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Frequently Asked Questions (FAQs)

Find answers to commonly asked questions related to BATA.

Last updated 25 November 2024

General information

1. What does the Biological Agents and Toxins Act regulate?
2. When did the Biological Agents And Toxins Act enforced?
3. How can I get the latest version of the Biological Agents And Toxins Act and its regulations?
4. Does the Biological Agents And Toxins Act regulate the export of biological agents, inactivated biological agents and toxins listed in the schedules?
5. Which agency controls the export of biological agents (BAs) and toxins?
6. Who is covered by the Biological Agents And Toxins Act (BATA)?
7. 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?
8. What is the definition of "diagnosis" in the Biological Agents And Toxins Act (BATA)?
9. 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?
10. 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?
11. Why is the First Schedule subdivided into 2 parts? Are there any differences in the requirements for working with such biological agents?
12. 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?
13. 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?
14. 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?
15. 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?
16. 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.
17. If I have further inquiries on the Biological Agents And Toxins Act, to whom should I direct my enquiries to?

Approvals and permits

1. 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?
2. How do I apply for approvals and permits?
3. 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?
4. Does the same procedure apply for approvals and permits of genetically modified microorganism?

Possession

1. What is an approval to possess?
2. What kind of information must be submitted in an application for an approval to possess a Second Schedule biological agent?
3. What are the requirements for working on a Fifth Schedule toxin?
4. Does the approval to possess have an expiry date?
5. 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?
6. 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?
7. 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?
8. 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?
9. How do I know if a HIV lentiviral vector system falls under the Fourth Schedule?
10. 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?

Special approval to handle

1. What is a special approval to handle?

Large scale production

1. What is an approval to produce?
2. What is large-scale production?
3. Which should I apply first, approval to produce or an approval to possess?
4. Does the approval to produce have an expiry date?
5. Is large-scale production prohibited for any of the schedules?

Inactivation of First and Second Schedule biological agents

1. Can an uncertified facility work with an inactivated (First or Second Schedule) biological agents?
2. What are the requirements to be able to perform an inactivation of First or Second Schedule biological agents in a local facility?
3. 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?
4. Do laboratories that intend to handle inactivated First or Second Schedule biological agents need to apply for approval to possess the biological agent?
5. Can MOH provide a list of approved methods of inactivation of biological agents?

Risk assessment

1. What does the BATA state regarding risk assessment?
2. When are we supposed to conduct risk assessment?
3. May I know who should conduct the risk assessment?
4. Are there any guidelines on how to perform a risk assessment?

Import/Transhipment permits

1. Do all the biological agents and toxins listed in the schedules of the Biological Agents And Toxins Act (BATA) require permits to be imported?
2. 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?
3. I am from a research laboratory. How can we apply for an import permit?
4. Who is responsible for obtaining an import permit? Is it the importer or the courier service provider?
5. 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?
6. What is an Import Specific Product (ISP) code?
7. How long is the validity of the Import Specific Product (ISP) code?
8. 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?
9. Is an import permit required for importation of diagnostic test kits?
10. What are the types of packaging that I must follow for importation of biological agents and toxins?
11. Where can I get more information on import permit?
12. Do all the biological agents and toxins listed in the schedules of the Biological Agents And Toxins Act require transhipment permits?
13. How should I apply for transhipment permit?
14. Where can I get more information on transhipment permit?

Healthcare Application and Licensing Portal (HALP)

1. What is the Healthcare Application And Licensing Portal biosafety module (HALP-Biosafety)
2. I am not able to access HALP-Biosafety, what should I do?
3. What are the functions available to the master administrator (with and without facility assigned), facility administrator, alternative administrator and facility officer?
4. What is the procedure for changing the facility administrator?
5. Is there a guidance on how to navigate and use HALP-Biosafety?

Notification

1. What are the types of notification in the Biosafety IT system (BiosIS)?
2. Who needs to submit a notification of transfer?
3. What is considered “failure of receipt”?
4. How should I submit a Notification of Failure to Receive?
5. What incidents are required to be notifiable under the BATA?
6. What are the types of incident notification that can be submitted in BiosIS?
7. What is the difference between “notification of disposal/inactivation” and “notification of consume”?
8. I am unable to submit my incident notification via BiosIS. What should I do?
9. I have submitted my incident report in the BiosIS. What should I do next?

