### Genetically Modified Organisms (Control of Release) Ordinance 《基因改造生物(管制釋出)條例》

11. Request for variation of decisions on GMO approval applications
(1) If the Director refuses to approve a GMO for release into the environment under section 10(1), the applicant under the GMO approval application may, on any of the grounds specified in subsection (3), request the Director to vary the decision by approving the GMO for such release with or without conditions.
(2) If the Director approves a GMO for release into the environment with conditions under section 10(1), the applicant under the GMO approval application may, on any of the grounds specified in subsection (3), request the Director to vary the decision by cancelling or varying the conditions.
(3) The grounds specified for the purposes of subsections (1) and (2) are—
(a) a change in circumstances that may influence the Director’s assessment on the possible adverse biosafety effect of the GMO has occurred;
(b) additional scientific or technical information that may influence the Director’s assessment on the possible adverse biosafety effect of the GMO has become available.
(4) A variation request must—
(a) be in the specified form; and
(b) be accompanied by—
(i) relevant information in support of the request; and
(ii) the prescribed fee payable on the request.
(5) Within 90 days after receiving a variation request, the Director must—
(a) decide whether to confirm or vary the decision on the GMO approval application; and
(b) give the applicant a written notice of the confirmation or variation and the reason for it.

### Genetically Modified Organisms (Control of Release) Ordinance 《基因改造生物(管制釋出)條例》

12. Variation of decisions on GMO approval applications or variation requests on Director’s own initiative
(1) The Director may, on his or her own initiative on any of the grounds specified in subsection (2), vary the decision made on a GMO approval application or variation request under section 10(1)(a) or 11(5)(a) by—
(a) cancelling or varying any condition attached to, or adding any condition to, the approval of the GMO; or
(b) revoking the approval of the GMO.
(2) The grounds are—
(a) a change in circumstances that influences the Director’s assessment on the possible adverse biosafety effect of the GMO has occurred;
(b) additional scientific or technical information that influences the Director’s assessment on the possible adverse biosafety effect of the GMO has become available;
(c) the Director considers it in the public interest to do so.
(3) After varying a decision on a GMO approval application or variation request under subsection (1), the Director must give the applicant a written notice of the variation and the reason for it.
(4) If—
(a) the approval of a GMO is revoked under subsection (1)(b); and
(b) the GMO has been released into the environment under the approval,
the applicant under the GMO approval application must, within the period specified in the notice of variation under subsection (3), inform the Director of the release by written notice.
(5) A notice under subsection (4) must contain the information set out in Part 1 of Schedule 1.
(6) A person who contravenes subsection (4) commits an offence and is liable to a fine at level 5.
(7) If the approval of a GMO is revoked under subsection (1)(b), the Director may, by the notice of variation under subsection (3), give the applicant under the GMO approval application any direction that the Director thinks fit on the safekeeping or disposal of—
(a) the GMO; or
(b) any container containing the GMO.
(8) A person given a direction under subsection (7) must, subject to section 43(5), carry out the direction at the person’s cost within the period specified in the notice.
(9) A person who contravenes subsection (8) commits an offence and is liable to a fine at level 6.

### Genetically Modified Organisms (Control of Release) Ordinance 《基因改造生物(管制釋出)條例》

13. Entry of information on GMO approval applications and variation requests (other than that specified in non-disclosure requests) in register
(1) Within 14 days after the Director is satisfied that a GMO approval application contains, on the face of it, the information set out in Part 1, or Parts 1 and 2, of Schedule 2, as the case requires, the Director must enter the information in the register.
(2) If, after entering any information in the register under subsection (1), the Director receives further information from the applicant—
(a) on the GMO approval application; or
(b) on a variation request on the Director’s decision on that application, 
the Director must enter the further information in the register within 14 days after receipt of it.
(3) Subsections (1) and (2) do not apply in relation to any information that is specified in a non-disclosure request.

14. Making of non-disclosure requests
(1) When providing any information to the Director for the purposes of a GMO approval application or variation request, the applicant may request the Director not to enter the information in the register.
(2) A non-disclosure request must—
(a) be in the specified form;
(b) specify the information that the Director is requested not to enter in the register; and
(c) set out the justifications for the request.
(3) Subsection (1) does not apply in relation to the following information—
(a) the name and address of the applicant;
(b) a general description of the GMO;
(c) a summary of the risk assessment on the possible adverse biosafety effect of the GMO; and
(d) any proposed methods and plans for dealing with the possible adverse biosafety effect of the GMO in emergency circumstances.

15. Director’s decisions on non-disclosure requests
(1) Within 30 days after receiving a non-disclosure request on a GMO approval application or variation request, the Director must—
(a) decide—
(i) that none of the proposed confidential information is to be entered in the register;
(ii) that only some of the proposed confidential information is to be entered in the register; or
(iii) that all of the proposed confidential information is to be entered in the register; and
(b) give the applicant a written notice of the decision and the reason for it.
(2) The Director may decide not to enter certain proposed confidential information in the register if the Director is satisfied that—
(a) entering the information would adversely affect the applicant’s interest; and
(b) not entering the information would not be contrary to the public interest.

### Genetically Modified Organisms (Control of Release) Ordinance 《基因改造生物(管制釋出)條例》

16. Review of Director’s decisions on non-disclosure requests
(1) An applicant under a GMO approval application or variation request who is aggrieved by a decision of the Director under section 15(1)(a)(ii) or (iii) may, within 14 days after receiving notice of the decision, request the Director to review the decision.
(2) A request for review must—
(a) be in the specified form;
(b) set out the justifications for the request; and
(c) be accompanied by the prescribed fee payable on the request.
(3) Within 30 days after receiving a request for review, the Director must—
(a) decide on the request; and
(b) give the applicant a written notice of the decision and the reason for it.