Please note that access to BiosIS will not be available on 22 September 2019 (Sunday) from 0000 hrs to 0800 hrs due to a scheduled maintenance.

FAQs


1. General Information


What does the Biological Agents and Toxins Act regulate?

The Act regulates the possession, use, import, transhipment, transfer and transportation of biological agents, inactivated BAs and toxins that are known to be hazardous to human health in Singapore.

The BATA is a risk-based legislation that sets stringent controls on biological agents and toxins that pose high or significant risk to public health and security and lighter control on biological agents that pose lesser risk.

Biological agents are of negligible risk to public health and security are not regulated.


When did the Biological Agents and Toxins Act enforced?

The Biological Agents and Toxins Act passed by the Parliament on 18th October 2005 and enforced on the 3rd January 2006.

How can I get the latest version of the Biological Agents and Toxins Act and its regulations?

The Biological Agents and Toxins Act can be accessed by:

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

Does the Biological Agents and Toxins Act regulate the export of biological agents, inactivated biological agents and toxins listed in the schedules?

The Act DOES NOT regulate the export of biological agents and toxins. However, if it is a First or Second Schedule biological agent or a Fifth Schedule toxin, then you are advised to notify MOH at moh_biosafety@moh.gov.sg.

Which agency controls the export of biological agents (BAs) and toxins?

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.

Who is covered by the Biological Agents and Toxins Act (BATA)?

The Act applies to any person or party (laboratories, companies or institutions, etc),  who is dealing with biological agents or toxins listed in the Schedules of the Act.

Individuals who wish to work, possess, use, store, etc., the biological agents  and toxins should also be aware of the requirements of the Act, as these can affect their operations.

Courier service providers transporting biological agents and toxins within and into Singapore should also be aware of the requirements for the transportation, transhipment and transfer of biological agents and toxins.

Are there any "general exemptions" on activities involving the scheduled biological agents or toxins listed in the Biological Agents and Toxins Act (BATA) that are exempted from the Act?

The Act does not apply to any of the following activities:

  1. Disposal of any biological agent by a hazardous waste contractor;
  2. Handling of any biological agent or toxin in the course of carrying out a diagnosis or an autopsy;
  3. 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 or toxin that is present in such samples or in the environment from which such samples have been taken; or
  4. Use or possession by any of the following persons of any finished cosmetic or medicinal product consisting of any toxin:
    1. any person lawfully manufacturing, supplying, selling or dispensing the finished cosmetic or medicinal product;
    2. any registered medical practitioner using the finished cosmetic or medicinal product in the course of treating another person;
    3. any person using the finished cosmetic or medicinal product for the cosmetic or medical purposes for which it is intended.

What is the definition of "diagnosis" in the Biological Agents and Toxins Act (BATA)?

The Act defines "diagnosis" as 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; 
  4. Determining the cause of death of any person or animal in an autopsy;
  5. Identifying or determining the nature of the toxin that is or suspected to be present in the specimen for public health purposes.

I am a director of a facility involved in the activities listed under Section 4 of the Biological Agents and Toxins Act (BATA). Do I need to register with the Ministry of Health (MOH) that I am working with such biological agents and toxins?

There is NO need to register, seek approval or inform MOH if your facility is involved in the activities listed in Section 4 of the Act.

However,  for diagnostic activities listed in the same section, note that you are not allowed to carry out any activities "diagnosis", or the Act shall apply.

Detailed information can be found in the MOH Circular 34/2006BATA Proficiency Testing Regulations S28/2008 and the BATA Exemption Regulations S451/2009.


Why are there several schedules in the Biological Agents and Toxins Act? What are the kinds of biological agents and toxins covered by the Act?

The 5 Schedules in the Act cover a wide spectrum of biological agents and toxins. Different levels of controls have been adopted for each Schedule, depending  on the risk of the biological agents or toxins. 

The table below shows an overview of the Schedules with the corresponding risk. 

ScheduleDescription of Risk
First Schedule Part I Risk group 3 biological agents.
First Schedule Part II Risk group 3 biological agents perceived to have the potential to be weaponised.
Second Schedule Risk group 4 biological agents.
Third Schedule Risk group 2 biological agents that needs special attention if produced in large scale.
Fourth Schedule Risk group 2 biological agents including those listed under the Third Schedule.
Fifth Schedule Microbial toxins perceived to have the potential to be weaponised.

Why is the First Schedule subdivided into 2 parts? Are there any differences in the requirements for working with such biological agents?

The table below shows the different characteristics and requirements for the possession of First Schedule Part I and Part II biological agent:

First ScheduleDescription of RiskBasic Requirement for Possession
Part I biological agentRisk group 3 biological agents.Certified facility
Part II biological agentRisk group 3 biological agents perceived to be potentially weaponizable.Certified facility that is also gazetted as a protected place under the Infrastructure Protection Act

I do not see any biological agents listed in the Fourth Schedule of the Biological Agents and Toxins Act. Where can I find the list of the Fourth Schedule biological agents?

Fourth Schedule biological agents cover ALL risk group 2 agents. The list is non-exhaustive as the number us too large to be listed in the Act.

However, to facilitate importation of Fourth Schedule biological agents, we have listed the more common risk group 2 biological agents (with MOH import product codes) under the "Fourth Schedule" of the "List of Biological Agents and Toxins".

As the list is not exhaustive, importers are advised to consult MOH on any risk group 2 biological agent that they intend  to import, even if they are not found in the list. Importers may send their enquiries to moh_biosafety@moh.gov.sg.

Please check the list of "Biological Agents and Toxins" from the Biosafety Website before submitting any application for import as MOH updates this list from time to time.


I am from a research laboratory. Must I be familiar with all the requirements for all the scheduled biological agents and toxins under the Biological Agents and Toxins Act?

The provision of the Act is dependent on the type of biological agent that you are working on, rather than the type of laboratory or industry. Hence, the type or schedule of the biological agents or toxins, and the work involved will determine which sections of the Biological Agents and Toxins Act (BATA) is applicable.

I am a researcher working with genetically modified micro-organisms (GMMs). Are there any specific requirements related to GMMs in the Biological Agents and toxins Act?

The Biological Agents and Toxins Act does not differentiate genetically modified micro-organisms (or genetically modified biological agents or GMBAs) from non-GMMs (on non-GMBAs).

Anyone who intends to work on GMMs or GMBAs shall adhere to the Singapore Biosafety Guidelines for Research on Genetically Modified Organisms, conduct risk assessment on the proposed work and submit their proposal to the Genetic Modification Advisory Committee (GMAC) for formal endorsement and approval, keeping MOH updated.

More details on the GMAC's framework can be obtained from the GMAC Secretariat at info@gmac.sg or visit the GMAC Website


I am a courier service provider handling the transportation of biological agents and toxins. Which sections in the Biological Agents and Toxins Act apply to me?

For courier service providers, you need to be familiar with the requirements for import, transhipment and transport of biological agents and toxins.

