Press Releases
Public Consultation On The Proposed Biological Agents And Toxins Act
1 June 2005
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11 Apr 2005
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. The legislation will provide for the safe practises and security in the handling of such agents and toxins.
The Ministry is seeking views and feedback from the public and stakeholders on the draft Biological Agents and Toxins Bill below. A copy of the draft bill has been sent to 89 institutions with laboratory facilities and courier service providers to seek their feedback. All feedback should be provided on the e-consultation page at the Ministry's website. All feedback should reach the Ministry by 14th May 2005.
THE NEED FOR LEGISLATION
There has been an increase in the number of institutions working with high-risk biological agents and toxins in Singapore. This can be attributed to worldwide recurrent outbreaks of infectious diseases in recent years and Singapore's aim to become a biomedical hub.
The lab-acquired Severe Acute Respiratory Syndrome (SARS) infections in China, Taiwan and Singapore have also underscored the risk of disease transmission to laboratory workers as a result of imperfect biosafety. Such occurrences pose a danger of transmission of the infection to the community. Hence, it is necessary that operators of high-containment laboratories put in place the management structure, engineering control as well as work procedures and practises to protect the laboratory workers, the general public and the environment from exposure to high-risk biological agents and toxins.
Furthermore, certain biological agents and toxins may be used as weapons of terror and thus pose a threat to the security of Singapore and Singaporeans. Consequently, there is a need for a regulatory framework to provide for proper security of such agents and prevent possible misuse.
OUR REGULATORY APPROACH
The proposed Biological Agents and Toxins Act adopts a comprehensive approach to the regulation of high-risk biological agents and toxins to ensure complete coverage from acquisition, either through import or transfer, to eventual disposal. Different levels of controls are applied to biological agents and toxins in accordance to their infectivity, transmissibility and potential of being weaponised.
The proposed legislation will require the operators of facilities to be responsible for the compliance of safety standards and security measures at their facilities. The key provisions of the draft biosafety bill are shown in the table below:
Table caption
Key provisions | Brief description |
|---|---|
Facility Control | An operator of a facility handling certain high-risk biological agents and toxins shall be responsible for the safety of his staff and visitors to the facility. He is to ensure that risk assessment is carried out and staffs are adequately trained. He is also responsible to ensure the facility and any equipment therein are in safe working condition, and that no biological and toxin waste is discharged into the environment. An operator must establish a biosafety committee and appoint a biosafety coordinator. Such facilities will need to undergo certification by MOH-approved independent assessor. A facility handling agents with potential to be weaponised will also need to be gazetted as a 'protected place' to ensure proper security measures are in place. |
Agent Control | Approvals for possession and import and notifications of transfer are required for high-risk biological agents and toxins to enable effective inventory control and tracking. |
Transport control | Transportation of agents only if properly packaged and labelled according to International Air Transport Association (IATA) standards. Drivers are required to be licensed under the Hazardous Materials Transportation Driver Permit (HTDP) scheme awarded by the Singapore Civil Defence (SCDF) and vehicles need to be prominently labelled. |
The draft Bill has taken into considerations the recommendations of the National Biosafety Committee and its Technical Working Committees, which are represented by key industry players in both the government and private sectors. This included the adoption of the Laboratory Biosafety Manual (Third Edition) by the World Health Organisation (WHO) below as the biosafety standards for Singapore.
OVERSEAS TRENDS
Developed countries such as the USA and United Kingdom (UK) have already established separate legislations on biosafety and biosecurity. These legislations generally provide for proper security of such agents and prevent possible misuse. Details can be found at Annex A below.
ANNEX A
Biosafety & Biosecurity Legislations Overseas
United States
In the US, the importation of infectious biological agents is under the purview of the Centre for Disease Control (CDC).
In response to potential bioterrorism threats in the US, the Anti-terrorism and Effective Death Penalty Act was enacted in 1996 to set up rules governing a comprehensive list of select infectious agents ("Select Agents Programme"), which specified transfer controls and agent disposal requirements.
Both the CDC and National Institutes of Health (NIH) have their own guidelines for laboratory biosafety, although they are not specified in the legislations.
Subsequently the Public Health Security and Bioterrorism Preparedness Act (2002) revised the list of Select Agents and expands control over the Select Agents by stipulating additional requirements for facility registration and subjecting these facilities to biosafety and biosecurity controls (e.g. access control, security screening).
The US Patriot Act (2001) further criminalises possession of any biological agents or toxins (not limited to the Select Agents) for non-peaceful means. Subsidiary federal regulations also govern the transportation of the Select Agents.
United Kingdom
In the UK, the Control of Substances Hazardous to Health Regulations (1999) and relevant EU regulations govern workplace biosafety, while the Antiterrorism, Crime and Security Act (2001) imposes requirements on individuals to inform the government of the possession and use of select biological agents in the Act's schedules, and gives the State broad investigatory powers for incidents involving such agents.