Only allowing the most experienced and well trained staff to perform research with biohazards
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1. General InformationExpand All | Collapse All 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:
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 . Which agency controls the export of biological agents (BAs) and toxins?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:
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 -
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?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.
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:
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 . 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 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; 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 . Our officers will respond to you within 5 working days. 2. Approvals & PermitsExpand All | Collapse All 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?
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 -
Does the same procedure apply for approvals and permits of genetically modified microorganism?3. Possession
Expand All | Collapse All 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:
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
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?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 be altered by genetic modification. As such, HIV lentiviral vectors (HIV-LV) are divided 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 classified as Fourth Schedule biological agents under the BATA. HIV-LVs with risk higher than risk group 2, remain as First Schedule Part I biological agents. The use of HIV-LV is subject to the BATA requirements that correspond to their respective Schedules, unless otherwise specified. You may refer to the next question for the description of HIV-LV that fall under the Fourth Schedule. How do I know if a HIV lentiviral vector system falls under the Fourth Schedule?Any HIV lentiviral vector system which has at least 2 of the following features will be classified under the Fourth Schedule :
A HIV lentiviral vector system that does not satisfy the above given definition, is likely to fall under the First Schedule. 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 the criteria of a Fourth Schedule lentiviral vector system under the BATA. What should I do now?In cases 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 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:
MOH will review the information provided and will advise you accordingly. 4. Special Approval to HandleExpand All | Collapse All 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:
5. Large Scale ProductionExpand All | Collapse All 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:
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 AgentsExpand All | Collapse All 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:
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 for consideration:
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 AssessmentExpand All | Collapse All 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 the commencement of any work and thereafter, upon any of the conditions below, whichever is earlier:
This is to ensure that the measures that were put in place previously are still effective and to assess if there is any need to make changes to the existing measures or implement additional measures. May I know who should conduct the risk assessment?The Act stipulates that the biosafety committee (comprised of members 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 is also responsible for devising measures, formulating policies, programmes, codes of practices to manage the risks that may arise from the proposed activity and ensuring that the proposed activity can be carried out safely. Commencement of activity is not allowed unless the biosafety committee has determined that the proposed activity can be carried out safely and securely at the facility. Are there any guidelines on how to perform a risk assessment?8. Import / Transhipment PermitsExpand All | Collapse All 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?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:
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:
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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?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. NotificationExpand All | Collapse All What are the types of notification in the Biosafety IT System (BiosIS)?The following are the notifications that can be done using the BiosIS:
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 . 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 to 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:
Alternatively, you may send an e-mail to 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:
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 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. Subsequent or final report must be submitted to MOH via e-mail to include the details above. 10. Facility CertificationExpand All | Collapse All 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. A 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:
Supporting documents required for registering a “protected” facility include:
Supporting documents required for registering/renewing of a “protected” certified facility include:
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 . 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:
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 for the arrangements on the re-certification, at least 1 month ahead of the recertification. 11. Facility CertifiersExpand All | Collapse All 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;
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 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 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 here. 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 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 PlaceExpand All | Collapse All 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?
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?
Please contact the MOH-Biosafety Branch at 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 FacilityExpand All | Collapse All 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 for assessment:
14. TransportationExpand All | Collapse All What are the requirements of a vehicle used in transportation of biological agents/toxins?
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 . 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?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?15. Transfer of Biological Agents and Toxins Between Facilities Within SingaporeExpand All | Collapse All 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:
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 , 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 LaboratoryExpand All | Collapse All 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 examinations given by an MOH-Approved Training Provider. The Biosafety Management Course which was offered by the Asia-Pacific Biosafety Association (A-PBA) has been discontinued. Moving forward, persons who intend to take on the role of a Biosafety Coordinator will need to complete the Biosafety Professional Programme (BPP) which will be offered by the National University of Singapore School of Continuing and Lifelong Education. For information regarding BPP, please contact Cheryl () and Jessie () from NUS SCALE. 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 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. Biosafety IT SystemExpand All | Collapse All 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 . 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
Table B. MOH-Approved Facility Certifier (MOH-AFC)
Table C. MOH-Approved Training Provider
Table D. Public
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 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. 18. Glossary of TermsExpand All | Collapse All Glossary of Terms
Back to Top How long should Researchers wash their hands with soap and water after handling biohazards?Scrub your hands and wrists vigorously for at least 20-30 seconds.
What is the lowest BSL that requires all manipulations of biohazards to take place within biological safety cabinets or other primary containment enclosures?BSL-1 is the lowest security level for handling biological material.
Which of the following is a good work practice when centrifuging biohazards quizlet?Which of the following is a good work practice when centrifuging biohazards? Decontaminate the exterior of tubes, safety buckets, and/or sealed rotors before removal from the biosafety cabinet.
What is the first step in the immediate aftermath of an exposure to a biohazard involving a percutaneous injury?Wash exposed skin, cuts, and needlestick injuries thoroughly with soap and water. If you have been splashed by potentially infectious fluids around the eyes, nose or mouth, flush the area with water. Immediately report the incident to emergency medical services.
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