April The Objectives Of The Proposed Act

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1 Public Consultation On Draft Biological Agents And Toxins Act The Objectives Of The Proposed Act... 1 Biological Agents And Toxins... 2 Application And Scope Of The Proposed Act... 2 Regulatory Regime Proposed... 3 Other Applicable Acts... 4 Anticipated In-Force Date... 4 Conclusion... 4 Table A: Biological Agents And Toxins Under Each Schedule... 5 Table B: Approvals And Permits Required... 6 The Ministry of Health ( MOH ) is considering legislation to regulate the possession, use, import, transfer and transportation of biological agents and toxins that are known to be hazardous to human health. On 11, it issued a draft Biological Agents and Toxins Act ( Act ) for public consultation. The proposed Act provides for safe practices and security in the handling of such agents and toxins. This Update provides a summary of the regime proposed under the Act. The Objectives Of The Proposed Act As a result of Singapore s aim to become a bio-medical hub, there has been an increase in the number of institutions working with high-risk biological agents and toxins in Singapore. Accordingly, the Government has felt it timely to introduce legislation dealing with biosecurity and biosafety processes relating to biological agents and toxins. These twin objectives are broadly considered below. Biosafety The need for greater biosafety was highlighted by the recent labacquired Severe Acute Respiratory Syndrome ( SARS ) infections in China, Taiwan and Singapore. Simply put, the objective of biosafety is to reduce or eliminate the exposure of laboratory workers or other persons and the outside environment to potentially hazardous agents involved in microbiological or biomedical facility research. Achieving biosafety requires the implementation of various degrees of laboratory containment, or safe methods of managing infectious materials in a laboratory setting. There are three elements to containment: laboratory practice and technique; safety equipment (primary barriers); and facility design and construction (secondary barriers). Of these, the most crucial element is a firm adherence to sound laboratory practices and techniques. Personnel working with infectious material must be aware of the hazardous nature of their work and properly trained in the procedures for safely handling such material. Examples of laboratory practices and techniques include controlling access during experiments, establishing a disposal policy for sharp objects, following decontamination procedures, and prohibiting food and drink within the laboratory. Safety equipment is utilised in conjunction with laboratory procedures and techniques to further ensure containment. Equipment such as biological safety cabinets, safety centrifuge cups, and personal protective covering are frequently employed to prevent exposure to and release of hazardous materials. Such primary barriers focus on the protection of the investigator and, by extension, the outside environment. Lastly, facility design and construction, or secondary barriers, supplement the containment provided by procedures and equipment. Facility containment provides a physical barrier to prevent infectious transmission within and outside the laboratory. Rajah & Tann, Knowledge & Risk Management Page 1