You should not execute the clearance of any import/tranship of biological agents or toxins unless you have ascertained that a VALID permit has been secured from MOH. 

Your responsibilities during the transportation of biological agents and toxins are covered in Section 47 of the Biological Agents and Toxins Act. In brief, you should have been provided with the appropriate training and a valid Hazmat Drivers Training Permit (if it involved First, Second and Third Schedule biological agents and Fifth Schedule toxins). You shall also ensure that there are no unreasonable delays in the transportation, and to protect the security of the biological agents or toxins that you are transporting. 

For more details, please refer to the section for courier service providers in this FAQ’s and the Biological Agents and Toxins Act and the Transportation Regulations.


I noted that both MOH and Animal and Veterinary Service (AVS) are controlling the import and/or use of certain biological agents (or infectious agents). Please clarify the difference or overlapping of regulations between the two agencies.

The Biological Agents and Toxins Act BATA) under MOH, regulates biological agents capable of causing disease in humans (human pathogens), while the Animals and Birds Act under AVS controls biological agents capable of causing disease in animals (animal pathogens). However, there is a subset of biological agents that can cause disease in both humans and animals (zoonotic agent) and that are jointly regulated by MOH and AVS.

Depending on the risk group or schedule of the zoonotic pathogens, MOH and AVS may have their own set of requirements.  Thus, you are advised to refer to the respectively authorities on such requirements.

AVS's contact: 6805 2840; animal_feedback@nparks.gov.sg

More information on how to apply for an import permit for jointly controlled agents can be found under "Import/Transhipment Permits".


If I have further inquiries on the Biological Agents and Toxins Act, to whom should I direct my enquiries to?

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


2. Approvals & Permits


Can you list the approvals and permits in the Biological Agents and Toxins Act (BATA) that would apply to facilities handling Biological Agents (BAs) and Toxins in each Schedule?

ControlsFirst Schedule Biological AgentsSecond Schedule Biological AgentsThird Schedule Biological AgentsFourth Schedule Biological AgentsFifth Schedule ToxinsInactivated Biological Agents
Part IPart IIFirst ScheduleSecond Schedule
Certified Facility
Protected Place
Approval to Possess (for first-time use)
Large Scale productionPROHIBITED
Special Approval to Handle


Import Permit
Transhipment Permit
Transfer Notification
Failure of Receipt
Incident Notification

How do I apply for approvals and permits?

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 NTP.


I have not received approval from my Biosafety Committee for work involving First Schedule biological agent in my laboratory. Should I proceed with my application for approvals and permits under the Biological Agents and Toxins Act?

You may apply for approvals or permits under the Act if you have met the set of criteria for the approvals or permits.  

However, even if you have been granted with the approvals or permits, you are not allowed to start any activities on any First, Second or Third Schedule biological agents, or Fifth Schedule toxins unless -

  1. Your biosafety committee has-
    i. conducted risk assessment on the activities;
    ii. devised appropriate measures to manage the risk; 
    iii. formulated the appropriate policies, programmes and codes of practice to ensure the proposed activity can be carried out safely with adequately trained and competent 
  2. Your Biosafety Co-ordinator has implemented the measures, policies, programmes and codes of practice as devised or formulated by the Biosafety Committee; and
  3. For First Schedule Part II and Second Schedule biological agents, or Fifth Schedule toxins, staffs are also required to be vetted and cleared by the respective authority before they are allowed access to the biological agents or toxins. 

Does the same procedure apply for approvals and permits of genetically modified microorganism?

Yes, but in addition to the above, you should seek an endorsement from Genetic Modification Advisory Committee (GMAC) before submitting application for approvals and permits to MOH.

You may e-mail the GMAC Secretariat at mailto:info@gmac.sg or visit the GMAC Website.



3. Possession

What is an approval to possess?

An approval to possess is an approval granted by the Director of Medical Services, MOH, to possess First and Second Schedule biological agents and Fifth Schedule toxins. You need to apply for this approval for every first time possession of a biological agent or toxin in those schedules. An approval to possess is agent specific and is issued based on the following requirements:

  1. The person who requires the First and Second Schedule biological agent or Fifth Schedule toxin has to put adequate measures to contain the risk to public health and security posed by such scheduled biological agent or toxin. This may include a certified facility for First Schedule Part I biological agents, a certified and protected facility for First Schedule Part II and Second Schedule biological agents; and a protected facility for Fifth Schedule toxins.
  2. For Second Schedule biological agent, approval to possess can only be granted if special approval to use/handle the biological agent has been granted.

What kind of information must be submitted in an application for an approval to possess a Second Schedule biological agent?

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 Infrastructure Protection Act
  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.

What are the requirements for working on a Fifth Schedule toxin?

An approval to possess is needed before one can possess a toxin under the Fifth Schedule. However, before an approval to possess is granted, the facility should be gazetted as a protected place under the Infrastructure Protection Act.

Does the approval to possess have an expiry date?

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 First Schedule Part I Biological Agents, a valid certified facility and gazetted protected place under the Infrastructure Protection Act for First Schedule Part II and Second Schedule biological agents or a gazetted protected place under the Infrastructure Protection Act for Fifth Schedule Toxins.

Note that MOH has the right to revoke any approval granted under the Act. 


I am from a diagnostic laboratory and we have just diagnosed a First and/or Second Schedule biological agent. Do I need to apply for an approval to possess?

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 diagnosis is confirmed, you are required to destroy the biological agent or the samples containing the biological agent, or transfer it to a certified facility that has the approval to possess the said biological agent.

However, if you intend to keep the biological agent or the samples containing the biological agent, or to carry out any activities that go beyond performing a diagnosis, you will need to apply for an approval to possess from MOH, and all the provisions of the Act shall then apply. 


Can a diagnostic laboratory transfer a sample that has been diagnosed as having a First Schedule biological agent to a reference laboratory for independent diagnosis purposes? Would the latter need to have an approval to possess?

You may transfer samples between diagnostic laboratories for the purposes of confirming a diagnosis. In such case, the reference laboratory does not need an approval to possess the biological agent. However, the reference laboratory have to destroy the samples after completion of the diagnosis or confirmation.

If I am working with a zoonotic agent (i.e. a biological agent that is jointly controlled by AVS and MOH), how should I proceed with the application for an approval for possession?

Researchers who wish to work with zoonotic agents should write to both authorities, AVS and MOH, for approval to possess these agents. The researchers shall inform or update either authority on the outcome of their applications.

I intend to work with HIV lentiviral vectors. Is there any approval that I need to secure from MOH before I can start to work with the HIV lentiviral vectors?

