The BATA stands for Biological Agents and Toxins Act.

It is a legislation that regulates the possession, use, import, transhipment, transfer and transportation of biological agents (BAs), inactivated BAs and toxins that are known to be hazardous to human health in Singapore.

In writing the legislation, recommendations from the National Biosafety Committee (NBC) and its Technical Working Committees (TWC), which are represented by related government agencies, research institutes, hospitals and key industry players, were taken into consideration.

The Ministry has also adopted the Laboratory Biosafety Manual, 3rd Edition, by the World Health Organization (WHO) as the national guidelines for biosafety to supplement the BATA.

The BATA was passed by the Parliament on 18th October 2005 and has come into force on the 3rd January 2006.

The Biological Agents and Toxins Act can be accessed through:

1. Singapore Statutes Online
2. Subscription to the LawNet service provided by the Singapore Academy of Law.
3. Purchase from Singapore National Printers Corporation Ltd (SNP)
4. Downloading from the Biosafety Website

The BATA does not regulate the export of biological agents and toxins listed in the schedules.

The exportation of BAs and toxins is regulated by the Strategic Goods Control Act under the Strategic Goods Control Unit of the Singapore Customs.

You can contact them at 6355 2000 or 6337 5996 or you can send an e-mail to customs_stgc@customs.gov.sg.

The BATA will be relevant to companies and institutions (including educational institutions) involved in biomedical and life sciences work or research with biological agents and toxins listed in the Schedules of the BATA.

Individuals who wish to work with the biological agents in the Schedules should note the requirements stated in the Act, as these could have an impact on the day-to-day operations of their research facilities and companies.

Carriers transporting biological agents (BAs) and toxins within and into Singapore should also be aware of the requirements for the transportation, transhipment and transfer of BAs and toxins.

Yes. The BATA would not apply to the following activities:

a. the disposal of any biological agent by a hazardous waste contractor;

b. the handling of any biological agent in the course of carrying out a diagnosis or an autopsy;

c. the collection of food samples or samples from the environment for the purpose of carrying out any laboratory analysis to determine or identify, for public health purposes, the nature of any biological agent that is present in such samples or in the environment from which such samples have been taken; or

d. the use or possession by any of the following persons of any finished cosmetic or medicinal product consisting of any Fifth Schedule toxin:

• any person lawfully manufacturing, supplying, selling or dispensing the finished cosmetic or medicinal product;
• any registered medical practitioner using the finished cosmetic or medicinal product in the course of treating another person;
• any person using the finished cosmetic or medicinal product for the cosmetic or medical purposes for which it is intended.

According to Section 2 of the BATA, "diagnosis" means any activity undertaken solely with the intention of analysing any specimen from a person or an animal in which a biological agent is or is suspected of being present for the purpose of -

1. determining the cause of any disease suffered by any person or animal;


2. assessing the clinical progress of any person or animal;


3. carrying out the clinical management of any person or animal; or


4. determining the cause of death of any person or animal in an autopsy.

There is no need to inform the MOH if your facility is involved in the activities listed in Section 4 of the BATA.

However, if you carry out activities beyond the exempted purpose, or if you intend to transfer the BAs to another facility for purposes other than the exempted purposes, then the Act shall apply.

The 5 Schedules in BATA cover a wide spectrum of BAs and toxins. Different levels of controls have been adopted for each Schedule. BATA differentiates between higher risk group and lower risk group BAs, and also those with the potential to be weaponised. The table below shows a quick overview of the Schedules with the corresponding description and number of BAs for each: Schedule Description Number Schedule 1 Part I Risk Group 3 BAs which can cause serious disease which is of high risk to the individual 55 Schedule 1 Part II Description is the same as Schedule 1 Part I but they also have the potential to be weaponised. 23 Schedule 2 Risk group 4 BAs which can cause severe/lethal disease, easily transmitted and of high risk to the individual and the community. These agents have the potential to be weaponised. 14 Schedule 3 Risk Group 2 BAs that need special attention in large scale production 3 Schedule 4 All Risk Group 2 BAs (including those in Schedule 3) which cause disease in humans 250+ Schedule 5 Microbial toxins that have the potential to be weaponised. 7

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Biological Agents under Schedule 1 are risk group 3 agents causing serious disease in humans. It is subdivided into Part I and Part II based on their potential to be weaponised. Schedule 1 Part II BAs have the potential to be weaponised. Both Parts of Schedule 1 BAs require a certified facility, but facilities wishing to work with Schedule 1 Part II must also be gazetted as a protected place under the Protected Areas and Protected Places Act (Cap. 256).

Schedule 4 includes any BA which is likely to cause human disease (with the exception of those already mentioned in Schedule 1 and 2), the BATA has not listed the individual BAs due to the large number of BAs under this particular schedule.
However, you may refer to the "List of Biological Agents and Toxins" for the list of Schedule 4 BAs currently under MOH's import control.

