BIOLOGICAL AGENTS AND TOXINS BILL

BIOLOGICAL AGENTS AND TOXINS BILL: Order for Second Reading read.

The Senior Minister of State for Health (Dr Balaji Sadasivan): Mr Deputy 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

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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 mean 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 can 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 Agents and Toxins 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

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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.

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 Schedules 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 93 such biological agents and five such toxins. Of these, 37 biological agents and all the

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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

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 regard 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

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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 labelling 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 minimise any threat to public health. In view of the possibility of serious outbreaks that could arise if one or more laboratory 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.

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It ranges from a fine not exceeding $5,000 and/or imprisonment for a term not exceeding six 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, is also exempted from the requirements of the Bill.

Public consultation

My Ministry has consulted widely with the 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

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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.

Sir, I beg to move.

Question proposed.

4.33 pm

Mdm Halimah Yacob: Mr Deputy Speaker, Sir, thank you for allowing me to speak on this Bill.

The Biological Agents and Toxins Bill is an important piece of legislation. It represents one critical part of the armoury that we need to put in place under our national security framework. The key focus of this legislation is to enhance Singapore's biosafety and biosecurity. It aims to put in place measures to guard against the deliberate release of biological agents and toxins for malicious purposes or, as stated under clause 5 of the Bill, for non-peaceful purposes.

Clause 2 defines what is meant by non-peaceful purposes, by listing seven

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situations. This includes using biological agents and toxins to cause death or endanger any person's life, create a serious risk to the health or the safety of the public or release into the environment, distribute or expose the public to any biological agents or toxins in order to cause damage or harm to the environment. So, the possession, use and development of biological agents or toxins for legitimate purposes, such as research work, are not prohibited. This Bill is our effort at prevention, by trying to reduce the risk of an attack and ensure higher standards in the handling of such materials.

If biological agents and toxins fall into the wrong hands, the destruction and dangers posed will be indescribable. At the Fourth Review Conference of the Biological Weapons Convention held in Geneva, one expert described how dangerous biological weapons could be. He said:

"Biological weapons are immensely destructive. In the right environment, they can multiply, and so self-perpetuate. And they can naturally mutate, frustrating protective measures. Chemical weapons, for all their horrors, become less lethal as they are dispersed and diluted. But even the tiniest quantities of disease organisms can be lethal. For example, the botulinum toxin has been described as three times more potent than the chemical nerve agent Sarin."

Bioterrorism, Sir, is not a hypothetical threat. It became a harsh reality soon after September 11, when letters containing a refined preparation of dried anthrax spores were sent to the US mail, infecting more than 20 people and killing five. Although the damage in that attack was limited, it gave us a glimpse of the mayhem that could result from the use of biological weapons. So, I would like to applaud the Ministry of Health for proposing this Bill. This is indeed a far-sighted and strategically important move

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to protect our people. It will enhance the security environment for our people.

Sir, as I was running through this Bill, I found a research paper published by Jonathan B Tucker from the US Institute of Peace very useful. Mr Tucker was also the biological weapons inspector in Iraq in February 1995. He suggested that good biosecurity standards should include the following elements:

(1) Mechanisms to account for pathogens that are being stored, used during experiments or transferred or exported;

(2) The regulation and licensing of facilities that work with dangerous pathogens;

(3) Physical security at these locations; and

(4) Procedures for screening laboratory personnel.

I notice that most of the provisions of the Biological Agents and Toxins Bill are focused around these four elements. There are, however, a number of clarifications, Sir, that I wish to seek.

Firstly, I note that the Bill requires every operator of a facility to appoint a biosafety committee comprising specified persons. The biosafety committee has the responsibility to formulate measures, policies, programmes and codes of practice for the operator of the facility to comply with. Members of the biosafety committee are also subject to penalties, if they give advice in a reckless, grossly negligent manner or in bad faith. Depending on the size, resources and capabilities of the facility operator, we can expect biosafety committees to have different capacities to formulate measures on biosafety in the facility.