HIV is classified as a First Schedule Part I biological agent under the Biological Agents and Toxins Act (BATA) and an approval to possess HIV is required from MOH. Although HIV lentiviral vectors are derived from HIV, the risk of these viral vectors may altered by genetic modification.  As such, the BATA stratified HIV lentiviral vectors (HIV-LV) into different schedules, based on the extent of genetic modification and the risk associated with the vectors.                                                 

HIV lentiviral vectors with risk equivalent to or lower than a risk group 2 agent are considered as “advanced” generation vectors and thus, classified as Fourth Schedule biological agents under the BATA.  HIV-LVs with risk higher than risk group 2, are considered as “non-advanced” generation vectors, and remain as First Schedule Part I biological agents. All HIV-LV shall comply with the BATA requirements that correspond to their respective Schedules, unless specified otherwise. You may refer to the next question below for a more detailed description of the criteria for “advanced” generation HIV-LV.


How do I know if a HIV lentiviral vector is considered as advanced generation?

The BATA, under the Fourth Schedule has defined advanced generation as any third or higher generation HIV vector lentiviral vector with all of the following features:

  1. comprised of a minimum of 4 plasmids in total which includes all types of plasmid (e.g. packaging, structural, accessory, etc);
  2. HIV genes are split to a minimum of 2 packaging plasmids;
  3. the env gene encoding for the HIV envelope is replaced;
  4. the vifvprvpu and nef genes are either absent or altered to be non-functional;
  5. the rev and tat genes are absent, non-functional or expressed from a separate construct; and
  6. the gag and pol genes are split over at least 2 plasmids or there is deletion in the 3’LTR or both.

If the HIV lentiviral vector does not satisfy the above given definition, it could possibly be a “non-advanced” generation lentiviral vector.


I intend to work with a commercially available HIV lentiviral vector. The product info state that it is a Fourth generation HIV lentiviral vector but upon checking the other information for the vector, it does not satisfy all the criteria for an advanced generation lentiviral vector stipulated in the BATA. What should I do now?

In case where there is mismatched information, you should always base your assessment on the criteria provided under the BATA, as described in the previous question above.

As with all any other genetically modified biological agents, you are required to submit your research proposal involving HIV lentiviral vectors to GMAC for their assessment. Please highlight to GMAC, the discrepancies between the manufacturer’s claim and the criteria stipulated under the BATA Fourth Schedule.

Once you have received GMAC’s assessment, you’ll need to send the following information to MOH:

  1. Work involved
  2. Vector information
  3. Safety features
  4. GMAC assessment report
  5. Biosafety Committee assessment of the proposal and the generation of the HIV lentiviral vector
  6. Risk Assessment
  7. Any other information that you or MOH deemed necessary for this application

MOH will review the information provided and will advise you accordingly.


Would you be able to provide us with a quick guide to assess the generation of the lentiviral vector?

You may also use the table below as a quick guide on the classification of HIV lentiviral vectors:

Number of HIV-LV Criteria satisfied under the BATA Fourth ScheduleHIV-LV created in-house or from a non-commercial sourceHIV-LV purchased from a commercial sourceHIV-LV generation as stated in the product specification or as claimed by the producerLikely Assessment of the generation of the HIV-LVs
63 and aboveAdvanced Generation
4-53 and aboveRequires further assessment*
3 and above
0-32 and belowNon-advanced Generation**
2 and below

 

*HIV lentiviral vector have to be highlighted to GMAC and MOH for further assessment and advice

**Approval to possess is required from MOH



4. Special Approval to Handle


What is a Special Approval to Handle?

Special approval to handle is only applicable to Second Schedule biological agents. The application will not be considered unless the following conditions are met:

  1. The use of the Second Schedule biological agent is necessary for the public interest; and
  2. The person who requires the biological agent has placed adequate measures to contain the risk to public health and security posed by the Second Schedule biological agent.


5. Large Scale Production


What is an approval to produce?

An approval to produce is the approval granted to facility who intends to produce in large-scale, First and Third Schedule biological agents.

What is large-scale production?

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.

Which should I apply first, approval to produce or an approval to possess?

For First Schedule biological agents, you need to apply for an approval to possess the biological agent first. Your facility needs to meet the requirements to possess the biological agent before MOH will consider granting the approval to engage in large scale production. Once the approval to possess is granted, then you may apply for an approval to produce.

For Third Schedule biological agents, since the approval to possess is not required, you may directly apply for an approval to produce the biological agent in large quantities.


Does the approval to produce have an expiry date?

Although in general, there is no expiry date for the approval to produce First and Third Schedule biological agents, the validity of the approval is tied to:

  1. the facility having a valid “approval to possess” the First Schedule biological agent;
  2. the production is carried out at the facility specified in the approval; and
  3. in accordance with any other conditions stipulated in the approval, and this may include an expiry date.

Also, note that MOH has the right to revoke any approval granted under the Act.


Is large-scale production prohibited for any of the Schedules?

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


6. Inactivation of First and Second Schedule Biological Agents


Can an uncertified facility work with an inactivated (First or Second Schedule) biological agents?

Yes, an uncertified facility may work with inactivated (First or Second Schedule) biological agents provided by another local facility that is permitted to carry out the inactivation process. In such case, the receiver must practice due diligence in ensuring that the sender has successfully rendered the agent inactive (non-infectious or non-replicative).

An uncertified facility may also import inactivated (First or Second Schedule) biological agents. In the latter case, the importer or recipient (uncertified local facility) need to furnish MOH, the proof of successful inactivation of the biological agent by the overseas laboratory, prior to importation of the agents.

Although the biological agents are deemed to be inactivated, the facility shall remain cautious and treat it as potentially infectious using appropriate biosafety practices and measures.

Should the “inactivated” biological agents be found or suspected to contain live, infectious or replication-competent First or Second Schedule biological agents, facility shall ceased all work on the “inactivated” biological agents, store in a safe and secure manner and notify MOH immediately.


What are the requirements to be able to perform an inactivation of First or Second Schedule biological agents in a local facility?

Before carrying out any inactivation of biological agents listed under the First or Second Schedule of the Act, the facility operator has to ensure that:

  1. there is a valid approval to possess the biological agent;
  2. the inactivation procedure has to be reviewed, endorse or approved by the Biosafety Committee; 
  3. the inactivation procedure has been validated or verified effective in rendering the agent non-infectious/non-replicative and the efficacy date and all relevant data is documented and filed;
  4. the inactivation procedure is performed at the facility specified in the approval to possess; and
  5. a system in place to monitor and to ensure that the inactivation procedure continues to be effective in rending the biological agent non-replicative and non-infectious.

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


What kind of proof of inactivation information would be required by MOH for the application of an import permit for inactivated (First or Second Schedule) biological agents?

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

  1. The source of the inactivated biological agent;
  2. The name and curriculum vitae of the person who carried out the inactivation;
  3. The method of inactivation (procedures) used and its efficacy (validation report with detailed results);
  4. The approval from the local Biosafety Committee (BC) with risk assessment;
  5. The credentials of the institution which carried out the inactivation ( if the biological agent is coming from an overseas institution);
  6. Research proposal or activities to be carried out on the inactivated biological agent;
  7. Any other documents that MOH deem necessary in the evaluation proces.

Do laboratories that intend to handle inactivated First or Second Schedule biological agents need to apply for approval to possess the biological agent?