As the list is not exhaustive, importers are advised to consult MOH on any BA that is likely to cause human disease even if they are not found on the import list. Importers may write in to moh_biosafety@moh.gov.sg for their inquiries.

Please check the Biosafety Website regularly since the list of biological agents and toxins controlled by the BATA is being updated periodically.

The provision of the Act is dependent on the biological agent (BA) you work with, rather than what kind of laboratory you come from. Hence, depending on the type of BA and work involved, you would need to determine which section of the Biological Agents and Toxins Act (BATA) would be applicable to you.

The type of BAs that you would be handling would determine the facility, transfer and agent controls that you would be required to comply with. Once you have determined the BAs that you would be handling in your laboratory, you can then refer to the relevant sections in the Act for more details.

There are no specific requirements for work involving GMOs in the BATA. However, all work with GMOs should be submitted to the Genetic Modification Advisory Committee (GMAC) for formal endorsement and approval. Projects involving GMOs should also be approved by the respective Institutional Biosafety Committee.

If you are working with GMOs derived from Schedule 1 and 2 BAs, you need to comply with the requirements for the respective Schedules in the BATA. You may send an e-mail to GMAC Secretariat at info@gmac.gov.sg or visit the GMAC Website.

For carrier, you need to be familiar with the requirements for import, transhipment and transport of BAs in the Schedules. Your responsibilities during the transportation of BAs are covered in Section 47 of the BATA.

You may refer to the section for carriers in this FAQ and the BATA Transportation Regulations as well for more detailed information.

The Infectious Diseases Act (IDA) stipulates the requirement for permits for the importation of infectious biological agents (BAs). This requirement was replaced by those stipulated in the BATA. In addition, BATA also regulates the import of toxins. In summary, starting from 3 January 2006, the import and transhipment requirements for BAs and toxins listed on the Schedules are being regulated by the BATA.

The Schedules in the BATA cover only biological agents capable of causing disease in humans (human pathogens). Some of the BAs in the Schedules may similarly cause diseases in animals, and these BAs are termed zoonotic pathogens and are jointly controlled by AVA under the Animals and Birds Act and MOH under the BATA. Therefore if you are importing, transhipping, working with or transferring zoonotic agent, you would need to comply with MOH and AVA's requirements.

Pure animal and plant pathogens are regulated solely by AVA and all queries related to these classes of BAs should be directed to AVA. You can contact AVA's Animal, Meat & Seafood Regulatory Branch of the Import & Export Division, AVA at 6227 0670 or 6325 7333. You can also send them an e-mail at ava_email@ava.gov.sg or ava_importexport_animals@ava.gov.sg

You may send your enquiries through e-mail to moh_biosafety@moh.gov.sg. Our officers will respond to you within 5 working days.

Schedule 1 Part I

• Approval to possess (for first-time use)
• Approval to produce (for large-scale production)
• Import permit
• Transhipment permit
  
  Note: The facility has to be certified by MOH Approved Facility Certifiers (AFCs)

Schedule 1 Part II

• Approval to possess (for first-time use)
• Approval to produce (for large-scale production)
• Import permit
• Transhipment permit
• Transfer Notification (for transfer of BAs within Singapore)
• Notification of failure of receipt of transfer or import
  
  Note: The facility has to be certified by MOH Approved Facility Certifiers (AFCs) and gazetted as a protected place under the Protected Areas and Protected Places Act

Schedule 2

• Special Approval to Handle
• Approval to Possess (for first-time use)
• Import permit
• Transhipment permit
• Transfer notification (for transfer of BAs within Singapore)
• Notification of failure of receipt of transfer or import
• Large-scale production is prohibited under BATA
  
  Note: In addition, the facility has to be certified by MOH Approved Facility Certifiers (AFCs) and gazetted as a protected place under the Protected Areas and Protected Places Act.

Schedule 3

• Approval to produce (for large-scale production)
• Import permit

Schedule 4

• Import permit

Schedule 5

• Approval to possess (for first-time use)
• Import permit
• Transhipment permit
• Transfer notification (for transfer of BAs within Singapore)
• Notification of receipt of transfer or import
  
  Note: The facility has to be gazetted as a protected place under the Protected Areas and Protected Places Act

Approval for possession, Special Approval to Handle and Approval to Produce (for large scale production) can be done online through the Biosafety Website.

Application for import and transhipment permit is done through the Singapore Customs Tradenet System.

NO. All activities involving Schedule 1, 2 and 5 BAs and toxins should be endorsed by the respective Institutional Biosafety Committee before applications for approvals and permits are submitted to MOH.

