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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.