Approval to possess is not required for use and possession of inactivated First or Second Schedule biological agents, if and only if the “inactivated” biological agent has proven to be render non-infectious and unable to replicate under any conditions. It is the laboratory’s responsibility to ensure that the inactivation process is effective and successful.

The inactivated biological agents and their components should not be used to synthesize, modify or make to become infectious or replication competent.


Can MOH provide a list of approved methods of inactivation of biological agents?

The Biosafety Branch of the MOH may help to review inactivation procedures on a case-by-case basis but will not provide any procedures for inactivation.


7. Risk Assessment


What does the BATA state regarding risk assessment?

Sections 39 and 41 of the Act, requires risk assessment to be conducted for any activity proposed to be carried out in the facility.

When are we supposed to conduct risk assessment?

Risk assessments are conducted before any work commences and thereafter, upon any of the conditions below, whichever is earlier:

  1. once every 2 years
  2. upon occurrence of accidents, near misses, dangerous acts, or
  3. when there are changes in work processes or workplace conditions / layout.

This is to ensure that the measures that were placed previously are still effective or if there is any need to add or change these measures in place.  


May I know who should conduct the RA?

The Act stipulates that the biosafety committee (comprised of the appropriate expertise) appointed by the facility operator shall conduct risk assessments in relation to any activity proposed to be carried out in the facility. The biosafety committee will also be responsible to devise measures, formulate policies, programmes, codes of practices to manage the risks that may arise from the proposed activity and to ensure the proposed activity can be carried out safely. No activity is allowed to be commenced unless the biosafety committee has determined that the proposed activity can be carried out safely at the facility.

Are there any guidelines on how to do perform a risk assessment?

The Guidelines on Laboratory/Work Risk Assessment and a sample risk assessment template can be found in our website under “Useful Info”. You may also refer to the MOM website for the guidelines.


8. Import / Transhipment Permits


Do all the biological agents and toxins listed in the Schedules of the Biological Agents and Toxins Act (BATA) require permits to be imported?

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

Do I need to apply for an import permit if the biological agent that I am importing is not in the list of biological agents?

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.


I am from a research laboratory. How can we apply for an import permit?

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

  1. If you have an account with the Singapore Customs NTP, you can apply directly for the import permit provided that you have a Unique Entity Number (UEN) or a Central registration Number (CRN) of your company or institution. The UEN/CRN is required for all import, export and transhipment permits, certificates and other documents issued by the Singapore Customs. For more information, please direct your inquiry to Singapore Customs at 6355 2000 or send an e-mail to customs_documentation@customs.gov.sg.
  2. If you do not have a NTP account, you may engage a courier service provider who already has an existing NTP account to apply for the import permit on your institution’s behalf. In this case, it is your responsibility to provide the correct information (e.g. UEN/CRN of your institute, MOH product code, etc.) to the courier. In addition, it is also your responsibility to verify that the permit that the courier has secured is correct and valid before the consignment clears the customs.

Who is responsible for obtaining an import permit? Is it the importer or the courier service provider?

The importer (the laboratory or end user of the biological agent or the toxin) is responsible for ensuring that a valid import permit is obtained for the biological agents and toxins. Even if a courier service provider is engaged to apply for an import permit on behalf of the importer (e.g., the laboratory personnel or end user), the importer is responsible for providing the correct information needed for the import permit declaration to the courier service provider, and to ensure that the correct import permit has been obtained from MOH.

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


I will be importing some biological agents listed in the First and Second Schedule. I understand that I need to obtain both an approval to possess and an import permit, but may I know which comes first?

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.

What is an Import Specific Product (ISP) Code?

Import Specific Product codes or ISP codes are given to specific laboratories for the regular importation of biological agents with known regular schedules coming from the same source or exporter (proficiency test provider) such as proficiency samples. These ISP codes are NOT import permits. They are only to be used in place of the MOH product code in the submission of an import permit application. The issuance of ISP codes aims to facilitate the importation process.

How long is the validity of the Import Specific Product (ISP) Code?

The longest validity of an ISP code is 3 years from the date of issue. Some laboratories may have more than one ISP codes issued at different time. To reduce confusion, we have aligned the validity of all the ISP codes for a particular laboratory to a single expiry date. As such, some of the ISP codes may have a less than 3 years validity.

How should I apply for a permit to import zoonotic agents that are controlled by both MOH and Animal and Veterinary Service (AVS) of Singapore?

For zoonotic agents, Importers are required to obtain import permit from both AVS and MOH. AVS and MOH have streamlined the import processing workflow as shown in the table below:

Pure culture/isolates of zoonotic agentsClinical samples that are very likely to contain zoonotic agentsClinical samples that are very likely to contain AVS regulated agents, which are not zoonoticAll other clinical samples of animal origin
Applicant applies through NTP with MOH and AVS codes.Applicant declares MOH code in NTP and applies for AVS permit separatelyApplicant applies for AVS permit only

                                               

Clinical samples likely to contain Risk Group 3 zoonotic agentsClinical samples likely to contain Risk Group 2 zoonotic agents (of animal/human origin)
Animal OriginHuman Origin
  • Primary CA: AVS
  • Secondary CA: MOH
  • Primary CA: MOH
  • Secondary CA: AVS
  • Primary CA: AVS
  • Secondary CA: MOH

Application for import permit for zoonotic agents can be done online at the NTP. Please use the following codes: HS code – 30029000 or 21021000; Product Code Field – MOH Product Code and AVS Product Code.

The List of Biological Agents with the MOH product code and the corresponding AVS product code for zoonotics can be found on the Biosafety website.


Is an import permit required for importation of diagnostic test kits?

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 kit contain highly infectious biological agents that are capable of causing death, disease or other biological malfunction in humans, please inform MOH prior to its importation. An import permit may then be needed.

What are the types of packaging that I must follow for importation of biological agents and toxins?

Packaging and labelling requirements should comply with the transportation regulations of the Biological Agents and Toxins Act (Transportation) Regulations. However, please note that the packaging of items via air transport shall also adhere to the packaging instructions of the International Air Transport Association (IATA) of Dangerous Goods regulations.

Where can I get more information on import permit?

Please refer to the MOH guidelines for the Importation and Transhipment of Human Pathogens and Toxins.

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


Do all the biological agents and toxins listed in the Schedules of the Biological Agents and Toxins Act require transhipment permits?

No. Only biological agents and toxins listed in the First and Second biological agents and Fifth Schedule toxins require transhipment permits.

How should I apply for transhipment permit?

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

Where can I get more information on transhipment permit?



9. Notification


What are the types of notification in the Biosafety IT System (BiosIS)?

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

  1. Notification of transfer
  2. Notification of failure of receipt
  3. Notification of disposal/inactivation
  4. Notification of export of biological agent/toxins
  5. Incident report involving biological agents or toxins that may potentially cause the transmission of an infectious disease or a toxic effect or a potential release of a biological agent or toxin to the environment
  6. Incident report for suspected or confirmed laboratory acquired infection
  7. Incident report for the loss of biological agent or toxin

Any other incident that may have a potential impact to laboratory safety & security, public health, and national security must be reported by e-mail to moh_biosafety@moh.gov.sg.