A formal approval letter from your Institutional Biosafety Committee should be submitted in the application to MOH for our assessment. Similarly, approval should be sought for activities involving large-scale production of Schedule 3 BAs.

For GMOs, approval should be sought from Genetic Modification Advisory Committee (GMAC) before submitting application for approvals and permits to MOH.

For more information, you may send an e-mail to the GMAC Secretariat at info@gmac.gov.sg or visit the GMAC Website.

An approval to possess is an approval granted by the Director of Medical Services, MOH, to possess Schedule 1, 2 and 5 biological agents (BAs) and toxins.

You need to apply for this approval for every first time possession of a BA or toxin in those schedules. An approval to possess is agent specific and is issued based on the following requirements:

1. The use of Schedule 2 BA is necessary for the public interest
2. The person who requires the BA or toxin has put in place adequate measures to contain the risk to public health and security posed by the BA or toxin. That is, a certified facility for Schedule 1 Part I, a certified and protected facility for Schedule 1 Part II and Schedule 2 BA; and a protected facility for Schedule 5 toxins.

The facility must submit the following documents to MOH for consideration

1. Proof of the Special Approval to Handle
2. Proof of certification of facility certified by a MOH-Approved Facility Certifier
3. Proof that the facility is gazetted as a protected place under the Protected Areas and Protected Places Act (Cap. 256)
4. Approval from your Institutional Biosafety Committee (IBC) with risk assessment.
5. Approval from Genetic Modification Advisory Committee (GMAC), if the agent involved is related to genetic manipulation or modification work.

An approval to possess is needed before one can possess a toxin under Schedule 5. However, before an approval to possess is granted, the facility should:

• be gazetted as a protected place under the Protected Areas and Protected Places Act (Cap. 256)
• have approval from its Institutional Biosafety Committee

There is no expiration for the approval to possess.

However, the validity of the approval is tied to the facility being a certified BSL 3 facility for Schedule 1 Part I biological agents, a certified facility and gazetted protected place under the Protected Areas and Protected Places Act for Schedule 1 Part II and Schedule 2 biological agents or a gazetted protected place under the Protected Areas and protected Places Act for Schedule 5 toxins.

Handling of a biological agent in the course of carrying out a diagnosis is exempted from the Act, provided that you do not carry out activities beyond performing a diagnosis as defined in the Act.

Once the BA is no longer needed for diagnosis, you are required to destroy the BA or transfer it to a certified facility that has the approval to possess it. However, if you intend to keep the BA, or to carry out any activities that go beyond performing a diagnosis, you will need to apply for an approval to possess from MOH, then alll provisions of the Act shall then apply.

You may transfer samples between diagnostic laboratories for the purposes of confirming a diagnosis. Similarly, the reference laboratory does not need an approval to possess the BA. However, transfer of any Schedule 1 BA for any other purpose would require the receiver to have an "approval to possess" prior to the transfer.

Researchers who wish to work with zoonotic agents should also write to AVA for approval of possession of these agents. AVA would need to inspect your facility before granting an approval for importation. Once you have received AVA's approval, you may proceed to apply for approvals under the Biological Agents and Toxins Act (BATA).

A special approval to handle is only applicable to Schedule 2 biological agents (BAs) and is only granted by the Director of Medical Services under the following circumstances:

• The use of the Schedule 2 BA is necessary for the public interest
• The person who requires the biological agent has put in place adequate measures to contain the risks to public health and security posed by the Schedule 2 biological agent.

An approval to produce is granted by the Director of Medical Services for large-scale production of Schedule 1 and 3 biological agents. The approval to produce is necessary for facilities engaged in large-scale production of Schedule1 and 3 biological agents.

Large-scale production is defined as the production by any person of the biological agent using equipment at a facility capable of producing in aggregate 10 or more litres of the biological agent at any one time.

For Schedule 1 biological agents (BAs), you need to apply for an approval to possess the biological agent first. Your facility would need to meet the requirements to possess the biological agent before MOH will consider granting the approval to engage in large-scale production of the biological agent. Once the approval to possess is granted, you may apply for an approval to produce.

For Schedule 3 biological agents, since the approval to possess is not required, you may directly apply for an approval to produce if your facility intends to produce the BA in large quantities.

There is no expiry date for the approval to produce for a Schedule 1 or 3 biological agents (BA). However the validity of the approval is tied to:

• the facility having a valid “approval to possess” for Schedule 1 BA.
• the production is carried out at the facility specified in the approval; and
• in accordance with the conditions of the approval.

Large-scale production is prohibited for Schedule 2 biological agents.

Yes, an uncertified facility may work with inactivated Schedule 1 or 2 BAs provided by another local facility that is permitted to carry out the inactivation.

An uncertified facility may also seek to receive inactivated Schedule 1 or 2 BAs via importation. However, the importer would need to furnish proof of inactivation by the overseas laboratory for the MOH's assessment before an import permit would be granted for the import of the inactivated BA.