2 Secondary barriers range from simple hand washing facilities to specialised ventilation systems that ensure directional airflow. Biosecurity There has been an increased concern that certain biological agents and toxins may be used as weapons of terror and thus pose a threat to the security of Singapore and Singaporeans. The objective of biosecurity is to protect facilities against the theft or diversion of high-consequence microbial agents, which could be used by someone who maliciously intends to conduct bioterrorism or pursue biological weapons proliferation. A comprehensive system that deals with bioterrorism would usually include many of the following elements: physical protection; personnel reliability; adequate scientific and commercial programme oversight; pathogen accountability; and transportation security. Biological Agents And Toxins The Act defines a biological agent as: any micro-organism (including any bacterium, virus, fungus, rickettsia and parasite); any infectious substance (including any prion); and any component of a microorganism or an infectious substance (but not including any toxin), that is capable of causing death, disease or other biological malfunction in a human. Toxins are defined as any poisonous substance that is produced and extracted from any micro-organism. Biological agents and toxins are treated differently depending on their level of risk to the individual and the community, as well as the type of risk that they represent. The Act generally adopts the classification of biological agents used by the World Health Organisation ( WHO ) in its Laboratory Biosafety Manual which divides biological agents into four main groups: Risk Group 1: These are biological agents that pose no or low individual and community risk as they are unlikely to cause human or animal disease. Risk Group 2: These are biological agents that pose a moderate individual risk, but low community risk. Such pathogens can cause human or animal disease but are unlikely to be a serious hazard to laboratory works, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk or spread of infection is limited. Risk Group 3: These are biological agents that pose a high individual risk, but low community risk. Such pathogens usually cause serious human or animal disease but do not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. Risk Group 4: These are biological agents that pose high individual and community risk. Such pathogens usually cause serious human or animal disease and can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available. Based on these four main groupings, the Act further subdivides biological agents and toxins according to whether they have the ability to be used as weapons. Accordingly, biological agents and toxins are grouped under five schedules in the Act (please refer to Table A at the back). Application And Scope Of The Proposed Act Persons And Activities Affected The proposed Act will affect and be relevant to the following persons: companies and institutions (including educational institutions) involved in biomedical and life sciences research who work with the biological agents and toxins specified in the Schedules of the proposed Act; and courier service providers transporting such biological agents and toxins within and into Singapore. As noted above, the proposed Act will regulate not only the possession, use, import, transfer and transportation of biological agents and toxins, but also provide for safe practices and security in the handling of such agents and toxins. This regulatory regime is outlined under the section headed Regulatory Regime Proposed below. The proposed Act also makes it a criminal offence to use and possess any biological agent or toxin for biological warfare or any non-peaceful purpose. Exemptions It should be noted that certain activities have been exempted from the proposed Act. These are: the disposal of any biological agent by a hazardous waste contractor; Rajah & Tann, Knowledge & Risk Management Page 2

3 Rebecca Chew Partner Contact Details Direct: (65) Facsimile: (65) Please feel free also to contact the Knowledge & Risk Management Group at the handling of any biological agent in the course of carrying out a diagnosis or an autopsy; the collection of food samples or samples from the environment for the purpose of carrying out any laboratory analysis to determine or identify, for public health purposes, the nature of any biological agent that is present in such samples or in the environment from which such samples have been taken; or the use or possession by any of the following persons of any finished cosmetic or medicinal product consisting of any Fifth Schedule toxin (this would cover, for example, botox treatments): o any person lawfully manufacturing, supplying, selling or dispensing the finished cosmetic or medicinal product; o any registered medical practitioner using the finished cosmetic or medicinal product in the course of treating another person; or o any person using the finished cosmetic or medicinal product for the cosmetic or medical purposes for which it is intended. Regulatory Regime Proposed The proposed Act applies different levels of control to biological agents and toxins in accordance to their infectivity, transmissibility and potential of being turned in to weapons (ie, according to which Schedule they fall under). The measures required to be adopted in respect of each such biological agent and toxin cover all processes from acquisition, either through import or transfer, to eventual disposal. Approvals And Permits Required The Act essentially proposes that each step of the process of handling and using the various biological agents and toxins stipulated in its Schedules will require the grant of requisite approvals or permits from the Director of Medical Services. The approvals and permits required for the biological agents and toxins under each Schedule are set out in Table B. Duties And Obligations In Relation To Facilities In addition to the above, the proposed Act requires the operators of facilities that possess biological agents falling under the First or Second Schedules, or that produce biological agents falling under the Third Schedule, or that possess toxins falling under the Fifth Schedule to be responsible for the compliance of safety standards and security measures at their facilities. Accordingly, they must ensure, among others, the following: that staff are kept safe and are adequately trained; that visitors to the facility are kept safe and, where appropriate, must be accompanied by a staff member; that a risk assessment is carried out; that the facility and any equipment therein are maintained in safe working condition; that no biological and toxin waste is discharged into the environment; and that a biosafety committee is established and a biosafety coordinator is appointed. In relation to setting up adequate safety standards and practices, it should also be noted that on the Rajah & Tann, Knowledge & Risk Management Page 3