Who needs to submit a notification of transfer?

Anyone who is transferring or receiving a First and Second Schedule biological agent or a Fifth Schedule toxin must submit a notification of transfer or receipt in the BiosIS.

Both the sender and the receiver must submit a notification of transfer and receipt, respectively, if both sender and receiver are registered facilities in the BiosIS.

However, if the sender is a local non-registered facility, an e-mail should be sent to moh_biosafety@moh.gov.sgto inform MOH of the transfer. This will not be applicable to an overseas facility. The receiver, who is a registered facility, will submit a “notification of receipt from a non-registered facility” in the BiosIS in both situations.


What is considered “failure of receipt”?

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

How should I submit a notification of failure of receipt?

Once there is failure to receive an import of First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxins, MOH should be immediately notified via telephone (96654196) then followed by submitting an online notification of failure of receipt in the Biosafety IT System (BiosIS) by following the instructions below:

  1. Login to BiosIS
  2. Proceed to “workbench” 
  3. Select “My Application status” and, choose “Create Notification of Receipt”. 
  4. Choose the biological agent or toxin from the drop down list 
  5. Once the notification page is displayed, click the “Notify Failure of receipt” tab on the lower part of the page. Note that This function can only be done when there is an existing “notification of transfer” submitted by the transferring facility

Alternatively, you may send an e-mail to moh_biosafety@moh.gov.sg or call the Biosafety Branch at 96654196.


What incidents are required to be notifiable under the BATA?

The BATA requires the following to be notified to MOH immediately:

  1. 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 in the facility;
  2. All adverse incidents involving biological agents that may potentially cause transmission of any infectious diseases;
  3. All adverse incidents involving toxins
  4. All loss, whether through theft or otherwise, of biological agents and toxins;
  5. The destruction of any of his stocks of First Schedule Part II and Second Schedule biological agents and Fifth Schedule toxins.

What are the types of incident notification that can be submitted in BiosIS?

All the 5 incidents mentioned in the previous item can be notified via the BiosIS. Confirmed or suspected infections, adverse incidents involving biological agents and toxins and loss of biological agents or toxins can be done via the “Incident Report” option while the destruction of biological agents and toxins can be notified via “Notification of Disposal/Inactivation” or “Notification of Consume”.

What is the difference between “Notification of Disposal/Inactivation” and “Notification of Consume”?

“Notification of Disposal/Inactivation” will be used if all your stocks of the biological agent or toxin has been destroyed/inactivated completely and that no stock is left within your facility while “Notification of Consume” is used when only a certain portion of your biological agent or toxin stock was used/destroyed/inactivated or disposed and balance remains in the facility.

Notification of Disposal/Inactivation will remove the specified biological agent or toxin in your inventory list.


I am unable to submit my incident notification via BiosIS. What should I do?

You can send your initial incident notification and/or report via e-mail at moh_biosafety@moh.gov.sg or you may call the Biosafety Team at 96654196. However, you are still required to login to BiosIS to submit an online notification once it is possible for you to do so. 

I have submitted my incident report in the BiosIS. What should I do next?

A thorough investigation on the incident should be conducted by your facility.
A follow-up on the status of any staff affected in the incident, if applicable. Risk identification and mitigation measures must be identified. You facility must be able to put up plans, SOP’s or measures to avoid the possibility of having an incident recurrence.

Subsequent or final report must be submitted to MOH via e-mail to include the details above.



10. Facility Certification


What kind of facility needs to undergo certification as stipulated in the Biological Agents and Toxins Act?

Facilities that wish to handle First and Second Schedule biological agents should be certified by an MOH-Approved Facility Certifier, 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.

I will be working with First Schedule Part II, Second Schedule biological agents and Fifth Schedule toxins. How should I proceed to get my facility gazetted as a protected place under the Infrastructure Protection Act?

Any person who needs to work with First Schedule Part II, Second Schedule biological agents and Fifth Schedule toxins must have a facility gazetted as a protected place under the Infrastructure Protection Act.

Application for Gazette to be gazetted as a Protected Place must be submitted to the Biosafety Branch, MOH stating the justification for such request.

If MOH is satisfied with the justification, MOH will issue a letter of support to the applicant. The applicant can then submit his application to be gazetted as a Protected Place, together with MOH letter of support, to the Ministry of Home Affairs.


What are the supporting documents required for a new registration or renewal of registration of a certified facility or protected place with MOH?

Supporting documents required for the registration/renewal of a certified facility:

  1. Certificate issued by the MOH-Approved Facility Certifier (MOH-AFC);
  2. Complete certification report (including certification checklist, engineering data, etc.) from the MOH-AFC; 
  3. MOH-Biological Agents and Toxins Act Compliance Report;
  4. Biosafety Committee meeting the requirements in the Biological Agents and Toxins Act;
  5. Supporting documents for the Biosafety Coordinator;
  6. List of personnel working in the facility;
  7. Emergency Drill Audit Report;
  8. Any other document or information that MOH may deem relevant or necessary for the application.

Supporting documents required for registering a “protected” facility include:

  1. MHA Gazette Report or Certificate; 
  2. MOH-Biological Agents and Toxins Act Compliance Report;
  3. Biosafety Committee meeting the requirements in the Biological Agents and Toxins Act;
  4. Supporting documents for the Biosafety Coordinator;
  5. List of vetted personnel working in the facility; and
  6. Red Teaming Report; 
  7. Emergency Drill Audit Report;
  8. Any other document or information that MOH may deem relevant or necessary for the application.

Supporting documents required for registering/renewing of a “protected” certified facility include:

  1. Certificate issued by the MOH-Approved Facility Certifier (MOH-AFC);
  2. Complete certification report (including certification checklist, engineering data, etc.) from the MOH-AFC; 
  3. MHA Gazette Report or Certificate; 
  4. MOH-Biological Agents and Toxins Act Compliance Report;
  5. Biosafety Committee meeting the requirements in the Biological Agents and Toxins Act;
  6. Supporting documents for the Biosafety Coordinator;
  7. List of vetted personnel working in the facility; 
  8. Emergency Drill Audit Report;
  9. Red Teaming Report; 
  10. Any other document or information that MOH may deem relevant or necessary for the application.

Is there a checklist that MOH-Approved Facility Certifiers will use during the certification process?

Yes, the checklist can be downloaded from our website.

Does an Animal Biosafety Level 3 (ABSL3) facility need to be certified and registered? Do the controls of Biological Agents and Toxins Act apply for ABSL3 facility?

If the ABSL3 facility is used for the handling or storage of live First and Second Schedule biological agents, then it has to be certified and registered with MOH.

Similarly, other controls, including the possession, large-scale production, inactivation, transfer and transport of First and Second Schedule biological agents and Fifth Schedule toxins in the Act applies to the ABSL3 facility.

Additional criteria may be required by Animal and Veterinary Service (AVS). You may send your inquiries to AVS at animal_feedback@nparks.gov.sg.


