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THE MINISTRY OF
ENVIRONMENT AND NATURAL RESOURCES OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
08/2013/TT-BTNMT
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Hanoi, May 16,
2013
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CIRCULAR
PROCEDURES FOR
ISSUANCE AND REVOCATION OF CERTIFICATE OF BIOSAFETY FOR GENETICALLY MODIFIED
PLANTS
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. 21/2013/ND-CP dated March
4, 2013 of the Government on functions, tasks, powers, and organizational
structures of the Ministry of Environment and Natural Resources;
At request of the General Director of Vietnam
Environment Administration and Director of Department of Legal Affairs;
The Minister of Environment and Natural
Resources hereby prescribes procedures for issuance and revocation of
certificate of biosafety of genetically modified plants,
Chapter 1.
GENERAL PROVISIONS
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This Circular prescribes procedures for issuance and
revocation of certificate of biosafety for genetically modified plants
(hereinafter referred to as “certificate of biosafety”).
Genetically modified plants (hereinafter referred
to as “GM plants”) that are created as a result of cross-breeding two or more
cultivars carrying transformation events and issued with certificate of
biosafety are not regulated by this Circular.
Article 2. Regulated entities
This Circular applies to domestic and foreign
organizations and individuals (hereinafter referred to as “organizations,
individuals”) whose operation is related to the issuance and revocation of
certificate of biosafety in Vietnamese territory.
Article 3. Groups of GM plants eligible for
certificate of biosafety
1. GM plants carrying single transformation events
created as a result of transferring one or multiple genes dictating a desirable
characteristic by gene delivery technology.
2. GM plants carrying stacked transformation event
created as a result of:
a) Delivering genes dictating multiple desirable
characteristics simultaneously to plants that have not undergone genetic
modification by gene delivery technology; or
b) Delivering gene or genes dictating one or
multiple desirable characteristics to a GM plant.
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ISSUANCE AND REVOCATION OF CERTIFICATE OF BIOSAFETY
Article 4. Procedures for issuance, revocation
of certificate of biosafety
1. Application for issuance of certificate of
biosafety shall conform to Article 5 hereof.
2. Receipt, inspection of application, and issuance
of certificate of biosafety shall conform to Articles 6 through 8 hereof.
3. Revocation of issuance of certificate of
biosafety shall conform to Article 9 hereof.
Article 5. Application for issuance of certificate
of biosafety
1. Application for issuance of certificate of
biosafety consists of:
a) 1 application using form under Appendix 1
attached hereto;
b) 10 copies of test reports acknowledged by the
Ministry of Agriculture and Rural Development (of which there are 1 original
copy and 9 copies) and 1 copy of document issued by the Ministry of Agriculture
and Rural Development acknowledging test results;
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d) 1 electronic file containing information on the
risk assessment report using form under Appendix 3 hereof;
2. Applicants are responsible for:
a) paying fees for assessing application for
issuance of certificate of biosafety as per applicable laws within 5 days from
the date on which the applicants receive notice of authority that receives the
applications (hereinafter referred to as “receiving authority”) informing the
applicants that their application is adequate;
b) providing additional information at written
request of receiving authority.
Article 6. Receipt of application
1. The receiving authority shall be the Vietnam
Environment Administration (VEA). The VEA shall assign one affiliated entity to
act as standing assessment agency and organize processing, assessment of
application, issuance, and revocation of certificate of biosafety.
Responsibilities of the standing assessment agency are specified under Article
16 hereof.
2. Within 7 working days from the date on which
application for issuance of certificate of biosafety is received, receiving
authority is responsible for sending notice informing the applicants about
legitimate application or required revision to application. The time in which
applicants revise their application does not count towards the time limit for
assessment.
Article 7. Assessment of application for
issuance of certificate of biosafety
1. Within 5 working days from the date on which
adequate application is received, receiving authority shall upload information
on risk assessment report mentioned under Point d Clause 1 Article 5 hereof on
the website http://www.antoansinhhoc.vn to measure public opinion. Measuring of
public opinion shall last for 30 days from the date on which the information is
uploaded. Within 5 working days from the date on which public opinion
measurement ends, receiving authority shall consolidate opinion in writing to
serve the assessment.