Before carrying out any inactivation of BAs listed under Schedules 1 or 2, you need to ensure that you have the following:

• proof of a valid approval to possess for that BA;
• a declaration that the inactivation method to be used is approved by your Institutional Biosafety Committee (IBC);
• inactivation is performed at the facility specified in the approval to possess;
• information on the inactivation method or procedure with regards to its efficacy and effectivity.

You may refer to Section 27 of the Biological Agents and Toxins Act (BATA) for more information.

Facility must submit the following documents to moh_biosafety@moh.gov.sg for consideration:

• the name and curriculum vitae of the person who carried out the inactivation;
• the method of inactivation used and its efficacy;
• the approval from the local Institutional Biosafety Committee (IBC) with risk assessment; and
• credentials of overseas institution which carried out the inactivation (if the biological agent is coming from an overseas institution)
• research proposal.

Approval to possess is not required for use and possession of inactivated First or Second Schedule biological agents and their components, as long as they are no longer capable of causing death, disease or other biological malfunction in a human, as stated in Section 2, Part I of the Biological Agents and Toxins Act (BATA).
However, it is your responsibility to ensure that the inactivation process is effective and successful. The inactivated biological agents and their components should not be used to synthesize infectious agents.

The Biosafety Branch does not provide standard operating procedures for inactivation but can evaluate the inactivation methods on a case-by-case basis.

Yes, all biological agents (BAs) and toxins listed in the Schedules require import permit.

There are biological agents that are not listed in the schedules that may also require an import permit.

For biological agents not in the "List of Biological Agents and Toxins" in the Biological Agents and Toxins Act (BATA), you may send an inquiry to moh_biosafety@moh.gov.sg so that we can advise you whether you need to get an import permit for your item.

The application for import permit is done online at Singapore Customs Tradenet System. Applications should preferably be submitted on the Tradenet at least 5 working days before the biological agents (BAs) or toxins are due to arrive in Singapore. There are 2 ways of obtaining the import permit:

• You may apply for a Central Registration Number (CRN) for your research institution from Singapore Customs. The CR number is for use in all import, export and transhipment permits, certificates and any other documents issued by the Singapore Customs.
  
  Once you receive the CR number, you can access the Tradenet System and apply for the import permit for the BA. For more information and online application of CRN, you may visit the Online Business Licensing Service (OBSL).
  
  You may also contact Singapore customs at 6355 2000 or send your inquiry to customs_documentation@customs.gov.sg.



• Alternatively, you may engage a carrier who already has an existing CR number registered with Singapore Customs, to apply for import permits on your institution’s behalf. In such cases, it is your responsibility to ensure that acurate information has been provided to the carrier for declaration purposes and also to ensure that a proper and valid import permit was obtained.

The importer (the laboratory or end-user of the biological agent or toxin) is responsible for ensuring that a valid import permit is obtained for the biological agent (BA) or toxin. Even if you engage a carrier to apply for an import permit on your behalf, you are responsible for providing the correct information needed for the import permit declaration to the carrier. You should ensure that the correct permit has been obtained from the MOH.

You may require the carrier to fax the import permit so that you can verify the declaration details on the import permit is correct before authorizing the carrier to bring the goods into Singapore.

You should apply for the approval to possess the BA first. Once the approval to possess is granted, you may then apply for the import permit.

Import Specific Product Code or ISP codes are given to specific laboratories for the regular importation of biological agents with known schedules coming from the same source or exporter such as proficiency samples. These ISP codes shall be used in the import declaration of the items. The issuance of ISP codes aims to facilitate the importation process.

The validity of the ISP code is 3 years from the date of issue. However, at the MOH-Biosafety Branch's discretion, the ISP codes may be revoked anytime.

For zoonotic agents, importers are required to obtain import permit from both AVA and MOH. AVA and MOH have streamlined the import processing workflow on the Singapore Customs Tradenet System.

Application for import permit for zoonotic agents can be done online at the Tradenet.
Please use the following codes:
HS code - 30029000;
Primary Product Code - MOH Product code for the particular biological agent/toxin;
Secondary Product Code - AVA Product code.

The "List of Biological Agents and Toxins" with the MOH product code and the corresponding AVA product code for zoonotics can be found on the Biosafety Website.

In general, an import permit for test kits is not required under the Biological Agents and Toxins Act (BATA). The reason being most controls in a diagnostic kit have been inactivated. However, if it is known that the test-kits contain highly infectious biological agents that are capable of causing death, disease or other biological malfunction in a human, please inform MOH prior to its importation. Although diagnostic kits are generally not controlled by MOH, they are controlled by the Centre for Medical Device Regulation, Health Sciences Authority (HSA).

