PART 3 BIOLOGICAL AGENTS AND
INACTIVATED BIOLOGICAL AGENTS |
| Prohibition against use of biological agents for non-peaceful purpose, etc. |
5.—(1) A person must not —| (a) | use; | | (b) | develop or produce; | | (c) | acquire, stockpile, retain or possess; or | | (d) | transfer to another person, whether directly or indirectly, |
| any biological agent for any non-peaceful purpose. |
(2) Any person who contravenes subsection (1) —| (a) | shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $1 million or to imprisonment for a term which may extend to life imprisonment or to both; and | | (b) | may be arrested without warrant by a police officer or an enforcement officer. |
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| Division 2 — First Schedule biological agents |
| Subdivision (1) — Possession and use |
| Prohibition against possession of First Schedule biological agents without approval |
| 6.—(1) A person must not possess any First Schedule biological agent unless the person’s possession of the First Schedule biological agent is authorised by and is in accordance with the conditions of an approval granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] (2) Subject to subsection (3), for the purpose of subsection (1), no approval to possess a First Schedule biological agent may be granted to any person unless —| (a) | the person is the operator of a certified facility; and | | (b) | where the biological agent is a First Schedule (Part 2) biological agent, the facility is a protected place. |
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| (3) Despite subsection (2)(a), the Director‑General may grant an approval to possess a First Schedule biological agent to the operator of an uncertified facility if the Director‑General is satisfied that any activity involving the use of the First Schedule biological agent will be carried out at such facility in a safe and proper manner. [Act 11 of 2023 wef 01/05/2023] |
(4) A person who has been granted an approval to possess a First Schedule biological agent must keep or use the First Schedule biological agent only at the following places:| (a) | where the person is the operator of a certified facility, at the certified facility specified in the approval to possess; and | | (b) | where the person is the operator of an uncertified facility, at such facility as may be specified in the approval to possess. |
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(5) Any person who —| (a) | possesses any First Schedule biological agent in contravention of subsection (1); or | | (b) | keeps or uses such biological agent at any facility in contravention of subsection (4), |
| shall be guilty of an offence and shall be liable on conviction to be punished as follows: |
| (c) | in the case of a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (d) | in the case of a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both. |
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(6) Where any person possesses any First Schedule biological agent in contravention of subsection (1) or keeps or uses such biological agent at any facility in contravention of subsection (4), the Director‑General may order any one or more of the following:| (a) | the immediate cessation of any activity involving the First Schedule biological agent carried out by the person at the facility; | | (b) | the destruction of the First Schedule biological agent at the facility; | | (c) | the decontamination of the facility; | | (d) | the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation; | | (e) | that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to the First Schedule biological agent at the facility should —| (i) | undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or | | (ii) | be quarantined at such place and for such period as the Director‑General may specify in the order. |
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[Act 11 of 2023 wef 01/05/2023] |
(7) Any person who contravenes any order made by the Director‑General under subsection (6) shall be guilty of an offence and shall be liable on conviction to be punished as follows:| (a) | where the order has been made in relation to or in connection with a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (b) | where the order has been made in relation to or in connection with a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both. |
[Act 11 of 2023 wef 01/05/2023] |
(8) This section does not apply to —| (a) | any person who has been engaged to transport any First Schedule biological agent within Singapore and whose possession of the First Schedule biological agent is merely incidental to the person’s transporting it in accordance with such engagement; or | | (b) | any person who has been engaged to store any First Schedule biological agent within Singapore pending —| (i) | the delivery of the First Schedule biological agent to the person who has procured its import into Singapore; or | | (ii) | the export of the First Schedule biological agent from Singapore in the course of transhipment, |
| and whose possession of the First Schedule biological agent is merely incidental to the person’s storing it in accordance with such engagement. |
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| Prohibition against large-scale production of First Schedule biological agents without approval |
7.—(1) A person must not carry out or procure any large-scale production of any First Schedule biological agent unless the large‑scale production of the First Schedule biological agent —| (a) | is authorised by an approval granted by the Director‑General; and [Act 11 of 2023 wef 01/05/2023] | | (b) | is carried out —| (i) | at the facility specified in the approval; and | | (ii) | in accordance with the conditions of the approval. |