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a) issuing decisions on establishment of expert
teams. Organization and operation of expert teams are specified under Article
20 hereof;
b) submitting reports to request the Ministry of
Environment and Natural Resources to consider and issue decisions on
establishment of Council for biosafety. Compositions and structure of Council
for biosafety are specified under Article 10 hereof.
3. Within 90 days from the date on which decisions
on establishment of Council for biosafety, standing assessment agency is
responsible for organizing technical support in order to consider and evaluate
application for issuance of certificate of biosafety, consolidating, and
sending results of the Council for biosafety.
When necessary, standing assessment agency shall
request the VEA to request the applicants in writing to provide additional
information on risk assessment of GM plants; the time in which the applicants
provide additional information does not count towards the time limit for
application assessment.
4. Within 70 days from the date on which written
consolidation technical support results under Clause 3 of this Article is
received, the VEA shall hold meetings of the Council for biosafety in order to
assess application for issuance of certificate of biosafety.
Article 8. Issuance of application for issuance
of certificate of biosafety
1. Within 30 days from the date on which the
Council produces assessment results, the Minister of Environment and Natural
Resources shall consider and issue decisions on issuance of certificate of
biosafety for registered GM plants using form under Appendix 4 hereof.
If the application is rejected, the VEA shall issue
written notice and state reasons to the applicants.
2. Within 10 working days from the date on which
certificate of biosafety is issued, the Ministry of Environment and Natural
Resources is responsible for:
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b) adding GM plants to the List of GM plants issued
with certificate of biosafety.
Article 9. Revocation of certificate of
biosafety
1. Certificate of biosafety shall be revoked for
cases mentioned under Clause 1 Article 24 of Decree No. 69/2010/ND-CP dated
June 21, 2010 of the Government.
2. The VEA is responsible for verifying information
under Clause 1 of this Article and requesting the Minister of Environment and
Natural Resources to consider, issue decisions on revocation of certificate of
biosafety.
3. In case of revocation of certificate of
biosafety, the Ministry of Environment and Natural Resources is responsible
for:
a) sending original copies of the decisions on
revocation of certificate of biosafety to organizations, individuals that have
previously been issued with certificate of biosafety, uploading on
http://www.antoansinhhoc.vn and other mass media within 3 working days from the
date on which the decisions are issued;
b) removing the GM plants from the List of GM
plants issued with certificate of biosafety within 10 working days from the
date on which decisions on revocation of certificate of biosafety are issued.
4. Starting from the date on which decisions on
revocation of certificate of biosafety are issued, organizations and individuals
are not allowed to release GM plants which have had certificate of biosafety
revoked to the environment.
Chapter 3.
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Article 10. Composition and structure of Council
for biosafety
1. The Minister of Environment and Natural
Resources shall issue decisions on establishment of Council for biosafety
(hereinafter referred to as “Council”) using form under Appendix 5 hereof. The
Council must have at least 9 members, of which:
a) Heads of the VEA shall act as Chairpersons of
the Council;
b) Heads of standing assessment agency shall act as
Vice Chairpersons of the Council;
c) Officials of the standing assessment agency
shall act as secretary members;
d) Representatives of Ministry of Industry and
Trade, Ministry of Science and Technology, Ministry of Agriculture and Rural
Development, Ministry of Health shall act as 6 members and 2 experts. Among
which, 2 members shall be selected as review members.
2. Operation costs of the Council shall conform to
applicable laws.
Article 11. Responsibilities and powers of
Chairpersons of the Council
In addition to responsibilities and powers
specified under Article 13 hereof, the Chairpersons of the Council have
responsibility and power to:
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2. Process remarks mentioned in meetings and
provide conclusions for meetings of the Council.
3. Sign meeting minutes of the Council and be
legally responsible to the Ministry of Environment and Natural Resources for
conclusions that they produce in meetings of the Council.
