting Board
Member 1
(Full name and signature)
Member 2
(Full name and signature)
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Head of vote counting Board
(Full name and signature)
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)
MINISTRY OF AGRICULTURE AND RURAL
DEVELOPMENT
COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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Hanoi, date
month 20…
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:
...
...
...
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- 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:
...
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...
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3. Guests attending the meeting:
No.
Full name
Working
place
1
2
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...
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:
No.
Full name of
opponent experts
Note (The
opponent experts are Council members or non-members)
1
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2
…
- The Council unanimously appoints:
+ Mr/Mrs :..............................................................is
the scientific secretary of the Council
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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:
…………………………………………………………………………………………
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Absent: ........ persons,
including the members:
..................................................................
3. Guests attending the meeting:
No.
Full name
Working
place
……………………………………………………………………………………………
……………………………………………………………………………………………
...
...
...
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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
...
...
...
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- 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:
……………………………………………………………………………………………
……………………………………………………………………………………………
...
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...
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VII. Other notes in
completion of dossier (if any):
……………………………………………………………………………………………
……………………………………………………………………………………………
……………………………………………………………………………………………
Secretary
(Full name
and signature)
Chairman
(Full name
and signature)
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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)
MINISTRY OF AGRICULTURE AND RURAL
DEVELOPMENT
COUNCIL OF GENETICALLY MODIFIED FOOD AND FEED SAFETY
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
Hanoi, date
month 20…
...
...
...
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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
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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
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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
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- 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);
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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).
Council secretary
(Sign and full name)
Council Chairman
(Sign and full name)