My BSL-3 facility certification will be expiring soon. In preparation for the re-certification of my facility, does MOH require pre-certification tests to be conducted?

MOH only requires a re-certification to be conducted annually by the MOH-Approved Facility Certifier (AFC) if your facility intends to possess First or Second Schedule biological agents. The facility operator shall decide if a pre-certification procedure is useful or necessary for its facility. 

Do I need to shut-down* my facility for the re-certification?

Some positive aspects of having facility shut down for recertification include:

  1. It allows all personnel to access the facility safely without the need to don protective clothing. Personnel accessing the facility at this time, which may include certifiers, controlling authorities, facility maintenance crews who are non-laboratory personnel can carry out their respectively duties freely and safely without being limited by a PPE.
  2. More robust and extensive testing and challenging of the facility equipment, engineering and/or ventilation systems can be carried out without being worried of any possible containment breach and adverse impact to the environment and the surrounding due to test or system failure.
  3. Facility can take the shutting time as opportunity to conduct housekeeping, in-house maintenance, servicing, repairing or replacing of equipment, engineering or ventilation parts, and training of staff on emergency preparedness.  

Individual facility operator shall assess if there is a need for its facility to shut down for re-certification, weighing the benefits and the potential delay or interruption of laboratory services or research, and taking into consideration the facility conditions and safety of personnel involved in the re-certification process.

* Shut-down includes stopping all laboratory activities, storage of all biological agents and toxins, and the facility to be fully decontaminated.   


What should I do if I decided not to shut-down my facility for re-certification?

If you’ve decided to carry out re-certification of your facility without shutting it down, please contact the Biosafety Branch at biosafety_moh@moh.gov.sg for the arrangements on the re-certification, at least 1 month ahead of the recertification.


11. Facility Certifiers


What is a MOH-Approved Facility certifier?

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

What are the criteria or requirements to be an MOH-Approved Facility Certifier?

The following are the requirements for MOH-Approved Facility Certifier;

  1. Team Requirement – there should be one identified lead certifier for each team. The team must, at least be comprised of a qualified microbiologist and an engineer; 
  2. Certifier’s organization background and history, certifying and commissioning experiences and any accreditation received; 
  3. Certifiers internal standard operating procedures (SOP), detailing the methods used to ascertain the BSL- 3 facility under certification has the necessary engineering and administrative controls to ensure safe practice;
  4. Certifiers credentials – curriculum vitae, academic and professional certificates for each team member;
  5. Testimonials from previous BSL- 3 clients, for the company and the certifying team members;
  6. Any other document or information that MOH may deem relevant or necessary for the application.

How can I apply to be an MOH-Approved Facility Certifier?

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 checklist and other supporting documents in a CD and send it to:

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


Where can I obtain a list of MOH-Approved Facility Certifiers for certification of a BSL3 facility?

The list of MOH-Approved Facility Certifier can be found at the Biosafety Website.

Can I engage the service of a facility certifier that is not on the list of the MOH-Approved Facility Certifier?

If you intend to engage the service of a facility certifier that is not listed as a MOH-Approve Facility Certifier (MOH-AFC), please write 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. Upon that, you can engage the service of that certifier.

I am currently an MOH-Approved Facility Certifier. Am I required to renew my Approved Facility Certifier status?

Yes. You’ll need to submit an application to renew your MOH-Approved Facility Certifier status. Please note that all renewal applications are reviewed and subject to approval from MOH.

We are currently an MOH-Approved Facility Certifier. Can I add new members to the certification team?

Yes, you can add new team members to the certification team but, they will be subject to approval as MOH-Approved Facility Certifier. Also, your current status as an MOH-Approved Facility Certifier may be cancelled or suspended pending the approval of the new certification team members. 


12. Protected Place


I was informed that I need to have my facility gazetted as a protected place. What is a protected place?

“Protected Place” means any premises declared to be a protected place as defined in section 5 of the Infrastructure Protection Act.

What schedule of biological agents requires a facility that is gazetted as a protected place?

A facility gazetted as a protected place is required for facilities intending to work or store First Schedule Part II and Second Schedule biological agents and Fifth Schedule Toxins.

Note that for First Schedule Part II and Second Schedule biological agents, that facility must also be a certified BSL-3 facility in addition to it being gazetted as a protected place.


I will be working with First Schedule Part II, Second Schedule biological agents and Fifth Schedule toxins. How should I proceed to get my facility gazetted as a protected place under the Infrastructure Protection Act?

Any person who needs to work with First Schedule Part II, Second Schedule biological agents and Fifth Schedule toxins must have a facility gazetted as a protected place under the Infrastructure Protection Act.

A letter of request to be gazetted as a Protected Place must be submitted to the Biosafety Branch, MOH stating the justification for such request.

If MOH is satisfied with the justification, MOH will issue a letter of support to the applicant. The applicant can then submit his application to be gazetted as a Protected Place, together with MOH letter of support, to the Ministry of Home Affairs. 


What are the supporting documents required to be submitted to MOH as proof that my facility has been gazetted as a protected place under the Infrastructure Protection Act?

  1. Singapore Government Gazette published announcement or letter from the Ministry of Home Affairs if published gazette is not available;
  2. List of vetted personnel working in the facility; and
  3. Any other document or information that MOH may deem relevant or necessary for the application.

Is there a requirement for staff working inside a facility gazetted as a protected place?

Staffs working in a protected (place) facility are required to be security cleared by the Ministry of Home Affairs. Otherwise, they should not be allowed to enter the facility on their own.

How can I have my staff security cleared by the Ministry of Home Affairs?


Application procedures can be found at under the “Useful Info” of this website or you can click here.

Please contact the MOH-Biosafety Branch at moh_biosafety@moh.gov.sg for more details.


Do I need all staffs and visitors to be security cleared before allowing them to enter my protected facility?

No, visitors or short term (1 month or less) staffs are not required to undergo security clearance by the Ministry of Home Affairs as the clearance process may take longer that their intended visit or stay.

For visitors and non-security cleared staffs, Is there any entry requirements that they should follow?

All entries to the protected facility must be recorded with the following information: Name of visitor and accompanying security cleared personnel, date and time of entry and exit and the purpose of the visit.

All visitors and no-security cleared staff must always be accompanied by a security cleared facility staff at all times that the visitor and non-security cleared personnel are in the protected facility.


I have new staffs who were recently cleared by the Ministry of Home Affairs and staff who have resigned or are no longer working in the protected facility. How can I update MOH of these changes?

Any change in your security cleared personnel must be updated in your BiosIS facility registration. You can do this via the “Update Profile” function to make the necessary changes. Please ensure that your list is always up to date.

My facility has been gazetted as a protected place. However, we no longer intend to work with First Schedule Part II and Second Schedule biological agents and Fifth Schedule toxins. Is it possible to have our facility de-gazetted?

A facility no longer working on First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxin can de-register as a protected place. However, they have to ensure that they have no First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxin left in their possession.