Article 12. Responsibilities and powers of Vice
Chairpersons of the Council
In addition to responsibilities and powers
specified under Article 13 hereof, the Vice Chairpersons of the Council have
responsibilities and powers similar to those of the Chairpersons if they are
authorized by the Chairpersons.
Article 13. Responsibilities and powers of
members of the Council
1. Members of the Council are responsible for:
a) studying and providing remarks regarding
relevant documents provided by standing assessment agency; producing written
feedback on application for issuance of certificate of biosafety using form
under Appendix 6 hereof and sending to standing assessment agency prior to
official meetings of the Council;
b) participating in Council meetings and other
activities while assessing application under assignment of standing assessment
agency;
c) managing provided documents, preventing provided
documents from going missing or being transferred to third party, and returning
these documents at request of standing assessment agency after finishing
assessment;
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2. Members of the Council have the right and power
to:
a) request standing assessment agency to provide
adequate documents and information relating to application for issuance of
certificate of biosafety; organize meetings and other activities that directly
serve assessment process;
b) directly converse with organizations and
individuals at Council meetings;
c) have their feedback preserved and recorded in
meeting minutes of the Council if their feedback is different from that of the
Council;
g) receive wages in accordance with applicable
financial regulations for: producing written feedback on application,
participating in Council meetings and other activities, assigned tasks during
assessment process; receive disbursement for travel, accommodation, meal
allowances and other costs as per the law when participating in activities of
the Council.
Article 14. Responsibilities and powers of
secretary members
In addition to responsibilities and powers under
Article 13 hereof, secretary members have responsibility and power to:
1. Provide written feedback and assessment for
application for issuance of certificate of biosafety to Council members.
2. Report primary errors of the application to the
Chairpersons by studying and consolidating feedback of Council members and
expert teams; read feedback of Council members who do not participate in the
meetings.
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4. Perform other tasks serving operation of the
Council at request of the Chairpersons and standing assessment agency.
5. If secretary members do not participate in
Council meetings, secretary members shall report and request Chairpersons to
assign a member to act as secretary of the meetings.
Article 15. Non-voting members of Council
meetings
1. Standing assessment agency shall select and
invite non-voting members to Council meetings. Non-voting members shall not
vote in Council meetings.
2. Members of expert teams shall be invited to
Council meetings and provide independent scientific assessment; shall not vote
in Council meetings.
3. Non-voting members shall provide comment in
Council meetings, be coordinated by hosts of the meetings, and receive wages as
per the law.
Article 16. Tasks of standing assessment agency
1. Request the VEA to report to the Minister of
Environment and Natural Resources to establish the Council.
2. Report to the VEA to establish expert teams.
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a) uploading information on risk assessment report
on http://www.antoansinhhoc.vn, consolidate public opinion in accordance with
Clause 1 Article 7 hereof;
b) organizing Council meetings and activities with
procedures under Articles 17, 18, and 20 hereof;
c) drafting decisions on issuance of certificate of
biosafety and requesting competent authority to consider and decide;
d) storing documents relating to assessment process
for issuance of certificate of biosafety;
dd) monitoring, consolidating, and reporting
information on biosafety management of GM plants issued with certificate of
biosafety to competent authorities;
e) performing other tasks assigned by the VEA
relating to issuance and revocation of certificate of biosafety.
Article 17. Conditions for official meetings of
the Council
Official meetings of the Council shall only be held
when all conditions below are met:
1. At least 2/3 of Council members according to
decision on establishment of the Council are present (either physically at
meetings or online in online meetings). Among which, the presence of
Chairpersons or Vice Chairpersons if the Chairpersons are absent and at least 1
review member is required.
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3. The applicants have incurred assessment fees as
per the law.
Article 18. Agenda and procedures of official
Council meetings
Chairpersons or Vice Chairpersons (if the
Chairpersons are absent) shall hold meetings within their competence in
accordance with Article 11 hereof and coordinate the meetings as follows:
1. Secretary members shall read decisions on
establishment of the Council, introduce the participants, provide brief reports
on processing of the applications, provide consolidated feedback of expert
teams and operation of standing assessment agency prior to the meeting.
