Biological Agents and Toxins Act 2005 - Singapore Statutes Online

PART 5

DUTIES AND OBLIGATIONS
IN RELATION TO BIOLOGICAL AGENTS
AND TOXINS

Division 1 — Duties and obligations of operators,
biosafety committees, biosafety co‑ordinators
and staff of facilities

Application

38.—(1) Except as otherwise specified, the duties and obligations specified in this Division apply to the operator of a facility who has been granted —

(a)	an approval to possess any First Schedule biological agent or Second Schedule biological agent;
(b)	an approval to produce on a large scale any First Schedule biological agent or Third Schedule biological agent; or
(c)	an approval to possess any Fifth Schedule toxin,

in relation to or in connection with the possession or production allowed by such approval.

(2) In this Division —

“biological agent” means —

(a)	any First Schedule biological agent;
(b)	any Second Schedule biological agent; or
(c)	any Third Schedule biological agent produced on a large scale;

“toxin” means any Fifth Schedule toxin.

Appointment of biosafety committee and biosafety co‑ordinator

39.—(1) Every operator of a facility must, in accordance with such requirements as may be prescribed —

(a)	appoint a biosafety committee comprising the persons specified in the Sixth Schedule; and
(b)	appoint a biosafety co-ordinator.

(2) The biosafety co-ordinator of a facility must undergo such training as the Director‑General may from time to time require.

[Act 11 of 2023 wef 01/05/2023]

(3) Subject to subsection (4), every operator of a facility must, before carrying out any of the following activities at the facility, obtain the advice of the biosafety committee as to the safety measures required for the carrying out of that activity:

(a)	any activity involving any biological agent or toxin;
(b)	the inactivation of any biological agent.

(4) Nothing in subsection (3) requires the operator of a facility to obtain the advice of the biosafety committee in respect of an activity which the operator proposes to carry out at the facility if the proposed activity is of the same type and is to be carried out in the same manner as an activity in respect of which the operator had previously obtained the advice of the biosafety committee in accordance with that subsection and which had been carried out safely.

(5) In order to properly advise the operator of a facility as to the safety measures required for the carrying out of any activity referred to in subsection (3) at the facility, the biosafety committee must —

(a)

conduct risk assessments in relation to the activity proposed to be carried out;

(b)

devise such measures for the management of the risks that may arise from the proposed activity; and

(c)

formulate such other policies, programmes and codes of practice as may be necessary for —

(i)	the proposed activity to be carried out safely at the facility; and
(ii)	the training of staff who will be involved in the carrying out of the proposed activity.

(6) An operator of a facility must not commence or allow the commencement of any activity involving any biological agent or toxin at the facility unless —

(a)	the biosafety committee has determined that the proposed activity may be carried out safely at the facility;
(b)	the biosafety co-ordinator has implemented the measures, policies, programmes and codes of practice as devised or formulated by the biosafety committee under subsection (5); and
(c)	where the proposed activity involves the use of any biological agent inactivated at the facility, the biosafety committee has verified that the biological agent has been properly inactivated.

(7) The biosafety committee must review every 2 years or earlier, as may be appropriate, all measures, policies, programmes and codes of practice devised or formulated by it under subsection (5), and must immediately inform the operator of the facility of any change to such measures, policies, programmes and codes of practice as the biosafety committee thinks necessary.

(8) Where the biosafety committee has proposed changes to any existing measure, policy, programme or code of practice —

(a)	the biosafety co-ordinator of the facility must implement such changes as soon as possible within the timeframe stipulated by the biosafety committee; and
(b)	the operator of the facility must, if so advised by the biosafety committee, discontinue the activity to which the changes relate until such time as the biosafety co-ordinator has implemented those changes.

Maintaining facilities and equipment

40. Every operator of a facility must —

(a)	ensure that the facility is appropriate for its purpose and complies with such requirements as may be prescribed;
(b)	maintain the facility, and any equipment therein, in an optimal and a safe working condition;
(c)	establish and implement adequate security systems to control access to the facility itself, to those parts of the facility where the biological agents or toxins are kept or handled, and to such biological agents or toxins themselves;
(d)	ensure that the biohazard sign set out in the Seventh Schedule is prominently displayed at every door leading into the facility; and
(e)	implement a pest control programme within the facility.