Packaging and labelling requirements should comply with the Transportation Regulations of the BATA, which is available under the public information of the Biosafety Website. However, please note that packaging of imports transported via air shall adhere to the packaging instructions of the International Air Transport Association (IATA) of Dangerous Goods Regulations.

Please refer to the MOH Circular on the Control of Importation and Transhipment of Human Pathogens and Toxins.

You may also refer to the Singapore Customs Tradenet Website or send an e-mail to customs_documentation@customs.gov.sg for more information on import permits.

No. Only biological agents and toxins listed in Schedules 1, 2 and 5 require transhipment permits.

Application for transhipment permit can be done online on Singapore Customs Tradenet System. Applications for transhipment permits should preferably be submitted on Tradenet at least 5 working days before the biological agents or toxins are due to arrive in Singapore.

Please refer to the MOH Circular on the Control of Importation and Transhipment of Human Pathogens and Toxins found under Public Information of the Biosafety Websiste.

The following are the notifications that can be done using the BiosIS:

• Notification of transfer
• Notification of failure of receipt
• Notification of disposal/inactivation
• Notification of export of biological agent/toxins
• Incident report of near misses for laboratory accidents
• Incident report of suspected or confirmed laboratory acquired infection

Under the Biological Agents and Toxins Act (BATA) the importer has to notify MOH of any failure of receipt of Schedule 1 Part II, Schedule 2 and Schedule 5 biological agents and toxins within 24 hours of such time as they may be reasonably estimated by him for the receipt.

Once there is failure to receive an import of Schedule 1 Part II, Schedule 2 and Schedule 5 biological agents and toxins, MOH should be notified via the Biosafety IT System (BiosIS).

After login, proceed to "Workbench" and under "My Tasks", choose the function of "Create Notification of Receipt". Choose the biological agent or toxin from the drop down list then click the "Notify Failure of Receipt" tab on the lower part of the page.
This function can only be done when there is an existing "notification of transfer" submitted by the transferring facility.

Facilities that wish to handle Schedule 1 and 2 biological agents (BAs) should undergo certification by a MOH-Approved Facility Certifier (AFC), as certification is one of the pre-requisite for the application for an "approval to possess" the above mentioned scheduled biological agents.

For new facilities, certification of the facility shall be carried out after the commissioning of the facility. Thereafter, the facility needs to be re-certified yearly or whenever any design or structural change is made to the facility, whichever is earlier.

Facilities who needs to work with Schedule 1 Part II, Schedule 2 biological agents (BAs) and Schedule 5 toxins needs to have facilities gazetted as a protected place. The applicant should send a letter to both of the following, indicating the reasons/justification for gazetting the facility:

Permanent Secretary
Ministry of Home Affairs
28 Irrawaddy Road
Singapore 329560

and

Assistant Director
Security and Counter Terrorism Division
Operations Department
Singapore Police Force
28 Irrawaddy Road
Singapore 329560

Once the application for gazetting is accepted for processing, the applicant needs to get a registered surveyor to demarcate the boundary using the Coordinated Cadastral System and to store the data with the Global Positioning System in the Draft Order. Thereafter, submit the Draft Order bearing the coordinates, with a covering letter and the plan of the premises to the following addresses:

Assistant Director
Security and Counter Terrorism Division
Operations Department
Singapore Police Force
28 Irrawaddy Road
Singapore 329560

and

Ministry of Home Affairs
28 Irrawaddy Road
Singapore 329560

At the same time, the applicant will also submit to MOH, the list of personnel who will be working in the facility. The applicant will be informed by MHA on the outcome of the gazetting.

You need to submit a full copy of the certification report and the certificate issued by the MOH-Approved Facility Certifier (MOH-AFC).

The certification is based on an expanded checklist derived from the World Health Organization (WHO) Laboratory Biosafety Manual, 3rd Edition checklist.
In addition to items specified by WHO, the checklist also includes items recommended by the National Biosafety Committee as well as legislative requirements specified by the Biological Agents and Toxins Act (BATA).

If the ABSL3 facility is used for the handling or storage of live and/or inactivated biological agents and toxins from Schedules 1, 2 and 5, then it has to be certified and registered as a certified facility using the Biosafety IT System. Similarly, other controls, including the possession, large-scale production, inactivation, transfer and transport of the Schedule 1, 2, and 5 biological agents and toxins apply to the ABSL3 facility handling and storing them.

Additional criteria may be required by Agri-food and Veterinary Authority of Singapore.
You may send your inquiries to AVA at ava_email@ava.gov.sg.

MOH-AFC are external facility certifiers which are registered with the Ministry of Health to perform certification of BSL 3 facilities.

