| Legislative： |
1.Full text of 35 articles enacted and promulgated on June 29,2005
by Council of Agriculture, Executive Yuan Order Nung-Shou-Liang
-Tzu No. 094105798
2.Articles 29 and 35 amended and promulgated on October 05, 2012
through Order Nung-Liang-Tzu No. 1011050336
3.Article 14- 1 amended and promulgated on March 5, 2014 through
Order Nung-Liang-Tzu No. 1031064107A
4.Article 4, 5, 6, 7, 9, 14-1, 16, 17, 18, 21, 24, 30 and 31
amended and promulgated on December 30, 2025 through Order
Nung-Liang-Tzu No. 1141135255A |
| Content： |
Chapter 1 General Principles
Article 1
These Regulations are enacted in accordance with Article 52,
Paragraph 3 of the Plant Variety and Plant Seed Act
(hereinafter referred to as "this Act").
Article 2
Terms used in these Regulations shall be defined as follows:
1. "Host plant" shall mean the plant receiving foreign genes
via gene transfer.
2. "Vector" shall mean a self-replicating DNA molecule able
to accept the insertion of foreign genes, and able to
transfer the foreign genes to the host plant.
3. "Field testing of transgenic plants" shall mean the genetic
characteristics investigation and biosafety assessment of
transgenic plants within a designated isolation facility.
4. "Genetic characteristics" shall mean the characteristics
expressed under the control or influence of genetic factors
.
5. "Biosafety" shall mean the policies and procedures to
prevent transgenic plants from potential risk or possible
hazard to human health, the ecological environment, and
biodiversity.
6. "Transgenic strain" shall mean a strain consisting foreign
genes transferred using genetic engineering or molecular
biotechnology.
7. "Target organism" shall mean the target pest, plant pathogen
, or weed to be controlled.
8. "Non-target organism" shall mean the non-target animal,
plant, or microbe of control efforts.
9. "Release" shall mean the provision of seed for propagation,
sale, and extension of field cultivation after a transgenic
plant has passed field testing review.
Article 3
The field testing of transgenic plants (hereinafter referred to
as "field testing") shall be performed by a transgenic plant
field testing institution (hereinafter referred to as a "field
testing institution") approved by the central competent
authority.
Article 4
The central competent authority shall establish a transgenic
plant evaluation committee (herein referred to as the
"evaluation committee") to review field testing and relevant
management matters.
Article 5
The evaluation committee shall have the following missions:
1. review of application cases for a field testing institution;
2. review of genetic characteristics testing application cases
and the cases' investigation reports;
3. review of biosafety assessment application cases and the
cases' assessment reports;
4. assessment of emergency incident handling measures during
the field testing period;
5. review of appointment or entrustment cases and decide the
matter of test results in conjunction with the testing
specified in Article 33;
6. provision of technical and policy consulting;
7. and other relevant matters.
Article 6
The evaluation committee shall consist of from 9 to 13 members
appointed for two-year terms. Members shall include the
following:
1. two representatives of the central competent authority, one
of whom shall serve as the chairman;
2. one representative each of the National Science and
Technology Council, Ministry of Health and Welfare, and
Ministry of Environment; and
3. the central competent authority shall invite 4 to 8
specialists in biotechnology, crop breeding, biodiversity,
plant protection, or other relevant fields to serve on the
committee.
Article 7
The evaluation committee chairman shall convene and chair
meetings upon requirement. The chairman shall appoint another
committee member to chair a meeting if the chairman is unable
to attend that meeting. The chairman may, when deemed
necessary, invite relevant agency personnel or specialists to
attend meetings in a non-voting capacity.
A quorum of at least two-thirds of evaluation committee members
must be present, and a majority of those members present must
grant their assent for resolutions to be valid.
Chapter 2 Application and Its Review of the Establishment of
Field Testing Institution
Article 8
An experimental research institution or juristic person group
with the ability to implement transgenic plant field testing
and possessing a relevant isolation facility and inspection
equipment may apply to the central competent authority for
approval as a field testing institution.
Article 9
When applying for approval as a field testing institution, the
applicant shall fill out and submit to the central competent
authority an application form, and shall state the following
items:
1. the location of the testing facility and a plan map with an
appropriate scale;
2. the established isolation facility;
3. the available inspection equipment;
4. a map of the layout of facilities and equipment within the
testing area;
5. field testing operating management standards of transgenic
plants;
6. personnel assignments and list of professional personnel; and
7. organization of biosafety committee and a list of members.
Article 10
Isolation facilities may be of the following four types
according to testing environment:
1. confined greenhouse;
2. semi-confined greenhouse;
3. isolated greenhouse or net house; or
4. isolated field.