The procedure on how to de-gazetted a protected facility can be found in our website under “Useful info”. 

Note that once the facility has been de-gazetted, any future intention of possessing any First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxin will have to undergo a fresh application to be gazetted as a protected place from the Ministry of Home Affairs and will be subject to review and assessment by MOH.



13. Working with Schedule 1 Biological Agents in an Uncertified Facility

I would like to work with a First Schedule biological agent. Although the requirement of the Biological Agents and Toxins Act is such that the First Schedule biological agent must be handled in a certified facility, I am confident that I can handle the biological agent safely in an uncertified facility. Can I make an appeal?

You may submit an appeal for approval to possess First Schedule biological agent in an uncertified facility by submitting the following documents to moh_Biosafety@moh.gov.sg for assessment:

  1. The name of the First Schedule biological agent, and the associated activities on the biological agent; 
  2. The volume of the biological agent that you are going to handle;
  3. The importance of the proposed work (e.g., in public health aspect) and justifications of why or how the work could be carried out safely and securely within the facility
  4. A Biosafety Committee that meeting the requirements stipulated in the Biological Agents and Toxins Act;
  5. Risk assessment carried out on the proposed work (by or endorsed by the Biosafety Committee);
  6. Risk management measures put in place that ensure safety and security of the biological agent and the work; 
  7. Proof that the uncertified facility is gazetted as a protected place under the Infrastructure Protection Act, if the work involves any First Schedule Part II biological agent; 
  8. Review or endorsement from Genetic Modification Advisory Committee (GMAC) if work involves genetic modified microorganism or genetic manipulation activity;
  9. Any other information or supporting documents that may help to support your appeal; and
  10. Any other information that MOH may deem necessary or relevant.

14. Transportation


What are the requirements of a vehicle used in transportation of biological agents/toxins?

Item transportedLabel
Biohazard SignToxic Sign
AgentsToxins
First and Second Schedule Biological Agent
Fifth Schedule toxins
First and Second Schedule biological agents and Fifth Schedule toxin

Third Schedule biological agents

Please refer to the Biological Agents and Toxins Act (Transportation) Regulations for more details.


Does a driver involved in the transportation of biological agents and toxins need to be trained?

A driver transporting First, Second, Third Schedule biological agents and Fifth Schedule toxins must be trained and possesses a valid Hazmat Transport Driver Permit (HTDP - Biologicals).  

For more information on the HTDP, please contact CPT John Soh at 6848-1540. 

For information on the Hazmat Transport Driver Permit Course, you may call the SCDF Customer Service Team at 6794-5502/5606 or send your enquiries by e-mail to scdf_cda@scdf.gov.sg.  


Can a researcher transport a biological agent in his/her own vehicle?

A researcher may use his personal vehicle to transport a biological agent. However, if a First, Second or Third Schedule biological agent, or Fifth Schedule toxin is involved, the researcher must possess a valid Hazardous Materials Transportation Driver Permit (HTDP-Biologicals) and the vehicle must be appropriately labelled.

In no circumstances can public transport and mail be used in the transportation of biological agents or toxins listed under the Schedules of the Biological Agents and Toxins Act.

What should the driver do in the event of an emergency incident (e.g. spillage or leakage) or transport accident?

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 then notify his supervisor and the owner of the biological agent or toxin, SCDF (at 995) and MOH (at 9665-4196) of the incident.

Please refer to Section 47 of the Biological Agents and Toxins Act (BATA) for more information and the Biological Agents and Toxins (Transportation) Regulations.


Is there any requirement for the packaging of the biological agents/toxins prior to transportation?

The biological agent or toxin has to be properly packaged as stipulated in the Biological Agents and Toxins Act (Transportation) Regulations. The name and the 24-hr emergency contact number of the person who is responsible and has the knowledge on the biological agent or toxin, has to be displayed on the outer package containing the biological agent.

What are the unacceptable modes of transportation for transporting a biological agent/toxin?

It is strictly prohibited to transport any of the scheduled biological agent or toxins under the Biological Agents and Toxins Act by mail or public transportation.

See section 47 of the Biological Agents and Toxins Act and the Biological Agents and Toxins (Transportation) Regulations for additional requirements for transportation of First, Second and Third Schedule biological agents, and Fifth Schedule toxins.



15. Transfer of Biological Agents and Toxins Between Facilities Within Singapore


I wish to transfer a biological agent/toxin from my research laboratory to another research laboratory. Can I do that under the Biological Agents and Toxins Act?

The transfer notification only applies to First Schedule Part II, Second and Fifth Schedule biological agents and toxins.

The Biological Agents and Toxins Act requires both the transferor (sender) and transferee (receiver) to have a valid approval to possess First, and Second Schedule biological agent or Fifth Schedule toxin before a transfer can be effected.

As the transferor, you should have an approval to possess the biological agent unless the sample containing the biological agent or toxin resulted from a diagnostic activity.

The transferor also needs to ensure that the transferee has a valid approval to possess the biological agent or toxin before proceeding to transfer the biological agent or toxin.

The transferor is also required to:

  1. Notify MOH of the proposed transfer by creating a notification of transfer via the Biosafety website E-services or by sending an e-mail to moh_biosafety@moh.gov.sg if you are not a registered user of the Biosafety E-services;
  2. Notify the transferee of the estimated time of transfer of the agent;
  3. Provide the carrier of the agent with a 24-hour emergency number of the person who has the knowledge of the hazards and characteristics of the biological agent or toxin being transported; and that

The transferee needs to ensure that the scheduled agents are received within 24 hours from the expected date and time frame as agreed upon by the transferor and transferee. Upon receipt of the biological agent or toxin, the transferee needs to acknowledge the “receipt of biological agent or toxin” in the BiosIS. Otherwise, the transferee shall notify MOH of failure of receipt of the scheduled biological agent or toxin.


A laboratory that has not been granted an approval to possess First and Second biological agent or Fifth Schedule toxin plans to transfer the scheduled biological agents or toxins to a laboratory that has a valid approval to possess the agents or toxin. What do the transferor (sender) and the transferee (receiver) have to do?

For First and Second biological agents and Fifth schedule toxins, the transferor and the transferee should ensure that the sample is packed and transported in accordance to the transport regulations of 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 and time of the transfer and where the biological agent or toxin will be transferred to. The transferor should also send another e-mail to MOH once they have completed the transfer.

The transferee has to log in to BiosIS and create a “Notification of receipt of biological agent/toxin from a non-registered facility”.


What should I do if my consignment failed to arrive at the expected time?

Under the Biological Agents and Toxins Act (BATA), a transferee (receiving facility) 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” is mandated for First Schedule Part II and Second Schedule biological agents and Fifth Schedule toxins. However, you may also notify MOH of any failure of receipt of any other biological agents or toxins listed in the Schedules for public health purposes.


Can I add a new Alternate Administrator to our existing facility’s account?