The following are the requirements for MOH-AFC:

• Team Requirement - there should be one identified lead certifier for each team. The team must, at least be comprised of a microbiologist and an engineer.
• Certifiers' credentials - curriculum vitae, academic and professional certificates
• Testimonials from previous BSL3 clients
• Certifiers internal standard operating procedures (SOP), detailing the methods used to ascertain that the BSL3 facility under certification has the necessary engineering and administrative controls to ensure safe practice
• Certifier's organization background and history, certifying and commissioning experiences and any accreditation received.

You may apply online via the E-services of the Biosafety Website. Alternatively, you may send an e-mail to moh_biosafety@moh.gov.sg indicating your interest in becoming and MOH-Approved Facility Certifier. An application package will be sent to you. Please include the necessary documents such as CV's of the certifiers, the Standard Operating Procedure (SOP) checklist and other supporting documents in a CD and send it to:

The Ministry of Health
College of Medicine Building
16 College Road
Singapore 169854
Attn: The Biosafety Branch

The list of MOH-Approved Facility Certifier is available at the Public Information of the Biosafety Website.

If you intend to engage the service of a facility certifier that is not a MOH-AFC, please write in to MOH or send an e-mail to moh_biosafety@moh.gov.sg to provide more information on the certifier. MOH will invite the facility certifier to apply for MOH-AFC. Once the application is approved, the facility certifier will be included in the list of MOH-AFC. MOH will then recognize the certification by that particular certifier.

The AFC status expires after 5 years. You need to re-submit your aplication to MOH after 5 years to renew your MOH-AFC status. However, you need to inform MOH if there are any changes to the members of the certifying team.

Yes. Applicant who appeals for approval to possess Schedule 1 biological agent in an uncertified facility shall submit the following documents to moh_biosafety@moh.gov.sg for consideration:

• proof that the facility is gazetted as a protected place under the Protected Areas and Protected Places Act (Cap. 256), if the work involves any Schedule 1 Part II BA;
• research proposal involving the BA;
• approval from your Institutional Biosafety Committee (IBC) with risk assessment;
• approval from Genetic Modification Advisory Committee (GMAC) if work involved genetically modified organism or genetic manipulation activity
• justification of why or how the work could be carried out safely and securely within the facility; and
• supporting documents for all of the above mentioned.

The risk assessment should at least include the risk identification, risk assessment and risk management.

Risk Identification	Risk Assessment	Risk Management
Identify the hazards involved (e.g biological, chemical, radiological, etc)	Assess the risks posed by the hazardous agent to the laboratory worker, the public and the environment.	Identify the type of facility, equipment and personal protective equipment needed
Identify the characteristics of the hazardous biological agent as to mode of transmission, infectious dose,vector involved,genetic manipulation, type of sample, concentration and quantity handled, stability of the agent, susceptible host range and the diseases associated with the agent		Proper and adequate training of personnel in handling the hazardous agent
Identify the procedures involved in handling the hazardous agent.		Policies and Standard Operating Procedures in place that will help in managing the risks from the hazardous agent

Item transported	Label
	Toxic Sign	Biohazard Sign
Schedule 1 and 2 Biological Agent	No	Yes
Schedule 5 toxins	Yes	No
Both Schedule 1 or 2 biological agent and Schedule 5 toxin	Yes	Yes
Schedule 3 biological agents in quantities aggregating 10 litres or more on any conveyance at any one time	No	Yes

Yes. A driver who is involved in transporting Schedules 1, 2, 3 biological agents (BAs) and Schedule 5 agents must be trained and possess a valid Hazardous Materials Transportation Driver Permit (HTDP-Biologicals).
For more information on the HTDP, please contact Lta Steve Koa at 68483326.

Yes. A researcher who intends to transport Schedule 1, 2, 3 biological agent or schedule 5 toxins in his/her own vehicle has to be trained and has to possess a valid Hazardous Materials Transportation Driver Permit (HTDP-Biologicals).

For more information on the HTDP, please contact Lta Steve Koa at 68483326.
For information on the Hazmat Driver Training Course, you may call Cpt Subari at 67945632.

In the event of emergency incidents or transport accidents, the driver shall immediately cordon off the area surrounding the vehicle and the spillage/leakage. He should also notify his supervisor, the SCDF (at 995) and MOH (at 9826 9294) of the incident.

The biological agent or toxin has to be properly packaged as stipulated in the Transportation Regulations of the Biological Agents and Toxins Act (BATA). If the reasearcher is not the person responsible for the biological agent (i.e.has knowledge of the characteristics and hazards of the biological agent/toxin), a 24-hr emergency contact number has to be provided on the outer package containing the biological agent/toxin. Please ensure that the transport regulations of the BATA are complied. The Biological Agents and Toxins Act Transportation Regulations is available at the Biosafety website under About BATA.