4 recommendation of the National Biosafety Council, MOH has adopted WHO s Laboratory Biosafety Manual, 3rd Edition as the national guidelines for biosafety to supplement the proposed Act. Clients who wish to obtain a copy of this manual may obtain a copy from the WHO website ( or the MOH website ( This manual provides practical guidance on biosafety techniques for use in laboratories at all levels. Other Applicable Acts It should be noted that notwithstanding the proposed Act, certain other laws will still continue to apply after its passing: The export of biological agents and toxins will not be governed by the proposed Act but will continue to be controlled by the Strategic Goods Control Act, which is administered by Singapore Customs. Where the biological agents covered by the Act may also cause diseases in animals, these zoonotic pathogens will be jointly controlled by the Agrifood and Veterinary Authority under the Animals and Birds Act and MOH under the proposed Act. Therefore persons importing, transhipping, working with or transferring such biological agents must comply with the separate requirements of both acts. Pure animal and plant pathogens will continue to be regulated solely by the Agrifood and Veterinary Authority. On the other hand, the current requirements for import permits under the Infectious Diseases Act will be superseded by the requirements in the proposed Act once it comes into force. Anticipated In-Force Date MOH has indicated that the Act is expected to be passed by Parliament by June Following from its enactment, it is anticipated that there will be a transitional period of six months for facilities working with any biological agents falling under Part I of the First Schedule. These facilities may continue working with these biological agents for a period of six months after the enactment of the Act even if they have not met the requirements as stipulated therein. It is important to note, however, that MOH has indicated that no transitional provisions will be provided for requirements pertaining to the other biological agents and toxins specified in the proposed Act. In anticipation of the coming enactment, MOH has therefore advised that all facilities dealing with such biological agents and toxins should ensure compliance to the proposed Act as soon as possible. Conclusion MOH is seeking views and feedback from the public and stakeholders on the proposed legislation. All feedback should reach MOH by 14 May 2005, and must be submitted from the feedback page on the MOH website ( ces/econsultation/index.do). The Firm will be happy to help with any feedback which you may wish to submit. Rajah & Tann is one of the largest law firms in Singapore, with a representative office in Shanghai. It is a full service firm and, given its alliances, is able to tap into resources in a number of countries. Rajah & Tann is firmly committed to the provision of high quality legal services. It places strong emphasis on promptness, accessibility and reliability in dealings with clients. At the same time, the firm strives towards a practical yet creative approach in dealing with business and commercial problems. The information contained in this Update is correct to the best of our knowledge and belief at the time of writing. The contents of the above are intended to provide a general guide to the subject matter and should not be treated as a substitute for specific professional advice for any particular course of action as the information above may not necessarily suit your specific business and operational requirements. It is to your advantage to seek legal advice for your specific situation. In this regard, you may call the lawyer you normally deal with in Rajah & Tann or the Knowledge & Risk Management Group at eoasis@rajahtann.com. Rajah & Tann, Knowledge & Risk Management Page 4

5 Table A: Biological Agents And Toxins Under Each Schedule Schedule General Description Examples Of Agent / Toxin Listed First Schedule, Part I First Schedule, Part II Second Schedule Third Schedule Fourth Schedule Fifth Schedule Biological agents falling under Risk Group 3 which can cause serious disease which is of high risk to the individual. Biological agents falling under Risk Group 3 which can cause serious disease which is of high risk to the individual and which also have the potential to be used as weapons. Biological agents falling under Risk Group 4 which can cause severe / lethal disease, be transmitted easily and are of high risk to individual and community. They also have the potential to be used as weapons for the purpose of causing severe diseases within the community. Biological agents falling under Risk Group 2 that need special attention in large scale production. Biological agents falling under Risk Group 2 that cause disease in humans. The biological agents in the Third Schedule will also fall under the Fourth Schedule. Microbial toxins that have the potential to be turned into weapons. Mycobacterium tuberculosis (bacteria that cause tuberculosis) Hantaviruses West Nile virus Agents associated with the transmission of Spongiform Encephalitis. Bacillus anthracis (bacteria that cause anthrax) Yersinia pestis (bacteria that cause the black plague) Rickettsia (various types of bacteria that cause typhus, spotted fever, trench fever, and Q fever) SARS coronavirus (virus that causes SARS) Marburg virus Nipah virus Ebola virus Variola major virus (virus that causes smallpox) Legionella (bacteria that cause Legionnaires disease and Pontiac fever) Hepatitis B virus The Fourth Schedule of the Act covers any biological agent which is likely to cause human disease (with the exception of those already mentioned in the First and Second Schedules). Accordingly, due to the large number of such biological agents, they are not listed in the proposed Act. Verotoxins Botulinum toxins Rajah & Tann, Knowledge & Risk Management Page 5

