Frequently Asked Questions (FAQs)

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

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

The Biological Agents and Toxins Act can be accessed by:

• downloading from the Singapore Statutes Online;

• subscribing to the LawNet service provided by the Singapore Academy of Law;

• purchasing from Singapore National Printers Corporation Ltd (SNP); or

• downloading from the Biosafety Website.

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.

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

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

The 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.

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 [PDF, 29.5 KB] 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 [PDF, 26.5 KB] 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:

   • any person lawfully manufacturing, supplying, selling or dispensing the finished cosmetic or medicinal product;

   • any registered medical practitioner using the finished cosmetic or medicinal product in the course of treating another person;

   • any person using the finished cosmetic or medicinal product for the cosmetic or medical purposes for which it is intended.

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.

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 34/2006, BATA Proficiency Testing Regulations S28/2008 [PDF, 27.8 KB] and the BATA Exemption Regulations S451/2009 [PDF, 26.5 KB].

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.

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 [PDF, 465 KB].

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 [PDF, 465 KB] from the Biosafety Website before submitting any application for import as MOH updates this list from time to time.

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.

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.

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 [PDF, 110 KB].

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 [PDF, 123 KB].

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

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.

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-

   • conducted risk assessment on the activities;

   • devised appropriate measures to manage the risk;

   • 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.

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 info@gmac.sg or visit the GMAC Website.

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.

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

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.

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 [PDF, 465 KB], a valid certified facility and gazetted protected place under the Infrastructure Protection Act for First Schedule Part II and Second Schedule biological agents [PDF, 465 KB] or a gazetted protected place under the Infrastructure Protection Act for Fifth Schedule Toxins [PDF, 465 KB].

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

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.

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.

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.

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.

Any HIV lentiviral vector system which has at least 2 of the following features will be classified under the Fourth Schedule:

1. the U3 region of the 3’LTR in the transfer vector is absent or altered, which results in a stable self-inactivating (SIN) configuration;

2. the HIV genes for packaging function are splitto a minimum of 2 packaging plasmids(excluding the env plasmid);

3. the vpr, vpu, vif and nef genes are either absentor altered to be non-functional;

4. the vector system requires minimally4-recombination to achieve ReplicationCompetent Lentivirus (RCL).

A HIV lentiviral vector system that does not satisfy the above given definition, is likely to fall under the First Schedule.

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:

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.

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.

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

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

For 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.

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.

Large-scale production is prohibited for 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.

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.

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.

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.

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.

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

Risk assessments are conducted before the commencement of any work 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, equipment or workplace conditions / layout.

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.

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.

The Guidelines on Laboratory/Work Risk Assessment [PDF, 90.5 KB] and a sample risk assessment template[XLSX, 48.5KB] can be found in our website under “Useful Info”. You may also refer to the MOM website for the guidelines [PDF, 90.5 KB].

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

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

For biological agents not in the List of Biological Agents and Toxins [PDF, 465 KB] in the Biological Agents and Toxins Act (BATA), you may send an inquiry to moh_biosafety@moh.gov.sg so that we can advise you whether you need to get an import permit for your item.

The application for import permit is done online at Singapore Customs 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.

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.

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

Import Specific Product 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.

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.

For zoonotic agents, Importers are required to obtain import permit from both AVS and 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 [PDF, 465 KB] with the MOH product code and the corresponding AVS product code for zoonotics can be found on the Biosafety website.

In general, an import permit for test kits is not required under the Biological Agents and Toxins Act (BATA). The reason being most controls in a diagnostic kit have been inactivated. However, if it is known that the test 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.

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.

Please refer to the MOH guidelines for the Importation and Transhipment of Human Pathogens and Toxins [PDF, 123 KB].

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.

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

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.

Please refer to the MOH Guidelines on Import and Transhipment of Biological Agents and Toxins [PDF, 123 KB], in the Biosafety Website.

The HALP-Biosafety is an e-services portal for facility operators to:

• Register with MOH to obtain the approvals related to biological agents or toxins.

• Apply to handle Fifth Schedule toxins for exempted activities.

• Apply to retain/handle materials positive or potentially positive for sabin poliovirus.