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This being the case, I wonder whether it will be more prudent for the Ministry of Health to come out with some standard guidelines which can be used by the biosafety committees and the facilities, subject to modifications to suit their own needs. The guidelines could be used as the reference point for all biosafety committees. I believe that, in this manner, there will be some consistency as well as some minimum standards for all facilities, as otherwise standards could fluctuate significantly from facility to facility. As these will be minimum standards, all facilities can be expected to reach for higher standards to protect their own interest. I believe that these guidelines will be useful, especially for smaller facilities, as the current Bill will cover all places, big or small, where biological agents or toxins are stored, used or developed, including both public and private laboratories.

Secondly, Sir, I wish to ask the Minister whether complying with this Bill will result in a significant cost increase for research bodies, hospitals, as well as laboratories operating these facilities. There will obviously be more paperwork now, as well as costs, in introducing the other measures required under this Act. Will insurance costs, for instance, shoot up for facility operators who would want to insure their risks, which have increased? The real issue, I suppose, is to ensure that the standards imposed reflect the balance between costs and risks. There is no doubt that biosafety and biosecurity are very important subjects, and we should have stringent measures in place. Nevertheless, increase in costs is one of the complaints that had been cited overseas when such measures were introduced.

The real concern here is whether the increase in costs will result in disincentives for companies or individuals wanting to do research on dangerous pathogens. If this happens, it will not be a positive development as, in today's

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context, we certainly need to have more and not less research conducted on this subject. Hence, I would also like to urge the Ministry and the Senior Minister of State not to make it too expensive to register facilities as well as other licensing requirements under the Act.

Thirdly, Sir, this Bill alone is not sufficient to prepare Singaporeans for the dangers posed to them, if there is a biological weapons attack. In addition to this legislation, we should also include an effective medical and public health response programme as part of our overall strategy to deal with the possibility of such an attack. I would like to ask the Senior Minister of State whether we already have such a programme in place, and whether we are also taking steps to educate Singaporeans on the dangers posed by a biological weapons attack, as my sense is that Singaporeans are generally more aware of the dangers posed by bombings and are not so sure on how to protect themselves against a biological weapons attack.

Fourthly, Sir, clause 6(3) provides that there could be uncertified facilities operating without the restrictions and conditions stipulated under the Act. The Senior Minister of State had cited a few examples, but could he also please clarify what other types of facilities can remain uncertified and therefore operate outside the ambit of this Act? What is the purpose of excluding them? What safeguards will be introduced with regard to the use and/or storage of biological agents and weapons in these places? Will these non-certified facilities be gazetted, so that there is transparency and people know that these are facilities which are not certified?

Finally, Sir, I would like to ask the Senior Minister of State whether there are any plans to work with other countries in the region, particularly those that have

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not adopted any standards or the equivalent of this Bill. We may be very vigilant and supervise closely the facilities dealing with biological agents and toxins within our own borders. But if nothing is done to get other countries in the region to adopt the same standards, that could also weaken and undermine our efforts to keep Singapore safe. If other countries in the region have lax standards so that it is easy for biological agents and toxins to fall into the wrong hands and end up being used for non-peaceful purposes, these will undermine our efforts to protect ourselves. So, it is useful if there could be some collaboration in the region on this issue. I would appreciate the Senior Minister of State's comments on this.

On this note, Sir, I support the Bill.

Dr Lily Neo: Mr Deputy Speaker, Sir, I stand to speak in support of the Biological Agents and Toxins Bill.

This Bill is important and timely, in view of prevailing circumstances and developments. Yes, the prevailing situation where there is an ever-increasing number of laboratories, 100 or so presently, in Singapore; the opening of more high-safety laboratories dealing with biohazard materials; the emergence of infectious diseases, such as SARS, and, of course, the threats in our fight against bioterrorism.

Sir, establishment of laws on biosafety and biosecurity is not new and had been adopted by other developed countries, such as the United States and Britain. This Bill seeks to regulate the safe handling of biological agents and toxins, and to ensure that laboratories are responsible for safety standards and security measures, and to make sure all their staff is adequately trained to prevent mishaps. The safeguarding of the community from accident taking place is especially critical in a densely-populated small country like Singapore. Having well-

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recognised biosecurity and biosafety standards in place would also boost the confidence of international scientists seeking to do research in Singapore.

May I ask the Senior Minister of State whether his Ministry has enough expertise and trained personnel to audit the 100 or so laboratories here in order to certify these laboratories when the Bill is enacted and when annual certification is required after that? How long will his Ministry take to certify all the laboratories? Are recruited safety-officers trained professionally to carry out their duties, and will they be well-protected with all the protection, such as vaccinations?