6 Table B: Approvals And Permits Required First Schedule, Part I Approval to possess Approval to produce (for large-scale production) Import permit Transhipment permit Restrictions applicable to transfer / transport within Singapore Approval to possess is required for every first-time use of a biological agent specified in Part I of the First Schedule of the Act. The approval is agentspecific, and there is no expiry date for the approval. However the validity of the approval is tied to the facility being appropriately certified. An approval to produce is necessary for a facility engaged in large-scale production of a biological agent in Part I of the First Schedule. 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 culture of the biological agent at any one time. For work involving such biological agents, an approval to possess must first be obtained before the approval to produce. This is because the facility would need to have met the requirements to possess the biological agent before MOH will consider granting the approval to engage in largescale production. All biological agents require import permits. The approval to possess must first have been issued before an import permit will be granted. Biological agents falling under Part I of the First Schedule that are to be transhipped (ie, brought into Singapore solely for the purpose of taking them out) require a transhipment permit. Both the transferor and transferee must have a valid approval to possess the relevant biological agent being transported before effecting a transfer. The transferor must therefore ensure that the transferee possesses a valid approval to possess before he proceeds to transfer the biological agent to the recipient facility. No public transportation or transport via mail is allowed. A driver who is involved in the transportation of biological agents falling under Part I of the First Schedule must be trained and possess a valid Hazardous Materials Transportation Driver Permit (HTDP) (Biologicals). Vehicles used in transportation must be labelled with a biohazard warning panel or label. Biological agents being transported must be properly packaged and labelled according to International Air Transport Association standards. Rajah & Tann, Knowledge & Risk Management Page 6

7 Certification of facility Facilities wishing to handle biological agents under Part I of the First Schedule of the Act must undergo external certification by an MOH-approved certifier. For new facilities, certification of the facility will be carried out after the commissioning of the facility. Thereafter, the facility needs to be re-certified yearly or upon any design or structural change made to the facility. The certification is based on an expanded checklist derived from the WHO Laboratory Biosafety Manual, 3rd edition checklist. In addition to items specified by WHO, the checklist also includes items recommended by the National Biosafety Committee as well as legislative requirements specified by the proposed Act. First Schedule, Part II Approval to possess Approval to produce (for large-scale production) Import permit Transhipment permit Restrictions applicable to transfer / transport within Singapore Approval to possess is required for every first-time use of a biological agent specified in Part II of the First Schedule of the Act. The approval is agentspecific, and there is no expiry date for the approval. However the validity of the approval is tied to the facility being appropriately certified. An approval to produce is necessary for a facility engaged in large-scale production of a biological agent in Part II of the First Schedule. 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 culture of the biological agent at any one time. For work involving biological agents under Part II of the First Schedule, an approval to possess must first be obtained before the approval to produce. This is because the facility would need to have met the requirements to possess the biological agent before MOH will consider granting the approval to engage in large-scale production. All biological agents require import permits. The approval to possess must first have been issued before an import permit will be granted. Biological agents falling under Part II of the First Schedule that are to be transhipped (ie, brought into Singapore solely for the purpose of taking them out) require a transhipment permit. Both the transferor and transferee must have a valid approval to possess the relevant biological agent being transported before effecting a transfer. The transferor must therefore ensure that the transferee possesses a valid approval to possess before he proceeds to transfer the biological agent to the recipient facility. Rajah & Tann, Knowledge & Risk Management Page 7