• Register with MOH to be an MOH-Approved Facility Certification Body and Certifier to conduct facility certification or audit required under the BATA.

Firstly, you need to ensure that you have a valid CorpPass access to HALP. Please contact your company's CorpPass Administrator to enable your CorpPass access to HALP.

If you have a valid CorpPass access to HALP but cannot access the system, please contact your company's Master Admin for HALP-Biosafety to create or activate your account.

For a change of facility administrator, the Master Admin has to:

1. Create a HALP account for the incoming facility administrator (if he/she is not an existing user) and assign him/her as the incoming facility administrator.

2. ndicate the effective start date of the incoming facility administrator and the effective end date of the existing facility administrator's facility assignment.
   Note: The effective start date of the incoming facility administrator must be after the effective end date indicated for the existing facility administrator.

3. Once the above are completed, update the Facility Registration to reflect the changes to the facility administrator.

A User Guide is currently under development. In the meantime, please refer to the training slides for basic information on the use of HALP-Biosafety.

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.

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.sg 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.

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.

In the event of a failure to receive a First Schedule or Second Schedule biological agents or Fifth Schedule toxins, notify MOH immediately at 9665 4196, and submit a Notification of Failure to Receive in HALP-Biosafety.

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.

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”.

“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.

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.

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.

A certified facility is a high or maximum containment facility that has been certified by a MOH-Approved Facility Certifying Body and Certifier (MOH-AFCB and MOH-AFC) to meet the biorisk (biosafety and biosecurity) management requirements to handle high-risk (i.e. First Schedule and Second Schedule) biological agents.

Facilities that wish to handle First and Second Schedule biological agents shall be certified by an MOH-AFCB and MOH-AFCs, as certified facility 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.

A facility that is gazetted as a protected place under the Infrastructure Protection Act (IPA) and meeting all the requirements of the Physical Security Working Group (PSWG) [PDF, 423 KB], are required for work involving First Schedule Part 2 or Second Schedule biological agents or Fifth Schedule toxins.

The facility shall submit an application to be gazetted as a protected place to the Biosafety Branch, MOH stating the justification for the request.

If MOH is satisfied with the justification, MOH will issue a letter of support to the applicant. The applicant can then submit his/her application to be gazetted as a protected place to the relevant regulatory authority together with the letter of support from MOH.

Details of the procedures can be found in the Application for Gazette or De-gazette as a protected place [PDF, 228 KB].

To register with MOH as a certified facility, submit your application via the Healthcare Application and Licensing Portal Biosafety Module (HALP-Biosafety) with the following information and/or supporting documents:

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

1. Facility Administrative Oversight plan.

2. Facility layout and air-conditioning and mechanical ventilation (ACMV) schematics.

3. Facility biorisk (biosafety and biosecurity) management manual.

4. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

5. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

6. List of personnel working in the facility.

7. Certification reports and supporting documents.

8. Approval letters from the relevant authorities (e.g. Public Utilities Board’s written approval for discharge of trade effluent into public sewage).

9. Any other documents or information that MOH may deem relevant or necessary for the application.

Supporting documents required for the registration of a “protected” facility include:

1. Gazette documentation related to protected place status under the IPA.

2. Completed PSWG checklist.

3. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

4. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

5. List of vetted personnel working in the facility.

6. Any other documents or information that MOH may deem relevant or necessary for the application.

Supporting documents required for the registration/renewal of a “protected” certified facility include:

1. Facility Administrative Oversight plan.

2. Facility layout and ACMV schematic.

3. Facility biorisk (biosafety and biosecurity) management manual.

4. Gazette documentation related to protected place status under the IPA.

5. Completed PSWG checklist.

6. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

7. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

8. List of vetted personnel working in the facility.

9. Certification reports and supporting documents.

10. Approval letters from the relevant authorities (e.g. Public Utilities Board’s written approval for discharge of trade effluent into public sewage).

11. Any other documents or information that MOH may deem relevant or necessary for the application.

Yes, the following documents are to be used for the certification process, whenever relevant.

