The Biological Agents And Toxins Act Second Reading Speech

17 Oct 2005

By Dr Balaji Sadasivan, Senior Minister of State for Information, Communications and the Arts and Health

Venue: Parliament

Mr Speaker, Sir, I beg to move that the Bill be now read a second time.

Background

In 2001, shortly after the 9/11 attack there was an anthrax attack in the United States. As a result of the attack, thousands had to be treated for anthrax. Five people died as a result of the attack. Although, the source of the anthrax spores is not known, it is clear that they came from a sophisticated laboratory. The anthrax attack showed that there is a need to have a framework to control biological and toxic agents.

The public health dangers posed by infectious diseases like SARS, avian flu, and Nipah virus means that there will be more laboratories doing research with such biological agents. When there are lapses in safety, workers in the laboratory can get infected. This happened in laboratories working with the SARS virus in China, Taiwan and Singapore. All three outbreaks were the result of lapses in laboratory practices. This highlights the importance of biosafety in our laboratories.

High containment laboratories are designed for handling dangerous pathogens.  They are a vital part of the arsenal against emerging infectious diseases, where we could perform diagnosis and undertake research before, during and after an outbreak.  High containment laboratories are also needed to strengthen Singapore's position as the leading biomedical hub in the region.  What we cannot afford, are lapses in laboratory design and practices that could endanger the laboratory workers and public health. 

To this end, MOH has drawn up a comprehensive national biosafety framework to control the access to and usage of biological agents and toxins in high containment laboratories and to promote a safety culture in the industry.  A key component of this framework is the Biological Agent and Toxin Bill (BAT Bill).  The new Bill was drafted to regulate biological agents and toxins that are of public health concern, some of which could pose threats to biosecurity.  The requirements in the Bill are in line with what is practised in developed countries like the United States and the United Kingdom.

Provisions of the BAT Bill

Mr Speaker, Sir, I would now like to introduce the proposed BAT Bill.  In general, the first part of the proposed Bill deals with the requirements to be fulfilled before a biological agent can be imported or used; the second part of the proposed Bill outlines the duties and responsibilities of the operator of laboratories and those involved in the transportation of biological agents and toxins; while the third part of the Bill spells out the enforcement powers of the Director of Medical Services.

Control of biological agents and toxins

The biological agents and toxins are divided into five Schedules according to their risk to individual and public health.  The classification takes into consideration the ability to cause death and illness, the availability of preventive measures and medical treatment and the potential to be used as agents of bioterrorism.  The operator of the facility would need to obtain relevant permits and approvals from the Director before an agent can be imported or used. 

Mr. Speaker, Sir, although biosafety requirements may differ for different biological agents, there are a number of general provisions which apply across the board to all biological agents and toxins.  These include the prohibition of the use of any biological agent or toxin for non-peaceful purpose and the transportation of any biological agent or toxin by postal mail or public transportation. 

First, Second and Fifth Schedules

The biological agents listed in the First and Second Schedule and the toxins in the Fifth Schedule are subjected to more stringent regulatory requirements as they have greater potential to cause serious disease.  There are a total of ninety-three such biological agents and 5 such toxins.  Of these, thirty-seven biological agents and all the toxins are further identified to have specific bioterrorism risk. 

Facilities handling these biological agents need to be certified that they are able to meet the engineering and procedural controls to ensure safe-handling in the laboratories.  This certification will be carried out annually by external certifiers that are approved by MOH.  In addition, facilities handling toxins and biological agents with bioterrorism potential need to be gazetted as protected places under the Protected Areas and Protected Places Act. 

Third and Fourth Schedules

The Third Schedule of the Bill comprises biological agents that are normally of low public health risk but require special attention when they are produced on a large scale.  The Fourth Schedule covers the remaining infectious biological agents which are deemed to be of low public health concern as effective treatment and preventive measures are available. These biological agents are only subjected to importation control which is currently required under the Infectious Diseases Act.

Duties and responsibilities of the operator

Mr Speaker Sir, the second part of the Bill defines the duties and responsibilities of the operator of a facility handling higher-risk biological agents and toxins and in the large-scale production of biological agents.  The Bill requires the operator to appoint a biosafety committee and a biosafety coordinator.  The Bill stipulates that the operator need to obtain the advice of the biosafety committee with regards to safety measures that are required and to ensure that these measures are implemented by the biosafety coordinator before any activity is carried out at the facility.  The operator is also required to ensure that the facility is properly maintained, staff are properly trained, risk assessments are carried out, safety measures are in place, proper inventory is kept and biological and toxin wastes are decontaminated before removal from the facility.

Transport of Biological Agents and Toxins

The manner by which the more dangerous biological agents and toxins are transported within Singapore will also be regulated under this Bill.  Vehicles used need to be affixed with biohazard labels.  The Bill also requires drivers of these vehicles to be trained in the management of accidents involving biohazardous materials.  This is in line with current practices involving transportation of other high-risk substances such as toxic chemicals in Singapore.  Packaging and labeling of the biological agents and toxins for transport will also be prescribed.

Enforcement

The Bill empowers the Director of Medical Services to investigate any lapses or suspected lapses in biosafety and to take necessary measures to rectify the situation.  Where necessary, he can order the immediate cessation of any activities in the facility, destruction of the biological agents as well as the decontamination and closure of the facility.  This is to ensure that timely action can be taken to minimize any threat to public health.  In view of the possibility of serious outbreaks that could arise if one or more lab workers get infected, the Director is also empowered to subject any person who may have been exposed to the biological agent in the facility to medical examination, medical treatment and where necessary, quarantine.

Penalties

The penalties proposed in the Bill vary according to the severity of the offences.  It ranges from a fine not exceeding $5000 and/or imprisonment for a term not exceeding 6 months for lapses in fulfilling requirements for importation of a biological agent to a fine of $1 million and/or life imprisonment for deliberate offences related to the non-peaceful use of gazetted biological agents and toxins.

Exemptions

The provisions of the Bill will not apply in the clinical care setting where laboratory testing of samples, that may contain the Scheduled biological agents, is carried out for diagnostic purposes or when carrying out an autopsy to determine the cause of death.  The collection of environmental or food samples to determine the presence of biological agents or toxins, will also be exempted from the provisions of the Bill.   This is to ensure that diagnostic services and public health investigations can proceed as normal and not curtailed in any way. 

The use or possession of toxins in finished medicinal or cosmetic products, for example the use of botox by plastic surgeons and biohazard waste contractors who handle biological agents or toxins as part of the disposal process are also exempted from the requirements of the Bill.

Public Consultation

My Ministry has consulted widely with stakeholders in the drafting of the Bill.  We engaged key players in the biomedical industry and researchers in tertiary institutions in dialogue sessions.  They were briefed on the requirements of the proposed Bill and in-depth discussions were held on the possible impact the provisions may have on their businesses and operations.  The majority of the stakeholders agreed on the need for legislation to regulate the handling of biological agents and toxins.  They were also assured that the Ministry would continue to engage them to allow for smooth implementation of the provisions of the Bill. 

Conclusion

Mr. Speaker, Sir, the provisions outlined in the proposed Biological Agents and Toxins Bill will establish a comprehensive legal framework to regulate the import and handling of high-risk biological agents and toxins to ensure complete coverage from acquisition to eventual disposal.  It will enhance Singapore's international standing as a country with adequate infrastructure and systems in place to ensure the safety of workers in the biomedical industry.  The proposed Bill will address pertinent issues related to laboratory safety and the risk of laboratory-acquired infections; and the security of biological agents and toxins that have potential to be used as agents of terror. 

23 Sir, I beg to move.