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| (2) For the purposes of subsection (1), an approval to produce a First Schedule biological agent must not be granted to any person unless the person has already been granted an approval to possess the First Schedule biological agent as referred to in section 6. |
(3) Where any person produces any First Schedule biological agent at any facility in contravention of subsection (1) —| (a) | the person shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both; and | | (b) | the Director‑General may order any one or more of the following:| (i) | the immediate cessation of any activity involving the First Schedule biological agent carried out by the person at the facility; | | (ii) | the destruction of the First Schedule biological agent at the facility; | | (iii) | the decontamination of the facility; | | (iv) | the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation; | | (v) | that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to the First Schedule biological agent at the facility should —| (A) | undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or | | (B) | be quarantined at such place and for such period as the Director‑General may specify in the order. |
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[Act 11 of 2023 wef 01/05/2023] |
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| (4) Any person who contravenes any order made by the Director‑General under subsection (3)(b) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. [Act 11 of 2023 wef 01/05/2023] |
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| Subdivision (2) — Import and transhipment |
| Prohibition against import or transhipment of First Schedule biological agents without permit |
| 8.—(1) A person must not import or procure the import of any First Schedule biological agent unless the import of the First Schedule biological agent is authorised by and is carried out in accordance with the conditions of a permit granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] | (2) A person must not tranship any First Schedule biological agent unless the transhipment of the First Schedule biological agent is authorised by and is carried out in accordance with the conditions of a permit granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] |
| (3) For the purposes of subsection (1), a permit to import a First Schedule biological agent must not be granted to any person unless the person has already been granted an approval to possess the First Schedule biological agent as referred to in section 6. |
| (4) Every permit to import or tranship a First Schedule biological agent is valid only in respect of one consignment of the First Schedule biological agent for which an application for the permit has been made. |
(5) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to be punished as follows:| (a) | in the case of a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (b) | in the case of a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both. |
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| Notification of failure of receipt of import |
| 9.—(1) Every holder of a permit to import any First Schedule (Part 2) biological agent must immediately notify the Director‑General, in such form and manner as the Director‑General may require, in the event the holder of the permit fails to receive the consignment of the First Schedule (Part 2) biological agent to which the permit to import relates. [Act 11 of 2023 wef 01/05/2023] | (2) For the purposes of subsection (1), the holder of the permit to import is deemed to have failed to receive the consignment of the First Schedule (Part 2) biological agent to which the permit to import relates if the holder of the permit does not receive the consignment within 24 hours of such time as may be reasonably estimated by the holder of the permit for the receipt. |
| (3) Any person who fails to comply with subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000. |
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| Storage of First Schedule biological agents upon import or pending transhipment |
10.—(1) Where any First Schedule biological agent that has been imported into Singapore is required to be stored temporarily at any place before it is delivered to the facility for which it is destined, the person to whom the permit to import the First Schedule biological agent has been granted must ensure that the First Schedule biological agent is stored at a place which is safe and secure, and that the storage at such place is carried out in accordance with such requirements as may be prescribed.| (2) Where any First Schedule biological agent that is being transhipped through Singapore is required to be landed and stored temporarily at any place before it is delivered to the conveyance on which it will be taken out of Singapore, the person to whom the permit to tranship the First Schedule biological agent has been granted must ensure that the First Schedule biological agent is stored at a place which is safe and secure, and that the storage at such place is carried out in accordance with such requirements as may be prescribed. |
(3) Where a holder of a permit to import or tranship any First Schedule biological agent stores the biological agent in contravention of subsection (1) or (2), as the case may be —| (a) | the holder of the permit shall be guilty of an offence and shall be liable on conviction to be punished as follows:| (i) | in the case of a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (ii) | in the case of a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both; and |
