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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.