2. The applicants shall summarize risk assessment
reports.
3. Review members and other members of the Council
present the feedback.
4. Secretary members shall read feedback provided
by absent Council members.
5. Response of competent representatives of
applicants (if any).
6. Remarks of non-voting members (if any).
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a) The Council shall discuss applications based on
criteria for commenting on and assessing biosafety of GM plants against the
environment and biodiversity;
b) Council members shall fill in and submit written
assessment under Appendix 7 hereof;
c) Secretary members shall count written
assessment, consolidate, and produce reports on assessment count;
d) The Council shall discuss and reach an agreement
on draft conclusion.
8. Hosts of the meetings shall approve conclusion
of the Council and declare the end of the meetings.
Article 19. Rules for reaching conclusion of the
Council
Conclusion of the Council shall be officially
approved if at least 3/4 of participating Council members approve via their
votes.
Article 20. Organization and operation of expert
teams
1. Expert teams shall be established by the VEA
under decisions produced using form under Appendix 8 hereof and consist of at
least 3 members that are experts with sufficient expertise and experience
relating to the application.
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2. Expert teams are responsible for providing
technical support for the Council during assessment of application for issuance
of certificate of biosafety via the standing assessment agency, including:
studying application for issuance of certificate of biosafety; proposing
response to public opinion; finalizing consolidated remarks of expert teams in
field-specific meetings.
3. Members of expert teams are responsible for:
a) studying and providing technical advice for the
Council regarding application for issuance of certificate of biosafety using
form under Appendix 9 hereof;
b) requesting receiving authority to request the
applicants to provide additional documents vital for technical support when
necessary;
c) returning all provided documents to standing
assessment agency upon completing tasks; refraining from providing information
on their remarks and application to a third party; refraining from using remark
results in a manner that violates intellectual property laws.
Chapter 4.
ORGANIZING IMPLEMENTATION
Article 21. Responsibilities of organizations
and individuals
Upon obtaining certificate of biosafety,
organizations and individuals are responsible for submitting reports on
implementation of biosafety measures under certificate of biosafety to the
Ministry of Environment and Natural Resources, Ministry of Agriculture and
Rural Development, and provincial People’s Committees where GM plants are
released to the environment on an annual basis.
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1. This Circular comes into force from July 1,
2013.
2. Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of
Environment and Natural Resources./.
PP. MINISTER
DEPUTY MINISTER
Bui Cach Tuyen
APPENDIX 1
APPLICATION FOR
ISSUANCE OF CERTIFICATE OF BIOSAFETY
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
(1)
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No. …
On applying for certificate of biosafety for (2)
(Location
and date)
To: (3)
Name of applicant:
Name of representative of applicant:
Position:
Contact person of applicant:
Address:
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E-mail:
Hereby request the Ministry of Environment and
Natural Resources to consider and issue certificate of biosafety for (2)
Common name (Vietnamese, English) of GM plant
Scientific name of GM plant
Name of transformation event
Unique identifier (if any)
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Characteristics relating to delivered gene
Expected method of use, location of use after
obtaining certificate of biosafety
Attachments:
No.
Quantity
Type of
document
1
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Report on test results acknowledged by the
Ministry of Agriculture and Rural Development.
2
1 copy
Document issued by the Ministry of Agriculture
and Rural Development acknowledging test results
3
10 original copies
Risk assessment report for risks of GM plants to
the environment and biodiversity together with electronic files.
4
01 original copy
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…
Attachment: …
We hereby guarantee and assume responsibility to
the law of the Socialist Republic of Vietnam for accuracy of information and
data provided in attachments.
Hereby request the VEA to adopt necessary
procedures for assessing application and issuing certificate of biosafety./.