| | (b) | the Director‑General may order the holder of the permit, at the expense of the holder of the permit, to do any one or more of the following:| (i) | take such measures as the Director‑General may specify to ensure that the First Schedule biological agent is properly stored; | | (ii) | destroy the First Schedule biological agent; | | (iii) | decontaminate the place at which the First Schedule biological agent was stored in contravention of subsection (1) or (2). |
[Act 11 of 2023 wef 01/05/2023] |
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(4) Any holder of a permit to import any First Schedule biological agent and any holder of a permit to tranship any First Schedule biological agent who contravenes any order made by the Director‑General under subsection (3)(b) shall be guilty of an offence and shall be liable on conviction to be punished as follows:| (a) | where the order has been made in relation to or in connection with a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (b) | where the order has been made in relation to or in connection with a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both. |
[Act 11 of 2023 wef 01/05/2023] |
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| Subdivision (3) — Transfer |
| Prohibition against transfers of First Schedule biological agents except by certain persons |
11.—(1) Subject to subsection (2), a person must not transfer any First Schedule biological agent unless —| (a) | the person has an approval to possess the First Schedule biological agent as referred to in section 6; and | | (b) | the transferee —| (i) | has also been granted an approval to possess the First Schedule biological agent as referred to in section 6; or | | (ii) | is outside Singapore. |
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(2) A person to whom any First Schedule biological agent has been provided for any excluded purpose must not transfer the First Schedule biological agent to any other person for any purpose other than an excluded purpose unless the transferee —| (a) | has been granted an approval to possess the First Schedule biological agent as referred to in section 6; or | | (b) | is outside Singapore. |
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(3) Any transferor who transfers any First Schedule biological agent to any transferee in Singapore, knowing or having reason to believe that such transferee does not have an approval to possess the First Schedule biological agent as referred to in section 6, shall be guilty of an offence and shall be liable on conviction to be punished as follows:| (a) | where the biological agent is a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (b) | where the biological agent is a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both. |
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| Notifications relating to transfers of First Schedule biological agents |
12.—(1) Any transferor who wishes to transfer any First Schedule (Part 2) biological agent to a transferee must notify —| (a) | the Director‑General of the proposed transfer within such time and in such form and manner as the Director‑General may require; [Act 11 of 2023 wef 01/05/2023] | | (b) | the transferee of an estimated time of receipt by the transferee of the biological agent being transferred; and | | (c) | the carrier of the biological agent (where the carrier is not the transferor or transferee) prior to the despatch of the biological agent of a 24‑hour emergency number that is monitored at all times by a person who —| (i) | has knowledge of the hazards and characteristics of the biological agent being transported; or | | (ii) | has immediate access to a person who possesses such knowledge and information. |
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| (2) Where a transferee fails to receive any First Schedule (Part 2) biological agent which is being transferred to the transferee, the transferee must immediately notify the Director‑General, in such form and manner as the Director‑General may require, of the failure of receipt. [Act 11 of 2023 wef 01/05/2023] |
| (3) For the purposes of subsection (2), a transferee is deemed to have failed to receive the First Schedule (Part 2) biological agent which is being transferred to the transferee if the transferee does not receive the biological agent within 24 hours of the estimated time of receipt of the biological agent provided by the transferor. |
| (4) Any person who contravenes subsection (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000. |
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| Subdivision (4) — Transportation |
| Prohibition against transportation by certain means |
13.—(1) A person must not transport or procure the transportation of any First Schedule biological agent within Singapore by mail or public transportation.(2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to be punished as follows:| (a) | where the biological agent is a First Schedule (Part 1) biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and | | (b) | where the biological agent is a First Schedule (Part 2) biological agent, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both. |
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| Division 3 — Second Schedule biological agents |
| Subdivision (1) — Possession and use |
| Prohibition against use of Second Schedule biological agents without special approval |