Article 11
Each type of isolation facilities shall respectively possess
the following functions:
1. Confined greenhouse:
(1) Must be highly airtight and covered with transparent glass
or plastic material. Vents to outside the greenhouse must
be equipped with air filters to prevent the escape of
pollens, spores, seeds, or other particles.
(2) There must be sterilization or incineration equipment for
disposal or treatment of any wastewater, plant waste,
culture medium, or tools.
(3) There must be a personnel entry control point, and an air
shower, buffered double doors, and changerooms, etc.
2. Semi-confined greenhouse:
(1) The greenhouse must have a transparent glass or plastic
roof and be surrounded with glass or plastic material; the
greenhouse may also be isolated from its environs by fine
netting with mesh openings of less than 0.6mm.
(2) Vents or windows extending outside the greenhouse must be
equipped with fine netting with mesh opening of less than
0.6mm.
(3) There must be sterilization or incineration equipment for
disposal or treatment of any wastewater, plant waste,
culture medium, or tools.
(4) There must be a personnel entry control point, and an air
shower, buffered double doors, and changerooms, etc.
3. Isolated greenhouse or net house:
(1) Must have isolation bags or tools able to prevent pollens
and seeds of tested flowering plants from dispersing.
(2) There must be sterilization, incineration, or burial
equipment for disposal or treatment of any wastewater,
plant waste, culture medium, or tools.
(3) There must be equipment to prevent insects and animals from
entering.
(4) There must be a personnel entry control point and
appropriate disinfection facilities at the entrance.
4. Isolated field:
(1) The field must be surrounded by an iron mesh fence and
perimeter fence to isolate plants from the environs.
(2) The field shall possess sterilization, incineration, or
burial equipment for disposal or treatment of any
wastewater,plant waste, culture medium, or tools.
(3) There must be personnel and vehicle control facilities at
all entrances to the test field.
(4) The field must have a materials handling room.
(5) There must be a washing area allowing personnel to wash
themselves and any agricultural machinery that has been
used.
Article 12
The field testing institution must assign a specific
professional personnel possessing the ability to implement
transgenic plant safety assessment to bear responsibility for
management of the testing facility and implementation of
testing.
The professional personnel referred to in the preceding
Paragraph shall possess the following basic qualifications:
1. the person responsible for a testing facility and the
testing personnel shall be graduates of an agriculture/
forestry/life science-related department, and shall possess
actual work experience in transgenic plant testing or in
agriculture/ forestry;
2. testing facility management personnel shall be graduates
of an agriculture/forestry-related department, and shall
possess at least two years of actual cultivation experience;
and
3. sealed greenhouse or semi-sealed greenhouse management
personnel shall possess greenhouse management experience,
and shall including technicians in relevant areas such as
electrical machinery or technicians who have signed repair
contracts with relevant firms.
Article 13
Operating management regulations for the field testing of
transgenic plants shall include the following items:
1. clear signs marking the facility to those outside;
2. entry and exit controls on testing materials, personnel,
apparatus, and vehicles;
3. regular inspection of operations, facilities, and
equipment;
4. cleaning and management of the isolation facility and
apparatus; disposal of waste and plants remaining from
testing;
5. records shall be kept of operations, inspections, entry/
exit, and other matters subject to control;
6. emergency handling and notification mechanisms for
violations of operating regulations and other safety
problems; and
7. other precautions or prohibitions connected with the
implementation of testing.
Article 14
The central competent authority shall perform an on-site
audit after accepting a approval application for field
testing institution; the central competent authority shall
issue a certificate of approval and make an announcement if
the institution passes review.
The certificate in the preceding Paragraph shall have a
valid period of ten years, and the institution may send a
photocopy of the certificate to the central competent
authority within three months before the expiration date in
application for issuance of a new certificate.
Article 14-1
When it is necessary for a field testing institution to
terminate the use of a isolation facility approved for the
original purpose, it shall specify the type, area, reason
for the termination, and the use status of the isolation
facility to be discontinued and enclose the meeting records
indicating consent from its Biosafety Committee in the
submission to the central competent authority for revocation
of the approval and change to the original certificate for
the said isolation facility.
The central competent authority shall announce the type and
area of the isolation facility whose approval is revoked and
notify the field testing institution in writing.
Article 15
Field testing shall be implemented in accordance with the
instruction manual for operation and management of field
testing of transgenic plants.
The central competent authority shall send personnel at
unfixed intervals to inspect the field testing institution's
relevant facilities, equipment, and the state of field
testing operation management. If the institution fails to
pass inspection, the central competent authority shall
explain the reason and notify the institution to make
improvements within a limited time period. The central
competent authority may revoke the institution's approval
certificate and make an announcement to that effect if the
institution fails to make improvements by the deadline.