8 In addition, the transferor must notify MOH of the proposed transfer. It must also notify the transferee of an estimated time of receipt of the agent and provide the carrier of the agent with a 24-hour emergency number of a person who has knowledge of the hazards and characteristics of the agent being transported. No public transportation or transport via mail is allowed. A driver who is involved in the transportation of biological agents falling under Part II of the First Schedule must be trained and possess a valid Hazardous Materials Transportation Driver Permit (HTDP) (Biologicals). Vehicles used in transportation must be labelled with a biohazard warning panel or label. Biological agents being transported must be properly packaged and labelled according to International Air Transport Association standards. Notification of failure of receipt of transfer or import Certification of facility The Act requires a transferee to notify MOH of any failure of receipt of a Part II, First Schedule biological agent being transferred / imported within 24 hours of the time which he reasonably estimated he would receive the biological agent. Facilities wishing to handle biological agents under Part II of the First Schedule of the Act must undergo external certification by an MOH-approved certifier. For new facilities, certification of the facility will be carried out after the commissioning of the facility. Thereafter, the facility needs to be recertified yearly or upon any design or structural change made to the facility. The certification is based on an expanded checklist derived from the WHO Laboratory Biosafety Manual, 3rd edition checklist. In addition to items specified by WHO, the checklist also includes items recommended by the National Biosafety Committee as well as legislative requirements specified by the proposed Act. In addition, facilities that deal with biological agents falling under Part II of the First Schedule are deemed to have bioterrorism potential. Accordingly, they must also be gazetted as a Protected Place under the Protected Areas and Protected Places Act. Rajah & Tann, Knowledge & Risk Management Page 8

9 Second Schedule Special approval to handle Approval to possess Import permit Biological agents falling under the Second Schedule require a special approval to handle. Such an approval will only be granted if: the use of the biological agent is necessary in the public interest; and the person who requires the biological agent has put in place adequate measures to contain the risks to public health and security posed by the agent. It should be noted that no large-scale production of biological agents falling under the Second Schedule of the Act is allowed. Approval to possess is required for every first-time use of a biological agent specified in the Second Schedule of the Act. The approval is agent-specific, and there is no expiry date for the approval. However the validity of the approval is tied to the facility being appropriately certified. All biological agents require import permits. The approval to possess must first have been issued before an import permit will be granted. Transhipment permit Biological agents falling under the Second Schedule that are to be transhipped (ie, brought into Singapore solely for the purpose of taking them out) require a transhipment permit. Restrictions applicable to transfer / transport within Singapore Both the transferor and transferee must have a valid approval to possess the relevant biological agent being transported before effecting a transfer. The transferor must therefore ensure that the transferee possesses a valid approval to possess before he proceeds to transfer the biological agent to the recipient facility. In addition, the transferor must notify MOH of the proposed transfer. It must also notify the transferee of an estimated time of receipt of the agent and provide the carrier of the agent with a 24-hour emergency number of a person who has knowledge of the hazards and characteristics of the agent being transported. No public transportation or transport via mail is allowed. A driver who is involved in the transportation of biological agents falling under the Second Schedule must be trained and possess a valid Hazardous Materials Transportation Driver Permit (HTDP) (Biologicals). Vehicles used in transportation must be labelled with a biohazard warning panel or label. Biological agents being transported must be properly packaged and labelled according to International Air Transport Association standards. Rajah & Tann, Knowledge & Risk Management Page 9