| 14.—(1) A person must not use any Second Schedule biological agent for any purpose unless the use of the Second Schedule biological agent is authorised by and is carried out in accordance with the conditions of a special approval to handle the Second Schedule biological agent granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] (2) A special approval to handle any Second Schedule biological agent must not be granted to any person unless the Director‑General is satisfied that —| (a) | the use for which the person requires the Second Schedule biological agent is necessary in the public interest; and | | (b) | the person who requires the Second Schedule biological agent has put in place adequate measures to contain the risks to public health and security posed by the Second Schedule biological agent. |
[Act 11 of 2023 wef 01/05/2023] |
| (3) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. |
(4) This section does not apply to —| (a) | any person who has been engaged to transport any Second Schedule biological agent within Singapore and whose possession of the Second Schedule biological agent is merely incidental to the person’s transporting it in accordance with such engagement; or | | (b) | any person who has been engaged to store any Second Schedule biological agent within Singapore pending —| (i) | the delivery of the Second Schedule biological agent to the person who has procured its import into Singapore; or | | (ii) | the export of the Second Schedule biological agent from Singapore in the course of transhipment, |
| and whose possession of the Second Schedule biological agent is merely incidental to the person’s storing it in accordance with such engagement. |
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| Prohibition against possession of Second Schedule biological agents without approval |
| 15.—(1) A person must not possess any Second Schedule biological agent unless the person’s possession of the Second Schedule biological agent is authorised by and is in accordance with the conditions of an approval granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] (2) For the purposes of subsection (1), an approval to possess a Second Schedule biological agent must not be granted to any person unless the person —| (a) | is the operator of a certified facility which is a protected place; and | | (b) | has been granted a special approval to handle the Second Schedule biological agent as referred to in section 14. |
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| (3) A person who has been granted an approval to possess a Second Schedule biological agent must keep or use the Second Schedule biological agent only at the certified facility specified in the approval to possess. |
(4) Any person who —| (a) | possesses any Second Schedule biological agent in contravention of subsection (1); or | | (b) | keeps or uses such biological agent at any facility in contravention of subsection (3), |
| shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. |
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(5) Where any person possesses any Second Schedule biological agent in contravention of subsection (1) or keeps or uses such biological agent at any facility in contravention of subsection (3), the Director‑General may order any one or more of the following:| (a) | the immediate cessation of any activity involving the Second Schedule biological agent carried out by the person at the facility; | | (b) | the destruction of the Second Schedule biological agent at the facility; | | (c) | the decontamination of the facility; | | (d) | the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation; | | (e) | that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to the Second Schedule biological agent at the facility should —| (i) | undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or | | (ii) | be quarantined at such place and for such period as the Director‑General may specify in the order. |
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[Act 11 of 2023 wef 01/05/2023] |
| (6) Any person who contravenes any order made by the Director‑General under subsection (5) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. [Act 11 of 2023 wef 01/05/2023] |
(7) This section does not apply to —| (a) | any person who has been engaged to transport any Second Schedule biological agent within Singapore and whose possession of the Second Schedule biological agent is merely incidental to the person’s transporting it in accordance with such engagement; or | | (b) | any person who has been engaged to store any Second Schedule biological agent within Singapore pending —| (i) | the delivery of the Second Schedule biological agent to the person who has procured its import into Singapore; or | | (ii) | the export of the Second Schedule biological agent from Singapore in the course of transhipment, |
| and whose possession of the Second Schedule biological agent is merely incidental to the person’s storing it in accordance with such engagement. |
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| Prohibition against large-scale production of Second Schedule biological agents |
16.—(1) A person must not carry out or procure any large‑scale production of any Second Schedule biological agent.(2) Where any person produces any Second Schedule biological agent at any facility in contravention of subsection (1) —| (a) | the person shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both; and | | (b) | the Director‑General may order any one or more of the following:| (i) | the immediate cessation of any activity involving the Second Schedule biological agent carried out by the person at the facility; | | (ii) | the destruction of the Second Schedule biological agent at the facility; | | (iii) | the decontamination of the facility; | | (iv) | the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation; | | (v) | that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to the Second Schedule biological agent at the facility should —| (A) | undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or | | (B) | be quarantined at such place and for such period as the Director‑General may specify in the order. |