…. (4) …
(Signature, full name, position, and seal)
Note:
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2. Name of GM plant (name of transformation event);
3. Vietnam Environment Administration (VAE) (Nature
and Biodiversity Conservation Agency);
4. Competent representative of (1).
APPENDIX 2
SAMPLE RISK
ASSESSMENT REPORT OF GENETICALLY MODIFIED (GM) PLANT FOR RISK TO THE
ENVIRONMENT AND BIODIVERSITY
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
Applicant for
certificate of biosafety
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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RISK ASSESSMENT
REPORT OF GENETICALLY MODIFIED (GM) PLANTS FOR RISK TO THE ENVIRONMENT AND
BIODIVERSITY
Requirements:
The applicant must answer all questions under
risk assessment report. Each answer in the report must be proven by attached
documents. All documents must be numbered. The answers must be accompanied by
page number and number order of aforementioned attachments.
I. General information
1. Applicant
Name of applicant
Name of representative of applicant:
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Contact person of applicant:
Address:
Telephone:
Fax:
Email:
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2. GM plant:
Common name (Vietnamese, English) of GM plant
Scientific name
Transformation event
Unique identifier (if any)
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Purpose of GM plant
□ As food
□ As husbandry feed
□ Other purpose
If GM plant is used for other purpose, specify
the purpose below:
Method for detecting GM plant
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II. Information related to recipient organism
(plant)
II.1. Name of recipient organism?
Common name (Vietnamese, English)
Scientific name
II.2. Whether recipient organism can cause
diseases?
Human
○ Yes
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Animal
○ Yes
○ No
Plant
○ Yes
○ No
Provide reasoning for the answers and attach
written proof.
II.3. Whether the recipient organism originates
from Vietnam
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○ No
Provide reasoning for answers and indicate proof
documents.
II.4. Whether the organism is cultivated in
Vietnam for the first time If no, proceed with III.5.
○ Yes
○ No
If yes, describe natural habitats of the
organism, including information on species with direct and indirect
relationship in the food chain.
5. Describe distribution and living environment,
including information on species with direct and indirect relationship in the
food chain, history of cultivating and using recipient organism in Vietnam.
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III.6. Whether the organism is capable of
pollinating (or being pollinated) with other wild species If yes, list
several species and their distribution
○ Yes
○ No
Provide reasoning for the answers and attach
written proof.
III.7. Describe survivability of the recipient
organism and specific factors affecting survivability.
III. Information relating to gene delivery
process
III.1. Which gene delivery process is used to
create the GM plant?
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III.2 Vectors used (if any): Characteristics of
vectors, including identifiers, origin, host range of the vectors.
III.3. Describe gene structures, including
functions and DNA sequence of desirable gene(s) within the genetic structure,
origin and DNA sequence of other genes in the genetic structure (produce a
schedule indicating compositions of genetic structures and origin of these
compositions). Attach proof documents.
III.4. Whether donor organism(s) has a history of
safe use If not, what are the risks of donor organism(s)?
○ Yes
○ No
Provide reasoning for the answers and attach
written proof.
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○ Yes
○ No
Provide reasoning for the answers and attach
written proof.
IV. Information relating to the GM plant
IV.1. Specify composition of genetic structures
inserted to genes of the plant and their respective functions. How are these
compositions expressed? Attach proof documents
IV.2. If the GM plant carries stacked
transformation event, describe:
a) Whether interaction between genes and genetic
products creates toxic substances or allergic substances
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c) Whether there is any different between GM
plants carrying stacked transformation event and GM plants carrying single
transformation event Including: level of express of the gene, agronomy
characteristics, stability of genotype and phenotypes of donor gene, and
cultivation methods, etc.
Attach proof documents
IV.3. Detailed description of desirable
characteristics, stability of the characteristics, and methods for studying
the characteristics. Attach proof documents
IV.4. Describe differences between the GM plant
and recipient organism Explain the mechanism behind the differences and
attach proof documents.
IV.5. In which countries has the GM plant been
licensed? (produce list of countries where GM plant is licensed to be
released to the environment; consolidate remarks of competent authorities
pertaining to GM plant in countries where the plant is licensed).