1. The MOH Laboratory Certification Checklist [PDF, 201 KB] and/or the Singapore Standard (SS696:2023) Specification for High Containment Facility, for Biosafety Level 3 (BSL3) facility; or

2. The National Biosafety Standard for Maximum Containment Facility, for biosafety level 4 (BSL4) facility.

   Both the MOH Laboratory Certification Checklist and the National Biosafety Standard for Maximum Containment Facility can be downloaded from the MOH Biosafety website. While the Singapore Standard (SS696:2023) Specification for High Containment Facility can be purchased through the Singapore Standards website.

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 requirements by the Animal and Veterinary Service (AVS), under the National Parks Board (NParks) may also apply. ou are advised to contact AVS directly for enquiries related to their requirements.

MOH only requires a re-certification to be conducted annually by the MOH-Approved Facility Certifying Body and Certifiers (MOH-AFCB and MOH-AFCs) if your facility intends to possess First or Second Schedule biological agents. The facility operator shall decide if pre-certification tests is necessary.

Positive aspects of shutting down the facility for recertification include the following:

1. Allows all personnel to access the facility safely without the need to don personal protective equipment (PPE). Personnel accessing the facility at this time may include certifiers, controlling authorities, facility maintenance crews who are non-laboratory personnel. Such personnel can carry out their respective duties freely and safely without being limited by the PPE.

2. It allows more robust and extensive testing and challenging of the facility equipment, engineering and/or ventilation systems without having to worry about possible containment breach and adverse impact to the environment and the surrounding due to test or system failure.

3. Facility can take the opportunity to conduct housekeeping, perform in-house maintenance, servicing, repairing or replacing of equipment, engineering or ventilation parts, and conduct on-site staff training on emergency responses.

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

*Shut down includes stopping all laboratory activities, storage of all biological agents and toxins in a safe and secure manner, and full decontamination of the facility.

If you have decided to carry out re-certification of your facility without shutting it down, you shall work with your biosafety committee to conduct a comprehensive risk assessment and put in place proper measures to protect the safety and health of all personnel who may participate in the maintenance and re-certification of the facility. These shall be approved by your biosafety committee and the facility operator; and agreed upon by the service crew and the appointed MOH-AFCB and MOH-AFCs. MOH Biosafety Branch shall be notified of the decision via moh_biosafety@moh.gov.sg at least 1.5 months ahead of the recertification so that proper arrangement can be made.

An uncertified facility is a typical Biosafety Level 2 (BSL2) facility that has implemented enhanced biorisk (biosafety and biosecurity) management measures and has received approval from MOH to handle Fifth Schedule toxins, Third Schedule biological agents and/or perform low risk activities associated with materials positive for First Schedule biological agents.

Yes, an uncertified facility is require to undergo compliance (biosafety and biosecurity) verification inspection or audit by the Ministry of Health and/or an MOH-Approved Facility Certifying Body and Certifiers (MOH-AFCB and MOH-AFCs) prior to being granted an approval to possess materials positive for First Schedule biological agent or Fifth Schedule toxin or an approval to large-scale produce a Third Schedule biological agent. Thereafter, the facility is subject to biennial or triennial renewal inspection or audit based on MOH’s risk assessment.

Uncertified facility applying for approval to possess First Schedule Part 2 biological agent or Fifth Schedule toxin is also required to be gazetted as a protected place under the Infrastructure Protection Act (IPA) and meet all the Physical Security Working Group requirements [PDF, 423 KB].

Please refer to Q2 under Certified Facility for the process to have your facility gazetted as a protected place under the Infrastructure Protection Act (IPA).

To register with MOH as an uncertified facility, submit your application via Healthcare Application and Licensing Portal Biosafety Module (HALP-Biosafety), with the following information and/or supporting:

Supporting information and/or documents required for the registration/renewal of an uncertified facility:

1. Facility Administrative Oversight plan.

2. Schematic layout of facility.

3. Biosafety level of the facility.

4. Type of approval (possession and/or large-scale production), and the name of the biological agent.

5. Characteristics of the biological agent or the materials that will be handled.

6. List of activities to be carried out on the biological agent or the materials.

7. Justification that the biological agent or the materials can be safely handled in the facility.

8. Facility biorisk (biosafety and biosecurity) management manual.

9. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

10. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

11. List of personnel working in the facility.

12. Biorisk management inspection or audit report or supporting documents.

13. Approval letters from the relevant authorities, where applicable.

14. Any other documents or information that MOH may deem relevant or necessary for the application.

Supporting documents required for the registration/renewal of a “protected” uncertified facility:

1. Facility Administrative Oversight plan.

2. Schematic layout of facility.

3. Biosafety level of the facility.

4. Type of approval (possession or large-scale production), and the name of the biological agent or toxin.

5. Characteristics of the biological agent or toxin or the materials that will be handled.

6. List of activities to be carried out on the biological agent or toxin or the materials.

7. Justification that the biological agent or the materials can be safely handled in the facility.

8. Facility biorisk (biosafety and biosecurity) management manual.

9. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

10. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

11. List of vetted personnel working in the facility.

12. Biorisk management inspection or audit report or supporting documents.

13. Gazette documentation related to protected place status under the IPA.

14. Completed PSWG checklist.

15. Approval letters from the relevant authorities, where applicable.

16. Any other documents or information that MOH may deem relevant or necessary for the application.

A biomanufacturing facility generally refers to a facility involved in the use of large quantities of cells or other living microorganisms to produce commercially viable products such as vaccines, monoclonal antibodies, and proteins for medicinal use.

A biomanufacturing facility that wants to possess any First Schedule biological agent or Fifth Schedule toxin or perform large-scale production of First or Third Schedule biological agent is required to register with MOH under the BATA.

If your facility is required to comply with Good Manufacturing Practices (GMP), you shall register your facility as a biomanufacturing facility. Otherwise, you can register it as a certified facility or an uncertified facility depending on the Schedule of the biological agent that will be produced in large-scale. Refer to the summary table below for the requirements.

Yes, a biomanufacturing facility is require to undergo compliance (biosafety and biosecurity) verification inspection or audit by the Ministry of Health and/or an MOH-Approved Facility Certifying Body and Certifiers (MOH-AFCB and MOH-AFCs) prior to being granted an approval to possess a First Schedule biological agent or an approval to large-scale produce a First or Third Schedule biological agent. Thereafter, the facility is subject to biennial or triennial renewal inspection or audit based on MOH’s risk assessment.

A biomanufacturing facility applying for approval to possess and/or approval to large-scale produce a First Schedule Part 2 biological agent is also required to be gazetted as a protected place under the Infrastructure Protection Act (IPA) and to meet all the Physical Security Working Group requirements [PDF, 423 KB].

To register with MOH as a biomanufacturing facility, submit your application via Healthcare Application and Licensing Portal Biosafety Module (HALP-Biosafety), with the following information and/or supporting:

Supporting information and/or documents required for the registration/renewal of a biomanufacturing facility:

1. Facility Administrative Oversight plan.

2. Facility layout and air-conditioning and mechanical ventilation (ACMV) schematics.

3. Type of approval (possession and/or large-scale production), and the name of the biological agents.

4. Characteristics and risk group of the biological agents or the materials.

5. List of activities to be carried out on the biological agents or the materials.

6. Facility biorisk (biosafety and biosecurity) management manual.

7. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

8. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

9. List of personnel working in the facility.

10. Biorisk management inspection or audit report or supporting documents.

11. Approval letters from the relevant authorities, where applicable.

12. Any other documents or information that MOH may deem relevant or necessary for the application.

Supporting documents required for the registration/renewal of a “protected” biomanufacturing facility include:

1. Facility Administrative Oversight plan.

2. Facility layout and ACMV schematics.

3. Type of approval (possession or large-scale production), and the name of the biological agents or toxins.

4. Characteristics and risk group of the biological agents or toxins or the materials.

5. List of activities to be carried out on the biological agents or toxins or the materials.

6. Facility biorisk (biosafety and biosecurity) management manual.

7. Biosafety committee and biosafety coordinator meeting the requirements in the BATA.

8. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.