Article 16
A field testing institution shall establish a biosafety
committee responsible for reviewing field testing plans and
other relevant matters, and implementing the emergency
safety measures specified in Article 31.
Chapter 3 Field Testing Management
Section 1 Application for Field Testing
Article 17
A transgenic plant breeder or person authorized by a breeder
may apply to the central competent authority for a field
test permit.
The application stipulated in the preceding Paragraph shall
include a testing plan reviewed and approved by the field
testing institution's biosafety committee.
Article 18
Field testing shall include genetic characteristics
investigation and biosafety assessment.
Application for genetic characteristics investigation shall
be made after the completion of laboratory testing, or
before the plant material is acquired from overseas.
Application for biosafety assessment shall be made after
genetic characteristics investigation has been completed
and the results have passed review.
Genetic characteristics investigation and biosafety
assessment may, after review and approval, be implemented
concurrently for tree species that will not bloom during
the year and plants that do not produce pollen.
If a transgenic plant acquired from overseas has completed
genetic characteristics investigation in the exporting
country, the testing institution may submit verifying
documents before acquiring the plant, and may apply
directly for biosafety assessment if the plant passes
review by the evaluation committee.
Article 19
Applications for field testing permits shall be accepted
and reviewed as individual cases.
A single genetic characteristics investigation application
case may submit up to ten transgenic strains with distinct
serial numbers. The transgenic strains must be derived from
host plants of the same variety or strain using identical
foreign genes and identical gene transfer methods.
A single biosafety assessment application shall be limited
to submitting one transgenic strain with a distinct serial
number. That transgenic strain shall be chosen as having
stable genetic characteristics after genetic
characteristics investigation; the serial number of that
strain must be the same as during genetic characteristics
investigation.
Article 20
To cope with possible hazards during the transgenic plant
field testing period and to the need for safety management,
the applicant must submit information including the screen
markers needed in testing the transgenic plant, relevant
testing methods, and necessary testing materials to the
central competent authority when applying for a field
testing permit. The central competent authority shall
maintain the confidentiality of any business secrets among
the information submitted by the applicant.
The central competent authority may refuse to accept the
field testing application if the applicant fails to submit
the information specified in the preceding Paragraph.
Section 2 Genetic Characteristics Investigation
Article 21
The following documents shall be submitted to the central
competent authority when making a genetic characteristics
investigation application:
1. application form;
2. genetic characteristics investigation plan of the
transgenic plant;
3. a description of the transgenic plant's characteristics;
and
4. verifying documents reviewed and approved by the field
testing institution's biosafety committee.
Article 22
The genetic characteristics investigation plan of
transgenic plants shall state the following items:
1. the investigating goal and deadline;
2. investigating items and methods;
3. the isolation facility to be used;
4. relevant safety management and preventive measures;
5. a review of domestic and foreign literatures concerning
the foreign genes to be transferred and anticipated
possible impact on the environment; and
6. methods of disposal of testing waste including plants
and plant products during and after the testing periods.
The testing items referred to in Subparagraph 2 of the
preceding Paragraph shall include the following items:
7. the transgenic plant's propagation characteristics and
general expressed characteristics;
8. the likelihood of the transgenic plant hybridizing with
relative plants, wild species, or plants of the same
species;
9. the part where the foreign genes will be expressed in
the transgenic plant and the gene stability of the gene;
10. toxicity analysis of the genetic products of the
foreign genes in transgenic plants; and
11. other necessary items.
Article 23
The explanation of a transgenic plant's characteristics
shall state the following items:
1. host plant's name, source, taxonomic status, uses, state
of domestic cultivation, general botanical characteristics,
propagation and pollination methods, and any wild species or
closely related species in Taiwan;
2. the kinds, number, designations, and sources of the
foreign genes having been used, the control mechanisms of
gene expression, and locations and expression of the gene
within the cells of the transgenic plant;
3. the designation, source, and molecular characteristics
of the vector; and
4. the gene transfer method, identification method, and
theoretical support; molecular evidence of the target gene
after transfer.
Section 3 Biosafety Assessment
Article 24
The following documents shall be submitted to the central
competent authority when making a biosafety assessment
application:
1. application form;
2. biosafety assessment plan of the transgenic plant;
3. the approved genetic characteristics investigation
report, or the information needed when applying for
concurrently implementation in Article 18, Paragraph 4 or
the verifying documents needed for direct application in
Article 18, Paragraph 5; and
4. documents verifying review and approval of the
investigating plan by the field testing institution's
biosafety committee.