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[Act 11 of 2023 wef 01/05/2023] |
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| (3) Any person who contravenes any order made by the Director‑General under subsection (2)(b) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $1 million or to imprisonment for a term which may extend to life imprisonment or to both. [Act 11 of 2023 wef 01/05/2023] |
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| Subdivision (2) — Import and transhipment |
| Prohibition against import or transhipment of Second Schedule biological agents without permit |
| 17.—(1) A person must not import or procure the import of any Second Schedule biological agent unless the import of the Second Schedule biological agent is authorised by and is carried out in accordance with the conditions of a permit granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] | (2) A person must not tranship any Second Schedule biological agent unless the transhipment of the Second Schedule biological agent is authorised by and is carried out in accordance with the conditions of a permit granted by the Director-General. [Act 11 of 2023 wef 01/05/2023] |
| (3) For the purposes of subsection (1), a permit to import a Second Schedule biological agent must not be granted to any person unless the person has already been granted an approval to possess the Second Schedule biological agent as referred to in section 15. |
| (4) Every permit to import or tranship a Second Schedule biological agent is valid only in respect of one consignment of the Second Schedule biological agent for which an application for the permit has been made. |
| (5) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. |
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| Notification of failure of receipt of import |
| 18.—(1) Every holder of a permit to import any Second Schedule biological agent must immediately notify the Director‑General, in such form and manner as the Director‑General may require, in the event the holder of the permit fails to receive the consignment of the Second Schedule biological agent to which the permit to import relates. [Act 11 of 2023 wef 01/05/2023] | (2) For the purposes of subsection (1), the holder of the permit to import is deemed to have failed to receive the consignment of the Second Schedule biological agent to which the permit to import relates if the holder of the permit does not receive the consignment within 24 hours of such time as may be reasonably estimated by the holder of the permit for the receipt. |
| (3) Any person who fails to comply with subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000. |
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| Storage of Second Schedule biological agents upon import or pending transhipment |
19.—(1) Where any Second Schedule biological agent that has been imported into Singapore is required to be stored temporarily at any place before it is delivered to the facility for which it is destined, the person to whom the permit to import the Second Schedule biological agent has been granted must ensure that the Second Schedule biological agent is stored at a place which is safe and secure, and that the storage at such place is carried out in accordance with such requirements as may be prescribed.| (2) Where any Second Schedule biological agent that is being transhipped through Singapore is required to be landed and stored temporarily at any place before it is delivered to the conveyance on which it will be taken out of Singapore, the person to whom the permit to tranship the Second Schedule biological agent has been granted must ensure that the Second Schedule biological agent is stored at a place which is safe and secure, and that the storage at such place is carried out in accordance with such requirements as may be prescribed. |
(3) Where a holder of a permit to import or tranship any Second Schedule biological agent stores the biological agent in contravention of subsection (1) or (2), as the case may be —| (a) | the holder of the permit shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both; and | | (b) | the Director‑General may order the holder of the permit, at the expense of the holder of the permit, to do any one or more of the following:| (i) | take such measures as the Director‑General may specify to ensure that the Second Schedule biological agent is properly stored; | | (ii) | destroy the Second Schedule biological agent; | | (iii) | decontaminate the place at which the Second Schedule biological agent was stored in contravention of subsection (1) or (2). |
[Act 11 of 2023 wef 01/05/2023] |
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| (4) Any holder of a permit to import any Second Schedule biological agent and any holder of a permit to tranship any Second Schedule biological agent who contravenes any order made by the Director‑General under subsection (3)(b) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. [Act 11 of 2023 wef 01/05/2023] |
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| Subdivision (3) — Transfer |
| Prohibition against transfers of Second Schedule biological agents except by certain persons |