Activities and staff

41. Every operator of a facility must —

(a)

ensure that proper assessments of risk, management of risk, operational monitoring, supervision and review of the storage of or activities involving biological agents or toxins at the facility are carried out;

(b)

ensure that the storage of or activities involving biological agents are carried out at an appropriate biosafety level at the facility and in accordance with such requirements as may be prescribed;

(c)

ensure that no research, teaching or operational activity involving biological agents or toxins at the facility is undertaken until a risk assessment of the activity is conducted by the biosafety committee and it is demonstrated that any hazard that may arise from the activity can be controlled;

(d)

ensure that emergencies arising from any storage of or activity involving biological agents or toxins carried out at the facility are dealt with in accordance with appropriate procedures;

(e)

ensure that no biological agent, toxin or waste which contains a biological agent or toxin is discharged into the environment without the appropriate decontamination and ensure that such waste is lawfully discharged and disposed of;

(f)

ensure that activities involving biological agents or toxins are conducted by staff of the facility who are properly trained to conduct such activities, or conducted under the supervision of such persons;

(g)

ensure that all staff of the facility receive such training as may be required by the Director‑General;

[Act 11 of 2023 wef 01/05/2023]

(h)

ensure that all staff of the facility are properly protected against any risk of exposure to any biological agent or toxin, including —

(i)	ensuring that all staff of the facility are appropriately attired;
(ii)	ensuring that all staff of the facility adhere to safe working practices and techniques;
(iii)	making available to all staff of the facility the appropriate vaccination or prophylaxis; and
(iv)	ensuring that all staff of the facility are not exposed to hazards arising out of the use, handling, transport or storage of any biological agent or toxin; and

(i)

establish a health and medical surveillance system for the staff of the facility so that any member of the staff who has been infected by or who has been exposed to any biological agent or toxin in the course of carrying out any activity involving biological agents or toxins may be expeditiously identified and treated.

Visitors

42.—(1) Where a person who is not a member of the staff of a facility is required to carry out any work at the facility, the operator of the facility must ensure that that person is made aware of the biological hazards associated with the storage of and activities involving biological agents and toxins carried out at the facility.

(2) Subject to subsection (3), where a person who is not a member of the staff of a facility is required to enter any part of the facility where there is a risk of exposure to biological agents or toxins, the operator of the facility must ensure that that person —

(a)

is accompanied by a member of the staff of the facility —

(i)	when that person enters the facility;
(ii)	when that person leaves the facility; and
(iii)	for such time that that person is in the facility as the operator of the facility thinks necessary; and

(b)

is properly protected against any risk of exposure to such biological agent or toxin at the facility.

(3) Where a person who is not a member of the staff of a facility is required to enter the facility at which any First Schedule (Part 2) biological agent or Second Schedule biological agent is kept, the operator of the facility must ensure that that person —

(a)	is accompanied by a member of the staff of the facility at all times and in all parts of the facility; and
(b)	is properly protected against any risk of exposure to such biological agent at the facility.

Use of animals

43. Every operator of a facility who uses any animal for experimentation involving biological agents or toxins at the operator’s facility must comply with such requirements as may be prescribed in relation to animal containment.

Records and reporting requirements

44. Every operator of a facility must —

(a)

maintain an inventory of all biological agents and toxins at the facility, which must include records of the following:

(i)

the storage location of the biological agents and toxins;

(ii)

the personnel having approval to access any of the biological agents and toxins, and the biological agents and toxins to which such approval relates;

(iii)

the use to which the biological agents or toxins are to be and have been put;

(iv)

the transfers of the biological agents and toxins within the facility and between the facility and any other facility;

(v)

the inactivation of the biological agents;

(vi)

the disposal of the biological agents and toxins; and

(vii)

where the biological agents and toxins are First Schedule (Part 2) biological agents, Second Schedule biological agents or Fifth Schedule toxins —

(A)	the personnel who have dealt with the biological agents or toxins; and
(B)	the personnel who have entered the area where the biological agents or toxins are used or stored;

(b)

maintain a record of all visitors to the facility; and

(c)

report immediately to the Director‑General in such form and manner as the Director‑General may require —

(i)	all confirmed or suspected infections or illnesses acquired by any member of the staff of the facility in the course of carrying out any activity involving biological agents or toxins at the facility;
(ii)	all adverse incidents involving biological agents that may potentially cause transmission of any infectious disease;
(iii)	all adverse incidents involving toxins;
(iv)	all loss, whether through theft or otherwise, of biological agents and toxins; and
(v)	the destruction by the operator of the facility of any of the operator’s stocks of First Schedule (Part 2) biological agents, Second Schedule biological agents and Fifth Schedule toxins.

