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 Ministry of Science and
Technology, Ministry of Health and Welfare , and
Environmental Protection Administration; 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
he 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:
1. the transgenic plant's propagation characteristics and
general expressed characteristics;
2. the likelihood of the transgenic plant hybridizing with
relative plants, wild species, or plants of the same
species;
3. the part where the foreign genes will be expressed in the
transgenic plant and the gene stability of the gene;
4. toxicity analysis of the genetic products of the foreign
genes in transgenic plants; and
5. 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:
1. the possibility of the transgenic plant becoming a weed and
its effect;
2. possible direct or indirect influence of the transgenic plant
on the target organism;
3. possible direct or indirect influence of the transgenic plant
on non-target organisms;
4. the possibility of foreign genes transferring from the
transgenic plant into other plants, animals, or pathogens and
their effects;
5. possible impact on the domestic ecological environment and
wild species if gene flow occurring from the transgenic plant
;and
6. 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. |