10 Notification of failure of receipt of transfer or import Certification of facility The Act requires a recipient to notify MOH of any failure of receipt of a Second Schedule biological agent being transferred / imported within 24 hours of the time which he reasonably estimated he would receive the biological agent. Facilities wishing to handle biological agents under the Second Schedule of the Act must undergo external certification by an MOH-approved certifier. For new facilities, certification of the facility will be carried out after the commissioning of the facility. Thereafter, the facility needs to be re-certified yearly or upon any design or structural change made to the facility. The certification is based on an expanded checklist derived from the WHO Laboratory Biosafety Manual, 3rd edition checklist. In addition to items specified by WHO, the checklist also includes items recommended by the National Biosafety Council as well as legislative requirements specified by the proposed Act. In addition, facilities that deal with biological agents falling under the Second Schedule are deemed to have bioterrorism potential. Accordingly, they must also be gazetted as a Protected Place under the Protected Areas and Protected Places Act. Third Schedule Approval to produce (for large-scale production) Import permit Restrictions applicable to transfer / transport within Singapore An approval to produce is necessary for a facility engaged in large-scale production of a biological agent in the Third Schedule. 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 culture of the biological agent at any one time. All biological agents require import permits. No public transportation or transport via mail is allowed. If biological agents falling under the Third Schedule are being transported in quantities of 10 litres or more, the following requirements apply: the driver who is involved in the transportation must be trained and possess a valid Hazardous Materials Transportation Driver Permit (HTDP) (Biologicals); the vehicle used in transportation must be labelled with a biohazard warning panel or label; and the biological agents being transported must be properly packaged and labelled according to International Air Transport Association standards. Rajah & Tann, Knowledge & Risk Management Page 10

11 Fourth Schedule Import permit Restrictions applicable to transfer / transport within Singapore All biological agents require import permits. As noted above, the Act does not list biological agents falling under the Fourth Schedule due to the large number of such biological agents. However, MOH maintains a list of such biological agents that are also under MOH s import control. It should be noted that this list is not exhaustive and importers seeking to import any biological agent that is likely to cause human disease are advised by MOH to write in for approval. No public transportation or transport via mail is allowed. Fifth Schedule Approval to possess Import permit Transhipment permit Restrictions applicable to transfer / transport within Singapore Approval to possess is required for every first-time use of a toxin specified in the Fifth Schedule of the Act. The approval is toxin-specific, and there is no expiry date for the approval. However the validity of the approval is tied to the facility being appropriately certified. All toxins require import permits. The approval to possess must first have been issued before an import permit will be granted. Toxins falling under the Fifth Schedule that are to be transhipped (ie, brought into Singapore solely for the purpose of taking them out) require a transhipment permit. Both the transferor and transferee must have a valid approval to possess the relevant toxin being transported before effecting a transfer. The transferor must therefore ensure that the transferee possesses a valid approval to possess before he proceeds to transfer the toxin to the recipient facility. In addition, the transferor must notify MOH of the proposed transfer. It must also notify the transferee of an estimated time of receipt of the agent and provide the carrier of the agent with a 24-hour emergency number of a person who has knowledge of the hazards and characteristics of the toxin being transported. No public transportation or transport via mail is allowed. A driver who is involved in the transportation of toxins falling under the Fifth Schedule must be trained and possess a valid Hazardous Materials Transportation Driver Permit (HTDP) (Biologicals). Rajah & Tann, Knowledge & Risk Management Page 11

12 Vehicles used in transportation must be labelled with a biohazard warning panel or label. Toxins being transported must be properly packaged and labelled according to International Air Transport Association standards. Notification of failure of receipt of transfer or import Certification of facility The Act requires a recipient to notify MOH of any failure of receipt of a toxin being imported / transferred within 24 hours of the time which he reasonably estimated he would receive the toxin. Note that while facilities that deal with toxins do not need certification under the proposed Act, they are deemed to have bioterrorism potential, and accordingly, must be gazetted as a Protected Place under the Protected Areas and Protected Places Act. Rajah & Tann, Knowledge & Risk Management Page 12