You can add a new Alternate Administrator via the “Renewal” function.  This can be done at the time when you renew your facility, or any other time when you wants to add the new Alter Administrator. However, it is to note that there is only one alternate administrator per facility.


16. Training Requirements for Staff Working in a Laboratory


What are the training requirements for a biosafety coordinator working in a certified facility or a facility possessing First or Second Schedule biological agents or Fifth Schedule toxins, or large scale production of Third Schedule biological agents?

All biosafety coordinators working in such a facility are required to attend a structured course and pass the examination given by an MOH-Approved Training Provider.

Can I be a biosafety coordinator if I have attended other biosafety related courses other than the course offered by the MOH-Approved Training Provider?

Biosafety Coordinators are required to have attended the structured training course and qualified the examination conducted by the MOH-Approved Training Provider.

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 proof of participation to moh_biosafety@moh.gov.sg 
MOH will review the application on a case to case basis. 


What are the training requirements for staff working in a certified facility?

Training for Biosafety Level 3 Facility (BSL3) staff is mandated under the Biological Agents and Toxins Act. Such training can be conducted in-house or by experienced external trainers.

The facility should maintain proper training records of their staff.  


What are the training requirements for a biosafety coordinator working in an uncertified facility?

The Biological Agents and Toxins Act (BATA) only stipulates training requirements for biosafety coordinator working in facility (certified or un-certified) possessing First or Second biological agents, Fifth Schedule toxins or large scale production of Third Schedule biological agents (see answer in question 1).

Personnel (including biosafety coordinator) from facilities that do not possess the scheduled biological agent or toxins mentioned above, although not mandated, are encouraged to attend such training courses.


What are the training requirements for staff working in an uncertified facility?

The Biological Agents and Toxins Act (BATA) only stipulates training requirements for biosafety coordinator working in facility (certified or non-certified) possessing First or Second Schedule biological agents or Fifth Schedule toxins or large scale production of Third Schedule biological agents.

Training of staff from facilities (certified or un-certified), possessing First or, Second Schedule biological agents or Fifth Schedule toxins or large scale production of Third Schedule biological agent is mandated in the Act. However, their training can be conducted in-house or externally by experienced trainers.



17. Training Providers


What is an MOH-Approved Training Provider?

The MOH-Approved Training Providers are entities that are registered and recognized by the MOH as having the relevant resources to conduct training courses for biosafety coordinators required under the Biological Agents and Toxins Act.

What are the requirements to be an MOH-Approved Training Provider?

The requirements may include:

  1. The company must have a structural biosafety training course in place, which covers both theoretical and practical sessions, and means to verify the competency of the trainees;
  2. The lead trainer must have significant experience in direct laboratory safety management and in conducting biological safety courses; and
  3. Other trainers’ with relevant experience and qualification in the related field.

I am interested to be endorsed as an MOH-Approved Training Provider. How should I apply?

You can apply to be an MOH-ATP online via the Biosafety Website E-services. Alternatively, you may also download the application form (under “Forms” in the Biosafety Website) and send via e-mail to moh_biosafety@moh.gov.sg

You also need to submit the following to MOH for assessment:

  1. Brief write-up on the organization/company applying to be an MOH-Approved Training Provider which will include the organizations background, experience in conducting training courses and any accreditation received;
  2. Course syllabus for theoretical and practical sessions – includes the topics and course outline, duration of each session and examinations to be conducted; 
  3. Proposed course notes and examinations or competency testing;
  4. Supporting documents for the lead trainer and all other trainers, which may include their qualifications, curriculum vitae, academic or professional certificates, testimonials, etc.
  5. Any other information or documents that may support the application; and
  6. Any other information that may require by MOH.
The explanatory notes on the requirements for the application of MOH-Approved Training Provider can be downloaded from the Biosafety Website under “Forms”.

I am currently an MOH-Approved Training Provider. Am I required to renew my ATP status?

You need to submit a renewal application to MOH to renew your Approved Training Provider status once it expires.

You are also responsible to update MOH whenever there are changes to the status of the company, the trainers or the course content. Such changes will be subjected to MOH’s assessment and approval. Failing to do so may result in the revocation of the Approved Training Provider status. 



18. Biosafety IT System


Why is the BiosIS prompting me to change password every 90 days?

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.

The system has locked me out of the BiosIS, What should I do next?

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.


What should I do upon reactivation of my account?

Once reactivated, you are required to login to the BiosIS.

After successful login, you will be prompted to change your password.


What are the responsibilities/functionalities that can be exercised by the Facility Administrator, Alternate Administrator, Facility Officer, Approved Training Provider and Approved Facility Certifier?

Table A. Facility Personnel

Function/ RolesFacility AdministratorAlternate AdministratorFacility Officer
Facility AdministratorInactivate User
Maintain Alternate
Update profile
Maintain profile
Reset/Unlock Password of other facility officers
Transfer My Facility
Switch Facility
Facility RegistrationRenew Certificate
Register New facility
Cancel Registration
Withdrawal of Application to Register
Facility ApplicationApplication to Possess for First-time Use of Agent
Application for Special Approval to Handle
Application for Approval to Produce
NotificationTransfer
Disposal
Export
Receipt of Biological Agent/Toxin from an Non-registeredFacility
Acknowledge Notification of Receipt
Incident ReportReport Incident
View Incident Report
Work BenchMy Task
My application Status
Other Application Status
My Draft
EnquiryInventory List

 

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

Function/ RolesApproved Facility Certifier
AFC AdminMaintain Profile
Cancellation
Renew/Update/reassessment
Work BenchMy Task
My application Status
Other Application Status
My Draft

 

Table C. MOH-Approved Training Provider

Function/ RolesApproved Training Provider
ATP AdminMaintain Profile
Renewal
Cancellation of Application
Withdrawal of application
Update Course profile
Work BenchMy Task
My application Status
Other Application Status
My Draft

 

Table D. Public

Function/ RolesPublic
RegistrationRegister as Facility
Apply as New Facility Officer
Apply for Approved Training Provider
Apply for Approved Training Provider

What is the procedure for changing the facility administrator?

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.

You are also required to send an official letter or e-mail moh_biosafety@moh.gov.sg informing MOH at least 2 weeks before the change in facility administrator.  The system will automatically generate an e-mail notification to the new facility administrator once your submission has been approved/acknowledge by MOH.


19. Glossary of Terms


Glossary of Terms

AFCApproved Facility Certifier
ATPApproved training provider
AVSAnimal and Veterinary Service
BABiological Agent
BATABiological Agents and Toxins Act
BSLBiosafety Level
BTBioterrorism
GMACGenetic Modification Advisory Committee
GMOGenetically Modified Organism
HTDPHazardous Materials Transportation Driver Permit
HSAHealth Science Authority
IATAInternational Air Transport Association
IBCInstitutional Biosafety Committee
IDAInfectious Diseases Act
MOHMinistry of Health
NBCNational Biosafety Committee
OBSLOnline Business Licensing Service
PAPPProtected Areas and Protected Places
TWCTechnical Working Committee
WHOWorld Health Organization

Back to Top