Certified Facility

1. What is a certified facility?
2. What kind of facility needs to undergo certification as stipulated in the Biological Agents And Toxins Act?
3. 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?
4. What are the supporting documents required for a new registration or renewal of registration of a certified facility or protected place with MOH?
5. Is there a checklist that MOH-Approved Facility Certifiers will use during the certification process?
6. 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?
7. 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?
8. Do I need to shut-down* my facility for the re-certification?
9. What should I do if I decided not to shut-down my facility for re-certification?

Uncertified Facility

1. What is an uncertified facility?
2. Is an uncertified facility required to undergo certification or inspection?
3. I would like to apply to be an uncertified facility to handle to Fifth Schedule toxins, Third Schedule biological agents or to perform low risk activities associated with materials positive for First Schedule biological agents. How should I proceed to get my facility ready for the work and to register with MOH?

Biomanufacturing Facility

1. What is a biomanufacturing facility?
2. Is a biomanufacturing facility regulated under the Biological Agents and Toxins Act (BATA), and is it required to register with MOH?
3. My facility is handling large-scale production of First or Third Schedule biological agents. Should I register my facility as a biomanufacturing facility, a certified or uncertified facility handling large-scale production of biological agent?
4. Is a biomanufacturing facility required to undergo certification or inspection?
5. I would like to apply to be a biomanufacturing facility to produce (in large-scale) First and/or Third Schedule biological agents. How should I proceed to get my facility ready for the work and to register with MOH?

Facility Certifiers

1. What is a MOH-Approved Facility Certifying Body (MOH-AFCB) and what is MOH-Approved Facility Certifier (MOH-AFC)?
2. What are the criteria or requirements for being a MOH-Approved Facility Certifying Body (MOH-AFCB) and MOH-Approved Facility Certifier (MOH-AFC)?
3. How can I apply to be an MOH-Approved Facility Certifying Body (MOH-AFCB) or MOH-Approved Facility Certifier (MOH-AFC)?
4. Where can I obtain a list of MOH-Approved Facility Certifying Body (MOH-AFCB) and the Associated Certifiers (MOH-AFC) For Certification Of Facility?
5. Can I engage the service of a facility certifier that is not on the list of the MOH-Approved Facility Certifying Body (MOH-AFCB) or MOH-Approved Facility Certifier (MOH-AFC)?
6. Can an existing MOH-Approved Facility Certifying Body (MOH-AFCB) add new members to the certification team?

Protected Place

1. I was informed that I need to have my facility gazetted as a protected place. What is a protected place?
2. What schedule of biological agents requires a facility that is gazetted as a protected place?
3. 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 gazette as a protected place under the infrastructure protection act?
4. 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?
5. Is there any requirement for staff working inside a facility gazetted as a protected place?
6. How can I have my staff security cleared by regulatory vetting authority?
7. Do I need all staffs and visitors to be security cleared before allowing them to enter my protected facility?
8. For visitors and non-security cleared staffs, is there any entry requirements that they shall follow?
9. I have new staff who have recently been cleared by the regulatory vetting authority and staff who have resigned or are no longer working in the protected facility. How can I update MOH of these changes?
10. 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?

Working with Schedule 1 biological agents in an uncertified facility

1. 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?

Transportation

1. What are the requirements of a vehicle used in transportation of biological agents/toxins?
2. Does a driver involved in the transportation of biological agents and toxins need to be trained?
3. Can a researcher transport a biological agent in his/her own vehicle?
4. What should the driver do in the event of an emergency incident (e.g spillage or leakage) or transport accident?
5. Is there any requirement for the packaging of the biological agents/toxins prior to transportation?
6. What are the unacceptable modes of transportation for transporting a biological agent/toxin?

Transfer of biological agents and toxins between facilities within Singapore

1. 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?
2. 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?
3. What should I do if my consignment failed to arrive at the expected time?

Training requirements for staff working in a laboratory

1. 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?
2. 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?
3. What are the training requirements for staff working in a certified facility?
4. What are the training requirements for a biosafety coordinator working in an uncertified facility?
5. What are the training requirements for staff working in an uncertified facility?