Sir, while molecular biology and genetic engineering are medical excellence when applied to fight diseases and advance mankind's needs, they can, in the wrong hands, be a real bane when misused to create bioweapons. Bioterrorism must always be a concern for one and all, and we should emphasise prudence and deterrence in all our approach when dealing with it. While it is our intention to support research and not to encumber it with rules and regulations, we must be able to identify and disrupt criminals and terrorists to safeguard our well-being.

May I ask the Senior Minister of State whether there should be more precautionary measures being taken on bioterrorism and national security? For instance, will there be judicious screening of certain foreign nationals for research work in sensitive areas? Should medical researchers working with potentially hazardous agents be registered? This Bill does not provide for this.

Should there also be consideration of a system in place to include the life sciences community in our national security threat? How does the Senior Minister of State ensure that laboratory biosecurity threats such as

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misuse, diversion and unauthorised production of pathogens and toxins are always on the radar screens of surveillance and intelligence networks?

Clause 8(4) of this Bill stipulates that the permit for import or transhipment of First Schedule biological agent shall be limited to one consignment. May I ask the Senior Minister of State whether the term 'one consignment' can be rather vague and should not that quantity be specified? If the importer or transhipper wishes to have more in quantity, they ought to apply to the Director for the permit.

Clause 39(7) of this Bill states that the biosafety committees are to review their measures, policies, programmes and codes of practice every two years. Is a two-year time frame not too long as pace of progress may be so fast that such implemented measures, policies, programmes and codes of practice might quickly become outdated? A review ought to be carried out every year and it is up to the biosafety committee to decide whether to continue to adopt such measures, policies, programmes and codes of practice or to change them. Sir, the best way to protect against the effects of harmful incidents is to be prepared.

This Bill does not provide for contingency plans and emergency procedures to the hazard of agents and toxins being handled by laboratories during disasters. There should be a written contingency plan and a protocol for containment, management and reporting of accidents. May I also ask the Senior Minister of State whether our hospitals are equipped to treat infected individuals or those contaminated with hazardous agents in the event of laboratory mishaps? Should there be a designated higher risk hospital ward set aside to contain infectious diseases in order to prevent the spread to the community? And should there be special

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medical personnel trained to cope with specific laboratory infectious agents in case of such an eventuality? So I hope the Senior Minister of State will enlighten this House on the issues raised.

4.50 pm

Dr Chong Weng Chiew (Tanjong Pagar): Mr Deputy Speaker, Sir, I rise in support of the Bill. The enactment of the Biological Agents and Toxins Bill is timely for two reasons. Firstly, the legislation is in line with our goal to be a regional biomedical hub. To gain ground more quickly in this sector we need to increase our collaboration with the international scientific community. In order to attract world class researchers and organisations, we have to establish a good regulatory framework, supportive Government policies and the necessary infrastructure. The new laws will boost their confidence in our research environment, the quality of the work done here and help ensure the safety of their staff.

Secondly, we face the threats of bioterrorism, however remote the possibility. These measures will help to minimise and secure access to agents with bioterrorism potential. The bomb attacks in Bali a couple of weeks ago are chilling reminders of the danger terrorism poses. Terrorism will continue to be a grave problem in the near future.

Terrorists will use any means at their disposal to wreak damage and chaos. Thus, we must guard against this vigilantly. Our laws have to strike a balance keeping research safe and being too restrictive. Our legislation should not be so onerous that we discourage vital research work from being conducted here. However, we must be mindful that as we develop into a biomedical hub, more laboratories will be working with biological agents that could pose public health risk.

The necessity of legislation took on urgency after an incident here in 2003

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when a staff was infected after he was exposed to the SARS virus in his laboratory. Soon after, there were two other similar reports of laboratory-acquired SARS in our region. These incidents highlighted the potential of laboratories becoming sources of outbreaks. As a result, most would agree with the need to regulate the safe handling of biological agents and toxins through legislation. This Bill follows the league of developed nations such as the United States and Britain which have established laws on biosafety and biosecurity. I am convinced, after reading the Bill, that we will have adequate measures to establish a high standard of biosafety in Singapore. These will minimise the probability of accidents like those I have mentioned earlier on.