Article 25
The biosafety assessment plan of transgenic plant shall
state the following items:
1. testing goal and deadline;
2. uses of the transgenic plant and its products;
3. assessment items and assessment methods;
4. plan diagram of the transgenic plant's field
cultivation; types of crops grow around the area where the
transgenic plant will be grown;
5. cultivation and management measures of the transgenic
plant;
6. physiological or biological isolation strategies and
methods intended to prevent the transgenic plant from
hybridizing with closely-related crops outside the test
area;
7. a review of domestic and foreign literatures concerning
the foreign genes to be transferred and anticipated
possible impact on the environment;
8. emergency response procedures and relevant safety
management and preventive measures;
9. method of disposal of testing waste including plants
and plant products after the completion of testing; and
10. method of treating the test site after the completion
of testing.
The assessment items stipulated in Subparagraph 3 of the
preceding Paragraph shall include the following items:
11. the possibility of the transgenic plant becoming a weed
and its effect;
12. possible direct or indirect influence of the
transgenic plant on the target organism;
13. possible direct or indirect influence of the
transgenic plant on non-target organisms;
14. the possibility of foreign genes transferring from the
transgenic plant into other plants, animals, or pathogens
and their effects;
15. possible impact on the domestic ecological environment
and wild species if gene flow occurring from the
transgenic plant; and
16. other necessary matters to be assessed.
Section 4 Implementation and Monitoring
Article 26
Field tests shall be implemented in accordance with the
testing plan approved by the central competent authority.
The organization shall request the central competent
authority's approval of any changes in the content of the
testing plan.
Article 27
Transgenic plant testing materials shall be transported
alone in secure breakage-resistant devices that will
prevent the dispersal of material; transgenic plant
material may not be packed with other plant material, and
must be clearly marked with characters depicting
tansgenics.
Units and individuals engaged in the transport and storage
of transgenic plant testing materials shall follow strict
safety procedures during the transport and storage process
in order to prevent the dispersal of material; specified
personnel shall manage and record the transport and storage
process.
If an accident or improper transport causes the escape of
testing materials or contamination, the entrusting
institution and the transport company shall immediately
adopt emergency safety measures and clean up any
contamination.
Article 28
The central competent authority shall make public the
approved biosafety assessment plans; this information shall
include the following items:
1. the title of the testing plan;
2. the applicant;
3. the institution implementing field testing;
4. the characteristics of the transgenic plant;
5. date of plan approval; and
6. the implementation deadline of the plan.
Article 29
The applicant shall submit an annual report within one
month after the end of each year when the testing period
exceeds one year.
The applicant shall submit a test report to the central
competent authority within six months after the completion
of the genetic characteristics testing or biosafety
assessment field testing plan.
The central competent authority shall notify the applicant
in writing and make public the results of review of the
testing reports referred to in the preceding Paragraph.
Field tests with any of the following conditions are
considered to have been disapproved through review, for
which the central competent authority may close the case
directly with written notice to the applicant and through
announcement:
1. Failure to submit the annual report upon notice by the
central competent authority on the submission deadline,
which is in violation of the requirement in Paragraph 1.
2. Failure to submit the test report upon notice by the
central competent authority on the submission deadline,
which is in violation of the requirement in Paragraph 2.
3. Failure to supplement information for the annual report
and test report submitted in accordance with Paragraphs 1
and 2 despite notice by the central competent authority on
the deadline.
Article 30
The evaluation committee may make on-site visits at
unfixed intervals to better understand the state of
implementation during transgenic plant field testing
period. When necessary, the evaluation committee may ask
the applicant to revise the test content or extend the
testing deadline.
When, in the preceding Paragraph, the evaluation committee
resolves that the content of field testing must be changed,
central competent authority shall notify the applicant in
writing to revise the testing plan.
Article 31
If gene flow or some other major safety hazard has been
detected during the field testing period, the field testing
institution shall immediately suspend testing, the
biosafety committee shall adopt emergency safety measures,
and the institution shall immediately notify the central
competent authority. The evaluation committee shall perform
an assessment, and the central competent authority may when
necessary rely on its authority to revoke the field testing
permit.
Article 32
The release of a transgenic plant shall be handled in
accordance with transgenic plant labeling and packaging
regulations.
Article 33
In order to ensure safe management of transgenic plants and
implement long-term observation of the released transgenic
plants, the central competent authority may appoint or
entrust an institution possessing testing qualifications
and capabilities to perform transgenic plant testing.
Chapter 4 Supplementary Provisions
Article 34
The central competent authority shall prescribe the format
of forms and documents specified in these Regulations.
Article 35
These Regulations shall take effect on the day this Act is
enforced.
These amended articles of the Regulations shall take effect
on the day they are announced.
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