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Chapter Law Content

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.