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V.1. Determine risk of genetic drifts and
potential consequences based on worldwide research results and test results
in Vietnam of the GM plant. Specify risk management solutions and genetic
drift consequences. Attach proof documents
V.2. Determine risks of being turned to weed,
becoming persistent, or becoming invasive species and potential consequences;
rely on worldwide research results and test results in Vietnam of GM plant to
prove these points; specify risk management solutions and consequences of
being turned to weed, becoming persistent, or becoming invasive species.
Attach proof documents
V.3. Determine potential impact of GM plant to
nontarget organisms in the ecosystem:
(a) Determine nontarget organisms in the
ecosystem, including herbivores, natural enemies, and parasites that can be
exposed to GM plants in Vietnam. Reason for the selection;
b) Determine risks and consequences caused by the
GM plant to nontarget organisms in the ecosystem, rely on worldwide research
results and test results in Vietnam of the GM plant to prove points above.
Specify risk management solutions and consequences caused by GM plants to
nontarget organisms in the ecosystem.
Attach proof documents
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a) Whether the new characteristics require new
cultivation methods in order to be effective Describe the new cultivation
methods.
b) Whether long-term application of the new
cultivation methods produces any negative effect If not, provide explanation
c) If yes, how are these risks managed?
Provide reasoning for the answers and attach
written proof.
V.5. Impact on soil ecosystem
(a) Determine groups of soil animals and
transformation processes within the soil that are potentially affected by GM
plants. Reason for the selection;
(b) Determine risks and consequences caused
by GM plant to soil ecology, including: soil animals, and transformation
processes (carbon, nitrogen, etc.). Rely on worldwide research results and
test results in Vietnam (if any) of GM plant to prove the points above.
Specify risk management solutions and consequences caused by GM plant to
nontarget organisms in the ecosystem.
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VI. Information on risks of GM organisms to
human health
VI.1. If GM plant is used as food or husbandry
feed
Whether the GM plant has been issued with
certificate of eligibility for use as food and husbandry feed
○ Yes
○ No
If yes, provide copies of certificate of
eligibility for use as food and husbandry feed issued by the Ministry of
Agriculture and Rural Development
If not, produce list of countries where the GM
plant is licensed for use as food, husbandry feed and describe management
plans in order to ensure that the GM plan is not mixed up with food,
husbandry feed chain.
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VII. Proposed risk management solutions for
risks of GM plant to the environment and biodiversity
VII.1. List all risks mentioned above together
with corresponding risk management plans.
VII.2. Describe plans for supervising risks of
the GM plant to the environment, biodiversity, and human health when release
the plant to the environment.
VIII. Conclusion and recommendations
Appendix.
Consolidated Risk assessment report for risks to the environment and
biodiversity
(enclosed with Risk assessment report for risk of (GM plant) to the
environment and biodiversity of (applicant for biodiversity))
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- Column 1: Determine possible risks to the
environment and biodiversity if the GM plant is released to the environment.
- Column 2: Determine possibility of risks under
Column 1.
- Column 3: Determine consequences of risks
mentioned in Column 1.
- Column 4: Conclusion of the risks. If the risks
occur, specify risk management solutions in detail.
- Column 5: Provide brief explanation for risk
conclusion.
- Column 6: Indicate attachments that provide proof
for explanation in Column 5.
Risk
Possibility
Consequence
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Explanation
Attachment
(1)
(2)
(3)
(4)
(5)
(6)
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SAMPLE INFORMATION
ON RISK ASSESSMENT REPORT OF GENETICALLY MODIFIED (GM) PLANT FOR RISK TO THE
ENVIRONMENT AND BIODIVERSITY
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
Applicant for
certificate of biosafety
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
(Location
and date)
INFORMATION ON
RISK ASSESSMENT REPORT FOR RISK OF GM PLAN TO THE ENVIRONMENT AND BIODIVERSITY
I. General information
1. Name, address, representative, and contact
person of the applicant.
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II. Information on recipient organism
Provide brief description of the organism,
including name, biological characteristics of the recipient organism,
relationship with natural environment and biodiversity in Vietnam, history of
use of the recipient organism.