20.—(1) Subject to subsection (2), a person must not transfer any Second Schedule biological agent unless —| (a) | the person has an approval to possess the Second Schedule biological agent as referred to in section 15; and | | (b) | the transferee —| (i) | has also been granted an approval to possess the Second Schedule biological agent as referred to in section 15; or | | (ii) | is outside Singapore. |
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(2) A person to whom any Second Schedule biological agent has been provided for any excluded purpose must not transfer the Second Schedule biological agent to any other person for any purpose unless the transferee —| (a) | has been granted an approval to possess the Second Schedule biological agent as referred to in section 15; or | | (b) | is outside Singapore. |
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| (3) Any transferor who transfers any Second Schedule biological agent to any transferee in Singapore, knowing or having reason to believe that such transferee does not have an approval to possess the Second Schedule biological agent as referred to in section 15, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. |
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| Notifications relating to transfers of Second Schedule biological agents |
21.—(1) Any transferor who wishes to transfer any Second Schedule biological agent to a transferee must notify —| (a) | the Director‑General of the proposed transfer within such time and in such form and manner as the Director‑General may require; [Act 11 of 2023 wef 01/05/2023] | | (b) | the transferee of an estimated time of receipt by the transferee of the biological agent being transferred; and | | (c) | the carrier of the biological agent (where the carrier is not the transferor or transferee) prior to the despatch of the biological agent of a 24‑hour emergency number that is monitored at all times by a person who —| (i) | has knowledge of the hazards and characteristics of the biological agent being transported; or | | (ii) | has immediate access to a person who possesses such knowledge and information. |
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| (2) Where a transferee fails to receive any Second Schedule biological agent which is being transferred to the transferee, the transferee must immediately notify the Director‑General, in such form and manner as the Director‑General may require, of the failure of receipt. [Act 11 of 2023 wef 01/05/2023] |
| (3) For the purposes of subsection (2), a transferee is deemed to have failed to receive the Second Schedule biological agent which is being transferred to the transferee if the transferee does not receive the biological agent within 24 hours of the estimated time of receipt of the biological agent provided by the transferor. |
| (4) Any person who contravenes subsection (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000. |
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| Subdivision (4) — Transportation |
| Prohibition against transportation by certain means |
22.—(1) A person must not transport or procure the transportation of any Second Schedule biological agent within Singapore by mail or public transportation.| (2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both. |
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| Division 4 — Third Schedule biological agents |
| Prohibition against large-scale production of Third Schedule biological agents without approval |
23.—(1) A person must not carry out or procure any large-scale production of any Third Schedule biological agent unless the large‑scale production of the Third Schedule biological agent —| (a) | is authorised by an approval granted by the Director‑General; and [Act 11 of 2023 wef 01/05/2023] | | (b) | is carried out —| (i) | at the facility specified in the approval; and | | (ii) | in accordance with the conditions of the approval. |
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(2) Where any person produces any Third Schedule biological agent at any facility in contravention of subsection (1), the Director‑General may order any one or more of the following:| (a) | the immediate cessation of any activity involving the Third Schedule biological agent carried out by the person at the facility; | | (b) | the destruction of the Third Schedule biological agent at the facility; | | (c) | the decontamination of the facility; | | (d) | the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation; | | (e) | that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to the Third Schedule biological agent at the facility should —| (i) | undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or | | (ii) | be quarantined at such place and for such period as the Director‑General may specify in the order. |
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[Act 11 of 2023 wef 01/05/2023] |
| (3) Any person who contravenes any order made by the Director‑General under subsection (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both. [Act 11 of 2023 wef 01/05/2023] |
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| Prohibition against transportation by certain means |
24.—(1) A person must not transport or procure the transportation of any Third Schedule biological agent within Singapore by mail or public transportation.| (2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both. |
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| Division 5 — Fourth Schedule biological agents |
| Prohibition against import of Fourth Schedule biological agents without permit |
