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Chapter Law Content

Chapter 3 Field Testing Management
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.