The regulations are thorough covering the possession, import, transportation and the disposal of biological agents and toxins. They will ensure that the operators of facilities handling high risk agents put in place adequate measures and policies to maintain biosafety. It is also very reassuring to know that the Ministry will conduct regular audits to make sure that the laws are followed and safety standards being met. I am also pleased to note that a good degree of flexibility has been included in the legislation to address the issue of balance between safety and freedom of research. Measures to increase safety should not obstruct other essential operating systems within the laboratory. Neither should they hinder the researcher's ability to perform experiments in a timely manner. The agents have been categorised into five Schedules according to the ability to cause death and illness, the availability of preventive measures and treatment and their potential for bioterrorism. These criteria determine the degree of regulation. With this categorisation, we will be able to strike a better balance between allowing more latitude in the handling of low risk agents and greater restrictions for the more dangerous organisms.

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Now that we have addressed the issue of biosafety, I would like to ask the Minister if we could do more to enhance biosecurity in Singapore. The objective of biosafety measures is to prevent the accidental release of dangerous agents and toxins, and, on the other hand, the aim of biosecurity measures is to prevent deliberate theft or diversion of purposes of biological terrorism or warfare. This Bill addresses both issues. However, I would like to request that the Government consider putting in place more substantial biosecurity measures in view of our rapid developments in the field of biomedical research. The reason is simple - there are national as well as international security issues involved here. For it is biosecurity or rather the inadequacy of which is what that worries me. Although the possibility of bio-terrorism occurring in Singapore at this point in time seems remote, a single incident could definitely be potentially devastating. We are an international travel and transit hub. Every year, we have 8.3 million foreign visitors, 80 of the world's airlines converge here through 3,900 scheduled weekly flights to more than 180 cities in 56 countries. More than 5 million air passengers stop over here.

Our reputation for safety in all aspects from health to low crime rates is an important asset which must be defended vigorously. We need substantial biosecurity guidelines for the physical protection, control and accounting of dangerous organisms. Security resources are, as we all know limited. However, in view of the lethal potential of certain agents, we need to deploy the best resources available from security technology to armed escorts to ensure that certain agents do not fall into the wrong hands. Insiders, those with approved access, would be the most difficult to guard against. They would be familiar with the protocols and security procedures, they could be motivated by

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any number of reasons such as financial temptations or threats. I would like to ask the Minister whether we have a detailed and standardised personnel screening programme in place at all facilities to determine the integrity of the individuals seeking approval for handling higher risk agents or regular access to the facilities containing these agents. Do we have a human reliability programme which conducts regular background investigations? Do we have in place a framework to assess, protect and investigate the claims of maybe whistle blowers? Such policies and procedures should be uniform across similar facilities depending on the types of agents they deal with. They should not be left to the discretion of various management committees of the facilities.

Thus, in conclusion, to ensure high standards of biosafety and biosecurity we must establish uniform standards for the physical protection, control, accounting, and transportation security of listed agents and toxins together with personnel vetting procedures to ensure the reliability of scientists and workers granted access to these agents. This is regardless of whether the personnel are working for private or Government facilities. Equally high standard should be expected of the auditors as a flawed audit in the case of deadly pathogens would be a matter of life and death unlike failed audits in the world of businesses and commerce or charities for that matter.

With this, I support the Bill.

Dr Balaji Sadasivan: Mr Deputy Speaker, Sir, I would first like to thank Mdm Halimah Yacob, Dr Lily Neo and Dr Chong Weng Chiew for their support of the Biological Agents and Toxins Bill. Sir, while the Biological Agents and Toxins Bill enhances biosecurity in Singapore, it also regulates activities that are important to ensure safe practices in the handling of highly infectious agents and toxins. My Ministry, on the recommendation of the

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National BioSafety Committee, which comprises members from key Ministries and agencies and members of the life sciences community, has adopted the latest WHO guidelines for laboratory biosafety and biosecurity. This set of international guidelines is not only comprehensive in addressing all aspects of biosafety and biosecurity but allows for flexibility to accommodate contemporary technologies and ever-changing approaches to achieving safety in the laboratory. This approach would ensure that there is a good balance between safety, security and cost.