Transportation of all scheduled biological agent/toxins (BA/toxin) under the Biological Agents and Toxins Act (BATA) by mail or public transportation is not permitted. You may refer to section 47 of the BATA for more information on the transportation requirements.

For Schedule 1, 2 and 5 agents and toxins, the BATA requires that both the transferor (sender) and transferee (receiver) to have a valid approval to possess the agent before effecting a transfer. The transferor shall ensure that the transferee has a valid approval to possess before he proceeds to transfer the biological agent (BA) or toxin.
In addition, the transferor has the responsibility to notify MOH of the proposed transfer by creating a notification of transfer via the Biosafety Website E-services or send an e-mail to moh_biosafety@moh.gov.sg, if the transferor is not a registered user of the Biosafety E-services.
The transferor needs to notify the transferee of the estimated time of transfer of the agent and to provide the carrier of the agent with a 24-hour emergency number of a person who has the knowledge of the hazards and characteristics of the agent being transported.
The transferee is required to ensure that the scheduled agents are received within the estimated time frame given by the transferor. otherwise, the transferee should notify MOH of any failure of receipt of the scheduled agent.
The transfer notification shall only apply to Schedule 1 Part II, Schedule 2 and Schedule 5 agents and toxins.
Note that a valid approval to possess is not a prerequisite for the transferor, if

• the BA is a clinical sample, byproduct or derivative obtained from the routine diagnosis activity of the lab, AND
• the transferor has no intention to keep the BA, and decided to transfer all the BA stock to the transferee

For Schedule 1, 2 and 5 biological agents and toxins, the transferor and the transferee should ensure that the sample is packed and transported in accordance to the Transportation Regulations of the Biological Agents and Toxins Act (BATA). The transferor should also inform the transferee of the estimated date and time of transfer prior to the actual transfer.
Prior to the transfer, the transferor shall send an e-mail notification to MOH at moh_biosafety@moh.gov.sg, regarding the details of the transfer which includes the date, time and to where the biological agent or toxin will be transfered to. The transferor should also send another e-mail to MOH once they have completed the transfer.
Notification of receipt of BA/toxin from a non-registered facility can be done via the Biosafety IT System by the transferee.

Under the Biological Agents and Toxins Act (BATA), the transferee (receiver) shall notify failure of receipt of transfer to the MOH if he/she did not receive the consignment within 24 hours of the estimated time of receipt of the agent provided by the transferor (sender).
The notification of failure of receipt of transfer only applies to transfer of Schedule 1 Part II, Schedule 2 biological agents and Schedule 5 toxins.

All biosafety coordinators working in a certified facility are required attend a structured course and passed the examination, organized by an MOH-Approved Training Provider (MOH-ATP).

Biosafety Coordinators are preferred to have attended the structured training course and pass the examination conducted by the MOH-ATP.
In cases wherein you have attended biosafety training courses other than the one given by the MOH-ATP, you may submit information of the course and MOH will review each application on a case by case basis.

Training for Biosafety Level 3 Facility (BSL3) staff is mandated under the Biological Agents and Toxins Act (BATA). Such training for personnel working in a BSL 3 facility can be conducted in-house or by experienced external trainers, if the institution does not have the expertise to train. The staff or organization may wish to plan the course topics as recommended by the MOH-Aproved Training Provider.

The Biological Agents and Toxins Act (BATA) does not require a biosafety coordinator working in an uncertified facility to undergo structured training endorsed by the MOH. However, if an uncertified facility wishes to work with a Schedule 1 agent, the MOH may impose additional training requirement.

The Biological Agents and Toxins Act (BATA) do not require workers in an uncertified facility to attend structured course. It is, however, recommended that they undergo training and the management should ensure that the staffs are competent in working in an uncertified facility.

MOH-ATP are MOH-Approved Training Provider registered and recognized by the MOH as organizations or individuals with relevant and suitable resources to conduct courses for biosafety coordinators.

The following are the requirements for MOH-ATP:

• Trainers' qualification which includes curriculum vitae, academic and professional certificates. The lead trainer must have conducted biological safety management courses. There should also be significant experience of at least 3 years in directy laboratory safety management.


• Course syllabus for theoretical and practical sessions - include the topics and course outline, duration of each session and examinations to be conducted.


• Proposed course notes and examinations


• Brief write-up on the organization applying to be an MOH-ATP which will include the organizations' background, experience in conducting training courses and any accreditation received.

You can apply to be an MOH-ATP online via the Biosafety Website E-services. Alternatively, you may also send an e-mail to moh_biosafety@moh.gov.sg indicating your interest to apply as ATP. An application package will be sent to you.

MOH-ATP status expires after 2 years. You need to re-submit your application to MOH to renew your ATP status once it expires. However, you need to update MOH whenever there are changes to the trainers list or the course content.

