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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/12/05 03:45
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Chapter Law Content

Chapter 3 Field Testing Management
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.
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