[Act 11 of 2023 wef 01/05/2023]

Failure to perform duties and obligations

45.—(1) Where the operator of a facility fails to comply with any duty or obligation imposed under this Division —

(a)

the operator 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 and, in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction; and

(b)

the Director‑General may order any one or more of the following:

(i)

the immediate cessation of any activity involving any biological agent or toxin at the facility;

(ii)

the destruction of any biological agent or toxin 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 any biological agent or toxin 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.

[Act 11 of 2023 wef 01/05/2023]

(2) Any person who contravenes any order made by the Director‑General under subsection (1)(b) shall be guilty of an offence and shall be liable on conviction to be punished as follows:

(a)	where the offence involves a First Schedule (Part 1) biological agent or a Third Schedule 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 offence involves a First Schedule (Part 2) biological agent, a Second Schedule biological agent or a Fifth Schedule toxin, 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]

(3) Where it is proved to the satisfaction of the court that the biosafety committee of a facility has rendered any advice to the operator of the facility under section 39(3) in a reckless or grossly negligent manner or in bad faith, every member of the biosafety committee 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 unless the member proves that —

(a)	the advice was rendered without the member’s consent or connivance; and
(b)	the member had exercised all such diligence to prevent the biosafety committee from rendering that advice as the member ought to have exercised in the circumstances.

(4) Where any member of staff of a facility fails to comply with any measure, policy, programme or code of practice implemented by the biosafety co‑ordinator of the facility pursuant to section 39(6)(b) or (8)(a), the member of staff 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.

Division 2 — Duties and obligations of carriers
of biological agents and toxins

Application

46.—(1) Except as otherwise specified, the duties and obligations specified in this Division apply to any carrier, being a person (including a transferor or transferee) who undertakes the transportation in Singapore of —

(a)	any First Schedule biological agent;
(b)	any Second Schedule biological agent;
(c)	any Third Schedule biological agent in quantities aggregating 10 litres or more carried on any conveyance at any one time; or
(d)	any Fifth Schedule toxin.

(2) In this Division —

“biological agent” means —

(a)	any First Schedule biological agent;
(b)	any Second Schedule biological agent; or
(c)	any Third Schedule biological agent transported in quantities aggregating 10 litres or more on any conveyance at any one time;

“toxin” means any Fifth Schedule toxin.

Transportation of biological agents and toxins

47.—(1) A carrier must ensure that there are no unreasonable delays in the carrier’s transportation of any biological agent or toxin.

(2) The carrier must ensure that any person employed by the carrier to drive any conveyance for the purpose of transporting biological agents and toxins is trained in the management of accidents involving biohazardous materials.

(3) For the purpose of subsection (2), the training of any person employed by a carrier to drive any conveyance for the purpose of transporting biological agents and toxins must include such training as the Director‑General may specify.

[Act 11 of 2023 wef 01/05/2023]

(4) The carrier must ensure that any conveyance used for the transportation of biological agents and toxins is affixed with such biohazard warning panel or label as the Director‑General may require when transporting biological agents or toxins.

[Act 11 of 2023 wef 01/05/2023]

(5) Where, in the course of transporting biological agents or toxins on any conveyance, there is any spillage or leakage of the biological agents or toxins, the person employed by the carrier to drive the conveyance must —

(a)	immediately cordon off the area surrounding the conveyance and the spillage or leakage; and
(b)	immediately notify the Commissioner of the Singapore Civil Defence Force or such officer as the Commissioner may authorise for the purpose of this section.

(6) For the purpose of transporting —

(a)	any First Schedule (Part 2) biological agent;
(b)	any Second Schedule biological agent;
(c)	any Third Schedule biological agent in quantities aggregating 10 litres or more; or
(d)	any Fifth Schedule toxin,

the carrier must take all necessary steps to ensure the security of the biological agent or toxin in the course of the transportation, including the use of security personnel and the prevention of unauthorised access to the biological agent or toxin.

Packaging and labelling of biological agents and toxins

48. The transferor must ensure that the packing and labelling of biological agents and toxins being transported comply with such requirements as may be prescribed.

Failure to perform duties and obligations

49. Any person who contravenes any provision of this Division shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000.

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