| 25.—(1) A person must not import or procure the import of any Fourth Schedule biological agent unless the import of the Fourth Schedule biological agent is authorised by and is carried out in accordance with the conditions of a permit granted by the Director‑General. [Act 11 of 2023 wef 01/05/2023] | (2) Every permit to import a Fourth Schedule biological agent is valid only in respect of one consignment of the Fourth Schedule biological agent for which an application for a permit to import has been made. |
| (3) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 6 months or to both. |
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| Prohibition against transportation by certain means |
26.—(1) A person must not transport or procure the transportation of any Fourth Schedule biological agent within Singapore by mail or public transportation.| (2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 6 months or to both. |
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| Division 6 — Inactivated biological agents |
| Prohibition against inactivation of biological agents |
27.—(1) A person must not inactivate or procure the inactivation of any First Schedule biological agent or Second Schedule biological agent unless —| (a) | the person has been granted an approval to possess the First Schedule biological agent as referred to in section 6, or an approval to possess the Second Schedule biological agent as referred to in section 15, as the case may be; and | | (b) | the inactivation of the biological agent is carried out —| (i) | in accordance with such method as may be approved by the person’s biosafety committee; and | | (ii) | at the facility specified in the person’s approval to possess the First Schedule biological agent or Second Schedule biological agent. |
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| (2) Subsection (1) does not apply insofar as the inactivation relates to the decontamination of any First Schedule biological agent waste or Second Schedule biological agent waste. |
(3) Where any person has inactivated or attempted to inactivate any First Schedule biological agent or Second Schedule biological agent at any facility in contravention of subsection (1) (whether or not the inactivation is successful), the Director‑General may order any one or more of the following:| (a) | the immediate cessation of any activity involving that First Schedule biological agent or Second Schedule biological agent carried out by the person at the facility; | | (b) | the destruction of that First Schedule biological agent or Second Schedule biological agent at the facility; | | (c) | the decontamination of the facility; | | (d) | the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation; | | (e) | that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to that First Schedule biological agent or Second Schedule biological agent at the facility should —| (i) | undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or | | (ii) | be quarantined at such place and for such period as the Director‑General may specify in the order. |
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[Act 11 of 2023 wef 01/05/2023] |
| (4) Any person who contravenes any order made by the Director‑General under subsection (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 6 months or to both. [Act 11 of 2023 wef 01/05/2023] |
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| Prohibition against import of inactivated biological agents without permit |
28.—(1) A person must not import or procure the import of —| (a) | any inactivated First Schedule biological agent; or | | (b) | any inactivated Second Schedule biological agent, |
| for any purpose unless the import of the inactivated First Schedule biological agent or inactivated Second Schedule biological agent (as the case may be) is authorised by and is carried out in accordance with the conditions of a permit granted by the Director-General. |
[Act 11 of 2023 wef 01/05/2023] | (2) The Director‑General must not grant any permit to import any inactivated First Schedule biological agent or any inactivated Second Schedule biological agent to any person unless the Director‑General is satisfied that the biological agent has been properly inactivated. [Act 11 of 2023 wef 01/05/2023] |
(3) Without prejudice to section 50, for the purpose of satisfying himself or herself that any First Schedule biological agent or Second Schedule biological agent has been properly inactivated, the Director‑General may require an applicant for a permit to import to provide such information relating to —| (a) | the person by whom the inactivation of the First Schedule biological agent or Second Schedule biological agent (as the case may be) has been carried out; and | | (b) | the method of the inactivation used and its efficacy. |
[Act 11 of 2023 wef 01/05/2023] |
| (4) Every permit to import an inactivated First Schedule biological agent or an inactivated Second Schedule biological agent entitles the holder of the permit to import from the person referred to in subsection (3)(a) any number of consignments of the inactivated First Schedule biological agent or the inactivated Second Schedule biological agent, as specified in the permit, which has been so inactivated using the method referred to in subsection (3)(b). |
| (5) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 6 months or to both. |
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| Prohibition against transportation by certain means |
29.—(1) A person must not transport or procure the transportation of any inactivated First Schedule biological agent or any inactivated Second Schedule biological agent within Singapore by mail or public transportation.| (2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 6 months or to both. |
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