Biological Agents and Toxins Act 2005 - Singapore Statutes Online

PART 6

APPROVALS, PERMITS AND
CERTIFICATION OF FACILITIES

Approvals and permits

50.—(1) An application for any approval or permit required under this Act must be made to the Director‑General in such form and manner as the Director‑General may require and must be accompanied by —

(a)	such particulars, information and documents as the Director‑General may specify; and
(b)	if required by the Director‑General, a statutory declaration by the applicant verifying any information contained in or relating to the application. [Act 11 of 2023 wef 01/05/2023]

(2) An applicant for any approval required under this Act must, if required by the Director‑General or an enforcement officer, provide the Director‑General or enforcement officer access to the facility of the applicant in order that the Director‑General or enforcement officer may inspect such facility and observe the work processes and procedures undertaken thereat.

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

(3) Upon considering an application made under subsection (1), the Director‑General may —

(a)	grant the approval or permit applied for, with or without conditions; or
(b)	refuse to grant the approval or permit applied for. [Act 11 of 2023 wef 01/05/2023]

(4) The Director‑General may at any time vary or revoke any of the existing conditions imposed under subsection (3)(a) or impose new conditions.

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

(5) Where the Director‑General refuses to grant any approval or permit under subsection (3)(b), the Director‑General must, if requested to do so in writing by the applicant, state in writing the reasons for the Director‑General’s refusal.

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

(6) An approval to possess any biological agent or toxin ceases to be valid upon the occurrence of any of the following events:

(a)	upon the person to whom the approval has been granted ceasing to be the operator of the facility (whether certified or uncertified) specified in the approval;
(b)	where the facility in respect of which the approval has been granted is required under this Act to be a certified facility, upon that facility ceasing to be such a certified facility.

(7) If the Director‑General has reason to believe that —

(a)	the grant of any approval or permit was obtained by fraud or misrepresentation;
(b)	the person to whom the approval or permit was granted has contravened, is contravening or is likely to contravene any provision of this Act or any condition imposed under subsection (3)(a) or (4); or
(c)	any activity carried out at the facility to which the approval or permit relates poses a risk to public health,

the Director‑General may do all or any of the following:

(d)

suspend or cancel the approval or permit;

(e)

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]

(8) The Director‑General may suspend or cancel any approval or permit without any prior notice of such suspension or revocation.

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

(9) Where any approval or permit ceases to be valid or is suspended or cancelled, the Director‑General or an enforcement officer may seize any biological agent or toxin to which the approval or permit relates, and any other material arising out of any activity carried out in relation to or in connection with the biological agent or toxin to which the approval or permit relates.

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

(10) Any person who contravenes any order made by the Director‑General under subsection (7)(e) 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.

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

Certification of facilities

51.—(1) Any facility which is required to be a certified facility for the purposes of this Act must be certified by an approved certification body.

(2) For the purpose of this Act, a certification of a facility under subsection (1) ceases to be valid —

(a)	upon the expiry of one year from the date of the certification; or
(b)	upon any design or structural change made to the facility,

whichever is earlier.

(3) Where a certification of a facility ceases to be valid under subsection (2), the facility may be re‑certified as a certified facility for the purposes under subsection (1).

(4) Where a facility is certified by an approved certification body under this section, the operator of the facility must inform the Director‑General of its certification in such form and manner as the Director‑General may specify and provide to the Director‑General a copy of the certification report issued by the approved certification body, before storing or carrying out any activity involving any biological agent at the certified facility.

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

(5) The operator of a certified facility must comply with such requirements as may be prescribed.

(6) Where —

(a)	the operator of a facility stores or carries out any activity involving any biological agent without the facility being certified in accordance with this section;
(b)	the operator of a facility stores or carries out any activity involving any biological agent to which the certification relates without notifying the Director‑General of the certification under this section or providing to the Director‑General a copy of the certification report as required under subsection (4); or
(c)	the operator of a certified facility fails to comply with any prescribed requirement referred to in subsection (5),

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

(d)

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

(e)

the destruction of any biological agent at the facility;

(f)

the decontamination of the facility;

(g)

the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation;

(h)

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 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. [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 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.

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

(8) In this section, “approved certification body” means a certification body approved by the Director‑General for the purpose of subsection (1).

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

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