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

3. Meanings of released into environment and contained use
(1) For the purposes of this Ordinance, a GMO is released into the environment if—
(a) it is not in contained use; and
(b) it is exposed to a condition in which it may grow or reproduce.
(2) For the purposes of this Ordinance, a GMO is in contained use if—
(a) it is involved in an operation that is undertaken within a facility, installation or other physical barrier; and
(b) it is controlled by specific measures that effectively limit its contact with, and its impact on, the environment.

4. Ordinance applies to Government
(1) Subject to subsections (2) and (3), this Ordinance applies to the Government.
(2) Neither the Government, nor any public officer in the officer’s capacity as such, is liable to be prosecuted for an offence against this Ordinance.
(3) No prescribed fee is payable by any Government department that does not operate under a trading fund within the meaning of the Trading Funds Ordinance (Cap. 430).

5. Restrictions on release into environment and maintenance of lives of GMOs
(1) This section does not apply to or in relation to a GMO that is a pharmaceutical product for use by human beings.
(2) A person must not knowingly cause a GMO to be released into the environment, unless each of the conditions specified in subsection (4) is complied with.
(3) A person must not knowingly maintain the life of a GMO that is in a state of being released into the environment, unless each of the conditions specified in subsection (4) is complied with.
(4) The conditions specified for the purposes of subsections (2) and (3) are—
(a) the GMO is an approved GMO;
(b) the approval is entered in the register under section 18;
(c) every condition (if any) for the approval of the GMO, as set out in the register, has been complied with.
(5) A person who contravenes subsection (2) or (3) commits an offence and is liable to a fine at level 6 and to imprisonment for one year.

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

6. Notification to Director of certain releases of GMOs
(1) This section applies where a person who has control of a GMO knows that—
(a) if the GMO is an approved GMO—
(i) the GMO has been released into the environment; and
(ii) any condition for the approval of the GMO, as set out in the register, has not been complied with;
(b) if the GMO is not an approved GMO but is exempted under section 46 from the application of section 5—
(i) the GMO has been released into the environment; and
(ii) any condition for the exemption of the GMO, as set out in the register, has not been complied with; or
(c) if the GMO is not an approved GMO and is not exempted under section 46 from the application of section 5—
(i) the GMO has been released into the environment; and
(ii) the GMO is not a pharmaceutical product for use by human beings.
(2) As soon as practicable after the person knows of the release, the person must, by written notice, inform the Director of the release.
(3) Subsection (2) does not require a person to inform the Director of the release if—
(a) another person also has control of the GMO; and
(b) that other person has informed the Director of the release in compliance with that subsection.
(4) A person who contravenes subsection (2) commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months.
(5) A notice under subsection (2) must contain the information set out in Parts 1 and 2 of Schedule 1.
(6) On receiving a notice under subsection (2), the Director may—
(a) direct an authorized officer to enter, during reasonable hours, the place or premises in or on which the GMO was released to dispose of the GMO; or
(b) direct the person to dispose of the GMO.

7. Restrictions on import of GMOs intended for release into environment
(1) This section does not apply to or in relation to—
(a) a GMO that is in transit or transhipment;
(b) a GMO that is intended—
(i) for direct consumption as food or feed; or
(ii) for processing; or
(c) a GMO that is a pharmaceutical product for use by human beings.
(2) A person must not knowingly import a GMO that is intended for release into the environment unless—
(a) the GMO is an approved GMO;
(b) the approval is entered in the register under section 18; and
(c) every condition (if any) for the approval of the GMO, as set out in the register, has been complied with.
(3) A person who contravenes subsection (2) commits an offence and is liable to a fine at level 6 and to imprisonment for one year.

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

8. Application for approval of GMOs for release into environment
(1) A person may apply to the Director for approval of a GMO for release into the environment.
(2) A GMO approval application must—
(a) be in the specified form;
(b) contain the information set out in Part 1 of Schedule 2; and
(c) be accompanied by—
(i) a report on a risk assessment carried out, or caused to be carried out, by the applicant in accordance with Schedule 3, on the possible adverse biosafety effect of the GMO; and
(ii) the prescribed fee payable on the application.
(3) If the GMO is to be imported, the GMO approval application must also contain the information set out in Part 2 of Schedule 2.

9. Acknowledgement of receipt of GMO approval applications
(1) Within 90 days after receiving a GMO approval application, the Director must issue a written acknowledgement to the applicant confirming the receipt of the application.
(2) An acknowledgement must state—
(a) the date on which the Director received the application; and
(b) whether the 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.

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

10. Approval of GMOs
(1) Within 270 days after receiving a GMO approval application, the Director must—
(a) decide whether the GMO is approved for release into the environment; and
(b) give the applicant a written notice of the decision.
(2) The Director must not approve a GMO for release into the environment unless the Director is satisfied that the possible adverse biosafety effect of the GMO is acceptable or manageable.
(3) On approving a GMO for release into the environment, the Director may attach any condition that the Director thinks fit to the approval.
(4) If the Director refuses to approve a GMO for release into the environment or attaches a condition to an approval, the Director must state the reason for the decision in the notice given under subsection (1).
(5) The Director may, before the expiry of the period within which a decision must be made on a GMO approval application under subsection (1), extend that period by written notice to the applicant.
(6) A notice under subsection (5) must—
(a) specify the duration of the extended period; and
(b) set out the reason for the extension.
(7) If the Director has, by written notice, required an applicant to provide additional information or supporting documents under section 19(1), the number of days falling within the period specified in subsection (8) must be disregarded in calculating the 270-day period or the extended period for the purposes of subsection (1).
(8) The period is the one—
(a) beginning with the date of the written notice; and
(b) ending with the date on which the additional information or supporting documents required were received by the Director.