The BiosIS will be requiring you to change your password every 90 days regardless of your last login. This feature will help to enhance the security of the system.

Your last log in is probably more than 90 days. You need to keep your acount active by at least logging into the system frequently and not leaving the account inactive for more than 90 days.

If your account is inactivated, you may contact the Biosafety Branch by sending an e-mail to moh_biosafety@moh.gov.sg.

Once reactivated, you are required to login to the BiosIS.
After successful login, you will be prompted to change your password.

Table A. Facility Personnel

	Function/ Roles	Facility Administrator	Alternate Administrator	Facility Officer
Facility Administrator	Inactivate User	Yes	No	No
	Maintain Alternate	Yes	No	No
	Update profile	Yes	Yes	No
	Maintain profile	Yes	Yes	No
	Reset/Unlock Password of other facility officers	Yes	No	No
	Transfer My Facility	Yes	No	No
	Switch Facility	Yes	Yes	Yes
Facility Registration	Renew Certificate	Yes	Yes	No
	Register New facility	Yes	Yes	No
	Cancel Registration	Yes	Yes	No
	Withdrawal of Application to Register	Yes	Yes	No
Facility Application	Application to Possess for First-time Use of Agent	Yes	Yes	Yes
	Application for Special Approval to Handle	Yes	Yes	Yes
	Application for Approval to Produce	Yes	Yes	Yes
Notification	Transfer	Yes	Yes	Yes
	Disposal	Yes	Yes	Yes
	Export	Yes	Yes	Yes
	Receipt of Biological Agent/toxin from a Non-Registered Facility	Yes	Yes	Yes
Incident Report	Report Incident	Yes	Yes	Yes
	View Incident Report	Yes	Yes	Yes
Work Bench	My Task	Yes	Yes	Yes
	My application Status	Yes	Yes	Yes
	Other Application Status	Yes	Yes	No
	My Draft	No	No	No
Query	Inventory List	Yes	Yes	No

Table B. MOH-Approved Facility Certifier (MOH-AFC)

	Function/ Roles	Approved Facility Certifier
AFC Admin	Maintain Profile	Yes
	Cancellation	Yes
	Reassessment	Yes
Work Bench	My Task	Yes
	My application Status	Yes
	Other Application Status	No
	My Draft	No

Table C. MOH-Approved Training Provider

	Function/ Roles	Approved Training Provider
ATP Admin	Maintain Profile	Yes
	Renewal	Yes
	Cancellation of Application	Yes
	Withdrawal of application	Yes
	Update Course profile	Yes
Work Bench	My Task	Yes
	My application Status	Yes
	Other Application Status	No
	My Draft	Yes

Table D. Public

	Function/ Roles	Public
Registration	Register as Facility	Yes
	Apply as New Facility Officer	Yes
	Apply for Approved Training Provider	Yes
	Apply for Approved Training Provider	Yes

If you are the existing/registered facility administrator, you may transfer your facility to the new facility administrator via the Biosafety E-services using the "Transfer my Facility" option. If the new facility administrator has not registered in the system before, then he need to apply and register online as facility administrator.
Also, inform MOH by sending an official letter or e-mail to moh_biosafety@moh.gov.sg at least 2 weeks before the change in facility administrator. The new facility administrator will be sent an e-mail notification.

RSA Authentication is a mechanism for performing two-factor authentication for a user to a network or internet resource. Two-factor authentication will involve something you know (user and password of application) and something you have (a piece of token).

RSA Authentication will add another level of security to the transactions that are being handled over the internet. In cases where in your BioSafety log-in account was breached by an unauthorized person, he will not be able to access your account because the RSA Authentication will act as a second level of verification into your account.

RSA Authentication is only required for main administrator, alternate administrator and facility officer users of approved/registered Certified Facility, Uncertified Facility and Large Scale Production Facility.

Other groups of users such as Approved Facility Certifier (AFC), Approved Training Provider (ATP) and new applicant of Certified Facility/Uncertified Facility/Large Scale Production Facility do not require RSA Authentication. They can just simply login through BioSafety website as usual.

AFC	Approved Facility Certifier
ATP	Approved training provider
AVA	Agri-food and Veterinary Authority of Singapore
BA	Biological Agent
BATA	Biological Agents and Toxins Act
BSL	Biosafety Level
BT	Bioterrorism
GMAC	Genetic Modification Advisory Committee
GMO	Genetically Modified Organism
HTDP	Hazardous Materials Transportation Driver Permit
HSA	Health Science Authority
IATA	International Air Transport Association
IBC	Institutional Biosafety Committee
IDA	Infectious Diseases Act
MOH	MInistry of Health
NBC	National Biosafety Committee
OBSL	Online Business Licensing Service
PAPP	Protected Areas and Protected Places
TWC	Technical Working Committee
WHO	World Health Organization