Mdm Halimah wondered if the Ministry should come up with standardised guidelines for all laboratories. We have not done this because the laboratories can be quite different and we need to individualise the biosafety and biosecurity controls. To begin with, most of the agents listed in the First Schedule, Second Schedule, and Third Schedule as well as the toxic agents in the Fifth Schedule are agents that are not present in Singapore and we do not have the capabilities of dealing with them. Suppose a laboratory were to ask for permission to do research with the SARS virus. Before the permit is given, the laboratory will have to ensure that the people that it has are not just ordinary experts in microbiology or in viruses, but staff who have the proven capability of doing research with the SARS virus. These staff will form the biosafety committee and they would then draw up all the protocols that are required for dealing with that specific agent and only when it is satisfactory will the Ministry of Health give them a permit. And to ensure that these protocols are satisfactory, we will have external auditors audit the protocols, and the external auditors that we will call to audit the protocols must be experts in that area.

Since these are very specialised areas, it is not possible for the Ministry of Health

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to draw standard guidelines and have these guidelines apply for all laboratories. A less dangerous agent like the dengue virus may require a different set of rules.

For example, with the dengue virus, we would not have the same public health danger of a community outbreak of dengue because of release of the virus. But with SARS, if one of the workers got infected with the SARS virus, you could have a risk of a community outbreak of SARS. So the protocols that are required for a laboratory that is going to deal with the SARS virus will have to be quite different from the protocol for a laboratory that is dealing with the dengue virus, and the protocol for the SARS virus will have to have detailed procedures on what to do if there was a lapse in biosafety. Hence, the importance and the need for biosafety committees.

The Sixth Schedule stipulates that there has to be a biosafety co-ordinator who is trained to implement the necessary measures at the facility so as to ensure biosafety and biosecurity. In addition, the committee must consist of a person having expertise in microbiology and knowledge in the physical and biological sciences and laboratory practices, thus are relevant to the agent that has been dealt with in that laboratory. The committee must also include senior management and a person responsible for maintenance of the laboratory. The committee has its own interest at stake as its members and fellow workers will be at risk if biosafety is compromised. The committee will be responsible to conduct risk assessment and draw up policies, programmes and codes of practices necessary for the safe handling of the biological agents and toxins. These would be reviewed at least once every two years, or earlier, if deemed necessary by the committee. Through external audit, the committee will be able to improve the biosafety culture in the laboratory and the standards in the laboratory.

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Cost and paper work was Mdm Halimah's second concern. Since the biosafety committee will customise its measures to fit the laboratory, the paper work in administrative cost should be kept to what is considered necessary. My Ministry is mindful that unnecessary administrative cost should not be imposed. I am pleased to announce that the Ministry will not levy any administrative charges for the application of approvals and permits for the import and use of biological agents and toxins. Operators must ensure safe practices within the facility to protect laboratory workers as well as the environment. The cost of managing a biosafety breach leading to an outbreak of disease among laboratory workers, or in the community, is much higher than the cost of having good biosafety culture. So research companies with laboratories and insurance companies that are involved in this area insuring the facility will welcome needed biosafety measures.

I would now like to address Mdm Halimah's, Dr Chong's and Dr Neo's concerns over biosafety. In view of the potential dangers involving the use of certain biological agents and toxins for bioterrorism, the Bill has accorded more stringent requirements for facilities handling biological agents and toxins that have bioterrorism potential. For instance, in addition to the requirement for the facility working on such agents to be certified, the facility has to be gazetted as a protected place under the Protected Areas and Protected Places Act, which means it will be working with the Ministry of Home Affairs very closely with regard to security concerns. To be a protected place, the facility must fulfil a set of security requirements which will limit access to the facility and all persons working at the facility would need to undergo security clearance. Access to the biological agents and toxins will also be

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controlled and monitored through records and inventories. To ensure that there is no unauthorised production of biological agents, the facilities' inventories would be checked against their import permits and transferred notifications during the annual recertification exercise.

The Act also empowers my Ministry to enter, inspect and search any facility if there is a reason to suspect that there is a contravention of the Act. If such contravention has occurred, my Ministry can order the cessation of activities, closure of the facility, destruction of the biological agent or toxin concerned and the decontamination of the facility. As an additional measure to ensure public health, persons exposed to the biological agent or toxin can be quarantined.

