Submitted by Ai Ee Ling
Ministry of Health, Singapore
This Erratum is regarding the submission entitled “Biological Agents and Toxins Act:
Development and Enforcement of Biosafety and Biosecurity in Singapore” by Tin Tun, Kristen
E. Sadler, and James P. Tam that appears on pages 39–43 of Applied Biosafety (Volume 12,
Number 1, 2007).
The following are changes to page 40 under the heading “Schedules versus Risk
Groups”:
First paragraph, line 6: Currently reads: Dengue Virus Type 1–4 was
classified as Risk Group 2 in Singapore (previously), Canada and Australia but…
Should read: Dengue virus Type 1–4 was classified as Schedule 4
biological agent in Singapore, Canada, and Australia, but…
The following are changes to page 40, Table 1:
Heading row, second column: Currently reads: Risk Group, Should
read: Biological Agent
First row, second column: Currently reads: 3, Should
read: nothing
First row, fourth column: Currently reads: 56, Should
read: 55
First row, fifth column: Currently reads: BSL3 Certified
(Uncertified…), Should read: Certified facility (uncertified…)
Second row, second column: Currently reads: 3, Should
read: nothing
Second row, fifth column: Currently reads: BSL3 Certified and
Protected Place (Uncertified facility and protected place can appeal), Should
read: Certified facility and Protected Place (uncertified facility but
protected place can appeal)
Third row, fifth column: Currently reads: BSL3 Certified and Protected
Place with Special Approval granted by the Director (Medical Services), Should
read: Certified facility and Protected Place
Fourth row, second column: Currently reads: 2, Should
read: nothing
Fourth row, fifth column: Currently reads: Specified in the Approval
by the Director (Medical Services), Should read: nothing
Fifth row, second column: Currently reads: 2, Should
read: nothing
Fifth row, fifth column: Currently reads: Conditions of a Permit
granted by the Director (Medical Services), Should read: nothing
Sixth row, fourth column: Currently reads: 5, Should
read: 7
Sixth row, fifth column: Currently reads: Protected Place and
Conditions of an Approval granted by the Director (Medical Services), Should
read: Protected Place
Note 1: Facility certification by an approved certifier (by the
Ministry of Health, Singapore) is a prerequisite for granting approval (for
possession) or permit (import, transshipment, etc.) for schedule 1 and 2 organisms.
The Ministry of Health does not of itself certify facilities, it grants approval and
permits.
Note 2: BATA classifies biological agents and toxins in schedules and
not by risk groups.
The following are changes to page 41 under the heading “Biosafety Branch”:
First paragraph, last sentence: Currently reads: …and, prevents
bioterrorism by controlling the use of high risk biological agents. Should
read: …and, prevents non-legitimate use by controlling the possession and
use of high risk biological agents and toxins.
Second paragraph, line 8: Currently reads: A webpage has been created
and all relevant information is available online for the Biosafety Level 3 (BSL-3)
facilities in Singapore (MOH Biosafety, 2006). Should read: A webpage
has been created and all relevant information related to the BATA is available
online.
Second paragraph, line 13: Currently reads: …applications for permits
and approvals, notification of transfers, receipt, inactivation and disposal,
reporting of incident and inventory for biological agents, etc. Should
read: …applications for approvals, notification of transfers, receipt,
inactivation and disposal, reporting of incident and inventory for biological
agents, etc. (Note: Application of permits is through the Tradenet, Singapore
Customs, Ministry of Finance and not the biosafety IT system.)
The following are changes to page 41 under the heading “Possession Control”:
First paragraph, lines 6–7: Currently reads: …to the facility being a
certified BSL-3 facility. Should read: …to the facility being a
certified facility.
First paragraph, lines 7–9: Currently reads: The approvals to possess
BA in schedule 1 (part II) and schedule 2 are granted to a certified BSL-3 facility
which… Should read: The approval to possess BA in schedule 1 (part II)
and schedule 2 are granted to a certified facility which…
The following are changes to page 41 under the heading “Import Control”:
First paragraph, lines 4–8: Currently reads: The importer of the BA
into Singapore must have approval to possess the BA. The importer or the end-user is
responsible for ensuring that a valid permit is obtained before bringing the BA into
Singapore. Should read: The importer bringing in Schedule 1 and 2 BAs
and Schedule 5 toxins into Singapore must have approval to possess the BAs and
toxins. The importer or the end-user is responsible for ensuring that a valid permit
is obtained before bringing the above scheduled agents into Singapore.
Note: The whole second paragraph needs to be revised in which a requirement of
transshipment permit is not limited to biological agents (BAs) only, but applies to
both biological agents (BAs) and Toxins. For BAs, it is limited to Schedule 1 and
Schedule 2 agents.
The following are changes to page 42 under the heading “Facility Requirements”:
First paragraph, line 1: Currently reads: BSL-3 facility must be…
Should read: The facility must be…
Second paragraph, first sentence: Currently reads: It is a requirement
for a BSL-3 facility to establish an Institutional Biosafety Committee (IBC) which
includes at least biosafety coordinator, microbiologist, facility maintenance
personnel and representative from senior management. Should read: It is
a requirement for a facility that has been granted approval to possess any First,
Second, and Fifth Schedule agents, or approval to produce First or Third Schedule
biological agents in amounts over 10 litres (considered large-scale) to establish an
Institutional Biosafety Committee (IBC), which includes…
The following are changes to page 42, Table 2:
Seventh row, second column: Currently reads: Yes, Should
read: No
Eighth row, second column: Currently reads: Yes, Should
read: No
Ninth row, first column: Currently reads: Certified BSL3 Facility,
Should read: Certified Facility
The following are changes to page 43 under the heading “Facility Requirements”:
First full paragraph, lines 4–9: Currently reads: Training for BSL-3
staff is mandated under the BATA. Such training for personnel working in a BSL-3
facility can be conducted in-house or by experienced external trainers. The BATA has
given a six-month transitional period from the date of commencement of the BATA to
BSL-3 facilities in Singapore for… Should read: Training for staff
handling Schedule 1 and 2 biological agents is mandated under the BATA. Such
training can be conducted in-house or by experienced external trainers. The BATA has
been given a six-month transitional period from the date of commencement of the BATA
to facilities handling the above scheduled agents in Singapore for…