9. List of personnel working in the facility.

10. Biorisk management inspection or audit report or supporting documents.

11. Gazette documentation related to protected place status under the IPA.

12. Completed PSWG checklist.

13. Approval letters from the relevant authorities, where applicable.

14. Any other documents or information that MOH may deem relevant or necessary for the application.

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MOH-AFCB is an independent company that is approved by the MOH to provide biocontainment facility certification service. While MOH-AFC is an individual certifier working or engaged by a MOH-AFCB, and who is approved by MOH as having the necessary experience and is credible in certifying biocontainment facilities.

Detailed requirements for MOH-AFCB and MOH-AFC can be found in MOH Approved Facility Certifying Body and Facility Certifier.

You may apply online via the Biosafety E-services portal. Alternatively, you may send an e-mail to moh_biosafety@moh.gov.sg indicating your company interest in becoming an MOH-AFCB with the list of the facility certifiers. Documents or information required for the submission can be found in MOH Approved Facility Certifying Body and Facility Certifier.

The list of MOH-AFCB and MOH-AFC can be found here [PDF, 39.7 KB].

If you intend to engage the service of a facility certifying body and/or facility certifiers that is/who are not in the MOH approved list, please write or send an e-mail to moh_biosafety@moh.gov.sg to provide more information on the company and the certifiers. MOH will invite the facility certifier to apply to be MOH-AFCB and MOH-AFCs. Once the applications are approved, the AFCB and AFCs will be included in the list of MOH-AFCB and MOH-AFCs [PDF, 39.7 KB]. Upon that, you can engage their service.

New team members may be added to the certification team but this will be subject to MOH's review and approval. The MOH-AFCB status may be suspended pending the approval of the new certification team members.

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

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.

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 relevant regulatory authority.

1. Singapore Government Gazette published announcement;

2. List of vetted personnel working in the facility;

3. Completed Checklist for Premises Storing and/or Handling Security Sensitive Materials; and

4. Any other document or information that MOH may deem relevant or necessary for the application.

Staff working in a protected (place) facility are required to be security cleared by the relevant regulatory authority.

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.

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

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 when the visitor and non-security cleared personnel are in the protected facility.

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.

A facility no longer working on First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxin can de-gazette as a protected place. However, prior to degazetting the facility, facility operatory must ensure that there is no First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxins left or in possession in the facility.

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 toxins will have to undergo a fresh application to be gazetted as a protected place from the relevant regulatory authority and will be subjected to review and assessment by MOH.

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 nature of the First Schedule biological agent;

3. the volume of the biological agent that you are going to handle;

4. 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

5. a biosafety committee and biosafety coordinator meeting the requirements stipulated in the Biological Agents and Toxins Act;

6. risk assessment carried out on the proposed work (by or endorsed by the Biosafety Committee);

7. risk management measures put in place that ensure safety and security of the biological agent and the work;

8. 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;

9. review or endorsement from Genetic Modification Advisory Committee (GMAC) if work involves genetic modified microorganism or genetic manipulation activity;

10. any other information or supporting documents that may help to support your appeal; and

11. any other information that MOH may deem necessary or relevant.

Please refer to the Biological Agents and Toxins Act (Transportation) Regulations [PDF, 110 KB] for more details.

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 information on the Hazmat Transport Driver Permit Course [PDF, 23.3 KB], 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.

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 any Schedules of the Biological Agents and Toxins Act, including inactivated biological agents.

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 and MOH 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.

The biological agent or toxin has to be properly packaged as stipulated in the Biological Agents and Toxins Act (Transportation) Regulations [PDF, 110 KB]. 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.

It is strictly prohibited to transport any of the scheduled biological agent or toxins, or inactivated biological agent 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 [PDF, 110 KB] for additional requirements for transportation of First, Second and Third Schedule biological agents, and Fifth Schedule toxins.

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 shall 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 HALP-Biosafety 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.

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”.

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 any of the BATA Schedules for public health purposes.

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.

Persons who intend to take on the role of a Biosafety Coordinator will need to complete the Professional Biorisk Management Course (PBRMC) which will be offered by the National University of Singapore Yong Loo Lin School of Medicine (BSL-3 Core Facility). For information regarding PBRMC, please contact Course Administrator (medbx260@nus.edu.sg) or visit the course page.

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.

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.

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.

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).

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.