Mdm Halimah asked why certain laboratories were excluded from certification. These are diagnostic laboratories. In a hospital, a person may come in with a chest infection and one may be testing the sputum for a variety of diseases, and one of the diseases could very well be anthrax, very rarely you may get a positive result. But such a laboratory would not be a laboratory doing research in anthrax, neither would such a diagnostic laboratory pose any public health hazard. So that is the reason why these diagnostic laboratories in a clinical setting where they test for viruses, other biological agents or toxins in samples taken from patients, are excluded from the certification process. Theoretically, if they get a positive result, there is, within that laboratory, a minute amount of the biological agent. But, in terms of risk, there is no major risk.

We would like to assure Mdm Halimah that my Ministry has worked with other Ministries and relevant agencies to formulate a comprehensive plan to respond to both natural disease outbreak as well as bioterrorism attacks. As stated yesterday by my Minister, in reply to Dr

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Geh Min and Mdm Halimah's queries on MOH preparedness to cater for global and regional epidemics, including avian influenza, we have formulated various outbreak scenarios, including biosecurity breaches and biosafety breaches in laboratories, and have planned specific response strategies. Following SARS, we have significantly strengthened our capabilities and capacity to cope with outbreaks. We now have a more effective surveillance system and a response system in place.

In response to Dr Neo's query on the ability of hospitals to cope with mishaps involving hazardous agents, I am happy to say that the hospitals are already equipped to handle cases requiring decontamination and isolation following exposure to such agents. Isolation rooms are also available in all hospitals to cater for this.

In answer to Mdm Halimah's query on whether there are plans for Singapore to work with the region in biosafety and biosecurity measures, I am pleased to inform her that the process has already started. In April this year, my Ministry, through the Regional Emerging Disease Intervention (REDI) Centre, organised a two-day conference to launch the latest edition of WHO's Laboratory Biosafety Guidelines as well as to discuss concerns relating to biosecurity of infectious pathogens in the laboratory environment. Representatives from a total of nine countries from the Asia Pacific region attended the conference. There was a general consensus that laboratory biosafety and biosecurity are important issues, and each country would have to find the best way to address these issues. Through REDI and through the courses that WHO is running at REDI, we hope that the biosafety culture will spread in the laboratories in this region.

Dr Neo had a specific question on whether the quantity of the agent should

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be specified. One reason why the permits do not specify the quantity of the agent is that because these agents will be grown in the research laboratory, the quantity will vary. So even if a small amount of the biological agent is taken to the research laboratory, they can then grow a lot of it. Instead, the permit is given for the importation of the biological agent and toxin on a consignment basis. So each time, there is a quantity of the agent going to the laboratory, we want to know about it and we want to have records of it. The quantity, even if it is small, can be cultured in the final laboratory and therefore the quantity can be much, much greater than what was actually imported. So that is why the permit is on a consignment basis which is more important than the actual quantity.

Sir, the biosecurity and biosafety culture strengthening process in our institutions is an ongoing process and we have been working on it quite diligently over the last three years even since the anthrax attack. With this Bill, another major step will be taken. But this is just a step in the process. We have to continue to strengthen our biosafety culture and the environment in all our laboratories.

Dr Lily Neo: Mr Deputy Speaker, may I seek another clarification because I am still concerned about the consignment in specifying the amount? Researchers do not normally require big amounts because when big amounts are being transported from another place, we have to be wary what are they intended for. Are they being used by terrorists or for other purposes?

Dr Balaji Sadasivan: Sir, the agents are classified according to the Schedules. In terms of virus, no one carries large quantities of virus, because it is not carried by containers, etc. A small amount in a test tube will have enough virus to cause all the problems that you can think

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of. So that is why we do not use measurable quantities that you expect like, say, one litre or two litres. But for each consignment imported, we need to know about it, and if you have a laboratory that can culture the virus, from one virus, you can get a billion viruses. So trying to control by quantifying the number of viruses that a laboratory can import is not a feasible method of control. That is why it is managed by consignment. However, in the Third Schedule, the agents are generally quite safe. But if large quantities are kept, then they can pose a danger. There is a limit to the quantity that they can have, which is ten litres.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. - [Dr Balaji Sadasivan].

Bill considered in Committee; reported without amendment; read a Third time and passed.