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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.