III. Information on gene delivery process
Describe the process through which GM plant is
created, including brief description of gene delivery process.
IV. Information on GM plant
1. Describe new characteristics and features of GM
plant compared to regular organisms;
2. Information on history of licensing and use of
the GM plant worldwide.
V. Information on assessment of potential risks
of GM plant to the environment and biodiversity
Describe risk assessment activities for risks of
the GM plant to the environment and biodiversity conducted and results thereof.
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Information on recorded risks of the GM plant to
human health.
VII. Information on proposed risk management
solutions
Provide brief description of proposed risk
management solutions (if any)
Note:
Information on Risk management report of the GM
plant to the environment and biodiversity does not include secret information
as per applicable laws.
APPENDIX 4
SAMPLE CERTIFICATE
OF BIOSAFETY ATTACHED TO DECISION OF THE MINISTER OF ENVIRONMENT AND NATURAL
RESOURCES ON ISSUANCE OF CERTIFICATE OF BIOSAFETY FOR GM PLANT
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
THE MINISTRY OF
ENVIRONMENT AND NATURAL RESOURCES OF VIETNAM
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CERTIFICATE OF
BIOSAFETY
(Attached
to Decision No. …../QD-BTNMT dated ……… of the Minister of Environment and
Natural Resources)
1. GM plant issued with the certificate:
- Common name:
- Scientific name:
- Transformation event:
- Characteristics relating to delivered gene:
- Unique identifier (if any):
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- Address:
- Phone number: Fax:
3. Organization/individual issued with the
certificate of biosafety is responsible for implementing biosafety requirements
applicable to GM plant above, including:
-
-
(Location
and date)
MINISTER
(Signature and seal)
................................
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SAMPLE DECISION ON
ESTABLISHMENT OF COUNCIL FOR BIOSAFETY
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
THE MINISTRY OF
ENVIRONMENT AND NATURAL RESOURCES OF VIETNAM
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No. /QD-BTNMT
(Location
and date)
DECISION
On establishment
of the Council for biosafety
THE MINISTER OF
ENVIRONMENT AND NATURAL RESOURCES
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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 Circular No. 08/2013/TT-BTNMT dated May
16, 2013 of the Minister of Environment and Natural Resources on procedures for
issuance and revocation of certificate of biosafety for GM plant;
At request of Chief of Ministry Office and General
Director of Vietnam Environment Agency,
HEREBY DECIDES:
Article 1. Establish the Council for
biosafety (hereinafter referred to as “Council”) consisting of individuals
under list attached below.
Article 2. The Council shall review and
assess application for certificate for biosafety for (GM plant, transformation
event) of (applicant), be held responsible for assessment results, and send
results to the Ministry of Environment and Natural Resources.
The Council shall dissolve upon completing their
tasks.
Article 3. Operational expenditure of the
Council shall be incurred in accordance with applicable laws.
Article 4. This Decision comes into force
from the date of signing. Chief of the Ministry Office, General Director of the
VEA, and individuals under Article 1 are responsible for implementation of this
Decision./.
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MINISTER
(Signature and seal)
……………
LIST OF COUNCIL
FOR BIOSAFETY
(Attached
to Decision No. …../QD-BTNMT dated ……… of the Minister of Environment and
Natural Resources)
No.
Full name
Academic
titles, academic degree, position, workplace
Position in the
Council
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2.
3.
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4.
5.
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(The list contains ... people)
APPENDIX 6
SAMPLE FEEDBACK
ABOUT APPLICATION FOR ISSUANCE OF CERTIFICATE OF BIOSAFETY USED BY MEMBERS OF
COUNCIL FOR BIOSAFETY
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
THE MINISTRY OF
ENVIRONMENT AND NATURAL RESOURCES
COUNCIL FOR BIOSAFETY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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(Location
and date)
FEEDBACK
APPLICATION FOR
ISSUANCE OF CERTIFICATE OF BIOSAFETY
I. General information on the application
1. Name of applicant:
2. Name of GM plant:
- Common name:
- Scientific name:
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- Purpose of GM plant:
- Unique identifier (if any):
3. Application number:
II. Information on members of the Council for
biosafety
1. Full name (academic rank, academic degree,
academic titles):
2. Workplace:
3. Position:
III. Feedback contents:
1. The application:
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2. Risk assessment report and attachments
Analyze the science, logic, and adequacy in
determining of risks, possibility of the risks, consequences of the risks,
conclusions of the risks, and risk management solutions of GM plants.
IV. Conclusion:
1. Conclusion
a) Approve without revision □
b) Approve with revision □
c) Not approve □
If b) is selected, specify details to be revised
2. Recommendations
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Member of the
Council for biosafety
(Signature and full name)
APPENDIX 7
SAMPLE ASSESSMENT OF
APPLICATION FOR ISSUANCE OF CERTIFICATE OF BIOSAFETY USED BY MEMBERS OF COUNCIL
FOR BIOSAFETY
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
THE MINISTRY OF
ENVIRONMENT AND NATURAL RESOURCES
COUNCIL FOR BIOSAFETY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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ASSESSMENT
APPLICATION FOR ISSUANCE OF CERTIFICATE
OF BIOSAFETY
I. General information on the application
1. Name of applicant:
2. Name of GM plant:
- Common name:
- Scientific name:
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- Purpose of GM plant:
- Unique identifier (if any):
3. Application number:
II. Information on members of the Council for
biosafety
1. Full name (academic rank, academic titles):
2. Workplace:
3. Position:
III. Conclusion:
1. Conclusion
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b) Approve with revision □
c) Not approve □
If b) is selected, specify details to be revised
2. Recommendations
Specific requirements for biosafety during use of
GM plant
Member of the
Council for biosafety
(Signature and full name)
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SAMPLE DECISION ON
ESTABLISHMENT OF EXPERT TEAM
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
THE MINISTRY OF
ENVIRONMENT AND NATURAL RESOURCES
VIETNAM ENVIRONMENT ADMINISTRATION
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No. /QD-TCMT
(Location
and date)
DECISION
On establishment
of expert team
GENERAL DIRECTOR
OF VIETNAM ENVIRONMENTAL ADMINISTRATION
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At request of Chief of Administration Office and
Director of Nature and Biodiversity Conservation Agency,
HEREBY DECIDES:
Article 1. Establish expert team consisting
of:
No.
Full name
Academic
titles, academic degree
Workplace
1
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2
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3
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Expert team shall dissolve upon completing the
tasks.
Article 3. This Decision comes into force
from the date of signing. Chief of Administration Office, Director of the
Nature and Biodiversity Conservation Agency, and individuals under Article 1
are responsible for the implementation of this Decision./.
GENERAL
DIRECTOR
(Signature and seal)
…………….
APPENDIX 9
SAMPLE FEEDBACK OF
EXPERT TEAM
(Attached to Circular No. 08/2013/TT-BTNMT dated May 16, 2013 of the
Minister of Environment and Natural Resources)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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FEEDBACK FORM OF
EXPERT TEAM
I. General information on the application:
1. Name of applicant:
2. Name of GM plant:
- Common name:
- Scientific name:
- Transformation event:
- Purpose of GM plant:
- Unique identifier (if any):
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II. Expert feedback:
1. Full name of expert (academic rank, academic
titles):
2. Workplace:
3. Position:
4. The expert receives application on: ………………
(date)
III. Detailed assessment:
1. Provide comment on risk assessment report and
attachments
Comment on risk assessment report on the basis of
analyzing the science, logic, and adequacy of determining of risks, possibility
of the risks, consequences of the risks, conclusions of the risks, and risk
management solutions of GM plant.
2. Propose response to public opinion
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1. Regarding risk assessment report and attachments
- List details that meet requirements:
- List details that do not meet requirements:
- Other remarks;
2. Regarding safety of GM plant
a) Safe for the environment and biodiversity
□
b) Safe for the environment and biodiversity in
specific conditions
□
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□
If b) is selected, specify all requirements in
detail.
Filing
individual
(Signature and full name)